Section 418(l) of the FD&C Act establishes modified requirements for "qualified facilities." The Agency describes what a qualified facility is in section VIII.D, where the Agency proposes the requirements for such a facility (proposed
The Agency tentatively concludes that it should include the exemption provided in section 418(l)(2)(A) of the FD&C Act in the proposed rule to establish by regulation the reach of the provision. Proposed
a. Requirements of section 103 of FSMA. As discussed in section VII.A.1, section 103(c)(1)(A) of FSMA requires that the Secretary publish a proposed rule to issue regulations with respect to "(i) activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership for purposes of section 415 of the [FD&C Act]; and (ii) activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership for purposes of section 415." Section 103(c)(1)(B) of FSMA directs that the rulemaking "shall enhance the implementation of such section 415 [of the FD&C Act] and clarify the activities that are included as part of the definition of the term "facility" under such section 415." In section VII, the Agency discusses clarifications of certain on-farm activities and whether they trigger the section 415 registration requirement in order to enhance the implementation of section 415 by clarifying the treatment of various activities for purposes of section 415, including activities conducted on farms.
In the proposed rule for preventive controls for human food (78 FR 3646),
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