Guide to US Food Laws and Regulations

Patricia A. Curtis is Professor and Director of the Auburn University Food Systems Institute, Auburn University, Alabama. She also is an approved lead instructor and accredited course provider for the International Meat and Poultry HACCP Alliance and the Seafood HACCP Alliance.

List of Contributors xv

About the Companion Website xvii

Chapter 1 Introduction to Laws and Regulations 1
Patricia A. Curtis

Introduction 1

Sources of American Law 2

The Constitution 2

Statutory Law 3

Common Law 3

Equity 3

Public and Private Law 3

Private Law 3

Public Law 3

Legislative Branch 4

Judicial Branch 5

Federal Court System 5

The Supreme Court 5

Courts of Appeals 5

US District Courts 6

Special Courts 6

Executive Branch 6

Sources of Legislation 7

How a Bill Becomes a Law 8

Introduction 8

Considered in Committee 8

Reintroduction 9

Debate in Congress 9

Presidential Action 10

Enrollment

Where to Find Legal Information 11

Law-making Process 12

The Laws 13

Conventional Search Method 16

Example Search 16

How Regulations are Made 17

The Rule-making Process and Publication 17

Example 18

Code of Federal Regulations 18

Using the Code of Federal Regulations 19

Example 19

References 20

Additional Resources 21

Chapter 2 How Did We Get Where We Are Today? 23
Patricia A. Curtis, Emily L. Steinberg, Michelle A. Parisi, and Julie K. Northcutt

Introduction 23

Reasons for Food Laws 24

American Food Laws 25

The “Poison Squad” 28

The Jungle 31

The Need for a New Food and Drug Law 33

Elixir of Sulfanilamide: Raspberry Flavored Death 36

Food Drug and Cosmetic Act of 1938 37

Silent Spring and the Environmental

Protection Agency 38

First Amendment to the Food, Drug and Cosmetic Act 38

Public Health Service Act 39

Milestones in US Food and Drug History (FDA 2010) 39

A Brief History of Agricultural-Related Agencies 46

USDA 47

State Departments of Agriculture 47

Environmental Protection Agency 47

Food and Drug Administration 48

Current Consumer and Regulatory Concerns 48

Summary of Major Food Laws 49

Pure Food and Drug Act of 1906 49

Federal Meat Inspection Act of 1906 49

Food Drug and Cosmetic Act of 1938 49

Poultry Products Inspection Act of 1957 (as amended 1968) 49

Food Additive Amendment of 1958 49

Color Additive Amendment of 1960 50

Fair Packaging and Labeling Act of 1966 50

Egg Products Inspection Act of 1970 50

Nutrition Labeling and Education Act of 1990 50

Dietary Supplement Health and Education Act of 1994 50

Saccharin Notice Repeal Act of 1996 50

Food Quality Protection Act of 1996 50

Food and Drug Administration Modernization Act of 1997 50

Pediatric Rule (1999) 51

The Best Pharmaceuticals for Children Act of 2002 51

Public Health Security and Bioterrorism Preparedness and Response Act of 2002 51

Project BioShield Act of 2004 51

Food Allergy Labeling and Consumer Protection Act of 2004 51

Anabolic Steroid Control Act of 2004 51

Minor Use and Minor Species Animal Health Act of 2004 52

References 52

Further Reading 53

Chapter 3 Federal, State, and Local Laws 55
Patricia A. Curtis

Introduction 55

National versus State Government 56

National Government 56

State Government 57

The Civil War Amendments 58

Powers of the National Government and State Governments 58

Food-related Laws and Regulations 60

Food Safety and Inspection Service 60

Food and Drug Administration 62

Shellfish Program 62

Milk Program 63

Retail Food Protection Program 64

Food Safety 65

Local Government 67

Tribal Governments 69

Summary 70

References 70

Chapter 4 Major Food Laws and Regulations 73
Julie K. Northcutt and Michelle A. Parisi

Introduction 73

Pure Food and Drug Act (1906) and Federal Meat Inspection Act (1906) 73

Amendments to the Federal Meat Inspection Act (1906) 76

Poultry Products Inspection Act (PPIA) of 1957 76

Wholesome Meat Act of 1967 and Wholesome Poultry Product Act of 1968 77

Food, Drug and Cosmetic Act (FDCA), 1938 77

Amendments to the Food, Drug and Cosmetic Act, 1938 80

Miller Pesticide Amendment, 1954 81

Food Additive Amendment, 1958 82

Color Additive Amendment, 1960 83

Dietary Supplement Health Education Act (DSHEA) of 1994 86

Public Health Security and Bioterrorism Preparedness Response Act of 2002 89

FDA Food Safety Modernization Act (FFSMA) of 2011 91

Patient Protection and Affordable Care Act (PPACA) of 2010 93

Conclusion 95

References 95

Chapter 5 US Federal Laws affecting Food Labeling 97
Michelle A. Parisi, Julie K. Northcutt, and Emily L. Steinberg

Introduction 97

History of food labeling 98

Standards of identity 98

Overview of major food labeling laws 99

Construction of a food label 103

The principal display panel (PDP) 103

NLEA of 1990 105

The nutrition facts panel 107

Food labeling nutrient and health claims 113

The FDA Modernization Act of 1997 116

Labeling exemptions 117

Results of over 70 years of food labeling regulation 117

Conclusion 118

References 118

Chapter 6 Environmental Regulations and the Food Industry 121
Theodore A. Feitshans

Introduction 121

Discharges to surface and ground waters 121

Solid waste 124

Hazardous waste 126

Use of water 126

Regulation of water sources 128

Discharges to air 129

Chemical use, storage, release, and transport 131

Toxic Substance Control Act (TSCA) 131

Emergency Planning and Community Right-to-Know Act 132

Siting and operation of facilities 137

Environmental risk management 138

References 140

Legal authorities 141

Chapter 7 OSHA Regulations and the Food Industry 143
Patricia A. Curtis

Introduction 143

Mission 144

OSHA statistics 145

Women of Hispanic or Latino ethnicity 145

Workplace fatalities 146

Retail trade sector 146

Food manufacturing 147

Food service 148

Government workers 148

Rights and responsibilities under OSHA law 149

Selected OSHA Standards and Guidelines 151

Hazard communications 151

Ergonomics 152

Enforcement 153

Inspections 154

Outreach, education, and compliance assistance 155

Filing a complaint with OSHA 156

Complaint filing options 157

Summary 157

References 158

Further Reading 159

Chapter 8 Federal Trade Commission Regulations and the Food Industry 161
Patricia A. Curtis

Introduction 161

Mission 161

Authorizing Acts 162

Bureau of Consumer Protection 162

The Division of Advertising Practices 163

The Division of Enforcement 164

Division of Consumer and Business Education 165

Division of Financial Services 165

Division of Marketing Practices 166

Division of Planning and Information 167

Division of Privacy and Identity Protection 168

Bureau of Competition 169

Bureau of Economics 169

Sample enforcement actions 169

References 170

Chapter 9 An Introduction to Kosher and Halal Food Laws 171
Joe M. Regenstein, Muhammad M. Chaudry, and Carrie E. Regenstein

Introduction 171

The kosher and halal laws 172

The kosher and halal market 175

Kosher 176

The kosher dietary laws 176

Kosher: special foods 184

Passover 187

Kosher: other processing issues 188

Halal 194

Halal dietary laws 194

Halal cooking, food processing, and sanitation 200

Both kosher and halal 200

Science 200

Pet food 202

Health 202

Regulatory 203

Federal and State Regulations 209

Animal welfare 210

Acknowledgment 211

References 211

Further Reading 212

Additional Resources 212

Chapter 10 Biotechnology and Genetically Modified Agricultural Crops and Food 213
Emily L. Steinberg, Michelle A. Parisi, and Julie K. Northcutt

Introduction 213

Biotechnology, genetically modified, and genetic engineering 215

Regulation of GM foods in the United States 216

USDA 216

EPA 216

FDA 217

Biotechnology versus organic agriculture 220

Legal issues – NOP and biotechnology 221

Common examples of GM products 221

Flavr Savr TomatoTM 221

Bt corn 222

L-tryptophan 223

Biotechnology-related court cases 224

International Dairy Foods Assoc. v. Boggs 224

Alliance for Bio-Integrity v. Shalala 225

Monsanto v. Geertson Farms 225

Conclusion 225

References 226

Chapter 11 Animal Welfare Regulations and Food Production 227
Kenneth E. Anderson

Introduction 227

Participants in the welfare debate 229

Impact on public perception 232

Economics 233

What needs to be done 234

References 235

Further Reading 238

Chapter 12 Egg Laws and Regulations 239
Patricia A. Curtis

Introduction 239

History 239

Federal Egg Laws 241

Egg Products Inspection Act (EPIA) 243

Federal-State Agreements 243

Egg Safety Final Rule Implementation 246

Compliance Dates 246

Salmonella Enteritidis 246

Required SE Prevention Measures 247

State Egg Laws 254

References 254

Additional Resources 255

Chapter 13 Regulations Governing Poultry Processing 257
Brooke Caudill

Introduction 257

Poultry Products Inspection Act (21 USC 451) 260

Poultry Products Inspection Regulations (9 CFR 381) 263

Poultry Processing Operations 265

Ante-mortem 266

Slaughter 267

Feather Removal 267

Evisceration and Post-mortem Inspection 268

Reinspection 272

Finished Product Standards (FPS) 273

Facilities Required for Inspection 276

Chilling 278

Post-chill 279

Pathogen Reduction Standards 279

HACCP Systems (9 CFR 417) 280

New Inspection System Proposal 281

New Poultry Inspection System for Young Chickens and Turkeys 282

Online Carcass Inspection 283

Offline Verification Inspection 283

Elimination of Finished Product Standards 284

Maximum Line Speeds 284

Proposed Changes Affecting All Poultry Slaughter Establishments 285

Zero Tolerance for Visible Fecal Material Before Chilling 285

Generic E. coli Testing and Salmonella Performance Standards 287

HACCP 288

Proposed Changes Affecting Only Traditional Inspection 289

Poultry Products Inspection Regulations (9 CFR 381) 292

Definitions of Nonconformances 300

References 305

Chapter 14 What Are They Doing Up There? Contacting Your Congressional (House) Member 307
Jessica Butler

Writing to your Congressman/Congresswoman 307

Calling your Congressman/Congresswoman 308

District office 308

DC office 309

Visiting your Congressman/Congresswoman 309

Jobs on the Hill (House of Representatives) 310

Intern 310

Staff Assistant (SA) 311

Legislative Correspondent (LC) 311

Communications Director (Comm’s Director) 312

Legislative Assistant (LA) 312

Legislative Director (LD) 313

Chief of Staff (COS) 313

Fellowships 313

When traveling to Washington DC 314

Index 317