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

Monday, June 09, 2014
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.

- a Fish & Wildlife Service 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 (June)

- a final rule establishing conditions under which a license from the Directorate of Defense Trade Controls is not required for the export or reexport of defense articles incorporated into an end-item that is subject to the Export Administration Regulations (June)

- a State Department final rule updating policies regarding exports of replacement parts and components (June)

- a State Department final rule updating the International Traffic in Arms Regulations regarding defense services, clarifying the scope of activities considered a defense service, and providing definitions of various terms (June)

- a Food and Drug Administration supplemental proposed rule requiring certain facilities to establish and implement hazard analysis and risk-based preventive controls for animal food, including ingredients and mixed animal fee (July)

- an FDA supplemental proposed 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 (July)

- an FDA supplemental proposed 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 (July)

- an FDA supplemental proposed rule 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. (July)

- an FDA final rule allowing for the inclusion of certain stand-alone symbols for medical devices (August)

- an FWS 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 (August)

- 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 August)

- a CPSC final rule amending the regulations on information disclosure to the public (rule expected to be sent to CPSC in September)

- 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 (September)

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

- an FDA proposed rule defining and implementing certain conditions under which compounded products may qualify for exemptions from certain requirements (October)

- a proposed rule updating and clarifying policy related to exports made by or for a U.S. government department or agency (October)

- a proposed rule to require temporary import licenses only for those defense articles enumerated on the U.S. Munitions List-Import (October)

- a proposed rule to clarify the requirements for compliance with the Arms Export Control Act and the ITAR with regard to the maintenance of records and, when requested, the provision of such records to DDTC (October)

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

- a State Department interim final rule addressing how individuals and entities can request reconsideration of their sanctioned status pursuant to certain sanctions programs related to Iran, weapons proliferation and terrorism (December)

- a CPSC final rule clarifying certificate of compliance requirements in light of new rules on testing and labeling and component part testing and requiring electronic certificates to be filed at the time of entry for imported products (rule expected to be sent to CPSC in December)

- an FDA final rule establishing requirements to ensure the sanitary transportation of human and animal food (March 2016)

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