The National Agricultural Law Center
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Food Safety


Overview

The United States food regulatory system has developed piecemeal over the last century, generating new rules and regulations in response to emerging food problems. As a result, an organizational structure allocates to various government agencies differing responsibilities for specific food safety concerns. A key to effective regulation within this complex and fragmented system is interagency cooperation and cooperation between these agencies and public and private stakeholders. Although this overview focuses on federal regulation of food safety, it is important to note that state regulatory agencies also play an important role in food safety regulation, especially in enforcement. Most notably, state regulatory agencies are primarily responsible for food sanitation and safe food handling by food retailers, foodservice providers, and food-vending operations. Read the full overview

Note: Recently added resources are posted at the top of the applicable sections.

Major Statutes

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-397
Federal Meat Inspection Act, 21 U.S.C. §§ 601-695
Poultry Products Inspection Act, 21 U.S.C. §§ 451-471
Egg Products Inspection Act, 21 U.S.C. §§ 1031-1056
Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. §§ 135-136y

Regulations

General Regulations for the Enforcement of the Federal Food, Drug, and Cosmetic Act,
21 C.F.R. Parts 1-99
Food Labeling, 21 C.F.R. Parts 100-169
Food Additives, 21 C.F.R. Parts 170-199
Animal Drugs, Feeds, and Related Products, 21 C.F.R. Parts 500-599
Mandatory Meat Inspection, 9 C.F.R. Parts 301-335
Voluntary Inspection/Certification, 9 C.F.R. Parts 350-362
Poultry Products Inspection Regulations, 9 C.F.R. Part 381
Food Safety and Inspection Service Administrative Provisions, 9 C.F.R. Parts 390-391
Regulatory Requirements FMIA/PPIA, 9 C.F.R. Parts 416-417
Food Ingredients/Sources of Radiation, 9 C.F.R. Part 424
Egg Products Inspection, 9 C.F.R. Parts 590-592
Hazard Analysis and Critical Control Point (HACCP) Systems, 9 C.F.R. Part 417
Pathogens, 9 C.F.R. Part 301
Eggs, 7 C.F.R. Part 94
National Marine Fisheries Service (Shellfish), 50 C.F.R. Part 260
Phytosanitary Treatment (APHIS), 7 C.F.R. Part 305
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 40 C.F.R. Parts 150-189
Federal Register Rules Open for Comment
Center published Federal Register Digest

Case Law

Note: Recently summarized cases are listed and linked in Recent Postings.

Case Law Index for Food Safety

Administrative Law Decisions

FDA Dockets Management
USDA Office of the Administrative Law Judges
USDA Office of the Judicial Officer
USDA National Appeals Division
Center published USDA Judicial Officer's Decisions

Center Research Publications

Research Articles
International Legal Issues Concerning Animal Cloning and Nanotechnology -- More of the Same
or Are "The Times They Are A-Changin'"?
(Roberts, 2008)
Private Standards in the Global Food Sector: Relationship to WTO Agreements -
PowerPoint Presentation
(Roberts, 2008)
Introduction to Food Law in the People's Republic of China (Roberts, 2007)
From the Farm to the Factory: An Overview of the American and European
Approaches to Regulation of the Beef Industry
(Houston, 2006)
Is a Picture Worth More Than 1,000 Words? The Fourth Amendment and the FDA's
Authority to Take Photographs Under the Federal Food, Drug, and Cosmetic Act
(Fortin, 2006)
United States Food Law Update - II (Roberts, 2006)
European Union Food Law Update - II (Coutrelis, 2006)
United States Food Law Update (Roberts and Alsbrook, 2005)
European Union Food Law Update (Coutrelis, 2005)
Anatomy of the Government's Role in the Recall of Unsafe Food Products (Roberts, 2004)
Animal Identification: Liability Exposure and Risk Management (Roberts and O'Brien, 2004)
Animal Identification: Confidentiality of Information (Roberts and O'Brien, 2004)
Legal Issues in Developing a National Plan for Animal Identification (Roberts and Pittman, 2004)
State and Federal Food Safety Standards and Regulations


Congressional Research Service Reports

CRS Subject(s):
Food Safety
Animal Agriculture

Reference Resources

FDA Resources
Guidelines for Starting a Food Business
Food and Drug Administration
FDA Enforcement Reports
FDA Guidance Documents for Regulated Industry
FDA Warning Letters & Responses
Center for Food Safety and Applied Nutrition
Compilation of FDA Laws and Regulations
Compilation of Food and Cosmetic Guidance Documents
Center for Veterinary Medicine
Office of Regulatory Affairs
FDA Codex Activities


USDA Resources
Food Safety and Inspection Service Homepage
Regulations & Policies
Regulations, Directives & Notices
HAACP (Hazard Analysis and Critical Control Point)
HAACP Guidance Documents
U.S. Codex Office
Economic Research Service
Topic: Diet, Health, & Safety
Topic: Food Safety & Trade
Briefing Room: Industry Food Safety Actions
Briefing Room: Economics of Foodborne Disease
Topic: Food Safety
Topic: Food Safety Policy
Briefing Room: Government Food Safety Policies
Briefing Room: Traceability in the U.S. Food Supply
Publications: Food Safety
Research Emphasis: A Safe Food Supply
Bovine Spongiform Encephalopathy (BSE) (Foreign Agricultural Service)
Bovine Spongiform Encephalopathy (BSE) (APHIS Legislative and Public Affairs)
National Programs: Food Safety (Agricultural Research Service)
National Agricultural Library
Food and Nutrition Information Center
Food Safety Research Information Office
Foodborne Illness Education Information Center


EPA Resources
Food Safety/Agriculture
The Use of Irradiation for Post-Harvest and Quarantine Commodity Control
National Ag Compliance Assistance Center: Food Safety
Food Safety/Pesticides
Regulating Pesticides
Food Quality Protection Act Background
Food Irradiation


Congressional Resources
U.S. Senate and House Committees
Hearing of Senate Agriculture Committee: Examining the Effects of Bovine Spongiform
Encephalopathy (BSE) on U.S. Imports and Exports of Cattle and Beef
(Feb. 3, 2005)
U.S. House Committee Hearing on Government Reform: Question: What Is More
Scrambled Than an Egg? Answer: The Federal Food Inspection System
(May 17, 2005)
House Agriculture Committee Report: National Uniformity for Food Act of 2005
(Feb. 28, 2006)
Senate Committee Report: Homeland Security Food and Agriculture Act of 2005
(Dec. 15, 2005)
Food Safety: Agriculture, Nutrition, and Forestry Committee
Government Accountability Office (GAO) Reports:
Food Safety: Selected Countries' Systems Can Offer Insights into Ensuring Import Safety
and Responding to Foodborne Illness
(GAO 08-794)
Food Safety: Improvements Needed in FDA Oversight of Fresh Produce (GAO 08-1047)
Plum Island Animal Disease Center: DHS and USDA Are Successfully Coordinating Current
Work, but Long-Term Plans Are Being Assessed
(Dec. 19, 2005)
Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA Implemented in 2003
With Recommendations for Making the Program a Better Oversight Tool
(Oct. 11, 2005)
Overseeing the U.S. Food Supply: Steps Should be Taken to Reduce Overlapping
Inspections and Related Activities
(May 17, 2005)
Oversight of Food Safety Activities: Federal Agencies Should Pursue Opportunities
to Reduce Overlap and Better Leverage Resources
(Mar. 30, 2005)
Mad Cow Disease: FDA's Management of the Feed Ban Has Improved, but Oversight
Weaknesses Continue to Limit Program Effectiveness
(Feb. 25, 2005)
Food Safety: Experiences of Seven Countries in Consolidating Their Food Safety Systems
(Feb. 22, 2005)
Food Safety Publications Links
Mad Cow Disease Links
Posthearing Questions Related to Fragmentation and Overlap in the Federal Food Safety
System
(May 26, 2004)
USDA & FDA Need to Better Ensure Prompt, Complete Recalls of Potentially Unsafe Food
(Oct. 2004)
Congressional Food Safety Caucus


Other Federal Resources
Centers for Disease Control and Prevention
Food Irradiation
Foodborne and Diarrheal Diseases Branch
Food Safety Office
Health Topic: Food Safety
Bovine Spongiform Encephalopathy (BSE)
Foodborne Illness Education Information Center Publications
Global Beef Trade: Effects of Animal Health, Sanitary, Food Safety, and Other Measures on U.S.
Beef Exports
(U.S. Int'l Trade Comm'n)
FoodSafety.gov: Gateway to Government Food Safety Information
Health and Human Services Food Safety Links


International Resources
Food and Agriculture Organization of the United Nations (FAO)
Pan-European Conference on Food Safety and Quality
International Portal for Food Safety, Animal and Plant Health (FAO)
Strategy for a Food Chain Approach to Food Safety and Quality
FAO Nutrition and Consumer Protection (Food Safety)
FAO Feed and Food Safety Gateway
National and EU Feed Legislation from FAOLEX Database
Animal Ag. Feed and Food Safety
FAO Animal Production and Health Division
World Health Organization (WHO)
Topic: Foodborne Diseases
Avian Influenza; Food Safety Issues
Health Topics: Food Safety
Food Safety Department
Bovine Spongiform Encephalopathy
Joint FAO/WHO Initiatives
Codex Alimentarius (Joint FAO/WHO Food Standards Programme)
Understanding the Codex Alimentarius (2005)
Codex General Standard for Food Additives (GSFA) Online Database
FAO/WHO Model Food Law
Procedural Manual - Fifteenth Edition
Food Unit - Food Safety (United Nations Industrial Development Organization)
World Trade Organization
Standards and Trade Development Facility Database: Sanitary and Phytosanitary Measures
Sanitary and Phytosanitary Measures
SPS Agreement
European Union
European Food Safety Authority
Activities of the European Union: Food Safety
Food Safety: From the Farm to the Fork
Food and Feed Safety
BSE
The Future of Agriculture and Food in Europe
Food Safety, Health, and Consumer Affairs Policy (European Union in the U.S.)
Food Safety Agencies in Various Countries
Canada's BSE in North America Site
Food Standards Australia/New Zealand
Canadian Food Safety and Quality
Canadian Food Inspection Agency
Food Safety Authority of Ireland
United Kingdom Food Standards Agency
Non-Governmental Agencies (NGOs)
Regulation & Food Safety (International Dairy Foods Association)
International Food Information Council
U.S. Foreign Agricultural Service Mission to the European Union: Food Safety

Publications
Building a Modern Food Safety System: For FDA Regulated Foods (DeWaal and Plunkett, Center for
Science in the Public Interest, 2007)
Regulating Functional Foods; Pre- and Post-Market Strategy (Ziker, 2002)
Protecting Our Food: A Critical Look at the National Uniformity for Food Act of 2004
and Food Safety in America
(Danko, 2005)
Food Irradiation: Why Aren't We Using It? (Prejean, 2001)
Ensuring Safe Food: From Production to Consumption (National Academies Press)
Foodborne Illness Education Information Center Publications


Additional Resources
U.S. State and Local Food Law
National Food Safety Database (U. FL)
Institute of Food Technologists
Food Safety & Inspection (American Meat Institute)
Food Safety Center (Organic Consumers Association)
Food Safety Consortium (U. AR)
Food Safety Project: From Farm to Table (IA St. U. Ext.)
National Food Products Association
Food Safety Risk Analysis Clearinghouse (Joint Institute for Food Safety and Applied Nutrition, U. MD)
State and Local Food Safety Agencies (Foodsafety.gov)





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