Implications of Bioterrorism Act

Published: September 30, 2004, By Sheila A. Millar, Attorney-at-Law, Keller & Heckman, Washington, DC

As converting industry members know, the US Food and Drug Administration (FDA) has issued regulations implementing the Bioterrorism Act — officially known as the “Public Health Security and Bioterrorism Preparedness and Response Act of 2002.”

They cover administrative detention, registration of food facilities, prior notice of imported food shipments, and maintenance and inspection of records.

Foods were targeted because food products comprise about 20% of US imports and represent an attractive target for biological agents. Manufacturers of “food contact substances” and pesticides are exempt from the registration and prior notice requirements of the Bioterrorism Act.

Nevertheless, because substances used in packaging (including food contact packaging) may include substances also used as direct food additives covered by these requirements, confusion may exist regarding Bioterrorism Act obligations, particularly prior notice obligations, and obligations under the Toxic Substances Control Act (TSCA).

Bioterrorism Act prior notices regarding food product or ingredient shipments must be sent to FDA directly or through the US Customs and Border Patrol (CBP). The more vexing questions relate to prior notice requirements when the product or material involved is used for both direct food and for food packaging or other applications. “Food” that is imported into the US without appropriate prior notice may be refused admission and detained.

Questions about mixed-use substances have been creating delays for shippers and their customers. Many components of food-contact packaging also are used for non-food-contact packaging and are subject to import certification under TSCA.

Thus, to assure compliance and avoid shipment delays, a comprehensive understanding of the materials being sold, the intended end-use application, and the applicable law is needed.

For foreign facilities manufacturing substances with both food and non-food applications, facility registration and prior notice obligations will apply if it is reasonably foreseeable the product will be used in food applications. Even if in a particular case the producer makes the product only for food contact or other non-food applications, companies are finding shipments may be held up if the substance is known to be a food ingredient or the paperwork suggests use in foods.

It does not take much imagination to understand that busy officials looking at thousands of products coming into the US may make assumptions about the likely end use by virtue of the product name, the identity of the shipper, or the identity of the recipient. Careful attention to paperwork requirements — for example, by including appropriate language on invoices, shipping papers, and product labels — may help assure products are not improperly detained. For food contact applications, consideration should be given to use of a statement such as: “Not intended for direct addition to food.” For applications not involving any FDA-regulated use, an alternative is: “This product is not intended for any use that is covered by the Federal Food, Drug and Cosmetic Act.”

Remember the entry document or invoice for any chemical substance (defined to exclude foods, food additives, drugs, cosmetics, or devices when manufactured or distributed in commerce for such use) brought into the US must contain the following certification: “I certify that all chemical substances in this shipment comply with all applicable rules or orders under the Toxic Substances Control Act (TSCA) and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order thereunder.”

A negative TSCA certification (e.g., “I certify that all chemicals in this shipment are not subject to TSCA.”) is required unless the exempt status is otherwise obvious. See the Introduction to the Import Requirements of the Toxic Substance Control Act at: epa.gov/oppt/chemtest/importguide.pdf.

The FDA has updated its Compliance Policy Guide on the prior notice rule, which was to have been subject to full enforcement August 12. FDA will continue enforcement discretion until November 1. FDA's Center for Food Safety and Applied Nutrition Web site (cfsan.fda.gov/~pn/pnoview.html) has resources available to help affected manufacturers and importers in understanding and complying with the requirements of the Bioterrorism Act. Members of the converting industry, including those making dual-use ingredients, should find these materials helpful.