Import/Export Regulatory Plans Outlined by FDA, USDA, EPA
Several agencies with a hand in import/export regulation issued their plans for new regulations in the Fall 2013 Unified Agenda. The Food and Drug Administration is planning to issue proposed and final rules on food and drug facility registrations and sanitary transport of food in 2014. The Agriculture Department’s Animal and Plant Health Inspection Service is set to propose a fee hike for agricultural quarantine and inspection services at ports of entry. The Environmental Protection Agency will propose changes to its regulations on import and export of hazardous materials, and will finalize regulations on composite wood formaldehyde emissions and exports of cathode ray tubes.
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
FDA to Issue Rules on Facility Registration, Sanitary Transport of Food
The Food and Drug Administration this year plans to issue a final rule on drug establishment registration requirements, according to its entry in the Unified Agenda. The rule will “reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list human drugs, certain biological drugs, and animal drugs,” and will contain information on “when, how, and where to register drug establishments and list drugs, and what information must be submitted,” says FDA. A proposed rule on drug establishment registration was issued in 2006, but a final version has been absent from recent FDA regulatory plans.
A proposed rule to clarify food facility registration is still in the pipeline as well, says FDA’s plan. The proposal would clarify “information required in food facility registrations, the authority for FDA to require registrations to be submitted in an electronic format, requirements for biennial registration of food facilities, and certain definitions related to food facility registration, including the term "retail food establishment." The Spring 2013 Unified Agenda scheduled a proposed rule on the subject for December 2013, but FDA missed its internal deadline. The Fall 2013 Unified Agenda now says a proposed rule will come out in April.
FDA’s proposed rule under the Food Safety Modernization Act to establish requirements for shippers and carriers engaged in the transportation of food is planned for January. That would meet a deadline set by the Northern California U.S. District Court, which ordered FDA to issue its sanitary transport proposal by Jan. 31 (see 13081418).
APHIS Set to Increase Agricultural Quarantine and Inspection Fees
The Agriculture Department’s Animal and Plant Health Inspection Service plans to issue a proposed rule to adjust user fees for agricultural quarantine and inspection services performed at ports of entry. According to the Unified Agenda, the proposed rule is set to come out in April. The proposal would add new fee categories and adjust current fees for services provided for commercial vessels, trucks, railroad cars and aircraft, as well as international passengers, arriving at ports within U.S. customs territory. It would also adjust fee caps for commercial vessels, trucks, and railcars. The Government Accountability Office in March 2013 urged APHIS to raise its agricultural quarantine and inspection fees to cover increasing costs (see 13030601).
EPA to Propose Hazmat Import-Export Changes
Anticipated trade-related rulemakings at the Environmental Protection Agency include revisions to regulations on the import and export of hazardous waste. The proposed rule, scheduled in the Unified Agenda for October 2014, would make existing export- and import-related requirements more consistent with the current Organization for Economic Cooperation and Development standards. It would also enable electronic submission of all export- and import-related documents like export notices and annual reports, and would enable electronic validation of export shipment data prior to exit, said EPA.
Meanwhile, EPA is set to finalize its standards for formaldehyde emissions in composite wood products. The Unified Agenda says EPA is scheduled to issue its final rule on formaldehyde emissions in September. The proposed rule came out in June 2013 (see 13060715). The agency is also scheduled to issue its final rule on cathode ray tube export requirements, which was originally proposed in 2012 (see 12031611).