FSMA's Exemption For Farm-To-Consumer Sales

By Melissa Lind, contributing writer

One of the most concerning parts of the Food Safety and Modernization act has been the FDA’s definition of a food facility. Some have been concerned that certain farms will fall under “facility” regulation, but a proposed rule may clarify that issue.

The Food and Drug Administration requires that facilities that manufacture, process, or pack food for human consumption in the U.S. must register with the agency as a food facility. Retail food establishments, farms that do not sell to the public, restaurants, and other business are exempt from the registration requirement. Some confusion has existed with the definition of what a farm is, specifically whether farms selling food directly to the public were required to register. A new proposed rule to expand the definition of “retail food establishment” would increase the number of businesses that don’t have to register, including farming businesses or cooperatives that sell directly to the public.

The FDA estimates there are over 70,000 farming businesses that only sell directly to the consumer. These businesses or groups sell through roadside stands, farmers markets, and Community Supported Agriculture (CSA) programs. A requirement for registration would have made these groups subject to FSMA rules for facilities in addition to FSMA’s preventive controls rule.

The proposed ruling change would also amend certain portions of FSMA for facilities that are not exempt including:

Registration Addresses — registrations for domestic facilities will require the email address of the contact person at the facility and registrations for foreign facilities will require the email address of the facility’s U.S. agent.

Registration Frequency — food facilities with registration requirements must renew registration every two years. Registration renewals must occur between October 1 and December 31 of even-numbered years.

Registration Assurance — food facility registrations must contain assurance that the facility will permit the FDA to inspect the facility at times and according to the Food, Drug, and Cosmetic Act.