Laboratory Accreditation for Analyses of Foods

The American Frozen Food Institute (AFFI) appreciates the opportunity to provide comments on the Food and Drug Administration's (FDA) proposed rule Laboratory Accreditation for Analyses of Foods under the FDA Food Safety Modernization Act (FSMA). As the voice of the U.S. frozen food industry, AFFI is the national trade association that represents the interests of all segments of the frozen food industry. AFFI members manufacture and distribute frozen foods throughout the United States and globally. AFFI represents a broad group of companies throughout the food distribution chain, including food producers, distributors, and retailers. AFFI and its members supported the passage of FSMA and have been working for nearly a decade to ensure effective and practical implementation of the law to improve food safety. We appreciate the importance of ensuring accurate and reliable food and environmental test results and the significance of such to ensuring food safety. We also recognize the need for FDA to carry out the mandate in Section 202 of FSMA (Section 422 of the Federal Food, Drug, and Cosmetic Act (FFDCA)) and establish a program for the testing of food by accredited laboratories. We have reviewed the proposed rule and have substantial concerns with the agency's proposal that it be able to issue "food testing orders" whereby certain product and environmental testing would need to be conducted by an accredited lab and the testing results sent to FDA. This proposal raises significant legal, policy, and practical concerns. Due to the lack of dialogue between the agency and the food industry regarding this proposed tool, as well as the significant legal concerns, open questions, and lack of clarity as to how it will function, we recommend the agency remove the provision related to food testing orders from the final rule. Alternatively, the agency should issue a supplemental proposed rule to cure the legal and policy issues surrounding this proposal and provide an opportunity for meaningful input by the industry. We share our concerns in greater detail in the attached comments.