by Michael J. O’Flaherty
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which essentially directed FDA to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply, added section 415 to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Among other actions taken to implement the Bioterrorism Act, pursuant to section 415 the agency established regulations requiring that food facilities register with FDA. These regulations became effective on December 12, 2003.
The FDA Food Safety Modernization Act (FSMA) of 2011 amended section 415 of the FD&C Act to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the U.S. submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. As amended, section 415 also requires food facilities to renew their registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances. FDA has issued a number of guidance documents to assist the industry in complying with the food facility registration requirements. See generally Guidance for FDA Staff: Compliance Policy Guide Sec. 100.250 Food Facility Registration – Human and Animal Food (June 2014); Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Sixth Edition) (rev. Nov. 18, 2014); Guidance for Industry: What You Need to Know About Registration of Food Facilities; Small Entity Compliance Guide (rev. Dec. 17, 2014); and Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (rev. May 18, 2014)..
Under FDA’s present regulations, certain food facilities, including retail food establishments, are exempted from the requirement to register. The proposed rule would amend the regulatory definition of a “retail food establishment” in a way that would expand the number of establishments that are subject to the exemption. A retail food establishment is currently defined as an establishment that sells food products directly to consumers as its primary function. An establishment’s primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. The proposed rule would clarify that, in determining the primary function of an establishment, the sale of food directly to consumers from an on-farm establishment includes sales by the establishment at such direct sales platforms as roadside stands, farmers’ markets, and Community Supported Agriculture (CSA) programs. Based on currently available data, FDA estimates that there are approximately 71,000 farms that only sell food products directly to consumers in ways that include farmers markets, roadside stands, and CSA programs. [Note: Inasmuch as the amended definition would exempt additional establishments from the requirement to register, these establishments also would not be subject to the requirements of the FSMA preventive controls rulemakings, which apply to facilities that are required to register.] See generally Questions and Answers for Farmers on FSMA Proposed Rule for Food Facility Registration (rev. Apr. 8, 2015).
For food facilities that are not exempt from registration, the proposed rule would add new provisions to the current regulations to codify certain requirements of FSMA that were self-implementing and effective upon enactment of FSMA. Those requirements are:
- Registrations for domestic facilities must contain the email address of the contact person of the facility, and registrations for foreign facilities must contain the email address of the U.S. agent for the facility.
- Food facilities that are required to register with FDA must renew their registrations every two years, between October 1 and December 31 of each even-numbered year.
- All food facility registrations must contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.
In addition, the proposed rule would add certain new requirements, including:
- All food facility registrations would be required to be submitted to FDA electronically; however, this requirement would not take effect before January 4, 2016.
- Registrations would be required to contain the type of activity conducted at the facility for each food product category.
- The proposed rule would provide for measures to verify certain information submitted in registrations.
- The proposed rule would identify additional circumstances under which FDA will cancel registrations (i.e., FDA independently verifies that the facility is not required to register; information about the facility’s address was not updated in a timely manner; the registration was submitted by a person not authorized to submit it).
Public comments on FDA’s proposed rule may be submitted electronically or by regular mail until June 8, 2015.