Recordkeeping Requirements at Food Production Facilities - FDA is seeking public comments on the paperwork and regulatory burdens associated with its regulatory program which "... requires that persons who manufacture, process, pack, hold, receive, distribute, transport, or import food in the United States establish and maintain records identifying the immediate previous sources and immediate subsequent recipients of food ... The requirement to establish and maintain records [is intended to] improve [FDA's] ability to respond to, and further contain, threats of serious adverse health consequences or death to humans or animals from accidental or deliberate contamination of food ..."
Comments Due By: June 8, 2020
Web site: The April 7, 2020 FDA Federal Register Notice is posted at
Contact: Questions about the paperwork and regulatory burdens of the information collection may be directed to Domini Bean who is with the FDA Office of Operations in North Bethesda, Maryland at 301 796 5733; e-mail: PRAStaff@FDA.HHS.gov
* The Federal Register Notice did not provide contact information for an individual to whom technical questions about the information collection may be directed.
Summary: The following information is taken from the April 7, 2020 FDA Federal Register Notice:
Recordkeeping and Records Access Requirements for Food Facilities--21 CFR 1.337, 1.345, and 1.352
OMB Control Number 0910-0560--Extension
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 added section 414 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350c), which requires that persons who manufacture, process, pack, hold, receive, distribute, transport, or import food in the United States establish and maintain records identifying the immediate previous sources and immediate subsequent recipients of food. Sections 1.326 through 1.363 of our regulations (21 CFR 1.326 through 1.363) set forth the requirements for recordkeeping and records access. The requirement to establish and maintain records improves our ability to respond to, and further contain, threats of serious adverse health consequences or death to humans or animals from accidental or deliberate contamination of food.
Information maintained under these regulations helps us identify and quickly locate contaminated or potentially contaminated food and inform the appropriate individuals and food facilities of specific terrorist threats. Our regulations require that records for non- transporters include the name and full contact information of sources, recipients, and transporters; an adequate description of the food, including the quantity and packaging; and the receipt and shipping dates (Sec. Sec. 1.337 and 1.345). Required records for transporters include the names of consignor and consignee, points of origin and destination, date of shipment, number of packages, description of freight, route of movement and name of each carrier participating in the transportation, and transfer points through which shipment moved (Sec. 1.352). Existing records may be used if they contain all the required information and are retained for the required time period.
Section 101 of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) amended section 414(a) of the FD&C Act and expanded our access to records. Specifically, FSMA expanded our access to records beyond records relating to the specific suspect article of food to records relating to any other article of food that we reasonably believe is likely to be affected in a similar manner. In addition, we can access records if we believe that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that we reasonably believe is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. To gain access to these records, our officer or employee must present appropriate credentials and a written notice, at reasonable times and within reasonable limits and in a reasonable manner.
The information collection provisions of Sec. 1.361 are exempt from OMB review under 44 U.S.C. 3518(c)(1)(B)(ii) and 5 CFR 1320.4(a)(2) as collections of information obtained during the conduct of an administrative action, investigation, or audit involving an agency against specific individuals or entities. The regulations at 5 CFR 1320.3(c) provide that the exception in 5 CFR 1320.4(a)(2) applies during the entire course of the investigation, audit, or action, but only after a case file or equivalent is opened with respect to a particular party. Such a case file would be opened as part of the request to access records under Sec. 1.361. Accordingly, we have not included an estimate of burden hours associated with Sec. 1.361 in table 1.