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Third-Party Testing Costs, ITDS Implementation Among Upcoming New Regulations

Thursday, June 04, 2015
Sandler, Travis & Rosenberg Trade Report

Reducing the costs of third-party testing of consumer products, readying for deployment of the International Trade Data System and implementing provisions of the Food Safety Modernization Act 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, the Food and Drug Administration and the Consumer Product Safety Commission. 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.

Upcoming Regulations

- 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 (June; previously 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 (June; previously December 2014)

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

- several State Department final rules modifying the International Traffic in Arms Regulations 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 (various; June through November)

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

- a Consumer Product Safety Commission proposed rule on ways to reduce the cost of third-party testing requirements (July; not previously published)

- a Department of Agriculture final rule exempting from assessments for promotion activities conducted under marketing order or research and promotion programs (a) certified organic commodities (those comprising at least 95 percent organic components) and (b) certified organic commodities that are produced, handled, marketed or imported by operations that also deal in conventional products (July)

- 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 (August, previously 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 (August, previously April)

- an FDA proposed rule setting forth the minimum current good manufacturing practice requirements for human drug products compounded by an outsourcing facility (July 2016)

- 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)

- a Drug Enforcement Administration proposed rule to allow for the implementation of the International Trade Data System with respect to the import and export of controlled substances and listed chemicals (November; not previously published)

- an FDA final rule establishing requirements for parties including shippers, motor and rail carriers, and receivers engaged in the transportation of food (including food for animals) to use sanitary transportation practices (March 2016)

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


- 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 was published in April but no timeline for a final rule has been established

- a CPSC final rule establishing guidelines for uniform information to be included in voluntary recall notices that firms provide as part of corrective action plans, which had been expected earlier this year, was not included in the most recent CPSC regulatory agenda

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