Regulatory Agencies Outline Plans for Import-Export Regulations

Among the deregulatory actions in FDA’s agenda is a proposed rule set for 2018 that would remove “written assurance” requirements from Food Safety Modernization Act regulations on preventive controls and Foreign Supplier Verification Programs. Currently, a manufacturer or importer does not have to control a food safety hazard (or perform standard supplier verification activities required in FSVP for importers) if it gets written assurance that a downstream customer will address it. Though the proposed rule would leave in place a requirement “to provide documentation that the food has not been processed to control the identified hazard,” the manufacturer or importer “would no longer be required to obtain written assurance from the customer that the identified hazard will be controlled,” FDA said.

FDA also plans to issue a direct final rule requiring certain data elements be submitted in ACE for imports of veterinary devices. “This rule ensures that the regulations on import submissions for veterinary devices are the same as for all other FDA regulated products,” FDA said. A proposed rule planned for 2018 would implement FDA’s authority to suspend the registration of food facilities that handled unsafe food. The agency also revived previously existing plans to create a requirement for owners or consignees to label imported food that is refused entry into the U.S. as "UNITED STATES: REFUSED ENTRY,” and to establish standards for state licensing of third-party logistics providers under the Drug Supply Chain Security Act.

The Department of Agriculture is apparently reviving plans to issue several regulations that had been mentioned in previous regulatory agendas but were omitted from the Spring 2017 version. USDA’s Animal and Plant Health Inspection Service intends to finalize revisions to its plant pest regulations and its rules on importation of plants for planting. APHIS also plans to issue a final rule amending its bovine spongiform encephalopathy and scrapie regulations on importation of small ruminants. APHIS and FSIS continue to list regulations they plan to issue on Lacey Act exemptions for products containing small amounts of plant matter or composite plant materials, and importation of poultry slaughtered in China, respectively.

The Commerce Department’s regulatory agenda includes more information on plans for the Commerce Trusted Trader Program for importers of high-risk seafood. The program will “reduce the burden on importers by reducing the reporting requirements” that take effect Jan. 1, 2018, under the Seafood Import Monitoring Program (see 1612080014), and “allowing more flexible approaches to keep supply chain records,” it said. “The costs of the Commerce Trusted Trader Program will be minimal in that applicants to the program will have a small application fee and will incur the costs for an independent audit of several entries on an annual basis,” Commerce said. “Benefits of Trusted Trader status will include reduced reporting costs at entry and reduced recordkeeping costs due to flexibility in archiving.”

The Consumer Product Safety Commission shelved its immediate plans to issue new safety standards for table saws and magnet sets, moving each regulation to its list of long-term actions. Listed on CPSC’s active agenda are proposed standards for all-terrain vehicles, crib bumpers, gates and stationary activity centers. CPSC said it intends to issue final rules on safety standards for fireworks, infant bouncer seats, high chairs, infant inclined sleep products, baby changing products, booster seats and residential garage door openers.