Draft 2021-2031 Long Term Plan - SUBMISSIONS - Buller ...

Tab 1: ACHTERBERG Katharina

SUBMISSION FORM Draft 2021-2031 Long Term Plan SurveyMonkey

1 / 2

Q1

CONTACT DETAILS

Name Katharina Achterberg

Postal address 220 Willis St

City/Town Wellington

Post code 6012

Email address [email protected]

Q2

PRESENTING YOUR SUBMISSION IN PERSON

I do not wish to speak to my submission

Q3

INFORMATION MANAGEMENT (see page 5 of the

Consultation Document for more information)Option 1 - A

full approach to information management implementation

including digitising all paper data and recordsOption 2 -

Implement a partial information management system and

not digitise the paper records

I prefer Option 1

Q4

CLIMATE CHANGE (see page 6 of the Consultation

Document for more information)Option 1 - A staged

approach to develop a strategic plan, with ongoing

monitoring costsOption 2 - Immediately develop a

strategic plan, with ongoing monitoring costs

I prefer Option 2

#5#5

COMPLETECOMPLETE

Collector:Collector: 21-31 LTP 21-31 LTP (Web Link)(Web Link)

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IP Address:IP Address: 203.109.207.115203.109.207.115

8

Tab 1: ACHTERBERG Katharina


2 / 2

Q5

WESTPORT PORT AND KAWATIRI DREDGE (see page

7 of the Consultation Document for more

information)Option 1 - Ring-fence the portOption 2 -

Operate as a Council cost codeOption 3 - Consider

special purpose governance structure for the Kawatiri

Dredge

I prefer Option 2

Q6

FURTHER FEEDBACK - do you have any other items or requests that you would like Council to consider in its Long

Term Plan?

Taking 5 years to develop a Climate Change Strategy is an utter waste of time nobody has. If this is not done immediately, it will cost

the community much more than the rates increase incurred by speeding the process up. I would expect the Council to start taking

climate change as a scientifically proven risk seriously and expect this work to be done in no more than 2 years.

9

Tab 2: ANSELL Beverley

10

Tab 3: ARLIDGE Richard

Richard Arlidge – BDC 2021-2031 LTP submission. Page 1

Submission to: BDC – LTP 2021-2031

From Richard Arlidge

1 Hartmount Place

Punakaiki

03 7311 877 or 0274 510 888

Postal: CMB 3 RD1 Rūnanga, 7873

Email: [email protected]

YES - I would like to be heard

Climate Change Resilience and Environmental Sustainability

Climate change resilience is a key issue for low lying coastal areas in the Buller.

Coastal communities face an increasing burden and currently there is a mismatch

between the scale of our adaption challenge and the resources available to address

it.

Suggested addition: The impact of climate change in the Buller will be sea level

rise generating accelerated coastal erosion and inundation. The vulnerable

sand country (south to north) is Punakaiki River & Punakaiki Resort, Punakaiki

village; Charleston to Tauranga Bay; Kawau Point to the Mokihinui; Little

Wanganui to Kohaihai. Future sea level rise modelling shows much of this

land being inundated from circa 2050 onwards.

The Options

My preferred option is that Council carry out climate change work as soon as

practical. Look at the work that Nelson CC and Tasman DC are doing on climate

change resilience and adaptation. See also the work of the community based Nelson

Tasman Climate Forum.

The BDC is currently allowing people to construct dwellings on concrete foundations

in areas that will be inundated by sea level rises in the near future. These property

owners will have the right to demand compensation from Council (all other

ratepayers) as the Crown and the Council are aware of the risks of sea level rise for

some time.

Wooden foundations may cost a little more but almost all of the capital outlay can be

retained/recovered if the building can be moved to higher ground. The next question

is - Where is the higher ground going to be?

Council must ensure new infrastructure will not be impacted by sea level rise. (see

Punakaiki Water Supply below).

11



The Natural Environment – PROTECTED BUT NEGLECTED

The Climate Change Commission Draft Report (1 Feb) reads:

“Priority areas for action include …. planting more native trees to provide a long-term

carbon sink”. (Executive Summary: work must start now). …“Native forests can

create a long-term carbon sink while providing a range of other benefits, like

improving biodiversity and erosion control. Incentives are needed to get more native

trees planted”.

“New permanent native forests absorb carbon more slowly but will continue to do

so for centuries until they reach maturity. Because of this, we consider that carbon

removals from new permanent native forests have a role to offset the remaining

long-lived gas emissions in sectors with limited opportunities to reduce emissions

from 2050. For instance, this could include offsetting nitrous oxide emissions from

agriculture and residual industrial process emissions”.

One third on New Zealand is in Crown ownership which is predominantly highlands

and forested lands. The Crown conservation estate in the South Island runs from the

Marlborough Sounds through Tasman, Buller, Grey, Westland, Fiordland and into

Southland. These forests and wetlands are the lungs of Aotearoa sequestering

carbon dioxide. The West Coast (Buller, Grey & Westland) is probably the only

carbon negative area in New Zealand.

“Carbon Negative” is described as the reduction of an entity’s carbon footprint to

less than neutral, so that the entity (region) has a net effect of removing

carbon dioxide from the atmosphere rather than adding it. (Dr Janet Stevenson -

University of Otago).

If we are serious about reducing the impact of climate change we could divert the

maximum amount of Central Government resources to be applied to eradicating the

feral goats, deer, chamois, tahr, pigs and possums from our existing forest estate.

Goats eat 25% or their body weight every 24 hours and feral deer eat 20% of their

body weight daily. Possums are estimated to consume 20,000+ tonnes of vegetation

every night - being 300g wet weight x 70 million possums. (www.Landcare/Maanaki

Whenua).

The health of our forests has not been maintained and much of the Buller is

protected but neglected. To date the Crown has been a negligent owner and

manager of the lands in its care. Feral goats now occupy about 14% of New Zealand

- about half of this on public conservation land. The total population size is unknown

but is estimated to be several hundred thousand.

(https://www.doc.govt.nz/nature/pests).

The Defence Forces currently uses the Crown estate in goodie verses baddie type

exercises. Instead the troops should be hunting goats, deer and pigs during the day

and possums by night and trapping rats and stoats. What will the Defence Force

have to defend if we allow sea levels to continue to rise?

12



If we do not make immediate and widespread efforts to eradicate these pest species

then planting more trees will not lead to the increase in the amount of sequestration

envisaged.

The slogan must be – Plant More Trees - The Goats/Deer/Possums are Hungry.

Stewardship Land

The debate around Stewardship Land will get even more complicated if those areas

in regenerating native forests are retained by the Crown for carbon sinks.

If our recent experience of the Crown response when we requested a concession on

a small area of stewardship land for a community facility at Dolomite Point is an

example of how the debate will pan out then wider community ambitions may be

thwarted.

Punakaiki Water Rates - Profits to Westport

The LTP shows annual water supply charges for Punakaiki increasing dramatically

from the 2024-25 year. This may be due to an assumption that the Punakaiki River

water supply will come on stream and be considerably more expensive to run. The

proposed intake site does not take into account the effect of rising sea levels.

The Punakaiki water supply is maintained by Westreef and appears to be a cost plus

contract. A Punakaiki based person could maintain the system at a much lower cost

as there would be far less travel and time involved. This was the case a decade ago.

Westreef is owned by Buller Holdings Ltd which in turn supports the Pulse Energy

Recreation Area.

The Punakaiki Recreation Reserve is now the Punakaiki Beach Camp and revenue

from this enterprise goes to the Buller District Council.

Punakaiki residents have a community of interest that is not focused on Westport.

The supply lines of power, phone, medical and emergency services are all delivered

from Greymouth based entities. As the residents of Punakaiki rarely use the

community facilities we pay for based in Westport or Reefton the BDC.

END

13

Tab 4: ASHWORTH Dale


1 / 2

Q1

CONTACT DETAILS

Name Dale Ashworth

Postal address 4/133 Powerhouse Road

City/Town Westport

Post code 7891


Phone number 0272236900

Q2



Q3







I prefer Option 1

Q4






I prefer Option 2

#17#17

COMPLETECOMPLETE


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Tab 4: ASHWORTH Dale


2 / 2

Q5






Dredge

I prefer Option 1

Q6


Term Plan?

Buller is so full of natural resources and beauty that it would be great to continue to ensure these resources are foremost available to

residents to utilise and develop and protected for future generations. While outside investment does assist the community short term, I

believe the community is more than capable of developing and providing for itself in most respects. I am so happy to see Climate

Change planning in action. Once this strategy is in place I believe it will influence future decisions in every area of the community.

Thanks for listening. :)

15

Tab 5: ASHWORTH Dale - Youth Voice Kawatiri

SUBMISSION FORMDraft 2021-2031 Long Term Plan

Name

Organisation

Postal Address

Town Post code

Phone

Email

Presenting your submission in person

I wish to speak to my submission I do not wish to speak to my submission

Have your say!

Information Management (see page 5 of the Consultation Document for more information)

Option 1 - A full approach to information management implementation including digitising all paper data and records

Option 2 - Implement a partial information management system and not digitise the paper records

I prefer Option 1 I prefer Option 2 I prefer neither option

Additional feedback

Climate Change (see page 6 of the Consultation Document for more information)

Option 1 - A staged approach to develop a strategic plan, with ongoing monitoring costs

Option 2 - Immediately develop a strategic plan, with ongoing monitoring costs


Additional feedback

Westport Port and Kawatiri Dredge (see page 7 of the Consultation Document for more information)

Option 1 - Ring-fence the port

Option 2 - Operate as a Council cost centre

Option 3 - Consider special purpose governance structure for the Kawatiri Dredge

I prefer Option 1 I prefer Option 2 I prefer Option 3 I do not prefer any of

these options

Additional feedback

Shapingour district

Council is considering options for the following three major items in it’s draft 2021-2031 Long Term Plan. Please read the corresponding Consultation Document for further information and provide your views. More information is available on Council’s website www.bullerdc.govt.nz.

Please take the time to have your say and help ‘Shape our District’ by reading the draft 2021-2031 Long Term Plan’s Consultation Document and providing feedback to the three things we are consulting on. We also encourage feedback on other items relating to the LTP - see over. www.bullerdc.govt.nz

Dale Ashworth on behalf of Youth Voice Kawatiri committee

Youth Voice Kawatiri - currently under the 'umbrella' of Sport Tasman

PO Box 13

Westport

0272236900

[email protected]

16


Shapingour district

FURTHER FEEDBACK - do you have any other items or requests that you would like Council to consider it its Long Term Plan?

Consultation closes 18 May

www.bullerdc.govt.nz

[email protected]

or complete your submission online at www.surveymonkey.com/r/21-31-LTP

Privacy Statement: In accordance with the Local Government Act 2002, all submissions (including

your name and contact details) will be made available online as part of the LTP decision-making

process. Please refer to www.bullerdc.govt.nz/privacy or contact Council for a copy of Council’s

Privacy Statement.

Thank you for the opportunity to have our say. We have attached to this our

four page written submission and supporting survey document.

17


1 | P a g e

TO: Buller District Council

FM: Kawatiri Youth Voice

RE: Long term plan

12 May 2021

___________________________________________________________________________

PURPOSE:

The purpose of this paper is to:

Firstly, support councils Long Term Plan, especially

The Community Outcomes

Option 2 of the Climate Change approach (as long-term solutions to climate and environment is

important to rangatahi and immediate action is required)

Ongoing work in the District Revitalisation (as this impacts rangatahi and we see the Kawatiri

Youth Voice an important piece of the puzzle with invigorating and connecting communities)

Secondly, to secure the place and importance of the Kawatiri Youth Voice, in our region, for the next 10

years.

The importance of Kawatiri Youth Voice is to ensure that the voice of the rangatahi (and the future

employees, voters, and rate payers) is heard in our region, that they are consulted on decisions that will

affect their future outcomes and where appropriate initiatives directly impacting rangatahi are co-

designed with them in a fully inclusive manner.

This funding request represents a $19.5k investment annually over a 10 year period by Buller District

Council, to support the appointment of an ongoing Kawatiri Voice Youth Coordinator who supports the

Kawatiri Youth Council with admin, funding, insight gathering techniques, community engagement and

connections, event, and future planning support. This will secure the role and give it sustainability in to

the future.

This financial contribution will assist the Kawatiri Youth Voice, and its supporting organisations (Buller

Reap, Sport Tasman, West Coast Home Builders and BDC) to secure additional leverage funding through

sponsorship, partnerships and external funding.

BACKGROUND:

The Kawatiri Youth voice has been in place for the last 20 months, supported by four community

organisations - Buller Reap, Sport Tasman, West Coast Home Builders and BDC. We now call these parties

the ‘Advisory Group’. In the last 12 months we have focussed on letting the rangatahi take the lead by

listening and understanding the voice of rangatahi in the Buller region through surveys, so we can utilise

these insights to create traction in the community via community events, gathering ongoing insights and

providing opportunities to the rangatahi to connect with the culture and environment.

ALIGNMENT TO COUNCIL

Like the council wanting community input and buy in, the Kawatiri Youth Voice want to listen to the youth

of our community and be the voice on key decisions that directly affect or impact us.

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2 | P a g e

As a group we won't just talk to them, lecture them on how to live or decide what's best for their future.

We want them to talk to us, tell us how they'd like to live and what they feel is best for their future.

Our approach is “By rangatahi for rangatahi.”

The Advisory Group’s Vision is: To engage youth for a positive future.

Our strategy is below and either through our annual planning or via insights gained from the rangatahi

we have alignment and/or interest in supporting the following BDC Community outcomes;

However, more importantly, the Youth Voice group themselves have also come up with their own

Purpose, Vision, Values and main objectives:

Our Purpose:

To be a sustainable group of youth that provides a voice for rangatahi in Buller, shares ideas which

enact change and create events that support our community.

Our Vision:

To be an independent, diverse, collective voice, that strives to improve wellbeing and protect the

futures of Buller youth.

Values:

Passionate

Accountable

Progressive

Inclusive

Supportive

Our main objectives are as follows:

Advocate, support and strive for a stronger voice for young people.

Engage and promote the ideas of active collaboration and participation in order to encourage

young people to contribute to their communities.

19


3 | P a g e

Create a space and a positive environment for young people to be encouraged to speak, be

connected, be empowered and be involved with issues affecting them.

Foster networks and build relationships with decision makers in order to influence change for

young people.

USING INSIGHTS & LOCALLY LEAD APPROACH

The way we have structured the Kawatiri Youth Voice is to be seen as a contributor to the overall

wellbeing of all rangatahi in the Buller region. Through the Locally Led Approach and ongoing insights we

have undertaken the below in Westport, Reefton and Karamea over the last 12 months.

Organised a total of 4 x youth focused community events

Supported a total of 9 x community events

o Of the above 8 x community events had a cultural or environment focus

o We played a major part in Youth Week

o We supported Neighbours days organised by Council

Organised and facilitated 3 x youth surveys

Engaged with 9 x schools across Buller

Partnered with 7 X community organisations

Employed 1 person as of Jan 2021

Had growth in rangatahi wanting to be a part of Kawatiri Youth Voice due to increased profile and

recruitment.

CONSIDERATIONS:

We acknowledge that in this current climate any investment is significant, so we have attempted to

outline the key factors that need to be considered.

If we proceed:

Confidence that Kawatiri Youth Voice aligns with Rangatahi in our Community.

Confidence that we will continue to employ a part time Kawatiri Youth Voice Coordinator year round

(0.5 FTE)

Confidence we will continue to advocate and support community events that not only encourage

community participation but put a larger emphasis on the wellbeing of our rangatahi.

Confidence that we will continue to gain insights from the rangatahi in our region, consulting with

them on what is important to them and what they would like to see in the future.

Confidence that additional funding will be achieved to support Kawatiri Youth Voice activity.

Confidence we will be in a position to co-design on projects with community organisations and

councils that we believe are important to the rangatahi.

Confidence that Kawatiri Youth Voice experiences will be designed for rangatahi by rangatahi.

Greater rangatahi and community buy-in around the importance and benefits of understanding the

voice of the youth leading to a higher level of influence and advocacy.

Increased community collaboration and connection opportunities as identified through the Locally

Lead approach.

If we do not proceed:

Loss of the Kawatiri Youth Voice Coordinator leading to less support for the rangatahi to gather

insights, run events and to collaborate with a community.

The level of influence or advocacy by rangatahi for rangatahi will be lower in the community as we

are not seen as key players due to the capacity.

20


4 | P a g e

Less wellbeing opportunities provided to rangatahi.

Less events and activities available for our rangatahi.

Missed opportunities to connect local providers and community organisations that surround the

rangatahi needs, desires or long-term goals.

RECOMMENDATION:

That Buller District Council provide annual funding of $19,500 over the next 10 years to support the

Kawatiri Youth Voice employing a coordinator. This is calculated as $25 x 15 hours.

Note: The ‘umbrella’ organisation that employs the coordinator is decided by the Advisory Group, guided

by an MoU, and is reviewed annually.

FURTHER SUPPORTING DOCUMENTATION:

Please find attached the latest of our youth surveys.

21


On Friday 18th

December 2020, we held a youth event ‘Kura Out’ at the NUKU gardens behind the Salvation Army

shop. We had various activities on offer, along with food and music. Plus we also took the survey to the Buller

Marathon and Children’s Day.

We have had 154 rangatahi fill out surveys regarding the possibility of a youth hub in Kawatiri. Note: Those small

number that said ‘no’ to wanting a hub directly correlated with those that didn’t enjoy natural world and didn’t want

to know about Maori culture. These are the results:

97%

3%

Would you like to see a youth hub in Kawatiri?

yes

no

0

5

10

15

20

25

30

35

40

45

never 1x month 2x month once a week 1-3x a week more than 3x

per week

How often would you visit a youth hub in

Kawatiri?

22


‘Other’ options included: boxing, exercise, cooking classes, bubble soccer, large board games and opportunities for

youth.

96%

2%2%

Do you enjoy connecting to the natural world?

yes

no

no answer

0

20

40

60

80

100

120

music food art relaxation

area

dance seminars activities health

advice

mara kai

What would you like at your youth hub?

23


0

5

10

15

20

25

30

35

40

1 = nothing

at all

2 3 4 5 6 7 8 9 10 = totally

understand

How much do you feel you understand about the Maori

culture?

0

5

10

15

20

25

30

35

40

45

50

1 = not at all 2 3 4 5 6 7 8 9 10 = totally

want to

How much would you like to understand Maori culture?

24

Tab 6: BARNES David

David Barnes

40 McKenna Road

Westport

[email protected]

021 159 159 3

SUBMISSION on the Draft 2021-2031 Long Term Plan

I am very concerned Council agreed to allow the Draft LTP to go out to consultation with a qualified audit report

regarding assumptions made attached to it. Ratepayers should have had the opportunity to fully understand the

implications of the audit report before any decisions on whether or not to send out the LTP for consultation were

made.

My first comment on the DLTP is that the plan will only be adequate if it actually recommends deliverable and

pragmatic solutions whilst keeping ratepayers at the forefront of decision-making. The core issue from my perspective

comes down to council processes. In the business world, you adjust expenses to meet your expected income. A

responsible and viable business does not commit to spending it cannot afford or has questionable income prospects.

The simple fact is, that BDC rates are ever increasing, yet service delivery is not improving at the same rate. Two

reason for that are many unquestioned “Nice to have” projects along with sweeping Government requirements on

Council placing costs which ultimately are beyond the ratepayers ability to pay. Local Government Minister Nanaia

Mahuta’s call to review local government is welcomed and probably overdue. It’s overdue because of the simple

fact above whilst infrastructure in many areas is woeful and creaking if not failing.

Council place too much reliance on advice from consultants who have a first concern to ensure their position is

safeguarded and only then will the document be offered. Many such 'qualified' opinions are often based on

theoretical considerations rather than dealing with things sensibly and realistically based on long term practical

experience.

Reading through Westport Port and the Kawatiri Dredge chapter exposes much of the above. Sound strategy is

lacking showing little understanding of the physics of Westport Harbour, the Buller River and Littoral Drift.

Of course, Kawatiri requires a strategic approach to stem operational losses with no eye to the future ... it always has.

But the last 6 years have been full of politically motivated interference leading to ill-informed retrenchment, the

dissipation of real experience and resources with consequent neglect.

In turn the resulting return-to-service required a complete reset, leading to continual unnecessary but essential

expense. I have to say that the particular job of returning 'Kawatri' to service by the then Port Manager and

Dredgemaster was exceptionally well done. The essential expertise at the heart of the dredging operation then left

leaving an uphill task to retain an operational vessel. The expertise of the long term Dredgemaster, who I had to seek

from South Africa in1996 due to the total lack of experience to be found in NZ was eagerly snapped up by the

opposition and is now beginning to bite Councillors on the backside. The lack of support and understanding by

Council has led to the situation we have today.

In the 10 years I was Harbourmaster/Port Manager I attended every monthly Harbour Committee meeting and I have

to say that that form of Governance was effective. There was a two way flow of information which led to the Council

Table dealing with things sensibly and realistically in a way that was based on practical, factual information rather

than theoretical, grasping considerations.

That Harbour Committee format should be promptly reformed and adopted before any of the 3 ill conceived and

potentially expensive proposals in the LTP are even considered.

The question of 'Vested Interests' has to be raised in that most of the Kawatiri report and subsequent Port Plans are

heavily involved in support of, and to the advantage to, a proposed Commercial interest utilising money designated

by the PGF for all Port Development.

There is a definite lack of understanding of the harbour dredging on the various berths and Bar to enable sustainable

future growth which do not warrant the proposed, expensive and unnecessary projects on the Kawatiri to be

undertaken. I warn Councillors to be extremely cautious in making those decisions. The statement that “Initially it is

expected the Port and Dredge Kawatiri will make a loss and it will take four years until this loss is recovered and the

Port is profitable” should ring the alarm bells loud and clear.

Fishing relies on 'West Coast Fishing' companies which provide jobs which are most welcome to the Town but

revenues to both the Port and those workers involved will never be a significant source of income. Long overdue Port

Facilities for the industry are much needed and warranted which will hopefully encourage more trade.

Information Management

25

Tab 6: BARNES David

Option 2 – Limiting Digitising to essential requirements rather than going to far back to historical matters which are not

of urgent search requirements.

2.

CLIMATE CHANGE

I cannot comfortably sit alongside the statement in the consultation document that “Maintaining the status quo, with

no specific resources or plan to address this challenge, is not considered to be an option given the changed

legislative environment we are now operating in.”

Like it or not Westport is situated on a “Delta Flood Plain” developed by the Buller River and exposed to the ravages

of the Coastal elements and Tasman Sea. It has been so for thousands of years not just the last 50 on which most of

todays emotionally charged rhetoric is based.

Westport itself has existed for nearly 200 years since the early 1830's, gradually developing as people have settled into

the town we have today. Through that period of time it has survived Earthquakes and inundations of greater or lesser

magnitudes, described by the media of the day more or less accurately but constrained within the means of

dissemination. Today, we have instant, international access to any and everything by everybody which is

consequentially greatly and emotionally distorted to suit the situation and personal opinions.

My career at sea has taken me all over the planet, I have visited 216 different ports of the world - many several times.

In those travels I have experienced the vastly different conditions - geological, meteorological and those influenced

by Man. It is those latter ones that I can see have been most ineffective and Westport falls into that category. The

continual efforts to dredge and make the port fit the ships (and not the other way round) by the various Councils over

the years is proof. The wonderful 'Tipheads' are a legacy which will stand as testimony in years to come to our

particular local inability to combat and make the forces of nature do as we need. What makes this Council think it

can do any better or has the means to succeed in future proofing the town against the forces of nature without

bankrupting us.

Climate Change and Global Warming has and will continue to evolve over time ...it is not as instant or dramatic as

many have said and its effects cannot be successfully mitigated longterm by planning such as proposed by the

Climate Change Commission and no doubt followed by Buller District Council.

The Draft LTP does not have my backing to insidiously increase my rates to expend on such politically inspired

projects.

26

Tab 7: BARRY Shayne


1 / 2

Q1

CONTACT DETAILS

Name Shayne Barry

Postal address 13 Cook Street

City/Town Westport

Post code 7825


Phone number +64226944592

Q2


I wish to speak to my submission

Q3







I prefer Option 1

Q4






I prefer Option 1

#16#16

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Tab 7: BARRY Shayne


2 / 2

Q5






Dredge

I prefer Option 1

Q6


Term Plan?

I would like to support the Carters Beach Reserve Sub Committee's application for money from the Reserves fund to enhance the hall,

toilets and Reserve. Part of this funding could come from the District revitalization fund. I would like to speak to this part of my

submission with Cody Frewin (Secretary Carters Beach Reserve Sub Committee Secretary)

28

Tab 8: BERSEMANN Elaine

29

Tab 9: BERTHOLD Jennifer

30

Tab 10: BERTHOLD Trevor

31

Tab 11: BICKNELL Penny - Pounamu Pathway

27th

April 2021

Attention: Rachel Townrow

Group Manager, Community Services

By email: [email protected]

Kia ora Rachel,

Re: Coaltown – Te Ara Pounamu Funding

Te Ara Pounamu Ltd currently has a Memorandum of Understanding with Buller District Council to

direct funding from Coaltown Museum to the Pounamu Pathway project for the first three years of

operation commencing on 1 July 2021 at $150k p.a.

Due to unavoidable delays on the project, the Company will not be in a position to take over the

premises on 1 July and would request that we push the funding out for an additional year.

Consequently, we request that the funding be included into Year 4 of the Long Term Plan.

We are unable to give you a date of when we will be in a position to take over the premises, we are

still hopeful that this will be later this calendar year, in which case we would see the commencement

date of the 3 years of funding from the date on which we take over the building.

Ngā mihi

Penny Bicknell

CEO

Te Ara Pounamu Ltd

[email protected]

cc. Sharon Mason, CEO Buller District Council

Francois Tumahai, Chairman Te Runanga o Ngati Waewae

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Tab 12: BILLINGS Christine

33

Tab 13: BIRD Maegan


1 / 2

Q1

CONTACT DETAILS

Name Maegan Bird

Postal address 2/67 Lighthouse Road, Cape Foulwind

City/Town Westport

Post code 7892



Q2



Q3







I prefer Option 1

Q4






I prefer Option 2

#8#8

COMPLETECOMPLETE


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Tab 13: BIRD Maegan


2 / 2

Q5






Dredge

I do not prefer any of these options

Q6


Term Plan?

I would like the council to consider Rangitahi/Youth in their long term plan. Young people need a safe space to hangout, develop their

interests, connect with their support people, and spend time. I believe this idea needs council backing to prevent young people from

just 'hanging out on the streets' and create a space they feel attached to.

35

Tab 14: BLAIR Warwick and Pam

36

Tab 15: BLINCOE Michael

37

Tab 16: BOUGEN John - Inangahua Community Board

38


39


40


41

Tab 17: BUCKLEY Kevin

42

Tab 18: CAMPAGNOLO Sarah - PGF Group


1 / 4

Q1

CONTACT DETAILS

Name Sarah Campagnolo

Company/Organisation (if applicable) PGF Services

Postal address The Loft, Eastgate Mall

City/Town Christchurch

Post code 8062



Q2



Q3







I prefer Option 1

Q4






I prefer Option 1

#18#18

COMPLETECOMPLETE


Started:Started: Tuesday, May 18, 2021 12:03:33 PMTuesday, May 18, 2021 12:03:33 PM

Last Modified:Last Modified: Tuesday, May 18, 2021 12:13:22 PMTuesday, May 18, 2021 12:13:22 PM



Page 1

43



2 / 4

Q5






Dredge

I prefer Option 1

44



3 / 4

Q6


Term Plan?

PGF Services Submission to the Buller Plan

The PGF Services (PGF) is the largest single treatment provider for problem gambling in Australasia with locations throughout New

Zealand.

Qualified counsellors provide free, professional and confidential counselling for gamblers and others affected by gambling, and a

dedicated public health team focus on problem gambling issues in the community using a public health approach.

PGF believes:

Vulnerable individuals, families and communities should be protected and supported. Social justice is at the heart of PGF’s objectives.

A just society is one where benefits and opportunities are equally accessible and equally shared and where all communities have the

same opportunity and the same rights.

PGF’s vision for Aotearoa New Zealand is: Families and communities are healthy and resilient in a just society.

PGF’s mission is: Enhancing the mana of individuals, families and communities: to be free from gambling harm.

Community Outcomes – Social, Prosperity and Culture

Gambling harm impacts many parts of society and impacts on Community Outcomes that the Buller Council is prioritising. The

attached White Paper discusses the impact that Class 4 gambling has on communities, especially communities vulnerable to job

losses and poverty. Having a prosperous, well-connected community, that Buller is aiming for, needs to have a pragmatic approach to

gambling harm and the pokies. Buller District’s Class 4 review is due at the end of 2021, and we encourage the Buller Council to

consider a strong approach to gambling harm reduction as part of the Long Term Plan Community Outcomes.

We currently have a counsellor doing monthly clinic based at Poutini Waiora in Westport. While she is still building the clinic (people

experiencing gambling harm are very reluctant to seek help, often even more than other mental health or addictions), she speaks to at

least 20 (different) people each trip who have experienced gambling harm. She is in contact with Probation services, other NGOs, and

community organisations that all comment on the prevalence of gambling harm in the Buller District.

The Future of Harmful Gambling in Buller

A sustainable approach

Currently Buller is losing $2.2 million a year to pokies (or $6,000 a day). PGF recommends a consistent framework across all local

community boards and local councils that will prioritise harm minimisation, reduce disparity in high deprivation areas, prioritise the

needs and aspirations of Māori and whānau and encourage the reduction of pokie machines.

Ensuring a sustainable reduction in harm would require the Council to provide the framework and monitor its application. Regarding

gambling policy, Buller Council should operate a true sinking lid on pokie machines and TAB venues.

True sinking lid

A sinking lid means a district-wide ban on any additional class 4 gambling venues or machines so this reduces the number of venues

over time and would not affect existing venues or current community funding in the short term. This reduces the harm caused by

gambling, including the social and economic harm caused in areas of high deprivation.

A ‘true’ sinking lid policy would not allow any relocations of pokie machines or venue mergers. Hamilton City Council introduced a ‘true’

sinking lid policy for pokies which PGF strongly endorses and encourages other councils to adopt. A true sinking lid is nation-leading

and would demonstrate the Council’s commitment to improving health and wellbeing for all Buller residents by reducing harm and

disparities in opportunities.

A ban on any new venues and machines is preferable to a cap

A ban on any new venues and machines is preferable to a cap. It is possible that a cap on machine numbers or venues may result in a

greater number of licensed venues and machines being located in poorer communities (i.e. venues shift from more prosperous

localities, suburbs and town centres). This would ensure the Draft Plan would benefit all Buller residents.

Community funding

PGF recommends sustainable community funding. Buller Council could consider a policy that reduces the reliance on funding from

pokies ensuring that CCOs and Local Boards do not receive funding from pokie trusts for community projects. This would ensure that

organisations look at alternative funding options that prioritises harm minimisation, and reduction of disparity in high deprivation areas.

45



4 / 4

Please read the attached ‘White Paper’, created by PGF Group, Salvation Army Oasis and Hāpai Te Hauora, to bring about a

discussion on how we can move past funding that relies on the harm of our vulnerable members of society.

Community empowerment

While PGF does not support the Class 4 community funding model, community empowerment could ensure a fairer and more equitable

distribution of funding derived from gambling. Currently, for every $115 that is lost on a pokie machine in a community ($100 plus

GST), only $40 will go back to the community and it’s not necessarily from the community it came from. In 2019 in Buller District, the

number was 36% (see attached information sheet). More money leaves communities than is returned to them in the form of grants.

There is also concern that some Trusts and some TLA Councillors have vested interests in some venues.

Buller Council could work in with the current mental health and addictions sector to de-stigmatise harmful gambling and address co-

existing problems. Individuals and affected others are inhibited from seeking help because of the stigma associated with harmful

gambling and the lack of understanding in the mental health and justice sector of the associations between family violence, mental

health and gambling.

Conclusion

Gambling harm is a contributing factor to the poverty and joblessness that affect Buller. PGF recommends that the Draft Plan include

directions and focus areas that enable sustainable harm reduction in all Buller communities so that harmful gambling can be reduced.

PGF recommends a Buller-wide framework for harm reduction, tangible investment in high need areas and a community empowerment

approach.

46


POKIES BY NUMBERS

Buller District

$2.2millionTotal $ lost on Class 4 pokies 2019

- thats more than $6,000 every day!

PGF Group provides free and confidential counselling and support services

For more information visit: pgf.nz/tla

0800 862 342www.asianfamilyservices.nz

0800 212 122www.mapumaia.nz

0800 664 262www.pgf.nz

adults in NZ use pokies at least once a week

OF ALL

1.3%72Total # machines

2019

of adults in NZ are moderate

to severe risk gamblers

Class 4 pokie losses come from those moderate to

severe risk gamblers

30%1.8%

1.2%

AT RISK GAMBLER

0.9%

AT RISK GAMBLER

8.6%

AT RISK GAMBLER

7.6%

AT RISK GAMBLER

Buller’s ethnic group population vs national moderate to severe risk gamblers

AsianEuropean/Other Maori Pacific

0 change from 2018 Very

LowMedium

LowMedium Medium

HighHigh

0 change from 2018

8Total # venues

2019

returned as grants to the Buller community.

Pokie trusts operate pokie machines in pubs, clubs and TABs. The societies, their machines and the pubs, clubs and TABs that operate them make up the Class 4 gambling sector.

$62,779 Up from 2018

2

6

000

91.8%

11.2

%

1.4

%

7.4

%

2019 Venues by Deprivation

Council gambling policies should prioritise the needs of Maori, Pacific and Asian Peoples because these populations experience twice the rate of moderate and severe gambling harm than the general population.

$813

thousand

This figure includes grants made directly to Buller District only, and does not include grants that might have been shared with more than one Territorial Local Authority (TLA) or distributed by a national body.

47


Ending community sector dependence on pokie funding

White Paper

Updated Friday 17 July 2020

48


02 ABOUT THIS PAPER

03 EXECUTIVE SUMMARY

04 THE POKIE SYSTEM

05 WHERE IS THE MONEY COMING FROM?

06 FUNDING MODEL

06 GRANT DISTRIBUTION

07 CLASS 4 GRANTS FOR COMMUNITY GROUPS

07 CLASS 4 GRANTS FOR SPORT

08 IMPACT ON TAX COLLECTED

08 COVID-19

09 AN INTERIM SOLUTION

10 ABOUT THE AUTHORS

11 APPENDICES

CONTENTS

49


ABOUT THIS PAPER

PGF Group, Hāpai Te Hauora and the

Salvation Army have long been concerned at

the reliance many community groups have

on grants from pokie trusts or societies to

underpin their operations.

Many of these groups share our concerns

because of the ethical dilemma it poses for

them. The services that these organisations

provide are largely essential to many people

and they deserve to have certainty and

sustainability in their funding providers. The

current system of funding from pokies does

not provide that surety, relying on a small

group of people in our poorer communities

putting money into the machines.

A number of important community social

services and sporting groups rely on

community funding and know that in doing

so the money is often coming from the very

whānau and communities they are trying to

support into wellbeing.

The COVID-19 Level 4 lockdown and the

consequent closure of hospitality businesses

has starkly highlighted the dependency of

community organisations on grants from

pokie machine losses in the Class 4 gambling

sector.

There is no better time to look at reforming

this system for funding community services

to give more direction and certainty in a

whole of community approach.

At this time, the system needs to be

substantially supported. We believe there

should be a publicly funded continuation of

grant distribution for a year from the time of

the beginning of the alert level 4 lockdown

and there are a number of ways this could

be done.

Image source: ruapehudc.govt.nz

50


03

EXECUTIVE SUMMARY

• From losses of $939 million in pokie machines in pubs, clubs and TABs in 2019, a total of $241 million was paid out in grants to community and sports groups

Community $120,812,075

Sports $120,444,774

Total $241,256,849

• Four of those groups received $1 million in one year. The top recipients in the calendar year 2019 are listed in the table below.

Community

Supreme Sikh Council of New Zealand

$4,241,691

New Zealand Flying Doctor Trust

$2,513,000

Canterbury West Coast Air Rescue Trust

$1,952,267

Bruce Pulman Park Trust 2018

$1,947,789

Sports

Auckland Rugby Union Inc.

$1,520,000

Waikato Rugby Union $897,427

NZ Metropolitan Trotting Club

$747,677

Bay of Plenty Rugby Union

$707,914

Auckland City FC $639,213

• Problem gamblers contribute between 30% - 60% of the amount paid out in community grants meaning that problem gamblers either lose the amount equal to grants or considerably more: $282m, $376m or $563m.

• Grants in 2019 totalled $289 million.

• Fifty percent of the 15,476 machines (7,700) are in the most deprived communities (decile 8-10 on the Ministry of Health measurement of deprivation).

• It is estimated that community groups and services would need up to approximately $60 million to continue uninterrupted services to their communities and the wider public, for six months.

• It is estimated that sports groups would need about $60 million to continue uninterrupted services to their respective disciplines for six months.

• However, government may want to review the larger Unions’ needs in relation to measures they are taking themselves to manage the impact of COVID-19 level 4 and beyond.

• If pokie machine losses were replaced with a government grants programme, four things would be achieved:

• Community and sports funding would be secured so services can continue to be delivered where they are needed.

• Losses from the most deprived communities would stop being diverted to national public programmes and national sports interests.

• Transparency about who gets what money and what it is used for would be provided.

• Time would be provided to review the whole programme and manage the reintroduction of pokie machines in ways that did not exacerbate gambling harm and is manageable as the COVID-19 levels of lockdown are worked through.

51


THE POKIE SYSTEM

Trusts and Societies were created to collect gambling proceeds and distribute grants. Together with clubs they make up the Class 4 gambling sector.

There are currently 34 Trusts and Societies holding licenses for the 15,470 Class 4 pokie machines. It should be noted that this excludes the 3078 pokies in casinos and casinos are sited as the largest contributor to problem gambling for the Asian community. A Trust or Society may be based in one location but will have their machines in venues across New Zealand.

In the 2019 calendar year, Class 4 Trusts and Societies had a surplus of $124 million1 to run their operations which largely incur processing, management and machine replacement and maintenance costs.

There are 205 clubs with 2,702 machines reported in Department of Internal Affairs (DIA) gambling statistics who retain all gambling proceeds for the purposes of the club.

At Territorial Local Authority (TLA) gambling policy reviews, the Class 4 sector are well heard and often with legal representation. They are also supported by groups who receive funding in the form of grants. The voice heard the least is that of the problem gambler and their family and community.

There is also significant risk of self-interest and inequity in the system when the Boards of the Trusts and Societies are self-appointed and only accountable to themselves when deciding which groups do and do not receive the proceeds of pokie losses.

1 Calculated using 40% of ex GST losses for the grants

distributed and 16% of the ex GST losses for the venue

payment

52


05

WHERE IS THE MONEY

COMING FROM?

In the 2019 calendar year, $939 million (GST inc.) was lost in pokie machines in pubs, clubs and TABs (Class 4 gambling).

Only 1.3% of New Zealanders regularly use pub pokie machines1, and 50% of the 15,476 machines (7,700) are in the most deprived communities (decile 8-10 on the Ministry of Health measurement of deprivation). It is therefore reasonable to conclude that the majority of the money being paid out by Trusts and Societies to community groups is coming from the poorest New Zealanders.

There are a range of estimates on how much of pokie machine expenditure comes from problem gamblers, outlined in the table at Appendix 1. The rate of losses from problem gamblers is at best equal, but most likely exceeds the amount paid out in community grants that go back to the families and communities who lost the $939 million in 2019.

At whatever percentage, it is evident that community grants come from a small number of people who cannot afford this level of losses and even less so now with the impacts of COVID-19.

We think there should be a publicly funded continuation of the Class 4 system payments for a year from the time of the beginning of the level 4 lockdown. This could be done in a number of ways, but services should get a roll-over to take them through this transition.

In doing so, groups can continue to support communities of interest or specific communities and provide wider population needs where for some time, there will likely be more not less demand.

The DIA estimate that 30% of Electronic Gaming Machine (EGM) expenditure is from problem and moderate risk-gamblers (2016). This is based on self-reported expenditure from National Gambling Study (NGS) participants. Self-reported EGM (pokie) gambling expenditure has historically been shown to be inaccurate.

Published sections of the NGS have already warned that self-reported expenditure does not often correspond to actual expenditure, especially for EGM gamblers2. The NGS self-reported EGM expenditure estimates for Class 4 gambling were $296m in 2012, $193m in 2013, and $157m in 2014; the actual expenditure recorded by the DIA was $854m, $826m, and $808m, respectively3. Similarly, an Australian study found respondents in the ACT reported an expenditure that was 45% of their actual spend4.

A NZ study relating time and money spent gambling with quality of life measurements noted that their use of self-reported expenditure data likely underestimated losses, and their results would have been stronger if they had an objective way to measure expenditure5. Whatever estimate is applied, it is problem gamblers who support the community funding scheme and many of the recipients perform necessary and valuable services to the community and the public of New Zealand.

1 Health Promotion Agency (HPA) 2018. Kupe 2016: Health and Lifestyles Survey [data file]. Retrieved from http://kupe.hpa.org.nz/2 Abbott, Bellringer, Garrett, & Mundy-McPherson, 2014, pp. 140–141; Bellringer, Garrett, Kolandai-Matchett, & Abbott, 20153 Bellringer et al., 2015, p. 724 Australian Institute for Gambling Research, 20015 Lin et al., 2010

53


06

THE FUNDING MODEL

The money lost on pokie machines is called Gross Machine Proceeds (GMP). GMP is the amount wagered, less the amount paid back as prizes. The money collected is applied in a complex model before it can be distributed in grants.

Venue Payments A Trust can pay up to 1.28% of the venue’s turnover that week to a venue as commission, meaning higher earning venues can be paid proportionately more.

Prior to 2016, venues were paid on a fixed rate. Payments to all venues across the financial year must still not exceed 16% of losses for that year.

Problem gambling levy The levy is 0.78% of GMP and funds treatment services, public health and research.

Trust Operating Costs These must be kept as low as possible and only used for “reasonable” costs. The true proportion will be unique to each Trust based on their grant contributions etc. but estimated at 20%.

Regulator fees Fees are 3% and are paid to the Department of Internal Affairs.

Gaming duty Duty is 20% (GST inclusive, paid to the Crown): Section 12C of the Gaming Duties Act 1971.

Community grants Grants must be 40% of GMP but Trusts can pay more.

The table at Appendix 2 details the source of GMP and the amount distributed in grants for the year ended December 2019. The Department of Internal Affairs publishes GMP figures quarterly.

GRANT DISTRIBUTION

In the year to December 2019, a total of 13,000 organisations received approximately $241 million in grants (according to the PGF Group grants analysis system which uses discoverable published grants lists from the gambling societies and trusts rather than the theoretical figure 0f 40% of GMP).

PGF categorises grants into community services, community groups and sports groups.

Community services are classified as groups that provide paid and volunteer services. Community groups are classified as groups that service a discreet population and include faith-based groups but also include arts societies and some research groups.

Sports groups include everything from large Unions to local tennis clubs and children’s sports. Grants are generally shared 50/50 between sports groups and community groups and services.

For grant recipients, many of which support laudable causes and communities, the Class 4 community funding programme represents revenue of between $250 million to $300 million per year. Few community recipients can see any alternative to meet their revenue needs.

2019 calendar year grants split

Community $120,812,075

Sports $120,444,774

Total $241,256,849

54


07

CLASS 4 GRANTS FOR SPORT

Approximately $120 million, or about half of the money raised through the Class 4 community funding scheme, goes to sports.

National sports bodies and community sports groups are now highly dependent on Class 4 gambling losses. This dependency, in terms of the history of New Zealand sport is relatively contemporary.

While there may be long standing relationships and “rollover” application processes in place between some sports groups and some Trusts or Societies, this is not the case for all. For some groups the annual and uncertain application cycle limits development.

A categorised list of sport funding recipients can be found at Appendix 4.

CLASS 4 GRANTS FOR

COMMUNITY SERVICES

The types of community groups that benefit from Class 4 funding include amateur dramatics, arts groups and recreational groups outside clubs.

It also includes health, mental health and social services groups, often working with vulnerable people and communities. Other groups might include groups like those involved in public-benefit research but who aren’t providing any services, for example some medical researchers.

The community services which benefit from the community funding scheme are all services which the whole of the New Zealand public benefit from either directly or indirectly.

The existence of an ambulance service, for example, may not be used by each of us, but that it is there for those who do, is a benefit to all New Zealanders.

These groups of beneficiaries are more difficult to plan for because they are often small and are only known in their immediate communities.

A way of dealing with this is to provide more government support to the Community Organisation Grants Scheme (COGS). An alternative model is to utilise the regional community foundations.

Government guidance could be provided for the philanthropic sector on applications and criteria but recognising these programmes often service valuable niche and localised organisations. At current grant levels the funding programme would be about $60 million per annum. Community group dependency is significant.

A categorised list of community funding recipients can be found at Appendix 3.

55


08

IMPACT ON TAX COLLECTED

The benefits to government from gambling losses are made up of the:

• GST collected• gaming machine duty and levy, providing

problem gambling services and research• community funding not demanded from

Vote

The GST is a function of money spent and it seems very reasonable to assume that if the money spent on pokies in Class 4 was not spent there, it would be spent elsewhere, and with the possibility that a multiplier effect would see revenue to the government increased.

The gaming machine duty is an income/turnover tax proxy. As such, this may equal the amount of income tax the government

collects through businesses paying income tax on the level of income that would have been spent on pokies (ex GST). This approximation may overstate or understate the tax take by the government from taxable business activity.

A multiplier effect may act in the government’s favour in this regard if the money was going through non-pokie businesses. The levy is derived from gambling losses and is a function of the size of the problem. Gambling treatment services are not taxpayer funded.

Government dependency is not significant with opportunity money spent for the tax gathered from losses, to be spent on other consumables.

COVID-19

The grants system on which valuable community services survive is based on the assumption that it is acceptable for a small proportion of New Zealanders living in the poorest communities to lose money in support of a national benefit. Many community groups would rather not take pokie funding to deliver their programmes but have no other option.

There is little transparency about the application process and who gets what grants. In addition, some Trusts and Societies are approving grants from proceeds of pokie losses gathered from areas outside of which the community group may be operating. The Class 4 funding system may be seen as a way to keep the hospitality industry afloat at the time of this pandemic. The Gambling Act (2003) prohibits venues operating as pokie dens (section 69A(e) and 70 (1) (i)).

As lockdown levels change and pubs are permitted to operate, the license conditions for pokie machines must be maintained and monitored. If a pub with pokies does not reopen, then the machines cannot be moved to another location if the TLA gambling policy prohibits this. Nor can alternative venues increase their number of pokie machines, if the TLA policy precludes this.

Of note also is that gambling policy reviews are subject to TLA public consultation processes. As 50% of pokies are in the poorest areas in New Zealand and these areas are likely to be in need of significant COVID-19 income support for the foreseeable future, it would make sense to ensure that gambling harm is not further exacerbated, despite the need to support community and sports groups.

56


09

AN INTERIM SOLUTION

Pubs and clubs face a long and uncertain future before revenue streams return. Even if pubs return to some normal operation it is likely that social distancing rules for various levels of lockdown may preclude some or all pokie machines operating in the same way.

Both limited patronage and the limited number of machines able to be used at any one time will impact on gambling losses. This is positive. However, it will also flow into less revenue for the community grants programme.

Most Trusts and Societies have suspended grants, effective from COVID-19 alert level 4 lockdown.

An interim solution is for the Government to directly fund current community and sports grant recipients as part of its COVID-19 support packages. This could be done for a six month period while the whole programme is reviewed.

It is estimated that community groups and services would need up to about $60 million to continue uninterrupted services to their community groups and wider public, for six months. This will cover the period of level 4 lockdown through to September 2020.

It is estimated that sports groups would need about $60 million to continue uninterrupted services to their respective disciplines for six months. However, government may want to review the larger Unions’ needs in relation to measures they are taking themselves to manage the impact of COVID-19 Level 4 and beyond.

If pokie machine losses were replaced with a government grants programme several things would be achieved.

Firstly, community and sports funding would be secured so services can continue to be delivered.

Secondly, there would be transparency about who gets what money and what it is used for. This does not mean that funding would only go to approved government projects but does mean there can be some equity oversight.

Importantly, losses from the most deprived communities would stop being diverted to national interests.

Finally, this will provide time to review the whole programme and manage the reintroduction of pokie machines in ways that does not exacerbate gambling harm and is manageable as the COVID-19 levels of lockdown are worked through.

57


10

ABOUT THE AUTHORS

PGF Group

The Problem Gambling Foundation is now trading as PGF Group, with Asian Family Services, Mapu Maia Pasifika Service, and PGF Services, part of this overarching brand. The organisation is a Charitable Trust operating nationally with services delivered under contract to the Ministry of Health (MoH) and funded from the gambling levy.

Established in 1988 as the Compulsive Gambling Society, the organisation started out as a telephone service then expanded to include face-to-face services as demand grew. In 2001, the Problem Gambling Foundation succeeded the Compulsive Gambling Society and today, we deliver treatment and public health services nationwide. We have a skilled and diverse workforce with staff who are qualified in clinical work and in health promotion.

PGF Services provide free counselling, advice and support to gamblers and their families and work to ensure that support for our Māori clients fits a kaupapa Māori way of working. Our specialist teams provide culturally and linguistically appropriate support to Asian and Pasifika communities living in New Zealand.

Hāpai Te Hauora

In 1996, Hāpai Te Hauora Tapui Ltd (Hāpai) was established as a regional provider of Māori public health services in the greater Auckland region. Hāpai was created from a tripartite Memorandum of Understanding between Te Rūnānga o Ngāti Whātua, Raukura Hauora o Tainui and Te Whānau o Waipareira Trust Board. The subsequent arrangement provided an integrated and collaborative entity that cemented regional Maori public health services in one place for Tāmaki Makaurau.

The mission and vision of Hāpai is to increase opportunities for Māori to enjoy good health and to be sustained by healthy environments. This is done by providing a strategic focus that is underpinned by our values, evidence based research, innovation and leadership for the advancement of health and well-being for all. Work is undertaken regionally and nationally to address health inequities and provide strategic solutions for long term outcomes across all areas of well-being.

The Salvation Army Oasis

For over two decades, The Salvation Army has provided help to those impacted by harmful gambling. The Salvation Army Oasis was formally established in June 1997 in Auckland in response to growing evidence that the proliferation of gambling opportunities was having a negative impact on society. Prior to this in 1992 and 1995, services to support gamblers were established in Wellington and then Christchurch after the opening of the Christchurch casino. Consequently, the Army’s reducing gambling harm services have expanded to seven regions across New Zealand.

We are funded by the Ministry of Health to provide preventing and minimising gambling harm clinical and public health services. We have a diverse team of professional and clinically qualified and registered counsellors and public health practitioners. Our team support and encourage wellbeing and reduce gambling harm through education, self-reflection and creative and research based therapies. Public health workers provide accurate information and education to raise awareness and support community and professional groups, services and Government to be free from gambling harm.

58


11

APPENDICES

2019 Calendar Year $ MillionsNon-club Class 4

operating payments

Class 4 losses 939

Club losses 98

Non-club losses 841

GST on non-club losses 110

Non-club losses less GST 731

GST exclusive Machine duty (23%) 168

Non-club tax paid losses 563

Grants (40% ex GST losses) 292

Venue payments (16% ex GST losses) 117

Levy (0.78% ex GST losses) 6

Fees (3% ex GST losses) 22

Total gambling society operating payments 437 437

Gambling society surplus to run the trust 126

Percentage of ex GST paid losses available to trust 17%

Appendix 2: 2019 GMP Sources and Distribution of Grants

Rate of problem gambler

contribution to losses2019 Losses

2019 Grants

(40% of 2019 Losses less

GST)

Contribution from

problem gamblers

30%Department of Internal Affairs

$939 million $292 million $282 million

40%Australian ProductivityCommission minimum


60%Australian ProductivityCommission maximum


Appendix 1: Problem gambler contribution to annual GMP

59


12

Appendix 3: 2019 Community Services and Community Groups sub-categories

Community groups $37,838,195

Education $23,466,718

Arts $12,952,443

Health related $10,446,792

Community services $10,420,915

Faith based $6,819,355

Search and Rescue (excluding surf clubs)

$6,656,072

Māori $5,092,069

Kindergartens/Childcare/Plunket

$2,452,638

Ambulance services $2,401,716

Council $1,516,343

Fire Services $748,819

Total $120,812,075

Rugby $19,982,236

Other sports $19,861,454

Soccer $11,295,064

Cricket $8,908,166

Water sports $8,046,758

Racquets $6,012,940

Sports stadiums/academies/events centres

$5,478,896

Hockey $4,757,123

Basketball $4,743,441

Netball $4,524,828

Surf lifesaving clubs $4,438,863

Bowling $3,431,502

League $3,179,766

Racing $2,861,218

Cycling $2,695,279

Special Olympics/sports for the disabled

$2,433,512

Gym sports $2,341,199

Softball $1,766,541

Athletics $1,412,553

Equestrian/pony clubs $1,303,274

Motorsports $970,161

Total $120,444,774

Appendix 4: 2019 Sport Groups sub-categories

60

Tab 19: CAWOOD Wendy

61

Tab 20: CHIGNELL Bevan

SUBMISSION FORMDraft 2021-2031 Long Term Plan

Name

Organisation

Postal Address

Town Post code

Phone

Email

Presenting your submission in person

I wish to speak to my submission I do not wish to speak to my submission

Have your say!

Information Management (see page 5 of the Consultation Document for more information)

Option 1 - A full approach to information management implementation including digitising all paper data and records

Option 2 - Implement a partial information management system and not digitise the paper records


Additional feedback

Climate Change (see page 6 of the Consultation Document for more information)

Option 1 - A staged approach to develop a strategic plan, with ongoing monitoring costs

Option 2 - Immediately develop a strategic plan, with ongoing monitoring costs


Additional feedback

Westport Port and Kawatiri Dredge (see page 7 of the Consultation Document for more information)

Option 1 - Ring-fence the port

Option 2 - Operate as a Council cost centre

Option 3 - Consider special purpose governance structure for the Kawatiri Dredge

I prefer Option 1 I prefer Option 2 I prefer Option 3 I do not prefer any of

these options

Additional feedback

Shapingour district

Council is considering options for the following three major items in it’s draft 2021-2031 Long Term Plan. Please read the corresponding Consultation Document for further information and provide your views. More information is available on Council’s website www.bullerdc.govt.nz.

Please take the time to have your say and help ‘Shape our District’ by reading the draft 2021-2031 Long Term Plan’s Consultation Document and providing feedback to the three things we are consulting on. We also encourage feedback on other items relating to the LTP - see over. www.bullerdc.govt.nz

B Chignell

PO Box 232

Westport

x

x

X

X

62

Tab 20: CHIGNELL Bevan

Shapingour district

FURTHER FEEDBACK - do you have any other items or requests that you would like Council to consider it its Long Term Plan?

Consultation closes 18 May

www.bullerdc.govt.nz

[email protected]

or complete your submission online at www.surveymonkey.com/r/21-31-LTP

Privacy Statement: In accordance with the Local Government Act 2002, all submissions (including

your name and contact details) will be made available online as part of the LTP decision-making

process. Please refer to www.bullerdc.govt.nz/privacy or contact Council for a copy of Council’s

Privacy Statement.

63

Tab 21: CLARKSON Michael - Nuku Aotearoa

64


65


66


67


68

Tab 22: CLIMO Annette

69

Tab 23: COLEMAN Bruce

70

Tab 24: COLEMAN Viv

71

Tab 25: COOPER Chris - Carters by the Sea


1 / 2

Q1

CONTACT DETAILS

Name Chris Cooper

Company/Organisation (if applicable) Carters by the sea

Postal address 27 Marine Parade, Carters Beach

City/Town Westport

Post code 7825



Q2



Q3







I prefer Option 1

Q4






I prefer Option 2

#11#11

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Tab 25: COOPER Chris - Carters by the Sea


2 / 2

Q5






Dredge

I prefer Option 1

Q6


Term Plan?

After 4 years of submissions to the LTP with no result, can the council invest funds into resurfacing the footpaths on Marine Parade

from Tasman St to Golf Links Road. The footpaths are basically now gravel and are a hazard to walk on and aesthetically a disgrace

alongside the outstanding cycle trail across the now revitalised domain.

Also there is significant stormwater discharge onto the domain from Marine Parade via the under road sumps that do not work

anymore. Soakpits should be installed at these points on the domain such as the one that was installed across the road at 27 Marine

Parade in Sept 2019. It is particularly bad on roadside of the playground.

Also the car park outside Donaldos requires extending towards the play ground due to the increase in size of motorhomes that stick

out into the road. Someone will get injured crossing the road to the shop one day.

Regards

Chris Cooper

73

Tab 26: CORRIE Margaret

74

Tab 27: CORRIE Paul

75

Tab 28: CRAWFORD Anne

76

Tab 29: CRAWSHAW Norman


1 / 3

Q1

CONTACT DETAILS

Name Norman Crawshaw

Company/Organisation (if applicable) Personal

Postal address 39A Queen Street

City/Town WESTPORT

Post code 7825



Q2



Q3







I prefer Option 1

Q4







#14#14

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77



2 / 3

Q5






Dredge

I prefer Option 1

78



3 / 3

Q6


Term Plan?

I request Council to consider the establishment of a History/Heritage centre to house tactile archives and similar, thus ensuring their

preservation and allowing public access.

WHY IS THIS NEEDED

Government at national level regards the preservation and management of its historical heritage and the public access to these, as an

essential aspect of its activity, hence the establishment of Archives NZ.. Regional and District Councils have a similar duty at regional

and district level.

WHO WOULD BENEFIT

There is a need to preserve, protect and retain for the public of Buller for residents, visitors, researchers (amateur and professional)

and future generations. This is becoming more and more important as more and more people are becoming interested in their own and

their family's history and culture.

Additionally, the government has now decreed that History, with an emphasis on local history, is to become a compulsory aspect of the

national curriculum at all levels.

Without the availability of such a centre, Buller students, especially those of coastal Buller) will be severely disadvantaged as on the

wider West Coast, Hokitika, Greymouth and Reefton have such centres. The establishment of such a centre in Westport would ensure

the continuity of access and support for present and future students of this district.

WHAT COULD BE INCLUDED

The proposed centre would be a repository for a wide range of tactile heritage items.This could include such things as Council

archives, historical newspapers, books, photographs, club and society historical archives/documents, donated birth, death and

marriage certificates, church and school records (original or photocopies). NB These are merely examples not a definitive list.

ADDITIONAL BENEFITS

Such a centre could become a visitor attraction in its own right and encourage researchers from other areas to visit, thus contributing

to the economy of the district. It could also sell and produce educational resource material for use in schools, thus providing a useful

revenue stream

SUMMARY

History and heritage provide us with a window to the past and allow us to better understand our present culture and society. There is a

need for this to be preserved and be accessible for the present and future generations.

The proposed centre would serve as both a guardian of resources and a gateway through which the wider community, both present and

future, can access and be a part of their regional identity, culture and heritage.

NOTE

This is a personal submission. However, as secretary of Buller Grey Power,I am aware that many of our 500+ members would be

supportive of this proposal.

79

Tab 30: DARK Geoffrey

80

Tab 31: DE FRIEZ Veronica

81

Tab 32: DE FRIEZ Veronica - Westport Whitebait Festival Trust

82


83


84


85


86


87

Tab 33: Deb


1 / 2

Q1

CONTACT DETAILS

Name De b

Postal address P.o.box 185

City/Town Westport

Post code 7892


Q2



Q3







I prefer Option 2

Q4






I prefer Option 2

#21#21

COMPLETECOMPLETE






Page 1

88

Tab 33: Deb


2 / 2

Q5






Dredge

I prefer Option 2

Q6


Term Plan?

Cycleways are important. Let's get more citizens out on bikes safely. Alma rd has so many near misses between car and car on blind

corners but buggies, pedestrians and bicycles need somewhere to go. Build a cycleway and improve visibility on corners. So much

development going in we need it now before the fences go up and no room to move on this.

Don't support mines that communities don't want. Barrytown mine is an environmental disaster and will b unliveable for the

residents.keep coast rd the scenic gem it is.

More education and legislation around packaging, rubbish and recycling. Businesses should reduce unsuitable products so that they

don't end up in landfill miles away burdening taxpayers and the environment.

Loving the palm trees, support for youth and improving of community facilities that increase well being and joy.

89

Tab 34: DODSWORTH Gary

90

Tab 35: DUNCAN Lynne - Northern Buller Communities Society Inc

91

Tab 35: DUNCAN Lynne - Northern Buller Communities Society Inc

92

Tab 36: EADE Lawrence


1 / 2

Q1

CONTACT DETAILS

Name Lawrence EADE

Company/Organisation (if applicable) Cape Foulwind Staple 2 Limited

Postal address PO Box 245,

City/Town WESTPORT

Post code 7866



Q2


I wish to speak to my submission

Q3








Q4






I prefer Option 2

#22#22

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93

Tab 36: EADE Lawrence


2 / 2

Q5






Dredge

I prefer Option 2

Q6


Term Plan?

Want to make a presentation regarding facilitating zonings in the Cape Foulwind precinct that enable light to general industrial uses +

residential development. There is already a lot of residential construction going on at the moment - this construction is being approved

under existing rural zoning

94

Tab 37: ELLEY Grant

95

Tab 38: EWERS Murray

96

Tab 39: FITZSIMMONS Carol

97

Tab 40: FREEMAN Scott


1 / 2

Q1

CONTACT DETAILS

Name Scott Freeman

Postal address PO Box 185

City/Town Westport

Post code 7825


Phone number 027 308 6420

Q2



Q3








Q4






I prefer Option 2

#24#24

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Page 1

98

Tab 40: FREEMAN Scott


2 / 2

Q5






Dredge

I prefer Option 1

Q6


Term Plan?

Footpaths for Alma Road. It is narrow and well used by walkers etc from an rapidly growing population in the area. Put new subdivision

reserve contribution monies from subdivisions on Alma Road towards this.

99

Tab 41: GEAR Nick


1 / 2

Q1

CONTACT DETAILS

Name Nick

Postal address 125 Romilly Street

City/Town Westport

Post code 7825


Q2



Q3







I prefer Option 1

Q4






I prefer Option 2

#1#1

COMPLETECOMPLETE


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Tab 41: GEAR Nick


2 / 2

Q5






Dredge

I prefer Option 1

Q6

FURTHER FEEDBACK - do you have any other items or

requests that you would like Council to consider in its Long

Term Plan?

Respondent skipped this question

101

Tab 42: GIBSON Peter

102


103


104


105


106


107


108


109


110


111


112


113

Tab 43: GIBSON Peter - Market Cross Community Group Inc

114

Tab 43: GIBSON Peter - Market Cross Community Group Inc

115

Tab 44: GILBERT Derek

116

Tab 45: GILBERT Kevin

117

Tab 46: GIRL Belinda and FLANAGAN Maurice

118

Tab 47: GOURLEY Allwyn - Karamea Swimming Club


1 / 2

Q1

CONTACT DETAILS

Name Allwyn Gourley

Company/Organisation (if applicable) KARAMEA SWIMMING CLUB

Postal address RD 3, 58 Baker Creek Road

City/Town Karamea

Post code 7893



Q2



Q3







I prefer Option 2

Q4






I prefer Option 1

#13#13

COMPLETECOMPLETE


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119

Tab 47: GOURLEY Allwyn - Karamea Swimming Club


2 / 2

Q5






Dredge


Q6


Term Plan?

On behalf of the Karamea Swimming Club I would like to apply for an annual grant of $10,000.00 to help pay for the cost of the power

and chemicals that is needed to run the community swimming pool. Power and chemical costs are steadily increasing and are

essential for the future of the this crucial asset in the community. It has been recently upgraded and is an amazing asset for our

young people to learn to swim and also for the health and well being of the wider community.

120

Tab 48: GRAMMER Linda and MULHOLLAND Ian

121


122


123


124


125


126


127


128


129


130


131


132


133


134


135


136


137


138


139


140


141


142


143


144


145


146


147


148


149


150


151


152


153


154


155


156


157


158


159


160


161


162


163


164


165


166


From: Linda Grammer

To: BDC_Long Term Plan

Cc: BDC_Info; Ian Mulholland

Subject: further info as part of our submission to BDC draft LTP 2021/31 ."GENE EDITING myth & reality- a guide

through the smokescreen"

Date: Tuesday, 18 May 2021 1:23:20 am

Attachments: 010b1026f294638ea501f7ceb6f347a7.pdf

Further information as part of our submission to the BDC draft

LTP 2021/31

Submittors:

Linda Grammer and Ian Mulholland

Seddonville

(We wish to be heard)

Tēnā anō koutou katoa:

For your information, please see the attached report

"GENE EDITING myth & reality- a guide through the

smokescreen"

and (information for council regarding Climate change)

https://rodaleinstitute.org/wp-content/uploads/rodale-white-

paper.pdf

"Regenerative Organic Agriculture

and Climate Change

a Down to Earth Solution to Global Warming"

Thank you.

also available on request: (in attachment)

"The Rise of Superweeds- and what to Do About it"

Policy briefing

Union of Concerned Scientists (USA)

Submitted by Linda Grammer and Ian Mulholland

(this Evidence is part of our submission to the BDC draft LTP

2021/31

167


A guide through the smokescreen

GENE EDITING

MYTHS AND REALITY

168

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169

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170

Tab

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his

gu

ide.

All

are

exp

ose

d a

s fa

lse

or

mis

lead

ing.

Th

e cl

aim

s ar

e b

ein

g

use

d t

o a

rgu

e fo

r th

ese

tech

niq

ues

to

be

exem

pte

d f

rom

the

EU

’s G

MO

reg

ula

tio

ns.

Th

is w

ou

ld m

ean

that

pro

du

cts

of

thes

e te

chn

iqu

es w

ou

ld n

ot

be

sub

ject

ed t

o s

afet

y te

stin

g, t

race

abil

ity,

or

GM

O la

bel

ing,

an

d E

U c

ou

ntr

ies

cou

ld

no

t b

an t

hei

r cu

ltiv

atio

n. A

s a

resu

lt, t

hes

e

GM

Os

wo

uld

en

d u

p o

n o

ur

fiel

ds

and

pla

tes

Summary

un

test

ed a

nd

un

lab

elle

d, a

nd

far

mer

s an

d

foo

d p

rod

uce

rs –

in

clu

din

g th

ose

op

erat

ing

un

der

org

anic

sys

tem

s –

wo

uld

hav

e n

o w

ay o

f

avo

idin

g th

em.

Th

e m

isre

pre

sen

tati

on

beg

ins

wit

h t

he

term

ino

logy

use

d t

o d

escr

ibe

them

. Co

ntr

ary

to i

nd

ust

ry c

laim

s, g

ene-

edit

ing

tech

niq

ues

are

no

t

bre

edin

g te

chn

iqu

es, b

ut

are

gen

etic

mo

dif

icat

ion

tech

niq

ues

th

at s

har

e so

me

of

the

sam

e m

eth

od

s as

old

-sty

le

gen

etic

mo

dif

icat

ion

.

Als

o c

on

trar

y to

th

e cl

aim

s

mad

e, t

hes

e te

chn

iqu

es a

re

no

t p

reci

se o

r co

ntr

oll

ed, n

or

do

th

ey h

ave

pre

dic

tab

le o

utc

om

es.

In a

dd

itio

n t

o t

he

inte

nd

ed g

enet

ic c

han

ge,

gen

e ed

itin

g ca

use

s m

any

un

inte

nd

ed c

han

ges

and

gen

etic

err

ors

. Th

is c

an i

ncl

ud

e th

e

inad

vert

ent

add

itio

n o

f fo

reig

n D

NA

fro

m

oth

er s

pec

ies,

or

even

en

tire

fo

reig

n g

enes

,

into

th

e ge

no

me

of

gen

e-ed

ited

org

anis

ms,

even

wh

en t

he

inte

nti

on

is

spec

ific

ally

to a

void

th

is.

Th

e ef

fect

s o

f th

ese

chan

ges

on

th

e

com

po

siti

on

of

gen

e-ed

ited

cro

ps,

foo

ds,

an

d a

nim

als,

as

wel

l as

the

con

sequ

ence

s to

hea

lth

an

d t

he

envi

ron

men

t,

hav

e n

ot

bee

n i

nve

stig

ated

an

d r

emai

n

un

kno

wn

. In

fo

od

cro

ps,

th

ey c

ou

ld i

ncl

ud

e

the

pro

du

ctio

n o

f u

nex

pec

ted

to

xin

s an

d

alle

rgen

s, o

r al

tere

d le

vels

of

exis

tin

g to

xin

s

and

all

erge

ns.

Th

e in

du

stry

say

s th

at t

he

chan

ges

mad

e b

y

gen

e ed

itin

g in

cro

ps

and

live

sto

ck a

nim

als

are

smal

l an

d t

he

sam

e as

co

uld

hap

pen

in

nat

ure

.

Bu

t th

is c

laim

is

pro

ven

fal

se b

y th

e

wo

rryi

ng

surp

rise

s th

at h

ave

alre

ady

com

e

to li

ght.

Fo

r ex

amp

le, t

he

com

pan

y th

at

dev

elo

ped

gen

e-ed

ited

ho

rnle

ss c

attl

e

clai

med

th

ey w

ere

free

fro

m u

nin

ten

ded

effe

cts

of

the

gen

e ed

itin

g. B

ut

the

catt

le w

ere

reve

aled

by

US

regu

lato

rs t

o c

on

tain

bac

teri

al

DN

A a

nd

fo

reig

n g

enes

th

at c

on

fer

resi

stan

ce

to a

nti

bio

tics

.

Als

o, C

RIS

PR

gen

e ed

itin

g o

f ri

ce p

lan

ts w

as

sho

wn

to

cau

se a

wid

e ra

nge

of

un

inte

nd

ed

mu

tati

on

s, b

oth

at

the

inte

nd

ed e

dit

ing

site

an

d a

t

oth

er lo

cati

on

s in

th

e ge

no

me.

Th

e re

sear

cher

s w

ho

mad

e

this

dis

cove

ry w

arn

ed t

hat

CR

ISP

R g

ene

edit

ing

”may

be

no

t as

pre

cise

as

exp

ecte

d

in r

ice”

. Th

ey a

dd

ed, ”

earl

y

and

acc

ura

te m

ole

cula

r

char

acte

riza

tio

n a

nd

scr

een

ing

mu

st b

e ca

rrie

d

ou

t fo

r ge

ner

atio

ns

bef

ore

tra

nsi

tio

nin

g

of

CR

ISP

R/C

as9

syst

em f

rom

lab

to

fie

ld”

– s

om

eth

ing

that

is

no

t ge

ner

ally

do

ne

by

dev

elo

per

s.

Gen

e ed

itin

g

cau

ses

man

y

un

inte

nd

ed

chan

ges

and

gen

etic

err

ors

171

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

98

Co

nve

nti

on

al b

reed

ing,

in

co

ntr

ast,

co

nti

nu

es

to b

e h

igh

ly s

ucc

essf

ul i

n a

chie

vin

g su

ch t

rait

s

and

far

ou

tstr

ips

GM

ap

pro

ach

es.

It i

s n

ot

eno

ugh

to

focu

s o

n g

enet

ics

as t

he

solu

tio

n

to a

gric

ult

ura

l

pro

ble

ms

– w

ho

le

syst

ems

app

roac

hes

are

nee

ded

. Th

is

wo

uld

en

tail

a la

rge-

scal

e sh

ift

to p

rove

n-s

ucc

essf

ul a

gro

eco

logi

cal

syst

ems

of

farm

ing,

wh

ich

in

clu

de

low

-in

pu

t,

gen

uin

ely

sust

ain

able

, an

d r

egen

erat

ive

met

ho

ds.

Th

ese

met

ho

ds

are

alre

ady

avai

lab

le

and

on

ly n

eed

to

be

pro

per

ly s

up

po

rted

to

enab

le b

road

er r

oll

ou

t

Gen

e ed

itin

g is

a c

ost

ly d

istr

acti

on

fro

m t

hes

e

syst

ems-

bas

ed s

olu

tio

ns.

Its

exc

lusi

on

fro

m

EU

GM

O r

egu

lati

on

s w

ou

ld s

erve

to

bo

ost

a qu

esti

on

able

exp

erim

ent

wit

h u

nkn

ow

n

con

sequ

ence

s fo

r

peo

ple

, an

imal

s an

d

the

envi

ron

men

t. I

t

wo

uld

als

o d

epri

ve

Eu

rop

ean

co

nsu

mer

s,

farm

ers

and

bre

eder

s

of

the

righ

t to

kn

ow

wh

ere

thes

e G

MO

s ar

e

and

im

ped

e ad

van

ces

in n

on

-GM

ap

pro

ach

es,

incl

ud

ing

org

anic

an

d a

gro

eco

logi

cal s

yste

ms.

It w

ou

ld r

epre

sen

t a

sign

ific

ant

wea

ken

ing

of

EU

hea

lth

an

d e

nvi

ron

men

tal p

rote

ctio

ns

and

un

der

min

e th

e ro

llo

ut

of

pro

ven

effe

ctiv

e an

d s

ust

ain

able

so

luti

on

s to

ou

r fo

od

and

farm

ing

chal

len

ges.

Giv

en t

he

inh

eren

t

inac

cura

cy o

f ge

ne-

edit

ing

tech

niq

ues

an

d t

he

chal

len

ges

of

pro

du

cin

g ge

ne-

edit

ed p

lan

ts o

r

anim

als

that

per

form

as

exp

ecte

d, c

laim

s th

at

gen

e ed

itin

g ca

n p

rod

uce

use

ful t

rait

s fa

r m

ore

quic

kly

than

co

nve

nti

on

al b

reed

ing

are

hig

hly

ques

tio

nab

le. E

ven

if

the

tim

e ta

ken

to

gai

n

regu

lato

ry a

pp

rova

l is

excl

ud

ed, i

t is

un

like

ly

that

th

e ti

me

nee

ded

to

com

mer

cial

ize

gen

e-

edit

ed c

rop

s w

ill b

e

sign

ific

antl

y sh

ort

er

than

wit

h c

on

ven

tio

nal

bre

edin

g. M

ore

ove

r,

ach

ievi

ng

use

ful t

rait

s

in c

rop

s o

r an

imal

s

is n

ot

just

a m

atte

r o

f

spee

d –

it

is a

qu

esti

on

of

usi

ng

the

bes

t to

ols

for

the

job

, an

d G

M

app

roac

hes

are

no

t an

eff

icie

nt

rou

te.

Des

pit

e ye

ars

of

rese

arch

an

d p

erm

issi

ve

regu

lato

ry r

egim

es i

n s

om

e co

un

trie

s, o

nly

two

gen

e-ed

ited

pro

du

cts

hav

e su

cces

sfu

lly

mad

e it

to

mar

ket

and

nei

ther

was

pro

du

ced

wit

h t

he

mu

ch-h

yped

CR

ISP

R/C

as t

oo

l.

Th

e cl

aim

th

at g

ene

edit

ing,

in

par

ticu

lar

thro

ugh

CR

ISP

R/C

as, w

ill m

ake

agri

cult

ura

l

inn

ova

tio

n a

cces

sib

le t

o p

ub

licl

y fu

nd

ed

bre

edin

g p

rogr

amm

es i

s d

isp

rove

n b

y th

e

fact

th

at t

he

tech

no

logy

is

alre

ady

ow

ned

an

d

con

tro

lled

by

a ve

ry f

ew la

rge

corp

ora

tio

ns,

led

by

Co

rtev

a an

d M

on

san

to/B

ayer

. Wh

ile

eval

uat

ion

an

d r

esea

rch

lice

nce

s ca

n b

e

ob

tain

ed c

hea

ply

or

free

of

char

ge, c

om

mer

cial

lice

nce

s an

d a

sso

ciat

ed r

oya

lty

pay

men

ts

on

pro

du

ct s

ales

wil

l rem

ain

to

o e

xpen

sive

for

anyo

ne

apar

t fr

om

larg

e m

ult

inat

ion

als.

Gen

e-ed

ited

pro

du

cts

are

also

pat

ente

d: i

n

cro

p p

lan

ts, p

aten

ts c

ove

r se

eds,

pla

nts

, an

d

oft

en t

he

har

vest

, rai

sin

g is

sues

of

con

soli

dat

ed

con

tro

l of

the

foo

d s

up

ply

, far

mer

s’ a

uto

no

my,

and

loss

of

foo

d s

ove

reig

nty

.

A f

orm

of

emo

tio

nal

bla

ckm

ail i

s b

ein

g

use

d t

o c

on

vin

ce p

oli

cym

aker

s o

f th

e m

ora

l

imp

erat

ive

to e

mb

race

new

GM

tec

hn

olo

gies

.

Th

e p

rom

ise

is t

hat

th

ese

tech

no

logi

es w

ill e

nab

le

the

dev

elo

pm

ent

of

cro

ps

that

req

uir

e le

ss p

esti

cid

e

and

are

ad

apte

d t

o c

lim

ate

chan

ge.

Ho

wev

er, t

he

sam

e

pro

mis

es w

ere

also

mad

e

for

firs

t-ge

ner

atio

n G

M

cro

ps

and

pro

ved

fal

se.

New

GM

tec

hn

iqu

es a

re

un

like

ly t

o s

ucc

eed

wh

ere

“old

GM

” fa

iled

,

bec

ause

des

irab

le t

rait

s su

ch a

s p

est

and

dis

ease

resi

stan

ce a

nd

ad

apta

tio

n t

o c

lim

atic

ch

ange

s

are

gen

etic

ally

co

mp

lex

trai

ts t

hat

can

no

t b

e

ach

ieve

d b

y m

anip

ula

tin

g o

ne

or

a fe

w g

enes

.

A f

orm

of

emo

tio

nal

bla

ckm

ail

is b

ein

g

use

d t

o c

on

vin

ce

po

licy

mak

ers

of

the

mo

ral

imp

erat

ive

to

emb

race

new

GM

tech

no

log

ies

Gen

e ed

itin

g i

s a

cost

ly

dis

trac

tio

n f

rom

rea

l,

syst

ems-

bas

ed s

olu

tio

ns

172

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

11

10

Eu

rop

ean

in

stit

uti

on

s al

so a

void

th

e te

rms

“gen

etic

mo

dif

icat

ion

” an

d “

GM

O”.

Th

e

Co

un

cil o

f M

inis

ters

in

tro

du

ced

th

e te

rm

“no

vel g

eno

mic

tec

hn

iqu

es”,

6 wh

ich

th

e

Co

mm

issi

on

ad

apte

d t

o “

new

gen

om

ic

tech

niq

ues

”.7 T

he

Co

mm

issi

on

als

o t

alk

s ab

ou

t

“new

tec

hn

iqu

es i

n b

iote

chn

olo

gy”.

8

Th

e u

se o

f th

e te

rm “

bre

edin

g” a

pp

ears

to

be

an a

ttem

pt

to g

ive

an a

ir o

f n

atu

raln

ess

to t

he

new

gen

etic

en

gin

eeri

ng

tech

niq

ues

an

d t

hu

s

con

vin

ce t

he

pu

bli

c to

acc

ept

them

. It

may

also

be

an a

ttem

pt

to m

ake

the

app

lica

tio

n

of

GM

O r

egu

lati

on

s ap

pea

r co

un

teri

ntu

itiv

e

and

ill

ogi

cal:

If g

ene-

edit

ed p

rod

uct

s ar

e

no

t G

MO

s, w

hy

sho

uld

th

ey b

e re

gula

ted

as

GM

Os?

Ho

wev

er, g

ene-

edit

ing

tech

niq

ues

are

no

t

bre

edin

g te

chn

iqu

es. T

hey

are

tec

hn

ical

ly a

nd

lega

lly

GM

tec

hn

iqu

es, g

ive

rise

to

gen

etic

ally

mo

dif

ied

org

anis

ms

(GM

Os)

, an

d f

all w

ith

in

the

sco

pe

of

EU

GM

O la

ws,

as

con

firm

ed b

y

the

Eu

rop

ean

Co

urt

of

Just

ice

ruli

ng

of

2018

.9,10

EU

law

def

ines

a

GM

O a

s an

org

anis

m

in w

hic

h “

the

gen

etic

mat

eria

l has

bee

n

alte

red

in

a w

ay

that

do

es n

ot

occ

ur

nat

ura

lly

by

mat

ing

and

/or

nat

ura

l

reco

mb

inat

ion

’’.11

Th

is

wo

rdin

g ac

cura

tely

des

crib

es t

he

way

in w

hic

h o

lder

-

styl

e tr

ansg

enic

an

d

new

GM

Os,

su

ch a

s

gen

e-ed

ited

pla

nts

, are

pro

du

ced

. Gen

etic

mo

dif

icat

ion

em

plo

ys a

rtif

icia

l tec

hn

iqu

es

that

req

uir

e d

irec

t h

um

an i

nte

rven

tio

n i

n t

he

gen

om

e. I

n c

on

tras

t, t

he

term

s “m

atin

g an

d/

or

nat

ura

l rec

om

bin

atio

n”

des

crib

e n

atu

ral

pro

cess

es u

sed

in

con

ven

tio

nal

pla

nt

and

anim

al b

reed

ing.

EU

GM

O la

w e

xem

pts

som

e G

MO

s, s

uch

as

tho

se p

rod

uce

d u

sin

g a

dec

ades

-old

tec

hn

iqu

e

call

ed m

uta

tio

n

bre

edin

g (a

lso

cal

led

ran

do

m m

uta

gen

esis

),

fro

m i

ts r

equ

irem

ents

for

auth

ori

sati

on

,

trac

eab

ilit

y an

d

lab

elli

ng.

Bu

t th

is i

s

on

ly p

oss

ible

if

they

wer

e p

rod

uce

d u

sin

g

tech

niq

ues

th

at h

ave

a “l

on

g sa

fety

rec

ord

”.9

Th

is i

s cl

earl

y n

ot

the

case

wit

h g

ene

edit

ing.

MY

TH

Gen

e-ed

itin

g te

chn

iqu

es a

re

“new

bre

edin

g te

chn

iqu

es’’,

“pre

cisi

on b

reed

ing’

’ or

“bre

edin

g in

nov

atio

n’’.

1.G

en

e e

dit

ing

isg

en

eti

c e

ng

ine

eri

ng

, n

ot

bre

ed

ing

Th

e ag

ricu

ltu

ral b

iote

chn

olo

gy i

nd

ust

ry

and

its

lob

byi

sts

oft

en r

efer

to

new

gen

etic

mo

dif

icat

ion

(G

M)

tech

niq

ues

, esp

ecia

lly

gen

e ed

itin

g, a

s “b

reed

ing

inn

ova

tio

n”,

“pre

cisi

on

bre

edin

g te

chn

iqu

es”

and

“n

ew

bre

edin

g te

chn

iqu

es”.

1,2,

3,4 T

hey

str

enu

ou

sly

try

to a

void

th

e te

rms

“gen

etic

mo

dif

icat

ion

”

and

“ge

net

ic e

ngi

nee

rin

g”. C

ort

eva,

th

e

com

pan

y th

at c

on

tro

ls t

he

use

of

CR

ISP

R

gen

e ed

itin

g in

cro

p p

lan

ts, e

ven

arg

ues

th

at

“CR

ISP

R-p

rod

uce

d p

lan

ts a

re n

ot

GM

Os”

.5

RE

AL

ITY

Tec

hn

ical

ly a

nd

lega

lly,

ge

ne-

edit

ing

tech

niq

ues

ar

e ge

net

ic m

od

ific

atio

n

tech

niq

ues

, not

b

reed

ing

met

ho

ds.

EU

law

def

ines

a

GM

O a

s an

org

anis

m

in w

hic

h “t

he

gen

etic

m

ater

ial

has

bee

n

alte

red

in

a w

ay

that

do

es n

ot

occ

ur

nat

ura

lly

by

mat

ing

and

/or

nat

ura

l re

com

bin

atio

n’’

173

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

Wh

ile

the

init

ial

bre

ak

in t

he

DN

A c

an b

e

targ

eted

to

a s

pec

ific

site

in

th

e ge

no

me,

th

e

sub

seq

uen

t “r

epai

r’’

can

no

t b

e co

ntr

oll

ed

by

th

e g

enet

ic e

ng

inee

r

13

12

Old

an

d n

ew G

MO

s h

ave

mo

re i

n c

om

mo

n

than

pro

po

nen

ts w

ou

ld h

ave

us

bel

iev

e. O

f

thre

e st

eps

inv

olv

ed i

n g

eno

me

edit

ing

–

gen

e d

eliv

ery,

gen

e ed

itin

g, a

nd

wh

ole

pla

nt

rege

ner

atio

n i

n t

issu

e cu

ltu

re –

th

e fi

rst

and

last

ess

enti

ally

re-

mai

n t

he

sam

e. T

he

firs

t st

ep,

del

iver

y o

f

fore

ign

gen

etic

ma-

teri

al i

nto

th

e p

lan

t

cell

s (a

lso

cal

led

GM

tra

nsf

orm

a-

tio

n)

is u

sual

ly d

on

e

wit

h t

he

hel

p o

f

smal

l ci

rcu

lar

DN

A

mo

lecu

les

(pla

smid

s)

that

are

in

tro

du

ced

into

th

e ce

lls

usi

ng

a so

il b

acte

riu

m

call

ed A

gro

bac

teri

um

tu

mef

acie

ns

or

a

met

ho

d c

alle

d p

arti

cle

bo

mb

ard

men

t. T

he

pla

smid

th

en i

nse

rts

itse

lf i

nto

th

e p

lan

t

cell

’s D

NA

.

Reg

ard

ing

the

“ed

itin

g st

ep’’,

th

e m

ajo

rity

of

gen

e-ed

itin

g ap

pli

cati

on

s in

vo

lve

firs

t cu

t-

tin

g th

e D

NA

wit

h e

nzy

mes

, ca

lled

nu

clea

s-

es,

wh

ich

are

su

pp

ose

d t

o a

ct o

nly

at

cho

sen

site

s in

th

e ge

no

me

of

a li

vin

g ce

ll.

Th

ese

gen

e-ed

itin

g ap

pli

cati

on

s ar

e ca

lled

“sit

e-d

irec

ted

nu

clea

se”

or

“SD

N”

pro

ce-

du

res.

Th

e S

DN

cre

ates

a d

ou

ble

-str

and

bre

ak i

n t

he

DN

A.

Th

e en

zym

es m

ost

com

mo

nly

use

d f

or

this

cu

ttin

g ar

e th

e C

as

fam

ily

of

pro

tein

s (f

or

CR

ISP

R)

and

Fo

kI

(fo

r T

AL

EN

s an

d Z

inc

Fin

ger

Nu

clea

ses)

.12

Th

e cu

ttin

g ev

ent

trig

gers

ala

rm s

ign

als

in t

he

cell

, as

bro

ken

DN

A i

s d

ange

rou

s to

the

org

anis

m.

S

o t

he

cell

in

itia

tes

a D

NA

rep

air

pro

cess

to

men

d t

he

do

ub

le-s

tran

d

DN

A c

ut.

Wh

ile

the

init

ial

bre

ak i

n t

he

DN

A

can

be

targ

eted

to

a s

pec

ific

sit

e in

th

e g

eno

me,

the

sub

seq

uen

t “r

epai

r” i

s ca

rrie

d o

ut

by

the

cell

’s i

nn

ate

rep

air

mec

han

ism

s an

d c

ann

ot

be

con

tro

lled

by

the

gen

etic

en

gin

eer.

’

Th

e re

pai

r is

oft

en

no

t cl

ean

or

pre

cise

,

bu

t ca

n r

esu

lt i

n

“ch

rom

oso

mal

may

-

hem

” in

th

e ge

no

me,

to c

ite

the

titl

e o

f

a co

mm

enta

ry o

n

stu

die

s o

n C

RIS

PR

/

Cas

gen

e ed

itin

g i

n

hu

man

em

bry

os.

13

Th

e re

sult

of

the

rep

air

is c

alle

d t

he

“ed

it”.

Res

earc

her

s m

ust

sel

ect

fro

m m

any

edit

ed

org

anis

ms

to o

bta

in t

he

on

e th

ey d

esir

e.1

2

HO

W D

OE

S G

EN

E

ED

ITIN

G W

OR

K?

Som

e d

ivid

e SD

N p

roce

du

res

into

SD

N-1

, SD

N-2

, an

d S

DN

-3.14

Th

ey c

an b

e d

efin

ed a

s fo

llo

ws:

•SD

N-1

ref

ers

to d

isru

pti

on

of

the

fun

ctio

n o

f a

gen

e (a

lso

kno

wn

as

gen

e kn

ock

ou

t).

Th

e re

pai

r o

f th

e d

ou

ble

-

stra

nd

bre

ak i

n t

he

DN

A

resu

lts

in e

ith

er a

del

etio

n

(rem

ova

l) o

f p

art

of

the

gen

e

or

the

inse

rtio

n o

f ad

dit

ion

al

DN

A b

ase

un

its,

wh

ich

are

take

n f

rom

th

e ge

no

me

of

the

org

anis

m t

hat

is

bei

ng

edit

ed.

Th

is d

isru

pts

th

e se

quen

ce o

f

the

gen

e an

d t

hu

s kn

ock

s o

ut

its

no

rmal

fu

nct

ion

.

•SD

N-2

ref

ers

to g

ene

alte

rati

on

. Wh

ile

the

bre

ak i

s

rep

aire

d b

y th

e ce

ll, a

rep

air

tem

pla

te i

s su

pp

lied

th

at i

s

com

ple

men

tary

to

th

e ar

ea

of

the

bre

ak, w

hic

h t

he

cell

use

s to

rep

air

the

bre

ak.

Th

e te

mp

late

co

nta

ins

on

e

or

seve

ral D

NA

bas

e u

nit

sequ

ence

ch

ange

s in

th

e

gen

etic

co

de,

wh

ich

th

e re

pai

r

mec

han

ism

exc

han

ges

into

the

pla

nt’s

gen

etic

mat

eria

l,

resu

ltin

g in

a m

uta

tio

n o

f th

e

targ

et g

ene.

Th

e m

uta

ted

gen

e

wil

l th

en p

rod

uce

an

alt

ered

pro

tein

pro

du

ct w

ith

an

alte

red

fu

nct

ion

.

•SD

N-3

ref

ers

to g

ene

inse

rtio

n. T

he

DN

A b

reak

is

acco

mp

anie

d b

y a

tem

pla

te

con

tain

ing

a ge

ne

or

oth

er

sequ

ence

of

gen

etic

mat

eria

l.

Th

e ce

ll’s

nat

ura

l rep

air

pro

cess

use

s th

is t

emp

late

to

rep

air

the

bre

ak, r

esu

ltin

g in

the

inse

rtio

n o

f n

ew g

enet

ic

mat

eria

l (fo

reig

n D

NA

, wh

ich

can

in

clu

de

a w

ho

le n

ew g

ene)

.

Th

e ai

m i

s to

co

nfe

r n

ove

l

fun

ctio

ns

and

ch

arac

teri

stic

s

on

th

e o

rgan

ism

.

An

oth

er g

ene-

edit

ing

tec

hn

iqu

e is

oli

gon

ucl

eoti

de-

dir

ecte

d m

uta

gen

esis

(O

DM

). O

DM

do

es

no

t ca

use

a d

ou

ble

-str

and

bre

ak i

n t

he

DN

A.

Inst

ead

it

inv

olv

es t

he

intr

od

uct

ion

of

sho

rt

seq

uen

ces

of

syn

thet

ic D

NA

an

d R

NA

– c

alle

d o

ligo

nu

cleo

tid

es –

in

to t

he

cell

s. T

he

oli

go-

nu

cleo

tid

e in

tera

cts

wit

h t

he

cell

’s D

NA

, tr

ick

ing

th

e ce

ll’s

rep

air

mec

han

ism

s in

to a

lter

ing

the

cell

’s o

wn

DN

A t

o m

atch

th

at o

f th

e o

ligo

nu

cleo

tid

e.

All

th

ese

tech

niq

ues

wil

l ch

ange

th

e b

ioch

emis

try

of

the

pla

nt

– t

his

is

the

aim

of

gen

e

edit

ing

– s

o t

hat

a n

ew t

rait

can

res

ult

.

GE

NE

ED

ITIN

G I

S

GE

NE

TIC

MO

DIF

ICA

TIO

N

Alt

ho

ugh

GM

an

d c

on

ven

tio

nal

bre

edin

g w

ill r

esu

lt i

n t

he

crea

tio

n o

f n

ew v

arie

ties

, th

e tw

o

are

dis

tin

ct m

eth

od

s an

d a

re n

ot

inte

rch

ange

able

. Gen

e ed

itin

g is

cle

arly

a G

M t

ech

niq

ue

bu

t

con

ven

tio

nal

bre

edin

g is

no

t, h

ow

ever

har

d t

he

agri

cult

ura

l bio

tech

in

du

stry

tri

es t

o b

lur

the

bo

un

dar

ies.

174

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

15

14

MY

TH

Gen

e-ed

itin

g to

ols

such

as

CR

ISP

R/C

as b

rin

g ab

out

chan

ges

in t

he

gen

ome

in a

p

reci

se a

nd

con

trol

led

way

, w

ith

pre

dic

tab

le o

utc

omes

.

RE

AL

ITY

Gen

e ed

itin

g is

not

p

reci

se, b

ut

cau

ses

man

y

gen

etic

err

ors,

wit

h

un

pre

dic

tab

le r

esu

lts,

in

ad

dit

ion

to

an

y

inte

nd

ed g

enet

ic

chan

ge.

2.G

en

e e

dit

ing

is n

ot

pre

cis

e a

nd

c

au

se

s u

np

red

icta

ble

g

en

eti

c e

rro

rs

Th

e ag

ricu

ltu

ral b

iote

ch i

nd

ust

ry a

nd

its

all

ies

clai

m t

hat

gen

e-ed

itin

g to

ols

su

ch a

s C

RIS

PR

/

Cas

bri

ng

abo

ut

chan

ges

in t

he

gen

om

e in

a

pre

cise

an

d c

on

tro

lled

way

.1,2,

3 So

me

even

cla

im

that

th

ey b

rin

g ab

ou

t o

nly

th

e sp

ecif

ic i

nte

nd

ed

chan

ges

and

no

thin

g el

se.4,

5 T

hey

arg

ue

that

gen

e-ed

ited

pro

du

cts

sho

uld

th

eref

ore

be

excl

ud

ed f

rom

th

e re

gula

tory

ove

rsig

ht

app

lied

to o

lder

-sty

le t

ran

sgen

ic G

MO

s,3,

5 wh

ere

(in

mo

st c

ases

) D

NA

is

intr

od

uce

d f

rom

an

oth

er

spec

ies

into

a p

art

of

the

gen

om

e th

at c

ann

ot

be

det

erm

ined

bef

ore

han

d.

Ho

wev

er,

thes

e cl

aim

s d

o

no

t su

rviv

e sc

ruti

ny.

A

larg

e an

d e

ver-

gro

win

g n

um

ber

of

scie

nti

fic

stu

dies

in h

um

an, a

nim

al a

nd

plan

t ce

lls

show

th

at g

ene

edit

ing

is n

ot

pre

cise

bu

t gi

ves

rise

to

nu

mer

ou

s ge

net

ic e

rro

rs, a

lso

kn

ow

n a

s

un

inte

nd

ed m

uta

tio

ns

(DN

A d

amag

e).

Th

ese

occ

ur

at b

oth

off

-tar

get

site

s in

th

e

gen

om

e (l

oca

tio

ns

oth

er t

han

th

at t

arge

ted

fo

r

the

edit

) an

d o

n-t

arge

t (a

t th

e d

esir

ed e

dit

ing

site

). T

he

type

s of

mut

atio

n in

clud

e la

rge

dele

tion

s,

inse

rtio

ns,

an

d re

arra

nge

men

ts o

f DN

A.6,

7,8

RE

FE

RE

NC

ES

1.E

uros

eeds

. Pla

nt b

reed

ing

inn

ovat

ion

. Eur

osee

ds.e

u. P

ub-

lish

ed 2

020.

Acc

esse

d D

ecem

ber

8, 2

020.

htt

ps:/

/ww

w.e

uros

eeds

.

eu/s

ubje

cts/

plan

t-br

eedi

ng-i

nnov

atio

n/

2.In

tern

atio

nal

See

d Fe

dera

tion

. Tec

hnol

ogic

al a

dvan

ces

driv

e in

nov

atio

n in

pla

nt b

reed

ing

to c

reat

e n

ew v

arie

t-

ies.

wor

ldse

ed.o

rg. P

ubli

shed

202

0. A

cces

sed

Dec

embe

r 8,

2020

. htt

ps:/

/ww

w.w

orld

seed

.org

/our

-wor

k/pl

ant-

bree

ding

/

plan

t-br

eedi

ng-i

nnov

atio

n/

3.V

on E

ssen

G. P

reci

sion

bre

edin

g –

smar

t rul

es f

or n

ew t

ech-

niqu

es! e

urop

ean

-bio

tech

nol

ogy.

com

. Pub

lish

ed 2

020.

Acc

esse

d

Dec

embe

r 8,

202

0. h

ttps

://e

urop

ean

-bio

tech

nol

ogy.

com

/peo

ple/

peop

le/p

reci

sion

-bre

edin

g-sm

art-

rule

s-fo

r-n

ew-t

echn

ique

s.

htm

l

4.N

BT

Pla

tfor

m. N

ew B

reed

ing

Tec

hniq

ues

Plat

form

. nbt

-

plat

form

.org

. Pub

lish

ed 2

015.

Acc

esse

d Ja

nua

ry 8

, 202

1. h

ttps

://

ww

w.n

btpl

atfo

rm.o

rg/

5.C

orte

va A

gris

cien

ce. C

RIS

PR Q

&A

– F

or i

nter

nal

use

on

ly.

Pub

lish

ed o

nli

ne

May

28,

201

9. h

ttps

://c

risp

r.cor

teva

.com

/

wp-

cont

ent/

uplo

ads/

2019

/05/

FIN

AL

_For

-Int

ern

al-U

se-O

n-

ly_C

orte

va-C

RIS

PR-Q

A-U

PDA

TE

D-5

.28.

19.p

df

6.E

urop

ean

Cou

nci

l. C

oun

cil D

ecis

ion

(EU

) 20

19/1

904

of 8

Nov

embe

r 20

19 R

eque

stin

g th

e C

omm

issi

on t

o Su

bmit

a S

tudy

in L

ight

of

the

Cou

rt o

f Ju

stic

e’s Ju

dgm

ent i

n C

ase

C-5

28/1

6

Reg

ardi

ng t

he S

tatu

s of

Nov

el G

enom

ic T

echn

ique

s un

der

Uni

on L

aw, a

nd

a Pr

opos

al, I

f A

ppro

pria

te i

n V

iew

of

the

Out

-

com

es o

f th

e St

udy.

Vol

293

; 201

9. A

cces

sed

Dec

embe

r 18

, 202

0.

http

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Com

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ourt

.(Eur

opea

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ourt

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sed

Sept

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9. h

ttp:

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Cou

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agen

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Os

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ub-

ject

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O D

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g-

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Con

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inis

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Agr

icul

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l’Agr

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men

tair

e et

de

la F

orêt

. Pub

lish

ed o

nli

ne

July

25,

201

8. h

ttps

://

curi

a.eu

ropa

.eu/

jcm

s/up

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18

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atha

m J.

Gen

e-ed

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g un

inte

ntio

nal

ly a

dds

bovi

ne

DN

A, g

oat D

NA

, an

d ba

cter

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NA

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se r

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ubli

shed

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tem

ber

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019.

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rd H

. CR

ISPR

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e ed

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Pla

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Nuc

leas

e T

ech-

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175

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

17

16

INA

DE

QU

AT

E S

CR

EE

NIN

G

FO

R U

NIN

TE

ND

ED

MU

TA

TIO

NS

A s

tud

y o

n r

ice

vari

etie

s fo

un

d t

hat

CR

ISP

R

gen

e ed

itin

g ca

use

d a

wid

e ra

nge

of

un

des

irab

le

and

un

inte

nd

ed o

n-t

arge

t an

d o

ff-t

arge

t

mu

tati

on

s. T

he

rese

arch

ers

wer

e ai

min

g

to i

mp

rove

th

e

yiel

d o

f al

read

y

hig

h-p

erfo

rmin

g

vari

etie

s o

f ri

ce

by

dis

rup

tin

g

the

fun

ctio

n o

f

a sp

ecif

ic g

ene,

in a

n S

DN

-1

(gen

e di

sru

pti

on

)

pro

cedu

re.15

Th

ey w

ere

tryi

ng

to p

rod

uce

sm

all i

nse

rtio

ns

and

del

etio

ns

of

DN

A b

ase

un

its

in t

he

gen

om

e. H

ow

ever

, wh

at

they

go

t w

as q

uit

e d

iffe

ren

t. I

n m

any

case

s

they

fo

un

d la

rge

inse

rtio

ns,

del

etio

ns,

an

d

rear

ran

gem

ents

of

DN

A, r

aisi

ng

the

po

ssib

ilit

y

that

th

e fu

nct

ion

of

gen

es o

ther

th

an t

he

on

e

targ

eted

co

uld

hav

e b

een

alt

ered

.15

As

for

the

ho

ped

-fo

r in

crea

sed

yie

ld, t

he

op

po

site

was

fo

un

d –

yie

ld w

as r

edu

ced

.15

Th

is s

ho

uld

no

t co

me

as a

su

rpri

se, a

s yi

eld

is

a ge

net

ical

ly c

om

ple

x tr

ait

that

in

volv

es t

he

fun

ctio

nin

g o

f m

any,

if

no

t al

l, ge

ne

fam

ilie

s

of

the

pla

nt.

Th

us

alte

rin

g th

e fu

nct

ion

of

on

e

gen

e to

im

pro

ve

yiel

d c

ou

ld b

e

view

ed a

s a

futi

le

exer

cise

.

Th

e re

sear

cher

s

war

ned

th

at

CR

ISP

R g

ene

edit

ing

“may

be

no

t as

pre

cise

as e

xpec

ted

in r

ice“

. Th

ey

add

ed, ”

earl

y

and

acc

ura

te

mo

lecu

lar

char

acte

riza

tio

n a

nd

scr

een

ing

mu

st b

e ca

rrie

d o

ut

for

gen

erat

ion

s b

efo

re

tran

siti

on

ing

of

CR

ISP

R/C

as9

syst

em f

rom

lab

to f

ield

”.15

Dev

elo

per

s d

o n

ot

gen

eral

ly d

o t

his

,

or

if t

hey

do

, th

e re

sult

s ar

e n

ot

pu

bli

shed

.

Th

e re

sear

cher

s co

ncl

ud

ed, “

Un

der

stan

din

g

of

un

cert

ain

ties

an

d r

isks

reg

ard

ing

gen

om

e

edit

ing

is n

eces

sary

an

d c

riti

cal b

efo

re a

new

glo

bal

po

licy

fo

r th

e n

ew b

iote

chn

olo

gy i

s

esta

bli

shed

”.15

Mo

st s

tud

ies

that

loo

k fo

r u

nin

ten

ded

mu

tati

on

s in

gen

e-ed

ited

pla

nts

gro

ssly

un

der

esti

mat

e th

e n

um

ber

of

mu

tati

on

s

resu

ltin

g fr

om

gen

e ed

itin

g an

d a

sso

ciat

ed

pro

cess

es s

uch

as

tiss

ue

cult

ure

(gr

ow

th o

f p

lan

t

tiss

ues

or

cell

s in

a g

row

th m

ediu

m).

Th

is i

s

tru

e b

oth

fo

r st

ud

ies

that

co

ncl

ud

e th

at g

ene

edit

ing

cau

ses

man

y su

ch m

uta

tio

ns

and

th

ose

that

co

ncl

ud

e th

at i

t ca

use

s fe

w o

r n

on

e.

Th

e re

aso

n i

s th

at t

he

auth

ors

of

thes

e st

ud

ies

use

in

adeq

uat

e d

etec

tio

n m

eth

od

s –

sh

ort

-ran

ge

PC

R a

nd

sh

ort

-rea

d D

NA

seq

uen

cin

g –

to

loo

k

for

mu

tati

on

s. T

hey

on

ly lo

ok

at s

ho

rt s

tret

ches

of

the

DN

A a

rou

nd

th

e ta

rget

ed e

dit

ing

site

an

d

com

pu

ter

pro

gram

me-

pre

dic

ted

off

-tar

get

site

s.

As

Ko

sick

i an

d c

oll

eagu

es f

ou

nd

in

a s

tud

y

on

hu

man

cel

ls, s

ho

rt-r

ange

PC

R a

nd

sh

ort

-

read

DN

A s

equ

enci

ng

can

mis

s m

ajo

r ge

net

ic

erro

rs, s

uch

as

larg

e d

elet

ion

s an

d i

nse

rtio

ns

GE

NE

ED

ITIN

G P

RO

DU

CE

S A

RA

NG

E O

F U

NIN

TE

ND

ED

MU

TA

TIO

NS

Eve

n t

he

sim

ple

st a

pp

lica

tio

n o

f ge

ne

edit

ing

(so

-cal

led

SD

N-1

),

wh

ich

is

inte

nd

ed t

o d

estr

oy

a ge

ne

fun

ctio

n, c

an le

ad t

o u

nw

ante

d

mu

tati

on

s.11

,12,

13 T

hes

e m

uta

tio

ns

can

lead

to

th

e cr

eati

on

of

new

gen

e se

quen

ces

pro

du

cin

g n

ew m

uta

nt

pro

tein

s, w

ith

un

kno

wn

con

sequ

ence

s to

th

e h

ealt

h o

f co

nsu

mer

s o

f th

e ge

ne-

edit

ed

org

anis

m. I

n a

dd

itio

n, a

lter

atio

ns

in t

he

pat

tern

of

gen

e

fun

ctio

n c

an t

ake

pla

ce

wit

hin

th

e o

rgan

ism

wh

ose

gen

om

e h

as

bee

n m

od

ifie

d.

In p

lan

ts, t

hes

e

alte

rati

on

s ca

n le

ad t

o

com

po

siti

on

al c

han

ges,

wh

ich

, sci

enti

sts

war

n,

cou

ld p

rove

to

be

toxi

c an

d/o

r al

lerg

enic

to h

um

an o

r an

imal

con

sum

ers.

6,8,

14

Un

inte

nd

ed m

uta

tio

ns

and

th

eir

effe

cts

are

un

der

-

rese

arch

ed i

n p

lan

ts

com

par

ed w

ith

hu

man

and

an

imal

cel

ls. B

ut

sin

ce t

he

mec

han

ism

s

of

gen

e ed

itin

g an

d s

ub

sequ

ent

DN

A r

epai

r ar

e th

e sa

me

bet

wee

n a

nim

als

and

pla

nts

, th

ere

is e

very

rea

son

to

bel

ieve

th

at t

he

typ

es o

f u

nin

ten

ded

mu

tati

on

s se

en i

n

hu

man

an

d a

nim

al c

ells

wil

l als

o b

e fo

un

d i

n p

lan

ts.

Rec

ent

rese

arch

in

ric

e p

lan

ts a

ttes

ts t

o t

his

fac

t.15

Th

ese

mu

tati

on

s o

ccu

r at

var

iou

s st

ages

of

the

pro

cess

, in

clu

din

g st

ages

th

at g

ene

edit

ing

has

in

co

mm

on

wit

h o

ld-s

tyle

tra

nsg

enic

GM

met

ho

ds,

su

ch a

s ti

ssu

e cu

ltu

re a

nd

GM

tran

sfo

rmat

ion

by

Agr

ob

acte

riu

m t

um

efac

ien

s

infe

ctio

n (

in w

hic

h t

his

so

il b

acte

riu

m i

s u

sed

to i

nse

rt t

he

fore

ign

gen

etic

mat

eria

l in

to t

he

DN

A o

f p

lan

t ce

lls)

.9

Eve

n t

he

inte

nd

ed c

han

ges

can

cau

se

un

inte

nd

ed e

ffec

ts (

“ple

iotr

op

ic e

ffec

ts”)

in t

he

edit

ed o

rgan

ism

,10 s

ince

gen

es a

nd

thei

r p

rote

in o

r R

NA

pro

du

cts

act

in

net

wo

rks

and

no

t in

iso

lati

on

.

In p

lan

ts, a

lter

atio

ns

in t

he

pat

tern

of

gen

e fu

nct

ion

ca

n le

ad t

o c

omp

osi

tion

al

chan

ges,

wh

ich

cou

ld p

rov

e to

be

tox

ic a

nd

/or

alle

rgen

ic

to h

um

an o

r an

imal

co

nsu

mer

s

Un

wan

ted

m

uta

tion

s ca

n le

ad

to t

he

crea

tion

of

new

gen

e se

quen

ces

pro

du

cin

g n

ew

mu

tan

t p

rote

ins,

w

ith

un

kn

own

co

nse

quen

ces

to t

he

hea

lth

of

con

sum

ers

of t

he

gen

e-ed

ited

or

gan

ism

176

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

19

18

“O

LD

” M

UT

AG

EN

IC G

M T

EC

HN

IQU

ES

AR

E U

SE

D I

N G

EN

E E

DIT

ING

Fir

st-g

ener

atio

n g

enet

ic e

ngi

nee

rin

g te

chn

iqu

es

are

stil

l oft

en u

sed

to

in

tro

du

ce C

RIS

PR

ed

itin

g

too

ls i

nto

pla

nt

cell

s. P

lasm

ids

con

tain

ing

gen

es e

nco

din

g th

e C

RIS

PR

/Cas

ed

itin

g to

ol

are

intr

od

uce

d i

nto

th

e ce

lls

usi

ng

eith

er

Agr

ob

acte

riu

m t

um

efac

ien

s in

fect

ion

or

par

ticl

e

bo

mb

ard

men

t.6 I

n a

dd

itio

n, t

issu

e cu

ltu

re i

s

use

d t

o g

row

th

e

pla

nt

cell

s. A

ll t

hre

e

pro

cess

es a

re h

igh

ly

mu

tage

nic

.25 T

he

mu

tati

on

s ca

use

d

by

thes

e p

roce

sses

wil

l be

in a

dd

itio

n

to t

he

un

wan

ted

mu

tati

on

s ca

use

d

by

the

gen

e re

pai

r

pro

cess

(th

e ac

tual

”ed

it”)

.

A s

tud

y b

y T

ang

and

co

llea

gues

on

CR

ISP

R g

ene-

edit

ed r

ice

illu

stra

tes

the

mu

tage

nic

nat

ure

of

thes

e

pro

cess

es. T

he

stu

dy

fou

nd

th

at m

any

off

-tar

get

mu

tati

on

s re

sult

ed f

rom

th

e ti

ssu

e cu

ltu

re,

and

yet

mo

re r

esu

lted

fro

m A

gro

bac

teri

um

infe

ctio

n (

aro

un

d 2

00 p

er p

lan

t). I

n c

on

tras

t,

seed

sav

ed f

rom

no

n-G

M r

ice

pla

nts

had

on

ly

30–

50 s

po

nta

neo

us

mu

tati

on

s p

er p

lan

t.9 T

hu

s

the

stu

dy

fou

nd

th

at t

he

CR

ISP

R p

roce

ss, t

aken

as a

wh

ole

, cau

sed

larg

e n

um

ber

s o

f o

ff-t

arge

t

mu

tati

on

s an

d f

ar m

ore

th

an c

on

ven

tio

nal

bre

edin

g.

Iro

nic

ally

, th

is s

tud

y is

oft

en c

ited

as

an e

xam

ple

of

the

pre

cisi

on

of

this

gen

e-ed

itin

g to

ol.

Th

is i

s b

ecau

se

it f

ou

nd

th

at t

he

CR

ISP

R e

dit

ing

too

ls t

hem

selv

es

did

no

t in

tro

du

ce

man

y o

ff-t

arge

t

mu

tati

on

s in

to

the

pla

nts

’ DN

A.9

Ho

wev

er, t

his

fin

din

g is

like

ly

no

t ac

cura

te, d

ue

to t

he

rese

arch

ers’

use

of

inad

equ

ate

scre

enin

g m

eth

od

s

(see

“In

adeq

uat

e sc

reen

ing

for

un

inte

nd

ed

mu

tati

on

s”, a

bo

ve)

– t

hey

did

no

t u

se lo

ng-

read

DN

A s

equ

enci

ng.

Als

o, t

he

fin

din

gs m

ust

be

view

ed i

n t

he

con

text

of

the

abo

ve-m

enti

on

ed

sep

arat

e st

ud

y o

n r

ice

that

fo

un

d t

hat

CR

ISP

R

gen

e ed

itin

g ca

use

d a

wid

e ra

nge

of

un

inte

nd

ed

on

-tar

get

and

off

-tar

get

mu

tati

on

s.15

TH

RE

AT

TO

HE

AL

TH

AN

D

EN

VIR

ON

ME

NT

Bas

ed o

n t

he

abo

ve e

vid

ence

, gen

e ed

itin

g is

nei

ther

pre

cise

no

r co

ntr

oll

able

, bu

t co

uld

inad

vert

entl

y p

rod

uce

tra

its

that

th

reat

en p

ub

lic

hea

lth

an

d t

he

envi

ron

men

t.

CIB

US

’S C

AN

OL

A:

“P

RE

CIS

ION

” G

EN

E

ED

ITIN

G O

R A

CC

IDE

NT

IN

A P

ET

RI

DIS

H?

In S

epte

mb

er 2

020,

th

e b

iote

ch c

om

pan

y C

ibu

s

clai

med

th

at i

ts h

erb

icid

e-to

lera

nt

SU C

ano

la

(oil

seed

rap

e) w

as n

ot

gen

e-ed

ited

bu

t w

as t

he

resu

lt o

f ra

nd

om

mu

tati

on

cau

sed

by

tiss

ue

cult

ure

– e

ffec

tive

ly, a

n a

ccid

ent

in a

lab

ora

tory

Pet

ri d

ish

. Th

is c

laim

cam

e af

ter

the

com

pan

y

had

fo

r m

any

year

s

said

(in

clu

din

g to

regu

lato

rs)

that

SU

Can

ola

was

mad

e

wit

h i

ts “

pre

cisi

on

gen

e ed

itin

g”

tech

niq

ue,

cal

led

oli

go-d

irec

ted

mu

tage

nes

is

(OD

M).

19,2

0,21

In f

act,

OD

M c

on

stit

ute

s th

e ve

ry f

ou

nd

atio

n o

f

its

bu

sin

ess

mo

del

.22

Ind

eed

, nu

mer

ou

s p

ub

lic

reco

rds

po

int

to t

he

fact

th

at C

ibu

s u

sed

gen

e ed

itin

g in

th

e p

roce

ss

of

engi

nee

rin

g SU

Can

ola

.19,2

0,23

Bu

t it

tu

rned

ou

t th

at t

he

oli

gon

ucl

eoti

de

use

d w

as d

esig

ned

to p

rod

uce

a d

iffe

ren

t ge

net

ic c

han

ge f

rom

the

on

e th

at w

as f

ou

nd

to

co

nfe

r h

erb

icid

e

tole

ran

ce i

n S

U C

ano

la a

nd

th

at C

ibu

s d

escr

ibed

in i

ts p

aten

t ap

pli

cati

on

.21 S

o t

he

“pre

cisi

on

”

too

l did

no

t w

ork

as

inte

nd

ed, l

ead

ing

Cib

us

to

an

no

un

ce t

hat

th

e cr

op

was

no

t ge

ne-

edit

ed

afte

r al

l.

It w

ou

ld a

pp

ear

that

Cib

us

mad

e th

at c

laim

on

ly t

o e

vad

e E

U G

MO

reg

ula

tio

ns.

Th

e ti

min

g

is r

emar

kab

le: S

ho

rtly

bef

ore

Cib

us

mad

e it

s

stat

emen

t,20

a

scie

nti

fic

pap

er h

ad

bee

n p

ub

lish

ed,

rep

ort

ing

the

dev

elo

pm

ent

of

the

firs

t p

ub

licl

y

avai

lab

le d

etec

tio

n

met

ho

d f

or

SU

Can

ola

.24 H

ow

ever

,

un

der

EU

law

,

even

if

the

spec

ific

mu

tati

on

th

at c

on

fers

th

e

her

bic

ide

tole

ran

ce w

as n

ot

the

inte

nd

ed r

esu

lt

of

the

OD

M e

dit

ing

pro

cess

, th

e fa

ct t

hat

th

e

OD

M t

oo

l was

use

d t

o d

evel

op

th

e SU

Can

ola

mea

ns

that

it

is a

GM

O. S

ince

it

has

no

EU

auth

ori

sati

on

, its

pre

sen

ce i

n E

U i

mp

ort

s w

ou

ld

be

ille

gal.23

Th

is e

pis

od

e ra

ises

qu

esti

on

s ab

ou

t C

ibu

s’s

ho

nes

ty a

nd

tra

nsp

aren

cy. B

ut

mo

re

imp

ort

antl

y, i

t sh

ow

s th

at t

he

pre

cisi

on

an

d

con

tro

l cla

imed

fo

r th

e O

DM

gen

e-ed

itin

g

tech

niq

ue

was

fal

se.

and

co

mp

lex

rear

ran

gem

ents

of

DN

A.16

,17 T

he

rese

arch

ers

con

clu

ded

th

at a

co

mb

inat

ion

of

lon

g-ra

nge

PC

R a

nd

lon

g-re

ad D

NA

sequ

enci

ng

is n

eed

ed t

o s

po

t th

e fu

ll r

ange

of

un

inte

nd

ed m

uta

tio

nal

eff

ects

.16 F

DA

sci

enti

sts

hav

e m

ade

the

sam

e re

com

men

dat

ion

, wit

h

rega

rd t

o g

ene-

edit

ed a

nim

als.

18

Th

is p

rin

cip

le a

pp

lies

to

pla

nts

just

as

mu

ch a

s

anim

als,

sin

ce t

he

mec

han

ism

s o

f ge

ne

edit

ing

and

th

e su

bse

quen

t re

pai

r th

at f

orm

s th

e “e

dit

”

are

the

sam

e.

In a

sci

enti

fic

revi

ew, K

awal

l an

d c

oll

eagu

es

con

firm

ed t

hat

th

e “v

ast

maj

ori

ty”

of

stu

die

s

on

gen

e-ed

ited

pla

nts

use

d b

iase

d d

etec

tio

n

met

ho

ds

to s

cree

n f

or

gen

etic

err

ors

, mea

nin

g

that

th

ey w

ill m

iss

man

y su

ch e

rro

rs. A

mo

ng

stu

die

s o

n g

ene-

edit

ed a

nim

als,

no

ne

incl

ud

ed a

tho

rou

gh a

nal

ysis

of

gen

etic

err

ors

.6

Th

e v

ast

maj

ori

ty o

f

stu

die

s o

n g

ene-

edit

ed

pla

nts

use

d b

iase

d

det

ecti

on

met

ho

ds

to

scre

en f

or

gen

etic

err

ors

A s

tud

y o

n C

RIS

PR

gen

e-

edit

ed r

ice

has

fo

un

d

that

man

y o

ff-t

arge

t

mu

tati

on

s re

sult

ed f

rom

tiss

ue

cult

ure

, an

d y

et

mo

re r

esu

lted

fro

m

Ag

rob

acte

riu

m i

nfe

ctio

n

177

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

21

20

Lo

bb

yist

s cl

aim

th

at g

ene

edit

ing

tech

niq

ues

“gen

eral

ly c

reat

e p

lan

t p

rod

uct

s th

at m

ay a

lso

be

ob

tain

ed u

sin

g ea

rlie

r b

reed

ing

met

ho

ds”

1

such

as

mu

tati

on

bre

edin

g, o

r th

at c

ou

ld r

esu

lt

“fro

m s

po

nta

neo

us

pro

cess

es i

n n

atu

re”.

2

Mu

tati

on

bre

edin

g (a

lso

cal

led

ran

do

m

mu

tage

nes

is)

is a

dec

ades

-old

tec

hn

iqu

e in

wh

ich

see

ds

are

exp

ose

d t

o c

hem

ical

s o

r

rad

iati

on

to

in

du

ce m

uta

tio

ns

in t

he

ho

pe

that

on

e o

r m

ore

may

res

ult

in

a u

sefu

l tra

it. T

he

lob

byi

sts

say

that

gen

e ed

itin

g is

mo

re p

reci

se

than

mu

ta

tio

n b

reed

ing,

yet

mu

tati

on

bre

d p

lan

ts a

re

exem

pte

d f

rom

th

e re

qu

irem

ents

of

the

GM

O

regu

lati

on

s, s

o g

ene-

edit

ed p

lan

ts s

ho

uld

als

o

be

exem

pte

d.3

Ho

wev

er, c

laim

s th

at g

ene

edit

ing

can

pro

du

ce

org

anis

ms

that

co

uld

ari

se i

n n

atu

re o

r th

rou

gh

mu

tati

on

bre

edin

g ar

e en

tire

ly t

heo

reti

cal.

MY

TH

Ch

ange

s b

rou

gh

t

abo

ut

by

gen

e ed

itin

g

are

the

sam

e as

co

uld

hap

pen

in

nat

ure

or

mu

tati

on

bre

edin

g.

3. G

en

e e

dit

ing

ca

us

es

g

en

eti

c c

ha

ng

es

th

at

are

diff

ere

nt f

rom

th

os

e

tha

t h

ap

pe

n in

na

ture

RE

AL

ITY

Gen

e ed

itin

g c

ause

s ge

net

ic

chan

ges

that

are

dif

fere

nt

fro

m t

ho

se t

hat

hap

pen

in n

atu

re o

r m

uta

tio

n

bre

edin

g a

nd

th

eir

con

seq

uen

ces

are

po

orl

y

un

der

sto

od

.

1. E

uros

eeds

. Pla

nt b

reed

ing

inn

ovat

ion

. Eur

osee

ds.e

u. P

ubli

shed

2020

. Acc

esse

d D

ecem

ber

8, 2

020.

htt

ps:/

/ww

w.e

uros

eeds

.eu/

subj

ects

/pla

nt-b

reed

ing-

inn

ovat

ion

/

2. In

tern

atio

nal

See

d Fe

dera

tion

. Tec

hnol

ogic

al a

dvan

ces

driv

e in

nov

atio

n in

pla

nt b

reed

ing

to c

reat

e n

ew v

arie

t-

ies.

wor

ldse

ed.o

rg. P

ubli

shed

202

0. A

cces

sed

Dec

embe

r 8,

2020

. htt

ps:/

/ww

w.w

orld

seed

.org

/our

-wor

k/pl

ant-

bree

ding

/

plan

t-br

eedi

ng-i

nnov

atio

n/

3. V

on E

ssen

G. P

reci

sion

bre

edin

g –

smar

t rul

es f

or n

ew t

ech-

niqu

es! e

urop

ean

-bio

tech

nol

ogy.

com

. Pub

lish

ed 2

020.

Acc

esse

d

Dec

embe

r 8,

202

0. h

ttps

://e

urop

ean

-bio

tech

nol

ogy.

com

/peo

ple/

peop

le/p

reci

sion

-bre

edin

g-sm

art-

rule

s-fo

r-n

ew-t

echn

ique

s.ht

ml

4. C

arls

on D

F, L

anct

o C

A, Z

ang

B, e

t al.

Prod

ucti

on o

f ho

rnle

ss

dair

y ca

ttle

fro

m g

enom

e-ed

ited

cel

l lin

es. N

atur

e B

iote

chn

olo-

gy. 2

016;

34:4

79-4

81. d

oi:1

0.10

38/n

bt.3

560

5. C

arro

ll D

, Van

Een

enn

aam

AL

, Tay

lor

JF, S

eger

J, V

oyta

s D

F.

Reg

ulat

e ge

nom

e-ed

ited

pro

duct

s, n

ot g

enom

e ed

itin

g it

self

. Nat

Bio

tech

nol

. 201

6;34

(5):4

77-4

79. d

oi:1

0.10

38/n

bt.3

566

6. K

awal

l K, C

otte

r J,

The

n C

. Bro

aden

ing

the

GM

O r

isk

asse

ss-

men

t in

the

EU

for

gen

ome

edit

ing

tech

nol

ogie

s in

agr

icul

ture

.

Env

iron

men

tal S

cien

ces

Eur

ope.

202

0;32

(1):1

06. d

oi:1

0.11

86/

s123

02-0

20-0

0361

-2

7. R

obin

son

C, A

nton

iou

M. S

cien

ce s

uppo

rts

nee

d to

sub

ject

gen

e-ed

ited

pla

nts

to s

tric

t saf

ety

asse

ssm

ents

. GM

Wat

ch.o

rg.

Pub

lish

ed N

ovem

ber

20, 2

019.

htt

ps:/

/ww

w.g

mw

atch

.org

/en

/

new

s/la

test

-new

s/19

223

8. A

gapi

to-T

enfe

n SZ

, Oko

li A

S, B

ern

stei

n M

J, W

ikm

ark

O-G

,

Myh

r A

I. R

evis

itin

g ri

sk g

over

nan

ce o

f G

M p

lant

s: T

he n

eed

to c

onsi

der

new

an

d em

ergi

ng g

ene-

edit

ing

tech

niqu

es. F

ront

Plan

t Sci

. 201

8;9.

doi

:10.

3389

/fpl

s.20

18.0

1874

9. T

ang

X, L

iu G

, Zho

u J,

et a

l. A

larg

e-sc

ale

who

le-g

enom

e

sequ

enci

ng a

nal

ysis

rev

eals

hig

hly

spec

ific

gen

ome

edit

ing

by

both

Cas

9 an

d C

pf1

(Cas

12a)

nuc

leas

es i

n ri

ce. G

enom

e B

iolo

gy.

2018

;19(

1):8

4. d

oi:1

0.11

86/s

1305

9-01

8-14

58-5

10. E

cker

stor

fer

MF,

Dol

ezel

M, H

eiss

enbe

rger

A, e

t al.

An

EU

pers

pect

ive

on b

iosa

fety

con

side

rati

ons

for

plan

ts d

evel

oped

by g

enom

e ed

itin

g an

d ot

her

new

gen

etic

mod

ific

atio

n te

ch-

niqu

es (n

GM

s). F

ront

Bio

eng

Bio

tech

nol

. 201

9;7.

doi:1

0.33

89/

fbio

e.20

19.0

0031

11. T

ulad

har

R, Y

eu Y

, Pia

zza

JT, e

t al.

CR

ISPR

-Cas

9-ba

sed

mut

agen

esis

fre

quen

tly

prov

okes

on

-tar

get m

RN

A m

isre

gula

-

tion

. Nat

Com

mun

. 201

9;10

(1):1

-10.

doi

:10.

1038

/s41

467-

019-

1202

8-5

12. M

ou H

, Sm

ith

JL, P

eng

L, e

t al.

CR

ISPR

/Cas

9-m

edia

ted

gen

ome

edit

ing

indu

ces

exon

ski

ppin

g by

alt

ern

ativ

e sp

lic-

ing

or e

xon

dele

tion

. Gen

ome

Bio

logy

. 201

7;18

:108

. doi

:10.

1186

/

s130

59-0

17-1

237-

8

13. S

mit

s A

H, Z

iebe

ll F,

Jobe

rty

G, e

t al.

Bio

logi

cal p

last

icit

y

resc

ues

targ

et a

ctiv

ity

in C

RIS

PR k

noc

k ou

ts. N

at M

etho

ds.

2019

;16(

11):1

087-

1093

. doi

:10.

1038

/s41

592-

019-

0614

-5

14. E

urop

ean

Net

wor

k of

Sci

enti

sts

for

Soci

al a

nd

Env

iron

men

-

tal R

espo

nsi

bili

ty (E

NSS

ER

). E

NSS

ER

Sta

tem

ent:

New

Gen

etic

Mod

ific

atio

n T

echn

ique

s an

d T

heir

Pro

duct

s Po

se R

isks

Tha

t

Nee

d to

Be

Ass

esse

d. E

urop

ean

Net

wor

k of

Sci

enti

sts

for

Soci

al

and

Env

iron

men

tal R

espo

nsi

bili

ty (E

NSS

ER

); 20

19. h

ttps

://e

ns-

ser.o

rg/p

ubli

cati

ons/

2019

-pub

lica

tion

s/en

sser

-sta

tem

ent-

new

-

gen

etic

-mod

ific

atio

n-t

echn

ique

s-an

d-th

eir-

prod

ucts

-pos

e-ri

sks-

that

-nee

d-to

-be-

asse

ssed

/

15. B

isw

as S

, Tia

n J,

Li R

, et a

l. In

vest

igat

ion

of C

RIS

PR/

Cas

9-in

duce

d SD

1 ri

ce m

utan

ts h

ighl

ight

s th

e im

port

ance

of

mol

ecul

ar c

hara

cter

izat

ion

in p

lant

mol

ecul

ar b

reed

ing.

Jour

-

nal

of

Gen

etic

s an

d G

enom

ics.

Pub

lish

ed o

nli

ne

May

21,

202

0.

doi:1

0.10

16/j

.jgg.

2020

.04.

004

16. K

osic

ki M

, Tom

berg

K, B

radl

ey A

. Rep

air

of d

oubl

e-st

ran

d

brea

ks i

ndu

ced

by C

RIS

PR–

Cas

9 le

ads

to la

rge

dele

tion

s an

d

com

plex

rea

rran

gem

ents

. Nat

ure

Bio

tech

nol

ogy.

Pub

lish

ed

onli

ne

July

16,

201

8. d

oi:1

0.10

38/n

bt.4

192

17. R

obin

son

C. C

RIS

PR c

ause

s gr

eate

r ge

net

ic d

amag

e th

an

prev

ious

ly t

houg

ht. G

MW

atch

.org

. Pub

lish

ed Ju

ly 1

7, 2

018.

Acc

esse

d D

ecem

ber

10, 2

020.

htt

ps:/

/gm

wat

ch.o

rg/e

n/n

ews/

arch

ive/

2018

/183

50-c

risp

r-ca

uses

-gre

ater

-gen

etic

-dam

-

age-

than

-pre

viou

sly

-tho

ught

18. N

orri

s A

L, L

ee S

S, G

reen

lees

KJ,

Tad

esse

DA

, Mil

ler

MF,

Lom

bard

i H

A. T

empl

ate

plas

mid

int

egra

tion

in

germ

-

lin

e ge

nom

e-ed

ited

cat

tle.

Nat

Bio

tech

nol

. 202

0;38

(2):1

63-1

64.

doi:1

0.10

38/s

4158

7-01

9-03

94-6

19. A

chte

rber

g F.

Gen

e ed

ited

cro

p ca

n’t s

tan

d th

e li

ght

of d

ay. G

reen

peac

e E

urop

ean

Uni

t. P

ubli

shed

Sep

tem

-

ber

15, 2

020.

Acc

esse

d Ja

nua

ry 2

, 202

1. h

ttps

://w

ww

.

gree

npea

ce.o

rg/e

u-un

it/i

ssue

s/n

atur

e-fo

od/4

5028

/

gen

e-ed

ited

-cro

p-ca

nt-s

tan

d-th

e-li

ght-

of-d

ay

20. R

obin

son

C. C

ompa

ny c

laim

s fi

rst c

omm

erci

al g

ene-

edit

ed

crop

was

n’t g

ene-

edit

ed a

fter

all

. GM

Wat

ch.o

rg. P

ubli

shed

21

Sept

embe

r. A

cces

sed

Dec

embe

r 10

, 202

0. h

ttps

://w

ww

.gm

wat

ch.

org/

en/n

ews/

late

st-n

ews/

1953

5-co

mpa

ny-d

enie

s-fi

rst-

com

mer

-

cial

-gen

e-ed

ited

-cro

p-is

-gen

e-ed

ited

21. V

LOG

, Ohn

e G

ente

chni

k he

rges

tellt

, IFO

AM

, Gre

enpe

ace.

GM

O s

tatu

s of

Cib

us S

U C

anol

a. P

ubli

shed

on

lin

e N

ovem

ber

9,

2020

. htt

ps:/

/afe

c408

b-c7

7e-4

bd1-

86e4

-dca

a6f3

e25d

f.fil

esus

r.com

/

ugd/

cbe6

02_7

3707

414d

4034

27fa

a2ef

e3ba

1e1c

83d.

pdf

22. C

ibus

. Inn

ovat

ing

trad

itio

nal

pla

nt b

reed

ing.

cib

us.c

om. P

ub-

lish

ed 2

021.

htt

ps:/

/ww

w.c

ibus

.com

/our

-tec

hnol

ogy.

php

23. R

obin

son

C. L

awye

r w

ades

int

o ro

w o

ver

Cib

us’s

gen

e-ed

it-

ed c

anol

a. G

MW

atch

.org

. Pub

lish

ed O

ctob

er 2

5, 2

020.

Acc

esse

d

Dec

embe

r 10

, 202

0. h

ttps

://w

ww

.gm

wat

ch.o

rg/e

n/n

ews/

late

st-

new

s/19

572-

law

yer-

wad

es-i

nto-

row

-ove

r-ci

bus-

s-ge

ne-

edit

ed-

can

ola

24. C

hhal

liyil

P, I

lves

H, K

azak

ov S

A, H

owar

d SJ

, Joh

nst

on B

H,

Faga

n J.

A r

eal-

tim

e qu

anti

tati

ve P

CR

met

hod

spec

ific

for

det

ec-

tion

an

d qu

anti

fica

tion

of

the

firs

t com

mer

cial

ized

gen

ome-

ed-

ited

pla

nt. F

oods

. 202

0;9(

9):1

245.

doi

:10.

3390

/foo

ds90

9124

5

25. L

atha

m JR

, Wil

son

AK

, Ste

inbr

eche

r R

A. T

he m

utat

ion

al

con

sequ

ence

s of

pla

nt t

ran

sfor

mat

ion

. J B

iom

ed B

iote

chn

ol.

2006

;200

6:1-

7. do

i:10.

1155

/JB

B/2

006/

2537

6

RE

FE

RE

NC

ES

178

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

23

22

Ev

iden

ce s

ho

ws

that

mu

tati

on

s in

du

ced

by

gen

e

edit

ing

are

no

t th

e sa

me

as

tho

se i

nd

uce

d b

y ch

emic

als

or

rad

iati

on

in

mu

tati

on

bre

edin

g. F

or

exam

ple

, a

scie

nti

fic

rev

iew

sh

ow

s th

at

gen

e ed

itin

g ca

n p

rod

uce

chan

ges

in a

reas

of

the

gen

om

e

that

are

oth

erw

ise

pro

tect

ed

fro

m m

uta

tio

ns.

In o

ther

wo

rds,

gen

e ed

itin

g

mak

es t

he

wh

ole

gen

om

e

acce

ssib

le f

or

chan

ges.

5

Dr

Mic

hae

l An

ton

iou

say

s

that

mu

tati

on

s in

du

ced

by

mu

tati

on

bre

edin

g w

ill m

ore

oft

en t

han

no

t o

ccu

r in

area

s o

f th

e ge

no

me

that

are

no

n-c

od

ing

and

no

n-r

egu

lato

ry

and

th

eref

ore

are

un

lik

ely

to a

ffec

t

gen

e fu

nct

ion

.

Wit

h g

ene

edit

ing,

in

con

tras

t, m

uta

tio

ns

are

mo

re li

kel

y to

hap

pen

at

loca

tio

ns

in t

he

gen

om

e th

at

dir

ectl

y af

fect

th

e

fun

ctio

n o

f o

ne

or

mo

re g

enes

. Fir

st, t

her

e

is i

nte

nti

on

al t

arge

tin

g o

f

a ge

ne’

s co

din

g re

gio

n o

r it

s

regu

lato

ry e

lem

ents

to

alt

er i

ts

fun

ctio

n. G

ene

edit

ors

wil

l

pre

fere

nti

ally

tar

get

site

s th

at

are

rele

van

t fo

r p

rote

in

pro

du

ctio

n a

nd

gen

e

regu

lati

on

fo

r al

tera

tio

ns,

sin

ce t

he

ob

ject

ive

is t

o c

han

ge

a tr

ait.

Sec

on

d, m

uch

of

the

off

-tar

get

mu

tati

on

-cau

sin

g

acti

vit

y o

f th

e ge

ne-

edit

ing

too

l wil

l occ

ur

at lo

cati

on

s

wit

hin

th

e ge

no

me

wit

h a

sim

ilar

DN

A s

equ

ence

to

the

inte

nd

ed t

arge

t si

te. T

his

mea

ns

that

if

the

inte

nd

ed

gen

e ed

itin

g ta

rget

sit

e is

a

gen

e’s

cod

ing

regi

on

or

its

regu

lato

ry e

lem

ents

, off

-tar

get

mu

tati

on

s w

ill

occ

ur

in o

ther

gen

es w

ith

a

sim

ilar

DN

A

seq

uen

ce.

As

a re

sult

, off

-tar

get

and

un

inte

nd

ed o

n-

targ

et m

uta

tio

ns

are

lik

ely

to

affe

ct i

mp

ort

ant

pro

tein

-co

din

g

gen

e re

gio

ns

and

gen

e

regu

lato

ry

acti

vit

y.

A s

epar

ate

scie

nti

fic

rev

iew

sho

ws

that

gen

e-ed

itin

g

tech

niq

ues

en

able

co

mp

lex

alte

rati

on

s o

f ge

no

mes

th

at

wo

uld

be

extr

emel

y d

iffi

cult

or

imp

oss

ible

to

ach

iev

e w

ith

con

ven

tio

nal

bre

edin

g o

r

mu

tati

on

bre

edin

g. I

n g

ene

edit

ing,

so

-cal

led

mu

ltip

lexi

ng

app

roac

hes

all

ow

th

e ta

rget

ing

and

alt

erat

ion

of

mu

ltip

le

gen

e v

aria

nts

, wh

ich

can

be

mem

ber

s o

f th

e sa

me

or

dif

fere

nt

gen

e fa

mil

ies.

6

In s

um

mar

y, g

ene

edit

ing

can

cau

se s

pec

ific

un

inte

nd

ed

effe

cts

and

can

be

use

d

to g

ener

ate

no

vel

gen

etic

com

bin

atio

ns

that

can

no

t

read

ily

be

ach

iev

ed u

sin

g

con

ven

tio

nal

bre

edin

g o

r

mu

tage

nes

is t

ech

niq

ues

. It

can

ov

erco

me

gen

etic

lim

itat

ion

s

that

exi

st i

n c

on

ven

tio

nal

bre

edin

g.6

Th

ese

un

iqu

e at

trib

ute

s o

f

gen

e-ed

itin

g ap

pli

cati

on

s sh

ow

that

th

ey p

ose

un

iqu

e ri

sks,

just

ifyi

ng

stri

ct r

egu

lati

on

.

MU

TA

TIO

NS

FR

OM

GE

NE

ED

ITIN

G A

RE

DIF

FE

RE

NT

IN

TY

PE

FR

OM

TH

OS

E F

RO

M

CO

NV

EN

TIO

NA

L O

R M

UT

AT

ION

BR

EE

DIN

GN

o o

ne

has

pro

ven

th

at a

ny

giv

en g

ene-

edit

ed

org

anis

m i

s th

e sa

me

as a

nat

ura

lly

occ

urr

ing

vo

r m

uta

tio

n b

red

org

anis

m, e

ith

er a

t th

e le

vel

of

the

gen

om

e o

r in

ter

ms

of

its

mo

lecu

lar

com

po

siti

on

(th

e p

rote

ins

and

nat

ura

l ch

emic

als

that

mak

e u

p t

he

stru

ctu

re a

nd

fu

nct

ion

of

the

org

anis

m).

Ind

eed

, if

som

eon

e w

ere

to p

rod

uce

a ge

ne-

edit

ed o

rgan

ism

th

at w

as t

he

sam

e as

a n

atu

rall

y b

red

on

e, t

his

wo

uld

cal

l in

to q

ues

tio

n a

ny

pat

ent

on

th

e ge

ne-

edit

ed o

rgan

ism

, as

pat

ents

req

uir

e an

“in

ven

tiv

e st

ep”.

Dr

Mic

hae

l An

ton

iou

, a m

ole

cula

r ge

net

icis

t

bas

ed a

t a

lead

ing

Lo

nd

on

un

iver

sity

, sai

d

that

cla

ims

that

th

e m

uta

tio

ns

ind

uce

d b

y

gen

e ed

itin

g ar

e th

e sa

me

as c

ou

ld h

app

en

in n

atu

re o

r m

uta

tio

n b

reed

ing

are

scie

nti

fica

lly

un

fou

nd

ed. M

ore

ov

er, h

e

said

th

ere

is n

o e

vid

ence

dem

on

stra

tin

g

that

gen

e ed

itin

g

is m

ore

pre

cise

, in

the

sen

se o

f ca

usi

ng

few

er m

uta

tio

ns,

than

co

nv

enti

on

al

bre

edin

g o

r

mu

tati

on

bre

edin

g.

He

said

“G

ene

edit

ing

can

cau

se

larg

e d

elet

ion

s,

inse

rtio

ns,

an

d

rear

ran

gem

ents

in

DN

A, w

hic

h c

an

affe

ct t

he

fun

ctio

n o

f m

ult

iple

gen

es a

t o

ff-

targ

et a

nd

on

-tar

get

site

s.”

I am

no

t aw

are

of

any

stu

die

s

usi

ng

reli

able

scre

enin

g m

eth

od

s

that

co

mp

are

the

freq

uen

cy o

f th

ese

typ

es o

f la

rge-

scal

e

DN

A d

amag

e in

con

ven

tio

nal

ly b

red

,

mu

tati

on

bre

d, a

nd

gen

e-ed

ited

pla

nts

.

Wh

at w

e d

o k

no

w

is t

hat

th

ere

is

clea

r ex

per

imen

tal

evid

ence

sh

ow

ing

that

ass

um

pti

on

s th

at g

ene

edit

ing

on

ly c

ause

s

smal

l in

sert

ion

s an

d d

elet

ion

s at

off

-tar

get

and

on

-tar

get

site

s ar

e fa

lse.

”4

NO

EV

IDE

NC

E T

HA

T C

HA

NG

ES

FR

OM

GE

NE

ED

ITIN

G A

RE

FE

WE

R

TH

AN

FR

OM

CO

NV

EN

TIO

NA

L

OR

MU

TA

TIO

N B

RE

ED

ING

“Gen

e ed

itin

g ca

n c

ause

larg

e d

elet

ion

s, i

nse

rtio

ns,

and

rea

rran

gem

ents

in

DN

A, w

hic

h c

an a

ffec

t th

e

fun

ctio

n o

f m

ult

iple

gen

es

at o

ff-t

arge

t an

d

on

-tar

get

site

s’’

- D

r M

ich

ael

An

ton

iou

179

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

25

24

Cla

ims

that

gen

e ed

itin

g is

“b

reed

ing”

, th

at i

t

is “

pre

cise

”, a

nd

th

at o

utc

om

es a

re “

nat

ure

-

iden

tica

l” a

re o

ften

mad

e to

im

ply

th

at g

ene-

edit

ed o

rgan

ism

s w

ill b

e sa

fe-b

y-d

esig

n.

Som

e G

MO

dev

elo

per

s h

ave

gon

e fu

rth

er,

exp

lici

tly

clai

min

g

that

gen

e-ed

ited

pla

nts

are

just

as

safe

as c

on

ven

tio

nal

ly

bre

d o

nes

.

Bay

er c

laim

s th

at

com

par

ed w

ith

con

ven

tio

nal

bre

edin

g, C

RIS

PR

/Cas

gen

e

edit

ing

is “

sim

ple

r, f

aste

r an

d m

ore

pre

cise

,

wit

h n

o i

mp

act

on

th

e sa

fety

of

the

fin

al c

rop

com

par

ed

to t

rad

itio

nal

pla

nt

bre

edin

g”.1

An

d C

ort

eva

says

th

at

CR

ISP

R-e

dit

ed p

lan

ts a

re

“as

safe

as

pla

nts

fo

un

d

in n

atu

re o

r p

rod

uce

d

thro

ugh

co

nve

nti

on

al

bre

edin

g”.2

Th

e ag

bio

tech

ind

ust

ry a

rgu

es t

hat

it w

ou

ld t

her

efo

re b

e

“dis

pro

po

rtio

nat

e” t

o

sub

ject

th

ese

pro

du

cts

to G

MO

reg

ula

tory

req

uir

emen

ts a

imed

at

ensu

rin

g th

eir

safe

ty.3 C

ort

eva

sees

no

nee

d t

o

con

du

ct s

afet

y te

stin

on

its

gen

e-ed

ited

cro

ps

MY

TH

Th

e p

reci

sio

n a

nd

co

ntr

ol

of

gen

e ed

itin

g m

ean

th

at i

t is

safe

-by

-des

ign

.

RE

AL

ITY

Th

e u

nin

ten

ded

ou

tco

mes

of

gen

e

edit

ing

lea

d t

o r

isk

s,

wh

ich

are

po

orl

y

un

der

sto

od

.

4.G

en

e e

dit

ing

is r

isk

ya

nd

its

pro

du

cts

ca

nb

e u

ns

afe

1.E

uro

seed

s. P

osi

tio

n: P

lan

t B

reed

ing

Inn

ov

atio

n.

Eu

rose

eds;

201

8. h

ttp

s://

ww

w.e

uro

seed

s.eu

/ap

p/

up

load

s/2

019/

07/

18.1

010

-Eu

rose

eds-

PB

I-P

osi

tio

n-1

.pd

f

2.E

uro

paB

io. A

chie

vin

g th

e p

ote

nti

al o

f ge

no

me

edit

ing.

Eu

rop

aBio

.org

. Pu

bli

shed

Ju

ne

201

9. A

cces

sed

Jan

uar

y10

, 202

1. h

ttp

s://

ww

w.e

uro

pab

io.o

rg/c

ross

-sec

tor/

pu

bli

cati

on

s/ac

hie

vin

g-p

ote

nti

al-g

eno

me-

edit

ing

3.A

skew

K. C

RIS

PR

gen

om

e ed

itin

g to

ad

dre

ss f

oo

dse

curi

ty a

nd

cli

mat

e ch

ange

: “N

ow

mo

re t

han

ev

er w

ear

e lo

ok

ing

to s

cien

ce f

or

solu

tio

ns.

” fo

od

nav

igat

or.

com

.P

ub

lish

ed o

nli

ne

May

4, 2

020

. Acc

esse

d J

anu

ary

29, 2

021.

htt

ps:

//w

ww

.fo

od

nav

igat

or.

com

/Art

icle

/202

0/05

/04/

CR

ISP

R-g

eno

me-

edit

ing-

to-a

dd

ress

-fo

od

-sec

uri

ty-a

nd

-cl

imat

e-ch

ange

-No

w-m

ore

-th

an-e

ver

-we-

are-

loo

kin

g-to

-sci

ence

-fo

r-so

luti

on

s

4.R

obi

nso

n C

, An

ton

iou

M. S

cien

ce s

up

po

rts

nee

d t

o

sub

ject

gen

e-ed

ited

pla

nts

to

str

ict

safe

ty a

sses

smen

ts.

GM

Wat

ch.o

rg. P

ub

lish

ed N

ov

emb

er 2

0, 2

019.

htt

ps:

//w

ww

.gm

wat

ch.o

rg/e

n/n

ews/

late

st-n

ews/

1922

3

5.K

awal

l K. N

ew p

oss

ibil

itie

s o

n t

he

ho

rizo

n: G

eno

me

edit

ing

mak

es t

he

wh

ole

gen

om

e ac

cess

ible

fo

r ch

ange

s.F

ron

t P

lan

t S

ci. 2

019;

10. d

oi:1

0.3

389/

fpls

.201

9.0

0525

6.K

awal

l K, C

ott

er J

, Th

en C

. Bro

aden

ing

the

GM

O r

isk

asse

ssm

ent

in t

he

EU

fo

r ge

no

me

edit

ing

tech

no

logi

esin

agr

icu

ltu

re. E

nv

iro

nm

enta

l Sci

ence

s E

uro

pe.

202

0;32

(1):

106

. do

i:10

.118

6/s1

2302

-02

0-0

0361

-2

7.D

ou

dn

a JA

, Ste

rnb

erg

SH. A

Cra

ck i

n C

reat

ion

: Gen

eE

dit

ing

and

th

e U

nth

ink

able

Po

wer

to

Co

ntr

ol E

volu

tio

n.

Ho

ug

hto

n M

iffl

in H

arco

urt

; 201

7.

Th

e ev

iden

ce s

ho

ws

that

th

e ge

net

ic c

han

ges

bro

ugh

t ab

ou

t b

y ge

ne

edit

ing

are

dif

fere

nt

fro

m t

ho

se t

hat

wo

uld

hap

pen

in

nat

ure

or

mu

tati

on

bre

edin

g an

d t

hei

r o

utc

om

es a

nd

th

e

risk

s at

tach

ed t

o t

hem

are

po

orl

y u

nd

erst

oo

d.

Wit

h t

his

in

min

d, g

ene

edit

ing

mu

st r

emai

n

un

der

th

e E

U’s

GM

O r

egu

lati

on

s an

d t

he

risk

asse

ssm

ent

sho

uld

be

bro

aden

ed t

o t

ake

acco

un

t

of

the

spec

ial r

isks

att

ach

ed t

o t

he

tech

no

logy

.

CR

ISP

R i

nve

nto

r Je

nn

ifer

Do

ud

na

has

mad

e

clea

r th

at t

he

aim

of

CR

ISP

R g

ene

edit

ing

is n

ot

to r

epli

cate

or

enh

ance

nat

ure

bu

t to

red

esig

n

and

rep

lace

it.

Sh

e w

rote

:

“Go

ne

are

the

day

s w

hen

life

was

sh

aped

excl

usi

vely

by

the

plo

dd

ing

forc

es o

f

evo

luti

on

. We’

re

stan

din

g o

n t

he

cusp

of

a n

ew e

ra, o

ne

in

wh

ich

we

wil

l hav

e

pri

mar

y au

tho

rity

ove

r

life

’s g

enet

ic m

akeu

p

and

all

its

vib

ran

t an

d

vari

ed o

utp

uts

. In

dee

d,

we

are

alre

ady

sup

pla

nti

ng

the

dea

f, d

um

b, a

nd

bli

nd

sys

tem

th

at h

as s

hap

ed g

enet

ic m

ater

ial

on

ou

r p

lan

et f

or

eon

s an

d r

epla

cin

g it

wit

h

a co

nsc

iou

s, i

nte

nti

on

al s

yste

m o

f h

um

an-

dir

ecte

d e

volu

tio

n.”

7

Ho

wev

er, g

iven

th

at s

cien

tist

s d

o n

ot

full

y

un

der

stan

d t

he

fun

ctio

n o

f th

e va

st c

om

ple

x

net

wo

rks

of

gen

es a

nd

th

eir

pro

du

cts

that

con

stit

ute

a h

ealt

hy

fun

ctio

nin

g o

rgan

ism

,

they

are

no

t re

mo

tely

clo

se t

o b

ein

g ab

le t

o

pre

dic

t th

e o

utc

om

e

even

of

a si

ngl

e ge

ne

man

ipu

lati

on

. Th

us

it

is d

iffi

cult

to

see

ho

w a

new

era

in

hu

man

-led

pre

dic

tab

le, d

irec

ted

evo

luti

on

has

daw

ned

.

Fro

m t

his

per

spec

tive

,

wh

en i

t co

mes

to

evo

luti

on

ary

pro

cess

es,

it i

s ar

guab

ly g

enet

ic e

ngi

nee

rin

g th

at i

s a

“dea

f,

du

mb

, an

d b

lin

d s

yste

m”,

rat

her

th

an n

atu

re.

Th

e li

mit

atio

ns

imp

ose

d b

y n

atu

ral p

roce

sses

may

hel

p, r

ath

er t

han

im

ped

e, e

volu

tio

n.

RE

DE

SIG

NIN

G N

AT

UR

E

NO

T N

AT

UR

E-

IDE

NT

ICA

L

RE

FE

RE

NC

EST

he

lim

itat

ion

s

imp

ose

d b

y n

atu

ral

pro

cess

es m

ay h

elp

,

rath

er t

han

im

ped

e,

evo

luti

on

So

me

GM

O d

evel

op

ers

clai

m t

hat

gen

e-ed

ited

pla

nts

are

ju

st a

s sa

fe

as c

on

ven

tio

nal

ly

bre

d o

nes

180

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

27

26

(ret

rovi

ruse

s in

clu

de

can

cer-

cau

sin

g “o

nco

-

retr

ovi

ruse

s” a

nd

hu

man

im

mu

no

def

icie

ncy

viru

s, H

IV, w

hic

h c

an le

ad t

o A

IDS)

. Th

us

gen

e

edit

ing

is a

po

ten

tial

mec

han

ism

fo

r h

ori

zon

tal

gen

e tr

ansf

er (

the

tran

sfer

of

gen

etic

mat

eria

l by

any

met

ho

d o

ther

th

an “

vert

ical

” tr

ansm

issi

on

of

DN

A f

rom

par

ent

to o

ffsp

rin

g) o

f d

isea

se-

cau

sin

g o

rgan

ism

s, i

ncl

ud

ing,

bu

t n

ot

lim

ited

to, v

iru

ses.

14

Th

e st

ud

y al

so f

ou

nd

that

DN

A f

rom

th

e

gen

om

e o

f E

.

coli

bac

teri

a ca

n

inad

vert

entl

y

inte

grat

e in

to t

he

targ

et o

rgan

ism

’s

gen

om

e. T

he

sou

rce

of

the

E. c

oli

DN

A

was

tra

ced

to

th

e

E.c

oli

bac

teri

al

cell

s u

sed

to

pro

du

ce t

he

vect

or

pla

smid

. Th

e

pla

smid

is

a sm

all c

ircu

lar

DN

A m

ole

cule

th

at

carr

ies

the

gen

es g

ivin

g in

stru

ctio

ns

for

the

man

ufa

ctu

re o

f th

e C

RIS

PR

/Cas

co

mp

on

ents

(an

d i

n S

DN

-2 a

pp

lica

tio

ns,

th

e D

NA

rep

air

tem

pla

te)

into

th

e ce

lls.

Im

po

rtan

tly,

the

rese

arch

ers

use

d s

tan

dar

d m

eth

od

s o

f

vect

or

pla

smid

pre

par

atio

n, s

o t

his

typ

e o

f

con

tam

inat

ion

co

uld

hap

pen

ro

uti

nel

y.12

Th

ese

fin

din

gs a

re c

lear

ly r

elev

ant

to g

ene-

edit

ed a

nim

als,

bu

t h

ow

do

th

ey r

elat

e to

pla

nt

gen

e ed

itin

g? T

issu

e cu

ltu

re m

ediu

m c

on

tain

ing

com

po

nen

ts f

rom

an

imal

s is

no

t u

sed

in

mak

ing

gen

e-ed

ited

pla

nts

, so

th

e p

rese

nce

of

anim

al

DN

A i

s n

ot

a co

nce

rn.

Ho

wev

er, i

n c

ases

wh

ere

gen

etic

en

gin

eers

del

iver

th

e ge

ne-

edit

ing

too

l in

to p

lan

t ce

lls

enco

ded

by

a p

lasm

id, t

her

e ar

e tw

o w

ays

in

wh

ich

fo

reig

n D

NA

can

bec

om

e in

adve

rten

tly

inte

grat

ed i

nto

th

e ge

no

me

of

the

pla

nt

bei

ng

edit

ed. F

irst

, th

e

pla

smid

en

cod

ing

the

gen

e-ed

itin

g

too

l, ei

ther

as

a

wh

ole

, or

frag

men

ts

ther

eof,

can

bec

om

e

inte

grat

ed. S

eco

nd

,

DN

A f

rom

th

e

gen

om

e o

f th

e E

.

coli

bac

teri

a u

sed

to p

rop

agat

e th

e

pla

smid

can

oft

en

con

tam

inat

e th

e fi

nal

pla

smid

pre

par

atio

n u

sed

in t

he

gen

e-ed

itin

g p

roce

ss, a

nd

th

us

cou

ld e

nd

up

bei

ng

inte

grat

ed i

nto

th

e ge

ne-

edit

ed p

lan

t’s

gen

om

e.

Fo

reig

n p

lasm

id o

r b

acte

rial

gen

om

ic D

NA

cou

ld b

e in

adve

rten

tly

inco

rpo

rate

d d

uri

ng

pla

nt

gen

e ed

itin

g. T

her

efo

re r

egu

lato

rs m

ust

lega

lly

ob

lige

dev

elo

per

s to

co

nd

uct

ap

pro

pri

ate

in-d

epth

mo

lecu

lar

gen

etic

ch

arac

teri

sati

on

of

thei

r p

rod

uct

s to

asc

erta

in i

f su

ch a

n o

utc

om

e

has

tak

en p

lace

or

no

t.

and

say

s it

tes

ts C

RIS

PR

-pro

du

ced

pla

nts

in

“th

e sa

me

way

” as

it

test

s co

nve

nti

on

ally

bre

d

pla

nts

.4

Ho

wev

er, a

s

we

hav

e se

en i

n

pre

vio

us

chap

ters

,

gen

e ed

itin

g is

no

t p

reci

se, n

or

are

the

ou

tco

mes

iden

tica

l to

th

ose

of

con

ven

tio

nal

bre

edin

g. W

hil

e th

e in

itia

l cu

t

in t

he

DN

A c

an b

e ta

rget

ed t

o a

sp

ecif

ic r

egio

n

of

the

gen

om

e, t

he

sub

sequ

ent

DN

A r

epai

r

pro

cess

cau

ses

un

wan

ted

mu

tati

on

s b

oth

at

on

-tar

get

and

off

-tar

get

site

s in

th

e ge

no

me.

5,6,

7

Tec

hn

iqu

es c

om

mo

n t

o b

oth

gen

e ed

itin

g an

d

old

er t

ran

sgen

ic G

M m

eth

od

s, s

uch

as

tiss

ue

cult

ure

an

d G

M t

ran

sfo

rmat

ion

, wil

l lea

d t

o

add

itio

nal

mu

tati

on

s

(see

ch

apte

r 2)

.

Th

ese

un

inte

nd

ed

gen

etic

ch

ange

s w

ill

alte

r th

e p

atte

rn o

f

gen

e fu

nct

ion

wit

hin

the

org

anis

m.

In p

lan

ts, t

his

can

alt

er b

ioch

emic

al p

ath

way

s

and

lead

to

co

mp

osi

tio

nal

ch

ange

s, w

hic

h,

scie

nti

sts

war

n, c

ou

ld i

ncl

ud

e th

e p

rod

uct

ion

of

no

vel t

oxi

ns

and

all

erge

ns

or

alte

red

leve

ls o

f

exis

tin

g to

xin

s an

d a

ller

gen

s.8,

9,10

Th

e p

rese

nce

of

un

inte

nd

ed m

uta

tio

ns

has

bee

n

wel

l do

cum

ente

d i

n h

um

an a

nd

an

imal

cel

ls a

nd

has

beg

un

to

gai

n m

ore

att

enti

on

in

pla

nts

.11

Ho

wev

er, a

no

ther

un

wan

ted

ou

tco

me

of

gen

e

edit

ing

has

rec

eive

d

litt

le a

tten

tio

n a

nd

it i

s u

ncl

ear

to w

hat

exte

nt

it o

ccu

rs i

n

anim

al a

nd

pla

nt

cell

s an

d w

hat

th

e

effe

cts

mig

ht

be.

Th

is o

utc

om

e w

as h

igh

ligh

ted

in

a s

tud

y b

y

Jap

anes

e re

sear

cher

s. T

he

stu

dy

fou

nd

th

at

even

SD

N-2

(ge

ne

alte

rati

on

) ap

pli

cati

on

s

of

CR

ISP

R/C

as g

ene

edit

ing,

wh

ich

aim

no

t

to i

ntr

od

uce

fo

reig

n D

NA

, res

ult

ed i

n t

he

un

inte

nd

ed i

nco

rpo

rati

on

of

fore

ign

an

d

con

tam

inat

ing

DN

A i

nto

th

e ge

no

me

of

gen

e-

edit

ed o

rgan

ism

s.12

Th

is u

nw

ante

d r

esu

lt i

s n

ot

rest

rict

ed t

o C

RIS

PR

bu

t h

as b

een

fo

un

d w

ith

oth

er t

ypes

of

gen

e ed

itin

g, t

oo

.13

Spec

ific

ally

, th

e re

sear

cher

s lo

oke

d a

t th

e

effe

cts

of

CR

ISP

R/

Cas

gen

e ed

itin

g

in m

ou

se c

ells

and

em

bry

os

and

fou

nd

th

at e

dit

ed

mo

use

gen

om

es

un

inte

nti

on

ally

acqu

ired

bo

vin

e o

r go

at D

NA

. Th

is w

as t

race

d

to t

he

use

, in

sta

nd

ard

cu

ltu

re m

ediu

m f

or

mo

use

cel

ls, o

f fo

etal

cal

f se

rum

an

d g

oat

ser

um

extr

acte

d f

rom

co

ws

or

goat

s.12

Eve

n m

ore

wo

rris

om

e, a

mo

ngs

t th

e D

NA

sequ

ence

s in

sert

ed i

nto

th

e m

ou

se g

eno

me

wer

e b

ovi

ne

and

go

at r

etro

tran

spo

son

s

(ju

mp

ing

gen

es)

and

mo

use

ret

rovi

rus

DN

A12

GE

NE

ED

ITIN

G C

AN

UN

INT

EN

TIO

NA

LL

Y

AD

D F

OR

EIG

N D

NA

IN

TH

E G

EN

OM

E

Un

inte

nd

ed g

enet

ic

chan

ges

wil

l al

ter

the

pat

tern

of

gen

e fu

nct

ion

wit

hin

th

e o

rgan

ism

Ed

ited

mo

use

gen

om

es

un

inte

nti

on

ally

acq

uir

ed

bo

vin

e o

r go

at D

NA

Gen

e ed

itin

g i

s a

po

ten

tial

mec

han

ism

fo

r

ho

rizo

nta

l ge

ne

tran

sfer

of

dis

ease

-cau

sin

g o

rga-

nis

ms,

in

clu

din

g, b

ut

no

t

lim

ited

to

, vir

use

s

181

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

29

28

Cla

ims

of

nat

ure

-id

enti

cal o

r sa

fe-b

y-d

esig

n

gen

e-ed

ited

pro

du

cts

sho

uld

be

vie

wed

wit

h

scep

tici

sm, a

s d

emo

nst

rate

d b

y th

e ca

se o

f th

e

gen

e-ed

ited

ho

rnle

ss c

attl

e.

In 2

019

rese

arch

ers

at t

he

US

Fo

od

an

d D

rug

Ad

min

istr

atio

n (

FD

A)

anal

ysed

th

e ge

no

mes

of

two

cal

ves

13 t

hat

had

bee

n g

ene

edit

ed b

y

the

bio

tech

co

mp

any

Rec

om

bin

etic

s u

sin

g

the

TA

LE

N t

oo

l

in a

n S

DN

-3 (

gen

e

inse

rtio

n)

pro

ced

ure

.

Th

e ai

m o

f th

e ge

net

ic

man

ipu

lati

on

was

to

pre

ven

t th

e an

imal

s fr

om

gro

win

g h

orn

s b

y in

sert

ing

into

th

eir

gen

om

e

the

PO

LL

ED

gen

e, t

aken

fro

m c

on

ven

tio

nal

ly

bre

d h

orn

less

cat

tle.

Rec

om

bin

etic

s sc

ien

tist

s h

ad c

laim

ed

that

th

e ge

ne

edit

ing

use

d i

n t

he

catt

le w

as s

o p

reci

se t

hat

“o

ur

anim

als

are

free

of

off

-tar

get

even

ts”.

22 T

he

com

pan

y’s

exec

uti

ves

had

to

ld B

loo

mb

erg

in 2

017,

“W

e k

no

w e

xact

ly

wh

ere

the

gen

e sh

ou

ld g

o, a

nd

we

pu

t it

in

its

exa

ct lo

cati

on

,”

and

“W

e h

ave

all t

he

scie

nti

fic

dat

a th

at p

rov

es t

hat

th

ere

are

no

off

-tar

get

effe

cts.

”23

A c

om

men

tary

by

acad

emic

rese

arch

ers,

so

me

of

wh

om

wer

e as

soci

ated

wit

h R

eco

mb

inet

ics,

cla

imed

th

at t

he

gen

e

edit

ing

use

d i

n t

he

catt

le w

as p

reci

se, t

hat

th

e

chan

ges

bro

ugh

t ab

ou

t ar

e la

rgel

y id

enti

cal

to w

hat

co

uld

hav

e ar

isen

nat

ura

lly,

an

d t

hat

any

anim

als

wit

h u

nw

ante

d t

rait

s w

ou

ld b

e

excl

ud

ed f

rom

bre

edin

g p

rogr

amm

es.24

Ho

wev

er, a

ll t

hes

e

clai

ms

wer

e p

rov

en

fals

e b

y w

hat

th

e F

DA

scie

nti

sts

fou

nd

.

At

on

e o

f th

e ta

rget

site

s o

f th

e ge

ne-

edit

ing

pro

ced

ure

wit

hin

th

e ca

lves

’ gen

om

e, t

he

PO

LL

ED

gen

e

had

in

sert

ed a

s p

lan

ned

. Ho

wev

er, a

t th

e o

ther

inte

nd

ed g

ene

edit

ing

site

, tw

o c

op

ies

of

the

enti

re c

ircu

lar

pla

smid

DN

A c

on

stru

ctio

n

that

car

ried

th

e

GE

NE

-E

DIT

ED

CA

TT

LE

CO

NT

AIN

ED

AN

TIB

IOT

IC R

ES

IST

AN

CE

GE

NE

S

Th

e d

isti

nct

ion

bet

wee

n S

DN

-1, -

2, a

nd

-3

is n

ot

use

ful f

or

dif

fere

nti

atin

g le

vel

s o

f ri

sk

for

each

typ

e o

f ge

ne-

edit

ed o

rgan

ism

. Th

is i

s

bec

ause

SD

N-1

, -2,

an

d -

3 re

fer

to t

he

inte

nti

on

of

the

gen

e ed

itin

g an

d n

ot

the

actu

al o

utc

om

e,

wh

erea

s th

e o

utc

om

e o

f a

gen

e-ed

itin

g ev

ent

can

be

ver

y d

iffe

ren

t fr

om

th

e in

ten

tio

n.

Als

o, e

ven

sm

all c

han

ges

in t

he

gen

om

e ca

n

cau

se la

rge

effe

cts.

15,1

6 T

he

Lo

nd

on

-bas

ed

mo

lecu

lar

gen

etic

ist

Dr

Mic

hae

l An

ton

iou

sai

d,

“T

he

size

of

gen

etic

chan

ges

do

es n

ot

det

erm

ine

risk

, sin

ce

smal

l gen

etic

ch

ange

s

may

res

ult

in

dra

mat

ic

and

no

vel

eff

ects

.

Fo

r ex

amp

le, a

sm

all

del

etio

n o

r in

sert

ion

foll

ow

ing

a ge

ne-

edit

ing

even

t co

uld

resu

lt i

n c

reat

ing

a n

ew

gen

e se

qu

ence

, wh

ich

can

giv

e ri

se t

o a

no

vel

mu

tan

t p

rote

in w

ith

un

kn

ow

n f

un

ctio

nal

co

nse

qu

ence

s. T

his

is

wh

y

all o

f th

e m

uta

tio

ns

cau

sed

by

gen

e ed

itin

g m

ust

be

asse

ssed

on

th

e b

asis

of

wh

at t

hey

do

, as

wel

l

as w

hat

typ

e an

d h

ow

nu

mer

ou

s th

ey a

re.”

SD

N-1

an

d -

2 ap

pli

cati

on

s ar

e o

ften

ass

um

ed t

o

be

less

dis

rup

tiv

e th

an S

DN

-3 b

ecau

se t

her

e is

no

in

ten

tio

n t

o p

erm

anen

tly

inte

grat

e fo

reig

n

DN

A i

nto

th

e ge

no

me.

Ho

wev

er, t

her

e is

no

evid

ence

th

at t

he

mu

tati

on

s ca

use

d a

re f

ewer

,

smal

ler,

or

less

ris

ky

in t

ype.

In

fac

t, m

ajo

r

mu

tati

on

s, i

ncl

ud

ing

larg

e d

elet

ion

s, i

nse

rtio

ns,

and

rea

rran

gem

ents

of

DN

A, h

ave

bee

n f

ou

nd

to b

e ge

ner

ated

ev

en b

y S

DN

-1 p

roce

du

res.

17,1

8

Ind

eed

, all

typ

es o

f ge

ne

edit

ing

– S

DN

-1, -

2,

and

-3

– c

an b

e ca

rrie

d o

ut

at m

ult

iple

loca

tio

ns

of

the

gen

om

e u

sin

g m

ult

iple

x ap

pro

ach

es,

wh

ich

tar

get

sev

eral

gen

es a

t o

nce

, or

in

rep

eate

d, s

equ

enti

al a

pp

lica

tio

ns.

19,2

0,21

Th

us

clai

ms

that

th

e ch

ange

s m

ade

are

“sm

all”

an

d

“sim

ilar

to

wh

at m

igh

t h

app

en i

n n

atu

re”

are

mis

lead

ing,

as

sev

eral

in

div

idu

ally

sm

all c

han

ges

can

co

mb

ine

to p

rod

uce

an

org

anis

m t

hat

is

ver

y d

iffe

ren

t fr

om

th

e p

aren

t o

rgan

ism

. Wh

ile

even

sm

all c

han

ges

can

pro

du

ce la

rge

effe

cts,

a n

um

ber

of

smal

l

chan

ges

mad

e v

ia g

ene

edit

ing

can

res

ult

in

even

gre

ater

ch

ange

s,

wh

ich

in

crea

ses

the

po

ssib

ilit

y o

f

un

inte

nd

ed a

lter

atio

ns

in t

he

edit

ed p

lan

t’s

bio

chem

istr

y an

d

ov

eral

l co

mp

osi

tio

n,

wit

h u

nk

no

wn

con

seq

uen

ces

for

bo

th c

rop

per

form

ance

an

d t

he

hea

lth

of

the

con

sum

er.

Th

us

the

risk

s o

f b

oth

sm

all a

nd

larg

e ch

ange

s

mu

st b

e ca

refu

lly

asse

ssed

. Alt

ho

ugh

un

wan

ted

gen

etic

ch

ange

s h

ave

bee

n s

tud

ied

in

gen

e-

edit

ed o

rgan

ism

s to

so

me

exte

nt,

no

saf

ety

stu

die

s h

ave

bee

n c

arri

ed o

ut

wit

h g

ene-

edit

ed p

rod

uct

s. S

uch

stu

die

s ar

e

com

pu

lso

ry u

nd

er E

U la

ws

bef

ore

a G

MO

pro

du

ct c

an b

e p

lace

d o

n t

he

mar

ket

.

SD

N D

IST

INC

TIO

NS

NO

T U

SE

FU

L

FO

R J

UD

GIN

G R

ISK

Th

e si

ze o

f ge

net

ic

chan

ges

do

es n

ot

det

erm

ine

risk

,

sin

ce s

mal

l ge

net

ic

chan

ges

may

res

ult

in

dra

mat

ic a

nd

no

vel

effe

cts

Th

ese

clai

ms

wer

e

pro

ven

fal

se b

y w

hat

the

FD

A s

cien

tist

s

fou

nd

182

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

31

30

GM

O d

evel

op

ers

oft

en c

laim

th

at g

ene-

edit

ed

org

anis

ms

wit

h g

enet

ic e

rro

rs a

nd

un

wan

ted

trai

ts w

ill b

e

elim

inat

ed

fro

m b

reed

ing

pro

gram

mes

,24

or

that

th

e er

rors

can

be

rem

ov

ed

by

sub

seq

uen

t

bac

kcr

oss

ing;

th

us

they

are

no

thin

g

to w

orr

y ab

ou

t.

Ho

wev

er, t

he

case

of

the

gen

e-ed

ited

cat

tle

that

tu

rned

ou

t to

un

exp

ecte

dly

co

nta

in

anti

bio

tic

resi

stan

ce g

enes

(se

e ab

ov

e) s

ho

ws

that

GM

O d

evel

op

ers

can

no

t b

e re

lied

up

on

to

iden

tify

gen

etic

err

ors

an

d u

nw

ante

d t

rait

s13

and

th

at s

tric

t

regu

lati

on

mu

st

be

in p

lace

to

enfo

rce

tho

rou

gh

scre

enin

g.28

Exp

erie

nce

wit

h

firs

t-ge

ner

atio

n

GM

cro

ps

sho

ws

that

bac

kcr

oss

ing

as c

on

du

cted

by

GM

O d

evel

op

ers

do

es n

ot

reli

ably

rem

ov

e

un

wan

ted

tra

its

and

th

at c

rop

s w

ith

su

ch t

rait

s

hav

e re

ach

ed t

he

mar

ket

.

OR

GA

NIS

MS

WIT

H U

NW

AN

TE

D M

UT

AT

ION

S

MA

Y N

OT

BE

RE

MO

VE

D F

RO

M B

RE

ED

ING

PR

OG

RA

MM

ES

Th

e su

pp

ose

dly

slo

w s

pee

d o

f co

nv

enti

on

al b

reed

ing

pro

gram

mes

rel

ativ

e to

gen

e ed

itin

g w

as c

ited

by

bo

th s

ets

of

auth

ors

.22,2

4

Ho

wev

er, t

his

do

es n

ot

seem

to

be

tru

e fo

r E

uro

pe.

27

Acc

ord

ing

to a

bre

eder

of

po

lled

Ho

lste

ins

in

Pen

nsy

lvan

ia, U

SA

, Eu

rop

ean

s “a

ggre

ssiv

ely

sele

cted

for

the

trai

t, a

nd

no

w t

hey

are

yea

rs a

hea

d o

f u

s as

far

as p

oll

ed g

enet

ics.

An

imal

wel

fare

legi

slat

ion

in

Eu

rop

e b

ased

on

co

nsu

mer

pre

ssu

re w

ill d

riv

e ev

en

furt

her

use

of

po

lled

.”27

Hen

dri

k A

lbad

a, c

o-o

wn

er o

f th

e H

ul-

Ste

in H

ols

tein

her

d i

n t

he

Net

her

lan

ds,

sai

d p

oll

ed s

ires

are

po

pu

lar

in E

uro

pe

bas

ed o

n g

enet

ic m

erit

alo

ne

–al

mo

st 1

0% o

f th

e co

ws

in G

erm

any

in 2

015

wer

e

bre

d t

o a

po

lled

bu

ll.27

It s

eem

s th

at c

on

ven

tio

nal

bre

edin

g h

as a

lrea

dy

ach

iev

ed w

hat

GM

O a

dv

oca

tes

clai

med

co

uld

on

ly b

e

do

ne

qu

ick

ly t

hro

ugh

gen

e-ed

itin

g te

chn

olo

gy. T

he

cost

an

d t

ime

inv

olv

ed a

re n

ot

pro

hib

itiv

e; p

oll

ed

catt

le a

re p

rod

uce

d w

ith

hig

h g

enet

ic m

erit

; an

d

goo

d p

rogr

ess

has

bee

n m

ade

in a

vai

lab

ilit

y o

f p

oll

ed

sire

s.

Th

is e

xam

ple

sh

ow

s th

at s

oci

ety

nee

ds

to c

riti

call

y

eval

uat

e cl

aim

s th

at g

ene

edit

ing

is t

he

on

ly o

r b

est

solu

tio

n t

o a

giv

en p

rob

lem

.

Th

e fa

ilu

re o

f th

e ge

ne-

edit

ed h

orn

less

cat

tle

ven

ture

rais

es a

n o

bv

iou

s q

ues

tio

n: W

hy

did

n’t

the

dev

elo

per

s

sim

ply

cro

ss t

he

gen

e in

to t

he

elit

e H

ols

tein

bre

ed

thro

ugh

bre

edin

g, in

stea

d o

f ge

ne

edit

ing

the

Ho

lste

in?

Th

e te

am o

f ac

adem

ic s

cien

tist

s ci

ted

ab

ov

e, s

om

e o

f

wh

om

wer

e as

soci

ated

wit

h R

eco

mb

inet

ics,

wro

te

that

in

pri

nci

ple

, co

nv

enti

on

al b

reed

ing

cou

ld a

chie

ve

this

en

d, b

ut

in p

ract

ice

the

cost

wo

uld

be

pro

hib

itiv

e:

“No

bre

eder

can

aff

ord

to

un

der

tak

e th

is a

pp

roac

h.”

24

In a

sep

arat

e p

aper

, Rec

om

bin

etic

s sc

ien

tist

s ci

ted

a

sho

rtag

e o

f b

reed

ing

sire

s p

rod

uci

ng

com

mer

cial

ly

avai

lab

le P

OL

LE

D s

emen

an

d t

he

po

or

“gen

etic

mer

it”

of

po

lled

Ho

lste

in s

ires

– t

hey

sai

d b

reed

ing

for

the

PO

LL

ED

tra

it b

rin

gs a

lon

g o

ther

un

des

irab

le t

rait

s

such

as

po

or

mil

k y

ield

.22

WH

Y G

EN

E E

DIT

ING

RA

TH

ER

TH

AN

BR

EE

DIN

G?

PO

LL

ED

seq

uen

ce, w

hic

h a

cted

as

the

rep

air

tem

pla

te D

NA

in

th

e S

DN

-3 p

roce

du

re,

had

bee

n u

nin

ten

tio

nal

ly i

nte

grat

ed. T

hes

e

un

inte

nti

on

ally

in

tegr

ated

pla

smid

s co

nta

ined

com

ple

te g

ene

seq

uen

ces

that

co

nfe

r re

sist

ance

to t

hre

e an

tib

ioti

cs (

neo

myc

in, k

anam

ycin

, an

d

amp

icil

lin

).13

It i

s n

ot

kn

ow

n i

f

the

pre

sen

ce o

f th

ese

anti

bio

tic

resi

stan

ce

gen

es c

ou

ld a

ffec

t

the

hea

lth

of

the

anim

al o

r o

f p

eop

le

wh

o c

on

sum

e it

s

pro

du

cts.

Ho

wev

er,

on

e ri

sk t

hat

mer

its

inv

esti

gati

on

is

that

thes

e ge

nes

co

uld

tran

sfer

to

dis

ease

-cau

sin

g b

acte

ria,

wh

ich

wo

uld

th

en b

eco

me

resi

stan

t to

an

tib

ioti

cs,

thre

aten

ing

hu

man

an

d a

nim

al h

ealt

h.25

Th

e R

eco

mb

inet

ics

scie

nti

sts

had

mis

sed

th

ese

un

inte

nd

ed e

ffec

ts b

ecau

se t

hey

use

d i

nad

equ

ate

anal

ytic

al m

eth

od

s.22

Tad

So

nte

sgar

d, C

EO

of

Acc

elig

en, a

su

bsi

dia

ry o

f R

eco

mb

inet

ics

that

ow

ned

th

e an

imal

s, s

aid

, “It

was

no

t so

met

hin

g

exp

ecte

d, a

nd

we

did

n’t

loo

k f

or

it”.

He

adm

itte

d

that

a m

ore

co

mp

lete

ch

eck

“sh

ou

ld h

ave

bee

n

do

ne”

.23

As

a re

sult

of

the

FD

A s

cien

tist

s’ d

isco

ver

y,

Bra

zil c

ance

lled

its

pla

ns

to c

reat

e a

her

d o

f th

e

gen

e-ed

ited

ho

rnle

ss

catt

le.26

Dev

elo

per

s ca

nn

ot

be

tru

sted

to

sel

f-re

gula

te

and

det

erm

ine

for

them

selv

es w

het

her

the

chan

ges

ind

uce

d

by

gen

e ed

itin

g ar

e

safe

or

the

sam

e

as c

ou

ld h

app

en

in n

atu

re. S

tric

t

regu

lati

on

mu

st

be

in p

lace

to

en

sure

th

oro

ugh

scr

een

ing

for

un

inte

nd

ed e

ffec

ts. A

s co

mm

on

ly u

sed

scre

enin

g m

eth

od

s w

ill m

iss

man

y m

uta

tio

ns,

a co

mb

inat

ion

of

lon

g-ra

nge

PC

R a

nd

lon

g-

read

DN

A s

equ

enci

ng

mu

st b

e u

sed

, as

no

ted

in c

hap

ter

2. I

n a

dd

itio

n, s

afet

y st

ud

ies

mu

st

be

con

du

cted

to

bet

ter

un

der

stan

d t

he

risk

s to

pu

bli

c h

ealt

h a

nd

th

e en

vir

on

men

t p

ose

d b

y th

e

gen

e-ed

ited

org

anis

m.

Ex

per

ien

ce w

ith

fir

st-

gen

erat

ion

GM

cro

ps

sho

ws

that

bac

kcr

oss

ing

as c

on

du

cted

by

GM

O

dev

elo

per

s d

oes

no

t re

liab

ly

rem

ov

e u

nw

an te

d t

rait

s

Dev

elo

per

s ca

nn

ot

be

tru

sted

to

sel

f-re

gu

late

and

det

erm

ine

for

them

selv

es w

het

her

the

chan

ges

ind

uce

d b

y

gen

e ed

itin

g a

re s

afe

183

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

33

32

CO

MP

AR

ING

GE

NE

ED

ITIN

G W

ITH

MU

TA

TIO

N B

RE

ED

ING

IS

MIS

LE

AD

ING

Ad

voca

tes

of

gen

e ed

itin

g cl

aim

th

at i

t is

mo

re p

reci

se a

nd

th

us

safe

r th

an m

uta

tio

n

bre

edin

g.34

Bu

t th

is c

laim

is

mis

lead

ing

bec

ause

it i

s th

e w

ron

g co

mp

aris

on

. Alt

ho

ugh

mu

tati

on

bre

edin

g is

use

d a

lon

gsid

e co

nve

nti

on

al

bre

edin

g, i

t is

a

min

ori

ty m

eth

od

that

can

no

t

be

equ

ated

to

con

ven

tio

nal

bre

edin

g. T

he

stan

dar

d m

eth

od

of

con

ven

tio

nal

bre

edin

g is

cro

ss-b

reed

ing

and

sel

ecti

on

of

des

ired

tra

its.

Th

e

pro

cess

can

be

mad

e qu

icke

r an

d m

ore

eff

icie

nt

by

usi

ng

the

bio

tech

no

logi

es k

no

wn

as

mar

ker

assi

sted

sel

ecti

on

an

d g

eno

mic

sel

ecti

on

35,3

6 (u

se

of

thes

e te

chn

olo

gies

do

es n

ot

in i

tsel

f re

sult

in a

GM

O).

Sta

nd

ard

co

nve

nti

on

al b

reed

ing

has

an

un

den

iab

le h

isto

ry o

f sa

fe u

se a

nd

is

the

tech

niq

ue

that

sh

ou

ld b

e u

sed

as

the

com

par

ato

r

to g

ene-

edit

ed c

rop

s.

As

we

hav

e se

en i

n c

hap

ter

3, g

ene

edit

ing

is

dif

fere

nt

fro

m m

uta

tio

n b

reed

ing

and

wo

uld

lead

to

dif

fere

nt

risk

s. J

ust

ho

w r

isky

mu

tati

on

bre

edin

g is

fo

r h

ealt

h a

nd

en

viro

nm

ent

rem

ain

s

un

kno

wn

bec

ause

co

ntr

oll

ed s

tud

ies

hav

e n

ot

bee

n d

on

e, t

ho

ugh

th

ere

is s

ugg

esti

ve e

vid

ence

that

it

may

be

less

ris

ky t

han

gen

e ed

itin

g.8

Nev

erth

eles

s,

for

the

pla

nt

itse

lf, m

uta

tio

n

bre

edin

g is

wid

ely

reco

gniz

ed

as r

isky

,

un

pre

dic

tab

le,

and

in

effi

cien

t

at p

rod

uci

ng

ben

efic

ial

mu

tati

on

s.

Pla

nt

cell

s ca

n b

e ki

lled

by

exp

osu

re t

o t

he

chem

ical

or

rad

iati

on

, wh

ile

man

y o

f th

e

resu

ltin

g p

lan

ts a

re d

efo

rmed

, no

n-v

iab

le, a

nd

/

or

infe

rtil

e.37

,38,

39

Mu

tati

on

bre

edin

g is

rec

ogn

ised

un

der

EU

law

as g

enet

ic m

od

ific

atio

n. I

t is

exe

mp

ted

fro

m t

he

requ

irem

ents

of

the

regu

lati

on

s b

ecau

se (

des

pit

e

the

abse

nce

of

rese

arch

on

ris

k) i

t is

dee

med

to

hav

e a

his

tory

of

safe

use

.40 B

ut

this

cle

arly

do

es

no

t ap

ply

to

gen

e ed

itin

g, w

hic

h h

as n

o h

isto

ry

of

use

, let

alo

ne

safe

use

.8

It i

s a

com

mo

n m

isco

nce

pti

on

th

at g

ene-

edit

ed

org

anis

ms

are

safe

r th

an o

lder

-sty

le G

MO

s.

Bu

t th

ere

is n

o

scie

nti

fic

bas

is

to t

his

no

tio

n,

as c

on

firm

ed b

y

Bay

er s

cien

tist

Dr

Lar

ry G

ilb

erts

on

,

wh

o s

aid

th

at

the

risk

s o

f n

ew

tech

niq

ues

like

gen

e ed

itin

g an

d

old

er t

ech

niq

ues

of

gen

etic

mo

dif

icat

ion

are

the

sam

e: “

I d

on

’t

thin

k th

ere’

s a

fun

dam

enta

l

dif

fere

nce

in

th

e ri

sk b

etw

een

th

ese

two

tech

no

logi

es s

ince

th

ey’r

e b

oth

fu

nd

amen

tall

y

just

ch

ange

s in

DN

A.”

32

In 2

018

this

sci

enti

fic

real

ity

was

ref

lect

ed

in t

he

Eu

rop

ean

Co

urt

of

Just

ice

ruli

ng

that

gen

e-ed

ited

org

anis

ms

(cal

led

in

th

e ca

se “

new

tech

niq

ues

/

met

ho

ds

of

mu

tage

nes

is”)

mu

st b

e re

gula

ted

in t

he

sam

e w

ay

as o

lder

-sty

le

GM

Os.

Th

e co

urt

exp

lain

ed:

“Th

e ri

sks

lin

ked

to t

he

use

of

tho

se

new

tec

hn

iqu

es/

met

ho

ds

of

mu

tage

nes

is

mig

ht

pro

ve

to b

e si

mil

ar t

o t

ho

se w

hic

h r

esu

lt f

rom

th

e

pro

du

ctio

n a

nd

rel

ease

of

a G

MO

th

rou

gh

tran

sgen

esis

,

sin

ce t

he

dir

ect

mo

dif

icat

ion

of

the

gen

etic

mat

eria

l of

an o

rgan

ism

th

rou

gh m

uta

gen

esis

GE

NE

-E

DIT

ED

OR

GA

NIS

MS

NO

T S

AF

ER

TH

AN

OL

DE

R-

ST

YL

E G

MO

S

Fo

r ex

amp

le, i

n t

he

case

of

glyp

ho

sate

-to

lera

nt

NK

603

mai

ze, a

n in

crea

se in

cer

tain

co

mp

ou

nds

was

fo

un

d in

th

e G

M c

rop

co

mp

ared

wit

h t

he

non

-GM

par

ent,

wh

ich

co

uld

pro

ve e

ith

er

pro

tect

ive

or

toxi

c, d

epen

din

g o

n c

on

text

. In

add

itio

n, m

etab

oli

c im

bal

ance

s w

ere

fou

nd

in

the

GM

mai

ze, w

hic

h c

ou

ld a

ffec

t n

utr

itio

nal

qual

ity.

29 T

hes

e u

nw

ante

d c

han

ges

may

exp

lain

ad

vers

e h

ealt

h i

mp

acts

ob

serv

ed f

rom

con

sum

pti

on

of

the

mai

ze.30

In

th

e ca

se o

f G

M

MO

N81

0 B

t in

sect

icid

al m

aize

, it

con

tain

ed

an a

ller

gen

, zei

n, t

hat

was

no

t p

rese

nt

in t

he

par

ent

cro

p.31

It

is p

oss

ible

th

at t

he

dev

elo

per

did

no

t n

oti

ce t

hes

e ch

ange

s, o

r if

th

ey d

id,

dee

med

th

em u

nim

po

rtan

t.

Wit

h G

M v

eget

ativ

ely

pro

pag

ated

cro

ps,

such

as

po

tato

es, b

anan

as, a

nd

fru

it t

rees

,

the

pre

sen

ce o

f la

rge

nu

mb

ers

of

un

wan

ted

mu

tati

on

s is

in

evit

able

. Th

is i

s b

ecau

se

pro

pag

atio

n t

akes

pla

ce n

ot

by

seed

s p

rod

uce

d

by

sexu

al r

epro

du

ctio

n (

po

llin

atio

n),

bu

t b

y

vari

ou

s as

exu

al m

eth

od

s, i

ncl

ud

ing

gro

win

g

fro

m t

ub

ers

(e.g

. po

tato

es),

cu

ttin

gs (

e.g.

ban

anas

), a

nd

gra

ftin

g (e

.g. f

ruit

tre

es s

uch

as

app

les)

– g

ener

atin

g a

new

pla

nt

fro

m a

par

t

of

the

par

ent

pla

nt.

Th

is m

ean

s th

at m

uta

tio

ns

cau

sed

by

gen

etic

en

gin

eeri

ng

pro

cess

es

(in

clu

din

g ge

ne

edit

ing)

can

no

t b

e b

red

ou

t

by

bac

kcro

ssin

g an

d w

ill p

ersi

st i

nto

th

e fi

nal

mar

kete

d p

rod

uct

.

“Th

e ri

sks

lin

ked

to

th

e u

se

of t

ho

se n

ew t

ech

niq

ues

/m

eth

od

s of

mu

tage

nes

is

mig

ht

pro

ve

to b

e si

mil

ar

to t

ho

se w

hic

h r

esu

lt

from

th

e p

rod

uct

ion

an

d

rele

ase

of a

GM

O t

hro

ugh

tr

ansg

enes

is’’

-E

uro

pea

n C

ourt

of

Just

ice

Just

how

ris

ky

mu

tati

on

bre

edin

g is

for

hea

lth

an

d

env

iron

men

t re

mai

ns

un

kn

own

bec

ause

co

ntr

olle

d s

tud

ies

hav

e n

ot

bee

n d

one

mak

es i

t p

oss

ible

to

ob

tain

th

e sa

me

effe

cts

as t

he

intr

od

uct

ion

of

a fo

reig

n g

ene

into

the

org

anis

m (

tran

sgen

esis

) an

d t

ho

se n

ew

tech

niq

ues

mak

e it

po

ssib

le t

o p

rod

uce

gen

etic

ally

mo

dif

ied

var

ieti

es a

t a

rate

ou

t

of

all p

rop

ort

ion

to

th

ose

res

ult

ing

fro

m

the

app

lica

tio

n o

f co

nve

nti

on

al m

eth

od

s o

f

mu

tage

nes

is.”

33

Gen

e-ed

itin

g te

chn

iqu

es p

ose

new

an

d d

iffe

ren

t

risk

s co

mp

ared

wit

h o

lder

-sty

le t

ran

sgen

ic G

M

tech

niq

ues

. So

me

scie

nti

sts

ther

efo

re a

rgu

e th

at

the

EU

’s r

isk

asse

ssm

ent

guid

elin

es s

ho

uld

be

exp

and

ed t

o t

ake

thes

e ri

sks

into

acc

ou

nt.

8,15

,16

Inte

rest

ingl

y, n

eith

er t

he

Bay

er s

cien

tist

, no

r

the

Eu

rop

ean

Co

urt

of

Just

ice,

no

r th

e sc

ien

tist

s

wh

o w

arn

of

the

spec

ial r

isks

of

gen

e ed

itin

g

sup

po

rt t

he

no

tio

n t

hat

gen

e-ed

ited

org

anis

ms

are

safe

r th

an o

lder

-sty

le t

ran

sgen

ic G

MO

s.

Th

ese

clai

ms

are

bas

ed o

n m

arke

tin

g co

nce

rns,

no

t sc

ien

ce.

184

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

35

34

17. R

obi

nso

n C

, An

ton

iou

M. S

cien

ce s

up

po

rts

nee

d t

o

sub

ject

gen

e-ed

ited

pla

nts

to

str

ict

safe

ty a

sses

smen

ts.

GM

Wat

ch.o

rg. P

ub

lish

ed N

ov

emb

er 2

0, 2

019.

htt

ps:

//w

ww

.gm

wat

ch.o

rg/e

n/n

ews/

late

st-n

ews/

1922

3

18. B

isw

as S

, Tia

n J

, Li

R, e

t al

. In

ves

tiga

tio

n o

f C

RIS

PR

/Cas

9-in

duce

d S

D1

rice

mu

tan

ts h

igh

lig

hts

th

e im

po

rtan

ce o

f m

ole

cula

r ch

arac

teri

zati

on

in

p

lan

t m

ole

cula

r br

eed

ing.

Jo

urn

al o

f G

enet

ics

and

G

eno

mic

s. P

ub

lish

ed o

nli

ne

May

21,

202

0. d

oi:1

0.1

016/

j.jg

g.2

020

.04.

00

4

19. W

ang

H, L

a R

uss

a M

, Qi

LS

. CR

ISP

R/C

as9

in g

eno

me

edit

ing

and

bey

on

d. A

nn

ual

Rev

iew

o

f B

ioch

emis

try.

201

6;85

(1):

227-

264.

do

i:10

.114

6/an

nu

rev-

bio

chem

-06

081

5-0

146

07

20

. Zet

sch

e B

, Hei

den

reic

h M

, Mo

han

raju

P, e

t al

. M

ult

iple

x ge

ne

edit

ing

by C

RIS

PR

–C

pf1

usi

ng

a si

ng

le

crR

NA

arr

ay. N

atu

re B

iote

chn

olo

gy.

201

7;35

(1):

31-3

4.

do

i:10

.103

8/n

bt.

3737

21. R

aits

kin

O, P

atro

n N

J. M

ult

i-ge

ne

engi

nee

rin

g in

pla

nts

wit

h R

NA

-gu

ided

Cas

9 n

ucl

ease

. Cu

rr

Op

in B

iote

chn

ol.

201

6;37

:69-

75. d

oi:1

0.1

016/

j.co

pbi

o.2

015.

11.0

08

22. C

arls

on

DF,

Lan

cto

CA

, Zan

g B

, et

al. P

rodu

ctio

n

of

ho

rnle

ss d

airy

cat

tle

fro

m g

eno

me-

edit

ed c

ell l

ines

. N

atu

re B

iote

chn

olo

gy.

201

6;3

4:47

9-4

81. d

oi:1

0.1

038/

nb

t.35

60

23. R

egal

ado

A. G

ene-

edit

ed c

attl

e h

ave

a m

ajo

r sc

rew

up

in

th

eir

DN

A. M

IT T

ech

no

log

y R

evie

w. P

ub

lish

ed o

nli

ne

Au

gust

29,

201

9. A

cces

sed

Mar

ch 2

0, 2

020

. htt

ps:

//w

ww

.te

chn

olo

gyr

evie

w.c

om

/s/6

1423

5/re

com

bin

etic

s-ge

ne-

edit

ed-h

orn

less

-cat

tle-

maj

or-

dn

a-sc

rew

up

/

24.

Car

roll

D, V

an E

enen

naa

m A

L, T

aylo

r JF

, Seg

er

J, V

oy

tas

DF

. Reg

ula

te g

eno

me-

edit

ed p

rodu

cts,

no

t ge

no

me

edit

ing

itse

lf. N

at B

iote

chn

ol.

201

6;3

4(5)

:477

-479

. d

oi:1

0.1

038/

nb

t.35

66

25. N

awaz

MA

, Mes

nag

e R

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. F

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eni

M. B

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edit

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s go

t sc

rap

ped

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ere’

s w

hy.

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ub

lish

ed o

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, 201

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ne

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her

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27. O

’Kee

fe K

. Po

lled

Ho

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ins:

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t, p

rese

nt

and

fu

ture

. Pro

gres

siv

e D

airy

. Pu

bli

shed

on

lin

e O

cto

ber

18

, 201

6. A

cces

sed

Jan

uar

y 10

, 202

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ttp

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28. S

olo

mo

n S

M. G

eno

me

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ing

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nim

als:

wh

y F

DA

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gula

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gap

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-Ten

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SZ

, Vil

per

te V

, et

al. A

n

inte

grat

ed m

ult

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mic

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e N

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. Sér

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. Rep

ub

lish

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icit

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f a

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bici

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a R

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net

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ly m

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d m

aize

. E

nv

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ence

s E

uro

pe.

201

4;26

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. do

i:10

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31. Z

oll

a L

, Rin

aldu

cci

S, A

nto

nio

li P

, Rig

het

ti P

G.

Pro

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mic

s as

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ple

men

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ed s

ide

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cts

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urr

ing

in t

ran

sgen

ic m

aize

se

eds

as a

res

ult

of

gen

etic

mo

dif

icat

ion

s. J

Pro

teo

me

Res

. 2

00

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185

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do

i:10

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32. F

ort

un

a G

, Fo

ote

N. B

ayer

sci

enti

st: “

Reg

ula

tio

n a

nd

ri

sk a

sses

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t m

ust

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h t

ech

no

log

y.”

Eu

rAct

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com

. Pu

bli

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nu

ary

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ps:

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ww

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ract

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om

/sec

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-ass

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mu

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gy/

33. E

uro

pea

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stic

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/16

- C

on

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uri

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34.

Ask

ew K

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ISP

R g

eno

me

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ing

to a

dd

ress

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od

se

curi

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e ch

ange

: “N

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or

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od

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esse

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anu

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ob

b J

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as P

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D. B

ack

to t

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eor

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, Bro

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et

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om

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assi

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r F

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of

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reed

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d

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pp

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Cam

brid

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M S

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n

Op

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ase

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1. B

ayer

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e ar

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. Pu

bli

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ps:

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cult

ure

-an

d-n

utr

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roch

ure

.p

df

2. C

ort

eva

Agr

isci

ence

. Fre

qu

entl

y A

sked

Qu

esti

on

s.

cris

pr.

cort

eva.

com

. Pu

bli

shed

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nu

ary

11, 2

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htt

ps:

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3. E

uro

paB

io. A

chie

vin

g th

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ote

nti

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f ge

no

me

edit

ing.

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e 2

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om

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4. C

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. CR

ISP

R Q

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or

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ay 2

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5. T

ula

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ar R

, Yeu

Y, P

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al. C

RIS

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mu

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req

uen

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at C

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019;

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ou

H, S

mit

h J

L, P

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eno

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om

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2

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7. S

mit

s A

H, Z

ieb

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, Jo

ber

ty G

, et

al. B

iolo

gica

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last

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scu

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arge

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in C

RIS

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kn

ock

o

uts

. Nat

Met

ho

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201

9;16

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i:10

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8. K

awal

l K, C

ott

er J

, Th

en C

. Bro

aden

ing

the

GM

O r

isk

asse

ssm

ent

in t

he

EU

fo

r ge

no

me

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vir

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men

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Eu

rop

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9. A

gap

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SZ

, Oko

li A

S, B

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stei

n M

J, W

ikm

ark

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, Myh

r A

I. R

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g ri

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nee

d t

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nd

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rop

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MW

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. Pu

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, Ais

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13. N

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L, L

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Tad

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, M

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F, L

om

bar

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HA

. Tem

pla

te p

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nte

grat

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ne

gen

om

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ited

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tle.

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202

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dep

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ttp

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15. E

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ikla

u M

, Gau

gits

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lan

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reed

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Tec

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oci

ated

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f

16. E

cker

sto

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MF,

Do

leze

l M, H

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erge

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, et

al. A

n E

U p

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on

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no

me

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etic

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Bio

tech

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389/

fbio

e.2

019.

00

031

RE

FE

RE

NC

ES

Gen

e ed

itin

g te

chn

olo

gy p

rod

uce

s u

nin

ten

ded

ou

tco

mes

, wh

ich

can

po

se r

isks

to

hu

man

and

an

imal

hea

lth

an

d t

he

envi

ron

men

t. E

ven

if d

evel

op

ers

are

op

tim

isti

c th

at u

nw

ante

d

ou

tco

mes

can

be

elim

inat

ed, t

hey

do

no

t:

• p

rop

erly

scr

een

fo

r th

em –

arg

uab

ly b

ecau

se

that

wo

uld

def

eat

the

pu

rpo

se o

f u

sin

g ge

ne

edit

ing

to g

ain

tim

e

• re

liab

ly r

emo

ve t

hem

• al

way

s h

ave

the

abil

ity

to r

emo

ve t

hem

(w

ith

vege

tati

vely

pro

pag

ated

cro

ps)

.

Fo

r th

ese

reas

on

s, s

trin

gen

t re

gula

tory

ove

rsig

ht

is c

ruci

al, a

s F

DA

sci

enti

st S

teve

n M

.

Solo

mo

n r

eco

mm

end

ed f

or

gen

e-ed

ited

an

imal

s

in t

he

US,

28 a

nd

as

the

Eu

rop

ean

Co

urt

of

Just

ice

has

ru

led

wit

h r

egar

d t

o a

ll g

ene-

edit

ed

org

anis

ms

in t

he

EU

.33

RE

GU

LA

TO

RY

OV

ER

SIG

HT

CR

UC

IAL

185

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

37

36

In f

act,

pat

ents

gen

eral

ly e

nco

mp

ass

spec

ific

gen

om

ic s

equ

ence

s in

dep

end

entl

y o

f h

ow

th

ey

are

der

ived

. Fo

r ex

amp

le, c

rop

s d

evel

op

ed

thro

ugh

mu

tati

on

bre

edin

g ca

n b

e id

enti

fied

on

th

e b

asis

of

the

spec

ific

seq

uen

ces

that

char

acte

rise

th

em a

nd

that

are

des

crib

ed i

n t

he

pat

ent.

Wh

en t

hes

e sp

ecif

ic

seq

uen

ces

are

kn

ow

n,

no

t o

nly

th

e d

evel

op

er

bu

t al

so o

ther

s ca

n

dev

elo

p s

pec

ific

det

ecti

on

met

ho

ds

for

thes

e cr

op

s. T

his

has

bee

n d

on

e fo

r C

ibu

s’

SU

Can

ola

. Cib

us

has

dev

elo

ped

its

ow

n d

etec

tio

n m

eth

od

to

id

enti

fy

its

pro

du

ct, a

nd

su

bm

itte

d i

t to

Can

adia

n

auth

ori

ties

,3 bu

t th

e au

tho

riti

es r

efu

sed

to

mak

e

it a

vai

lab

le t

o C

anad

ian

NG

Os

on

gro

un

ds

that

it

was

co

nfi

den

tial

bu

sin

ess

info

rmat

ion

.

Ho

wev

er, a

tea

m o

f sc

ien

tist

s h

as d

evel

op

ed

an o

pen

-so

urc

e d

etec

tio

n m

eth

od

fo

r th

is G

M

cro

p b

ased

on

pu

bli

cly

avai

lab

le i

nfo

rmat

ion

.4

SU

Can

ola

rep

rese

nte

d a

par

ticu

larl

y

chal

len

gin

g ca

se, s

ince

th

e al

tera

tio

n i

n

its

gen

etic

blu

epri

nt

con

sist

s o

f o

nly

a “s

ingl

e b

ase

pai

r” (

DN

A b

ase

un

it)

chan

ge w

ith

in a

sp

ecif

ic g

ene.

Th

e

rese

arch

ers

con

firm

ed t

hat

a s

ingl

e b

ase

pai

r

chan

ge c

an b

e d

etec

ted

wit

h s

tan

dar

d G

MO

det

ecti

on

tec

hn

olo

gy b

ased

on

po

lym

eras

e ch

ain

reac

tio

n (

PC

R)

met

ho

do

logy

. Th

us

it i

s li

kel

y

that

det

ecti

on

met

ho

ds

can

be

dev

elo

ped

fo

r

mo

st, i

f n

ot

all,

gen

e-

edit

ed o

rgan

ism

s,

acco

rdin

g to

th

e

rese

arch

ers,

pro

vid

ed

eno

ugh

in

form

atio

n o

n

the

nat

ure

of

the

edit

is

avai

lab

le.4

Th

ey s

tate

d: “

Ou

r w

ork

dem

on

stra

tes

that

it

may

be

po

ssib

le t

o d

evel

op

even

t-sp

ecif

ic, G

MO

regu

lati

on

co

mp

lian

t

det

ecti

on

met

ho

ds

for

vir

tual

ly a

ny

gen

e-ed

ited

org

anis

m b

ased

on

in

form

atio

n d

iscl

ose

d b

y

the

dev

elo

per

or

gath

ered

fro

m t

he

pu

bli

c

do

mai

n.”

4

Ind

ust

ry a

sso

ciat

ion

s h

ave

clai

med

th

at m

any

gen

e-ed

ited

pro

du

cts

can

no

t b

e d

isti

ngu

ish

ed

fro

m p

rod

uct

s d

evel

op

ed w

ith

co

nv

enti

on

al

bre

edin

g.1 A

nd

acc

ord

ing

to B

ayer

, a c

han

ge

mad

e th

rou

gh g

ene

edit

ing

is “

ind

isti

ngu

ish

able

fro

m a

co

nv

enti

on

al b

reed

ing

bre

akth

rou

gh o

r

a n

atu

ral m

uta

tio

n”.

2

Th

e o

bje

ctiv

e o

f th

ese

clai

ms

seem

s to

be

to p

ersu

ade

the

EU

auth

ori

ties

no

t to

ev

en

try

to a

pp

ly t

he

EU

’s

GM

O r

egu

lati

on

s to

gen

e ed

itin

g.

Ho

wev

er, a

lrea

dy-

avai

lab

le, s

tan

dar

d G

MO

det

ecti

on

tec

hn

iqu

es a

llo

w u

nam

big

uo

us

det

ecti

on

and

iden

tifi

cati

on

of

a w

ide

ran

ge o

f

gen

etic

mo

dif

icat

ion

s,

fro

m t

he

smal

lest

– e

.g.

a p

oin

t

mu

tati

on

of

a si

ngl

e n

ucl

eoti

de

(DN

A b

ase

un

it)

– t

o t

he

larg

est,

e.g

. in

sert

ion

of

larg

e ge

net

ic s

equ

ence

s,

pro

vid

ed i

nfo

rmat

ion

on

th

e ge

net

ic c

han

ge

is a

vai

lab

le. A

lso

, an

y

pat

ente

d s

eed

pro

du

ct c

an b

e d

isti

ngu

ish

ed

fro

m o

ther

pro

du

cts.

Oth

erw

ise

it w

ou

ld b

e

imp

oss

ible

to

en

forc

e p

aten

t ri

ghts

.

MY

TH

Gen

e-ed

ited

pro

du

cts

can

no

t b

e d

isti

ng

uis

hed

fro

m p

rod

uct

s d

evel

op

ed

thro

ug

h c

on

ven

tio

nal

bre

edin

g.

5. G

en

e-e

dit

ed

pro

du

cts

a

re d

ete

cta

ble

RE

AL

ITY

Met

ho

ds

can

be

dev

elo

ped

to

det

ect

all

pro

du

cts

of

gen

e ed

itin

g,

pro

vid

ed i

nfo

rmat

ion

on

th

e ge

net

ic c

han

ge

is a

vai

lab

le.

Wh

en t

he

spec

ific

seq

uen

ces

that

char

acte

rise

a c

rop

are

kn

ow

n, n

ot

on

ly t

he

dev

elo

per

bu

t al

so o

ther

s ca

n

dev

elo

p s

pec

ific

det

ecti

on

met

ho

ds

An

y p

aten

ted

see

d

pro

du

ct c

an b

e

dis

tin

gu

ish

ed f

rom

oth

er p

rod

uct

s

186

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

39

38

In t

he

mea

nti

me,

tra

nsp

aren

cy m

ust

be

dem

and

ed f

rom

dev

elo

per

s o

f ge

ne-

edit

ed

org

anis

ms.

Un

der

th

e E

U’s

GM

O r

egu

lati

on

s,

agri

cult

ura

l bio

tech

co

mp

anie

s ar

e re

quir

ed

to p

rovi

de

a d

etec

tio

n

met

ho

d a

nd

“re

fere

nce

”

sam

ple

mat

eria

l fo

r ea

ch

GM

O t

hat

is

auth

ori

sed

,

tho

ugh

th

e se

cto

r h

as

no

t ye

t su

bm

itte

d a

ny

gen

e-ed

ited

GM

Os

to b

e

mar

kete

d i

n t

he

EU

.

Mea

nw

hil

e re

sear

cher

s

at N

ort

h C

aro

lin

a St

ate

Un

iver

sity

are

cal

lin

g

for

a co

alit

ion

of

bio

tech

in

du

stry

, go

vern

men

t

and

no

n-g

ove

rnm

ent

org

aniz

atio

ns,

tra

de

org

aniz

atio

ns,

an

d a

cad

emic

exp

erts

to

wo

rk

toge

ther

to

pro

vid

e b

asic

in

form

atio

n a

bo

ut

gen

e-ed

ited

cro

ps

to li

ft t

he

veil

on

ho

w p

lan

ts

are

mo

dif

ied

an

d p

rovi

de

grea

ter

tran

spar

ency

on

th

e p

rese

nce

an

d u

se o

f ge

ne

edit

ing

in f

oo

d

sup

pli

es. T

hey

bel

ieve

th

at s

uch

tra

nsp

aren

cy i

s

cru

cial

to

bu

ild

ing

pu

bli

c tr

ust

an

d c

on

fid

ence

in g

ene-

edit

ed p

rod

uct

s.9

Ho

wev

er, t

he

pri

mar

y re

spo

nsi

bil

ity

for

tran

spar

ency

ove

r ge

ne-

edit

ed p

rod

uct

s li

es

wit

h t

hei

r d

evel

op

ers.

It

can

no

t b

e th

e jo

b

of

gove

rnm

ents

, civ

il s

oci

ety,

or

acad

emia

to f

ill k

no

wle

dge

gap

s cr

eate

d b

y in

du

stry

secr

ecy.

On

ce i

nfo

rmat

ion

has

bee

n d

iscl

ose

d b

y th

e

dev

elo

per

, it

sho

uld

be

org

anis

ed i

n a

pu

bli

cly

acce

ssib

le r

eso

urc

e. W

e ca

n u

se w

hat

is

alre

ady

ther

e –

th

e B

iosa

fety

Cle

arin

g-H

ou

se o

f th

e

Car

tage

na

Pro

toco

l

on

Bio

safe

ty,10

th

e

EU

gin

ius

GM

O d

atab

ase

of

the

Fed

eral

Off

ice

of

Co

nsu

mer

Pro

tect

ion

and

Fo

od

Saf

ety

(BV

L)

in G

erm

any

and

Wag

enin

gen

Fo

od

Safe

ty R

esea

rch

in

Th

e

Net

her

lan

ds,

11 a

nd

th

e

regi

ster

set

up

by

the

Eu

rop

ean

Co

mm

issi

on

for

EU

-au

tho

rise

d a

nd

wit

hd

raw

n G

MO

s.12

Th

e E

U m

ust

en

sure

th

at c

ou

ntr

ies

wis

hin

g to

exp

ort

to

th

e b

loc

par

tici

pat

e in

th

ese

regi

ster

s.

Th

e E

uro

pea

n C

om

mis

sio

n’s

reg

iste

r o

f E

U-

auth

ori

sed

GM

Os

is r

equ

ired

by

EU

law

to

als

o

“co

nta

in, w

her

e av

aila

ble

, rel

evan

t in

form

atio

n

con

cern

ing

GM

O w

hic

h a

re n

ot

auth

ori

sed

in t

he

Eu

rop

ean

Un

ion

”.13

Th

e C

om

mis

sio

n

and

/or

mem

ber

sta

tes

sho

uld

wo

rk w

ith

inte

rnat

ion

al p

artn

ers

to m

eet

this

req

uir

emen

t.

Cri

tics

of

the

op

en-s

ou

rce

SU C

ano

la t

est

hav

e

focu

sed

on

th

e fa

ct t

hat

it

do

es n

ot

det

ect

the

GM

met

ho

d u

sed

. So

me

– li

ke t

he

Eu

rop

ean

Pla

nt

Scie

nce

Org

anis

atio

n (

EP

SO)

– a

lso

sai

d

that

it

do

es n

ot

solv

e th

e p

rob

lem

of

un

kno

wn

gen

etic

mo

dif

icat

ion

s.5

Ho

wev

er, E

U la

w d

oes

no

t re

quir

e th

at

det

ecti

on

tes

ts a

re a

ble

to

sp

ecif

y th

e G

M

met

ho

d u

sed

to

dev

elo

p

the

cro

p. A

sci

enti

fic

revi

ew b

y re

sear

cher

s

fro

m G

erm

any’

s F

eder

al

Off

ice

of

Co

nsu

mer

Pro

tect

ion

an

d F

oo

d S

afet

y

(BV

L)

and

Ju

liu

s K

üh

n

Inst

itu

te r

eco

gnis

ed t

hat

GM

O d

etec

tio

n m

eth

od

s

gen

eral

ly d

o n

ot

allo

w a

ny

con

clu

sio

ns

on

th

e p

roce

ss

use

d, w

het

her

th

ey b

e

gen

e-ed

itin

g te

chn

iqu

es

or

old

er-s

tyle

tra

nsg

enic

gen

etic

mo

dif

icat

ion

tech

niq

ues

. Ho

wev

er, t

he

rese

arch

ers

com

men

ted

th

at “

bio

info

rmat

ics

and

sta

tist

ical

con

sid

erat

ion

s m

igh

t h

elp

to

eva

luat

e w

het

her

a

det

ecte

d s

equ

ence

was

po

ten

tial

ly i

ntr

od

uce

d b

y

gen

om

e m

od

ific

atio

n”.

6

Th

e d

etec

tio

n o

f u

nkn

ow

n G

MO

s h

as n

ever

bee

n s

ole

ly r

elia

nt

on

th

e d

etec

tio

n m

eth

od

s

use

d i

n t

he

lab

ora

tory

. Th

e E

U’s

Jo

int

Res

earc

h

Cen

tre

said

in

201

7 th

at t

he

mo

st e

ffic

ien

t w

ay

to t

est

imp

ort

s fo

r u

nkn

ow

n G

MO

s w

as t

o

chec

k au

tho

risa

tio

ns

in o

ther

co

un

trie

s, p

aten

t

app

lica

tio

ns,

sci

enti

fic

pu

bli

cati

on

s, a

nd

oth

er

info

rmat

ion

to

ap

ply

a t

arge

ted

ap

pro

ach

. Th

e

lab

ora

tory

det

ecti

on

tes

t ca

n t

hen

be

use

d t

o

pro

vid

e co

nfi

rmat

ion

of

info

rmat

ion

gat

her

ed

thro

ugh

oth

er m

ean

s.7

In a

dd

itio

n, i

t is

un

like

ly t

hat

a la

rge

nu

mb

er

of

un

kno

wn

gen

e-ed

ited

cro

ps

wil

l be

in

circ

ula

tio

n. S

eed

co

mp

anie

s ta

lk a

bo

ut

gen

e

edit

ing

wh

en t

hey

use

it

bec

ause

th

ey w

ant

to

be

able

to

pro

fit

in t

he

mar

ketp

lace

fro

m t

he

use

of

thes

e n

ew G

M t

ech

niq

ues

.

So f

ar, o

nly

tw

o g

ene-

edit

ed c

rop

s h

ave

bee

n

com

mer

cial

ised

: C

ibu

s’s

SU C

ano

la a

nd

Cal

yxt’s

“h

igh

ole

ic”

aso

ybea

n w

ith

an

alt

ered

oil

pro

file

. Th

us

far

it h

as p

rove

d p

oss

ible

to

trac

k a

sign

ific

ant

nu

mb

er

of

gen

e-ed

ited

pro

du

cts

dev

elo

ped

wo

rld

wid

e fo

r

com

mer

cial

mar

kets

, as

the

Juli

us

Kü

hn

In

stit

ute

in G

erm

any

has

do

ne

for

a p

eer-

revi

ewed

pu

bli

cati

on

.8

Als

o, t

he

po

ten

tial

fo

r

un

kno

wn

GM

Os

to s

lip

thro

ugh

off

icia

l co

ntr

ols

is

no

t n

ew. T

he

sam

e is

tru

e

for

the

GM

cro

ps

that

hav

e b

een

su

cces

sfu

lly

regu

late

d i

n E

uro

pe

and

oth

er c

ou

ntr

ies

for

the

last

tw

o a

nd

a h

alf

dec

ades

.

To

day

’s s

trat

egie

s fo

r sc

reen

ing

for

un

kno

wn

GM

Os

do

no

t ca

ptu

re a

ll o

f th

em. T

hey

on

ly

iden

tify

th

ose

th

at c

arry

cer

tain

co

mm

on

gen

etic

seq

uen

ces

that

are

use

d a

s “s

cree

nin

g

targ

ets”

. Bu

t th

e n

um

ber

of

GM

cro

ps

lack

ing

com

mo

n s

equ

ence

s h

as b

een

in

crea

sin

g in

rece

nt

year

s. I

t is

po

ssib

le t

hat

cu

rren

tly

ther

e

are

un

auth

ori

sed

GM

Os

in t

he

mar

ketp

lace

that

hav

e n

ot

bee

n d

etec

ted

bec

ause

th

ey d

o n

ot

carr

y an

y co

mm

on

seq

uen

ces.

No

on

e cl

aim

s

that

fo

r th

is r

easo

n, t

he

EU

GM

O le

gisl

atio

n

is i

mp

oss

ible

to

en

forc

e an

d t

hu

s u

sele

ss.

By

anal

ogy

, no

on

e w

ou

ld s

ugg

est

lega

lisi

ng

bu

rgla

ry b

ecau

se c

rim

inal

law

s d

o n

ot

pre

ven

t

all b

urg

lari

es.

UN

KN

OW

N G

EN

E-

ED

ITE

D C

RO

PS

Un

kno

wn

gen

e-ed

ited

cro

ps

are

just

an

oth

er

cate

gory

of

GM

pro

du

cts

that

GM

O s

cree

nin

g

met

ho

ds

can

mis

s an

d t

hat

mu

st b

e d

etec

ted

by

even

t-sp

ecif

ic m

eth

od

s su

ch a

s th

e o

ne

dev

elo

ped

fo

r SU

Can

ola

. Th

e p

rese

nce

of

gen

e-

edit

ed p

rod

uct

s in

th

e co

mm

erci

al f

oo

d s

yste

m

do

es n

ot

crea

te a

new

set

of

circ

um

stan

ces

that

dem

and

s fu

nd

amen

tal c

han

ges

in t

he

regu

lato

ry

regi

me

for

GM

Os.

Th

e re

sear

cher

s w

ho

dev

elo

ped

th

e te

st f

or

SU

Can

ola

bel

ieve

it

may

be

po

ssib

le i

n t

he

futu

re

to d

evel

op

scr

een

ing

met

ho

ds

for

vari

ou

s

clas

ses

of

gen

e-ed

ited

cro

ps.

4

TR

AN

SP

AR

EN

CY

RE

QU

IRE

D

Th

e d

etec

tio

n o

f

un

kn

ow

n G

MO

s

has

nev

er b

een

sole

ly r

elia

nt

on

the

det

ecti

on

met

ho

ds

use

d i

n

the

lab

ora

tory

It c

ann

ot

be

the

job

of

gov

ern

men

ts, c

ivil

soci

ety,

or

acad

emia

to f

ill

kn

ow

led

ge

gap

s cr

eate

d b

y

ind

ust

ry s

ecre

cy

187

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

41

40

Ad

voca

tes

clai

m t

hat

gen

e-ed

itin

g te

chn

iqu

es,

esp

ecia

lly

tho

se u

sin

g th

e C

RIS

PR

/Cas

sys

tem

,

can

dem

ocr

atis

e ge

net

ic e

ngi

nee

rin

g b

ecau

se

they

are

ch

eap

er a

nd

eas

ier

to a

pp

ly t

han

old

er

gen

etic

mo

dif

icat

ion

tec

hn

iqu

es. J

enn

ifer

Do

ud

na,

on

e o

f C

RIS

PR

’s i

nve

nto

rs, s

aid

th

e

tech

no

logy

“b

ecam

e a

dem

ocr

atis

ing

too

l th

at

allo

wed

lab

s to

do

exp

erim

ents

th

at i

n t

he

pas

t h

ad b

een

pro

hib

itiv

e fo

r va

rio

us

reas

on

s,

wh

eth

er

du

e to

exp

ense

or

just

tec

hn

ical

dif

ficu

lty”

.1 Bay

er c

alls

CR

ISP

R

the

“mo

st ‘d

emo

crat

ic’”

gen

e-ed

itin

g to

ol,

wh

ich

is s

o “

chea

p a

nd

sim

ple

” th

at i

t ca

n b

e u

sed

by

“un

iver

siti

es a

nd

in

stit

ute

s th

at d

o n

ot

hav

e

maj

or

rese

arch

bu

dge

ts”.

2

1. E

uro

pea

n S

eed

. 22

Eu

rop

ean

bu

sin

ess

org

anis

atio

ns

ask

the

EU

fo

r p

ro-i

nn

ov

atio

n r

ule

s fo

r p

lan

t br

eed

ing.

E

uro

pea

n-S

eed

.co

m. P

ub

lish

ed A

pri

l 24,

201

9.

Acc

esse

d J

anu

ary

12, 2

021.

htt

ps:

//eu

rop

ean

-see

d.

com

/201

9/0

4/22

-eu

rop

ean

-bu

sin

ess-

org

anis

atio

ns-

ask-

the-

eu-f

or-

pro

-in

no

vat

ion

-ru

les-

for-

pla

nt-

bree

din

g/

2. B

ayer

. Her

e ar

e th

e fa

cts

abo

ut

agri

cult

ure

an

d

nu

trit

ion

. Pu

bli

shed

on

lin

e N

ov

emb

er 2

018

. htt

ps:

//re

leas

e.ac

e.b

ayer

.co

m/s

ites

/def

ault

/fil

es/2

020

-04/

her

e-ar

e-th

e-fa

cts-

abo

ut-

agri

cult

ure

-an

d-n

utr

itio

n-b

roch

ure

.p

df

3. G

ov

ern

men

t o

f C

anad

a. D

D 2

013

-10

0: D

eter

min

atio

n

of

the

safe

ty o

f C

ibu

s C

anad

a In

c.’s

can

ola

(B

rass

ica

nap

us

L.)

ev

ent

5715

. ww

w.i

nsp

ecti

on

.gc.

ca. P

ub

lish

ed A

pri

l 16,

2

015.

Acc

esse

d J

anu

ary

3, 2

021.

htt

ps:

//w

ww

.in

spec

tio

n.

gc.c

a/p

lan

t-v

arie

ties

/pla

nts

-wit

h-n

ov

el-t

rait

s/ap

pro

ved

-u

nd

er-r

evie

w/d

ecis

ion

-do

cum

ents

/dd

-201

3-1

00/

eng

/142

7383

3322

53/1

4273

8367

46

69

4. C

hh

alli

yil P

, Ilv

es H

, Kaz

ako

v SA

, Ho

war

d S

J,

Joh

nst

on

BH

, Fag

an J

. A r

eal-

tim

e q

uan

tita

tiv

e P

CR

m

eth

od

sp

ecif

ic f

or

det

ecti

on

an

d q

uan

tifi

cati

on

of

the

firs

t co

mm

erci

aliz

ed g

eno

me-

edit

ed p

lan

t. F

oo

ds.

2

020;

9(9)

:12

45. d

oi:1

0.3

390/

foo

ds9

091

245

5. E

PS

O. E

PS

O s

tate

men

t “D

etec

tin

g a

po

int

mu

tati

on

d

oes

no

t cl

arif

y it

s o

rigi

n.”

EP

SO

. Pu

bli

shed

Sep

tem

ber

9,

202

0. A

cces

sed

Jan

uar

y 12

, 202

1. h

ttp

s://

epso

web

.org

/ep

so/e

pso

-sta

tem

ent-

det

ecti

ng-

a-p

oin

t-m

uta

tio

n-d

oes

-n

ot-

clar

ify-

its-

ori

gin

/202

0/0

9/0

9/

6. G

roh

man

n L

, Kei

lwag

en J

, Du

ensi

ng

N, e

t al

. D

etec

tio

n a

nd

id

enti

fica

tio

n o

f ge

no

me

edit

ing

in p

lan

ts:

Ch

alle

nge

s an

d o

pp

ort

un

itie

s. F

ron

t P

lan

t S

ci. 2

019;

10.

do

i:10

.338

9/fp

ls.2

019.

002

36

7. E

uro

pea

n N

etw

ork

Wo

rkin

g G

rou

p o

f G

MO

L

abo

rato

ries

. Det

ecti

on

, In

terp

reta

tio

n a

nd

Rep

ort

ing

on

th

e P

rese

nce

of

Au

tho

rise

d a

nd

Un

auth

ori

sed

Gen

etic

ally

M

od

ifie

d M

ater

ials

.; 2

017.

htt

ps:

//gm

o-c

rl.jr

c.ec

.eu

rop

a.eu

/EN

GL

/do

cs/W

G-D

IR-F

inal

-Rep

ort

.pd

f

8. M

enz

J, M

od

rzej

ewsk

i D

, Har

tun

g F,

Wil

hel

m R

, S

pri

nk

T. G

eno

me

edit

ed c

rop

s to

uch

th

e m

arke

t: A

vie

w

on

th

e g

lob

al d

evel

op

men

t an

d r

egu

lato

ry e

nv

iro

nm

ent.

F

ron

t P

lan

t S

ci. 2

020;

11. d

oi:1

0.3

389/

fpls

.202

0.5

8602

7

9. K

uzm

a J,

Gri

eger

K. C

om

mu

nit

y-le

d g

ov

ern

ance

fo

r ge

ne-

edit

ed c

rop

s. S

cien

ce. 2

020;

370

(651

9):9

16-9

18.

do

i:10

.112

6/sc

ien

ce.a

bd1

512

10. C

on

ven

tio

nal

on

Bio

logi

cal D

iver

sity

. Bio

safe

ty

Cle

arin

g-H

ou

se. T

he

Bio

safe

ty C

lear

ing-

Ho

use

(B

CH

).

Pu

bli

shed

202

1. A

cces

sed

Jan

uar

y 29

, 202

1. h

ttp

s://

bch

.cb

d.i

nt/

11. E

Ugi

niu

s. E

Ugi

niu

s: T

he

Eu

rop

ean

GM

O d

atab

ase.

P

ub

lish

ed 2

021.

Acc

esse

d J

anu

ary

29, 2

021.

htt

ps:

//eu

gin

ius.

eu/e

ugi

niu

s/p

ages

/ho

me.

jsf

12. E

uro

pea

n C

om

mis

sio

n. G

enet

ical

ly m

od

ifie

d

org

anis

ms:

Co

mm

un

ity

regi

ster

of

GM

fo

od

an

d f

eed

. w

ebga

te.e

c.eu

rop

a.eu

. Pu

bli

shed

201

7. h

ttp

s://

web

gate

.ec

.eu

rop

a.eu

/dy

na/

gm_

regi

ster

/in

dex

_en

.cfm

13. E

uro

pea

n P

arli

amen

t an

d C

ou

nci

l. R

egu

lati

on

(E

C)

No

. 183

0/2

003

of

the

Eu

rop

ean

Par

llia

men

t an

d o

f th

e C

ou

nci

l of

22 S

epte

mb

er 2

003

co

nce

rnin

g th

e tr

acea

bili

ty

and

lab

elli

ng

of

gen

etic

ally

mo

dif

ied

org

anis

ms

and

th

e tr

acea

bili

ty o

f fo

od

an

d f

eed

pro

duct

s p

rodu

ced

fro

m

gen

etic

ally

mo

dif

ied

org

anis

ms

and

am

end

ing

Dir

ecti

ve

20

01/1

8/E

C. O

ffic

ial J

ou

rnal

of

the

Eu

rop

ean

Un

ion

. P

ub

lish

ed o

nli

ne

Oct

ob

er 1

8, 2

003

:L 2

68/2

4-L

268

/28

. h

ttp

://e

ur-

lex.

euro

pa.

eu/L

exU

riS

erv/

Lex

Uri

Ser

v.d

o?u

ri=

OJ:

L:2

003

:268

:002

4:0

028:

EN

:PD

F

RE

FE

RE

NC

ES

MY

TH

Gen

e ed

itin

g, a

nd

th

e

CR

ISP

R t

oo

l in

par

ticu

lar,

pu

ts t

he

po

wer

of

gen

etic

eng

inee

rin

g i

nto

th

e

han

ds

of

hu

nd

red

s o

f

tho

usa

nd

s o

f sc

ien

tist

s,

incl

ud

ing

th

ose

wo

rkin

g i

n p

ub

licl

y

fun

ded

in

stit

ute

s an

d

smal

l co

mp

anie

s.

6. G

en

e-e

dit

ing

te

ch

no

log

y is

ow

ne

d

an

d c

on

tro

lled

by

big

c

orp

ora

tio

ns

RE

AL

ITY

Gen

e ed

itin

g t

ech

no

log

y

for

agri

cult

ura

l u

se i

s

alre

ady

fir

mly

un

der

the

con

tro

l o

f th

e

mu

ltin

atio

nal

s th

at

do

min

ate

the

seed

an

d

agro

chem

ical

s m

ark

ets.

Co

rtev

a h

as b

eco

me

the

mai

n g

atek

eep

er o

f

CR

ISP

R p

aten

ts i

n t

he

agri

cult

ura

l ar

ena

.

188

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

43

42

Co

rtev

a (t

he

agri

cult

ura

l div

isio

n s

pu

n o

ff

fro

m D

ow

Du

Po

nt)

is

the

mai

n g

atek

eep

er f

or

CR

ISP

R p

aten

ts i

n t

he

agri

cult

ura

l are

na10

an

d

has

gai

ned

un

pre

ced

ente

d m

arke

t p

ow

er d

ue

to

its

abil

ity

to g

ran

t ac

cess

to

th

is p

aten

t p

oo

l.6 T

o

un

der

stan

d w

hy,

we

nee

d t

o le

arn

the

his

tory

of

the

CR

ISP

R li

cen

sin

g

agre

emen

ts.

Th

e st

ory

beg

ins

wit

h t

wo

bio

tech

star

tup

s co

-fo

un

ded

by

the

inve

nto

rs o

f C

RIS

PR

tec

hn

olo

gy.

Th

e fi

rst,

Car

ibo

u B

iosc

ien

ces,

was

co

-fo

un

ded

in 2

011

by

on

e o

f th

e in

ven

tors

of

CR

ISP

R-

bas

ed g

ene-

edit

ing

tech

no

logy

, Jen

nif

er

Do

ud

na

fro

m t

he

Un

iver

sity

of

Cal

ifo

rnia

. Th

e

seco

nd

, ER

S G

eno

mic

s, w

as c

o-f

ou

nd

ed in

201

3

by

ano

ther

CR

ISP

R t

ech

no

logy

in

ven

tor

and

pat

ent

ow

ner

, Em

man

uel

le C

har

pen

tier

,

as a

“li

cen

sin

g en

gin

e” t

hat

“ex

ists

to

mak

e th

e

[CR

ISP

R]

tech

no

logy

mo

re b

road

ly a

vail

able

un

der

ap

pro

pri

ate

com

mer

cial

lice

nce

s”.

ER

S G

eno

mic

s

has

sig

ned

no

n-

excl

usi

ve a

nd

excl

usi

ve li

cen

sin

g

agre

emen

ts

wit

h c

om

pan

ies

op

erat

ing

in

dif

fere

nt

fiel

ds.

8

Du

Po

nt

(lat

er D

ow

Du

Po

nt

and

no

w C

ort

eva)

con

clu

ded

its

lice

nsi

ng

agre

emen

t w

ith

Car

ibo

u B

iosc

ien

ces

in 2

015.

In

th

e d

eal,

Du

Po

nt

rece

ived

exc

lusi

ve r

igh

ts f

or

CR

ISP

R

tech

no

logy

ap

pli

cati

on

s in

maj

or

row

cro

ps

and

no

n-e

xclu

sive

rig

hts

in

oth

er a

gric

ult

ura

l

CA

RIB

OU

BIO

SC

IEN

CE

S

AN

D E

RS

GE

NO

MIC

S

LIC

EN

SIN

G A

GR

EE

ME

NT

S

Cla

ims

of

dem

ocr

atis

atio

n t

hro

ugh

new

GM

tech

niq

ues

mu

st b

e vi

ewed

in

th

e li

ght

of

the

fact

th

at t

hes

e

tech

niq

ues

are

pat

ente

d, a

s ar

e

thei

r p

rod

uct

s

– t

he

pla

nts

and

an

imal

s

dev

elo

ped

usi

ng

them

. Pat

ents

are

mo

no

po

ly r

igh

ts.

Pat

ent

ho

lder

s

hav

e th

e ri

ght

for

up

to

20

year

s to

pro

hib

it o

ther

s fr

om

exp

loit

ing

the

pat

ente

d

inve

nti

on

or

to c

har

ge r

oya

ltie

s fo

r it

s u

se.

Th

is i

s n

ot

just

ab

ou

t li

mit

ing

com

mer

cial

exp

loit

atio

n, b

ut

also

fu

rth

er i

nn

ova

tio

n.

Exc

lusi

ve p

aten

t ri

ghts

pro

hib

it o

ther

s fr

om

bu

ild

ing

on

th

e p

rote

cted

in

ven

tio

n, a

s re

sear

ch

exce

pti

on

s to

pat

ent

righ

ts a

re u

sual

ly v

ery

stri

ctly

fo

rmu

late

d.

Th

e B

road

In

stit

ute

of

MIT

an

d H

arva

rd,

the

Un

iver

sity

of

Cal

ifo

rnia

, th

e

Un

iver

sity

of

Vil

niu

s

in L

ith

uan

ia, a

nd

the

Un

iver

sity

of

Vie

nn

a ar

e th

e

mai

n i

nst

itu

tio

nal

“in

ven

tors

” o

f C

RIS

PR

tech

no

logy

.6,7,

8,9 B

etw

een

th

em t

hey

hav

e

file

d (

and

fo

ugh

t ea

ch o

ther

ove

r9 ) h

un

dre

ds

of

fou

nd

atio

nal

pat

ents

, so

me

of

wh

ich

hav

e

alre

ady

bee

n g

ran

ted

in

Eu

rop

e.6

TE

CH

NO

LO

GY

PA

TE

NT

S

It i

s fu

rth

er a

rgu

ed t

hat

if

gen

e ed

itin

g w

ere

exem

pte

d f

rom

th

e E

U’s

bu

rden

som

e an

d

exp

ensi

ve-t

o-c

om

ply

-wit

h G

MO

reg

ula

tio

ns,

it w

ou

ld b

e re

mo

ved

fro

m t

he

con

tro

l of

the

big

agb

iote

ch m

ult

inat

ion

als

and

be

mad

e

avai

lab

le t

o p

ub

lic

rese

arch

in

stit

ute

s an

d

un

iver

siti

es, n

on

-pro

fit

org

anis

atio

ns,

and

sm

all a

nd

med

ium

-siz

ed e

nte

rpri

ses

(SM

Es)

.3,4 T

he

seed

in

du

stry

cla

ims

that

GM

O r

egu

lati

on

s “p

reve

nt

mo

st o

f

Eu

rop

e’s

pla

nt

bre

edin

g co

mp

anie

s fr

om

dev

elo

pin

g an

d u

sin

g th

ese

met

ho

ds”

.5

On

ce t

ech

no

logy

pat

ents

are

gra

nte

d, p

aten

t

ow

ner

s ca

n c

on

clu

de

lice

nsi

ng

agre

emen

ts w

ith

com

pan

ies

allo

win

g th

em t

o u

se t

he

tech

no

logy

in c

erta

in a

reas

or

in a

sp

ecif

ic a

pp

lica

tio

n.

Th

ese

agre

emen

ts c

an b

e ex

clu

sive

or

no

n-

excl

usi

ve. O

ther

co

mp

anie

s ca

n o

bta

in li

cen

sin

g

agre

emen

ts o

nly

if

the

righ

ts t

o u

se t

he

pat

ents

are

gran

ted

no

n-e

xclu

sive

ly t

o a

lice

nse

e.

An

ove

rvie

w o

f C

RIS

PR

-bas

ed g

ene-

edit

ing

tech

no

logy

lice

nsi

ng

agre

emen

ts w

as p

ub

lish

ed

in S

cien

ce i

n 2

017.

8

In t

he

area

s o

f C

RIS

PR

gen

e-ed

ited

pla

nts

and

live

sto

ck, l

icen

sin

g ag

reem

ents

rea

ched

by

pat

ent

ow

ner

s, t

he

Bro

ad I

nst

itu

te a

nd

the

Un

iver

sity

of

Cal

ifo

rnia

(o

r it

s sp

ino

ff

com

pan

y C

arib

ou

Bio

scie

nce

s), w

ith

lice

nse

es

Do

wD

uP

on

t (n

ow

Co

rtev

a) a

nd

Bay

er/

Mo

nsa

nto

, are

par

ticu

larl

y im

po

rtan

t.6,

8

Do

wD

uP

on

t co

ncl

ud

ed li

cen

sin

g

agre

emen

ts n

ot

on

ly w

ith

on

e o

f

the

ho

lder

s o

f th

e fo

un

dat

ion

al

CR

ISP

R t

ech

no

logy

pat

ents

(th

e

Bro

ad I

nst

itu

te),

bu

t al

so w

ith

all r

elev

ant

inst

itu

tio

ns,

incl

ud

ing

the

com

pan

ies

Car

ibo

u B

iosc

ien

ces

and

ER

S G

eno

mic

s, a

nd

th

e

Un

iver

sity

of

Vil

niu

s.3,

6P

aten

t h

old

ers

hav

e th

e

rig

ht

for

up

to

20

yea

rs

to p

roh

ibit

oth

ers

fro

m

exp

loit

ing

th

e p

aten

ted

inv

enti

on

or

to c

har

ge

roy

alti

es f

or

its

use

Th

e st

ory

beg

ins

wit

h

two

bio

tech

sta

rtu

ps

co-

fou

nd

ed b

y t

he

inv

ento

rs

of

CR

ISP

R t

ech

no

log

y

189

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

45

44

Bo

th B

ayer

/Mo

nsa

nto

an

d D

ow

Du

Po

nt

hav

e

app

lied

fo

r p

aten

ts o

n g

lyp

ho

sate

-to

lera

nt

pla

nts

pro

du

ced

wit

h t

he

CR

ISP

R-m

edia

ted

gen

e-ed

itin

g p

roce

ss. T

his

mea

ns

that

th

e co

re

agri

cult

ura

l GM

O

bu

sin

ess

– t

he

mar

keti

ng

of

her

bic

ide-

tole

ran

t

pla

nts

su

ch a

s so

y,

corn

, oil

seed

rap

e/

can

ola

an

d c

ott

on

– c

an c

on

tin

ue

to b

e p

rote

cted

by

new

pat

ent

app

lica

tio

ns

in t

he

futu

re.6

Th

e o

wn

ers

of

the

pat

ents

are

larg

ely

the

sam

e m

ult

inat

ion

als

that

do

min

ate

the

GM

Os

and

agr

och

emic

als

mar

kets

. Ch

rist

op

h T

hen

wro

te i

n 2

019

:

“Do

wD

uP

on

t le

ads

the

fiel

d i

n t

he

new

gen

etic

engi

nee

rin

g m

eth

od

s fo

r cr

op

s, w

ith

aro

un

d 6

0

inte

rnat

ion

al p

aten

t ap

pli

cati

on

s, w

hil

e B

ayer

/

Mo

nsa

nto

fo

llo

ws

in s

eco

nd

pla

ce w

ith

mo

re

than

30.

Cal

yxt…

co

mes

in

at

mo

re t

han

20.

Syn

gen

ta a

nd

BA

SF a

re a

lso

in

volv

ed, a

nd

a f

ew

pat

ents

hav

e al

so

bee

n a

pp

lied

fo

r b

y

trad

itio

nal

bre

edin

g

com

pan

ies

such

as

Rij

k Z

waa

n a

nd

KW

S.”6

A 2

016

revi

ew o

f

the

inte

llec

tual

pro

per

ty r

igh

ts

lan

dsc

ape

by

Ege

lie

and

co

llea

gues

fou

nd

th

at “

larg

er

ind

ust

ry p

laye

rs,

wit

h D

ow

an

d D

uP

on

t at

th

e fo

refr

on

t, a

lrea

dy

app

ear

to b

e m

ore

in

co

ntr

ol o

f th

e te

chn

olo

gy’s

agri

cult

ura

l an

d f

oo

d a

pp

lica

tio

ns.

”15

In a

dis

cuss

ion

do

min

ated

by

con

cern

s ab

ou

t

gain

ing

acce

ss t

o C

RIS

PR

tec

hn

olo

gy, i

t is

easy

, as

po

inte

d o

ut

by

May

wa

Mo

nte

neg

ro d

e

Wit

of

the

Un

iver

sity

of

Cal

ifo

rnia

, to

fo

rget

the

cru

cial

iss

ue

of

farm

ers

“lo

sin

g ac

cess

to

trad

itio

nal

cu

ltiv

ars

that

mig

ht

be

dis

pla

ced

wit

h e

xpan

ded

mar

kets

in

new

bio

tech

cro

ps,

or

min

ed a

s ge

net

ic r

eso

urc

es f

or

bre

edin

g ge

ne-

edit

ed v

arie

ties

”.1 T

her

e is

a d

ange

r th

at f

arm

ers

wil

l be

forc

ed t

o p

ay f

or

acce

ss t

o g

ene-

edit

ed

seed

s an

d b

reed

s, b

ut

lose

acc

ess

to n

on

-GM

seed

s an

d b

reed

s in

th

e p

roce

ss.

LO

ST

AC

CE

SS

TO

TR

AD

ITIO

NA

L C

UL

TIV

AR

S

PA

TE

NT

S O

N “

NE

W G

M”

CR

OP

S

DO

MIN

AT

ED

BY

DO

WD

UP

ON

T,

BA

YE

R/

MO

NS

AN

TO

Jean

Do

nn

enw

irth

of

Do

wD

uP

on

t (n

ow

Co

rtev

a) p

rese

nte

d t

he

com

pan

y’s

agre

emen

ts

on

5 N

ove

mb

er 2

018

at a

mee

tin

g b

etw

een

th

e

EU

Co

mm

issi

on

an

d v

ario

us

inte

rest

gro

up

s,

acco

rdin

g to

Dr

Ch

rist

op

h T

hen

of

Tes

tbio

tech

,

wh

o w

as p

rese

nt.

Acc

ord

ing

to D

on

nen

wir

th,

Do

wD

uP

on

t su

ccee

ded

in

co

mb

inin

g 48

bas

ic

pat

ents

in

to a

co

mm

on

pat

ent

po

ol (

35 p

aten

ts

fro

m t

he

Bro

ad I

nst

itu

te, 4

fro

m t

he

Un

iver

sity

of

Cal

ifo

rnia

, 2 f

rom

th

e U

niv

ersi

ty o

f V

iln

ius,

and

7 f

rom

Do

wD

uP

on

t).6

Do

nn

enw

irth

sai

d th

at a

cces

s to

th

is n

um

ber

of

pat

ents

is n

eces

sary

fo

r fu

ll u

se o

f th

e

tech

no

logy

in p

lan

t br

eedi

ng.

Do

wD

uP

on

t

can

off

er b

un

dle

d, n

on

-exc

lusi

ve li

cen

ses

givi

ng

acce

ss t

o t

his

pat

ent

po

ol.

Th

e

con

dit

ion

s in

clu

de

app

rop

riat

e fe

es, r

epo

rtin

g

ob

liga

tio

ns,

co

mp

lian

ce w

ith

gu

idel

ines

, an

d

con

fid

enti

alit

y.6 T

he

firs

t co

mp

any

to li

cen

ce

CR

ISP

R t

ech

no

logy

un

der

th

ese

con

dit

ion

s in

2018

was

th

e U

S co

mp

any

Sim

plo

t,

wh

ich

dev

elo

ps

GM

po

tato

es.13

In

201

9, a

Fre

nch

co

mp

any,

Vil

mo

rin

& C

ie, f

oll

ow

ed.14

Ch

rist

op

h T

hen

co

mm

ente

d, “

Do

wD

uP

on

t

has

un

pre

ced

ente

d m

arke

t p

ow

er t

han

ks t

o

the

po

ssib

ilit

y o

f gr

anti

ng

acce

ss t

o t

his

pat

ent

po

ol:

Wh

at i

s o

n t

he

on

e h

and

to

ute

d a

s a

‘dem

ocr

atis

atio

n’ o

f p

aten

t la

w t

urn

s o

ut,

on

clo

ser

exam

inat

ion

, to

be

a m

ean

s o

f co

ntr

oll

ing

com

pet

ito

rs a

nd

pro

tect

ing

a d

om

inan

t

po

siti

on

. Do

wD

uP

on

t b

eco

mes

, so

to

sp

eak,

th

e

gate

keep

er o

f an

in

tern

atio

nal

pat

ent

cart

el.”

6

DE

MO

CR

AT

ISA

TIO

N O

R P

AT

EN

T C

AR

TE

L ?

Th

e ‘d

emo

crat

ic’ c

red

enti

als

of

gen

e ed

itin

g

are

det

erm

ined

no

t o

nly

by

acce

ss t

o t

he

tech

no

logi

es b

ut

also

by

acce

ss t

o t

hei

r p

rod

uct

s

– g

ene-

edit

ed c

rop

s an

d s

eed

s. B

ut

just

like

th

e

tech

no

logi

es, t

he

pro

du

cts

are

circ

um

scri

bed

by

inte

llec

tual

pro

per

ty r

igh

ts.

Acc

ord

ing

to C

hri

sto

ph

Th

en, p

aten

t

app

lica

tio

ns

invo

lvin

g n

ew a

nd

old

gen

etic

engi

nee

rin

g re

late

to

pla

nts

wit

h m

od

ifie

d

gro

wth

an

d y

ield

, co

mp

osi

tio

n, o

r re

sist

ance

to

dis

ease

, as

wel

l as

tech

nic

al m

od

ific

atio

ns

of

the

nu

clea

ses.

As

a ru

le, t

he

pat

ents

co

ver

met

ho

ds,

seed

s, p

lan

ts a

nd

oft

en a

lso

th

e h

arve

st.6

AC

CE

SS

TO

TH

E T

EC

HN

OL

OG

Y F

OR

SM

ES

AC

TIN

G A

LO

NE

IS

IL

LU

SO

RY

Co

uld

th

e d

e-re

gula

tio

n o

f ge

ne

edit

ing

hel

p

emp

ow

er s

mal

l an

d m

ediu

m s

ize

ente

rpri

ses

(SM

Es)

to

dev

elo

p t

he

gen

e-ed

ited

cro

ps

and

foo

ds

that

wil

l en

able

us

to m

eet

the

chal

len

ges

of

clim

ate

chan

ge?4,

16

Th

is p

rosp

ect

is h

igh

ly u

nli

kely

, acc

ord

ing

to

mo

lecu

lar

gen

etic

ist

Dr

Mic

hae

l An

ton

iou

,

wh

o h

as m

any

year

s’ e

xper

ien

ce o

f d

evel

op

ing

pat

ente

d b

iote

ch p

rod

uct

s fo

r m

edic

al r

esea

rch

wit

h S

ME

s an

d la

rger

co

mp

anie

s.4

app

lica

tio

ns.

11 I

n 2

016

Car

ibo

u r

each

ed a

dea

l

wit

h t

he

com

pan

y G

enu

s in

wh

ich

th

e la

tter

rece

ived

an

exc

lusi

ve li

cen

ce t

o u

se C

RIS

PR

tech

no

logy

in

cer

tain

live

sto

ck s

pec

ies.

12

Du

Po

nt

also

rea

ched

an

exc

lusi

ve li

cen

sin

g

agre

emen

t in

201

8 w

ith

ER

S G

eno

mic

s. T

he

agre

emen

t ga

ve D

uP

on

t ex

clu

sive

rig

hts

to

use

CR

ISP

R t

ech

no

logy

in

th

e ag

ricu

ltu

ral

area

. ER

S G

eno

mic

s al

so g

ran

ted

su

b-l

icen

sin

g

righ

ts t

o D

uP

on

t. D

uP

on

t’s a

gric

ult

ura

l div

isio

n

was

sp

un

off

in

201

9 as

an

in

dep

end

ent

enti

ty

nam

ed C

ort

eva.

Th

us

Co

rtev

a ac

hie

ved

its

do

min

ance

of

the

CR

ISP

R t

ech

no

logy

in

th

e

agri

cult

ura

l fie

ld.

Bot

h B

ayer

/Mon

san

to a

nd

D

owD

uP

ont

hav

e ap

pli

ed

for

pat

ents

on

gly

ph

osa

te-

tole

ran

t p

lan

ts p

rod

uce

d

wit

h t

he

CR

ISP

R-

med

iate

d g

ene-

edit

ing

pro

cess

190

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

47

46

Exp

erie

nce

wit

h g

enet

ic e

ngi

nee

rin

g to

dat

e

sho

ws

that

pat

ent

law

has

bee

n t

he

dri

vin

g

forc

e b

ehin

d d

evel

op

men

t. T

he

adve

nt

of

gen

etic

en

gin

eeri

ng

mar

ked

th

e fi

rst

tim

e

that

pat

ent

law

was

syst

emat

ical

ly a

pp

lied

to p

lan

t b

reed

ing.

Lar

ge

agro

chem

ical

co

mp

anie

s,

wh

ich

had

pre

vio

usl

y

pro

tect

ed t

hei

r p

esti

cid

es

wit

h p

aten

ts, n

ow

als

o

app

lied

fo

r p

aten

ts o

n

GM

see

ds

and

at

the

sam

e ti

me

bo

ugh

t u

p

man

y p

lan

t b

reed

ing

com

pan

ies.

17

Wit

h n

ew g

enet

ic e

ngi

nee

rin

g te

chn

iqu

es,

this

str

ateg

y h

as c

on

tin

ued

an

d b

een

exp

and

ed.

Alr

ead

y, c

orp

ora

tio

ns

such

as

Co

rtev

a an

d

Bay

er/M

on

san

to c

on

tro

l

larg

e p

arts

of

the

seed

mar

ket.

17 P

aten

ted

gen

etic

en

gin

eeri

ng

tech

niq

ues

su

ch a

s

CR

ISP

R g

ene-

edit

ing

tech

no

logy

hel

p t

hem

exte

nd

an

d d

eep

en t

his

con

tro

l.6

PA

TE

NT

S T

HE

DR

IVIN

G F

OR

CE

OF

OL

D

AN

D N

EW

GE

NE

TIC

EN

GIN

EE

RIN

G

GA

ME

FO

R B

IG P

LA

YE

RS

He

exp

lain

ed t

hat

dif

fere

nt

typ

es o

f li

cen

ces

exis

t fo

r te

chn

olo

gies

like

CR

ISP

R g

ene

edit

ing,

wh

ich

in

du

stry

-bas

ed r

esea

rch

ers

(in

clu

din

g

tho

se w

ork

ing

in S

ME

s) m

ust

tak

e o

ut

at

dif

fere

nt

stag

es o

f p

rod

uct

dev

elo

pm

ent.

Th

ese

incl

ud

e ev

alu

atio

n, r

esea

rch

, an

d c

om

mer

cial

lice

nce

s. E

valu

atio

n li

cen

ses

are

gran

ted

to

rese

arch

ers

by

the

pat

ent

ow

ner

s o

r th

eir

sub

-lic

ensi

ng

affi

liat

e co

mp

anie

s to

all

ow

th

e

rese

arch

ers

to d

o p

reli

min

ary

wo

rk t

o s

ee i

f

the

tech

no

logy

co

uld

be

use

ful.

If t

he

rese

arch

ers

wan

t to

pu

rsu

e a

par

ticu

lar

app

lica

tio

n, t

hey

can

app

ly t

o t

he

pat

ent

ow

ner

s fo

r re

sear

ch

lice

nse

s.4

Eva

luat

ion

an

d

rese

arch

lice

nce

s ar

e

oft

en g

ran

ted

qu

ite

chea

ply

, an

d f

ees

can

eve

n b

e w

aive

d

alto

geth

er, s

ince

th

e

tech

no

logy

ow

ner

s

wan

t it

to

be

use

d t

o

dev

elo

p a

pro

du

ct

that

can

be

com

mer

cial

ised

.

Eve

n w

hen

eva

luat

ion

an

d r

esea

rch

lice

nce

fees

are

ch

arge

d, a

typ

ical

SM

E c

ou

ld a

ffo

rd

them

.4 Bu

t at

th

e co

mm

erci

alis

atio

n s

tage

,

thin

gs c

an q

uic

kly

get

very

exp

ensi

ve, w

ith

tech

no

logy

pat

ent

ho

lder

s d

eman

din

g h

igh

pay

men

ts f

or

use

of

the

tech

no

logy

, in

th

e fo

rm

of

com

mer

cial

lice

nce

fee

s an

d r

oya

lty

pay

men

ts

on

pro

du

ct s

ales

.

As

an e

xam

ple

, Co

rtev

a h

as m

ade

a

com

mit

men

t to

all

ow

fre

e ac

cess

to

th

e C

RIS

PR

tech

no

logy

fo

r “u

niv

ersi

ties

an

d n

on

pro

fit

org

aniz

atio

ns

for

acad

emic

res

earc

h”.

Th

e

com

pan

y h

as c

laim

ed t

hat

th

is w

ill p

ut

the

CR

ISP

R t

ech

no

logy

“in

th

e h

and

s o

f m

any”

,

resu

ltin

g in

“a

wid

e ar

ray

of

ben

efit

s fo

r th

e

glo

bal

fo

od

su

pp

ly”.

3 Bu

t sc

ien

tist

s w

ill o

nly

be

able

to

use

CR

ISP

R f

or

bas

ic n

on

-co

mm

erci

al

rese

arch

, no

t fo

r d

evel

op

ing

com

mer

cial

pro

du

cts.

May

wa

Mo

nte

neg

ro d

e W

it

con

clu

ded

: “D

esp

ite

the

op

enin

g u

p o

f C

RIS

PR

IP [

inte

llec

tual

pro

per

ty]

for

no

n-c

om

mer

cial

rese

arch

, CR

ISP

R’s

co

mm

erci

al d

evel

op

men

t

rem

ain

s ti

ghtl

y b

ou

nd

up

in

pat

ents

an

d

lice

nsi

ng

agre

emen

ts

– a

lan

dsc

ape

alre

ady

sho

win

g st

ron

g

sign

s o

f ag

roin

du

stry

do

min

ance

.”1

Pla

nt

bre

eder

s

usi

ng

con

ven

tio

nal

bre

edin

g to

dev

elo

p

a n

ew p

lan

t va

riet

y

can

pro

tect

it

thro

ugh

pla

nt

bre

eder

s’ r

igh

ts.

Bu

t if

th

ey d

ecid

e to

use

CR

ISP

R (

wh

eth

er

or

no

t th

e te

chn

olo

gy

is r

egu

late

d a

s G

M),

they

wil

l nee

d t

o

lear

n t

o n

avig

ate

a

far

mo

re c

om

ple

x

and

exp

ensi

ve p

roce

ss. T

hey

wil

l hav

e to

com

pen

sate

th

e C

RIS

PR

pat

ent

ho

lder

(s)

bo

th

at t

he

rese

arch

an

d d

evel

op

men

t st

age

and

als

o

at t

he

com

mer

cial

isat

ion

sta

ge.

Pat

ent

and

lice

nsi

ng

fees

wil

l rai

se t

he

cost

of

vari

ety

dev

elo

pm

ent

con

sid

erab

ly.

Pat

enti

ng

fees

can

eas

ily

accu

mu

late

to

six

-

figu

re s

um

s, s

ince

pat

ents

mu

st b

e ap

pli

ed f

or

– a

nd

pat

ent

law

yers

en

gage

d –

in

eac

h t

erri

tory

wh

ere

inte

llec

tual

pro

per

ty r

igh

ts a

re s

ou

ght.

Th

e p

aten

tin

g p

roce

ss c

an d

rag

on

fo

r ye

ars,

wit

h la

wye

rs’ f

ees

risi

ng

all t

he

wh

ile.

4

Du

e to

th

e ex

pen

se i

nvo

lved

, SM

Es

on

th

eir

ow

n w

ill n

ever

be

able

to

aff

ord

th

e p

aten

ts

and

co

mm

erci

al li

cen

sin

g ag

reem

ents

th

at

gove

rn g

ene

edit

ing.

So t

he

syst

em i

n

the

agri

cult

ura

l

bio

tech

mar

ket

is,

and

wil

l rem

ain

, th

at

rese

arch

ers

bas

ed i

n

smal

l co

mp

anie

s o

r

un

iver

siti

es, o

ften

wit

h

ind

ust

ry f

un

din

g, “

inve

nt”

a G

MO

an

d p

artn

er

wit

h i

nve

sto

rs a

nd

/or

a la

rge

com

pan

y to

pat

ent

the

pro

du

ct, o

bta

in r

egu

lato

ry a

pp

rova

l,

and

bri

ng

it t

o m

arke

t. T

he

inve

nto

rs a

nd

th

eir

inst

itu

tio

ns

enjo

y a

pro

fit-

shar

ing

arra

nge

men

t

wit

h t

he

inve

sto

rs o

r la

rge

par

tner

co

mp

any.

Oft

en i

n t

his

pro

cess

, th

e SM

E i

s b

ou

ght

up

by

larg

er c

om

pan

ies.

4

Th

is b

usi

nes

s m

od

el i

s n

ot

con

sid

ered

a

cau

se f

or

lam

enta

tio

n. O

n t

he

con

trar

y,

it i

s ce

leb

rate

d a

s a

pat

h t

o s

ucc

ess

for

all

invo

lved

, in

clu

din

g

the

ind

ivid

ual

s an

d

SME

th

at i

nve

nte

d t

he

pro

du

ct.4

Ho

wev

er, a

t th

e en

d o

f

the

day

, gen

e ed

itin

g is

a ga

me

for

big

pla

yers

and

wil

l rem

ain

so

. Th

e n

oti

on

th

at C

RIS

PR

wil

l gra

nt

smal

l pla

yers

acc

ess

to t

he

tech

no

logy

is a

myt

h.

“Des

pit

e th

e o

pen

ing

up

of

CR

ISP

R I

P f

or

no

n-

com

mer

cial

res

earc

h,

CR

ISP

R’s

co

mm

er ci

al

dev

elo

pm

ent

rem

ain

s

tig

htl

y b

ou

nd

up

in

pat

ents

an

d l

icen

sin

g

agre

emen

ts’’

- M

ayw

a M

on

ten

egro

de

Wit

At

the

end

of

the

day

,

gen

e ed

itin

g i

s a

gam

e

for

big

pla

yer

s an

d

wil

l re

mai

n s

o

Th

e ad

ven

t o

f

gen

etic

en

gin

eeri

ng

mar

ked

th

e fi

rst

tim

e th

at p

aten

t la

w

was

sy

stem

atic

ally

app

lied

to

pla

nt

bre

e din

g

191

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

49

48

Gen

e ed

itin

g is

pro

mot

ed a

s th

e fa

stes

t an

d m

ost

effi

cien

t w

ay t

o ac

hie

ve p

lan

t br

eedi

ng

goal

s.1,

2

Acc

ordi

ng

to C

orte

va, “

CR

ISP

R-p

rodu

ced

plan

ts

can

be

deve

lope

d in

just

a fe

w y

ears

ver

sus

wh

at o

ften

take

s de

cade

s”,3 a

nd

Bay

er in

sist

s th

at u

sefu

l cro

ps c

an

be d

evel

oped

“in

a fr

acti

on

of t

he

tim

e co

mpa

red

to o

lder

met

hod

s”.4

Th

e co

mpa

nie

s of

ten

su

gges

t it

is o

ner

ous

regu

lati

ons

that

hol

d ba

ck w

hat

wou

ld o

ther

wis

e be

rap

idly

intr

odu

ced

gen

e-ed

ited

pro

duct

s. C

orte

va a

rgu

es t

hat

“tr

eati

ng

CR

ISP

R-

prod

uce

d cr

ops

as G

MO

s w

ould

su

bsta

nti

ally

slo

w d

own

th

eir

path

to

mar

ket

and

adop

tion

of C

RIS

PR

inn

ovat

ion

in a

gric

ult

ure

.”3

1. M

on

ten

egro

de

Wit

M. D

emo

crat

izin

g C

RIS

PR

? S

tori

es, p

ract

ices

, an

d p

oli

tics

of

scie

nce

an

d

gov

ern

ance

on

th

e ag

ricu

ltu

ral g

ene

edit

ing

fro

nti

er.

Kap

usc

insk

i A

R, F

itti

ng

E, e

ds.

Ele

men

ta: S

cien

ce o

f th

e A

nth

rop

oce

ne.

202

0;8(

9). d

oi:1

0.1

525/

elem

enta

.405

2. B

ayer

. Her

e ar

e th

e fa

cts

abo

ut

agri

cult

ure

an

d

nu

trit

ion

. Pu

bli

shed

on

lin

e N

ov

emb

er 2

018

. htt

ps:

//re

leas

e.ac

e.b

ayer

.co

m/s

ites

/def

ault

/fil

es/2

020

-04/

her

e-ar

e-th

e-fa

cts-

abo

ut-

agri

cult

ure

-an

d-n

utr

itio

n-b

roch

ure

.p

df

3. C

amer

on

D. D

uP

on

t P

ion

eer

and

Bro

ad I

nst

itu

te

join

fo

rces

to

en

able

dem

ocr

atic

CR

ISP

R l

icen

sin

g in

ag

ricu

ltu

re. B

road

In

stit

ute

. Pu

bli

shed

Oct

ob

er 1

8, 2

017.

A

cces

sed

Dec

emb

er 4

, 202

0. h

ttp

s://

ww

w.b

road

inst

itu

te.

org

/new

s/du

po

nt-

pio

nee

r-an

d-b

road

-in

stit

ute

-jo

in-

forc

es-e

nab

le-d

emo

crat

ic-c

risp

r-li

cen

sin

g-ag

ricu

ltu

re

4. R

obi

nso

n C

. Wh

y re

gula

tio

n o

f ge

ne

edit

ing

wil

l n

ot

hu

rt s

mal

l an

d m

ediu

m s

ize

com

pan

ies.

GM

Wat

ch.

htt

ps:

//gm

wat

ch.o

rg/e

n/n

ews/

late

st-n

ews/

1923

9.

Pu

bli

shed

No

vem

ber

28,

201

9.

5. E

uro

seed

s. P

osi

tio

n: P

lan

t B

reed

ing

Inn

ov

atio

n.

Eu

rose

eds;

201

8. h

ttp

s://

ww

w.e

uro

seed

s.eu

/ap

p/

up

load

s/2

019/

07/

18.1

010

-Eu

rose

eds-

PB

I-P

osi

tio

n-1

.pd

f

6. T

hen

C. N

eue

Gen

tech

nik

ver

fah

ren

un

d

Pfl

anze

nzu

cht:

Pat

ente

-Kar

tell

fü

r gr

oß

e K

on

zern

e.

Fo

rum

Um

wel

t &

En

twic

klu

ng.

Pu

bli

shed

on

lin

e F

ebru

ary

201

9:10

-11.

htt

ps:

//ti

ny

url

.co

m/y

5hcu

996

7. U

niv

ersi

ty o

f C

alif

orn

ia O

ffic

e o

f th

e P

resi

den

t.

Un

iver

sity

of

Cal

ifo

rnia

’s fo

un

dat

ion

al C

RIS

PR

-C

as9

pat

ent

po

rtfo

lio

rea

ches

20

tota

l U.S

. pat

ents

. p

rnew

swir

e.co

m. P

ub

lish

ed D

ecem

ber

31,

201

9. A

cces

sed

D

ecem

ber

7, 2

020

. htt

ps:

//w

ww

.prn

ewsw

ire.

com

/n

ews-

rele

ases

/un

iver

sity

-of-

cali

forn

ias-

fou

nd

atio

nal

-cr

isp

r-ca

s9-p

aten

t-p

ort

foli

o-r

each

es-2

0-t

ota

l-u

s-p

aten

ts-3

00

980

003

.htm

l

8. C

on

trer

as J

L, S

her

kow

JS

. CR

ISP

R, s

urr

oga

te

lice

nsi

ng,

an

d s

cien

tifi

c d

isco

ver

y. S

cien

ce.

201

7;35

5(63

26):

698

-70

0. d

oi:1

0.1

126/

scie

nce

.aal

4222

9. W

agn

er J

K. D

isp

ute

s co

nti

nu

e o

ver

fo

un

dat

ion

al

pat

ents

fo

r ge

ne

edit

ing.

Th

e P

riv

acy

Rep

ort

. Pu

bli

shed

o

nli

ne

Ap

ril 1

8, 2

017.

Acc

esse

d J

anu

ary

12, 2

021.

htt

ps:

//th

epri

vac

yrep

ort

.co

m/2

017/

04/

18/d

isp

ute

s-co

nti

nu

e-o

ver

-fo

un

dat

ion

al-p

aten

ts-f

or-

gen

e-ed

itin

g/

10. O

’Mal

ley

M. C

RIS

PR

’s li

cen

sin

g la

nd

scap

e d

eco

ded

. In

tell

ectu

al P

rop

erty

Mag

azin

e. P

ub

lish

ed o

nli

ne

Jan

uar

y 2

, 201

8.

11. D

uP

on

t. D

uP

on

t an

d C

arib

ou

Bio

scie

nce

s an

no

un

ce

stra

tegi

c al

lian

ce. B

ioS

pac

e.co

m. P

ub

lish

ed O

cto

ber

8,

201

5. A

cces

sed

Dec

emb

er 7

, 202

0. h

ttp

s://

ww

w.b

iosp

ace.

com

/art

icle

/du

po

nt-

and

-car

ibo

u-b

iosc

ien

ces-

ann

ou

nce

-st

rate

gic-

alli

ance

-/

12. C

arib

ou

Bio

scie

nce

s. G

enu

s an

d C

arib

ou

Bio

scie

nce

s an

no

un

ce e

xclu

siv

e co

llab

ora

tio

n f

or

lead

ing

CR

ISP

R-

Cas

9 ge

ne

edit

ing

tech

no

log

y in

liv

esto

ck s

pec

ies.

ca

rib

ou

bio

.co

m. P

ub

lish

ed M

ay 1

8, 2

016

. Acc

esse

d

Dec

emb

er 7

, 202

0. h

ttp

s://

cari

bo

ubi

o.c

om

/in

-th

e-n

ews/

pre

ss-r

elea

ses/

gen

us-

and

-car

ibo

u-b

iosc

ien

ces-

ann

ou

nce

-ex

clu

siv

e-co

llab

ora

tio

n-l

ead

ing

13. N

oso

wit

z D

. Po

tato

co

mp

any

Sim

plo

t li

cen

ses

Do

wD

uP

on

t’s g

ene

edit

ing

tech

. Mo

der

n F

arm

er.

Pu

bli

shed

Au

gust

7, 2

018

. Acc

esse

d D

ecem

ber

7, 2

020

. h

ttp

s://

mo

der

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. Co

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ing

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l wit

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geli

e K

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, Str

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SP,

Jo

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he

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ract

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ilip

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-201

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RE

FE

RE

NC

ES

MY

TH

Gen

e ed

itin

g a

chie

ves

des

ired

tra

its

mo

re

qu

ick

ly t

han

con

ven

tio

nal

bre

edin

g.

7. G

en

e e

dit

ing

is n

ot

a f

as

t o

r re

lia

ble

ro

ute

to d

esir

ed

ou

tco

me

s

RE

AL

ITY

Th

ere

are

man

y l

eng

thy

step

s in

bri

ng

ing

a

gen

e-ed

ited

pro

du

ct t

o

mar

ket

, ev

en w

ith

ou

t

con

sid

erin

g r

egu

lati

on

,

and

co

nv

enti

on

al b

reed

ing

is m

ore

su

cces

sfu

l in

ach

iev

ing

des

ired

tra

its.

Th

eref

ore

gen

e-ed

itin

g te

chn

olo

gy w

ill

no

t m

ake

gen

etic

en

gin

eeri

ng

acce

ssib

le t

o

pu

bli

cly

fun

ded

bre

edin

g p

rogr

amm

es, b

ut

wil

l fu

rth

er c

on

soli

dat

e p

ow

er w

ith

in t

he

big

mu

ltin

atio

nal

s.

192

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

51

50

How

ever

, wh

ile b

reed

ing

a n

ew p

lan

t va

riet

y is

gen

eral

ly a

len

gth

y pr

oces

s, t

her

e is

no

evid

ence

that

pro

duci

ng

a vi

able

gen

e-ed

ited

var

iety

will

be

any

quic

ker.

Eve

n in

cou

ntr

ies

wit

h li

ght-

tou

ch

regu

lati

ons

like

the

US

and

Can

ada,

on

ly v

ery

few

gen

e-ed

ited

pro

duct

s h

ave

mad

e it

to

mar

ket.

A g

ene-

edit

ed t

omat

o ap

prov

ed b

y th

e Ja

pan

ese

gove

rnm

ent

in 2

020,

wh

ich

was

en

gin

eere

d to

con

tain

a c

ompo

un

d sa

id t

o lo

wer

blo

od p

ress

ure

,

took

15

year

s to

dev

elop

.5 Th

at is

th

e sa

me

tim

e

peri

od t

hat

exp

erts

est

imat

e is

nee

ded

to d

evel

op a

sexu

ally

pro

paga

ted

non

-GM

cro

p –

or a

n o

lder

-

styl

e tr

ansg

enic

GM

cro

p.6,

7,8

Wh

ile

gen

e ed

itin

g is

pre

sen

ted

as

a cu

ttin

g-ed

ge

new

tec

hn

olo

gy, i

t h

as a

ctu

ally

bee

n a

rou

nd

fo

r so

me

year

s. I

n

2012

, Jen

nif

er D

ou

dn

a

and

Em

man

uel

le

Ch

arp

enti

er p

rop

ose

d

that

CR

ISP

R c

ou

ld b

e

use

d f

or

pro

gram

mab

le

edit

ing

of

gen

om

es9

and

it

was

fir

st s

ho

wn

to w

ork

in

pla

nts

in

2013

.10 T

he

edit

ing

too

l

late

r n

amed

TA

LE

Ns

was

des

crib

ed i

n 2

009–

2010

.11,1

2 Reg

ard

ing

cro

ps

engi

nee

red

wit

h t

he

edit

ing

too

l

call

ed o

lig

on

ucl

eoti

de‐

dir

ecte

d m

uta

gen

esis

(O

DM

),

mai

ze w

as d

escr

ibed

in

200

013

and

ric

e in

200

4.14

Yet

to

dat

e, d

esp

ite

the

per

mis

sive

egu

lato

ry s

yste

ms

in p

lace

in

No

rth

an

d S

ou

th

Am

eric

a,15

on

ly t

wo

gen

e-

edit

ed p

lan

ts h

ave

mad

e it

to

mar

ket

– n

eith

er o

f w

hic

h

wer

e en

gin

eere

d u

sin

g

the

mu

ch-t

ou

ted

CR

ISP

R

tech

no

logy

. Th

ese

are

Cal

yxt’s

alte

red

-fat

-pro

file

so

ybea

n,

engi

nee

red

wit

h T

AL

EN

s,16

and

Cib

us’

her

bic

ide-

tole

ran

t ca

no

la/o

ilse

ed r

ape,

engi

nee

red

wit

h O

DM

.

Th

e O

DM

mai

ze13

an

d r

ice14

do

no

t ap

pea

r to

hav

e b

een

com

mer

cial

ised

an

ywh

ere

in t

he

year

s si

nce

th

ey w

ere

ann

ou

nce

d i

n 2

000

and

2004

. Th

e sa

me

is t

rue

of

a

no

n-b

row

nin

g m

ush

roo

m,

engi

nee

red

wit

h C

RIS

PR

/

Cas

,17 a

s w

ell n

um

ero

us

oth

er p

rod

uct

s. A

cco

rdin

g to

Tes

tbio

tech

,

“aro

un

d 8

0 p

lan

ts d

evel

op

ed

wit

h n

ew G

E t

ech

niq

ues

hav

e

bee

n d

ereg

ula

ted

by

the

US

FD

A”.

18

Co

nsu

mer

an

d f

oo

d i

nd

ust

ry

mis

tru

st o

f ge

ne-

edit

ed

foo

ds

is a

lso

a

del

ayin

g fa

cto

r in

com

mer

cial

isat

ion

. Th

e ge

ne-

edit

ed t

om

ato

ap

pro

ved

by

the

Jap

anes

e go

vern

men

t h

as

no

t ye

t b

een

co

mm

erci

alis

ed,

rep

ort

edly

du

e to

fo

od

pro

du

cers

sh

yin

g aw

ay

fro

m t

he

tech

no

logy

in

the

face

of

con

sum

er

reje

ctio

n. A

su

rvey

of

abo

ut

10,0

00 p

eop

le b

y

the

Un

iver

sity

of

To

kyo

fou

nd

th

at 4

0% t

o 5

0%

did

no

t w

ant

to e

at g

ene-

edit

ed c

rop

s o

r an

imal

pro

du

cts,

wit

h ju

st 1

0%

sho

win

g in

tere

st i

n t

ryin

g

them

.5

Th

is r

eco

rd s

ugg

ests

th

at

gen

e ed

itin

g is

no

t th

e ef

fici

ent

and

sp

eed

y ro

ute

to

ob

tain

ing

succ

essf

ul a

gric

ult

ura

l tra

its

that

is

UN

IMP

RE

SS

IVE

RE

CO

RD

As

sho

wn

in

ch

apte

r 2,

gen

e ed

itin

g an

d i

ts

asso

ciat

ed p

roce

sses

(su

ch a

s ti

ssu

e cu

ltu

re)

lead

to m

any

un

inte

nd

ed e

ffec

ts, s

om

e o

f w

hic

h w

ill

affe

ct p

lan

t p

erfo

rman

ce a

nd

gro

wth

as

wel

l as

the

des

ired

tra

it. S

o g

ene-

edit

ed p

lan

ts n

eed

to

go t

hro

ugh

a la

bo

rio

us

pro

cess

of

scre

enin

g,

sele

ctio

n a

nd

bac

kcro

ssin

g w

ith

th

e p

aren

t li

nes

to r

emo

ve a

ny

ob

vio

us

un

des

ired

mu

tati

on

s.

In a

dd

itio

n, s

ever

al y

ears

of

gree

nh

ou

se a

nd

fiel

d t

rial

s m

ust

be

do

ne

to e

nsu

re t

hat

th

e

des

ired

tra

it e

xpre

sses

in

a s

tab

le w

ay t

hro

ugh

the

gen

erat

ion

s an

d t

hat

th

e p

lan

t co

pes

wit

h

envi

ron

men

tal s

tres

ses,

su

ch a

s b

ad w

eath

er

con

dit

ion

s an

d p

est

atta

cks.

Mo

reo

ver,

gen

etic

ally

mo

dif

ied

pro

du

cts

are

no

rmal

ly o

nly

pla

ced

on

th

e m

arke

t o

nce

pat

ents

are

gra

nte

d –

an

d t

he

pat

enti

ng

pro

cess

can

tak

e ye

ars.

Th

is m

ean

s th

e o

vera

ll p

roce

ss

bef

ore

pro

du

cts

can

be

com

mer

cial

ised

can

be

len

gth

y.

All

th

is i

s w

ith

ou

t th

e ti

me

nee

ded

to

pu

t th

e

pla

nt

thro

ugh

reg

ula

tory

pro

cess

es.

PR

OC

ES

S F

OL

LO

WIN

G

TH

E “

ED

IT”

TA

KE

S T

IMEG

ene-

edit

ed p

lan

ts

nee

d t

o g

o t

hro

ug

h a

lab

ori

ou

s p

roce

ss o

f

scre

en in

g, s

elec

tio

n a

nd

bac

kcr

oss

ing

wit

h t

he

par

ent

lin

es t

o r

emo

ve

any

ob

vio

us

un

de s

ired

mu

tati

on

s

To

dat

e, o

nly

tw

o

gen

e-ed

ited

pla

nts

hav

e m

ade

it t

o

mar

ket

– n

eith

er

of

wh

ich

wer

e

eng

inee

red

usi

ng

the

mu

ch-t

ou

ted

CR

ISP

R t

ech

no

log

y

193

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

53

52

RE

FE

RE

NC

ES

Spee

d i

n b

rin

gin

g n

ew p

rod

uct

s to

mar

ket

and

fast

rep

lace

men

t o

f p

rod

uct

s is

a b

usi

nes

s m

od

el

that

is

inte

rest

ing

for

som

e se

ed/a

gro

chem

ical

com

pan

ies

and

live

sto

ck b

reed

ers,

bu

t le

ss

rele

van

t fo

r fa

rmer

s, w

ho

may

be

bet

ter

serv

ed

wit

h r

ob

ust

, lo

call

y ad

apte

d v

arie

ties

an

d b

reed

s

that

th

ey c

an u

se o

ver

a lo

ng

tim

esp

an. I

n

add

itio

n, i

t d

oes

no

t se

rve

con

sum

ers,

wh

ose

pri

mar

y co

nce

rn i

s a

safe

, wh

ole

som

e, a

nd

acce

ssib

le f

oo

d s

up

ply

.

In c

ases

wh

ere

spee

d i

s im

po

rtan

t, g

ene

edit

ing

is n

ot

the

quic

kest

or

mo

st r

elia

ble

way

to

pro

du

ce c

rop

s w

ith

des

ired

tra

its.

In

co

ntr

ast,

con

ven

tio

nal

bre

edin

g h

as p

rove

n h

igh

ly

effi

cien

t an

d s

ucc

essf

ul i

n p

rod

uci

ng

such

cro

ps.

IS S

PE

ED

DE

SIR

AB

LE

?

clai

med

. Th

e u

nim

pre

ssiv

e re

cord

of

pro

du

cts

bro

ugh

t to

mar

ket

in c

ou

ntr

ies

like

th

e U

S

and

Can

ada

sho

ws

that

it

is n

ot

regu

lati

on

s

that

slo

w m

arke

t ac

cess

,

bu

t fa

cto

rs i

nh

eren

t

in t

he

dev

elo

pm

ent

of

GM

pro

du

cts,

as

wel

l as

mar

ket

reje

ctio

n.

Du

rin

g th

e 20

yea

rs t

hat

gen

e ed

itin

g h

as e

xist

ed,

ther

e h

as b

een

mu

ch

rese

arch

act

ivit

y –

oft

en

gen

ero

usl

y fu

nd

ed w

ith

taxp

ayer

mo

ney

– b

ut

very

few

mar

keta

ble

pro

du

cts.

In

th

e

mea

nti

me

solu

tio

ns

hav

e al

read

y b

een

fo

un

d t

o

pro

ble

ms

such

as

extr

eme

wea

ther

co

nd

itio

ns

lin

ked

to

cli

mat

e ch

ange

. Th

ese

solu

tio

ns

rely

on

alr

ead

y p

rove

n a

nd

ava

ilab

le a

pp

roac

hes

.

Fo

r ex

amp

le, w

hil

e re

sear

ch o

n g

ene-

edit

ed

sali

ne-

tole

ran

t cr

op

s st

rugg

les

to p

rogr

ess

bey

on

d t

he

earl

y st

ages

,19 f

arm

ers

in I

nd

ia h

ave

rap

idly

an

d s

ucc

essf

ull

y

rem

edia

ted

so

il t

hat

was

mad

e sa

lin

e b

y a

dev

asta

tin

g ts

un

ami.

Th

e ke

y w

as f

ou

nd

in

org

anic

so

il r

egen

erat

ion

met

ho

ds

and

loca

l

seed

s ad

apte

d t

o t

he

con

dit

ion

s.20

Als

o, c

on

ven

tio

nal

bre

edin

g h

as c

on

sist

entl

y

ou

tstr

ipp

ed g

enet

ic

engi

nee

rin

g te

chn

iqu

es

(old

an

d n

ew)

in p

rod

uci

ng

cro

ps

tole

ran

t to

stre

sses

su

ch a

s d

rou

ght,

21 f

loo

ds,

22 p

ests

,23 a

nd

dis

ease

s.24

Fo

r m

ore

exa

mp

les

of

succ

essf

ul

alte

rnat

ives

to

GM

ap

pro

ach

es, s

ee c

hap

ter

8.

1. I

nte

rnat

ion

al S

eed

Fed

erat

ion

. Tec

hn

olo

gica

l ad

van

ces

dri

ve

inn

ov

atio

n i

n p

lan

t br

eed

ing

to c

reat

e n

ew v

arie

ties

. wo

rld

seed

.org

. Pu

bli

shed

202

0. A

cces

sed

D

ecem

ber

8, 2

020

. htt

ps:

//w

ww

.wo

rld

seed

.org

/o

ur-

wo

rk/p

lan

t-br

eed

ing

/pla

nt-

bree

din

g-in

no

vat

ion

/

2. E

uro

seed

s. P

osi

tio

n: P

lan

t B

reed

ing

Inn

ov

atio

n.

Eu

rose

eds;

201

8. h

ttp

s://

ww

w.e

uro

seed

s.eu

/ap

p/

up

load

s/2

019/

07/

18.1

010

-Eu

rose

eds-

PB

I-P

osi

tio

n-1

.pd

f

In t

he

mea

nti

me

solu

tio

ns

hav

e

alre

ady

bee

n f

ou

nd

to p

rob

lem

s su

ch a

s

extr

eme

wea

ther

con

dit

ion

s li

nk

ed t

o

clim

ate

chan

ge

3. C

ort

eva

Agr

isci

ence

. CR

ISP

R Q

&A

– F

or

inte

rnal

u

se o

nly

. Pu

bli

shed

on

lin

e M

ay 2

8, 2

019.

htt

ps:

//cr

isp

r.co

rtev

a.co

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4. T

rem

bla

y B

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art

and

su

stai

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le f

oo

d s

yste

ms.

P

oli

tico

. Pu

bli

shed

on

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ber

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uar

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oli

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/sp

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oo

d-s

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ms/

5. A

san

um

a N

, Oza

ki

T. J

apan

ap

pro

ves

gen

e-ed

ited

“s

up

er t

om

ato

”. B

ut

wil

l an

yon

e ea

t it

? N

ikke

i A

sia.

P

ub

lish

ed o

nli

ne

Dec

emb

er 1

2, 2

020

. Acc

esse

d J

anu

ary

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ikke

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nes

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rov

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ene-

edit

ed-s

up

er-t

om

ato

.-B

ut-

wil

l-an

yon

e-ea

t-it

6. G

oo

dm

an M

M. N

ew s

ou

rces

of

germ

pla

sm: L

ines

, tr

ansg

enes

, an

d b

reed

ers.

In

: Mar

tin

ez J

M, e

d. M

emo

ria

Co

ngr

esso

Nac

ion

al d

e F

ito

gen

etic

a. ;

20

02:2

8-4

1.

7. G

oo

dm

an M

M, C

arso

n M

L. R

eali

ty v

s. m

yth

: Co

rn

bree

din

g, e

xoti

cs, a

nd

gen

etic

en

gin

eeri

ng.

In

: Pro

c. o

f th

e 55

th A

nn

ual

Co

rn &

So

rgh

um

Res

earc

h C

on

fere

nce

. V

ol 5

5. ;

20

00

:149

-172

.

8. G

MW

atch

. Is

GM

qu

icke

r th

an c

on

ven

tio

nal

br

eed

ing?

GM

Wat

ch.o

rg. P

ub

lish

ed D

ecem

ber

23,

2

013.

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p:/

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mw

atch

.org

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dex

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ive/

201

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27

9. D

ou

dn

a JA

, Ste

rnb

erg

SH. A

Cra

ck i

n C

reat

ion

: Gen

e E

dit

ing

and

th

e U

nth

ink

able

Po

wer

to

Co

ntr

ol E

volu

tio

n.

Ho

ug

hto

n M

iffl

in H

arco

urt

; 201

7.

10. J

ian

g W

, Zh

ou

H, B

i H

, Fro

mm

M, Y

ang

B, W

eek

s D

P. D

emo

nst

rati

on

of

CR

ISP

R/C

as9/

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-med

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gen

e m

od

ific

atio

n i

n A

rabi

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psi

s, t

ob

acco

, so

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um

an

d r

ice.

Nu

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c A

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s R

es. 2

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41(2

0):e

188

. d

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11. B

och

J, S

cho

lze

H, S

cho

rnac

k S

, et

al. B

reak

ing

the

cod

e o

f D

NA

bin

din

g sp

ecif

icit

y o

f T

AL

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III

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cto

rs. S

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ce. 2

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59):

150

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12. d

oi:1

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scie

nce

.117

8811

12. B

och

J, B

on

as U

. Xan

tho

mo

nas

Av

rBs3

fam

ily-

typ

e II

I ef

fect

ors

: Dis

cov

ery

and

fu

nct

ion

. An

nu

R

ev P

hy

top

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:419

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. do

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13. Z

hu

T, M

ette

nbu

rg K

, Pet

erso

n D

J, T

agli

ani

L,

Bas

zczy

nsk

i C

L. E

ngi

nee

rin

g h

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e-re

sist

ant

mai

ze u

sin

g ch

imer

ic R

NA

/DN

A o

ligo

nu

cleo

tid

es. N

at

Bio

tech

no

l. 2

00

0;18

(5):

555

-558

. do

i:10

.103

8/75

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14. O

ku

zak

i A

, To

riya

ma

K. C

him

eric

RN

A/D

NA

o

ligo

nu

cleo

tid

e-d

irec

ted

gen

e ta

rget

ing

in r

ice.

Pla

nt

Cel

l R

ep. 2

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50

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15. G

enet

ic L

iter

acy

Pro

ject

. Glo

bal

Gen

e E

dit

ing

Reg

ula

tio

n T

rack

er: H

um

an a

nd

Agr

icu

ltu

re G

ene

Ed

itin

g: R

egu

lati

on

s an

d I

nd

ex. G

lob

al G

ene

Ed

itin

g R

egu

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on

Tra

cker

. Pu

bli

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202

0. A

cces

sed

Dec

emb

er

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. htt

ps:

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rg

16. C

aly

xt.

Cal

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t’s h

igh

ole

ic lo

w l

ino

len

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oyb

ean

d

eem

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-reg

ula

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US

DA

. cal

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Jun

e 3,

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Dec

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17. W

altz

E. G

ene-

edit

ed C

RIS

PR

mu

shro

om

esc

apes

U

S re

gula

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n. N

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re. 2

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759

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Ju

ly 6

, 2

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. htt

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regu

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-1.1

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4

18. T

estb

iote

ch. N

ew g

enet

ic e

ngi

nee

rin

g: C

on

fusi

on

ab

ou

t m

eth

od

of

pla

nt

iden

tifi

cati

on

. Tes

tbio

tech

.org

. P

ub

lish

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mb

er 1

1, 2

020

. Acc

esse

d J

anu

ary

14, 2

021.

h

ttp

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estb

iote

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od

e/26

34

19. Z

han

g A

, Liu

Y, W

ang

F, e

t al

. En

han

ced

ric

e sa

lin

ity

tole

ran

ce v

ia C

RIS

PR

/Cas

9-ta

rget

ed m

uta

gen

esis

of

the

OsR

R22

gen

e. M

ol B

reed

ing.

201

9;39

(3):

47. d

oi:1

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00

7/s1

1032

-019

-095

4-y

20

. Sam

uel

J. O

rgan

ic f

arm

ing

in I

nd

ia p

oin

ts t

he

way

to

su

stai

nab

le a

gric

ult

ure

. In

ter

Pre

ss S

erv

ice.

Pu

bli

shed

o

nli

ne

Jan

uar

y 7,

201

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sed

Dec

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. h

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ure

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21. G

MW

atch

. No

n-G

M s

ucc

esse

s: D

rou

gh

t to

lera

nce

. G

MW

atch

.org

. Pu

bli

shed

202

0. h

ttp

s://

gmw

atch

.org

/en

/d

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gh

t-to

lera

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22. G

MW

atch

. No

n-G

M s

ucc

esse

s: F

loo

d

tole

ran

ce. G

MW

atch

.org

. Pu

bli

shed

202

0. A

cces

sed

D

ecem

ber

18,

202

0. h

ttp

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mw

atch

.org

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on

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cces

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flo

od

-to

lera

nce

23. G

MW

atch

. No

n-G

M s

ucc

esse

s: P

est

resi

stan

ce.

GM

Wat

ch.o

rg. P

ub

lish

ed 2

020

. htt

ps:

//w

ww

.gm

wat

ch.

org

/en

/pes

t-re

sist

ance

24.

GM

Wat

ch. N

on

-GM

su

cces

ses:

Dis

ease

res

ista

nce

. G

MW

atch

.org

. Pu

bli

shed

202

0. A

cces

sed

Dec

emb

er 1

8,

202

0. h

ttp

s://

ww

w.g

mw

atch

.org

/en

/dis

ease

-res

ista

nce

194

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

55

54

Ind

ust

ry

lob

byi

sts

clai

m

that

th

e u

se o

f g

ene

edit

ing

is o

f “u

np

rece

den

ted

im

po

rtan

ce”

to d

eal

wit

h

clim

ate

chan

ge

and

sca

rcit

y o

f n

atu

ral

reso

urc

es

such

as

arab

le l

and

an

d w

ater

. Th

ey s

ay i

t is

nec

essa

ry t

o d

evel

op

cro

ps

that

are

pes

t- a

nd

dis

ease

-res

ista

nt

and

can

ad

apt

to d

iffi

cult

clim

atic

co

nd

itio

ns

such

as

dro

ug

ht,

hea

t, a

nd

sali

nit

y.1

,2

Acc

ord

ing

to

Bay

er,

gen

e ed

itin

g i

s

“fu

nd

amen

tal

in a

chie

vin

g t

he

go

als

of

the

EU

Gre

en D

eal”

3 t

hat

aim

s to

tac

kle

bo

th

clim

ate

chan

ge

and

en

vir

on

men

tal

deg

rad

atio

n

and

mak

e th

e E

U e

con

om

y su

stai

nab

le. T

he

com

pan

y sa

ys t

hat

if

the

EU

fai

ls t

o “

rev

erse

leg

isla

tio

n”

that

blo

cks

gen

e ed

itin

g,

it c

ou

ld:

“mis

s o

ut

on

on

e o

f th

e m

ost

pro

mis

ing

in

no

vat

ion

s o

f o

ur

life

tim

e to

en

able

mo

re s

ust

ain

able

res

ilie

nt

foo

d s

yste

ms”

.4

8. G

en

e e

dit

ing

is

a r

isk

y a

nd

ex

pe

nsiv

e

dis

tra

cti

on

fro

m p

rov

en

su

cc

es

sfu

l so

luti

on

s

to f

oo

d a

nd

fa

rmin

g

pro

ble

ms

MY

TH

Gen

e ed

itin

g i

s n

eces

sary

to g

row

fo

od

th

at i

s

bet

ter

for

peo

ple

an

d

the

env

iro

nm

ent,

so

no

t

app

lyin

g i

t w

ou

ld b

e

mo

rall

y r

epre

hen

sib

le.

RE

AL

ITY

We

nee

d t

o s

cale

up

pro

ven

su

cces

sfu

l so

luti

on

s

– c

on

ven

tio

nal

bre

edin

g a

nd

agro

eco

log

y –

fro

m w

hic

h

gen

etic

en

gin

eeri

ng

is

an

exp

ensi

ve

dis

trac

tio

n.

Bay

er s

ays

the

EU

cou

ld “

mis

s o

ut

on

on

e

of

the

mo

st p

rom

isin

g

inn

ov

atio

ns

of

ou

r

life

tim

e to

en

able

mo

re

sust

ain

able

res

ilie

nt

foo

d s

yst

ems’

’.

195

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

57

56

See

d i

nd

ust

ry a

sso

ciat

ion

s sa

y th

at g

ene

edit

ing

is a

way

to

fig

ht

pla

nt

dis

ease

s w

hil

e re

du

cin

g

pes

tici

de

use

. On

e p

rom

oti

on

al v

ideo

cla

ims

that

wh

eat

can

be

gen

e ed

ited

to

mak

e

it r

esis

tan

t to

ru

st

and

po

wd

ery

mil

dew

dis

ease

s.22

Ho

wev

er, p

ow

der

y

mil

dew

-res

ista

nt

wh

eat

has

alr

ead

y

bee

n d

evel

op

ed

thro

ugh

co

nv

enti

on

al b

reed

ing,

hel

ped

by

mar

ker

ass

iste

d s

elec

tio

n.23

Pro

gres

s h

as b

een

mad

e in

gen

e m

app

ing

for

po

wd

ery

mil

dew

resi

stan

ce i

n w

hea

t, t

o h

elp

bre

eder

s w

ho

wan

t

to u

se t

hes

e te

chn

iqu

es.24

Ru

st-r

esis

tan

t w

hea

t v

arie

ties

hav

e al

so b

een

dev

elo

ped

via

co

nv

enti

on

al b

reed

ing.

25,2

6,27

Acc

ord

ing

to t

he

Inte

rnat

ion

al M

aize

an

d

Wh

eat

Imp

rov

emen

t C

ente

r (C

IMM

YT

), i

ts

“ru

st-r

esis

tan

t v

arie

ties

no

w c

ov

er m

ore

th

an

90%

of

the

wh

eat

farm

ing

area

in

Ken

ya a

nd

Eth

iop

ia”.

28

Att

emp

ts t

o a

chie

ve

dis

ease

res

ista

nce

thro

ugh

gen

e ed

itin

g

are

un

lik

ely

to m

atch

thes

e co

nv

enti

on

al

bre

edin

g su

cces

ses.

Dis

ease

-cau

sin

g

mic

roo

rgan

ism

s, li

ke

inse

ct p

ests

, hav

e

grea

t ge

net

ic d

iver

sity

an

d t

hu

s ad

apta

bil

ity,

so t

hey

can

eas

ily

“bre

ak”

a re

sist

ance

bas

ed o

n

chan

ges

in o

ne

or

a fe

w g

enes

.

Mo

reo

ver

, th

e k

ey t

o c

on

tro

llin

g b

oth

cro

p

dis

ease

s an

d i

nse

ct p

ests

lies

in

pre

ven

tio

n

thro

ugh

go

od

far

min

g p

ract

ices

su

ch a

s cr

op

rota

tio

n,29

wh

ich

is

oft

en i

gno

red

in

mo

no

cro

p,

ind

ust

rial

ised

agr

icu

ltu

re.

CO

NV

EN

TIO

NA

L B

RE

ED

ING

AN

D G

OO

D

FA

RM

ING

PR

AC

TIC

ES

WO

RK

BE

TT

ER

TO

FIG

HT

PL

AN

T D

ISE

AS

ES

Agr

icu

ltu

ral b

iote

ch c

om

pan

ies

are

pro

mo

tin

g

the

new

er t

ech

niq

ues

of

gen

e ed

itin

g as

a w

ay t

o

man

age

inse

ct p

ests

th

at w

ou

ld r

edu

ce t

he

nee

d

for

chem

ical

in

sect

icid

es. P

rop

ose

d a

pp

roac

hes

incl

ud

e al

teri

ng

pla

nt

com

po

siti

on

in

ord

er t

o

rep

el p

ests

.19

Ho

wev

er, t

hes

e ap

pro

ach

es m

ay m

eet

the

sam

e

fate

as

old

er-s

tyle

GM

cro

ps

– as

pes

ts c

an r

apid

ly

evo

lve

resi

stan

ce t

o e

nvi

ron

men

tal s

tres

ses,

wh

eth

er t

hey

co

nsi

st o

f sp

raye

d-o

n c

hem

ical

pes

tici

des,

bu

ilt-

in p

esti

cide

s li

ke B

t to

xin

s, o

r

pla

nts

gen

etic

ally

en

gin

eere

d to

rep

el p

ests

.

GE

NE

ED

ITIN

G A

PP

RO

AC

HE

S

TO

PE

ST

CO

NT

RO

L S

ET

TO

FA

IL

Cla

ims

that

gen

etic

en

gin

eeri

ng

can

hel

p

farm

ers

to d

eal w

ith

ad

ver

se c

on

dit

ion

s an

d

pro

tect

th

e en

vir

on

men

t ar

e n

ot

new

.

Fir

st-g

ener

atio

n t

ran

sgen

ic G

M c

rop

s w

ere

pro

mo

ted

on

th

e b

asis

of

clai

ms

that

th

ey w

ou

ld

be

adap

ted

to

dif

ficu

lt

clim

atic

co

nd

itio

ns,

such

as

dro

ugh

t, a

nd

red

uce

pes

tici

de

use

.5

Th

ese

pro

mis

es

pro

ved

fal

se.

Reg

ard

ing

dro

ugh

t,

a tr

ansg

enic

GM

dro

ugh

t-to

lera

nt

mai

ze f

rom

Mo

nsa

nto

was

rel

ease

d i

n 2

011,

bu

t th

e U

S D

epar

tmen

t

of

Agr

icu

ltu

re (

US

DA

) sa

id i

t w

as n

o m

ore

effe

ctiv

e th

an c

on

ven

tio

nal

ly b

red

var

ieti

es.6

Far

mer

ad

op

tio

n o

f v

arie

ties

in

wh

ich

th

e

dro

ugh

t to

lera

nce

was

ach

iev

ed v

ia G

M h

as

“lag

ged

beh

ind

” v

arie

ties

in

wh

ich

it

was

ach

iev

ed b

y co

nv

enti

on

al b

reed

ing.

7

Th

e cl

aim

of

red

uce

d p

esti

cid

e u

se a

lso

pro

ved

to b

e fa

lse

Her

bic

ide-

tole

ran

t G

M c

rop

s ar

e so

ld

by

agri

chem

ical

co

mp

anie

s in

tan

dem

wit

h t

hei

r

pro

pri

etar

y h

erb

icid

es. T

hey

hav

e in

crea

sed

th

e

use

of

chem

ical

wee

dk

ille

rs, i

ncl

ud

ing

pro

du

cts

con

tain

ing

the

“pro

bab

le c

arci

no

gen

”

glyp

ho

sate

.8,9

Inse

ctic

ide-

pro

du

cin

g

GM

cro

ps

(so

-cal

led

Bt

cro

ps)

rap

idly

lost

eff

ecti

ven

ess

agai

nst

tar

gete

d

pes

ts, f

ell v

icti

m t

o

Bt

toxi

n-r

esis

tan

t

and

sec

on

dar

y p

ests

, an

d a

re n

ow

use

d i

n c

om

bin

atio

n w

ith

ch

emic

al

inse

ctic

ides

.10,1

1,12

,13,

14,1

5,16

,17,

18 T

hes

e in

clu

de

hig

hly

to

xic

neo

nic

oti

no

id i

nse

ctic

idal

see

d

trea

tmen

ts, t

he

use

of

wh

ich

has

ris

en i

n p

aral

lel

wit

h B

t cr

op

s in

th

e U

SA

.16

NE

W T

EC

HN

IQU

ES

, O

LD

CL

AIM

S

In t

he

UK

, Ro

tham

sted

Res

earc

h’s

so

-cal

led

“wh

iffy

wh

eat”

tri

al, i

n w

hic

h w

hea

t w

as

gen

etic

ally

en

gin

eere

d t

o r

elea

se a

n a

ph

id-

rep

elli

ng

chem

ical

fo

un

d i

n m

int,

fai

led

aft

er

£2.6

mil

lio

n o

f p

ub

lic

mo

ney

was

sp

ent

on

the

pro

ject

. Th

e ap

hid

s ra

pid

ly g

ot

use

d t

o t

he

smel

l.20

Iro

nic

ally

, pre

vio

us

gov

ern

men

t-fu

nd

ed

rese

arch

un

der

tak

en b

y R

oth

amst

ed a

nd

oth

ers

dem

on

stra

ted

th

at a

ph

id le

vel

s ca

n b

e

kep

t b

elo

w e

con

om

ical

ly s

ign

ific

ant

lev

els

by

mai

nta

inin

g d

iver

se f

ield

mar

gin

s an

d

hed

gero

ws.

21 T

his

in

no

vat

ive

rese

arch

was

bas

ed o

n a

n u

nd

erst

and

ing

of

agro

eco

logy

.

Bu

t se

emin

gly,

it

has

bee

n i

gno

red

by

GM

rese

arch

ers

and

th

eir

inst

itu

tio

ns.

Th

e E

U s

eed

in

du

stry

ass

oci

atio

n, w

hic

h B

ayer

is p

art

of,

say

s it

is

the

EU

’s “

pro

hib

itiv

e” G

MO

law

s th

at p

rev

ent

inn

ov

atio

n “

for

a m

ore

sust

ain

able

agr

i-fo

od

sys

tem

at

the

pac

e th

at i

s

urg

entl

y n

eed

ed”.

1

Su

ch a

rgu

men

ts c

reat

e a

con

text

in

wh

ich

gen

etic

en

gin

eeri

ng

is v

iew

ed a

s th

e m

ora

l

imp

erat

ive

– a

nd

rej

ecti

on

, or

even

just

regu

lati

on

, as

mo

rall

y re

pre

hen

sib

le.

Her

bic

ide-

tole

ran

t

GM

cro

ps

are

sold

by

ag

rich

emic

al

com

pan

ies

in t

and

em

wit

h t

hei

r p

rop

riet

ary

her

bic

ides

Th

e k

ey t

o c

on

tro

llin

g

bo

th c

rop

dis

ease

s

and

in

sect

pes

ts l

ies

in

pre

ven

tio

n t

hro

ug

h

goo

d f

arm

ing

pra

ctic

es

196

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

59

58

Wh

en i

t co

mes

to

so

lvin

g ch

alle

nge

s o

f p

ests

,

dis

ease

s, o

r cl

imat

e ch

ange

, it

is c

ruci

al t

o

loo

k a

t w

ho

le f

arm

ing

syst

ems

rath

er t

han

emp

loyi

ng

a re

du

ctio

nis

t ap

pro

ach

th

at o

nly

loo

ks

at g

enes

, esp

ecia

lly

gen

etic

en

gin

eeri

ng

app

roac

hes

th

at

on

ly m

anip

ula

te

on

e o

r a

few

gen

es.

As

wel

l as

rob

ust

cro

ps

pro

vid

ing

stab

le y

ield

s u

nd

er

adv

erse

co

nd

itio

ns,

we

nee

d r

esil

ien

t

farm

ing

syst

ems

that

co

pe

wit

h

a v

arie

ty o

f

env

iro

nm

enta

l

stre

sses

. Su

ch s

yste

ms

incl

ud

e so

il b

uil

din

g w

ith

org

anic

mat

ter

to r

etai

n m

ois

ture

an

d p

lan

tin

g

a d

iver

sity

of

cro

ps

to p

rev

ent

pes

t an

d d

isea

se

pro

ble

ms.

Su

cces

sfu

l sys

tem

s ap

pro

ach

es i

ncl

ud

e :

• T

he

org

anic

sys

tem

. In

th

e lo

nge

st-r

un

nin

g

tria

l co

mp

arin

g o

rgan

ic a

nd

co

nv

enti

on

al

grai

n c

rop

pin

g sy

stem

s (i

ncl

ud

ing

GM

cro

ps)

,

the

Ro

dal

e In

stit

ute

Far

min

g S

yste

ms

Tri

al,

rese

arch

ers

fou

nd

th

at o

rgan

ic s

yste

ms

pro

du

ce

yiel

ds

that

are

co

mp

etit

ive

wit

h c

on

ven

tio

nal

syst

ems

afte

r a

5-ye

ar t

ran

siti

on

per

iod

. Yie

lds

in t

he

org

anic

sys

tem

s w

ere

up

to

40%

hig

her

in t

imes

of

dro

ugh

t. T

he

tria

l als

o f

ou

nd

th

at

org

anic

sys

tem

s u

se 4

5% le

ss e

ner

gy a

nd

rel

ease

40%

few

er c

arb

on

emis

sio

ns.

Cro

p

rota

tio

ns

wer

e u

sed

inst

ead

of

pes

tici

des

to

con

tro

l pes

ts.38

• T

he

Sys

tem

of

Ric

e In

ten

sifi

cati

on

(SR

I). S

RI

is a

n

agro

eco

logi

cal m

eth

od

of

incr

easi

ng

the

pro

du

ctiv

ity

of

rice

by

chan

gin

g th

e m

anag

emen

t o

f p

lan

ts, s

oil

, wat

er,

and

nu

trie

nts

. Th

e b

enef

its

of

SR

I in

clu

de

yiel

d

incr

ease

s o

f 20

–10

0%, u

p t

o a

90%

red

uct

ion

in

the

amo

un

t o

f se

ed r

equ

ired

, an

d w

ater

sav

ings

of

up

to

50%

.39

• A

gro

eco

logy

pro

ject

s in

th

e G

lob

al S

ou

th a

nd

oth

er d

evel

op

ing

regi

on

s. T

hes

e p

roje

cts

hav

e

pro

du

ced

dra

mat

ic i

ncr

ease

s in

yie

lds

and

fo

od

secu

rity

.40,4

1,42

,43,

44,4

5

SY

ST

EM

S,

NO

T J

US

T G

EN

ES

Gen

e ed

itin

g p

lan

ts f

or

dis

ease

res

ista

nce

bri

ngs

oth

er r

isk

s, t

oo

, so

me

of

wh

ich

hav

e al

read

y

com

e to

ligh

t. A

ttem

pts

to

use

CR

ISP

R g

ene

edit

ing

to p

rod

uce

vir

us-

resi

stan

t ca

ssav

a p

lan

ts

fail

ed, a

nd

in

th

e p

roce

ss b

rok

e th

eir

alre

ady-

exis

tin

g n

atu

ral r

esis

tan

ce t

o a

dif

fere

nt,

mo

re

wid

esp

read

vir

us.

Th

e ex

per

imen

t al

so r

esu

lted

in

th

e p

rop

agat

ion

of

mu

tate

d v

iru

ses

that

, if

they

had

esc

aped

th

e

Co

nv

enti

on

al b

reed

ing

con

tin

ues

to

ou

tstr

ip

GM

in

dev

elo

pin

g cr

op

s w

ith

du

rab

le r

esis

tan

ce

to p

ests

an

d d

isea

ses,

dro

ugh

t to

lera

nce

,

enh

ance

d n

utr

itio

nal

qu

alit

y, a

nd

to

lera

nce

to s

alin

ity.

30,3

1,32

,33 T

his

is

bec

ause

th

ese

are

gen

etic

ally

co

mp

lex

trai

ts, m

ean

ing

that

th

ey

are

the

pro

du

ct

of

man

y ge

nes

wo

rkin

g to

geth

er i

n

a p

reci

sely

reg

ula

ted

way

. Su

ch t

rait

s w

ill

be

extr

emel

y d

iffi

cult

or

imp

oss

ible

to a

chie

ve

by

man

ipu

lati

ng

on

e

or

a fe

w g

enes

,

wh

ich

is

all t

hat

gen

e

edit

ing

and

gen

etic

mo

dif

icat

ion

in

gen

eral

can

ach

iev

e, e

ven

usi

ng

mu

ltip

lex

app

roac

hes

.

GM

has

larg

ely

succ

eed

ed o

nly

in

pro

du

cin

g

cro

ps

wit

h g

enet

ical

ly s

imp

le t

rait

s su

ch

as h

erb

icid

e to

lera

nce

or

the

abil

ity

to

exp

ress

an

in

sect

icid

e. G

ene

edit

ing

is s

et t

o

con

tin

ue

on

th

e sa

me

pat

h. T

he

gen

e-ed

ited

cro

ps

com

mer

cial

isat

ion

pip

elin

e is

mai

nly

char

acte

rise

d b

y ge

net

ical

ly s

imp

le t

rait

s, s

uch

as

or

her

bic

ide

tole

ran

ce, o

r m

od

ifie

d c

om

po

siti

on

to i

ncr

ease

pro

du

ct s

hel

f li

fe o

r p

rov

ide

raw

mat

eria

ls f

or

pro

cess

ing

ind

ust

ries

.34 T

hes

e

trai

ts d

o n

ot

imp

rov

e th

e su

stai

nab

ilit

y o

r

clim

ate

resi

lien

ce o

f ag

ricu

ltu

re, b

ut

allo

w

dev

elo

per

s to

con

tin

ue

to s

ell

GM

see

ds

wit

h

agro

chem

ical

s

and

hel

p i

nd

ust

ry

to o

pti

miz

e it

s

man

ufa

ctu

rin

g

pro

cess

es.

It i

s n

ot

surp

risi

ng,

then

, th

at t

hu

s fa

r

the

on

ly g

ene-

edit

ed c

rop

s th

at h

ave

mad

e it

to m

ark

et a

re C

alyx

t’s s

oyb

ean

an

d C

ibu

s’ S

U

Can

ola

. Th

e so

ybea

n h

as a

n a

lter

ed f

at p

rofi

le

to a

vo

id c

reat

ing

un

hea

lth

y tr

ans

fats

wh

en

coo

kin

g fo

od

at

hig

h t

emp

erat

ure

s.35

Th

e

can

ola

has

bee

n e

ngi

nee

red

to

en

able

in

crea

sed

her

bic

ide

use

wit

ho

ut

kil

lin

g th

e cr

op

– t

he

op

po

site

to

th

e cl

aim

ed r

edu

ctio

ns

in p

esti

cid

e

use

fro

m g

ene-

edit

ing

tech

no

logy

.

GE

NE

ED

ITIN

G C

AN

BR

ING

AD

DIT

ION

AL

RIS

KS

GE

NE

ED

ITIN

G C

AN

NO

T C

ON

FE

R

DE

SIR

AB

LE

CO

MP

LE

X T

RA

ITS

lab

ora

tory

, co

uld

hav

e le

d t

o “

the

dev

elo

pm

ent

of

a tr

uly

pat

ho

gen

ic n

ov

el v

iru

s”, a

cco

rdin

g

to t

he

rese

arch

ers.

36 T

he

lead

res

earc

her

qu

esti

on

ed o

n T

wit

ter

wh

eth

er t

his

was

a “

risk

”

wo

rth

tak

ing

in f

ield

s. M

ean

wh

ile,

no

n-G

M

pro

gram

mes

fo

r b

reed

ing

and

su

pp

lyin

g v

iru

s-

resi

stan

t ca

ssav

a h

ave

pro

ven

su

cces

sfu

l ov

er

man

y ye

ars,

bu

t st

rugg

le f

or

fun

din

g.33

Cu

rren

tly,

so

-cal

led

gen

e d

riv

es, a

par

ticu

lar

app

lica

tio

n o

f ge

ne-

edit

ing

tech

no

logy

, are

bei

ng

pro

mo

ted

as

a w

ay t

o e

rad

icat

e in

sect

pes

ts.19

Bu

t th

e ri

sks

po

sed

by

gen

e d

riv

es

are

un

pre

dic

tab

le a

nd

th

e im

pac

ts p

ote

nti

ally

sev

ere.

37

Gen

etic

ally

co

mp

lex

trai

ts w

ill

be

extr

emel

y

dif

ficu

lt o

r im

po

ssib

le t

o

ach

iev

e b

y m

anip

ula

tin

g

on

e o

r a

few

gen

es

Ag

roec

olo

gy

pro

ject

s

in t

he

Glo

bal

So

uth

an

d

oth

er d

evel

op

ing

reg

ion

s

hav

e p

rod

uce

d d

ram

atic

incr

ease

s in

yie

lds

and

foo

d s

ecu

rity

197

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

61

60

1. E

uro

seed

s. P

osi

tio

n: P

lan

t B

reed

ing

Inn

ov

atio

n.

Eu

rose

eds;

201

8. h

ttp

s://

ww

w.e

uro

seed

s.eu

/ap

p/

up

load

s/2

019/

07/

18.1

010

-Eu

rose

eds-

PB

I-P

osi

tio

n-1

.pd

f

2. C

ort

eva

Agr

isci

ence

. Fre

qu

entl

y A

sked

Qu

esti

on

s.

cris

pr.

cort

eva.

com

. Pu

bli

shed

202

1. A

cces

sed

Ja

nu

ary

11, 2

021.

htt

ps:

//cr

isp

r.co

rtev

a.co

m/

faq

s-cr

isp

r-ca

s-co

rtev

a-ag

risc

ien

ce/

3. T

rem

bla

y B

. Sm

art

and

su

stai

nab

le f

oo

d s

yste

ms.

P

oli

tico

. Pu

bli

shed

on

lin

e D

ecem

ber

9, 2

020

. A

cces

sed

Jan

uar

y 13

, 202

1. h

ttp

s://

ww

w.p

oli

tico

.eu

/sp

on

sore

d-c

on

ten

t/sm

art-

and

-su

stai

nab

le-f

oo

d-s

yste

ms/

4. E

uro

pea

n C

om

mis

sio

n. A

Eu

rop

ean

Gre

en D

eal.

ec

.eu

rop

a.eu

. Pu

bli

shed

202

0. A

cces

sed

Jan

uar

y 14

, 202

1.

htt

ps:

//ec

.eu

rop

a.eu

/in

fo/s

trat

egy/

pri

ori

ties

-201

9-2

024/

euro

pea

n-g

reen

-dea

l_en

5. R

uss

ell K

, Hak

im D

. Bro

ken

Pro

mis

es o

f G

enet

ical

ly

Mo

dif

ied

Cro

ps

(Pu

bli

shed

201

6). T

he

New

Yo

rk T

imes

. h

ttp

s://

ww

w.n

yti

mes

.co

m/i

nte

ract

ive/

201

6/10

/30/

busi

nes

s/gm

o-c

rop

s-p

esti

cid

es.h

tml,

htt

ps:

//w

ww

.n

yti

mes

.co

m/i

nte

ract

ive/

201

6/10

/30/

busi

nes

s/gm

o-

cro

ps-

pes

tici

des

.htm

l. P

ub

lish

ed O

cto

ber

29,

201

6.

Acc

esse

d D

ecem

ber

13,

202

0.

6. V

oo

sen

P. U

SD

A lo

ok

s to

ap

pro

ve

Mo

nsa

nto

’s d

rou

gh

t-to

lera

nt

corn

. New

Yo

rk T

imes

. htt

p:/

/ny

ti.m

s/m

QtC

nq

. P

ub

lish

ed M

ay 1

1, 2

011.

7. M

cFad

den

J, S

mit

h D

, Wec

hsl

er S

, Wal

lan

der

S.

Dev

elo

pm

ent,

Ad

op

tio

n, a

nd

Man

agem

ent

of

Dro

ug

ht-

To

lera

nt

Co

rn i

n t

he

Un

ited

Sta

tes.

Un

ited

Sta

tes

Dep

artm

ent

of

Agr

icu

ltu

re; 2

019.

htt

ps:

//w

ww

.ers

.usd

a.go

v/p

ub

lica

tio

ns/

pu

b-d

etai

ls/?

pu

bid

=91

102

8. B

enbr

oo

k C

. Im

pac

ts o

f ge

net

ical

ly e

ngi

nee

red

cr

op

s o

n p

esti

cid

e u

se i

n t

he

US

– T

he

firs

t si

xte

en

year

s. E

nv

iro

nm

enta

l Sci

ence

s E

uro

pe.

201

2;2

4(2

4).

do

i:10

.118

6/21

90

-471

5-2

4-2

4

9. B

enbr

oo

k C

M. T

ren

ds

in g

lyp

ho

sate

her

bici

de

use

in

th

e U

nit

ed S

tate

s an

d g

lob

ally

. En

vir

on

men

tal S

cien

ces

Eu

rop

e. 2

016;

28(1

):3.

do

i:10

.118

6/s1

2302

-016

-00

70-0

10. B

aute

T. E

uro

pea

n c

orn

bo

rer

resi

stan

ce t

o B

t co

rn f

ou

nd

in

Can

ada.

Fie

ld C

rop

New

s. h

ttp

s://

fiel

dcr

op

new

s.co

m/2

019/

05/e

uro

pea

n-c

orn

-bo

rer-

resi

stan

ce-t

o-b

t-co

rn-f

ou

nd

-in

-can

ada/

. Pu

bli

shed

May

10

, 201

9. A

cces

sed

Dec

emb

er 1

3, 2

020

.

11. T

abas

hn

ik B

E, W

u K

, Wu

Y. E

arly

det

ecti

on

of

fiel

d-e

volv

ed r

esis

tan

ce t

o B

t co

tto

n i

n C

hin

a: c

ott

on

b

oll

wo

rm a

nd

pin

k b

oll

wo

rm. J

In

ver

tebr

Pat

ho

l.

201

2;11

0(3

):3

01-3

06

. do

i:10

.101

6/j.j

ip.2

012

.04.

00

8

12. D

ivel

y G

P, V

enu

gop

al P

D, F

inke

nbi

nd

er C

. Fie

ld-

evo

lved

res

ista

nce

in

co

rn e

arw

orm

to

Cry

pro

tein

s ex

pre

ssed

by

tan

sgen

ic s

wee

t co

rn. P

LO

S O

NE

. 2

016;

11(1

2):e

0169

115.

do

i:10

.137

1/jo

urn

al.p

on

e.01

6911

5

13. T

abas

hn

ik B

E, C

arri

ère

Y. S

urg

e in

in

sect

res

ista

nce

to

tra

nsg

enic

cro

ps

and

pro

spec

ts f

or

sust

ain

abil

ity.

N

atu

re B

iote

chn

olo

gy.

201

7;35

(10)

:926

-935

. do

i:10

.103

8/n

bt.

3974

14. G

uti

erre

z A

P, P

on

ti L

, Kra

nth

i K

R, e

t al

. Bio

-ec

on

om

ics

of

Ind

ian

hyb

rid

Bt

cott

on

an

d f

arm

er

suic

ides

. En

vir

on

men

tal S

cien

ces

Eu

rop

e. 2

020;

32(1

):13

9.

do

i:10

.118

6/s1

2302

-02

0-0

04

06

-6

15. B

BC

New

s. T

he

Ind

ian

far

mer

s fa

llin

g p

rey

to

pes

tici

de.

BB

C N

ews.

htt

ps:

//w

ww

.bb

c.co

m/n

ews/

wo

rld

-asi

a-in

dia

-415

1073

0. P

ub

lish

ed O

cto

ber

5, 2

017.

A

cces

sed

Ju

ly 8

, 201

8.

16. D

ou

gla

s M

R, T

oo

ker

JF. L

arge

-sca

le d

eplo

ym

ent

of

seed

tre

atm

ents

has

dri

ven

rap

id i

ncr

ease

in

use

o

f n

eon

ico

tin

oid

in

sect

icid

es a

nd

pre

emp

tiv

e p

est

man

agem

ent

in U

.S. f

ield

cro

ps.

En

vir

on

Sci

Tec

hn

ol.

P

ub

lish

ed o

nli

ne

Mar

ch 2

0, 2

015.

do

i:10

.102

1/es

50

6141

g

17. U

ng

lesb

ee E

. EPA

pro

po

ses

ph

asin

g o

ut

do

zen

s o

f B

t co

rn a

nd

co

tto

n p

rodu

cts.

DT

N P

rogr

essi

ve

Far

mer

. Pu

bli

shed

on

lin

e S

epte

mb

er 2

9, 2

020

. A

cces

sed

Dec

emb

er 1

3, 2

020

. htt

ps:

//w

ww

.dtn

pf.

com

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icu

ltu

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rop

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ticl

e/2

020/

09/

29/

epa-

pro

po

ses-

ph

asin

g-d

oze

ns-

bt-

corn

18. Z

hao

JH

, Ho

P, A

zad

i H

. Ben

efit

s o

f B

t co

tto

n

cou

nte

rbal

ance

d b

y se

con

dar

y p

ests

? P

erce

pti

on

s o

f ec

olo

gica

l ch

ange

in

Ch

ina.

En

vir

on

Mo

nit

Ass

ess.

2

010;

173:

985

-994

. do

i:10

.10

07/

s10

661

-010

-143

9-y

19. T

yagi

S, K

esir

aju

K, S

aak

re M

, et

al. G

eno

me

edit

ing

for

resi

stan

ce t

o i

nse

ct p

ests

: An

em

ergi

ng

too

l fo

r cr

op

im

pro

vem

ent.

AC

S O

meg

a. 2

020;

5(33

):2

067

4-2

068

3.

do

i:10

.102

1/ac

som

ega.

0c0

1435

20

. Co

ok

son

C. G

M “

wh

iffy

wh

eat”

fai

ls t

o d

eter

pes

ts,

£2.6

m U

K s

tud

y fi

nd

s. F

inan

cial

Tim

es. h

ttp

s://

ww

w.

ft.c

om

/co

nte

nt/

1c8d

17fa

-1b1

5-1

1e5

-a13

0-2

e7d

b721

f996

. P

ub

lish

ed J

un

e 25

, 201

5. A

cces

sed

Jan

uar

y 31

, 202

1.

21. P

ow

ell W

, A’H

ara

SA, H

arli

ng

R, e

t al

. Man

agin

g B

iod

iver

sity

in

Fie

ld M

argi

ns

to E

nh

ance

In

tegr

ated

P

est

Co

ntr

ol i

n A

rab

le C

rop

s (‘3

-D F

arm

ing’

Pro

ject

):

Pro

ject

Rep

ort

No

. 356

Par

t 1.

Ho

me-

Gro

wn

Cer

eals

A

uth

ori

ty (

HG

CA

); 2

00

4. h

ttp

s://

ahd

b.o

rg.u

k/m

anag

ing-

bio

div

ersi

ty-i

n-f

ield

-mar

gin

s-to

-en

han

ce-i

nte

grat

ed-

pes

t-co

ntr

ol-

in-a

rab

le-c

rop

s-3

-d-f

arm

ing-

pro

ject

22. L

ofr

ese

S. G

eno

me

Ed

itin

g M

akes

Wh

eat

Cro

ps

Mo

re S

ust

ain

able

. Am

eric

an S

eed

Tra

de

Ass

oci

atio

n

(AS

TA

) an

d E

uro

seed

s; 2

020

. Acc

esse

d J

anu

ary

15, 2

021.

h

ttp

s://

vim

eo.c

om

/485

430

922

23. J

ia M

, Xu

H, L

iu C

, et

al. C

har

acte

riza

tio

n o

f th

e p

ow

der

y m

ild

ew r

esis

tan

ce g

ene

in t

he

elit

e w

hea

t cu

ltiv

ar J

imai

23

and

its

ap

pli

cati

on

in

mar

ker-

assi

sted

sel

ecti

on

. Fro

nt

Gen

et. 2

020;

11. d

oi:1

0.3

389/

fgen

e.2

020

.002

41

24.

Kan

g Y

, Zh

ou

M, M

erry

A, B

arry

K. M

ech

anis

ms

of

po

wd

ery

mil

dew

res

ista

nce

of

wh

eat

– a

rev

iew

of

mo

lecu

lar

bree

din

g. P

lan

t P

ath

olo

gy.

202

0;69

(4):

601

-617

. d

oi:

htt

ps:

//d

oi.

org

/10

.111

1/p

pa.

1316

6

RE

FE

RE

NC

ES

GM

ap

pro

ach

es h

ave

bee

n s

ho

wn

to

be

an

exp

ensi

ve d

istr

acti

on

fro

m a

lrea

dy-

avai

lab

le

app

roac

hes

to

so

lvin

g ch

alle

nge

s o

f cl

imat

e

chan

ge, p

ests

, an

d

dis

ease

s. T

hes

e

app

roac

hes

, bas

ed

on

th

e sc

ien

ce

of

agro

eco

logy

,

are

also

th

e

mo

st s

ust

ain

able

way

to

en

d o

ur

dep

end

ency

on

chem

ical

pes

tici

des

.

Th

e n

eed

to

red

uce

pes

tici

de

use

is

pre

ssin

g, b

ut

this

go

al

wil

l no

t b

e ac

hie

ved

by

loo

kin

g to

co

mp

anie

s

that

sel

l th

ese

pro

du

cts.

In

fac

t, t

he

agri

cult

ura

l

bio

tech

co

mp

anie

s p

rom

oti

ng

gen

e ed

itin

g

(fo

r ex

amp

le, C

ort

eva,

Bay

er, S

ynge

nta

, an

d

BA

SF)

are

also

agr

och

emic

al c

om

pan

ies

and

thei

r b

usi

nes

s m

od

el i

s b

uil

t o

n s

elli

ng

seed

s in

a p

acka

ge w

ith

pes

tici

des

an

d o

ther

ch

emic

al

inp

uts

.

Res

ou

rces

sh

ou

ld

inst

ead

be

dir

ecte

d

tow

ard

s m

akin

g

pro

ven

-su

cces

sfu

l

agro

eco

logi

cal

met

ho

ds

mo

re w

idel

y

avai

lab

le t

o f

arm

ers.

In a

tim

e o

f cl

imat

e

and

eco

logi

cal

bre

akd

ow

n, t

his

– n

ot

risk

y ge

net

ic e

ngi

nee

rin

g

tech

no

logi

es o

wn

ed a

nd

pro

mo

ted

by

agri

chem

ical

co

mp

anie

s –

is

the

mo

ral

imp

erat

ive.

EX

PE

NS

IVE

DIS

TR

AC

TIO

N

In 2

008

a gr

ou

nd

-bre

akin

g st

ud

y o

n t

he

futu

re

of

farm

ing

was

pu

bli

shed

. Sp

on

sore

d b

y th

e

Wo

rld

Ban

k an

d t

he

Un

ited

Nat

ion

s an

d

con

du

cted

by

ove

r 40

0 in

tern

atio

nal

sci

enti

sts,

the

Inte

rnat

ion

al A

sses

smen

t o

f A

gric

ult

ura

l

Kn

ow

led

ge, S

cien

ce a

nd

Tec

hn

olo

gy f

or

Dev

elo

pm

ent

(IA

AST

D)

did

no

t en

do

rse

GM

cro

ps

as a

so

luti

on

to

wo

rld

hu

nge

r.

Th

e re

po

rt n

ote

d t

hat

yie

lds

of

GM

cro

ps

wer

e

“hig

hly

var

iab

le”.

It a

dd

ed t

hat

saf

ety

ques

tio

ns

rem

ain

ed o

ver

GM

cro

ps

and

th

at t

he

pat

ents

att

ach

ed t

o t

hem

cou

ld u

nd

erm

ine

seed

sav

ing

and

fo

od

sec

uri

ty

in d

evel

op

ing

cou

ntr

ies.

Th

e re

po

rt c

on

clu

ded

that

th

e ke

y to

fo

od

secu

rity

lies

in a

gro

eco

logy

.46

OV

ER

40

0 I

NT

ER

NA

TIO

NA

L S

CIE

NT

IST

S

SA

Y A

GR

OE

CO

LO

GY

IS

TH

E W

AY

FO

RW

AR

D

Th

e n

eed

to

red

uce

pes

tici

de

use

is

pre

ssin

g,

bu

t th

is g

oal

wil

l n

ot

be

ach

iev

ed b

y l

oo

kin

g t

o

com

pan

ies

that

sel

l th

ese

pro

du

cts

198

Tab

48: G

RA

MM

ER

Lin

da a

nd

MU

LH

OLLA

ND

Ian

63

62

25. M

arti

n N

. “Su

per

wh

eat”

res

ists

dev

asta

tin

g ru

st.

Sci

Dev

.Net

. htt

p:/

/ww

w.s

cid

ev.n

et/e

n/n

ews/

-su

per

-w

hea

t-re

sist

s-d

evas

tati

ng-

rust

.htm

l. P

ub

lish

ed J

un

e 17

, 2

011.

26. L

atin

Am

eric

an H

eral

d T

ribu

ne.

Mex

ican

sc

ien

tist

s cr

eate

pes

t-re

sist

ant

wh

eat.

Lat

in A

mer

ican

H

eral

d T

ribu

ne.

htt

p:/

/ww

w.l

aht.

com

/art

icle

.as

p?A

rtic

leId

=36

016

4&

Cat

ego

ryId

=14

091

. Pu

bli

shed

Ju

ly

201

0. A

cces

sed

Jan

uar

y 15

, 202

1.

27. R

uit

enb

erg

R. C

imm

yt

intr

odu

ces

wh

eat

tole

ran

t to

Ug9

9 fu

ngu

s in

Ban

gla

des

h. B

loo

mb

erg.

htt

ps:

//w

ww

.blo

om

ber

g.co

m/n

ews/

arti

cles

/201

2-03

-26/

cim

my

t-in

tro

duce

s-w

hea

t-to

lera

nt-

to-u

g99-

fun

gus-

in-

ban

gla

des

h. P

ub

lish

ed M

arch

26,

201

2. A

cces

sed

Jan

uar

y 15

, 202

1.

28. D

ahm

M. L

et t

her

e b

e fo

od

to

eat

. CIM

MY

T.

Pu

bli

shed

Dec

emb

er 9

, 202

0. A

cces

sed

Jan

uar

y 15

, 202

1.

htt

ps:

//w

ww

.cim

my

t.o

rg/n

ews/

let-

ther

e-b

e-fo

od

-to

-eat

/

29. M

arsa

li M

A, G

old

ber

g N

P. L

eaf,

Ste

m a

nd

Str

ipe

Ru

st

Dis

ease

s o

f W

hea

t. C

oll

ege

of

Agr

icu

ltu

ral,

Co

nsu

mer

an

d E

nv

iro

nm

enta

l Sci

ence

s, N

ew M

exic

o S

tate

U

niv

ersi

ty; 2

016

. Acc

esse

d J

anu

ary

15, 2

021.

htt

ps:

//ac

es.

nm

su.e

du/p

ub

s/_

a/A

415/

wel

com

e.h

tml

30

. GM

Wat

ch. N

on

-GM

su

cces

ses:

Dro

ug

ht

tole

ran

ce.

GM

Wat

ch.o

rg. P

ub

lish

ed 2

020

. htt

ps:

//gm

wat

ch.o

rg/e

n/

dro

ug

ht-

tole

ran

ce

31. G

ilb

ert

N. C

ross

-bre

d c

rop

s ge

t fi

t fa

ster

. Nat

ure

N

ews.

201

4;51

3(75

18):

292

. do

i:10

.103

8/51

3292

a

32. G

MW

atch

. No

n-G

M s

ucc

esse

s. g

mw

atch

.org

. P

ub

lish

ed 2

020

. htt

p:/

/ww

w.g

mw

atch

.org

/in

dex

.ph

p/

arti

cles

/no

n-g

m-s

ucc

esse

s

33. R

obi

nso

n C

. Is

the

pu

bli

c to

bla

me

for

coll

apse

of

the

GM

O v

entu

re?

– P

art

2. G

MW

atch

. Pu

bli

shed

May

8,

201

8. A

cces

sed

Ju

ly 9

, 201

8. h

ttp

s://

ww

w.g

mw

atch

.org

/en

/new

s/la

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60 rue Wiertz/Wiertzstraat 601047 Brussels, Belgium

[email protected]

200


From: Linda Grammer


Cc: BDC_Info; Ian Mulholland

Subject: further Evidence (as part of the submission to the BDC draft LTP 2021/31 regarding controversial Stevenson Mining/

Rangitira Ltd application/ proposal for large open cast coal mine Te Kuha above Westport

Date: Tuesday, 18 May 2021 3:27:11 pm

Attachments: image001.png

2018-05-28 Linda Grammer evidence.docx

att: BDC draft LTP 2021/31 team

Further information as part of our submission to the BDC draft LTP

2021/31

Submittors:


Seddonville



For your information, please see the attached Evidence (Linda

Grammer Evidence submitted to the Environment Court in May 2018

regarding Stevenson Mining/ Rangitira Ltd proposal for a large open

cast coal mine on Te Kuha

ENV-2017-CHC-090 - Royal Forest and Bird Protection Society of

NZ Inc v BDC & WCRC

This Evidence is supplementary to our submission to the BDC draft

LTP 2021/31 and relevant to the Climate Change, sustainability,

indigenous biodiversity, Outstanding Landscapes and other

environmental issues

201



(this Evidence is part of our submission to the BDC draft LTP 2021/31

Chrissie McKee

Case/Hearing Manager

Environment Court of New Zealand | Land Valuation Tribunal

| 20 Lichfield Street | PO Box 2069 | WX11113 | Christchurch

E-mail: [email protected]

Website: https://environmentcourt.govt.nz/

Confidentiality notice:

This email may contain information that is confidential or legally privileged. If you have received it

by mistake, please:

(1) reply promptly to that effect, and remove this email and the reply from your system;

(2) do not act on this email in any other way.

Thank you.

202


1

THE ENVIRONMENT COURT

CHRISTCHURCH

ENV-2017-CHC-90

IN THE MATTER of the Resource Management Act 1991

AND IN THE MATTER of an appeal under section 120 of the Resource

Management Act

BETWEEN THE ROYAL FOREST AND BIRD PROTECTION SOCIETY

OF NEW ZEALAND INCORPORATED

(Appellant)

AND

WEST COAST REGIONAL COUNCIL and BULLER DISTRICT COUNCIL

(Respondents)

AND

STEVENSON MINING LTD

(Applicant)

ENV-2017-CHC-90

Forest & Bird v Buller District Council and West Coast Regional Council

WITNESS BRIEF

LINDA GRAMMER

DATED: 20 MAY 2018

SUMMARY

I am opposed to the proposal to develop and operate a new open-cast coal

mine* at the south-western part of the Mt William Range (Mt Te Kuha,

lower Kawatiri river / Buller Gorge) within Mining Permit 41-289 and

strongly support the appeal lodged by the Royal Forest and Bird Protection

Society to the Environment Court.

My name is Linda Grammer. I am a member of Rural Women NZ and the

Buller Tramping Club, and live north of Westport.

203


2

I strongly support the position of Federated Mountain Clubs (our national

organisation) on the proposed new coal mine on Te Kuha, due to Te

Kuha's high ecological, recreational, and cultural values.

See

https://www.fmc.org.nz/2017/12/10/federated-mountain-clubs-says-no-to-te-kuha-mine/

I understand that the proposed coal mine's "footprint" would cause

significant destruction of 12ha of (high ecological value) public conservation

land and adversely impact on the natural values and mauri of the Westport

Water Conservation Reserve (100 ha).

As a member of the public, I expect our public conservation lands of high

ecological value and Westport Water Conservation Reserve (Westport

residents water supply) to be protected from degradation caused by mining.

I urge Buller District Council (in keeping with section 32 of the Reserves

Act) to protect the Westport Water Conservation Reserve's valuable natural

features. I understand that under Section 32 of the Reserves Act BDC is

required to "protect the features of scenic, natural and biological features of

the reserve". I understand Forest and Bird is appealing a recent decision

on this matter.

In my view, our local councils (Buller District Council and West Coast

Regional Council) have failed (by approving the Stevenson Mining Ltd

application) to honour their obligation to manage natural and physical

resources in a truly sustainable manner and have acted contrary to the the

requirements of the RMA.

I also note that Buller District Council states (in the BDC draft Long Term

Plan 2018-28) under "Sustainable Environment"

-"The distinctive character of the environment is retained"

-Natural environment valued & protected

-Quality of natural environment improved and maintained

-The distinctive character of the environment appreciated and retained

I supported all of the above points in my recent submission to the BDC

draft LTP 2018/28 but BDC's support for a new open-cast coal mine on Te

Kuha contradicts all of the above, which is of concern to local residents and

ratepayers like myself.

(see Appendix for page #"s from the BDC draft LTP 2018/28)

204


3

In recent years, too much degradation of pristine landscapes in the Buller

has been allowed to occur. We now have ugly, linear scars across the

faces of the formerly pristine Lyell Range and Mt Rochfort face. The

landscape of the Stockton Plateau, including the expansion of the Rockies

Mine, is increasingly unattractive. Sub-alpine environments do not heal

easily due to slow vegetative growth at high altitudes. We have already lost

too much of the natural beauty of our District, which international visitors

acclaim, and many local people love and treasure.

Te Kuha's high ecological values and beauty must be protected from

inappropriate development like a new open- cast coal mine.

I welcome the Department of Conservation decision to join Forest and

Bird's appeal, with Expert Witnesses detailing the Department's legitimate

concerns about the proposed mine's adverse effects on Te Kuha's high

ecological values including significant indigenous vegetation, significant

habitat of indigenous fauna, intactness and ecological integrity, and rare

species of conservation concern.

I urge the Department of Conservation to refuse access to Stevenson

Mining Ltd/ Rangatira Developments for a new open cast coal mine on Te

Kuha.

High Ecological Values of Te Kuha need Protection

I want to see the distinctive character of Te Kuha retained and it's high

ecological values (which I understand are not disputed by any party) and

rare endangered species/ endemic species protected in perpetuity. In my

view the Stevenson Mining proposal for a new mine on Te Kuha is

unnecessary and (given the extent of the environmental damage it would

cause) the claims by the applicant about the benefits for Westport are

exaggerated.

The fact is that on the Denniston plateau the Sullivan mine and Escarpment

are lying idle, the proposal for new open cast coal mine in a pristine area

(Te Kuha) is ridiculous when other coal mines that exist in degraded areas

are not being fully utilized.

I am concerned about what would result in not only the highly visible

degradation of an Outstanding natural landscape that this new open cast

coal mine would cause, but the destruction of habitat for endangered and

rare species and adverse impacts on the water supply for the people of

Westport.

205


4

The proposed new mine would not only destroy an Outstanding Landscape

but destroy the habitat of these and other rare and endangered native

species:

Great Spotted Kiwi, kiwi, South Island fernbird, kakariki, rifleman, forest

gecko, speckled skink, rare eyebright plants, the largest known population

of the rare forest ringlet butterfly as well as the following unique endemic

native species including a recently discovered new species of tiger beetle

as well as a unique leaf-veined slug. The mine would also cause the

destruction of 500 year old native trees including rimu in an area beloved

by trampers and hunters (of feral pest animals).

The proposed mine could push Great Spotted kiwi and other endangered

species such as South Island fernbird and the West Coast green gecko

closer to extinction. This must not be allowed to happen.

Stevenson Mining has yet again (I understand this is the second time that

Stevenson has applied to construct a mine at this site, previously without

success) overstated the benefits of a new coal mine on Te Kuha to the

local community. Short term jobs (for a period of about 15 years) do not

justify destroying public conservation lands of high ecological and cultural

significance (in an Outstanding Landscape).

If development is to be beneficial to the District over the long term, it must

not be at the expense of the natural environment, endangered and endemic

native species. I do not find the lawyer's (representing Rangitira

Developments) claim that Rangatira will undertake robust "mitigation" and

"environmental compensation" within our public conservation lands/

reserve and on adjacent land credible.

How do you "mitigate" felling 500 year old rimu trees within the short time

frame (15 years) of the application?

It is impossible.

The applicant's mining proposal is for an area that is the last, untouched

portion of the highly unique Brunner coal measures, being part of the north-

west Nelson Cretaceous peneplain. Coal mining has already caused

extensive destruction to unique ecosystems in the Buller District, with

toxins including heavy metals and acidic mine drainage adversely affecting

downstream waterways. The Te Kuha area and the town of Westport must

be protected from companies like Stevenson Mining/ Rangatira.

In my view, promises that the applicant will "undertake pest control" on our

public conservation lands on Te Kuha or the Westport Water Conservation

Area is no compensation if Rangitira is allowed to destroy the actual home/

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5

habitat of endangered rare (and endemic) species. The native species

(indigenous flora and fauna) are not protected by allowing mining to occur

on our public conservation lands or Water Conservation Reserve, even if

ground based feral control is done on adjacent areas and at the mine site.

Claims by the applicant that the site can be quickly remediated are not

credible. The destruction of the beautiful rimu forest (35 metres high in

places) would take hundreds of years to recover. The scars will be visible

from Westport including the beautiful walks at the mouth of the Buller river.

The beautiful rimu forest at Te Kuha, home of Great Spotted Kiwi and other

rare and endangered indigenous flora and fauna must be protected in

perpetuity.

I support the evidence of the Crown experts who note the harm that this

proposal will do to endangered and rare native species and those with

geological expertise who note the unsuitability of the site for an open cast

mine. I understand this proposal has been turned down before by BDC. If

the applicants proposal is allowed to proceed, it would have a significant

and negative permanent impact on rare and threatened (and endemic)

animal and plant species.

WATER QUALITY- DEGRADATION THAT WOULD BE CAUSED BY THE

PROPOSED MINE

Te Kuha waterways are unmodified and of high value (and should remain

this way).

The proposed mine would cause degradation of the Westport Water

Conservation Reserve and toxic discharges to side creeks and the

Kawatiri/ Buller river. Stevenson Mining Ltd's own aquatic ecologist stated

(when he gave evidence at the Westport hearing):

"The mine would discharge extra sediment and heavy metals into

tributaries of West and Camp creeks which become part of Coal creek and

discharge into the Buller River."- Ian Boothroyd, 19 September 2017

Westport News

Large-scale opencast mining in particular permanently changes natural

landscapes and destroys high value ecological areas. It can result in

significant water pollution. The loss of habitat means the loss of aquatic

habitat and associated aquatic flora and fauna (which is unacceptable).

The proposed mine access road would be through a mix of old-growth

indigenous forests on the lower slopes leading up to the plateau, and the

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6

indigenous shrublands and herb fields characteristic of the Buller plateau,

crossing wild, beautiful and unmodified streams carrying the purest water.

The adverse effects to the Te Kuha waterways include but are not limited

to: Loss of pristine, beautiful waterways (also visited and enjoyed by

trampers and hunters), loss of quiet enjoyment, loss of water quality, loss of

indigenous aquatic species and habitat, adverse impacts on the water

quality of the Buller River, with potential negative implications for white

baiting. I am mindful of what has happened to the beautiful Ngakawau

river (below an existing mine site), which is still (despite recent best

practice efforts to clean up the river) highly degraded.

ADVERSE IMPACTS ON TOURISM AND LOCAL PEOPLE

The huge draw card of our indigenous ecosystems and the beautiful

landscapes in which they are found is central to the current surge in

tourism that helps drive the NZ economy. That's why (along with the way

many local residents highly value Te Kuha and the Westport Water

Conservation Reserve) it makes so much sense to protect them.

The biodiversity and productive ecosystems / ecosystem services of Te

Kuha and the Westport Water Conservation Reserve must be protected as

these are highly important to the health and wellbeing of the people of

Westport

The proposed mine will damage Westport's important "West Coast:

Untamed Natural Wilderness" Brand and make tramping in the Buckland

Peaks unpleasant (as the view from Caroline Terrace/ Virgin Flat/ Buckland

peaks will be adversely effected with a devastating visual impact). The

negative visual impact would be during the day and potentially by night as

the applicant can easily apply for a new resource consent to do permanent

24/7 night shift, which has been granted in the past to Bathurst Resources.

Not only would having a new open cast coal mine on the West coast have

a negative effect on NZ's global image but it will damage the national

image of Westport and its suitability as a destination for tourism (and in

particular eco-tourism).

The main street of Westport (Palmerston) has various attractive signs

proclaiming "WEST COAST- UNTAMED NATURAL

WILDERNESS". Approval of this application for a destructive, extractive

new coal mine on highly visible (from Westport and surrounding area)

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7

public conservation lands would damage this valuable brand. It would delay

the badly needed transition to a West Coast economy that is not dependent

on the polluting extraction of non-renewable resources.

Aside from the significant threat to biodiversity – unique native species, the

web of life in this particular place – the proposed mine on Te Kuha would

have devastating visual impact when seen from Westport, the mouth of the

Kawatiri river (where locals and tourists go to recreate), and the

surrounding mountains, including (as already mentioned) the spectacular

Buckland Peaks on the southern side of the Buller gorge.

This mine, if given the green light, would be a symbolic visual sore shaping

the image and reputation of Westport among other New Zealanders and

international tourists for generations.

The proposal, while needlessly harmful to the Westport-Buller Gorge

environment, also flies in the face of the biggest challenge of our time –

climate change. New Zealand has committed to act. Regardless of where

coal is burned if it’s burned it increases global climate disruption.

The Buller region, the Coast, and many Kiwis & their families, who almost

by definition love the outdoors, can do better than open-cast coal mining,

which is permanently destructive, polluting, harms valuable ecosystems,

and simply outdated.

NOISE & LIGHT POLLUTION

Noise pollution from the proposed mine will be a problem for some

Westport residents, dependent very much by wind direction. Light pollution

is likely to be a problem for Westport residents including those who live

near the Orawaiti/ Sargeants Hill area if the application goes ahead during

the stated hours that Stevenson Mining has sought permission for (early in

the day and late in the afternoon/ evening). Night pollution (from lighting

towers and vehicles) would also be a problem as Stevenson Mining is likely

to apply for a new resource consent for permanent night shift 24/7 (as other

mining companies like Bathurst has done- they do not let valuable mining

equipment lie idle overnight).

On top of all the unacceptable adverse impacts that a new open cast mine

on beautiful Te Kuha would cause, the truth is we can’t afford to burn coal

that would be obtained from Te Kuha without going over 2 degrees, and

staying within 2 degrees is Government policy

CLIMATE CHANGE

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8

Buller District is already feeling the effects of climate change, with severe

storms and coastal erosion threatening local communities and (for

example) the Granity school.

Allowing this mine to proceed would not only destroy valuable high value

ecosystems and harm rare endangered (and endemic) native species but

burning the coal mined would contribute to taking us over 2 degrees (Paris

Climate Change Agreement) and staying within 2 degrees is government

policy in New Zealand. So why would a new coal mine, especially in such a

pristine environment (Te Kuha) be permitted?

In addition to the permanent damage that the proposed open cast coal

mine would cause to the unique ecological values and indigenous

biodiversity/ Outstanding Landscape of Te Kuha, and damage to water

quality (side creeks, the Buller river, the Westport Water Conservation

Reserve), our growing tourism industry, the peace and quiet/ well being of

the people of Westport, the contribution a mine would make to climate

change is unacceptable.

Background:

NZ is a signatory to the Paris Agreement 2015, which agreed to do

everything possible to keep temperature rise to less than 2 degrees, and if

possible less than 1.5 degrees. Information is readily available at the IPCC

website

Intergovernmental Panel on Climate Change

http://www.ipcc.ch/

and at

http://www.mfe.govt.nz/climate-change/why-climate-change-matters/global-response/paris-

agreement

Thank you for the opportunity to be heard in Westport. Please keep me

informed of any hearing. I have some photographic evidence I would like to

table on the day. Thank you.

ENDS

* The open-cast coal mine's "footprint" would cover 144ha, including

12ha of conservation land, 100ha of the Westport Water Conservation

Reserve and the remainder on private land.

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9

Original submission by Linda Grammer available online:

http://www.wcrc.govt.nz/our-services/resource-consents-and-

information/Documents/Submitters%20Evidence/Grammer,%20Linda%20

%E2%80%93%20Updated%20Written%20Submission.pdf

Date:

Monday, 25 September 2017 hearing Westport

and

MEMORANDUM IN RE RESOURCE CONSENT APPLICATION (Wi Pere

Trust entity) TO MINE TE KUHA - MY ANCESTRAL MOUNTAIN

TO: Ms Linda Grammer Buller District

FROM: Ms Iri Sharon Rose Sinclair BA LLB – Nihorere whanau-whanui

25th September 2017

APPENDIX:

In my recent submission in response to the Buller District Council draft

Long Term Plan 2018/28 I supported the following content

P. 44 it states under the heading "Sustainable environment"

"the distinctive character of the environment is retained"

see also

on p. 47 Sustainable Environment

"Water management and quality"

"Visitor level of appreciation"

and then

"Council Advocates"

-Natural environment valued & protected

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10

-Quality of natural environment improved and maintained

Climate Change

p. 27 "Climate change, it affects us all"

p. 28 "what council is doing about climate change" (in my view BDC needs

to do more)

p. 51

Point 4 (Sustainable Environment)

The distinctive character of the environment appreciated and retained.

What does council want to achieve?

-An appropriate balance between development and protection that

promotes the diversity and sustainability of our natural environment

How will council contribute to achieving these objectives?

-Develop policies and implement practices that enhance our environmental

sustainability and natural diversity

-Recognise and preserve the essential elements of the district's landscape

that contributes to Buller's unique natural identity

p. 52

Point 5 (Prosperity)

A thriving resilient and innovative economy creating opportunities for

growth and employment

What does council want to achieve?

Support sustainable responsible development, innovation and excellence

How will Council contribute to these objectives?

-Develop within a regulatory framework that supports sustainable economic

growth without compromising the environment

Comment: a new open cast coal mine on Te Kuha does not fit the above

stated goals/ criteria

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From: Linda Grammer


Cc: BDC_Info

Subject: further Evidence (Iri Sinclair submitted Evidence as part of Linda Grammers Evidence re: Te Kuha) as part of Linda

Grammer/Ian Mulholland submission to BDC draft LTP 2021/31

Date: Tuesday, 18 May 2021 3:36:02 pm

Attachments: Te Kuha Submission - Nihorere whanui.docx

nihorere whakapapa.pdf

att: BDC draft LTP 2021/31 team

Further information as part of our submission to the BDC draft LTP

2021/31

Submittors:


Seddonville



For your information, please see the attached Evidence (Iri Sinclair

Evidence submitted to the Environment Court as part of the

Evidence by Linda Grammer in May 2018 regarding Stevenson

Mining/ Rangitira Developments Ltd proposal for a large open cast

coal mine on Te Kuha above Westport

ENV-2017-CHC-090 - Royal Forest and Bird Protection Society of

NZ Inc v BDC & WCRC

This Evidence is supplementary to our submission to the BDC

draft LTP 2021/31 and relevant to the Climate Change,

sustainability, indigenous biodiversity, Outstanding Landscapes

and other environmental issues as well as council obligation to

respect Te Tiriti o Waitangi and act on the concerns/ wishes of

local mana whenua regarding indigenous biodiversity and other

natural values (as well as cultural)

213



(this Evidence is part of our submission to the BDC draft LTP

2021/31

Chrissie McKee

Case/Hearing Manager

Environment Court of New Zealand | Land Valuation Tribunal

| 20 Lichfield Street | PO Box 2069 | WX11113 | Christchurch

E-mail: [email protected]

Website: https://environmentcourt.govt.nz/

Confidentiality notice:

This email may contain information that is confidential or legally privileged. If you have received it

by mistake, please:

(1) reply promptly to that effect, and remove this email and the reply from your system;

(2) do not act on this email in any other way.

Thank you.

214


MEMORANDUM IN RE RESOURCE CONSENT APPLICATION BY RANGATIRA HOLDINGS LTD

(Wi Pere Trust) TO MINE TE KUHA - MY ANCESTRAL MOUNTAIN

TO: Ms Linda Zelka Grammer

Seddonville

Buller District

FROM: Ms Iri Sharon Rose Sinclair BA LLB

26th

September 2017

___________________________________________________________________________

Tena koe,

Thank you for contacting me about this resource consent application, which I was completely unaware of, and

taken aback to learn of. Please find below some points I wish you to put to the consent authority considering the

application, which are pertinent to my status as tangata whenua of the land which Rangatira Holdings Ltd seeks

resource consent to mine.

I submit that the application for resource consent/s should be declined. My reasons are set out below – but in

summary concern Resource Management Act (1991) sections 6(e), 7 and 8, and the Fourth Schedule to the Act

which sets out the requirements for an Assessment of Effects etc.

Thank you for being so kind as to agree to including the following information on behalf of myself and our

whanau whanui, hapu & iwi etc as part of your own submission opposing this resource consent application. Nga

mihi nunui ki a koe!

Please let me know how you go. If there is any opportunity for me to speak to my submission I would be happy

to do so – either in person or via skype etc. As you know I reside in Otautahi Christchurch where I work for our

Wairewa Runanga Natural Resources Komiti, as I am also Ngati Irakehu. I thank you for contacting me from

the bottom of my heart.

No reira e hoa, kai te mihi, kai te mihi, kai te mihi!

Heoi ano, na

Iri Sinclair BA LLB

Papa Associates

Resource Management

Ko Tuhuru te tangata

Ko Arahura te awa

Ko Poutini te taniwha

Ko Pounamu te taonga

Ko Mawhera te whenua

Ko Ngati Waewae, Poutini Ngai Tahu nga hapu

Waitaha, Ngati Mamoe, Kai Tahu oku iwi!

Ti hei Mauri Ora!

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I am a Resource Management Consultant, with a law degree from the University of Canterbury specialising in

natural resource (environmental) law. I also have a Bachelor of Arts degree (Art History and Anthropology) from

the University of Auckland. I am Ngai Tahu and work and reside in my turangawaewae Te Waipounamu. I am a

former member of Nga Tauira Maori, the Maori Students Association of the University of Auckland – Te Whare

Wananga o Tamaki Makaurau.

Following the enactment of the Resource Management Act 1991 I was employed as the Kaitakawaenga/Iwi

Planner by the West Coast Regional Council (WCRC) and also acted as the Secretary of the Treaty Partnership

planning committee ‘Te Komiti Rangapu’. That standing committee included elected Regional Councillors and

hapu representatives from throughout Te Tai Poutini.

I designed and managed the tangata whenua consultation process for the West Coast Regional Policy Statement,

and the West Coast Regional Coastal Plan. The WCRPS chapter ‘Issues of Significance to Poutini Ngai Tahu’

was penned by myself after a thorough consultation process and sign off by tangata whenua.

My appointment to that role was requested and endorsed by Arahura Kahui Kaumatua and my esteemed Uncle

Mr Eli Weepu of Arahura Pa, and our tribal hapu council (Runanga). During my five year tenure at the WCRC I

also developed a publication for the Council - ‘Tangata whenua Consultation Guidelines for Resource Consent

Applicants’ which every resource consent applicant received. I was also seconded at that time to Maruwhenua –

the Maori Secretariat of the Ministry for the Environment.

In 2004 I returned to study at the University of Canterbury and graduated LLB in 2009. My specialty is Natural

Resource Law, and my lecturer in this subject was Dr David Round. I am also interested in Jurisprudence and the

Common Law.

Since that time I have worked as a Resource Management Consultant. Presently I work for Wairewa Runanga and

Te Kete o Wairewa Ltd undertaking a range of work in Canterbury.

Ka nui taku mihi mahana ki a koutou.

I request that the consent authority considering the application by ‘Rangatira Developments Ltd’ decline ALL of

the resource consents sought for the Te Kuha mining project enterprise, for the following reasons.

The Arahura Deed of Purchase (1860) includes a map which defines my tribal rohe or area recognised by the

Crown – extending from Kahurangi Point (North of Karamea) south to Piopiotahi (Milford Sound, Fiordland)

from the coast inland to the peaks of the Southern Alps.

This year my iwi Ngai Tahu commemorate the 20th

anniversary of the settlement of the Ngai Tahu claim to the

Waitangi Tribunal by the Crown. Our hui a tau (AGM) is on 23rd

November 2017 at Tuahiwi Pa.

Regrettably the fact of our Treaty settlement two decades ago has not engendered any greater understanding of

our people and our culture and traditions on the West Coast (Te Tai Poutini) by developers, as evident by the

resource consent application concerning a proposal to mine my ancestral mountain Te Kuha.

We have a saying in my Nihorere whanau: “We fight from the Coast”.

The proposed 116 ha mine footprint is located over two different types of publicly owned Crown. I understand

that the land tenure of this ‘public’ or Crown land includes the following:

(1) Public conservation land administered by the Department of Conservation (DOC) as Stewardship land

under the Conservation Act 1986; and

(2) Land managed by the Buller District Council under the Reserves Act 1977 as ‘Local Purpose (Water

Conservation) Reserve’.

Much of the proposed site (approximately 100 hectares) is land held by the Buller District Council as a water

conservation area. It seems logical that this land would have been designated a water conservation area for the

important purpose of providing a safe potable fresh water supply for the town of Westport.

Any alternative usage of this parcel of land must therefore be ultra vires the regulations or statutes under which

the Crown and local government in Buller originally set aside the area and deigned it a ‘Water Conservation

Reserve area’. Even if this alternative purpose – land disturbance and other activities related to coal mining – was

216


valid at law, it is my submission that the application needs to be declined in its entirety under the Resource

Management Act 1991 as a matter of law.

Water quality issues are a hot topic in local government circles in Aotearoa New Zealand, in the wake of the

outbreak of waterborne disease in the Hawkes Bay due to the negligence of the Hastings District Council. A more

recent outbreak of waterborne disease in the Hawkes Bay region indicates that Council’s with legal duties

regarding potable water supply to their communities and ratepayers really need to take their legal responsibility

for protecting healthy water sources most seriously indeed. Typhoid is a potentially fatal disease. A number of

residents in that district are now ill and have been hospitalised for urgent treatment according to recent news

reports.

We have a whakatauake which reflects our Maori world view of the importance of health and wellbeing of people

and communities, and thus it follows that wai Maori or drinking water must be protected for the community of

Westport:

He aha te mea nui? He tangata, he tangata, he tangata! Translated this proverb asks the question: What is the most

important thing? It is people, it is people, it is people!’

Our rich gold and coal mining history here in Te Tai Poutini is widely known and has been written about in many

published tomes. Gold was in fact discovered by Chief Tarapuhi the eldest son of Tuhuru.

Some of the negative ‘legacy’ issues arising from the historical mining that took place in the 19th century

throughout the West Coast region continue to be problematic, with acid and heavy metal leachate from old mine

workings creating serious health risks in numerous waterways, which do not meet National Standards for safe

contact (eg swimming, whitebaiting etc). An example of this is at Paroa in the Grey District.

The West Coast Regional Council maintains a register of contaminated sites as required by law. The remediation

of these sites is financially costly and often imposes a burden on the present generation of ratepayers.

Therefore, consent authorities ought to have these facts at front of mind when considering applications for mining

activities and other activities which could have a downstream effect or a cumulative effect on water quality now

or in the future, which is necessary for potable public water supply.

On the face of it, it seems obvious that this proposal to carry out mining operations on land set aside for fresh

water conservation is at odds with the RMAct (1991), in particular the overarching sustainable purpose of the Act.

At any rate, it would appear, that the Buller local authorities historically in their wisdom saw fit to set aside this

land specifically to safeguard the water supply of the Westport and surrounding communities.

It also needs to be taken into account that West Coast tangata whenua have in the past expressed concern that

identified toxic sites which are contaminated by toxic waste and/or leachate or discharges from old mine workings

or tailings etc, need to be remediated as a priority. Creating problems for future generations of West Coasters is

not a good idea, and I can confidently say that it is not something that we Poutini Ngai Tahu people have ever

supported. Our world view is neatly set out in the WCRPS which I cite in support of this part of my submission.

In addition, the West Coast Regional Policy Statement contains issues of significance to the tangata whenua,

which are required to be taken into account in the consideration and determination of resource consent

applications, including that of the application in question.

I might add, that I was working as ‘Kaitakawaenga – Iwi Planner’ for the West Coast Regional Council in the

early 1990’s following the enactment of the Resource Management Act (1991). It was my responsibility to arrange

the consultation hui and wananga for Poutini Ngai Tahu, and also to act as the Secretary of the ‘Komiti Rangapu

– Treaty Partnership Committee’ which was then a Standing Committee of the West Coast Regional Council. If I

remember rightly the relevant chapter in the West Coast Regional Policy Statement (WCRPS) was entitled “Issues

of Significance to Poutini Ngai Tahu”.

The WCRPS will have by now undergone a statutory review. However, I am confident that the issues as stated

back then therein remain the same. Therefore, I refer the Hearings Commissioner/s and the Applicant ‘Rangatira

Holdings Ltd’ to the WCRPS which I cite in support of my submission that this resource consent application to

establish a mining operation on our maunga Te Kuha must be declined in full.

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Turning now to the other land that would be impacted if these consents were granted, I understand that the

remaining area within which the resource consent applicant wants to operate a coal mine is on Conservation Land

held by the Crown for the purposes of conservation.

Mining purposes and conservation purposes are in my view mutually exclusive concepts.

The privatisation by stealth by the Crown in the guise of DOC on the West Coast and throughout New Zealand,

by way of ‘public-private’ partnerships has drawn the wrath of ordinary Kiwi’s concerned at the loss of public

access to our National Parks and other conservation lands, as private organisations such as the ‘Old Ghost Road

Trust’ etc have been seen to enter contractual agreements with the Minister of Conservation to build tourist

facilities, new bridges and roads, fell ancient Kahikatea and other native trees, and encourage hoards of mountain

cyclists in the Buller back country between Lyell in the Buller (Kawatiri) Gorge and Mokihinui-Seddonville, in

the Mokihinui Ecological area, which is dangerous for people like me – Ngati Waewae – who like to walk in

peace in the bush.

Perhaps the new MMP coalition Government will revisit the Conservation Act (1987) and review changes to that

and other pieces of legislation and regulations which have eaten away at public access to bush walks, tramping,

deerstalking and hunting in our beautiful natural native forest areas in Te Tai Poutini, through granting leases,

licenses and concessions to private business interests who profit from their exploitation of the public conservation

estate. I live in hope.

My concerns regarding the proposal relate in particular to my being tangata whenua and a direct descendent of

Tuhuru & Papakura of Ngati Waewae, Poutini Kai Tahu.

Tuhuru was the paramount chief of Te Tai Poutini whose mana extended over the Kawatiri or Buller District

including Te Kuha and the environs of our maunga Te Kuha. This fact has been recognised by numerous official

enquiries, and the Crown eg Young Commission in the 19th

century which held hearings in Greymouth at which

my tupuna gave evidence, and the Waitangi Tribunal.

My whanau come from the Mataamua line – the matriarchal chiefly line. My Great-Grandmother Kura Arapata

Horau was a member of the Mawhera Land Committee in the early 20th

Century. She married my Poua Tame

West and together they farmed our whanau land beside the famous Arahura River.

My late Aunt Rt Hon Whetu Tirikatene Sullivan was the first Minister for the Environment in the 1972 Labour

Government and was the second longest serving Member of Parliament for the Labour Party. Her father Sir Eruera

Tirikatene was my Grandmother’s first cousin – their respective mothers were sisters (Kura Arapata Horau & Tini

Arapata Horau who married Mr Tregerthen (anglicised to Tirikatene).

My cousin Rt Hon Sandra Lee Vercoe QSM was the Minister of Conservation in the Labour-Alliance Government

led by Prime Minister Rt Hon Helen Clark.

We are all direct descendants of Papakura through Nihorere who was born here about the time of the Battle of

Waterloo, and we have over 70 generations of custom, usage and tino rangatiratanga here in Te Tai Poutini and

Te Wahi Poenamu. Ka tangi te titi, Ka tangi te kaka!

I give my pedigree or whakapapa as it relates to my turangawaewae Te Kuha, to show my tangata whenua status

under the RMAct (1991):

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Tuhuru=Papakura

/ I

Nihorere = Te Niho (Ngati Rarua Rangatira) from North of Kahurangi Point where he was still living when

Heaphy was guided into our tribal area by our relative Kehu et al from Ngati Apa in 1846.

/

Kapaki Wikitoria (the daughter of Nihorere) = Pokaka aka Arapata Horau (after whom Albert Street in Greymouth

is named – as it was the site of their town residence. Arapata Horau was the Native Assessor for Greymouth which

was the equivalent of a District Court Judge. He and Kapaki gifted the land for the first Anglican Church in

Greymouth which was lost in a fire).

/

Kura Arapata Horau = Tame Whakamaua Pihawai West

/

Roka Te Hakamatua Pihawai West = Cyril Seymour Johnson

/

Iri May Johnson = Albert Joseph George Barber

/

Sharon Rose aka Iri Sinclair nee Barber.

It must be emphasised that when Heaphy staggered (with the assistance of dedicated Maori guides without whom

he would have died), down the West Coast in 1846 he found our people had cultivated hundreds of acres on the

south bank of the Kawatiri (Buller) River in both taro and potatoes. This was a practical demonstration of our

sovereignty or mana motuhake, mana whenua, te tino rangatiratanga over the northern West Coast which we call

Te Tai Poutini. Interestingly during that 1846 whitebait season, Mr Heaphy also saw one of our tohunga

conducting traditional customary rites relating to the self-management of our whitebait fishery on the Kawatiri or

Buller River.

My pepeha set out above upholds these facts.

If resource consent is granted, there will be major detrimental environmental effects upon my role as a kaitiaki

for Te Kuha, and the role my whanauka play in taking care of our environment properly, to uphold the mana of

our illustrious tipuna.

There are numerous rare and threatened species of flora and fauna in the application area at Te Kuha, which are

‘Taonga Species’ as identified in the Ngai Tahu Settlement Act. Others are ‘taonga’ in the sense that word is used

in Te Tiriti o Waitangi (see s.8 RMAct 1991).

Te Kuha is a mighty mountain which is part of an outstanding ancestral Maori landscape highly visible from

Westport and the lower Buller Gorge, where our fighting Pa was – as is recorded on historic maps, and known to

archaeologists and the former NZ Historic Places Trust, now called ‘Heritage New Zealand’..

I am unaware as to whether the West Coast Regional Council followed through on the WCRPS by undertaking a

‘Silent File’ project such as that included in the Canterbury Regional Policy Statement, which Komiti Rangapu

agreed to do in the 1990’s. However, I refer you to the ‘Mahaanui Iwi Management Plan 2013 which is recognised

in all planning documents by Environment Canterbury (ECAN) and the Christchurch City Council, which contains

information relating to the Silent File register. This Iwi Management Plan (IMP) has been written by the Ngai

Tahu Papatipu Runanga in the Canterbury and Horomaka or Banks Peninsula/Lake Ellesmere rohe.

I have sincere concerns that the application site may include wahi tapu and other sites of significance to myself,

my whanau and our hapu and iwi, which cannot be made certain without some research into the matter, and a full

and proper site visit etc. In any event, the removal of our mountain top is non-negotiable and cannot be allowed

to proceed under any circumstances.

The Assessment of Effects is inadequate due to inadequate consultation with tangata whenua, and no full and

proper AEE in terms of the special relationship of tangata whenua and our culture and traditions with our lands,

waters and other taonga under the RMAct 1991.

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Lastly, I would ask the Commissioner/s to ask the applicant company – which I understand has a relationship to

the Wi Pere Trust, whether the Directors and Shareholders of the applicant legal entity, or the related Trust, would

be happy for myself, or one of our Ngai Tahu or hapu companies, or Trusts named after one of our illustrious

tipuna, to make an application for a resource consent to remove the top off our other sacred mountain Hikurangi

in our ancestral homelands of Te Tairawhiti, for the purposes of mining coal or some other activity?

My tipuna Rt Hon H.K Taiaroa MP (and for a brief period Mr Ihaia Tainui MP the tipuna of my Uncle Eli Weepu

of Arahura Pa) sat in the Upper House of Parliament after 1867 with Wi Pere MP and were all on the Native

Affairs Select Committee when Fenton CJ and Premier Fox ran the Law Courts and Colonial then Settler

Government respectively. The Maori Members of Parliament all knew each other well and supported each other.

I would never entertain the notion of going into another tribal rohe to takahia upon the mana of the chiefs of that

place.

Worse still is that we are related to Te Aitanga a Mahaki. According to our tipuna Tikao (a recognised whakapapa

expert and the inaugural Chairman of the Kotahitangi Maori Parliament at Papawai Marae), our Ngai Tahu

whakapapa is senior to Ngati Porou who are our much loved relations whom we left behind in Te Tairawhiti to

take care of our sacred mauka Hikurangi, while we came South to Aoraki (Mt Cook), to Te Kuha overlooking the

Kawatiri River, to Tuhua standing beside our Arahura River, and Mt Tutoko in the southern part of Tai Poutini.

Whāia te iti kahurangi ki te tūohu koe, me he maunga teitei.

Pursue excellence – should you stumble/bow your head, let it be to a lofty

mountain.

This submission has been made on behalf of my lofty mountain Te Kuha!

No reira, Ka nui te mihi ki a koutou

Iri Sinclair BA LLB

Resource Management Consultant

Papa Associates

Email Contact – [email protected]

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