overview of the us regulatory system for plant and animal modern agricultural biotechnology

United StatesDepartment ofAgriculture

ForeignAgriculturalService

Overview of the US Regulatory System for Plant

and Animal Modern Agricultural Biotechnology

US Department of AgricultureForeign Agricultural Service

March 2012

Slide 1 of 16



Regulation of Plant Biotechnology in the United States

• The U.S. Coordinated Framework (1986)• The potential risks posed by genetically engineered organisms are

not fundamentally different from those posed by conventional products

• Regulation should be science-based and oversight conducted on a case-by-case basis

• Existing laws provide adequate authority

Slide 2 of 16



Coordination of U.S. Agencies

FDA Safe for usefood and feed

USDASafe for agriculture and the environment

EPA Safe for usein pesticides

Products are regulated according to their intended use, with some products being regulated under more than one agency.

Slide 3 of 16



Regulation under the Coordinated Framework

New Trait/Crop Agency Review

Insect resistance in food crop(Bt corn)

USDAEPAFDA

Agricultural and environmental safety Environmental, food safety of pesticideFood/feed safety

Herbicide tolerance in food crop(Roundup Ready soybeans)

USDAEPAFDA

Agricultural and environmental safetyNew herbicide useFood/feed safety

Herbicide tolerance in ornamental crop

USDAEPA

Agricultural and environmental safetyNew herbicide use

Modified oil in food crop(High oleic acid soybeans)

USDAFDA

Agricultural and environmental safetyFood/feed safety

Modified flower color (Blue roses)

USDA Agricultural and environmental safety

Slide 4 of 16



• Corn - HT, IR, AP• Soybean - HT, PQ• Cotton - HT, IR• Canola - HT, AP, PQ• Papaya – VR• Squash – VR• Tobacco – PQ• Sugar beet - HT

Tomato - PQ Chicory – AP Potato - IR, VR Rice – HT Flax – AP Plum - VR

HT – herbicide toleranceIR – insect resistanceAP – agronomic propertiesVR – virus resistancePQ – product quality

• large scale production not in commercial production

Commercialization of Transgenic Plant Varieties in the U.S.

Slide 5 of 16



Adoption of Genetically Engineered Crops in the United States (2011)

CornCorn 1616 2323 4747 8888

CottonCotton 1717 1515 5858 9090

SoybeansSoybeans 00 9494 00 9494

Insect Insect Resistant Resistant

Herbicide Herbicide TolerantTolerant

Stacked Gene Stacked Gene VarietiesVarieties Total*Total*

Source: http://www.ers.usda.gov/Data/BiotechCrops/

* Values represent percentages of each crop planted in 2011* Values represent percentages of each crop planted in 2011

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Why U.S. growers use biotech crops: Environmental Benefits

– Reduction in pesticides– Savings on fossil fuels– Decreasing CO2 emissions

through no/less plowing– Improved soil health by

conserving soil and moisture by optimizing the practice of no till

– Increased birdlife and beneficial insects

Slide 7 of 16



– Fuel savings– Labor efficiency– Herbicide and Pesticide

savings– Increased yields

Why U.S. growers use biotech crops: Economic Benefits

Slide 8 of 16



DroughtTolerance

(Monsanto/BASF) Higher

Yield(Monsanto/

BASF)

Broad Lep- MIR 162(Syngenta)approved

Corn Amylase

(Syngenta)

IncreasedEthanol

(Syngenta)

RW dualMode of

action(Syngenta)

Novel Insect Traits

(Syngenta)

VT Doublepro

(Monsanto) Triple-modeHerb. Tol.(Pioneer/DuPont)

Droughttolerance(Pioneer/DuPont)

Nitrogenutilization

(Monsanto/BASF)

Increased Yield

(Pioneer/DuPont)“SmartStax

(Monsanto/Dow)

HerbicideTol.

(Dow)

ImprovedFeed

(BASF)

Agronomic Trait

Quality Trait

Improved Feed(Pioneer/DuPont)

Industry Corn Portfolio*

A Steady Pipeline of Events

2010 201X

[*Estimated commercialization pipeline of corn biotech events prepared by the U.S. Grains Council. Commercialization dependent on many factors, including successful conclusion of regulatory process]

Nitrogenutilization

(Pioneer/DuPont)

Nitrogenutilization(Syngenta)

IncreasedEthanol

(Pioneer/DuPont)

DroughtTolerance(Syngenta)

2/2010

“Optimum”Herb. Tol.(Pioneer/DuPont)

Slide 9 of 16



Soybean Industry Portfolio Quality/Food

Agronomic

2020

Modified 7S Protein FF

(Pioneer/DuPont)

High-Oleic, Stearate

(Pioneer/DuPont)

Source: Pipeline from Industry Sources; prepared by ASA, USSEC, USB. Updated January, 2010

Nematode Resistance

(Monsanto; Syngenta;

Pioneer/DuPont)

LibertyLink (Bayer)

Imidazolinone TolerantBrazil only.

(BASF/Embrapa Brazil)RR2Y(Monsanto)

Dicamba Tolerant

(Monsanto)

Omega-3 Stearidonic Acid

(Monsanto)

High Beta- Conglycinin

(Pioneer/DuPont)

Low-Phytate(Pioneer/DuPont)

Feed: High Protein Soybean

(Pioneer/DuPont)

Omega-3EPA/DHA

(Pioneer/DuPont)

2010 2012

GAT/Glyphosate-ALS Soybean

(Pioneer/DuPont) Bt/RR2YBrazil only

(Monsanto)

HPPD Tolerant (Syngenta)

High Oleic / Low-Sat

(Monsanto)

HighStearate(Monsanto;

Pioneer/DuPont)

Pipeline of biotech events and novel trait releases

2,4-D Tolerant(Dow)

Disease Resistance

(Syngenta; Pioneer/DuPont)

Glufosinate & Isoxaflutole Tolerant (Bayer/MS Technologies)

Low Raff-Stach

(Virginia Tech)

RVSD Biotech Pipeline 02-04-10 V3

Commercialized

Glufosinate & Isoxaflutole Tolerant

& LibertyLink(Bayer/MS Technologies)

High-Oleic(Pioneer/DuPont)

Low-Linolenic(Syngenta)

Higher Yield I(Monsanto;

Pioneer/DuPont)

Higher Yield II(Monsanto;

Pioneer/DuPont)

Rust(Monsanto; Syngenta;

Pioneer/DuPont)

Aphid Resistance(Monsanto)

Slide 10 of 16



FDA/CVM regulates GE animals under the New Animal Drug Provisions of Federal Food, Drug, and Cosmetic Act Mandatory premarket approval Consideration of animal health, food safety, and requirement to

address National Environmental Policy Act (NEPA) Food safety assessment consistent with Codex Guideline Reviewed by on Case-by-Case basis Other requirements apply, including those of NEPA At this time, food from GE Animals will require additional labeling only

in cases where the food is materially different from its traditional counterpart labeling issues would be evaluated and regulated by the FDA-

CFSAN (Center for Food Safety and Nutrition)

Regulation of Animal Biotechnology:GE Animals for Food

Slide 11 of 16



GE Animals: Current Status

Products in development:• AA Salmon - FDA initiated public

comment on this first GE animal for food, awaiting environmental assessment

• GE Insects: disease and pest control (mosquito release)

• Disease resistance: avian influenza (chicken), FMD, BSE

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South Africa’s Agricultural Productivity and Biotech Adoption

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South African GE Maize Plantings

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Average Corn Yields in South Africa

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Questions?

Slide 16 of 16

overview of the us regulatory system for plant and animal modern agricultural biotechnology

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