Memoranda

On February 8, 2021, the U.S. Environmental Protection Agency (EPA) received a petition seeking a rule reversing EPA’s 1991 Bevill regulatory determination excluding phosphogypsum and process wastewater from phosphoric acid production (process wastewater) from hazardous waste regulation under Subtitle C of the Resource Conservation and Recovery Act (RCRA). The petition also urges EPA to promulgate regulations under RCRA Subtitle C governing the safe treatment, storage, and disposal...

On March 10, 2021, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing on “The Path Forward: Restoring the Vital Mission of EPA.” According to the March 7, 2021, memorandum from Representative Frank Pallone, Jr. (D-NJ), Chair of the Committee, to the Subcommittee, the U.S. Environmental Protection Agency’s (EPA) current responsibilities include reviewing national air pollution standards and overseeing or carrying out cleanups at most of the...

The United Kingdom (UK) Health and Safety Executive (HSE) published an HSE Biocides eBulletin on March 8, 2021, announcing upcoming deadlines for businesses under the Great Britain (GB) Biocidal Products Regulation (GB BPR). As of January 1, 2021, HSE no longer has access to the European Union’s (EU) information technology (IT) systems to access applications (including the data dossiers) previously submitted under those systems. Businesses must therefore resubmit applications for...

On March 5, 2021, the U.S. Environmental Protection Agency (EPA) announced that “[i‌]n support of the Biden-Harris Administration’s commitment to making evidence-based decisions to protect human health, U.S. Environmental Protection Agency (EPA) is taking an important step by proposing the cancellation of the registration of pentachlorophenol.” Pentachlorophenol, a well-recognized wood preservative in use for decades, is registered under the Federal Insecticide, Fungicide, and...

The European Chemicals Agency (ECHA) has begun a public consultation on a derogation to the exclusion criteria for creosote for product type 8 (PT 8; wood preservatives). Under the European Union (EU) Biocidal Products Regulation (BPR), active substances that meet the exclusion criteria can be approved or renewed only if they meet one or more of the following derogation criteria: exposure is negligible; the active substance is essential to prevent a serious danger to human or animal...

The United Kingdom (UK) Health and Safety Executive (HSE) published a REACH eBulletin on February 26, 2021, announcing upcoming deadlines for businesses for UK REACH. As reported in our February 9, 2021, memorandum, “Following Brexit, UK Establishes New Chemical Regulatory Regimes,” the UK brought the European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation into law on January 1, 2021, as UK REACH. According to HSE, measures have...

On January 26, 2021, several public health advocacy organizations and scientists (Petitioners) filed a notice of intent (NOI) to sue the U.S. Environmental Protection Agency (EPA) to compel it “to perform its non-discretionary duty to address the use and disposal of ‘legacy’ asbestos” in its risk evaluation for asbestos under Section 6(b) of the Toxic Substances Control Act (TSCA). As reported in our January 4, 2021, memorandum, “EPA Publishes Final Risk Evaluation for...

On February 16, 2021, the Occupational Safety and Health Administration (OSHA) published a notice of proposed rulemaking (NPRM) to amend the Hazard Communication Standard (HCS). The HCS is the federal-level regulation that sets forth the classification, labeling, Safety Data Sheet (SDS), and training requirements for hazardous chemicals intended to be used, handled, or stored in workplaces. The current HCS is based on the third revised edition (Rev 3) of the United Nations (UN)...

The United Kingdom (UK) completed its withdrawal from the European Union (EU) on December 31, 2020, and, as of January 1, 2021, is a “third country” from the EU perspective.  Companies worldwide must be aware of the significant implications for compliance under the following newly established independent chemical regulatory regimes:  the Great Britain (England, Scotland, and Wales) (GB) Biocidal Products Regulation (GB BPR); the GB Classification, Labeling, and Packaging Regulation...

The U.S. Environmental Protection Agency (EPA) announced on January 15, 2021, that it has issued test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on nine of the next 20 chemicals undergoing risk evaluation. EPA states that after reviewing the available data on these chemicals, it needs additional data and is using its TSCA test order authority to require companies to develop and submit information on environmental hazard and inhalation...

The U.S. Environmental Protection Agency (EPA) announced on January 14, 2021, the release of the final risk evaluation for C.I. Pigment Violet 29 (PV29) under the Toxic Substances Control Act (TSCA), meeting a “major chemical safety milestone.” In the risk evaluation, EPA reviewed 14 conditions of use for PV29, including as an intermediate for other perylene pigments, as well as a component of paints, coatings, industrial carpeting, and plastic and rubber products used...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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,...

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...

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...

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...

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...

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...

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...

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....

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...

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...

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...

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...

The U.S. Department of Agriculture (USDA) held a forum on its Agriculture Innovation Agenda (AIA) on August 16, 2020. The forum focused on science-informed policies and programs from government agencies with the shared aim of supporting environmentalism and enhanced productivity. AIA seeks to spur developments in biotechnology and support accessibility in response to modern industry challenges. Stakeholders were given a chance to hear from representatives and participate in a question and answer...

On August 20, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is seeking to add chitosan to the list of active ingredients allowed for in minimum risk pesticides exempted from pesticide registration requirements under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b).  A minimum risk product must meet six specific conditions to be exempted from pesticide registration.  One of those conditions is that the active ingredient in the minimum...

The Chinese Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP), issued the “Measures on the Environmental Management of New Chemical Substances” (MEE Order No. 12) on April 29, 2020, which will replace the current MEP Order No. 7 on January 1, 2021. To implement MEE Order No. 12, the MEE released the “Guidance for Environmental Management Registration of New Chemical Substances (Draft for Consultation)” (Draft Guidance) on August 17,...

On August 11, 2020, the U.S. Environmental Protection Agency (EPA) published the final risk evaluation for 1-bromopropane (1-BP). After evaluating 25 conditions of use, EPA determined that 16 present an unreasonable risk to workers, occupational non-users (ONU), consumers, and bystanders. EPA found no unreasonable risk to the environment from any conditions of use and no unreasonable risks to the general population. According to EPA, the next step in the process required by the Toxic Substances...

Federal U.S. Senators Vote Against Deputy Secretary Of Energy Nominee On August 4, 2020, U.S. Senators Joni Ernst (R-IA) and Chuck Grassley (R-IA) voted against Mark Menezes, who is nominated to become Deputy Secretary of Energy. In a statement, both Senators said that “[g]iven the uncertainty with the ‘gap year’ small refinery waivers, the wasted time and resources to score the waivers again, the lack of transparency in the entire process, and most importantly, the toll...

On July 30, 2020, the U.S. Environmental Protection Agency (EPA) announced it approved amended labels for 13 products based on laboratory testing that shows the products are effective against SARS-CoV-2, the virus that causes COVID-19. These products, and two previously announced products (see our July 7, 2020, blog), are the only products for which EPA has reviewed laboratory testing data and approved label claims specifically against SARS-CoV-2.  In January 2020, at the...