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Wildlife Ports, Drug Imports, High-Risk Foods Among Topics of Upcoming Rules

Monday, December 09, 2019
Sandler, Travis & Rosenberg Trade Report

New rules on wildlife ports, drug imports, and high-risk foods 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. 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 Fish and Wildlife Services 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 that are currently listed as non-designated to the list of designated ports, and (c) authorize 15 ports for the importation or exportation of venomous reptiles (December 2019; first time published)

- 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 (December 2019; previously July)

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

- an FDA proposed rule to allow pharmacists and wholesalers to import prescription drugs from Canada if they meet conditions designed to ensure that the importation poses no additional risk to safety and will achieve cost savings (January 2020; first time published)

- a State Department proposed rule to provide for the filing of trade documents for shrimp and shrimp products in the International Trade Data System (March 2020; previously August 2019)

- 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 (March 2020; previously October 2019)

- 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 (March 2020; previously October 2019)

- an FDA proposed rule to make clarifying changes to the general provisions related to the registration of food facilities rule (April 2020; previously November 2019)

- 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 (July 2020; previously October 2019)

- a State Department proposed 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 (September 2020; previously September 2019)

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

Rulemakings Completed

- Federal Maritime Commission proposed rules on (a) the filing, review, and monitoring of ocean common carrier and marine terminal operator agreements and (b) financial responsibility requirements and general duties for ocean transportation intermediaries

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 International Traffic in Arms Regulations, and the Commerce Control List

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