PGAs List New Regulations on Food Traceability, Steel Transshipment in Fall 2019 Unified Agenda

Partner government agencies list several new regulations on their lists of upcoming rulemakings in the Fall 2019 Unified Agenda. The Food and Drug Administration says it intends to propose new recordkeeping requirements for high-risk foods, and again lists proposed rules to revise written assurance requirements under its Food Safety Modernization Act regulations. The Fish and Wildlife Service intends to expand its list of ports designated for importation of wildlife, and the Commerce Department is set to modify its licensing requirements for steel imports to monitor transshipment through Canada and Mexico.

FDA Fall 2019 regulatory agenda now lists a proposed rule mandated by the Food Safety Modernization Act that would establish traceability recordkeeping requirements for certain foods. Under the proposal, FDA would establish additional recordkeeping requirements for food facilities that handle foods designated by FDA as high-risk. FDA is required by court order to issue the proposed rule by Sept. 8, 2020, according to a settlement with advocacy groups in the Northern California U.S. District Court. The final rule is now due by September 2022, at which time FDA will also issue its final list of high-risk foods. FSMA had set a 2013 deadline for the proposed rule.

FDA also lists a new proposal to allow importation of prescription drugs from Canada by pharmacists and wholesalers. That proposed rule is currently under review by the Office of Management and Budget (see 1911060008), and FDA says it should be issued in January 2020. Another newly listed proposal, set for publication in June 2020, would set new labeling requirements for animal drugs.

Again listed in FDA’s regulatory agenda are three proposed rules on written assurance requirements for importers under FSMA’s preventive control rules for human and animal food and Foreign Supplier Verification Program regulations. FDA said it wouldn’t enforce the requirements (see 1801040035), which had mandated written assurances from downstream customers that control food safety hazards. Under the proposals, “although that manufacturer/processor would still be required to provide documentation that the food has not been processed to control the hazard, that manufacturer/processor would no longer be required to obtain written assurance from the commercial customer that the hazard will be controlled,” FDA says.

FWS lists a new proposed rule that would expand the list of designated ports for the importation and exportation and wildlife to add the ports of Denver, Dulles, Erlanger, Fort Lauderdale, Norfolk, Philadelphia, Savannah and Tampa. “In addition, several ports currently listed as non-designated along the U.S./Canadian border and the U.S./Mexican border will be added to the list of designated ports,” FWS said. “Finally, the Service proposes 15 designated ports that will be authorized for the importation or exportation of live venomous reptiles.”

According to the U.S. Department of Agriculture’s agenda, the Animal and Plant Health Inspection Service expects to issue its final rule, now under OMB review, setting a de minimis exemption from Lacey Act declaration requirements by January 2020. APHIS had proposed the exemption in 2018 (see 1807060013). APHIS also plans to issue a final rule amending import requirements related to brucellosis and bovine tuberculosis in 2020 (see 1512150083), as well as a final rule on the importation and movement of genetically engineered organisms (see 1906050019).

Commerce listed a new proposal to modify its Steel Import Monitoring and Analysis system to require import license applicants to identify the country where steel used in the manufacture of an imported steel product was melted and poured. The proposal would prevent transshipment of steel products to take advantage of exemptions from Section 232 tariffs for Canada and Mexico. Commerce also intends to soon issue its final rule, currently under OMB review (see 1911060039), allowing the imposition of countervailing duties for currently undervaluation.

Commerce’s agenda also lists a new proposal from the National Marine Fisheries Service to “revise the regulatory definition of illegal, unreported, and unregulated (IUU) fishing under provisions of the High Seas Driftnet Moratorium Protection Act to include nations that engage in a pattern of IUU fishing activity in the exclusive economic zones of foreign nations.”