Background

A new rule on the Food and Drug Administration’s foreign supplier verification program as well as proposed and final rules on topics such as the International Trade Data System, import and export procedures, and food facility registrations are among the regulations set forth in the semiannual regulatory agendas recently issued by a number of federal agencies. These online resources list the following regulations affecting international trade that could be issued within the next year, with the expected timeframes indicated in parentheses.

Upcoming Regulations

- a State Department proposed rule to provide for the filing of trade documents for shrimp and shrimp products in the ITDS (November 2018; previously October)

- a Food and Drug Administration final rule requiring certain data elements to be submitted to the FDA and U.S. Customs and Border Protection for veterinary devices (November 2018; previously October)

- a Fish and Wildlife Service proposed rule to revise the regulations on the importation, exportation, and transportation of wildlife to adapt to the ITDS, clarify prior notification requirements and clearance refusal options, and add the ability for FWS to offer a conditional release of certain wildlife to coordinate release activities under ITDS (December 2018; previously June)

- FDA rules that would remove requirements that apply to importers of food for humans (final rule scheduled for December 2018; previously November) and animals (proposed rule scheduled for December 2018; first time published) concerning requirements to obtain written assurance from the customer that identified hazards will be controlled

- an FDA final rule on gluten-free labeling of fermented, hydrolyzed, or distilled foods (December 2018; unchanged)

- an FDA proposed rule revising requirements that apply to produce that satisfies criteria for an exemption from the produce safety rule because the produce will receive commercial processing to adequately reduce the presence of microorganisms of public health significance (December 2018; first time published)

- an FDA proposed rule to streamline provisions requiring disclosure to commercial customers and receipt of written assurances from commercial customers in the foreign supplier verification program (December 2018; first time published)

- a proposed rule from the Justice Department’s Bureau of Alcohol, Tobacco, Firearms, and Explosives to replace the term “specifically designed” with the term “specially designed” in 27 CFR Part 447 to make terminology consistent among the U.S. Munitions Import List, the International Traffic in Arms Regulations, and the Commerce Control List (April 2019; previously December 2018)

- an FDA proposed rule to make clarifying changes to the general provisions related to the registration of food facilities rule (April 2019; unchanged)

- a Federal Maritime Commission proposed rule to revise the regulations on the filing, review, and monitoring of ocean common carrier and marine terminal operator agreements (May 2019)

- a State Department final rule clarifying when exports may be made to or on behalf of a U.S. government agency without a license and expanding this exemption to allow for permanent exports (August 2019; previously May 2018)

- a proposed rule from the Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau to amend the regulations on the exportation of distilled spirits, wine, beer, and tobacco products to update export procedures and implement the ITDS (September 2019; previously September 2018)

Rulemakings Removed

The following appear to have been removed from the associated regulatory agendas.

- an FWS proposed rule to (a) add a definition of “shellfish and fishery products” to the regulations that govern the importation, exportation, and transportation of wildlife and (b) revise the regulations regarding the exemption from import/export license requirements for certain shellfish and fishery products

- a State Department final rule clarifying the requirements for the licensing and registration of U.S. persons providing defense services while in the employ of foreign persons

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