* Contact information;
* Facility type;
* Hazards identified for each product;
* Preventive controls established for each of the identified hazards;
* Third-party audit information (have you had one and which audit firm(s));
* Preventive control employee training conducted;
* Facility size (square footage);
* Full time operation or seasonal;
* Operations schedule.
This information could be submitted at the same time as facility registration and updated biennially simultaneously with the required biennial update of the food facility registration. FDA requests comment on the utility and necessity of such an approach and on the specific types of information that would be useful in developing a facility profile. The Agency also requests comment on any additional benefits that might be obtained from using such an approach and any potential concerns with this approach.
The Agency has previously announced an opportunity for public comment on the proposed collection of additional food facility profile information on a voluntary basis from firms that complete the FDA food facility registration process (77 FR 27779,
XI. Proposed Subpart D--Withdrawal of an Exemption Applicable to a Qualified Facility
A. Requirements of Section 418 of the FD&C Act
Section 418(l)(3)(A) of the FD&C Act specifies that, in the event of an active investigation of a foodborne illness outbreak that is directly linked to a qualified facility subject to an exemption under section 418(l) of the FD&C Act, or if the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a qualified facility that are material to the safety of the food manufactured, processed, packed, or held at such facility, the Secretary may withdraw the exemption provided to such facility under section 418(l) of the FD&C Act. Section 418 does not expressly prescribe the procedures for withdrawing an exemption provided to a qualified facility under section 418(l). The Agency tentatively concludes that it is appropriate to be transparent about the process it would use to withdraw an exemption and that the Agency should include the process in the proposed rule.
B. Proposed SEC 507.60--Circumstances That May Lead FDA To Withdraw an Exemption Applicable to a Qualified Facility
1. Proposed SEC 507.60(a)--Withdrawal of an Exemption in the Event of an Active Investigation of a Foodborne Illness Outbreak
Proposed SEC 507.60(a) would provide that FDA may withdraw the exemption that would be applicable to a qualified facility under proposed SEC 507.5(c) in the event of an active investigation of a foodborne illness outbreak that is directly linked to the qualified facility. Proposed SEC 507.60(a) would implement the statutory language of section 418(l)(3)(A) of the FD&C Act. An outbreak of foodborne illness is the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food (or exposure to a common food in the case of microbiological illness in humans from handling animal food.) Animal food can become contaminated at many different steps: On the farm; in packing, manufacturing/processing, or distribution facilities; during storage or transit; at retail establishments; and at the location of the animal. When foodborne illness is associated with food, a traceback investigation may enable FDA to directly link the illness to the facility or facilities that manufactured, processed, packed, and/or held the animal food. See section XIV.B.1 of the document for the proposed rule for preventive controls for human food (78 FR 3646) for a discussion of an FDA traceback investigation.
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