Facility Registration

NOTE: This text has been updated to reflect changes in the proposed FSMA rules as of October 2014.

Whether or not a farm currently has to register with FDA as a “facility” depends on whether the farm conducts certain manufacturing, processing, packing, or holding activities that also make it a “facility.”  Figuring out which activities trigger the facility registration for farms is one of the most confusing aspects of FDA’s regulations.  Our “Do I Operate a Farm or a Facility?” page will help you figure out whether you conduct activities that make you a facility and, therefore, have to register with FDA as a facility and comply with requirements for facilities.

Since the passage of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), all food facilities have been required to register with FDA.  FSMA’s definition of “facility” comes from the definition used in the Bioterrorism Act.  Farms and retail food establishments were exempt from registration in the Bioterrorism Act, and FSMA upholds those exemptions, as long as the farm is not also doing activities that trigger the facility definition.

When Congress passed FSMA, it did not change that definition of “facility,” but it did clarify that farmers’ markets, community-supported agriculture programs, and other direct-to-consumer sales platforms come under the definition of a retail food establishment and, therefore, are not facilities and do not have to register with FDA.  FDA has said that it will release a separate rulemaking specifically to clarify the definition of retail food establishment.  However, that proposed rule has yet to be published.  Until then, there is still significant uncertainty regarding which types of direct marketing operations have to register and which do not.

FSMA did make changes to the requirements around facility registration.  FSMA requires facilities to renew their registrations every two years (during even-numbered years), requires facilities to submit additional information to FDA, and allows FDA to suspend a facility’s registration if the food manufactured, processed, packed, received, or held might cause illness or death.  FSMA also required FDA to issue a compliance guide for small entities that have to register as food facilities.

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