Background

Textile labeling, food import requirements, and countervailing duties on imported goods are among the topics of 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. They also list rulemaking proceedings that have been in process for some time and are not as likely to see further progress in the near term.

Upcoming Regulations

- a final rule from the Office of the U.S. Trade Representative updating the designations of World Trade Organization members eligible for special de minimis countervailable subsidy and negligible import volume standards under the countervailing duty law (July 2020; first time published)

- a Federal Trade Commission final rule to add seven generic fiber names to the Textile Rules (July 2020; proposed rule published in February 2020)

- a Fish and Wildlife Service proposed rule to (a) add the ports of Denver, Dulles, Erlanger, Fort Lauderdale, Norfolk, Philadelphia, Savannah, and Tampa to the list of designated ports authorized for the importation or exportation of wildlife, (b) add several ports along the borders with Canada and Mexico to the list of designated ports, and (c) authorize 15 ports for the importation or exportation of live venomous reptiles (July 2020; previously December 2019)

- a Food and Drug Administration final rule requiring certain data elements to be submitted in the Automated Commercial Environment for veterinary devices (July 2020; previously December 2019)

- FDA proposed rules to remove requirements that apply to importers of food for humans and animals concerning requirements to obtain written assurance from the customer that identified hazards will be controlled (July 2020; previously December 2019)

- a State Department final rule to amend the International Traffic in Arms Regulations to (a) create definitions for activities that are not exports, re-exports, or retransfers, (b) remove from ITAR licensing requirements the electronic transmission and storage of unclassified technical data via foreign communications infrastructure when the data is secured sufficiently to prevent access by foreign persons, and (c) create definitions for access information and revise the definition of release to include the improper provision of access information to foreign persons (July 2020; interim final rule published December 2019)

- an FDA final rule instituting procedures by which the FDA may (1) establish or amend tolerances for unapproved new animal drugs where edible portions of animals imported into the U.S. may contain residues of such drugs or (2) revoke an existing import tolerance (July 2020)

- a State Department proposed rule to provide for the filing of trade documents for shrimp and shrimp products in the International Trade Data System (September 2020; previously March 2020)

- an FDA proposed rule to establish additional recordkeeping requirements for facilities that manufacture, process, pack, or hold foods designated as high-risk (September 2020; unchanged)

- a Drug Enforcement Administration final rule adjusting the fees relating to the registration and control of the importation, exportation, manufacture, distribution, and dispensing of controlled substances and List I chemicals (September 2020; proposed rule published in March 2020)

- a State Department advance notice of proposed rulemaking on revising the definitions of “public domain” “technical data,” and “fundamental research” in the ITAR (September 2020)

- 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 (November 2020; previously March 2020)

- an FDA proposed rule to allow imports of certain prescription drugs from Canada under certain circumstances, including demonstration that the importation poses no additional risk to public health and safety (December 2020; previously January 2020)

- an FDA proposed rule to make clarifying changes to the general provisions related to the registration of food facilities rule (December 2020; previously April 2020)

- a State Department final rule revising and excluding entries in the U.S. Munitions List that do not warrant inclusion and adding entries for critical and emerging technologies that do warrant inclusion (December 2020)

- an FDA proposed rule to revise certain written assurance requirements that currently apply to importers of human or animal food under the foreign supplier verification program rule whey they identify hazards that require a control and the hazards are applied after importation (April 2021; previously July 2020)

Regulations Completed

- a Federal Maritime Commission final rule on demurrage and detention practices for imports and exports of containerized cargo

- an FMC final rule eliminating the essential terms publication requirement for vessel carriers

- a Federal Trade Commission proposed rule to prohibit marketers from including unqualified “made in USA” claims on labels unless specified conditions are met

Regulations Removed

- an FWS 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

Regulations in Process

- an FDA final rule on gluten-free labeling of fermented, hydrolyzed, or distilled foods (proposed rule published November 2015)

- a State Department final rule updating defense trade policy concerning several countries (interim final rule published September 2016)

- 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 ITAR, and the Commerce Control List

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