U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
November 13, 2002

Letter to Stakeholders

"The Bioterrorism Act:" New Import for Export Provisions

Dear Colleague, FDA Foods Community:

Among its other changes, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, "the Bioterrorism Act" or the "Act" (Public Law 107-188), ⁽¹⁾ introduced new import for export provisions. These provisions increase FDA's authority regarding the oversight and monitoring of certain violative articles and components of food additives, color additives, dietary supplements, drugs, and devices that are imported into the United States for further processing and export. Title III, Section 322 of the Act amends the prior import for export requirements, Section 801(d)(3) of the Federal Food, Drug, and Cosmetic Act, and became effective on September 9, 2002. In response to the new requirements in Section 322, FDA has issued a new guidance document to FDA field office investigators. ⁽²⁾

While the new guidance document explains how FDA will implement the new requirements for all FDA-regulated products imported for export, this letter focuses on the food aspects of the new guidance document, and therefore is addressed solely to food community stakeholders.

In the guidance, FDA is implementing new regulatory procedures to be employed by FDA management and staff regarding articles of food additives, color additives, and dietary supplements imported for export. The Act requires the importer to submit to FDA the following information at the time of importation of food additives, color additives, or dietary supplements:

1. A statement that the article is intended to be further processed and exported;

2. The identity of the manufacturer of the article, and each processor, packer, distributor, or other entity that had possession of the article in the chain of possession from the manufacturer to the importer of the article; and

3. Such certificates of analysis as are necessary to identify the article.

Under the Act, the initial owner or consignee of the product must execute a bond providing for the payment of liquidated damages in the event of default. The bond is issued by U.S. Customs.

In addition, the Act requires the initial owner or consignee of an article to maintain records on the use or destruction of the article or portions of it, and to provide these records to FDA upon request. The initial owner or consignee is also required to submit a report to FDA, upon request, that provides an accounting of the export or destruction of the imported article or portions, and the manner in which such owner or consignee complied with the requirements of the Act.

Finally, under the Act, FDA may refuse admission of any article if there is credible evidence or information indicating that the article is not intended to be further processed or incorporated into a product to be exported.

cc: Dr. Lester Crawford, Deputy Commissioner
Mr. John Taylor, Associate Commissioner for Regulatory Affairs
Dr. Stephen Sundlof, Director, Center for Veterinary Medicine

¹ You may obtain a full copy of the Act on FDA's website at http://www.fda.gov/oc/bioterrorism/bioact.html.

² The full guidance can be read at http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9impex.html.