The potential impact of EU legal clarification on the practical application of Plant Breeding InnovationPetra Jorasch, Manager Plant Breeding& Innovation AdvocacyWarsaw, 15.11.2017

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ESA MEMBERS TODAY

38 national seed associations(ESA Association Members)

40 direct company members (ESA Individual Members)

29 associate company members (ESA Associate Members)

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3.500 New varieties are authorized for marketing within the European Union each year.

42.000 Different varieties of agricultural and vegetable species are available to farmers in the European Union.

US $~ 50 bn Global Seed MarketEU seed market share around 20%

EU SEED MARKET – KEY FACTS AND FIGURES

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Size of largest company in each sector of the agri-food chain

and chemicals globally

Source: Sylvie Bonny, Sustainability 2017, 9, 1632; doi:10.3390/su9091632

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Size of top 10 players in the global agri-food chain & pharmacy

Source: Sylvie Bonny, Sustainability 2017, 9, 1632; doi:10.3390/su9091632

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PLANT BREEDERS’ RESPONSE TO

GLOBAL CHALLENGES

Plant Breeders’ Response to Global Challenges

© ISF

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A HISTORY OF CONSTANTLY IMPROVED BREEDING METHODS

©BDP

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Potatoes: Traits to be taken into account by a breeder

Resistances:

Potato cancer resistance

Nematode resistance

Virus susceptibility

Phytophthora susceptibility

Yield and Quality Traits:

Maturity period

Tuber yield

Tuber Size

Sprouting sensitivity

Starch content and yield

Tuber Characteristics:

Deepness of potato eyes

Tuber form

Skin color

Flesh color, raw

Flesh color, cooked (for table potatoes)

https://www.croptrust.org/crop/potato/

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New Plants

Crossing

classicalGMO

Mutation

How do the latest plant breeding methods fit into the breeding process?

VARIATION

SELECTION

testing

resistence, yield, quality

years, locations,test repeating

official testing

new variety

selection

SDN-1,2 ODMRNAi

inducedEpigenesis

cis-Genesis

Grafting on GMO

rootstock

SyntheticBiology

SDN-3 (foreign genes)

Reverse Breeding

Agro-inokulation

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Genome Editing allows for very precise and relatively small changes

1) Targeted exchanges (SDN 12)

2) Targeted deletions (SDN 1/2)

3) Targeted insertions (SDN 3)

x

1)

2)

3)

*50-100 mutations/generation occur naturally

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Existing Breeding Goals can be achieved in a more efficient way

Quality Traits Yield Resistances

Baking quality (e.g. Amylose content/Glycemic Index; lowacrylamide potato, gluten free wheat)

Corn yield Viruses

Brewing quality (e.g. low lox barley) Biomass yield Bacteria

Fatty acid composition (e.g. soybean/ Camellina)

Starch, Protein, Sugar content

Insect

Increased Vitamin content Nutrient use Efficiency Fungi (e.g. powdery mildew in wheat, late blight potato)

Improved shelf life (improved cold storage potato, non-browning mushroom/apple/potato)

Water use Efficiency Drought, Heat

Starch quality (e.g. waxy corn, amylopectin potato)

Herbicides (e.g. oilseed rape)

Feed quality

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THE LATEST PLANT BREEDING METHODS: IMPORTANCE TO PRIVATE BREEDERS

▪ Methodologies can be used across all agriculturally important crops

▪ Efficient and precise

─ Reduces R&D and breeding time

─ Important for plants with long generation times

─ Important for crops with rapidly evolving diseases and pests

▪ Accessible & relatively inexpensive

─ Important to companies of all sizes

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Genome Editing 1/2 is faster and more efficient: the resultidentical

Crossing and Selection Genome Editing – SDN1/2

High-performance

varietyWilde type with desired

trait

High-performance

variety

7 generations / about 1000 plants 2 generations / about 20-50 plantsImproved high-

performance variety

© KWS

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Political framework - Lots of Activity since 2007 but still noGuidance by EU-Commission

EU-Commission

JRC

IPTS/IHCP

• JRC-Report (scientific

and economic evaluation)

• Detection (modifications

on molecular level)

• International Regulation

Member State Experts

Working Group

Competent

Authorities

Scientific evaluation with

regard to directive 2001/18

EFSASafety Aspects

Cisgenesis

other NBTs

ZFN3

French ECJ Courtcase

SAM(Scientific Advice

Mechanism)

• Focus Genome Editing;

• Key characteristics of

methods

• Comparison with earlier

methods

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Directive 2001/18 on the deliberate release into the environment of genetically modified organisms

Article 2

Definitions

For the purposes of this Directive:

(1) ……

(2) "genetically modified organism (GMO)" means 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;

Article 3

Exemptions

1. This Directive shall not apply to organisms obtained through the techniques of genetic modification listed in Annex I B.

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Directive 2001/18 on the deliberate release into the environment of genetically modified organisms

ANNEX I B

TECHNIQUES REFERRED TO IN ARTICLE 3

Techniques/methods of genetic modification yielding organisms to be excluded from the Directive, on the condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those produced by one or more of the techniques/methods listed below are:

(1) mutagenesis,

(2) cell fusion (including protoplast fusion) of plant cells of organisms which can

exchange genetic material through traditional breeding methods.

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Basic Principle for regulatory Requirements

Plant varieties developed through the latest breeding

methods should not be subject to different or additional

regulations if they could also have been produced

through earlier breeding methods or by natural

processes without human intervention.

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Principles for Regulatory Requirements

The genetic variation in the final plant product is not covered under the scope of existing regulation if:

there is no novel combination of genetic material (i.e. there is no stable insertion in the plant genome of one or more genes that are part of a designed genetic construct), and;

the final plant product solely contains the stable insertion of inherited genetic material from sexually compatible plant species, or;

the genetic variation is the result of spontaneous or induced mutagenesis.

Even if Plants are non-GM, there is extensive Regulation in Place

Seed Producer

Farmer/Producer

Agricultural crops

DUS, VCU, Common Catalogue

Breeder

Food Processor

VegetablesDUS,

Common Catalogue

Directives for Seed Marketing (min. product quality) and Treatment; Plant Health Regulation and official Controls

Food Regulations

FertilizersPesticidesRespective regulations

Sustainable Use DirectiveOther on Farm Quality Controls

Gen

eral Fo

od

Law an

d P

rod

uct Liab

ility Legislation

GM

O D

irective inclu

din

g Labelin

g

Standard Regulations for all Plant Varieties, Seeds and Resulting ProductsPossible additional

RegulationsO

rganic Farm

ing R

egulatio

n

No

vel Foo

d R

egulatio

n

Varieties

Seeds

HarvestGrain, Vegetables etc.

Food

OEC

D, ISTA

Seed specific Rules & private Standards &

Stewardship

Glo

bal G

ap

ESTA

Trader

Gen

eral Enviro

nm

ental Liab

ility Legislation

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CONSISTENT, SCIENCE-BASED CRITERIA BRING BENEFITS FOR

Consistent and Science based Criteria bring Benefits for

ACADEMIC

INSTITUTIONS

• opportunities

for international

collaborations

• funding &

public-private

partnerships

PLANT

BREEDERS

• access to latest

methods

• legal certainty

• access to genetic

diversity

FARMERS

• access to better

seed

• level playing field

• ensure livelihood

& prosperity

• sustainable

agricultural

production

TRADERS

• ensure consistent

supply

• avoid new

trade barriers

CONSUMERS

• high quality

& wide variety

• affordable

prices

© ISF

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IMPACT OF CUMBERSOME REGULATIONS ON EUROPE’S AGRICULTURE

• Prevent esp. SME’s from developing and using these methods

• Eroding competitiveness and leading to a less diversified plant breeding sector

• Exodus of innovative breeding companies from Europe

• Competitive advantage to the plant breeding industries outside Europe

• European scientific excellence (private and public), related jobs, innovation and consequently economic growth driven out of Europe;

• Small size of niche markets would not justify the regulatory approval costs

• Portfolio of products reduced

• less choice in products for Europe’s farmers, growers, processing industries and consumers;

• Achieving goals of increased sustainability of EU agriculture will be put at risk

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ALL TOOLS SHOULD BE AVAILABLE TO FOSTER INNOVATION

©BDP

www.plantbreeding.eu

CONTACT USESA European Seed Association

Avenue des Arts 52B 1000 Brussels

T. +32 (0)2 743 28 60

secretariat@euroseeds.eu

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Applying the Criteria to the latest Plant Breeding Methods