On December 10, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft compliance guide that outlines which imported articles are covered by EPA’s July 2020 final significant new use rule (SNUR) that prohibits companies from manufacturing, importing, processing, or using certain long-chain per- and polyfluoroalkyl substances (PFAS) without prior EPA review and approval. The draft guide will be “the official compliance guide for imported...
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...
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...
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...
The Chinese Ministry of Emergency Management (MEM) released the “Law on Safety of Hazardous Chemicals (Draft for Consultation)” (LSHC) on October 2, 2020, to replace the “Regulations on Safe Management of Hazardous Chemicals” (Decree No. 591). The deadline to submit comments to MEM regarding the LSHC is November 1, 2020. Comments can be submitted to MEM via e-mail (yjbzfs@163.com). What Is New? The draft LSHC was first introduced in 2017. This draft revision will replace the...
September 30, 2020
EC Begins Public Consultation on Inception Impact Assessment for “Sustainable Products Initiative”
The European Commission (EC) began a public consultation on September 14, 2020, on the Inception Impact Assessment (Assessment) for a directive on the “Sustainable Products Initiative” (Initiative). According to the EC, this Initiative, which will revise the Ecodesign Directive and propose additional legislative measures as appropriate, intends to make products placed on the European Union (EU) market more sustainable. The EC states that consumers, the environment, and the climate...
September 29, 2020
OIRA Memorandum Directs Agencies to Consider Principles of Fairness in Administrative Enforcement and Adjudication
The Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) issued memorandum M-20-31 on August 31, 2020, on the implementation of Section 6 of Executive Order (EO) 13924, “Executive Order on Regulatory Relief to Support Economic Recovery.” Section 6 of the EO directs the “heads of all agencies” to “consider the principles of fairness in administrative enforcement and adjudication” enumerated in the EO and to “revise their procedures...
On September 24, 2020, the U.S. Environmental Protection Agency (EPA) published the final risk evaluation for cyclic aliphatic bromide cluster (HBCD). EPA found unreasonable risks to the environment from six out of 12 conditions of use and unreasonable risks to workers and occupational non-users (ONU) from the processing, use, and disposal of HBCD, largely from building and construction materials. EPA’s website states “EPA did not find unreasonable risks to the general population or...
September 16, 2020
China Tariffs: Court of International Trade Lawsuit Challenges Section 301 Tariffs
A recent legal challenge may be of interest to some of our clients. The challenge involves a case filed in the U.S. Court of International Trade (CIT) challenging President Trump’s authority to impose supplemental tariffs on goods from China identified on Lists 3 and 4A and seeking refunds. As our clients know well, some pesticides and cleaning products are listed on List 3 and thus subject to 25% China tariffs. There are two prongs to the argument....
September 16, 2020
EPA Releases Final Rule Intended to Promote Transparency in Developing Regulatory Guidance Documents
On September 14, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication version of 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.” The final regulation provides a definition of guidance document for the purposes of this rule, establishes general requirements and procedures...
September 10, 2020
EPA’s OCSPP Reorganization Will Include New Risk Evaluation and Risk Management Divisions
The U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) will be reorganizing at the end of September 2020. OCSPP currently consists of the Office of Pollution Prevention and Toxics (OPPT), the Office of Pesticide Programs (OPP), and the Office of Science Coordination and Policy (OSCP). According to reporting in Bloomberg Environmental, EPA is reorganizing within OPPT and OPP, as well as reorganizing at the OCSPP level. EPA has recently...
September 4, 2020
EPA Publishes Final Scope Documents and List of Manufacturers Subject to Fees for Risk Evaluations of High-Priority Chemicals
On September 4, 2020, the U.S. Environmental Protection Agency (EPA) published two Federal Register notices regarding the risk evaluations for the 20 high-priority chemicals designated in December 2019. In the first notice, EPA announced the availability of the final scope documents for the risk evaluations to be conducted under the Toxic Substances Control Act (TSCA) for the 20 high-priority substances. 85 Fed. Reg. 55281. The scope document for each chemical substance includes...
August 26, 2020
EPA Announces Approval of First-Ever Long-Lasting Antiviral Product for Use against COVID-19
On August 24, 2020, the U.S. Environmental Protection Agency (EPA) announced the issuance of a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 emergency exemption to the state of Texas permitting it to allow American Airlines and Total Orthopedics Sports & Spine to use a new product that is believed to inactivate coronaviruses like the SARS-CoV-2 virus on surfaces for up to seven days. EPA states that after carefully reviewing the available data and...