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USDA Food Safety and Inspection Service Overview: Laws and Regulations.

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Presentation on theme: "USDA Food Safety and Inspection Service Overview: Laws and Regulations."— Presentation transcript:

1 USDA Food Safety and Inspection Service Overview: Laws and Regulations

2 Authority Constitution –Legislative –Executive –Judicial

3 Constitution Article I, Section 1 –Legislative power of the Federal Government is reposed in U.S. Congress Article 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.

4 Constitution Article II, Section 1 –Executive power is vested in the President of the United States Article III, Section 2 –Judicial power is vested in one supreme Court, and in such inferior Courts as the Congress may … establish.

5 Legislative Branch: U. S. Congress Laws –Act –Rider to an Act (SIS Cattle) Legislative History Committee Hearings Approval of Appointments

6 Laws Enforced by FSIS Federal Meat Inspection Act (FMIA) 21 U.S.C. §§601, et seq. Poultry Product Inspection Act (PPIA) 21 U.S.C. §§451, et seq. Egg Product Inspection Act (EPIA) 21 U.S.C. §§1031, et seq. Humane Slaughter Act of 1958

7 Other Food Laws Federal Food Drug and Cosmetic Act (FFDCA) 21 U.S.C. §§301, et seq. –FDA ensures human food /animal feeds are safe Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) –EPA establishes tolerances & recommends action levels Toxic Substances Control Act (TSCA) –EPA regulates other chemical substances

8 Other Food Laws cont. Federal Plant Pest Act (FFPA) Plant Quarantine Act (PQA) Virus-Serum-Toxin Act (VSTA) 21 U.S.C. §151-§158 –Provides APHIS with authority to regulate a virus, serum, toxin or analagous product

9 Laws Affecting Rulemaking Federal Register Act, 44 U.S.C. Chap. 15 –Required publication of rules in Federal Register Administrative Procedures Act, 5 U.S.C. §§551 et seq. –Provided for public participation in rulemaking –Effective date > 30 days after publication Regulatory Flexibility Act Unfunded Mandates Reform Act

10 Legislative History Used for interpretation of law/rulemaking Short Explanation –Identifies committees and hearings –Reviews dates different versions passed Section by Section Analysis Departmental Views –Correspondence to/from Departments –Departments support/objections –Departmental interpretations

11 Congressional Hearings To obtain public input –Hearings prior to passage of Humane Slaughter Act of 1958 Congressional Oversight –Review of Departments activities

12 Executive Branch Presidential Appointments Executive Orders/Presidential Memorandum Department/Agency Rulemaking Opinions of the Attorney General Memorandum of Understanding

13 Presidential Appointments Department Heads –Cabinet Secretaries (Dan Glickman) –Attorney General of the United States –Deputy Secretaries (Richard Rominger) –Under Secretaries (Catherine Woteki) –Administrators (FSIS: Tom Billy) Judicial –Supreme Court Justices –Judges to Appeals Court and District Courts

14 Executive Orders Directive by President usually to 1 or more Federal Agencies and/or employees thereof Regulatory Reform –E.O Established criteria for a Major Rule - $100 Million –E.O Regulatory Planning and Review Prescribes criteria of significance that apply to regulatory actions Presidents Office of Management and Budget (OMB) reviews rules before publishing

15 Regulation 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.

16 FSIS 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

17 Regulatory Process Identify a need Research and evaluate Develop a rule (regulation) Publish as a proposed rule: Federal Register Re-evaluate proposed rule & public comments Develop the final rule Publish the final rule: Federal Register Implementation of the final rule

18 HACCP Regulation Proposed : 2/3/95 FR Vol 60, 6774 Final: 7/25/96 FR Vol 61, pg Implementation –Sanitation SOPs: January 27, 1997 –Escherichia coli testing: January 27, 1997 –HACCP large plants: January 26, 1998 –HACCP smaller plants: January 25, 1999 –HACCP <10 employees: January 25, 2000 –Salmonella standards: simultaneous w/HACCP

19 FSIS Regulations Title 9 Code of Federal Regulations Chapter III Part 300 to End –Mandatory Meat Inspec. §§ –Voluntary Insp/Certif. §§ –Mandatory Poultry Prod Insp. §381 –FSIS Admin. Provisions §§ –Regulatory Requirements FMIA/PPIA§§ –Food Ingredients/Surces of Radiation §424 –Rules of Practice §500 –Egg Products Inspection §590

20 Agency 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.

21 FSIS 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 regulations Will have an expiration date not exceeding 1 year from date originally issued.

22 Opinions of the Attorney General Interpret the law Based on law, legislative history, and past practices Published in Opinions of the Attorney General Some are cited in United States Code Annotated

23 A.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

24 Memorandum 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 contaminants FSIS MU-334 (FSIS & APHIS) –Surveillance for Animal Diseases

25 Judicial Branch Interpret the law and constitutionality Interpret regulations and their constitutionality/legality

26 Court Cases vis a vis FMIA Food Additives –Chip Steak Co. v. Clifford Hardin, etc. (332 F.Supp [N.D. Cal. 1971]. Appd., 467 F. 2d 481 [9th Cir. 1972]) FMIA §601 (m) Adulteration: –Texas Food Industry Assn v. Espy, W.D.Tex.1994, 870 F.Supp. 143 FMIA §620 Imports –Ganadera Indus, S.A. v. Block, C.A.D.C. 1984, 727 F.2d 1156, 234 U.S.App.D.C. 57.

27 Other Court Cases USDA violated Administrative Procedures Act –Texas Food Industry Association etc v. USDA, W.D. Tex. Oct 14, 1993 Ritual slaughter provisions of the Humane Slaughter Act of 1958 –Jones v. Butz 1974, 374 F.Supp FFDCA §343 Misbranded Food –People v. Enders, 1963, 237 N.Y.S.2d 879, 38 Misc.2d 746

28 United States Department of Agriculture Research, Education, & Economics (ARS, CSREES, ERS, NAL, NASS) Natural Resources & Environment ( FS, FAS) Rural Development (RHS, RUS) Farm & Foreign Ag. Services (FSA, FAS) Marketing & Regulatory Programs (AMS, APHIS, GIPSA) Food Nutrition & Consumer Services (FCS) Food Safety (FSIS)

29 Agricultural Marketing Service (AMS) Grading, certification, standardization, market news purchase programs (surplus; school lunch) market orders, commodity programs

30 Grain Inspection, Packers & Stockyards Administration Grain Inspection certifies that grain meets standards; vital for trade Packers & Stockyards insure fair trading practices among livestock buyers and sellers

31 Food & 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

32 Inspection of Meat, Poultry & Eggs by USDA

33 Food Safety and Inspection Service Mandatory Inspection –Meat & Meat Food Products (FMIA) –Poultry Products (PPIA) –Processed Egg Products (EPIA) Voluntary Inspection –Products from non-amenable species (AMA)

34 FSIS Inspection Operations Programs (FY 1996) 8,000 inspection operations employees (1100 veterinarians) 6,400 slaughtering/processing plants Over 90% of FSISs $645 million dollar budget

35 FSIS Inspection Requirements Continuous inspection of slaughter and processing facilities animals receive ante-mortem inspection Every carcass receives post-mortem inspection supervised by a FSIS veterinarian Processed products are reinspected before shipping

36 Federal Meat Inspection Act (FMIA) Preceded by Meat Inspection Act of 1889 Meat Inspection Act of 1891 Meat Inspection Act of 1906

37 Federal Meat Inspection Act of 1906 Mandated antemortem inspection of livestock (cattle, swine, sheep, goats, equines) Mandated post-mortem inspection of every carcass Established sanitary standards for slaughter and processing plants Required continuous USDA inspection of slaughter and processing operations

38 Antemortem 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.

39 Postmortem 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 …

40 Disposition 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.

41 Limitations of the Federal Meat Inspection Act Covered only meat and meat products intended for interstate commerce Did not cover any poultry products

42 Agricultural Marketing Act of 1946 Defined grading services All grading is voluntary Site-based programs elected by packer Used by Secretary of Agriculture to provide voluntary inspection for species not covered by the Federal Meat Inspection Act of 1906

43 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 commerce Only 29 states imposed mandatory inspection during slaughter of animals intended for sale as food in intrastate commerce Congress. Investigations 1960

44 Wholesome Meat Act of 1967 Curtis Amendment Humane Methods of Slaughter Act 1978 Agriculture and Food Act 1981 Amendments to the Federal Meat Inspection Act

45 Amended FMIA to assure uniformity in regulation of products shipped interstate, intrastate, and in foreign commerce Gave 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 Wholesome Meat Act of 1967

46 Incorporated provisions against adulteration and misbranding of food products almost identical to FFDCA provisions Provided greater enforcement authority, including withdrawal or refusal of inspection services, detention, injunctions

47 Wholesome Meat Act of Federal State Cooperation Allows states to have own meat/poultry inspection programs if their requirements are at least equal to federal requirements USDA pays 50% of program & provides training, etc. 25 states have state inspection programs

48 Curtis Amendment (1967) Exempted farmers when meat was used for family or nonpaying guests Exempted custom slaughterers Exempted processors of farm animals

49 Humane Methods of Slaughter Act 1978 Provided for humane handling in connection with slaughter of livestock Livestock must be rendered insensitive to pain prior to shackling/hoisting The first Humane method of slaughter: a single blow, electrical, chemical or any other means that is rapid and effective. Method two: religious ritual slaughter

50 Agriculture 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 States Provided for certification of exporting establishments by the Secretary of Agriculture

51 Poultry Inspection Early 1900s: 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.

52 Poultry Products Inspection Act of 1957 Made Federal inspection mandatory for poultry products shipped in interstate commerce.

53 Wholesome Poultry Products Act of 1968 Modeled after the Wholesome Meat Act No express humane slaughter provisions

54 Egg Products Act of 1970 Required USDA to ensure egg products are safe, wholesome, & accurately labeled Only included breaker egg establishments –FDA is responsible for shell egg establishments Egg products inspection was transferred from the Agricultural Marketing Service to FSIS in the 1995 reorganization (AMS retains surveillance of restricted eggs)

55 The End


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