Background

Import and export rules and requirements for food facilities 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

- Food and Drug Administration 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 (December 2020; previously July 2020)

- 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 (December 2020; previously July 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; no change)

- 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 (January 2021; previously 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 (January 2021; previously September 2020)

- an FDA proposed rule to make clarifying changes to the general provisions related to the registration of food facilities rule (March 2021; previously December 2020)

- 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 (April 2021, previously July 2020; interim final rule published December 2019)

- a Federal Trade Commission final rule to repeal the apparel care labeling rule (June 2021; supplemental proposed rule issued July 2020)

- an FDA proposed rule revising requirements that apply to produce that satisfies criteria for an exemption from the produce safety rule because it will receive commercial processing to adequately reduce the presence of microorganisms of public health significance (July 2021; previously November 2020)

- an FWS proposed rule to revise the inspection fees associated with the importation and exportation of wildlife (July 2021)

- an FDA final rule requiring certain data elements to be submitted in the Automated Commercial Environment for veterinary devices (August 2021, previously July 2020; proposed rule issued August 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 when they identify hazards that require a control and the hazards are applied after importation (August 2021; previously April 2021)

Regulations Completed

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

- an FTC final rule related to “made in USA” and other unqualified U.S.-origin claims on product labels

- an FTC final rule to add seven generic fiber names to the Textile Rules 

Regulations Removed

- 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 

Regulations in Process

- 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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