On May 5, 2020, the U.S. Government Accountability Office (GAO) released a report updating its open priority recommendations for the U.S. Environmental Protection Agency (EPA). According to GAO, in April 2019, it identified 17 priority recommendations for EPA. Since then, EPA has implemented three of those recommendations by, among other things, assessing established timeframes for each step in the Integrated Risk Information System (IRIS) process and publishing current information...
On April 27, 2020, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluation of perchloroethylene. According to EPA, it reviewed 68 conditions of use and preliminarily found unreasonable risk to workers, occupational non-users (ONUs), consumers, bystanders, and the environment from certain uses. EPA will use feedback received from the peer review and public comment process to inform the final risk evaluation. EPA notes that if its final risk evaluation finds there...
Under the amended Toxic Substances Control Act (TSCA), the U.S. Environmental Protection Agency (EPA) has authority to collect fees from chemical manufacturers and importers to defray a portion of the EPA costs associated with implementation efforts. The EPA fees rule, which became effective on October 18, 2018, required payment of fees for eight categories of fee-triggering events under TSCA, including EPA-initiated risk evaluations under TSCA Section 6. As part of the final fees rule, EPA...
April 21, 2020
EPA Releases Second Set of Draft Scope Documents for Remaining High-Priority Substances
On April 17, 2020, the U.S. Environmental Protection Agency (EPA) released the draft scope documents for the remaining seven of the 20 chemicals designated as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA). The draft scope documents include the proposed conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations EPA expects to consider in the risk evaluations. The documents also include: a description of...
The U.S. Food and Drug Administration (FDA) issued on April 18, 2020, an Emergency Use Authorization (EUA) for manufacturers and distributors of face masks in response to the ongoing efforts for prevention of the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As discussed below, in issuing this EUA, the FDA is effectively allowing manufacturers and distributors to address well-publicized concerns relating to national personal protective equipment (PPE)...
The U.S. Environmental Protection Agency (EPA) announced on April 6, 2020, that the first set of draft scope documents for the next group of chemicals undergoing risk evaluation under the Toxic Substances Control Act (TSCA) is available for comment. EPA released draft scope documents for 13 of the next 20 chemicals undergoing risk evaluation, and stated that it will soon release and accept public comments on the seven remaining draft scope documents. According to EPA, the scope...
The Russia Federation issued in final the Technical Regulation on the Safety of Chemical Products (TRSCP; Decree No. 1019) in October 2016 to establish a framework for regulation of chemical substances. Its implementation created a chemical inventory to include chemicals and mixtures in circulation and those intended for circulation in the territory of the Russian Federation. Inventory information is to be submitted online to the Russian Federation’s Governmental Industry Information Exchange...
April 1, 2020
EPA Publishes Draft Risk Evaluation of Asbestos, Will Hold Virtual Peer Review Meeting
The U.S. Environmental Protection Agency (EPA) published the draft risk evaluation of asbestos on March 30, 2020. EPA will publish a notice of availability in the Federal Register, beginning a 60-day comment period. EPA will hold a virtual peer review meeting of the Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation April 27-30, 2020. The virtual peer review meeting is open to the public to attend and provide comments. EPA will hold a...
On March 30, 2020, the U.S. Environmental Protection Agency (EPA) published the 2020 Mercury Inventory Report on the supply, use, and trade of mercury in the United States. The report presents aggregated data submitted on imported mercury, mercury manufactured in the United States, imported mercury-added products, mercury-added products made in the United States, and mercury used in manufacturing processes. The inventory report also provides a broad view of U.S. mercury stored, sold,...
India released the fourth draft Chemicals (Management and Safety) Rules to select groups on March 16, 2020. This fourth draft is believed to be the final draft, despite assurances in February that the third draft was the final draft. The government is accepting comments until March 31, 2020. The draft Rules include significant revisions to the list of priority substances that are subject to importation notifications, and hazard communication obligations (i.e., safety data sheets,...
March 23, 2020
NGOs File Suit against EPA for Failing to Disclose Information about New Chemical Substances
On March 18, 2020, a coalition of non-governmental organizations (NGO) filed suit in the U.S. District Court for the District of Columbia against the U.S. Environmental Protection Agency (EPA), claiming that EPA fails to disclose information about new chemical substances under the Toxic Substances Control Act (TSCA). According to the plaintiffs’ complaint, EPA fails to publish full and complete notices of its receipt of new chemical applications in a timely fashion and does not disclose...
On March 17, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a final rule amending the Chemical Data Reporting (CDR) rule. According to EPA, the amendments are intended to reduce the burden for certain CDR reporters, improve the quality of CDR data collected, and align reporting requirements with the Frank R. Lautenberg Chemical Safety for the 21st Century Act’s (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA). EPA states that...
March 9, 2020
EPA Releases Supplemental Proposed Rule to the Proposed Rule on Strengthening Transparency in Regulatory Science
On March 3, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a supplemental notice of proposed rulemaking (SNPRM) to the Strengthening Transparency in Regulatory Science proposed rule. EPA notes that the SNPRM “is not a new rulemaking; rather, it provides clarifications on certain terms and aspects of the 2018 proposed rule.” The SNPRM: Proposes that the scope of the rulemaking applies to influential scientific information, as well as significant...
March 4, 2020
EPA Plans to Provide Additional Clarification on Self-Identifying as a Manufacturer or Importer of a High-Priority Chemical
Given the considerable industry stakeholder confusion and angst that has arisen related to the January 27, 2020, U.S. Environmental Protection Agency (EPA) Federal Register notice on identifying the preliminary lists of manufacturers (including importers) of the 20 chemical substances that EPA designated as high-priority substances for risk evaluation and for which fees will be charged (85 Fed. Reg. 4661), EPA leadership has repeatedly stated that EPA is considering options to...
In a recent Bergeson & Campbell, P.C. (B&C®) advisory memorandum, we noted that enforcement activity under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) has been increasing during the last couple of years. That memorandum provides guidance to TSCA stakeholders on how to respond to a typical U.S. Environmental Protection Agency (EPA) TSCA inspection letter, and notes that it is often unclear why a particular manufacturer...
Today as never before, the old adage “there is strength in numbers” rings true. As the U.S. Environmental Protection Agency (EPA) continues to implement the amended Toxic Substances Control Act (TSCA), industry stakeholders are recognizing the immense importance of working within consortia to leverage resources, reduce cost, and increase opportunities for successful results. EPA statements in connection with TSCA implementation have repeatedly reinforced its expectation that industry will...
February 28, 2020
Proposed Supplemental SNUR Would Remove Exemption for LCPFAC Chemical Substances Used as Surface Coatings on Articles
The U.S. Environmental Protection Agency (EPA) released on February 20, 2020, a proposed supplemental significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances that would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles. Under the proposed supplemental SNUR, issued under Section 5(a)(2) of the Toxic Substances Control Act (TSCA), this subset of LCPFAC chemical...
February 28, 2020
EPA Releases Final Rule on Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory
On February 19, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication version of its final rule on procedures for review of confidential business information (CBI) claims made under the Toxic Substances Control Act (TSCA). The final rule includes the requirements for regulated entities to substantiate certain CBI claims made under TSCA to protect the specific chemical identities of chemical substances on the confidential portion of the TSCA Inventory, and...
On February 21, 2020, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluation of trichloroethylene (TCE), “a chemical used as a solvent and an intermediate for refrigerant manufacture in industrial and commercial processes, and with limited consumers uses like as a spot cleaner in dry cleaning facilities.” The Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) will meet on March 24-26, 2020, to peer review the...
February 26, 2020
EPA May Extend March 27 Deadline to Self-Identify as a Manufacturer or Importer of a High-Priority Chemical
On February 24, 2020, the U.S. Environmental Protection Agency (EPA) hosted a conference call to review certain provisions of the final rule on fees for the administration of the Toxic Substances Control Act (TSCA), particularly those related to EPA-initiated risk evaluations. EPA published a Federal Register notice on January 27, 2020, identifying the preliminary lists of manufacturers (including importers) of the 20 high-priority chemical substances for risk evaluation for...