Certain establishments that are not required to register under section 415 of the FD&C Act conduct nonclinical laboratory studies in animals to support applications for research or marketing permits for products regulated by FDA, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. These establishments must comply with Good Laboratory Practice regulations already in place in part 58 (21 CFR part 58), which include certain food safety measures. For example, SEC 58.45 states "there shall be storage areas, as needed, for feed, bedding, supplies, and equipment. Storage areas for feed and bedding shall be separated from areas housing the test systems and shall be protected against infestation or contamination. Perishable supplies shall be preserved by appropriate means." In addition, SEC 58.90(g) states "feed and water used for the animals shall be analyzed periodically to ensure that contaminants known to be capable of interfering with the study and reasonably expected to be present in such feed or water are not present at levels above those specified in the protocol . . ."
Finally, while establishments that are not required to register under section 415 of the FD&C Act would not need to comply with the proposed rule, they would still be subject to the adulteration provisions of section 402 of the FD&C Act.
2. Proposed SEC 507.5(b)--Exemption Applicable to Animal Food Subject to SEC 500.23 and Part 113-Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
Section 418(j)(1)(C) of the FD&C Act provides that section 418 of the FD&C Act shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, "[t]he Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the [FDA] (or any successor standards)." (The Agency interprets "Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards" to mean the requirements of SEC 500.23 and part 113. Section 500.23 establishes that part 113 also applies to food for animals.) Importantly, section 418(j)(2) of the FD&C Act limits the express exemption associated with SEC 500.23 and part 113 to microbiological hazards that are regulated under SEC 500.23 and part 113 (or any successor regulations). FDA considers the language of section 418(j)(1)(C) of the FD&C Act to be ambiguous with regard to application of the exemption. The language of section 418(j)(1)(C) exempts a facility from section 418 of the FD&C Act if the owner, operator, or agent in charge of the facility is required to comply with, and is in compliance with, SEC 500.23 and part 113 "with respect to such facility[.]" However, SEC 500.23 and part 113 do not apply to "facilities," establishments, or plants. Rather, they apply to the specified foods (low-acid canned foods) and to persons defined as "commercial processors" who conduct certain activities involving those foods. See, e.g., SEC 113.3(d) (definition of "Commercial processor"), and section 404 of the FD&C Act (21 U.S.C. 344), which provides FDA with legal authority to issue SEC 500.23 and part 113 ("[The Secretary] shall promulgate regulations providing for the issuance, to manufacturers, processors, or packers of such class of food [presenting specific risks defined in the section] in such locality of permits to which shall be attached such conditions governing the manufacture, processing, or packaging of such class of food . . ."). Thus, it is unclear for purposes of section 418(j)(1)(C) under what circumstances a low-acid canned food processor is required to comply with SEC 500.23 and part 113 "with respect to [a] facility," especially when such a person also conducts activities involving other foods not subject to SEC 500.23 and part 113 at the same facility.