December 10, 2020

Manufacturer and Importer Liability under the TSCA Fees Rule for EPA-Initiated Risk Evaluations: An Opaque and Evolving Story

Under Toxic Substances Control Act (TSCA) Section 26(b), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), the U.S. Environmental Protection Agency (EPA) is authorized to collect fees from chemical manufacturers (defined to include importers under TSCA) to defray a portion of the EPA costs associated with TSCA implementation efforts. The TSCA Fees Rule, which became effective on October 18, 2018, requires payment of fees for eight categories of...
December 1, 2020

EPA Releases Draft Scope Documents for Risk Evaluations of DIDP and DINP for Public Comment

On November 27, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of the draft scope documents for the manufacturer-requested risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP). 85 Fed. Reg. 76077; 85 Fed. Reg. 76072. EPA notes in its November 25, 2020, announcement that both DIDP and DINP “belong to a family of chemicals called phthalates and are commonly used as plasticizers in the production of plastic and...
November 24, 2020

EPA Evaluates 54 Conditions of Use for TCE, Finding That 52 Present an Unreasonable Risk

The U.S. Environmental Protection Agency (EPA) released the final risk evaluation for trichloroethylene (TCE) on November 23, 2020. 85 Fed. Reg. 75010 (Nov. 24, 2020). Of the 54 conditions of use that EPA reviewed, EPA found that 52 present an unreasonable risk to workers, occupational non-users (ONU), consumers, and bystanders. EPA determined that distribution in commerce and consumer use of TCE in pepper spray do not present an unreasonable risk. EPA also found no...
November 23, 2020

China Issues Final Guidance for Environmental Management Registration of New Chemical Substances

The Chinese Ministry of Ecology and Environment (MEE) Order No. 12, “Measures on the Environmental Management Registration of New Chemical Substances,” will replace the Ministry of Environmental Protection (MEP) Order No. 7, “Measures of Environmental Management of New Chemical Substances,” on January 1, 2021. To implement MEE Order No. 12, the MEE issued in final its “Guidance for Environmental Management Registration of New Chemical Substances” (Guidance) on November 17, 2020,...
November 4, 2020

China Publishes Final Notice on Convergence Matters Related to Transition from MEP Order No. 7 to MEE Order No. 12

The Chinese Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP), released the final Notice on Convergence Matters Related to Environmental Management Registration of New Chemical Substances on October 27, 2020. Different from the draft Notice published in early June, new chemical substance registrations submitted and accepted by MEE before December 31, 2020, will be reviewed and approved under current MEP Order No. 7 until June...
November 4, 2020

Final Risk Evaluation for Carbon Tetrachloride Finds Unreasonable Risks to Workers and Occupational Non-Users

The U.S. Environmental Protection Agency (EPA) published the final risk evaluation for carbon tetrachloride on November 4, 2020. 85 Fed. Reg. 70147. EPA states that it reviewed 15 conditions of use, “all of which are associated with industrial and commercial work and primarily involve the manufacturing of other chemicals.” EPA found unreasonable risks to workers and occupational non-users (ONU) for 13 of the 15 conditions of use. EPA found no unreasonable risks to the...
October 29, 2020

TSCA Section 21 Petition Seeks Section 4 Test Rule for 54 PFAS

On October 14, 2020, a coalition of non-governmental organizations (NGO) petitioned the U.S. Environmental Protection Agency (EPA) under Section 21 of the Toxic Substances Control Act (TSCA) to request that EPA require health and environmental effects testing on 54 per- and polyfluoroalkyl substances (PFAS). The petition seeks issuance of a rule or order under TSCA Section 4 compelling The Chemours Company (Chemours) to fund and carry out this testing under the direction of a panel of...
October 26, 2020

UK REACH Statutory Instrument Laid before Parliament

The transition period for the United Kingdom’s (UK) exit from the European Union (EU) will end on December 31, 2020. At the end of the transition period, the EU Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation will be brought into UK law under the European Union (Withdrawal) Act 2018 as amended by the European Union (Withdrawal) Agreement 2020. The UK intends to replicate EU REACH, and related legislation, with the necessary changes to make...
October 22, 2020

EPA Provides Expedited Pathway for Companies to Claim “Long-Lasting” Efficacy for Antiviral Products

On October 14, 2020, the U.S. Environmental Protection Agency (EPA) released a much-anticipated draft guidance that is intended to help companies demonstrate to EPA that their products have “long-lasting” or “residual” effectiveness on surfaces against viruses like SARS-CoV-2, the coronavirus that causes COVID-19. EPA has not before now provided guidance on how stakeholders can demonstrate to EPA’s satisfaction that their product remains efficacious for periods of time given...
October 21, 2020

Final Rule Intended to Promote Transparency in Developing EPA Regulatory Guidance Documents Will Take Effect in November

On October 19, 2020, the U.S. Environmental Protection Agency (EPA) published a final rule establishing the procedures and requirements for how EPA will manage the issuance of guidance documents consistent with Executive Order (EO) 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents.” 85 Fed. Reg. 66230. The final regulation provides a definition of guidance document for the purposes of this rule, establishes general requirements and procedures for certain...