Overview of the US Regulatory System for Plant and Animal Modern Agricultural Biotechnology

1. Overview of the US Regulatory System for Plant and Animal Modern Agricultural Biotechnology US Department of Agriculture Foreign Agricultural Service March 2012

2. 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 Regulation of Plant Biotechnology in the United States

3. USDASafe for agriculture and the environment FDASafe for usefood and feed EPASafe for usein pesticides Coordination of U.S. Agencies Products are regulated according to their intended use, with some products being regulated under more than one agency.

4. Regulation under the Coordinated Framework

5. large scale production • not in commercial production Commercialization of Transgenic Plant Varieties in the U.S. • Tomato -PQ • Chicory –AP • Potato -IR, VR • Rice –HT • Flax –AP • Plum -VR • Corn -HT, IR, AP • Soybean - HT, PQ • Cotton - HT, IR • Canola - HT, AP, PQ • Papaya – VR • Squash – VR • Tobacco – PQ • Sugar beet - HT HT – herbicide tolerance IR – insect resistance AP – agronomic properties VR – virus resistance PQ – product quality

6. Adoption of Genetically Engineered Crops in the United States (2011) * Values represent percentages of each crop planted in 2011 Source: http://www.ers.usda.gov/Data/BiotechCrops/

7. 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

8. Why U.S. growers use biotech crops: Economic Benefits • Fuel savings • Labor efficiency • Herbicide and Pesticide savings • Increased yields

9. Industry Corn Portfolio* A Steady Pipeline of Events Agronomic Trait Quality Trait Nitrogen utilization (Monsanto/BASF) Improved Feed (Pioneer/DuPont) Drought Tolerance (Monsanto/ BASF) Nitrogen utilization (Pioneer/DuPont) RW dual Mode of action (Syngenta) Higher Yield (Monsanto/ BASF) Broad Lep - MIR 162 (Syngenta) approved Improved Feed (BASF) Drought Tolerance (Syngenta) Novel Insect Traits (Syngenta) 2010 201X Herbicide Tol. (Dow) Increased Ethanol (Syngenta) Increased Ethanol (Pioneer/DuPont) Corn Amylase (Syngenta) VT Double pro (Monsanto) Increased Yield (Pioneer/ DuPont) Triple-mode Herb. Tol. (Pioneer/ DuPont) Drought tolerance (Pioneer/ DuPont) Nitrogen utilization (Syngenta) “SmartStax (Monsanto/Dow) “Optimum” Herb. Tol. (Pioneer/ DuPont) [*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] 2/2010

10. Quality/Food Agronomic Pipelineofbiotecheventsandnoveltraitreleases Commercialized Omega-3 Stearidonic Acid (Monsanto) High-Oleic, Stearate (Pioneer/DuPont) High Oleic / Low-Sat (Monsanto) Omega-3 EPA/DHA (Pioneer/DuPont) High Beta- Conglycinin (Pioneer/DuPont) Modified 7S Protein FF (Pioneer/DuPont) Soybean Industry Portfolio High-Oleic (Pioneer/DuPont) High Stearate (Monsanto; Pioneer/DuPont) Low-Linolenic (Syngenta) Feed: High Protein Soybean (Pioneer/DuPont) Low Raff-Stach (Virginia Tech) Low-Phytate (Pioneer/DuPont) 2010 2012 2020 Glufosinate & Isoxaflutole Tolerant (Bayer/MS Technologies) HPPD Tolerant (Syngenta) Disease Resistance (Syngenta; Pioneer/DuPont) 2,4-D Tolerant (Dow) Higher Yield II (Monsanto; Pioneer/DuPont) Glufosinate & Isoxaflutole Tolerant & LibertyLink (Bayer/MS Technologies) Imidazolinone Tolerant Brazil only. (BASF/Embrapa Brazil) Higher Yield I (Monsanto; Pioneer/DuPont) RR2Y (Monsanto) Rust (Monsanto; Syngenta; Pioneer/DuPont) Nematode Resistance(Monsanto; Syngenta; Pioneer/DuPont) LibertyLink (Bayer) GAT/Glyphosate-ALS Soybean (Pioneer/DuPont) Dicamba Tolerant (Monsanto) Bt/RR2Y Brazil only (Monsanto) Aphid Resistance (Monsanto) Source: Pipeline from Industry Sources; prepared by ASA, USSEC, USB. Updated January, 2010 RVSD Biotech Pipeline 02-04-10 V3

11. 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

12. 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

13. South Africa’s Agricultural Productivity and Biotech Adoption

14. South African GE Maize Plantings

15. Average Corn Yields in South Africa

16. Questions?