FSMA: Comment Period Opened on Food Facility Information Collection Program

The Food and Drug Administration (FDA) recently announced an opportunity for public comment on the proposed collection of certain information by the Agency.  This notice solicits comments on the information collection provisions of FDA’s program of voluntary submission of food facility profile information and the new Form FDA 3797, which may be submitted electronically via the FDA Industry Systems Website. 

Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188) (the “Bioterrorism Act”) FDA was further authorized to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. The Bioterrorism Act added section 415 of the FD&C Act (21 U.S.C. 350d), which requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA.  (emphasis added).  FDA regulations at 21 CFR 1.230 through 1.235 set forth the procedures for registration of food (including animal food/feed) facilities.

The types of information the FDA proposes to collect in its voluntary food facility profile includes, among other things:

  • The facility type (i.e. manufacturer/processor, re-packer/packer, warehouse/holding facility)
  • The products and related hazards (i.e. biological, physical, chemical), along with preventive control measures associated with said products
  • Facility information (i.e. food safety training, facility size, number of employees, operational schedule, etc.)

With respect to the collection of information, FDA invites comments on the following topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

The deadline to submit either electronic or written comments on the collection of information summarized above is July 10, 2012.  Please take full advantage of this opportunity.  These rules will affect how the industry operates and establishs another key standards against which a food facility will be measured.  As such, it is important to voice your concerns to the FDA during these comment periods.

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