Terminology , Policies, Laws/bills, Regulations,

Guidelines, Standard Operating

Procedures & BiotechLegal issues

MSU Biosafety

East Lansing, MIJuly 30, 2013

Thomas P. RedickGEEC, LLC

Clayton, MO

Overview of Presentation Pipeline stacking up Terminology Policies, laws/bills, regulations,

guidelines • U.S. Federal statutes• U.S. State statutes • U.S. State common law (UK-

style, not French civil law) Standard Operating Procedures

(SOPs) • Identity-preserved production

Legal issues in Biotech

Ten Years To Biotech Approval & Market

Crossing of parent varieties, transformation events

Plant, select and harvest early generations

Plant, select and harvest multiple

location trials

Consumer Acceptance

Regulatory

Discard

X%

Discard

X%

Discard

X%

This “Last Interface” can prevent successful commercialization (after $100 mil. R&D?)

Plant, select and harvest field trials Discard

X%

Food Mfg Feasibility

Liability

Herbicide-pest-resistant soy, cotton, corn and canola dominates biotech sector – feed, fuel, and food

Reduced ag-chem benefits agricultural workers Food safety improved – better than organic toxins? Yields matter given high demand, peak “P”, GHGs

etc Reduced ag-chem, mycotoxins, positive increase soil

health, earthworms, etc. have won over key environmental groups (WWF, EDF, NRDC etc.)

Acreage expanding 10%+ annual rate for 20 years.

Biotech Crops – Past

Pipeline promises new approaches to food and agriculture – finally, direct consumer benefits?

Improve consumer health (high oleic, omega 3 soy, etc) “Stress-tolerance”, N-fixing corn, C4 soy next? Environmental impact management – lower GHGs Feeds to reduce feedlot waste (less phosphorous waste

as EPA & LOST* enforces law on nutrients in rivers?) More crop from a drop – drought-tolerance just in time

for climate-disrupted agriculture?

Biotech Crops – Pipeline

Stacks are required for various reasons• Herbicide-resistant weeds serious

enough for EPA to act?• Added value, particularly if royalty-

free “generic” event. Regulatory delays, US and abroad, make

a stacked line.• Added level of regulation for stacks

in some places.• Variations in regulatory approach can

surprise breeders.• Uncertainty plaguing new breeding

tools -- investors need to know cost.

Biotech Pipeline stacking up

Canada – mutagenesis too!

EU-etc – stack approval

New forms of plant breeding evade some US regulation but pose coexistence issues • Keep them separate from exports to nations

that need approval?• Non-GMO and organic crops still consider

these “GMO” (patents owning life and “unnatural” technology?) cannot commingle

National Environmental Policy Act looms over all plant breeding now – how to prevent it? Go on “offense”?

New Plant Breeding Methods

 J.R. Simplot Company’s “Cisgenic” potatoUSDA plant pest?EPA role & FDA voluntary safetyEU-JAPAN-Etc approval?

Biotech Regulatory Glossary “Genetically modified organisms” (“GMOs”) is

disfavored by industry interests – “biotech crops” is my preference, some accept “genetically engineered” (“GE”)

Living Modified Organisms (LMOs) Biosafety Protocol’s term for GMOs.

Transgenic: An organism that has had genes from another organism added to its genome through recombinant DNA techniques (GMO)

Event (biotech or transformation event):  Specific gene changes enabling traits

Biotech Regulatory Glossary p. 2

Agricultural biotechnology:  Tools, including traditional breeding techniques and recombinant DNA techniques to improve domesticated plants, animals, or microbes with enhanced traits for ease or efficiency of production or end use qualities and characteristics.

Gene: The fundamental physical and functional unit of heredity. A gene is typically a sequence of DNA that encodes a specific functional product (such as a protein or RNA molecule).

Genetic engineering: Manipulation of an organism's genes by introducing, deleting, or rearranging specific genes or DNA sequences using the methods of modern molecular biology, particularly those referred to as recombinant DNA techniques.

Biotech Regulatory Glossary p. 3 World Trade Organization

• International Plant Protection Convention - control of plant pests, weed seeds etc. in transit

• Codex Alimentarius Commission – food safety reference body for WTO

Trade-Related Aspects of Intellectual Property Rights (TRIPS)

1970 Patent Cooperation Treaty (PCT) Patenting Life – USA

• 1987 US Patent office oks animals etc. • 2013 -- Myriad draws “natural” line.

Canada’s Mouse,   EC Directive 98/44/EC

Biotech Regulatory Glossary p. 4

1993 Convention on Biological Diversity – Conservation and sustainable use of genetic resources (incl. IP rights)• Conservation and sustainable use of genetic

resources (incl. IP rights)• US is not a party but complies via presidential decree

with its own interpretation. 2003 Cartagena Protocol on Biosafety -

international law regulating biotech organisms 2010 Nagoya-Kuala Lumpur Supplemental

Protocol on Liability Capacity Building refers to building the capacity

to regulate biotech crops. Biosafety Clearinghouse useful online resource Dysfunctional regulatory system that lacks

capacity or unreasonably delays biotech approval

Biotech Regulatory Glossary p. 5 2000 U.S. Plant Protection Act (“PPA”)

says “Biotech crops” can be a “plant pest” Animal and Plant Health Inspection Service

(APHIS): "Protecting American agriculture" is the basic charge of the U.S. Department of Agriculture's (USDA) - ensuring the health and care of animals and plants.

Biotechnology Regulatory Services (BRS): USDA APHIS unit overseeing approvals (importation, interstate movement and environmental release) with four program units: policy coordination, environmental risk analysis, regulatory operations and resource management.

Association of Official Seed Certifying Agencies (AOSCA) - AOSCA establishes minimum standards for genetic purity and identity and recommends minimum standards for seed quality.

Regulatory Glossary P. 6

Deregulated: a biotech crop variety after USDA APHIS BRS rules grants a "petition to determine regulatory status." 

Notifications: Introductions of most crop varieties are familiar to APHIS so it authorizes them under a streamlined notification procedure. 

Permits:  new biotech plant varieties or plant associated microbes if APHIS sees a plant pest risk. These are "regulated articles." 

Plant-Made Pharmaceuticals (PMPs) – plant-derived proteins (e.g., serum albumen tobacco) that are subject to stricter US regulation (no commingling with food allowed)

Biotech Regulatory Glossary p.7

Mandatory “GM” food labeling applies at “tolerances” (percentage of “GM” content).

Adventitious presence (also known as low-level presence, or LLP) is mixing of biotech crop where it is not authorized, but in very low amounts.

Identity-preserved production – keep it segregated.

Introgression:  When genes move from one population to another, usually via pollen carried by wind, or animal pollinators (“Genetic drift”)

Regulatory Glossary Page 8 Experimental Use Permit (EUP) EPA for B.t. Herbicide-tolerant crops: Crops that have been

developed to survive application(s) of particular herbicides 

Insect Resistance Management (IRM) – refuges for preventing insect developing genes resisting B.t. (EPA-protected resource)

Quality Management: In stewardship, a system to maintain quality throughout a product life cycle

Remedial Measures: APHIS uses PPA to order remedial measures for known/suspected pest risk.

Stewardship: Responsible management of a product throughout a product life cycle including attention to product safety and market impact. 

 

US Federal Regulatory Laws

1986 “Coordinated Framework” -- No New Laws• USDA – all biotech crops go through “Plant Pest” approval.

Limit scope of review to “noxious weeds” and “plant pest” Expanding “noxious” to “interrelated” economic impacts”?

• EPA – fungicide, insecticide etc. (FIFRA) including food safety• FDA – only food, not feed, meat etc.

2000 Plant Prot. Act tinkered with weeds-pests (“noxious weed” includes “other interests of ag, navigation, nat. resources, public health,” etc.)

2005-2008 Office of Inspector General offers critical reports on gaps in regulatory oversight

2008 Farm Bill ordered improved oversight of GE crops under PPA of 2000, after OIG audits

Canada Regulatory Framework

Canadian Food Inspection Agency (CFIA) shares responsibility with Health Canada for regulating products derived from biotechnology.

Mutagenesis breeding is regulated 8 million + ha of biotech canola, corn & soybeans,

$2 billion (US) in farm income. CFIA regulates “novel trait” in:

• Animal biotechnology, Veterinary biotech and novel feeds• Labeling of novel foods derived from genetic engineering• Novel fertilizer supplements• Plants with novel traits (PNTs)

Health Canada, like US FDA, is concerned with food safety issues.

EU approval requires extensive safety data• Initial safety finding by EU’s Food Safety

Authority.• EU Ministers generally fail to reach

majority. European Commission then approves. Approved many events for food-feed, few

for planting (Monsanto recently decided to drop most planting approval applications).

GM labeling law (1996) keeps most GM inputs out of food (higher prices for consumers with no clear benefit?) – approval process “dysfunctional”?

EU “Precautionary” Approval

US/Argentina/Canada sued at World Trade Organization (WTO) over approval delays in 2006

Ruling on Appeal over 1,000 pages• EU must meet own statutory deadlines • The “precautionary approach” does not apply

in trade with non-parties to the Cartagena Protocol.

Europa BIO study finds approvals for food-feed are still too slow, planting near-impossible.

EU-US Transatlantic Trade & Investment Partnership talks opening

EU Loses at WTO - 2006

Tracing/ Tolerance Traps

% TOLERANCE FOR GMGMO Free 1%

COST

5%0.1% 2% “PROCESS”

GMO Free (China, Zero Zealots)

0.1% = Dupont STS (99.9% snafu)

0.9% = EU Labels (impracticable?)

2% = Some Certified Seed

5% = US Organic Rule & NAFTA & Asian standard

Risk Shifting and Disclosures Disclaimer -- NO Implied/Express

Warranties

Limitation A Free Bag of Seed!

No damages

Does “Bag Rip” bind grower to disclaimer?

Stewardship - Disclosure + Common facts = Class Action

Effective now – growers must adhere to an approved sustainable ag standard (ISCC, RTRS, RSB etc)

EU seeking data from individual US growers

Traceability to farmers is not feasible so sample of data (5% of farms) being offered.

Aggregate data, information about USDA program should be sufficient to allow continued exports.

Billions in trade in corn and soybeans at risk.

EU Renewable Energy Directive

US Growers mailed this letter (Cargill and ADM)

Regulatory Driver: EU Renewable energy directive forcing biofuel plants to certify suppliers.

Sign self-declaration form, ISCC criteria

Random audit 5% of corn suppliers!

.

Commodity Biofuels and ISCC:Growers responding to data demands

Socio-economic considerations• Europe’s “Collective Preferences” and need

for sustainability may violate WTO’s science-based trading system.

• US system & economic impacts Common law liability of each US State USDA pressured by courts enjoining Monsanto’s

alfalfa and sugar beets due in part to economic impact to exports, organic-nonGMO

• Canada denied organic grower claims in court

• Argentina “Mirror” policy of EU approval may be yielding to Mercusor-wide approach to approving new biotech crops.

US Barriers to Biotech Crops• State regulations, present and future (CA,

ARK) could stop NEPA risk, or be barrier• Liability risks – Starlink, LL Rice• “Anticipatory nuisance” could be used for

injunction, similar to NEPA injunction• Customer attitudes + retailers = “last

interface” stopped lettuce, tomato etc.?• EU “mirror” policies – some

export/sustainability standards require no GMOs (e.g. Hardwoods, Seafood, Trees)

Seralini Study – rat testing from 90 days to 2 yrs?

Long term health and enviro risks missed here?

The “Precautionary Approach” just for biotech crops misses real risks, keeps benefits from market for endless test (hypotheses)

Greenpeace, Center for Food Safety, Just Label It will never go away entirely – struggle to demonize new plant breeding too.

Opposition to GMOs Continues

Just another flyer found at your local People’s Food Coop: Why fear our food?

i

Sufferin’ Succotash (Beans & Corn)

Liberty Link Soy Aventis did not get

EU approval 1997 ASA warns of

billion dollar nuisance --$0.40 premium needed.

Positive press release, no launch

$100 mil in R&D, 10 years

Starlink Corn Same company &

growers, but corn. NCGA complains

1997, CEO retires, Starlink commingles

EPA on NPR “clearly illegal” corn in food

Settle suits, fire CEO $3 billion recall +

shareholder impact

Standard Operating Procedures Protect Economic Interests

ASA 1998 -- Use jointly agreed “standard of care” for closed-loop identity preservation and premiums to pay growers for cost (Dupont high-oleic soy)

Biotechnology Industry Organization (BIO) “Excellence Through Stewardship” (ETS) 2007 program with “Guide for Maintaining

Plant Product Integrity” Global Stewardship Audit Process that involves

third-party audits of members to verify that stewardship programs and quality management systems are in place

Economic Nuisance Lawsuits

2000 – Starlink Corn (Maize)• Unapproved –recalled in US• Disrupted trade, cost billions?

2005 – Mrs. Schmeiser (Canada)• Claimed genetic drift• Husband Percy lied under oath

2005 - Hoffman – Canada• Dismissed common law but let

state statute proceed.• Denied anticipatory nuisance

• 2006 – Liberty Link Rice -- legal in US, exports disrupted, exceeding $1 billion in payments.

States Protect Economic Interests

Idaho-Wash and MO have “grower district” laws enabling coexistence via contract• Univ of MO promoting chestnut hybrids• Tool for segregation by districts available

Most farm states now have laws preempting non-GMO counties

California GM-free Rice law – “Rice Certification Act”• Economic impact assessed, fees to cover segreg. costs• Effectively stopped commercial biotech rice in CA

US 2008 Farm Bill proposed, then dropped Preemption of State law provisions

No Votes on Non-GMO all over

NonGMO zones in California• Marin, Trinity, Mendocino

& Santa Cruz ’06, NonGM• All the rest – We want GM

Community standards for nuisance can be statutory

Commerce clause preemption triggered?• Industry stopped NonGM

in production ag counties• CA proposed liability bill?

VT backed down CA pass weaker bio-

liability (no trespass)

No thanks, we like GMOs!

Hey, man, don’t

ban my weed!

IdahoRapeseed

GrowerDistricts

• 7 Production Districts• Edible vs. Industrial• Exceptions Available

District 2

District 1

District 4

District 3

District 7District 6

District 5

Review of NEPA/Nuisance

National Environmental Policy Act • Activists ready to stop all biotech crops?• “Inter-related economic impact”

includes exports, non-GMO, organic etc.• Avoiding this requires concerted effort

Economic impact also driving nuisance cases (Liberty Link rice)

Coexistence strategies exist, but come at a cost – hindsight is 20-20

Balanced Committee of exports (AC21) addressed two questions for Sec. Vilsack (USDA)Types of compensation mechanisms, if any.Mechanism to implement (tolerances, testing etc)

USDA's crop insurance programs Vote taken – tied evenly on fund issue.Can seed companies contractually require

growers to cooperate with neighbors on buffers?

USDA AC 21 and "Compensation" fund

Biotech Barriers Go Global

• Biosafety Protocol and CBD considering the same issues, international setting Regulatory approval with EIS & “precaution” Economic damages under Biosafety (Art. 27)

Liability managed under voluntary industry compact• Standing Ovation in Cartagena 2008• States become "third party beneficiaries" if

they consent, and if their claim is allowed. “Gene Use Restriction Technologies”

(“GURTs”) ok to use to reduce risk?

1992 Convention on Biological Diversity objectives: 1) conservation, 2) sustainable use, and 3) equitable distribution of benefit and “appropriate access to genetic resources”

CDB Art. 14 suggested that the parties “examine the issues” of liability, except where internal issue.

Rio Principle 13 has similar suggestion. Cartagena Protocol on Biosafety must

serve objectives of CBD. Cartagena Protocol on Biosafety, ten years

after its text, created a text on liability.

Convention in Biological Diversity, Cartagena & Nagoya-KL Supp. Protocl

Defining “Harm” to Biodiversity

First, what is the “baseline” of life that we want to protect from harm?

Second, will the release of the biotech crop be “Significant” or mere transient effects?

Should we have national laws protecting pockets of valuable biodiversity from any and all threats?

Nagoya ABS Protocol Nagoya Protocol (to CBD) on Access

to Genetic Resources & Fair & Equitable Sharing of Benefits Arising from their Utilization

Fair & equitable sharing of the benefits [from use] of genetic resources -- 1 0f 3 CBD objectives

50 ratifications to enter into force.• 92 signatures, 18 ratifications to date

RR Soybean patents expiring all over (US 2015) – now available to overseas breeders of all crops, including specialty (lettuce etc.)

EU, China approvals also expire varying years after 1st renewal (e.g., 10, 5 years)

Expired events can disrupt global trade• EU, China = $15 billion post-

equilibrium• EU 0.9% tolerance – zero in China?

Patents/APPROVALS Expire

Sustainability Standards & “GM”

Some standards bar biotech (genetically modified, “GM”)• ANSI LEO 4000 - producer to “prevent

migration”• US Green Building Counsel adopting

anti-GM FSC standard before biotech trees show up?

• Rainforest Alliance sustainable ag standard also anti-GMO

Global GAP – similar requirement to prevent migration. Also considering whether this should apply in US, Canada, (Arg. too?)

Sustainability Standards w/ “GM” Some standards changed in

response to input Tech-neutral WWF RT on

Responsible Soybeans (S.America)• Non-GMO grower must maintain buffer

in GM area• Unless local law or practice requires

segregation of GM RT Sustainable Biofuels –

Technology neutral now?

Expanding Pipeline – new crops, new methods – will encounter complex patchwork of legal issues• IP rights are multi-layered – it pays to know what is

free.• Trade barriers are a shifting sea of requirements,

enforcement spotty (which makes business harder to conduct safely)

New players – public researchers, internationals Sustainability matters now, soon to matter

more.

Conclusions

THANK YOU Here