USDA Food Safety and
Inspection Service
Overview:
Laws and Regulations

Authority
•
Constitution
– Legislative
–
Executive
– Judicial

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

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

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

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

Congressional Hearings
•
To obtain public input
–
Hearings prior to passage of Humane
Slaughter Act of 1958
•
Congressional Oversight
– Review of Department’s activities

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

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

Regulation Definition
• E.O. 12866: “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.

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

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

HACCP Regulation
•
Proposed : 2/3/95 FR Vol 60, 6774
•
Final: 7/25/96 FR Vol 61, pg 38805-38989
•
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

FSIS Regulations
•
Title 9 Code of Federal Regulations
Chapter III Part 300 to End
–
Mandatory Meat Inspec. §§301-335
–
Voluntary Insp/Certif. §§350-362
–
Mandatory Poultry Prod Insp. §381
–
FSIS Admin. Provisions §§390-391
–
Regulatory Requirements
FMIA/PPIA§§416-417
– Food Ingredients/Surces of Radiation §424
–
Rules of Practice §500
– Egg Products Inspection §590

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.

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.

Memorandum of
Understanding
– Set forth working relationships among agencies to promote and coordinate Federal regulatory activity.
•
FSIS 12-37-MU-330, 10/5/84 (between
FSIS, APHIS, FDA, and EPA)
– Drugs, pesticides and environmental contaminants
•
FSIS 12-37-MU-334 (FSIS & APHIS)
– Surveillance for Animal Diseases

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

Court Cases vis a vis FMIA
•
Food Additives
–
Chip Steak Co. v. Clifford Hardin, etc. (332
F.Supp. 1084 [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.

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)

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

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

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

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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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)