FDA Seeks Public Comment on Food Facility Registration
The Food and Drug Administration (FDA) has requested public comments on
the information collection provisions of regulations that “require registration
for domestic and foreign facilities that manufacture, process, pack, or hold food
for human or animal consumption in the United States.”
According to FDA, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires food facilities to provide information via Form FDA 3537 (§1.231) or the electronic Food Facility Registration Module that will support FDA’s enforcement activities and help the agency issue notifications in the event of accidental or deliberate contamination. In 2011, the Food Safety Modernization Act amended these regulations to compel facilities to renew their registrations biennially and to submit additional information, such as “the email address for the contact person of a domestic facility and the email address of the U.S. agent for a foreign facility.”
Based on the registrations received in previous years, FDA has estimated that (i) the annual number of new domestic facility registrations will be 11,080, requiring a burden of approximately 2.7 hours per average domestic facility registration; (ii) the annual number of new foreign facility registrations will be 19,900, requiring a burden of approximately 8.9 hours per average foreign domestic facility registration; (iii) the average number of registration updates will remain unchanged at 118,530 updates annually over the next 3 years, requiring a burden of approximately 1.2 hours per average facility; and (iv) the average number of registration cancellations will remain unchanged at 6,390 cancellations over the next 3 years. The agency has also estimated that the new biennial registration required by FSMA “will require 30 minutes (0.5 hour) per response,” with 224,930 biennial registrations submitted over the next 3 years on an annualized basis. FDA will accept comments on the proposed information collection by March 25, 2013. See Federal Register, January 22, 2013.
