Companies in the food industry can breathe a sigh of relief when it comes to complying with the Food Safety Modernization Act (FSMA). In light of the then-impending (and now passed) July 3 effective date for certain provisions of the FSMA, the FDA notified certain food industry trade associations that it will delay enforcement of these provisions until after it has adopted final regulations to implement them.

More specifically, with respect to sections 103 and 301 of the FSMA, FDA wrote that it will be issuing proposed rules implementing those sections and “will expect to enforce compliance with these new FSMA requirements in timeframes that will be described in the final rules.” Given that FDA has not issued proposed rules, and there will be a public comment period before any final rules are adopted, it appears enforcement will be delayed for some time.

As noted in a prior Alert, Section 103 relates to hazard analysis and risk-based process controls (HARBPC) and requires a food facility to “evaluate the hazards that could affect food manufactured, processed, packed, or held” by the facility, to “identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards,” to “monitor the performance of those controls,” and to “maintain records of this monitoring as a matter of routine practice.” Section 103 expressly requires the facility to prepare a written plan analyzing the potential hazards and identifying the preventive controls adopted to address them. It also requires the facility to re-analyze potential hazards whenever there is a significant change in operations or every three years at a minimum. Finally, Section 103 requires the facility to maintain records of at least the following: (1) monitoring of the preventive controls implemented; (2) instances of non-conformance material to food safety; (3) testing and other appropriate means of verification; (4) instances when corrective actions were implemented; and, (5) the efficacy of preventive controls and corrective actions. The facility must retain the records for at least two years.

Section 301, titled “Foreign Supplier Verification Program,” requires each importer of food into the US to “perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported” complies with US law. Section 301 requires the FDA to issue guidance and promulgate regulations that require an importer’s verification program to “provide the same level of public health protection as those required” under Section 103 (discussed above) and another section of the FSMA. It also identifies potential verification activities that can be required, including (1) monitoring records for shipments, (2) lot-by-lot certification of compliance, (3) annual on-site inspections, (4) checking the foreign supplier’s HARBPC plan, and (5) periodically testing and sampling shipments. Again, the FSMA requires that importers maintain records of their verification program, retain them for at least two years, and make them available to FDA upon request.

A copy of one of the FDA’s letters to a trade association can be found here.