Proposed SEC 507.7(d) would enable consumers to contact the facility where an animal food was manufactured or processed (e.g., if the consumer identifies or suspects a food safety problem with a product) irrespective of whether the animal food product bears a label. The use of the term "business address" in section 418(l)(7) of the FD&C Act contrasts with Congress' use of a different term, "place of business," in section 403(e) of the FD&C Act (21 U.S.C. 343(e)). Section 403(e) provides that foods in package form are misbranded unless the product label bears the name and place of business of the manufacturer, packer, or distributor of the food. The Agency's regulations interpret "place of business" as requiring only the firm's city, state, and zip code to appear on the product label, as long as the firm's street address is listed in a current telephone directory or other city directory (21 CFR 501.5(d)). The Agency tentatively concludes that the use of the term "business address" in section 418(l)(7) demonstrates Congress' intent to require the facility's full address, including the street address or P.O. box, to appear on labels or other required notifications when the facility has opted to not submit documentation directed to food safety practices under section 418(l)(2)(B)(i)(I) of the FD&C Act. If Congress had considered the less complete address already required under section 403(e)(1) of the FD&C Act and the "place of business" labeling regulation ( SEC 501.5(d)) to be adequate for notification to consumers for animal foods required to bear labels, there would have been no need to impose a new, more specific requirement in section 418(l)(7) for the facility's "business address" to appear on the food label. When proposed SEC 507.7(d) would apply to an animal food for which a food packaging label is required under any other provision of the FD&C Act, the complete business address would substitute for the "place of business" required under section 403(e)(1) of the FD&C Act and SEC 501.5(d) and would not impose any requirement for a label that would be in addition to any label required under any other provision of the FD&C Act. The Agency asks for comment on this interpretation.
Proposed SEC 507.7(e) would require that a qualified facility maintain records relied upon to support the documentation that would be required by SEC 507.7(a). Proposed SEC 507.7(a) would not require that a qualified facility establish any new records, but merely retain those that the facility relied upon to support the documentation that would be required by proposed SEC 507.7(a). Proposed SEC 507.7(e) would establish that the records that a qualified facility must maintain are subject to the requirements of subpart F of part 507. As discussed in section XII, proposed subpart F would provide the general requirements that apply to all records required to be established and maintained by proposed part 507, including provisions for retention of records and for making records available for official review. Together, proposed SEC 507.7(a) and (b) would make the underlying records qualified facilities would rely on to support their self-certifications available to FDA upon request. The Agency tentatively concludes that it is appropriate to require that the records relied upon to support a self-certified statement be retained and made available to FDA upon request.