Customs compliance extends far beyond duties and classification. More than 47 federal agencies regulate the importation of goods into the United States, each with their own requirements, filing deadlines, and enforcement mechanisms. Failure to comply with agency-specific requirements can result in detention, refusal of admission, seizure, or penalties independent of any customs violations. Understanding which agencies regulate your products is a critical part of import planning.
Food and Drug Administration (FDA)
The FDA regulates the import of food, drugs, medical devices, cosmetics, tobacco products, and radiation-emitting electronic products. Importers of FDA-regulated products must file Prior Notice for food imports (at least 15 days before arrival for foreign facilities, 24 hours for specific shipments), register foreign food facilities under the Bioterrorism Act, and comply with product-specific requirements such as New Drug Applications (NDAs) for pharmaceuticals, 510(k) premarket notifications for medical devices, and Voluntary Cosmetic Registration. FDA issues import alerts that list products and firms subject to Detention Without Physical Examination (DWPE), meaning shipments are automatically detained at the border.
USDA — Animal and Plant Health Inspection Service (APHIS)
USDA APHIS regulates the import of live animals, animal products, plants, plant products, and organisms that could introduce pests or diseases. Import permits are required for most regulated articles, and phytosanitary certificates from the exporting country are typically mandatory. Products like fresh fruits and vegetables are subject to the Lacey Act declaration requirements, and wood packaging material must comply with ISPM-15 treatment standards (heat treatment or fumigation with methyl bromide, marked with the IPPC logo).
Consumer Product Safety Commission (CPSC)
CPSC regulates the import of consumer products for safety compliance. Under Section 17(a) of the CPSA, importers must file Certificates of Compliance electronically through ACE for consumer products, and Children's Product Certificates (CPCs) for products designed for children 12 and under. Third-party testing by CPSC-accepted laboratories is required for children's products. Non-compliant shipments face seizure and civil penalties of up to $100,000 per violation.
Environmental Protection Agency (EPA)
The EPA regulates imports of motor vehicles and engines (emissions compliance), pesticides (FIFRA registration), chemicals (TSCA compliance), and ozone-depleting substances. Importers must file EPA Form 3520-1 for vehicles/engines and ensure TSCA certification for chemical substances. The Significant New Use Rule (SNUR) may require importers to notify EPA before importing certain chemical substances for new uses.
- FDA: Prior notice, facility registration, product-specific approvals. File through ACE ITACS.
- USDA APHIS: Import permits, phytosanitary certificates, ISPM-15 wood packaging. File through ACE.
- CPSC: General Certificates of Conformity (GCC), Children's Product Certificates (CPC), third-party testing.
- EPA: Vehicle emissions, TSCA certification, pesticide registration (FIFRA).
- TTB (Alcohol and Tobacco Tax and Trade Bureau): Permits, labels, and formulas for imported alcoholic beverages and tobacco.
- FCC (Federal Communications Commission): Equipment authorization for electronic devices that emit radio frequency energy.
- DOT (Department of Transportation): Federal Motor Vehicle Safety Standards (FMVSS) for vehicles and equipment.
Most Partner Government Agency (PGA) data must now be filed electronically through ACE using PGA Message Sets. This means your customs broker or filing agent must include agency-specific data elements in the entry filing. Work with your broker to ensure all applicable PGA flags and message sets are identified before the first shipment arrives.