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The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (commonly called the Bioterrorism Act of 2002) became law on June 12, 2002. Title III of the Act contains four sections that apply to foods. The U.S. Food and Drug Administration (FDA; Rockville, MD) issued four major regulations implementing the provisions of the act: Registration of Food Facilities (October 10, 2003), Prior Notice of Imported Foods (October 10, 2003), Administrative Detention of Food for Human and Animal Consumption (June 4, 2004), and Establishment and Maintenance of Records (December 9, 2004).
Now that the final compliance date listed in the regulations, December 6, 2006, for small businesses (less than 11 employees) under the provisions of the recordkeeping regulations, has passed, it is a good time for food companies to review their compliance status. Determining whether your facility is covered by the Bioterrorism Act and its implementing regulations is a good place to start.
Generally speaking, the bioterrorism regulations apply to domestic facilities and certain foreign facilities that manufacture, process, pack, or hold food for human or animal consumption. The recordkeeping regulations extend to those that transport, distribute, receive, or import foods. Food is defined by reference to section 201(f) of the Federal Food, Drug, and Cosmetic (FD&C) Act. Examples of food include:
• Dietary supplements and dietary ingredients.
• Infant formula.
• Beverages (including alcoholic beverages and bottled water.
• Fruits and vegetables.
• Fish and 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, and candy (including chewing gum.
• Live food animals.
• Animal feeds and pet food.
Farms, restaurants, retail food establishments, nonprofit food establishments, certain fishing vessels, and facilities regulated exclusively by USDA are generally exempt from these regulations. As you can see, the scope of the regulations is quite broad and encompasses the vast majority of food and food-related companies.
A full discussion of the compliance issues raised by these regulations is not possible within the limited space of this article. However, we’ll briefly look at key points that are most likely to cause compliance problems.
Administrative Detention of Foods (section 303(a) of the Bioterrorism Act) authorizes FDA to detain an article of food if there is “credible evidence or information that indicates the article presents a threat of serious adverse health consequences or death to humans or animals.” FDA regulations establish expedited procedures for perishable foods, explain the procedures to be used in detaining an article of food, and set a process for appealing a detention order. There are really no ongoing “compliance” issues with these regulations. The agency, however, now has detention authority available to them if efforts to have potentially harmful foods removed from distribution voluntarily or when other regulatory means fail.
Effective December 12, 2003, FDA must receive prior notice of any shipments of food for humans and animals that are imported into the United States (section 307 of the Bioterrorism Act). There are a few limited exclusions (including gifts and quality assurance and marketing samples). FDA must receive prior notice before the food shipment reaches the first port in the United States. The notice must be received no more than five days before a shipment arrives. The deadline for submitting prior notice depends on the mode of transportation used for shipment. Further details can be found in the FDA booklet titled What You Need to Know About Prior Notice of Imported Food Shipments (November 2003).
The remaining two sections of the Bioterrorism Act (Registration of Food Facilities (section 305) and Establishment and Maintenance of Records (section 306) have a more direct impact on day-to-day operations at food facilities.Registration with FDA of all domestic and foreign facilities that manufacture or process, pack, or hold food for human or animal consumption is required as of December 12, 2003. Each facility is required to register only once but the required registration information must be updated if it changes. Required information includes:
• Facility name, address, phone number, and emergency contact phone number.
• Parent company name, address, and phone number (if applicable).
• Name, address, and phone number of the owner, operator, or agent in charge.
• All trade names the facility uses.
• Name, address, and phone number of a foreign facility’s U.S. agent and the phone number of the facility’s emergency contact if it is someone other than the U.S. agent.
• Certification that the information submitted is true and accurate and that the person submitting it is authorized to do so.
The agency also requests optional registration information including the type of activity conducted at the facility and food categories not included in the required information.
Registration is accomplished by completing Form 3537 and submitting it to the agency. The form is available online and in paper form. The Web site for facility registration is www.access.fda.gov. Online registration is the most efficient method. A registration number and confirmation of registration are available almost immediately after completing the registration process. If paper forms are used, the registration information is returned by surface mail.
The same form is used to update required information if it changes. For example, if the facility manager is designated as the agent in charge and a new person fills the position, FDA must be notified within 60 days. Facilities should establish a policy for routinely reviewing the information on its registration form. The form should be reviewed at least annually but should be scheduled every six months if items produced or personnel change frequently.
If there is a change of ownership, the former owner must cancel the facility’s registration within 60 days and the new owner must register the facility before starting operations. Registrations are cancelled by using Form 3537a, which is also available online or in paper form.
The Establishment and Maintenance of Records (or recordkeeping) section of the Bioterrorism Act is perhaps the most complex and far-reaching of the implementing regulations and the one that most affects daily operations. The rules apply to domestic persons who manufacture, process, pack, transport, distribute, receive, hold, or import food and foreign persons who transport food.
Nontransporters are required to identify the immediate previous sources (one back) of all foods received and immediate subsequent recipients (one forward) of all foods released. The final rule does not specify the form that the records must take or the recordkeeping system to be used. Existing records can be used to meet the requirements of the rule as long as the records relied upon contain all of the required information.
The required information includes:
• The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the “nontransporter immediate previous source” or “non-transporter immediate previous recipient.”
• An adequate description of the type of food released, including the brand name and specific variety.
• The date the food was received or released.
• For persons who manufacture, process, or pack food, the lot or code number or other identifier of the food (if the information is readily available).
• The quantity and how the food is packaged.
• The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the transporter.
There are a number of software and data collection programs and packages available to assist covered facilities with their recordkeeping requirements. When considering these systems, users should make certain they are compatible with their existing systems, are easy to use, actually provide the required information in a timely manner, and that they are cost-effective. Keep in mind, however, that compliance can be achieved without using electronic methods, if the information is properly organized and managed.
Transporters are required to maintain similar but slightly different information. A detailed discussion of all of its provisions is beyond the scope of this article. A good source of basic information on this section can be found in the FDA booklet titled What You Need to Know About Establishment and Maintenance of Records (December 2004).
FDA must request records subject to this regulation in writing usually via FDA Form 482c, Notice of Inspection-Request for Records. FDA cannot invoke this authority during routine establishment inspections, but must satisfy the requirements for record access under the Bioterrorism Act. Requested records must be made available to FDA for inspection and copying as soon as possible, but not to exceed 24 hours from the time the official request was made. Recipes, financial data, pricing data, research data, and sales data are excluded from record access requirements.
Failure to comply with any of the regulations promulgated by FDA under the Bioterrorism Act is prohibited under the FD&C Act. The federal government can bring civil or even criminal action in federal court against those responsible for the prohibited act. Additionally, FDA may refuse entry to foods from foreign facilities that are not registered.
While complying with the provisions of the Bioterrorism Act may seem a daunting task at first, compliance is simply a matter of understanding the requirements, reviewing and collecting the pertinent data, and organizing them so that they are readily available when required. Facilities may find that the information that must be maintained under the act may also be valuable in other situations, such as recalls or quality concerns.
Extensive information, including fact sheets, booklets, questions and answers, and compliance guides are available on FDA’s Web site at www.cfsan.fda.gov.
Stan Iwanicki is principal consultant of Hill Country Food Consultants (Fredericksburg, TX). For more information, contact Hill Country Food Consultants by visiting www.hillcountryfoodconsultants.com or calling 830/990-1778.