As discussed in section VII.A.2, section 103(c)(1)(C) of FSMA requires that the Secretary conduct a science-based risk analysis of "(i) 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 animal foods; and (ii) 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 discussed in section VII.B, consistent with the requirements of section 103(c)(1)(C) of FSMA the Agency has conducted a qualitative risk assessment related to activity/animal food combinations for the purpose of determining which activity/animal food combinations would be considered low risk.
Section 103(c)(1)(D)(i) of FSMA requires that, in issuing the regulations under section 103(c)(1)(A), "the Secretary shall consider the results of the science-based risk analysis conducted under [section 103(c)(1)(C) of FSMA], and shall exempt certain facilities from the requirements in section 418 of the [FD&C Act] . . ., including hazard analysis and preventive controls, and the mandatory inspection frequency in section 421 of [the FD&C Act] . . . or modify the requirements in [sections 418 or 421 of the FD&C Act], as the Secretary determines appropriate, if such facilities are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities that the Secretary determines to be low risk involving specific foods the Secretary determines to be low risk." Section 103(c)(1)(D)(ii) of FSMA provides that "[t]he exemptions or modifications under section 103(c)(1)(D)(i) of FSMA shall not include an exemption from the requirement to register under section 415 of the [FD&C Act] . . . if applicable, and shall apply only to small businesses and very small businesses, as defined in the regulation promulgated under section 418(n) of the [FD&C Act]."
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