... “nonGM”? How much GM research funded in specialty crops? ... squash).
Monsanto, Dupont/Pioneer, Dow Agrosciences, .... of 3000-5000 metric tons.
NC 1034 College Park TX June 5, 2013 Thomas P. Redick Global Environmental Ethics Counsel, LLC St. Louis, MO www.geeclaw.com
“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
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..NonGM only? New breeding methods “nonGM”? How much GM research funded in specialty crops?
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 count, given high demand, peak “P”, GHGs… 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.
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
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
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.
New forms of plant breeding evade some
US regulation but pose new 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”? Will USDA require Environmental Impact Statement for any new specialty “GM”?
J.R. Simplot Company’s “Cisgenic” Tater USDA plant pest? EPA role via FIFRA? FDA voluntary role?
Stacks are required for various
reasons Herbicide-resistant weeds serious
enough for EPA to act? Added value, particularly if royaltyfree “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.
Quality/Food Agronomic
Pipeline of biotech events and novel trait releases High Oleic / Low-Sat (Monsanto)
Omega-3 Stearidonic Acid
Commercialized Modified Protein
(Monsanto)
High-Oleic, Stearate
(Pioneer/DuPont)
High-Oleic
(Pioneer/DuPont)
Low RaffStach
(Pioneer/DuPont)
Feed: High Protein Soybean
(Virginia Tech)
Low-Linolenic
(Pioneer/DuPont)
(Syngenta)
2010 Imidazolinone Tolerant
Brazil only. (BASF/Embrapa Brazil)
RR2Y
2012 LibertyLink (LL) (Bayer)
2020 Glytol/HPPD (Bayer/MS Technologies)
(Bayer/MS Technologies)
(Bayer)
Bt/RR2Y Brazil only
(Monsanto)
Dicamba Tolerant (Monsanto)
Source: Pipeline from Industry Sources; prepared by ASA, USSEC, USB. Updated May, 2011
HPPD Tolerant
(Dow)
Glytol / HPPD / LL
(Monsanto)
LibertyLink (LL)
2,4-D Tolerant
Sclerotinia Resistance (Pioneer/ DuPont)
GAT/
(Syngenta/ Bayer)
Higher Yield II
(Monsanto; Pioneer/ DuPont)
Glyphosate
-ALS Soybean (Pioneer/ DuPont)
Higher Yield I (Monsanto)
Disease Resistance
Rust
(Monsanto; Syngenta; Pioneer/DuPont)
Aphid Resistance (Monsanto; Pioneer/DuPont)
(Syngenta; Pioneer/ DuPont)
Nematode Resistance (Monsanto; Syngenta; Pioneer/ DuPont)
Lepidoptera Resistance (Pioneer/ DuPont)
Crossing of parent varieties, transformation events Discard
Plant, select and harvest early generations
Discard
Plant, select and harvest field trials
X%
Plant, select and harvest multiple location trials Regulatory Food Mfg Feasibility Consumer Acceptance
X%
Discard X% Discard X%
Any “Last Interface” can prevent successful commercialization (after $100 mil.+ R&D?)
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.
Just another flyer found at your local People’s Food Coop: Why fear our food?
i
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
USDA approvals slowing to do EIS for all? New regulatory opposition – grain trade, millers and “functional” traits interference with marketing. Enogen biofuel corn delayed pending assessment 2-4-D corn, High oleic soy delayed18 mos for EIS? No regulation of bentgrass – no “plant pest” DNA? Looming threat of Nat’l Env Policy Act
gone?
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)
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 postequilibrium EU 0.9% tolerance – zero in China?
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.
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
Biosafety Protocol
Codex Alimentarius
2003 – up to 158 (&
1964, nearly all (191) nations UN’s Food Standards Body,
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
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
Farm Transport
Contract
Farm
• Farmer and buyer contract well in advance of planting for specific variety at specific premium
• Specific Variety Grown Separately
• Farmer puts in bags or containers
• Special unloading & handling procedures
• Harvested and stored separately
• Maintain separate storage
• Stored in separate bins or containers
Processor • Separate processing runs or processing lines for high value products
Elevator
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Processor Storage • Special dedicated storage
Transport • Via Coastal vessel, barge, truck or rail
Port of Discharge • Unloaded via common machinery into 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
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.
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
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
District 1 District 2 District 3 District 4 District 5 District 6 District 7
• 7 Production Districts • Edible vs. Industrial • Exceptions Available
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.
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.
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 nonGMO 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?
2005 snapshot
Hey, man, don’t ban my biotech marijuana!
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!
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
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….
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
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
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.
