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

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

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

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

5. Nancy S. Bryson, The Bryson Group PLLC Imported Products – The Equivalency Requirement Imported meat and meat products must meet US safety standards 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) 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 FSIS is responsible for determining equivalency Regulatory process that includes evaluation criteria/process Regulatory process that includes evaluation criteria/process

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

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

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

9. Nancy S. Bryson, The Bryson Group PLLC Animal Health and Safeguarding Authorities Animal Health Protection Act (“AHPA”); APHIS 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 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 (2) seize, quarantine and dispose of any animal, article or means of conveyance determined to be necessary

10. Nancy S. Bryson, The Bryson Group PLLC Animal Health and Safeguarding Authorities Animal – any member of animal kingdom (except a human) 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 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 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 Pest - protozoan, plant, bacteria, fungus, virus or viroid, infectious agent or pathogen, arthropod, parasite, prion, vector, or similar or allied organism Disease – USDA defined Disease – USDA defined Livestock – all farm raised animals Livestock – all farm raised animals

11. Nancy S. Bryson, The Bryson Group PLLC 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

12. Nancy S. Bryson, The Bryson Group PLLC Animal Health and Safeguarding Authorities Close linkage with OIE (World Organization for Animal Health) 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 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) 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 OIE Resolution on Animal Production Food Safety

13. Nancy S. Bryson, The Bryson Group PLLC 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... “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. 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.

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

15. Nancy S. Bryson, The Bryson Group PLLC 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 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

16. Nancy S. Bryson, The Bryson Group PLLC Marketing, Labeling and Process Verification AMS is authorized to “develop and improve standards of quality, condition, quantity, grade and packaging.” 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.) 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. 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) Can be rapidly developed to address market needs (export verification process developed for beef in response to BSE developments)

17. Nancy S. Bryson, The Bryson Group PLLC The Organic Foods Production Act Also administered by AMS Also administered by AMS Statutory Authority to Statutory Authority to Establish national organic production process standards Establish national organic production process standards Assure consumers of a consistent organic standard Assure consumers of a consistent organic standard Facilitate interstate commerce in fresh and processed organic food 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. 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) Does Apply to Livestock and Poultry (origin, feed, health care practices and living conditions)

18. Nancy S. Bryson, The Bryson Group PLLC 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). 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 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 U.S. country of origin (exclusively born, raised and slaughtered in the U.S.) and Multiple countries of origin (may designate all such countries) Multiple countries of origin (may designate all such countries)

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

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