My presentation to MSU's International Short Course Biosafety and Biotechnology for Lawyers, in coordination with the AU/NEPAD African Biosafety Network of Expertise (ABNE)

1. Terminology , Policies, Laws/bills,
Regulations, Guidelines,
Standard Operating Procedures &
BiotechLegal issues
MSU Biosafety
East Lansing, MI
July 30, 2013
Thomas P. Redick
GEEC, LLC
Clayton, MO

2. 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

3. 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
Discar
d
X%
Discar
d
X%
Discar
d
X%
This “Last
Interface” can
prevent successful
commercialization
Plant, select and harvest field trials Discar
d
X%
Food Mfg
Feasibility
Liability

4.  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

5.  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

6.  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

8.  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” potato
USDA plant pest?
EPA role & FDA
voluntary safety
EU-JAPAN-Etc
approval?

9. 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

10. 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.

11. 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

12. 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

13. 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.

14. 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)

15. 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”)

16. 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.

17. 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

18. 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.

19.  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

20.  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

21. Tracing/ Tolerance Traps
% TOLERANCE FOR GM
GMO 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

22. 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

23.  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

24.  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

25. 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.

26. 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)

27.  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

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

29. 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

30. 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

31. 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.

32. 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

33. 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!

34. Idaho
Rapeseed
Grower
Districts
• 7 Production Districts
• Edible vs. Industrial
• Exceptions Available
District 2
District 1
District 4
District 3
District 7
District 6
District 5

35. 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

36.  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

37. 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?

38.  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

39. 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?

40. 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

41.  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

42. 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?)

43. 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?

44.  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