- Do farms now have to register?
Under the current regulations for food facility registration, entities that meet the definition of “farm” are not required to register. The proposed rule would not change that. Under the proposed rule, farms would continue to be exempt from the registration requirement.
- Is FDA still changing the farm definition?
The registration proposed rule would not result in any changes to the definition of “farm.” However, FDA has proposed to change that definition in another FSMA rulemaking (the rulemaking related to preventive controls for human food).
- If I’m a farm now, will I have to register in the final rule?
As stated above, the registration proposed rule is not proposing to change the definition of “farm.” Therefore, this rulemaking is not proposing to affect whether entities that currently meet the definition of a “farm” are required to register.
- Will the rule have any effects on who qualifies as a “retail food establishment” and will this affect who is required to register?
Yes. The proposed rule is proposing to change the definition of “retail food establishment” in ways that we expect would increase the number of establishments that fall within that definition. Because retail food establishments are exempt from the requirement to register, we expect that this proposal, if finalized, would result in fewer establishments being required to register.
- If I’m now a farm mixed-type facility, how will the proposed change to the definition of “retail food establishment,” if finalized, affect me?
FDA uses the term “mixed-type facility” to refer to cases in which, for example, a farm grows oranges and processes them into orange juice for sale to a distributor. In that example, in which the establishment engages in both activities that are exempt from registration (the farm activities) and activities that require the establishment to be registered (the processing activities), the establishment is required to register because its processing activities are not covered by the farm definition. If, however, most of the orange juice is going to a local farmers market, the establishment could meet the proposed rule’s definition for a retail food establishment. Accordingly, the establishment would be exempt from the requirement to register under the proposed rule, if finalized.
- If I don’t have to register, does that mean I am not subject to the FSMA requirements?
No. While some FSMA requirements only apply to facilities that are required to register, others do not. For example, a farm that may not have to register still could be subject to the final rule on produce safety, which is still under development.
- Under the supplemental notice of proposed rulemaking for preventive controls for human food, FDA has proposed changing the farm definition for registration and other purposes. Under the proposed change, a farm would no longer be required to register as a food facility solely because it packs or holds raw agricultural commodities grown on a farm under different ownership. While the rulemaking is still ongoing, what is FDA’s policy regarding farms that also pack or hold raw agricultural commodities grown on a farm under different ownership?
FDA does not intend to prioritize enforcing the registration requirement in this circumstance.