genome editing in agriculture implications for society · 1 independent scientific advice for...

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INDEPENDENT SCIENTIFIC ADVICE FOR POLICY MAKING

SCIENTIFICEVIDENCE

GENOME EDITING IN AGRICULTUREIMPLICATIONS FOR SOCIETY

Professor Rolf-Dieter Heuer, Chair of EC’s Group of Chief Scientific Advisors,

Professor Janusz Bujnicki, Member of EC’s Group of Chief Scientific Advisors

European Parliament, 2 April 2019

SCIENTIFICADVICEMECHANISM

Scientific AdviceMechanism

REQUEST FOR ADVICE

College of EU Commissioners

Policy Challenge

top-down bottom-up

Scientific Advice MechanismGroup of Chief Scientific Advisors

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Scientific Advice Mechanism

Expert Scientists

evidence reviewall published data

policy options

Group of Chief Scientific Advisors

evidence synthesisand recommendations

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SAM Unit:Intrinsic connectors

monitor the needs of the advisee,

policy context, timing, format, relevance

TBD


• SAM helps ensure that the EC’s proposals for policy or legislation

are well-informed

• SAM complements an extensive scientific advisory system

that already underpins EU policies,

including the Joint Research Centre

and a number of specialised European agencies.

• SAM does not duplicate other existing advisory bodies.

It cooperates with these bodies

and provides complementary expertise

directly to the College of Commissioners

Scientific Advice Mechanism


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Requested by Comissioner Andriukaitis,

published in April 2017

describes and compares breeding techniques:

- Conventional Breeding Techniques,

including selection (natural and human-driven)

and random mutagenesis

- Established Genetic Modification Techniques

- New Breeding Techniques,

including gene editing

Explanatory Note:

New Techniques in Agricultural Biotechnology


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• Since the beginning of agriculture around 10,000 years ago

humans endeavoured to improve their crops and animals.

• We have selected plants, animals and microorganisms

that give a greater yield, are more palatable, easier to process, etc.

• Features of plants, animals and microorganisms

that make them useful for agriculture

are a result of an organism's genetic makeup,

which in turn is the product of natural, spontaneous mutations.

Techniques in Agricultural Biotechnology


• As technology has developed,

the ways in which new varieties can be generated faster

have become more sophisticated.

• At first, chemical or physical agents (such as X-rays)

were used to make random changes to plant seeds;

this procedure (induced mutagenesis)

still requires selection of organisms with desirable traits.

• More targeted changes became possible during the 1980s, involving

the insertion of genetic material into organisms,

some of which may be from other species

(genetic modification, GM).

Techniques in Agricultural Biotechnology


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• Recently, a variety of new breeding techniques (NBT)

including gene editing have been developed

• Gene editing can be used to introduce different changes

– local mutations (one or few nucleotides) and genetic rearrangements

(both are undistinguishable from spontaneous mutations)

– inclusion of genetic material from other species

(similar to natural processes or to the techniques of GM)

• When changes to genetic sequences are made with gene editing,

they are typically made in a more precise manner

than those made with GM techniques.

Techniques in Agricultural Biotechnology NEW


Legal situation

• According to Directive 2001/18/EC on the deliberate release

of genetically modified organisms into the environment ('GMO Directive'),

a GMO is defined as:

‘an organism, with the exception of human beings,

in which the genetic material has been altered

in a way that does not occur naturally

by mating and/or natural recombination’

• The GMO Directive refers to established techniques of genetic modification

• Products of random mutagenesis are GMOs,

but are excluded from the obligations of the Directive


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Court of Justice of the European Union

Judgment in Case C-528/16

Are organisms obtained by mutagenesis GMOs, and which of those organisms

are exempt from the provisions of the GMO Directive?

• Organisms obtained by the new techniques of directed mutagenesis

are GMOs, within the meaning of the GMO Directive,

and are subject to its obligations

• Only organisms obtained by means of techniques/methods of mutagenesis,

which have conventionally been used in a number of applications

and have a long safety record, are exempt.

25 July 2018


Statement

by the Group of Chief Scientific Advisors

• A scientific perspective on the regulatory status of products

derived from gene editing and the implications for the GMO directive

• Based on the NTAB explanatory note, follows the judgement of the Court

• Takes a purely scientific point of view

while appreciating the existence of other important considerations

• Analyses the implications of the application of the GMO Directive

to gene editing

13 November 2018


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• In view of the Court’s ruling it becomes evident that

new scientific knowledge and recent technical developments

have made the GMO Directive no longer fit for purpose.

• The GMO Directive gives rise to major problems,

in particular with regard to:

- the definition of GMOs in the context of naturally occurring mutations,

- safety considerations,

- detection and identification.

Statement

by the Group of Chief Scientific Advisors


• Mutations occur naturally / spontaneously without human intervention.

• From the time of the adoption of the GMO Directive until now,

extensive scientific evidence has been accumulated

on spontaneously occurring genetic alterations, including

point mutations, insertions, deletions and rearrangements of the genome,

as well as the acquisition of exogenous genetic material across species.

• The concept of ‘naturalness’ should be based on current scientific evidence

of what indeed occurs naturally, without any human intervention,

in organisms/ in their DNA.

GMOs vs naturally occurring mutations


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Safety considerations

Unintended effects in gene editing are a common concern. However:

• Compared to random mutagenesis,

gene editing results in much fewer unintended changes

and thus fewer unintended effects and better characterised products

• Unintended effects are not necessarily harmful

they need to be addressed case by case

• The safety of a product depends on its features

rather than the technique used

• What does ‘long record of safety’ mean?


Detection & identification Issues

• Gene editing can introduce mutations that are identical

to those occurring spontaneously or through random mutagenesis

• In the absence of prior knowledge about the ‘reference’,

we cannot detect a change

• There is no reliable analytical approach

for detecting and quantifying all possible gene edited products

• It is impossible to provide a universal detection method

meeting the regulatory standards

• The Report of the European Network of GMO Laboratories/ the Joint

Research Centre ‘Detection of food and feed plant products obtained by new

mutagenesis techniques’, provides an in depth-analysis of these issues

(published 26 March 2019)


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Conclusions of the GCSA Statement

• The GMO Directive states that ‘the regulatory framework for biotechnology

should be reviewed so as to identify the feasibility of improving the

consistency and efficiency of that framework’ (Recital 63).

• There is a need to improve EU GMO legislation to be clear, evidence-based,

implementable, proportionate and flexible enough

to cope with future advances in science and technology in this area.

• We recommend revising the existing GMO Directive

to reflect current knowledge and scientific evidence, in particular

on gene editing and established techniques of genetic modification.

This should be done with reference to other legislation

relevant to food safety and environmental protection.


• We need a participatory public debate to address concerns and challenges.

• It is essential to promote a broad dialogue with relevant stakeholders,

and with the public at large.

• We need a wider public reflection on

how we want our food to be produced in Europe.

• Need for addressing products in their broader context to evaluate safety:

product features, use, agricultural practices, environment, exposure.

• Need for the systematic and transparent provision

of robust and independent scientific evidence to the Court(s).

Conclusions of the GCSA StatementScientific Advice MechanismGroup of Chief Scientific Advisors

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I. New Breeding Techniques (NBT) and agricultural applications

– what can the science deliver?

II. Ethical/ societal considerations

related to agricultural applications of NBT

III. Regulatory issues

(post-Court of Justice of the European Union decision)

IV. Science quality and science-informed decision making

V. NBTs - international comparison (USA, Argentina, China…)

Plan for the debate today: roundtables


• New techniques for new challenges (e.g., climate change)?

• Healthier, more nutritious, safer, cheaper food?

• All false promises?

Can the NBT actually deliver on their promises?

• What lessons have we learned

from the established techniques of genetic modification?

• Off the beaten tracks:

can gene editing contribute to sustainable and/ or organic agriculture

(as random mutagenesis)?

Roundtable INew Breeding Techniques (NBT) and agricultural applications

– what can the science deliver?


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• What are ethical concerns related to the use (or non-use) of gene editing

in agriculture?

• What type of agriculture do we want in Europe?

• Consumers' choices (healthier, more nutritious, safer, cheaper food)

• Can a participatory public debate help? How to frame the public debate?

• What are the lessons learned from the issues related to GMOs?

• New business models for gene editing?

• How to improve communication with the public:

what is the role of scientists/ regulators/ politicians/ media?

Roundtable IIEthical/ societal considerations related to agricultural applications of NBT


• What exactly do we want to regulate with the European legislation?

• Does the EU GMO legislation still achieve what it was intended for?

• Can we think of a different approach for dealing with/ regulating organisms

of which the genome has been modified by using different techniques

(other than GMO/ no GMO)?

• How to deal with detection/ identification issues related to gene edited

products?

• The concept of 'naturalness' for the definition of GMOs

• What does 'long safety record' mean (Recital 17)?

• What does ‘safety’ mean? How to consider features, use, agricultural

practices, environment?

• How to deal with questions left unanswered by the ECJ decision?

Roundtable IIIRegulatory issues (post-Court of Justice of the European Union decision)


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• How should scientific evidence be provided to the Court?

• The Gordian knot: How to disentangle scientific facts

from other aspects in the public debate?

• What additional scientific evidence is needed

to answer questions and concerns of the public/ the regulators?

• How to increase public trust in evidence provided by experts

in this highly politicised, controversial, value-loaded area?

• How to improve communication with the public:

what is the role of scientists/ regulators/ politicians/ media?

Roundtable IVScience quality and science-informed decision making


• What will be the impact of the ECJ decision:

on the competitiveness of European agriculture, biotech, seed companies?

on international trade and cooperation?

on research using gene editing?

• Do we ‘impose’ our values/ preferences/ regulations on third countries?

• What will be the role of the EU

in the discussions on NBT/ gene editing at the international level?

Roundtable VNBTs - international comparison (USA, Argentina, China…)


genome editing in agriculture implications for society · 1 independent scientific advice for...

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