3Constitution Article I, Section 1 Article I, Section 8 Legislative power of the Federal Government is reposed in U.S. CongressArticle I, Section 8“…Make all Laws which shall be necessary and proper of carrying into Execution …all… Powers vested by this Constitution in the Government of the United States, or in any Department or Officer thereof.
4Constitution Article II, Section 1 Article III, Section 2 Executive power is vested in the President of the United StatesArticle III, Section 2Judicial power is “vested in one supreme Court, and in such inferior Courts as the Congress may … establish”.
5Legislative Branch: U. S. Congress LawsAct“Rider” to an Act (SIS Cattle)Legislative HistoryCommittee HearingsApproval of Appointments
6Laws Enforced by FSISFederal Meat Inspection Act (FMIA) U.S.C. §§601, et seq.Poultry Product Inspection Act (PPIA) U.S.C. §§451, et seq.Egg Product Inspection Act (EPIA) U.S.C. §§1031, et seq.Humane Slaughter Act of 1958
7Other Food LawsFederal Food Drug and Cosmetic Act (FFDCA) 21 U.S.C. §§301, et seq.FDA ensures human food /animal feeds are safeFederal Insecticide, Fungicide, and Rodenticide Act (FIFRA)EPA establishes tolerances & recommends action levelsToxic Substances Control Act (TSCA)EPA regulates other chemical substances
8Other Food Laws cont. Federal Plant Pest Act (FFPA) Plant Quarantine Act (PQA)Virus-Serum-Toxin Act (VSTA) 21 U.S.C. §151-§158Provides APHIS with authority to regulate a “virus, serum, toxin or analagous product”
9Laws Affecting Rulemaking Federal Register Act, 44 U.S.C. Chap. 15Required publication of rules in Federal RegisterAdministrative Procedures Act, 5 U.S.C. §§551 et seq.Provided for public participation in rulemakingEffective date > 30 days after publicationRegulatory Flexibility ActUnfunded Mandates Reform Act
10Legislative History Used for interpretation of law/rulemaking Short ExplanationIdentifies committees and hearingsReviews dates different versions passedSection by Section AnalysisDepartmental ViewsCorrespondence to/from DepartmentsDepartment’s support/objectionsDepartmental interpretations
11Congressional Hearings To obtain public inputHearings prior to passage of Humane Slaughter Act of 1958Congressional OversightReview of Department’s activities
12Executive Branch Presidential Appointments Executive Orders/Presidential MemorandumDepartment/Agency RulemakingOpinions of the Attorney GeneralMemorandum of Understanding
13Presidential Appointments Department HeadsCabinet Secretaries (Dan Glickman)Attorney General of the United StatesDeputy Secretaries (Richard Rominger)Under Secretaries (Catherine Woteki)Administrators (FSIS: Tom Billy)JudicialSupreme Court JusticesJudges to Appeals Court and District Courts
14Executive OrdersDirective by President usually to 1 or more Federal Agencies and/or employees thereofRegulatory ReformE.O Established criteria for a “Major Rule” - $100 MillionE.O “Regulatory Planning and Review”Prescribes criteria of “significance” that apply to regulatory actionsPresident’s Office of Management and Budget (OMB) reviews rules before publishing
15Regulation Definition E.O : “Regulation” or “rule” means an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.
16FSIS Rulemaking Authority Delegations of authority from Secretary of Agriculture for administering the FMIA, PPIA and EPIA are found in 7 Code of Federal Regulations §§ 2.18, 2.53
17Regulatory Process Identify a need Research and evaluate Develop a rule (regulation)Publish as a proposed rule: Federal RegisterRe-evaluate proposed rule & public commentsDevelop the final rulePublish the final rule: Federal RegisterImplementation of the final rule
18HACCP Regulation Proposed : 2/3/95 FR Vol 60, 6774 Final: 7/25/96 FR Vol 61, pgImplementationSanitation SOP’s: January 27, 1997Escherichia coli testing: January 27, 1997HACCP large plants: January 26, 1998HACCP smaller plants: January 25, 1999HACCP <10 employees: January 25, 2000Salmonella standards: simultaneous w/HACCP
19FSIS RegulationsTitle 9 Code of Federal Regulations Chapter III Part 300 to EndMandatory Meat Inspec. §§Voluntary Insp/Certif. §§Mandatory Poultry Prod Insp. §381FSIS Admin. Provisions §§Regulatory Requirements FMIA/PPIA§§Food Ingredients/Surces of Radiation §424Rules of Practice §500Egg Products Inspection §590
20Agency Publications Meat and Poultry Inspection Manual “official publication of procedural guidelines and instructions to aid FSIS employees in enforcing laws and regulations...”FSIS Directives:“Provide continuing instructions to employees for implementing Agency policy and procedures.”FSIS Directive 5,000.1: Enforcement of Regulatory Requirements in Establishments Subject to the HACCP System Regulations.See FSIS Directive , Revision 4, October 30, 1997.Subject Matter Classification System: Attachment 1.1
21FSIS Notices May do one or more of the following: Provide interim guidance to employees until a more detailed directive can be issued.Give information of temporary importance.Remind offices of periodic actions.Call attention to existing procedures or regulationsWill have an expiration date not exceeding 1 year from date originally issued.FSIS Directive , Revision 4, FSIS Issuance System
22Opinions of the Attorney General Interpret the lawBased on law, legislative history, and past practicesPublished in Opinions of the Attorney GeneralSome are cited in United States Code Annotated
23A.G. Opinions vis a vis FMIA “The federal mark of inspection cannot be lawfully placed upon any meat food product unless the animal from which it was derived received a post mortem examination by [USDA] inspectors.” 1912, 29 OpAttyGen 335“The inspection and sanitation provisions of [the FMIA] do not apply to retail establishments … [and] adulteration and misbranding provisions [were intended] to cover retail establishments …” 1972, 42 Op. Atty. Gen. 459
24Memorandum of Understanding Set forth working relationships among agencies to promote and coordinate Federal regulatory activity.FSIS MU-330, 10/5/84 (between FSIS, APHIS, FDA, and EPA)Drugs, pesticides and environmental contaminantsFSIS MU-334 (FSIS & APHIS)Surveillance for Animal DiseasesFSIS MU-330: Regulatory Activities Concerning Residues of Drugs, Pesticides and Environmental Contaminants in Foods. The purpose of this agreement is to set forth the working relationships among the USDA, FDA and EPA to promote more effective, efficient and coordinated Federal regulatory activities concerning residues of drugs, pesticides, and environmental contaminants that may adulterate food.FSIS MU-334: Cooperation with Respect to Surveillance for Animal Diseases. "... parties to this [MOU] agree to cooperate in meeting their respective needs relative to information exchange of disease surveillance, diagnostic testing, investigations, tracebacks, and animal and public health emergencies, in order to achieve their related objectives of reducing diseases of animal and public health concern and of providing a wholesome and economical food supply..."
25Judicial Branch Interpret the law and constitutionality Interpret regulations and their constitutionality/legality
26Court Cases vis a vis FMIA Food AdditivesChip Steak Co. v. Clifford Hardin, etc. (332 F.Supp [N.D. Cal. 1971]. App’d., 467 F. 2d 481 [9th Cir. 1972])FMIA §601 (m) Adulteration:Texas Food Industry Ass’n v. Espy, W.D.Tex.1994, 870 F.Supp. 143FMIA §620 ImportsGanadera Indus, S.A. v. Block, C.A.D.C. 1984, 727 F.2d 1156, 234 U.S.App.D.C. 57.The Secretary of Agriculture has the power, under the Meat Inspection Act, to promulgate regulations prohibiting or restricting the use of food additives in meat products notwithstanding the designation of such additives as "generally recognized as safe" in regulations promulgated by the Secretary of Health Education and Welfare under the Food, Drug, and Cosmetic ActUnited States Department of Agriculture's (USDA's) decision to consider Escherichia coli (E. Coli) present in raw ground beef an "adulterant" under Federal Meat Inspection Act (FMIA) did not exceed USDA's statutory authority, despite claim that such contaminated beef was only injurious to health if improperly cooked; under FMIA, product was "adulterated" if it contained substance "which may render it injurious to health" and, unlike other pathogens, it was not "proper" cooking, but "thorough" cooking that was necessary to protect consumers from E. coli.Under this chapter, Department of Agriculture was not limited to withdrawing foreign company's privilege to import meat into United States only when that company's products failed to meet specific provision of Act; rather, in light of legislative history strongly suggesting that Congress intended that Secretary err on side of preventing importation in enforcing standards of this chapter, Secretary had power to bar importation where he had sufficient reason to doubt that meat complied with standards of this chapter.
27Other Court Cases USDA violated Administrative Procedures Act Texas Food Industry Association etc v. USDA, W.D. Tex. Oct 14, 1993Ritual slaughter provisions of the Humane Slaughter Act of 1958Jones v. Butz 1974, 374 F.Supp. 1284FFDCA §343 Misbranded FoodPeople v. Enders, 1963, 237 N.Y.S.2d 879, 38 Misc.2d 746...USDA...Defendant are herby preliminarily enjoined and restrained from enforcing or implementing the USDA's new interim rule on mandatory labeling for meat and poultry products published in the Federal Register on August 16, The USDA has not demonstrated any reason that would justify a departure from the normal rulemaking procedures under the APA.... A federal agency does not have power tantamount to that of Congress and powers of federal agencies are limited and these powers are, and should be, strictly constructed.Even if throat-cutting ritual method of slaughter allowed under Humane Slaughter Act was permitted due to deference to religious beliefs of certain orthodox Jews and even if fact that Act did not restrain prior handling of livestock attendant on such ritual slaughter, such as requiring that animals be rendered insensible to pain before shackled and hoiste, was due to similar deference, such deference did not cause Act to be in violation of establishment clause of First Amendment, U.S.C.A.Const.Amend. 1:Hamburger, which was added non-deleterious, unadulterated, beef blood approved for human consumption before hamburger was weighed and sold at specified price per pound, had been "misbranded".
29Agricultural Marketing Service (AMS) Grading, certification, standardization, market newspurchase programs (surplus; school lunch)market orders, commodity programs
30Grain Inspection, Packers & Stockyards Administration Grain Inspection certifies that grain meets standards; vital for tradePackers & Stockyards insure fair trading practices among livestock buyers and sellers
31Food & Consumer Services Food for needy (e.g. food stamps and WIC)Improve eating habits/nutrition of children (school lunch, school breakfast)Stabilize farm prices through distribution of surplus foods
33Food Safety and Inspection Service Mandatory InspectionMeat & Meat Food Products (FMIA)Poultry Products (PPIA)Processed Egg Products (EPIA)Voluntary InspectionProducts from non-amenable species (AMA)
34FSIS Inspection Operations Programs (FY 1996) 8,000 inspection operations employees (1100 veterinarians)6,400 slaughtering/processing plantsOver 90% of FSIS’s $645 million dollar budget
35FSIS Inspection Requirements Continuous inspection of slaughter and processing facilitiesanimals receive ante-mortem inspectionEvery carcass receives post-mortem inspection supervised by a FSIS veterinarianProcessed products are reinspected before shipping
36Federal Meat Inspection Act (FMIA) Preceded by Meat Inspection Act of 1889Meat Inspection Act of 1891Meat Inspection Act of 1906
37Federal Meat Inspection Act of 1906 Mandated antemortem inspection of livestock (cattle, swine, sheep, goats, equines)Mandated post-mortem inspection of every carcassEstablished sanitary standards for slaughter and processing plantsRequired continuous USDA inspection of slaughter and processing operations
38Antemortem Inspection All animals subject to the act must be inspected before they are allowed to enter any slaughtering or processing operations.Any animal whose disease status is suspect is set aside and slaughtered separately from other animals to ensure they receive an antemortem and postmortem examination by a veterinarian.
39Postmortem Inspection After slaughter, the carcass and various parts are provided a post-mortem examination by USDA inspectors to determine if the product is adulterated.“The federal mark of inspection cannot be lawfully placed upon any meat food product unless the animal from which it was derived received a post mortem examination by [a federal] inspector …”The quotation in the second bullet is from the 1912, Volume 29 Opinion of the United States Attorney General (OAG) page It can also be found in the 1972 United States Code Annotated, Title 21, Food and Drugs, Section 603,page 549.
40Disposition by an Inspector After inspection, all carcasses and parts found to be adulterated are marked “U.S. Inspected and Condemned”.The Federal Meat Inspection Act requires that all condemned carcasses and parts must be destroyed for food purposes by the said establishment in the presence of an inspector.
41Limitations of the Federal Meat Inspection Act Covered only meat and meat products intended for interstate commerceDid not cover any poultry products
42Agricultural Marketing Act of 1946 Defined grading servicesAll grading is voluntarySite-based programs elected by packerUsed by Secretary of Agriculture to provide voluntary inspection for species not covered by the Federal Meat Inspection Act of 1906
43Congress. Investigations 1960 15% of all commercially slaughtered animals and 25% of all commercially prepared meat products were not subject to inspection because they were intended only for intrastate commerceOnly 29 states imposed mandatory inspection during slaughter of animals intended for sale as food in intrastate commerce
44Amendments to the Federal Meat Inspection Act Wholesome Meat Act of 1967Curtis AmendmentHumane Methods of Slaughter Act 1978Agriculture and Food Act 1981
45Wholesome Meat Act of 1967Amended FMIA to assure uniformity in regulation of products shipped interstate, intrastate, and in foreign commerceGave USDA regulatory authority over food brokers, animal food manufacturers, and freezer storage facilities as well as transporters and retailers of food products.The inspection requirements of the FMIA as amended do not apply to retail establishments
46Wholesome Meat Act of 1967Incorporated provisions against adulteration and misbranding of food products almost identical to FFDCA provisionsProvided greater enforcement authority, including withdrawal or refusal of inspection services, detention, injunctions
47Wholesome Meat Act of 1967 - Federal State Cooperation Allows states to have own meat/poultry inspection programs if their requirements are “at least equal to” federal requirementsUSDA pays 50% of program & provides training , etc.25 states have state inspection programs
48Curtis Amendment (1967)Exempted farmers when meat was used for family or nonpaying guestsExempted custom slaughterersExempted processors of farm animals
49Humane Methods of Slaughter Act 1978 Provided for humane handling in connection with slaughter of livestockLivestock must be rendered insensitive to pain prior to shackling/hoistingThe first Humane method of slaughter: a single blow, electrical, chemical or any other means that is rapid and effective.Method two: religious ritual slaughter
50Agriculture and Food Act 1981 Imported carcasses, meat and meat food products must meet the inspection, sanitary, quality, species verification and residue standards applied to products produced in the United StatesProvided for certification of exporting establishments by the Secretary of Agriculture
51Poultry InspectionEarly 1900’s: poultry were raised on small farms for personal consumption.1927: the first poultry plant received voluntary inspection.Post World War II: explosive growth in the poultry industry.1954: legislation was initiated for mandatory poultry inspection.
52Poultry Products Inspection Act of 1957 Made Federal inspection mandatory for poultry products shipped in interstate commerce.
53Wholesome Poultry Products Act of 1968 Modeled after the Wholesome Meat ActNo express humane slaughter provisions
54Egg Products Act of 1970Required USDA to ensure egg products are safe, wholesome, & accurately labeledOnly included breaker egg establishmentsFDA is responsible for shell egg establishmentsEgg products inspection was transferred from the Agricultural Marketing Service to FSIS in the 1995 reorganization (AMS retains surveillance of “restricted” eggs)