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From Health Law Daily, July 13, 2016

Some farms harvest registration exemptions from Final rule

By Bryant Storm, J.D.

Food establishments that sell food products at a roadside stand, farmers’ market, or through a community supported agriculture (CSA) program are exempted from food facility registration requirements under newly revised FDA regulations. The Final rule updating the regulations, published as an advance release, implements certain provisions of section 415 of the Federal Food, Drug, and Cosmetic Act (FDC Act), in accordance with Section 102 of the Food Safety Modernization Act (FMSA) (P.L. 111-353). The Final rule also updates registration requirements and processes for food facilities required to register under the FDC Act. The regulatory changes are designed to allow the FDA to better focus its scarce inspection resources. The Final rule is set to publish in the Federal Register on July 14, 2016.

Retail food establishment. Under current regulations, food facilities that manufacture, process, pack, or hold food for consumption in the United States must register with FDA. However, establishments that are designated as "retail food establishments"— farms, restaurants, and certain other entities—are exempt from the requirement to register. The FDA has issued previous guidance on the definition of farms that would are exempt from the registration requirements (see Farm definition impacts food facility registration, November 19, 2014).

New definition. The Final rule amends the definition of retail food establishment to include new categories of food establishments based upon the "primary function of an establishment or a retail food establishment." The new regulations recognize the sale of food products directly to consumers as including: (1) The sale of food products or food directly to consumers by such establishment at a roadside stand or farmers’ market where such stand or market is located other than where the food was manufactured or processed; (2) the sale and distribution of such food through a CSA program; and (3) the sale and distribution of such food at any other such direct sales platform as determined by the HHS Secretary—door-to-door sales; mail, catalog and Internet orders; online farmers’ markets and online grocery deliveries; religious or other organization bazaars; and state and local fairs.

Registrations. Under the new regulations, food facility registrations—for those facilities that are not exempted—must: (1) include an email address contact; (2) be renewed every two years; and (3) contain an assurance permitting the FDA to inspect the facility at the times and in the manner permitted by the FDC Act. Additionally, in accordance with FMSA authorization, the FDA will require—beginning on January 4, 2020—that food facility registration submissions use an electronic format. In addition to extending the mandatory electronic submission date until 2020, the Final rule also provides a waiver request provision allowing a registrant to submit a written request explaining why an electronic submission is not reasonable for the establishment.

Database. Under the new regulations, the FDA is updating the food facility registration database with a unique facility identifier (UFI) for food facility registrations, new verification measures, and added circumstances under which the FDA will cancel registrations. Although the Proposed rule proposed to shorten the timeframe for submitting registration updates and cancellations from 60 days to 30 days, due to comments received, the FDA decided not to change the timeframe (see Farm to fork, food facility registrations clarified, April 9, 2015).

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