Editor’s note: This article updates an earlier article on the Bioterrorism Act by Mr. Rubin in HerbalGram 58. The article refers to recordkeeping and potential FDA actions against "foods," but the reader should bear in mind that herbs and other "dietary supplements" are considered foods under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
In the aftermath of the events of September 11, 2001, Congress recognized the need to enhance the security of the U.S. food supply. On June 12, 2002, President Bush signed into law the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act),1 a specific section of which, Title III, covers food products, and which provides the US Food and Drug Administration (FDA or Agency) with substantial new powers to regulate and review foods and dietary supplements imported into the United States. A prior article published in HerbalGram 58 summarized the provisions of the Bioterrorism Act, and FDA’s proposed regulations associated with "prior notice" and registration requirements.2 In short, all affected food facilities will have had to register with FDA by December 12, 2003. Also, as of this date, manufacturers, importers and/or processors will have to provide advance notice to FDA of any shipment of human food imported or offered for import. Foreign exporters of foods and dietary supplement ingredients (including botanicals) for import into the United States will also have to designate a US-based agent.
As explained in the prior article, establishments that are exempt from the registration requirements include the following: farms; retail food operations; restaurants; non-profit operations that prepare food for, or serve food directly to, consumers; fishing vessels not engaged in processing; and facilities regulated exclusively throughout the entire facility by the US Department of Agriculture.
This new system will permit 400,000 facilities to register worldwide in 60 days, and will give FDA new capabilities to work with everyone involved in our food supply to keep it safe and secure, said FDA Commissioner Mark McClellan, MD, PhD.3
The "interim final" regulations for "prior notice" and registration were released by the FDA on October 9, 2003 and published in the Federal Register the following day.4 This article focuses exclusively on the administrative detention and recordkeeping requirements of the Bioterrorism Act, including the respective proposed rules issued on May 9, 2003.5
The Bioterrorism Act authorizes FDA to detain an article of food for which there is credible evidence or information indicating such article presents a threat of "serious adverse health consequences or death to humans or animals." This standard for administrative detention is quite stringent, and basically tracks the standard for a Class I recall (i.e., the most significant type of recall administered by the FDA).6 FDA’s administrative detention authority became effective when the Bioterrorism Act was signed into law on June 12, 2002, and the proposed rule issued by the FDA establishes procedures for implementing the requirement.
It should initially be noted that even prior to the grant of administrative detention authority to the FDA under the Bioterrorism Act, 48 states already had food detention authority (the only exceptions being Utah and South Dakota); FDA has historically contacted state authorities to detain food products in situations where the Agency believed detention was necessary. As detention authority is more limited in scope under the Bioterrorism Act than under most state laws, FDA is expected to continue to rely upon state enforcement except in situations where the Agency believes time is of the essence, in which case the Agency will take action under its own enforcement mechanisms.
FDA’s proposed rule authorizes an officer or qualified employee of FDA to order a detention of any article of food that is found during an inspection, examination, or investigation if the FDA official has credible evidence or information indicating such article presents a threat of serious adverse health consequences or death to humans or animals. A detention order must be approved by the District Director of the district where the detained article of food is located.
Upon detention, the FDA may require the food to be moved to a secure facility if the Agency believes such isolation is necessary. For a "perishable food" (defined as including foods that are not heat-treated or frozen and not preserved in a manner to prevent the quality of the food from being adversely affected if held longer than 7 days), a company may appeal the detention order within 2 days, and a hearing must be held within 2 days after the appeal is filed and a decision granted within 5 days after an appeal is filed.
For nonperishable food, a notice of intent to file an appeal must be filed within 4 days, and the actual appeal must be filed within 10 days. If a hearing is requested and granted, FDA must hold the hearing within 3 days after the appeal is filed, and the Agency must issue its decision within 5 days after the appeal is filed.
FDA has indicated that it will issue a final rule for the establishment and maintenance of records not later than December 12, 2003, and such rule will become effective within 6 months after its publication. The Agency has indicated that companies need not comply with the requirements of the proposed rule at the present time – but noted that some recordkeeping and inspection requirements are already in effect under current law. It should be noted, however, that many legal experts question FDA’s legal authority to inspect company records that are not expressly authorized for inspection under the Bioterrorism Act or Federal Food, Drug, and Cosmetic Act.
In general, recordkeeping requirements require non-transporter companies to identify both the immediate source and immediate recipient of all food – along with the transporter of the applicable food. Required information includes contact information, type of food, date received or released, lot number (if available), quantity and method by which the food was packaged, and the contact information for each and every mode of transportation (e.g., company truck, private carrier, rail, air, etc.). Transporters must maintain similar records.
Records must generally be maintained for one to two years, and such records must be made "reasonably available" to the Agency during inspections (currently defined as within 4 hours of a request during an inspection within normal business hours, and within 8 hours of a request made at any other time). FDA has proposed that companies can utilize existing recordkeeping methods to maintain records under the Bioterrorism Act – as long as the existing records are made available to FDA and contain all of the required information. Failure to maintain records constitutes a prohibited act under the Federal Food, Drug, and Cosmetic Act – and may result in enforcement action.
The author makes the following recommendations:
• A recent on-line survey of more than 1,200 food industry participants, conducted by The Food Institute and reviewed by the Food Policy Institute at Rutgers University, indicates that over 50 percent of the food industry professionals surveyed are unaware of Bioterrorism Act requirements, and another 21 percent are generally aware of the requirements but have not initiated compliance efforts.7 Companies should immediately draft standard operating procedures (SOPs) to cover food imports, and should have initiated compliance activities well before the "prior notice" and registration implementation date of December 12, 2003.
• Companies should establish SOPs to cover administrative detention and should identify a company official responsible for acting immediately in response to a detention order. It may be necessary to file an appeal within 2 days, and companies should have a process in place to address potential public relations issues that may emerge in the event a crisis-management plan must be initiated.
• Companies should evaluate those records that are currently being maintained, and determine whether such records already satisfy FDA requirements under the Bioterrorism Act. It may be necessary to reorganize such records in order to ensure immediate availability in the event of an FDA inspection request.
• A document retention program should be developed to ensure that records are maintained for at least the period required by the Agency. For product liability and other reasons, companies should evaluate whether certain records should be voluntarily maintained for longer than the mandatory period. Such an evaluation should be conducted on a case-by-case basis depending upon the type of document, and other practical and legal considerations.
More information on the interim final rules and additional information about the Bioterrorism Act can be found at the FDA’s website: <www.fda.gov/oc/bioterrorism/bioact.html>.
Paul D. Rubin is a Partner in the Food and Drug Practice Group of Patton Boggs LLP, Washington D.C. He may be reached via e-mail at <firstname.lastname@example.org>.
1. Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). Public Law 107-188 (2002).
2. Rubin PD. The Bioterrorism Act: overview and implications for industry. HerbalGram 2003;58:65-7.
3. FDA Introduces New Technology to Improve Food Security: Electronic Food Facility Registration Goes "Live," Allowing More Than 400,000 Facilities to Register in Minutes; FDA Reports on Progress in Developing Rapid Tests of Food Contamination (press release). October 16, 2003.
4. US Food and Drug Administration. Interim Final Rule and Request for Comment on the Registration and Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Federal Register October 10, 2003;68(197):58894.
5. US Food and Drug Administration. Interim Final Rule and Request for Comment on the Registration and Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Federal Register October 10, 2003;68(197):58974.
6. See 21 C.F.R. §7.12(m)(1) ("Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.").