FDA also requests comment on whether more detail would be appropriate, by, for example:
* Requiring that the supplier approval and verification program include a written list of approved suppliers;
* Requiring that, in determining appropriate verification activities, the owner, operator, or agent in charge of a facility consider relevant regulatory information regarding the supplier, including whether the raw material or ingredient is the subject of an FDA warning letter or import alert relating to the safety of the animal food.
* Specifying circumstances when a supplier approval and verification program would not be required, e.g., when the preventive controls at the receiving facility are adequate to significantly minimize or prevent each of the hazards the receiving facility has identified as reasonably likely to occur; or when the receiving facility obtains from its customer written assurance that the customer has established and is following procedures that will significantly minimize or prevent the hazard.
* Specifying that the type of verification activity be linked to the seriousness of the hazard, e.g., whether to:
* Require an onsite audit when there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals;
* Provide more flexibility with respect to hazards for which there is not a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals, e.g., periodic onsite audits, periodic or lot-by-lot sampling and testing of the raw material or ingredient, and periodic review of the supplier's animal food safety records;
* Specifying requirements for audits, e.g., the qualifications (including training, experience, and conflict of interest) for persons who conduct audits; content of an audit (such as compliance with applicable animal food safety regulations and, when applicable, compliance with a facility's food safety plan);
* Specifying the frequency of verification activities (e.g., initially, annually, or periodically);
* Specifying whether, for some hazards, it will be necessary to conduct more than one verification activity to provide adequate assurances that the hazard is significantly minimized or prevented;
* Providing for alternative requirements if a supplier is a qualified facility, e.g., documenting that the supplier is a qualified facility and obtaining written assurance that the supplier is producing the raw material or ingredient in compliance with sections 402 of the FD&C Act;
* Specifying those records that would be appropriate for a supplier approval and verification program;
* Providing for substitution of a regulatory inspection (e.g., by FDA or a comparable State regulatory agency or foreign animal food safety authority), for an onsite audit; and
* Specifying that a receiving facility take appropriate action (e.g., discontinuing use of a supplier) if the facility determines that the supplier is not controlling hazards that the receiving facility has identified as reasonably likely to occur.
is aware that many firms that could be affected by supplier verification may be importing their ingredients. The Agency believes that these firms are interested in how a supplier verification component of preventive controls will interface with the regulations FDA is required to implement foreign supplier verification under new section 805 of the FD&C Act (21 U.S.C. 384a). Section 805 requires FDA to issue regulations to require importers to implement foreign supplier verification programs (FSVPs) that are adequate to provide assurances that the importer's foreign suppliers produce food, including animal food, in compliance with processes and procedures, including risk-based preventive controls, that provide the same level of animal and human health protection as those required under section 418 (concerning hazard analysis and preventive controls) of the FD&C Act, and in compliance with section 402 (concerning adulteration) of the FD&C Act.
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