31 December 2004

New FDA record-keeping rules

The following article is excerpted from the 28 December 2004 edition of “The Journal of Commerce”.

In the Dec. 9, 2004 Federal Register, the U.S. Food and Drug Administration (FDA) published final regulations regarding the establishment and maintenance of records for food "non-transporters" and "transporters" under the authority of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("Bioterrorism Act").

This notice sets forth the regulations implementing FDA's new record keeping requirements which are imposed on persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States (covered entities). A number of exclusions are available under the regulations, which are identified briefly below. These regulations require both non-transporters and transporters to establish and maintain certain records that will allow FDA to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging, when FDA has "a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals."

Note that these regulations focus on FDA's requirements for the covered entities to establish and maintain certain information/records for food as well as those entities whose records are to be made available for viewing and copying upon the agency's request when the evidentiary burden is met.

On the same date, FDA also issued a document, Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, that represents FDA's "current thinking" vis-à-vis its access to and copying of food distribution records when FDA believes the food to be adulterated and to present a threat to health under the Bioterrorism Act. The Guidance document only relates to FDA's access to information/records for food FDA believes presents a threat of serious adverse consequences or death. The Guidance itself does not require the creation of any documents or records, although the information or records covered by the Guidance may be information or records that the newly issued record keeping regulations require to be established and maintained.

The new regulations and Draft Guidance both relate to and implement food record keeping authority established by the Bioterrorism Act and both are triggered by the same circumstances, namely:

... if (1) The Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, and (2) the records are necessary to assist FDA in making such a determination. 69 FR at 71657.

The newly published regulations are final rules that will be the subject of public meetings in early 2005 at which time FDA will explain them in further detail. The first such meeting is scheduled for Jan. 13, 2005.

Highlights of the Final Regulations

The following significant points are readily observable from the current record keeping proposal:

* If you manufacture, process, pack, transport, distribute, receive, hold or import food, you are required to establish and maintain records related to your food, and to grant FDA access to those records when the agency has the appropriate level of evidence to support a request for access, but you are also required to grant access to any records you may have respecting your food's packaging (packaging includes the outer packaging of food that bears the label and does not contact the food directly)
* FDA's requirement to establish and maintain a record keeping system applies to any person, subject to certain exclusions identified below, who manufactures, processes, packs, transports, distributes, receives, holds, or imports food in the United States regardless of whether the food is intended for consumption in the United States;
*