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ITDS, Food Facilities, Defense Exports Among Topics of Upcoming Rules

Tuesday, May 31, 2016
Sandler, Travis & Rosenberg Trade Report

Readying for deployment of the International Trade Data System, electronic registration for food facilities and modifying regulations on defense exports are among the topics of proposed and final regulations set forth in the semiannual regulatory agendas recently issued by a number of federal agencies, including the departments of State, Justice, the Interior and the Treasury and the Food and Drug Administration. These online resources list the following regulations affecting international trade that could be issued within the next year. The expected timeframes for issuance of the rules are indicated in parentheses.

- a Fish and Wildlife Service proposed rule revising the general permitting regulations, primarily to increase fees for applying for permits that allow otherwise prohibited activities under the Lacey Act, the Convention on International Trade in Endangered Species of Wild Fauna and Flora, and other laws (May; previously December 2015)

- a Drug Enforcement Administration proposed rule to update regulations for the import and export of controlled substances and listed chemicals to allow for the implementation of the International Trade Data System (May; previously January)

- a Food and Drug Administration final rule requiring food facilities to submit registrations in an electronic format and codifying the requirement for facilities to renew their registrations every two years (June; unchanged)

- an FDA final rule allowing for the inclusion of certain stand-alone symbols in the labeling of medical devices (June; previously March)

- 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 Import List, the International Traffic in Arms Regulations and the Commerce Control List (July; previously December)

- an FWS proposed rule to rewrite a substantial portion of the regulations on the importation, exportation and transportation of wildlife, including changes to the port structure and inspection fees (July; previously February)

- a State Department final rule amending the ITAR to update the definitions of “defense services,” “technical data” and “public domain;” create a definition of “product of fundamental research;” revise the definition of “export” to stipulate that the electronic transmission of unclassified technical data abroad is not an export provided the data is sufficiently secured to prevent access by unauthorized parties; and create a new exemption to allow for the electronic storage of unclassified technical data abroad provided it is secured to prevent access by unauthorized parties (August; previously May)

- an FDA proposed rule to remove essential use exemptions from the ban on ozone-depleting substances for sterile aerosol talc administered intrapleurally by thoracoscopy for human use, metered-dose atropine sulfate aerosol human drugs administered by oral inhalation, and anesthetic drugs for topical use on accessible mucous membranes of humans where a cannula is used for approved versions that contain ODSs (August; not previously published)

- an Alcohol and Tobacco Tax and Trade Bureau final rule updating and reissuing the regulations pertaining to minimum manufacturing, marking and importer permit requirements for tobacco products and cigarette papers and tubes (September; unchanged)

- an FDA final rule establishing user fees for the accreditation of third-party auditors under the Food Safety Modernization Act (November; proposed rule published in July 2015)

- a State Department final rule amending the ITAR to clarify the requirements for the licensing and registration of U.S. persons providing defense services while in the employ of foreign persons (January 2017; previously December 2015)

- a State Department proposed rule that would establish procedures addressing how individuals and entities can request reconsideration of their sanctioned status pursuant to certain sanctions programs related to Iran, weapons proliferation and terrorism (January 2017, previously March 2016) 

- a State Department final rule revising the licensing exemption for exports made to or on behalf of a U.S. government agency (January 2017)

- an FWS rule finalizing prohibitions on imports of 201 salamander species (January 2017; interim rule published in January)

- an FDA proposed rule establishing a requirement for foreign establishment registration and listing for manufacturers of tobacco products (March 2017; previously September 2016)

- an FDA final rule on gluten-free labeling of fermented or hydrolyzed foods (April 2017; proposed rule published in November 2015)

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