GENETICALLY MODIFIED FOOD ANIMALS: USDA Legal Authorities Backgrounder

1. GENETICALLY MODIFIED FOOD ANIMALS: USDA Legal Authorities Backgrounder Nancy B. Bryson The Bryson Group PLLC Nancy S. Bryson, The Bryson Group PLLC

2. OVERVIEW • Food Animals Genetically Modified for Food and Non-Food Uses • Regulatory authority for food safety (FSIS) • Health and disease safeguarding authority (APHIS) • Animal Welfare (APHIS) • Market Development and Promotion (AMS) • Research and Education (ARS, CSREES, ERS, NASS) • Consultative Role Nancy S. Bryson, The Bryson Group PLLC

3. Safety of Food Products from Animals • Federal Meat Inspection Act – meat and meat products are safe (not adulterated or misbranded), FSIS • Adulterated: • contains any poisonous or deleterious substance that would be unsafe under the FFDCA (FDA) • Produced under unsanitary conditions • From animal that died other than by slaughter Nancy S. Bryson, The Bryson Group PLLC

4. Safety of Food Products From Animals • Misbranded: • Label is “false or misleading” • Statutory/regulatory definitions • Implementation: • Continuous in-plant inspection of slaughter plants and production facilities • HACCP requirements • Review and pre-approval of product labels • Enforcement activity • Administered through regulations, policy memoranda, guidance and directives Nancy S. Bryson, The Bryson Group PLLC

5. Imported Products – The Equivalency Requirement • Imported meat and meat products must meet US safety standards • The standards of the exporting country do not have to be identical but they must be “equivalent” (SPS WTO trade standard) • FSIS is responsible for determining equivalency • Regulatory process that includes evaluation criteria/process Nancy S. Bryson, The Bryson Group PLLC

6. Imported Products- The Equivalency Requirement • System evaluation • Organizational structure/staffing • National government control • Competent, qualified inspectors • Enforcement responsibility • Same inspection, sanitation, quality, species verification, residue standards applied to products in the U.S. Nancy S. Bryson, The Bryson Group PLLC

7. Imported Products – The Equivalency Requirement • Legal authority • Ante-mortem inspection by or under supervision of vets • Post-mortem inspection of carcasses • Official controls by national government over establishment construction, facilities, and equipment • Direct and continuous official inspection • Separation of establishments certified for export • Sanitation requirement/HACCP/control of condemned materials Nancy S. Bryson, The Bryson Group PLLC

8. Imported Product – The Equivalency Requirement • Review initiated at request of foreign government • Documentary review (laws, regulations, procedures) • On-site in country review by FSIS • Periodic in-country compliance reviews • Individual plants must be certified for export • Imported product: foreign-meat inspection certificate/inspected at an official establishment or import inspection establishment • Plant certifications can be suspended at FSIS discretion based on information of noncompliance Nancy S. Bryson, The Bryson Group PLLC

9. Animal Health and Safeguarding Authorities • Animal Health Protection Act (“AHPA”); APHIS • Authority: (1) to prohibit or restrict the import, export or interstate movement of any animal, article, or means of conveyance, or use of any means of conveyance or facility, if the Secretary determines necessary to prevent the introduction into or dissemination within the U.S. of any pest or disease of livestock, and • (2) seize, quarantine and dispose of any animal, article or means of conveyance determined to be necessary Nancy S. Bryson, The Bryson Group PLLC

10. Animal Health and Safeguarding Authorities • Animal – any member of animal kingdom (except a human) • Article – any pest or disease or any material or tangible object that could harbor a pest or disease • Means of conveyance – any personal property used to move any other personal property • Pest - protozoan, plant, bacteria, fungus, virus or viroid, infectious agent or pathogen, arthropod, parasite, prion, vector, or similar or allied organism • Disease – USDA defined • Livestock – all farm raised animals Nancy S. Bryson, The Bryson Group PLLC

11. Animal Health and Safeguarding Authorities Purpose – to protect: - animal health - health and welfare of people - economic interests of livestock and related industries - environment of the U.S. and interstate commerce - foreign commerce in animals and articles Nancy S. Bryson, The Bryson Group PLLC

12. Animal Health and Safeguarding Authorities • Close linkage with OIE (World Organization for Animal Health) • OIE risk-based criteria for trade in animals have been used as basis for U.S. SPS standards • Animal identification and animal traceability systems are essential components of OIE criteria (from place of origin to end of meat production chain) • OIE Resolution on Animal Production Food Safety Nancy S. Bryson, The Bryson Group PLLC

13. Animal Welfare • “Animal” – any live or dead dog, cat, monkey, guinea pig, hamster, rabbit, or such other warm-blooded animal as the Secretary may determine is being used, or is intended for use, for research, testing, experimentation or exhibition purposes . . . • Excludes: “other farm animals, such as, but not limited to livestock or poultry, used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. Nancy S. Bryson, The Bryson Group PLLC

14. Animal Welfare • Animal Welfare Act does not apply to farm animals used for food • Could apply to such animals being used in certain types of laboratory research. • Requirements for humane treatment of animals being used in laboratory research. • FSIS regulations – exclude food animals used in research investigation for experimental drugs, etc. from slaughter (a few risk-based exceptions). Nancy S. Bryson, The Bryson Group PLLC

15. Marketing, Labeling, Process Verification • Agricultural Marketing Act: An integrated administration of all laws enacted by Congress to aid the distribution or agricultural products through research, market aids and services, and regulatory activities, to the end that marketing methods and facilities may be improved, . . . [and] . . . , that new and wider markets for American agricultural products may be developed, both in the United States and in other countries, with a view to making it possible for the full production of American farms to be disposed of usefully, economically, profitably, and in an orderly manner Nancy S. Bryson, The Bryson Group PLLC

16. Marketing, Labeling and Process Verification • AMS is authorized to “develop and improve standards of quality, condition, quantity, grade and packaging.” • Voluntary standards (beef grading standards, 100% Angus beef, grass-fed, naturally raised, etc.) • Participating producers pay a user fee for AMS review and audit process supporting the verification system. • Can be rapidly developed to address market needs (export verification process developed for beef in response to BSE developments) Nancy S. Bryson, The Bryson Group PLLC

17. The Organic Foods Production Act • Also administered by AMS • Statutory Authority to • Establish national organic production process standards • Assure consumers of a consistent organic standard • Facilitate interstate commerce in fresh and processed organic food • National certification program for application of national standards to individual farms through an Organic Systems Plan developed with a USDA accredited certifier. • Does Apply to Livestock and Poultry (origin, feed, health care practices and living conditions) Nancy S. Bryson, The Bryson Group PLLC

18. Country of Origin Labeling • 2002 Farm Bill – requirements for various meat products (muscle cuts of beef, lamb and pork and ground product, farm-raised and wild fish). • 2008 Farm Bill – extends to goats and chickens and adds on • U.S. country of origin (exclusively born, raised and slaughtered in the U.S.) and • Multiple countries of origin (may designate all such countries) Nancy S. Bryson, The Bryson Group PLLC

19. Research Authorities • Authority: conduct and administration of a wide variety of research and extension assistance related to agriculture and food • ARS • Ensure high-quality, safe food and other agricultural products • Assess nutritional needs • Sustain a competitive agricultural economy • Enhance natural resource base and environment • Provide economic opportunities for rural citizens, communities Nancy S. Bryson, The Bryson Group PLLC

20. Research Authorities • CSREES • Extension/ work with state and local partners • ERS (briefing rooms, publications, data) • Competitive agricultural system • Safe food supply • Healthy and well-nourished population • Harmony between agriculture and environment • Enhanced quality of life for rural Americans • NASS – U.S. agriculture statistics Nancy S. Bryson, The Bryson Group PLLC