FDA Completes Implementation of the Bioterrorism Act's Provisions

When Congress enacted the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Food and Drug Administration (FDA) was given the task of preparing four sets of regulations to implement the provisions of the Act relating to facility registration, import notification, recordkeeping, and administrative detention. This task will be completed when the final rule on prior notice of imported food shipments becomes effective on May 6, 2009.

The Agency first issued proposed rules on facility registration and import notification in February 2003, and, after considering comments, issued interim final rules in October 2003. FDA published the final rule on facility registration in October 2005 and the final rule on import notification in November 2008. Proposed rules on recordkeeping and administrative detention were issued in June 2003. The final rule on administrative detention was issued in May 2004, and the final rule on recordkeeping was issued in December 2004.

What are these rules, what is their purpose, do they apply to food contact materials, and where do things stand currently?

1. Final Regulation on Facility Registration, 70 Fed. Reg. 57505 (Oct. 3, 2005).

This rule requires the registration of domestic and foreign facilities that manufacture/process, pack, or hold food for consumption in the United States. However, the Agency clarified that the definition of food has the meaning given in the Federal Food Drug and Cosmetic Act (FD&C Act) except for food contact substances and pesticides. Thus, facilities that produce food contact substances and pesticides are exempt from registration.

Some food contact substances, however, are also added directly to food. If the substance is intended for use as a direct additive, the facility dealing with the substance must be registered.

The owner, operator, agent in charge, or an individual authorized by the owner, operator or agent in charge must register the facility. Registration may be completed electronically via the Internet or by fax or mail.

A facility must ensure that the information it provides will enable FDA to contact a live person representing the facility 24 hours a day, seven days a week. This requirement necessitates that all foreign facilities designate a U.S. agent to serve as the primary point of contact. According to the rules, contact with the U.S. agent is deemed to be contact with the foreign facility.

A facility's failure to register is considered a prohibited act subject to sanctions.

2. FDA's Final Rule on Prior Notice of Imported Food Shipments, 73 Fed. Reg. 66294 (Nov. 7, 2008).

Under this rule, FDA has established the procedure for providing prior notice of imported food shipments. The rule established a timeframe for submitting the notices. Prior notice must be received and confirmed electronically by FDA no more than 15 days prior to arrival of the shipment for submissions made through the Agency's Prior Notice System Interface (PNSI), and no more than 30 days prior to arrival of the shipment for submissions made through the U.S. Customs and Border Protection's Automated Broker Interface of the Automated Commercial System (ABI/ACS). This is a change from the Interim Final Rule, 68 Fed. Reg. 58974 (Oct. 10, 2003), which required notification no more than 5 days prior to arrival. However, the final rule retains the requirement that prior notice must be submitted no fewer than 2 hours prior to arrival by land by road, 4 hours before arrival by air or by land by rail, and 8 hours prior to arrival by water.

Like the facility registration rule, the definition of "food" in the prior notification rule excludes food contact substances and pesticides. Again, however, substances that have direct food uses as well as food-contact uses are subject to prior notice of import when intended for direct use.

The prior notice rule applies to all food for humans and animals that is imported or offered for import into the United States. However, it does not apply to products regulated exclusively by the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act.

Food that is imported into the United States without adequate prior notice is subject to refusal of admission and holding at the port of entry or in secure storage. Furthermore, failure to provide adequate prior notice is a prohibited act subject to civil or criminal action.

Finally, the final rule allows an alternative to the requirement to provide the registration number of a food facility. If a facility's registration number is not available, a submitter may instead supply the full address of the site-specific facility and the reason why a registration number is not being provided.

A Compliance Policy Guide on prior notification of imported food was issued by FDA and the Department of Homeland Security. It was last updated in October 2008.*

3. Final Rule on Administrative Detention, 69 Fed. Reg. 31660 (June 4, 2004).

This final rule provides procedures for the detention of an article of food, if an officer or qualified employee of FDA has credible evidence or information indicating that the food presents a threat of serious adverse health consequences or death to humans or animals.

The final rule explains that the period of administrative detention must be reasonable and cannot exceed 20 days after the date the detention order is issued. The rule also establishes an expedited procedure, including a 4-day detention period, for perishable food. FDA, however, may detain food for an additional 10-day period if necessary to institute a seizure or injunction action.

Unlike the interim final rules on facility registration and prior notice which exempted food contact substances and pesticides from the definition of food, this administrative detention rule incorporates the FD&C Act's definition of "food" and thus applies to human and pet food, food and feed additives and ingredients, and food packaging materials that contact or may migrate to food. FDA specifically rejected comments seeking to exclude food contact materials, from being subject to this regulation.

4. Final Regulation on Recordkeeping, published Dec. 9, 2004 (69 Fed. Reg. 71562).

A final guidance on records access was issued in November 2005.

The new recordkeeping regulations require "persons that manufacture, process, pack, transport, distribute, receive, hold, or import food" to establish and maintain records that identify the immediate previous source of all food received (one step back), as well as the immediate subsequent recipient (one step forward) of all food released. [Editor's Note: The focus below is on manufacturers, but please be aware that all other functions listed above are within the scope of the regulation as well.] These records would allow FDA, in the event of accidental or deliberate contamination of food, to determine the source and cause of the event and to improve the agency's ability to quickly notify consumers and/or facilities that might be affected.

What does this mean for those who manufacture or otherwise handle food packaging and food contact materials?

• Manufacturers of food packaging that bears the label but is never directly in contact with food (such as secondary packaging) are completely exempt from the recordkeeping requirements, i.e., there is no requirement that they establish, maintain, or make available existing records.
• Manufacturers of finished containers that come in contact with food and who also put the food directly into the finished containers are required to establish and maintain records.
• Manufacturers of finished containers that come in contact with food but who do not actually put the food into the containers are required only to make existing records available to FDA with respect to the container.
• Manufacturers of food contact materials that are not the finished container that contacts food are only required to make existing records available to FDA upon request.

If FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health effects or death to humans or animals, any records must be available for inspection and copying as soon as possible, not to exceed 24 hours from the time of receipt of the official written request. The act provides that FDA may bring civil or criminal actions in federal court for violations of the rule.

For those subject to the recordkeeping requirements, the record retention period for human food ranges from six months to two years, depending on the shelf life of the food. Records for animal food, including pet food, must be retained for one year. The maximum length of retention of records by transporters for all types of food is one year. Records must be retained at the establishment where the activities covered in the records occurred, or at a reasonably accessible location. To minimize the burden on food companies, the required information may be kept in paper or electronic format.

*Editor's note: The Compliance Policy Guide was updated again in May 2009, after this article was published.