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USDA Food Safety and Inspection Service

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Presentation on theme: "USDA Food Safety and Inspection Service"— 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 Article I, Section 8
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 Article III, Section 2
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) 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

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 Department’s 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 Department’s 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 President’s 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 SOP’s: 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. See FSIS Directive , Revision 4, October 30, 1997. Subject Matter Classification System: Attachment 1.1

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. FSIS Directive , Revision 4, FSIS Issuance System

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 FSIS 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..."

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]. 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. 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. 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 Act United 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.

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. 1284 FFDCA §343 Misbranded Food People 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".

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 FSIS’s $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 …” 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.

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

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

45 Wholesome Meat Act of 1967 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

46 Wholesome Meat Act of 1967 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 1967 - 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 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.

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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