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Upcoming Regulations on Defense Exports, Wildlife Trade, Food Facilities, Product Safety

Friday, January 09, 2015
Sandler, Travis & Rosenberg Trade Report

Numerous federal agencies recently issued their semiannual regulatory agendas, which list proposed and final regulations affecting international trade that could be issued this year. Highlights of such rules from the departments of State, Justice and the Interior, the Food and Drug Administration and the Consumer Product Safety Commission include the following. Items newly added to the agendas are marked with an asterisk.

- a Fish and Wildlife Service proposed rule revising the general permitting regulations, primarily to propose increases in fees for applying for permits that allow otherwise prohibited activities under the Lacey Act, Convention on International Trade in Endangered Species of Wild Fauna and Flora, and other laws (November 2014)

- an FWS proposed rule rewriting a substantial portion of the regulations on the importation, exportation and transportation of wildlife, including changes to the port structure and inspection fees (December 2014)

- a Food and Drug Administration final rule allowing for the inclusion of certain stand-alone symbols for medical devices (December 2014)

- an FDA proposed rule to ban powdered natural rubber latex and powdered synthetic latex surgeon’s and patient examination gloves (December 2014)

- (*) a State Department proposed rule that would (a) update the definitions of defense services, technical data and public domain, (b) revise the definition of “export” to stipulate that the electronic transmission of unclassified technical data abroad is not an export provided that the data is sufficiently secured to prevent access by unauthorized parties, and (c) create a new exemption to allow for the electronic storage of unclassified technical data abroad provided that the data is secured to prevent access by unauthorized parties (January)

- a Consumer Product Safety Commission final rule establishing guidelines for uniform information to be included in voluntary recall notices that firms provide as part of corrective action plans (final staff briefing package expected in January)

- (*) a Bureau of Alcohol, Tobacco, Firearms and Explosives proposed rule replacing the term “specifically designed” with the term “specially designed” to align with terminology in the U.S. Munitions List, the International Traffic in Arms Regulations and the Commerce Control List (March)

- an FDA proposed rule requiring food facilities to submit registrations in an electronic format beginning in 2016 and codifying the requirement that facilities renew their registrations every two years (March)

- (*) proposed rules from the Alcohol and Tobacco Tax and Trade Bureau amending the regulations on the importation and exportation of distilled spirits, wine, beer and tobacco products to implement the International Trade Data System (April)

- (*) several State Department final rules modifying the ITAR and certain forms to remove any reference to paper-based processing to ensure that license technical data, manufacturing license and technical assistance agreements are submitted electronically (June)

- an FDA proposed rule setting forth the minimum current good manufacturing practice requirements for human drug products compounded by an outsourcing facility (July)

- an FDA final rule requiring certain facilities to establish and implement hazard analysis and risk-based preventive controls for animal food, including ingredients and mixed animal feed (August)

- an FDA final rule requiring food facilities to have and implement preventive controls to significantly minimize or prevent the occurrence of hazards that could affect food manufactured, processed, packed or held by the facility (August)

- an FDA final rule providing the owner or consignee of a drug that has been refused admission into the U.S. and is valued at $2,500 or less with written notice that FDA intends to destroy the drug before such action is taken (September)

- an FDA final rule establishing science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the FDA has determined that such standards minimize the risk of serious adverse health consequences or death (October)

- an FDA final rule on the foreign supplier verification program describing what a food importer must do to verify that its foreign suppliers produce food that is as safe as food produced in the U.S. (October)

- an FDA final rule establishing regulations for the accreditation of third-party auditors auditing foreign facilities to assist in ensuring the safety of imported food (October)

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