January 21, 2021

Proposition 65:  OEHHA Proposes Significant Changes to “Short-Form” Warnings

On January 8, 2021, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed significant revisions to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form” warnings. When OEHHA’s revisions to the warning requirements were issued in 2016 (and in full effect as of August 30, 2018), OEHHA included a short-form warning option as an acceptable alternative to the revised requirements for consumer product exposure...
January 20, 2021

EPA and OSHA Sign MOU Regarding EPA’s Review of New Chemicals under TSCA

The U.S. Environmental Protection Agency (EPA) announced on January 12, 2021, that it signed a memorandum of understanding (MOU) with the Occupational Safety and Health Administration (OSHA) “that advances collaboration and communication on EPA’s review of new chemicals under the Toxic Substances Control Act (TSCA).” The goal of the MOU is to improve the combined efforts of the agencies to protect workers who may be exposed to a new chemical substance by providing guidelines for...
January 19, 2021

Sustainable Chemistry Research and Development Act Passed as Part of National Defense Authorization Act

On December 28, 2020, the House overrode President Trump’s veto and passed the National Defense Authorization Act for Fiscal Year 2021 (H.R. 6395) by a vote of 322 to 87, and the Senate passed the bill on January 1, 2021, by a vote of 81 to 13. Subtitle E of Title II of the Act (Subtitle E) includes the text of the bipartisan Sustainable Chemistry Research and Development Act of 2019. Subtitle E will establish an interagency...
January 14, 2021

Proposed Amendments to the Hazardous Products Regulations in Canada

On December 19, 2020, the Department of Health in Canada published in the Canada Gazette, Part I a notice of its intent to amend the Hazardous Products Regulations (HPR). The HPR is the federal level legislation that sets forth the classification, labeling, and Safety Data Sheet (SDS) requirements for hazardous products intended to be used, handled, or stored in workplaces in Canada. The HPR is based on the fifth revised edition (Rev 5) of the United Nations...
January 13, 2021

Final Risk Evaluation for 1,4-Dioxane Finds Unreasonable Risk to Workers for Certain Uses

On January 8, 2021, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for 1,4-dioxane. 86 Fed. Reg. 1495. The final risk evaluation identifies unreasonable risk to workers for 13 out of 24 conditions of use. EPA states that it found no unreasonable risk to the general population and the environment. EPA notes that it also published a supplemental analysis to the draft risk evaluation that evaluated eight additional conditions of use for 1,4-dioxane...
January 11, 2021

EPA Issues Final Rule Intended to Strengthen Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information

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...
January 9, 2021

Forecast for U.S. Federal and International Chemical Regulatory Policy 2021

Click here for a PDF brochure of the memorandum. Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to offer you our Forecast 2021. In this document, rich with detail and helpful content, the legal, scientific, and regulatory professionals of B&C, Acta, and BCCM distill key trends in U.S. and global chemical law and policy, and provide our best...
January 4, 2021

EPA Publishes Final Risk Evaluation for Asbestos, Part 1:  Chrysotile Asbestos

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...
December 29, 2020

EPA Releases Final Chemical Risk Evaluation for NMP

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...
December 23, 2020

EPA Releases Final TSCA Section 6(h) Rules for Five PBT Chemicals

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...
December 21, 2020

K-OSHA Amendments Effective January 16, 2021

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...
December 16, 2020

Important Changes to Annex II to REACH Come into Force January 1, 2021

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,...
December 14, 2020

EPA Publishes Draft Compliance Guide Addressing Surface Coatings under PFAS SNUR

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

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...