On January 6, 2021, the U.S. Environmental Protection Agency (EPA) issued a final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.” 86 Fed. Reg. 469. EPA’s January 5, 2021, press release states the final rule establishes that when promulgating significant regulatory actions or developing influential scientific information, EPA will give greater consideration to studies where the...
The U.S. Environmental Protection Agency (EPA) released on December 30, 2020, the final risk evaluation for asbestos, part 1: chrysotile asbestos. Of the six use categories evaluated (chlor-alkali diaphragms, sheet gaskets, other gaskets, oilfield brake blocks, aftermarket automotive brakes/linings, and other vehicle friction products), EPA states that it found that there is unreasonable risk to workers, occupational non-users (ONU), consumers, and/or bystanders within each of the six...
December 30, 2020
EPA Intends Proposed Rule to Increase Flexibility and Reduce Burdens under TSCA Fees Program
On December 21, 2020, the U.S. Environmental Protection Agency (EPA) released a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule. According to EPA, the proposed rule “reflects real-world situations, narrows the broad scope of current requirements, significantly reduces the burden on American businesses, and increases the flexibility for surrounding TSCA fees requirements.” Under TSCA, EPA collects fees from chemical manufacturers and...
On December 23, 2020, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for N-methylpyrrolidone (NMP). Of the 37 conditions of use that EPA reviewed, EPA found that 26 present unreasonable risks to workers and consumers. These uses include an unreasonable risk to workers when domestically manufacturing or importing NMP, processing NMP for a variety of uses, and when used in a variety of industrial and commercial conditions of use. These uses also include...
The U.S. Environmental Protection Agency (EPA) released on December 22, 2020, final rules under Section 6(h) of the Toxic Substances Control Act (TSCA) for five persistent, bioaccumulative and toxic (PBT) chemicals — decabromodiphenyl ether (decaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)); 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP). TSCA required EPA to take expedited action on...
We write to alert you to an important and imminent deadline. Consideration for confidential business information (CBI) for hazardous substance ingredient disclosure on safety data sheets (SDS) will require formal submission and approval in South Korea starting January 16, 2021. Background On January 15, 2019, the South Korean government announced a major amendment to the South Korean Occupational Safety and Health Act (K-OSHA). The amendment requires that companies provide a copy...
December 17, 2020
Final Risk Evaluation for Perchloroethylene Finds 59 Conditions of Use Pose Unreasonable Risks to Workers, ONUs, Consumers, and Bystanders
On December 14, 2020, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for perchloroethylene. Of the 61 conditions of use that EPA reviewed, EPA found that 59 present unreasonable risks to workers, occupational non-users (ONU), consumers, and bystanders. The conditions of use that EPA determined do not present an unreasonable risk are distribution in commerce and industrial and commercial use in lubricants and greases for penetrating lubricants and cutting...
As 2021 begins, new safety data sheet (SDS) requirements in the European Union (EU) will enter into force. Commission Regulation (EU) 2020/878 of June 18, 2020, amends Annex II to Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH). The requirements for SDS layout and content appear in REACH, while the hazard classification criteria and labeling requirements are derivative of Regulation (EC) No 1272/2008 on the Classification,...
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...