NOTE: FDA did not re-propose this section of the proposed FSMA rules; this text is up to date as of October 2014.
Whether or not a farm currently has to register with FDA depends on whether the farm conducts certain manufacturing, processing, packing, or holding activities that also make it a “facility.” If a farm is not also considered a facility under the proposed rules, it does not have to register with FDA.
Figuring out which activities trigger the facility registration for farms is one of the most confusing aspects of FDA’s regulations. To figure 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, click here.
In addition to requiring facility registration, FDA is considering whether to require farms that are subject to the Produce Rule to register with FDA. Farm registration under the Produce Rule would allow the agency to create a nationwide database with the names and locations of farms covered by the Produce Rule. The agency argues that this would allow for better outreach and technical assistance, as well as enable the agency to better allocate inspection resources. For farms that already have to register with FDA as facilities and are subject to the Produce Rule, it is unclear how Produce Rule registration requirements would impact them and whether they would have to register twice.
This information may be shared if credited to NSAC and accompanied by a link to this page