FDA, USDA List Plans for 2016 Trade Regulations in Fall Unified Agenda
Federal agencies with a hand in regulating trade listed their plans for issuing new regulations in the Fall 2015 Unified Agenda (here). New rules from FDA would amend labeling requirements for animal drugs, finalize changes to food facility registration requirements and continue to implement the Food Safety Modernization Act. Upcoming rules from the Agriculture Department are set to affect genetically engineered foods and labeling of meat products.
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FDA’s FSMA Rules Continue Apace, But Third-Party Auditor Fee Rule Delayed
The Food and Drug Administration’s Fall 2015 regulatory agenda (here) lists several new rulemaking actions, including new labeling requirements for animal drugs and a system for accreditation of laboratories performing analysis, with proposed rules coming in June and August, respectively. The agency will also amend performance standards for laser products it proposed in 2013, issuing a "reproposal" in July in order to “achieve closer harmonization between the current standard and the recently amended International Electrotechnical Commission (IEC) standard for laser products and medical laser products.”
Included in the agency’s plans for the first time since 2011 is a final rule, scheduled for August 2016, that would allow requests to establish or amend tolerances for unapproved new animal drugs in imported meat, providing “a basis for legally marketing food of animal origin that is imported into the United States and contains residues of unapproved new animal drugs.” A rule finalizing new requirements for food facility registration, proposed in April 2015 (see 1504080017), is scheduled for June 2016. The proposed rule included new notification and confirmation procedures for U.S. agents of foreign food facilities, meant to address concerns that the U.S. agents are often unaware of their role and increased liability for fees assessed on their foreign facilities.
Final rules required by the Food Safety Modernization Act on sanitary transportation of food and measures to prevent intentional adulteration of food are scheduled for March 31 and May 31, respectively, in time to meet deadlines imposed by federal court (see 14022124). However, despite agency plans to begin its Voluntary Qualified Importer Program in 2017 (see 1503260014), a final rule setting user fees for FDA’s accreditation system for third-party auditors moved to the “long-term actions” section of its regulatory agenda, with a final rule not scheduled until November 2016. An industry lawyer recently said the user fee final rule must be published before FDA can launch the accreditation system (see 1511190058).
USDA Agenda Includes New Rules on Importing GE Foods, Nutrition Labels for Meat
The regulatory agenda for the Animal Plant Health Inspection Service, included under the Department of Agriculture (here), lists a new rulemaking on the importation and interstate movement of genetically engineered organisms, in an effort to develop a “more focused, risk-based regulation of GE organisms that pose plant pest or noxious weed risks” and “implement regulatory requirements only to the extent necessary to achieve the APHIS protection goal.” The agency’s regulatory agenda says a notice of intent to prepare an environmental impact statement is coming in November, with actual proposed regulations on GE organisms coming in July 2016. Meanwhile, APHIS’ Fall 2015 plan again kicks the can down the road on its long-anticipated final rule removing the exemption from treatment and marking requirements for wood packaging materials from Canada, scheduling a final rule in March 2016 (from May 2015 in the Spring 2015 agenda).
Another branch of USDA, the Food Safety and Inspection Service, lists a new rulemaking to modify nutrition facts labels for meat and poultry products, in part to update daily reference values, with a proposed rule coming in March. Another new proposed rule, also due in March, would make Honduras eligible to export poultry to the United States. A final rule providing for an electronic export application and certification system and associated user fees is still scheduled for December, as it was in the Spring 2015 agenda.
FWS Rewrite of Import-Export Regs, Permit Fee Hikes Again Listed in Agenda
The Fish and Wildlife Service (here) continues to include several proposed rules on its regulatory agenda that have long been listed without any agency action. A rewrite of the FWS regulations on importation, exportation and transportation of wildlife is scheduled to be issued as a proposed rule in May, after three years on the agency agenda, as is a proposal to increase permit fees and procedures for the Lacey Act, CITES and other programs. An overhaul of FWS seizure and forfeiture procedures, listed in the agency’s regulatory agenda since the mid-90s, is also scheduled for publication in May.
CPSC Lists New Safety Standards, Rule on Voluntary Recalls
Finally, through its general import rulemakings on certificates of compliance and sampling are on hold, the Consumer Product Safety Commission is planning to set a series of mandatory safety standards on off-road vehicles, infant sling carriers, infant bath tubs, phthalates and hook-on chairs, it said (here). The agency also lists a controversial rule on voluntary recalls, which could make corrective action plans legally binding (see 13112028), for a final vote in September.