North American Agbiotech Council 2013 Specialty Crops
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  • Nix v. Hedden, 149 U.S. 304 (1893),[1] tomato should be classified under customs regulations as a vegetable rather than a fruit.USDA Defineshttp://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5082113Specialty crops are defined in law as “fruits and vegetables, tree nuts, dried fruits and horticulture and nursery crops, including floriculture.” This definition, although more exact than previous legal definitions, leaves a certain amount of latitude in interpretation. The legal definition of specialty crops is, however, intimately tied to the definition of horticulture and its various components. Horticulture is defined as that branch of agriculture concerned with intensively cultivated plants that are used by people for food, for medicinal purposes, and for aesthetic gratification. There are two key components of this definition that differentiate horticultural crops from other crops: “intensively cultivated” and “used by people for …”. Therefore, horticultural crops are differentiated from other crops by the level of management employed in their production and by their subsequent use. Horticultural plants are commonly divided into those that are edible, those that are used for culinary or medicinal purposes, and those that are used for ornamental or aesthetic purposes. Horticulture is also divided into specializations. The te terms used to describe these specializations derive from millennia of common usage and are sometimes at odds with botanical nomenclature. For example, vegetables are described as herbaceous plants of which some portion is eaten raw or cooked during the main part of a meal. Fruits, for horticultural purposes, are described as plants from which a more or less succulent fruit or closely related botanical structure is commonly eaten as a dessert or snack. By these definitions, plants such as tomato, squash and cucumber are considered vegetables despite the fact that the edible portion is defined botanically as a fruit. The delineation of plants by common usage was legally established in 1893 by the unanimous U.S. Supreme Court decision in the case of Nix vs. Hedden. Over the last 60 years, agriculture, including horticulture, has become increasingly reliant on science and technology to maintain profitable production. The scientific study of horticulture is divided into various sub-disciplines. Pomology is defined as that branch of horticulture dealing with fruit and tree nut production. Fruit production includes the so-called tree fruits; such as apple, peach, and orange, and small fruits; such as strawberry, blueberry, and raspberry. Olericulture is defined as that branch of horticulture dealing with the production of vegetables and herbs. Floriculture is that branch of horticulture dealing with the production offield-grown or greenhouse-grown plants for their flowers or showy leaves. Environmental horticulture is that branch of horticulture that deals with the production of plants for ornamental use in constructed environments, both indoors and outdoors. There are many facets to environmental horticulture. Nursery production involves growing plants under intensive management for use in another location. Nurseries are defined in a variety of ways: a) the type of plant grown, such as fruit tree, turf or Christmas tree nurseries; b) the function of the nursery, such as production, wholesale, retail, mail-order or landscape nurseries; and c) the production system, such as field-grown or container-grown. Landscape horticulture involves the design, installation, and maintenance of both outdoor and indoor environments. Public horticulture involves the design and maintenance of arboreta, public gardens, parks, and athletic facilities. Horticultural therapy involves the use of horticultural plants to improve the condition of people with physical, intellectual or emotional disabilities. Horticultural therapy also includes the use of plants in hospitals and other medical facilities to ease the pain and suffering of patients. Home horticulture involves the use of horticultural plants as a recreational activity, generally by non-professionals. Home horticulture is the most popular hobby in the United States with a commercial value of over $35 billion in 2007. As discussed above, specialty crops are plants that are intensively cultivated. There are many plants that are specialty crops when cultivated, but are also collected from wild populations. Wild plants are not considered specialty crops even though they may be used for the same purpose as cultivated plants. This is somewhat common among medicinal herbs and woodland plants. There are a number of native ferns that are collected from wild populations for use in the floral trade. There are also a number of marine plants that are collected from wild populations both for direct consumption and for industrial uses. Table 6. Number of applications submitted in fiscal year 2008 that specified crops to be used in research and extension projects. Some applications used broad, generic terms to address a wide range of specialty crops. Those numbers are not reflected here. Sorting occurs in order of decreasing number of applications submitted. The number of awards actually made for a particular crop follows the “/” character.#Crop#Crop#Crop#Crop20/4Grape 6/1Peach 2/1Cucumber1Chard15/5Tomato6/1Pecan 2/1Raspberry1Mushroom 14/5Apple 5/2Almond2Sweet corn1Pineapple 12/3Nursery 5/3Pear 2Chestnut 1Purslane11/2Strawberry 5/2Walnut2Edamame1Anthurium11/3Greenhouse 5/1Onion 2Plum1Blackberry 10/1Turf grass 3Bean 2Sweet potato 1Lima bean 10/1Potato 3/1Cranberry 1Hazelnut1Mustard 10/1Pepper3Pea 1Taro 1Pistachio 10/2Lettuce 3/1Melon 1Banana 1Two-winged silverbell9/3Citrus 3/2Carrot 1Elderberry1Guava 8Spinach 2Hops 1Mint1Lotus 8/2Cherry 2/1Squash1/1Ohelo1Rose 7/2Blueberry2Brassica 1Christmas tree 1/1Asparagus 7Pollinator2/1Watermelon 1Eggplant  
  •   New phosphorous mines being created.B.      New mine-able phosphate deposits being found/proved.C.      New technologies being developed to recover phosphorous from waste streams (e.g., municipal sewage treatment plants   Estimated lifespan for existing U.S. mine-able phosphate to be at least 53 years.. but could “increase substantially” (e.g., if wetlands legal restrictions in Florida were to become more realistic, or if phosphate fertilizer prices increase—thus making lower-grade ore deposits economically viable to build new mines).ii.                   Estimated lifespan for existing worldwide mine-able phosphate to be at least 351 years.iii.                   #C as viable for significantly adding to those above lifespans soon. 
  •   New phosphorous mines being created.B.      New mine-able phosphate deposits being found/proved.C.      New technologies being developed to recover phosphorous from waste streams (e.g., municipal sewage treatment plants   Estimated lifespan for existing U.S. mine-able phosphate to be at least 53 years.. but could “increase substantially” (e.g., if wetlands legal restrictions in Florida were to become more realistic, or if phosphate fertilizer prices increase—thus making lower-grade ore deposits economically viable to build new mines).ii.                   Estimated lifespan for existing worldwide mine-able phosphate to be at least 351 years.iii.                   #C as viable for significantly adding to those above lifespans soon. Republic of Nauru -- http://www.youtube.com/watch?v=-hQs6VHXGt4
  • $http://www.isaaa.org/resources/publications/briefs/44/pptslides/default.aspInternational Service for the Acquisition of Agri-Biotech Applications (ISAAA).G-8 leaders in 2008 for the first time recognized the significance of biotech crops and called to “accelerate research and development and increase access to new agricultural technologies to boost agriculture production; we will promote science-based risk analysis, including on the contribution of seed varieties developed through biotechnology.” The European Union also has acknowledged that biotech crops “can play an important role in mitigating the effects of the food crises.”In China, Premier WenJiabao has said “to solve the food problem, we have to rely on big science and technology measures, rely on biotechnology, rely on GM.” As a result, China has committed an additional US $3.5 billion over 12 years for continued research and development. Biotech rice alone, already developed and field tested in China, has the potential to increase food availability and net income by about $100 per hectare for approximately 440 million people in the country.An additional 1.3 million farmers planted 10.7 million new hectares of biotech crops in three new countries in 2008, according to the ISAAA brief Global Status of Commercialized Biotech/GM Crops 2008. ISAAA has been tracking global biotech crop adoption trends since 1996. In its annual study, ISAAA found that 13.3 million farmers in a record 25 countries planted 125 million hectares of biotech crops last year, the sixth largest growth spurt in 13 years of reporting. The 2 billionth cumulative acre of biotech crops also was planted in 2008, just three years after the first billionth acre, a milestone which required a decade to reach.Most notably, in 2008 biotech farming began in the African nations of Egypt and Burkina Faso. Africa is considered the “final frontier” for biotech crops as it has perhaps the greatest need and most to gain. In 2008, Egypt planted 700 hectares of Bt maize and Burkina Faso planted 8,500 hectares of Bt cotton. They join South Africa, which since 1998 has benefited from biotech cotton, maize and soybean
  • Chloragen’s technology could of-fer significant cost advantages over both cell culture production methods and existing plant transgenic methods by greatly increasing the protein yield of a plant. Unlike traditional methods of producing proteins in plants, in which a new gene is introduced into the cell nucleus, CTT involves introducing a new gene into the roughly 100 chloroplasts within a plant cell.
  • This slide shows the coming biotech soybean events. Those in green boxes above the line are food quality traits and those in the red boxes below the line are input traits with better agronomic characteristics.
  • Evil scientist shrinking ray reminds me of the lower yields we’ll see without biotech innovationAround the corner from the PFC is the alley where L-t was sold – not the “bad batch” this time?Consumers post-recall were on notice – comparative fault, not an intervening tortfeasor.
  • Once “deregulated” USDA has no authority over the crop. Liability, FDA etc takes over.“Cavalier” dismissal of RR resistance – “cramped reading of what constitutes an environmental impact”7 U.S.C. § 7711(a); Center for Food Safety v. Johanns, 451F.Supp.2d 1165, 1176 (D. Haw. 2006).RR WEEDS ” Nothing in NEPA, the relevant regulations, or thecaselaw support such a cavalier response.”Cert STATUS?Winter case cite and discussion of Supreme Court on injunction law and precautionary approach.
  •  Japan does not require labeling for GM oil in food, but would mandate GM label on biotech oils for output traits used in food production.MAFF originally excluded oil and other highly processed food made withGM ingredients from the List because the absence or presence of GM content could notbe verified through testing, with foreign DNA being destroyed during processing.Nonetheless, on 3 September 2001, MAFF revised the labeling proposal to requirehigh oleic acid soybean oil made from high oleic acid GM soybeans be labeled as "GMhigh oleic soybean oil."Diana Wong, Genetically Modified Food Labeling (19 March 2003)http://www.legco.gov.hk/yr02-03/english/sec/library/0203rp05e.pdf
  • RTRS and RSB responded to US soybean and corn grower association comments by going technology neutral. expert group decided non-GM must establish a buffer, changing current text requiring “GM” growers to “prevent migration” to non-GM cropshoLiSTiCapproaChaQuaCuLTureTotal number of Control points: 231Food Safety65Environment (incl. Biodiversity)
  • 5% of supply chain might not be selling to Wal-Mart – bye
  • 5% of supply chain might not be selling to Wal-Mart – bye

North American Agbiotech Council 2013 Specialty Crops North American Agbiotech Council 2013 Specialty Crops Presentation Transcript

  • Thomas P. Redick Global Environmental Ethics Counsel, LLC St. Louis, MO www.geeclaw.com NC 1034 College Park TX June 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
  •  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?
  •  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.
  •  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
  • 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 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.
  •  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
  •  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
  •  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?
  •  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.
  • 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)
  • 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.
  • 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 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.
  • • 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”)
  •  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 post- equilibrium  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  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
  • 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
  • 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
  • • 7 Production Districts • Edible vs. Industrial • Exceptions Available District 2 District 1 District 4 District 3 District 7 District 6 District 5
  • 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 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?
  •  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!
  •  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….
  •  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.