FDA has released a Small Entity Compliance Guide (SECG) to help food facilities comply with the registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Section 415 of the FD&C Act requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with FDA. While the registration requirement has been in effect since 2003, the requirements were revised under the Food Safety and Modernization Act (FSMA).

As previously reported on this blog, FDA published a final rule on July 14, 2016, as part of its FSMA implementation strategy that added new provisions to the facility registration requirements. These new provisions included an email address requirement, required assurance that FDA will be permitted to inspect registered facilities, and a revised definition for “retail food establishment.” In an announcement about the SECG, FDA also noted that in addition to the Guide, the Agency also updated its Registration of Food Facilities webpage to include a flowchart to help facilities determine if they are considered a retail food establishment and, therefore, exempt from food facility registration requirements.

FDA has previously issued both final and draft guidance documents on the food facility registration requirement since the final rule was published in 2014. These include a guidance that updated the food products categories that companies can select when registering as a food facility (see our September 28, 2016 blog) and several versions of a Draft Q&A Guidance on Food Facility Registration (see our January 3, 2017 blog for information on the most recent update). The Q&A draft guidance contains specific details on the registration process—such as whether using chlorinated water to wash lettuce on a farm is considered processing or whether facilities that operate under USDA FSIS inspection are required to register—however, that guide remains in draft format.

The SECG includes information on why facilities must register, details on which facilities must register and which facilities are exempt, an explanation of who is required to register, a discussion of the consequences of not registering, and an explanation of when FDA can suspend a facility registration. It also provides detailed information on how to register a food facility and discusses electronic submissions, which will be required beginning January 4, 2020. (A Federal Register notice on the SECG was published on May 28, 2018.)