PGA Regulatory Agendas List Rules Requiring Registration for Drug Importers, Revising SIMP

Regulatory agencies involved in trade again added relatively few new rulemakings to their regulatory agendas for spring 2023, but FDA, the Food Safety and Inspection Service, the National Oceanic and Atmospheric Administration and the State Department all included new proposed rules or moved forward existing rulemakings that could affect imports.

A new FDA proposal would establish registration and good importing practice requirements for commercial importers of drugs. Beyond importer registration requirements, the proposal would also require drug importers to establish a quality management system, conduct risk evaluations of drugs and suppliers, and perform shipment verifications, investigations, corrective actions and records maintenance.

Another new FDA rule would require the front of food labels to display nutrition information, in addition to existing nutrition facts labeling requirements. The proposal would “help address the epidemic of diet-related chronic disease by, among other things, empowering consumers with nutrition information to help them more easily identify healthier choices and encouraging industry innovation to produce healthier foods,” FDA said.

The State Department is returning to its agenda a proposed rule that would “revise procedures and requirements for filing import documentation for shrimp and products from shrimp” via ACE, and update the tariff schedule numbers to which form DS-2031 applies. The rule had been moved to State’s long-term actions list in fall 2022, though it had appeared regularly on the agency’s agenda for years before that.

A NOAA proposed rule issued in December (see 2212270034) that would expand Seafood Import Monitoring Program requirements to cover additional species, as well as amend the SIMP regulations to clarify the responsibilities of the importer of record, is being moved to the final rule stage in NOAA’s regulatory agenda.

Also moving forward to the final rule stage is a USDA Food Safety and Inspection Service proposal that would “define the conditions under which the labeling of meat, poultry, and egg products, as well as voluntarily-inspected products, can bear voluntary statements indicating that the product is of United States (U.S.) origin,” that agency said.