FDA Implements the Bioterrorism Act

Food Registration, Notice Requirements, and Exemptions for Food Contact Substances

The September 11, 2001 attacks prompted federal decisionmakers to assess the vulnerability of the United States’ major infrastructure systems and critical supply sources. Included in this analysis was a review of the security of the U.S. food supply. In response, on June 12, 2002, President Bush signed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.¹

Key food-related provisions went into effect on December 12,2003.The applicable regulations, published by the Food and Drug Administration (FDA)as interim final regulations on October 10, 2003,establish requirements for the registration of foreign and domestic food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States,² and for prior notice of imported food shipments.³ The registration information should help FDA determine the source of a bioterrorism incident or outbreak of food-borne illness, and facilitate agency notification of facilities that may be affected.

Required information includes:

• name, address, and phone number for the facility and its parent company (if applicable);

• name, address, and phone number of the owner, operator, or agent in charge;

• trade names the facility uses;

• applicable food product categories as identified in FDA ’s regulations;

• statements certifying that the information submitted is true and that the person submitting the registration - if not the owner, operator, or agent in charge - is authorized to submit the registration;

• foreign facilities must provide the name, address, and phone number of its U.S. agent; and

• domestic facilities must provide an emergency contact phone number.

The prior notice provision requires FDA to be given advance notice of when food shipments will arrive at U.S. ports-of-entry, allowing FDA and U.S. Customs and Border Protection, Department of Homeland Security (formerly the U.S. Customs Service) to more effectively target inspections and ensure the safety of imported food. FDA expects to receive approximately 25,000 daily electronic notifications, with notice of each shipment no more than five days before its arrival and no fewer than two hours of arrival by land-road, four hours by land-rail, or eight hours by water.

Among noteworthy changes was a narrowing of the definition of "food" in both the registration and prior notice regulations to exclude coverage of food contact substances, including packaging and pesticides. Several commenters requested this narrowed definition. Although FDA noted that the term "food" was not given an identical meaning throughout the Federal Food, Drug, and Cosmetic Act (FDCA),⁴ it is striking that the agency chose not to be expansive in terms of its authority and provided an extensive legal rationale for the change. In the interim final regulations, FDA changed the definition to exclude "food contact substances" as defined in section 409(h)(6) of the FDCA. FDA received requests for this change on the grounds that the proposed definition of "food" was made too broad with the inclusion of food packaging and components, food processing equipment, glassware, dishware, cutlery, kitchen appliances, and so-called "indirect additives. "Supporters argued that Congress intended the registration provision to apply only to facilities that manufacture, process, pack, or hold edible food"; products "traditionally understood as food," or articles that are "intended for consumption."

In making its decision, FDA applied the Chevron ⁵ test to determine what Congress intended "food" to mean when applied to the registration of facilities. The first prong of Chevron requires a determination of whether Congress articulated its intent on the matter. If not, the second prong requires an examination of whether an agency’s interpretation of the statute, which is silent or ambiguous on the issue, is based on a permissible construction of the statute.

FDA concluded that Congress had not spoken directly to the meaning of "food." In fact, FDA determined that the term was given different meanings throughout the FDCA, particularly with respect to exemptions for different types of facilities.

These exemptions do not make clear whether Congress intended them to cover only food that is ordinarily eaten at some point by consumers primarily for taste, aroma, or nutritive value or whether, for example, a retail food establishment could include retailers of food contact materials, such as retail cookware stores.⁶

Ultimately, FDA held that when Congress modified the term "food" by the phrase "for consumption in the United States" this signified an intent for less extensive regulatory authority than that understood in the broad definition of "food" found in existing FDCA section 201((f). "Excluding food-contact materials (including food packaging)is consistent with the statutory phrase, ‘food for consumption,’ section 415(a)(1),in that foods that are ‘consumed ’ are generally those intentionally eaten for their taste, aroma, or nutritive value."⁷

Despite this limitation, the number of "food" items subject to the new requirements is large, and includes:

• dietary supplements and ingredients;

• infant formula;

• beverages (including alcoholic beverages and bottled water);

• fruits and vegetables;

• seafood;

• dairy products and shell eggs;

• raw agricultural commodities for use as food or components of food;

• canned and frozen foods;

• bakery goods, snack food, candy, and chewing gum;

• live food animals; and

• animal and pet feeds.

Failure of a facility to register with FDA is a prohibited act that can result in a civil action to enjoin those responsible. FDA also can bring a criminal action. FDA indicated it will use discretion when enforcing the interim. final rule, particularly during the initial months, although the agency has announced its intention to take actions necessary for food security. FDA expects to publish a Compliance Policy Guide outlining how the agency intends to exercise enforcement.

These rules already are having unprecedented impacts on food manufacturers and processors, as well as foreign facilities and the import community generally. The impact on international trade alone will be far-reaching. Given the potential for both civil and criminal sanctions, those subject to the new requirements need to become familiar with the registration and reporting requirements of the new law, in addition to managing the additional risks we all face in our post-September 11th world.

The content of this article does not constitute legal advice and should not be relied on in that way. Specific advice should be sought about your specific circumstances.