Practicing Precaution and Adaptive Management: Legal, Institutional and Procedural Dimensions of...

PRACTICING PRECAUTION and ADAPTIVE MANAGEMENT: LEGAL, INSTITUTIONAL AND PROCEDURAL DIMENSIONS

OF SCIENTIFIC UNCERTAINTY

FINAL REPORT

Submitted to

SSHRC & LAW COMMISSION OF CANADA June 2005

Prepared by

Institute of the Environment University of Ottawa

Jamie Benidickson Nathalie Chalifour & Yves Prévost

Jennifer Chandler André Dabrowski

C. Scott Findlay & Annik Déziel Heather McLeod-Kilmurray

Dan Lane

Authors i

AUTHORS

Jamie Benidickson Faculty of Law

University of Ottawa [email protected]

613-562-5800 ext. 3287

Nathalie Chalifour Assistant Professor of Law

Faculty of Law University of Ottawa [email protected]

613-562-5800 ext. 3331

&

Yves Prévost Law Student

Faculty of Law University of Ottawa

[email protected]

Jennifer A. Chandler Assistant Professor of Law

Faculty of Law University of Ottawa [email protected] 562-5800 ext. 3286

André Dabrowski Full Professor

Department of Mathematics and Statistics University of Ottawa

[email protected] 613-562-5800 ext. 3511

C. Scott Findlay Director


[email protected] 613-562-5874

&

Annik Déziel

Research Assistant Institute of the Environment

University of Ottawa [email protected]

613-562-5895

Heather McLeod-Kilmurray Assitant Professor of Law



Dan Lane Full Professor

School of Management University of Ottawa

[email protected] 613-562-5800 ext.

Acknowledgements ii

ACKNOWLEDGEMENTS

Practicing Precaution and Adaptive Management: Legal, Institutional and Procedural Dimensions of Scientific Uncertainty This report on Practicing Precaution and Adaptive Management is the result of a collaborative research effort involving University of Ottawa faculty members from law, mathematics, biology and management. Professor Jennifer Chandler, (Law) prepared the GMO case study. Dr. Scott Findlay, Director of the Institute of the Environment, and collaborator Annik Déziel prepared the Pesticide study. Dr. Dan Lane, of the School of Management, contributed the Fisheries study. Professor Nathalie Chalifour, (Law) in collaboration with Yves Prévost, a student at the Law Faculty, prepared the case study on invasive species. Dr. André Dabrowski, (Mathematics and Statistics) produced the statistical analysis and commentary. Professors Jamie Benidickson and Heather McLeod-Kilmurray (Law) wrote the introductory and concluding sections of the report.

As the designated principal investigator for the project I would like to thank each of my fellow researchers for their enthusiastic contributions to group discussions and to the particular aspects of the study for which they assumed responsibility. Our interaction in a multi-disciplinary undertaking produced valuable benefits at the level of understanding and communication; virtually every page of the report reflects insights that one or other of us acquired or refined as a result of exchanges amongst members of the team. This is much as one would hope for and expect in the context of a project carried out with the assistance and support of the Institute of the Environment.

As a research group, we would also like to extend our collective thanks to the Law Commission and the SSHRC for financial contribution to the project and to record our appreciation for other forms of guidance and assistance. A number of extremely qualified observers accepted our invitation to attend a workshop in March of this year where draft versions of our case studies and a preliminary analysis of statistical findings were presented. The generous contributions of those who attended the workshop are gratefully acknowledged. Suzanne Monette of the Institute of the Environment provided valuable administrative support and assistance and Shahbaz Maqbool, also of the Institute of the Environment, developed and provided technical assistance for the online Document Questionnaire database. We are grateful as well to George Haas for logistical support from time to time in arranging meetings and reminding us of the timetable and impending deadlines.

Several student research assistants who were helpful to the project should also be acknowledged: Neera Sivarajah, Elene Berube. Melanie Mallet provided research assistance and as rapporteur for the March Workshop produced a summary of observations which is reproduced in an appendix. Jamie Benidickson

Table of Contents iii

TABLE OF CONTENTS Authors………………………………………………………………………………… i Acknowledgements……………………………………………………………………. ii Table of Contents……………………………………………………………………… iii A- Executive Summary……….……………………………………………………….. A-1 B- Introduction: Uncertainty, Precaution and Adaptive Management in Administrative Decision-making ………………………………………………….. B-1 C- Research Methodology……………………………………………………………... C-1 D- Case Studies………………………………………………………………………… D-1

1) L’évaluation du risqué, le principe de précaution ou de prudence et la gestion adaptive: Une étude des cas de l’Agence canadienne de l’inspection des ailments et son approche pour gérer les risques d’introduction d’espèces envahissantes par voie des matériaux d’emballage en bois non traité.

Nathalie J. Chalifour et Yves Prévost………………………………………….. D-3

2) The regulation of genetically modified plants: Authorization of unconfined environmental release.

Jennifer A. Chandler……………………………………………………………. D-35

3) Potentially practicing precaution: Canadian pesticide regulation and the Pest Regulation Management Agency.

C. Scott Findlay and Annik Déziel…………………………………………….. D-61

4) Setting total allowable catches (TACs) in the 4X5Y cod and haddock fisheries.

Dan E. Lane……………………………………………………………………. D-85

E- Commentary and Analysis of Research Questionnaires - André Dabrowski…........ E-1 F- Conclusions and Summary………………………………………………………… F-1

G-Appendices………………………………………………………………………… G-1

i. Document Questionnaire……………………………………………………… G-3 ii. Institutional Questionnaire…………………………………………………… G-11 iii. Workshop Summary………………………………………………………… G-25 iv. Workshop Participants………………………………………………………. G-29

Executive Summary A-1

A- EXECUTIVE SUMMARY INTRODUCTION With reference to four case studies of decision-making in the face of scientific uncertainty, this report considers the potential impact of the precautionary principle and the principle of adaptive management on the traditional administrative law values of Fairness, Legitimacy and Effectiveness. Otherwise expressed, we set out to examine (i) how the emerging principles of precaution and adaptive management are understood and applied in a number of concrete settings (ii) how their introduction might affect the operation of traditional administrative law values; and, (iii) how the new principles may be most appropriately accommodated within the general framework of administrative law values. The concept of Fairness revolves around opportunities for effective participation on the part of those who are interested in or affected by decisions. Legitimacy refers to the general acceptability of decision-making institutions, processes and outcomes to society. Effectiveness relates to the quality and validity of substantive outcomes, that is, the ability of the decision-maker to accomplish its assigned task. The administrative law values of Fairness, Legitimacy and Effectiveness have traditionally been realized through a series of quite variable institutional practices, instruments, or devices. For the purposes of this study we highlight a series of such measures:

Personnel selection and qualifications Administrative procedures Mechanisms of participation Opportunities for review Mechanisms of accountability

The specific application of these five features of decision-making arrangements will vary from one decision-making setting to another. However, in any given administrative or regulatory process, each has the potential to contribute something towards Fairness, Legitimacy and Effectiveness. Precaution and adaptive management have been advanced in response to a recognition that scientific uncertainty and thus limited understanding are often significant features of the administrative decision-making context. While this may be generally true, it is particularly so in relation to health and environmental matters where as a society we are continuously engaged in assessing the opportunities presented to us by scientific and technological innovations in relation to the risks these same interventions may entail. The notion of uncertainty is central to the concept of risk: if one can predict with complete certainty the consequences of a given decision, there is no risk, irrespective of the magnitude of the effect. In fact it is possible to proceed beyond the general framework of risk, uncertainty and, on occasion, ignorance to inquire into the basis of our limited understanding. Attempts to isolate factors contributing to scientific uncertainty as it affects the spectrum of legal decision-making, including environmental, have identified six kinds of descriptive uncertainty: (1) conceptual, (2) measurement, (3) sampling, (4) modeling, (5) causal, and (6) epistemic.


To assist in dealing with an increasing appreciation of uncertainty and the potential for unanticipated adverse impacts several principles have been advanced. Notable amongst these are the precautionary principle and the principle of adaptive management. The precautionary principle, although existing in several formulations around the world, asserts generally that when scientific uncertainty is high, and the potential for substantial negative (but possibly unexpected) effects exists, administrative decision-making should err on the side of caution. The principle which may be acquiring a general normative status has also been legislatively introduced in Canada in several settings. Adaptive management also has important implications for administrative decision-making in light of its premises. First, adaptive management acknowledges that scientific understanding of any system, an ecosystem, for example, will always be incomplete. Secondly, it is assumed that as scientific knowledge of the system in question improves, so too will the accuracy and reliability of decision-makers’ ability to predict outcomes. And, third, given the preceding, decisions about the management of resources and the environment should be considered – and used – as an opportunity to gain enhanced understanding of the system involved. The broad operational implications of adaptive management are consistent with these premises. Specifically, management interventions should be regarded as essentially experimental: hypotheses or expectations should be expressed; controls should be in place and opportunities for replication should be contemplated. Moreover, results should be assessed in a timely and efficacious manner and the knowledge thereby derived should be used to inform subsequent decision-making. Recognizing the trend towards greater adoption of precaution and adaptive management in a range of decision-making settings, we are interested in the implications of increasing acceptance of precaution and adaptive management for administrative and regulatory decision-making processes and institutions. That is, how are they actually applied? What practical measures are involved in putting them into practice? What are the legal, institutional and procedural implications of possible measures to implement precaution and adaptive management in administrative and regulatory decision-making, including, in particular, the potential significance of these concepts for Fairness, Legitimacy and Effectiveness? METHODOLGY To provide a foundation for exploring these questions, this research project examines four case studies with reference to a set of assessment dimensions (expertise, participation, procedure, review, and accountability) that correspond to the institutional practices previously noted as being primary contributors to the administrative law values of fairness, legitimacy and effectiveness. Each of the case studies involves determinations about health or environmental risk, and, accordingly, each examines the notion of scientific uncertainty in relation to those risks and the role played by precaution and adaptive management in responding to them.

For the purpose of establishing a data base, a questionnaire was developed and revised on an ongoing basis, and ultimately completed by case study researchers who consulted with each other in the interests of increasing the consistency of interpretation of the questions answered. The findings were subsequently examined and analyzed. The methodological and statistical sections of the report set out in greater detail the particularities and the limitations of the procedure followed.


This study must be considered as an exploratory or pilot study. The limited sample size, in course modifications to questions and response scales, missing and recoded data issues, and confounding of inter-rater differences with inter-case differences make the assignment of statistical significance untenable. A future study must address these issues by adjusting the questions to include the possibility of non-response, include a larger number of cases to permit using statistical methods, and have any single rating group evaluate several cases each. To assess inter-rater variation, some cases must be evaluated by multiple rating groups.

The questionnaire process and its analysis was accompanied in each case by a narrative or descriptive account of the decision-making experiences under review. The four case studies are summarized below. CASE STUDIES CFIA Invasive Species Nathalie J. Chalifour & Yves Prévost The objective of the Canadian Food Inspection Agency (CFIA) invasive species study was to evaluate CFIA’s application of scientific uncertainty, precaution, and adaptive management in the context of controlling for the introduction of invasive species through importations. In order to create a manageable case study, the evaluation was limited to an examination of the decision-making process of CFIA’s Plant Products Directorate, Plant Health Division relating to two invasive species - the Asian Longhorn Beetle (Anoplophora glabripennis) and Emerald Ash Borer (Agrilus planipennis). While many documents were reviewed in the process of undertaking the case study, the study concentrated on the following pieces of legislation, regulation and policy: the CFIA Act, the Plant Protection Act and corresponding regulations, the International Wood Packaging Standard (ISPM no. 15), two Plant Protection Policy Directives relating to the two insects (known as “D-memos”) and Pest Risk Assessments for the two inspect species in question. The case study demonstrates clearly that the Agency has embraced the notion of precaution in implementing a system designed to reduce the risks of accidental importations of these two invasive species. The two risk assessments attempt to balance uncertainty and risk and take a reasonably precautionary approach in reducing the risk of accidental importations. The extent to which the Agency applies an adaptive management approach is less apparent, although elements of adaptive management are present in the Agency’s approach (such as addressing elevated risks from particular countries when circumstances warrant). A couple of observations about this case study merit consideration. First, while the Agency’s application of a precautionary approach is essential for safeguarding Canadian ecosystems, the approach appears to be largely rooted in the government’s desire to safeguard economic interests. The Asian Longhorned Beetle, for instance, poses major risks to the maple products, tourism and hardwood lumber industries, and the risk assessment highlights these as the predominant concerns. The Emerald Ash Borer also poses a threat to hardwoods, and the risk assessment identifies the risk of adverse effects to shade trees and ornamentals in urban areas as a major concern. Second, the fact that the case study was drafted in French facilitated observations relating to the language of precaution in the relevant legislation. The case study notes that there are several synonyms used in both the English and French languages to refer to notions of


precaution, including precaution (“précaution” in French), prudence (“prudence” in French) and prevention (“prévention” in French). While the English legislation uses the word “precaution” almost exclusively, the French legislation shows greater use of the word “prudence”. While the difference may initially appear insignificant, the dictionary definitions of these terms are distinct and such differences could lead to inconsistent interpretations of the terms by tribunals. Overall, this case study presents a good example of a Canadian government agency applying a precautionary approach to a problem that presents a grave ecological and economic risk. It is interesting to contrast it to cases where the risks posed are more ecological than economic in nature. The Regulation of Genetically Modified Plants: Authorization of Unconfined Environmental Release Jennifer A. Chandler This case study considers the application of the precautionary principle and the adoption of an adaptive management approach in the context of the regulation of genetically modified plants in Canada. The regulatory decisions of interest are those taken by the Plant Biosafety Office (Canadian Food Inspection Agency) to approve the unconfined release of novel plants into the Canadian environment. The assessment of these decisions is based on publicly available documents only. Since the publicly available decision documents contain nearly no detailed information regarding individual safety assessments, it is difficult to be certain about the application of the precautionary principle or the adaptive management approach by this regulator. One can, however, observe and comment upon the problem of inadequate transparency in the regulation of genetically modified plants in Canada. The regulatory scheme is fairly precautionary on paper. It places the burden on the applicant to provide test data and other information to show that the risks posed by the novel plant are minimal when compared to plants of the same species already present in the environment. Nevertheless, this burden may be incomplete in that it may fail to address the possibility of unanticipated types of risk or of unexpected long-term effects. It is not clear from the public record whether the requirement that applicants supply a “general post-release monitoring plan to monitor for unintended or unexpected environmental effects” is being applied or enforced effectively. The standard of proof demanded of the applicant is described in government documents as high, although it is once again not possible, on the basis of the public record, to verify independently the quality and quantity of data submitted by applicants. There are no public refusals of authorization, and it would appear that applicants are thus generally able to produce the quality and quantity of data required by the regulator. One wonders, however, whether increasing pressure will be placed on the regulator to accept less “conclusive” test data as more complex genetic modifications are introduced and it becomes increasingly difficult to show that there is no more than minimal risk present. The legislation states that plants posing “unacceptable risk to the environment” are to be refused authorization for unconfined release, while those posing “minimal risk to the environment” are to be approved. Unfortunately, it is not clear what these risk-tolerance levels mean in practice. A detailed discussion of the costs and benefits of novel plants is not included in decision documents.


The regulatory scheme does not explicitly adopt an adaptive management approach, although it does incorporate some elements of such an approach. In particular, it contemplates some degree of ongoing monitoring for unexpected impacts, requires that new information be provided to the regulator, and permits earlier approvals to be modified or revoked in light of the new information. However, it is unclear from the public record whether the post-release monitoring plans required of applicants are effective in design or enforcement. There is a clear problem with the transparency of the regulatory decision-making process for genetically modified plants. The lack of transparency is a key theme in the regulation of biotechnology, as noted inter alia in the Royal Society of Canada Report on the regulation of food biotechnology in Canada. The Government response to the Royal Society Report noted the importance of transparency and indicated that it would consider means of increasing public and expert consultation, including potential legislative revision to permit greater disclosure while respecting the legitimate concerns about the confidentiality of proprietary information. The CFIA’s recently announced “Notices of Submission” project is an improvement, but will neither permit meaningful public participation nor greatly increase public confidence. The Pest Management Regulatory Authority C. Scott Findlay & Annik Déziel Pesticide registration and re-evaluation in Canada are the responsibility of the Pesticide Management Regulatory Agency (PMRA), with legislative authority derived from the Pest Control Products Act (PCPA) and associated Regulations. The Act governs pesticide importation, manufacture, sale and use and provides the authority for risk-based decision-making and risk management; the new PCPA received royal assent on Dec. 12, 2002, but is not yet in force. Given this legislative context, our objective was to assess how, in practice, uncertainty is treated in the current pesticide registration process, with particular emphasis on the extent to which the precautionary principle and the principle of adaptive management are currently implemented. To this end, we examined all documents published on the PMRA website (as of Feb 1, 2005) including regulatory decisions, proposed decisions, policies and policy directives, PMRA plans and reports, and registration guidance documents. Historically, precaution in PMRA registration and re-evaluation decisions took primarily two forms: (1) the reversal of the onus of proof; and (2) in risk assessment, precautionary safety factors (of various magnitudes) for estimating reference doses in classical toxicological assessments. More recently, additional precautionary elements have been introduced by moving from single to aggregate-exposure assessments, and to multiple exposure assessments for compounds of (putatively) similar modes of action. Under the new PCPA, PMRA will have a statutory obligation to use the precautionary principle in re-evaluations and special reviews. At present, it is unclear to everyone – including PMRA – how this obligation will affect decisions in general, and the risk assessment process in particular. What is clear, however, is that operationalizing precaution in pesticide regulation requires that PMRA bring forward operational prescriptions as to (a) what constitutes both necessary and sufficient evidence that a product poses a “serious risk” to human health or the environment; (b) how the degree of precaution is determined in registration and (particularly) re-evaluation decisions; (c) how weight of scientific evidence and scientific uncertainty are assessed during the review process. Active adaptive management involves treating management decisions as bona fide experiments. As such, the minimal requirements for truly adaptive decision-making by PMRA


are that: (1) registration and re-evaluation decisions must be accompanied by an explicit and unambiguous statement of what are considered unacceptable effects arising from pesticide use; (2) there must be systematic monitoring of effects of product use, where and when they are applied, and such monitoring must be designed in such a way as to maximize the detection of unacceptable effects; (3) there must be regular reviews of previous decisions; (4) there must exist the statutory authority to revoke or amend previous decisions on re-evaluation; and (5) there must be a systematic procedure for incorporating information from past decisions into current evaluations. Our research indicates that while currently, conditions (3) and (4) are met, conditions (1) and (2) are not. Pesticide regulation in Canada will not, therefore, be truly adaptive until regulatory decisions are formally treated as scientific hypotheses through the specification of both acceptable and unacceptable effects; a systematic post-registration effects and exposure monitoring system is developed, including an appropriate electronic registry and database; and a clear, well-defined protocol is implemented whereby new scientific and regulatory information is systematically assimilated, assessed, and integrated directly into the decision process in a timely fashion. Setting TACs in the 4X5Y cod and haddock fisheries. Dan E. Lane This case study explores the practice of setting Total Allowable Catches (TACs) in Atlantic Canada and examines how precaution is practised in setting TACs for the groundfish stocks of cod and haddock in the management area of southwest Nova Scotia and the Bay of Fundy (NAFO Divisions 4X and 5Y) in 2002 and 2003. The historical procedures of TAC-setting are presented including the changes that took place in recent years in reaction to the collapse of the Northern cod stock in 1992. In 1993, a more transparent process for recommending advice on TACs to the Minister of Fisheries and Oceans was inaugurated. This new process established an intermediary consultative group known as the Fisheries Resources Conservation Council (FRCC). The FRCC was a partnership between government, the scientific community, and the stakeholders in the fishery. Its mission was to review stock assessments contained in annual science-based Stock Status Reports (SSRs) together with other relevant information, and to recommend to the Minister TACs and other conservation measures, including some idea of the level of risk and uncertainty associated with these recommendations. The 2002 and 2003 TAC process - Cod experienced a small increase in estimated biomass since 1999 however, the year-over-year increases were small and fishing mortality estimates remained high despite restrictive quotas since the mid-1990s. In contrast, the estimates from the haddock stock were highly optimistic-the haddock stock was estimated to be growing since 1990 and estimates exceeded the stock thresholds. The “retrospective analysis” examined the fit of the Virtual Population Analysis (VPA) model to the data, and the “risk analysis” incorporated data variability with the impact on the range of TAC values under expected exploitation rates. In 2002 and 2003, both cod and haddock exhibited a “retrospective pattern” whereby biomass estimates tended to be over-estimates in the most recent year. The risk analyses for haddock in the 2002 and 2003 exhibited steep curves indicating robust estimates. Risk analyses were not provided for cod, in either 2002 or 2003. In 2002, the Minister of Fisheries and Oceans decided that the ‘status quo’ would be applied to the cod and haddock TACs compatible with the FRCC recommendations. In 2003, the Minister adopted the FRCC recommendations for haddock and


increased the TAC. However, for cod, the Minister allocated a status quo harvest for 2003 in spite of the concerns of the FRCC. The TAC decision for the two stocks demonstrates that precaution and adaptive management are present as quantitative measures as well as qualitative descriptions. However, evidence from the cod and haddock TAC decisions in 2002 and 2003 suggest that the process for applying precaution and adaptive management are not fully consistent and therefore not easily comparable. The decision to maintain the haddock TAC in 2002 despite the stock’s growth is qualitatively precautionary. However, if these same qualitative interpretations were applied to cod, then more precautionary decisions could have been taken to reduce the cod TAC in 2003. It is understood that precaution with respect to other dimensions of the decision (e.g., socioeconomic or administrative) may take precedence over resource sustainability. However, it is required that formal analyses for these other dimensions be specified. Other recommendations include: standardizing the minimal scientific content for stock estimation; involving stakeholders in the collection of data and in the development of estimates to improve their ownership in the process; providing a unified fisheries system analysis that would link all stocks of the mixed fishery in a joint stock status analysis; extending authority to fisheries stakeholders for strategic TAC decisions and reducing the ultimate authority of the DFO Minister for these stock-by-stock annual decisions. COMMENTARY AND CONCLUDING OBSERVATIONS In considering policy conclusions, the limited number of case studies and the tentative nature of the statistical analysis must be acknowledged. Nonetheless, it is clear from this inquiry that precaution and adaptive management are principles whose application is intimately connected with values. The most frequently recurring theme in the literature on precaution, in analyses of administrative goals and structures, and in the case studies, is that both administrative law and the principles of precaution and adaptive management do have, and must have, underlying values or priorities which support their implementation. These values not only determine goals, but also appropriate means for achieving them. The case studies and Workshop also indicated that the values which drive the interpretation and application of precautionary and adaptive management may vary from one government department to another. For example, the GM Plants study found that, “since …adverse outcomes are to be delayed rather than avoided altogether, it seems that a decision has been taken that they are to be tolerated.” This is also evident in the Forest Pests study, where the authors observe how much easier it is to encourage precaution when seeking to protect the economy rather than the environment. The studies also suggest variability in the manner in which precaution and adaptive management are implemented and applied. There is variation in the definitions and interpretations of the principles, as well as in the kinds of risks, and the kinds of uncertainty about these risks, that decision makers face. This means that, although the appropriate mechanisms for implementing precaution and adaptive management must meet the requirements of administrative fairness, the mechanisms for doing so will vary between institutions, and according to the nature of the risk and of the uncertainty involved. The lack of uniformity, as demonstrated in several of the case studies, points towards the importance of increased specificity in granting, exercising and assessing precautionary and adaptive exercises of power. This specificity is necessary if judges in the context of judicial


review are ultimately going to feel comfortable in determining whether precaution has been appropriately applied. In many cases, the challenge of dealing with ambiguity has been dealt with by being specific about several aspects of risk based decisions: what kind of risk, what kind of uncertainty, what kinds of decisions, what kinds of follow-up measures to monitor what kinds of remaining uncertainties? The more specific we are about these elements, the more confident we will be about the thoroughness and reasonableness of the decision made, even if scientific uncertainty remains. Tools such as legislated criteria to be met in terms of the threshold for triggering precaution and adaptive management, and criteria for the burden and standard of proof increase the specificity and thus reduce the unpredictability involved in precaution and adaptive management. Adaptive management raises most distinctly the divergence between administration and science with regard to their visions of finality. Adaptive management calls for decisions made in the context of uncertainty to be taken as hypotheses, to be tested and reevaluated as additional information becomes available. By contrast, administrative decision-makers and reviewing courts have as one of their primary goals the final resolution of disputes. Fundamental legal principles such as the rule of precedent, res judicata, and functus all indicate that, at least in the traditional view to date, administrative tribunals and courts, as mechanisms of conflict resolution, must be certain and final. If administrative and judicial decisions – apart from measures specifically designated as interim - become temporary or tentative, the argument is that this will reduce the certainty, predictability and hence legitimacy of the legal system. It is possible, however, for decision-makers to approach this problem by explicitly stating that the relevant context is one of uncertainty, and therefore it is reasonable to issue a decision that is limited by time, or by particular criteria. The reasons could explain that in this arena, administrative decisions are necessarily contingent on the state of existing scientific knowledge and normative issues as to what society considers “acceptable” risk. Therefore, a time-limited or conditional decision is being made precisely out of respect for the need to be efficient, fair and legitimate: the parties need some finality immediately, but long-term finality is unreasonable in a context of risk. Therefore, while on the surface the approaches to finality in science and law seem anathema to one and other, once the underlying rationale for seeking finality is uncovered and applied to the uncertainty context, these approaches may become less difficult to reconcile. The report concludes with some suggestions for future related initiatives, including additional research. Examination of a broader pool of decisions and a wider range of decision-makers currently engaged in implementing precaution and adapative management would substantially strengthen the data base. In particular, interview opportunities which were not pursued in the context of this report would enrich understanding of the operational challenges of implementing precaution and adaptive management. It would also be worthwhile to revisit or re-enact clusters of past decisions to generate concrete examples of how more precautionary or adaptive decision-making processes might be conducted. The suggestion is also strongly made that training programmes for decision-makers are important to ensure a high level of understanding of such concepts as risk and uncertainty alongside precaution and adaptive management, (amongst other emerging guiding principles).

Introduction B-1

B – INTRODUCTION: UNCERTAINTY, PRECAUTION AND ADAPTIVE MANAGEMENT IN ADMINISTRATIVE DECISION MAKING

Our societal commitment to safeguarding the broad public interest in environment and public health must often be pursued in the particularized confines of administrative and regulatory decision-making bodies. In Canada, such institutions have been legislatively charged with a wide range of specialized responsibilities concerning new drugs, or toxic substances, or natural resources, for example. The types of decisions to be made also vary. Some are understood to be legislative, regulatory or policy-making in nature, sometimes involving standard-setting. Other decisions are highly individualized permit, license, and approval decisions governing substance approvals or uses, or access to and use of natural resources. Each type of decision also proceeds in stages.1 The complexity of the subject matter involved in each of these and other similar settings renders comparisons difficult, but administrative and regulatory decision-making institutions are customarily evaluated in accordance with broad general principles or norms. It is even possible for such norms to have constitutional status in the form of Charter requirements that “the principles of fundamental justice” be observed where governmental action entails possible interference with “life, liberty and security of the person.” Should such interests be implicated in governmental decision-making, the applicable principles of fundamental justice may involve both substantive and procedural elements.2 As expressed by the Supreme Court of Canada, principles of fundamental justice represent, “principles which have been recognized by the common law, the international conventions, and by the very fact of entrenchment in the Charter, as essential elements of a system for the administration of justice which is founded upon the belief in the dignity and worth of the human person and the rule of law. Consequently, the principles of fundamental justice are to be found in the basic tenets and principles, not only of our judicial process, but also of the other components of our legal system…”3 The broad potential scope of fundamental justice suggests that any attempt to inventory specific elements comprehensively will be problematic. We do not attempt to do so here, but instead turn to a set of traditional principles used to assess administrative performance, notably Fairness, Legitimacy and Effectiveness, all relevant whether or not constitutional considerations arise. The concept of Fairness revolves around opportunities for effective participation on the part of those who are interested in or affected by decisions or recognized as having standing or entitlement to participate in the proceedings of the decision-maker. Legitimacy refers to the general acceptability of decision-making institutions, processes and outcomes to society more broadly. Effectiveness relates to the quality and validity of substantive outcomes, that is, the ability of the decision-maker to accomplish its assigned task, whether this entails resolving disputes, promoting safety, guiding economic and resource development, and so on. It is important to emphasize that there are often two aspects of the administrative law system that are sometimes not distinguished clearly. The first is the enabling aspect, in which administrative institutions are created to safeguard and promote public interests. In this aspect, the state is generally viewed as trying to serve the public, and act on its behalf. The second is the controlling aspect of administrative law, ensuring that the exercise of government power – even in fulfillment of its lawful and intended purposes - is monitored and controlled. The Supreme Court’s emphasis on “a system for the administration of justice which is founded upon the belief in the dignity and worth of the human person and the rule of law” signals that administrative law in Canada is based largely on the English model, which values highly the protection of the individual against the state and its exercise of power. Thus, the exercise of administrative

Introduction B-2

powers has traditionally been reviewed according to administrative law principles that tend to emphasize individual and proprietary interests, and to protect these from undue encroachment in the name of the “public interest.”4 It is these values and priorities that may be challenged when interacting with the emerging principles of precaution and adaptive management which will shortly be introduced. In addition, administrative law values and principles have tended to focus more strongly on procedural fairness than on substantive outcomes – on the process rather than the result. When the decisions of administrative agencies are challenged in judicial proceedings, the inquiry is overwhelmingly, (indeed, almost exclusively,) focused on very specific circumstances. Audits, royal commissions, parliamentary reviews and other forms of systematic assessment of agency performance are much less common. What we have described as the general administrative law values of Fairness, Legitimacy and Effectiveness have traditionally been realized or achieved through a series of quite variable institutional practices, instruments, or devices. For the purposes of this study we highlight a series of such measures:

Personnel selection and qualifications: the professional or legal expertise of decision-makers, or perhaps their ability to represent interests that may be affected; Administrative procedures: evidentiary matters such as rules of evidence, standards and burdens of proof are particularly important examples, along with such issues as access to information, whether or not public hearings or open deliberations are elements of the decision-making process; Mechanisms of participation: opportunities for participation are influenced by rules on standing, duties to consult, notification arrangements, and related considerations such as rules on costs or the availability of other financial assistance; Opportunities for review: rights of statutory appeal, whether to another administrative body or to a court, along with judicial review, are the central issues here, each affected by related considerations as to time limitations, the scope and nature of the review process and so on; Mechanisms of accountability: to whom does the decision-maker report? Is their term at pleasure, for a fixed period, permanent? Are there duties to inform, respond or report to a government official, an elected body, members of the public? These are important not only in ensuring that decision-making authority delegated by means of legislation remains under parliamentary scrutiny for its lawfulness, but also in providing opportunities to assess its effectiveness;

The specific application of these five features of decision-making arrangements will vary from one decision-making setting to another. However, in any given administrative or regulatory process, each has the potential to contribute something towards Fairness, Legitimacy and Effectiveness. Yet potential conflicts among these three underlying values must also be acknowledged. Circumstances arise – even in cases not involving scientific uncertainty (a subject to which we will shortly return) – where one of these values must give way to another. For example,

Introduction B-3

mechanisms of participation, such as rules of standing or rules governing interveners, can help to achieve fairness by ensuring that all those affected have a right to be heard; this also contributes to legitimacy by leading to better informed decisions and by ensuring greater accountability in decision-makers by requiring an open and public forum5; however, many argue that increasing the number of participants reduces efficiency by lengthening the process. Indeed, some argue that the rules permitting public interest standing and interventions allow opponents to unduly delay important initiatives by procedural manoeuvring. Thus there is a balance to be achieved between the competing values and priorities in the administrative endeavor. The questions this research project ultimately seeks to illuminate relate to the possible influence on administrative practice of two relatively new concepts, the precautionary principle and the principle of adaptive management: (i) how can these emerging principles be accommodated within the general framework of administrative law values; and (ii) will their introduction and application alter the existing balance between those administrative law values. Precaution and adaptive management have been advanced in response to a recognition that uncertainty or limited understanding are significant features of the administrative decision-making context. While this may be generally true, it is particularly so in relation to health and environmental matters where as a society we are continuously engaged in assessing the opportunities presented to us by scientific and technological innovations in relation to the risks these same interventions may entail. Accordingly, it is appropriate to introduce the questions of risk and uncertainty before addressing precaution and adaptive management and their possible implications for administrative decision-making. Risk and Uncertainty Deliberative processes have always, of course, been subject to conditions of uncertainty, and so it is sometimes asked whether there is anything new to merit closer scrutiny of the significance of uncertainty as it affects contemporary decision-makers. The factors typically adduced as distinguishing present circumstances include greater risks associated with projects and activities proposed and undertaken on a larger scale than in the past, or with more elaborate innovation or more extensive intervention in natural systems. Pressures arising from the presence of mass-media and a better-informed and more-concerned population have also been noted, along with higher degrees of globalization and trade.6 Stephen Bocking’s assessment of the novel features of contemporary risks is similar: “they affect whole ecosystems; they affect not just specific places, but the entire globe; and they can affect all humanity, not just those within a specific group.” He adds increased concern for human health as a further distinguishing characteristic along with an accentuated interest in establishing priorities associated with the costs and benefits of regulation, particularly where the economic stakes are high.7 Although elaborate arrangements have evolved to assess and to respond to risk, the essential challenge of risk may be informally described.8 The risk associated with a particular decision may be considered as the sum of the products of the probability of all negative outcomes and the magnitude of these outcomes. Or, as articulated in a recent synthesis: “risk is the predicted or expected chance that a set of circumstances over some time frame will produce some harm that matters.”9 Decision-makers thus seek to identify both the probability and magnitude, (severity,) of different outcomes. At the core of the current risk management framework for administrative and regulatory decision-making in Canada is the concept of scientific risk. Science is concerned, first and

Introduction B-4

foremost, with the establishment of causal relationships, often conveniently expressed in the form “If A, then B”. The estimation of risk requires that the set of possible outcomes be determined, and that there be data on both the probability of occurrence and the magnitudes of the effects of these outcomes. These are very stringent requirements. For example, the set of “possible” outcomes is clearly circumscribed by current knowledge. So risk analysis can, by definition, apply only to “known” outcomes, that is, outcomes “B” for which there is some scientific evidence of a causal link with “A.” If a possible causal relationship between an action and its possible consequences has never even been investigated, then we cannot (by definition) estimate the risk of B given A. Indeed, for many issues on the regulatory or administrative aganda, the collection of “known” outcomes may well be much smaller than the set of possible outcomes, which may themselves have large associated effects. The notion of uncertainty is central to the concept of risk: if one can predict with complete certainty the consequences of a given decision, there is no risk, irrespective of the magnitude of the effect. In an attempt to clarify overall understanding, Gee and Stirling distinguish risk, uncertainty, and ignorance with reference to knowledge about impacts and probabilities. In confronting risk, we are seeking to deal with known risks and known probabilities. A condition of uncertainty combines known impacts with unknown probabilities. We may also be required to address situations on the basis of ignorance of both impacts, and therefore necessarily of probabilities.10 In fact it is possible to proceed beyond this general framework of risk, uncertainty and ignorance to inquire into the basis of our limited understanding. One of the more systematic attempts to isolate factors contributing to scientific uncertainty as it affects the spectrum of legal decision-making, including environmental decision-making, identified six kinds of descriptive uncertainty: (1) conceptual, (2) measurement, (3) sampling, (4) modeling, (5) causal, and (6) epistemic.11 These, with modest variations, have been widely adopted in other legal commentaries on the challenges of addressing uncertainty.12 In elaborating some of the distinctions relevant to the nature of our uncertainty, an important report for the Royal Society of Canada contrasts ‘absence of evidence’ (about risk) from ‘evidence of absence.’13 Taking the example of the statement that “there are no known adverse health or environmental effects” associated with a given technology, the report elaborates a range of possible bases for the assertion: “It can mean that rigorous and intensive scientific investigation of the potential harms that might be induced by the technology has failed to show any of those harms (and in the best case, provided a reliable explanation why the harmful effects do not or will not occur). At the other extreme, this claim might mean simply that no studies to determine if the harmful effects occur have been carried out, in which case the claim is simply an admission of ignorance.” Pursuant to the first explanation, the claim about no known adverse effects would equate with an “evidence of absence” of risk; in the latter case it is equivalent to acknowledging an “absence of evidence” relevant to the inquiry.14 Larry Reynolds, in a more simplified classification, distinguishes information uncertainty from knowledge uncertainty. In the former case, relevant data is unavailable, either because it has not been collected or assembled, or, if it is available to some, it has not been publicly provided to the decision-maker. More challenging is knowledge uncertainty resulting from limits in scientific understanding or from circumstances where it is not feasible to collect data. Where either of these forms of uncertainty arise, “… it is often difficult for an environmental decision-maker to determine whether the degree of certainty with which a particular view is held within the scientific community translates into the standard of certainty required by the legal burden of proof….”15

Introduction B-5

Some causes of uncertainty are more subject to responses than others. Ultimately, however, scientific uncertainty varying in type and extent from one problem to another will remain, with the consequence that scientific knowledge will not – in and of itself – produce administrative decisions.16 These will therefore emerge under the broader influence of social values or preferences and within the applicable procedural framework. The implications of procedural design for outcomes may be illustrated with further reference to the general distinction between information and knowledge uncertainty noted above: “There is no clear demarcation between information uncertainty and knowledge uncertainty; the marginal point at which information becomes so difficult or expensive to collect that it is effectively unobtainable will often be indistinct. Nevertheless, the dichotomy is significant from a legal perspective because the consequences of allocating the burdens of production and proof may vary greatly depending on the nature of the uncertainty presented. Information uncertainty can be eliminated if the value of the missing data makes collection worthwhile. A doctrine designating one party responsible for resolution of information uncertainty presents that party with a realistic choice: either provide the information or surrender the point. Which alternative is selected depends on how the designated party perceives the relative costs and benefits of production. The picture is quite different when knowledge uncertainty is involved. Research may be directed toward a critical problem, but there is rarely any assurance that the desired knowledge can be acquired, especially within the time frame associated with a specific legal controversy. Thus, a rule assigning legal responsibility for knowledge uncertainty also determines the eventual result in most cases: whoever bears that burden generally loses.”17 Accordingly, where administrative decision-makers have taken steps to identify the nature of the uncertainty or uncertainties with which they are confronted, they will be in a better position to identify aspects of that limited understanding which are subject to some corrective effort. This type of determination, as Smith and Wynne’s observations underline, may in turn become the foundation for decisions about the appropriate allocation of responsibility for undertaking that effort, or for the failure to do so. To assist in dealing with an increasing appreciation of uncertainty and the potential for unanticipated adverse impacts several principles have been advanced. Notable amongst these are the precautionary principle and the principle of adaptive management, the focus of this inquiry. Precaution The precautionary principle, although existing in several formulations around the world, asserts generally that when scientific uncertainty is high, and the potential for substantial negative (but possibly unexpected) effects exists, administrative decision-making should err on the side of caution. Otherwise put, the precautionary approach endorses “l idée qui’l n’est pas approprié d’attendre la preuve irréfutable de l’existence d’un risque potentiel avant de chercher à le circonscrire.’’18 The previously noted study by the Royal Society of Canada linked its discussion of evidence to the precautionary principle, remarking that precaution “counsels restraint in proceeding with the deployment of a technology in the “absence of evidence,” and requires that the greater the potential risks, the stronger and more reliable be the “evidence of their absence.”19 It is of course a difficult question to determine what degree of scientific certainty is in fact necessary to establish the existence of a potential risk to health or the environment, or the safety of a proposed product or course of action. 20

Introduction B-6

The precautionary principle has found growing recognition in international agreements, to many of which Canada is a signatory.21 Existing domestic Canadian acknowledgement of precaution includes the Oceans Act, CEPA 1999, and the revised Pest Control Products Act. Precaution appeared in the preamble to CEPA 1999 in this form: “Whereas the Government of Canada is committed to implementing the precautionary principle that, where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.” The significance of the presence of the precautionary principle in the preamble of CEPA, 1999, as explained by Marcia Valiante, is that: “if a regulation adopted in conformity with it is challenged, it could assist a tribunal or court in interpreting the specific operative sections of the Act.” Difficulties arise, however, because “there is no guidance in the statute as to how much and what kinds of scientific evidence could justify a shift to a lesser standard” and because of the decision to refer to “cost-effective” measures. These factors contribute to unpredictability, “making it difficult for the government to withstand a legal challenge to a regulation based on this provision.” In Valiante’s view, “Governments thus far have not regulated when the science was quite uncertain and this provision is unlikely to encourage them to do so.”22 Another example of the infiltration of the precautionary principle into specific realms of regulatory activity appears in the report of the Walkerton Inquiry where Justice Dennis O’Connor comments on its application to “situations in which risk cannot be estimated with any reliability and in which uncertainty prevails regarding the relationship, if any, between cause and supposed effect.” The Report suggests that appropriate precautionary measures called for in such circumstances might include investments in risk mitigation, utilization of alternative technologies or additional research. The consequences of such an approach were also described: “At worst, such an approach means that resources that might have been devoted to more productive use elsewhere may be consumed to reduce certain risks. Although this prudent approach must still take account of costs, when the potential consequences of the hazard in question are large, the precautionary principle has a role to play in practical risk management and should be an integral part of decisions affecting the safety of drinking water.”23 Actual implementation of precautionary decision-making may be further advanced in other jurisdictions than Canada where experience with precaution remains comparatively limited.24 However, federal officials have begun to consider practices and procedures relevant to the application of precaution in decision-making whether the term is described as a principle or an approach.25 Possible distinctions between principle and approach, at least as they have influenced international debate, have been thoughtfully explored by Jacqueline Peel who describes the former as an “obligation” which would require decision-makers to take measures to address potential harm in the presence of scientific uncertainty.26 On the other hand, to view precaution as an approach, she suggests “is to say that it authorizes or permits regulators to take precautionary measures in certain circumstances, without dictating a particular response in all cases.” Regulators applying precaution as an approach would enjoy greater flexibility to respond, according to their understanding of the underlying uncertainties and depending on the seriousness of threatened environmental damage. “In situations where a high degree of value attaches to the aspect health or the environment potentially affected by an activity, applying this understanding of precaution would lead to stricter precautionary measures than in situations where strong, countervailing social and economic considerations arise.” The existence of scientific uncertainty thus serves to indicate the need for a ‘precautionary approach’ to decision-making, without automatically triggering protective measures.27

Introduction B-7

The distinction between principle and approach rooted in the association of a stronger obligation with the idea of principle has certainly not been universally adopted, for the precautionary principle is often understood to be permissive or enabling. “Le principe de précaution, tel quìl est formulé notamment en Europe et dans certains conventions internationales, permet aux pouvoirs publics de prendre des mesures dìnterdiction ou de contrôle à lèndroit de lùtilisation de substances ou de produits, même lorsquìl nèst pas précisement établi, sur le plan scientifique, que ceux-ci puissent être toxiques. Il est entendu cependant que ces mesures pourront être modifiées lorsque lìncertitude scientifique sera levée. » 28 It is not uncommon for both hortatory and obligatory characteristics to be attributed simultaneously with precaution: “The precautionary principle is a guiding principle. Its purpose is to encourage – perhaps even oblige – decision-makers to consider the likely harmful effects of their activities on the environment before they pursue those activities.”29 The variety of formulations of precaution, together with the range of interpretations and applications that have emerged in practice, has become a commonly noted problem. During the CEPA parliamentary review process, the House of Commons Standing Committee on Environment and Sustainable Development was fully aware in 1995 of this difficulty. David VanderZwaag’s background paper had emphasized that: “Debates continue over what should trigger the principle, with words such as ‘likely harm’ or ‘serious or irreversible harm’ being favored verbal candidates. Who should ‘pull the trigger’ and make such determinations is open for discussion, as is the question of required precautionary control measures.”30 As Hélène Trudeau observes, though, it is in the context of potential risk – however that potential is to be established – that precaution may alter the state of the law.31 As this process unfolds, and the precautionary principle becomes integrated – whether expressly or implicitly – in aspects of Canadian decision-making significant operational challenges will arise. Following the introduction of adaptive management - another principle sometimes advocated as an appropriate response to uncertainty - we will address the manner in which the case studies constituting the core of this research project attempt to identify and analyse those operational challenges. Adaptive management To a greater degree than is true for precaution, the principle of adaptive management is associated with the insights and analyses of a number of specific individuals whose pioneering contributions should be acknowledged.32 The idea is now in wider circulation, although it has not yet achieved precaution’s prominence. “Adaptive planning and management,” according to a committee of the U.S. National Research Council, “involves a decision making process based on trial, monitoring, and feedback.” The relationship to uncertainty is clearly established in the description: “Rather than developing a fixed goal and an inflexible plan to achieve the goal, adaptive management recognizes the imperfect knowledge of interdependencies existing within and among natural and social systems, which requires plans to be modified as technical knowledge improves.”33 Another synthesis of adaptive management refers to it as a “‘learning-by-doing’ approach that views policies and management interventions as explicitly experimental and provisional, and looks to revise both our understanding of ecosystems and subsequent policies as we learn from an iterative series of policy experiments.”34 Adaptive management may also be described as an

Introduction B-8

approach or strategy that “pragmatically and continuously adjusts both ends and means in light of experience and learning”35 The premises of adaptive management should be explicitly noted in light of their eventual relevance to administrative decision-making. First, adaptive management acknowledges that scientific understanding of any system - an ecosystem, for example - will always be incomplete. Secondly, it is assumed that as scientific knowledge of the system in question improves, so too will the accuracy and reliability of decision-makers’ ability to predict outcomes. Third, given the preceding, decisions about the management of resources and the environment should be considered – and used – as an opportunity to gain enhanced understanding of the system involved. The broad operational implications of adaptive management are consistent with these premises. Specifically, management interventions should be regarded as essentially experimental: hypotheses or expectations should be expressed; controls should be put in place, and opportunities for replication should be contemplated. Moreover, results should be assessed in a timely and efficacious manner and the knowledge thereby derived should be used to inform subsequent decision-making. As explained by the FAO, adaptive management is particularly suited to ecosystem management: “The ecosystem approach requires adaptive management to deal with the complex and dynamic nature of ecosystems and the absence of complete knowledge or understanding of their functioning. Ecosystem processes are often non-linear, and the outcome of such processes often shows time lags. The result is discontinuities, leading to surprise and uncertainty. Management must be adaptive in order to be able to respond to such uncertainties and contain elements of ‘learning by doing’ or research feedback. Measures may need to be taken even when some cause-and-effect relationships are not yet fully established scientifically.”36 Rod Dobell, a Canadian observer, echoes the virtues of adaptive management in responding to evolving knowledge. “The machinery of adaptive management offers possibilities for improved risk management and ongoing decision-making.”37 Citing several influential works on the recurring trade-offs involving deeply-held and not-easily reconciled social values,38 Dobell further observes that adaptive management may also contribute to a beneficial process of continuing re-balancing and re-consideration: “Such a continuing dynamic adaptation makes it possible to live with conflicting fundamental values without permanently surrendering allegiance to any, and thus enables the system to continue to command the loyalty of the community as a whole.”39 The inherent wisdom of adaptive management is further underscored from the perspective of the ecological sciences where it is increasingly observed that the complex systems we are struggling to understand are themselves dynamic. To focus exclusively on seemingly static, point-in-time, characteristics limits understanding and will not enhance the quality of decision-making.40 Viewed in this light, adaptive management may arguably contribute to, rather than undermine, decisional legitimacy. Explicit reference to adaptive management in Canadian policy and legislation is rare, but not unknown. Where, in connection with federal environmental assessment, a follow-up program is implemented, the results “may be used for implementing adaptive management measures for improving the quality of future environmental assessments.”41 In the Canada-Ontario Agreement on Great Lakes Water Quality adaptive management is described among the principles of the agreement as “openness, continuous learning, innovation, and improvement [to] ensure effective and efficient management of the Agreement.” In addition, examples of the application of the concept in an operational sense may be found in several settings. National Energy Board hearings on available reserves have been conducted periodically for the purpose of formulating supply and demand estimates. Such

Introduction B-9

estimates serve as a notional benchmark used for making such other determinations as levels of permissible energy exports. As supply and demand estimates are revised in light of ongoing results from exploration, analysis, and experience other features of the overall regulatory regime are subject to adjustment. Forest management planning under Ontario’s Crown Forest Sustainability Act also displays some features of adaptive management. The legislation is intended to achieve sustainability according to a set of regulatory indicators which constitute standards against which twenty year management plans are assessed and adjusted in five year cycles. On a more modest scale, environmental permit and approval schemes typically call for regular monitoring and reporting and provide administrative authority for revision or cancellation in altered circumstances. Proposed Ontario legislation on source water protection following the recommendations of the Walkerton Inquiry and the subsequent work of advisory panels is expected to embrace adaptive management in principle if not in name. As emphasized by the technical experts committee, “source protection planning should be viewed as an ongoing process: the plan is developed, actions are implemented, results are monitored, progress is reported, and then plans are updated.”42 In the American context, adaptive management has been urged as a response to highly fragmented institutional arrangements imbued with gaps, overlaps and an absence of coherence such that ecosystem health never clearly emerges as a goal within a confusing cluster of discrete regulatory objectives.43 For this reason, adaptive management is regarded as profoundly different from established regulatory approaches in the resource and environmental fields. Yet what some regard as a great virtue promising substantive improvements, has attracted legal criticism: “Adaptive management presents a fundamental challenge to familiar natural resource management and environmental protection paradigms: It displaces fragmentary fixed rules with integrative science and management predicated on a continuous process of experimentation and mutually informed readjustments of both goals and means. This process appears to many lawyers as distinctly un-law-like and therefore deeply threatening.”44 American legal criticisms of adaptive management express the concern that “the absence of clear, legally enforceable, fixed procedural rules and substantive standards will translate into a kind of open-ended discretion likely to yield to unprincipled compromise, self-dealing, and a lack of accountability in basic governance processes.”45 The concept has even fallen victim to legal innuendo, and is described by one prominent environmental academic as “shadowy,” or a “polite term for muddling through.”46 Without necessarily adopting the severity of the Americans’ self-criticism, it may be observed that the Canadian regulatory system is often regarded as comparatively flexible and strongly influenced by negotiation and discretion. To the extent that more scope already exists in Canada for regulatory compromise and negotiation, the extension of adaptive management into decision-making here may appear less transformative than in the U.S. context.47 Questions surrounding the acceptability of administrative discretion in Canadian environmental decision-making remain to be addressed, of course, but might be accompanied in the specific context of adaptive management with more systematic attempts to structure the implementation of adaptive management in ways intended to preserve accountability, reduce the prospect of arbitrary judgments and so on. Some of these matters are addressed in the concluding section of this report. Before describing this report’s methodology in connection with the case studies some further introductory discussion may be appropriate on the relationship between precaution and adaptive management. Some believe that adaptive management conflicts with precaution, while others view the two principles as complementary: “Some see these as competing approaches,

Introduction B-10

with precaution weighing in favour of ‘doing nothing’ until an action can be shown to be harmless, and adaptive management favouring controlled interventions which increase understanding of the system in question. However, others view adaptive management as an inherently precautionary strategy, as it recognizes that in complex systems certainty of outcome is impossible, and seeks to create a dynamic regime capable of responding to unpredictable changes. Proponents view adaptive management as a primary means by which precaution should be implemented at national local levels in conservation/NRM.”48 According to this second view, precaution tells us that we should be cautious, while adaptive management suggests a means for doing so. Like administrative law in its enabling aspect, precaution and adaptive management appear to embody substantive values, such as the need to protect health or resources, to admit our ignorance in the face of the complexity of environmental systems, yet not to be paralyzed by lack of certainty. These concepts call upon us to do two things: to take action even in the face of uncertainty, and to respond to our deficiencies of understanding by means of constant re-evaluation and improvement of our learning and knowledge. Yet since adaptive management is one approach to being cautious, it, like the controlling aspect of administrative law, and like the uncertainty aspect of precaution, also tends to emphasize procedure as the best we can do in the face of unknowns to reach optimal decisions. The legal status of precaution and adaptive management, that is, the obligation or opportunity to implement or to apply these principles is not in question here. Rather, recognizing the trend towards greater adoption of these two principles in a range of decision-making settings, we are interested in the implications of increasing acceptance of precaution and adaptive management for administrative and regulatory decision-making processes and institutions. That is, how are they actually applied? What practical measures are involved in putting them into practice? What are the legal, institutional and procedural implications of possible measures to implement precaution and adaptive managment in administrative and regulatory decision-making, including, in particular, the potential significance of these concepts for Fairness, Legitimacy and Effectiveness? In this regard, it will be of interest to inquire what it might mean ultimately in the context of judicial review, for a decision maker to have concluded: “I have reached my decision in this matter having regard to the precautionary principle,” or, “I reach this conclusion in light of the principle of adaptive management.” To scrutinize the particularities of such a decision admirably engages the skills and training of the client-oriented litigator. That day will come in Canada, if it has not yet arrived. To provide some foundation for exploring these questions, this research project examines four case studies with reference to a set of assessment dimensions (expertise, participation, procedure, review, and accountability) that correspond to the institutional practices previously noted as being primary contributors to the administrative law values of fairness, legitimacy and effectiveness. Each of the case studies involves a specific decision-making institution charge with making determinations about health or environmental risk, and, accordingly, each examines the notion of scientific uncertainty in relation to those risks and the role played by precaution and adaptive management in responding to them. The next section of this report sets out the methodological approach to the case studies which follow. These in turn (with explicit acknowledgment of the pilot project nature and inherent limitations of our small sample of studies) are followed by a cautious statistical analysis of the findings. In the concluding section of the report, issues relating to the impact of precaution and adaptive management on administrative law values and practices are addressed.

Introduction B-11

1 As Jonathan Wiener emphasizes, regulatory systems are exceedingly difficult to characterize, let alone to compare,

in relation to a predilection towards precaution or other features. The regulatory process itself is comprised of a range of steps which require careful and distinct analysis to determine how each might further or inhibit precautionary measures. The inventory of those steps includes: framing, risk assessment methods, risk management standards, choice of risks to regulate, choice of policy instruments, degree of integration across hazards and media, enforcement mechanisms and hierarchical level of government. Jonathan B. Wiener, “Whose Precaution After All? A Comment on the Comparison and Evolution of Risk Regulatory Systems” (2003) 13 Duke J. Comp. & Int’l L. 207 at 215

2 Reference Re s. 94(2) of the Motor Vehicle Act (British Columbia), [1985] 2 S.C.R. 486 3 Ibid. 4 See J.M. Evans, H.N. Janisch, David J. Mullan, and R.C.B. Risk, Administrative Law: Cases, Text, and Materials

(5th Edition, 2003) 30 5 Ibid. 6 David Gee and Andrew Stirling, “Late Lessons from Early Warnings: Improving Science and Governance Under

Uncertainty and Ignorance” in Joel A. Tickner, ed. Precaution, Environmental Science, and Preventive Public Policy (New York, Island Press, 2003)199

7 Stephen Bocking, Nature’s Experts: Science, Politics and the Environment (Rutgers, 2004), 137 8 Cindy G. Jardine et al “Risk Management Frameworks for Human Health and Environmental Risks” (2003) 6

Journal of Toxicology and Environmental Health, 569 9 William Leiss and Steve E. Hrudey, “On Proof and Probability: Introduction to ‘Law and Risk’” Law and Risk,

(UBC, 2005) 4 10 David Gee and Andrew Stirling, “Late Lessons from Early Warnings: Improving Science and Governance Under

Uncertainty and Ignorance” in Joel A. Tickner, ed. Precaution, Environmental Science, and Preventive Public Policy (New York, Island Press, 2003) 195-213 at 196

11 Vern Walker, “The Siren Songs of Science: Towards a Taxonomy of Scientific Uncertainty for Decision-makers” (1991) 23 Connecticut Law Review 567 at 572

12 European Commission, “Communication on the Precautionary Principle” (Brussels, 2000); Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada, Expert Panel Report by the Royal Society of Canada (January 2001) 197

13 Ibid. 198 14 Ibid. 15 Reynolds, “The Era of Juriscience: Investigating the Relationship Between Science, Law and the Environment”

(1995) 9 CJALP 61at 86 16 Elizabeth Fisher, “Is the Precautionary Principle Justiciable?” (2001) 13 Journal of Environmental Law, 313 at

317-8 17 R. Smith and B. Wynne, Expert Evidence: Interpreting Science in the Law (London: Routledge, 1989) 357,

quoted in Reynolds at 87 18 Hélène Trudeau, “Du droit international au droit interne: l’émergence du principe de précaution en droit de

l’environnement” (2003) 28 Queen’s L. J. 455 at 459 19 Royal Society of Canada, supra at 198 20 Trudeau, supra at 462 21 Rio Declaration; Vienna Convention on Ozone (22 March 1985, 26 ILM 1516); Montreal Protocol on Ozone

Depleting Substances (16 Sept 1987, 26 ILM 1541); FCCC; Kyoto Protocol (11 Dec 1997, 37 ILM32); Convention on Biodiversity (29 Jan 2000, 39 ILM 1027); 1996 Protocol on Convention on Ocean Dumping (7 Nov 1996, 36 ILM 1) all as cited in Trudeau, note 3

22 “Legal Foundations of Canadian Environmental Policy” in Debora L. VanNijnatten and Robert Boardman eds. Canadian Environmental Policy: Context and Cases 2d edn. (Oxford University Press Canada, 2002) 13

23 Report of the Walkerton Inquiry, Part Two: A Strategy for Safe Drinking Water, (The Honourable Dennis R. O’Connor, Commissioner) (Queen’s Printer for Ontario, 2002) 77

24 On the United States, see, for example, Fullem, “The Precautionary Principle: Environmental Protection in the Face of Scientific Uncertainty” (1995) 31 Willamette Law Review 495 and Jonathan B. Wiener, “Whose Precaution After All? A Comment on the Comparison and Evolution of Risk Regulatory Systems” (2003) 13 Duke Journal of Comparative and International Law, 207. On the EU, see Theofanis Christoforou, “The Precautionary Principle in European Community Law and Science” in Joel A. Tickner ed. Precaution, Environmental Science, and Preventive Public Policy (Island Press, 2003) 241. On Australia, see W. Gullett,

Introduction B-12

“The Precautionary Principle in Australia: Policy, Law and Potential Precautionary EIAs”, (2000) 11 Risk: Health, Safety and Environment 93

25 Government of Canada, “A Canadian Perspective on the Precautionary Approach/Principle” (Discussion Document, September 2001); “A Framework for the Application of Precaution in Science-based Decision Making about Risk.” For commentary, see Hugh Benevides and Theresa McClenaghan, “Implementing Precaution: An NGO Response to the Government of Canada’s Discussion Document” (Canadian Environmental Law Association, Report No. 419, April 2002).

26 Jaqueline Peel, “Precaution – A Matter of Principle, Approach or Process?” 5 Melbourne Journal of International Law, 483

27 Ibid., 491 28 Hélène Trudeau, “La precaution en cas d incertitude scientifique : une des interprétations possibles de l’article 20

in fine de la Loi sur la qualité de l’environnement,” (2002) 43 Les Cahiers de Droit, 103 at 114. See also, Rosie Cooney, The Precautionary Principle in Biodiversity Conservation and Natural Resource Management (IUCN Policy and Global Change Series No. 2) IUCN, 2004, 5-6

29 Reynolds, supra at 88 30 David VanderZwaag, CEPA and the Precautionary Principle/Approach, (1994) 5 31 Trudeau, Les Cahiers de Droit, supra at 115 32 Kai N. Lee, “Appraising Adaptive Management” (1999), 3(2) Conservation Ecology 3 ,C. Walters, Adaptive

Management of Renewable Resources ( (New York, 1986); C.S. Holling, Adaptive Environmental Assessment and Management (New York, 1978)

33 National Research Council, Committee on Restoration of Aquatic Ecosystems, Restoration of Aquatic Ecosystems: Science, Technology and Public Policy (1992) 357, quoted in A.Dan Tarlock, “Putting Rivers Back in the Landscape” (1999-2000) 6 Hastings W.- Nw. J. Envt’l L. & Pol’y 167 at 192

34 Bradley C. Karkkainen, “Adaptive Ecosystem Management and Regulatory Penalty Defaults: Toward a Bounded Pragmatism” (2003) 87 Minn. L. Rev 943 at 948

35 Ibid., 943 36 www.fao.org 37 Dobell, “Social Risk, Political Rationality and Official Responsibility: Risk Management in Context” (Walkerton

Inquiry, 2000), 7-8 38 Guido Calebresi and Philip Bobbitt, Tragic Choices (1978) 39 Dobell, supra at 10 4040 Jack Manno, “The Ecological Dynamics of Environmental Law and Policy” 41 CEEA, S.C. 1992, c. c.37 s. 38(5) 42 “Watershed-Based Source Protection Planning: Science-based Decision-making for Protecting Ontario’s Drinking

Water Resources” Technical Experts Committee Report to the Minister of the Environment, (Queen’s Printer, November 2004,) viii

43 Karkkainen, supra at 946 44 Ibid. at 956-7 45 Ibid. at 944 46 Richard B. Stewart, “A New Generation of Environmental Regulation” (2001-2) 21 Capital University Law

Review 21 at 54, 57 47 For literature on comparative regulatory cultures, notably contrasting U.S. and European styles, and on the debate

about current convergence, see: Ronald Brickman, Sheila Jasanoff, and Thomas Ilgen, Controlling Chemicals: The Politics of Regulation in Europe and the United States (Cornell, 1985); David Vogel, National Styles of Regulation: Environmental Policy in Great Britain and the United States (1986); Robert Kagan and Lee Axelrod eds. Regulatory Encounters: Multinational Corporations and American Adversarial Legalism (2000)

48 Precautionary Principle Project, 2003, w.pprincople.net/the_issues.html

Research Methodology C-1

C- RESEARCH METHODOLOGY

EVALUATING INSTUTIONAL PRECAUTION AND ADAPTIVE MANAGEMENT C. Scott Findlay, André Dabrowski, Jamie Benidickson and the Practicing Precaution team I. INTRODUCTION

Given the emphasis currently being placed on precaution, and, to a lesser extent, adaptive management, the question arises as to the extent to which these principles are currently being invoked or applied by environmental decision-making bodies in general, and administrative or regulatory agencies in particular. Answering this question requires instruments that allow one to quantify, for a given agency and (institutional) decision process (1) how (and if) scientific uncertainty is accommodated ;(2) the extent to which (and how) precaution and adaptive management are employed, and how they are interpreted; and (3) the effect (if any) on classical administrative law values of fairness, legitimacy and effectiveness. We describe several such instruments below.

II. INSTRUMENT DESIGN CRITERIA Any instrument must fulfill several criteria. First, it must provide for an evaluation of precaution and adaptive management based on rendered decisions rather than (professed) intentions (here, as always, the proof is in the pudding). However, because there are issues (e.g. those related to the decision process, resource capacities and institutional organization) that transcend individual decisions, the set of instruments must also allow for evaluation of precaution and adaptive management at the institutional level. Moreover, because certain precautionary and adaptive management elements – if present – are expected to be manifested both in individual decisions and at an institutional level, any instrument must allow for decision-level/institutional level co-validation by, for example, allowing investigators to quantify the correlation between the two levels for common shared elements. Finally, the instrument must allow comparison between case studies, which implies that all (or at most) assessment elements must be broadly applicable to a wide range of administrative decision-making contexts, yet specific enough to uncover important differences, if indeed they exist. III. THE QUESTIONNAIRES Two questionnaires were designed to fulfill the above criteria. One (the Document Questionnaire) was completed for each document assessed as part of the case study investigation: these documents ranged from legislation, statutes and regulations through policy statements to decisions. A second (the Institutional Questionnaire) was completed for each case study. Both questionnaires were subject to a series of revisions and modifications throughout the course of the study. Prototype versions were discussed in the abstract by case study participants,


and then underwent a series of revisions as attempts to use the questionnaires for particular case studies uncovered errors of omission and commission, infelicities and ambiguities.

The initial version of the questionnaires included open-ended (i.e. fill-in-the-blank) questions and a variety of true/false or numeric scales for responses. To standardize responses most of the open-ended questions were rephrased as multiple choice questions, and responses were standardized to either true/false or a 7-point numeric scale. The interpretation of the 7-point scale was described as part of the questionnaire. This attempted to address concerns of comparability of numeric responses across questions. Unlike many social surveys, survey questions were all unidirectional with higher scores representing stronger awareness, extent of implementation, importance etc. No attempt to randomize “positive” or “negative” responses was made, but this was not anticipated to be a significant problem.

Both questionnaires included several different sections, with each section comprising a set of questions addressing different themes (e.g. scientific uncertainty, precaution, administrative law values, etc.). A key issue for data quality was the fact that each case study (and set of associated documents) was assessed by different evaluators. While the confounding evaluator and case study effects was unavoidable, we attempted to minimize this by having all evaluators discuss their responses to the questions and to arrive, as much as possible, at a common understanding of the meaning of their responses.

As the study progressed, some changes to the original measurement plans were introduced and difficulties with the data collection process identified. Although a seven-point scale (1 to 7) for measuring response had been described in the questionnaire, the raters felt the need to introduce a 0 entry to indicate the state of “unknown,” i.e. insufficient information to decide. Similarly a “2” code in true/false (yes/no) responses was introduced and interpreted as an inability to decide. From a data analysis point of view, the purely numeric assessment scales (weak to strong) became a mixture of qualitative and quantitative measurements because of these additions, and consequently more difficult to analyze. The Document Questionnaire: The final version of the Document Questionnaire is shown in Appendix i. In addition to standard bibliographic information, the questionnaire includes information fields about:

• The type of document being considered (questions 1, 3). Preliminary analysis of documents published by several different agencies indicated that the extent to which precaution and/or adaptive management was either explicit or implicit in the document depended on the document type, e.g. decisions versus policy notes.

• The types of effects (question 4). Different agencies are charged with different responsibilities, and the possibility exists that the application of precaution and/or adaptive management might well depend on statutory/regulatory responsibilities (e.g. human health versus the health of fish populations)

• Explicit versus implicit reference to the precautionary principle, adaptive management and scientific uncertainty (q. 5-9, 11 (precaution); q. 12-14 (uncertainty); q. 16-20, 22 (adaptive management))

• Concepts associated with the precautionary principle (q. 10), scientific uncertainty (q. 16) and adaptive management (q. 21). These questions are the core of the


questionnaire: for each concept, the document is scored on a scale from 0 (unable to assess), 1 (very weak) -7 (very strong) with respect to the extent to which the concept was implicated in the document.

The Institutional Questionnaire:

Part I of the Institutional Questionnaire (Appendix ii) includes questions about the nature of the administrative setting. Part II concerns the role of scientific uncertainty in the decision-making, the degree and specificity of the institution’s awareness of the problem, and the types of scientific uncertainty of most concern. Particularly important here are questions dealing with the sources of information generally used to assess and evaluate uncertainty (q. II-5, II-7). Several questions in this section are identical to those in the Document Questionnaire, notably q II-6 which rates the institutional concern with different types of scientific uncertainty (identical to q. 16 in the Document Questionnaire). Part III identifies whether the precautionary principle is expressly required to be used (e.g. is a statutory requirement) and how in practice precaution is understood and applied. Particularly important here are questions which concern the “trigger” for precaution, addressed in the context of the type (q. III.7-III.11) and severity (q. III-8 – III.12) of harm, and the uncertainty associated with these assessments (q. III.13). Section IV considers institutional experience with adaptive management, exploring the extent to which different adaptive management elements are used or employed by the institution (q. IV.3, analogous to q. 21 in the Document Questionnaire), with special emphasis on the treatment of decisions as scientific experiments (q. IV.4) and the use of follow-up monitoring to inform subsequent decisions (q. IV.5-IV.8). The final section of the questionnaire explores administrative law values in the context of (a) institutional expertise in or experience with the precautionary principle, adaptive management or scientific uncertainty (q. V.1-V.7), processes and procedures (q. V.8-V14), participation by external parties (q. V.15-V.17), appeals and judicial review (q. V.18-V.20); and public and political accountability (q. V.21-V.24).

Case Studies D-1

D- CASE STUDIES

1) L’évaluation du risqué, le principe de précaution ou de prudence et la gestion adaptive: Une étude des cas de l’Agence canadienne de l’inspection des ailments et son approche pour gérer les risques d’introduction d’espèces envahissantes par voie des matériaux d’emballage en bois non traité.

Nathalie J. Chalifour et Yves Prévost…………………………….. D-3

2) The regulation of genetically modified plants: Authorization

of unconfined environmental release.

Jennifer A. Chandler………………………………………………. D-35

3) Potentially practicing precaution: Canadian pesticide regulation and the Pest Regulation Management Agency.

C. Scott Findlay and Annik Déziel……………………………….. D-61

4) Setting tacs in the 4X5Y cod and haddock fisheries.

Dan E. Lane………………………………………………………. D-85

Nathalie Chalifour & Yves Prévost - Une étude de cas de l’Agence canadienne de l’inspection des D-3 aliments et son approche pour gérer les risques d’introduction d’espèces envahissantes par voie des matériaux d’emballageen bois non traité.

L’EVALUATION DU RISQUE, LE PRINCIPE DE PRÉCAUTION OU DE PRUDENCE ET LA GESTION ADAPTIVE

UNE ÉTUDE DE CAS DE L’AGENCE CANADIENNE DE L’INSPECTION DES

ALIMENTS ET SON APPROCHE POUR GÉRER LES RISQUES D’INTRODUCTION D’ESPÈCES ENVAHISSANTES PAR VOIE DES MATÉRIAUX D’EMBALLAGE EN

BOIS NON TRAITÉ.

Nathalie Chalifour Assistant Professor of Law

Faculty of Law University of Ottawa [email protected]

613-562-5800 ext. 3331

et

Yves Prévost Law Student


[email protected]


TABLE OF CONTENTS

I. INTRODUCTION ................................................................................................................... D-7

I.A. Processus de décision existant ................................................................................ D-7 I.A.1. Nature du sujet ......................................................................................... D-7 I.A.2. Nature du processus de décision .............................................................. D-7 I.A.3. Quelle partie du système de décision analyse-t-on et pourquoi? ............ D-8 I.A.4. Nature du décideur ................................................................................... D-8

I.B. Existence ou absence de risque, principe de la précaution et principe de la gestion adaptative ...................................................................................................... D-9

I.B.1. Expériences et définitions ........................................................................ D-9 I.B.2. Aspects particuliers de l’étude de cas .................................................... D-11

I.C. Méthodes ................................................................................................................ D-11 I.C.1. Choix des politiques, du cas à l’étude et des procédures ...................... D-11 I.C.2. Limitation de l’analyse .......................................................................... D-11

II. ÉTUDE DE CAS .................................................................................................................. D-12

II.A. La LACIA, la LPV et le RPV à la lumière des définitions ................................. D-12 II.A.1. Loi sur l’Agence canadienne d’inspection des aliments ....................... D-12 II.A.2. Loi sur la protection de végétaux ......................................................... D-12 II.A.3. Règlement sur la protection de végétaux .............................................. D-13

II.B. Les NIMP 2 et les ARP’s de l’AF et du LA à la lumière des definitions ......... D-14 II.B.1. Normes internationales pour les mesures phytosanitaires n° 2 ........... D-14 II.B.2. Analyse du risque phytosanitaire de l’agrile du frêne (AF) ................. D-15 II.B.3. Analyse du risque phytosanitaire du longicorne asiatique (LA). ......... D-16

II.C. Les règlements additionnels et les directives à la lumière des definitions ...... D-18 II.C.1. Agrile du frêne ..................................................................................... D-18 II.C.2. Longicorne asiatique ............................................................................ D-20

II.D. Application des lois, des règlements et des directives dans la lutte contre l’AF et le LA. ........................................................................................................ D-22

III. OBSERVATIONS ET IMPRESSIONS ........................................................................... D-23

III.A. Risque, prudence et lois environnementales .................................................... D-23 III.B. Application du CAPP par l’ACIA .................................................................... D-25

III.B.1. Principe 4.1 L’utilisation de la précaution est une démarche légitime et particulière de décision dans la gestion du risque. ............ D-25

III.B.2. Principe 4.2 Il est légitime que les décisions soient guidées par le niveau de protection contre le risque que choisit la société. ................ D-25

III.B.3. Principe 4.3 L’application de la précaution doit reposer sur des données scientifiques solides et sur leur évaluation; la nature des données scientifiques et la partie chargée de les produire peuvent changer avec l’évolution du savoir. ..................................................... D-26


III.B.4. Principe 4.4 Il devrait y avoir des mécanismes pour réévaluer le fondement des décisions et pour tenir éventuellement d’autres consultations dans un processus transparent. ..................................... D-26

III.B.5. Principe 4.5 Il convient d’assurer un degré élevé de transparence, de reddition de comptes et de participation du public. ....................... D-26

III.B.6. Principe 4.6 Les mesures de précaution devraient être sujettes à réexamen selon l’évolution de la science, de la technologie et du niveau de protection choisi par la société. .......................................... D-27

III.B.7. Principe 4.7 Les mesures de précaution devraient être proportionnelles à la gravité possible du risque que l’on veut gérer et au niveau de protection choisi par la société. ................................. D-27

III.B.8. Principe 4.8 Les mesures de précaution devraient être non discriminatoires et concorder avec celles prises dans des circonstances similaires. ...................................................................... D-27

III.B.9. Principe 4.9 Les mesures de précaution devraient être efficientes et avoir pour objectif d’assurer (i) un avantage net global à la société au moindre coût et (ii) un choix judicieux de mesures. ........... D-27

III.B.10. Principe 4.10 Lorsque plusieurs options réunissent ces caractéristiques, on devrait choisir celle qui entrave le moins le commerce. ............................................................................................ D-28

IV. CONCLUSION .................................................................................................................. D-28 V. BIBLIOGRAPHIE .............................................................................................................. D-29 VI. ANNEXE I. ABRÉVIATIONS ......................................................................................... D-30


I. INTRODUCTION Cet article offre un cas d’étude de l’application du principe de précaution et de la gestion adaptive par l’Agence canadienne de l’inspection des aliments (ACIA) dans sa gestion des risques d’introduction d’espèces envahissantes au Canada. Les espèces envahissantes posent un grave risque à l’environnement et, dans les cas ou les invasions touchent une ressource économique, peuvent avoir des conséquences importantes pour l’économie. Une approche de précaution peut jouer un rôle important à trouver une équilibre acceptable à la société entre le risque d’introduction de telles espèces et le risque de nuire au commerce international efficace. Le cas d’étude est divisé en trois grandes parties. La première partie offre le contexte pour le cas d’étude, discutant le processus de décision de l’ACIA en ce qui concerne les espèces envahissantes, l’approche de l’Agence au principe de précaution et à la gestion adaptive, et les méthodes du cas d’étude. La deuxième partie offre le cas d’étude, incluant une discussion des textes législatifs et politiques pertinents et l’analyse du risque d’invasion de deux insectes particulières. La troisième partie discute des observations et impressions ressorties du cas d’étude. I.A. Processus de décision existant I.A.1. Nature du sujet Cet article traite de deux insectes ravageurs des forêts canadiennes, accidentellement introduits dans le commerce international avec les matériaux d’emballage de bois non manufacturé et non traité (ME). En juillet 2002, on a découvert l’agrile du frêne, Agrilus planipennis Fairemaire (Coleoptera : Buprestidae) (AF), dans des frênes, Fraxinus spp. (Oleaceae), de la ville de Windsor, dans le comté d’Essex1. En septembre 2003, on a confirmé la présence du longicorne asiatique, Anoplophora glabripennis (Motschulsky) (Coleoptera : Cerambycidae) (LA), dans le parc industriel de Toronto-Vaughan2. Ce dernier ravage plusieurs espèces d’arbres, notamment les érables, Acer spp. (Aceraceae), les peupliers, Populus spp. (Salicaceae), et les saules, Salix spp. (Salicaceae)3. Les effets écologiques et économiques négatifs possibles de ces deux insectes sont importants4. I.A.2. Nature du processus de décision L’Agence canadienne d’inspection des aliments (ACIA) gère le dossier de la protection des végétaux5 et la nature du processus de décision est réglementaire. Ce processus est basé sur les obligations internationales du Canada6 en vertu de la Convention internationale pour la protection des végétaux (CIPV), qui prévoit7 :

[…] reconnaissant la nécessité d’une coopération internationale en matière de lutte contre les organismes nuisibles aux végétaux et aux produits végétaux, et afin de prévenir leur dissémination internationale et spécialement leur introduction dans des zones menacées;[…].


Le Canada a aussi des obligations en vertu de la Convention sur la diversité biologique (CDB)8. Celle-ci énonce que chaque pays est responsable pour sa diversité biologique :

Réaffirmant également que les États sont responsables de la conservation de leur diversité biologique […]

et

[…] que la conservation de la diversité biologique exige essentiellement la conservation in situ des écosystèmes […]

La Loi sur l’Agence canadienne d’inspection des aliments (LACIA)9 fournit les pouvoirs pour appliquer la Loi sur la protection des végétaux (LPV)10 qui établit ce qui est permis, tandis que le Règlement sur la protection des végétaux (RPV)11 dicte la procédure à suivre selon des Normes internationales pour les mesures phytosanitaires (NIMP). L’application de la LPV et du RPV est fondée sur l’analyse du risque phytosanitaire (ARP), qui a pour but12 :

[…] de déterminer si des produits pourraient transporter des parasites ou des maladies capables de s’établir au Canada et d’occasionner des pertes aux agriculteurs ou aux forestiers ou de provoquer des changements environnementaux.

Par la suite, si un risque existe, des règlements additionnels et des directives peuvent émaner de la LPV13 pour empêcher l’entrée ou l’établissement et la propagation des insectes14. I.A.3. Quelle partie du système de décision analyse-t-on et pourquoi? Cet article examine les décisions prises en vertu de la LPV, du RPV, de l’ARP, des règlements additionnels et des directives pour apprécier l’interaction entre les éléments essentiels du processus de filtre contre les insectes ravageurs afin de protéger l’environnement ainsi que l’économie du Canada. L’environnement et l’économie sont protégés par une approche de précaution quand ce principe veille les risques à une ressource. I.A.4. Nature du décideur Un des deux décideurs principaux est le ministre de l’Agriculture et de l’Agroalimentaire en vertu de l’article 4(1) de la LACIA. Le ministre est responsable de la LPV en vertu de l’article 11 de la LACIA. Le ministre peut, en vertu de l’article 15 (2) de la LPV, annuler toute déclaration d’inspecteur; en vertu de l’article 15 (3), déclarer des lieux infestés; en vertu de l’article 20(2), demander une inspection des lieux de transport international; en vertu de l’article 20(3), contrôler tous lieux de transport international pour aussi longtemps que les lieux ne soient pas conformes à la LPV; en vertu de l’article 37, réaliser des prélèvements; en vertu de l’article 39, ordonner le versement d’une indemnité; en vertu de l’article 24(1) de la LACIA et de l’article 44(1) de la LPV, fixer le prix à payer pour la fourniture des services de l’ACIA. Le deuxième décideur principal est l’inspecteur, qui est désigné par le président de l’ACIA en vertu de l’article 13(3) de la LACIA. L’ACIA, à son tour, exerce le rôle de gouverneur


en conseil en vertu de l’article 5 de la LACIA. L’inspecteur peut, en vertu de l’article 7 de la LPV, interdire l’importation de toutes choses qui ne sont pas conformes; en vertu de l’article 11(1), déclarer des lieux infestés; en vertu de l’article 24 (1), disposer de toutes choses lorsque le sceau réglementaire a été brisé; en vertu de l’article 25, inspecter pour vérifier la présence de parasites; en vertu de l’article 28, perquisitionner avec un mandat s’il croit qu’une infraction de la LPV a été commise; en vertu de l’article 29, saisir des choses visées pour une poursuite; et en vertu de l’article 35, confisquer automatiquement toutes choses qui sont des parasites ou parasitisées. En cas de différends, une Commission de révision peut restituer les choses saisies en vertu de l’article 32(3) de la LACIA ou confisquer les choses en vertu de l’article 33. En outre, un évaluateur révise la suffisance des indemnisations en vertu des articles 40 et 43(1). Par ailleurs, le juge de paix peut octroyer un mandat de perquisition en vertu de l’article 28. Finalement, le gouverneur en conseil peut, par règlement, prendre toute mesure d’application de la loi. I.B. Existence ou absence de risque, principe de la précaution et principe de la gestion adaptative I.B.1. Expériences et définitions Les lois canadiennes sur l’économie, l’environnement et la santé semblent passablement contestées. Il y a au moins seize lois canadiennes, sans inclure les lois axées principalement sur la santé et l’économie, qui traitent le risque environnemental comme un élément à considérer lorsqu’un acte est commis15. L’objet est de protéger l’eau, la flore, les animaux, leur habitat contre les déchets dangereux, la pollution et les produits dangereux. Le risque peut être interprété comme un danger, un hasard ou un péril16. Par exemple, l’article 19(1) de la LACIA parle de situation qui « […] présente un risque pour la santé publique ou celle des animaux ou des végétaux ». Le préambule de la LACIA prévoit des méthodes d’inspection fondées sur les risques, y compris la possibilité de « courir le risque », c’est-à-dire de s’exposer au risque. L’article 12(1) de la LACIA utilise la phrase « les parasites risquent à son avis de se propager ». Les lois canadiennes ne se servent pas de l’expression « principe de précaution ». Les premières lois qui ont traité de l’application de la précaution sont la Loi canadienne sur l’évaluation de l’environnement (LCEE) en 1992, la Loi sur les océans (LO) en 1996 et la Loi canadienne sur la protection de l’environnement (LCPE) en 199917. La LCEE parle du « principe de la prudence » ou « precautionary principle »; la LO, du « principe de la prévention » ou « precautionary approach »; et la LCPE, du « principe de la prudence » ou « precautionary principle ». Selon le dictionnaire, la prévention signifie « aller au devant pour faire obstacle; empêcher par ses précautions »18. La précaution signifie « la disposition pour éviter le mal ou en atténuer l’effet »19. La prudence souligne « l’attitude d’esprit réfléchissant à la portée et aux conséquences de ses actes »20. Selon le dictionnaire, la traduction de « precaution » de l’anglais au français est bel et bien précaution21. La prévention et la prudence semblent donc de portée plus grande que la précaution, car les deux premiers termes font référence à des gestes plutôt actifs afin d’éviter le danger, tandis que la précaution est un terme plus passif qui suggère une réaction aux situations.


En septembre 2001, le gouvernement fédéral a publié un document de consultation qui hésite à utiliser l’expression « principe de précaution », lui préférant plutôt l’expression « approche de précaution »22. Une explication possible de ce choix est que le terme « principe » pourrait suggérer une opinio juris de la part du Canada en matière de la précaution, ce qui pourrait avoir des répercussions sur le plan du développement du droit international coutumier23. En mars 2002, l’ACIA a participé à l’élaboration d’un plan de mise en application de la précaution au sein du gouvernement fédéral, Cadre d’application de la précaution dans un processus décisionnel scientifique en gestion du risque (CAPP)24, en discutant le document de consultation25. Par la suite, en juin et décembre 2002, le Parlement a sanctionné trois lois qui appliquent finalement le « principe de la prudence » : la Loi sur les aires marines nationales de conservation du Canada, la Loi sur les produits antiparasitaires et la Loi sur les espèces en péril26. Le Canada semble avoir décidé que la prudence était plus appropriée que la précaution pour la prise de décisions environnementales. Même si aucune des dix lois régies par l’ACIA en vertu de l’article 11(1) de la LACIA ne mentionne le principe de la prudence, à l’heure actuelle la politique de l’ACIA reflète la définition suivante de précaution27 :

L’application de la « précaution » exprime l’idée qu’il ne faut pas invoquer l’absence de certitude scientifique complète pour différer les décisions comportant un risque de préjudice grave ou irréversible. Au Canada, l’application de la précaution est intrinsèque à la prise de décisions scientifiques pour gérer le risque, et se caractérise par trois éléments fondamentaux : la nécessité de prendre une décision, l’existence d’un risque de préjudice grave ou irréversible et l’absence de certitude scientifique absolue.

Cette définition inclut les trois éléments – le préjudice, l’incertitude et la prise de décision – notés dans le CAPP. Notre étude de cas démontre que la politique semble guider les décisions du corps professionnel de l’ACIA, au moins dans cette situation particulière. En plus de la prudence, il y a trois autres éléments à considérer : 1) le fardeau de preuve, 2) l’application transparente du principe et 3) l’examen de toutes les options prévues dans la définition de précaution de Wingspread, partagée dans les délibérations28 :

Quand une activité menace la santé ou l’environnement, des mesures de précaution s’imposent même lorsque le rapport de cause à effet n’est pas clair du point de vue scientifique. Le fardeau de la preuve appartient alors au promoteur et non au public. Le processus d’application du principe de précaution doit être ouvert, éclairé et démocratique, inclure les parties vulnérables et comporter un examen de toutes les possibilités, y compris l’absence de mesures.

Ces options devraient être explicitement incluses dans les lois sur l’environnement, la santé et l’économie. La gestion adaptative suppose l’utilisation des hypothèses et de l’adaptation en cas de résultats inattendu. Une forme de gestion adaptative formule des politiques pour voir les réactions des écosystèmes aux changements des comportements humains vivant dans ces systèmes29. En réponse aux réactions des écosystèmes, les politiques sont modifiées afin d’encourager de nouveaux comportements humains. Ce mécanisme permet une « symbiose » entre l’écosystème et les humains qui y vivent. L’aménagement d’un écosystème peut alors se faire par l’application de politiques via la législation, en autant que la législation est suffisamment flexible pour permettre cette adaptation.


Les lois canadiennes parlent très peu de la gestion adaptative explicitement. Il semble y en avoir une seule mention dans la LCEE30. Cependant tous les systèmes réglementaires qui octroient des permis, établissent des quotas et proposent des mesures de surveillance reflètent une forme ou une autre de gestion adaptative. En plus, la gestion adaptative encadrée par des règlements comprend un système de décision afin d’éviter tout préjudice grave sous un parapluie d’incertitude, très semblable à la prudence. La gestion adaptative suppose un effort pour encourager l’activité, mais en stabilisant les effets néfastes potentiels en changeant les comportements par les règlements. La gestion adaptative est donc un outil commun dans les lois. I.B.2. Aspects particuliers de l’étude de cas

a) Examen de la LACIA, de la LPV, du RPV à la lumière des définitions du risque ou de l’incertitude, de la précaution et de la gestion adaptative; b) Étude des Normes internationales pour les mesures phytosanitaires n° 2 (NIMP 2)31 et des ARP’s de l’AF et du LA à la lumière des définitions du risque ou de l’incertitude, de la précaution et de la gestion adaptative. c). Analyse des règlements additionnels et des directives pour l’AF et le LA à la lumière des définitions du risque ou de l’incertitude, de la précaution et de la gestion adaptative en suivant l’évolution de ces textes. d) Observation de l’application des lois, des règlements et des directives dans le combat contre l’AF et le LA.

I.C. Méthodes I.C.1. Choix des politiques, du cas à l’étude et des procédures La prise de décision par l’ACIA est au cœur de cette étude. Nous avons choisi parmi les cas de l’AF et du LA gérés par cette agence, en tenant compte de leur caractère actuel, de leur importance et du fait que beaucoup de décisions ont été prises relativement à ces deux insectes. Nous avons reçu une orientation générale de l’ACIA par l’intermédiaire de madame Doreen Watler. Nous avons aussi obtenu les ARP’s pour l’AF (PHDP request : 2002-2832) et le LA (PHD request : 98-5633) de monsieur Gordon Henry de l’ACIA. Les politiques et les procédures ont été sélectionnés parce qu’ils font partie intégrale des connaissances essentielles pour l’analyse de la prise de décisions en matière de l’AF et du LA. I.C.2. Limitation de l’analyse L’ACIA a pour mandat de s’occuper des dossiers de l’AF et du LA en provenance des ME importés au Canada par voie du commerce international. Par conséquent, l’analyse se limite aux


données de l’ACIA. Le Service canadien de forêts et les ministères des Ressources naturelles des différentes provinces travaillent en collaboration avec l’ACIA, mais nous n’analysons pas leurs décisions. Les CIPV et CDB ne sont pas incluses dans l’analyse, ni d’ailleurs les décisions américaines relativement à l’AF et au LA. II. ÉTUDE DE CAS II.A. La LACIA, la LPV et le RPV à la lumière des définitions II.A.1. Loi sur l’Agence canadienne d’inspection des aliments Le préambule de la LACIA suggère une forme de prudence qui comporte trois éléments qui fondent la politique de l’ACIA : le préjudice, l’incertitude et la prise de décision. Ce passage incorpore ces trois éléments :

[…] agence unique contribuera à la protection des consommateurs et facilitera l’application uniforme et coordonnée des normes de salubrité, de sécurité et de qualité et des méthodes d’inspection fondées sur les risques. (soulignement ajouté)

La « protection » représente l’élément de préjudice; l’« application uniforme » a trait à la prise de décision et, enfin, le « risque » suggère l’incertitude, avec un élément de danger. Le fait que le principe de la prudence soit énoncé dans le préambule de la loi de mise en œuvre de l’ACIA indique que le fonctionnement de l’ACIA sera fortement influencé par la prudence. Par conséquent, les lois nommées à l’article 11(1) de la LACIA tombent toutes sous la coupole de la prudence, même si la prudence n’est pas mentionnée explicitement dans le texte. L’article 19(1) de la LACIA est explicite et confirme que les lois nommées à l’article 11(1) sont régies par le principe de la prudence. Par conséquent, la LACIA est une loi préventive qui vise à prévenir les difficultés du commerce international et les conséquences environnementales négatives. Le préambule indique aussi un aspect de gestion adaptative en parlant des inspections entreprises afin de dégager du comportement humain de nouvelles données utiles pour modifier une politique. Ces inspections sont menées en cas d’incertitudes scientifiques afin d’éviter un préjudice. L’article 22 expose clairement la révision des procédures de fonctionnement de l’ACIA tous les cinq ans. Cette révision pourrait être basée sur les expériences de l’ACIA dans l’application des lois, des règlements et des politiques. II.A.2. Loi sur la protection de végétaux Le préambule de la Loi sur la protection des végétaux prévoit :

Loi visant à empêcher l’importation, l’exportation et la propagation des ennemis des végétaux et prévoyant d’une part, les moyens de lutte et d’élimination à cet égard et, d’autre part, la délivrance de certificats à l’égard de plantes et d’autres choses.


Ce préambule illustre donc un aspect de la gestion adaptative, en exigeant l’octroi de certificats à l’égard des plantes. L’objet de la LPV dénote des aspects de la prudence, notamment l’élément du préjudice souligné par la protection de la vie végétale et la décision suggérée par l’action afin d’empêcher le mouvement, en assurant une défense. Il manque cependant l’élément de l’incertitude scientifique pour que cet objet soit un énoncé clair du principe de la prudence. Le risque, le danger ou l’incertitude scientifique est parfois souligné par les articles 5 et 37(1). Par contre, lues de paire avec l’objet de la LPV, ces dispositions constituent le principe de la prudence. La gestion adaptative cherche à changer le comportement humain par l’intermédiaire d’autorisations, de certificats ou d’autres documents, ainsi que par l’inspection. Ce principe est énoncé aux articles 6(1), 6(2), 7(1), 8, 11, 12, 13, 14, 15(3), 16, 19, 20(2), 20(3), 20(4), 24, 28, 30, 33(1) et 34(1). L’exécution de ces articles se fait dans le cas d’incertitudes scientifiques afin d’éviter un préjudice; ensemble ces dispositions donnent lieu à une gestion adaptative. On peut donc considérer que ces articles incorporent un élément de la prudence, puisqu’ils contiennent les trois éléments de la prudence. Ces articles se transforment cependant en gestion adaptative lorsqu’ils fournissent un mécanisme de changement du comportement humain. La précaution peut être un acte qui ne change pas nécessairement le comportement. Les infractions et les peines sont clairement des dispositions qui tentent de changer le comportement humain. Par conséquent, les articles 48, 49 et 50 suggèrent une gestion adaptative, lorsqu’on les lit de paire avec l’objet.

Le principe de la précaution semble clairement inclus dans les articles 25, 26, 32(1), 35 et 36 (qui ne dénote aucune tentative de changer le comportement humain) car l’action de l’inspecteur comporte les trois éléments. Même s’il y a un avis ou une constatation, ce sont des annonces seulement qui ne cherchent pas à changer le comportement humain; la décision est prise, et tout changement de comportement n’est pas le fait de la décision. II.A.3. Règlement sur la protection de végétaux L’incertitude scientifique est soulignée à l’article 4. Lu de paire avec l’objet de la LPV, l’article 4 semble constituer le principe de la prudence, car il inclut les trois éléments. Le principe de la prudence semble présent dans les articles 3, 11, 16(1), 26(1), 27 et 32. L’action de l’inspecteur comporte directement ces trois éléments. La gestion adaptative est suggérée aux articles 5, 16(2), 18, 19, 20, 21, 22, 23, 29, 30, 31, 34, 37, 38, 39, 40, 41, 42, 43, 44 ainsi qu’aux parties III et IV qui comportent les trois éléments qui accompagnent un changement de comportement. Les articles, 8, 9 et 10 sont de simples interdictions, mais lus avec l’objet de la LPV ils constituent une gestion adaptative. Ces articles, en effet, incluent les trois éléments ainsi que l’élément de changement du comportement.


II.B. Les NIMP 2 et les ARP’s de l’AF et du LA à la lumière des definitions Afin de mieux apprécier les ARP’s, il faut examiner attentivement les NIMP n° 2. Ces normes sont appliquées dans les ARP’s. II.B.1. Normes internationales pour les mesures phytosanitaires n° 2 Selon l’article 1, il y a deux points de départ pour une ARP : 1) l’identification d’une filière qui est susceptible d’introduire des organismes de quarantaine ou 2) l’identification d’un organisme nuisible (ON) qui remplit les conditions en tant qu’organisme de quarantaine (OQ). Selon les définitions inclus dans les NIMP 2, un OQ est défini comme suit:

Organisme nuisible qui a une importance potentielle pour l’économie de la zone menacée et qui n’est pas encore présent dans cette zone, ou bien qui y est présent, mais à distribution restreinte, et faisant l’objet d’une lutte officielle.

L’article 1.1 énumère cinq situations où une filière peut déclencher une ARP : une nouvelle marchandise, l’importation d’une nouvelle espèce végétale, une nouvelle filière d’importation, une révision des dispositions phytosanitaires et un nouveau processus ou de l’information nouvelle relativement à une décision antérieure. L’article 1.2 énumère dix situations où un nouvel ON peut déclencher une ARP : une nouvelle infestation, une découverte d’un nouvel ON, une nouvelle ARP pour un ON, un nouvel ON dans une nouvelle région, des effets d’un ON plus nocifs que dans le lieu d’origine ou la zone de l’ARP, des contrôles indiquant l’interception fréquente d’un ON, une demande d’importation d’un organisme, de nouvelles politiques relatives à un ON connu, une proposition par un autre groupe et un nouveau processus ou de l’information nouvelle relativement à une décision antérieure. Ces dix situations créent un climat d’incertitude scientifique qui oblige l’ACIA à exercer son mandat de protection de l’environnement, de la santé et de l’économie des Canadiens. Une fois que l’ON est identifié, l’ON est analysé sur plusieurs fronts. Premièrement, selon l’article 2, il faut déterminer si l’ON est un organisme de quarantaine, selon la définition. Par la suite, il faut considérer la distribution géographique, la biologie et l’importance économique. L’article 2.1 a trait à l’aspect géographique, c’est-à-dire à la détermination de la zone de l’ARP. C’est là un critère clé pour la définition d’un OQ. Cinq situations sont possibles; les trois premières qualifient l’ON en tant qu’OQ : l’ON n’est pas encore présent mais pourrait le devenir; l’ON est présent, n’a pas atteint ses limites écologiques et est officiellement combattu dans la zone de l’ARP; l’ON est présent, n’a pas atteint ses limites écologiques et n’est pas combattu officiellement dans la zone de l’ARP mais pourrait l’être; l’ON est présent et a atteint ses limites écologiques; enfin, l’ON est présent, n’a pas atteint ses limites écologiques et n’est pas combattu officiellement. Combattre officiellement l’ON et le qualifier d’OQ est donc une question de politique. Si l’ON satisfait aux exigences pour être considéré un OQ, l’analyse biologique continue. Selon l’article 2.2, on considère ensuite le potentiel d’établissement et de dissémination. Selon les définitions, l’établissement consiste en « la perpétuation, dans un avenir prévisible, d’un


organisme nuisible dans une zone après son entrée. » C’est ici qu’on aura besoin des services d’un ou d’une entomologiste qui puisse fournir des données sur la présence et la quantité des hôtes, la qualité de l’écosystème pour l’ON, la reproduction de l’ON et sa survie. C’est relativement facile d’obtenir des données de qualité pour répondre aux exigences de cette étape. Les seules difficultés sont le temps et les ressources nécessaires pour combler les trous de connaissances. Si l’ON peut s’établir, l’analyse de la dissémination continue. Selon les définitions, la dissémination consiste en l’« extension de la répartition géographique d’un organisme nuisible à l’intérieur d’une zone. » Un ou une entomologiste peut fournir des données sur le déplacement de l’ON dans un milieu naturel ou modifié par les humains, la distribution de l’ON dans le paysage et les ennemis naturels potentiels dans la zone de l’ARP. Un ou une économiste peut fournir des données sur l’utilisation et le déplacement de la marchandise. Cette étape de l’analyse est également importante pour prédire s’il est possible d’éradiquer l’ON de la zone de l’ARP. Les seules difficultés pour l’obtention de ces données sont le temps et les ressources. Le degré de dissémination joue un rôle important pour évaluer le potentiel économique. Plus la dissémination est grande, plus importantes seront les répercussions négatives. L’article 2.2.3 énumère huit facteurs à prendre en ligne ce compte : les types de dégâts, les dommages écologiques et les coûts sociaux. S’il n’y a pas de risque économique, l’analyse se termine. La dernière étape consiste à évaluer le potentiel d’introduction. À cette fin, on doit analyser la filière avec les pays exportateurs. Selon les définitions, l’introduction consiste en l’« entrée d’un organisme nuisible, suivie de son établissement. » L’entrée consiste en l’« arrivée d’un organisme nuisible dans une zone où il est absent ou présent mais à distribution restreinte et faisant l’objet d’une lutte officielle. » Selon l’article 3, cinq facteurs influencent la probabilité d’entrée : l’ON contamine la marchandise au moyen du transport; la survie de l’ON pendant le transport; la difficulté de détecter l’ON; la fréquence et la quantité d’ON par déplacement; enfin, la fréquence et nombre de personnes qui pourraient transporter l’ON. L’établissement dépend des facteurs biologiques de l’environnement, mais aussi de la fréquence et de la quantité d’ON disséminée lors des déplacements et l’usage prévu de la marchandise. Si l’ON est un OQ, qui peut s’introduire, s’établir, disséminer et entraîner des conséquences économiques, l’ON présente un risque de préjudice grave, alors l’ARP prend fin et le mécanisme de gestion du risque phytosanitaire est déclenché afin de ramener les risques à un niveau acceptable. Les mesures doivent être proportionnelles aux risques et sont mises en œuvre en conformité avec les lois, les règlements, les politiques et les autres instruments. II.B.2. Analyse du risque phytosanitaire de l’agrile du frêne (AF) L’AF est un coléoptère asiatique introduit au Canada qui ravage les frênes, les ormes, Ulmus spp. (Ulmaceae), et les noyers, Juglans spp. (Ulmaceae), en forant les troncs et les branches et en détruisant le système vasculaire de l’arbre. Les incidences environnementales et économiques possibles sont élevées34. Après les premières découvertes de l’AF à Windsor en Ontario et au Michigan en 2002 et prévoyant sa dissémination dans la région, l’ACIA a préparé une ARP. Il semble que l’AF était déjà établie en Ontario et au Michigan depuis cinq ans. La zone de l’ARP est tout le Canada, selon l’article 1.1.2.


L’AF se qualifie comme OQ, car l’insecte est présent dans la zone, fait l’objet d’un combat officiel et présente un potentiel économique élevé. Les quatre filières d’introduction de l’AF, selon l’article 3.3, sont :1) les ME, 2) le bois de chauffage, 3) les grumes (bois avec écorce) et 4) le matériel de pépinière. Les trois premières filières posent un potentiel d’introduction élevé, tandis que le dernier pose un potentiel moyen. Le potentiel d’introduction de l’AF via les ME, le bois de chauffage et les grumes, est élevé, car les larves hivernent dans le bois et peuvent survivre à de dures conditions durant le passage de la marchandise. De plus, les ME et le bois de chauffage sont distribués partout au Canada. Le plus grand risque d’introduction est le fait que l’AF est répandu partout en Chine, de laquelle le Canada reçoit énormément de cargaisons emballées avec du frêne. Le Canada a déjà intercepté l’AF à plusieurs reprises dans des cargaisons en provenance de la Chine. Le potentiel d’établissement de l’AF est élevé selon l’article 3.4.1. Les frênes, les noyers et les ormes leur servant d’hôtes sont nombreux au Canada et s’étendent tout le long de la frontière américaine, où le climat est favorable à l’AF. Cet insecte est très flexible dans son cycle vital, détient un taux de reproduction de 77 œufs par femelle et peut survivre aux hivers canadiens. Le potentiel de dissémination naturel de l’AF est moyen selon l’article 3.4.2. L’AF se déplace localement sur une distance de huit à dix mètres, et parfois en cherchant de nouveaux habitats l’AF peut se déplacer de quelques kilomètres. Le potentiel d’ennemis naturels est inconnu. Il y en a probablement très peu, car l’AF passe la grande partie de son cycle vital caché; habituellement ces introductions accidentelles n’ont pas d’ennemis naturels. Le potentiel de dissémination par le déplacement des ME, du bois de chauffage et des matériaux de pépinière sont autant d’occasions de dissémination de l’AF. Le potentiel économique de l’AF est élevé selon l’article 3.4.3, car trois genres de feuillus importants sont attaqués et meurent à tous les stages de leurs vies. Les conséquences négatives incluent le coût pour enlever les arbres morts afin d’éviter que ceux-ci n’entraîne d’autres dommages, le coût de remplacement des arbres, la perte de la valeur des arbres pour la construction de meubles et de charpente et la perte des bénéfices écologiques fournis par les arbres naturels ou urbains. Finalement, l’incertitude scientifique est moyenne et le risque général est élevé selon l’article 3.5. Les scientifiques n’ont pas beaucoup de données sur le comportement de l’AF et ne peuvent donc prédire très bien comment l’AF se déplacera sur le terrain. On doit aussi souligner qu’il y a un manque de données sur les ennemis naturels qui peuvent exercer un certain contrôle sur les populations d’AF. La filière des ME suscite le plus d’ennuis. Le commerce entre le Canada et la Chine est en plein essor; l’ACIA a donc fourni une directive spécifique pour régler ce trafic. Cette croissance et ce volume de commerce augmentent le risque général. En outre, l’AF est maintenant établi au Canada, où le climat est propice et où il y a une abondance d’arbres hôtes. L’AF est adaptable et peut se déplacer sur des distances moyennes. II.B.3. Analyse du risque phytosanitaire du longicorne asiatique (LA) Le LA est un coléoptère asiatique introduit qui ravage les érables, les peupliers et les saules parmi tant d’autres espèces en forant les troncs et les branches et en détruisant le système vasculaire de l’arbre. Les conséquences environnementales et économiques possibles du LA sont


élevé35. Après les premières découvertes du LA à Toronto-Vaughan en Ontario en septembre 2003,36 à New York en 1996 et dans l’Illinois en 199837, craignant une présence plus grande encore du LA dans la région, l’ACIA a préparé une ARP en 1998 et vient d’en faire la révision en 2004. La zone de l’ARP est tout le Canada, selon l’article 1.1.2. Le LA se qualifie comme OQ, car l’insecte est présent dans la zone, fait l’objet d’un combat officiel et présente un potentiel économique élevé. Les quatre filières d’introduction du LA, selon article 3.3, sont : 1) les ME, 2) les matériaux de pépinière, 3) le bois de chauffage, les grumes (bois avec écorce), le bois de charpente et 4) l’écorce et les copeaux. Le premier pose un potentiel d’introduction élevé, le second, un potentiel moyen et les deux derniers, un potentiel bas. Le potentiel d’introduction du LA via les ME est élevé, car les larves hivernent dans le bois et peuvent tolérer les dures conditions pouvant survenir durant le passage de la marchandise. De plus, les ME sont distribués partout au Canada. Le plus grand risque d’introduction est le fait que le LA est répandu partout en Chine, de laquelle le Canada reçoit beaucoup de cargaisons emballées avec du bois provenant de toutes les espèces d’arbres de la Chine. Le Canada a déjà intercepté le LA à plusieurs reprises dans des cargaisons en provenance de la Chine. Le potentiel d’établissement du LA est élevé selon l’article 3.4.1. Les érables, les peupliers, les saules et au moins huit autres espèces d’arbres leur servent d’hôtes. Ces espèces sont nombreuses au Canada et s’étendent le long de la frontière américaine, où le climat est favorable au LA. Cet insecte est très flexible dans son cycle vital, détient un taux de reproduction de 50 à 200 œufs par femelle et peut survivre aux hivers canadiens. Le potentiel de dissémination naturel du LA est bas selon l’article 3.4.2. Le LA se déplace localement sur une distance de 25 à 46 mètres et peut se déplacer jusqu’à un maximum de 426 mètres. Le potentiel d’ennemis naturels est inconnu. Il y en a probablement très peu, car le LA passe la grande partie de son cycle vital caché et habituellement ces introductions accidentelles n’ont pas d’ennemis naturels. Le potentiel de dissémination par le déplacement des ME, du bois de chauffage et de matériaux de pépinière présentent d’autres occasions de dissémination du LA. Le potentiel économique de l’AF est élevé selon l’article 3.4.3, car le LA s’attaque à au moins onze espèces importantes de feuilluse, en tuant plusieurs à tous les stages de leur vie. Les conséquences négatives incluent le coût d’enlèvement des arbres morts pour éviter que d’autres dommages ne surviennent, le coût de remplacement des arbres, la perte de la valeur des arbres pour la construction de meubles et de charpente, la perte des bénéfices écologiques fournies par les arbres naturels ou urbains. En particulier, leur ravage des érables risque de diminuer la production de sirop d’érable, de nuire au commerce de l’acériculture et à la préservation du patrimoine culturel lié cette production. Enfin le risque général est moyen selon l’article 3.5. Encore, la filière des ME suscite le plus d’ennuis. Les autres raisons sont semblables celles évoquées plus haut relativement à l’AF. Le LA est maintenant établi au Canada, où le climat est propice à son développement et où il y a une plus grande quantité d’arbres hôtes. De plus, le LA est adaptable et peut se déplacer sur des distances moyennes. Les scientifiques sont incertains à propos du taux de fécondité et des ennemis naturels.


II.C. Les règlements additionnels et les directives à la lumière des definitions II.C.1. Agrile du frêne II.C.1a. Ordonnance sur les lieux infestés par l’agrile du frêne(OLIAF) À la suite des enquêtes préliminaires effectuées en 2002 dans le but de déterminer l’étendue de la distribution de l’AF en Ontario38, le ministre, en vertu de l’article 15(3) de la LPV, a déclaré le 17 septembre 2002 la partie Ouest du conté d’Essex lieux infestés par l’AF et vise à restreindre :

le déplacement des produits réglementés (notamment le matériel de pépinière, les arbres, les billes, le bois d’œuvre et le bois avec écorce, les copeaux de bois ou les morceaux d’écorce provenant d’arbres du genre Fraxinus, de même que le bois de chauffage de toutes les espèces et les véhicules qui ont servi au transport de ces produits et qui n’ont pas été traités de façon à éliminer l’agrile du frêne) hors de la zone déclarée infestée par le ravageur (soit les villes de Windsor, Amherstburg, Essex, LaSalle et Tecumseh)39.

L’utilisation de l’article 15(3) est un exemple classique de la gestion adaptative, où l’on apprend par l’action. En vertu de l’article 4 de l’OLIAF, le transport du produit réglementé est interdit, sauf avec l’approbation d’un inspecteur, ce qui représente un mesure pour changer le comportement. Pour complémenter l’ordonnance et faire connaître les attentes du gouvernement à la population, une énorme campagne médiatique est entreprise dans le Sud-Ouest de l’Ontario et dans les États avoisinants. Ces campagne comprend des centaines d’entrevues, des publications, des affiches, des discussions avec les entreprises arboricoles de la région et des efforts de sensibilisation des douaniers40. La politique sert d’expérience; d’abord pour étudier l’établissement de l’insecte, mais aussi sa propagation dans une zone cernée et, deuxièmement, pour vérifier l’adaptation des citoyens à la nouvelle politique. II.C.1b. Exigences phytosanitaires D-03-0841 À la suite de l’ARP de l’AF indiquant que la probabilité d’entrée de l’AF était élevée42, une directive est publiée selon la liste de distribution, afin que tous nos partenaires économiques soient au courrant des nouvelles exigences sanitaires du gouvernement du Canada régissant :

[…] l’importation et le transport en territoire canadien de matériel de pépinière, d’arbres, de grumes, de bois avec écorce, de copeaux de bois ou d’écorce et de bois de chauffage provenant d’arbres du genre Fraxinus (communément appelé frêne) pouvant contenir des agriles du frêne (Agrilus planipennis) à tout stade de leur développement43.

Cette directive constitue de la gestion adaptative et impose un changement de comportement aux commerçants étrangers afin de protéger l’environnement, la biodiversité et l’économie canadiens. Tous les produits réglementés non conformes sont renvoyés ou disposés44. La révision de la directive tous les deux ans indique la reconnaissance des nouvelles données, ce qui caractéristique de la gestion adaptative. Cette directive répond à notre obligation internationale en vertu la CIPV, de la CBD et des attentes des États-Unis en matière de la lutte contre l’AF.


II.C.1c. Ordonnance sur les lieux infestés par l’agrile du frêne 2003 (OLIAF03)45 L’inspection effectuée pendant l’été et à l’automne 2003 dans le comté d’Essex a révélé une infestation importante hors des lieux infestés déclarés par l’ordonnance. Réagissant à ces nouvelles données d’une façon adaptative, le ministre, en vertu de l’article 15(3) de la LPV, rend une nouvelle ordonnance le 17 novembre 2003. Celle-ci agrandit la superficie des lieux infestés déclarés à la totalité du comté d’Essex. II.C.1d. Règlement sur la création d’une zone sans frêne (RCZSF)46 De concert avec l’agrandissement des lieux infestés, le ministre, en vertu de l’article 47 de la LPV, crée une zone de dix kilomètres sans frênes (ZSF) entre le 26 janvier et le 31 mars 2004 qui est subventionnée par l’ACIA47 afin d’endiguer l’AF.

En plus de définir les limites du secteur qui fait partie de la zone, le règlement limitera l’entrée dans la zone, la sortie de la zone et le déplacement à l’intérieur de la zone des produits forestiers du frêne, y compris du matériel de pépinière et du bois de chauffage. Ces restrictions visent également la plantation et le déplacement de ce matériel48.

L’objet est de créer une barrière physique afin de prévenir la dissémination de l’AF vers l’est. Cette politique est basée sur le fait biologique que l’AF se déplace habituellement localement sur une distance de huit à dix mètres; parfois, en cherchant de nouveaux habitats. l’AF peut se déplacer de quelques kilomètres49. La création de la ZSF est une approche expérimentale, appliquée pour la première fois, afin de vérifier si cette barrière peut freiner la dissémination de l’insecte. Le préjudice peut être énorme; il a beaucoup d’incertitude scientifique, et une décision doit être prise rapidement. Il est intéressant de noter qu’une évaluation environnementale est exclue lors de cette intervention, car l’article 7 b) de la LCEE exempte d’une telle évaluation les situations de crise nationale :50

7. (1) N’ont pas à faire l’objet d’une évaluation en application des articles 5 ou 8 à 10.1 les projets :

[…] b) qui sont mis en oeuvre en réaction à des situations de crise nationale pour lesquelles des mesures d’intervention sont prises aux termes de la Loi sur les mesures d’urgence;

La menace que pose l’AF aux frênes du Canada est clairement une crise nationale. Cette décision dans le cadre de la LCEE souligne la prudence, puisqu’il y a les trois éléments, mais qu’aucun comportement humain ne doit être changé. Les fondements scientifiques proviennent de la Chine, où les frênes ont été ravagés par l’AF et l’on craint que l’AF ne se comporte pareillement au Canada. En appliquant ces données nous pouvons tirer la conclusion qu’un préjudice grave est imminent; il faut donc prendre une décision par mesure de prudence afin de préserver nos frênes et empêcher par règlement l’introduction de l’insecte dans le pays et sa dissémination de son point initial d’introduction.


II.C.1e. Règlement sur l’indemnisation relative aux parasites forestiers introduits (RIRPFI)51 À la suite de l’abattage d’environ 80 000 arbres dans les comtés d’Essex et de Chatham-Kent, le gouvernement offre d’indemniser le remplacement de ces arbres avec des arbres non hôtes. En vertu des articles 39(1) a) et 47 q) de la LPV, le ministre prend ce règlement en juin 2004 afin d’indemniser, dans certaines limites, les propriétaires de frênes de la ZSF et des lieux infestés qui ont reçu un avis d’enlever leurs arbres susceptibles d’attaques par l’AF. Cette politique encourage la collaboration des citoyens et le partage des coûts afin de trouver une solution à l’envahissement de l’AF sur le territoire canadien. Cette action renforce le nouveau comportement d’éviter de cultiver des frênes et d’autres espèces afin de prévenir la dissémination de l’AF. Les résultats de cette expérience ne seront disponibles que dans quelques années. II.C.2. Longicorne asiatique II.C.2a. Exigences relatives à l’entrée au Canada des matériaux d’emballage D-98-0852 À la suite de l’ARP de le LA indiquant la haute probabilité d’entrée de l’AF par les ME en provenance du commerce international53, une directive est publiée selon la liste de distribution afin que tous nos partenaires économiques soient au courant des nouvelles exigences sanitaires du gouvernement du Canada régissant :

[…]tous les matériaux d’emballage en bois non manufacturé, y compris les pièces de calage, palettes et caisses, à leur entrée au Canada en provenance de toutes les régions du monde, à l’exception de la zone continentale des États-Unis. Elle précise également les méthodes de destruction ou transformation à utiliser pour les matériaux d’emballage en bois réglementés qui ne respectent pas ces exigences54.

Cette directive est un autre exemple de gestion adaptative, semblable à la directive D-03-08 qui impose un changement de comportement chez tous les commerçants étrangers utilisant des ME, sauf les américains. Les ME ne sont pas permis; le bois doit être traité pour le passage de biens sur le territoire canadien. Aucun permis n’est requis, mais l’importateur doit fournir un certificat phytosanitaire ou un marquage approuvé par l’organisation régionale pour la protection des végétaux. Les certificats sont acceptés seulement jusqu’au premier avril 2005. Par la suite, les ME doivent tous porter un marquage reconnu pour le passage de biens au Canada55. Cette directive est révisée tous les cinq ans; en juin 2004 des changements importants y ont été apportés. Le Canada a adopté la Norme internationale pour les mesures phytosanitaires no 15 (NIMP 15)56, l’incorporant dans la directive. Le Canada normalise ainsi les mesures approuvées pour le traitement des ME et le marquage accepté comme preuve d’un traitement approuvé. Le Canada et les États-Unis ont aussi ratifié un accord bilatéral relativement à l’adoption des NIMP 1557, lesquelles entreront en vigueur le 16 septembre 200558. C’est un effort de création d’une zone régionale libre de restrictions administratives afin de faciliter l’échange et le commerce. Cet acte réciproque reflète une confiance respective dans la gestion du risque


acceptable déterminé par les NIMP 15. C’est de la gestion adaptative ou l’on apprend par l’action, mais l’erreur est ici plus coûteuse qu’à l’interne. Cette directive vise également l’AF. II.C.2b. Exigences relatives à l’importation des matériaux d’emballage provenant de la Chine D- 98-1059 Il y a eu au Canada et au États-Unis plusieurs interceptions de LA dans des ME provenant de la Chine et de la région administrative spéciale de Hong Kong (Chine).60 En conséquence, des exigences plus rigoureuses sont imposées à la Chine qu’aux autres pays; le passage de biens n’est garanti que si le connaissement est accompagné d’un certificat phytosanitaire ou d’un certificat de fumigation ou de désinfection délivré par l’organisme de la Chine responsable de la protection des végétaux, attestant la conformité aux modalités de la directive. Le gouvernement semble vouloir prendre le chemin de la prudence pour éviter un préjudice grave et irréversible. Cette directive vise aussi l’AF. Cette directive a été annulée en janvier 2004, car les protocoles chinois pour le traitement des ME sont maintenant conformes aux normes internationales. C’est un très bon exemple de gestion adaptative, c’est-à-dire de modification d’une directive en fonction de nouvelles données61. II.C.2c. Ordonnance sur les lieux infestés par le longicorne asiatique (OLILA)62 À la suite des inspections préliminaires effectuées à la fin de 200363 dans le but de déterminer l’étendue de la distribution du LA à Toronto-Vaughan, le ministre présente un plan d’éradication du LA et lance une campagne médiatique pour encourager les gens à ne pas transporter de bois de chauffage de la région infestée afin de limiter la dissémination du LA64. Cette politique est fondée sur le fait biologique que le LA se déplace localement de 25 à 46 mètres, et jusqu’à un maximum de 426 mètres65, et que la coupe des arbres hôtes est la méthode la plus fiable pour éradiquer le LA66. Enfin, le 13 février 2004, le ministre, en vertu de l’article 15(3) de la LPV, déclare la région de Toronto-Vaughan lieux infestés et rend l’OLILA dans le but d’empêcher la propagation du LA à l’extérieur de la zone de quarantaine.

Des interdictions et des restrictions sont maintenant imposées relativement au transport de matériel de pépinière, des arbres, des feuilles, des billes, du bois d’œuvre, du bois, des copeaux de bois ou des copeaux d’écorce provenant d’arbres hôtes du LA et du bois de chauffage de toutes les espèces d’arbres. À moins qu’un certificat de circulation ait été délivré, le déplacement des produits réglementés hors de la zone réglementée est interdit67.

C’est la même stratégie que celle utilisée pour lutter contre l’AF, avec une différence importante : l’interdiction de circulation du produit réglementé se fait dans le plus grand centre urbain canadien. C’est une méthode de gestion adaptative par une politique obligeant les habitants de Toronto-Vaughan à s’adapter aux nouvelles exigences du gouvernement.


II.C.2d. Règlement sur l’indemnisation relative aux parasites forestiers introduits À la suite de l’abattage d’environ 15 000 arbres dans la région de Toronto-Vaughan, le gouvernement offre d’indemniser le remplacement de ces arbres par des arbres non hôtes68. La discussion de l’AF s’applique également à la LA. II.D. Application des lois, des règlements et des directives dans la lutte contre l’AF et le LA. Les décisions stratégiques de l’ACIA pour combattre l’AF et le LA se présentent sur plusieurs fronts. Le premier front consiste en une ARP afin de développer une base de connaissances sur l’ON, de cerner les trous d’information, de savoir si l’ON est important et si l’on doit prendre action, d’exposer les filières d’entrée de l’ON présentant le plus grand risque et le pays auquel il faut prêter le plus attention. Les ME en provenance de la Chine représente la plus importante filière pour l’AF et le LA. L’ACIA peut ainsi utiliser ses ressources plus efficacement en ciblant les cargaisons de la Chine ou d’autres pays à haut risque pour combattre l’AF et le LA. Le deuxième front est la prévention avant que les ME n’arrivent à la frontière par en communiquant nos directives, par exemples D-03-08, D-98-08 et D98-10, à nos partenaires commerciaux internationaux. Le Canada a adopté en janvier 2004 les NIMP 15 qui entreront en vigueur le 16 septembre 2005. De plus, le Canada a conclu un accord bilatéral avec les États-Unis relativement à l’entrée en vigueur en Amérique du Nord des NIMP 15. Le Canada encourage aussi tous ses partenaires commerciaux à adopter les NIMP 15. Ces politiques reflètent l’esprit de gestion adaptative, selon laquelle on apprend par l’action à changer le comportement des commerçants internationaux. L’effet de cette nouvelle coopération est une diminution des efforts de surveillance de tous les pays commerçants. Depuis le 1er avril 2005, cet esprit s’est transformé en prudence, car seuls les pays ayant un système de certification national en vigueur peuvent maintenant exporter des ME au Canada69. Le troisième front est l’application de la LPV, du RPV et des directives à la frontière. Le Canada reçoit environ 800 000 conteneurs de 20 pieds dans ses ports chaque année70, et le contrôle complet de ce volume est impossible. De ceux-ci, 158 000 proviennent de la Chine. Les taux d’inspection varient selon le plan de travail des régions71; seulement 10 p. 100 des importations à hauts risques sont inspectées, sauf celles en provenance de la Chine qui sont inspectés à un taux probablement plus élevé72. La procédure consiste à lire le certificat attaché au connaissement ou à inspecter physiquement la cargaison afin de vérifier le marquage et de confirmer que le bois d’emballage est libre d’insectes. En cas de non-conformité, la marchandise peut être renvoyée en vertu de l’article 8(1) de la LPV ou confisquée en vertu de l’article 8(3) de la LPV. Le Canada peut disposer des ME en conformité avec les annexes des directives D-98-08 et D-98-10. Une telle infraction, sur déclaration de culpabilité par procédure sommaire, entraîne une amende de cinquante mille dollars et un emprisonnement maximal de deux ans ou l’une de ces peines en vertu de l’article 49 de la LPV. Selon l’article 24(1) de la LACIA et l’article 44 de la LPV, le gouvernement peut réclamer des redevances au taux prescrit pour les inspections, les analyses, les certificats de circulation et ainsi de suite73. Ces coûts peuvent être évités si la cargaison est conforme aux normes.


Le quatrième front consiste en un combat local, en déclarant deux zones infestées au moyen des ordonnances OLIAF et OLILU afin de circonscrire l’infestation, du RCZSF, de l’abattage d’arbres à Toronto-Vaughan, de sites Internet pour informer les citoyens et annoncer des réunions74, d’interviews médiatiques et enfin de mesures d’indemnisation encourageant les citoyens à reboiser la forêt d’arbres non hôtes. L’effort est intense afin d’éradiquer l’AF et le LA. Les plus grands dangers de dissémination de l’AF et du LA en Ontario sont le transport de bois de chauffage, de jeunes arbres infectés provenant de pépinières et de ME à l’intérieur des zones non infestées Dans les zones infestées, il y a beaucoup de bois morts, et la tentation est grande, principalement pour les amateurs de camping et les propriétaires de chalets, de s’en servir comme bois de chauffage. Les règlements sont difficiles à appliquer75. Pendant l’été 2004, des nouvelles infestations ont franchi la ZSF, il semblerait à cause du retrait de bois de chauffage de la zone d’ARP.76 Il est possible, par contre, que ces infestations étaient déjà présentes avant la création de la ZSF. Plusieurs infestations d’AF ont été découvertes à Chatham; par la suite, 5 000 résidences ont reçu un avis qu’un arbre infesté avait été découvert à 500 mètres de leurs résidences77. L’avis interdisait de déplacer du bois de chauffage afin d’éviter la dissémination de l’AF. Le retrait non autorisé de bois de chauffage de la zone d’ARP est illégal en vertu des articles 13(1) et 15(3) de la LPV. Une telle infraction, sur déclaration de culpabilité par procédure sommaire, entraîne une amende de cinquante mille dollars et un emprisonnement maximal de deux ans ou l’une de ces peines en vertu de l’article 50 de la LPV. En dépit de toute la publicité sur l’AF, le 13 août 2004, des inspecteurs ont remis deux avis de contravention sur 250 inspections, à des campeurs dans le parc provincial Pinery qui avaient transporté du bois hors du comté d’Essex; cinq résidents campant dans le parc provincial Wheatley78 se sont également vu imposer des amendes. De plus, du 4 au 6 septembre 2004, sur 500 inspections, une amende a été imposée à un résident et à un visiteur du Michigan. Les contrevenants, lors d’une première infraction, risquent une peine de 400 $ et la confiscation du bois de chauffage. III. OBSERVATIONS ET IMPRESSIONS III.A. Risque, prudence et lois environnementales Lorsqu’on parle de risque, on planifie pour demain en cherchant à éviter les écueils. Les lois environnementales visent à rendre l’avenir moins incertain et plus sain. Le danger provient en grande partie de l’activité humaine, dont assez souvent nous ignorons toutes les conséquences. C’est justement cette filière entre l’activité et l’avenir que nous voulons maîtriser pour éviter le danger ou le préjudice. Nous ne pouvons pas limiter tous les préjudices, car les ressources nécessaires seraient énormes, mais nous pouvons prêter attention aux filières plus importantes. La précaution justement nous aide à prendre des décisions quand les conséquences du risque sont trop graves. La difficulté est de savoir quand cesser une activité pour éviter un préjudice grave, car il est toujours possible que le préjudice ne se matérialise pas. Si nous décidons d’agir avec prudence, nous risquons de perdre les bénéfices d’une activité. Par contre, si nous continuons d’agir, nous risquons d’imposer une conséquence grave et irréversible. Le


défi est donc de savoir quand s’arrêter, de trouver le juste équilibre entre les bénéfices d’une activité et le préjudice en découlant. Nous avons noté une différence intéressante entre les textes législatifs anglais et français en ce qui concerne le risque et l’incertitude. En particulier, les lois environnementales en français utilise les termes « prévention » et « prudence », plutôt que précaution. Par exemple, en 2002, trois nouvelles lois sur l’environnement ont choisi le terme « prudence » plutôt que « précaution ». Cela veut dire que cinq lois environnementales sur six favorisent le terme « prudence » à celui de « précaution ». L’autre loi utilise l’expression « prévention ». La question reste à savoir si le choix de termes est pertinent. Il se peut que, selon les définitions des dictionnaires discutées au début de l’étude de cas, le terme prudence signale un acte de prévoyance et que la précaution est un acte axé sur le danger à éviter. En d’autres mots, le premier terme est actif et le second, passif. Les textes anglais utilisent le mot « precaution » S’il y a une nuance possible dans l’interprétation de ces termes, un problème pourrait surgir. Les lois environnementales auraient potentiellement plus de force en français sous le parapluie de la prudence qu’en anglais sous la coupole de la précaution. Cette question mérite plus de données et d’ample réflexion. Le Bureau du Conseil privé énonce la politique de prudence du gouvernement canadien en entier dans le document CAPP.79 Par contre, ce document cadre, déposé le 25 juillet 2003, après les trois nouvelles lois environnementales de 2002, reprend le principe de la précaution et non celui de la prudence. Ce manque de constance est troublant à divers égards; la politique devrait être constante pour l’institution dans son ensemble et se refléter uniformément dans tous les documents énonçant la politique; or, au moment où le fardeau de preuve semblait s’alourdir pour les promoteurs, de nouveau il s’allègue. Il semblerait que les délibérations de 2002 sur le principe de précaution qui avaient convaincu les législateurs que la prudence était un meilleur terme que la précaution ont été ignorées80. Il est intéressant de noter que même si le principe de la prudence n’est pas explicitement énoncé, il fonctionne souvent quand le texte législatif est lu en entier ou quand un règlement est lu avec sa loi habilitante. Quand nous considérons la prudence, il faut rechercher les trois éléments. Souvent une disposition soulève seulement deux éléments, l’incertitude et la prise d’une décision, mais une telle disposition lue de paire avec la prévention du préjudice grave et irréversible du préambule ou de l’objet, comporte les trois éléments de la prudence. La disposition devrait donc être interprétée comme la prudence. La gestion adaptative n’est pas explicite dans les lois, mais elle est omniprésente dans l’intention des régimes réglementaires, comme celui qui fonde l’ACIA. La gestion adaptative vise à permettre une flexibilité de gestions, pour répondre, par exemple, aux nouveaux renseignements. La gestion adaptive vise en certains cas à changer le comportement des citoyens; ces textes comprennent essentiellement des dispositions autorisant ou prohibant certaines activités. C’est un genre d’évolution forcée du comportement humain pour composer avec de nouvelles circonstances dans la société, en l’espèce, la présence de nouveaux insectes ravageurs dans notre environnement naturel. Ceux qui ne s’adaptent pas à la nouvelle réalité sont punis par une amende, l’incarcération ou la perte de leur privilège de pratiquer de commerce avec le Canada. La gestion adaptative est fondée en partie sur la philosophie de l’apprentissage par l’action. Le résultat recherché par la société est dicté dans le régime réglementaire provenant de la politique qui reflète les données scientifiques. Par contre, le texte réglementaire n’est pas


statique; il évolue en conformité avec les nouvelles données scientifiques et les nouvelles interprétations jurisprudentielles des textes. En l’espèce, une des méthodes de traitement des ME était la fumigation à la phosphine. Des insectes ayant survécu à cette forme de fumigation, la méthode à été déclarée inefficace et a été bannie81. III.B. Application du CAPP par l’ACIA L’ACIA a adopté le principe de la prudence tel qu’énoncé dans le préambule de la LACIA et le CAPP, comme outil de travail. Nous aimerions souligner ici l’application des principes du CAPP. En plus, l’ACIA pratique déjà les trois éléments additionnels de Wingspread en appliquant les principes du CAPP. III.B.1. Principe 4.1 L’utilisation de la précaution est une démarche légitime et particulière de décision dans la gestion du risque. L’ACIA met clairement en pratique le principe de la prudence ou de la précaution. Le préambule de la LACIA indique que l’Agence exécutera des inspections fondées sur les risques. L’Agence est une branche du gouvernement et doit respecter ses obligations internationales. L’Agence prend ses décisions en se basant sur les lois et les règlements cadres ainsi que sur les règlements additionnels, les ordonnances et les directives. Ces trois derniers sont particulièrement importants pour relever le défi présenté par l’AF et le LA et sont fondés sur les ARP’s qui servent à déterminer les besoins de la société et les trous de connaissances. Le fondement des ARP’s proviennent des données scientifiques fournies par des scientifiques internationaux et canadiens. III.B.2. Principe 4.2 Il est légitime que les décisions soient guidées par le niveau de protection contre le risque que choisit la société. Bien que le principe de la participation publique soit reconnu, nous ne sommes pas certains que la grande société choisit le risque de ces défis. L’Agence travaille pour les Canadiens et fournit un effort coordonné partout au pays et dans le monde afin de protéger notre environnement physique, notre santé et notre économie. Elle a des pages Web, organise des séances d’information, des discussions personnalisées entre des scientifiques et le public, encourage la coopération du public lorsqu’un arbre mourant est suspect ou qu’un insecte inconnu est aperçu et offre une orientation dans le choix des espèces d’arbres à planter. Mais il semble difficile de traduire cela par la participation du public dans la prise de décision. L’Agence reconnaît que des preuves solides sont importantes dans l’application de la précaution, et le public en général ne peut fournir de telles preuves. On doit se poser la question si le public a la compétence de prendre des décisions techniques. On peut argumenter que ce sont les députés, les représentants des Canadiens qui sont le public et que c’est eux, par intermédiaire de la consultation avec les scientifiques de l’ACIA, qui choisissent le risque de la société.


III.B.3. Principe 4.3 L’application de la précaution doit reposer sur des données scientifiques solides et sur leur évaluation; la nature des données scientifiques et la partie chargée de les produire peuvent changer avec l’évolution du savoir. Les connaissances scientifiques coûtent chères. On doit se demander précisément quelles connaissances sont encore requises pour prendre une décision. L’ACIA reconnaît ce fait et ne cherche pas nécessairement des quantités de données, mais plutôt la qualité des données. En préparant les ARP’s dans cette étude de cas, les scientifiques révisent la documentation disponible, échangent avec leurs collègues dans le monde pour en savoir le plus possible sur l’AF et le LA, sans exiger de dépenses importantes. Souvent les ARP’s sont requises d’urgence, et les décisions sont prises à la lumière des données disponibles82 quand il y a beaucoup d’incertitude. Il faut aussi souligner que les trous d’information peuvent souvent être comblés en analysant des situations parallèles. Parfois c’est tout ce qui est requis. La création d’une ZSF de 10 km et l’abattage des arbres infestés à Toronto-Vaughan pour limiter les populations d’AF et de LA, respectivement, sont deux exemples de décisions fondées sur des données scientifiques. Les NIMP’s deviennent utiles au Canada, obligeant les commerçants étrangers à fournir la preuve que leurs cargaisons sont saines pour notre environnement. Ce principe prévoit aussi l’évaluation des situations cas par cas, ce qui peut fournir de meilleures données. Le gouvernement peut, par contre, réclamer les coûts de ses efforts, ce qui est une façon d’imposer le fardeau de la preuve au promoteur. III.B.4. Principe 4.4 Il devrait y avoir des mécanismes pour réévaluer le fondement des décisions et pour tenir éventuellement d’autres consultations dans un processus transparent. L’ACIA discute toujours avec les parties visées par les décisions pour tenter de régler la question. L’ACIA peut s’adapter relativement facilement à des nouvelles situations; un bon exemple est la situation avec la Chine relativement aux ME quand la filière de la Chine au Canada a été établie pour le LA. La Chine n’étant pas en mesure de régler ses difficultés techniques avec les ME, la directive D-98-10 a été prise pour établir les modalités du commerce avec la Chine. Par contre, une fois que les commerçants chinois ont pu traiter leurs ME et se conformer aux NIMP, l’ACIA a réévalué la situation et accepté l’entrée des cargaisons de la Chine au Canada aux mêmes conditions que les autres pays. III.B.5. Principe 4.5 Il convient d’assurer un degré élevé de transparence, de reddition de comptes et de participation du public. Le processus de transparence de l’ACIA est très bon. Les directives sont publiées sur son site Web et envoyées à des listes préétablies pour que tous sachent ses attentes. Ses agents répondent aux questions individuelles et les réponses aux questions fréquentes sont archivées sur le site Web. Le site comprend également des annonces de réunions publiques, des articles pour les médias et des aperçus de résultats dès qu’ils deviennent disponibles.


III.B.6. Principe 4.6 Les mesures de précaution devraient être sujettes à réexamen selon l’évolution de la science, de la technologie et du niveau de protection choisi par la société. La fréquence de révision des documents varie. Les ARP’s ainsi que la directive D-98-08 sont révisés au moins à tous les cinq ans. La dernière révision de l’ARP a eu lieu en mai 2004, pour inclure les nouvelles données depuis 1998. La directive D-98-08 a été révisée en janvier 2004, une quatrième fois, pour inclure les NIMP 15 et déclarer le traité bilatéral avec les États-Unis. La directive D03-08 est révisée tous les deux ans. L’OLIAF a été modifié 14 mois après son adoption pour agrandir la superficie de la zone infestée par l’AF et pour déclarer que l’Ouest du comté d’Essex devrait inclure tous le comté après que les sondages ont indiqué que l’insecte était présent dans tout le comté. Voir le principe 4.4. III.B.7. Principe 4.7 Les mesures de précaution devraient être proportionnelles à la gravité possible du risque que l’on veut gérer et au niveau de protection choisi par la société. En l’espèce, il est urgent d’atténuer les effets néfastes de l’AF et du LA. Nos forêts de feuillus sont menacées et la qualité de notre environnement urbain et rural est en jeu. Les répercussions possibles sur l’industrie de l’acériculture, par exemple, sont importantes. Le bien-être même de la société est menacé, car les arbres, en particulier les érables, sont importants pour les Canadiens. Nous croyons que les mesures strictes interdisant l’entrée de tous ME non traités sont proportionnelles aux menaces. Cependant, le risque d’entrée de ME infestés demeure, puisque les NIMP 15 ne sont pas en vigueur et que les commerçants internationaux n’ont pas encore adopté de telles normes. L’ACIA fait son possible pour les encourager tous à adopter les NIMP, afin d’attaquer la menace à sa source plutôt que simplement traiter le symptôme. III.B.8. Principe 4.8 Les mesures de précaution devraient être non discriminatoires et concorder avec celles prises dans des circonstances similaires. L’ACIA semble travailler d’une façon systématique en appliquant la LPV et ses règlements. Les agents participent régulièrement à des séminaires de formation les renseignant sur les nouveaux développements. Leur but, selon le préambule de LACIA, est d’encourager les échanges commerciaux et le commerce en protégeant les consommateurs par l’application uniforme de la loi. Quand la Chine était incapable d’assurer le traitement des ME exigé, le gouvernement a visé directement la source de la non-conformité. Un fois le problème rectifié, les cargaisons de la Chine ont été traitées comme celles de tous les autres pays commerçants. III.B.9. Principe 4.9 Les mesures de précaution devraient être efficientes et avoir pour objectif d’assurer (i) un avantage net global à la société au moindre coût et (ii) un choix judicieux de mesures. La marchandise en provenance de la Chine est en grande demande; des 800 000 conteneurs qui


arrivent aux ports canadiens tous les ans, 158 000 proviennent de la Chine. C’est important de garder les frontières ouvertes pour cette marchandise, malgré les difficultés. En gérant le risque des ME de la Chine, les Canadiens ont eu les bénéfices de jouir de la marchandise chinoise sans qu’il y ait de répercussions démesurées sur notre environnement une fois la filière dépistée. Les analyses des coûts et des bénéfices conclues par l’ACIA dans les ARP’s semblent inclure non seulement la valeur économique, mais certains aspects des conséquences environnementales et des coûts sociaux. Aujourd’hui, les systèmes de GPS permettent à l’ACIA de suivre n’importe quelle cargaison en voie vers le Canada et, une fois arrivée, les agents de l’ACIA peuvent facilement les retrouver dans les ports pour les inspecter. Cette nouvelle technologie est indispensable en 2005. III.B.10. Principe 4.10 Lorsque plusieurs options réunissent ces caractéristiques, on devrait choisir celle qui entrave le moins le commerce. L’ACIA reconnaît l’importance d’avoir le plus grand choix possible d’options pour éradiquer l’AF et le LA. La gestion à cette heure est basée sur la prévention administrative et écologique. À l’échelle internationale et locale, l’ACIA tente de changer les comportements humains en décourageant l’expédition de ME non traités et le transport de bois de chauffage. L’option écologique utilisée contre l’AF et le LA est la sylviculture, c’est-à-dire la création d’une ZSF ou l’abattage des arbres infestés par l’AF et le LA afin de détruire leur habitat et d’enlever physiquement les arbres abattus. IV. CONCLUSION En conclusion, l’ACIA semble bien gérer les dossiers de l’AF et du LA. C’est un défi pour tous les pays pratiquant le commerce international, de maîtriser les infestations qui proviennent des ME. En l’espèce, l’ACIA semble pratiquer la gestion adaptative, et ses efforts sont expérimentaux. Quand le commerce présentait un risque (tel que dans le cas temporaire de la Chine), l’ACIA a agi avec prudence. L’ACIA envisage l’avenir et participe activement à la promotion de mesures de prévention encourageant l’adoption des NIMP 15 par tous les pays. Le choix extrême de permettre l’entrée de toutes les cargaisons sans inspection ou de bloquer toutes les cargaisons utilisant des ME n’est pas acceptables d’un point de vue sociétal. L’ACIA a choisi de gérer les risques en déterminant les filières les plus importantes pour l’entrée de l’AF et du LA au Canada, et par la suite de surveiller attentivement les entrées et de sensibiliser les commerçants et le public à l’égard du risque. L’atténuation des conséquences de ces deux ON’s peut seulement se réaliser par un effort collectif. L’ACIA prévoit que les risques que pose la filière des ME pour l’entrée au Canada de l’AF et du LA diminueront une fois qu’un grand nombre de nos partenaires commerciaux adopteront les NIMP 15. Il y a déjà eu des invasions de l’AF et du LA au Canada, et ces invasions ont eu des conséquences économiques importantes. Nous espérons que l’application du principe de la prudence et de la gestion adaptive tels que décrites dans ce cas d’étude aiderons a réduire le risque d’invasions à l’avenir.


V. BIBLIOGRAPHIE ACIA, La communication des risques et le gouvernement, en ligne <http://www.inspection.gc.ca/francais/corpaffr/publications/riscomm/riscommf.shtml>. C. Coglianese et G. E. Marchant, Shifting Sands: The Limits of Science in Setting Risk Standards, en ligne, The Social Science Research Network <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=443080>. Commission of the European Communities, Communication from the Commission on the Precautionary Principle, Online: Europa <http://europa.eu.int/comm/dgs/health_consumer/library/pub/pub07_en.pdf>. D. E. Adelman, « Harmonizing Methods of Scientific Inference with the Precautionary Principle: Opportunities and Constraints” (2004) 34 Environmental Law Review 10131. European Environment Agency, Late Lessons from Early Warnings: the Precautionary Principle 1896–2000, Online: European Environment Agency <http://reports.eea.eu.int/environmental_issue_report_2001_22/en/Issue_Report_No_22.pdf> J. Ruhl, Taking Adaptive Management Seriously for the Endangered Species Act—Lots of Talk, Little Action, en ligne: The Social Science Research Network <http://ssrn.com/abstract=506962>. J. Tickner et L. Ketelsen, Precaution: Who Decides? Why Democratic Methods of Decision-Making Are Critical to Implementing the Precautionary Principle, en ligne: GRACE <http://www.gracelinks.org/corp/ecological/corp-precautionary.html>. M. Geistfeld, Implementing the Precautionary Principle, en ligne: The Social Science Research Network <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=289146>. M. Miller et L. Gunderson, Biological and Cultural Camouflage: The Challenges of Seeing the Harmful Invasive Species Problem and Doing Something About It, en ligne: The Social Science Research Network <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=452982>. N. Myers, The Precautionary Principle Puts Values First, en ligne Environmental Research Foundation <http://www.rachel.org/library/getfile.cfm?ID=188>. San Francisco Government, The Precautionary Principle and the City and County of San Francisco, en ligne: SFGov <http://temp.sfgov.org/sfenvironment/aboutus/policy/white_paper.pdf>.


VI. ANNEXE I. ABRÉVIATIONS ACIA Agence canadienne d’inspection des aliments AF Agrile du frêne ARP Analyse de risque phytosanitaire CAPP Cadre d’application de la précaution dans un processus décisionnel

scientifique en gestion du risque CDB Convention sur la diversité biologique CIPV Convention internationale pour la protection des végétaux LA Longicorne asiatique LACIA Loi sur l’Agence canadienne d’inspection des aliments LCEE Loi canadienne sur l’évaluation de l’environnement LCPE Loi canadienne sur la protection de l’environnement 1999 LO Loi sur les océans LPV Loi sur la protection des végétaux ME Matériaux d’emballage NIMP Normes internationales pour les mesures phytosanitaires NIMP 2 Normes internationales pour les mesures phytosanitaires no 2 NIMP 15 Normes internationales pour les mesures phytosanitaires no 15 RPV Règlement sur la protection des végétaux OLIAF Ordonnance sur les lieux infestés par l’agrile du frêne OLIAF03 Ordonnance sur les lieux infestés par l’agrile du frêne 2003 OLILA Ordonnance sur les lieux infestés par le longicorne asiatique ON Organisme nuisible OQ Organisme de quarantaine RCZSF Règlement sur la création d’une zone sans frêne RIRPFI Règlement sur l’indemnisation relative aux parasites forestiers introduits ZSF Zone sans frêne 1 CFIA, « Emerald Ash Borer, Agrilus planipennis. Pest Risk Assessment », Canadian Plant Health and Production Division Request No. 2002-28, 9 août 2002 [non publié, archivé à l’Agence canadienne pour l’inspection des aliments] à la p.7. La présence de l’agrile du frêne a été confirmée à Windsor, en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/corpaffr/newcom/2002/20020822f.shtml>. 2 CFIA, « Anoplophrora glabripennis (Mots.), Asian Longhorned Beetle (Starry Sky Beetle) », Pest Risk Assessment, Canadian Plant Health and Production Division Request No. 98-56 May 5, 2004. [non publié, archivé à l’Agence canadienne pour l’inspection des aliments] à la p.4 .; découverte d’un longicorne asiatique à Woodbridge (Ontario), en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/corpaffr/newcom/2003/20030912f.shtml>. 3 Ibid. à la p. 9. 4 AF: Ibid., supra note 1 aux pp. 23-25; LA: Ibid., supra note 2 aux pp. 28-30. 5 Loi sur l’Agence canadienne d’inspection des aliments, 1997, ch. 6, art. 11(1), en ligne : ministère de la Justice <http://lois.justice.gc.ca/fr/c-16.5/texte.html>. 6 Cadre d’application de la précaution dans un processus décisionnel scientifique en gestion du risque, art. 4.1, en ligne : Bureau de Conseil privé <http://www.pco-bcp.gc.ca/default.asp?Language=F&Page=publications&Sub=precaution&Doc=precaution_f.htm>.


7 Convention internationale pour la protection des végétaux, au préambule, en ligne : International Phytosanitary Portal <https://www.ippc.int/servlet/BinaryDownloaderServlet/1997_French.pdf?filename=1034340690890_frippc.pdf> Le Canada a ratifié cette Convention le 10 juillet 1953. 8 Convention sur la diversité biologique, au préambule, en ligne : Convention on Biological Diversity <http://www.biodiv.org/convention/articles.asp?lg=2&a=cbd-00>; Le Canada a ratifié cette Convention le 4 décembre 1992. 9 Ibid., supra note 5. 10 Loi sur la protection des végétaux, 1990, ch.22, en ligne : ministère de la Justice <http://lois.justice.gc.ca/fr/P-14.8/86741.html>. 11 Règlement sur la protection des végétaux, DORS/1995-212, en ligne : ministère de la Justice <http://lois.justice.gc.ca/fr/P-14.8/DORS-95-212/index.html>. 12 Évaluation des risques phytosanitaires, en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/sci/surv/phra_f.shtml>. 13 Ibid., supra note 10 art. 47(a). 14 Liste des parasites réglementés par le Canada, en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/plaveg/protect/listpesparf.shtml>. 15 Par exemple, la Loi sur l’Agence canadienne d’inspection des aliments, 1997,ch. 6, la Loi canadienne sur l’évaluation environnementale, 1992, ch. 37, la Loi canadienne sur la protection de l’environnement, 1999, 1999, ch. 33, et la Loi sur les espèces en péril, 2002, ch.29 exige une considération de risque environnemental. 16 13B Le petit Robert, 1982, s.v. « risque ». 17 Loi canadienne sur l’évaluation environnementale, 1992, ch. 37, art. 4(2), en ligne : ministère de la Justice <http://lois.justice.gc.ca/fr/c-15.2/texte.html>; Loi sur les Océans, 1996, ch. 31, au préambule, en ligne : ministère de la Justice <http://lois.justice.gc.ca/fr/o-2.4/texte.html>; Loi canadienne sur la protection de l’environnement (1999), 1999, ch. 33, au préambule, art’s. 2.1(1), 6(1.1), 76.1, en ligne : ministère de la Justice <http://lois.justice.gc.ca/fr/c-15.31/texte.html>. 18 Ibid., supra note 16, s.v. «prévention». 19 Ibid., supra note 16, s.v. «précaution». 20 Ibid., supra note 16, s.v. «prudence». 21 Le Robert & Collins dictionnaire, 1982, s.v. «precaution». 22 Une perspective canadienne sur l’approche/principe de précaution: Document de consultation, para. 2.4, en ligne : Environnement Canada <http://www.ec.gc.ca/econom/discussion_f.htm>. 23 Ibid. Le Canada le reconnaît pas à l’heure actuelle le principe de précaution comme une règle de droit international coutumier. 24 Ibid., supra note 6. 25 Délibérations de l’atelier sur le document de consultation du gouvernement du Canada concernant l’approche/principe de précaution et son application à la LCPE 1999, en ligne : Environnement Canada <http://www.ec.gc.ca/econom/proceeding_f.htm>. 26Loi sur les aires marines nationales de conservation du Canada, 2002, ch.18, au préambule, en ligne : ministère de la Justice < http://lois.justice.gc.ca/fr/c-7.3/texte.html>. On se sert de l’expression prudence pour indiquer la précaution : « […] le principe de la prudence dans le cadre de la conservation et de la gestion du milieu marin, de sorte que l’absence de certitude scientifique absolue ne puisse être invoquée comme motif pour différer la prise de mesures de prévention lorsque l’environnement risque de subir des dommages; » Loi sur les espèces en péril, 2002, ch. 29, au préambule, art. 38, en ligne : ministère de la Justice <http://lois.justice.gc.ca/fr/s-15.3/texte.html>. On se sert de l’expression : « […] s’il existe une menace d’atteinte grave ou irréversible à une espèce sauvage, le manque de certitude scientifique ne soit pas prétexte à retarder la prise de mesures efficientes […] » Loi sur les produits antiparasitaires, 2002, ch.28, art 20(2), en ligne : ministère de la Justice <http://lois.justice.gc.ca/fr/p-9.01/texte.html>. On se sert de l’expression : « En cas de risques de dommages graves ou irréversibles, l’absence de certitude scientifique absolue ne doit pas servir de prétexte pour remettre à plus tard la prise de mesures rentables visant à prévenir toute conséquence néfaste pour la santé ou la dégradation de l’environnement. » 27 Ibid., supra note 6. 28 Ibid., supra note 25.


29 Kai N. Lee, « Appraising Adaptive Management » (1999), en ligne : Conservation Ecology <http://www.consecol.org/vol3/iss2/art3>. 30 Loi canadienne sur l’évaluation environnementale, supra note 14, art. 38(5). 31 Directives pour l’analyse du risque phytosanitaire, Normes internationales pour les mesures phytosanitaires n° 2, en ligne : International Phytosanitary Portal <https://www.ippc.int/servlet/BinaryDownloaderServlet/ISPM2_Fr.pdf?filename=1086172409346_ispm2f.pdf>. 32 CFIA, «Emerald Ash Borer, Agrilus planipennis, Pest Risk Assessment», supra note 1. 33 CFIA, « Pest Risk Assessment Anoplophora glabripennis (Mots.) Asian Longhorned Beetle (Starry Night Beetle», supra note 2. 34 CFIA, «Emerald Ash Borer, Agrilus planipennis, Pest Risk Assessment», supra note 1 à la p.7. 35 Le LA a été découvert cinq à sept ans après son établissement dans la région de Toronto. CFIA, « Pest Risk Assessment Anoplophora glabripennis (Mots.) Asian Longhorned Beetle (Starry Night Beetle», supra note 2, art.3.4.3. 36 CFIA, « Pest Risk Assessment Anoplophora glabripennis (Mots.) Asian Longhorned Beetle (Starry Night Beetle», supra note 2 à la p.2. 37 CFIA, « Pest Risk Assessment Anoplophora glabripennis (Mots.) Asian Longhorned Beetle (Starry Night Beetle», supra note 2 à la p.4 38 Stratégie pour l’agrile du frêne au Canada, en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/plaveg/protect/pestrava/ashfre/eabfall03f.shtml>. 39 Interdiction de déplacer des frênes et du bois de frêne hors de la région de Windsor, en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/corpaffr/newcom/2002/20021015f.shtml>. 40 Ibid., supra note 38. 41 Exigences phytosanitaires destinées à prévenir l’introduction et la propagation au Canada de l’agrile du frêne, (Agrilus planipennis (Fairmaire)) D-03-08, en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/plaveg/protect/dir/d-03-08f.shtml>. 42 CFIA, «Emerald Ash Borer, Agrilus planipennis, Pest Risk Assessment», supra note 1 à la p.14. 43 Ibid., supra note 41, Objet. 44 Ibid., supra note 41, art. 4.0. 45 Ordonnance sur les lieux infestés par l’agrile du frêne 2003, en ligne: Agence canadienne d’inspection des aliments < http://www.inspection.gc.ca/francais/plaveg/protect/pestrava/ashfre/eabmof.pdf>. 46 Règlement sur la création d’une zone sans frêne-Loi sur la protection des végétaux, DORS/2004-137, en ligne : Gazette du Canada <http://gazetteducanada.gc.ca/partII/2004/20040602/html/sor137-f.html - a>. 47 Résumé de l’étude d’impact de la réglementation, Ibid. 48 Ibid., supra note 46. 49 CFIA, «Emerald Ash Borer, Agrilus planipennis, Pest Risk Assessment», supra note 1 à la p.10. 50 Loi canadienne sur l’évaluation environnementale, 1992, ch. 37, art.7(b), supra note 17. 51 Règlement sur l’indemnisation relative aux parasites forestiers introduits-Loi sur la protection des végétaux, DORS/2004-113, en ligne : Gazette du Canada <http://gazetteducanada.gc.ca/partII/2004/ 20040519/html/sor113-f.html>. 52 Exigences relatives à l’entrée au Canada des matériaux d’emballage en bois produits dans toute région du monde autre que la zone continentale des États-Unis, D-98-08, en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/plaveg/protect/dir/d-98-08f.shtml>. 53 CFIA, « Pest Risk Assessment Anoplophora glabripennis (Mots.) Asian Longhorned Beetle (Starry Night Beetle», supra, note 2 à la p.22. 54 Ibid., supra, note 52, Objet. 55 Ibid., supra, note 52, art.2.2. 56 Directives pour la réglementation de matériaux d’emballage à base de bois dans le commerce international, Normes internationales pour les mesures phytosanitaires n° 15, en ligne : International Phytosanitary Portal <https://www.ippc.int/servlet/BinaryDownloaderServlet/ISPM_15_French.pdf?filename=1060169841413_NIMP_15_French.pdf>. 57 Ibid., supra, note 52, Introduction. 58 Examen des modifications des mesures associées à la mise en oeuvre de la NIMP n° 15, en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/plaveg/for/cwpc/ispm15f.shtml>.


59 Exigences relatives à l’importation des pièces d’arrimage, palettes, caisses et autres matériaux d’emballage en bois provenant de la Chine et de la région administrative spéciale de Hong Kong, D-98-10, art. 2.2 en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/plaveg/protect/dir/d-98-10f.shtml>. 60 CFIA, « Pest Risk Assessment Anoplophora glabripennis (Mots.) Asian Longhorned Beetle (Starry Night Beetle», supra note 2 à la p.21. 61 Directives sur la protection des végétaux, en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/plaveg/protect/dir/directf.shtml>. 62 Ordonnance sur les lieux infestés par le longicorne asiatique, en ligne: Agence canadienne d’inspection des aliments < http://www.inspection.gc.ca/francais/plaveg/protect/pestrava/asialong/alhbmof.pdf 5>. 63 Longicorne asiatique (LA) - Situation actuelle, en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/plaveg/protect/pestrava/asialong/infof.shtml>. 64 Le ministre Vanclief expose un plan de lutte contre le longicorne asiatique et reconnaît le geste d’un résidant, en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/ corpaffr/ newcom/2003/20031112f.shtml>. 65 CFIA, « Pest Risk Assessment Anoplophora glabripennis (Mots.) Asian Longhorned Beetle (Starry Night Beetle)», supra note 2 à la p.16. 66 CFIA, « Pest Risk Assessment Anoplophora glabripennis (Mots.) Asian Longhorned Beetle (Starry Night Beetle)», supra note 2 à la p.27. 67 L’ordonnance visant à empêcher la propagation du longicorne asiatique est maintenant en vigueur dans la région de Toronto-Vaughan, en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/corpaffr/newcom/2004/20040226f.shtml>. 68 Ibid., supra note 63, le 5 avril 2004. 69 Ibid., supra note 52, art.2.2. 70 CFIA, « Pest Risk Assessment Anoplophora glabripennis (Mots.) Asian Longhorned Beetle (Starry Night Beetle», supra note 2 à la p.23. 71 Ibid., supra note 52, art.3.0. 72 CFIA, «Emerald Ash Borer, Agrilus planipennis, Pest Risk Assessment», supra note 1, p.15. 73 Arrêté sur le recouvrement des coûts -Loi sur la gestion des finances publiques, DORS/98-161, en ligne : Gazette du Canada <http://gazetteducanada.gc.ca/partII/1998/19980401/html/sor161-f.html>. 74 Agrile du frêne - Information pour le public / médias, en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/plaveg/protect/pestrava/ashfre/newcomf.shtml#agen>. Longicorne asiatique, en ligne: Agence canadienne d’inspection des aliments<http://www.inspection.gc.ca/ francais/plaveg/protect/pestrava/asialong/asialongf.shtml>. 75 CFIA, « Pest Risk Assessment Anoplophora glabripennis (Mots.) Asian Longhorned Beetle (Starry Night Beetle», supra note 2 à la p.24. 76 Les activités d’enquête de l’Agence révèlent la présence de populations de l’agrile du frêne, en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/corpaffr/newcom/ 2004/20040707f.shtml>. 77 La présence de l’agrile du frêne à plusieurs endroits dans Chatham, en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/corpaffr/newcom/2004/20041008f.shtml>. 78 Le point sur les enquêtes relatives à l’agrile du frêne, le 24 août, en ligne: Agence canadienne d’inspection des aliments <http://www.inspection.gc.ca/francais/plaveg/protect/pestrava/ashfre/survenqf.shtml> 79 Ibid., supra note 6. 80 Ibid., supra note 25. 81 Ibid., supra note 59, Contexte. 82 CFIA, «Emerald Ash Borer, Agrilus planipennis, Pest Risk Assessment», supra note 1, Appendix 1. CFIA, « Pest Risk Assessment Anoplophora glabripennis (Mots.) Asian Longhorned Beetle (Starry Night Beetle», supra note 2, Appendix 1.

Jennifer A. Chandler - The Regulation of Genetically Modified Plants: D-35 Authorization of Unconfined Environmental Release

THE REGULATION OF GENETICALLY MODIFIED PLANTS: AUTHORIZATION OF UNCONFINED ENVIRONMENTAL RELEASE

Jennifer A. Chandler Assistant Professor of Law

Faculty of Law University of Ottawa [email protected] 562-5800 ext. 3286


TABLE OF CONTENTS

I. INTRODUCTION .................................................................................................................. D-39

I.A. Focus of the case study ........................................................................................... D-39 I.B. The legislative and regulatory context .................................................................. D-39

II. APPLICATION OF THE PRECAUTIONARY PRINCIPLE ......................................... D-43

II.A. Introduction........................................................................................................... D-43 II.B. Precautionary Principle: Burden of Proof......................................................... D-44 II.C. Precautionary Principle: Standard of Proof ..................................................... D-45 II.D. Precautionary Principle: Level of Acceptable Risk .......................................... D-48

III. APPLICATION OF THE PRINCIPLE OF ADAPTIVE MANAGEMENT ................ D-49 IV. TRANSPARENCY .............................................................................................................. D-52 VII. CONCLUSION .................................................................................................................. D-55


I. INTRODUCTION I.A. Focus of the case study This case study examines the Canadian approach to regulating the unconfined release of genetically modified plants (“GM plants”) into the Canadian environment. The particular focus is on whether and how Canadian regulators apply the precautionary principle1 (“PP”) and the principle of adaptive management (“PAM”) in their risk-based decision-making. This case study does not address all aspects of the Canadian regulation of genetically modified organisms. Instead, it considers only GM plants rather than other genetically modified organisms (such as microorganisms and animals), and it considers only the regulation of the unconfined environmental release of GM plants rather than other possible issues of regulatory concern (such safety for human consumption or for livestock consumption). Another limitation of this case study lies in the information sources considered. The assessment contained in this case study is based on the public information available, inter alia, from the Canadian Food Inspection Agency (“CFIA”). This case study raises some concerns about the public legitimacy of the regulatory process. These concerns flow from the very limited amount of detailed information that is publicly available regarding regulatory decisions to approve the unconfined release of GM plants. Further research into the advisability of increasing public transparency of the decision-making process is recommended, and this research should go beyond the public record considered in this case study to include interviews with the regulators themselves in order to evaluate the constraints on increased transparency from their perspectives. I.B. The legislative and regulatory context The regulation in Canada of GM plants is split between the CFIA (which is responsible for the confined and unconfined release into the environment, importation, use in animal feeds of plants with novel traits (“PNTs”), as well as for the registration of new plant varieties)2 and Health Canada (which is responsible for the safety assessment of novel human foods).3 The Plant Biosafety Office (“PBO”) is a section of the CFIA, and it is responsible for the approval and inspection of confined field trials of PNTs, the approval of unconfined release of PNTs and the assessment of import applications for PNTs.4 The Seeds Act R.S.C. 1985, c.S-8 and Seeds Regulations C.R.C. c.1400 Part V “Release of Seed” provide the legislative framework for the authorization of the unconfined release of PNTs. Section 109 of the Seeds Regulations provides that no person may release seed without first filing a notification under s.110 and receiving authorization for the release under s.111.5 Section 108, however, provides that certain types of seeds are exempt from the requirements of Part V of the Seeds Regulations. In particular,

“seed that is derived from seed referred to in paragraph (a), or from seed in respect of which an unconfined release has been authorized under paragraph 111(1)(b), and that is substantially equivalent, in terms of its specific use and safety both for the environment and for human health, to seed of the same species, having regard to weediness potential, gene flow, plant pest potential, impact on non-target organisms and impact on biodiversity.” 6


As a result, a new plant is exempt from regulation under Part V where the new plant is (1) derived from a plant that was already being grown as a distinct and stable population in Canada before Part V of the Seeds Regulations came into effect, or from a plant whose unconfined release was already authorized, and (2) the new plant is substantially equivalent in terms of its use and safety. Further exemptions to the notification and authorization requirements in s.109 are provided in s.109(2)-(4).7 A question arises as to who is responsible for determining whether or not the new plant is “substantially equivalent, in terms of its specific use and safety” to seed of the same species. It appears that, in some cases at least, the applicant might conclude on its own that its new plant is substantially equivalent in terms of specific use and safety for the environment to its counterpart plant, and thus is exempt from all notification and authorization requirements by virtue of the exemption available under s.108. In such cases, the threshold decision about whether the regulator’s jurisdiction is engaged appears to be confounded with the very safety assessment that the regulator (rather than the applicant) ought to conduct. Directive 94-08 “Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits” is published by the Plant Biosafety Office in order to “provide guidance regarding the submission of an application for the authorization of the unconfined release of a plant with a novel trait (PNT) in Canada, as may be required under Part V of the Seed Regulations.”8 Directive 94-08 states that “a new variety of a species is subject to the notification and authorization requirements of the Seeds Regulations when it possesses trait(s) novel to that species in Canada, i.e., (i) the new trait is not present in stable, cultivated populations of the plant species in Canada, or (ii) the trait in the plant species is present at a level significantly outside the range of that trait in stable, cultivated populations of that plant species in Canada.”9 On its surface, this would appear to solve the problem that an applicant might, in some cases, conclude that its new plant is “substantially equivalent” to its counterpart already growing in the Canadian environment, and thus be exempt from notification and authorization requirements. However, Directive 94-08 also notes that “a plant that is substantially equivalent to its counterpart and is derived from seed authorized for unconfined release may be exempted from the notification and authorization requirements under the Seeds Regulations.”10 Directive 94-08 emphasizes that “[a]ll PNTs are subject to an environmental safety assessment,”11 but it is not clear that the PBO will be conducting or reviewing the assessment in these cases if the plant is exempted from notification and authorization requirements. In any event, where the exemptions do not apply, section 109 of the Seeds Regulations provides that no person may release seed without first filing a notification under s.110 and receiving authorization for the release under s.111. The information that an applicant must provide in its notification and request for authorization for unconfined release of its plant is set out in s.110 of the Seeds Regulations. Certain information is required for the release of any non-exempted seed, while additional information is required of seeds “with a novel trait.”12 The applicant seeking authorization for the unconfined release of a seed with a novel trait must provide:13

a) The name of the person or body responsible for the proposed release (s.110(1)(a)). b) The name of the person who will be in charge of carrying out the release (s.110(1)(a)).


c) The purpose and objectives of the proposed release (s.110(1)(b)). d) The plants derived from the unmodified host seed (s.110(1)(c)). e) The novel trait expressed by the plants derived from the modified seed, and where applicable, details of the donor organism and method of incorporating the trait into the host seed (s.110(1)(d)(i)). f) The plants derived from the modified seed resulting from the introduction of the novel trait, including details relating to the expression of the novel trait and the stability of the incorporation of the novel trait, and a comparison of the characteristics of the plants derived from the modified seed and those derived from unmodified seed (s.110(1)(d)(ii)). g) All other information relevant to identifying risk to the environment, including risk to human health, that the applicant possesses or to which the applicant reasonably ought to have access (s.110(1)(e)). h) Other government agencies (Canadian or foreign) that have been provided with information about the plants, and the purpose for which it has been provided to them (s.110(1)(f)). i) A description of the analytical methodologies followed in generating any submitted data, including quality control and assurance procedures (s.110(1)(g)). j) Data describing the potential interactions of the seed, or plants derived from the seed, with other life forms, and an evaluation of potential risk of harm posed to the environment (including potential risk of harm to human health) as a result of those interactions (s.110(3)).

Information required under s.110(1)(d)(ii), 110(1)(e), 110(1)(g) and 110(3) may omitted if the decision-maker determines, on the basis of the applicant’s “written scientific rationale” that the information is not relevant or cannot practicably be obtained, and is not required for the Minister's decision under section 111. The decision-maker must take a decision on whether or not to authorize the release “after considering all relevant matters, including the information provided…[by the applicant as required by paragraph 110]…and after evaluating the potential impact on and risk to the environment, including the potential impact on and risk to human health posed by the proposed release.”14 The Seeds Regulations provide that the decision-maker “shall” authorize an unconfined release “where the proposed release poses minimal risk to the environment, and may, where necessary in order to minimize the risk, impose conditions for the management of the risk.”15 However, “where the proposed release poses an unacceptable risk to the environment,” the


decision-maker “shall” refuse to authorize the release.16 In evaluating the risk to the environment, the decision-maker is directed “to consider such matters as (i) the effects of the release on the environment, and (ii) the magnitude of the exposure to the environment of the seed involved in the proposed release, and (b) assess whether the seed is toxic.”17 Directive 94-08 provides additional information on environmental safety assessment. The PBO uses the “substantial equivalence” approach to assessing the risk posed by the PNT. In essence, this approach compares the PNT, in terms of its specific use and environmental safety, to its counterpart species that is in use and generally considered as safe in Canada.18 As a result, the determination of environmental risk is relative rather than absolute. In particular, the PBO assesses environmental safety based on 5 criteria:19

a) Potential to become a weed of agriculture or to be invasive of natural habitats. b) Potential for gene-flow to wild relatives whose hybrid offspring may become more weedy or more invasive. c) Potential for the PNT to become a plant pest. d) Potential impact of the PNT or its gene products on non-target species, including humans. e) Potential impact on biodiversity.

The PBO uses two main sets of information in conducting its environmental safety assessments.20 First, it uses a “companion biology document,” which provides baseline information for the plant species (to which the PNT belongs). Second, it uses the information submitted by the applicant in its notification and request for authorization for unconfined release of the PNT. Directive 94-08 contains two appendices setting out the specific information relevant to an environmental safety assessment, including information regarding the biochemistry of the PNT itself and information about its biology and interactions in the environment. Directive 94-08 also mentions the requirement, set out in the Seeds Regulations, that all relevant information and test data in the applicant’s possession or to which the applicant should reasonably have access should be provided in the application.21 The PBO may also use peer-reviewed scientific literature as appropriate, and may consult relevant scientific experts on issues relating to the environmental safety of a PNT.22 If the applicant becomes aware of new information regarding risk to the environment (including risk to human health) that could result from the release, the applicant must immediately provide the new information to the PBO.23 The PBO is empowered to re-evaluate the risk to the environment (including risk to human health) and may maintain, change or remove any conditions where the risk appears to be less than was originally thought,24 and may change the conditions or impose new conditions where the risk appears to be greater.25 If, in light of the new information, the risk is determined to be unacceptable, the PBO may refuse authorization or cancel the authorization and require the applicant to take “any appropriate action necessary to eliminate or minimize the risk.”26 Directive 94-08 requires other information to be submitted along with an application. These include (1) a test methodology that can detect and identify the PNT,27 (2) a stewardship


plan to address the potential longer term effects for PNTs expressing novel herbicide tolerance (to avoid problems relating to the control of volunteers, the development of resistant weeds etc.) or novel insect resistance (to delay the development of insect resistance to the insecticidal compound),28 (3) a post-release monitoring plan to watch for unintended or unexpected environmental effects.29 The PBO has issued 42 decision documents since 1995 approving the unconfined environmental release of PNTs, including novel varieties of canola, corn, flax, lentils, potato, soybeans, sugar beet, sunflowers and wheat.30 A broader range of PNTs have been approved for confined field trials in Canada.31 II. APPLICATION OF THE PRECAUTIONARY PRINCIPLE II.A. Introduction The precautionary principle is a central tenet of international environmental law, and is contained in over 20 international legal instruments.32 The 1992 United Nations Conference on Environment and Development articulates the precautionary principle in Article 15:

“In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.”33

The Canadian government’s general approach to the precautionary principle is set out in a series of five general principles and five principles for precautionary measures.34 In essence, the Canadian approach to the precautionary principle “recognizes that the absence of full scientific certainty shall not be used as a reason for postponing decisions where there is a risk of serious or irreversible harm.”35 The principles in the Canadian formulation of the precautionary principle also include considerations of cost-effectiveness. The precautionary principle is subject to varying interpretations which differ on three major points: (1) who should bear the burden of proof (the party alleging risk of harm or the party denying risk of harm), (2) what the standard of proof should be (i.e., how much proof is required to conclude that a risk exists), and (3) once proven to exist by the appropriate person and on the appropriate standard of proof, what level of risk is to be tolerated (i.e., zero-risk, or is there some level of acceptable risk, where acceptability is based on considerations such as cost of the precautionary restraint).36 The most precautionary interpretations of the principle place the burden of proof of safety upon the proponent of a new technology, require a high standard of proof of zero-risk (safety), and prefer restraint even if the opportunities foregone are valuable.37 The least precautionary interpretations place most of the burden of proof on the party alleging risk, and, although they may relax the standard of proof, they usually insist that the social and economic costs of exercising restraint be balanced against the potential risks.38 An intermediate approach would assign the burden of proof to those who develop or benefit from the technology in question. In


the intermediate situation, proof of safety would not be required, but restraint would be applied where uncertainty about potential risks is high.39 Although the legislative framework for the regulation of PNTs and Directive 94-08 do not mention the precautionary principle or explicitly call for precaution, the Canadian approach to regulating GM plants is potentially quite precautionary. The word “potentially” is used because, on the basis of the limited public disclosure of information relating to specific decisions, it is not possible to be sure how precautionary the decisions are in practice. Furthermore, as discussed above, there may be some difficulty as the regulatory scheme appears to contemplate that the applicant may exempt itself from the regulatory requirements on the basis of its own assessment of the substantial equivalence in terms of environmental safety of its own new plant to plants of the counterpart species. II.B. Precautionary Principle: Burden of Proof The Canadian scheme places the burden of proof on the applicant seeking approval for the unconfined release of a plant that may pose potential environmental risks. In essence, the regulatory scheme postulates five types of environmental risk,40 and requires the applicant to provide test data and other information to show that these risks are minimal when compared to plants the same species already in use in the environment. It is important to note that the burden of proof is not placed completely on the applicant under this approach, as the applicant bears the burden only in relation to the five types of environmental risk named in Directive 94-08. Other unanticipated types of risk may exist, although, given the breadth of the five identified types of risk, it is perhaps not an unreasonable assumption that they would cover the possible harms. Nevertheless, it is at least possible that other types of risk might exist – if so, the burden theoretically rests on the PBO or the public to advance them. Given the lack of transparency in the decision-making process as well as the lack of opportunities for meaningful public participation in the decision-making process, it would be very difficult for the public to discharge this burden. There is also some uncertainty about the potential long-term environmental impacts of GM plants. Given that the applicants’ burden of proof is discharged once evidence is provided regarding the five types of environmental risk based on time-limited small-scale confined field trials, they do not bear the burden of proof of long-term environmental safety either. Once again, it is the PBO or the public that must pursue the risk of long-term effects if it is to be addressed under the current regulatory framework. The Canadian Biotechnology Advisory Committee and the Royal Society Expert Panel Reports both noted that knowledge of the long-term environmental impact of GM plants is limited.41

“Even though transgenic crops have been grown on more than 175 million hectares worldwide, knowledge of how they might affect agricultural and natural ecosystems in the long term is limited. Assertions of the lack of any adverse environmental effects are unverified, given the lack of any systematic monitoring to detect such effects. The pre-market assessment of environmental risks of GM crops is based on data obtained from small-scale confined field trials that are not suited to detecting small or low-probability effects that would become apparent only at larger spatial scales and over extended periods of time.”42

The CBAC suggested that rather than relying on applicants to bring new information forward, it would be better to schedule reviews of approval decisions after a specified interval of time (e.g.,


10 years), at which time all new information could be considered.43 During the recent consultations leading to the revision of Directive 94-08,44 one of the questions debated was whether to use time-limited (interim) authorizations, with subsequent renewals dependent upon re-assessment. The opinions of consultation participants and the public were split on the desirability of interim authorizations, and this approach has not been retained as a general operating procedure.45 The problem of unexpected environmental effects (of a type falling outside the 5 types of risk contemplated by Directive 94-08, or of a type that only becomes manifest in the long term) could be partly answered by the requirement mentioned in section 7.6 of Directive 94-08 that applicants must supply with their applications a “general post-release monitoring plan to monitor for unintended or unexpected environmental effects of an authorized product,” and must supply any new information thus produced regarding environmental risk to the PBO. The public decision documents do not mention these general post-release monitoring plans. As a result, it is not possible to assess their content, or to determine the degree to which they are effectively applied. In any event, the use of the “general post-release monitoring plans” may not provide a complete answer to the problem of unexpected environmental effects given that more specific stewardship plans (i.e., herbicide tolerance management plans or insect resistance management plans) may be considered sufficient replacements for a general post-release monitoring plan.46 There may be a danger that a plan designed to monitor for only one particular effect might miss others. The PBO need not accept a stewardship plan in lieu of a general post-release monitoring plan, and one assumes that it would do so only where the stewardship plan is designed to capture unanticipated effects other than herbicide tolerance or insect resistance. Due to lack of transparency, it is not possible, on the basis of the public record, to determine whether this is the case. The answer to the problem of potential long-term effects may come from the government. The government has acknowledged the Royal Society’s recommendation that long-term monitoring studies and research on the impact of GM organisms be undertaken,47 and an interdepartmental initiative led by Environment Canada (“Ecosystem Effects of Novel Living Organisms (EENLO)” in partnership with the CFIA and others is being developed.48 Agriculture and Agri-Food Canada is also conducting a 12 year research program (starting in 2000) on the environmental impacts of GM crops including corn, potatoes and canola.49 The issue of what happens when an applicant does not or cannot provide the safety evidence required will be addressed below under the heading of “Precautionary principle: Standard of Proof.” In sum, the bulk of the burden of proof to demonstrate safety of the PNT appears to be placed on the applicant (in a manner consistent with a fairly strong application of the precautionary principle), although the burden is restricted to five types of potential environmental impact and may thus leave long-term impacts and unexpected types of impacts to be raised by the government or the public, if at all. II.C. Precautionary Principle: Standard of Proof The standard of proof demanded of the applicant appears to be fairly high in relation to the five types of environmental risk outlined in Directive 94-08. The applicant must gather “appropriate


data and relevant scientific information describing the environmental risk of the PNT relative to its counterpart(s) already present in the Canadian environment”50 through testing and analysis and during confined research field trials.51 Directive 94-08 indicates that the data submitted in an application must be equivalent in quality to that provided for peer-reviewed publication.52 The applicant must describe the test procedures used, including “test methods, reference products, quality control, quality assurance procedures, appropriate statistical analysis, together with bibliographic references, including numbered patents, where these are appropriate.”53 Applicants are directed to a reviewers’ checklist which describes the details required in six analytical biochemical procedures.54 Although the information requirements seem to be rigorous, it is not possible to independently verify the quality and quantity of data using the public record. The decision documents describe in very general terms the data submitted by the applicants to address the five types of environmental risk considered by the PBO, but do not provide details of methodology or the precise data gathered. As a result, independent external verification of the results is not possible. For example, the portion of Decision Document 2004-46 addressing the altered plant pest potential of a new line of lentils stated:

“The intended effect of the novel trait is not expected to affect plant pest potential, and L. culinaris is not a plant pest in Canada. Line RH44 and an appropriate non-mutagenized line of similar genetic background were tested for responses to several common insect pests of lentil and several important fungal pathogens. There were no indications in the data supplied by BASF that line RH44 has an altered plant pest potential. In all cases, responses of line RH44 were within the normal range of typical commercial lentil cultivars. In addition, agronomic characteristics of line RH44 were shown to be within the range of values displayed by currently commercialized L. culinaris varieties, leading to the conclusion that plant pest potential has not been inadvertently altered. No gene sequences from plant pathogens were used in its development and it is therefore highly unlikely that line RH44 expresses any novel plant pathogen characteristics. The CFIA has therefore determined that line RH44 is unlikely to display any altered plant pest potential.”55

Furthermore, it is not clear what would happen if the applicant were unable to provide any test data, or were able to provide only weak data. Presumably, if the applicant is unable to provide the necessary evidence showing that the PNT does not pose an unacceptable environmental risk, it will not be approved. Indeed, the PBO has indicated that,

“Products are not approved until CFIA evaluators are satisfied that the application addresses all regulatory requirements, the science has been properly carried out, and no significant risks are found. If the data is scientifically unsound, incomplete or inadequate, government regulators require that the product developer examine shortcomings in their submissions before the assessment can continue. If any part of the information provided is insufficient, evaluators require the product developer to supply further studies or information.”56

So far, there have been no refusals of authorization. Perhaps this is because applicants submit applications only for those PNTs which they are sure can be shown not to pose unacceptable risk


according to PBO criteria, or perhaps because applications are withdrawn before they are refused. The table of decision documents published by the CFIA indicates one instance (Corn MON832) in which an application for approval of unconfined release was withdrawn (although novel food approval was granted by Health Canada). The standard of proof demanded seems to have been workable from the applicants’ perspective for the relatively simple PNTs approved so far, as applicants have been able to demonstrate that there is either no unacceptable environmental risk, or that the risk that can be managed so as to reduce it to an acceptable level (in the case of insect resistance and herbicide tolerance). The decision documents show that the PBO has been able to conclude in most instances that there is no environmental risk at all for most of the five potential environmental safety concerns outlined in Directive 94-08 (i.e., increased weediness, gene-flow etc.). The only matters about which risk seems to have been recognized are (1) the problems arising from herbicide resistance57 and (2) insect resistance.58 Where these risks have been found to exist, stewardship plans are required of applicants. As a result of the applicants’ ability to generate conclusive evidence, whereby it has been possible to establish zero-risk with respect to the five potential environmental safety concerns, there has likely not been much pressure by applicants against the PBO’s adherence to a precautionary approach involving a fairly high standard of proof of safety. In other words, as far as it is possible to see from the public record, it has not been necessary to refuse to authorize release of a PNT because the evidence submitted was insufficiently conclusive regarding the level of risk. One assumes that there has therefore been relatively little pressure from industry regarding the use of a precautionary approach. The PBO may need to make more awkward decisions in future because it may be harder to provide the same degree of conclusive evidence regarding the environmental impact of the more complex GM plants now in development. The “first generation” of GM plants has involved mostly plants engineered to be herbicide resistant or to contain insecticidal compounds in order to facilitate weed and pest control in large crops.59 (Some of this first group of “early” GM plants involved other modifications, such as altered fertility or nutrient content.) A much broader range of new traits is under development, including disease resistance, increased resistance to environmental stresses and enhanced productivity.60 A review of the CFIA list of approved confined field trials by year61 shows that, in recent years, many confined field trials have been approved for plants with novel traits providing for environmental stress resistance, production of compounds of industrial and pharmaceutical interest, disease resistance, and enhanced yield, in addition to the “traditional” herbicide resistance and insect resistance. One might imagine that enhanced productivity (such as improved photosynthetic efficiency) or stress-tolerance would confer competitive advantages that would raise real uncertainty about the disruption of natural ecosystems and the loss of biodiversity. It would likely be more difficult to prove that the risk is nil, which would force the PBO to determine the quality and quantity of evidence required in order to establish the level of risk (as well as to determine more clearly the meaning of “minimal” risk, as discussed further below).

“The first generation of GM crops largely involved genes conferring resistance to herbicides and to various pests and diseases, but new genes associated with stress tolerance (e.g. salt, drought and temperature tolerance) are also likely to become commercially available in the near future. It is not difficult to imagine that the escape of such genes could have potential influences on the ecology of wild plant communities…[T]he potential ecological impacts of other targeted genes in the second generation of GM crops (e.g. vitamin-rich rice and increased floral longevity in ornamental species) are more difficult to assess.”62


The PBO has already anticipated the likely increase in regulatory complexity with some of the newer applications of biotechnology, singling out plant molecular farming (i.e., the modification of plants to produce compounds of interest for industrial or pharmaceutical applications)63 and “stacked traits” (i.e., the insertion of multiple novel traits) for special treatment in the regulatory process.64 II.D. Precautionary Principle: Level of Acceptable Risk As noted earlier, the application of the precautionary principle depends upon a choice about how much risk a society wishes to tolerate. Strong applications would apply precautionary measures unless it could be shown that a technology is safe (i.e., there is zero risk).65 The strongest application would also require the applicant of the technology to prove this to a high degree of certainty. Weaker versions of the precautionary principle would balance the social and economic costs of foregoing the technology (or of applying precautionary measures) against the risks, and would tolerate some level of risk.66 The Royal Society Report suggests that the acceptability of the risk will depend upon various factors such as the severity of the potential harm, the degree of voluntary choice in risk-taking, and the off-setting benefits of the risk-taking (and whether they are fairly distributed).67 The Seeds Regulations provide that authorization shall be refused where an unconfined release poses “unacceptable risk to the environment.”68 Authorization shall be granted where the proposed release “poses minimal risk to the environment.”69 The Seeds Regulations also provide that where necessary to minimize the risk, conditions for risk management may be imposed.70 This last clause is ambiguous in its impact. It could mean that where risks greater than minimal can be reduced to minimal or lower, the proposed release may be authorized along with conditions. It may also mean that where risk management options exist, they may be imposed to reduce even minimal risks. In any event, the regulatory structure seems to provide that any risk above minimal will be considered unacceptable (or if not unacceptable, the outcome will be the same as if it were unacceptable – the application will be refused). In fact, the CFIA has recently noted that it “would not authorize a PNT if it could produce herbicide tolerant hybrids that do not have effective or sustainable control options.”71 We do know what the particular adverse outcomes at issue in this safety assessment process are, and as a result know what “risk to the environment” means in the phrase “unacceptable risk to the environment.” Directive 94-08 specifies the five environmental safety assessment criteria at issue.72 However, there is little guidance in Directive 94-08 or in the legislation on the meaning of the terms “unacceptable” and “minimal.” The only guidance available for assessing the level of risk is that the PBO should, in assessing environmental risk, consider the magnitude of the exposure to the environment of the seed involved in the proposed release, and should also assess whether the seed is toxic.73 Toxic seed is defined in the Seeds Regulations as seed entering the environment in a quantity or concentration or under conditions that “have or may have an immediate or long-term harmful effect on the environment or its biological diversity,” “constitute or may constitute a danger to the environment on which life depends,” or “constitute or may constitute a danger in Canada to human life or health.”74 The definition of toxic seed is broad, and appears to suggest that seed that may have any degree of harmful effect on the environment would be considered toxic. If all releases of toxic seed were to be considered to pose unacceptable risk, the application of the precautionary principle would


be very strong. However, the toxicity of the seed is only one matter to be assessed by the PBO in evaluating the risk to the environment in order to reach a determination of whether the risk is unacceptable or minimal. The decision documents do not provide much more information that would permit some conclusions to be drawn about the level of risk to be tolerated by Canadians under this regulatory scheme. In the decision documents considered in this case study, the applicants have been able to establish with sufficient certainty that relative risks are minimal or non-existent with the exception of the novel traits for herbicide tolerance or insect resistance. In these latter two cases, due to concerns about the development of herbicide-resistant weeds and of pesticide-resistant insects, stewardship plans have been imposed. The decision documents do not clearly state that the stewardship plans are considered to reduce the environmental risks to “minimal” or lower. Instead, the decision documents suggest that the herbicide tolerance management plans may “minimize the development” of herbicide tolerant weeds and multiple herbicide tolerant crop volunteers,75 or may permit deployment “while managing these concerns.”76 Insect resistance management plans are intended to “delay the development of resistant” insects,77 or “significantly reduce and delay the development” of resistant insects.78 Since the decision documents for insect resistance management seem to suggest that these adverse outcomes are to be delayed rather than avoided altogether, it seems that a decision has been taken that they are to be tolerated. Given that the adverse impact seems fairly certain to occur eventually (i.e., the language chosen is “delay” rather than “prevent”), the adverse impact itself must be considered to be of minimal consequence. This is perhaps not a surprising conclusion given that the problems of herbicide tolerance and insect resistance arise in conventional agriculture, and are not unique to the use of GM plants. Unfortunately, it is not possible on the basis of the decision documents to draw any further insight into the process by which the PBO determines that Canada will tolerate a particular risk. The decision documents do not provide a detailed discussion of the relative costs and benefits of using these PNTs in the present against the eventual costs of dealing with herbicide resistant weeds and pesticide resistant insects. As a result, the way in which the PBO may eventually decide to balance the costs and benefits of new more complex PNTs is hard to predict. While the discussion of stewardship plans provides some insight into how Canada’s chosen level of acceptable risk is determined, it shows only that the PBO has accepted a particular non-zero risk to be minimal, and not to constitute a barrier to approval for unconfined release. As there are no refusals on record, it is not possible on the basis of the public record to determine what constitutes an unacceptable risk from the PBO’s perspective, or what criteria would enter into such a discussion. III. APPLICATION OF THE PRINCIPLE OF ADAPTIVE MANAGEMENT The principle of adaptive management (PAM) holds that regulatory decisions should take the form of scientific experiments, so that the outcomes of specific decisions can be evaluated in order to provide information for use in subsequent decision-making. The legislation and policy documents relevant to the approval of the unconfined release of PNTs do not mention PAM expressly. Nevertheless, the decision-making structure does incorporate some elements of an adaptive management approach.


As noted earlier, the environmental safety assessment departs from the presumption that the unconfined release of a given PNT threatens five possible harms.79 The applicant must then produce evidence (of a quality suitable for peer-review) that the PNT does not in fact pose more than a minimal risk of each of the five possible harms. The decision documents state their conclusions on the basis of the evidence provided in a manner that, in theory, would be amenable to empirical observation for correctness.80 The regulatory structure does contemplate some degree of ongoing monitoring for unexpected impacts, requires that new information be provided to the PBO, and permits earlier approvals to be modified or revoked in light of the new information. As noted earlier in the discussion on the precautionary principle (burden of proof), Directive 94-08 requires that applicants submit a “general post-release monitoring plant to monitor for unintended or unexpected environmental effects of an authorized product,” and must supply any new information thus produced regarding environmental risk to the PBO. The imposition of a positive duty to gather data is much better from the perspective of PAM than a system which merely requires the applicant to send new information of which it happens to become aware to the PBO.81 The latter system could encourage unscrupulous applicants to arrange their monitoring and reporting systems in such a way as to minimize the possibility of “becoming aware” of unwelcome new information that might disrupt the commercialization of a product in which large amounts of R&D costs have been invested. However, it is unclear from the public record whether these general post-release monitoring plans are effective. The public decision documents do not mention them. As a result, it is not possible to assess their content, or to determine the degree to which they are effectively designed and enforced. In response to questions received during the consultation process leading to the revision of Directive 94-08, the CFIA has indicated, with respect to post-release monitoring plans, that;

“[a]pplicants are required to provide a suitable post-release monitoring plan, which will be evaluated, as with all data provided in an unconfined release submission, on a case-by-case basis. Applicants are required to use appropriate indicators and parameters that will be based on the characteristics of the PNT. The use of appropriate baseline data to detect unintended or unexpected environmental effects of the PNT after its release in the environment must also be considered in the monitoring program. The PBO will only [sic] authorize the release of a PNT until an acceptable post-release monitoring plan has been proposed by the applicant.”82

Furthermore, as discussed earlier, there is a possibility that the “general post-release monitoring plans” are sometimes replaced by a more limited “stewardship plan” (i.e., herbicide tolerance management plans or insect resistance management plans).83 Although the PBO presumably would not accept the substitution of a stewardship plan for a general post-release monitoring plan where the stewardship plan was too narrowly focused on one particular risk and might miss unanticipated effects, it is not possible to determine whether this is the case from the public record. It is not clear how often applicants do forward new information to the PBO, although it appears that this has happened on occasion without provoking a change in the original authorization. In response to a public petition for information under the Auditor General Act, R.S.C. 1985, c. A-17, the Government has indicated that;

“[t]here have been occasions when new information has become available; however, based on this new information, there have been no changes in the outcome of the environmental and


livestock feed safety assessments of any approved PNTs (or products derived from such crops) that have resulted in amendments to the regulatory requirements of the original authorizations at this time. This has been the case, regardless of the method used to produce the change to molecular make-up of the PNT (e.g., whether it is a product of modern recombinant DNA techniques or mutagenesis).”84

Other methods for obtaining post-release information that could support the use of an adaptive management approach include the use of interim authorizations (discussed above in the context of the precautionary principle (burden of proof)). The Canadian Biotechnology Advisory Committee recommended that a pre-scheduled (e.g. 10 years post-release) re-assessment should be adopted as a standard operating procedure to provide an opportunity for consideration of new information.85 The CBAC also recommended that the new information be available for scientific peer review and public comment. This possibility was canvassed in the recent consultations leading to the revision of Directive 94-08, but was not adopted as a general operating procedure. Instead, it appears to be available as an option for situations in which follow-up information is required for the proper implementation of a management plan, but where the PNT is otherwise assessed to be safe.

“Interim approval” is a “time-limited approval.” Time-limited approval will be granted in cases where a PNT is assessed to be safe, but where a follow up with the applicant for additional information is required in order for proper implementation of a specific management plan (e.g., new insect resistance management plan). For instance, the PBO may grant a time-limited approval for the unconfined environmental release of a PNT expressing novel insect resistance, when the ability of a developer to fully research on a proposed IRM plan is restricted due to the limitations in size of the confined field trials. The applicant will be notified of the required additional information by a deficiency letter. Renewal of the time-limited approval is contingent upon the submission of adequate study reports, and/or demonstration of significant progress in research related to the PNT. An indeterminate authorization may only be granted when the applicant has submitted all the information the PBO deems necessary to complete its environmental safety assessment.”86

The problems associated with an interim approval system that are identified in the consultation-related documents do not appear to be insurmountable obstacles (with the possible exception of the resource implications). Some consultation participants suggested that interim approvals would undermine public confidence and create undesirable “public optics.” The contrary view is also possible – namely, that the failure to adopt a truly effective means to detect and respond to long-term unanticipated impacts will undermine public confidence. If the source of the concern is that the public might perceive the PBO to be approving the release of PNTs whose long-term impacts are unknown, surely it might be possible to make it clear that the authorization is made only after determining that, based on all presently available data and attempts to anticipate long-term impacts, there is no reason to expect harmful long-term consequences and that the pre-scheduled revision of the decision is essential to focus applicants’ attention on long-term unanticipated effects, to gather useful information relevant to subsequent regulatory decisions, as well as to verify the appropriateness of the previous decision. In addition to new information provided by the applicant, the government also inspects and monitors some PNTs following approval for unconfined release. Inspection appears to be limited to those for whom approval was conditional.

“Plants derived through biotechnology go through rigorous environmental assessments before field trials or environmental release is permitted. These are carried out by the CFIA’s Plant


Biosafety Office (PBO). The plants are closely monitored at the various stages of the process. During approved confined field trials, test sites are visited by CFIA inspectors to assure that producers are complying with the conditions such as reproductive isolation, and post-harvest land use restrictions of the trial permit. If approvals are conditional (e.g., in the case of Bt plants or potatoes), they continue to be subject to inspection and monitoring.”87

The Government has also indicated, in its response to a recent petition under the Auditor General Act, that it “may carry out post-market sampling, auditing, and testing, either as routine post-market surveillance for compliance with post-approval conditions or on a case-by-case basis…”88 The same response describes the auditing effort conducted by the CFIA in 2000 and 2002 of every product developer marketing approved Bt technology-derived corn and potatoes to ensure compliance with insect resistance management plans.89 CFIA post-release monitoring appears to be focused on compliance with stewardship plans (which is undoubtedly essential and welcome to ensure that the regulatory system is functioning as it should) but does not appear to be aimed at detecting the kind of information necessary for an adaptive management approach – namely, whether the predictions that the PNTs would not cause environmental harms were correct. To be fair, the CFIA has also commissioned various research projects involving field studies to assess the impacts of approved PNTs.90 As a result, although the legislative structure is in place to permit decisions to be revised in light of new evidence that suggests that earlier predictions were incorrect, and to permit new information to be used in subsequent decisions, it seems questionable whether the system for gathering information about post-release environmental impact is sufficiently robust to support an adaptive management approach. IV. TRANSPARENCY This case study has been unable to draw strong conclusions about the application of either the precautionary principle or the principle of adaptive management mostly because of a lack of transparency in the regulatory process. Although the regulatory structure may appear one way on paper, the lack of voluntary public disclosure of more detail regarding decisions, follow-up monitoring etc. makes it difficult to determine how the system operates in practice. On this point, the Royal Society’s assessment of scientific integrity of the regulatory system for food biotechnology in Canada states,

“In principle, the Regulations specified by CFIA, Food and Drugs Act, and Canadian Environment Protection Act for approval of GMOs, particularly those that pertain to microbes and plants, are comprehensive in their breadth of required information, ranging from the molecular nature of the novel gene construct to potential consequences to human health and the environment. However, despite this breadth, the Panel has concluded that there is no means of determining the extent to which these information requirements are actually met during the approval process, or of assessing the degree to which the approvals are founded on scientifically rigorous information. The Panel attributes this uncertainty to a lack of transparency in the process by which GMOs are approved within the present regulatory framework.”91

One of the central themes in the regulation of biotechnology is the degree of transparency of the regulatory process. The Royal Society Report notes that “one of the concerns frequently voiced


about the regulation of biotechnology in Canada and elsewhere involves the question of the independence, objectivity and transparency of the science involved in the assessment of the technologies.”92 Concern is most often expressed about the objectivity and disinterestedness of the scientists who develop, test and regulate GM products or about the degree to which the science used to assess the biotechnology products is made available for independent validation.93 Increased transparency in the regulation of GM plants would have numerous benefits: access to a greater range of outside scientific expertise to improve the quality of safety assessments, improved accountability of the CFIA and improved insulation of CFIA regulators from improper pressures (if any exist) by other government actors and the applicants, and improved public confidence in the system. Increased transparency may have negative consequences as well from the public perspective. Valuable and useful PNTs that do not raise environmental safety concerns may not be brought to market in Canada if developers fear that commercially sensitive information will be disclosed to their competitors. Whether or not this is a valid concern will depend upon which information is required to be made public. At the moment, it seems questionable whether some of the data being withheld is really commercially sensitive. A requirement that it be disclosed may annoy but fundamentally not harm developers of PNTs. The Royal Society Report notes that much of the test data submitted in an application for regulatory approval is protected as “confidential business information” under the Access to Information Act. Indeed, Directive 94-08 assures applicants several times that information submitted to the PBO may be protected under the Access to Information Act, and that all requests for information are subject to that Act and the Privacy Act.94 As the Royal Society Report notes, the information made public in decision documents summarizes the assessment conclusions without providing the “actual data and scientific judgments leading to that assessment.”95 The Royal Society Report suggests that by refusing to make data publicly available, Canadian regulators are being unduly protective of industry interests, which reflects a fundamental conflict of interest between both promoting and regulating an industry, and which undermines the scientific integrity of the regulatory process.96

“In meetings with senior managers from the various Canadian regulatory departments, the Expert Panel addressed questions related to their handling of the issues of transparency and confidentiality in dealing with applicants for licensing of new biotechnology. Their responses uniformly stressed the importance of maintaining a favourable climate for the biotechnology industry to develop new products and submit them for approval on the Canadian market. If the regulatory agencies do not respect industry interests in protecting the confidentiality of product information as well as data obtained from extensive health and environmental testing, industry in turn will be deterred from engaging in the regulatory approval process. Several of the managers referred to the importance of maintaining a relationship of trust between industry and the regulators. Only in an atmosphere of trust, they argued, can government and industry work together in the cooperative way necessary to generate the product and test data required for the protection of public safety. Such concern with industry development, though understandable, highlights another aspect of the regulatory conflict. The conflict of interest involved in both promoting and regulating an industry or technology, discussed in the previous section, is also a factor in the issue of maintaining the transparency, and therefore the scientific integrity, of the regulatory process. In effect, the public interest in a regulatory system that is “science based” — that meets scientific standards of objectivity, a major aspect of which is full openness to scientific peer review — is significantly compromised when that openness is negotiated away by regulators in exchange for cordial and supportive relationships with the industries being regulated.


In the judgment of the Expert Panel, the more regulatory agencies limit free access to the data upon which their decisions are based, the more compromised becomes the claim that the regulatory process is “science based”. This is due to a simple but well-understood requirement of the scientific method itself — that it be an open, completely transparent enterprise in which any and all aspects of scientific research are open to full review by scientific peers (Kennedy, 2000). Peer review and independent corroboration of research findings are axioms of the scientific method, and part of the very meaning of the objectivity and neutrality of science.”

The Royal Society Expert Panel recommended that “the Canadian regulatory agencies seek ways to increase the public transparency of the scientific data and the scientific rationales upon which their regulatory decisions are based.”97 It also recommended that an external (non-governmental), independent panel of experts be used to conduct a system of regular peer review of the risk assessments upon which approvals are based, and that the data and the rationales upon which the risk assessment and regulatory decision are based be available to public review.98 The Canadian Biotechnology Advisory Committee Report, released in August, 2002, also recommends increased public transparency.99 Recommendation 2.4. suggests that the “detailed scientific and technical data pertinent to the human health and environmental safety assessments of GM foods and other novel foods be made public, except for details that could unduly jeopardize a company’s competitive position (e.g. details of how to manufacture the product),” and, importantly, that “if it is determined that the Access to Information Act does indeed preclude the release of information as recommended above, the government should consider amending the act.”100 The Government published its response to the Royal Society Report on November 23, 2001.101 It agreed with “the need for and the benefits of the recommendations related to transparency and increasing public confidence.”102 The Government agreed to study the approaches taken in other countries where there is more opportunity for public and expert consultation.103 The Government response also indicated;

“Further, we commit to discussions with industry to encourage the publication of further information. We will also consider regulatory and legislative revision to grant us the authority, where not already provided for, to publish further information while respecting legitimate concerns to safeguard the confidentiality of proprietary information.”104

The commitment to “consider regulatory and legislative revision” was not associated with an action item nor was a progress report promised. In subsequent governmental progress reports,105 there has been no mention of legislative revision to enable greater public disclosure of safety-related information. Another mechanism for transparency is the public petition process under s.22 of the Auditor General Act, R.S.C. 1985, c.A-17, which provides for public petitions on environmental matters related to sustainable development. While useful in obtaining further detail about the decision-making process, it does not appear to provide the kind of detail about specific decisions that would permit independent verification and review of data submitted by applicants.106 The CFIA announced a new initiative to increase transparency in its August, 2004 report; the “Notices of Submission” project.107 These notices, which are provided on a voluntary basis, are an improvement over the previous system as they offer the public an opportunity to comment on some applications before a decision is rendered, as well as to know prior to approval about the


existence of some applications under consideration. However, the information provided is very minimal, suggesting that no meaningful public input can realistically be expected.108 The data submitted consists of a brief description of the PNT and a list of the types of test data submitted. In some cases the description of the test data related to environmental impact is particularly skeletal, and adds nearly nothing beyond a list of data types known to be required in an application from a review of Directive 94-08. One notice of submission states only that,

“[i]n order to assess the environmental impact of the novel plant the following has been submitted: Potential for ALS3 wheat to become a weed Potential for gene flow to wild relatives Potential impacts on non-targets Agronomic data, germination data confirming ALS3 wheat is equivalent to other wheat, with the exception of imidazolinone tolerance In addition, herbicide tolerant crop management strategies were submitted in the application.”109

Clearly, little meaningful external input on the environmental impact of ALS3 wheat is likely. The Government is perhaps overly hopeful that the '"notices of submission" initiative will significantly improve transparency when it suggests that,

“[w]ith the launch of this [Notices of Submission] project, the federal government is responding with a credible means of addressing the public’s interest in a more transparent process of regulating novel products…[T]his new initiative allows for public input during the approval process itself, rather than only after approval is given.”110

Although the initiative is a good one, it does not address the concerns raised by the Royal Society Expert Panel Report or the CBAC with respect to transparency in the decision-making process. Given that the safety assessments of some of the newer GM plants now under production will be more complex, and possibly less amenable to conclusive determinations that risks are zero or minimal, the pressure for transparency is likely to become more acute. Other possible solutions do exist. For example, publicly-funded or applicant-funded independent testing of the PNT might be adopted. In the UK, independent researchers have been funded to conduct their own trials on GM crops and the raw data has been made publicly available.111 VII. CONCLUSION This case study has focused on the application of the precautionary principle and the principle of adaptive management in the context of the Plant Biosafety Office’s decisions on whether to authorize the unconfined environmental release of GM plants in Canada. While the regulatory structure seems to display the attributes of a precautionary approach (i.e., burden of proof of safety or minimal risk lies with the applicant, the applicant must produce a reasonable quality and quantity of evidence, and only minimal risks will be tolerated), it is not clear from the public record how this plays out in practice. Due to the lack of transparency with


respect to the test data submitted and to the scientific reasoning underlying decisions, it is not possible to be certain about the actual application of the precautionary principle. So far, the applications seem to have concerned types of GM plants in respect of which the PBO has been able to conclude that there are nearly no short-term risks at all (with the exception of herbicide tolerance and insect resistance, both of which have been treated as manageable using stewardship plans). As the complexity of GM plants increases and applications are made with respect to GM plants which are less amenable to proof of safety (e.g. those containing traits that could conceivably confer competitive advantage in wild ecosystems such as increased stress tolerance or productivity), it is possible that the PBO will face more awkward decisions that will require the PBO to take a decision under conditions of greater uncertainty. This will raise more sharply the issues of the standard of proof to be demanded of applicants, as well as of the degree of acceptable risk to be tolerated. The consequences in terms of public confidence and quality of the scientific risk-assessment of the current lack of transparency may well grow for future applications. Some aspects of an adaptive management approach also exist (i.e., requirements that applicants transmit new information to the PBO, provision for the modification of decisions in light of new information, etc.). However, the procedures in place for the systematic monitoring of long-term and unanticipated effects seem inadequate for a full adaptive management approach. Once again, because of lack of transparency, it is not possible to be fully confident that this is the case. It may be that the procedures in place are in fact adequate. An essential step is to seriously address the question of transparency, and to carry forward the government’s stated commitment to reviewing the current legislation (e.g. Access to Information Act) to ensure that the maximum amount of information regarding decisions is in fact being made available to the public. There are many advantages to greater transparency including (1) access to a greater range of outside scientific expertise, which would improve the quality of safety assessments, (2) improved accountability of the CFIA and improved insulation of CFIA regulators from improper pressures (if any exist) applied by other government actors and the applicants, and (3) improved public confidence in the system. Attention must, however, also be paid to the potential disadvantages of increased public disclosure under the Access to Information legislation. One potential disadvantage, mentioned during the workshop conducted by the Practicing Precaution project, was the possibility that increased disclosure under access to information legislation may have the counter-productive effect of causing decision-makers to include less detail in records that might be subject to access requests. 1 The Canadian approach to the precautionary approach is set out in Canada, Privy Council Office, “A Framework for the Application of Precaution in Science-based Decision Making about Risk,” (25 July 2003), <http://www.pco-bcp.gc.ca/default.asp?Language=E&Page=publications&Sub=precaution&Doc=precaution_e.htm >. 2 Canadian Food Inspection Agency Act, S.C. 1997, c.6, s.11 sets out the responsibilities of the CFIA, one of which is the administration and enforcement of the Seeds Act R.S.C. 1985, c.S-8. 3 Food and Drugs Act, R.S.C. 1985, c. F-27, Food and Drug Regulations, C.R.C. c.870, Part B, Division 28 Novel Foods. 4 The Seeds Act R.S.C. 1985, c.S-8 and Seeds Regulations C.R.C. c. 1400, Part V govern the confined and unconfined release of PNTs, while the Plant Protection Act, S.C. 1990, c.22 governs the importation of PNTs. 5 Seeds Regulations C.R.C. c. 1400, s.109(1). 6 Seeds Regulations C.R.C. c. 1400, s.108. Section 108(a) provides that “[t]he following seed is exempt from the operation of this Part: (a) seed grown in Canada outside of containment before the coming into force of this Part in such a manner that the seed constitutes a distinct, stable population in the Canadian environment.”


7 Seeds Regulations C.R.C. c. 1400, s.109 provides exemptions for seed varieties registered under Part III (s.109(2)), seeds for which unconfined release was authorized before Part V came into force (s.109(3)), and, in certain cases, where the information required in a notification has already been provided (s.109(4)). 8 Plant Biosafety Office, CFIA, “Directive 94-08 (Dir 94-08) Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits” (updated 29 October, 2004), <http://www.inspection.gc.ca/english/plaveg/bio/dir/dir9408e.shtml >. 9 Ibid. Section 2.1. “Regulatory Scope: Determination of Novelty.” 10 Ibid. 11 Ibid. Section 1 “Introduction” 12 Seeds Regulations, C.R.C. c. 1400, s.110. 13 Note that the information requirements vary for notifications involving seeds without novel traits, and for applications for the approval of confined release. 14 Seeds Regulations, C.R.C. c. 1400, s.111(1). 15 Seeds Regulations, C.R.C. c. 1400, s.111(1)(b). 16 Seeds Regulations, C.R.C. c. 1400, s. 111(1)(c). 17 Seeds Regulations, C.R.C. c. 1400, s.111(2). The Seeds Regulations define “toxic” in s.107(1) as a seed which “is entering or may enter the environment in a quantity or concentration or under conditions that (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity; (b) constitute or may constitute a danger to the environment on which life depends; or (c) constitute or may constitute a danger in Canada to human life or health.” 18 Directive 94-08, supra note 8, p.4 and p.20. 19 Ibid., section 6.1. These are the same criteria mentioned in relation to a finding of “substantial equivalence” in the Seeds Regulations, s.107 “definition of novel trait” and s.108(c) “exemptions.” 20 Ibid., section 6.2. 21 Ibid. section 7.1. 22 Ibid., sections 6.2 and 6.3. 23 Seeds Regulations, C.R.C. c. 1400, s. 112(1). Directive 94-08, supra note 8, s.9, also reiterates this requirement. 24 Seeds Regulations, C.R.C. c. 1400, s. 112(2)(a). 25 Ibid., s. 112(2)(b). 26 Ibid., s. 112(2)(c). 27 Directive 94-08, supra note 8, section 7.4. The PBO supplies criteria for an acceptable detection and identification method at <www.inspection.gc.ca/english/plaveg/bio/detecte.shtml>. 28 Ibid., section 7.5. 29 Ibid., section 7.6. 30 A summary document of approvals is available at on the CFIA website at <http://www.inspection.gc.ca/english/plaveg/bio/pntvcne.shtml>. Note that an additional seven decision documents are available from the PBO in which approvals for use in livestock feed have been granted for plants that do not grow in Canada (i.e., rice and cotton). In addition, there have been approvals by Health Canada for novel squash and tomato plants without PBO approvals as they are not grown in Canada nor are they proposed for use in livestock feeds. 31 Summary documents are available on the CFIA website at <http://www.inspection.gc.ca/english/plaveg/bio/triesse.shtml>. 32 Royal Society of Canada, “Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada,” (January 2001), <http://www.rsc.ca//files/publications/expert_panels/foodbiotechnology/GMreportEN.pdf>, p. 194. 33 United Nations, “Report of the United Nations Conference on Environment and Development, Annex 1: Rio Declaration on Environment and Development, 3-14 June, 1992, A/CONF.151/26 (Vol. 1), <http://www.un.org/documents/ga/conf151/aconf15126-1annex1.htm>. 34 Supra note 1. 35 Ibid. 36 Royal Society Report, supra note 32, pp. 196, 204. 37 Ibid., p. 196. 38 Ibid., p. 197. 39 Ibid., p. 197.


40 These are (1) the potential of the plant with a novel trait to become a weed of agriculture or be invasive of natural habitants, (2) the potential for gene-flow to wild relatives whose hybrid offspring may become more weedy or more invasive, (3) the potential for the plant with a novel trait to become a plant pest, (4) the potential impact of the plant with a novel trait or its gene products on non-target species, including humans, and (5) the potential impact on biodiversity. 41 CBAC, “Improving the Regulation of Genetically Modified Foods and Other Novel Foods in Canada: Report to the Government of Canada Biotechnology Ministerial Coordinating Committee,” (August 2002), <http://cbac-cccb.ca/epic/internet/incbac-cccb.nsf/en/ah00186e.html> at p.34. 42 Ibid. 43 Ibid., Recommendation 3.6; Royal Society Report supra note 32, Recommendation 6.2. 44 CFIA, “Health Canada and Canadian Food Inspection Agency Consultation on Revisions to Regulatory Directives and Guidelines May 29-31, 2002,” <http://www.inspection.gc.ca/english/plaveg/bio/gatconsult/consulrevise.shtml>, section 9; CFIA, “Online Feedback Form on the Revision of Regulatory Directives and Guidelines on Novel Foods, Plants with Novel Traits and Novel Livestock Feeds,” <http://www.inspection.gc.ca/english/plaveg/bio/gatconsult/responrespone.shtml>. 45 Some thought that interim approvals would permit tighter control over PNTs, reduce reliance on companies to bring new information forward, offer an opportunity to monitor long-term impact, and shift responsibility for monitoring long-term impact from the regulator to the developer. Others were concerned that interim approvals posed questionable “public optics,” that a PNT with potential long-term negative impacts shouldn’t be released in the first place, that they would be labour-intensive, that they are not supported by science, and are of questionable utility given that it may be difficult to remove a PNT from the environment once released. 46 Directive 94-08, supra note8, section 7.6. 47 CFIA, “Response of the Federal Departments and Agencies to the Petition Filed August 16, 2004 by Jenn Robus under the Auditor General Act: Environmental, Livestock Feed, and Human Health Safety Assessments of Plants with Novel Traits,” (December 24, 2004), <http://www.inspection.gc.ca/english/sci/biotech/tech/pntvcne.shtml>, para. 69. 48 Ibid., para. 70. 49 Ibid., para. 72. 50 Directive 94-08, supra note 8, section 6.2. 51 Ibid., section 6.2. 52 Ibid., section 7.3. 53 Ibid. 54 CFIA, “Reviewers Checklists,” <http://www.inspection.gc.ca/english/plaveg/bio/usda/usda04e.shtml>, lists requirements for six analytical techniques: Southern blot, Western blot, Northern blot, polymerase chain reaction, RNA dot blot, enzyme- linked immunosorbent assay (ELISA), and enzyme assays. 55 CFIA, Decision Document DD2004-46 “Determination of the Safety of the BASF Canada Imidazolinone-Tolerant Lentil Line RH44,” <http://www.inspection.gc.ca/english/plaveg/bio/dd/dd0446e.shtml#4 >. 56 Supra note 47 at para. 25. 57 These problems include controlling resistant crop volunteers, the production of resistant weeds through selective pressures stemming from continued use of a specific herbicide, etc. 58 Namely, the development of resistance in targeted insects to the insecticidal compound expressed by the PNT. 59 Royal Society Report, supra note 32, p. 19. 60 Ibid., p. 20-21. 61 CFIA, “Summary of Confined Research Field Trials” <http://www.inspection.gc.ca/english/plaveg/bio/triesse.shtml>. 62 Royal Society Report, supra note 32, p. 128. 63 Directive 94-08, supra note 8, section 1. The CFIA has also undertaken public consultations on plant molecular farming – see <http://www.inspection.gc.ca/english/plaveg/bio/mf/mf_cnsle.shtml>. 64 Directive 94-08, supra note 8, section 2.4. 65 Royal Society Report, supra note 32, p.196. 66 Ibid., p. 197. 67 Ibid., p. 204. 68 Seeds Regulations, C.R.C. c.1400, s.111(1)(c). 69 Seeds Regulations, C.R.C. c.1400, s.111(1)(b). 70 Ibid.


71 Supra note 47, para 74. 72 Supra note 8. 73 Seeds Regulations, C.R.C. c.1400, s. 111(2). 74 Seeds Regulations, C.R.C. c.1400, s. 107(2). 75 Decision Document DD2002-39 “Determination of the Safety of Aventis CropScience Canada Inc. Glufosinate Ammonium Tolerant Sugar Beet (Beta vulgaris) Lines Derived from Event T120-7,” <http://www.inspection.gc.ca/english/plaveg/bio/dd/dd0239e.shtml> at section IV(6). Another example is DD 2002-35 “Determination of the Safety of Monsanto Canada Inc.’s Roundup Ready Corn (Zea mays L.) Line 603,” <http://www.inspection.gc.ca/english/plaveg/bio/dd/dd0235e.shtml>, at section IV(1). 76 DD2004-46 “Determination of the Safety of BASF Canada Imidazolinone-Tolerant Lentil Line RH44,” <http://www.inspection.gc.ca/english/plaveg/bio/dd/dd0446e.shtml>, section IV(1). Another example is DD2004-48 “Determination of the Safety of BASF Canada’s Imidazolinone-Tolerant (Clearfield) Wheat Teal 11A,” <http://www.inspection.gc.ca/english/plaveg/bio/dd/dd0448e.shtml>, section IV(1). 77 DD 2002-38 “Determination of Environmental Safety of RBMT21-129 and RBMT21-350 Colorado Potato Beetle and Potato Leaf Roll Virus Resistant Potato Line Developed by Monsanto Canada Inc.,” <http://www.inspection.gc.ca/english/plaveg/bio/dd/dd0238e.shtml>, section IV(4). See also DD2002-36 “Determination of Environmental Safety of RBMT22-082 Colorado Potato Beetle and Potato Leaf Roll Virus Resistant Potato Line Developed by Monsanto Canada Inc.,” <http://www.inspection.gc.ca/english/plaveg/bio/dd/dd0236e.shtml>, section V. 78 DD 2002-41 “Determination of the Safety of Dow AgroSciences Canada Inc. and Pioneer Hi-Bred International’s Insect Resistant and Glufosinate-Ammonium Tolerant Corn (Zea mays L.) Line 1507,” <http://www.inspection.gc.ca/english/plaveg/bio/dd/dd0241e.shtml>, section IV(6). 79 Directive 94-08, supra note 8. These harms are:

• Potential to become a weed of agriculture or to be invasive of natural habitats. • Potential for gene-flow to wild relatives whose hybrid offspring may become more weedy or more

invasive. • Potential for the PNT to become a plant pest. • Potential impact of the PNT or its gene products on non-target species, including humans. • Potential impact on biodiversity

80 For example, decision document DD2002-41, supra note 78, contains an assessment of the impact on non-target organisms of the novel corn. After noting evidence that the novel protein (an insecticidal toxin derived from Bacillus thuringiensis) was not toxic to humans, other vertebrates and non-lepidopteran invertebrates, the document states that “the CFIA has determined that the unconfined release of line 1507, when compared with currently commercialized corn, will not result in altered impacts on non-target organisms.” 81 The current Seeds Regulations C.R.C. c.1400, s.112 and Directive 94-08, supra note 8, section 9 specify that the applicant must provide new information of which it “becomes aware” that is relevant to the environmental safety of the PNT. 82 CFIA, “Revisions to Regulatory Directives Dir94-08 ‘Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits’ and Dir95-03 ‘Guidelines for the Assessment of Livestock Feeds from Plants with Novel Traits’” <http://www.inspection.gc.ca/english/anima/feebet/bio/revisione.shtml> 83 Directive 94-08, supra note 8, section 7.6. 84 Supra note 47, para. 33 <http://www.inspection.gc.ca/english/sci/biotech/tech/pntvcne.shtml>. 85 CBAC Report, supra note 41, Recommendation 3.6., p. 28-29. 86 Supra note 82. 87 CFIA, “Inspection and Monitoring,” <http://www.inspection.gc.ca/english/sci/biotech/reg/inspe.shtml>. 88 Supra note 47, para 32. 89 Ibid. para 34. 90 Some of the progress reports published by the Government in response to the Royal Society Expert Panel’s recommendations contain lists of studies commissioned by the CFIA. See, for example, “Progress Report: December 2002, Action Plan of the Government of Canada in response to the Royal Society of Canada Expert Panel Report” at para.41. The Progress Reports are available on the CFIA website at <http://www.inspection.gc.ca/english/sci/biotech/trans/royale.shtml>. 91 Royal Society Report, supra note 32, p. 214. 92 Ibid., p. 211.


93 Ibid. 94 Directive 94-08, supra note 8, sections 3.4 and 7.4. 95 Royal Society Report, supra note 32, p. 213. 96 Ibid. 97 Royal Society Report, supra note 32, Recommendation 9.2, p.218. 98 Ibid., Recommendation 9.3, p. 218. 99 Supra note 41. 100 Ibid., recommendation 2.4 at p.22. 101 Canada, “Action Plan of the Government of Canada in response to the Royal Society of Canada Expert Panel Report Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada” (23 November 2001), <http://www.hc-sc.gc.ca/english/pdf/RSC_response.pdf>. 102 Ibid., p.15. 103 Ibid. 104 Ibid., p. 16. 105 The Progress Reports are available on the CFIA website at <http://www.inspection.gc.ca/english/sci/biotech/trans/royale.shtml>. The progress Reports are dated January 31, 2002, May 31, 2002, December 23, 2002, June 27, 2003, December 18, 2003, and August, 2004. 106 See for example, Government of Canada “Response of the Federal Departments and Agencies to the Petition Filed January 18, 2002 by Greenpeace Canada under the Auditor General Act: Petition on the Roundup Ready™ Soybean,” (4 June 2002), <http://www.inspection.gc.ca/english/sci/biotech/tech/greenrounde.shtml>. 107 Canada, “Progress Report: August 2004 Action Plan of the Government of Canada in response to the Royal Society of Canada Expert Panel Report Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada,” <http://www.hc-sc.gc.ca/english/protection/royalsociety/progress_report_august_2004.html> at p. 5. 108 The Notices of Submission are posted on the CFIA website at <http://www.inspection.gc.ca/english/plaveg/bio/subs/subliste.shtml>. 109 Plant Biosafety Office, CFIA, “Notice of Submission for Approval of Novel Food, Livestock Feed and Unconfined Environmental Release for Herbicide Tolerant Wheat from BASF Canada,” (posted September 7, 2004), <http://www.inspection.gc.ca/english/plaveg/bio/subs/2004/20040907e.shtml>. 110 Supra note 47, para 86. 111 UK, Dept for Environment, Food and Rural Affairs, “Farm Scale Evaluations,” <http://www.defra.gov.uk/environment/gm/fse/index.htm>.

C. Scott Findlay & Annik Déziel – Potentially Practicing Precaution: Canadian Pesticide D-61 Regulation and the Pest Regulation Management Agency

POTENTIALLY PRACTICING PRECAUTION: CANADIAN PESTICIDE REGULATION AND THE PEST REGULATORY

MANAGEMENT AGENCY

C. Scott Findlay Director



and

Annik Déziel Research Assistant




TABLE OF CONTENTS

I. INTRODUCTION ......................................................................................................................65 II. METHODS .................................................................................................................................65 III. A BRIEF HISTORY OF PESTICIDE REGULATION IN CANADA ...............................66 IV. THE STATUTORY CONTEXT ............................................................................................67

IV.A. The Pest Control Products Act (PCPA) ................................................................67 IV.B. The Food and Drug Act and the Pesticides Residues Compensation Act...........68

V. THE PEST MANGEMENT REGULATORY AGENCY .....................................................68 VI. PESTICIDE REGISTRATION: RISK ASSESSMENT AND MANAGEMENT .............69 VII. REGISTRATION, RE-EVALUATION AND UNCERTAINTY ......................................71 VIII. REGISTRATION, RE-EVALUATION AND PRECAUTION ........................................72

VIII.A. PCPA (2002)...........................................................................................................72 VIII.B. The Review Process ..............................................................................................73

VIII.B.1. Screening.................................................................................................73 VIII.B.2. Review ....................................................................................................73 VIII.B.3. Review of decisions ................................................................................74

VIII.C. Is PMRA practicing precaution? Conclusions and Recommendations............76 IX. REGISTRATION, RE-EVAULATION AND ADAPTIVE MANAGEMENT ..................77

IX.A. THE PCPA ...............................................................................................................78 IX.B. The Review Process ..................................................................................................79

Review of decisions ................................................................................................79 IX.C. Is PMRA practicing adaptive management? Summary and Conclucions.........81

X. REFERENCES..........................................................................................................................83

LIST OF TABLES

Table 1. Sources of scientific uncertainty and how these sources of uncertainty are addressed

during the decision process (PMRA response). ............................................................. 71

LIST OF FIGURES Fig. 1. Average (+/- 1 standard error) semantic congruence scores for various precautionary

elements based on a sample of 25 implicitly precautionary decisions. .......................... 75 Fig. 2. Average (+/- 1 standard error) semantic congruence scores for various adaptive

management for registrations (a) and re-evaluations (b). . .............................................. 80


I. INTRODUCTION The past several decades have seen the elaboration of generic decision principles to guide political decision-makers, policy makers, and regulators. Some of these principles - including the precautionary principle (henceforth PP) (O’Riordan et al, 2001) and the principle of adaptive management (henceforth PAM) – are responses to the problem of scientific uncertainty. These two principles offer potential assistance to decision-making in relation to uncertainty associated with certain types of health and environmental risks (Leiss, 2001; Holling, 1978; Walters, 1986). Uncertainty lies at the heart of the issue of pesticide regulation. While there is little doubt that, at least historically, increased pesticide use has resulted in increased food production there is mounting public and scientific concern about the environmental and human health risks associated with pesticide exposure. Institutions responsible for pesticide regulation must weigh the economic benefits of pesticide use against the environmental and human health risks and as such, are increasingly looking to generic decision principles like the PP for guidance (Gocklany, 2001). In Canada, decisions concerning pesticide registration are the responsibility of the Pesticide Management Regulatory Agency (PMRA). Here we provide a brief history of pesticide regulation in Canada, summarize the current statutory context, structure and organization of the PMRA, and give an overview of the registration process. We then move to an analysis of how, in practice, uncertainty is treated in the current registration decision process, with particular emphasis on the extent to which the PP and PAM are currently implemented, and explore the implications for traditional administrative law values. We conclude with some suggestions as to what, in our view, needs to be done in order to render the current decision process more precautionary and adaptive. II. METHODS We examined all documents published on the PMRA website (http://www.pmra-arla.gc.ca/english/pubs/pubs-e.html) as of Feb 1, 2005. This included all New Pesticide documents (Regulatory Decision (RDD series), Proposed Regulatory Decision Documents (PRDD), Regulatory Notes (REG series), all Regulatory Policies documents (including the BGR, DIR (only years 1999-2004), DIS, LPS, PRO and SPN series), all Re-evaluation Documents, all Agency Plans and Reports, all Registration Guidance Documents, and all International Documents. Each document was evaluated/scored using the Practicing Precaution Document Questionnaire (see Appendix i), with scores entered into the document questionnaire database. As we did not have access to any of the documents or information that went into the decision process, the questionnaire was completed using only information supplied in, or inferred from, the final published or proposed decision.


III. A BRIEF HISTORY OF PESTICIDE REGULATION IN CANADA The recent history of federal pesticide regulation in Canada begins with the Pest Control Products Act (PCPA), proclaimed in 1969, and the associated Pesticide Control Products Regulations. The 1969 Act went through several minor amendments between 1969 and 1985, with little or no substantive change despite accumulating scientific evidence of the environmental impacts of pesticides. In 1987, Castrilli and Vigod (1987) on behalf of the Law Reform Commission of Canada, produced a set of 23 recommended reforms for federal pesticide policy and regulations. Within 2 years, the Minister of Agriculture convened the Pesticide Registration Review task force to examine the pesticide regulation question. There followed almost two years of extensive consultation with stakeholders, culminating in the 1990 task force recommendations (the so-called ‘Blue Book”) including that legislative authority for pesticide registration be transferred from Agriculture Canada to Health Canada. In 1993, as part of the Liberal party’s “Red Book” campaign, the then Leader of the Official Opposition Jean Chrétien pledged to act on the recommendations of the review team by introducing new federal pesticide legislation. In October 1994, the (Liberal) federal government issued the Government Proposal for the Pest Management Regulatory System (known as the “Purple Book”), outlining its plans to implement the recommendations of the multistakeholder Pesticide Registration Review. Provincial and stakeholder comments on the proposal along with the government's response, accompanied the government's February 1995 announcement that it was proceeding with reforms. Shortly thereafter the Pest Management Regulatory Agency (PMRA) was created, and legislative authority for the PCPA was transferred to Health Canada by an Order in Council on March 28, 1995. The period between 1996 and 1998 saw the establishment of the Federal/Provincial/Territorial Committee on Pest Management in 1997, and the striking of the Pest Management Advisory Committee, a multi-stakeholder group involving ENGOs, industry associations, environment and health organizations, and the public. In 1999, the Commissioner on Environment and Sustainable Development (CESD, 1999) issued a critical report on the state of pesticide regulation in Canada in general, and the PMRA in particular, with special concern being expressed over the glacial pace of reforms concerning pesticide re-evaluation:

“The need to re-evaluate pesticides has been formally recognized by the federal government for over 13 years, and we expected that it would have developed a program to do so. We found Canada's track record to be one of inaction and unfulfilled commitments.” (CESD 1999, section 3.134)

In 1999, largely in response to the Commissioner’s report, PMRA (PMRA, 1999) brought forward a package of regulatory and legislative reforms, which was, in turn, scrutinized carefully by an (ultimately) largely unimpressed Standing Committee on Environment and Sustainable Development. Their report (SCESD, 2000) highlighted “serious omissions and flaws” in the PMRA proposal, which, in the committee’s view, stemmed from the often conflicting PMRA objectives of (a) encouraging and enhancing industry effectiveness and competitiveness; and (b) environmental and human health protection. The SCESD outlined 4 major principles which, in it’s view, should guide new pesticide regulation, including the need to consider human health concerns and environmental protection as the first priority, the need to ensure that a precautionary approach is taken in decision-making, and the need to ensure an open and


transparent regulatory process. The October 2000 Government Response to the Report of the Standing Committee on Environment and Sustainable Development described how the government places protection of human health and the environment as its top priority in regulating pesticides using a fundamentally precautionary approach, and in 2002, then Minister of Health Anne McLellan introduced the first substantive amendments to the PCPA in 31 years. IV. THE STATUTORY CONTEXT IV.A. The Pest Control Products Act (PCPA) The Pest Control Products Act (PCPA) and associated Regulations are the primary federal legislation for the regulation of pesticides in Canada. The Act governs pesticide importation, manufacture, sale and use and provides the authority for risk-based decision-making and risk management. Part of the regulatory context is consideration of the compatibility of pesticide registrations with federal policies, such as the Toxic Substances Management Policy (TSMP), international agreements on Persistent Organic Pollutants (POPs), and the Montreal Protocol on ozone depleting substances. Substances identified as Track 1 under the federal TSMP, ozone depleting substances and POPs are not acceptable for registration as new pesticide active ingredients. Moreover, pesticides cannot be approved for use under the PCPA if the use contravenes other federal statutes. Under the PCPA (1985), the Minister shall refuse to register, or amend the registration of a product, if:

18. (d) the use of the control product would lead to an unacceptable risk of harm to (i) things on or in relation to which the control product is intended to be used, or (ii) public health, plants, animals or the environment; (Pest Control Products Regulations)

Thus with respect to impacts or effects, the critical regulatory question is whether the product in question poses “unacceptable” environmental or human health risks. The new Pest Control Products Act (PCPA, 2002) received royal assent on Dec. 12, 2002, but is not yet in force. The new act represents the response of the federal government in general, and Health Canada in particular, to the major criticisms pointed out by the SCESD in 2000. The Act has as its primary objective the prevention of unacceptable risks to people and the environment from exposure to pesticides (PCPA 2002, section 4.1). Ancillary objectives include the promotion of sustainable development such that the needs of the present are met without compromising the ability of future generations to meet their needs (para 4.2(a)), and the minimization of the health and environmental risks posed by pesticide products (para 4.21. (b)). The new Act provides explicit authority for risk-based decision-making with the critical regulatory question being whether the product in question poses “unacceptable” risks to human health or the environment, with acceptable being defined as:

(2) For the purposes of this Act, the health or environmental risks of a pest control product are acceptable if there is reasonable certainty that no harm to human health, future generations or the environment will result from exposure to or use of the product, taking


into account its conditions or proposed conditions of registration (PCPA 2002, interpretation)

IV.B. The Food and Drug Act and the Pesticides Residues Compensation Act The PMRA is also responsible for regulating the nature and amount of pesticide residues in food under the Food and Drugs Act (FDA) and Regulations (FDAR). Section 4(a) and 4(d) of the FDA authorizes PMRA to set a maximum residue limit (MRL) within Regulation B.15.002(1) of the Food and Drugs Regulations (FDR) or an exemption from the requirement of a MRL under Regulation B.15.002(2) of the FDR. The Agency performs various types of risk assessments to evaluate the safety of pesticides in food, including analyses to determine the nature and the amounts of pesticides that people might be exposed to in a single day. Moreover, the agency must, in rendering decisions, also consider other acts that have an impact on pest management, in particular the Pesticides Residues Compensation Act (PRCA) which provides for compensation of farmers whose agricultural products have been contaminated by pesticide residues. V. THE PEST MANGEMENT REGULATORY AGENCY The Pest Management Regulatory Agency (PMRA) was created as a branch of Health Canada in 1995 following the transfer of legislative authority from Agriculture and Agri-Food Canada (AAFC). PMRA’s mandate is:

To protect human health and the environment by minimizing the risks associated with pest control products in an open and transparent manner, while enabling access to pest management tools, namely, these products and sustainable pest management strategies. (PMRA 2004b, p. 4)

The PMRA’s overall administrative decision-making structure includes input from a variety of sections within PMRA and from external agencies, notably Environment Canada, Health Canada, Natural Resources Canada, and Fisheries and Oceans Canada. The Executive Director’s Office oversees the operation of the PMRA and is comprised of the directors of all divisions. The Business Line Improvement Section is responsible for cost recovery policy and business line improvement projects. The Chief Registrar ensures that the PMRA makes integrated, science-based registration decisions, investigates registration appeals, and provides policy advice. The Submission Management and Information Division manages and tracks submissions, conducts scientific screenings, and publishes regulatory documents. The remaining divisions provide specific expertise on various topics of interest in the decision-making process for various pesticides. The Product Sustainability and Coordination Division provides expertise on antimicrobials, fungicides, herbicides, insecticides and other pesticides, and conducts efficacy assessments, sustainability evaluations and value assessments for PCPs. The Health Evaluation Division provides expertise on human health hazards, risk assessments and risk mitigation and conducts toxicology evaluation and exposure assessments of PCPs. The Environmental Assessment Division provides expertise on environmental hazards, risk assessments and risk mitigation and conducts assessments of the environmental fate and


effects of PCPs. The Alternative Strategies and Regulatory Affairs Division develops policies, programs, and projects related to sustainable pest management, and directs the development, review and assessment of policies, regulations, programs and legislative amendments. Compliance and Regional Operations enforces the Pest Control Products Act and conducts national pesticide compliance inspections and investigations. Laboratory Services provides expertise on the chemistry of pest control products and analytical testing and conducts product chemistry evaluations. These divisions all liaise with industry and participate in national and international activities to facilitate harmonization of testing and evaluation procedures. The Management Planning and Coordination Division provides financial, administrative, and human resources services. Additionally, the PMRA uses an advisory infrastructure consisting of the following councils: the Economic Management Advisory Committee (EMAC), the Pest Management Advisory Council (PMAC), the Policy Council, and the Federal-Provincial-Territorial Committee on Pest Management and Pesticides. VI. PESTICIDE REGISTRATION: RISK ASSESSMENT AND MANAGEMENT Registration decisions involve three stages. At the screening stage, the critical question is the extent to which the health and environment risks can be evaluated. On the basis of information submitted by the applicant, PMRA evaluators may decide that information is lacking, inadequate or inconsistent, in which case applicants are asked to provide additional information. As in other OECD countries, it is the applicant’s responsibility to provide all required information, including all required scientific studies. Scientific studies submitted as part of the registration process are expected to conform to the OECD’s Test Guidelines and Principles of Good Laboratory Practice (PMRA 1998), and independent audits may be conducted under GLP guidelines to verify data integrity. The primary objective of the screening stage is to determine whether submissions meet the agency requirements (with respect to format, content, etc.) before being sent for detailed review. During the science review stage, information in the application is used to conduct a health risk assessment, an environmental risk assessment, and a value and efficacy assessment. Using largely data and information provided by the applicant, (in principle) supplemented by information from other sources, three questions are addressed: (1) are the heath risks acceptable? (2) are the environmental risks acceptable? (3) can these risks be mitigated, and if so, how? Health and environment risk assessments both follow a classic four-step process: (1) hazard identification, (2) dose–response assessment, (3) exposure assessment and (4) risk characterization. For human health risk assessment, the main source of information for hazard identification are animal toxicological studies, and the PMRA relies heavily on toxicological data to establish reference doses for acute (ARD) and chronic (ADI) effects and to derive estimates of potential cancer risks. With the exception of carcinogenic and mutagenic endpoints, the evaluation process assumes that toxic effects occur only after some dose (or exposure) threshold is exceeded. As such, the review process involves establishing a reference dose that takes into account both the acute and the chronic nature of the toxic effects. The starting point for the estimation of the reference dose is the No Observed Adverse Effect Level (NOAEL), the highest dose at which no adverse effects are observed in animals exposed to the product in a


manner representative of the route, frequency and duration of human exposure. The NOAEL is then multiplied by two safety factors: (a) a 10-fold factor to account for extrapolation uncertainty from animals to humans; and (b) a second 10-fold factor to account for the variation in susceptibility within exposed (human) populations. The calculated reference dose for humans is therefore at least 100 times lower than the NOAEL estimated from animal exposure studies. PMRA evaluators then compare the reference dose to the estimated human exposure: if the latter is less than the former, the risk is considered acceptable. For carcinogenicity and mutagenicity endpoints, the assessment is considerably different. Cancer risks are estimated based on carcinogenicity studies in several species, along with in vitro and in vivo genotoxicity studies. The results of these studies are then used in statistical models to estimate cancer risks at the lower levels of exposure observed in humans. These models provide estimates of the lifetime cancer risk associated with exposure to the product through ingestion or unintentional exposure. If the estimated lifetime cancer risk is less than 1 X 10-6, the risk is considered acceptable, while risks above 1 X 10-4 are considered unacceptable. Environmental risk assessment proceeds in a similar fashion, using the 4-stage process outlined above. This assessment in principle includes not only an assessment of the impacts of the product on ecosystems where it is applied, but also on potential effects associated with its movement in groundwater or surface water, or atmospheric transport to remote areas. The assessment begins by identifying the environmental elements of concern (environmental components), and selects a set of indicator organisms on which to evaluate effects associated with exposure for specified environmental components. Laboratory and field studies, including acute and chronic toxicity tests in a range of standard test organisms from different taxonomic groups, are used to determine the dose–effect relationship of the pesticide and its major degradation products. The adverse effects considered are usually lethal and sub-lethal effects, including mortality, organ toxicity and reduced growth. The median lethal dose or the median lethal concentration (LD50 or LC50) and the median effective dose or the median effective concentration (ED50 or EC50) are determined as well as the highest dose at which no effect is observed, the No Observed Effect Concentration (NOEC). Environmental exposures (concentrations) are usually estimated using fate-transport models that generate predictions of the transport of the product (and/or its degradation products) in different media (air, water, soil) as well as plant uptake and transfers along food chains. The assessment of risk is invariably based on a comparison of the NOEC in a relevant, sensitive species with the estimated (expected) environmental concentration (EEC) in a relevant environmental component. The larger the ratio NOEC/EEC, the lower the risk, with ratios below 1 considered unacceptable. The final decision is based on the results of the review process. As is the case with its counterparts in the United States and the OECD, PMRA employs a risk-based decision process. In order to be registered a pesticide must be deemed to pose no unacceptable health risks, no unacceptable environmental risks, and to be of significant value. When the risks to health and the environment are considered acceptable and the pesticide has value, the pesticide is registered, or, in the case of a re-evaluation, the registration is renewed. If a product is deemed to have value but the risks to health or the environment are considered unacceptable, PMRA identifies risk management options intended to mitigate the identified risk(s) to an acceptable level. If identified mitigation measures render the product ineffective, then it is not registered. If the estimated mitigated risk to the environment or health is still unacceptable, then the product is not registered, or in the context of a re-evaluation, the registration of an existing pesticide is discontinued or phased out.


VII. REGISTRATION, RE-EVALUATION AND UNCERTAINTY Determining what levels of exposure pose acceptable risks to human health or the environment is the core operational problem for pesticide regulators. Clearly, such assessments are fraught with uncertainty. PMRA recognizes this explicitly:

“It is the nature of predictive toxicology and risk assessment that scientific uncertainties may arise even when the database [of effects] is complete. For example, interpretation of the applicability of toxic effects in animals to humans, or extrapolation from small scale laboratory and field trials to actual pesticide use situations are both potential sources of uncertainty. These uncertainties are dealt with at each appropriate step in the framework. Where scientific uncertainties cannot be fully resolved through additional data, the PMRA applies “worst case” assumptions and uses increased safety factors in its risk assessment” (PMRA, 2000, p. 5)

Indeed, the consideration of scientific uncertainty is part of both the risk analysis and risk management process used by PMRA and other pesticide regulatory agencies worldwide. Table 1 below shows major sources of uncertainty, and how they are addressed in the PMRA risk assessment process. Several points are evident. First, it is primarily extrapolation uncertainties that, at least historically, have been given the most attention in the decision process; these uncertainties have been accommodated largely through the use of safety factors (see below). Second, while PMRA is currently examining various probabilistic risk assessment methods for dealing with prediction uncertainty (PMRA 2004b), historically all decisions were based on single point estimates (e.g. NOAEL, reference doses, etc.) and safety factors. Third, as was (and still is) the case with all pesticide regulatory agencies, PMRA decisions have historically been based on single ingredient – (possibly) cumulative exposure - estimates; cumulative effects assessment (which are only now beginning to be used) have been developed only for multiple exposure scenarios where the ingredients in question have similar modes of action (PMRA 2004a).

Table 1. Sources of scientific uncertainty and how these sources of uncertainty are addressed during the decision process (PMRA response). Source of scientific uncertainty PMRA response

Lack of knowledge on pesticide effects on health or environment

Re-evaluation and special review based on information accumulated since the original evaluation; safety factors for gaps in data base

Uncertainty around predicted effects of exposure on human health or the environment

Probabilistic risk assessment (in development); safety factors

Poor quality evidence (e.g. weakly circumstantial evidence) Unable to assess based on reviewed information

Sparse empirical data (e.g. few studies) Request for more data/information; temporary registration pending additional information

Extrapolation from small/short spatial or temporal scales to longer/larger spatiotemporal scale Safety factors

Inter-species extrapolations Safety factors Extrapolation from laboratory exposure-effects to field exposure-effects Field trials; safety factors

Inferences from single-ingredient studies to multiple-ingredient exposures

Cumulative effects assessment for pesticides of similar mode of action

Uncertainty about validity of modelling assumptions Unable to assess based on reviewed information


Precisely how the various uncertainties are characterized during the risk assessment process is not evident from the documents we examined. Particularly unclear is the extent to which uncertainty characterization is based on studies submitted by the applicant versus “external” research. While it is certainly true that more science can resolve some types of uncertainties (e.g. by increasing precision of estimated parameters in exposure models), it is equally true that more science may well uncover uncertainties that would otherwise be unknown. In particular, although PMRA apparently uses a “weight of evidence” approach in risk assessment (PMRA 2000), precisely how far the evidentiary net is cast, and how much of what is caught is considered irrelevant (and hence, discarded), is unknown. We return to this issue below. The above discussion concerns scientific uncertainty, that is, scientific understanding of causal relationships. But there are other uncertainties. All registration (or re-evaluation) decisions include specifications of how, when and where the product is to be used: such information includes dosages, preparation instructions, timing and number of applications, method of application, etc. Exposures are estimated based on the assumption that these instructions will be complied with. And in cases where the initial assessment concludes that the risks are unacceptable, proposed mitigation measures invariably take the form of reduced dosages or application rate, restricted timing of application, modified methods of application, and/or reduced area(s) of application. Of course, mitigation measures can only achieve the desired effect (i.e. rendering unacceptable risks acceptable) if they are complied with. Yet in 2003, the Commissioner for Environment and Sustainable Development (CESD, 2003) noted that at the time of her assessment, PMRA had no systematic method for monitoring (and hence, assessing) compliance with the PCPA or the associated regulations. It is, therefore, still an open question as to whether estimated (mitigated or unmitigated) exposure levels reflect “real” exposure levels for registered products. VIII. REGISTRATION, RE-EVALUATION AND PRECAUTION VIII.A. PCPA (2002) The 1985 PCPA makes no reference to precautionary approaches, either implicitly or explicitly. However, PCPA (2002) states that in the case of re-evaluations and special reviews:

20. (2) Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent adverse health impacts or environmental degradation.

With respect to the issue of reversed burden of proof, the act is equally explicit. Section (7) states that during an application:

7. (6)(a) the applicant has the burden of persuading the Minister that the health and environmental risks and the value of the pest control product are acceptable, Similarly, section 19 states that during an evaluation as part of a re-evaluation or special review: (b) the registrant has the burden of persuading the Minister that the health and environmental risks and the value of the pest control product are acceptable (19.1(b))


The new PCPA is clearly precautionary with respect to the reversal of burden of proof, as in the case of applications, re-evaluations and special reviews, the applicant must demonstrate the product poses no unacceptable risk. For products deemed to pose risks of serious or irreversible effects, PCPA (2002) does not require the responsible authority to mitigate these risks, absence of strong scientific evidence notwithstanding. Rather, when such risks are identified, absence of strong evidence is, under the Act, not legitimate grounds for failing to institute mitigation measures. Clearly this leaves open the possibility that failure to mitigate may be justified on other grounds. Moreover, mitigation measures are of a special sort, namely, those that are cost-effective. As such, the Act does not rule out the postponing of decisions due to lack of full scientific certainty in instances where cost-effective measures cannot be identified.

VIII.B. The Review Process VIII.B.1. Screening The screening process is supposed to ensure that only complete, submissions are brought forward for assessment; indeed, the PMRA decision framework for risk assessment and management – on which all registration and re-evaluation decisions are supposed to be based – notes:

“Only products with a database that includes all of the required studies are allowed to progress within the evaluation process and reach the decision stage” (PMRA 2000, pp. 4-5)

This notwithstanding, CESD (2003) notes that, historically at least, many applications were provided with temporary registrations pending additional information, information that would appear critical in the decision process:

“Examples of information gaps at the time of temporary registration include what happens to the pesticide after it is released into the environment, what impact it is likely to have on children’s nervous systems, and how toxic it is to invertebrates and non-target plants” (CESD, 2003, p. 9).

VIII.B.2. Review There are at least five elements of the review process that are in keeping with a precautionary approach. First, as noted in section VIII.A above, there is the reversed onus of proof: it is up to applicants or registrants to adduce sufficient evidence to convince PMRA that the product does not pose an unacceptable risk to either human health or the environment. The implication is that unless such evidence is adduced, PMRA will not register a new product, nor re-register a product currently registered in the case of a re-evaluation. The key operational question is, of course: what weight of evidence is sufficient to satisfy this criterion? Second, at least in the case of re-evaluations, if there is evidence of serious or irreversible risks to either human health or the environment, a special review process may be triggered:

“In addition, the re-evaluation program allows for placing pesticides with particular identified concerns under a “special review.” Threats of serious or irreversible damage to health or the environment are triggers for special reviews and regulatory action. These actions could include severe restrictions of use, phase-out or cancellation of a pesticide.” (PMRA 2000, p.)


In the past, special reviews have been conducted by PMRA on a number of registered products, including lindane, carbofuran and organotin antifouling paints. Third, in setting reference doses for pesticides or active ingredients, the estimated NOAEL from toxicity studies is multiplied by at least two safety factors: (a) a 10-fold factor to account for extrapolation uncertainty from animals to humans; and (b) a second 10-fold factor to account for the variation in susceptibility within exposed (human) populations. Moreover, PMRA regularly uses a 3 to 10-fold correction to account for missing data in the toxicity database, particular when assessing exposure from pesticide residues on food (PMRA 2003b). In addition, as is the case with USEPA, PMRA regularly employs an additional safety factor (often 10-fold) to take into account the increasing susceptibility of infants and children to – at least in principle – ensure the safety of infants and children. Finally, the PMRA may employ additional safety factors to account for variation in the severity of toxicity endpoints, with higher safety factors (i.e., 10-fold) for endpoints such as mortality, malformations, reproductive failure. Thus, estimated reference doses used in the risk assessments are 100 – 3 000 times lower than the NOAEL. Indeed, the PCPA (2002), section 19(2), explicitly obliges the Minister - as part of a “scientific approach” to evaluation and re-evaluation – to apply (unspecified) safety factors to take into account differential sensitivities of human populations and subpopulations (children, pregnant women, the elderly etc.) (7(b)(ii); 19(2)b(ii) and at least a 10-fold safety factor for products having suspected threshold effects if they are applied in the vicinity of homes or schools (7(b)(iii); 19(2)(b)(iii)). Fourth, PMRA currently uses (estimated) aggregate exposures for single pesticide active ingredients (PMRA 2003a). These aggregate exposures represent the cumulative exposure associated with all routes of exposure, including (a) food residues; (b) drinking water; and (c) residential exposure. Aggregate exposure assessment – now standard practice for OECD pesticide regulators – represents a substantial improvement over the single exposure assessments conducted in the early stages of PMRA’s mandate. Fifth, in January 2003, the PMRA issued a proposal to amend Division 15 of the Food and Drug Regulations, Regulation B.15.002(1), and revoke the 0.1 ppm General Maximum Residue Limit (GML), and to replace the GML with specific maximum residue levels (MRLs) depending on the pesticide and food(s) in question. This action was in response primarily to the new U.S. Food Quality Protection Act (FQPA). The use of the default level for domestic and imported foods permits unnecessarily high levels of pesticide residues in food. Among major developed countries, Canada is one of a very few to continue to rely on a 0.1 ppm default level. The proposed setting specific MRLs for each pesticide and food combination would bring Canada in line with regulatory practices in other jurisdictions. VIII.B.3. Review of decisions We reviewed 47 new registration decisions and 106 re-evaluations conducted during the period 1987-2005. All of these decisions were rendered while PCPA (1985) and the associated regulations were in force, not PCPA (2002). While none of the 153 reviewed decisions made explicit reference to precaution, 25 (18/47 = 38.3 % of registrations and 7/106 = 6.6 % of re-evaluation decisions) made reference to rationales that implied or implicated elements of a precautionary approach. Henceforth we refer to these decisions as “implicitly precautionary”.


For the 25 registration decisions, we evaluated the degree to which various elements of a precautionary approach were implied in the stated decision rationale(s) using a semantic congruence scale from 0-7 (see Appendix ii, q. 10). On this scale, 0 indicates an inability to assess, 1 that the precautionary element in question was not implied or implicated, whereas 7 indicates that the element in question was strongly implied or implicated in the decision. The precautionary elements were (1) the greater the potential severity of harm of an action (in this case, the decision to register or re-register a pesticide), the greater the evidence that such harm will not occur before the action is taken (in this instance, the product is registered); (2) the greater the potential spatial or temporal scale/scope of an action, the greater the required evidence that the action is unlikely to be harmful before the action is pursued; (3) uncertainty surrounding expected outcomes of actions must be considered along with the expected outcomes of the actions themselves; (4) the greater the uncertainty about the predicted negative impacts of an action, the less likely it is that the action will be taken; (5) precautionary (either preventative or anticipatory) action does not require a high degree of scientific certainty concerning cause-effect relationships; (6) evidence is required that an action will not cause serious harm before it is taken, rather than an action is taken unless substantial evidence exists that it will cause serious harm. As shown in Fig. 1, implicitly precautionary decisions had comparatively high semantic congruence with respect to elements (1) and (6), but low congruence with respect to all other elements. Elements (1) and (6) are clearly similar insofar as both are concerned with the reversed burden of proof; this similarity is reflected in the strong correlation (Spearman rank correlation = 0.87, df = 24, p < 0.001) between them in the sample of implicitly precautionary decisions. Thus, to the extent that stated rationales for past decisions have been implicitly precautionary, the implicated precautionary elements are almost exclusively those associated with a reversed onus of proof.

Precautionary element

1 2 3 4 5 6

Sem

antic

con

grue

nce

scor

e

0

1

2

3

4

5

Fig. 1. Average (+/- 1 standard error) semantic congruence scores for various precautionary elements based on a sample of 25 implicitly precautionary decisions. For further explanation, see text and Appendix ii.


VIII.C. Is PMRA practicing precaution? Conclusions and Recommendations. Historically, precaution in PMRA registration and re-evaluation decisions took primarily two forms: (1) the reversal of the onus of proof; and (2) in risk assessment, precautionary safety factors (of various magnitudes) for estimating reference doses in classical toxicological assessments. More recently, additional precautionary elements have been introduced by moving from single to aggregate-exposure assessments, and to multiple exposure assessments for compounds of (putatively) similar modes of action Under PCPA (2002) PMRA will have a statutory obligation to use the precautionary principle in re-evaluations and special reviews. At present, it is unclear to everyone – including PMRA – how this obligation will affect decisions in general, and the risk assessment process in particular. This is, of course, precisely why, in its 2003-2008 strategic plan, PMRA notes that it intends to achieve its primary strategic objective (of protecting human health and the environment from unacceptable risks associated with the use of pest control products) by “… developing new science policies, methodologies and guidelines to assess risk and value, including a PMRA policy on use of the precautionary principle” (PMRA 2004b, p. 11). In developing such a policy, we suggest that PMRA:

1) Make explicit what is required to trigger the application of precaution under PCPA (2002) 20.(2). In practice, this means that PMRA must produce a set of guidelines as to what constitutes both necessary and sufficient evidence that a product poses a “serious risk” to human health or the environment; 2) Establish guidelines for how the “degree” or “extent” of precaution is determined in registration and (particularly) re-evaluation decisions. Some progress has been made on this front by other institutions. For example, the Government of Canada in its document “A Canadian Perspective on the Precautionary Approach/Principle” (GOC 2001, p. 10), notes, as a guiding principle, that “Precautionary measures should be proportional to the potential severity of the risk being addressed and to society’s chosen level of protection”. But other criteria may be equally – if not more - important. For example, Goklany (2001, 2002) suggests that, all other things being equal, the degree of precaution exercised in decisions should increase with the immediacy, certainty, potential severity of the threat, and the cost and difficulty of adaptation; 3) Make explicit how, precisely, weight of scientific evidence is assessed during the review process. Such a specification should include details on: (a) what information sources were tapped for scientific information; (b) how the published scientific literature was searched (e.g. search criteria); (c) what criteria were used to determine whether a particular study was relevant to the decision at hand; and (d) how the “weight of evidence” associated with both a particular study and the collection of studies deemed relevant was determined; 4) Make explicit how uncertainty – and in particular, different types of uncertainty – are to be addressed in the decision process. There are different types of scientific


uncertainty (see e.g. Funtowitz and Ravetz 1990) and while there is no universal agreement on either the importance of each type, or on how they ought to be accommodated, there is agreement that (a) these sources, in any given application, will vary in their magnitude (and hence importance); and (b) that in general, the appropriate method of accommodating uncertainty will vary from source to source, both in the risk analysis itself (Suter 1993) and the ultimate decision (Harwood and Stokes 2003). So far as we can ascertain, at present most of the attention at PMRA is focused on extrapolation uncertainty, and its accommodation would appear to be almost entirely by way of safety factors. Yet other approaches exist. Popper et al. (2005), for example, suggest that given the generally low predictive power (and hence, high uncertainty) associated with the most pressing environmental issues, uncertainty analysis should take the form of robustness analysis in which the question is not: what is the best decision based on predicted outcomes, but rather, which decision is most likely to produce reasonably satisfactory outcomes even if predictions are wrong (see also Bankes (2002), Lempert (2002)) Interestingly, the failure of PMRA to take precisely this approach to uncertainty analysis was criticised by the CESD:

“However, despite uncertainties in an all of the different assumptions evaluators make, we found that they have not determined how reliable their predictions of risks are. For example, evaluators have not tried systematically altering their assumptions slightly to see if that would reverse the decision to approve a pesticide.” (CESD 2003, section 1.40, p. 10).

IX. REGISTRATION, RE-EVAULATION AND ADAPTIVE MANAGEMENT Adaptive management is one of several forms of institutional learning (Lee, 1999). Active adaptive management involves treating management decisions as bona fide experiments designed to probe the causal structure of the system being managed (Walters and Holling, 1990). This implies that: (a) hypotheses are elaborated before decisions are taken; (b) predictions concerning the effects of alternate decisions are derived from these hypothesis/es; (c) outcomes of decisions are assessed and compared to predicted outcomes; and (d) information obtained from the comparison of observed and expected outcomes is used in subsequent decisions. The criterion for registration under both PCPA (2002) and PCPA (1985), namely, that the product does not pose an unacceptable risk to either human health or the environment,satisfies the criterion for a scientific hypothesis (sensu Popper (1965)) provided that “unacceptable risk” is sufficiently well defined and, even more importantly, operationalized, i.e. that possible observed effects of the product on the environment or human health are assigned a priori to one of (at least) two categories: “acceptable” and “unacceptable”. A decision to register a product implies that PMRA has (provisionally, at least) accepted as true the hypothesis that the product poses no unacceptable risk The corresponding prediction is then that if the product is used, no unacceptable effects will be observed. Consequently, if unacceptable effects are observed, then the hypothesis is falsified. Observing unacceptable effects in turn requires that the effects of product use be monitored. More specifically, it requires that monitoring be designed to maximize the likelihood of detecting “unacceptable” effects. (Clearly, if monitoring is such that “unacceptable” effects, even if present, are very unlikely to be detected, then their absence cannot be construed as evidence supporting the hypothesis.)


From these considerations, the minimal requirements for truly adaptive decision-making by PMRA are clear: (1) registration and re-evaluation decisions must be accompanied by an explicit and unambiguous statement of what are considered unacceptable effects arising from pesticide use; (2) there must be systematic monitoring of effects of product use, where and when they are applied, and such monitoring must be designed in such a way as to maximize the detection of unacceptable effects; (3) there must be regular reviews of previous decisions; (4) there must exist the statutory authority to revoke or amend previous decisions on re-evaluation; and (5) there must be a systematic procedure for incorporating information from past decisions into current evaluations. IX.A. THE PCPA Neither PCPA (1985) nor the associated Pest Control Product Regulations contain any specifications concerning monitoring of product effects, by either the applicant, the registrant (in the case of re-evaluation) or PMRA. PCPA (2002) is a distinct improvement in three respects. First, it requires the registrant to maintain and report to the Minister on product sales:

8(5) A registrant of a pest control product shall, as a condition of registration, record, retain and report to the Minister information on sales of the product in the form and manner directed by the Minister and in accordance with the regulations made under paragraph 67(1)(u).

The precise nature of the information that must be included in this report has not yet been determined, but the associated draft regulation suggests that all registrants be required to submit an annual report specifying annual sales, by province or territory, for the previous calendar year, with sales information covering “all end-use products, technical grade active ingredients and manufacturing concentrates” (PMRA 2003d) The importance of a comprehensive sales database has been recognized for some time. In 1997, the joint federal-provincial-territorial National Pesticide Sales Database Working Group was established to identify effective approaches for data collection, retrieval, reporting and analysis, for all registered pesticide products. The Working Group includes representation from the PMRA, provinces and territories, pesticide and agriculture industries and environmental and consumer organizations. Registrant members of national pesticide industry associations voluntarily contributed sales data for 1999 and 2000, which allowed the PMRA to test database elements including data entry, database structure and reporting functionality. At present, a draft version of the database has been developed and tested, but has not yet been fully implemented. Second, the act obliges the Minister to set up and maintain an electronic product registry:

42. (1) The Minister shall establish and maintain a Register of Pest Control Products in accordance with the regulations, if any, that contains information about pest control products, including information about applications, registrations, re-evaluations and special reviews.

Required information for the registry is detailed in section 42 of the act, and essentially covers all information submitted by the applicant or registrant (42.2(c), (d)) as well as any evaluation reports produced by PMRA (42(2)f) during the review process, as well as the final notification of decision (42.2. (k),(l)). Third, the act includes a mandatory adverse effects reporting provision:


13. An applicant for registration of a pest control product, a person who makes an application under subsection 10(2) or a registrant shall report any prescribed information that relates to the health or environmental risks or the value of the pest control product to the Minister within the prescribed time and in the form and manner directed by the Minister.

As with the annual sales reporting, the associated regulation is not yet finalized. The draft regulation (PMRA 2003c) establishes responsibilities for adverse effects reporting by both registrants and applicants of adverse effects on humans, domestic animals and the environment, using a classification system and reporting time frame almost identical to that used by the USEPA, with reporting time frames ranging from 15 days (for severe adverse effects on humans) to one year (for mild effects). All applicants/registrants must submit an Aggregate Annual Summary Report (AASR) of all incidents, consistent with Health Canada Food and Drug regulations, with the AASRs being placed in the Register as they are received. IX.B. The Review Process In assessing the level of adaptation inherent to the PMRA review process, we need first to distinguish between adaptive responses to new internal information (that is, information or data generated by PMRA itself), versus adaptive responses to new external information (e.g. information from the scientific community writ large, other regulatory agencies, etc.). With respect to the latter, the review process does incorporate certain, comparatively minimal, adaptive elements. First and perhaps most importantly, the Minister must undertake a special review if new information constitutes “reasonable” grounds for the belief that the product poses unacceptable risks (PCPA 2002, 17(1)). Second, the Minister has discretionary authority to initiate a re-evaluation or special review if she believes that the information required to adequately evaluate health and or environmental risks has changed since the original registration (16(1)). Third, the Minister must initiate a re-evaluation within 15 years for all registered products (16(2)(b)). These three stipulations mean that every PMRA registration decision must be revisited, minimally, every 15 years, Review of decisions Of the 153 reviewed decisions, none made explicit reference to adapative management. However, 149 (46/47 = 97.9% of new applications and 103/106 = 97.2 % of re-evaluation decisions) made reference to rationales that implied or implicated elements of an adaptive management approach. Henceforth we refer to these decisions as “implicitly adaptive”. For the 152 implicitly adaptive decisions, we evaluated the degree to which various elements of adaptive management were implied in the stated decision rationale(s) using a semantic congruence scale from 0-7 (see Appendix ii, q. 21). The adaptive management elements were (1) decisions are treated as scientific experiments (that is, are structured so as to allow testing of causal hypotheses); (2) past decisions are assumed to be correct unless demonstrated otherwise; (3) predicted effects of alternative decisions are made explicit and considered; (4) knowledge accrued from past decisions is used to inform future decision-making; (5) data and information on the effects of previous decisions are analyzed and assessed in a timely manner; (6) effects of previous decisions are systematically monitored; (7) predicted


effects of decisions are systematically compared with observed effects as determined from monitoring or surveillance; (8) large discrepancies between observed and predicted effects of past decisions reduce the likelihood that the same decision will be made in future. Unlike the case of precaution, the degree of semantic congruence assigned to a particular adaptive management element depends on whether one considers “knowledge” and “past decisions” to refer to knowledge and past decisions of PMRA only (internal knowledge and decision-making) versus scientific knowledge and/or past decisions generated by institutions other than PMRA (external knowledge and decisions). Under the former interpretation, elements (2) and (4) – (8) by definition apply only to re-evaluations, so that registrations can be evaluated only with respect to elements (1) and (3). Under the latter interpretation (i.e. where “past decisions” may be previous decisions by PMRA or another regulatory agency), elements (1) and (3) – (8) apply to both registrations and re-evaluations, and only element (2) is not applicable to the former. We use this interpretation here. The results of the analysis are striking (Fig. 2). First, in no instance was there any indication that PMRA decisions were treated as a scientific experiment, in the sense described above (Fig. 2a, b). Secondly, for all other elements with the exception of element (3), both registration and re-evaluation decisions scored poorly. The intermediate average score (and large variance) for element (2) reflects two different subpopulations in the sample. First, under both PCPA (1985) and PCPA (2002), all re-evaluations (either discretionary or required) are supposed to take into account two issues: (1) new information, acquired since the original registration, on the health or environmental impacts of the product in question (or its value); and (2) changes in “risk” tolerance, i.e. changing societal views on what constitutes an “acceptable” risk. So when little or no new information adjudged relevant to the re-evaluation process is adduced by the registrant, and there is no “reasonable cause” to believe that the product poses an unacceptable risk, the original registration decision is implicitly considered to have been correct. Such decisions score highly with respect to element (2). On the other hand, the sample also includes re-evaluations of products for which there was reasonable cause to believe that the original decision may not be currently appropriate, either because new information does suggest that the product indeed poses unacceptable risks (perhaps as used originally) or because societal standards have changed. These decisions score poorly with respect to element (2). – the result is an overall intermediate score and large within-group variance (Fig. 2b).

Fig. 2. Average (+/- 1 standard error) semantic congruence scores for various adaptive management for registrations (a) and re-evaluations (b). For further explanation, see text and Appendix ii.


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IX.C. Is PMRA practicing adaptive management? Summary and Conclucions Currently, the level of active adaptive management practiced by PMRA is low. Although the review process lays out an explicit process for the estimation or risks to human health and the environment (PMRA 2000), none of the 153 reviewed decisions included (a) an explicit statement of the estimated risk to various endpoints; (b) an explicit statement of the cutoff (crisp or fuzzy) between acceptable and unacceptable risk; or (c) an explicit statement of what would be considered unacceptable observed effects. Because this information is not specified, no registration or re-evaluation decision rendered thus far can be considered a scientific hypothesis. Second, even if conditions (a) – (c) above were satisfied, PMRA engages in virtually no systematic post-registration monitoring, either of exposure or effects. Despite noting (correctly) in 2000 that:

“There are three essential elements to post-registration monitoring: (1) the enforcement of compliance with the PCP Act and the FDA; (2) the conduct of routine inspections and special monitoring (e.g., for environmental levels and effects), food residue surveys and health surveys; and (3) the maintenance of a modern database on the potential effects on human health and the environment including periodic up-dating of approaches to risk assessment and risk management.” (PMRA 2000, p. 16)

Nonetheless CESD (2003) noted:

“When the health or environmental risks of a pesticide are considered unacceptable, evaluators try to identify measures that could reduce the predicted risks to an acceptable level …Evaluators have to predict whether such mitigation measures will prevent or minimize the impacts of pesticides, but the Agency and other federal departments do very little follow-up to determine whether the measures, when implemented, actually reduce the risk to acceptable levels.” (1.41, p. 11)

PMRA (2004a) reports that between 1998 and 2003, there were 180 compliance monitoring programs to evaluate compliance with terms and conditions of registration and or label specifications. But these programs, as designed and implemented, provide virtually no information on actual field exposures or effects. Exposure analysis was limited almost entirely to food residues (5900 of 6200 samples) (PMRA 2004a, p. 60), and so far as we were able to determine, none of these results are publicly available. PMRA recognizes this deficiency and has, apparently, “taken steps towards improving its current reporting of results, and has also commenced the development of a framework for generating a report of compliance activities to be posted on the Agency website.” (PMRA 2004a, p. 62). To date, the only quasi-systematic monitoring conducted by PMRA involves assessing post-registration compliance: for (non-residue) exposure and/or effects data and information, PMRA relies almost exclusively on (a) other government (provincial, federal or territorial) departments, especially Environment Canada; or (b) other regulatory agencies, especially US EPA and partner regulators in the OECD. This fundamental problem for adaptive management may, at least partially, be overcome if the proposed adverse effects reporting regulation comes into force, and the proposed database is well designed, well-populated and well-functioning. Specifically, the database must be such as to allow for the fitting of epidemiological models of reported incidences to the rate, frequency of application and location of registered products. This in turn requires that the database include information on pesticide concentrations in different media when and where adverse effects are


reported. Note furthermore that this will only partially resolve the problem, because as proposed, reporting will be the responsibility of the registrant, not PMRA. As such, there is no proposal for a monitoring system that would allow for independent validation of registrant information. Third, although under PCPA (2002) the Minister may use information other than that submitted by the applicant or registrant, the extent to which external information is actually used in the decision is unclear. Informal inquiries of evaluators at PMRA suggest that when external information is used, it usually takes the form of information provided by other regulatory agencies: only rarely do evaluators have the time to initiate – let alone complete – comprehensive reviews of the existing scientific literature on the effects of the products in question. Fourth, there is the issue of the interval between registration and re-evaluation. In adaptive management, the rate of adaptation depends in part upon how rapidly new information is incorporated into the decision process. The glacial pace of re-evaluations was initially pointed out by CESD (1999), a point reiterated strongly in SCESD (2000) and CESD (2003). In our view, PMRA will not make significant headway on the adaptive management front unless:

1) Regulatory decisions are formally treated as scientific hypotheses. In instances where products are registered or re-registered (following re-evaluation), this will involve an explicit specification of (a) unacceptable risk; (b) unacceptable effects. 2) In collaboration with other partners (e.g. applicants, other regulatory agencies, provincial ministries, municipalities, and other federal departments and agencies) the development and implementation of a systematic post-registration effects and exposure monitoring system, including an appropriate electronic registry and database. The monitoring system must be expressly designed so as to maximize the chances of detecting unacceptable effects, given that they exist. It is worth noting that section 12.1 of PCPA (2002) gives the Minister discretionary authority to require of a registrant post-registration information which might include monitoring of effects, and that indeed, such monitoring may be a condition of registration (PCPA 2002, 12.2). However, in none of the registration decisions we reviewed was post-registration effects monitoring a condition of registration. 2) A clear, well-defined protocol is implemented for the incorporation of new information, both internal and external, into the decision process. Minimally this will involve a mechanism whereby new scientific and regulatory information is systematically assimilated, assessed, and integrated directly into the decision process in a timely fashion.


X. REFERENCES

Bankes, Steven C. 2002. “Tools and Techniques for Developing Policies for Complex and Uncertain Systems,” Proceedings of the National Academy of Sciences 99: 7263-7266. Castrilli, F. and T. Vigod, 1987. Pesticides in Canada: An Examination of Federal Law and Policy, Protection of Life Series, prepared for the Law Reform Commission of Canada, the Law Reform Commission of Canada. Commissioner of the Environment and Sustainable Development (CESD) 1999. Report to Parliament. Commissioner of the Environment and Sustainable Development (CESD) 2003. Report of the Commissioner of the Environment and Sustainable Development to the House of Commons, Ch. 1. Managing the safety and accessibility of pesticides. Cat. No FA1-2/2003-IE , Minister of Public Works and Government Services Canada,. Government of Canada 2001. A Canadian perspective on the Precautionary Approach/Principle. Funtowitz, S, and J. Ravetz. 1990. Uncertainty and quality in science for policy. Kluwer, Dordrecht. Goklany, I.M. 2001. The Precautionary Principal: A critical appraisal of environmental risk assessment. Cato Institute, Washington, D.C. Goklany, I.M. 2002. From precautionary principle to risk-risk analysis. Nature Biotechnology. 20: 1075. Harwood, J., Stokes, K., Holling, C.S. (Eds). 1978. Coping with uncertainty in ecological advice: lessons from fisheries Trends in Ecology and Evolution. Adaptive environmental assessment and management. Volume: 18, Issue: 12, December, 2003, pp. 617-622. John Wiley, New York, New York, USA. Leiss W. 2001, In the Chamber of Risks. Montreal: McGill-Queens University Press Lee, K.N. 1993. Compass and gyroscope: Integrating science and politics for the environment. Island Press, Washington, DC. Lee, K. N. 1999. Appraising adaptive management. Conservation Ecology 3: 3. [online] URL: http://www.consecol.org/vol3/iss2/art3/ Lempert, Robert J., 2002, “New Decision Sciences for Complex Systems.” Proceedings of the National Academy of Sciences. 99: 7309-7313. O=Riordan, T., Cameron, J. and A. Jordan. (Eds.) 2001. Re-Interpreting the Precautionary Principle. London: Camera and May Ltd.


Pest Management Regulatory Agency (PMRA), 1998. Good laboratory practices. Regulatory Driective DIR 98-01, Submission Management and Information Division, Pest Management Regulatory Agency. Pest Management Regulatory Agency (PMRA), Proposed Amendments to the Pest Control Products Act, January 1999. Pest Management Regulatory Agency (PMRA), 2000. A decision framework forrisk assessment and rsik management at the Pest Management Regulatory Agency. Science Policy Notice SPN 2000-01, Submission Management and Information Division, Pest Management Regulatory Agency. Pest Management Regulatory Agency (PMRA), 2003a. General principles for performing aggregate exposure and risk assessments. Science Policy Notice SPN2003-04, Submission Management and Information Division , Pest Management Regulatory Agency . Pest Management Regulatory Agency (PMRA), 2003b. Assessing exposures from pesticides in food: a user’s guide. Science Policy Notice SPN2003-03, Submission Management and Information Division, Pest Management Regulatory Agency . Pest Management Regulatory Agency (PMRA), 2003c. Pesticide adverse effects reporting regulation. DIS 2003-03, Submission Management and Information Division Pest Management Regulatory Agency Pest Management Regulatory Agency (PMRA), 2003d. Preliminary consultation on proposed sales reporting regulation . DIS 2003-04. Pest Management Regulatory Agency . Pest Management Regulatory Agency (PMRA), 2004a. Pest Management Regulatory Agency Progress Report, 1998-2003. Catalogue number: H114-13/2003E (H114-13/2003E-PDF), Minister of Public Works and Government Services, Canada . Pest Management Regulatory Agency (PMRA), 2004b. Strategic Plan 2003-2008. Catalogue Number: H114-14/2003E-PDF, Minister of Public Works and Government Services. Popper, K. (1965). Conjectures and Refutations: The Growth of Scientific Knowledge, Harper and Row, New York Popper, S.W., Lempert, R.J and S.C. Bankes. 2005. Shaping the future. Scientific American Vol. 292 Issue 4, p66, 6p Standing Committee on Environment and Sustainable Development (SCESD) 2000. Making the right choice for the protection of health and the environment. Suter, G.W., 1993. Ecological risk assessment. Lewis Publishers, Michigan. Walters, C.J. 1986. Adaptive Management of Renewable Resources. New York: Macmillan.

Dan E. Lane - Setting TACs in the 4X5Y Cod and Haddock Fisheries D-85

CASE STUDY REPORT: SETTING (TOTAL ALLOWABLE CATCHES) TACs

IN THE 4X5Y COD AND HADDOCK FISHERIES

Dan E. Lane Full Professor

School of Management University of Ottawa


Dan E. Lane – Setting TACs in the 4X5Y Cod and Haddock Fisheries D-86


TABLE OF CONTENTS

I. INTRODUCTION .......................................................................................................................89 I.A. Existing decision-making arrangements: Background ............................................89 I.B. Decision-making arrangements: The FRCC Era .....................................................91 I.C. Existing presence (or absence) of risk, PP and PAM .............................................94

I.C.1. PP and PAM in the Preparation of the Stock Status Report........................95 I.C.2. PP and PAM in FRCC Consultations.........................................................97 I.C.3. PP and PAM in the FRCC Recommendation Report...................................98 I.C.4. PP and PAM in the Minister’s final decision. .............................................98

I.D. Methodology.................................................................................................................99 II. CASE STUDY ..........................................................................................................................100

II.A. Setting TACs in the 4X5Y cod and haddock fisheries: Background .................100 II.A.1a. The 4X5Y Cod Stock. ..............................................................................100 II.A.1b. The 4X5Y Haddock Stock........................................................................100 II.A.2. Management Issues...................................................................................102 II.A.3. Stock Prognoses. .......................................................................................102

II.B. Definitions and the use of principles: : PP and PAM ...........................................104 II.B.1 Retrospective Analysis. ..............................................................................105 II.B.2 Risk Analysis. .............................................................................................105

II.C. The practice of precaution: Gaps between theory and practice ..........................106 II.C.1a. 4X5Y Haddock in 2002. .........................................................................107 II.C.1b. 4X5Y Cod in 2002...................................................................................108 II.C.1c. Actual Decisions in 2002 ........................................................................110 II.C.2a. 4X5Y Haddock in 2003. ..........................................................................110 II.C.2b. 4X5Y Cod in 2003...................................................................................112 II.C.2c. Actual Decisions 2003 ............................................................................115

III. FINDINGS/IMPRESSIONS..................................................................................................115

III.A. Presence of PP and PAM .......................................................................................115 III.A.1a. 2002 and 2003 SSRs for Cod.................................................................116 III.A.1b. 2002 and 2003 SSRs for Haddock .........................................................116 III.A.2a. 2002/2003 and 2003/2004 FRCC Recommendations for Cod .............117 III.A.2b. 2002/2003 and 2003/2004 FRCC Recommendations for Haddock ......117

III.B. Interpretation and application of PP and PAM. .................................................117 III.C. Variation in the definition of PP and PAM..........................................................118 III.D. Institutional changes from use of PP and PAM. .................................................118 III.E. Evidence of administrative conflicts. ....................................................................119

IV. RECOMMENDATIONS .......................................................................................................120

IV.A. Case study performance .........................................................................................120 IV.B. Suggested improvements .......................................................................................120

V. REFERENCES.........................................................................................................................122 VI. APPENDIX A..........................................................................................................................126 VII. APPENDIX B ........................................................................................................................128

Dan E. Lane – Setting TACs in the 4X5Y Cod and Haddock D-88

LIST OF TABLES

Table 1. Stock Status Report for Haddock – 2002, Pros and Cons by Text Heading................. 107 Table 2. Stock Status Report for Cod – 2002, Pros and Cons by Text Heading......................... 109 Table 3. Stock Status Report for Haddock – 2003, Pros and Cons by Text Heading................. 111 Table 4. Stock Status Report for Cod – 2003, Pros and Cons by Text Heading......................... 113

LIST OF FIGURES Fig 1. NAFO Fishery Divisions of the Northwest Atlantic including 4X5Y ............................. 101 Fig 2. 4X5Y Cod Stock Status Report Data to 2002 .................................................................. 103 Fig 3. 4X5Y Haddock Stock Status Report Data to 2002........................................................... 103


I. INTRODUCTION

This report presents the results of one of four case studies developed for the Law Commission research project entitled “Practicing Precaution and Adaptive Management: Legal, Institutional and Procedural Dimensions of Scientific Uncertainty” under investigation at the University of Ottawa. The project investigates the incidence in science-based decision-making of the application of two methodologies for dealing with scientific uncertainty, namely, the precautionary principle (PP), and the principle of adaptive management (PAM). In particular, the research examines the implications of the PP and PAM for administrative decision-making and regulation with respect to five assessment dimensions: (1) personnel; (2) process and procedure; (3) participation; (4) appeals, and judicial review; and (5) public and political accountability. The purpose of this report is to examine how each dimension is currently incorporated into complex decision making in setting aggregate annual catch limits in fisheries. Under its own guidelines (Canada 2005) and as a signatory to the United Nations Fisheries Agreement (UNFA), Canada has a direct obligation to apply the PP according to the guidelines laid out by the UN (United Nations 1995), the Code of Conduct for Responsible Fisheries (FAO 1995a) and NAFO’s Scientific Council Report on the Precautionary Approach (NAFO 1998). In many commercial fisheries, the PP is understood to be operationalized in the setting of annual total allowable catches (TACs). While much work has appeared in the fisheries literature on the merits of implementing a fully adaptive precautionary approach (OECD 1998, FAO 1996, 1995abc, ICES 1998, 1997; Walters 1986), the empirical data indicate that there are nevertheless obstacles in the way of full implementation of PP and PAM in commercial fisheries. This case study explores these obstacles by reviewing the process of setting TACs, and examining how precaution is practised in the setting of annual fish stock exploitation limits by the Minister of Fisheries and Oceans for the groundfish stocks of cod and haddock in the management area of southwest Nova Scotia and the Bay of Fundy in Atlantic Canada. I.A. Existing decision-making arrangements: Background

The collapse of the Northern cod stock off the northeast coast of Newfoundland and Labrador (NAFO Divisions 2J3KL - see also Figure 1 below) in 1992, placed fisheries science and management decision making in the fisheries in a defensive position with respect to science’s ability to manage exploitation of marine resources in a sustainable manner. To that point, fisheries science in Canada had been accorded an elevated status in resource decision making. Since 1977, and the declaration of the United Nations Law of the Sea (UNCLOS), Canada took over jurisdiction of the substantial offshore fisheries out to 200 miles offshore that had been, to that point, freely accessible fishing grounds to international fleets. When the foreigners were “kicked out” after 1977, Canadians were accorded the domestic rights to a huge new supply of resources. The reaction of the industry, spurred on by government support, was for rapid expansion of what was essentially an artisanal inshore industry compared with the historical exploitation of the nearshore and the offshore that was the legacy of the international fleets. Thus, new fishing fleets were built and new coastal processing capabilities sprang up to accommodate the industrial expansion. Canadian fisheries science, which already had a strong reputation for research in support of the fisheries (cf. Ricker (1975) and the publications of the Fisheries Research Board of Canada), expanded rapidly as evidenced by the Canadian government’s creation in 1978 of a new Department of Fisheries and Oceans (previously part of the Department of the


Environment). As it expanded, Canadian fisheries research quickly earned a leading international reputation for developing and applying longitudinal data collection on fish stocks (especially groundfish), and in statistical stock assessment methodologies. Indeed, the process of fisheries decision-making in Canada after 1977 and the extension of jurisdiction was such that the information coming from scientific surveys and stock assessment analyses were the primary determinants in fisheries management decisions. In particular, during this period, key decisions on the domestic yearly TAC catch limits authorized by the Minister of Fisheries and Oceans (as his responsibility under the Fisheries Act of Canada) were based exclusively on the scientific advice from the Canadian Atlantic Fisheries Scientific Advisory Committee, CAFSAC, an internal DFO scientific advisory group (Lane 1992). As such, these decisions and their foundation on the analysis of scientific data, were understood by the public to be defensible. Moreover, the analyses were determined using state-of-the art methods based on the scientific method, and the public was ensured about the sustainability of resources despite recognized, but nagging (to an industry seeking stability for growth) environmental fluctuations over time. An industry consultation group known as AGAC, the Altantic Groundfish Advisory Council, was also put in place. AGAC offered critique to the Minister on the independent CAFSAC results previously provided to the Minister by the fisheries scientists. AGAC provided feedback rarely altered the science-based decisions of the Minister based on the CAFSAC advice. Given the “resource boom” period after extended jurisdiction, and the “promise of abundance” (Munro 1979) that followed from the prognosis of scientists to the expanding domestic industry (e.g., DFO 1986), there was tremendous optimism in the fishery. After 1992 and the collapse of groundfish, the public, having implicitly put their trust in the well-respected fisheries science machinery, now came to place the blame for the collapse of fish stocks squarely on the Department of Fisheries and Oceans. Fishermen and coastal communities that were directly affected by the loss of resources on which their livelihoods depended felt - and still feel - betrayed by a government system that in their view, let them down. Significantly, fishery scientists, given their trusted and elevated status as a group were largely held responsible for allowing the catastrophic collapse of commercial fish stocks to occur. Curiously, fishermen were generally held to be the victims rather than the active perpetrators of the collapse. This view has persisted despite the fact that over the post WWII years and increased industrialized fishing power, large-scale fishing by offshore draggers and factory freezer trawlers - domestic as well as international - were highly wasteful and poorly managed in their operations and compliance with the regulations. As well, the participation of a heavily populated small-scale coastal fishery dependent on the resource but difficult to monitor throughout Atlantic Canada also contributed to resource decline. In this respect, the Minister of Fisheries and Oceans and the department were once again singled out as responsible for allowing these inadequate management practices to take place year after year. Meanwhile, the unreliable data from these poorly managed fisheries led stock assessment scientists to update their results incorrectly leading to general overestimation of stock abundance. Subsequent analysis indicates that management decisions based on the scientific information that itself was based on questionable data from an overall noncompliant industry, were also made in a dynamically changing ecosystem environment that had effects throughout the North Atlantic. Thus, while the collapse of Northern cod stock was undoubtedly the most dramatic episode, by 1993, it was recognized that most Canadian commercial groundfish resources in the Northwest Atlantic were also in trouble. Thus, the Minister’s decision to declare a moratorium on fishing on the 2J3KL Northern cod stock in 1992 was swiftly followed by moratoria on other groundfish fishing in the Gulf of St. Lawrence and along the Scotian Shelf.


The fact that the whole of the North Atlantic ecosystem for groundfish experienced a shift in the mid-1990s, could be considered as shifting the “blame” from scientific mis-assessment (coupled with strict industry overexploitation), to the result of unpredictable ecosystem uncertainties. In the wake of the backlash, attempts were made to reform the role of fisheries and science and the decision making process. John Crosby, the colorful Minister of Fisheries and Oceans, replaced the primary and internal DFO science-based CAFSAC (Canadian Atlantic Fisheries Stock Advisory Committee) advisory group, and the industry consultation body AGAC (the Atlantic Groundfish Advisory Council) with an arm’s length intermediary advisory council (the Fisheries Resource Conservation Council, FRCC), whose task it was to receive the DFO science information on groundfish stock status and incorporate the scientific advice on stocks together with information from the fishing industry into an integrated set of public recommendations on TACs for regular submission to the Minister. While the process was purely consultative, i.e., the FRCC had no effective decision-making authority - this authority rested with the Minister - the process of recommending strategies to the Minister reduced the nearly complete institutional dependence on internal DFO fisheries science advice, and permitted a wider participation of stakeholders and a more open process (as described below) for considering integrated systems aspects in the exploitation decisions. I.B. Decision-making arrangements: The FRCC Era

The establishment of the FRCC in 1993 redefined the process for providing recommendations to the Minister. The Terms of Reference of the FRCC stated that:

“The Minister of Fisheries and Oceans has established the Fisheries Resources Conservation Council (FRCC) as a partnership between government, the scientific community and the direct stakeholders in the fishery. Its mission is to contribute to the management of the Atlantic fisheries on a ‘sustainable’ basis by ensuring that stock assessments are conducted in a multi-disciplined and integrated fashion and that appropriate methodologies and approaches are employed; by reviewing these assessments together with other relevant information and recommending to the Minister total allowable catches (TACs) and other conservation measures, including some idea of the level of risk and uncertainty associated with these recommendations; and by advising on the appropriate priorities for science.” (FRCC 2004a, Appendix)

The establishment of the FRCC did not alter the procedures by which scientific data on fish stocks were collected and analysed. However, the noted inclusion of “risk and uncertainty” certainly became more prominent after the crises in groundfish of the early 1990s in the Northwest Atlantic. As before, the scientific advice on stock status from fisheries scientists followed a similar process. However, now it was required that this information be developed first for the FRCC as part of its formal public consultations with the fishing industry and all interested stakeholders prior to the preparation of advice to the Minister of Fisheries and Oceans. In general, we may consider the annual decision making process as being comprised of four major steps. These are:

1) Fisheries science prepare stock status reports on a stock-by-stock basis; 2) DFO Science presents the stock status reports to the FRCC who consult with

stakeholders;


3) FRCC prepare TAC recommendations for the Minister; 4) The DFO Minister makes the TAC decision.

These steps are described in more detail below. 1) Preparation of the Stock Status Report This activity is the purview of fisheries scientists with expertise on the particular species of interest on a stock-by-stock basis designated by a specific marine management area, e.g., the southern Gulf of St. Lawrence cod stock, or the eastern Nova Scotia hake stock, etc. Data are amassed for each stock from groundfish surveys carried out annually by research vessels operated by fisheries scientists. Independently, catch data from the commercial fishery are also collected for the current season. At season’s end, the survey and commercial fishery data are collated into the historical database of area aggregated stock-at-age statistics. This information is used to complete the data requirements for the traditional virtual population analysis (VPA) models that provide aggregate estimates of stock size by age at start of year over the entire management area. The VPA results are the principle indicator of stock status as reported in the formal Stock Status Report for each stock. These results provide static current estimates of stock abundance (numbers of fish) and stock biomass (stock weight) for various age definitions, e.g., the exploitable stock, the adult stock, and the total stock. Given the current population estimates, projections are typically made for the subsequent period’s biomass estimates assuming another year of aging in the stock, new recruitment to the fishery (from young fish), and a standardized strategy of exploitation for the single upcoming period. The statistical analysis associated with the VPA parameter estimates also permits current estimate variability and variability of the projections to be presented. These are presented as “risk profiles” in the Stock Status Report document. The Stock Status Report also provides summary information on the background of the fishery, key events in the current fishery, other indicators about resource status (e.g., sampled stock condition), as well as other ecosystem considerations felt to be important as determinants of overall stock status. While Stock Status Reports are the responsibility of fisheries scientists, they are vetted and validated in an open peer review process called the Regional Advisory Process (RAP) that includes a formal remittance from DFO on the stock assessment requirement. The RAP is inclusive. It involves stakeholders, other departmental fisheries scientists (e.g., with expertise in fish stocks other than the stock of interest), external reviewers (e.g., academics or experts from international fisheries science bodies, e.g., ICES, FAO, NOAA, etc.), as well as members of the FRCC who sit down and go through the elements of the SSR including the fishery activities, stock data (catches and surveys), resource status indicators, the VPA assessment results, sources of uncertainty, stock outlook, and management considerations related to determining the TAC in the coming year and the implications on projected stock status out one year. The peer review process may also involve competing scientific assessment models and results which need to be resolved consensually to establish the accepted Stock Status Report. The results of the peer review process are approved by the Fisheries Science Branch within DFO and released as a public document summary of stock status. The SSR may also include implicit or explicit recommendations for a TAC for the coming season for the stock.


2) FRCC Consultations On completion of the RAP and the vetted product of the Stock Status Report, this assessment document is presented in public fora by the FRCC with the assistance of the fisheries assessment scientists to fishing industry and to other stakeholders in an open consultation process. Stakeholders also use these consultations to provide their own recommendations on the stock exploitation limits as well as other management issues to the FRCC. These independent recommendations may or may not be compatible with the scientific advice implied in the Stock Status Reports. The suite of recommendations from fisheries science (SSR), from the industry representations, and from other stakeholders, are gathered together by the FRCC representatives who report on the information to the entire Council during its regular sessions to prepare their report recommendations. Taking all the information into account, the FRCC prepares its stock-by-stock recommendations in a report to be delivered to the Minister (FRCC 2004ab, 2003ab, 2002, 2001). 3) FRCC Recommendation Report The full FRCC has an Atlantic-wide perspective and recommendations made are, as far as possible, held to be more or less consistent across all groundfish fisheries in the Canadina Northwest Atlantic region. This is despite the Regional differences that exist in the Atlantic, e.g., the Newfoundland and Labrador fisheries are operated by a different set of scientific experts, management personnel, and stakeholders who operate the fisheries from a historical perspective that differs from that of the Gulf of St. Lawrence fisheries or the southwest Nova Scotia regions. Accordingly, the FRCC recommendations developed from the regional science and stakeholder feedback needs to take any differences that exist across regions into account. With respect to the above issue of regionalism, most of the effort of the FRCC is to find consensus among its members in defence of particular recommendations made about the individual stocks. Since the members of the FRCC come from a variety of backgrounds, including science (e.g., academics and/or outside fisheries science experts), industry experience, (e.g., past or present representatives of fisheries groups or fishermen), and stakeholders (e.g., from environmental, aboriginal and/or community groups), reaching consensus positions can at times be difficult. As such, a consensus position is typically determined by subjective analysis and argumentation. The FRCC does not engage in analytical work to help it resolve its differences or, in particular, to consider aspects of uncertainty related to its mandate. Rather, it presents its final stock recommendations after presenting a logical, integrated consensus argument supported by the data and feedback it had received in the RAP and SSR, as well as that from the industry and stakeholders. The FRCC recommendations are produced according to a timely schedule that coincides with the operation of the fishery. On completion of the FRCC recommendations, the Chair of the Council reports to the Minister of Fisheries and Oceans and the department’s administrative staff including most importantly, the Assistant Deputy Minister (ADM) for Science, and the other ADMs for Fisheries Management, Policy, and Oceans (although these latter ADMs are not often involved in advising the Minister on the TAC decisons). Once the FRCC’s recommendations have been provided to the Minister and departmental staff, the FRCC Report (e.g., FRCC 2004ab, 2003ab, 2002, 2001) is made public and distributed to stakeholders via direct mailings and on the FRCC Website (http://www.frcc-ccrh.ca/).


4) The Minister’s Final Decision By the Fisheries Act, the Minister of Fisheries and Oceans is the “ultimate authority” with regard to the decision to set TACs for commercial stocks (DFO 2004d). Thus, the consultative process that ends when the FRCC presents its recommendations report, does in no way obligate the Minister to accept any or all of the recommendations. Since 1993, the track record is such that the Minister and the FRCC generally agree on what strategies need to be applied. Most notably, the FRCC’s first order of business in 1993 was essentially to provide the Minister with recommendations to close a succession of groundfish fisheries. Consequently, most Northwest Atlantic groundfisheries were placed under moratoria by 1995. Many of these moratoria have continued uninterrupted since the early 1990s. In later years, some stocks showed signs of rebounding after years of moratoria. Thus, the FRCC had to deal with the possibility of reopening some stocks to fishing again. In some cases, (e.g., cod of south eastern Newfoundland, NAFO Division 3Ps), the Minister, encouraged by the FRCC recommendations, was overly eager in reopening and expanding the annual exploitation fishery between 1999 and 2001 when it appeared from the scientific stock assessments to be growing rapidly. However, in subsequent years TACs for 3Ps cod have had to be curtailed. During this same time period, there was an active science-based “precautionary approach” movement that led the Canadian government science bodies - including DFO - to establish a “precautionary framework” as part of a wider science-based approach led by the Privy Council (Canada 2004). This approach led fisheries scientists to attempt to establish stock thresholds that would be used to determine the opening or closure of the stock to commercial exploitation. In 2003, DFO was actively pursuing arbitrarily defined thresholds as scientific basis for closing fisheries in the Gulf of St. Lawrence. The FRCC recommendations for 2003 (FRCC 2003b) argued for keeping the stable stocks of the northern and southern Gulf open at reduced levels to maintain a small commercial presence in the fisheries there. However, the Minister rejected the FRCC recommendations and closed both the northern and southern Gulf of St. Lawrence fisheries for the 2003 season. After much public outcry and lobbying by stakeholders (who claimed the science-based closure decision was founded on inappropriate data), the new Minister asked the FRCC for recommendations for 2004 in the then closed Gulf groundfisheries. The 2004 recommendations (FRCC 2004b) were essentially identical to the 2003 FRCC recommendations. The Minister accepted these for the 2004 fishery and reopened the Gulf fisheries as earlier recommended. While the consultative process is quite open and public, it is clear that this “open” process has not stopped the action of lobbying the sole decision-maker, the Minister. Fisheries has always been a more parochial system built on political deals for support regions or companies in “despair” areas of the Atlantic, e.g., the Fisheries Product International provincial commitment to Newfoundland and Labrador employment. I.C. Existing presence (or absence) of risk, PP and PAM

The focus of this report on determining annual exploitation limits or the TAC setting decision is a fundamental part of the operation of commercial fisheries and an important element of fisheries management toward achieving resource sustainability. This decision therefore provides a direct and important opportunity to “practice precaution”. As noted previously, there are formal and informal mechanisms currently in place that permit the operationalizing of PP and PAM. These can occur at each of the four major steps of


the process described above. The following paragraphs present opportunities for operationalizing PP and PAM in the fisheries process.

I.C.1. PP and PAM in the Preparation of the Stock Status Report DFO fisheries scientists have the responsibility of preparing the Stock Status Report within the Regional Advisory Process. This step is the most quantitative and analytical in the process leading to making the TAC decision. As such, it is in the development of the SSRs and the stock assessment “research documents” that quantitative aspects of PP and PAM are incorporated. The Stock Status Report has evolved. Originally, the SSR was a summary of the assessment scientists’ detailed analytical presentation of the virtual population analysis results in the form of a draft research document to fellow fisheries scientists as part of the earlier CAFSAC process. As such, CAFSAC stock assessment meetings were where scientific peer review took place. In this process, only when the research document containing the quantitative stock assessment results had been vetted among scientists - and after the detailed research document was finalized - then the stock status report was produced as a summary for presentation to the public. However, since 1993 and the establishment of the changed process involving reporting to the FRCC, the SSR has become a report on its own developed and vetted (as noted above) during the RAP for each stock. Accordingly, in most cases, the research document - from which the SSR is supposed to evolve - is not provided in draft form at the RAP. In fact, if the full research document is produced at all, it is only made public well after the public release of the SSR. The “short cut” to the SSR bypassing the research document has taken place to: (1) reduce the time to provide scientific advice in order to facilitate the FRCC and consultation processes; and (2) provide a more useful, non-technical document for public consumption and for eventual industry and stakeholder consultation. The RAP process that produces the SSR has become a watered down scientific peer review now tempered by more non-technical involvement from stakeholders, industry, and FRCC members. While this has the effect of increasing transparency, it reduces the opportunities for more technical, scientific treatment and presentation of precaution principles and quantitative analyses. At the same time, more subjective aspects of complexity and uncertainty are triggered with the often unfortunate result that indicators of stock status can be interpreted to serve the positions of diametrically opposite views about stock status. Coincident with the direct development of the SSR, changes in its content have also been made. SSRs are expected to include information with the following headings:

1) Background - static biological information about the stock and the species;

historical information about the fishery 2) Summary - itemized highlights of the results of the status report 3) The Fishery - events that occurred in the commercial fishery; annual catch totals 4) Resource Status - suite of stock indicators from research vessel surveys and

commercial data; VPA analysis of stock abundance estimates 5) Management and Ecosystem Considerations - areas of concern that may effect

stock status results but are not included in the quantitative single stock analysis 6) Sources of Uncertainty - variability with respect to the VPA statistics including

year-over-year patterns of estimates


7) Outlook - highlights of the abundance estimates results and expected impacts of one year stock projections assuming standardized exploitation rates.

With respect to PP and PAM, SSRs changes have included more detail on statistical variability of the VPA estimates and variability induced by projecting the stock one year subject to a specified exploitation strategy. These changes are captured in SSR text and discussions in the following sections:

• Sources of Uncertainty - including retrospective analysis of the numerical VPA results that may indicate bias in historical results, changes in methodology, or fundamental issues related to stock species and management area definition;

• Management Considerations - including potential impacts from exploiting mixed stocks with shared habitats and bycatch implications, impacts on non-targeted species subject to mortality from fishing targeted stocks, impacts of noncompliance to the regulations;

• Ecosystem Considerations - including discussions on the effects of fishing targeted species on other resources of the ecosystem community, the effects of fishing on marine habitat (e.g., dragging the bottom), and the effects on the stock overall that may be a consequence of fishing (e.g., stress at spawning time, impacts on age of maturity)

• Outlook - including “estimating uncertainties” using a “risk analysis” that measures VPA within model variability of one period stock projections; the “risk profiles” are actually probability assessments of a selected stock indicator, e.g., the target rate of continuous fishing mortality, F, for some assumed catch level for the coming season.

Each of these items implicitly projects a need for more precaution in setting annual exploitation levels for stocks. However, the extent of the impacts from these issues remains non-quantified. Rather, the discussions on these issues tend to take on a repetition of precaution each year as a “reminder” that quantified estimates likely should be estimated downward somewhat in order to take into account the totality of the variability and uncertainty in the stock status estimates. These items introduced stock status variability as a function of the best population model estimates from the given data. However, as noted there are other perhaps significant uncertainties that are not accounted for in these results, e.g., “The risk plot incorporates the discrepancy between the accepted model and the data. Other uncertainties not considered in this risk analysis include errors in the model assumptions, changes in fishing practices, and environmental effects on survivorship” (DFO 2004a). Once again, while acknowledging these unaccounted for uncertain elements, there is no attempt to relate the extent of the uncertainties to the potential need to adjust estimates accordingly. There are also other issues of concern that hinder the incorporation of precaution in the process for preparation of the stock status reports. These issues include:

1) Lack of time for a more comprehensive scientific review and the direct generation of summary SSRs versus a complete science peer review of the background research document as was done in the past;

2) Lack of alternative consideration of scientific methodology applied to estimating stock status, e.g., the appropriateness of: (i) traditional aggregate at-age population


statistics versus spatial-temporal analyses; (ii) deterministic (least squares optimization modeling) versus probabilistic approaches for describing stock status; (iii) predetermination of stock threshold values, extension of planning horizons beyond a single year projection;

3) Unaccustomed scientific expertise for applying analytical stock assessments since fisheries biologists who become stock assessment scientists must learn statistical analyses without the recourse of applying their learned biological skills; and the lack of retention of developed stock assessment expertise due to aging of the science staff and a movement away from the stock assessment mandate;

4) Lack of resources for enhanced considerations of precautionary options due to changing science mandate including the shift in budgets out of expensive assessment infrastructure, to a wider emphasis on understanding oceans ecosystems; part of this shift is the result of failures in our ability to sustain marine resources and therefore a demonstrated lack of further need to so do as a result.

I.C.2. PP and PAM in FRCC Consultations While much information is gleaned from the consultations with stakeholders that is to be integrated with the stock status data from science, there is less of an opportunity to quantify this information for analysis with respect to PP and PAM. Nevertheless, a qualitative notion of precaution is everywhere prevalent, albeit implicitly in these discussions with industry and stakeholders. There is however, a distinct difference in science “precaution” and industry/stakeholders’ “precaution” primarily to the planning horizon of these conflicting groups. Science allegedly has a more strategic “sustainability” perspective that is longer term. Industry however, are notorious for being myopic, short-sighted and intent only on maximizing gains in the short run. Their recommendations and lobby invariably seeks recognition for increased access and allocation and higher exploitation. Doubtless, part of this problem is attributable to the annual scientific renewal process that feeds the short-term perspective. It is understood that if one can make it through this year, then next year we start all over again with new scientific data, a new assessment of stock status and new recommendations based on the most recent information. In other words, the perspective of the fishery overall appears to be consequently short-term. However, given the opportunity to plan more strategically, there is strong evidence that industry would collectively embrace a more precautious approach if it were given the responsibility to engage in the planning process and if participation came with guarantees of access and allocation to a selected and manageable industry sector. Joint project agreements by DFO with selected commercial fisheries groups are representative of the kind of longer term cooperation where evidence of a more strategic perspective can exist. With respect to being more precautious, a longer term view would provide a more secure and sustainable perspective than an annual renewal process which effectively negates opportunities for industry to plan ahead and reduces stable access to the resource. Arguably, the fishing industry and fishing communities could better express their strategic views if, for example, the process of setting TACs were set (albeit at lower conservative levels) for an extended period to restricted sets of users rather than open to many users on a year-by-year basis. Moreover, if those responsible for resource exploitation were given more direct responsibility for the strategic decisions and their ultimate consequences then they would be demonstrably more precautious in their decision making. Currently, under the Fisheries Act, the Minister retains


ultimate authority for all access and allocation decisions thereby absolving the industry from decisions that are attributed back to the Minister including decisions resulting in declining resource status. I.C.3. PP and PAM in the FRCC Recommendation Report As noted previously, preparation of recommendations from the arm’s length body is a consensus-driven process guided subjectively by historical precedent, persuasion, and personal argument. While this approach does not exclude the introduction of PP and PAM perspectives, it does provide an unstructured and subjective mechanism in a forum for multiple participants in which to integrate precautionary measures. As such, it does not prevent the recommendation of inappropriate decisions or avoid reckless decision making by the Minister from taking place. The dilemma of the FRCC often stems from the need to reconcile opposing positions of a pessimistic scientific view of stock status and the more optimistic view of industry interested in obtaining justification for a less restrictive level of resource exploitation. In many situations, science expresses restrictive advice in the form of multiple stock status indicators that are not definitive and are also associated with considerable variability. Moreover, these same indicators can sometimes be construed to be indications of favorable stock status, e.g., declining catches of fish at older ages, changes in ages of first maturity, relative increases in stock recruitment. It obviously becomes more difficult to achieve consensus when the same indicators are sometimes used to support opposing views of stock status leading to resource exploitation decisions. From about 1999, the FRCC attempted to move out of the annual renewal process described previously and toward establishing long-term strategic plans for fisheries. However, after 10 years of FRCC processes (1993-2003) including the ups and downs of resource closures and mixed success of fisheries reopenings, the original mandate of the FRCC was changed. Originally focused on groundfish, in 2003, the FRCC was tasked by the Minister to abandon the established process of stock-by-stock review, consultation, and recommendations and to focus more directly on analysis of the crab fishery. At the time, crab that had gone through a difficult period related to access and allocation and it was felt that a more committed study of the fishery by the intermediary body would provide a much needed forum for stakeholders to develop advice for the Minister. Consequently, and apart from its requested re-review of the groundfish stocks in the Gulf of St. Lawrence for 2004, the FRCC was no longer in a position to try to integrate the scientific perspective on stock status with the industry and stakeholders view of the stocks. Hence, with the disappearance of a formal intermediary report on advice to the Minister on stock exploitation, the process of decision making for setting stock TACs continues to include the annual RAPs with SSR development and independent industry lobbying directly to the Minister. I.C.4. PP and PAM in the Minister’s Final Decision This is the final step by which PP and PAM can be directly incorporated in decision making. As in the FRCC report writing step, the adoption of a more precautionary approach is the result of informal considerations by the Minister within the complexity of the fishery system. The Minister, while responsible under the Fisheries Act for his access and allocation decisions, is not obligated to justify his decision on the grounds of resource conservation or sustainability,


socioeconomic viability, or administrative efficiency although each of these dimensions are likely considered in the ultimate decision. The Minister’s ultimate authority tends to fall back on the Minister’s own Departmental resources and advice, especially from the advice of his ADM Science and ADM Fisheries Management who are most directly implicated in TAC setting decisions. This is, of course, tempered with the recommendations that have been provided to the Minister via industry and stakeholder lobbying concerns. After the fact, the basis on which the Minister makes his decision is especially difficult to ascertain. For example, the TAC decisions in the Gulf of St. Lawrence in 2003 and in 2004 were based on public recommendations from the FRCC that were unchanged (FRCC 2003b, 2004b). However, in 2003, the Minister closed the fisheries in the Gulf (against the advice of the FRCC recommendations) based on the stocks’ positions relative to recently established DFO Science stock thresholds. In 2004, however, the fisheries were opened in spite of no change in the stock positions values. Without fully understanding the Minister’s suite of criteria related to stock sustainability, socioeconomic viability, and administrative efficiency, it is difficult to criticize whether or not these decisions are ordained to be precautionary or not. I.D. Methodology

The following specific cases for determining the TACs for the cod and haddock stocks in southwestern Nova Scotia and the Bay of Fundy were selected because they present two similar yet starkly different cases. Firstly, these two stocks inhabit the same management area (NAFO Divisions 4X and 5Y) and both, as groundfish, follow similar life cycles. Consequently, they are fished by mobile gear (draggers) and fixed gear (handlines and gillnets) that access both stocks on the fishing grounds together under separate quota allocations for each stock. However, currently, these stocks have experienced quite different resource status for reasons that are not entirely clear. The 4X5Y cod stock - like many cod stocks in the North Atlantic - is having continued difficulty growing as scientists would expect, and its abundance level has been depressed for over a decade. On the other hand, the state of abundance of the haddock stock in this same area is booming and is currently at record high levels last seen in the 1950s. These similarities and differences suggest different exploitation strategies are required for both stocks and, accordingly different applications of PP and PAM for these two stocks. The following case study reviews the TAC decisions applied to both of these stocks in 2002 and 2003 in order to test the actual applications of practising precaution. In carrying out this analysis, it should be noted that the impacts on practicing precaution in the case of cod and haddock along the Scotia Shelf and in the Bay of Fundy will not take account of the following items:

• The changed mandate of the FRCC after 2003 and the impact on the TAC decision process post 2004;

• The apparent ecosystem shift in the Northwest Atlantic and its movement away from lower-valued groundfish (cod, haddock, and pollock) into an ecosystem that is comprised of higher-valued invertebrates (lobster, shrimp, and crab);

• The DFO mandate shift into managing whole ecosystems and oceans management, while all the time shifting out of stock-by-stock assessment analyses.


II. CASE STUDY II.A. Setting TACs in the 4X5Y cod and haddock fisheries: Background

The cod and haddock stocks of southwest Nova Scotia and the Bay of Fundy were two of the only groundfish stocks in the Northwest Atlantic that survived without a moratorium during the early 1990s. Commercial fishing continued uninterrupted, albeit at reduced restricted levels. These two groundfish species share the same ecosystems and habitat areas and are fished by similar gear - mainly the less than 65’ mobile trawlers (draggers) and fixed gear, handlines and gillnets. However, their current resource status history is quite different. For the past decade, the haddock stock in this management area has been steadily growing, while the cod stock has been either stable or declining despite measures thought to ensure higher stock growth. While measures in place to protect one stock also protect the other, it is unclear why one stock (haddock) has in recent years taken advantage of a more restrictive management regime to grow, while cod seem less likely able to rebound from an historically depressed state of abundance. The Stock Status Reports for these two complementary stocks provide background information as noted below (DFO 2003ab, 2002ab). II.A.1a. The 4X5Y Cod Stock Atlantic cod (Gadus morhua) is a bottom dwelling fish occurring on both sides of the North Atlantic. In the Canadian Atlantic, cod range from northern Georges Bank to northern Labrador. There are several concentrations of cod within this range, including those on the southern Scotian Shelf and Bay of Fundy (NAFO Division 4X and Canadian portions of 5Y - see also Figure 1 below). Cod in this area reach on average 53 cm (21 inches) by age 3 years and increase to 72 cm (29 inches) by age 5 and 110 cm (43 inches) by age 10. Growth rates, however, vary among cod in this area with more rapid growth noted in the Bay of Fundy. Age at first reproduction generally occurs at 3 years and individuals tend to spawn several batches of eggs during a single spawning period. Cod has supported a commercial fishery in this area since the 1700s and until the 1960s was primarily an inshore fishery. Following extension of jurisdiction to 200 miles by coastal states in 1977, only Canada has made substantial landings of cod from this area. Minimum mesh size and hook size regulations have been enacted to reduce the catch of juvenile cod. Closure of Browns Bank is in place from 1 February-15 June. Average landings of 4X5Y cod were over 20,000t from 1950 to 1990 when catches fell to less than 10,000t. From 2000-2004, the TAC was 6,000t but in 2003, only 5,600t were caught, the lowest annual catch of cod in this area on record (DFO 2003a). II.A.1b. The 4X5Y Haddock Stock Haddock (Melanogrammus aeglefinus) are found on both sides of the North Atlantic. In the west Atlantic, they occur from southwest Greenland to Cape Hatteras. A major stock exists in the southern Scotian Shelf and Bay of Fundy area in NAFO Divisions 4X and Canadian portions of


5Y (Fig 1). This bottom-dwelling species is a member of the cod family and feeds mainly on small invertebrates. Haddock in the Bay of Fundy grow more rapidly than those on the southern

Fig 1. NAFO Fishery Divisions of the Northwest Atlantic including 4X5Y


Scotian Shelf. Approximately 50% of female haddock are mature by age 3; however the number of eggs produced by a female of this age is low and increases dramatically with age. Browns Bank is the major spawning area for the stock and peak spawning occurs in April/May. Reported annual landings have been as high as 43,000t and the long-term average is about 18,000t. Landings have been below 11,000t since 1988. Historically this fishery has been dominated by mobile gear except during 1990-93 when the proportion of landings taken by fixed gear was greater. Quotas for this stock were introduced in 1970 and a spawning season/area closure has been in place since that time. In 2003, the TAC was 10,000t - the highest TAC since 1990. Haddock are caught together with cod in the fishery in 4X5Y (DFO 2003b). II.A.2. Management Issues Cod and haddock are captured together in the mixed fishery of 4X5Y together with pollock and flatfish, white hake, Atlantic halibut, cusk, and monkfish. Bycatches in this fishery is a particular concern, e.g., cusk is designated as “threatened” by the Committee on the Status of Endangered Wildlife in Canada (COSEWIC) (see also http://www.cosewic.ca/). Mobile gear is more successful in avoiding cod in the targeted haddock fishery whereas the ratio of cod and haddock in the fixed gear fisheries are closer to 50-50 by proportion. Avoiding cod while targeting haddock is a particular management concern. Part of this is due to the understanding in the fixed gear fishery that cod are more attracted to the hook than are haddock. In recent years as the abundance of haddock has increased and that of cod has not, cod has become a non-targeted bycatch in a directed fishery for the more highly valued haddock catch. Bycatch of cod has been a continuing concern for the haddock fishery as the stocks continue to move in opposite directions. Actual fishing mortality of cod and haddock have remained uncertain due to incidences of discarding, especially of cod in recent years. Only a small proportion of trips landing cod and haddock in 4X5Y are observed and monitored. Both cod and haddock are subject to fishing regulations with respect to small fish protocols and mesh size used by gillnets and otter trawls. II.A.3. Stock Prognoses The current position and consequently the outlook for the cod and haddock stocks vary. Figure 2 gives the time series profile of cod abundance estimates and annual catches since 1970 through to 2002. Cod has experienced a small increase in estimated biomass since 1999 however, the year-over-year increases are small and fishing mortality estimates remain high despite restrictive quotas since the mid-1990s. Biomass estimates are still near historic lows relative to the high period of the late 1970s and early 1980s and recruitment levels have been low throughout the 90s (with the sole exception of 1993). Longer-term increases in cod biomass are dependent on reductions in the mortality rate. Finally, relative to biomass thresholds, recent estimates indicate that the stock is not yet achieving its targets (DFO 2003a).


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Fig 2. 4X5Y Cod Stock Status Report Data to 2002 In contrast to cod, the estimates from the haddock stock are highly optimistic (Fig 3). This stock is estimated to be growing since 1990 and it has lately achieved levels near the high estimates of the late 1970s and early 1980s. Fishing mortality has been low and falling thanks to holding the line on annual catches and recruitment levels have been at historic high levels. Estimates in recent years have exceeded the stock thresholds. The outlook for this stock is positive but guarded with concern for the impact of slow growth among the spawning stock (ages 4+ years), future years of average recruitment or below, and the mixed fishery with cod in 4X5Y (DFO 2003b).

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2002Recruits Canada Total 2002VPA Total Biomass 2002VPA SSB Ages 4+TAC Biomass Limit SSB Target Catch Limit

Fig 3. 4X5Y Haddock Stock Status Report Data to 2002


The prognoses of the stocks for 2002 and 2003 by the FRCC refer to stock targets previously established for cod and on fishing practices in the mixed cod-haddock fishery. In 2002, the FRCC report on cod noted the continuation of the third year of the three year plan at constant exploitation of 6,000t for 4X5Y cod. Then in 2003, the FRCC reported on the earlier obligations and long-term conservation criteria for continued exploitation of this stock after the 3 years were up. The FRCC’s cod outlook implicates DFO Science and Fisheries Management to deal with poor fishing practices and to respond to commitments about attaining stock threshold limits at the end of the 3 year period. Recommendations made to the Minister on cod imply that there had been no effective response to the earlier commitments but that a response should be forthcoming based on the stock status estimates and that the consequences of the estimates be recognized in terms of the anticipated response. In contrast, the FRCC was optimistic with respect to the status and outlook of the haddock stock and after recommending a continuation of low level haddock exploitation in 2002, they recommended an increase from 8,100t in 2002 to 10,000t in 2003. The following section critiques the application of PP and PAM in the determination of stock status and outlooks for these two stocks. II.B. Definitions and the use of principles: PP and PAM The general definition of “precaution” as a mode of action and interpretation for DFO stock assessments are arguably provided in the overarching Framework for the Application of Precaution in Science-based Decision Making about Risk produced by the Privy Council Office (Canada 2005). However, in the case of Stock Status Report development, it is understood that the process of peer scientific review, the established methodology of data collection and numerical Virtual Population Analyses (VPA), and the routine of the consultative and ultimate decision making process effectively embody the precautionary principles outlined in the framework. Given the prior existence of the stock assessment process, it is noteworthy however that reference to “serious or irreversible damage”, “scientific certainty” (or lack of it), or “weight of evidence” are not referred to in the production of SSRs for cod and haddock as would be expected in the course of decision analyses involving PP. Inasmuch as the SSRs are not so much recommendations as “advice”, it is tacitly recognized that the authority for making actual TAC decisions are not publicly within the purview of fisheries science. Rather, SSRs and associated fisheries stock assessments are provided as information documents to be used in support of ultimate decision making. Thus, it is understood that it is not appropriate for SSRs to recommend specific decisions regarding TACs for stocks, but rather to analyse standard TAC options, e.g., such as a TAC determined from the F0.1 standard (that in the 1980s was the single determinant for groundfish stocks TACs based on the VPA assessments), or TAC values near the ‘status quo’ or current harvest levels. The analysis of these alternatives are generally presented in the SSRs to provide a range of decision making alternatives along with their projections on stock estimates after one year. In terms of the use of principles in PP and PAM, the SSRs employ two primary analyses used to indicate the extent of data uncertainty in the calculation of model estimates. These analyses focus on the application of the Virtual Population Analysis stock assessment model.


This population model provides the basis for the exploitation rate applied to the estimated population that determines the TAC decision. The first analysis examines the fit of the VPA model to the data (“retrospective analysis”), and the second incorporates the data variability with the impact on the range of TAC values under expected exploitation rates (“risk analysis”). II.B.1 Retrospective Analysis The appropriateness of the VPA model for stock abundance estimation is critical to the development of the TAC decision. The use of the VPA is argued from model performance measures referred to as “retrospective analysis”. The retrospective analyses examine the year-over-year adjustments to the age aggregated abundance estimates. When differences are observed to be consistent over several annual time periods, e.g., the abundance estimates of year t in year t-1, turn out to be higher than the year t estimates in year t and year t+1, etc., then the model is said to exhibit an overestimation bias. Trends of this kind are an indication to decision makers that estimates in the current year may in fact be overestimates that should be expected to be adjusted downward in future years. For example, the 2002 and 2003 haddock stock VPA estimates tend to exhibit a “retrospective pattern” whereby biomass estimates tend toward over-estimation of population abundance in the most recent year, particularly when strong year classes occur - as has been the case for the recent period in this stock and the high recruitment of 1999 to 2001 (Fig 3). The cod SSR in 2002 also reports a “marked” retrospective problem that had existed in the estimates for this stock since 1998. For cod, population estimates for a given year decline and fishing mortality estimates increase as additional years of data are included, e.g., the 2000 estimate of cod in 2000 exceeded the 2000 estimates that were made in 2001, 2002, etc. (There was no VPA estimate for 4X5Y cod in the 2003 SSR for this stock.) Information of this type is provided without commentary to decision makers as a means of substantiating arguments for or against relative change in the ‘status quo’, or current exploitation rates. II.B.2 Risk Analysis In terms of actual use of methods for PP analysis, the SSRs for cod and haddock also typically include what is called a “risk analysis”. This is actually a calculation based on the variability of the least square fit of the VPA model to the catch at age data. The “risk” information is presented as a probability that a given TAC decision will (or will not) exceed an expected exploitation benchmark rate (e.g., the F0.1 standard). The variability follows from the variance in the catch at age data (from commercial and research vessel data) assuming normal errors, and relative to the appropriateness of the VPA model. It is noted that

“Other uncertainties not considered in this risk analysis include errors in the model assumptions, changes in fishing practices, and environmental effects on survivorship.” (DFO 2003b, p.10)

The probability assessment graphic is used to interpret how data variability associated with the fit of the VPA stock assessment model brackets the 1-year forecasts for cod and haddock. Thus, assuming high variability in the fit of data to the VPA model, the wider the distribution of the stock abundance estimates, and the higher the probability that the standard fishing mortality rate,


F0.1, used as the benchmark rate, may be exceeded by lower TAC values. The decision maker’s level of risk is interpreted as accepting (or rejecting) a TAC when it is projected to imply that there is a probability p that the selected TAC may exceed the benchmark fishing mortality rate. These “risk analysis” results require the estimation of the stock abundance via VPA or a surplus production model population abundance estimates. (For the case of cod and haddock in 4X5Y, the VPA is the accepted estimation method.) The risk analyses for haddock in the 2002 and 2003 SSRs exhibit relatively steep curves for TAC versus the probability of exceeding F0.1. This would indicate that the VPA estimates provided are relatively robust to estimation error for abundance. The message implied is that decision makers can be relatively confident about not exceeding the F0.1 benchmark assuming the selected TAC is at levels below the 50% probability (the expected value) that F0.1 is exceeded. For cod, risk analyses were not provided in either 2002 or 2003 SSRs. In 2002, it was reported that:

“Projections and risk analyses of the consequences of alternate TAC’s (total allowable catch) cannot be provided for situations with pronounced retrospective patterns suspected to be caused by substantial problems with reported catch.” (DFO 2003a, p.7)

No VPA for the 2003 cod SSR means that no “risk analysis” was provided in that year. Implicitly, the lack of analysis indicates that TAC options for cod would be considered precautionary at lower values, ceteris paribus, in order to ensure higher probability that the benchmark exploitation rates would not be exceeded. Finally, as noted previously, the SSRs also point out “sources of uncertainty” but do not attempt to quantify these in relation to how they might be expected to impact stock status and outlook. The recommendations for TACs to the Minister by the FRCC do not place their information in the context of what is assumed to be known or what is assumed to be uncertain. Rather, the FRCC recommendations attempt to present alternatives that encapsulate all sources of uncertainty (“weight of evidence”) that stems from subjective interpretation of feedback from all the stock data (pro and con) and from all participants in the process. As noted above, the FRCC recommendations reports do not apply any formal analysis or calculate special indicators of precaution. The FRCC reports do provide a textual summary of various stock indicators taken from the SSRs.

II.C. The practice of precaution: Gaps between theory and practice

As noted previously, the “theory” and application of precaution in TAC decision making are provided in the Framework for the Application of Precaution in Science-based Decision Making about Risk produced by the Privy Council Office (Canada 2005). Specifically, science-based analysis of precaution is applied in the analyses of the SSRs discussed above for cod and haddock. For 2002 and 2003, the science-based SSR was used to develop the FRCC’s recommendations according to the processes described in Section I.B and I.C above. This section discusses the actual practice of operationalizing precaution for the case of 4X5Y cod and haddock in 2002 and 2003.


II.C.1a. 4X5Y Haddock in 2002 In 2002, the SSR for haddock indicated strong year classes were entering the fishery (high “recruitment”) and fishermen were reporting high haddock availability. Moreover, the haddock stock had reached the biomass and abundance targets that had been indicated by DFO Science in the Maritimes Region (in conjunction with the 3-year cod and haddock strategy inaugurated in 1999). Nevertheless, there was some concern for: (i) the haddock overestimation bias of the large expected recruiting year class; (ii) reports of discarding in 4X5Y in the mixed cod and haddock fishery; and (iii) the ongoing precarious nature of the cod stock and the completion of the 3-year fixed TAC strategy for cod in 2003. While the 2002 haddock SSR indicated that more haddock than the status quo of 8,100t could be taken without jeopardizing concerns for maintaining low fishing mortality rates, there was clear concern, especially due to the mixed fishery with cod (and the fear that any increase in the haddock TAC would mean more cod would be caught and perhaps discarded), that an increase in the haddock TAC would be difficult to manage. Neither the retrospective analysis nor the optimistic risk analysis indicated a more precautious approach compared with the status quo TAC. Rather, sources of uncertainty and a more precautious “tone” in the SSR left the interpretation that a range of TACs may be appropriate between the status quo TAC level of 8,100t and an increase to approximately 10,000t. (See also Table 1 - Stock Status Report for Haddock – 2002, Pros and Cons by Text Heading.) The FRCC in its report for 2002, adopted the view that it would be premature to increase the haddock TAC. They were particularly concerned about the variability in recruitment, the need to protect the recruiting year classes, discards in the mixed haddock fishery with cod, and the desire to continue the upturn in stock growth. In the end, the FRCC made the recommendation for a continuation of the 8,100t in the 2002 fishery. In its analysis, the FRCC considered the optimistic stock estimates for haddock in the SSR along with the concerns raised about discards both in the SSR as well as in its consultations with industry, and the negative potential implications of increasing the haddock TAC while maintaining the cod TAC at its current level as part of the 3-year continuing plan. Table 1. Stock Status Report for Haddock – 2002, Pros and Cons by Text Heading Heading Reported Text - Pros Cons The Fishery Reported Landings:

Landings in the first quarter high due to the ability to direct for Haddock with a minimal bycatch of Cod at that time of the year. The proportion of catches from 4Xn and 4Xp increased. Mean Weights at age: The age 5 weight at age is very high similar to 1970s.

Mean Weights at age: 7 and older are very low.

Industry Perspective

Abundance has been good throughout the stock area. Discarding and misreporting are minimal.

Catches of small fish have been prevalent.

Resource Status

Abundance of ages 4+: Above long term average (RV Survey). Highest observed according to ITQ survey.

Many ages are below the long term mean length and weight and some are at the smallest size.


Age Structure: All ages were above average. Recruitment: RV Survey – 1998 yearclass is the largest and 1999 yearclass is third largest. ITQ Survey – 1998 yearclass is the largest and 1999 yearclass is the second largest Area occupied by Haddock 43cm and greater in length is high and local density is about average. Area occupied and local density by Haddock 26-42cm in length is at the highest level according to RV survey. Growth rate is stabilizing. Total mortality is stable for ages 5-7. Spawning stock biomass will increase due to average 1997 and large 1998 yearclass.

Fish condition (Fulton’s K) has reached a minimum in 2002. Poor condition reflects low productivity. Exploitation rate on older ages are high.

Sources of Uncertainty

Biomass estimates exhibit a consistent pattern of over estimation of population abundance.

Outlook Indicators of Abundance: above average value for 2002. Indicators of Recruitment: 1998 yearclass is the strongest. Indicators of Distribution: Fish at lengths that approximate the spawning stock are near the widest area occupied and local density is about average. The area occupied by fish at lengths that approximate recruits is at the widest observed and local density is also at the highest. Indicators of Mortality: Low. Spawning stock biomass is currently near historically high levels.

Indicators of Production: Are at or near the lowest levels observed. Spawners exhibit: Low growth rate Below average size at age Lower condition.

II.C.1b. 4X5Y Cod in 2002 The SSR for cod in 2002 was overall not optimistic. Of particular concern in this year were the reports of extensive discarding of cod in order to avoid overshooting quotas on cod (6,000t versus 8,100t for haddock) in a year in which haddock were more available, but cod were nevertheless more easily caught. In the second year of the 3-year constant 6,000t strategy for cod, although not referred to in the SSR, estimates from the VPA did not indicate that the stock targets would be met by 2003 as originally expected. It was understood that the 6,000t TAC would remain in effect, as previously ordained by the Minister for the 2000-2002 seasons. (See also Table 2 - Stock Status Report for Cod – 2002, Pros and Cons by Text Heading.) The FRCC recommendations for the stock reflected the more pessimistic view of the stock prognosis and called for further vessel monitoring to ensure improved compliance, and increased tagging studies to understand stock dynamics, migration patterns, and spawning locations. There was concern by the FRCC that at the current exploitation rate of the plan (6,000t), the stock targets would not be met by the end of the planning period in 2003.


Table 2. Stock Status Report for Cod – 2002, Pros and Cons by Text Heading Heading Reported Text - Pros Cons The Fishery Landings:

Quota has been held at 6000t as part of a rebuilding strategy for 4X cod. Fishing improved in deeper water. Catch rates for Otter trawlers and Gillnet catch rates have increased. 1998 yearclass dominated the landings of 4X cod.

Winter landings of Cod taken as a by-catch have increased. Fishing in inshore areas of 4Xo was poor with fishermen having to travel further offshore. Fishing is reported to have been poor in most coastal areas. The number of vessels active in the fishery in 4X continues to decline. The contributions from ages 6 and over were below average.


Mobile gear and fixed gear fishermen indicated that cod abundance has increased.

Low cod quota is leading to discarding and unreported landing. Amount of cod recorded in landing data may be significantly less than is killed in the fishery in some areas.

Resource Status

The catch per tow of cod aged 3 and over increased to above the median in 4X (RV survey). Catches were above the median at all lengths in the Bay of Fundy. Recruitment: 1998,1999 and 2000 yearclasses are double the size of the 5 preceding yearclasses. 2001 yearclass is positive with above average catches in both the RV and ITQ surveys. Fish condition is currently above average for cod in 4X. Total mortality for ages 2 and 3 has followed a declining trend. Exploitation rate has declined. Population biomass increased from 2001 to 2002 due to contributions from the 1998 and 1999 yearclasses. Age Structure: Although low since 1992, this has increased in 2001. Surplus production: Although declined to a historically low number throughout 1990s, this number has increased due to improved recruitment.

Catches were below the median at lengths less than 75cm on the Scotian Shelf. ITQ survey catch declined in 2002. Recruitment: Below average since 1992 yearclass. Area occupied is low for 2002 according to RV survey. Local density has declined to levels similar to those in the 1970s. Total mortality is high despite the reductions in reported landings.(RV survey).



Principal source of uncertainty is the actual removals in each year. Discarding and underreporting vary from year to year due to stock condition and fishermen’s perceived incentives and risks. There is additional mortality of 4X cod beyond what is accounted for in the data used in the analysis.

Outlook Indicators of Recruitment: Has improved for the 1998 and later year classes. The area occupied by fish at lengths that approximate recruits has decreased but still above the long term average and local density is high. Indicators of Mortality: Relative mortality has declined in recent years. Indicators of Production: Growth rate and condition remains good. Surplus production has been low however, has increased due to improved recruitment. Increase in biomass is likely in the short term due to improved levels of recruitment. Stock rebuilding is only possible if mortality rate is reduced.

Indicators of Abundance: Indicate that the abundance has been low. (however, has shown improvements). Indicators of Distribution: Local density and area occupied has declined and are now low. Indicators of Mortality: Generally high reflecting unreported fishing mortality. Restrictive quotas have not been effective at reducing total mortality.

II.C.1c. Actual Decisions in 2002 In 2002, the Minister of Fisheries and Oceans decided that the ‘status quo’ would be applied to the cod and haddock TACs at 6,000t and 8,100t respectively (same TACs as in 2001). The cod TAC was predetermined for the third year of the 3-year constant TAC plan, whereas the haddock TAC was maintained in an attempt to stabilize the mixed fishery to the end of the 3-year plan. II.C.2a. 4X5Y Haddock in 2003 In 2003, the SSR for haddock and the updated haddock VPA confirmed again the presence of strong year classes entering the fishery. While the SSR for haddock repeated the concerns for the retrospective analysis and the sources of uncertainty, the message was nevertheless optimistic for the prognosis of this stock. (See also Table 3 - Stock Status Report for Haddock – 2003, Pros and Cons by Text Heading.) The FRCC report was similarly optimistic for haddock at this, the end of the 3-year plan, and an increase in the TAC was recommended to 10,000t. The FRCC also recommended close monitoring for compliance in the mixed cod and haddock fishery and protection of the small fish of the recruiting year classes.


Table 3. Stock Status Report for Haddock – 2003, Pros and Cons by Text Heading Heading Reported Text - Pros Cons The Fishery Reported Landing:

The proportion of catches from 4Xn and 4Xp increased. Mean Weights at age: The age 5 and younger weights at age is very high similar to 1970s.

This fishing year is progressing more slowly than the last year. Proportion of small (<43cm) fish in the catch has increased. Mean Weights at age: Ages 7 and older are very low.


Abundance has been good throughout the stock area. Discarding and misreporting are minimal.

Resource Status

Abundance of ages 4+: Very high levels are observed similar to the levels observed in late 1970s (RV Survey). Highest observed according to ITQ survey. Recruitment: RV Survey – 1998 yearclass is the largest and 1999 yearclass is third largest. ITQ Survey – 1998 yearclass is the largest and 1999 yearclass is the second largest. Area occupied by Haddock 43cm and greater in length is near the high levels. Area occupied and local density by Haddock 26-42cm in length, although decreased, still at above the long term average and local density is near the highest levels according to RV survey. Total mortality is relatively stable for ages 5-7. Relative fishing mortality is also stable. Spawning stock biomass increases to 67000t in 2003.

Age Structure: Decreased by one age from 2002. Mean lengths at age: Has decreased particularly at older ages. Mean Weights at age: Most ages are below the long term average length and weight. Many are at or near the smallest size. (However, trend is stabilizing). Growth rate shows a long term decreasing trend. (However, has stabilized in the last few years). Fish condition (Fulton’s K) has shown a decreasing trend. Exploitation rate on older ages remain high at about 20%.

Management Considerations

Bycatch of Cod is a concern

Ecosystem Considerations

Reviews of comprehensive biophysical data should be undertaken to gain greater understanding of the relationship between fish and the environment in which they live.

Fishing gears can have negative physical impacts on the sea floor, reducing epi-fauna and flora and damaging or modifying fish and invertebrate habitat.


The biomass estimates exhibit a general tendency of over


estimation of population abundance. Strong yearclasses may be overestimated by a factor 2.

Outlook Indicators of Abundance: Indicate that value for 2003 is near the high levels observed (similar to late 1970s). Indicators of Recruitment: 1998 yearclass is the strongest, 1999 is very strong, 2000 above average and 2001 below average. Indicators of Distribution: Fish at lengths that approximate the spawning stock are near the widest area occupied. The area occupied by fish at lengths that approximate recruits has decreased but still above the long term average and local density is high. Indicators of Mortality: Low.

Indicators of Production: Are at or near the lowest levels observed (However, shows signs of stability).

II.C.2b. 4X5Y Cod in 2003 The 2003 SSR for cod contained a number of anomalies. In particular, it was decided that there would be no VPA analysis in this year (in spite of the fact that data were available similar to that used to carry out the 2003 haddock VPA that was completed) and, there was no scientific analysis or references to the stock targets required for the continuation of the commercial fishery at the end of the 3-year plan. These anomalies made it difficult to analyse and compare the stock status from the previous year with the current subjective view of the stock. The SSR for cod in 2003 concluded that:

“Overall biomass has not increased since 1999, when the quota was reduced to 6,000t to promote recovery; therefore an increase in quota above 6000t is not supported.” (DFO 2003a, p.8)

For details of the SSR on cod in 2003, see also below Table 4 - Stock Status Report for Cod – 2003, Pros and Cons by Text Heading. The FRCC report on this stock in 2003 was generally critical of the loss of information in the cod SSR and its lack of reference to the stock targets from the 3-year plan. (In the 3-year plan established in 1999 for 2000-2003, the Minister stated that a key element was the establishment of a rebuilding objective of the spawning stock biomass of 40,000t by 2003. The announcement of the plan also stated that should the target not be met, reductions in catch or complete closure of the fishery would be implemented in subsequent years, FRCC 2003a). The FRCC felt that the subjective view of the stock provided in the SSR (without the usual VPA estimates) permitted the continuation of the status quo without the backing of usual scientific data and analysis, and


without the reference to the required targets of the 3-year plan. (The 3-year plan was inaugurated by a different Minister who was no longer DFO minister when the plan terminated and the target review was expected.) Furthermore, it was alleged that a more thorough analysis of the cod stock might not permit a status quo TAC that would be required to support an expected increase in the haddock TAC. The FRCC called for:

“…a system to ensure that total removals do not exceed 6,000t in 2003/2004. No directed fishery should be allowed until a satisfactory system has been approved and implemented. If the Council concludes that the situation has not been satisfactorily remedied, it will advise that the fishery be substantially reduced.” (FRCC 2003a, p.19)

At the same time, although the FRCC did not recommend a TAC for cod, it continued to call for a system to ensure compliance, more monitoring, and for a cod tagging program. Table 4. Stock Status Report for Cod – 2003, Pros and Cons by Text Heading Heading Reported Text - Pros Cons The Fishery Landings: Quota has been held at 6000t as

part of a rebuilding strategy for 4X cod. Fishing effort is stable for Otter trawl, longline and gillnet. 1998 and 1999 year classes dominated the landings of 4X cod. Age range in the fishery shows some expansion, with the 1996 year class at age 7. No reports of discarding.

Winter landings of Cod taken as a by-catch have increased. Fishing was poor in most coastal areas. Handline effort, once significant part of the fishery, continues to decline. Discarding of cod in the flat fish fishery may be a problem (Cod bycatch is difficult to avoid) isn’t this contradicting?

Resource Status

RV survey index for the Bay of Fundy is above the median. ITQ survey: Length frequencies were similar to the median in the Bay of Fundy and on the Scotian Shelf, were well above the median from 28-49cm. 2003 catches were at or above the median at most lengths in the Bay of Fundy (RV). Recruitment: Catch at age 2 has improved in the Bay of Fundy according to both RV and ITQ surveys. ITQ survey indicates recruitment in 2000-2003 is roughly double the previous 4 years. RV catch of the 2001 yearclass in the Bay of Fundy at age 2 in 2003 is above the median. Length at age and fish condition is currently

Index below the median on the Scotian Shelf. Very low for lengths >28cm on the Scotian Shelf (RV) Recruitment: On the Scotian Shelf, RV survey catch at age 2 has been uniformly low. Area occupied has declined on the Scotian Shelf according to RV survey. According to ITQ, area occupied has a declining trend since 1998 for the Scotian Self. SPA indicates high level of unaccounted mortality, highest on fishable ages which would be consistent with a high level of


above average for cod in 4X. Area occupied remains about average in the Bay of Fundy. (RV survey) Relative fishing mortality has declined. Stable biomass index.

discarding or unreported landings in the past years.(reliable interpretation of SPA results cannot be made without resolving these issues)


Should use areas where high ratios of haddock to cod may be caught to minimize cod bycatch when directing for haddock.

Half of cod landings came from trips where cod was not the main species: potential impacts on cod should therefore be considered in managing other groundfish. The ability to target haddock while keeping cod catch low is a concern.


Fishing gears can have negative physical impacts on the sea floor, reducing epi-fauna and flora and damaging or modifying fish and invertebrate habitat. Reduced growth. Species show sexual maturity at small ages. Implies a significant loss in potential yield relative to historical catches.


Principal source of uncertainty is the actual removals in each year. Discarding and underreporting vary from year to year due to stock condition and fishermen’s perceived incentives and risks.

Outlook Biomass remains about average in the Bay of Fundy. Indicators of Recruitment: Bay of Fundy has improved starting with 1998 yearclass. 2000-2003 is roughly double the previous years according to ITQ survey. Area occupies remains about average on the Bay of Fundy. A gradual increase in biomass for 4X cod in the short term can be anticipated due to improvements in recruitments following the 1997 yearclass, if fishery catches are kept to 6000t.

Overall biomass has not increased since 1999. Decline in cod abundance on the Scotian Shelf. RV survey catch at age 2 is low since 1995 on the Scotian Shelf. Area occupied has declined on the Scotian Shelf.


II.C. 2c. Actual Decisions 2003 In 2003, the Minister of Fisheries and Oceans adopted the FRCC recommendations for haddock and increased the haddock TAC to 10,000t. The Minister allocated the status quo harvest of 6,000t to cod for 2003. The case of cod and haddock in 2002 and 2003 provides an interesting contrast for the actual application of precautionary decision making. On one hand, the decision to restrict the increase in the haddock TAC in 2002 could be viewed as a precautionary decision with respect to the stock of cod and haddock in the mixed fishery. However, the 2003 decision to allocate 6,000t to cod without the usual suite of information and without deference to an earlier Minister’s instructions re targets that were not attained for this stock, could be seen as being particularly risk-seeking and not at all precautionary. In any case, logical defence of these decisions as legitimate, precautionary decisions need to be considered in the wider context of the following points:

• the use of flexible and selective scientific information that could be interpreted variously;

• the avoidance of established targets and objectives with repercussions that had existed as part of agreed to strategies;

• the impact of lobbying the Minister by commercial fishermen; • the impact of other unspecified goals, e.g., socioeconomic impacts, and the need to

be precautionary with respect to these goals (as well as the goals of resource sustainability);

• the potential conflict among science, industry, communities, management, and conservation groups regarding an acceptable means of using and interpreting data.

III. FINDINGS/IMPRESSIONS The following paragraphs present a discussion of the practice of precaution for the case of the fisheries in general and of the 4X5Y cod and haddock fisheries in particular. III.A. Presence of PP and PAM

As noted previously, “precaution” is a prominent element of fisheries TAC decision making especially following the demise of the 2J3KL Newfoundland and Labrador Northern cod stock in 1992. PP and PAM appear under the guidelines of the Framework (Canada 2005), as science-based decision support through quantitative performance indicators as well as subjective interpretation of measures that are provided as additional information for ultimate decision makers. PP and PAM are definitely present in the process of TAC decision making, as well as in the text and the analyses of the SSRs developed by fisheries scientists for the two stocks analysed here. Aspects of PP and PAM appear as well in the more holistic FRCC recommendations built on the science-based SSRs as well as from other fisheries system information. For the FRCC, PP and PAM concepts are subjective and recommendations are


constructed on the basis of the weight of evidence across many factors in the fishery. The following presents a general perception of the SSR and FRCC documents for 2002 and 2003. III.A.1a. 2002 and 2003 SSRs for Cod It is somewhat difficult to follow the report from 2002 to 2003 since the same format was not followed in each of the reports. This was the result of no VPA formulation in 2003. Most graphs that appeared in 2002 were therefore missing in the 2003 SSR. In 2003, most of the information was given separately for the Bay of Fundy and the Scotian Shelf, which was not consistent with 2002 thus making it difficult to make comparisons. Appendix A – Stock Status Reports Content presents a comparison of the content of the 2002 versus the 2003 SSR for cod and haddock. Appendix B – 2002 and 2003 Documents Linkages compare the year-over-year content of the SSR and FRCC reports for cod and haddock Accordingly, 2003 SSR did not report catch rates. It is stated that catch rates have limited information value regarding Cod abundance due to changes in fishing patterns and impact of management measures. If such is the case, this change could have been demonstrated using the data in order to show the potential distortion from the real picture. Most confusing information was on discarding and unreported landings. Different stakeholders reported contradicting information. For instance “Fishermen claimed that the anecdotal reports of dumping, discarding and unreported landings were not as widespread as indicated in the SSR.” This statement leaves the reader uncertain about the real state of affairs. In the 2002 SSR, it was stated that “Traffic Light Analysis was considered to be a premier tool for implementation of a precautionary management network”. If such was the case, it is puzzling why such a “premier tool” was not presented in the following year. Up to and including year 2002, biomass was considered to be 4+. The sudden change to 3+ in year 2003 was not consistent with the previous years. It could be construed that this change was made to improve the presented state of cod and therefore to misrepresent the potential real state of cod in 4X5Y. The Outlook for 2003 is a gradual increase in biomass for 4X Cod in the short term due to improvements in recruitment. However, the reader may be pessimistic given the reported discarding and unreported landings to be a bigger problem than mentioned in these reports and it maybe therefore anticipated that the increase in biomass might not be achieved. III.A.1b. 2002 and 2003 SSRs for Haddock The haddock SSR were easily compared between the two years since the same format was followed for each year. As for cod, however, it was also stated in the 2002 haddock SSR that “Traffic Light Analysis was considered to be a premier tool for implementation of a precautionary management network”, yet this tool was not used in the following year’s SSR for this stock. The Outlook is very optimistic for all the indicators except the production indicator. Since there were no changes made to distort the reality with regard to this stock and due to the consistency between the two years, the tone of the reader is confident that the targets will be achieved for haddock. (See also Appendices A and B for year-over-year content and linkages in the SSRs reports for haddock.)


III.A.2a. 2002/2003 and 2003/2004 FRCC Recommendations for Cod Since the FRCC report includes a summary of the cod SSR, it is clear that changes have been made as per the SSR from years 2002/2003 to 2003/2004. One of the interim stock objectives is to rebuild the commercial cod stock. According to 2002/2003 report, spawning stock biomass is indicated to be ages 4+ and the following year no age specification for the spawning stock biomass is noted. It is confusing why this change was made since there is no reason given and it could be construed that this may have been done in order to avoid year-over-year comparison, or to show improvement in the stock status indicators and estimates. As in SSR, the FRCC reports of dumping, discarding and unreported landings were confusing and contradicting due to diverse statements from stakeholders. The FRCC recommendations do not report on progress (or lack thereof) with respect to the previous non-TAC recommendations, e.g., to develop increased monitoring or to apply stock tagging programs. It would be consistent with PP and PAM approaches to provide follow up in subsequent years as to whether the FRCC recommendations are being considered by DFO in practice. In this case, the FRCC repeats the same recommendation in both years without an update or a follow up. The FRCC report on cod stock targets with an overall indicator of spawning stock biomass (SSB). It is noted in the FRCC reports that the SSB target for cod was adjusted from 40,000t SSB by 2003 to >45,000t SSB by 2006. This adjustment indirectly confirms that the stock rebuilding was not close to what was initially anticipated in the 3-year plan stock objectives. The report gives the impression that stock rebuilding is further affected by discarding and unreported landings. Thus, it would appear clear that in order to rebuild this stock, the preventative measures continually recommended by the FRCC including increased observer coverage to reduce discarding etc., are required. (See also Appendices A and B for year-over-year content and linkages in the FRCC reports for cod.) III.A.2b. 2002/2003 and 2003/2004 FRCC Recommendations for Haddock As for the haddock SSRs, these FRCC reports are very consistent and follow the same format in each year. A precautionary perspective of an increase in the TAC for haddock presents risks to the population of haddock as well as to the cod stock and any increase in haddock needs to be considered for its impact on cod I the mixed fishery. Further scientific information of joint fishing practices would appear to be very important in this case. The haddock Outlook is very positive and the tone is one of confidence that stock objectives will be achieved for this stock. (See also Appendices A and B for year-over-year content and linkages in the FRCC reports for haddock.)

III.B. Interpretation and application of PP and PAM

While PP/PAM are present in the TAC setting procedures for cod and haddock, as noted above, their interpretation and application are quite different for these two stocks. Arguably, the decision for maintaining the TAC on haddock in 2002 at 8,100t was a “precautionary” decision that delayed the expected increase in the TAC to 10,000t by one year in order to realize the


expected growth in the stock, and to coordinate with the stability attached to the 3-year plan related to cod. In the case of cod however, whether or not the TAC decision in 2003 to maintain the status quo at 6,000t that could be judged as being precautionary is difficult to affirm. This is especially due to the differences in the comparable year-over-year science information (e.g., lack of an acceptable VPA in 2003 in the SSR), and the avoidance of applicable target objectives that were expected to be applied at the end of the 3-year plan. Evidence from the cod and haddock TAC decisions in 2002 and 2003 suggest that the process for applying PP and PAM are not always consistent. As such, science information in the SSRs provided from year to year is not always the same and therefore not always easily comparable. For example, for both cod and haddock in the 2002 SSRs, “traffic light indicators” were provided to accompany an annual table of stock indicators. In 2003, these indicators were omitted from the SSRs for both stocks; in 2002 VPA results were presented for both stocks whereas in 2003, only the VPA for the haddock stock was provided; similarly, risk analyses were presented for both stocks in the 2002 SSRs, but no cod risk analysis was provided for 2003. The form of the FRCC recommendations reports for cod and haddock in 2002 and 2003 are consistent. Overall, it appears from these cases, that information presented in the science-based SSRs is not required to be consistent from year to year. Moreover, the information that is presented appears to be selective with a potential bias toward supporting the continuation of the status quo. This conclusion supports the generally held notion that the SSR science-based information is not effective at detecting change in stock status until it is too late. III.C. Variation in the definition of PP and PAM

While the TAC setting process embraces a precautionary perspective, the overall application of PP and PAM for the cod and haddock stocks is comprised of quantitative indicators that are not consistently applied, and qualitative measures that imply a relatively wide range of decision options. As such, the definition of what constitutes a precautionary approach varies according to the suite of current information availability. As well, the historical and comparative perspective associated with year-over-year learning in PAM is diminished when the information sources change. III.D. Institutional changes from use of PP and PAM

In this analysis of cod and haddock TAC setting decisions, the institution is localized to the Maritimes Region of the Department of Fisheries and Oceans. Within this institutional segment, there is a degree of sharing and coordination among scientists at different biological stations. In the case of cod and haddock, the St. Andrews Biological Station has responsibility for assessing the 4X5Y cod stock, while scientists at the Bedford Institute of Oceanography are responsible for assessing the 4X5Y haddock stock. Scientists at these institutions share data and the support, in the peer review process, the application of consistent methodologies for vessel surveying, tagging, and numerical stock assessment estimation. Nevertheless, stock assessment scientists may opt to exclude certain key indicators of stock status, e.g., as was the case for no cod VPA in 2003.


It is important to note that the application of the TAC decision making process and the production of science-based SSRs for stocks also varies across regions of DFO. For example, the content of SSRs for cod stocks of Newfoundland and Labrador versus cod stocks in the Gulf of St. Lawrence versus those in the Maritimes Region of DFO all vary and are not directly comparable. Moreover, the interpretation of the management of these same species but different stocks across regions, is quite different. For example, estimates of spawning stock biomass in the Gulf of St. Lawrence at 80 thousand tonnes in 2003 led the Minister to closing this stock to all commercial fishing whereas estimates of less than 30 thousand tonnes for 4X5Y cod (Fig 3) supported a commercial fishery with a TAC of 6,000t. While it is difficult to compare regional stocks directly, the evidence points to a need for scientists throughout the institution responsible for providing information and analysis on stock status to compare and contrast their interpretations and understanding of the data to lead to consistent and precautionary results.

III.E. Evidence of administrative conflicts The process of TAC setting from the development of the science-based SSR to the consultation and holistic system approach of the FRCC recommendations is designed to avoid administrative conflicts encountered in the pre-1992 period. This process was meant to be a model of transparency and participation by all stakeholders following a period of reaction to a failed control system that arguably did not provide opportunity for full analysis and consideration of alternatives. After 1992, what changed was the DFO science stranglehold on the TAC advice to the Minister. While acknowledging the importance of science in the production of the SSRs, the opportunity to provide a critical review of the science contained in the SSR occurred through the FRCC. However, the FRCC remained a consultative body that provided recommendations. Accordingly, the Minister’s retention of the decision making authority effectively meant that he was ultimately influenced in setting TACs by his internal science and management staffers, the FRCC recommendations, as well as the lobbying of the fishing industry, and environmental NGOs. The Minister’s wide mandate as sole authority under the law, and the lack of a clear “weighting” of the resource sustainability versus the social viability versus the administrative cost of management means that the range of feasible TACs for a given stock can be defended as “precautionary” in spite of the inherent conflicts. Evidence of these inherent conflicts is presented in the parallel cases of cod and haddock in 4X5Y described above. Arguably, the presentation of the optimistic growth of haddock is qualitatively precautionary leading to no increase in exploitation in 2002 and a relatively small increase in the 2003 TAC. If these same interpretations were applied to the cod stock, then one would suspect that the SSR would not be inclined to defend the status quo exploitation rate and avoid all reference to the stock target objectives set by a previous Minister. When the FRCC attempted to act as the corporate memory for the 3-year plan, the Minister used his prerogative to decide on status quo despite evidence to the contrary. This does not imply that the Minister’s decision was not precautionary. Rather, it should be understood that precaution with respect to other dimensions of the decision took precedence over the resource sustainability dimension in this case. The fact that formal analyses for these other dimensions are not specified does not reduce the need for there full consideration, but it does confound the clarity of the basis on which the Minister’s decisions are made.


IV. RECOMMENDATIONS IV.A. Case study performance The presentation of the cod and haddock TAC decision processes for 2002 and 2003 illustrates two different applications of PP and PAM concepts in very similar contexts. In either case, cod and haddock TACs were determined and ultimately decided upon by the DFO Minister with full knowledge of the science-based stock status from SSRs, feedback from stakeholders, and system-wide recommendations from the FRCC. The two cases differed in terms of their performance with respect to stock status over 2002 and 2003, and with respect to targeted objectives at the end of the 3-year plan. The haddock stock was estimated to have achieved the stock targets (as defined in the FRCC’s Fisheries resource Conservation Plans or FRCPs) by the time of the 2003 TAC increase decision. On the other hand, the performance of the cod stock with respect to its target objectives as set out in the 3-year plan, and the cod FRCP was less than anticipated. As stated in the 2002 SSR:

“restrictive quotas for 4X cod have not been effective at reducing total mortality…Longer-term biomass increase and improvements in age structure for this stock are dependent on reductions in mortality rate.” (DFO 2002a, p.8)

Thus, the performance of the haddock stock exceeds that of the cod stock from the perspective of stock growth over the period. IV.B. Suggested improvements

The process for deciding on TAC for cod and haddock in Southwest Nova Scotia and the Bay of Fundy is similar to the process applied to groundfish stocks throughout the northwest Atlantic. A number of suggestions are made to improve on the current process, as follows:

• Standardize the minimal scientific content for stock status estimation, including calculation of stock abundance estimates and an analysis of the variability of the estimates;

• Involve stakeholders (e.g., commercial fishermen, coastal communities, environmental NGOs) in the collection of data for stock assessment processes and in the development of components of the “stock status report”, e.g., the fishing industry is assigned responsible for describing the fishery and its observations;

• Provide a unified fisheries system analysis that would link all stocks of the mixed fishery in a joint stock status analysis;

• Extend authority to fisheries stakeholders for the TAC decisions on stocks and reduce the ultimate authority of the DFO Minister for these stock-by-stock annual decisions;

• Prepare TAC decisions in the form of a strategic plan that projects exploitation by commercial interests into a longer-term outlook.


Although there is no claim to ensure growth and development in all stocks in the marine ecosystem, these suggestions are aimed at developing more structured analyses for implementing precautionary decisions on stocks’ annual TACs.


V. REFERENCES Canada 2005. A Framework for the Application of Precaution in Science-based Decision Making about Risk. Privy Council Office. http://www.pco-bcp.gc.ca/.

Clark, D., and Hinze, J. 2003. Assessment of Cod in Division 4X in 2003. Canadian Science Advisory Secretariat, CSAS Res. Doc. 2003/115. 39p.

DFO 2004a. Fisheries and Oceans Sustainable Development Strategy. Progress Report on 2001-2003 Strategy. Communications Branch, Fisheries and Oceans, Canada. DFO/2004-15.

DFO 2004b. Cod in the Southern Gulf of St. Lawrence. DFO Science Status Report. 2004/003. 6p.

DFO 2004c. Proceedings of a Maritimes Regional Advisory Process Meeting on Assessment Frameworks and Decision Rules for 4X-5Y Cod and Haddock. 10-14 June. CSAS Proceedings Series 2003/08. March. 67p.

DFO. 2004d. A Policy Framework for the Management of Fisheries on Canada’s Atlantic Coast. Department of Fisheries and Oceans Canada. Ottawa. March. 46p. DFO 2003a. Cod on the Southern Scotian Shelf and Bay of Fundy (Division 4X/5Y) in 2003. DFO Science Stock Status Report. 2003/050. 8p.

DFO 2003b. Haddock in the Southern Scotian Shelf and Bay of Fundy (Division 4X/5Y). DFO Science Stock Status Report. 2003/051. 11p.

DFO. 2003c. Financial stability, program renewal and modern management. The DAAP Final Report. Department of Fisheries and Oceans Canada. Ottawa. DFO. 2002a. Cod on the Southern Scotian Shelf and Bay of Fundy (Div. 4X/5Y). DFO Sci. Stock Status Report. A3-05(2002). 9p. DFO. 2002b. Haddock on the Southern Scotian Shelf and Bay of Fundy (Div. 4X/5Y). DFO Sci. Stock Status Report. A3-07(2002). 11p. DFO 2001. Proceedings of a Meeting on Scotian Shelf Groundfish Stocks. Regional Advisory Process, Maritimes Region. 30 October-3 November 2000. CSAS Proceedings Series 2000/33. March. 31p.

DFO 2000a. Science Strategic Project on the Precautionary Approach in Canada. Proceedings of the Second Workshop. 1-5 November 1999. CSAS Proceedings Series 99/41. January. 96p.

DFO 2000b. Proceedings of the 4th Meeting of CSAS and RAP Coordinators. 7-8 December 1999. CSAS Proceedings Series 2000/01. January. 56p.


DFO 2000c. Proceedings of the Autumn Finfish Stock Assessment Meeting. Regional Advisory Process, Maritimes Region. 1-5 November 1999. CSAS Proceedings Series 99/39. 36p.

DFO 1986. Stock Status Report for Northern Cod. CAFSAC Research Document.

FAO. 1996. Precautionary approach to fisheries. Part 2: Scientific papers. Food and Agriculture Organization of the United Nations. Fisheries Technical Paper 350/2. Rome. 210p. FAO. 1995a. Code of Conduct for responsible Fisheries. Food and Agriculture Organization of the United Nations. Rome. 41p. FAO. 1995b. Precautionary approach to fisheries. Part 1: Guidelines on the precautionary approach to capture fisheries and species introductions. Food and Agriculture Organization of the United Nations. Fisheries Technical Paper 350/1. Rome. 52p. FAO. 1995c. Reference points for fisheries management by J.F. Caddy and R. Mahon. Food and Agriculture Organization of the United Nations. Fisheries Technical Paper 347. Rome. 83p. FRCC 2004a. 2004/2005 Conservation Requirements for Groundfish Stocks on the Scotian Shelf and in the Bay of Fundy (4VWX5Z), in Sub-Areas 0,2+3 and Redfish Stocks. FRCC.2004.R.1. January.

FRCC 2004b. 2004/2005 Conservation Requirements for Groundfish Stocks of the Gulf of St. Lawrence (4T). FRCC.2004.R.2. March.

FRCC 2003a. 2003/2004 Conservation Requirements for Groundfish Stocks on the Scotian Shelf and in the Bay of Fundy (4VWX5Z), in Sub-Areas 0,2+3 and Redfish Stocks. FRCC.2003.R.1. January.

FRCC 2003b. 2003/2004 Conservation Requirements for Groundfish Stocks of the Gulf of St. Lawrence (4T). FRCC.2003.R.2. March.

FRCC 2002. 2002/2003 Conservation Requirements for Groundfish Stocks on the Scotian Shelf and in the Bay of Fundy (4VWX), in Sub-Areas 0,2+3 and Redfish Stocks. FRCC.2002.R.1. January. pp.A2.

FRCC 2001. 2001 Conservation Requirements for Scotian Shelf and Bay of Fundy Groundfish Stocks and Redfish Stocks. FRCC.2001.R.1. January. pp.A1.

Halliday, R.G., Fanning P.F., and Mohn, R.K. 2001. Use of the Traffic Light Method in Fishery Management Planning. DFO Canadian Science Advisory Secretariat Research Document 2001/108. Hurley, P., Black, G.A.P., Sumner, J.E., Mohn, R.K., and Comeau, P.A. 2003. Assessment of the Status of Division 4X/5Y Haddock in 2003. DFO Canadian Science Advisory Secretariat, CSAS Res. Doc. 2003/104. 71p.


Hutchings, J.A. 1996. Spatial and temporal variation in the density of Northern Cod and a review of hypotheses for the stock’s collapse. Canadian Journal of Fisheries and Aquatic Sciences. 53: 943-962.

ICES 1998. Report of the Study Group on the Precautionary Approach to Fisheries Management. ICES CM 1998/ACFM:10 Ref. D. 40p. ICES 1997. Report of the Study Group on the Precautionary Approach to Fisheries Management. ICES CM/Assess:7. 41p. Lane, D.E. and Stephenson, R.L. 1998. Toward a Framework for Risk Analysis in Fisheries Decision Making. ICES Journal of Marine Science, 55(1), 1-13. NAFO 1998. Scientific Council Report on the Precautionary Approach. N2987. SCR Doc. 98/1. Munro, G.R. 1979. Promise of Abundance. Report of the Economic Council of Canada. OECD 1997a. Evaluation of the Potential Gains and Costs of the Transition to Responsible Fisheries: Model for Analysis. OECD Fisheries Committee Report. September. AGR/FI(97)10. 34p.+appendices. OECD 1997b. Evaluation of the Potential Gains and Costs Involved in the Transition to Responsible Fisheries: Literature Review and Bibliography. OECD Fisheries Committee Report. September. AGR/FI(97)10/PART1. 35p. OECD. 1998. The Management Study. OECD Fisheries Committee Report. Paris. OECD 2000. Transition to Responsible Fisheries: Economic and Policy Implications. Paris. Pope, J.1972. An investigation of the accuracy of virtual population analysis using cohort analysis. International Council for Northwest Atlantic Fisheries Research Bulletin, 9: 65-74. Power, M.J., Stephenson, R.L., Clark, K.J., Fife, F.J., Melvin, G.D., and Annis, L.M. 2004. 2004 Evaluation of 4VWX herring. Canadian Atlantic Fisheries Scientific Advisory Committee. CAFSAC Research Document 2004/030, 123p.

Ricker, W.E. 1975. The Handbook of Fisheries Research. Fisheries Research Board of Canada.

Rivard, D.1988, Collected Papers on Stock Assessment Methods. Canadian Atlantic Fisheries Scientific Advisory Committee. CAFSAC Research Document 88/61, 167p.

United Nations. 1995. Agreement for the implementation of the provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the conservation and management of straddling fish stocks and highly migratory fish stocks. New York, 24 July-4 August 1995. Article 6, Application of the Precautionary Approach; Annex II, Guidelines for the Application of Precautionary Reference Points in Conservation and Management of Straddling Fish Stocks and Highly Migratory Fish Stocks.


Walters, C.J. 1986. Adaptive Management of Renewable Resources. New York: Macmillan. Winters, G.(1988). The development and utility of sequential population analysis in stock assessments in Collected Papers on Stock Assessment Methods by D. Rivard (ed.), Canadian Atlantic Fisheries Scientific Advisory Committee Research Document. 88/61, 349-368.


VI. APPENDIX A

Stock Status Report Documents Content

The following tables outline the content by major section of the Stock Status Reports for cod and haddock in 4X5Y for 2002 and 2003.

2002-2003 4X5Y Haddock Headings Content Included in

2002 Included in 2003

Resource Status Graph: Mean Length at age (cm)

X ü


Graph: Biomass (t) ages 2-10 Graph: Ages 4-10

ü ü

Traffic Light Analysis

Table of indicators ü X

Outlook Chart: High/ Low levels of Yield

ü X


Text discussion X ü



2002-2003 4X5Y Cod

Headings Content Included in 2002

Included in 2003

The Fishery Graph: Proportional Landings of 4X Cod by area Graph: Proportion at length (cm) in Commercial Landings of 4X cod by area in 2003 Chart: Level of observer coverage in Cod/Haddock directed fisheries in 4X

X

X

X

ü ü ü


Text discussion ü X

Resource Status Graph: Survey mean weight/ Tow(kg) Ages 3-16 Graph: Recruitment- Average for ages 2+3 in a yearclass Graph: Growth rate Graph: Local density for 4X Cod Graph: Mortality rates Graph: RV survey Biomass Estimates by area Graph: ITQ survey cod catch by

ü ü ü ü ü X

X

X

X

X X X ü ü


region in 4X Graph: ITQ survey Length composition compared to series medians Graph: RV survey length composition by region for 4X cod Graph: 4X cod RV survey indices (size proportional to abundance) Graph: 4X cod ITQ survey indices by area Graph: Proportion of ITQ survey sets where cod were caught Graph: Biomass and recruitment from VPA Graph: Age structure Graph: Exploitation rate Graph: Surplus Production

X

X

X

X

X ü ü ü ü

ü ü ü ü ü

X

X X X






Graph: Biomass 4+ (000s t) Graph: F (ages 3-8)

ü ü

X X

Traffic Light Analysis

Table of indicators ü X


VII. Appendix B

2002 and 2003 Documents Linkages

The following tables show the year-over-year linkages between the major sections of the Stock Status Reports for cod and haddock in 4X5Y for 2002 and 2003, as well as for the content of the FRCC Recommendations Reports for 2002/2003 and 2003/2004.

Stock Status Report for Haddock – 2002 and 2003 Heading Year over year linkage The Fishery Graph: Landings and TAC (000s t) – Consistent & updated

Graph: Commercial weight at age (kg) - Consistent & updated Industry Perspective Text is consistent & updated

Resource Status Graph : Survey Age 4+ Mean Weight /Tow (kg) – Consistent &

updated Abundance of ages 4+ - Consistent & updated Age Structure – “The # of above average yearclasses in the research vessel survey ages 4-10 is a measure of age structure. This may not be the best indicator of age structure because it is insensitive to the relative contribution of older ages within the age distribution, which are thought to have a higher reproductive potential. Further research is required in this area.” (Both years state the same text. However, there’s no mention in 2003 whether this research is being carried out) Graph: RV survey Age Structure (# of above average ages) - Consistent & updated Recruitment: Consistent & updated Graph: Survey Recruitment Index - Consistent & updated Graph: RV survey area occupied - Consistent & updated Graph: RV survey local density - Consistent & updated Mean length at age and mean weights at age - Consistent & updated Graph: RV survey Growth rate - Consistent & updated Graph: RV survey Fish Condition - Consistent & updated Graph: RV survey Total mortality - Consistent & updated Graph: Relative F - Consistent & updated SPA : Recruitment - Consistent & updated Graph: Spawning Stock Biomass (000 t) and Recruitment (millions) - Consistent & updated Spawning Stock Biomass (4+) - Consistent & updated Exploitation rate – 2002: Exploitation rate on ages 5-7 dropped again in 2000 & 2001. 2003: Exploitation rate on ages 5-7 dropped again in 1999.

Sources of Uncertainty Graph: F Ages 5-7 - Consistent & updated Graph: In 2002 Biomass (t) Ages (2-10) In 2003 Biomass (t) Ages (4-10) not consistent


Outlook Indicators of Abundance - Consistent & updated

Indicators of Recruitment - Consistent & updated Indicators of Distribution - Consistent & updated Indicators of Production - Consistent & updated Indicators of Mortality - Consistent & updated Projected Yield - Consistent & updated Graph: Probability of exceeding F0.1 - Consistent & updated

Stock Status Report for Cod – 2002 and 2003 Heading Year over year linkage The Fishery Graph: Landings & TAC (000 t) – Consistent & updated

Industry Perspective Missing heading in 2003 ( But text appears under “the fishery”)

2002: Reports of Cod being discarded or landed unreported to avoid exceeding the quota have increased. 2003: Reports of Cod being discarded or landed unreported was thought to have decreased in 2002. There have been no reports from industry of discarding in 2003. Discarding of cod in the flat fish fishery may be a problem (Cod bycatch is difficult to avoid) (These statements are contradictory) The level of observer coverage in 4X is generally below 1%, too low for any meaningful comparisons; thus it cannot be determined whether nominal landings are accurate reflection of mortality from fishing.

Resource Status (Observation – in 2003 separated between Bay of Fundy and Scotian shelf)

Catch rates were given in 2002 but not reported in 2003 – Reason: Catch rates may have limited information value regarding cod abundance due to changes in fishing patterns and the impact of management measures – Inconsistent. Recruitment – Consistent & updated. Condition - Consistent & updated. Graph: 2002 – Condition & Growth rate 2003 - Condition factor for 4X Cod by area :Inconsistent, updated Growth rate is not mentioned in 2003 Area Occupied - Consistent & updated. Local Density – not mentioned in 2003 Graph: 2002 – Area occupied & Local density for 4X cod 2003 – Area occupied by 4X from the RV survey Inconsistent Total mortality - 2002 – There’s no trend however, mortality remains high – RV survey 2003 – No trend can be discerned and no conclusions drawn in relation to total mortality. Relative Fishing Mortality - Consistent & updated


SPA – Following topics are discussed in 2002: Population Biomass, Recruitment, Exploitation rate, Age Structure and Surplus production 2003: indicate a high level of unaccounted mortality, appeared to be highest on fishable ages which would be consistent with a high level of discarding or unreported landings in the past years.

Sources of Uncertainty Text is consistent. (Graphs are missing)

Outlook 2002: separated into different topics, such as: Indicators of Abundance, Indicators of Recruitment, Indicators of Distribution, Indicators of Production, Indicators of Mortality However 2003 report discusses overall biomass, recruitment, area occupied, Condition and length at age.

FRCC Report for Haddock 2002/2003 and 2003/2004 Heading Year over year linkage Interim Stock Objective Consistent

Analysis Projection of spawning stock biomass in 2001 is 39,000t & 37,000t in

2002. There is no estimation in 2003/2004 report. – This is inconsistent. Environmental factors are not mentioned in 2002/2003 however, these factors are mentioned in 2003/2004 FRCC report. Recommended TAC – updated

Council’s Views on Stock Status

Overall stock indicator : updated & consistent Spawning Biomass: updated & consistent Total Biomass : updated & consistent Recruitment : updated & consistent Growth & Condition : updated & consistent Age structure : updated & consistent Distribution : updated & consistent Recent Exploitation Level : updated & consistent

FRCC Report for Cod 2002 / 2003 & 2003 / 2004 Heading Year over year linkage Interim Stock Objective Consistent except the objective of “Rebuild”

The objective in 2002/2003 report is to “rebuild the spawning stock biomass (ages 4+) to the targeted range. There is no age specification for the spawning stock biomass in 2003/2004 report

Analysis Landings – updated & consistent Biomass - updated & consistent It is stated in 2002/2003 report that “Fishermen did not think that there was much misreporting of cod & haddock” It is stated in 2003/2004 report that “The fishery has been plagued with unacceptably high discarding of catches and non-reporting of landings”


This is inconsistent ( different point of views between fishermen & FRCC) FRCC has recommended “Tagging Program” in both years. But there is no update in 2003 to report whether this recommendation is taken into consideration. Spawning Stock biomass is stated as ages 4-8 in 2002/2003 however, there’s no age specification in 2003/2004.

Council’s Views on Stock Status

Overall stock indicator : Target is 40,000t SSB by 2003 Target is >45,000t SSB by 2006. (Target is updated however, it has changed - inconsistent) Spawning Biomass: updated & consistent Total Biomass : updated & consistent Recruitment : updated & consistent Growth & Condition : updated & consistent Age structure : updated & consistent Distribution : Inconsistent Recent Exploitation Level : updated & consistent

Commentary and Analysis of Research Questionnaires E-1

E- COMMENTARY AND ANALYSIS OF RESEARCH QUESTIONNAIRES ON

PRACTICING PRECAUTION AND ADAPTIVE MANAGEMENT

Practicing Precaution – Exploratory Data Analysis of Institutional Questionnaire and Document Database…………………………………………………………………….E-3 André Dabrowski

Commentary and Analysis of Research Questionnaires E-2

André Dabrowski – Commentary and Analysis of Research Questionnaires E-3

COMMENTARY AND ANALYSIS OF RESEARCH QUESTIONNAIRES ON PRACTICING PRECAUTION AND ADAPTIVE MANAGEMENT

André Dabrowski Full Professor

Department of Mathematics and Statistics University of Ottawa



TABLE OF CONTENTS

I. PRACTICING PRECAUTION – EXPLORATORY DATA ANALYSIS OF INSTITUTIONAL QUESTIONNAIRE. .................................................................................E-7

I.A. Questionnaire Design and Use..................................................................................E-7 I.B. Quality of Measurements ..........................................................................................E-7 I.C. Data Issues..................................................................................................................E-7 I.D. Goals .........................................................................................................................E-10 I.E. Exploratory Data Analysis......................................................................................E-10 I.F. Approaches ...............................................................................................................E-10

I.F.1. Approach #1 (Cumulative sum method)...................................................E-10 I.F.2. Approach #2 (Dimension reduction method) ...........................................E-15

I.G. Summary and Recommendations on the Institutional Questionnaire............... E-19 II. PRACTICING PRECAUTION – EXPLORATORY DATA ANALYSIS OF

DOCUMENT DATABASE. . ..............................................................................................E-21 II.A. Questionnaire Design.............................................................................................E-21 II.B. Quality of Measurements ......................................................................................E-21 II.C. Goals........................................................................................................................E-23 II.D. Summary and Recommendations on the Document Questionnaire.................. E-25

André Dabrowski – Commentary and Analysis of Research Questionnaires E-7 Exploratory Data Analysis of the Institutional Questionnaire

I. PRACTICING PRECAUTION – EXPLORATORTY DATA ANALYSIS OF INSTITUTIONAL QUESTIONNAIRE I.A. Questionnaire Design and Use The questionnaire employed in this research was subject to a series of revisions and modifications throughout the course of the study. Prototype versions were discussed in the abstract, and then reworked in view of practical experience later in the process. As standard instruments are not established, this was not unexpected, and the exercise should be viewed more as a pilot study than a classically designed survey. Before proceeding to an exploratory data analysis, we can review the (statistical) concerns and issues highlighted by this project. The initial version of the questionnaire contained open-ended (i.e. fill-in-the-blank) questions and a variety of true/false or numeric scales for responses. To standardize responses many of the open-ended questions were rephrased as multiple choice questions, and responses were standardized to either true/false or a 7-point numeric scale. The interpretation of the 7-point scale was described as part of the questionnaire. This attempted to address concerns of comparability of numeric responses across questions. Unlike many social surveys, the questions here are all “uni-directional” in that higher values of the measurement represent stronger awareness etc. No attempt to randomize “positive” or “negative” responses was made, but this was not anticipated to be a significant problem. I.B. Quality of Measurements The questionnaire contained 5 “Parts” addressing separate aspects of interest to this study, and each Part contained several questions on its theme. Thus all areas were covered in the questionnaire, and the context of each question was explicitly provided. A key issue for data quality was the fact that each case study was to be evaluated by a separate team of raters. The confounding of a rater effect with any case effect was unavoidable, and this would impact the interpretability of the survey results. To minimize this confounding, the raters of all case studies discussed their responses to the questions and came, as much as possible, to a common understanding of the meaning of their responses. As the ratings remain qualitative assessments, a document database was established to record the rater’s assessments of key source documents. This may provide a quantitative basis for the rater’s evaluations on each case study. I.C. Data Issues As the study progressed, some changes to the original measurement plans were introduced and difficulties with the data collection process identified. Although a seven-point scale (1 to 7) for measuring response had been described in the questionnaire, the raters felt the need to introduce a 0 entry to indicate the state of “unknown,” i.e. there is not sufficient information to decide. Similarly a “2” code in true/false (yes/no) responses indicate an inability to decide. From a data analysis point of view, the purely numeric assessment scales (weak to strong) became a mixture


of qualitative and quantitative measurements because of these additions, and consequently difficult to analyze. In an attempt to accommodate this change, the actual data will be treated as numeric where 0 sits at the left-hand end of the 1-7 scale, and “2” is recoded as “0” (false/no). This is perhaps justified by making the equivalence between a lack of knowledge and a negative response. A second data issue that arose were the significant number of questions for which one or more of the case studies did not respond at all (missing data) or for which all the case studies provided identical responses. In both cases, these questions had to be deleted from the database: missing values could not be imputed to fill in the gaps when only 4 cases were evaluated, and constant responses across cases did not help in distinguishing one case from another.

Table 1: Questions suppressed from the database due to missing data or constant response. I2c I2d I3b I4a I4e II2a II2b II3 II4a II4b II4c II4d III2b III3a III3e III4b III7a III7b III8c III8f III8g III8h III8i III8j III9a III9c III9f III9g III9h III9i III9j III10b III10c III10e III10f III10g III10h III10i III10j III13a

IV1 IV2_1a IV2_1b IV2_2a IV2_2b IV2_2c IV2_2eb IV5b IV7a IV7b IV8a IV8d IV9b IV9c IV9d V5b V6a V6b V10a V10b V14a V14b V14c V14d V14e V14f V19 V20 V21a V21b V21c V21d V22V23a V23c V24b V24c

Table 2: Values for Questions with constant response. Question Value Question Value Question Value Question Value Question Value

I2c 0 I2d

0 I4a

7 I4e

1

II3 1

III3a 7 III3e

1 III4b

7 III8c

0 III8f

0

III8g 0 III9a

1 III9c

0 III9f

0 III9g

0

III10b 0 III10c

0

IV1 0 IV2_1a

0 IV2_2a

1 IV2_2b

1 IV2_2c

1

IV9c 1

V17 0 V22

1 V23a

1 V23c

1 V24b

1

V24c 1


Table 3: Questions with missing data for some or all cases. Question numobs pest_ fish_ gmo_ frst_ avg

I3b 2 . 3 . 10 6.50000

II2a 3 0 . 0 0 0.00000

III7a 3 5 6 . 7 6.00000

III7b 3 7 3 . 6 5.33333

III8h 2 0 1 . . 0.50000

III8i 2 0 1 . . 0.50000

III8j 1 1 . . . 1.00000

III9h 2 0 1 . . 0.50000

III9i 2 0 1 . . 0.50000

III9j 1 1 . . . 1.00000

III10e 3 . 0 0 0 0.00000

III10f 3 . 0 0 0 0.00000

III10g 3 . 0 0 0 0.00000

III10h 1 . 1 . . 1.00000

III10i 1 . 1 . . 1.00000

III10j 1 1 . . . 1.00000

III13a 3 7 0 . 1 2.66667

IV5b 2 0 . 0 . 0.00000

IV7a 3 0 . 2 2 1.33333

IV7b 3 0 . 2 2 1.33333

IV8a 3 0 . 0 1 0.33333

IV8d 2 . . 2 2 2.00000

IV9b 3 15 1 1 . 5.66667

IV9d 3 . 1 0 1 0.66667

V6a 3 1 1 . 1 1.00000

V6b 3 1 1 . 1 1.00000

V10a 1 . 1 . . 1.00000

V10b 1 . 0 . . 0.00000

V14a 2 1 1 . . 1.00000

V14b 2 1 1 . . 1.00000

V14c 2 1 1 . . 1.00000

V14d 2 1 1 . . 1.00000

V14e 2 1 1 . . 1.00000

V14f 0 . . . . .

V19 3 1 1 . 0 0.66667

V20 2 2 . 2 . 2.00000

V21a 3 1 1 . 1 1.00000

V21b 3 0 0 . 0 0.00000

V21c 3 0 0 . 0 0.00000

V21d 3 0 0 . 0 0.00000

avg=average over non-missing observations numobs=number of non-missing entries


I.D. Goals One general goal of the questionnaire was to identify similarities and differences among the four case studies; pesticides, fisheries, GMOs and forestry. The small study size (4 cases), questionnaire redesign, and data issues do not permit a rigorous statistical study of this question, but we can still employ exploratory data analysis to highlight differences between cases. This will suggest initial hypotheses to be tested in larger studies, validate the concept and questionnaire instrument, and provide proof-of-concept. I.E. Exploratory Data Analysis Two approaches to extracting information and differences among cases will be pursued here. Both approaches require significant “suspension of disbelief” as much larger and better characterized data sets are usually the targets of such methods, and their use on such a limited data set is speculative and exploratory. The first approach looks at the values obtained for the questions as a graph against question number. This yields four curves – one for each case – and they can be examined visually to identify which cases are similar or different. The second approach looks at each Part (I through V) within the questionnaire and attempts to find the linear combinations of responses that best discriminate among the questions, much as in principal components analysis. The one or two (simplified versions of) main components are retained and plotted against case. This yields a visual representation how cases cluster with respect to the questions of that Part. Both cases start from the data modified by recoding “2” to “0” and interpreting “0” as the low end of the seven point scale and where the missing or constant data have been deleted. I.F. Approaches I.F.1. Approach #1 (Cumulative sum method) We modify the data by standardizing the responses for each question to have mean 0 and standard deviation 1. This is done to make responses comparable across questions and to diminish the impact of the individual mean response per question on the analysis. It is only the relative differences in responses which are of interest in attempting to cluster cases. Assuming that each question was designed to yield higher responses for stronger structures or affinity to the concepts of adaptive management, precaution or uncertainty, we can look at the plot of response against question index for the four cases and look for general patterns of higher and lower responses. Figure 1 displays a plot of the standardized questionnaire data against question index. The four case studies are indicated by P (pesticides), F (fisheries), G (GMO’s) and R (forestry).


Figure 1. The raw data from the questionnaires were centered at 0, and plotted against question index (the depth of the question in the questionnaire). Narrowed sections correspond to true/false or 1/0 responses, and the broader areas to questions with a 0-7 response scale.

However, no easily-discernable patterns are visible in Figure 1. The variation in response from question to question is much greater than any general patterns that might distinguish the four cases. An alternative representation of the data plots the centered partial sum process against question index,

i.e. S(n)=∑=

−n

ii XX

1

)( ),

– a technique frequently used in statistical quality control to detect out-of-control manufacturing processes. If there is a general positive bias for one case versus another, we should see a gradual separation of the data points in the graph of S(n) against n. This is shown in Figure 2. That graph apparently shows that the forestry case study (R) separates from the other three, and that the GMO case (G) is somewhat distinct from the pesticide (P) and fisheries (F) cases. Similar graphs can be computed for each of the 5 parts of the questionnaire separately to highlight the distinct patterns within each of those parts. These are provided in Figures 3 through 7. The Part I graph is inconclusive. One can see that the forestry case lies above all the others for Parts II, III and IV. The pesticide case lies below or close to the bottom of the graphs for Parts II through V. Generally, the fisheries case is frequently a moderate one in the graphs. Of course, one must still question whether the differences are due to the cases or the raters, and these observations are purely tentative.


Figure 2. S(n) versus n graph for the complete questionnaire. The top and bottom lines correspond to the forestry and gmo case studies, respectively.

Figure 3. S(n) versus n for Part I of the questionnaire. No strong pattern is evident.


Figure 4. S(n) versus n for Part II of the questionnaire. On this Part, Forestry (R) generally scores highest, and Pesticides (P) the least. Most of the separation of cases occurs in question II.5.

Figure 5. S(n) versus n for Part III of the questionnaire. Again Forestry (R) scores highest, achieving some level of separation at several points in the questionnaire. The three others are comparable until the end of question 11, and through questions 12 and 13.


Figure 6. S(n) versus n for Part IV of the questionnaire. Forestry (R) and Fisheries (F) separate from the other two cases over the entire Part.

Figure 7. S(n) versus n for Part V of the questionnaire. There is an early separation over the first 5 questions of the Part, and then relative stability.


I.F.2. Approach #2 (dimension reduction method) In this section we employ principal components analysis (PCA) to reduce the dimension of the data to more readily interpretable values. For each Part, we first remove those variables with missing data or which are all of one value. Score variables are defined as sums of certain 0/1 (yes/no) variables to replace those multi-part questions by a single numeric score. For a group of related questions (e.g. in a Part), we will employ PCA to suggest the one or two composite (linear combinations) variables that best distinguish among the cases. This is illustrated here in detail for Part I: the other Parts are handled similarly.

I4b

0

1

2

3

4

5

6

7

8

case

1pest 2f i sh 3gmo 4frst

F

F

F

F

G

G

G

G

Figure 8. A plot of the responses to questions I4b,c,d against case.

Part I comprises only 3 retained questionnaire questions; I4b, I4c and I4d. Figure 8 shows the responses plotted against case, and it is evident that 2 of the 3 questions (I4c and I4d) yield almost identical patterns of response across the 4 cases. The third question (I4b) can be made to follow the same pattern by considering instead its negative (mirror). Consequently we may argue that the information conveyed by these three variables can be summarized by a single composite variable, I_1= bIdIcI 4)2/)44(( −+ , shown in Figure 9. PCA (executed using SAS) obtains the best composite variable automatically, and so suggests the one or two composite variables that can best be used to summarize the information in a large number of questions, and to indicate which cases are similar to each other for that Part. In the case of Part I, the composite variable seems to capture approximately 95% of the variation present in the original data set. This analysis must, however, be considered as exploratory. It remains that with only 4 cases, we will always have but a deformed tetrahedron in our data space, and its projection onto one coordinate will not carry that much information. We stress that the amount of data here is insufficient for a statistical analysis, and that this decomposition is more a dimension-reduction exercise than a statistical one.


Data reduct ion to 1 vari abl e

case 1pest 2f i sh 3gmo 4frstP P P F F F GGG R R R

dd

-7

-5

-3

-1

1

3

5

7

I_1

-7 -5 -3 -1 1 3 5 7

Figure 9. A graph of the composite PCA component I_1. The relative proximity of P to G indicates that these two cases have a similar response pattern for Part I – corroborating the general impression of Figure 3.

We now plot (Figures 10 to 13) the retained composite variables (suggested by PCA and rotation to the axes) against case ID separately by each Part, and attempt to interpret the plot either in terms of its ability to highlight differences among the 4 cases, or in terms of its ability to suggest how certain features of the data may be aligned. In each plot there is an attempt to highlight any similarity among cases or questions, and this is noted in the caption. Table 4, below, states the amount of variation in the data captured by the composite variables. Table 4: Rotated PCA variables Part I II III IV V Number of rotated PCA retained

1 2 2 2 2

Percentage of data variation

99% 85% 78% 85% 90%


Data reduct ion to 2 vari abl es


II_2

-20

-10

0

10

20

II_1

-10 0 10 20 30 40 50

Figure 10. PCA suggests that the Pesticide and GMO case studies have relatively similar response patterns for Part II.



II I_2

-50

-40

-30

-20

-10

0

10

20

30

II I_1

-10 0 10 20 30 40 50 60 70 80 90 100 110 120 130 140

Figure 11. PCA suggests that for Part III, the pattern of responses for the Pesticide and Fisheries case studies are relatively more alike those of the other cases.




IV_2

0

10

20

30

40

50

60

70

IV_1

0 20 40 60 80 100 120 140

Figure 12. As for Part I and II, Part IV shows that Pesticides and GMO have relatively similar response patterns.



V_2

-7

-6

-5

-4

-3

-2

-1

0

1

2

3

4

5

V_1

-1 0 1 2 3 4 5 6 7 8 9 10 11

Figure 13. Fisheries and Pesticides case studies are relatively similar for Part V, as observed in Figure 11.


I_1

-2

-1

0

1

2

case

1pest 2f i sh 3gmo 4frst

Figure 14. The most significant PCA component (rotated and mirrored) for each Part is here plotted against case study. The lines connect the values for each Part. The figure shows that there is a consistent general pattern across the five Parts of the Questionnaire. As in Figure 2 Forestry (R) distinguishes itself from the other cases, and the GMO (G) case does as well but to a lesser extent. We further see that the responses for Pesticide (P) are more variable across Parts than in the other cases.

I.G. Summary and Recommendations on the Institutional Questionnaire 1) This study must be considered as an exploratory or pilot study. The limited sample size, in-

course modifications to questions and response scales, missing and recoded data issues, and confounding of inter-rater differences with inter-case differences make the assignment of statistical significance untenable. A future study must address these issues by adjusting the questions to include the possibility of non-response, include a larger number of cases to permit using statistical methods, and have any single rating group evaluate several cases each. To assess inter-rater variation, some cases must be evaluated by multiple rating groups.

2) The cumulative sum (S(n) versus n) plots do indicate some forms of consistent trends across the questionnaire. This suggests that the questionnaire was indeed useful in separating the capacity for practicing precaution in one case from another. One must be careful, however, as some of the separation observed in those figures may be due to the recoding of “unable to assess” as a “0” on the 7-point scale, or of recoding “2” as “0” in true/false questions. Again, non-response must be included as either part of the response scale (i.e. “0”) or the questionnaire modified to account for the inability to assess the underlying documentation.


3) The dimension reduction plots are also suggestive of the ability of the questionnaire to consistently identify similarities and differences among groups. Figure 14, in particular, is encouraging in that it shows consistency of response pattern across the different Parts of the questionnaire for the four cases. Although it is comforting to see Forestry and GMO occupying the same relative positions in Figures 2 and 14, one must recall that the dimension reduction plots are effectively a projection of a tetrahedron (i.e. defined by 4 points in space) onto a plane, and that the restricted amount data implies a restricted range of possibilities for these projections. A future study can address this difficulty by including more cases, and having multiple case studies for each organization.

4) This study presents a simple snapshot of the scene presented by four quite different case studies. As there were no expectations as to how these case studies could be related, it is difficult to assess the amount of information being presented in the above Tables and Figures. A more easily interpreted experimental design would see a single case study with multiple observations. For example one could have the Fishery case study assessed over four distinct fishing seasons. The questionnaire would then track changes in the practice of precaution over time, and should be more sensitive to those changes as many underlying factors would remain constant over the period.

André Dabrowski – Commentary and Analysis of Research Questionnaires E-21 Exploratory Data Analysis of Document Database

II. PRACTICING PRECAUTION EXPLORATORY DATA ANALYSIS OF DOCUMENT DATABASE II.A. Questionnaire Design As each case study team reviewed documents related to its subject, a questionnaire on each such document was completed. This questionnaire collected bibliographic information and assessments by the reader of a number of questions related to three topics, scientific uncertainty (questions 4 to 12), precautionary principle (questions 13 to 15) and adaptive management (questions 16 to 22). These were a mix of “Yes/No” responses (coded 1/0) and responses on a 0-7 scale. As in the institutional questionnaire, all the questions were “unidirectional” in the sense that a higher score was to indicate a greater appreciation of the target feature. Most questions also contained sub-questions, and some parts of questions asked for non-numeric textual responses. II.B. Quality of Measurements The database comprises 266 documents. The distribution of documents by case study and type of document (Legislation/Regulation/etc.) is gven in Table 5. It is evident that the numbers of documents vary widely by case study and by document type. The database is dominated by documents related to the pesticide case study: relatively few are present for the Fisheries and GMO study, and none for the Forestry case. The types of documents also vary considerably from one case to another. Table 5: distribution of documents by case study and type of document. Frequency Q2_type_of_document case 1 2 3 5 7 9 Total pest 0 0 25 47 106 60 238 fish 3 2 0 0 0 10 15 gmo 0 0 0 13 0 0 13 Total 3 2 25 60 106 70 266

Three composite variable were defined to represent the overall response in the areas of scientific uncertainty (labeled “un”), precautionary principle (“pp”) and adaptive management (“am”). These were given by the sums of the responses over the corresponding questions in the document questionnaire: un = sum of numeric responses to questions 4 through 12, pp = sum of numeric responses to questions 13 to 15, and am = sum of numeric responses to questions 16 to 22. An initial examination of histograms for these three composite variables showed strong bimodality (see Figure 15). As the different document types would be expected to have different


scales of response, it is reasonable to center (mean 0) and scale (standard deviation 1) the data separately for each document type across cases prior to further analysis. Unfortunately, only document types 5 (Decision on application) and 9 (Directive) contain documents in more than one case study. Only these two classes of documents were retained for further examination.

measuri ng the precaut i onary pri nci pl e

pri or to correct i ng by document type

PERCENT

0

10

20

30

40

50

60

pp MIDPOINT

case1pest 2f i sh 3gmo

8 1216202428323640444852 81216202428323640444852 81216202428323640444852


af ter correct ing by document type

PERCENT

0

10

20

30

pp MIDPOINT

case1pest 2f i sh 3gmo

-1.6-0.80.00.81.62.43.24.0 -1.6-0.80.00.81.62.43.24.0 -1.6-0.80.00.81.62.43.24.0

Figure 15. Histograms for the measure “pp” of practicing precaution, before and after correcting for document type. This adjustment had greatest effect on the “pp” measure; the “am” measure showed a lesser effect, and the “un” measure none at all.


II.C. Goals The goal of this examination is to ascertain if the overall assessment of each case study is supported by each team’s assessment of the documents associated with that study. In Figures 4, 5 and 6 the response to the institutional questionnaire was represented for each case study, and we can summarize the response of each case study by three values, the value at the extreme right end of the corresponding graph. This is summarized in Table 6, below.

Table 6: Measures from Iinstitutional Questionnaire. case Part2

Scientific uncertainty

Part3 Precautionary principle

Part4 Adaptive Management

Pest -17.75 -6.25 -27.75 Fish 6.25 -17.25 30.25 GMO -4.75 -73.25 -52.75 Forestry 16.25 96.75 50.25

To examine the degree of positive correlation between the document assessments (un, pp and am) and the case study (institutional questionnaire) assessments (part2, part3, part4), we can plot the document assessment against the corresponding case study assessment (. If the document assessments support the case study assessments, we should observe a positive linear dependence in the graph.

measuri ng uncertai nty

un

-1

0

1

2

3

4

5

6

part2

-20 -10 0 10

Figure 16: A plot of the document assessment of scientific uncertainty (“un”) against the case study assessment of uncertainty (part2). We observe a few high outliers for the first two cases (Pesticides and GMO)., and a weak linear trend among the three main groups of points (Pesticides, GMO, Fishery). This generally agrees with the weak separation of case studies observed in Figure 4 among pesticide, GMO and Fisheries case studies.



pp

-2

-1

0

1

2

3

4

part3

-80 -70 -60 -50 -40 -30 -20 -10 0

Figure 17. Although the document assessments for the pesticide case study show great variation, there appears to be essential equivalence of document assessments of the precautionary principle across the three studies (GMO, Fishery, Pesticide). This is qualitatively similar to the information in Figure 5, where these three case studies are largely indistinguishable until the last few questions in Part III, where GMO declines due to a number of 0 scores due to an inability to judge the cases.

measuri ng adapt ive management

am

-2

-1

0

1

2

3

part4

-60 -50 -40 -30 -20 -10 0 10 20 30 40

Figure 18: The plot of document assessments (“am”) for adaptive management against the corresponding case study assessment show a definite positive correlation (GMO, Pesticide, Fishery from left to right). This agrees with the strong separation of the fisheries case from the other two cases evident in Figure 6.


Figures 16, 17, and 18 do not contradict the qualitative information obtained from Figures 4, 5 and 6, and so we can still consider that the document assessments support the assessments provided in the institutional questionnaires. It should be noted, however, that plots of un, pp and am against the summary scores show additional positive associations, so the corresponding parts of the document questionnaire and the institutional questionnaire may have additional correlations. II.D. Summary and Recommendations on the Document Questionnaire 1) Many of the questions in the document questionnaire elicited “0” responses, particularly in

the section on scientific uncertainty. It may be useful to convert the “Yes/No” questions into questions with responses on a 0-7 scale in order to provide better discernment in the responses between documents.

2) The Forestry case did not yield any document assessments, and yet was the most separated case in the institutional questionnaire. This left three cases whose case study response patterns were fairly close, and for which document assessments should not be expected to differ greatly. Consequently it becomes difficult to assess the correlation of the two questionnaires. A future study should ensure that each case study provides document assessments.

3) It would be preferable to have approximately equal numbers of documents for each case study, and each document type. This will increase confidence in the document assessment measures un, pp and am as being reflective of case differences rather than document type differences.

Conclusions & Summary F-1

F: CONCLUSIONS and SUMMARY


TABLE OF CONTENTS

I. GENERAL OBSERVATIONS ................................................................................................F-5

I.A. Values..........................................................................................................................F-5 I.B. Heterogeneity .............................................................................................................F-6 I.C. Specificity ...................................................................................................................F-6 I.D. The Challenge of Finality..........................................................................................F-7

II. RECOMMENDATIONS FOR PARTICULAR PROCESSES ...........................................F-7

II.A. Standards of Review ................................................................................................F-7 II.B. Deference...................................................................................................................F-9

II.B.1a. Relative Expertise of Reviewing Courts..................................................F-9 II.B.1b. Science Courts ......................................................................................F-10 II.B.1c. Environment Courts ..............................................................................F-11 II.B.1d. Non-Specialist Courts ...........................................................................F-11 II.B.2. Redefining “Reasonable” .......................................................................F-12 II.B.3. Standard of Review and Deference in Practice ......................................F-13

III REFORM POSSIBILITIES .................................................................................................F-14 Factoring in Uncertainty ..............................................................................................................F-14

III.A. Personnell and Experience ..................................................................................F-14 III.A.1. Selection ................................................................................................F-14 III.A.2. Training .................................................................................................F-14 III.A.3. Input/Consultation .................................................................................F-15

III.A.3a. Expert panels ........................................................................F-15 III.A.3b. Expert parties .......................................................................F-15 III.A.3c. Court-Appointed Experts .....................................................F-15 III.A.3d. Conclusion re Expertise .......................................................F-15

III.B. Participation..........................................................................................................F-16 III.C. Procedure ..............................................................................................................F-17

Triggers..............................................................................................................F-17 III.D. Precautionary Principle .......................................................................................F-18

III.D.1. Burden of Proof.....................................................................................F-18 III.D.2. Standards of proof.................................................................................F-18 III.D.3. Weight of Evidence................................................................................F-19

III.E. The Principle of Adaptive Management.............................................................F-19 III.E.1. Finality and Timeframes........................................................................F-19 III.E.2. Interaction Between the Precautionary Principle and the Principle

of Adaptive Management .......................................................................F-20 III.F. Accountability .......................................................................................................F-21

III.F.1. Transparency .........................................................................................F-21 III.F.2. Reasons..................................................................................................F-21

IV. CONCLUSION .....................................................................................................................F-22

Potential Future Work .....................................................................................................F-24


The four case studies and accompanying statistical analysis in this Report provide a modest foundation for some preliminary conclusions on how precaution and adaptive management might affect administrative law, and particularly its goals of fairness, legitimacy and effectiveness. Several recurring themes emerge from the case studies. A review of these will be followed by more detailed observations drawing on the growing body of emerging literature on precaution and adaptive management. I. GENERAL OBSERVATIONS I.A. Values The issue that arises most clearly is that precaution and adaptive management are principles whose application is intimately connected with the values of the societies they are intended to serve.1 The most frequently recurring theme in the literature on precaution, in analyses of administrative goals and structures, and in the case studies, is that both administrative law and the principles of precaution and adaptive management must reflect underlying social values or priorities which support their implementation. These values not only determine goals, but also the appropriate means for achieving them.

In administrative law terms, Fairness, Legitimacy and Effectiveness are fundamental values. Yet these are merely headings for a myriad of other administrative principles, goals, standards and priorities, such as transparency, participation, finality, flexibility, responsiveness, proportionality and so on. The scientific enterprise also embodies values including the notion of a rigorous quest for explanatory certainty, coupled with respect for the necessity of constant re-evaluation, a perspective very much in keeping with the principle of adaptive management.

It has been said that precaution and adaptive management embody their own values. In fact, many believe that how one defines the precautionary principle reveals one’s underlying priorities. An excellent example is the contrasting approach to the precaution evidenced by the EU and the USA, most recently highly profiled in WTO disputes.2 The EU generally uses the term “precautionary principle” as opposed to the US’s preferred term “precautionary approach.” The EU treats precaution as creating substantive duties to take care to prevent possible harm.3 By contrast, the ostensibly American “precautionary approach” relies more on strictly procedural changes to enable precaution, and continues to rely more heavily on “sound science” as the most important basis for judgment. Elizabeth Fisher indicates that one effect of the advent of the precautionary principle is to make us more aware of divergent administrative “cultures”; it calls upon us to clarify what we believe constitutes legitimate, fair and effective administration:

Even within a particular jurisdiction there will be large divergences in the institutions, processes, and principles that govern standard setting in relation to different risks. …The operation of the Precautionary Principle highlights these inconsistencies because taking action in the face of scientific uncertainty acutely emphasizes that policy and legal actors hold different understandings of what is rational and reasonable for public administration to do and what the evidentiary basis of their decisions might be.4

The case studies and our Workshop confirmed this notion that the institutional values which drive the interpretation and application of precaution and adaptive management may vary from


one government department to another. For example, the GM Plants study found that, “since …adverse outcomes are to be delayed rather than avoided altogether, it seems that a decision has been taken that they are to be tolerated.”5 This is even clearer in the Forest Pests study, where the authors observe how much easier it is to invoke precaution when seeking to protect the economy rather than the environment. These priorities will therefore inform what may be considered “reasonable” in terms of how to be precautionary, and how precautionary to be, in that context. I.B. Heterogeneity The studies also support our starting suspicion that decisions involving the precaution and adaptive management are made in different ways. There is variation in the definitions and interpretations of the principles, as well as in the kinds of risks, and the kinds of uncertainty about these risks, that decision makers face. This means that, although the appropriate mechanisms for implementing precaution and adaptive management must meet requirements of administrative fairness, these mechanisms will vary between institutions, and according to the nature of the risk and of the uncertainty involved. Subject of course to the criteria surrounding fairness, institutional heterogeneity may contribute positively to legitimacy and effectiveness as decision-making procedures are more closely tailored to the particular nature of relevant risks and uncertainties. I.C. Specificity The lack of uniformity, as demonstrated in several of the case studies, points towards the importance of specificity in granting, exercising and assessing precautionary and adaptive exercises of power. “[L]a crédibilité du principe de précaution en tant que norme du droit souffre de la diversité des interprétations auxquelles il peut se prêter. Un effort de réflexion considérable reste à accomplir de façon à ce que soit davantage précisé le contenu normatif du principe de précaution, surtout dans le contexte d’une application plus systématique de celui-ci.”6 This specificity is necessary if judges are going to feel comfortable with ensuring that precaution is appropriately applied: “le souci de sécurité juridique crée … une véritable demande sociale en faveur d’une délimitation de la portée normative du principe de précaution.”7 In many cases, the challenge of dealing with this potential ambiguity has been dealt with by being specific about several aspects of risk-based decisions: what kind of risk, what kind of uncertainty, what kinds of decisions, what kinds of follow-up measures to monitor what kinds of residual uncertainties? The more specific we are about these elements, the more confident we will be about the thoroughness and reasonableness of the decision made, even if scientific uncertainty remains. Tools such as legislated criteria to be met in terms of the threshold for triggering the precautionary principle and the principle of adaptive management, and criteria for the burden and standard of proof increase specificity and thus reduce the ambiguities involved in applying precaution and adaptive management. By way of linkage to administrative law values, increased specificity in the delegation of precautionary authority can strengthen accountability and thereby also enhance legitimacy.


I.D. The Challenge of Finality Adaptive management raises most distinctly the divergence between administrative decision-making and science with regard to their visions of finality. As we have seen, adaptive management calls for decisions taken in the face of uncertainty to be taken as hypotheses, to be tested and re-evaluated as additional information becomes available. By contrast, administrative decision-makers and reviewing courts have as one of their primary goals the final resolution of disputes or determination of matters before them. Fundamental legal principles such as the rule of precedent, res judicata, and functus officio all indicate the quest, at least in the traditional view to date, of administrative tribunals and courts for certainty and finality. This satisfies the administrative law principles of both fairness and efficiency, in that finality and certainty allow the parties and others relying on the law to know their position and arrange their affairs. If administrative and judicial decisions – apart from measures specifically designated as interim - become temporary or tentative, the argument is that this will reduce the certainty, predictability and hence legitimacy of the legal system.

However, decisionmakers could approach this problem by explicitly acknowledging the relevance of uncertainty. In the context of scientific uncertainty about risk, it is arguably more reasonable to issue a decision that is limited by time, or by particular criteria. The reasons could explain that in the particular arena in question, administrative and judicial decisions are contingent on the state of existing scientific knowledge and normative issues as to what society considers “acceptable” risk. Therefore, a time-limited or conditional decision is being made precisely out of respect for the need to be efficient, fair and legitimate: the parties need some finality immediately, but long-term finality may be inappropriate in a context of risk and changing perceptions of risk. Therefore, while on the surface the approaches to finality in science and law seem anathema, once the underlying rationale for seeking finality is uncovered and applied in the context of uncertainty, these approaches may become less difficult to reconcile. Indeed, as Rod Dobell observed in a passage quoted in the introduction to this Report, adaptive management may enhance legitimacy over time. Specific examples of the resolution of this dilemma include conditional permits or time-limited refusals. These provide immediate finality but also clarify to the greatest extent possible how the parties must proceed, in terms of ongoing research, monitoring and reporting, if they want to continue to hold or renew these rights in the future.

Based on these general themes, the following more specific observations suggest how Canadian administrative law might begin to adapt to incorporate precaution adaptive management.

II. RECOMMENDATIONS FOR PARTICULAR PROCESSES II.A. Standards of Review To determine what elements must be found in exercises of precautionary or adaptive administrative power in order for them to be valid, it is useful to begin from the criteria that will be applied to them if their lawfulness is challenged. The supervisory function of courts over administrative agencies is exercised in Canada through the process of judicial review. This


involves the scrutiny of procedural and substantive decisions made by such agencies according to a variety of standards of review applicable to the particular circumstances in question. Patent unreasonableness is understood to be the most deferential or least intense or intrusive standard of review, with reasonableness occupying a mid-point on the spectrum and a standard of correctness constituting the strictest measure of scrutiny. Which standard to apply is determined in the circumstances with reference to a series of factors including the nature of the issue in question and the expertise of the decision-maker in relation to that question and in comparison with the relative expertise of the reviewing court.8 The Supreme Court of Canada recently provided these general observations on the standard of review:

On questions of law, a decision-maker must generally be correct…. On questions of fact or mixed fact and law…a reviewing body may owe a degree of deference to the decision-maker. …The need for deference and its degree will depend on the nature of the question the tribunal was addressing and the extent to which the facts were within the expertise of the tribunal …Absent error on legal issues, the tribunal may be in a better position to evaluate the issue than the reviewing court, and some degree of deference may be required. In such a case, the standard of review is likely to be reasonableness. To the extent that the issue is one of pure law, and can be isolated from the issues of fact, the standard is correctness. However, where the two are inextricably entwined, the standard will likely be reasonableness.9

Although precaution and adaptive management have not figured prominently in judicial review of Canadian administrative tribunals to date,10 these concepts are being litigated in other jurisdictions11, and one can readily imagine circumstances in which the situation might arise. Indeed there has already been some academic speculation along these lines:

…il est facile de concevoir que le principe de précaution puisse être invoqué à l’encontre du décideur public qui, malgré la présence d’une controverse scientifique quant à la toxicité d’un produit, en autorise néanmoins l’utilisation. Dans ces circonstances, le respect du principe de précaution pourrait justifier, par exemple, l’annulation par les tribunaux de la décision administrative.12

Similar considerations have been most directly addressed in an analysis by Geneviève Cartier who was primarily concerned with the status of precaution as a normative principle of general application rather than with statutorily prescribed duties already established in such areas as health and environment.13 Cartier suggests that precaution may have effect by becoming an element of the reasonableness test in judicial review, based on the finding in Baker14 that “l’évaluation du caractère raisonnable de l’exercice d’une discrétion repose notamment sur sa compatibilité ‘avec les valeurs sous-jacentes à l’octroi d’un pouvoir discrétionnaire’”.15 This once again points us back to underlying social values, but also to the importance of specificity in exercising and assessing precaution and its purposes in a given context. Where a particular decision-maker is charged with the responsibility of applying the precautionary principle in the course of its duties, questions may arise as to the nature of the function actually being performed at any given stage of the deliberations, and as to the relative expertise of that decision-maker in relation to the particular function, among other factors, in order to determine what is “reasonable” in that context.

This paper has no ambition to resolve these issues. It is sufficient to illustrate a selection of determinations made by decision-makers in order to demonstrate some of the implications of precaution for administrative law. They include (1) identifying and assessing the nature and severity of risk; (2) sources and degree of uncertainty with reference to these determinations; (3)


cost-benefit evaluation in this context; and (4) the nature of precautionary/adaptive responses to be implemented. It is not easy to determine in the abstract whether these various issues are to be regarded as questions of fact, of law, or of mixed fact and law, and it is difficult as well in many instances to assert with confidence the relative expertise of the administrative decision-maker and the reviewing court. Does a statutory provision calling for precautionary decision-making establish a rule of law that is more likely subject to review on the basis of correctness, especially where the same provision may govern decision-making by a number of different institutions? Or does such a provision actually call for a particular form of regulatory inquiry, one in which the tools, processes and procedures are sufficiently distinct from legal process that the original decision maker would be entitled to some measure of deference or respect based on a stronger institutional capacity to conduct its deliberations in a precautionary manner? Are the considerations at play the same or different at a stage of decision-making where we are no longer asking whether the precautionary principle should be applied but are instead concerned with the nature of the response, in other words the remedial aspect possibly involving a clear rejection or denial of an application, or approval subject to conditions, or monitoring requirements, or a provisional approval subject to reconsideration?

However these questions might be answered in specific institutional settings, it remains the case that the overall assessment will revolve around the underlying values of administrative decision-making as strengthened or undermined by specific features of the decision-making process. Recognizing that the categories are not perfect and that other considerations will certainly arise, this commentary highlights only some of these, such as Deference (including the issues of discretion and expertise); Participation; Procedure and Accountability.

II.B. Deference The deference of courts to administrative decision-makers in judicial review is largely based on two essential elements – the expertise of the decision-maker and the discretionary nature of its powers.16 Since precaution and adaptive management are explicitly and deliberately applied in contexts of scientific uncertainty, is the implementation of these principles likely to increase or decrease the deference of reviewing courts? It has been argued that in Canada, “some of the potential difficulties those challenging administrative decisions in the light of the precautionary approach may face [include the fact that [w]here …] legislation provides broad licensing discretion, and even favours economic development, judges are likely to be highly deferential. Courts may also be hesitant to address reversal in the burden of proof given traditional faith in bureaucratic expertise.”17 How does the administrative law notion of expertise change in light of the precautionary principle and adaptive management? Several kinds and sources of expertise embodied in several institutional sources are relevant to the implementation of precaution and adaptive management. II.B.1a. Relative Expertise of Reviewing Courts

Cartier observes that in one sense, precaution re-inforces a decision-maker’s claim to deference because “c’est précisément [son expertise] qui lui permet d’établir que le contexte est un contexte de précaution.”18 Courts may be less willing to interfere with findings of experts who


can assess the risks inherent in a new product or process. However, where the science is uncertain, it is difficult to clearly separate science from legal and policy questions. The challenge of dealing with scientific uncertainty has led on occasion to proposals, not merely for reform but for complete transformation of existing institutions. This in itself speaks volumes about the perceived polar opposition between science and social decision-making, or what has been referred to elsewhere as “the texture of science-society relations.”19

II.B.1b. Science Courts

An example of a complete new institution arose in 1967, when Arthur Kantrowicz proposed, in the United States, an “Institution for Scientific Judgment”,20 later dubbed the “Science Court”.21 Its goals were “to assure more accurate scientific information about technical issues, to limit the policy-making power of scientists (who are claimed to have too much policy influence), to prevent policy makers from hiding behind scientific conclusions for their policy decisions, and to identify and expose discredited scientific claims.”22 Although the Science Court was never created in the USA, some still support the idea, or at least the elements of transparency and competence it proposes to lend to policy-making. Expert scientific panels do exist in many domestic and international policy-making and administrative settings, whose aim is to arrive at clear and objective scientific findings on which policy can be based. Yet it is noteworthy that in a US government report of 1993, it was concluded that a Science Court would not work particularly in a risk assessment context: “it is doubtful that scientific and policy issues can be separated … This is particularly true in connection with risk assessment decisions… in emotionally charged contexts.”23 Science Courts would therefore not be ideal for risk-based decision making because precaution requires decisions to be made despite the best efforts of scientists to resolve uncertainty.24

However, this is not to say that science is not important in the precautionary and adaptive contexts, or that we should abandon efforts to clarify and refine the contribution of scientific knowledge and expertise in public decision-making. Indeed, not only is additional reliance placed upon scientific findings in these circumstances, but the nature and quality of scientific inquiry may be changed by the demands of these principles. There remains a notion that there are areas in the context of risk that are more “purely” scientific than others, and these elements must be assigned to those with scientific expertise. The European Court of Justice has specified the importance of science in the recent Pfizer decision: “when a scientific process is at issue, the competent public authority must, in compliance with the relevant provisions, entrust a scientific risk assessment to experts who, once the scientific process is completed, will provide it with scientific advice. … they must ensure that their decisions are taken in the light of the best scientific information available and that they are based on the most recent results of international research.”25 So the goals of increasing the quality of science and its utility to social policy, remain important. There is certainly nothing anti-scientific in striving to do precaution or adaptive management well.


II.B.1c. Environment Courts In the environmental sphere, the idea of a new form of institution, marrying the expertise and approaches of science and law, was not lost; several Environment Courts currently exist. Australia and New Zealand have four environmental courts,26 and they are also found in Sweden, among other places. The International Court of Justice has an Environmental Chamber, a sub-group of its judges who have environmental expertise, but it has not yet been called upon.27 Although there is considerable variation, most Environmental Courts have several areas of jurisdiction, involving merits reviews of government or agency decisions, civil law suits seeking damages, injunctions or declarations for breaches of environment-related laws, and criminal law and environmental offences.28

Malcolm Grant29 identifies 10 criteria or aspirations that have led to the establishment of environmental courts,30 which can generally be reduced to three main concerns: improvements in expertise/capacity, access, and innovation. With regard to expertise, environment courts include judges qualified in the law, but also environmental experts, either as members of the tribunal or assistants to the court. For example, the New Zealand Environment Court includes “Environment Commissioners”31 whose varied expertise includes surveying, planning, medical sciences/biology, engineering, landscape architecture, resource studies, farming, conservation, Maori issues and local government experience. The expertise of the environment courts in Australia32 and Sweden is comparable.33 With regard to access, these courts have introduced procedural changes such as broader rules of standing and intervenor rights, changed costs rules, less formality, and “a more inquisitorial mode”34 of operation.

It is noteworthy that these new kinds of institutions, although closely modelled on traditional administrative and judicial institutions, have started with procedural changes in order to overcome the challenges of the competing paradigms of science and law. Equally important is that the new institutions accompanied changing attitudes toward the environment and its relative importance as a social value. Indeed, the new institutions have played a role in continuing or even leading these changes.

The substantive results of Environmental Courts have varied, but it has been generally recognized that the Australian and NZ Environment Courts particularly have been instrumental in strengthening the precautionary principle.35 One reason is their potential to centralize consideration of environmental issues, leading to greater specialization and expertise, and also to the development of innovative and coherent environmental jurisprudence.36 In fact, it has been argued that “[t]he greatest factor in promoting the judicial application of the precautionary principle … has been the availability of merits review by specialist courts.”37 The efforts of these courts may be a result of strong and more explicit environmental legislation, but specialist environmental courts do offer the expertise, flexibility and focus that make possible procedural changes which in turn impact the substantive interpretation of the precautionary principle. But is a specialist court necessary?

II.B.1d. Non-Specialist Courts As noted above, the Court of First Instance and the European Court of Justice have also had significant impact on the interpretation and application of precaution, despite their lack of specialized expertise.38 As in Australia and New Zealand, the precautionary principle is strongly


entrenched in the treaties and legislation of the E.U.39 We again encounter a chicken and egg scenario, as it is unclear whether the European Courts were emboldened by increasingly precise legislation on the precautionary principle, or whether the legislature was empowered by bold judicial opinions.

Although these courts do not have Environmental Commissioners or experts, the judges are assisted by Advocates General, whose task is to give a neutral, detailed opinion of the issues and arguments in the case. While the AGs are also lawyers, they have room in their reasons to touch in detail on issues such as the precautionary principle, its history and impact and potential consequences in a given case.

An example of the Court’s impact on the development of the precautionary principle is the Pfizer40case, in which the plaintiff challenged the Council’s Regulation revoking its permit for the use of antibiotics in animal feed. “[T]he Council relied on the precautionary principle as justification for adopting the regulation,”41 and the Court upheld the Council’s actions. In affirming the use of precaution, the court also clarified the burden of proof, the standard of review and the method and quality of scientific analysis in risk situations. This suggests that specialist courts are advantageous but not necessary for the implementation of precautionary decision-making. II.B.2. Redefining “Reasonable” What is “reasonable” in administrative decision-making must be determined from the social values or objectives underlying the grant of the discretionary power. If the precaution is gaining the status of a general normative principle in administrative law, as Cartier and Trudeau, among others, suggest, the principle itself can provide underpinning values against which to judge reasonableness. As pointed out at the Workshop, the standard of “patent unreasonableness” may discourage administrative decision makers from identifying uncertainties, and encourage them instead to focus on what is certain and justifiable as a basis for decision. Yet precaution and adaptive management require administrative decision-makers to be more active in seeking out uncertainty, to express it more clearly, to set out the alternatives and the information that is lacking. One example of this approach is found in the Rules of Procedure of Ontario’s Environmental Review Tribunal.42

The role of law is to resolve disputes and therefore it seems unlikely that the law will fully turn its back on the goal of finality. However, as suggested in the Workshop, we must try to reconcile uncertainty and finality, perhaps by means of interim licences or permits, which achieve a kind of “temporary finality.” These conditional decisions, as well as the specific details of the reasons provided for precautionary measures, again return us to the theme of specificity in the terms of the statutory delegation as a necessary element of precaution and adaptive management.

Ambiguity could be reduced by including more specific criteria in legislation on what is meant by precaution or adaptive management in a given context, and how it is to be implemented. Several of the case studies involve a detailed list of criteria as to the risks and the kinds and levels of uncertainty to be considered (e.g. GM Plants, PMRA), whereas the Forest Pests study calls for more explicit criteria, such as in Wingspread definition of the precautionary principle.43 This is not without controversy, as some have argued that specific definitions may


reduce the capacity of the precautionary principle to expand or “adapt” to new developments. It was noted at the Workshop that a definition of precaution limited to the idea that uncertainty should not be an excuse to postpone measures might impede a gradual development of the definition, for example to mean that a risk of serious harm creates a duty to act to prevent it. However, if explicitness is not considered advisable in the legislation, it is certainly necessary in the reasons given for precautionary and adaptive decisions, if they are to be found “reasonable” by administrative law standards.

II.B.3. Standard of Review and Deference in Practice There are generally two main elements of the determination to be precautionary: the scientific finding that precaution is called for, and the selection of precautionary measures to take. The first arguably engages the issue of expertise, while the latter is more closely associated with discretion. In Europe, as we have seen, the first determination must be based on the best possible scientific findings, whereas in connection with the second element, a “wide margin of appreciation” is left to policymakers to determine the level of risk that will be acceptable to that society.44 Again, therefore, the degree of deference will depend on the precise nature of various aspects of the precautionary decision, as will the notion of what is reasonable in that context.

In practice, it has been observed that in the case of many domestic and international courts, when faced with arguments regarding the precautionary principle, the degree of deference depends on whether the precautionary principle is being used as a shield or a sword.45 Where administrative decisions based on the precautionary principle have been challenged, for example by a proponent who has been refused a permit, the courts have tended to defer to the decision-maker and uphold the validity of relying on precaution as an element of reasonable administration. By contrast, where the decision is challenged as failing to be precautionary, or being insufficiently precautionary, the courts are much more reluctant to impose precaution as a duty on decision makers who have deemed its use inappropriate or unnecessary in the circumstances.46 It also seems likely that courts will be more willing to find fault when a decision-maker has completely refused to be precautionary, and less so when the decision-maker has expressly or impliedly exercised precaution and the complaint is that it has done this incorrectly or not vigorously enough. This may simply be an example of the general tendency for courts to defer to administrative expertise, since in both cases the courts are upholding rather than overturning the administrative decision. Yet it also suggests that, although courts can be helpful in strengthening the precautionary principle, the impetus for the increasing incorporation of these principles into administrative law may be more likely to come from within the administration itself, rather than being judicially imposed. This has implications for what the next steps should be in the incorporation and implementation of precaution and adaptive management.


III. REFORM POSSIBILITIES

Factoring in Uncertainty

Having highlighted the main issues and challenges illustrated by the case studies, the following are some specific observations on the strengths of existing mechanisms and the options for improvement. These suggestions recognize that by definition, uncertainty prevents us from providing one-size-fits-all procedures and processes to accommodate the kinds and degrees of risk and uncertainty that will be found in varying contexts. What is uniform, however, is that in order for a precautionary or adaptive decision to be reasonable, it must deal explicitly with the scientific uncertainty involved.47 III.A. Personnell and Experience III.A.1. Selection The case studies reveal that the composition of decision-making bodies varies considerably. The mix of science and policy involved in precautionary and adaptive decisions suggests that combining expertise within the original decision-making panel as well as any reviewing commissions or courts, as in the Environment Courts, will lead to better precautionary and adaptive decisions. This may enhance legitimacy by ensuring that all aspects of the decision receive proper input, and can promote fairness by ensuring that all aspects of the parties’ interests are adequately addressed. It may pose challenges to effectiveness in complicating resolution of problems by including experts with very different approaches and underlying values, but any ensuing debates and struggles may be precisely what is called for in trying to develop new approaches to risk.

III.A.2. Training Regardless of their particular field of expertise, decision-makers must be made aware of, and kept up to date on, the rapidly evolving science and policy involved in risk-based decision-making or relevant alternatives. This includes educating all types of experts involved on the intricacies of the areas of expertise of other members. In cases where both scientists and lawyers or social scientists are on the same panel, it would greatly enhance their collaboration if they had better tools to communicate. The need for education is particularly acute in generalist bodies, who may have little experience with environmental issues. Judicial education may have a beneficial impact if courts are going to continue to play as important a role in developing environmental principles as we have seen them do in Europe, Australia, and New Zealand.


III.A.3. Input/Consultation

III.A.3a. Expert Panels Many administrative branches have their own expert scientific panels to provide policy makers with the scientific bases for decision-making. Although we have seen the difficulties that this separation of tasks can engender, this is one method of bringing expertise to bear on precautionary or adaptive decision-making. The PMRA case study illustrates an administrative structure that seeks to obtain a range of expertise on issues relevant to the decision at hand.48

III.A.3b. Expert Parties In many of the case studies, considerable reliance is placed on the expertise and specialization of the proponents themselves to complement or in some cases entirely replace expertise in the administrative structure.49 In the case of certain GM plants, the proponent may conclude on its own that the notification and authorization requirements have not been triggered because of a legislative exemption for plants that are derived from and "substantially equivalent, in terms of its specific use and safety" to plants already existing in the Canadian environment. In such cases, the proponent, rather than the regulator seems to be conducting the key safety assessment. As a result, we are reliant on the proponent's expertise and vulnerable to their underestimation of safety risks. Where we are relying so heavily on the proponent for information, the importance of independent testing and monitoring is underlined, and consideration should be given to making this oversight mandatory rather than optional.

III.A.3c. Court-Appointed Experts

Where the proponent’s knowledge and/or decision-maker’s expertise is in some way inadequate or incomplete, there is also the option of court-appointed experts. This procedure is available in many contexts, and is a feature of the NSW Land and Environment Court.50 This procedure not only permits recourse to a wider range of expertise but also achieves the goal of objectivity and neutrality,51 one of the goals of the Science Court proposal, and an essential quality of valid administrative decision-making.

III.A.3d. Conclusion re Expertise

While challenges involving expertise arise frequently in law, precaution and adaptive management present distinctive circumstances. The special context of uncertainty in which they apply suggests an unquestionable need for expertise, and therefore highlights the importance of integrating expertise into the process of decision-making and review. Yet secondly, precaution and adaptive management alert us to the importance of science, but also to its limitations, and therefore require that the range of expertise must be appropriate to address all aspects of risk-


based decision-making. Finally, these principles may change what we consider to be expertise, as they require changes to approaches to science itself:

The Precautionary approach actually enhances the rigor of the scientific process because it is based on an awareness of the real limitations of science – ‘green science’ or ‘second-order science’ that will allow the uncertainties of scientific knowledge to be made explicit and promote the wider public debate on new products and processes that may cause environmental harm. … would not preclude scientific predictions under a precautionary approach from being subjective but would require information to be conveyed to decisionmakers in a manner that clearly draws attention to the uncertainties.52

The particular structures of expertise will vary according to the particular issue, but the need to address these two elements of expertise will remain constant, and a minimum requirement should be to insist that expert witnesses identify the sources and nature of the uncertainty and their degree of confidence in the conclusions they have reached.53 III.B. Participation We have seen that the complexity of environmental questions, particularly those involving scientific uncertainty, tends to induce both greater reliance on technical expertise, and at the same time greater wariness of relying solely on science. As this Report has repeatedly emphasized, uncertainty means that decisions must be made despite the fact that experts lack firm answers or disagree. Applying precaution and being adaptive means not only identifying and assessing risk, to the extent that expertise makes this possible, but also determining, and periodically revising, the level of risk that is acceptable to the society that will be asked to bear it. In terms of the effect on administrative law of precaution and adaptive management, therefore, one of the most significant effects is to re-enforce the importance of public participation in administrative law.

Participation is a central, and increasingly emphasized, element of fairness and legitimacy, and relates to issues of access to justice and of representativeness. In all exercises of administrative power, it is fundamental that immediate parties have the opportunity to be heard prior to a decision being made, as well as the opportunity to challenge final determinations. However, in many environmental cases, particularly those involving uncertainty and therefore raising the precaution and adaptive management, administrative decision-makers have been tasked with making decisions with a large focus on the public interest. In such cases fairness also requires a right to be heard for broader sections of the public.

Apart from requirements of fairness, rights of participation also have the benefit of enhancing the quality of administrative decisions, by ensuring that decision-makers have access to greater sources of information and a broader range of perspectives.

The precautionary principle and the principle of adaptive management simply enhance the relevance of these arguments. In situations of scientific uncertainty, consultation and participation become even more important. “[C]omment justifier la participation de simples citoyens à des décisions qui impliquent de considérations scientifiques complexes ? … À notre avis, cette participation est justifiée, rendue nécessaire, par une reconnaissance du fait que, lorsque preuves scientifiques sont insuffisantes ou contestées, les questions deviennent alors des questions sociales, qui concernent, au tout premier chef, les citoyens.”54 The federal government


document “A Canadian Perspective on the Precautionary Approach/Principle”55 also emphasizes the link between precaution and enhanced participation:

An understanding of the ‘public’s tolerance for risks’ or ‘society’s chosen level of protection’ underpins the need for greater transparency, clearer accountability and increased public involvement. Precautionary decision making is often associated with disputes and, eventually, balancing of values, high economic stakes and urgency….Public involvement can provide a platform to resolve conflict or engage in joint problem-solving by a specific set of rules. Importantly, it can bring about the recognition of ambiguities and uncertainties and promote acceptance that, ultimately, both expert and lay knowledge are relevant. Moreover, it can provide impetus for peer review and an opportunity to receive interpretations on uncertainty and risk from the public.56

The document also emphasizes that participation is important at several different steps in the decision-making process: “Public involvement should be structured into the scientific review and advisory process, as well as the decision-making process.”57 Thus, participation is important at the more “scientific” stages of identifying and assessing risk, as well as at the more purely policy-making stage of determining what risks are acceptable.

Some of the case studies, the study on Fisheries in particular, have presented examples of very participatory processes, while others have highlighted the lack of access to original decision-makers or opportunities to challenge. While most administrative decisions can be contested by means of judicial review in courts, the traditional barriers to litigation such as costs and delay can be prohibitive. Courts have, and must continue to, make changes to enhance access to justice, particularly for public interest litigants. Changes to procedures to allow greater participation is one of the hallmark features of the Environment Courts. Not only are rules of standing modified, but rules relating to costs are also changed to encourage greater access by a variety of participants.

Opportunities for input into original decisions, or opportunities to challenge decisions, are essential features of precautionary decision-making. The greater the uncertainty and the more serious the potential consequences, the more “reasonable” administrative decision-making should be based on greater opportunities for participation. Far from eclipsing the importance of participation, the increased focus on expertise which precaution and adaptive management raise also reinforces the importance of the participation of laypersons. Robust procedures for participation of parties and the public will help to counteract any tendency to automatically defer to scientific expertise, and will help to ensure that decisions to permit particular kinds and levels of risk are acceptable to the society that will be affected.

III.C. Procedure Triggers

As highlighted in the Introduction and Case Studies, there are a variety of triggers for precaution or adaptive management. The degree of harm required ranges from any harm to “serious and irreversible” harm. The likelihood of harm also varies, from a mere possibility to probability or conclusive proof of harm.58 Where the trigger is clearly stated in legislation, decisions must meet these express thresholds. Where the trigger is not clearly stated, this provides a further challenge to a reviewing court in determining whether the decision to be precautionary was reasonable.


The answers will depend on context, but generally, the less specificity in the guidance to decisionmakers, the greater the need to explicitly state in reasons for decision what the chosen trigger was and why this was appropriate in the circumstances. III.D. Precautionary Principle III.D.1. Burden of Proof Shifting the Burden The issue of the burden of proof is so important in the context of precaution that some use the expression “reversal of the burden of proof” and “precautionary principle” as synonymous.59 One reason for reversing the burden of proof in situations of uncertainty was the unfairness that resulted from demanding that opponents with limited resources and access to information or decision makers, bring sufficient evidence to prove that a new product or process was harmful. The requirements for permits are examples of processes that have applied a reversed burden of proof.

Many of the case studies demonstrate a reversal of the burden of proof, by presuming that the process or product is harmful until proven safe, which returns us to the idea of values. The precautionary principle and adaptive management, while allowing for a balancing of competing interests, call for the protection of the environment to be taken very seriously in this balancing.60 A presumption that environmental harm will be serious and irreversible, or that particular kinds of products or processes will be harmful, greatly changes the burden of proof.

Yet, while reversal of the burden or presumptions in favour of the environment are increasingly common features of precautionary processes, some questions remain. For example, although the GM Plants process is based on a reversed burden of proof, the proponent only has the burden of proving the five designated categories. The burden of proving that there are no “unanticipated risks” is not assigned, and therefore likely falls on the decision maker itself or the public. This is where adaptive management approaches would tie in, as discussed below. The question is whether the burden does and can remain with the proponent for any and all risks for an unlimited period of time, or whether fairness requires that the burden and its limitations be explicitly stated in advance.

III.D.2. Standards of Proof Another area of inconsistency is the standard of proof required in cases of risk. How can the party with the burden of proof meet that burden? As Cranor has defined it, “legal standards of proof are specified degrees of certainty that a finder of fact must have before coming to a legal conclusion.”61 In cases of precaution, sometimes the conclusion being sought is whether a party has produced enough evidence to “trigger” precaution. What can differ is the degree of certainty the decision-maker must attain before determining whether precaution is warranted, or before determining whether to grant or withhold a permit or licence, or before a court concludes that a decision-maker has erred in being precautionary, or in failing to be precautionary enough.


In the case studies, the standard of proof varies. In most cases, proponents are not required to prove that there is no risk to health or the environment, but standards such as “minimal risk” (GM Plants), “unacceptable risk”, and others are found. Neither the criminal standard (proving complete safety beyond a reasonable doubt) nor the civil standard (more likely to be safe than not) seem to be appropriate. Barton suggests a “standard of reasonable ecological concern”, lying somewhere between the two, which does “not require[e] proof from the proponents that no environmental harm would ever occur, but weigh[s] the risk of error in favor of the environment.”62 Such alterations to the underlying fundamental concepts of law, such as standards of proof, show the powerful conceptual changes that precautionary and adaptive management can have, but also the capacity of law to meet these challenges.

III.D.3. Weight of Evidence A further procedural change that can facilitate precaution is the weight of evidence approach, such as required in CEPA, 1999 relating to toxic substances.63 This approach has been defined as « a cumulative and qualitative (as opposed to quantitative) evaluation of a body of data. ».64 The weight of evidence approach “permet aux décideurs d’accepter et de considerer toutes les données disponibles pour ensuite prendre une décision avant qu’il ne soit trop tard, plutôt que d’attendre une preuve directe et irréfutable des dommages causés. »65 This approach requires decision-makers to seek out information about risk and uncertainty, and to diversify the sources of information they consider. The result is more precautionary and adaptive decisions, since the weight of evidence approach “a pour effet de miniser les ‘faux négatifs’ (croire faussement qu’une substance est inoffensive) et de faire en sorte que les inévitables erreurs scientifiques se manifestent davantage ‘du côté de la précaution’.”66

This is similar to the approach in the European Community. European courts have held that science is important, in that precautionary measures cannot be based on pure speculation, and that “precautionary measures may be taken ‘only if the risk, although the reality and extent thereof have not been fully demonstrated by conclusive scientific evidence, appears nevertheless to be adequately backed up by the scientific evidence available at the time when the measure was taken.”67 The weight of evidence approach is one manifestation of a reversal of the burden of proof, and is another useful tool in the implementation of precautionary decision-making and adaptive management.

III.E. The Principle of Adaptive Management While many of the procedural changes noted above are also applicable to implementing adaptive management, it has specific requirements of its own. III.E.1. Finality and Timeframes As noted above, one of the main conflicts between scientific and legal process is their approaches to finality. However, law and policymakers can take a page from the scientific method and start to view decisions made in the context of risk as hypotheses. Decisions are still


based on the administrative principles of certainty and finality to the extent possible in the circumstances, but reasons must more clearly state the limits applicable in each, and decision-makers must devise means to deal with the uncertainties that remain.

This can include making decisions that include conditions and ongoing duties, and are time limited. A decision may contain specific conditions itself, such as indicating that the permit will remain valid until evidence of harm is found, and may include ongoing duties to monitor and investigate known, suspected or unanticipated harms or to report these in a timely manner. Alternatively, the enabling legislation may create a general power in the particular decision maker to amend or revoke any permit or approval in the face of evidence of harm. A permit or approval may be specifically time-limited, requiring a review of up-to-date information in order for a renewal to take place. For example, the European GMO Directive 2001/18 provides that “[n]ot only must a risk analysis be performed before any releases, but releases will only be approved for limited durations, at the conclusion of which an additional risk analysis must be performed.”68 Given that most scientific evidence is based on research done for limited periods of time in limited locations, perhaps there should be another presumption that risk-based decisions should always be time-limited and subject to periodic review.

III.E.2. Interaction between the Precautionary Principle and the Principle of Adaptive Management Where it is possible to apply adaptive management principles by means of conditional or time limited approvals, does this increase or decrease precaution? Does the principle of adaptive management make a precautionary decision more or less “reasonable”?

One example of the interaction between precaution adaptive management, and the impact of systemic particularities in applying the principles, is a case demonstrating the effect of federalism on risk management. In Canada, federal registration of pesticides is followed by provincial review of a further set of considerations surrounding the actual use or application of the registered product. In British Columbia, where administrative decisions taken pursuant to the Pesticide Control Act are brought before the Environmental Appeal Board, it has been determined that the board “can consider a registered pesticide to be generally safe when used in accordance with the label.”69 It is also understood that “the fact that a pesticide is federally registered does not mean that it can never cause an unreasonable adverse effect” and that “the test for ‘unreasonable adverse effect’ is site specific and application specific.” Accordingly, while evidence of general toxicity is not ordinarily considered in the provincial permitting process, toxicity evidence might be important, and might indeed be considered, in certain circumstances. “One example,” as hypothesized by the British Columbia Supreme Court, “would be where new evidence relating to toxicity that is not specific to the site in question, has become available only after the federal process was complete.”70 Such an approach, while extending over the cumulative operation of federal and provincial decisions regarding pesticides, is arguably adaptive in character. It is also, in the explicit opinion of the court, consistent with the precautionary principle which “should help to inform the process of statutory interpretation and judicial review. …application of the precautionary principle would favour an interpretation that permitted the Board to consider evidence of toxicity beyond that limited to site specific and application specific concerns. An interpretation that precluded the Board from considering such evidence in any circumstance does not reflect the precautionary principle.” 71


The interaction between the two principles is involved in the issue of finality also, because some things are simply more final than others. The GM Plants study observes that it may in fact be impossible to reverse the effects of GM plants once permitted to enter the environment. This may suggest that if adaptive management is impossible in a given situation, the initial decision should be more precautionary, for example by requiring a higher standard of proof.

III.F. Accountability

III.F.1. Transparency

Perhaps one of the widest variations among the case studies is on the issue of transparency. A lack of transparency can affect legitimacy and fairness. It can give rise to an apprehension of bias in some cases. Requirements that decision-makers expressly state value judgments, such as the level and kind of risk that is acceptable in the given context, and how these levels were determined, would enhance transparency. While we have seen many examples of the flexibility of the administrative law system in accommodating precaution and adaptive management, transparency is one factor on which administrative law will likely remain firm. III.F.2. Reasons One way to ensure transparency, and to make decisions based on uncertainty more “reasonable” in an administrative law sense, is to provide detailed reasons. If there is one administrative law requirement that is greatly enhanced by precaution adaptive management, it is the requirement to give reasons. If we must accept that uncertainty compels us to accept less clarity than we would prefer, and that at some point we simply must choose one option over the other, what makes this acceptable to the parties and to the public, and what makes it legally defensible upon judicial review, is that the decision is buttressed by an adequate account of the deliberative process leading to the conclusions reached. Precautionary administrative rules should explicitly require decisionmakers to set out detailed reasons, and their absence should be considered an important factor in assessing the acceptability of outcomes. Reasons should address the issues that have been raised in this study, including (i) any underlying values that guide its decisions (whether mandated or chosen); (ii) the nature and degree of the risk; (iii) the nature, sources and magnitude of uncertainty; (iv) the burden and standard of proof; (v) any requirements involving adaptive management such as ongoing duties and conditions; and (vi) any remaining questions.

This requirement to give reasons will enhance the accountability of decision-makers, but is this the limit of the requirements of accountability? Workshop participants debated the question of whether, given the degree of reliance on proponents in several of the case studies, the proponent should be liable if the information turns out to have been unreliable when given, and to have resulted in harm that was unanticipated or exceeded predictions.

Another fundamental question whose surface has merely been scratched is who decisionmakers are accountable to. This returns us to the basic question of the nature of administrative law and the division between its enabling and controlling aspects. In discussing the contexts of specific decisions issued to particular proponents, and the requirements of judicial review, the focus is often on the parties themselves, and of course all precautionary and adaptive


decisions must maintain the administrative requirement of fairness to the parties. However, it goes without saying that environmental and health issues also require accountability to the public. This duty to the public may be met in several of the ways already enumerated, such as granting broad rights of standing or participation to the public and considering the public interest in all cases. Particular caution must be exercised, therefore, in contexts where there is no required representation of the public interest. In the GM Plants study, it is observed that the PBO seems to have duty to act in public interest and to be neutral and fair to the proponent, and this conflict should be resolved by enhancing participation in that process to ensure accountability to the public.72 Finally, accountability to the public is ultimately broader than responsibility for a series of individual decisions. Accordingly, consideration should also be given to mechanisms for reviewing and assessing, at suitable intervals, the overall or cumulative record of decision makers in the application of precaution and adaptive management. IV. CONCLUSION The actual implementation of precaution will be subject to the influence of the legal or institutional culture within which it may be applied. This observation pertains not only to differences at the scale of European vs American legal or regulatory cultures, but, as Workshop participants emphasized, to distinctions between departments of government where precaution must be added to, or integrated within, established patterns of scientific thinking and communication. Detailed implementation of precaution will also vary according to specific statutory formulations, while perhaps even greater variations may be expected where precaution is adopted as a general normative principle in the absence of specific statutory formulation. Similar observations might be made in connection with adaptive management, another response to uncertainty that is currently making its way from the realms of the ecological sciences to a range of settings where public decisions must be made.

These variations in the specific application of principles like precaution and adaptive management are barely captured in the four case studies and accompanying analysis that form the core of this report. Their existence is enough however to anchor our initial observation that for public decision-making to remain subject to scrutiny and assessment according to such general norms as fairness, legitimacy and effectiveness in the context of precaution and adaptive management, continuing attention must be given to the institutional and procedural characteristics of the agencies responsible for those decisions.

This report has highlighted expertise, participation, evidentiary and other procedural rules and mechanisms for review and accountability as among the central characteristics whose operation may require close monitoring as precautionary and adaptive decision-making become more common.

The GMO study highlights the question of transparency in the sense that records of decisional processes ought to be more generally available. It is also apparent, however, that even where such records are available for ex post scrutiny, there is a need for a comparatively high degree of refinement in their contents. The concepts involved in precautionary and adaptive management, (uncertainty, risk, harm…), to be truly effective as guides, require a degree of precision. Uncertainty in particular might usefully be associated with its principal cause or


causes. This in turn suggests the importance of reasons grounded in a more consistent framework than is likely to occur on an ad hoc basis.

To support such reasons, and the reasoning or analysis that underlies them, it will be important to ensure that decision-makers possess a suitable degree of understanding of the conceptual elements comprising precautionary and adaptive analysis. It is already clear that the idea of uncertainty may be usefully clarified in a variety of ways with reference, for example, to limitations in data, or in terms of causal hypotheses and so on. For this to occur systematically, rules of practice and procedure may need to encourage – as is the case for the Ontario Environmental Appeal Board – that those offering expert evidence to administrative decision-makers address directly the nature of uncertainty that conditions their evaluation of risks and impacts.

Greater clarity and precision on this front will in turn enhance opportunities for effective public participation, for as even a limited number of case studies and a reading of the varied formulation of precaution demonstrates, public understanding and acceptance of risk, and some appreciation of the manner in which costs and benefits of alternative courses of action are weighed and distributed, are often important elements of precautionary analysis. Technical expertise, while vitally important, is not necessarily conclusive in such circumstances.

As the precautionary principle and principles of adaptive management become more widely operationalized within the realm of administrative decision-making it will further be important to monitor the process of implementation and its effects not only at the level of individual decisions, but in relation to the broader mandate and overall responsibilities of decision-making bodies. While appeals and judicial review remain available in relation to the former, it is also the case that institutions themselves may require adaptation if we are, to follow the Royal Society Report on Biotechnology, to ensure that the values of health and environmental protection we seek to uphold are in fact being nurtured. We would anticipate that in time some agencies of government with general oversight responsibilities such as the Auditor General, the Commissioner for Environment and Sustainable Development, the Standing Committee on Environment and Sustainable Development or the Regulatory Affairs Committee will take up this challenge.

In addition to these general observations, this report, the case studies and the Workshop process have identified a number of more detailed matters that might in time become the basis of further detailed inquiry. These include issues of access to information; consistency of terminology in legislative drafting; problems of functus officio and finality; and of course the ever-present problem of resources.

The precautionary principle and adaptive management are simply tools in the quest for solutions to the environmental problems that confront us.73 We have seen that it is difficult to devise structures to implement precaution adaptive management until we have determined the values and priorities we are seeking to achieve with regard to environmental protection. The transparency which administrative fairness requires should lead decisionmakers to enunciate the values and premises upon which they are basing their evaluations. This will enrich the ongoing social dialogue in our search for the proper balance when practicing precaution.


Potential Future Work Among the many different issues and avenues of inquiry raised by this project, the following are some specific suggestions for future analysis:

• Increasing the database: Analysis of the operationalization of the principles of precaution and adaptive management could be enlarged by analyzing a broader pool of decisions, and a wider range of decision-makers.

• Concrete suggestions for operationalization: o Particular analysis of how the principles may change the

understandings and applications of administrative law notions such as “reasonableness”, “cost-benefit analysis”, standards of scientific proof, etc.

o In order to provide more guidance on possibilities for operationalizing precaution and adaptive management, several existing decisions could be revisited, to provide concrete examples of procedural and substantive changes in the decision-making process or reasoning that could lead to more precautionary or adaptive decisions.

• Education and training: training programmes on these principles for administrative

decision-makers, tribunals and judges could be designed and delivered.

• Future developments: One of many remaining questions is the degree to which new scientific knowledge is likely to affect precaution and adaptive management. Is there resistance to change? Can these two principles help to reduce the common time-lag between new scientific information and policies for implementing these discoveries?

1 See, e.g. Jacqueline Peel “Precaution – A Matter of Principle, Approach or Process?” (2004), 5 Melb. J Intl L. 483 at 499. 2 Ibid.. 3 See, e.g. Case T-13/99 Pfizer Animal Health v Council of the European Union [2002] ECR II-3305. 4Elizabeth Fisher “Precaution, Uncertainty, and Principles of Good Administration” http://upem.er.dtu.dk/files/L%20Fisher.pdf.] 5 GM Plants case study at 2-26. 6 Hélène Trudeau « Du droit international au droit interne : l’émergence du principe de précaution en droit de l’environnement. » (2003), 28 Queen’s L.J. 455. at 525-6. 7 Ibid., citing Kourilsy and Viney, Le principe de précaution (Paris, Éditions Odile Jacob, 2000) at 141. 8 Pushpanathan v Canada (Minister of Citizenship and Immigration), [1998] 1 S.C.R. 982 parag 30-38, as cited in Geneviève Cartier, « Le principe de précaution et la déférence judiciaire en droit administratif » (2002) 43 C. de D. 79-101 at 95. 9 Haida Nation v British Columbia (Minister of Forests), [2004] 3 S.C.R. 511 at para. 61. 10 See, e.g., Cartier supra note 8 at 88; David L. VanderZwaag, Susanna D. Fuller and Ransom A. Myers, “Canada and the Precautionary Principle/Approach in Ocean and Coastal Management : Wading and Wandering in Tricky Currents” (2002-03) 34 Ottawa L. Rev. 117-158 at 127. 11 Re Australia and New Zealand, see Charmian Barton “The Status of the Precautionary Principle in Australia: Its Emergence in Legislation and as a Common Law Doctrine” (1998), 22 Harv. Env Law R 509. Re the European Union, see W.Th.Douma, “Fleshing Out the Precautionary Principle by the Court of First Instance” (2003), 15 J.E.L. 372-405; T.J. Daemen “The EC’s Evolving Precautionary Principle” (2003) Eur. Env. L.Rev. 6-19; J. Cazala “Food


Safety and the Precautionary Principle: the Legitimate Moderation of Community Courts” (2004), 10 Eur. L.J. 539-554; Nicolas de Sadeleer “The Enforcement of the Precautionary Principle by German, French and Belgian Courts” (2000), 9 RECIEL 144-151. 12 Hélène Trudeau, « La précaution en cas d’incertitude scientifique: une des interprétations possibles de l’article 20 de la Loi sur la qualité de l’environnement », (2002) 43 les Cahiers de Droit 103 at 116. 13 Cartier, supra note 8. 14 Baker v Canada (Minister of Citizenship and Immigration), [1999] 2 S.C.R. 817. 15 Cartier, supra note 8 at 92. 16 Ibid. at 79. 17 (emphasis added) VanderZwaag et al., supra note 10 at 129. Similar arguments have been made in the European context, as noted by Advocate General Mischo in the BSE case before the European Court of Justice, Case C-241/01 National Farmers’ Union v Secretariat general du gouvernement, Opinion of Adv. Gen. Mischo, 2 July 2002, 73-74, as cited in Daemen, supra note 11 at 11. 18 Cartier supra note 8 at 97. 19 S. Jasanoff “The Life Sciences and the Rule of Law” (2002), 319 J. Mol. Biol. 891. 20 Arthur Kantrowitz “Proposal for an Institution for Scientific Judgment” (1967), 153 Science 763. See also several subsequent articles by Kantrowicz on the subject. For a good overview of debates on the Science Court proposal, see the proceedings of the “Science Court Symposia” in two issues of (1993), Volume 4 RISK: Issues in Health and Safety, particularly Thomas G. Field, “The Science Court is Dead; Long Live the Science Court!” at 95; Carl F. Cranor “Science Courts, Evidentiary Procedures and Mixed Science-Policy Decisions” at 113. See also Jeffrey N. Martin “Procedures for Decisionmaking under Conditions of Scientific Uncertainty: The Science Court Proposal” (1979) 16 Harv. J. on Legis. 443; “Gordon J. Zimmerman “Synergy and the Science Court: Scientific Method and the Adversarial System in Technology Assessment” (1980), 38 U. Tor. Fac. L. Rev. 170; Thomas G. Field Jr. “Pursuing Transparency Through Science Courts” (2000), 11 RISK 209. 21 Thomas Field Jr. supra note 20 at 210-1. Field notes that the project was not pursued due to political realities of the post-Watergate era, and the politicization of the idea, but that its core purposes remain worth pursuing. 22 Carl F. Cranor supra note 20 at 114. 23 Field supra note 20 at 214, citing Report entitled Improving Regulatory Systems Team, From Red Tape to Results – Creating a Government That Works Better and Costs Less (1993) http://govinfo.library.unt.edu/npr/library/nprrpt/annrpt/redtpe93/index.html at 60. 24 Barton supra note 11 at 549. 25 Pfizer supra note 2 at parags 157-158, as cited in Daemen supra note 11 at 380-81. 26 New Zealand has the Environment Court. In Australia, three jurisdictions have an environment court: New South Wales has the Land and Environment Court since 1979, Queensland has the Planning and Environment Court since 1990, and South Australia has the Environment, Resources and Development Court since 1993. See Malcolm Grant “Environment Court Final Report” (London: (UK Gvt) Department of the Environment, Transport and the Regions, 1999) [hereafter “Grant Report”], Executive Summary at 7. 27 “In July 1993 the Court also established a seven-member Chamber to deal with any environmental cases falling within its jurisdiction”. ICJ official website: http://www.icj-cij.org/icjwww/igeneralinformation/icjgnnot.html. However, the full ICJ court has considered the Precautionary Principle in several decisions: see The Royal Society of Canada, Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada (January 2001) (http://www.rsc.ca//files/publications/expert_panels/foodbiotechnology/GMreportEN.pdf.) at 194. 28 This is the jurisdiction of the NSW Land and Environment Court, and the others are similar. See http://www.lawlink.nsw.gov.au/lec/lec.nsf/pages/jurisimple. 29 See generally the intensive study of Environment courts, with a view to considering their creation in England, in Malcolm Grant “Environment Court Final Report” supra note 26. 30 (1) “specialist and exclusive jurisdiction”; (2) “power to determine merits appeals”; (3) “extent of vertical and horizontal integration”; (4) “hallmarks of a court or tribunal such as independence from government, power to make binding awards, proceedings in public, rules of procedure”; (5) “dispute resolution powers”; (6) “expertise”; (7) “access”; (8) “informality”; (9) “cost”; (10) “capacity for innovation” in Grant supra note 26, Executive Summary at 1-3. 31 See http://www.justice.govt.nz/environment/index.html. 32 In Australia, the 3 courts differ to some extent. For the New South Wales Land and Environment Court, the original and still most well-known court of its kind, see http://www.lawlink.nsw.gov.au/lec/lec.nsf/pages/jurisimple.


On the South Australia Environment, Resources and Development Court, see http://www.courts.sa.gov.au/courts/environment/about_the_court.html). On the Queensland the Planning and Environment Court see http://www.courts.qld.gov.au/about/role_pe.htm. 33 See http://www.dom.se/dom/DVhemsida/Informationsmaterial/Engelska/miljodomstoleneng.htm; James Hurst, "Sweden: the Environmental Code" E.E.L.R. 1999, 8(5), 134-135. 34 Grant Report, supra note 26 at 7. 35 The enabling legislation, or recent revisions to environmental legislation in these jurisdictions, has accompanied or quickly followed the creation of these courts (Stein notes that “All nine Australian jurisdictions have statutes which incorporate core ESD principles. New South Wales alone has in excess of 30 such statutes” see The Hon. Justice Paul L. Stein “Down Under Perspectives of the Environmental Court Project” (London, 27 June 2000) www.lawlink.nsw.gov.au/sc%5Csc.nsf/pages/stein_down at 1at 8) so it is difficult to allocate precisely the role the new institution itself has had, but these experiments do seem to make clear both that environmental decision making requires changes to administrative and judicial procedure, not to mention science, but also that different procedures lead to different substantive environmental outcomes, including different attitudes and results relating to principles such as precaution and adaptive management. 36 See also The Hon. Justice Paul L Stein “Down Under Perspectives of the Environmental Court Project” (London, 27 June 2000) www.lawlink.nsw.gov.au/sc%5Csc.nsf/pages/stein_down at 1 37 Elizabeth Fisher “Is the Precautionary Principle Justiciable?” (2001), 13 J.E.L. 315 at 325 (emphasis added). See also The Hon. Justice Paul L. Stein “A cautious application of the precautionary principle” (2000), 2 Env L Rev. 1; and Barton supra note 11. 38 See references supra note 11. The Indian Supreme Court is also an excellent example of a non-specialist court significantly affecting environmental policy, whose work could usefully be consulted in future research on this issue. 39 EC Treaty art 174(2) (see footnote 20 of Peel, supra note 1; Cazala supra note 11 at 539-40; and Communication from the Commission on the Precautionary Principle (2000) http://europa.eu.int/comm/dgs/health_consumer/library/pub/pub07_en.pdf. 40 See Pfizer supra note 2. 41 Ibid. parag 113. 42 See Guidelines for Technical and Opinion Evidence, adopted by the Tribunal pursuant to s. 25.1 of the Statutory Powers Procedures Act (R.S.O. 1990, c. S-22), on May 31, 2002. (http://www.ert.gov.on.ca/ERT_new_index30.htm) 43 “The Wingspread Consensus Statement on the Precautionary Principle” (Wingspread Conference on the Precautionary Principle, January 26, 1998: http://www.sehn.org/wing.html ). 44 Pfizer supra note 2. 45 Fisher supra note 37 at 321-330, among others. 46 Ibid. 47 Fisher supra note 3. 48 PMRA case study at 5.4-5.5. 49 Bruce Pardy “Applying the Precautionary Principle to Private Persons: Should it Affect Civil and Criminal Liability?” (2002) 43 C. de D. 63, as cited in Trudeau supra note 6 at 521. 50 NSW Land and Environment Court, Practice Direction No. 1 of 2005 - Court Appointed Experts- Practice Direction effective 1 February 2005 http://www.lawlink.nsw.gov.au/lawlink/lec/ll_lec.nsf/pages/LEC_pd_caes 51 One issue raised in the GM Plants casestudy is the conflict of interest of many decision-makers, who must assess requests for permits, with nobody to represent competing interests. The decision-maker must take into account the position of the applicant, any potential opponents as well as the public interest. The input of independent experts is one means of reducing this problem. 52 Barton supra note 11 at 545. 53 John Swaigen and Alan D. Levy, “The Expert’s Duty to the Tribunal: A Tool for Reducing Contradictions Between Scientific Process and Legal Process” (1997-98), 11 C.J.A.L.P. 277. 54 Cartier, supra note 8 at 86. 55 Discussion Document, Sept. 2001, s. 3.6 http://www.pco-bcp.gc.ca/raoics-srdc/docs/Precaution/Discussion/discussion_e.pdf. 56 Ibid., s. 2.2.


57 Ibid, s. 3.6. See also generally . See also Privy Council Office “A Framework for the Application of Precaution in Science-Based Decision Making about Risk”, s. 4.2 and 4.5, http://www.pco-bcp.gc.ca/default.asp?Language=E&page=publications&sub=precaution&doc=precaution_e.htm . 58 Trudeau supra note 6 at 461-2. 59 The first line of Barton supra note 11 at 509 is: “The precautionary principle, which places the burden of proof on proponents of change to show that their actions will not cause serious or irreversible environmental harm…” Of course, not everyone agrees that the two are equivalent. 60 The Royal Society of Canada, supra note 27, esp. section 8. (http://www.rsc.ca//files/publications/expert_panels/foodbiotechnology/GMreportEN.pdf.) 61 Carl Cranor, “Some Legal Implications of the Precautionary Principle: Expediting Information-Generation and Legal Protections” (Iowa State University Bioethics Program Winter Faculty Retreat on the Precautionary Principle, Ames, IA, January 10, 2003) http://www.bioethics.iastate.edu/retreat_2003/powerpoint/cranor2.ppt 62 At 540, referring to the decision in Simpson v Ballina Shire Council (1994) 82 L.G.E.R.A. 392. This new standard meets Barton’s third criterion for precautionary decisions, which is that “In determining whether an activity will cause serious or irreversible damage, the risk of error is weighted in favor of the environment.” – supra note 11 at p 520. 63 CEPA section 76.1. See generally Trudeau supra note 6 at 484-490. 64 Reference Manual for the WHMIS Requirements for the Hazardous Products Act and the Controlled Products Regulations, p. 32-1: http://www.hc-sc.gc.ca/hecs-sesc/whmis/pdf/ref_manual_part8a.pdf). 65 Trudeau supra note 6 at 486. 66 Ibid. at 487. 67 Pfizer supra note 3 parag. 144, as cited in Douma supra note 11 at 400-401. 68 OJ 2001 L106, as cited in Daemen supra note 11 at 15. 69 Weir v British Columbia (Environmental Appeal Board), [2003] B.C.J. No. 2221. 70 Ibid. parag 31. 71 Ibid. parag. 39. 72 Another example from the case study is the mention of the Access to Information Act, R.S.C. 1985, c. A-1. Section 20(2) of the Act allows exceptions to the confidentiality of commercial information in cases of public interest, but only where the public interest outweighs harm to a third party . A precautionary approach should include the presumption that this will be always be the case in the environmental context, and again, shift the burden to proponents to prove the material is confidential. 73 See VanderZwaag et al. supra note 10 at 157, emphasizing the importance of “other principles of sustainable development” in the ongoing development of precaution.

Appendices G-1

G - APPENDICES:

i. Document Questionnaire………………………………………………………………… G-3 ii. Institutional Questionnaire………………………………………………………………. G-11 iii. Workshop Summary…………………………………………………………………….. G-25 iv. Workshop Participants…………………………………………………………………... G-29

Appendices G-2

Appendix i. Document Questionnaire G-3

Practicing Precaution

To which case study does this document pertain?

____________________________

1) Name of tribunal, agency, or institution ____________________________ 2) Type of Document

____________________________

a) Legislation / Statue b) Regulation c) Policy statement d) Judicial decision

e) Decision on application (e.g. for a permit)

f) Agency/tribunal decision g) Review of previous decisions made by the agency/tribunal in question h) Review of previous decisions made by another agency / tribunal

i) Directive

j) Other ( please specify) _____________________________

3) Bibliographic Information (If you need help please see help page)

a) Title _____________________________ b) Authors _____________________________ c) Date of publication _____________________________ d) Start page _____________________________

e) End Page _____________________________ f) Document source _____________________________


4) Is the document concerned either implicitly or explicitly - with potential impacts on

a) The natural environment Yes No b) Human health Yes No c) Human economic welfare Yes No d) Human sociocultural values Yes No e) The natural environment independent of human impacts there on Yes No

f) Unspecified Yes No g) Other ( please specify)

Yes No ____________________________

5) Does the document make explicit reference to the precautionary principles? Yes No If so, indicate the first page in the document where the reference occurs.

____________________________

6) How many times is the precautionary principle explicitly referred to in the document?

____________________________

7) Does the document make explicit reference to or imply elements of a precautionary approach?

Yes No 8) Does the document include an explicit definition of the precautionary principle? Yes No If yes, please provide a) Page number on which the definition appears.

____________________________

b)The definition(verbatim)

____________________________

9) If the document refers implicitly or explicitly to the precautionary principle, is the intended meaning of the term clear? Please enter a score from 0 (PP not implicitly or explicitly referred to) to 1 (meaning completely unclear) to 7 (meaning crystal clear). Note: An explicit definition does not necessarily imply the meaning is clear.

0 1 2 3 4 5 6 7


10) The following is a list of "precautionary elements", that is, concepts associated with the precautionary principle. If the document either implies or explicitly mentions a precautionary approach or elements thereof, assign a score from zero to 7 which describes the importance or strength of implication associated with the listed concepts (0 = unable to assess, 1 completely unimportant or very weakly implies, 7 critical or very strongly implied)

• The greater the potential severity of harm of an action, the greater the evidence that such harm will not occur before the action is pursued.

0 1 2 3 4 5 6 7

• The greater the potential spatial or temporal scale/scope of an action, the greater the required evidence that the action is unlikely to be harmful before the action is pursued.

0 1 2 3 4 5 6 7

• Uncertainty surrounding expected outcomes of actions must be considered along with the expected outcomes themselves when evaluating different courses of action.

0 1 2 3 4 5 6 7

• The greater the uncertainty about the predicted negative impacts of an action, the less likely it is that the action will be pursued.

0 1 2 3 4 5 6 7

• Precautionary (either anticipatory or preventive) action does not require a high degree of scientific certainty concerning cause-effect relationships.

0 1 2 3 4 5 6 7


• Evidence is required that a potential course of action will not cause serious harm before proceeding, rather than requiring evidence that a potential course of action is likely to cause serious harm before not proceeding (i.e. the action is assumed harmful unless demonstrated otherwise, versus assumed innocuous unless demonstrated otherwise.)

0 1 2 3 4 5 6 7

11) Does the document

a) Explicitly invoke the precautionary principle as a contributing rationale, justification, foundation or criterion for decision making?

Yes No

b) Implicitly invoke the precautionary principle as a contributing rationale, justification, foundation or criterion for decision making?

Yes No

12) Does the document make explicit reference to uncertainty? Yes No If so, please indicate the first page on which such a reference is made

_____________________________

13) Does the document make explicit reference to scientific uncertainty? Yes No

If so, please indicate the first page on which such a reference is made

_____________________________

14) Does the document give; an explicit definition of scientific uncertainty? Yes No If so, please provide a) Page number on which the definition appears.

____________________________

b)The definition(verbatim) ____________________________


15) There are many different sources of scientific uncertainty. Score each potential source below on a semantic congruence scale with respect to the degree to which it captures the intended meaning of the term as used in the document( 0: unable to assess; 1: listed interpretation is very different from intended meaning; 7: listed interpretation almost identical to intended meaning).

• Lack of knowledge about cause-effect

relationship underlying the system(s) we are attempting to manage.

0 1 2 3 4 5 6 7

• Statistical uncertainty about the predicted effects potential course of action.

0 1 2 3 4 5 6 7 • Poor quality evidence, i.e. evidence

derived from studies that are poorly designed or that provide only weakly circumstantial rather than direct evidence.

0 1 2 3 4 5 6 7

• Evidence derived from sparse empirical data (i.e. few studies, though the studies may be of good quality).

0 1 2 3 4 5 6 7

• Uncertainty associated with potential inadequacies in the spatial or temporal resolution/scales of empirical sampling e.g. “evidence” that requires extrapolation from small time or space scales (at which the studies are done) to larger time space scales ( that we are really interested in). An example might be a study done over the space of a few months, the results of which are extrapolated to years or decades.

0 1 2 3 4 5 6 7

• Extrapolation uncertainty (e.g. from lab results to nature, from forest plots to an entire forest stand, from one species to all “similar” species, etc.)

0 1 2 3 4 5 6 7


16) Does the document make explicit reference to “adaptive management” ? Yes No

If so, please provide a) Page number on which the definition appears.

____________________________

b)The definition(verbatim) ____________________________

17) How many times is the adapative management explicitly referred to in the document?

____________________________

18) Does the document make explicit reference to or imply elements of adaptive management ?

Yes No If so, how many times is this something referred to in the document?

____________________________

19) Does the document include an explicit definition of the adapative management? Yes No If yes, please provide a) Page number on which the definition appears.

____________________________

b)The definition(verbatim) ____________________________ 20) If the document refers implicitly to the AM, is the intended meaning of term clear? Please enter a score from 0 (adaptive management not implicitly or explicitly referred to) to 1 (meaning completely unclear) to 7 (meaning crystal clear). Note: An explicit definition does not necessarily imply the meaning is clear.

0 1 2 3 4 5 6 7

21) The following is a list of adaptive management elements that is, concepts associated with the adaptive management. If the document either implies or explicitly mentions adaptive management or elements thereof, assign a score from zero to 7 which describes the importance or strength of implication associated with the listed concepts (0 = unable to assess, 1 completely unimportant or very weakly implies, 7 critical or very strongly implied


• Decisions are treated as scientific experiments (that is, are structured so as to allow testing of causal hypotheses).

0 1 2 3 4 5 6 7

• Past decisions are assumed to have been “correct” (i.e. are assumed to have had a desired effect) unless demonstrated otherwise.

0 1 2 3 4 5 6 7

• Predicted effects of alternative decisions are made explicit and considered.

0 1 2 3 4 5 6 7

• “Knowledge” accrued from past decisions is used to inform future decision making.

0 1 2 3 4 5 6 7

• Data and information on the effects of previous decisions are analyzed and assessed in a timely manner.

0 1 2 3 4 5 6 7

• Effects of previous decisions are systematically monitored.

0 1 2 3 4 5 6 7

• Predicted effects of decisions are systematically compared with observed effects as determined from monitoring or surveillance.

0 1 2 3 4 5 6 7

• Large discrepancies between observed and predicted effects of past decisions reduce the likelihood that the same decision will be made in future.

0 1 2 3 4 5 6 7

22) Does the document

a) Explicitly invoke the AM as a fundamental methodological principle for decision making.

Yes No

b) Implicitly invoke the AM as a fundamental methodological principle for decision making.

Yes No


Help Page

Bibliographic Information

1) Title: Title of the document, e.g., Metastasis genes: A progression puzzles etc. 2) Authors: Please write down the name of the Authors. If the number of authors is more than one then Names should be separated by a semi colon (;), e.g., Bernards,Rene; Weinberg,Robert A;. 3) Date: Please specify the date of publication in the format Month/Day/Year, e.g., 08/22/2004. 4) Start Page: Please enter only Integer values. 5) End Page: Please enter only Integer values. 6) Document Source: Please enter one of the following a) Peer reviewed journal paper b) Book c) Chapter in Book d) Conference proceedings e) Published report * f) Published document ** g) Unpublished report h) Unpublished document * A document which mainly presents factual information produced by the employees of the tribunal / agency/ institution in question, that is freely available to the public. An unpublished report is one that can be obtained only through an Access to Information request. ** A document which presents mainly opinion produced by the employees of the tribunal / agency/ institution in question, that is freely available to the public. An unpublished document is one that can be obtained only through an Access to Information request. Examples to published documents would include judicial decisions, permit decisions, etc.

Appendix ii – Institutional Que stionnaire G - 11

PRACTICING PRECAUTION: INSTITUTIONAL QUESTIONNAIRE

Revised February 25, 2005

Introduction and Commentary: The intent of this questionnaire, when revised and completed, is to provide as much as possible by way of a common frame of reference for understanding and eventually evaluating the experience revealed through the four case studies. To the extent that the research team is able in advance to establish a set of questions that each case study researcher can address we will strengthen the quality of the data available to Andre Dabrowski for presentation and interpretation. We will also have succeeded in generating more cumulative and more comparable results through a collective effort than any of the case studies might offer in isolation. There will, of course, be idiosyncratic and distinctive elements to each case study which the separate sections will capture independently. In order to increase the likelihood that we will have similar goals in mind for the data development exercise, we plan to arrange an opportunity for everyone to consider the questions together [“What does this mean? I don’t see it that way. That probably won’t work for my case study.” Etc] In addition, the current suggestion is to have the case study authors meet together to review their responses with a common moderator/interviewer to try again to ensure commonality. [e.g. “This is what I meant when I answered that way. Now that I hear how others did it, I guess I would shift the response a bit.”] For many of the questions, you will be asked to score a particular response in terms of either (a) frequency/likelihood of use in decision-making; (b) importance or priority in decision-making; (c) “semantic congruence”, e.g. the extent to which the meaning attached to a particular phrase (e.g. adaptive management) by a tribunal/agency implies a particular concept (e.g. decision-making as scientific experimentation). The scoring scale is always from 0-7 and is interpreted as follows:

Score Frequency/likelihood Importance Semantic congruence 0 Unknown (insufficient

information to assess) or not applicable

Unknown or not applicable Unknown or not applicable

1 Never (0%) Completely unimportant (never a factor in decision-making)

Understood meaning never implies concept; concept is irrelevant

2 Rarely (< 10%) Unimportant (occasionally a factor, always low priority)

Understood meaning rarely implies concept ; concept is always of low importance to meaning

3 Occasionally (11-24%) Low importance (occasionally a factor, usually low priority)

Understood meaning occasionally implies concept; concept is of low importance to meaning

4 Frequently (25-49%) Moderate (frequently or commonly a factor, usually of intermediate priority)

Understood meaning frequently implies concept; concept is of moderate importance to meaning

5 Commonly (50-69%) Important (usually a factor, usually higher priority)

Understood meaning commonly implies concept; concept is important to meaning;

6 Usually (69-89%) Very important (almost always a factor, almost always higher (but not necessarily top) priority)

Understood meaning usually implies concept; concept is very important to meaning

7 Almost always (90-100%) Critical (almost always a factor, always very high or top priority)

Understood meaning almost always implies concept; concept critical to meaning)


Part I: Nature of the Administrative Setting: Given the variability amongst the case studies, and between various aspects of each case study (policy-making, licensing, dispute resolution) we attempt in this introductory part of the questionnaire simply to keep track of some general characteristics of each of the decision streams that arise. I.1. Is the decision maker

I.1.a an individual official, or I.1.b a multi-member tribunal/agency?

I.2. What is the primary nature of the decision-making body for the purposes of the case study?

I.2.a policy-making I.2.b individualized decision-making (e.g. license, permit, approval) I.2.c review body overseeing the decisions of other agencies I.2.d dispute resolution

I.3. Does the agency exercise decision-making powers derived from or based upon more than one statute? I.3.a Yes No I.3.b. If yes, how many?

I.4. For each of the following “domains of impact”, assess the importance (0-7) each domain to the tribunal/agency e tribunal or agency in question. circle one I.4.a. impacts on the natural environment 0 1 2 3 4 5 6 7 I.4.b impacts on human health (mental or physical) 0 1 2 3 4 5 6 7 I.4.c impacts on human economic welfare 0 1 2 3 4 5 6 7 I.4.d impacts on human sociocultural values 0 1 2 3 4 5 6 7 I.4.e impacts on human spiritual or religious values 0 1 2 3 4 5 6 7 Part II: Experience with scientific uncertainty The PURPOSE of this section is to determine at a GENERAL level:

- the ROLE of scientific uncertainty in the decision-making - the degree and specificity of the tribunal’s AWARENESS of this problem - the NATURE of the scientific uncertainty most frequently encountered by the tribunal; and - whether there ARE any MEANS for dealing with it. (If there are, the details will come forward

later when dealing with the details of the Precautionary Principle and Principle of Adaptive Management, and in the Process and Procedure section)

The kinds of ANSWERS we are looking for is WHETHER scientific uncertainty is a RECOGNIZED problem for this decision maker, WHETHER it has any clear means of dealing with it, and if so, what are the ELEMENTS of these methods (presumably the more discursive portions of the case studies will evaluate whether these are adequate and how they might be improved, etc.)


II.1. Does the legislation constituting the tribunal or agency explicitly call for tribunal or agency decisions to address scientific uncertainty? Yes No

II.2.a Does the legislation contain a definition of scientific uncertainty? Yes No II.2.b. If yes, please provide the applicable definition.

II.3. Does the tribunal/agency have an explicit process for dealing with scientific uncertainty? Yes No (details to be assessed in section on “Process and Procedure” below).

II.4. If the agency has no explicit process for dealing with scientific uncertainty, do its mode of operations or decisions indicate that uncertainty is addressed (check one)

II.4.a in an ad hoc, case by case fashion, II.4.b in a systematic, but non-explicit, fashion, II.4.c not at all, II.4.d unknown?

II.5. Each of the following represents a potential source of information from which tribunals or agencies can acquire information or data on impacts. Score each on a scale from 0-7 on frequency/likelihood of use. (The term “white” scientific literature means literature published in peer-reviewed scientific journals; “grey” scientific literature refers to other scientific literature, such as government or consultant reports, that are generally not peer- reviewed):

II.5.a unsystematic review of existing “white” scientific literature 0 1 2 3 4 5 6 7 II.5.b unsystematic review of existing “white” and “grey” scientific 0 1 2 3 4 5 6 7 literature II.5.c systematic review of existing “white” scientific literature 0 1 2 3 4 5 6 7 II.5.d systematic review of existing “white” and “grey” scientific 0 1 2 3 4 5 6 7 literature II.5.e solicitation of external expert opinion from other government 0 1 2 3 4 5 6 7 institutions II.5.f solicitation of external expert opinion from academia 0 1 2 3 4 5 6 7 II.5.g solicitation of external expert opinion from industry and/or 0 1 2 3 4 5 6 7 business II.6. There are many different sources of scientific uncertainty. Score each potential source below on a scale from 0-7 of semantic congruence. II.6.a Lack of knowledge about the cause-effect relationships underlying 0 1 2 3 4 5 6 7 the system(s) we are attempting to manage.


II.6.b Statistical uncertainty about the predicted effects of potential courses 0 1 2 3 4 5 6 7 of action.

II.6.c Poor quality evidence, e.g. evidence derived from studies that are 0 1 2 3 4 5 6 7 poorly designed or that provide only weakly circumstantial rather than direct evidence. II.6.d Evidence derived from sparse empirical data (e.g.. few studies, though 0 1 2 3 4 5 6 7 the studies may be of good quality). II.6.e Uncertainty associated with potential inadequacies in the spatial or 0 1 2 3 4 5 6 7 temporal resolution/scales of empirical sampling (e.g. “evidence” that requires extrapolation from small time or space scales (at which the studies are done) to larger time-space scales (that we are really interested in). An example might be a study done over the space of a few months, the results of which are extrapolated to years or decades.

II.6.f Extrapolation uncertainty (e.g. from lab results to nature, from 0 1 2 3 4 5 6 7 forest plots to an entire forest stand, from one species to all “similar” species, etc.).

II.7. One measure of the “uncertainty” associated with potential impacts is the variability among assessments of impacts. The list below gives different means by which information on potential impacts may be obtained by the tribunal/agency. Score each one (0-7) according to the frequency with which it occurs in tribunal/agency decision-making. II.7.a single assessment followed by decision 0 1 2 3 4 5 6 7 II.7.b several assessments by several different individuals within the 0 1 2 3 4 5 6 7 tribunal/agency in a collaborative, interactive, consensual process II.7.c several independent assessments by several different individuals within 0 1 2 3 4 5 6 7 the tribunal/agency, followed by third-party arbitration/adjudication II.7.d several independent assessments by different individuals, at least one 0 1 2 3 4 5 6 7 of whom is external to the tribunal/agency, followed by third-party arbitration/adjudication II.7.e multiple assessments by independent external experts followed by 0 1 2 3 4 5 6 7 third-party adjudication II.7.f at least one internal and one external assessment, followed by internal 0 1 2 3 4 5 6 7 arbitration/adjudication II.7.g at least one internal and one external assessment, followed by external 0 1 2 3 4 5 6 7 third-party arbitration/adjudication Part III Experience with the Precautionary Principle The PURPOSE of this section is to identify: WHETHER the PP is expressly required to be used; and, whether expressly or by implication, HOW in practice the PP is understood and applied (if, when and how it is used by this decision-maker). III.1. Does the applicable legislation explicitly call for the application of the precautionary principle to decisions of the tribunal or agency? Yes No


III.2.a Does the legislation contain a definition of the precautionary principle? Yes No III.2.b If yes, please include definition.

III.3. For each of the following “domains of impact”, assign an importance score (0-7) that describes the degree to which the tribunal/agency or tribunal or agency in question takes account of precaution in relation to the specified domain:

III.3.a. impacts on the natural environment 0 1 2 3 4 5 6 7 III.3.b impacts on human health (mental or physical) 0 1 2 3 4 5 6 7 III.3.c impacts on human economic welfare 0 1 2 3 4 5 6 7 III.3.d impacts on human sociocultural values 0 1 2 3 4 5 6 7 III.3.e impacts on human spiritual or religious values 0 1 2 3 4 5 6 7

Comment: Although it is sometimes asked at a general level, “what triggers the precautionary principle?” we think that, depending upon the way in which the precautionary principle is described, there are at least three distinct dimensions involved in determining whether it might be applicable in any given case. (Other issues arise as to what precautionary measures may be taken and how they might be implemented). For present purposes we refer to the three application issues as:

(1) Type of harm (2) Severity of harm (3) Uncertainty about (1) and/or (2)

By way of example, the Rio Declaration states: “where there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat.” So, with regard to 1) type of harm, it is threats to “biological diversity” that must be established. Threats to cultural heritage or archeological sites don’t do the trick. With regard to 2), severity of harm, the threat to biological diversity must entail “significant reduction or loss”. Presumably marginal, minimal, trivial and insignificant losses don’t trigger the applicability of the principle. Issue 3) raises the problem of how it would be demonstrated that significant losses to biodiversity are established: some indication? Balance of probabilities? Beyond reasonable doubt? There are going to be refinements, but these look like the basic building blocks that we hope to identify for each of the case studies. The following questions ask for values to be placed on the listed factors, and the responses to these questions are then to be filled in to the tables at the end of this section. This will ultimately permit the creation of a grid that is intended to facilitate an understanding of the tribunal in question as well as to facilitate comparison between decision makers, in relation to their approach to the PP.


Type of Harm III.4 Attach an importance score (0-7) to each of the following types of harm based on the extent to which the tribunal or agency in question attaches importance to each:

III.4.a Harm to humans 0 1 2 3 4 5 6 7 III.4.b Harm to biota (wildlife, biological communities, etc.) 0 1 2 3 4 5 6 7 III.4.c Harm to the abiotic environment (water, soil, air etc.) 0 1 2 3 4 5 6 7

III.5 If the tribunal or agency considers potential harm to Humans, score the following types of harm depending on the extent to which the tribunal or agency attaches importance to each:

III.5.a Harm to human health (physical or mental) 0 1 2 3 4 5 6 7 III.5.b Economic harm 0 1 2 3 4 5 6 7 III.5.c Harm to cultural or social values 0 1 2 3 4 5 6 7 III.5.d Harm to spiritual or religious values 0 1 2 3 4 5 6 7

III.6 If the tribunal or agency considers potential harm to Biota, score each of the following types of harm depending on the extent to which the tribunal or agency attaches importance to each:

III.6.a Direct exploitation (fishing, hunting, trapping, collecting) 0 1 2 3 4 5 6 7 III.6.b Habitat loss fragmentation or degradation (including loss of 0 1 2 3 4 5 6 7 habitat/habitat degradation from things like climate change) III.6.c Pollution 0 1 2 3 4 5 6 7 III.6.d Invasive/exotic species 0 1 2 3 4 5 6 7

III.7 If the tribunal or agency considers potential harm to the abiotic environment, score each of the following types of harm depending on the extent to which the tribunal or agency attaches importance to each one :

III.7.a Direct harm to the abiotic environment 0 1 2 3 4 5 6 7 III.7.b Harm to humans as a result of harm to the abiotic environment 0 1 2 3 4 5 6 7 (e.g. water pollution creating human health hazards)

Severity of Harm III.8 Which of the following terms are mentioned in the legislation and regulations giving the tribunal/agency decision-making power?

III.8.a “Harm” or “impact” or “effect” III.8.b “significant” (harm or impact or effect) III.8.c “considerable” (harm or impact or effect) III.8.d “serious “(harm or impact or effect) III.8.e “irreversible” (harm or impact or effect) III.8.f “reversible” (harm or impact or effect) III.8.g “irreparable” (harm or impact or effect) III.8.h “danger”


III.8.i “endangered” III.8.j “acceptable” (harm or impact or effect)

III.9. For each of the terms below, indicate (Y/N) whether there are documents pertaining to the agency/tribunal (policy statements, decisions, etc) which use the term in question: Yes No

III.9.a “Harm” or “impact” or “effect” III.9.b “significant” (harm or impact or effect) III.9.c “considerable” (harm or impact or effect) III.9.d “serious “(harm or impact or effect) III.9.e “irreversible” (harm or impact or effect) III.9.f “reversible” (harm or impact or effect) III.9.g “irreparable” (harm or impact or effect) III.9.h “danger” III.9.i “endangered” III.9.j “acceptable” (harm or impact or effect)

III.10. For each of the terms below, indicate (Y/N) whether there are documents pertaining to the agency/tribunal (policy statements, decisions, etc) which define the term in question, or provide judgement/assessment criteria Yes No

III.10.a “Harm” or “impact” or “effect” III.10.b “significant” (harm or impact or effect) III.10.c “considerable” (harm or impact or effect) III.10.d “serious “(harm or impact or effect) III.10.e “irreversible” (harm or impact or effect) III.10.f “reversible” (harm or impact or effect) III.10.g “irreparable” (harm or impact or effect) III.10.h“danger” III.10.i “endangered” III.10.j “acceptable” (harm or impact or effect)

III.11. The table below gives different combinations of the three dimensions (type of harm, severity of harm, uncertainty about type and/or severity of harm). For each row in the table, provide a likelihood score which indicates the likelihood that the tribunal/agency will apply special measures under the specified conditions. Type of harm (Perceived) maximum severity of

harm (Perceived) uncertainty about type or severity of harm

Score (circle one)

To humans a Mild/trivial/insignificant low 0 1 2 3 4 5 6 7 b Mild/trivial/insignificant moderate 0 1 2 3 4 5 6 7 c Mild/trivial/insignificant high 0 1 2 3 4 5 6 7 d Substantial/significant/considerable low 0 1 2 3 4 5 6 7 e Substantial/significant/considerable moderate 0 1 2 3 4 5 6 7


f Substantial/significant/considerable high 0 1 2 3 4 5 6 7 g Serious/great/irreversible/irreparable low 0 1 2 3 4 5 6 7 h Serious/great/irreversible/irreparable moderate 0 1 2 3 4 5 6 7 i Serious/great/irreversible/irreparable high 0 1 2 3 4 5 6 7

To biota j Mild/trivial/insignificant low 0 1 2 3 4 5 6 7 k Mild/trivial/insignificant moderate 0 1 2 3 4 5 6 7 l Mild/trivial/insignificant high 0 1 2 3 4 5 6 7

m Substantial/significant/considerable low 0 1 2 3 4 5 6 7 n Substantial/significant/considerable moderate 0 1 2 3 4 5 6 7 o Substantial/significant/considerable high 0 1 2 3 4 5 6 7 p Serious/great/irreversible/irreparable low 0 1 2 3 4 5 6 7 q Serious/great/irreversible/irreparable moderate 0 1 2 3 4 5 6 7 r Serious/great/irreversible/irreparable high 0 1 2 3 4 5 6 7

To abiotic s environment (air, water, soil)

Mild/trivial/insignificant low 0 1 2 3 4 5 6 7

t Mild/trivial/insignificant moderate 0 1 2 3 4 5 6 7 u Mild/trivial/insignificant high 0 1 2 3 4 5 6 7 v Substantial/significant/considerable low 0 1 2 3 4 5 6 7 w Substantial/significant/considerable moderate 0 1 2 3 4 5 6 7 x Substantial/significant/considerable high 0 1 2 3 4 5 6 7 y Serious/great/irreversible/irreparable low 0 1 2 3 4 5 6 7 z Serious/great/irreversible/irreparable moderate 0 1 2 3 4 5 6 7

aa Serious/great/irreversible/irreparable high 0 1 2 3 4 5 6 7 III.12. “Severity of harm” can have both a spatial and temporal dimension. For example, “harm” that extends over a wide area (e.g. from nuclear fallout) would, all other things being equal, be considered of greater concern than harm that extends only over a smaller area (e.g. nutrient loading of a lake with no outflows). Similarity, “harm” that persists for a long period of time (for example, the case of pollutants that persist for long periods) is, all other things being equal, of more concern than harm that persists for only a short period of time (e.g. pollutants that degrade quickly). Score each of the following dimensions based on the importance (0-7) attached by the tribunal or agency to the dimension in question.

III.12.a magnitude of harm (the “size” of harm where and when it occurs) 0 1 2 3 4 5 6 7 III.12.b spatial distribution of harm (e.g. in local area versus over a 0 1 2 3 4 5 6 7 large area) III.12.c temporal scale: immediacy of harmtemporal scale: frequency 0 1 2 3 4 5 6 7 of harm III.12.d temporal scale: duration/longevity of harm 0 1 2 3 4 5 6 7

.

Uncertainty III.13. Uncertainty may pertain to the type of harm or the severity of harm. Score each uncertainty below based on the importance attached by the agency/tribunal to the uncertainty in question.


III.13.a Uncertainty about effects on human health. 0 1 2 3 4 5 6 7 III.13.b Uncertainty about effects on human economic welfare. 0 1 2 3 4 5 6 7 III.13.c Uncertainty about effects on the natural environment. 0 1 2 3 4 5 6 7 III.13.d Uncertainty about effects on human sociocultural values. 0 1 2 3 4 5 6 7 III.13.e Uncertainty about effects on human religious or spiritual values. 0 1 2 3 4 5 6 7 III.13.f Uncertainty about the effects on biota. 0 1 2 3 4 5 6 7 III.13.g Uncertainty about the effects on the abiotic environment (air, 0 1 2 3 4 5 6 7 water, soil, etc.). III.13.h Uncertainty about the magnitude of harm (i.e. about the 0 1 2 3 4 5 6 7 distribution of effects). III.13.i Uncertainty about the spatial extent of harm (e.g. about over how 0 1 2 3 4 5 6 7 large an area). III.13.j Uncertainty about the temporal extent of harm (e.g. how long 0 1 2 3 4 5 6 7 will it take before impacts are felt, and for how long will they be felt).

Part IV: Experience with the Principle of Adaptive Management IV.1. Does the legislation or statute from which the tribunal/agency derives decision-making authority explicitly call for the application of the principle of adaptive management (PAM) to decisions of the tribunal or agency? Yes No IV.2-1 Does the legislation (or any applicable regulation) contain a definition of the PAM? IV.2-1.a Yes No IV.2-1.b If so, please provide the definition.

IV.2-2 If no, are any of the following elements of PAM are present in the legislation? IV.2-2.a ongoing monitoring and reporting requirements IV.2-2.b ability to revoke or amend permits IV.2-2.c time- limited authorizations IV.2-2.d future research requirements for applications

IV.2-2.ea other (IV.2-2eb…please specify below)

IV.3. The PAM incorporates a number of different elements. Even if the PAM is not explicitly recognized, score each concepts/interpretations below on a semantic congruence scale (0-7) with respect to the degree to which these elements are used or employed by the agency/tribunal in question:


IV.3.a Decisions are treated as scientific experiments (that is, are structured 0 1 2 3 4 5 6 7 so as to allow testing of causal hypotheses). IV.3.b Past decisions are assumed to have been “correct” (i.e. are assumed 0 1 2 3 4 5 6 7 to have had the desired effect) unless demonstrated otherwise. IV.3.c Predicted effects of alternative decisions are made explicit and 0 1 2 3 4 5 6 7 considered. IV.3.d “Knowledge” accrued from past decisions is used to inform future 0 1 2 3 4 5 6 7 decision- making. IV.3.e Data and information on the effects of previous decisions are analysed 0 1 2 3 4 5 6 7 and assessed in a timely manner. IV.3.f Effects of previous decisions are systematically monitored. 0 1 2 3 4 5 6 7 IV.3.g Predicted effects of decisions are systematically compared with 0 1 2 3 4 5 6 7 observed effects as determined from monitoring or surveillance. IV.3.h Large discrepancies between observed and predicted effects of past 0 1 2 3 4 5 6 7 decisions reduce the likelihood that the same decision will be made in the future. IV.4. Treatment of Decisions as Scientific Experiments: Score each of the following on a frequency/likelihood scale based on the extent to which it occurs in the decision-making process of the tribunal/agency in question:

IV.4.a Experimental controls explicitly identified. 0 1 2 3 4 5 6 7 IV.4.b Experimental controls implicitly identified. 0 1 2 3 4 5 6 7 IV.4.c Controls considered to be current state of the receiving system 0 1 2 3 4 5 6 7 (e.g. the system in which the activities in question will occur). IV.4.e Controls considered to be the current state of the receiving system 0 1 2 3 4 5 6 7 as well as the current state of a non-receiving system. IV.4.f Predicted impacts/effects are specified explicitly. 0 1 2 3 4 5 6 7 IV.4.g Observed impacts/effects are compared to predicted impacts. 0 1 2 3 4 5 6 7

IV.5. Use of Follow-up Monitoring to Assess Outcomes and Impacts of Decisions. Score each of the following (except (b)) on a frequency/likelihood scale (0-7) based on the extent to which it occurs in the decision-making process of the tribunal/agency in question: IV.5.a Follow-up monitoring of tribunal/agency decisions. 0 1 2 3 4 5 6 7

IV.5.b Monitoring of actual experience of a licensed/approved product, substance, or process is mandatory. Yes No IV.5.c Monitoring requirements are included as conditions in the tribunal 0 1 2 3 4 5 6 7 or agency decisions. IV.5.d Terms of reference for monitoring (what should be monitored; 0 1 2 3 4 5 6 7 reporting structure etc) are specified by the tribunal/agency. IV.5.e Protocols for monitoring (where, when, duration etc) are specified 0 1 2 3 4 5 6 7 by the tribunal/agency. IV.5.f Monitoring is conducted on a spatial and temporal scale over 0 1 2 3 4 5 6 7 which adverse effects might reasonably be expected to occur.


IV.5.g Monitoring is conducted by the applicant/licensee. 0 1 2 3 4 5 6 7 IV.5.h Monitoring is conducted by the decision-maker. 0 1 2 3 4 5 6 7 IV.5.i Monitoring is conducted by an independent external body. 0 1 2 3 4 5 6 7

IV.6. Comparison of Predicted Effects/Impacts with Those Actually Observed. Score each of the following on a frequency/likelihood scale (0-7) based on the extent to which it occurs in the decision-making process of the tribunal/agency in question:

IV.6.a Predicted Impacts are specified explicitly by the tribunal/agency. 0 1 2 3 4 5 6 7 IV.6.b Predicted impacts are specified explicitly and quantitatively by 0 1 2 3 4 5 6 7 the tribunal/agency. IV.6.c Predicted impacts are specified explicitly and qualitatively by 0 1 2 3 4 5 6 7 the tribunal/agency. IV.6.d Predicted impacts explicitly include estimates of uncertainty. 0 1 2 3 4 5 6 7 IV.6.e Endpoints (the variables that are to be measured) for follow-up 0 1 2 3 4 5 6 7 monitoring match endpoints about which predictions are made. IV.6.f Endpoints for monitoring are specified by the tribunal/agency. 0 1 2 3 4 5 6 7

IV.7. Communication of Monitoring Results. Score each of the following (except (a) and (b)) on a frequency/likelihood scale (0-7) based on the extent to which it occurs in the decision-making process of the tribunal/agency in question:

IV.7.a Tribunal/agency has an in-house electronic archive of predicted impacts. Yes No IV.7.b Tribunal/agency has an in-house electronic archive of post-decision monitoring results. Yes No IV.7.c Reporting of post-decision monitoring includes comparison of 0 1 2 3 4 5 6 7 predicted and observed results. IV.7.d Follow-up monitoring results of tribunal/agency decisions are 0 1 2 3 4 5 6 7 regularly published. IV.7.e Follow-up monitoring results of tribunal/agency decisions are 0 1 2 3 4 5 6 7 made available to the public on a regular basis.

IV.8. Use of Comparison between Predicted and Observed Results to Inform Future Decision-Making. Score each of the following (except (a) and (d)) on a frequency/likelihood scale (0-7) based on the extent to which it occurs in the decision-making process of the tribunal/agency in question:

IV.8.a Tribunal/agency decisions require review of relevant previous decisions. Yes No IV.8.b Tribunal/agency decisions involve the review of relevant previous 0 1 2 3 4 5 6 7 decisions. IV.8.c Tribunal/agency decisions involve comparison of predicted and 0 1 2 3 4 5 6 7 observed results from previous decisions. IV.8.d The difference between predic ted and observed results from previous decisions makes it less likely that similar decisions will be taken. Yes No


IV.9. Reconsideration and Revision of Past Decisions on the Basis of New Data and Information Score each of the following (except (b), (c) and (d)) on a frequency/likelihood scale (0-7) based on the extent to which it occurs in the decision-making process of the tribunal/agency in question:

IV.9.a Terms and conditions of approvals explicitly limit authorization to 0 1 2 3 4 5 6 7 a fixed period of time subject to re-evaluation. IV.9.b Time period for re-evaluation is years? IV.9.c The decision-maker has authority to revoke its approval or amend conditions of approval. Yes No IV.9.d The process of re-evaluation explicitly requires the decision-maker to consider the effects of the initial approval. Yes No IV.9.e The tribunal revises previous decisions in light of new data or 0 1 2 3 4 5 6 7 information.

Part V: Administrative Law Values or Assessment Criteria

Personnel

V.1. Does the legislation that constitutes the tribunal or agency call for scientific expertise on the part of decision-makers? Yes No V.2. Does the tribunal or agency require ongoing (continuing) education for decision-makers to enhance their awareness and understanding of scientific issues? Yes No Unknown V.3. Does the tribunal or agency have an internal policy that explicitly encourages decision-makers to enhance their awareness and understanding of scientific issues? Yes No Unknown V.4. Does the tribunal or agency have an internal policy that implicitly encourages decision-makers to enhance their awareness and understanding of scientific issues? Yes No Unknown V.5.a Have any specific initiatives been taken to encourage decision-makers to become familiar with either the precautionary principle, the principle of adaptive management, or both in relation to the operations of the tribunal or agency? Yes No Unknown V.5.b If yes, what are these measures?

V.6. From the list below, check the opportunities that tribunal or agency provides for decision makers to become better informed on scientific issues:

V.6.a in-house seminars, lectures or other training V.6.b external seminars, lectures or other training sessions


V.7. Do decision-makers have access to in-house staff qualified to advise decision-makers on the application of the precautionary principle, or the PAM? Yes No Unknown Process and Procedures V.8. Does the tribunal or agency refer to the significance of either the PP, the PAM, or both in relation to the onus of proof applicable in its proceedings? Yes No V.9. Does the tribunal or agency employ a weight of the evidence approach in its deliberations? Yes No V.10. If the PP or PAM are used to maintain the status quo until better evidence is brought forward, how is the status quo defined?

V.10.a not interfering with the usual administrative process/decision V.10.b not interfering with the environment

V.11. Do procedures for receiving and evaluating expert witness evidence provide opportunities to assess such evidence in relation to either the PP, the PAM, or both? Yes No Unknown V.12. Does the tribunal or agency have access to independent sources of expertise to assist in assessing evidence in relation to either the PP, the PAM, or both? Yes No Unknown V.13. Has the tribunal or agency made reference to the PP, the PAM, or both in issuing reasons for decisions? Yes No V.14. Where the tribunal or agency has determined that either the PP or the PAM are applicable to the decision under consideration, what measures are available to put those principles into operation?

V.14.a Reversal of burden of proof V.14.b Ban, prohibition, denial of approval V.14.c Periodic or scheduled review of any approval V.15.d Amendment of terms and conditions of any approval V.14.e. Phaseout of existing supplies, export bans V.14.f Other

Participation V.15. Do the tribunal or agency’s practices concerning notice to interested parties anticipate or invite participation by scientific bodies or external expert interveners? Yes No Unknown V.16. Do the tribunal or agency’s practices with respect to standing or interveners accommodate parties with independent knowledge or expertise relating to PP or PAM? Yes No Unknown V.17. Do the tribunal or agency’s practices in relation to costs permit funding to public interest participants interested in testing the significance of the PP or PAM for the decision in question? Yes No Unknown


Appeals and Judicial Review V.18. Are opportunities available for the appeal, review or reconsideration of decisions? Yes No V.19. Do such appeals provide additional opportunities for the application of the PP or the PAM? Yes No V.20. In cases of judicial review, do courts show a high degree of deference to science-based decisions from the tribunal or agency? Yes No Public and Political Accountability V.21. What is the term of office of decision-maker?

V.21.a Fixed V.21.b Renewable V.21.c At Pleasure V.21.d Good Behaviour

V.22. Is the decision-maker subject to reporting requirements? Yes No V.23. Is the tribunal/agency required to (or does it make a practice to):

V.23.a Give notice of Policies/Decisions to the General Public, V.23.b Engage in Consultation with the Public, V.23.c Consider and Respond to input from the public?

V.24. Is the agency/tribunal required to (or does it make a practice to):

V.24.a Give Notice of Policies/Decisions to scientific experts, V.24.b Engage in consultation with scientific experts, V.24.c Consider and respond to input from scientific experts?

Appendix iii. Workshop Summary G-25

iii. WORKSHOP SUMMARY

“Precaution, Adaptive Management and Administrative Decision-Making”: Report from a Workshop Hosted by the Institute of the Environment

and the Faculty of Law, University of Ottawa

8 March 2005

Melanie J. Mallet Representatives from various government and academic fields attended the workshop, and presented their perspectives on how principles of precaution and adaptive management are or should be integrated into regulatory decisions affecting the environment and natural resource management. Workshop attendees listened to project participants present their research in progress, posed broad and specific questions about how these principles are defined and applied and reflected on how current decision-making structures should be modified to implement precaution and adaptive management. The questions and comments revealed several broad themes and are grouped accordingly in the summary that follows. These themes are: Numerous factors account for differences in survey data collected from the agencies studied; “Science”, while facially objective, is a value-laden, often controversial concept. Attendees offered a variety of comments on what science currently means in the context of precaution and adaptive management, and discussed what factors science does not take into account; The administrative decision-making process, and the process of judicial review relating to those decisions, must be modified in fundamental ways in order to embrace precaution. What does precaution capture: is it broad enough to sanction regulators who make bad decisions?; how do legal and scientific principles compare in the context of precaution? Points under this theme are not discussed separately, but pervade the entire summary. Factors Influencing Variations in Agency Response Discussion of this theme was initiated by a presentation of the survey instrument. The instrument, it was explained, is intended to be a reliable “ruler”, intended to account for differences in responses between the agencies studied. Participants offered their own perspectives on what factors might account for such changes; four main observations emerged. First, the nature of the decision (ostensibly its gravity and potential impact) will affect the process for making the decision. Second, the legislation governing a department often sets the context in which decisions are made, and can constrain or dictate how science is used. Departmental culture was offered as a third, enormously influential factor affecting the decision-making process. One participant noted that in those instances where


different departments are governed by the same legislation, such as the Species at Risk Act, differences in internal culture often override any harmonizing effect the statute might have. Cultural differences also affect attitudes towards and applications of science, further influencing how decisions are made. In addition, participants noted that inadequate resources often preclude precautionary approaches. This last comment re-emerged as the discussion progressed. Science Thoughts grouped under this theme built on the earlier observation that departmental attitudes often influence the application of science to decision-making processes. Attendees noted that attitudes toward science often become entrenched within government departments, and traditional approaches to both science and risk assessment can work against legislative initiatives that embrace precaution. As a counterpoint, one participant suggested that the evolution of scientific thought and application is gradual and that more precautionary approaches will evolve over time. The quantification of risk, which is integral to the assessment process, is, in certain respects, subjective and therefore affects notions of science and uncertainty incorporated into the precautionary exercise. This comment that science is not fully objective arose several times. In addition to the influence of departmental culture, it was noted that departments determine their own mix of variables in examining risk, without reference to the practices of other departments and agencies. Pragmatism and political expediency have also influenced the definition of the precautionary principle1, as government has realized it could not afford to alienate stakeholders. Participants also discussed the role of “soft” science and values in the precautionary exercise, commenting that this type of information should not be excluded from the process. Recent legislation such as the Pest Control Products Act2 incorporates language such as “protection of human health and safety and protection of the environment”3, suggesting that “softer” variables will be relied in the precautionary exercise, but this remains to be seen. To some, the fisheries management process is a model in terms of its inclusiveness: stakeholders are consulted and social and economic variables are factored into what is a relatively transparent assessment. The role of science was described as quantifying risk and pointing to options while other variables influence the ultimate course of action. DFO, for instance, has developed “conservation points”, which attempt to empirically measure risk and which trigger the precautionary threshold. The conservation points are themselves developed in light of precaution. Similarities between scientific and legal approaches to uncertainty were also raised, with participants attempting to equate or translate the precautionary threshold into a legal equivalent. It was determined that the threshold approximates the civil standard of the “balance of probabilities”. Legal and scientific approaches are also commensurable in that both try to infer causality: the greater the inferential strength, the less the uncertainty. Finally, law and science both are philosophically opposed to attributing fault (harmful effects) to a person (or substance, product) who is not blameworthy. In law, this relates to the presumption of innocence, in


science, to Type I and Type II errors. The precautionary principle, however, contradicts this model by impugning substances or processes in the absence of complete evidence, knowing that such substances or processes might later be adjudged harmless.4 Further on this theme, attendees offered comments about the inversion of the burden of proof which occurs under the precautionary principle, which may oblige the proponent of a risky activity to prove its safety. One participant noted that attitudinal or institutional constraints that prevent consideration of a full range of risks mean that the reversal of the burden is incomplete. Similarly, failure to consider the long-term consequences of risk-laden activities, such as propagating plants with novel traits, falls short of placing the burden of proof on the proponent. Modifying the Administrative Regime Apart from the discussion of science, the other predominant and perhaps distinct theme of discussion centred on administrative decision-making and administrative law. Participants reflected on how both processes need to change in order to accommodate a precautionary approach. One of the main concerns shared by participants is the current inability of decision-makers to revisit decisions to reflect new knowledge about risk. Administrative law values consistency and finality, embodied in such principles as respect for precedent and functus officio. The inability to revisit decisions is at odds with precaution and adaptive management; the latter operates on the basis of “learning by error”. Interim approvals were identified as one way that these concerns might be addressed. Time-limited approvals to engage in activities such as growing genetically modified crops allow the regulator to reassess applications at a later point in time, drawing on new knowledge about risk. Attendees also questioned whether the current legal regime allows regulators to be held responsible for decisions that ultimately prove to be harmful. Others doubted this, pointing both to statutes that exempt the Crown from liability, and to the notion that governance requires making decisions and accordingly, “it should not be a tort to govern”. The concept of legitimacy, fundamental to administrative law, was also discussed in the context of precaution. This principle flows from an open and participatory framework. The public, regulators and courts can be expected to embrace this principle, much as other legal norms have come to be accepted, if decision-making procedures are transparent, consistent and publicly accessible. 1 Reference was made to the Privy Council Office’s document A Framework for the Application of Precaution in Science-Based Decision-Making about Risk 2 2002, c. 28 (not in force). 3 Examples are found in the long title of the Act, as well as its preamble. 4 For a discussion of this concept, refer to The Royal Society of Canada’s Report entitled Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada (2001).

Appendice G-28

Appendix iv – Workshop Participants G-29

iv. WORKSHOP PARTICIPANTS

MARCH 8th, 2005 – PRACTICING PRECAUTION WORKSHOP PARTICIPANT LIST PRACTICING PRECAUTION TEAM JAMIE BENIDICKSON 613-562-5800 Extension 3287 [email protected] COMMON LAW SECTION Fauteux Hall 57 Louis Pasteur, Ottawa ON K1N 6N5 114 NATHALIE CHALIFOUR 613-562-5800 Extension 3331 [email protected] Fauteux Hall 57 Louis Pasteur, Ottawa ON K1N 6N5 381 JENNIFER CHANDLER 613-562-5800 Extension 3286 Fax: 613-562-5124 [email protected] COMMON LAW SECTION Fauteux Hall 57 Louis Pasteur, Ottawa ON K1N 6N5 364 HEATHER MCLEOD-KILMURRAY 613-562-5800 Extension 3138 [email protected] Fauteux Hall 57 Louis Pasteur, Ottawa ON K1N 6N5 375 DANIEL LANE 613-562-5800 Extension 4795 [email protected] Management MANAGEMENT, SCHOOL OF Vanier Hall 136 Jean-Jacques Lussier, Ottawa ON K1N 6N5 239


ANDRE R DABROWSKI 613-562-5800 Extension 3511 [email protected] MATHEMATICS AND STATISTICS, DEPARTMENT OF 585 King Edward, Ottawa ON K1N 6N5 203B C. SCOTT FINDLAY 613-562-5800 Extension 4574 [email protected] BIOLOGY, DEPARTMENT OF

Vanier Hall 136 Jean-Jacques Lussier, Ottawa ON K1N 6N5 306 also INSTITUTE OF THE ENVIRONMENT, DIRECTOR 555 King Edward, Ottawa. ON K1N 6N5 613-562-5874 PRÉVOST, YVES c/o Faculty of Law University of Ottawa DÉZIEL, ANNIK c/o Institute of the Environment University of Ottawa GUESTS University of Ottawa: CHARLES CACCIA 613-562-5800 Extension 1041 Fax: 613-562-5873 [email protected] Senior Fellow

ENVIRONMENT, INSTITUTE OF THE

555 King Edward 32


NATHALIE DES ROSIERS 613-562-5902 [email protected] Fauteux Hall 57 Louis Pasteur, Ottawa ON K1N 6N5 204 DANIEL KREWSKI 613-562-5379 Fax: 613-562-5380 [email protected], [email protected] POPULATION HEALTH, INSTITUTE OF 1 Stewart 320 RONALD-FRANS MELCHERS 613-562-5800 Extension 1801 [email protected] CRIMINOLOGY , DEPARTMENT OF 25 university 208B Melanie Mallet c/o Faculty of Law University of Ottawa Neera Sivarajah c/o Faculty of Law University of Ottawa. Agencies/Organizations/Professionals : Sarah Cosgrove Senior Advisor, Biotechnology & Cartagena Protocol Conseillère principale, biotechnologie et Protocole de Cartagena Fisheries and Oceans Canada / Pêches et Océans Canada Aquaculture Science Branch / Direction des sciences de l'aquaculture 200 Kent Street, Stn 12W129 Ottawa, ON K1A 0E6 tel. / tél. 613-998-2904 fax. / téléc. 613-993-7665 email / courriel [email protected]


Andrea Lockwood Counsel, Constitutional & Administrative Law Section Justice Headquarters, East Memorial Building 3rd Floor 284 Wellington Street OTTAWA ON K1A 0H8 Tel: 613-946-1945 Theresa McClenaghan Canadian Environmental Law Association 130 Spadina Avenue, Suite 301, Toronto, ON M5V 2L4 Tel: 416-960-2284 Fax: 416-960-9392 John Moffet Stratos Inc. #1404 – 1 Nicholas Street Ottawa, K1N 7B7 Tel: 613-241-1001 Dr Jake Rice Director, Assessment and Peer Review Fisheries and Oceans Canada CANADIAN SCIENCE ADVISORY SECRETARIAT 200 Kent Street Mail Stop: 12032 Ottawa, ON K1A 0E6 Tel: 613-990-0288 Hajo Versteeg, Environmental Law & Policy Advisor 5365 Hilltop Dr Manotick ON K4M 1G4 Tel: 613-692-4837; Fax: 692-0410 Cell: 613-852-3292 [email protected] Art Willett Executive Director Fisheries and Oceans Canada FISHERIES RESOURCE CONSERVATION COUNCIL 344 Slater Street Ottawa, Ontario Canada K1R 7Y3 Telephone: (613) 998-1143


Mike Wilson Director, Strategic Issues Environment Canada 351 St. Joseph Boulevard Gatineau, QC K1A 0H3 Telephone: 819-997-9011 Fax: 819-994-8921

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