c. Clarification of the term "facility." Generally, section 418 of the FD&C Act applies to the owner, operator, or agent in charge of a "facility." Section 418(o)(2) of the FD&C Act defines "facility" as "a domestic facility or a foreign facility that is required to register under section 415." Section 415 of the FD&C Act, in turn, requires any facility engaged in manufacturing, processing, packing, or holding food for consumption in
The requirement in section 415 of the FD&C Act that a facility must register does not apply to farms.
The term "farm" includes a facility that packs or holds food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership (
Section 103(c)(1)(A) of FSMA requires that not later than 9 months after the date of enactment, the Secretary publish a notice of proposed rulemaking in the
d. Science-based risk analysis and requirements under sections 418 and 421 of the FD&C Act. Section 103(c)(1)(C) of FSMA requires that in issuing the proposed rule the Secretary conduct a science-based risk analysis of:
* "Specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and
* Specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership."
As part of the rulemaking, the Secretary is required to consider the results of the science-based risk analysis and exempt certain facilities from the requirements in sections 418 and 421 of the FD&C Act or modify those requirements, as the Secretary determines appropriate, if such facilities are only engaged in specific types of on-farm manufacturing, processing, packing, or holding activities the Secretary determines to be low risk, and involving specific foods that the Secretary determines to be low risk (section 103(c)(1)(D)(i) of FSMA). Any exemption or modification is limited to small and very small businesses (section 103(c)(1)(D)(ii) of FSMA).
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