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American Association for Laboratory Accreditation

© 2012 by A2LA

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L:\BOD\Technical Forum Minutes\2012 Final Minutes\Life Sciences Advisory Committee Meeting Summary of 10

Summary of the 41st A2LA Life Sciences Advisory Committee (LSAC) Meeting The Sheraton Columbia Hotel

Columbia, MD Saturday, March 24, 2012

8:00 am – 5:00 pm

SUMMARY

AGENDA ITEM DISCUSSION MOTIONS / ACTION ITEMS Call to Order (V. Cook)

Meeting called to order at 8:05am. None.

Introductions / New members

All members introduced themselves and first time attendees identified themselves. Clarification was given on which attendees are voting members and how other people can become members if they wish.

None.

Review and Approval of Agenda (V. Cook)

The proposed agenda was discussed. Motion to add discussion of P102a – Life Sciences Reference Material Traceability Policy. (R. Brauninger, P. Royal second) Motion carried. Motion to remove discussion of Chemical sub disciplines. (C. Gunning, M. Miller second) Motion carried. Motion to move discussion of Life Sciences Traceability Policy/Guidance


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AGENDA ITEM DISCUSSION MOTIONS / ACTION ITEMS

Document to the end of the agenda. (R. Brauninger, J. Markwiese second) Motion carried. Motion to move presentation of NEFAP update to coincide with rest of Environmental Presentations (C. Gunning, J. Markwiese second) Motion carried. Motion to approve the agenda with the proposed changes (R. Sheibley, M. Miller second) Motion carried.

Last Meeting Minutes - Review/Approve (V. Cook)

Minutes from the previous LSAC meeting were reviewed. Motion to approve the previous minutes. (M. Miller, A Fox second) Motion carried.

2011 LSAC Officers: Chairman’s solicitation for and appointment of the ad hoc committee to prepare a slate of nominations for new LSAC Officers (V. Cook)

Ad hoc committee volunteers – M. Miller (chair), D. Mettler, B. Stawick

Motion to form an ad hoc committee to identify a slate of nominations of LSAC Officers. (N. Luedtke, S. McGeehan second) Motion carried.

Reports on Status of Task Group Assignments:

(See below.) (See below.)


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AGENDA ITEM DISCUSSION MOTIONS / ACTION ITEMS a. Task groups on

definition and categorization of Scope subdisciplines for Chemical scopes (M. Miller)

Removed per motion listed above in Review and Approval of Agenda.

None.

b. LSAC Reference Materials Traceability: The use of second source samples to establish traceability (R. Querry)

R. Querry and the group defined second source reference materials and their traceability requirements. It was clarified that the second source does not need to be from an accredited reference material provider. This topic applies only to Environmental Conformity Assessment Bodies.

None.

Discussion: Perspective on Technology vs. Specific Method Scopes (J. Gumpper)

This discussion was combined with R. Brauninger’s discussion of Flexible Scopes. Assessors who have assessed CABs with flexible Scopes gave their perspectives on how they adapt their auditing techniques in these circumstances.

None.

Discussion: Flexible Scopes (R. Brauninger)

See Attachment 1. R. Brauninger explained how Flexible Scopes differ from traditional specific Scopes and why some CABs may wish to use this format, which is based on technology. Some specific examples of implementation were discussed by the group. The option of adding a guide to the list of A2LA’s available program requirements was suggested. The expectations for determining measurement uncertainty were discussed. An ad hoc committee was established to develop requirements for flexible scopes. Members are: B. Kolbe, P. Royal, D. Fall, S. Audino, R. Audette, R. Brauninger, V. Cook (chair), H. Phillips,

Motion to form a committee to develop a guidance document outlining the requirements for flexible scopes (P. Royal, S. Audino second). Motion carried. ACTION: R. Brauninger to work with the committee (including B. Kolbe, P. Royal, D. Fall, S. Audino, R. Audette and V. Cook as chair) to develop a preliminary outline of


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AGENDA ITEM DISCUSSION MOTIONS / ACTION ITEMS B. Jackson

requirements for flexible scopes (by June 30, 2012).

Presentation: Ouida Holmes- EPA Office of Groundwater and Drinking Water-EPA Method Development

See Attachment 2. O. Holmes presented on the Water Laboratory Alliance’s (WLA) missions and method development activities for emergency response situations. O. Holmes answered questions regarding the requirements for a laboratory to participate in the WLA as well as technical questions about methodology.

None.

Discussion: Environmental Program Update (R. Querry)

See Attachment 3. R. Querry presented an overview of some of the subprograms within the Environmental Program. He began the discussion with an update on states participating as Accrediting Bodies in the Environmental TNI program as well as A2LA’s recognitions with TNI. R. Querry answered questions regarding the role of TNI and its accreditation bodies (Abs).

None.

Discussion: DoD ELAP Program Update (C. Gunning)

See Attachment 3. C. Gunning continued the discussion of Environmental programs with an update on the Department of Defense Environmental Laboratory Accreditation Program (ELAP) and took questions on the potential market for this program and growth potential for A2LA.

None.

Discussion: NEFAP Recognition Update (L. Smith)

See Attachment 3. L. Smith completed the Environmental program presentation by describing recent updates with National Environmental Field Activities Program recognition. L. Smith answered questions regarding the types of laboratories that can apply for this accreditation.

None.


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AGENDA ITEM DISCUSSION MOTIONS / ACTION ITEMS Discussion: A2LA Food Program Update (R. Brauninger)

See Attachment 4. R. Brauninger gave an overview of the Life Sciences market in general and subprograms including the Food Program specifically. R. Brauninger answered questions regarding interpretations of ISO 17025 and AOAC requirements, particularly 4.13.2.1 and the documentation of an audit trail. Discussion took place on the the implications of the Food Safety Modernization Act.

None.

Discussion: P102a – Life Sciences Reference Material Traceability Policy (R. Brauninger)

R. Brauninger presented a draft version of P102a for the group’s consideration and shared some of the discussion topics from the Reference Materials Producer Advisory Committee meeting. He educated the group on the different categories of Reference Materials as well as the concept of commutability and other definitions highlighted in the attached document. R. Brauninger took questions and suggestions from the group about the requirements defined in this document and how they apply to different Reference Materials that are currently on the market and also stated how CABs may make their own reference materials and comply with traceability requirements. An ad hoc committee was formed to make recommendations on further development of the P102a document. Members include: A. Liabastre, J. Weitzel (Chair), S. Audino, T. Sobania, R. Brauninger.

Motion to form an ad hoc committee to work with the P102a draft and make recommendations. (M. Miller, A. Liabastre second) Motion carried. ACTION: R. Brauninger to work with the committee (including A. Liabastre, S. Audino, T. Sobania and J. Weitzel as chair) to provide recommendations on further development of P102a. Submit list of recommendations to the LSAC (by July 31, 2012).

Discussion: Life Sciences Traceability Policy / Guidance Document (C. Gunning, R. Brauninger, K. Stoub, A. Klein)

C. Gunning led a discussion about the Criteria Council’s comments on the P113 Life Sciences Traceability Policy. Based on the CC’s comments, a guidance document was to be drafted to provide instructions for establishing traceability of different instruments. K. Stoub presented a revision to the version of P113 that was voted

None.


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AGENDA ITEM DISCUSSION MOTIONS / ACTION ITEMS on and reviewed supporting language from ISO 17025 as well as

from the Standard Council of Canada. K. Stoub answered questions about the language chosen, how CABs could meet the criteria set forth in the requirements, especially with regards to different specific examples of RMs such as pH buffers or microorganisms, and the intent of the guidance document which is meant to be applicable to testing laboratories as opposed to calibration laboratories. Work is continuing on both the draft P113 and guidance document and these documents will be presented to the LSAC upon completion.

New/Old Business

V. Cook asked for new or old business to discuss. None was raised. Motion to adjourn (A. Liabastre, B Stawick second). Motion carried.

Summary prepared by Lauren Smith, A2LA Accreditation Officer II.


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Attendees: Name Affiliation

Albert Liabastre Assessor Ann Muriv Food Safety Met Services Arlene Fox AOAC/Assessor Atefeh Fathi A2LA Staff Barbara Kendro PA Department of Health Betty Kolbe EPA/OPP/BEAD Beverly Prevette Tyson Foods Brad Rauch CAB, Assessor Brad Stawick Assessor Brenda Jackson North Carolina Department of Agriculture Brian Conner A2LA Staff Brian Lane Booz Allen Hamilton Brian Scott Booz Allen Hamilton Chris Gunning A2LA Staff Chuck Goudrean VHG Labs Cynthia Stoub E+J Gallo Winery Dan Tholen Assessor David Evanson Silliker David Fall Covance Laboratory Dawn Mettler Rockbridge Lab Services/Assessor Debra Jansen FDA/CBER Denise Archer Assessor


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Name Affiliation Derek Baylay Eurofins Diane Lawver Quality Assurance Solutions, LLC Dorothy Gill Assessor Ed Edelson Assessor Gail Parker FL Dept Agriculture Gina Steiner Jones Dairy Farm Heather Jordan American Proficiency Institute Heidi Phillips Colorado Department of Agriculture Hien Tran N/A James Markwiese Neptune & Co. Jane Weitzel Quality Analysis Consultants Joanne Simami Microbac Laboratories John Adams Assessor John Gumpper ChemVal Consulting DNC / Assessor Joseph Kellum Assessor Kelly Black Assessor Kelly Roberts Analytical Food Laboratories Ken Stoub Group 7 / Assessor Kiran Verma USEPA/OPP Laura Kwart Moore Assessor Lauren Smith A2LA Staff Lauryl Smith Micobac Laboratory Linda Dewitt Assessor Lorena Villarred Assessor Louise Ogden MN Department of Agriculture


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Name Affiliation Lynne Raines Assessor Marlene Moore Advanced Systems DNC / Assessor Marwa Adly Assessor Mary Pooeselager Assessor Michele Hoppenrath Silliker Michelle Serafin A2LA Staff Mitzi Miller Dade Moeller DNC / Assessor Nile Luedtke Assessor Ona Adair PA Department of Health Pat Royal QSC/Assessor Philip Engler Assessor Randy Querry A2LA Staff Renu Joshi Assessor Richard Scheibley Assessor Robert Audette Assessor Roger Brauninger A2LA Staff Saeed Hashim Almeer Chemist Samantha Bailey NMRC Samantha Saultz Microbac Laboratories, Central PA Sandra Menzies FDA/CBER Shannon Bradbury Chesnut Laboratory Shawn Grover Assessor Shawna Middleton USDA Skip Darley Assessor Steve Crupi SGS North America


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Name Affiliation Steve McGeehan University of Idaho Sue Styles American Proficiency Institute Susan Audino Assessor Susan Oldfather Assessor Tammy L Blake ALCS Tina Sobania Microbiologics Tess Gamber Assessor Vanessa Cook Tyson Foods Wayne Ziemer Assessor William Mills A2LA

Flexible Scopes

NOTE:

The flexible scope option is only available to laboratories accredited in the biological, chemical and forensics FOTs.

It is further limited to only those activities related to chemical, biochemical and molecular biology testing. Usually involves Instrumental analysis.

Any modifications to methodology must not incorporate new measurement principles that were not previously identified in their scope of accreditation.

When?

Situations usually arise when the laboratory requires flexibility in allowing for changes in the:

matrices within a product area (flexibility concerning object/matrix/sample) or;

with respect to parameters (flexibility concerning parameters/components/analytes).

How?

If a laboratory wishes accreditation under the flexible scope option, then they must:

Have previously demonstrated their competence to A2LA by prior accreditation to a defined set of published or in house developed methods.

Demonstrate that a fixed scope is too restrictive for the work they are currently undertaking and that a flexible scope is justified.

How?

Demonstrate that it has a management system which will control the flexible scope:

Ensure all tests will be carried out in accordance with the requirements for accreditation.

Have the technical competence and depth of experience to support the granting of a flexible scope.

Records requirements

Control and maintain on record the modifications and updates of its test methods or development activities.

Retain the underlying results and other relevant data (normally in the form of a validation and/or verification report) per ISO/IEC 17025 section 5.4

Make them available for review upon request at any time.

�

Review

Annually (at the time of Renewal or Annual Review) and anytime at the request of A2LA, the lab must:

Provide A2LA with an update on the methods which they have validated since the last assessment.

Regularly update their Proficiency Testing Plan accordingly(Some Programs require prior demonstration of proficiency)

Caveat This option will be reviewed on a case-by-case basis, final

decision on allowing the flexible scope option rests with A2LA.

A transition to the flexible scope option in most cases could not occur until their surveillance or first reassessment visit.

For those modifications to methodology that incorporate new measurement principles not previously evaluated by A2LA, laboratories must notify A2LA via the formal scope expansion process as outline in form F108.

Water Laboratory Alliance

EPA ‘s Method Development Activities

Ouida HolmesU.S. Environmental Protection Agency

Water Security Division

1

• EPA’s Method Development Process

• WSD Multi-laboratory validation of non-typhoidal Salmonella• Phase 1 Validation and Holding

Time Analysis

• Phase 2 Reproducibility Analysis

• Development of QC Criteria

• WLA Membership

Presentation Overview

2

Emergency Response Method Development Flow Chart

Single-Laboratory Verification Study

Security Review

Technical Work Group Review1

Quality Assurance Review

Publication Review

Management Review

Research Method2

SME Review of Study Design

Final Method Review and Issuance of Document number

Multi-Laboratory Validation Study

1

NHSRC

WSD

Method Development

Publication or Release3

Multi-Laboratory Validation of Standard Analytical Method for Non-Typhoidal Salmonella in Drinking

Water and Surface Water

Multi-Laboratory Validation of Standard Analytical Method for Non-Typhoidal Salmonella in Drinking

Water and Surface Water

Study Objectives

The following objectives were established for the Study:

•Assesses method performance

– Recovery

– Precision

– Reproducibility

•Develop quantitative QC criteria

•Assess holding times across multiple laboratories and drinking water and surface water matrices

Phase 1: Validation & Holding Time Analyses

Salmonella

Holding Time & Storage

Holding Times

• 0-Hour: sample analyses began within 0 – 8 hours of sample collection and spiking

• 30-Hour: sample analyses began within 30 ± 1 hours of sample spiking

Storage of 30-Hour Samples

• Refrigerated at <10°C, but above freezing to mimic shipping conditions for samples transported in coolers with ice or ice packs7

Laboratory-Specific Mean Recoveries for Surface Water at 0 & 30 Hours a-c

8a Data from Laboratory 6 were considered invalidb Laboratory 7 did not conduct 30-hour analysesc Error bars are +/- 1 standard error

Phase 2: Reproducibility Analyses

XLDMSRV

Reproducibility: Sample Collection

• Two participant laboratories collected drinking water and surface water samples

• 9 samples per matrix shipped on ice via priority overnight to other participant laboratories

• All laboratories analyzed samples from the same sites, collected at the same time

• 1 sample per matrix refrigerated at the collection laboratory for analyses the following day10

Reproducibility: Surface Water

11

a Laboratory 3 did not analyze of surface water sample 2 during the Reproducibility phase of the Study

b Laboratory 5 did not participate in the Reproducibility phase of the studyc Laboratory 8, for spiked surface water sample 2, n=3 (instead of 4)d Error bars are +/- 1 standard error

Reproducibility: Surface Water

Surface Water

• Differences may be due to varying degrees of laboratory proficiency with the protocol

– One laboratory retrospectively suggested that, they should have submitted more “questionable colonies” from MSRV to confirmation

– Another laboratory indicated that background bacteria from the initial enrichment made it very difficult to identify presumptively positive colonies on MSRV

12

Reproducibility: Drinking Water

Drinking Water

• No significant differences

• It appears that laboratory results are reproducible for drinking water

13

Development of QC Criteria

LIATSI Urea Broth

a Precision as maximum relative standard deviationb Ongoing precision and recovery (OPR) as percent recovery

Example QC Acceptance Criteria

Holding Time IPR/OPR Performance TestQC Acceptance

Criteria for 200-mL PBS Samples

0-Hour

IPR (4 PBS samples)

Mean percent recovery 61% - 151%

Precision a 67%

OPR b(1 PBS sample) Percent recovery 20% - 191 %

Results

• Results indicate that the protocol can be considered for implementation on a national-scale

• In most cases, samples can be shipped overnight, provided samples are held at <10°C, but above freezing

• It appears that laboratory results are reproducible for drinking water

• Reproducibility analyses for surface water demonstrated that laboratories must develop and maintain proficiency

16

Benefits from the Study

• Validated protocol for water addresses gap in Water Sector capability for non-typhoidal Salmonella

• Determined samples can be shipped overnight on ice or ice packs; affords greater flexibility in identifying laboratories to conduct analyses

• QC criteria can be used to maintain proficiency, and identify both laboratory issues and problematic matrices17

American Interplex HML, Inc.

Analytical Laboratories, Inc. NY State Department of Health, Wadsworth Center

City of Los Angeles,Bureau of Sanitation Texas A&M University, College Station

County Sanitation Districts of L.A.County, Joint Water Pollution

Control Plant

Unified State Laboratories, Utah Public Health

County Sanitation Districts of L.A. County, San Jose Creek Wisconsin State Laboratory of Hygiene

Acknowledgements:Volunteer Laboratories

Water Laboratory Alliance

What is the WLA?

The Water Laboratory Alliance (WLA) provides the Water Sector with an integrated nationwide network of laboratories

The WLA is composed of drinking water, public health, environmental, and select commercial laboratories

19

This network of laboratories offers capabilities and capacity to analyze drinking water in the event of:

• natural,• intentional, or• unintentional water contamination

Involving:• chemical,• biological, or• radiochemical contaminants

What does the WLA Address?

21

Components of the ERLN

The WLA focuses solely on water and is an integral part of EPA’s ERLN

22

WLA Benefits

• Improved Water Sector preparedness for response to water contamination incidents

• Improved communications

• Water security-related training opportunities

• Opportunity to participate in EPA-funded response exercises

• Access to additional analytical capability and capacity

• Validated methods for unregulated contaminants23

How to Join

1. Join the ERLN

Go to http://www.epa.gov/erln

24

Questions?

25

WLAContact Information

For comments and questions on the WLA, please contact:

Ouida HolmesOffice of Ground Water and Drinking WaterPhone: 202-564-6399 E-Mail: [email protected]

• Contact [email protected] • ERLN/WLA Helpline: 703-818-4200• Visit http://cfpub.epa.gov/safewater/watersecurity/wla.cfm26

Environmental Program Update

Randy Querry / Chris Gunning / Lauren Smith

A2LA Environmental Programs

The NELAC INSTITUTE (TNI) Department of Defense Environmental

Laboratory Accreditation Program (DoD)TNI Field Sampling Measurement

Organizations (FSMO)

Environmental TNI

15 state Accreditation Bodies Several state’s programs impacted by budget constraints Florida New Jersey California 3rd party initiative within TNI

Partnerships

Association of Public Health Laboratories (APHL) American Council of Independent Laboratories (ACIL)

TNI Proficiency Testing Providers Currently 2 PTP Accreditation Bodies (A2LA and ACLASS) A2LA has 5 PTPs accredited 2012 involves the renewal assessments for 4 of the 5 PTPs Significant amount of staff resources

DoD ELAP Program UpdateChris Gunning

DoD ELAP Labs in Progress

30 Labs have applied to be assessed to 17025:2005, 2003 NELAC Chapter 5, and the DoD ELAP requirements.

28 Labs have been accredited as of March 9, 2012. These include new applicants to A2LA and existing A2LA

accredited laboratories seeking to expand their current Scopes to to include the DoD ELAP requirements.

DoD ELAP Labs in Progress 2012 A2LA: 30 Labs in system—28 Accredited ACLASS: 18 Accredited L-A-B: 28 Accredited PJLA: 21 Accredited

2011 A2LA: 28 Labs in system—22 Accredited ACLASS: 19 Accredited L-A-B: 21 Accredited PJLA: 5 Accredited

QSM Version 5.0?

DoD EDQW is working with the DOE to combine their standard (QSAS) and the QSM into one standard (QSMAS).

This would be based on the NELAC 2009 standard. The new standard should be available for the EMDQ meeting next

week for the ABs to review.

EMDQ Meeting

A2LA will attend the annual EMDQ workshop the week of March 26.

Each AB will present on a pertinent section of the standard. A2LA will present on feedback, complaints, root cause analysis, and

corrective action. There will also be a discussion about the consistency of the

assessment process between the four ABs.

Questions

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Update on A2LA’s Participation in TNI’s National Environmental

Field Activities Program (NEFAP)

Presented by Lauren SmithA2LA Technical Forum & Annual Meeting

Life Sciences Advisory CommitteeColumbia, MDMarch 24, 2012

TNI’s National Environmental Field Activities Program (NEFAP)Established to develop an accreditation program

specifically for Field Sampling and Measurement Organizations (FSMO’s)

Developed a standard based on ISO 17025:2005 with additional requirements specifically tailored for Environmental field work

The StandardAdopted May 2007 – TNI Board

Volume 1: General Requirements for Field Sampling and Measurement Organizations (FSMO-V1-2008)

Volume 2: General Requirements for Accreditation Bodies Accrediting Field Sampling and Measurement Organizations (FSMO-V2-2008)

Recognized AB’s

A2LA, ACLASS, L-A-B, PJLA

Preliminary acceptance based on document review

First assessment will be observed by an evaluator

A2LA UpdatesPersonnel

A2LA Staff Members serving on NEFAP’s Field Activities Committee and Executive Committee

A2LA Assessors have participated in TNI’s NEFAP FSMO Assessor Training Course (webinar)

A2LA Staff Members promoting FSMO Accreditation by presenting at ASQ Energy and OnSite conferences

A2LA UpdatesDocuments

Updated R219 - Specific Requirements: TNI Field Sampling and Measurement Organization (FSMO) Accreditation Program

Revised F101 – Application for Accreditation Created F232 - Scope of Accreditation Selection List – Field

Sampling and Measurement Organizations Created F122 - A2LA NEFAP FSMO Summary Table

A2LA Updates

Applications

A couple of CABs currently accredited by A2LA have expressed interest in adding the FSMO requirements to their existing accreditation

A couple of new potential CABs have been provided with estimates at their request

Questions?

Life Sciences Update

Life Sciences Update Significant Rate of Growth in Interest/Applicants

Government States Federal

Commercial In-house Contract

Attributable to Multiple Factors/concerns? Food Safety Terrorism Governmental actions International Trade

Life Sciences Update Covers Multiple Fields

Biology: 42 applicants / 33 new accreds Chemical: 35/57 applicants / 23 new accreds RMP: 9 applicants / 6 new accreds PTP: 7 applicants / 5 new accreds

Variety of Areas Foods Drugs Contaminants Threat agents

Food Safety Commercial, In-house, State and Federal laboratories

~75% of Biological Scope Applicants ~30% of Chemical Scope Applicants

Focus Domestic production (primarily private sector) Imports (State and Federal and some private sector laboratories)

FSMA (FDA legislation) may impact imported foods

Drugs Pharmaceuticals and related materialsPrimarily private sector, some governmentSmall area but growing (no ISO 17025 mandate)Nutraceuticals (some big players Abbot, Nutrilite)Preclinical (NAMSL, WuXi); Post-tobacco labsVaccines (CBER)Allergen testing (Molds, foods)

Threat Agents/ CW/ Contaminants Primarily Federal and StatePresently A2LA has nearly all of the opportunitiesNGB CSTs (mobile labs), DOD labsWMD with 3 National labsSome private sector labs

Crosses into RMP, PTP, CRP (5 High profile USA labs)DOD RMPs and Contractor PTPs

A2LA Food Program Update

A2LA Food Program

AOAC International Accreditation Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, and Pharmaceuticals (Revised in March 2010)

Transition period allowed for renewal labs to be assessed for one additional 2 year period to the more restrictive 2006 criteria

All assessments beginning January 2011 are to 2010 revision To date A2LA has not received many negative comments regarding

the revision.

R204: INTERPRETATIVE GUIDANCE Per ISO/IEC 17025 4.13.2.1, the laboratory is required to retain

records containing sufficient information to establish an audit trail. Sufficient information in this context is defined as being what a testing

laboratory identifies as a critical parameter(s) to the satisfactory performance of the method.

The laboratory is required to identify and document critical parameters for its methods.

Once it has identified these parameters, the Laboratory shall be able to defend and / or justify the manner in which they have recorded the resulting data. Beginning September 1, 2012 currently accredited CABs, and Any new applicants received after April 1, 2012 will be subject to these

requirements.

A2LA Food Program 2010: Of the 63 new applicants in the last 12 months for Bio/Chem Fields,

~50% of the Chemical and 90% of the Biological have dealt with food safety. Increasing interest and steady growth is forecast.

2011: Of the 51 new applicants in the last 12 months for Bio/Chem fields, ~27% of the Chemical and 70% of the Biological have dealt with food safety (30% genetics, env, threat).

2012: Of the 77 new applicants in the last 12 months for Bio/Chem fields, ~10% of the Chemical (30% threat, 4% drug) and 78% of the Biological (22% genetics, env, threat) have dealt with food safety.

A2LA Food Program Commercial, In-house, State and Federal laboratories

~75% of Biological Scope Applicants ~70% of all Chemical Scope Applicants (25% of ~300 certs)

Focus Domestic production (primarily private sector) Imports (State and Federal and some private sector laboratories)

Melamine, etc. E coli (fresh peppers), Salmonella (black pepper, PCA)

FDA FSMA legislation may impact accreditations related to imported foods

The Food Safety Modernization Act

Main Themes of the Legislation

Prevention

Inspections, Compliance,

and Response

Import Safety

Enhanced Partnerships

FDA To Develop Criteria for Recognition of Accreditation BodiesRequires the Secretary to: periodically reevaluate accreditation bodies and revoke recognition of any not in compliance with this section.

FDA is also required to develop criteria for recognition of accreditation bodies and to periodically, at least every 5 years, reevaluate recognized accreditation bodies. FDA also may accompany auditors from an accreditation body to determine whether the accreditation body meets the FDA criteria for recognition. As a condition of recognition or accreditation, recognized accreditation bodies and accredited labs are required to notify FDA of any changes that would affect the recognition of such accreditation body or the accreditation of such lab.

Laboratory AccreditationThe FSMA adds. Section 202: Requires the Secretary to: recognize bodies that accredit laboratories with a demonstrated capability to conduct analytical testing of food products;

Not later than 2 years after the date of enactment, FDA is required to establish a program for the testing of food by accredited labs. This laboratory accreditation program would encompass independent private laboratories; foreign laboratories; and laboratories operated by Federal, State, and local government agencies. FDA is directed to work with recognized accreditation bodies to increase the number of accredited labs beyond the number in existence on the date of enactment

FDA To Develop Model Standards for Accreditation of LaboratoriesFDA is required to develop model stds that must meet to be accredited to perform specified sampling and analytical testing methods. Such model stds to include methods to ensure that:

i) appropriate sampling, analytical procedures, and commercially available techniques are followed; ii) reports of analyses are certified as true and accurate; iii) internal quality systems are established and maintained; iv) procedures exist to evaluate and respond promptly to complaints; and v) individuals who conduct sampling and analyses are qualified by training and experience.

Requirement to Use Accredited Labs for Regulatory TestsSecretary to: Set forth requirements for mandatory testing, includingTesting be conducted by federal or accredited nonfederal labs;

Not later than 30 months after enactment, All testing of food by or on behalf of its owner or consignee for the purposes listed below by either a Federal laboratory or a non-Federal laboratory accredited by a recognized accreditation body:

To support the admission of an imported food; To support removal from an Import Alert;To comply with a specific testing requirement under the FD&C Act or FDA regulations to address an identified or suspected food safety problem; and As otherwise required by FDA to address an identified or suspected food safety problem.

Questions / Comments?

Imports Team Team Leader: Roberta Wagner The Imports Team is divided up into seven working groups assigned the following areas: Importer Verification and Voluntary Qualified Importer Program Import Certification Accredited Third-Party Certification Lab Accreditation International Capacity Building Comparability Prior Notice and Smuggled Food Among the tasks assigned to these working groups are: Foreign Supplier Verification Program: For the first time, importers have an explicit responsibility to verify that their foreign suppliers

have adequate preventive controls in place to ensure that the food they produce is safe. Third Party Certification: The FSMA establishes a program through which qualified third parties can certify that foreign food facilities

comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports. Certification for high risk foods: FDA has the authority to require that high-risk imported foods be accompanied by a credible third

party certification or other assurance of compliance as a condition of entry into the U.S. Voluntary qualified importer program: FDA must establish a voluntary program for importers that provides for expedited review and

entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities. Authority to deny entry: FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the

country in which the facility is located.

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