Section 801 of the Federal Food, Drug, and Cosmetic Act (FFDCA) sets out the requirements for imports and exports of FDA regulated products.

Imports

The adulteration and misbranding standards for feed and feed ingredients of foreign origin are the same as for those of domestic origin. A notable difference is the burden of proof that FDA must meet to refuse the entry of products of foreign origin. Under Section 801(a), the agency must only establish that the product “appears” to be violative under the FFDCA. This is a lesser standard than that to establish a domestic product as violative.

The U.S. Customs Office alerts FDA when regulated products are entering the United States. FDA then has the option of releasing the product, detaining the product subject to further review, or refusing the product. Ordinarily these decisions are made at the District level but, at times, District personnel may consult with headquarters to determine the admissibility of a product. To assist field personnel in making these decisions, they have access to resources, which alert them to potential problems, or items that should be sampled. Some of these resources and other information on imports are available on the Internet from the FDA’s Office of Regulatory Affairs (ORA), Office of Regional Operations.

The legal requirements that must be met are the same for imported and domestic products, including feed mill licensing and new animal drug approval requirements. However, the enforcement procedures are different. Imported products regulated by FDA are subject to inspection at the time of entry through U.S. Customs. Shipments found not to comply with our laws and regulations are subject to detention. They must be brought into compliance, destroyed, or re-exported.

Generally, an USDA permit is required for imported materials derived from animals and plants. Animal products, which require permits, include dairy products and meat products (e.g., meat meal and bone meal) from countries with livestock diseases exotic to the United States. Import permit applications for animal products may be obtained through the Automated Document Retrieval by calling (301) 734-4952, or writing to the USDA-APHIS-VS at:

Import permit applications for plant products may be obtained by calling (877) 770-5990, fax (301) 734-5786, or writing to the USDA-APHIS-PPQ at:

Exports

The FDA Export Reform and Enhancement Act amended in 1996 changed the rules for the importation of products considered violative under U.S. law if they are intended to be further manufactured and then exported. Where this was previously illegal, it is now legal provided certain requirements are met.

Until the passage of the FDA Export Reform and Enhancement Act, new animal drugs intended for feed use could not be exported unless they were approved in the U.S. or intended to be sold to certain countries. Non-drug feed and feed components considered violative in the U.S could be exported as long as they met the provisions of 801(e). These 801(e) requirements are that the products must: 1) meet the foreign purchaser’s specifications, 2) not be in conflict with the laws of the country where they are being exported, 3) be labeled that they are intended for export and 4) not have been offered for sale in domestic commerce.

It is now legal to bring in drug and non-drug feed products considered violative in the U.S. if they are intended to be further processed and then exported. On November 24, 1998, the Agency published a proposed rule for Section 21 of the Code of Federal Regulations (CFR) Part 1.84, describing the conditions for implementing this provision. The Agency’s proposal was intended to assure that violative product that entered was appropriately documented to prove it was all exported. It is not known when the final rule will be published.

On April 2, 1999, the Agency published another proposed rule for 21 CFR 1.101, laying out the requirements for assuring that the provisions of 801(e) are met for violative products intended for export. This proposed rule identifies the notifications and documentation necessary to establish compliance. It is not known when the final rule will be published.

The Center for Veterinary Medicine issues three types of export certificates: The certificates are issued by the Division of Compliance.

Guidance for Industry #151: Guidance for Industry: FDA Export Certificates, July 2004. | htm | | pdf |

To facilitate agricultural exports, Animal and Plant Health Inspection Service (APHIS, USDA) officials certify animal and plant products that are shipped to foreign countries. APHIS’ Veterinary Service (VS) officials and its National Center for Import and Export provide health certificates for animals and animal products designated for export. The specific information on requirements for exporting animal products is available from the APHIS Veterinary Service area office serving your state. For additional information on foreign requirements governing exports of animal products, phone (301) 734-4401.

APHIS’ Plant Protection and Quarantine (PPQ) provides assurance that U.S. plant products meet the plant quarantine import requirements of foreign countries. This assurance is in the form of a phytosanitary certificate, issued by PPQ or its State cooperators. For information on phytosanitary certificates and regulations governing exports of plant products, phone (301) 734-8537 or send an e-mail inquiry to APHIS PPQ exports.