On June 21st, FDA released its latest regulatory agenda that outlines the agency’s plans for future rulemaking. Several of the items on the agenda will impact cold chain companies.
For the first time, the agency’s unified agenda includes a proposed rule, “Prior Notice of Imported Food,” that would require entities that import food into the United States to provide the name of the mail service and mail tracking numbers for their imported products as part of their so-called prior notice submissions. Companies that plan to import food into the United States are required to provide FDA with advance notice of the shipment so the agency and U.S. Customs and Border Protection can more effectively target import inspections more effectively and help protect that nation’s food supply against terrorist acts and other public health emergencies.
The agency’s proposed rule also would set up a timeframe for importers to submit information to FDA after the agency has refused or decided to hold their imported products. FDA also plans to clarify its process for exporting or destroying food if post-refusal and hold submissions are not submitted within a certain timeframe. FDA expects to publish the proposal by March 2023.
In addition, FDA plans to publish a proposed rule that would set up a certification process for entities that import food with known safety risks, as a way to ensure imported food complies with U.S. food safety requirements.
FDA also plans to finalize a rule that would establish additional recordkeeping requirements for facilities that manufacture, process, pack or hold high-risk foods. FDA released the proposed rule, “Requirements For Additional Traceability Records For Certain Foods,” in September 2020. Per a court order, the agency is required to publish the final rule by Nov. 7. FDA has listed November as the expected release date for the rule.
