A food product offered for import may be subject to regulation and enforcement by several different agencies within the U.S. government, depending upon the type of product. Understanding the legal and regulatory requirements that govern the importation of a given food product can help speed its entry into U.S. commerce.
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- Chapter 1—INTRODUCTION
- I. REQUIREMENTS FOR IMPORTED FOOD PRODUCTS
- II. RELEVANT U.S. REGULATORY AGENCIES
- A. U.S. Food and Drug Administration (FDA)
- B. U.S. Department of Agriculture (USDA)
- 1. USDA, Food Safety and Inspection Service (FSIS)
- 2. USDA, Animal and Plant Health Inspection Service (APHIS)
- 3. USDA, Agricultural Marketing Service (AMS)
- 4. USDA, Foreign Agriculture Service (FAS)
- C. U.S. Bureau of Customs and Border Protection (CBP)
- D. Other Agencies and Their Roles
- 1. U.S. Environmental Protection Agency (EPA)
- 2. U.S. Department of Commerce (DOC)
- a. National Marine Fisheries Service (NMFS)
- b. U.S. Patent and Trademark Office (PTO)
- 3. U.S. Department of Transportation (DOT)
- III. ABOUT THE GUIDE
- Chapter 2—FDA REGULATO REGULATORY REQUIREMENTS RY REQUIREMENTS
- I. INTRODUCTION
- II. FOOD PRODUCTS UNDER FDA JURISDICTION
- III. FDA RELIES ON PORT/BORDER INSPECTION
- IV. FDA STATUTORY AUTHORITY
- V. THE BIOTERRORISM ACT AND FDA IMPLEMENTING REGULATIONS
- A. Registration of Food Facilities
- 1. Definitions
- 2. Exemptions
- 3. How to Register
- 4. Foreign Facilities
- 5. Compliance
- B. Prior Notice of Food Imports
- 1. Definitions
- 2. Exemptions
- 3. How to Submit Prior Notice
- 4. Timeframes for Submitting Prior Notice
- 5. Information in the Prior Notice
- 6. Compliance
- C. Recordkeeping/Records Access
- 1. Definitions
- 2. Exemptions
- 3. Impact on Foreign Persons
- 4. Required Records
- 5. Form, Location, and Retention
- 6. Records Access
- 7. Compliance
- D. Administrative Detention
- 1. Definitions
- 2. The Detention Order
- 3. Effect of Detention
- 4. Appealing a Detention Order
- 5. Compliance
- E. Other Bioterrorism Act Provisions
- 1. Prohibition Against Port Shopping
- 2. Marking of Food Refused Admission
- 3. Import for Export
- 4. Debarment for Import Violations
- 5. 24-Hour Hold on Imported Foods
- 6. Notification to States
- VI. FDA FOOD SAFETY STANDARDS
- A. Good Manufacturing Practices
- B. Food Components
- 1. Intentional Components
- a. Food Additives
- b. Color Additives
- c. Generally Recognized as Safe (GRAS) Substances
- d. Prior Sanctions
- 2. Unintended Components
- C. Food Contaminants
- 1. Tolerances
- 2. Regulatory Limits
- 3. Action Levels
- 4. Defect Action Levels
- 5. Guidances
- 6. Substances Banned from Human Food
- D. Special Requirements for Particular Foods
- VII. FDA LABELING REGULATIONS
- A. Label Features
- B. Nutrition Facts
- 1. General Requirements
- 2. Required Format
- C. Labeling Claims
- 1. Health Claims
- 2. Nutrient Content Claims
- 3. Structure/Function Claims
- D. Warning Statements
- VIII. FOOD PRODUCTS WITH SPECIAL REQUIREMENTS
- A. Milk Safety
- B. Low Acid Canned Foods and Acidified Foods
- C. Infant Formula
- D. Juice
- E. Seafood
- F. Dietary Supplements
- G. Bottled Water
- IX. FDA IMPORT PROCEDURES AND ENFORCEMENT ACTIVITIES
- A. Entry Notice and Entry Bond
- B. FDA Decides Whether Food Is Admissible
- C. Notice of Sampling
- D. Conditional Release
- E. Notice of Detention and Hearing
- F. Application for Authorization to Recondition or to Perform
Other Action
- X. OTHER FDA POWERS
- A. Detention Without Physical Examination
- B. Import Alerts
- XI. WAYS TO SPEED FOOD IMPORTATION
- Chapter 3—USDA REGULATORY REQUIREMENTS
- I. INTRODUCTION
- II. FOOD PRODUCTS UNDER USDA JURISDICTION
- III. FSIS RELIES ON GOVERNMENT OF EXPORTING COUNTRY
- IV. USDA STATUTORY AUTHORITY
- V. THE BIOTERRORISM ACT
- A. Registration of Food Facilities
- B. Prior Notice of Food Imports
- C. Recordkeeping/Records Access
- D. Administrative Detention
- VI. FSIS: FOOD SAFETY “EQUIVALENCE” AND BORDER INSPECTION
- A. Obtaining an Equivalence Determination
- 1. Document Review
- 2. Initial Equivalence Audit
- B. “Equivalence” and FSIS List of Eligible Exporters
- C. Equivalence Verification
- 1. Document Analysis
- 2. Equivalence Verification System Audits
- D. FSIS Inspection at Port/Border
- VII. FSIS LABELING REQUIREMENTS
- A. Meat and Poultry Products
- B. Eggs and Egg Products
- VIII. ANIMAL AND PLANT HEALTH INSPECTION SERVICE (APHIS)
- A. Animal Products
- B. Bovine Spongiform Encephalopathy
- 1. BSE-Known Regions and Regions of Undue Risk
- 2. BSE Minimal-Risk Regions
- a. Canada Is a Minimal-Risk Region
- b. Importation of Commodities from a
Minimal-Risk Region
- C. Fruits and Vegetables
- 1. Phytosanitary Certificates
- 2. Import Permits
- IX. AGRICULTURE MARKETING SERVICE (AMS)
- A. AMS Import Requirements for Fruits, Vegetables, Specialty Crops
- B. National Organic Program (NOP)
- C. Labeling Regulations (COOL)
- X. FOREIGN AGRICULTURAL SERVICE (FAS)
- A. Sugar Import Programs
- B. Dairy Import Program
- Chapter 4—CBP REGULATORY REQUIREMENTS
- I. INTRODUCTION
- II. OVERVIEW
- A. Informed Compliance
- B. Reasonable Care
- III. ENTRY OF GOODS
- A. Types of Entry
- 1. Consumption Entry
- 2. Warehouse Entry
- 3. Transported in Bond to Another Port of Entry
- B. Entry Process
- 1. Right to Make Entry
- a. Entry by Importer
- b. Entry by Others
- c. Power of Attorney
- 2. Evidence of the Right to Make Entry
- 3. Entry Documents
- 4. Examination of Goods and Entry Documents
- a. Excess Goods or Shortages
- b. Damage or Deterioration
- c. Tare
- 5. Coordination with FDA and USDA
- 6. Unentered Goods
- 7. Recordkeeping
- IV. SPECIAL PROGRAMS TO SPEED ENTRY
- A. Special Permit for Immediate Delivery
- B. Importer Self-Assessment
- C. C-TPAT
- V. DUTIES, TARIFFS, AND QUOTAS
- A. Dutiable Status of Goods
- B. International Trade Agreements
- 1. Bilateral Trade Agreements
- 2. Regional Trade Agreements
- 3. Eligibility of Imported Goods
- C. Customs Rulings on Imports
- 1. Content of Ruling Requests
- 2. Content of Requests for Tariff Classification
- D. Payment of Duties
- E. Protesting an Article’s Dutiable Status
- F. Antidumping and Countervailing Duties
- G. Drawback
- 1. Manufacturing Drawback
- 2. Unused-Merchandise Drawback
- 3. Rejected-Merchandise Drawback
- H. Quotas
- 1. Tariff-Rate Quotas
- 2. Absolute Quotas
- VI. TARIFF CLASSIFICATION AND VALUE
- A. Classification
- 1. Harmonized Tariff Schedule
- 2. Liquidation
- B. Value
- 1. Transaction Value
- 2. Transaction Value of Identical Merchandise
- 3. Transaction Value of Similar Merchandise
- 4. Deductive Value
- a. Determining Unit Price
- b. Deductions
- 5. Computed Value
- 6. Values if Other Values Cannot be Determined
- VII. COUNTRY OF ORIGIN MARKING
- A. When Other Localities Appear on the Product
- B. Exemptions for Food Products
- VIII. COORDINATION WITH FDA AND USDA
- A. Food Products
- B. Agricultural Commodities
- 1. Cheese and Dairy Products
- 2. Fruits, Vegetables, and Nuts
- 3. Livestock and Animals
- 4. Meat and Meat Products
- 5. Plant and Plant Products
- 6. Poultry and Poultry Products
- 7. Seeds
- IX. PROTECTION OF INTELLECTUAL PROPERTY RIGHTS
- A. Trademarks and Trade Names
- B. Copyrights
- X. FOREIGN TRADE ZONES
- A. Treatment of Goods
- B. Advantages of Foreign Trade Zones
- C. Transfer of Goods in Bonded Warehouse
- XI. WAYS TO SPEED CUSTOMS CLEARANCE
- XII. RECENT DEVELOPMENTS
- A. SAFE Port Act
- 1. Container Security Standards and Procedures
- 2. Container Security Initiative
- 3. Automated Targeting System
- 4. Impact on C-TPAT Participants
- B. Implementation of the Automated Commercial Environment (ACE)
- APPENDICES
- APPENDIX A
- Useful Websites
- APPENDIX B
- FDA Field Office Information
- APPENDIX C
- Notice of FDA Action
- APPENDIX D
- Form FDA 766
- APPENDIX E
- FSIS District Office Information
- APPENDIX F
- APHIS Veterinary Services Area Office Information
- APPENDIX G
- CBP Ports of Entry Information
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