Review of Existing Center for Food Safety and Applied Nutrition Regulatory and Information Collection Requirements

The American Frozen Food Institute (AFFI), on behalf of its member companies, appreciates the opportunity to provide comments in response to the Food and Drug Administration's (FDA's) request for assistance identifying regulations that could be modified, repealed, or replaced to achieve a meaningful burden reduction while allowing the agency to achieve its public health mission and fulfill statutory obligations. FDA regulatory reform efforts have the potential to remove unnecessary regulatory barriers from businesses of all sizes while continuing to achieve the same level of public health protection. As FDA evaluates regulatory programs and considers reforms, AFFI has identified several regulatory programs and specific policies for review: Because it is not supported by the scientific evidence, FDA should reconsider its zero-tolerance regulatory action limit for Listeria monocytogenes (Lm) for foods that do not support the growth of the pathogen. FDA should make significant revisions to the Draft Guidance for Industry: "Hazard Analysis and Risk-Based Preventive Controls for Human Food" (PCHF). As written the document will become a prescriptive set of expectations that could be enforced like a regulation. This guidance should not be interpreted to limit industry's options for complying with the PCHF rule. Specifically, the content and application of Appendix 1, should be withdrawn pending substantial revisions and reissue it in draft form. FDA should revise final rule "Mitigation Strategies to Protect Food Against Intentional Adulteration" to maximize public health protection while minimizing unnecessary costs. FDA also should extend the compliance date for the Intentional Adulteration rule to allow for stakeholder engagement on this issue and adequate time for training and implementation of the rule. With respect to written disclosures in the PCHF regulations, FDA should provide additional flexibility through guidance regarding the appropriate methods for making the disclosure and the wording of the disclosure. The FDA should also recognize that a company can justify not making a disclosure in certain circumstances. While we appreciate FDA's recent decision to provide regulatory discretion with respect to written assurances in the PCHF regulations, we believe FDA should rescind these provisions. The goal of ensuring that the recipient of a food understands the need for further processing can be achieved through a more thoughtful written disclosure - i.e., if FDA increases the flexibility for the disclosure to ensure that it reaches the appropriate personnel, there will be no need for a written assurance. FDA should revise the Supply Chain Program requirements in Subpart G of the Preventive Controls for Human Food rule to allow brand owners to conduct supplier verification on behalf of their contract manufacturers to eliminate duplicative requirements. FDA should continue to collaborate with industry to better understand the types of activities regularly performed on human food by-products that are used in animal food, as well as typical storage and handling practices for such by-products. Using this information, FDA should issue supplemental guidance clarifying that the regulations should be interpreted in the context of safety for animal food, not human food, to ensure that industry may continue existing practices that pose no or negligible risk to animal food. FDA should extend the nutrition labeling compliance date until January 1, 2020. FDA also should consider granting an additional extension once the agency has a better sense of timing for the bioengineered food disclosure statement and final guidance on the nutrition labeling rules. Extending the compliance timeline should not deter individual companies from rolling out the new labels prior to the deadline. FDA should make several revisions to the Draft Guidance "Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in…