FDA would like food/feed facilities to voluntarily submit additional profile information through the Food Facility Registration Module – and wants to know what you think.

In a Federal Register Notice, FDA announced the opportunity for public comment on the information collection provisions of FDA’s program of voluntary submission of food facility profile information and new electronic form (FDA 3797).


The voluntary profile information is intended to help FDA determine whether a firm is high-risk or non-high-risk, and, from that, determine the frequency at which the firm would be inspected. Additionally, FDA noted that submission would benefit a food facility by enabling FDA to prepare for an inspection in advance “through interaction with better-informed investigators and potentially reduced inspection time.”

Firms will be offered the opportunity to complete or update a food/feed facility profile after electronic registration with FDA and anytime they access the Food Facility Registration Module. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States may also submit or update information at any time through a direct URL (to be provided by FDA).

The proposed information, to be submitted in English only, includes:

the facility type (e.g., manufacturer/processor, repacker/ packer, or warehouse/holding facility);

the products and hazards (e.g., biological, physical, chemical) and preventive control measures associated with those products, where either there is a regulation in place requiring identification of hazards and preventive control measures (e.g., seafood and juice), or the firm, as a matter of its own business practices, voluntarily identifies hazards and implements preventive control measures;

other facility information (such as food safety training, facility size, operational schedule, and number of employees).

Assuming that approximately half the registering firms will choose to provide profile information, FDA estimates annual submission of 6,780 domestic and 11,685 foreign firms. Information submission is estimated to take about 15 minutes by an average domestic facility and 45 minutes by a foreign facility (taking into account a potential lack of fluency in English.)

In 2011, the Food Safety Modernization Act (Section 102) added to the mandated food facility information, requiring that registrations contain the facility/U.S. agent contact e-mail address and an assurance that FDA would be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Additionally, if determined necessary by FDA, registrations are required to contain information regarding other applicable food categories, as determined appropriate by FDA, for foods manufactured/processed, packed, or held at registering facilities.

FSMA also added a renewal clause, requiring that all facilities renew their registrations between Oct. 1 and Dec. 31 of each even-numbered year, beginning this year. With comments on the voluntary profile submission proposal due by July 10, its timing is undoubtedly due to this upcoming renewal period.

While the request and voluntary aspect of the proposal seems fairly straight forward, it does bring to mind a few questions, specifically that since the form is voluntary, how will the information be evaluated? Will it move a facility that supplies information to a better spot – ostensibly penalizing those who do not fill it out? Or might a facility put itself in the cross hairs based on its responses?

Will the input data be electronically analyzed or will a person review it? Because the forms include the naming of hazards and preventive controls, it seems that it must be subject to some sort of human evaluation – which raises a few more questions in and of itself, including the availability of resources to do so.

And, while FDA states that it expects only half of those registering to complete the profile information, does it actually see the voluntary aspect as a precursor or trial to mandated submission of profile information?

Comment can be submitted electronically or by mail (Division of Dockets Management/HFA-305, Food and Drug Administration,5630 Fishers Lane, Rm. 1061, Rockville,MD 20852). All comments should be identified with the docket number FDA-2012-N-0430. Comment is due by July 10, 2012.


David Acheson, former Assistant Commissioner for Food Protection in the FDA, is a partner at Leavitt Partners. This commentary was riginally posted May 24, 2012 in the Leavitt Partners blog, Food Safety.