Food regulation: law, science, policy and practice
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Wiley
2009
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| Beschreibung: | XXIX, 677 S. |
| ISBN: | 9780470127094 |
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| 650 | 4 | |a Food law and legislation |z United States | |
| 650 | 4 | |a Food industry and trade |x Safety regulations |z United States | |
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Datensatz im Suchindex
| _version_ | 1804138676603584512 |
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| adam_text | Titel: Food regulation
Autor: Fortin, Neal D
Jahr: 2009
TABLE OF CONTENTS
SUMMARY OF CONTENTS xxi
PREFACE xxiii
ACKNOWLEDGMENTS xxix
PARTI: INTRODUCTORY CHAPTERS 1
1. Introduction to Food Régulation in the United States 3
1.1 Introduction 3
1.2 A Short History of Food Régulation in the United States 3
1.2.1 Why Do We Hâve Food Laws? 3
1.2.2 The 1906 Pure Food and Drug Act 5
1.2.3 Evolution of the Food Statutes 6
1.3 The U.S. Légal System 8
1.3.1 The Constitution 9
1.3.2 Statutes 9
1.3.3 Régulations 10
1.3.4 Case Law and Common Law 10
1.3.5 Federalism 11
1.4 Agency Procédural Régulation 13
1.4.1 The Administrative Procédure Act 14
1.4.2 Rulemaking 14
1.4.3 Adjudication 15
1.4.4 Judicial Review 16
1.4.5 Fédéral Advisory Committee Act (FACA) 16
1.4.6 Freedom of Information Act (FOIA) 17
1.4.7 Constitutional Limitations on Agency Power 17
1.5 Agency Jurisdiction 23
1.5.1 Food and Drug Administration 24
1.5.2 Centers for Disease Control and Prévention 24
1.5.3 USDA Food Safety and Inspection Service (FSIS) 25
1.5.4 U.S. Environmental Protection Agency 25
1.5.5 National Marine Fisheries Service (NMFS) 26
vii
VIII TABLE OF CONTENTS
1.5.6 Alcohol and Tobacco Tax and Trade Bureau (TTB) 26
1.5.7 U.S. Customs Service 26
1.5.8 U.S. Department of Justice 27
1.5.9 Fédéral Trade Commission 27
1.5.10 State and Local Governments 28
1.6 Major Fédéral Laws 29
1.6.1 The Statutes 29
1.6.2 Other Statutes 30
1.6.3 The Régulations 31
3.7 Informational Resources 32
1.7.1 Government Agencies 32
1.7.2 Associations and Trade Groups 32
1.7.3 Other Sources 32
Appendix 33
2. What Is a Food? 35
2.1 Introduction to the Food, Drug, and Cosmetic Act 35
2.1.1 Définitions 35
2.1.2 FDA s Jurisdiction and the Définition of Food 38
2.1.3 Spécifie Food Classifications 39
2.2 What Makes an Article a Food or a Drug? 40
Nutrilabs, Inc. v. Schweiker 40
2.3 The Central Rôle of Intended Use 43
2.4 Other Considérations 44
2.4.1 Products Ordinarily Considered Foods 44
2.4.2 Products Intended to Be Processed into Food 45
2.4.3 Products No Longer Fit for Food 45
2.4.4 Packaging Materials 45
2.4.5 Evidence of Intended Use 46
PART H: REGULATION OF LABELING AND CLAIMS 47
3. Food Labeling 49
3.1 Introduction 49
3.2 Légal Authorities 50
3.3 Labeling Terminology 51
3.3.1 Label versus Labeling 52
3.3.2 The Scope of Labeling 53
Kordel v. United States 53
3.3.3 Labeling versus Food Advertising 56
3.3.4 The Internet and Labeling 57
TABLE OF CONTENTS IX
3.4 Affirmative Label Requirements 59
3.4.1 Principle Display Panel (PDP) 59
3.4.2 Information Panel 59
3.4.3 Statement of Identity 60
Fédération of Homemakers v. Butz 61
3.4.4 Net Quantity 65
3.4.5 Ingrédient Labeling 67
3.4.6 Name and Address of the Responsible Party 70
3.4.7 Product Dates and Codes 71
3.5 Misbranded Food: Prohibited Représentations 71
3.5.1 Section 403 on Misbranded Food 71
United States v. 95 Barrels of Alleged Apple
Cider 74
3.5.2 False or Misleading as a Matter of Law 77
United States v. 432 Cartons Individually Wrapped
Candy Lollipops 78
3.6 Deceptive Packaging 80
United States v. 174 Cases Delson Thin Mints 80
3.7 Warning Statements: Products Requiring Warning Labels 82
3.8 Allergens 85
3.9 Alcoholic Beverages 88
3.9.1 Wine Coolers versus Flavored Wine 89
3.9.2 A Double Standard 89
3.10 USDA 90
3.10.1 Labeling Approval 90
3.10.2 Generic Approvals (Labels without Prior
Approval) 90
3.10.3 Safe Food-Handling Instructions 90
3.10.4 Additional Information Required 90
3.10.5 Record Keeping 91
3.11 Optional Label Information 91
3.11.1 Health Claims and Nutrient Level Claims 91
3.11.2 Grades 91
3.11.3 Trademarks and Copyrights 91
3.11.4 Religious Symbols 92
3.11.5 Universal Product Code 92
3.11.6 Organic 92
4. Nutritional Labeling, Nutrient Level Claims, and
Health Claims 93
4.1 Introduction 93
4.1.1 Nutrition and Public Health Expenditures 94
IC TABLE OF CONTENTS
4.1.2 McFat Litigation 95
Pelman et al. v. McDonald s Corp. 95
4.2 The Nutrition Labeling and Education Act (NLEA) 101
4.3 Nutrient Level Claims 103
4.3.1 Meals and Main Dishes 106
4.3.2 Standardized Foods 106
4.3.3 Healthy 106
4.4 Nutrition Panel Format 106
4.5 Trans Fats 111
4.5.1 Background on Trans Fat 112
4.5.2 Pétition to Ban Hydrogenated Oil 112
4.5.3 Highlights of the Trans Fat Rule 113
4.6 Health Claims 113
4.6.1 General Well-Being Claims 114
4.6.2 Classical Nutrient-Deficiency Disease and Nutrition 115
4.6.3 Structure-Function Claims 115
4.6.4 Pre-approved Health Claims (NLEA) 116
4.6.5 Authoritative Statements?FDA Modernization
Act of 1997 124
4.6.6 Qualified Claims?After Pearson v. Shalala 125
Pearson v. Shalala 127
4.6.7 Nutritional Claims Grading Proposed 138
4.6.8 Substantiation of Claims 139
4.7 NLEA and Restaurants 142
Public Citizen and CPSI v. Shalala 142
4.8 Advertising 145
4.8.1 Fédéral Trade Commission 145
4.8.2 Deceptive Advertising and Unfairness 146
4.8.3 Overview of Other Regulatory Aspects
of Advertising 146
5. Economie and Aesthetic Adultération 149
5.1 Introduction 149
5.2 Définitions 149
5.2.1 Food 149
5.2.2 Adulterated 150
5.2.3 Misbranded 151
5.3 Food Standards: Régulation of Food Identity and Quality 152
5.3.1 Historical Overview 153
5.3.2 FD C Act § 401, Power to Set Food Standards
of Identity 157
TABLE OF CONTENTS XI
Corn Products Co. v. Dept. of HEW 161
Libby, McNeil Libby v. United States 166
5.3.3 Current Issue 169
5.3.4 Penalties 169
5.3.5 Temporary Marketing Permits 169
5.4 Sanitation and Aesthetic Adultération 170
U.S. v. 1,500 Cases... Tomato Paste 170
5.4.1 GMPs 173
5.4.2 Waiter, There s a Fly in My Soup?FDA Defect
Action Levels 174
5.4.3 The FDA Food Defect Level Handbook 175
5.4.4 Blending 179
5.4.5 De minimis Filth 179
United States v. 484 Bags, More or Less 179
United States v. Capital City Foods, Inc. 181
5.4.6 Décomposition 183
United States v. An Article of Food... 915 Cartons
of Frog Legs 183
5.4.7 Insanitary Conditions 186
U.S. v. 1,200 Cans Pasteurized Whole Eggs by Frigid
Food Products 187
5.4.8 Good Manufacturing Practices (GMPs) 189
United States v. Nova Scotia Food Products Corp. 189
5.4.9 Otherwise Unfit for Food 194
PART III: FOOD SAFETY REGULATION 195
6. Food Safety Régulation 197
6.1 Introduction 197
6.1.1 Background?The Nature and Cost of Foodborne
Illness 198
6.1.2 Poisonous and Deleterious Substances 200
6.1.3 Added Substances 201
United States v. Lexington Mill Elevator Co.
232 U.S. 399 (1914) 201
6.1.4 Nonadded Substances 204
U.S. v. 1,231 Cases American Beauty Brand Oysters 204
6.1.5 Tolérances for Unavoidable or Necessary
Poisonous and Deleterious Substances 208
Young v. Community Nutrition Institute et al. 209
6.2 Pesticide Residues 212
XII TABLE OF CONTENTS
6.2.1 FIFRA and EPA 213
6.2.2 FQPA and Risk Assessment 213
6.3 Environmental Contaminants 214
United States v. Anderson Seafoods, Inc. 215
6.4 Tampering: The Anti-tampering Act 220
6.5 Carcinogens: The Delaney Clause 221
Scott v. FDA 222
Public Citizen v. Young 225
6.6 HACCP 240
6.6.1 HACCP s History 241
6.6.2 The Advantages of HACCP 241
6.6.3 The Nature and Cost of Foodborne Illness 242
Suprême Beef Processors, Inc. v. USD A 245
7 Food Additives, Food Colorings, Irradiation 253
7.1 Introduction 253
7.2 Background 253
7.3 Food Additives 260
7.3.1 The Food Additive Amendment of 1958 261
7.3.2 FD C Act Définition 262
7.3.3 Additive Safety and Approval 264
7.3.4 Prior Sanctioned Substances 266
7.3.5 GRAS (Generally Recognized as Safe) 267
7.3.6 Proving GRAS Status 268
United States v. An Article of Food, Coco Rico, Inc. 268
7.3.7 Indirect Additives 272
Natick Paperboard Corp. v. Casper Weinberger
and FDA 273
7.3.8 The FDA Modernization Act of 1997 (FDAMA) 277
7.3.9 MSG 278
7.3.10 Preservatives 283
7.3.11 Botanicals and Other Novel Ingrédients 289
7.4 Color Additives 293
7.4.1 Color Additive Amendments 293
7.4.2 Provisional Listing 294
United States v. An Article of Food Consisting of 12
Barrels.. . Lumpfish Roe 302
7.5 Food Irradiation 306
7.5.1 Irradiation as a Food Additive under FD C Act 306
7.5.2 Labeling 313
7.5.3 Agricultural Pests 314
TABLE OF CONTENTS XIII
PART IV: SPECIALIZED FOOD REGULATION 321
8. Dietary Suppléments 323
8.1 Introduction 323
8.2 Background 323
8.2.1 What Are Dietary Suppléments? 323
8.2.2 Background to DSHEA 324
8.3 The Statutory Définition 326
8.3.1 What Is a Dietary Supplément 328
8.3.2 What Is Not a Dietary Supplément 329
United States v. Ten Cartons of Ener-B Nasal Gel 330
Pharmanex v. Shalala 344
8.4 Approval and Safety 352
8.4.1 Presumption of Safety 352
8.4.2 No Food Additive Approval 355
8.4.3 New Dietary Ingrédients (Post-1994) 355
8.4.4 Adultération 356
8.5 Enforcement 357
8.5.1 Hurdles for the FDA 357
8.5.2 Adverse Publicity 358
8.5.3 Other Tools 358
8.6 Good Manufacturing Practices (GMPs) 359
8.7 Labels 360
8.7.1 Basic Labeling Requirements 360
8.7.2 Literature and Labeling 362
8.8 Health Claims 363
8.8.1 Background 364
8.8.2 DSHEA Authorized Health Claims 367
8.8.3 Permitted Health Claims 368
Whitaker v. Thompson 370
Pearson v. Shalala 380
8.9 Problem Suppléments 388
8.9.1 Ephedra 388
8.9.2 Androstenedione?Mark McGwire s Tonic 390
8.9.3 FDA Warnings 390
8.9.4 Third-Party Certification 391
8.10 Street Drug Alternatives 391
United States v. Undetermined Quantities of Articles
ofDrug 392
8.11 Advertising 399
8.11.1 Truthful and Not Misleading 399
8.11.2 Claim Substantiation 400
XIV TABLE OF CONTENTS
9. Biotechnology and Genetically Engineered Organisms 413
9.1 Introduction 413
9.1.1 Background 413
9.1.2 Regulatory Overview 415
9.2 Food Safety 417
9.3 FDA Policy 422
9.3.1 Labeling 423
9.3.2 The Proposed New FDA Approach 428
9.3.3 Enhancing the FDA s Oversight 429
9.4 USDA s Rôle 429
9.5 EPA s Rôle?The Safety of Pesticides in Bioengineered
Plants 431
9.5.1 Pesticidal Substances in Food 431
9.5.2 StarLink Corn Investigation and Recall 432
9.6 The Right to Know 434
International Dairy Foods Ass n v. Amestoy 436
Alliance for Bio-Integrity v. Shalala 443
10. Food Terrorism 457
10.1 The U.S. Food Safety System 457
10.2 The Threat 459
10.2.1 Illness and Death 459
10.2.2 Economie and Trade Effects 460
10.2.3 Social and Political Implications 460
10.3 Examples of Contamination 461
10.3.1 A Salmonella Tainted Election 461
10.3.2 Pesticide Poisoning in Michigan 462
10.4 The Bioterrorism Act and FDA s New Powers 465
10.4.1 Food Facility Registration 466
10.4.2 Prior Notice of Food Imports 466
10.4.3 New Penalties 466
10.5 Conclusions 467
11 Importation and Exportation 469
11.1 Introduction 469
11.2 The Major Fédéral Agencies 470
11.3 The FDA Import Process 470
11.3.1 Basic Import Procédure 471
11.3.2 Prior Notice of Import 472
11.3.3 Import Food Facility Registration 473
11.4
11.5
11.6
11.7
11.8
TABLE OF CONTENTS XV
11.3.4 Additional Forms for Certain Canned Foods, Milk,
Cream, and Infant Formula 473
11.3.5 When a Violation Is Found 474
11.3.6 When a Notice of Action Is Issued 474
11.3.7 Request for Authorization to Relabel or Perform
Other Acts 475
11.3.8 Inspection after Reconditioning or Relabeling 476
11.3.9 Good Agricultural Practices (GAPs) 476
11.3.10 Enforcement 477
USDA s Import System 477
11.4.1 Food Safety Inspection Service (FSIS) 477
11.4.2 Animal and Plant Health Inspection Service
(APHIS) 480
Other Import Controls 480
11.5.1 Customs (CBP) 480
11.5.2 Environmental Protection Agency 482
11.5.3 Alcohol and Tobacco Tax and Trade Bureau
(TTB) 482
11.5.4 National Oceanic and Atmospheric
Administration (NOAA) 482
Country-of-Origin Labeling 483
Challen ges Facing Import Régulation 484
Export 487
11.8.1 Export Exemption 487
11.8.2 Import for Export 488
U.S. v. 76,552 Pounds of Frog Legs 489
11.8.3 Export Certificates 491
PARTV: INSPECTION AND ENFORCEMENT 493
12. Fédéral Enforcement 495
12.1 Introduction 495
12.1.1 A Note on Materials 495
12.1.2 The Rôle of States 496
12.1.3 Public Records 497
12.2 Statutory Authorities 497
12.2.1 Prohibited Acts 497
12.2.2 FDA s Enforcement Discrétion 498
12.2.3 Rôle of the Justice Department 498
12.3 Enforcement Jurisdiction 499
XVI TABLE OF CONTENTS
12.3.1 Introduction into Interstate Commerce 499
12.3.2 Held for Sale after Shipment in Interstate
Commerce 500
United States v. 40 Cases... Pinocchio Brand. ..
Blended... OU 500
12.3.3 FD C Act Interstate Commerce Presumption 503
12.3.4 FDA Jurisdiction over Restaurants 503
12.4 Administrative Enforcement 504
12.4.1 List of Inspectional Observations 504
12.4.2 Warning Letters 504
12.4.3 Recalls 510
12.4.4 Debarment 511
12.4.5 Import Détentions 512
12.4.6 Civil Penalties 512
12.4.7 Withdrawal of Product Approvals 513
12.4.8 Inspection-Related Enforcement Powers of
FSIS 513
12.5 FDA Civil Court Actions 514
12.5.1 Seizure 514
12.5.2 USDA 515
12.5.3 Injunction 517
12.5.4 Contempt Action 518
12.5.5 Destruction of Products without a Hearing 518
North American Cold Storage Co. v. City of
Chicago et al. 518
12.6 Criminal Actions 524
12.6.1 Strict Liability 524
United States v. Park 526
12.6.2 Fines, Prison 532
12.7 Other Remédies and Concerns 533
12.7.1 Publicity 533
12.7.2 Referral to State Agencies 533
12.7.3 Postenforcement Compliance Monitoring 533
12.7.4 Criminal Code Charges 533
13. Inspections 537
13.1 Introduction 537
13.2 Constitutional Limits 538
13.2.1 Statutory Power for Inspections 539
13.2.2 Record Access under the Bioterrorism Act 541
13.2.3 The Warrantless Inspection Exception 541
United States v. Jamieson-McKames
Pharmaceuticals, Inc. 542
TABLE OF CONTENTS XVII
13.2.4 Consent to Inspect 546
United States v. Thriftimart, Inc. 547
13.2.5 Statements by Firm Représentatives 549
13.2.6 Scope of Inspections 550
13.2.7 Photographs 551
13.3 Planning for the Inspection 564
13.3.1 Policies 564
13.3.2 Training 564
13.3.3 FDA s Notice of Inspection 565
13.3.4 Inspectional Observations (FDA Form 483) 565
13.3.5 Times of Inspection 566
13.3.6 Samples 566
13.3.7 Follow-up Information 567
13.3.8 Etiquette for Dealing with FDA Inspectors 567
13.4 FSIS Inspection Authority 567
13.4.1 Major Enforcement Powers 568
13.4.2 Records Access 570
13.4.3 FSIS International Inspection Activities 571
13.4.4 Suprême Beef v. USDA 571
Suprême Beef Processors, Inc. v. USDA 572
14. State Laws and Their Relationship to Fédéral Laws 575
14.1 Introduction 575
14.1.1 Overview of the Rôle of States 575
14.1.2 FDA Jurisdiction over Restaurants 576
14.1.3 FSIS 576
14.1.4 Related Authorities 576
14.1.5 National and State Coopération 577
14.1.6 Organizations Fostering Uniformity 577
14.2 State Inspection and Enforcement Powers 579
14.2.1 Summary Seizure and Condemnation 579
14.2.2 Destruction of Products without a Hearing 579
14.3 State Warning Requirements 580
14.4 Fédéral Préemption of States 580
14.4.1 Express Préemption of Inconsistent State Law 582
14.4.2 Comprehensive Fédéral Scheme That Occupies
the Field 583
Florida Lime and Avocado Growers, Inc.
v. Paul 583
Hillsborough Co. v. Automated Médical
Labs, Inc. 588
14.4.3 Direct Conflict between Fédéral and State Law 593
XVIII TABLE OF CONTENTS
14.4.4 State Law an Obstacle to the Purposes and
Objectives of Congress 593
Jones v. Rath Packing Co. 594
14.4.5 Unreasonable Burden on Interstate Commerce 603
14.5 Fédéral Laws Delegating Authority to the States 604
15. Private Actions 605
15.1 Introduction 605
15.2 Products Liability 606
15.2.1 The Hot Coffee Case 606
15.2.2 Products Liability 606
15.2.3 Foreign-Natural Test versus Reasonable Expectation 609
Porteous v. St. Ann s Café Dell 610
Jackson v. Nestle-Beich, Inc. 615
15.2.4 Négligence Per se 621
Orthopédie Equipment Co. v. Eutsler 621
Blommer Chocolaté Co. v. Bongards Creameries, Inc. 625
15.3 Préemption of Tort Claims 630
15.3.1 Generally 630
15.3.2 State Law 631
15.4 The False Claims Act 632
15.5 No Private Cause of Action under the FD C Act 633
Florida ex rel. Broward Co. v. Eli Lilly Co. 633
Merrell Dow Pharmaceuticals, Inc. v. Thompson 635
PART VI: GENERAL CHAPTERS 637
16. International Food Law 639
16.1 Introduction 639
16.2 International Food Standards 640
16.2.1 Codex Alimentarius 640
16.2.2 The WTO and International Trade Agreements 643
16.2.3 Jurisprudence 645
16.3 Foreign Regulatory Systems 645
16.3.1 Background on the European Union 646
16.3.2 EU Food Issues with the United States 646
16.3.3 The GE Food Fight 647
16.3.4 The Precautionary Principle 648
16.3.5 EU Requirements on GE Food 649
16.3.6 EU Labeling 650
16.3.7 The U.S. Response to the European Union 650
TABLE OF CONTENTS XIX
17. Ethics 653
17.1 Professionalism and Ethics 653
17.2 Ethical Practice Pointers 656
17.3 Attorney Rules of Ethics 656
17.4 Criminal Statutes Related to Ethics 660
17.5 Resources 661
TABLE OF ABBREVIATIONS 663
TABLE OF CASES 669
INDEX 671
ABOUT THE AUTHOR 677
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| discipline | Rechtswissenschaft |
| format | Book |
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| geographic | USA USA (DE-588)4078704-7 gnd |
| geographic_facet | USA |
| id | DE-604.BV035354461 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-09T21:31:59Z |
| institution | BVB |
| isbn | 9780470127094 |
| language | English |
| lccn | 2008021433 |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-017158548 |
| oclc_num | 699532385 |
| open_access_boolean | |
| owner | DE-M382 DE-703 DE-521 |
| owner_facet | DE-M382 DE-703 DE-521 |
| physical | XXIX, 677 S. |
| publishDate | 2009 |
| publishDateSearch | 2009 |
| publishDateSort | 2009 |
| publisher | Wiley |
| record_format | marc |
| spelling | Fortin, Neal D. Verfasser (DE-588)14187080X aut Food regulation law, science, policy and practice Neal D. Fortin Hoboken, NJ Wiley 2009 XXIX, 677 S. txt rdacontent n rdamedia nc rdacarrier Food law and legislation United States Food industry and trade Safety regulations United States Food adulteration and inspection United States Lebensmittelrecht (DE-588)4034898-2 gnd rswk-swf USA USA (DE-588)4078704-7 gnd rswk-swf USA (DE-588)4078704-7 g Lebensmittelrecht (DE-588)4034898-2 s DE-604 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017158548&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Fortin, Neal D. Food regulation law, science, policy and practice Food law and legislation United States Food industry and trade Safety regulations United States Food adulteration and inspection United States Lebensmittelrecht (DE-588)4034898-2 gnd |
| subject_GND | (DE-588)4034898-2 (DE-588)4078704-7 |
| title | Food regulation law, science, policy and practice |
| title_auth | Food regulation law, science, policy and practice |
| title_exact_search | Food regulation law, science, policy and practice |
| title_full | Food regulation law, science, policy and practice Neal D. Fortin |
| title_fullStr | Food regulation law, science, policy and practice Neal D. Fortin |
| title_full_unstemmed | Food regulation law, science, policy and practice Neal D. Fortin |
| title_short | Food regulation |
| title_sort | food regulation law science policy and practice |
| title_sub | law, science, policy and practice |
| topic | Food law and legislation United States Food industry and trade Safety regulations United States Food adulteration and inspection United States Lebensmittelrecht (DE-588)4034898-2 gnd |
| topic_facet | Food law and legislation United States Food industry and trade Safety regulations United States Food adulteration and inspection United States Lebensmittelrecht USA |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017158548&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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