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

Nancy S. Bryson, The Bryson Group PLLC

GENETICALLY GENETICALLY MODIFIED FOOD MODIFIED FOOD

ANIMALS: ANIMALS: USDA Legal Authorities USDA Legal Authorities

BackgrounderBackgrounderNancy B. BrysonNancy B. Bryson

The Bryson Group PLLCThe Bryson Group PLLC


OVERVIEWOVERVIEW

Food Animals Genetically Modified for Food Animals Genetically Modified for Food and Non-Food UsesFood and Non-Food Uses Regulatory authority for food safety (FSIS)Regulatory authority for food safety (FSIS) Health and disease safeguarding authority Health and disease safeguarding authority

(APHIS)(APHIS) Animal Welfare (APHIS)Animal Welfare (APHIS) Market Development and Promotion (AMS)Market Development and Promotion (AMS) Research and Education (ARS, CSREES, Research and Education (ARS, CSREES,

ERS, NASS)ERS, NASS) Consultative RoleConsultative Role


Safety of Food Products from Safety of Food Products from AnimalsAnimals

Federal Meat Inspection Act – meat and Federal Meat Inspection Act – meat and meat products are safe (not adulterated meat products are safe (not adulterated or misbranded), FSISor misbranded), FSIS

Adulterated: Adulterated: contains any poisonous or deleterious contains any poisonous or deleterious

substance that would be unsafe under the substance that would be unsafe under the FFDCA (FDA)FFDCA (FDA)

Produced under unsanitary conditionsProduced under unsanitary conditions From animal that died other than by From animal that died other than by

slaughterslaughter


Safety of Food Products From Safety of Food Products From AnimalsAnimals

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 Continuous in-plant inspection of slaughter

plants and production facilitiesplants and production facilities HACCP requirementsHACCP requirements Review and pre-approval of product labelsReview and pre-approval of product labels Enforcement activityEnforcement activity

Administered through regulations, policy Administered through regulations, policy memoranda, guidance and directivesmemoranda, guidance and directives


Imported Products – The Imported Products – The Equivalency RequirementEquivalency Requirement

Imported meat and meat products must Imported meat and meat products must meet US safety standardsmeet US safety standards

The standards of the exporting country The standards of the exporting country do not have to be identical but they must do not have to be identical but they must be “equivalent” (SPS WTO trade be “equivalent” (SPS WTO trade standard)standard)

FSIS is responsible for determining FSIS is responsible for determining equivalencyequivalency

Regulatory process that includes Regulatory process that includes evaluation criteria/processevaluation criteria/process


Imported Products- The Imported Products- The Equivalency RequirementEquivalency Requirement

System evaluation System evaluation Organizational structure/staffing Organizational structure/staffing National government controlNational government control Competent, qualified inspectorsCompetent, qualified inspectors Enforcement responsibilityEnforcement responsibility Same inspection, sanitation, quality, Same inspection, sanitation, quality,

species verification, residue standards species verification, residue standards applied to products in the U.S.applied to products in the U.S.


Imported Products – The Imported Products – The Equivalency RequirementEquivalency Requirement

Legal authorityLegal authority Ante-mortem inspection by or under Ante-mortem inspection by or under

supervision of vetssupervision of vets Post-mortem inspection of carcassesPost-mortem inspection of carcasses Official controls by national government over Official controls by national government over

establishment construction, facilities, and establishment construction, facilities, and equipmentequipment

Direct and continuous official inspectionDirect and continuous official inspection Separation of establishments certified for Separation of establishments certified for

exportexport Sanitation requirement/HACCP/control of Sanitation requirement/HACCP/control of

condemned materialscondemned materials


Imported Product – The Imported Product – The Equivalency RequirementEquivalency Requirement

Review initiated at request of foreign governmentReview initiated at request of foreign government Documentary review (laws, regulations, Documentary review (laws, regulations,

procedures)procedures) On-site in country review by FSISOn-site in country review by FSIS Periodic in-country compliance reviewsPeriodic in-country compliance reviews Individual plants must be certified for exportIndividual plants must be certified for export Imported product: foreign-meat inspection Imported product: foreign-meat inspection

certificate/inspected at an official establishment certificate/inspected at an official establishment or import inspection establishmentor import inspection establishment

Plant certifications can be suspended at FSIS Plant certifications can be suspended at FSIS discretion based on information of noncompliancediscretion based on information of noncompliance


Animal Health and Animal Health and Safeguarding AuthoritiesSafeguarding Authorities

Animal Health Protection Act (“AHPA”); APHISAnimal Health Protection Act (“AHPA”); APHIS Authority: (1) to prohibit or restrict the Authority: (1) to prohibit or restrict the

import, export or interstate movement of any import, export or interstate movement of any animal, article, or means of conveyance, or use animal, article, or means of conveyance, or use of any means of conveyance or facility, if the of any means of conveyance or facility, if the Secretary determines necessary to prevent the Secretary determines necessary to prevent the introduction into or dissemination within the introduction into or dissemination within the U.S. of any pest or disease of livestock, andU.S. of any pest or disease of livestock, and

(2) seize, quarantine and dispose of any (2) seize, quarantine and dispose of any animal, article or means of conveyance animal, article or means of conveyance determined to be necessary determined to be necessary



Animal – any member of animal kingdom Animal – any member of animal kingdom (except a human)(except a human)

Article – any pest or disease or any material Article – any pest or disease or any material or tangible object that could harbor a pest or or tangible object that could harbor a pest or diseasedisease

Means of conveyance – any personal property Means of conveyance – any personal property used to move any other personal propertyused to move any other personal property

Pest - protozoan, plant, bacteria, fungus, virus Pest - protozoan, plant, bacteria, fungus, virus or viroid, infectious agent or pathogen, or viroid, infectious agent or pathogen, arthropod, parasite, prion, vector, or similar arthropod, parasite, prion, vector, or similar or allied organismor allied organism

Disease – USDA definedDisease – USDA defined Livestock – all farm raised animalsLivestock – all farm raised animals



Purpose – to protect:Purpose – to protect:

- animal health- animal health

- health and welfare of people- health and welfare of people

- economic interests of livestock and - economic interests of livestock and related industriesrelated industries

- environment of the U.S. and interstate - environment of the U.S. and interstate commercecommerce

- foreign commerce in animals and - foreign commerce in animals and articlesarticles



Close linkage with OIE (World Organization Close linkage with OIE (World Organization for Animal Health)for Animal Health)

OIE risk-based criteria for trade in animals OIE risk-based criteria for trade in animals have been used as basis for U.S. SPS have been used as basis for U.S. SPS standardsstandards

Animal identification and animal traceability Animal identification and animal traceability systems are essential components of OIE systems are essential components of OIE criteria (from place of origin to end of meat criteria (from place of origin to end of meat production chain)production chain)

OIE Resolution on Animal Production Food OIE Resolution on Animal Production Food SafetySafety


Animal WelfareAnimal Welfare

““Animal” – any live or dead dog, cat, monkey, Animal” – any live or dead dog, cat, monkey, guinea pig, hamster, rabbit, or such other warm-guinea pig, hamster, rabbit, or such other warm-blooded animal as the Secretary may determine blooded animal as the Secretary may determine is being used, or is intended for use, for is being used, or is intended for use, for research, testing, experimentation or exhibition research, testing, experimentation or exhibition purposes . . . purposes . . .

Excludes: “other farm animals, such as, but not Excludes: “other farm animals, such as, but not limited to livestock or poultry, used or intended limited to livestock or poultry, used or intended for use as food or fiber, or livestock or poultry for use as food or fiber, or livestock or poultry used or intended for use for improving animal used or intended for use for improving animal nutrition, breeding, management, or production nutrition, breeding, management, or production efficiency, or for improving the quality of food or efficiency, or for improving the quality of food or fiber.fiber.


Animal WelfareAnimal Welfare

Animal Welfare Act does not apply to Animal Welfare Act does not apply to farm animals used for foodfarm animals used for food

Could apply to such animals being used in Could apply to such animals being used in certain types of laboratory research.certain types of laboratory research.

Requirements for humane treatment of Requirements for humane treatment of animals being used in laboratory animals being used in laboratory research. research.

FSIS regulations – exclude food animals FSIS regulations – exclude food animals used in research investigation for used in research investigation for experimental drugs, etc. from slaughter experimental drugs, etc. from slaughter (a few risk-based exceptions). (a few risk-based exceptions).


Marketing, Labeling, Process Marketing, Labeling, Process VerificationVerification

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


Marketing, Labeling and Marketing, Labeling and Process VerificationProcess Verification

AMS is authorized to “develop and improve AMS is authorized to “develop and improve standards of quality, condition, quantity, grade standards of quality, condition, quantity, grade and packaging.”and packaging.”

Voluntary standards (beef grading standards, Voluntary standards (beef grading standards, 100% Angus beef, grass-fed, naturally raised, 100% Angus beef, grass-fed, naturally raised, etc.)etc.)

Participating producers pay a user fee for AMS Participating producers pay a user fee for AMS review and audit process supporting the review and audit process supporting the verification system.verification system.

Can be rapidly developed to address market Can be rapidly developed to address market needs (export verification process developed for needs (export verification process developed for beef in response to BSE developments)beef in response to BSE developments)


The Organic Foods Production The Organic Foods Production ActAct

Also administered by AMSAlso administered by AMS Statutory Authority toStatutory Authority to

Establish national organic production process Establish national organic production process standardsstandards

Assure consumers of a consistent organic standardAssure consumers of a consistent organic standard Facilitate interstate commerce in fresh and Facilitate interstate commerce in fresh and

processed organic foodprocessed organic food National certification program for application of National certification program for application of

national standards to individual farms through national standards to individual farms through an Organic Systems Plan developed with a an Organic Systems Plan developed with a USDA accredited certifier.USDA accredited certifier.

Does Apply to Livestock and Poultry (origin, Does Apply to Livestock and Poultry (origin, feed, health care practices and living feed, health care practices and living conditions)conditions)


Country of Origin LabelingCountry of Origin Labeling

2002 Farm Bill – requirements for 2002 Farm Bill – requirements for various meat products (muscle cuts of various meat products (muscle cuts of beef, lamb and pork and ground beef, lamb and pork and ground product, farm-raised and wild fish).product, farm-raised and wild fish).

2008 Farm Bill – extends to goats and 2008 Farm Bill – extends to goats and chickens and adds on chickens and adds on U.S. country of origin (exclusively born, U.S. country of origin (exclusively born,

raised and slaughtered in the U.S.) andraised and slaughtered in the U.S.) and Multiple countries of origin (may designate Multiple countries of origin (may designate

all such countries)all such countries)


Research AuthoritiesResearch Authorities

Authority: conduct and administration of Authority: conduct and administration of a wide variety of research and extension a wide variety of research and extension assistance related to agriculture and foodassistance related to agriculture and food ARS ARS

Ensure high-quality, safe food and other agricultural Ensure high-quality, safe food and other agricultural productsproducts

Assess nutritional needsAssess nutritional needs Sustain a competitive agricultural economySustain a competitive agricultural economy Enhance natural resource base and environmentEnhance natural resource base and environment Provide economic opportunities for rural citizens, Provide economic opportunities for rural citizens,

communitiescommunities


Research AuthoritiesResearch Authorities

CSREESCSREES Extension/ work with state and local partnersExtension/ work with state and local partners

ERS (briefing rooms, publications, data)ERS (briefing rooms, publications, data) Competitive agricultural systemCompetitive agricultural system Safe food supplySafe food supply Healthy and well-nourished populationHealthy and well-nourished population Harmony between agriculture and environmentHarmony between agriculture and environment Enhanced quality of life for rural AmericansEnhanced quality of life for rural Americans

NASS – U.S. agriculture statisticsNASS – U.S. agriculture statistics

Documents

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