Thomas P. Redick

Global Environmental Ethics Counsel, LLC

St. Louis, MO

www.geeclaw.com

The “Stacked” Pipeline of Biotech Specialty Crops and

Regulatory/Market Barriers to Coexistence

NC 1034College Park

TXJune 5, 2013

“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

Overview of Pipeline/Barriers

1893 U.S. Sup. Ct. Nix case – tomato = vegetableSpecialty 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 geneAny GM research funded?

“Specialty” Crops Definition, Issues

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

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

etcReduced 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

  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 phosphateU.S. -- around 53 years.Estimated 351 years  worldwide phosphate

“Peak P” Management Plan

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

Nationwide Six Sisters Approach to AgbiotechCorn, 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.

Biotech Cos “Concentration”

Patent expiration means free use of some input traitsPipeline 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

Biotech Specialty Crops – Pipeline

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 GHGsFeeds 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

Biotech Crops – Pipeline

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” TaterUSDA plant pest?EPA role via FIFRA?FDA voluntary role?EU-JAPAN –ETC?

Stacks are required for various reasonsHerbicide-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

Soybean Industry Portfolio 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 TolerantBrazil 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/RR2YBrazil only

(Monsanto)

Glytol/HPPD(Bayer/MS

Technologies)

Glytol / HPPD / LL(Bayer/MS Technologies)

2,4-D Tolerant

(Dow)

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%

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

Plant, select and harvest field trials Discard

X%

Food Mfg Feasibility

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

Innovators Giving Up Hope?Came and went…

Flavr-Savr tomatoB.t. Potato – McDonalds veto

Never saw Commercial launchHR rice – billion dollar Bayer caseOats, barley, lettuceVirus-resistant plum is no papaya…Whither Wheat?

Beet Sugar made it despite NEPAB.t sweet corn now in farmer mkts

Tree of Biotech Crops: Losing Limbs

What will Mommies say?

Lose 5% market share?

CAN’T LOSE EXPORTS

Not sustainable

INDUSTRIAL TREADMILL

USDA approvals slowed, just sped up a bit in 2012New regulatory opposition – grain trade, millers and

“functional” traits interference with marketing. Enogen, 2-4-D corn delayedNo regulation of bentgrass – no “plant pest” DNA?

Looming threat of Nat’l Env Policy Act litigation?USDA now cites “interrelated” economic/enviro/socialSued 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.

Biotech crops meet regulatory web

NEPA LAW & Biotech Crops

• 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”)

NIMBY vs. FONSI

Biosafety §18.2(a) “May Contain” + GM food labelingGeneric information , useless for recalls/tracingForces food-manufacturers to substitute inputsGreenpeace 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)

Biosafety Protocol Traceability & Labeling

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 tradeEU, China = $15 billion post-

equilibriumEU 0.9% tolerance – zero in China?

Patents/APPROVALS Expire

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.

Patent Uncertainty Looming?

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

Challenging GM Food Label/Liability Laws

Biosafety Protocol2003 – up to 158 (&

counting) nations “Precautionary

Approach” to biotech means delays

Oct. 2010 – Meeting of Parties, Nagoya JapanArticle 27 liability lawArticle 18 “Traceability”

= recalls and enviro-liability risks

1964, nearly all (191) nationsUN’s Food Standards Body,

WTO reference US, Canada belong, but

outvoted by EU (27 votes)No consensus on

precautionary principleTroubling traceability on

animals, fruits, oils etc.Committees on Fats-Oils +

GM label task force, and others worth tracking

Biosafety Protocol vs. Codex

Codex Alimentarius

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

ProcessorStorage

• 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

IDENTITY PRESERVATIONStep 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.

Risk Shifting and Disclosures

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

IDENTITY PRESERVATIONStep 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

IdahoRapeseedGrowerDistricts

• 7 Production Districts

• Edible vs. Industrial

• Exceptions Available

District 2

District 1

District 4

District 3

District 7District 6

District 5

IDENTITY PRESERVATION

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.

IDENTITY PRESERVATIONStep 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 non-

GMO counties.California Rice Export law – “Rice Certification Act”

Economic impact assessed, fees to cover costs to avoid itEffectively stopped commercialized biotech rice

CA Specialty sector ready for GE fruits-veggies?

State Laws on Coexistence

No Votes on Non-GMO all over2005 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!

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 SoybeansNon-GMO grower maintains buffer in GM areaUnless local law/practice requires segregation

Sustainability Standards & “GM”

Unilever -- 600 lb gorilla?50% reduction in footprint?RTRS – imposing Non-GMO?

Kelloggs – Kashi pressuredMiller –Coors – we can’t manage unless we

measure what our suppliers are using….

Industry & Supply Chain Data Demands

Wal-Mart environmental goals:100 percent renewable energyReach “zero” wasteSustainable 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

Contractual Drivers – Wal-Mart

Expanding Pipeline – new crops, new methods – will encounter complex patchwork of legal issuesIP 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, internationalsSustainability matters now, soon to matter

more.

Conclusions

Thanks!

tpr@geeclaw.com