1. Thomas P. Redick
Global Environmental Ethics Counsel, LLC
St. Louis, MO
www.geeclaw.com
NC 1034
College Park TX
June 5, 2013

2.  “Biotech crops’ Expanding to Specialty Sector?
 Pipeline stacking up in commodity crops
 New forms of plant breeding evade some US
regulation but pose coexistence issues?
 Barriers - Traceability -- Biosafety Protocol Article
18.2(a).
 Patent-Approval expiration lets specialty breeders
stack “free input trait” with new “output” traits.
 Sustainability may become new barrier/opportunity

3.  1893 U.S. Sup. Ct. Nix case – tomato = vegetable
 Specialty to USDA includes Fruits, veggies, etc.
 Trees - fruit/nuts/Xmas, nursery crops/floriculture
 “Horticulture” is defined as
 Intensively cultivated plants “level of management”
 Used in both food and medicine or “aesthetic” purposes
 USDA “Specialty Crop Research Initiative (SCRI) ”
 Edamame (nonGMO) could benefit from HR gene
 Any GM research funded?

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.

5.  New phosphorous mines being created.
 New phosphate deposits being found/proved.
 New technologies recover P from waste streams
(e.g., municipal sewage treatment plants
 Estimated lifespan for existing phosphate
 U.S. -- around 53 years.
 Estimated 351 years worldwide phosphate

6. International Service for the Acquisition of Agri-Biotech
Applications (ISAAA) 2012 report.
18 mega-producing countries growing over 50,000 hectares
biotech crops – MOSTLY DEVELOPING NATIONS

7.  Nationwide Six Sisters Approach to Agbiotech
 Corn, Soy, Cotton, Canola, Papaya and Beet (some
squash)
 Monsanto, Dupont/Pioneer, Dow Agrosciences,
Bayer Cropsciences (KC), Syngenta, and BASF
(some others…)
 New players
 rDNA - Arborgen trees, Chromatin, Chlorogen etc.
 Oligo-rna-etc – Cibus, Keygene etc.
 Public-academic breeding coming on fast?
 USDA does not see a plant pest, EPA sees resistance
issues etc.

8.  Patent expiration means free use of some input traits
 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?
 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?
* Law of the Sea Treaty aka Conv. Law of the Sea

9.  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?
* Law of the Sea Treaty aka Conv. Law of the Sea

10.  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”?
J.R. Simplot
Company’s
“Cisgenic” Tater
USDA plant pest?
EPA role via FIFRA?
FDA voluntary role?
EU-JAPAN –ETC?

11.  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.

12. Quality/Food
Agronomic
2020
Modified
Protein
(Pioneer/DuPont)
High-Oleic,
Stearate
(Pioneer/DuPont)
Source: Pipeline from Industry Sources; prepared by ASA, USSEC, USB. Updated May, 2011
Nematode
Resistance
(Monsanto;
Syngenta;
Pioneer/
DuPont)
LibertyLink
(LL)
(Bayer)
Imidazolinone
Tolerant
Brazil only.
(BASF/Embrapa Brazil)
RR2Y
(Monsanto)
Higher Yield I
(Monsanto)
Omega-3
Stearidonic Acid
(Monsanto)
Feed: High
Protein Soybean
(Pioneer/DuPont)
2010 2012
GAT/
Glyphosate
-ALS
Soybean
(Pioneer/
DuPont)
Dicamba
Tolerant
(Monsanto)
High Oleic /
Low-Sat
(Monsanto)
Pipeline of biotech events and novel trait releases
Disease
Resistance
(Syngenta;
Pioneer/
DuPont)
Low Raff-
Stach
(Virginia Tech)
Commercialized
High-Oleic
(Pioneer/DuPont)
Low-Linolenic
(Syngenta)
Higher
Yield II
(Monsanto;
Pioneer/
DuPont)
Rust
(Monsanto;
Syngenta;
Pioneer/DuPont)
Aphid Resistance
(Monsanto;
Pioneer/DuPont)
Sclerotinia
Resistance
(Pioneer/
DuPont)
Lepidoptera
Resistance
(Pioneer/
DuPont)
HPPD
Tolerant
(Syngenta/
Bayer)
LibertyLink (LL)
(Bayer)
Bt/RR2Y
Brazil only
(Monsanto)
Glytol/HPPD
(Bayer/MS
Technologies)
Glytol / HPPD / LL
(Bayer/MS Technologies)
2,4-D
Tolerant
(Dow)

13. 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%
Any “Last Interface”
can prevent successful
commercialization
(after $100 mil.+ R&D?)
Plant, select and harvest field trials Discard
X%
Food Mfg
Feasibility

14.  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.

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

16.  Innovators Giving Up Hope?
 Came and went…
 Flavr-Savr tomato
 B.t. Potato – McDonalds veto
 Never saw Commercial launch
 HR rice – billion dollar Bayer case
 Oats, barley, lettuce
 Virus-resistant plum is no papaya…
 Whither Wheat?
 Beet Sugar made it despite NEPA
 B.t sweet corn now in farmer mkts

17.  USDA approvals slowed, just sped up a bit in 2012
 New regulatory opposition – grain trade, millers and
“functional” traits interference with marketing.
 Enogen, 2-4-D corn delayed
 No regulation of bentgrass – no “plant pest” DNA?
 Looming threat of Nat’l Env Policy Act litigation?
 USDA now cites “interrelated” economic/enviro/social
 Sued eucalypts, may soon sue GE Salmon, 2-4-D corn etc.
 Include RR Alfalfa and Sugar Beets and US is probably
slower than EU in approval time for biotech crops.

18. • 1970 National Environmental Policy Act
(“NEPA”) requires environmental impact
assessment of significant environmental and
economic impacts
•2003 Monsanto Roundup Ready (RR) Alfalfa
filing (RR corn, soy, cotton, canola all over US
acreage)
• Comments suggested “cumulative” impact of RR
• Organic and “nonGM” alfalfa (WA-OR-etc)
NIMBY
• USDA did an “Environmental Assessment” after
a Finding of No Significant Impact” (“FONSI”)

19.  Biosafety 18.2(a) “May Contain” + GM food
labeling
 Generic information , useless for recalls/tracing
 Forces food-manufacturers to substitute inputs
 Greenpeace Japan found more stray biotech canola
 Why Worry? Just Use IPPC containment
 Patent-Approval expiration could cause disruption as old
events show up in exports (e.g. RR soy #1)
 Over-implementation (labels, tracing, precaution) can
bring the oils into the regulatory tent, discriminate on
health (which could be an SPS violation under WTO)

20.  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?

21.  Patent exhaustion defense in US
(Bowman), Brazil pending,
India accepts, other nations?
 Patenting cDNA – (Myriad-US,
Mouse Canada)
 Varying IP coverage can reduce
$ value of agbiotech innovation
to investors.

22.  2006 “SPS” (“Sanitary-Phytosanitary Agreement”) case
rejected “precautionary approach” & approval delays
but will this apply here?
 Over 40 nations label GM food, a few oil (EU, Brazil…)
 Traceability+Liability, EU-Style, will give rise to 20+
laws as nations start to test, toss and traceback
 WTO may allow T&L under Technical Barriers to
Trade Agreement (“TBT”) for different (not “like”)
products

23. Biosafety Protocol
 2003 – up to 158 (&
counting) nations
 “Precautionary Approach”
to biotech means delays
 Oct. 2010 – Meeting of
Parties, Nagoya Japan
 Article 27 liability law
 Article 18 “Traceability” =
recalls and enviro-liability
risks
 1964, nearly all (191) nations
 UN’s Food Standards Body,
WTO reference
 US, Canada belong, but
outvoted by EU (27 votes)
 No consensus on
precautionary principle
 Troubling traceability on
animals, fruits, oils etc.
 Committees on Fats-Oils +
GM label task force, and
others worth tracking
Codex Alimentarius

24. Farm
• Specific
Variety
Grown
Separately
• Harvested
and stored
separately
Farm
Transport
• Farmer puts
in bags or
containers
• Maintain
separate
storage
Delivery
to Port
• Loaded onto
dedicated
barges
carrying
limited cargo
or shipped by
rail car
Ships
• Loaded onto
container
ships; or into
separate
holds as
cargo in lots
of 3000-5000
metric tons
Port of
Discharge
• Unloaded via
common
machinery
into separate
storage
Transport
• Via Coastal
vessel, barge,
truck or rail
Processor
Storage
• Special
dedicated
storage
Processor
• Separate
processing
runs or
processing
lines for high
value
products
Elevator
• Special
unloading &
handling
procedures
• Stored in
separate bins
or containers
Contract
• Farmer and
buyer
contract well
in advance of
planting for
specific
variety at
specific
premium

25. Step 1: Contract
Growers provide IP crops
on an individual contract
basis for a specific variety
at a specific premium.
Some states have laws
protecting growers from
sudden termination of a
long-term production
contract.

26.  Disclaimer -- NO Implied/Express Warranties
 Limitation -- A Free Bag of Seed!
 Indemnity -- Grower Defend Seed Co.?
 Does “Bag Rip” bind grower to disclaimer?
Stewardship - Disclosure + Common facts = Class Action

27. Step 2: Farm
Specific varieties are grown
under contract, harvested
and stored separately on
the farm.
Some states (ID, WA, MO)
have “grower district”
statutes that enable
identity preservation

28. • 7 Production Districts
• Edible vs. Industrial
• Exceptions Available
District 2
District 1
District 4
District 3
District 7
District 6
District 5

29. Step 3, 4: Cleaning,
grading
IP varieties are usually
graded and cleaned using
special procedures.
Testing to a specific
“tolerance” for biotech
content can occur at this
stage of the process.

30. Step 5: Ships
The IP shipments are loaded
onto container ships and
stored completely separated
from other commodities
during the trans-oceanic trip.
Testing at point of export can
prevent trade disruption
from ‘unapproved-overseas”
biotech crops.

31.  Idaho, WA and MO have “grower district” laws
enabling coexistence via contract.
 Some “nonGMO” Counties, cities out West.
 Most farm belt states now have laws preempting non-
GMO counties.
 California Rice Export law – “Rice Certification Act”
 Economic impact assessed, fees to cover costs to avoid it
 Effectively stopped commercialized biotech rice
 CA Specialty sector ready for GE fruits-veggies?

32.  2005 snapshot
 Brown are Marin, Trinity,
Mendocino
 Add Santa Cruz ’06
 All the rest – No way!
 Community standards for
nuisance can be statutory
 Industry stopped NonGM
in production ag counties
 VT backed down from its
seed purity law and cannot
pass bio-liability
No thanks, we
like GMOs!
B.t. corn is
safer for
livestock!
Hey, man,
don’t ban
my biotech
marijuana!

33.  Borrowing from “Non-GM” zone
movement, standards bar biotech
(genetically modified, “GM”)
 US Green Building Counsel going “Non-GMO”
w/FSC standard just as biotech trees show up?
 Rainforest Alliance sust-ag standard anti-GMO
 RT Sustainable Biofuels – Technology
neutral?
 Global GAP – similar requirements on
migration?
 Tech-neutral WWF RT on Responsible
Soybeans
 Non-GMO grower maintains buffer in GM area
 Unless local law/practice requires segregation

34.  Unilever -- 600 lb gorilla?
 50% reduction in footprint?
 RTRS – imposing Non-GMO?
 Kelloggs – Kashi pressured
 Miller –Coors – we can’t manage unless we
measure what our suppliers are using….

35.  Wal-Mart environmental goals:
 100 percent renewable energy
 Reach “zero” waste
 Sustainable packaging
 Wal-Mart “sustainability index” reaches overseas
 Sustainable seafood requirements drove South
American changes in fisheries practices
 Chinese small producers signed up to meet index
 Do not fall into the 5% that fail to meet the supply
specification du jour that takes 5 years to sort out!
 Good news – opposed to US-State GM labeling

36.  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.