Memoranda

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...

On July 28, 2020, the House Energy and Commerce Subcommittee on Environment and Climate Change held an oversight hearing entitled “There’s Something in the Water: Reforming Our Nation’s Drinking Water Standards.” The hearing concentrated on the Safe Drinking Water Act (SDWA) and the provisions of its standard-setting process as administered by the U.S. Environmental Protection Agency (EPA) and whether legislative reform is necessary to ensure safe drinking water nation-wide. The...

On July 27, 2020, the U.S. Environmental Protection Agency (EPA) promulgated a final significant use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances. 85 Fed. Reg. 45109. EPA first proposed a SNUR for LCPFAC and perfluoroalkyl sulfonate chemical substances on January 21, 2015. 80 Fed. Reg. 2885. On March 3, 2020, EPA issued a proposed supplemental SNUR for LCPFAC chemical substances that would make...

On June 30, 2020, the Trump Administration released the Spring 2020 Unified Agenda of Regulatory and Deregulatory Actions for the U.S. Environmental Protection Agency (EPA).  According to the Unified Agenda, the Office of Chemical Safety and Pollution Prevention (OCSPP) is working on several rulemakings under the Toxic Substances Control Act (TSCA).  Rulemakings at the proposed stage are listed below: Rulemakings at the final stage include:...

On May 9, 2020, the European Commission (EC) began a public consultation on a roadmap for “Chemicals Strategy for Sustainability.” The roadmap states that the regulatory framework on chemicals needs to be strengthened to increase further the level of protection of human health and the environment — in particular from exposure to endocrine disruptors; combinations of chemicals; hazardous chemicals in products, including in imports; and very persistent chemicals. The regulatory...

On June 19, 2020, the U.S. Environmental Protection Agency (EPA) extended the comment period on its June 11, 2020, proposed rulemaking “Increasing Consistency and Transparency in Considering Benefits and Costs in the Clean Air Act Rulemaking Process.” 85 Fed. Reg. 37057. Comments are due August 3, 2020. EPA held a virtual public hearing on the proposed rulemaking on July 1, 2020, to provide interested parties the opportunity to present data, views, or arguments concerning EPA’s...

On June 18, 2020, the House Committee on Transportation and Infrastructure passed the Investing in a New Vision for the Environment and Surface Transportation (INVEST) in America Act (H.R. 2). The Committee’s June18, 2020, press release states that the INVEST in America Act marks a significant departure from previous surface transportation reauthorization bills by addressing the maintenance needs and building smarter, safer infrastructure while putting the United States on a path...

On June 3, 2020, the American Coatings Association (ACA), National Association of Manufacturers, Toy Association, National Association of Home Builders, and U.S. Chamber of Commerce filed a petition under Section 21 of the Toxic Substances Control Act (TSCA) requesting that the U.S. Environmental Protection Agency (EPA) develop a risk management procedural rule under TSCA Section 6. According to the petition, such a rule is necessary to implement the Frank R. Lautenberg Chemical Safety...

Federal DOE Announces RFI On Improving Battery Critical Materials Supply Chains On June 29, 2020, the United States (U.S.) Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) published a request for information (RFI) on challenges and opportunities in the up- and mid-stream critical materials battery supply chains. As demand for critical materials such as lithium and cobalt for the manufacturing of batteries continues to grow, DOE is seeking ways to reduce...

The U.S. Environmental Protection Agency (EPA) issued a memorandum on June 29, 2020, announcing an “addendum on termination” to its March 26, 2020, COVID-19 temporary enforcement policy. The memorandum notes that as states and businesses begin to re-open, there will be a period of adjustment as regulated entities plan how to comply with environmental legal obligations and with public health guidance from the Centers for Disease Control and Prevention (CDC) and other agencies...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on June 24, 2020, announcing the availability of the final Toxic Substances Control Act (TSCA) risk evaluation for methylene chloride. 85 Fed. Reg. 37942. This is the first risk evaluation that EPA has completed under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to TSCA. After evaluating 53 conditions of use of methylene chloride, EPA determined that...

On June 2, 2020, the Senate Committee on Finance hosted a full Committee hearing entitled “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process.” Witnesses represented the U.S. Food and Drug Administration (FDA), U.S. Government Accountability Office (GAO), and private sector companies. The hearing sought to examine the accountability of FDA’s vetting process, especially in regard to drugs necessitated by the COVID-19 pandemic. Lawmakers and witnesses...

The Chinese Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP), released a Notice on Convergence Matters Related to Environmental Management Registration of New Chemical Substances (Draft for Consultation) on June 3, 2020. The deadline to submit comments to MEE regarding the draft Notice is June 20, 2020. Comments can be submitted to MEE via e-mail (chem@mee.gov.cn). The key points in the draft Notice are summarized below: Commentary...

On May 19, 2020, the U.S. Environmental Protection Agency (EPA) released its “first ever” proposed rule intended to improve the transparency of guidance. According to EPA, the new rule will significantly increase the transparency of its practices around guidance and will improve its process for managing guidance documents. When final, the rule will: EPA has posted a pre-publication version of the proposed rule. Publication in the Federal Register will begin a...

On May 18, 2020, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued the much-anticipated final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. 85 Fed. Reg. 29790. The rule is intended to update and modernize USDA’s biotechnology regulations under the Plant Protection Act. The final rule amends the regulations regarding the movement (importation, interstate movement, and environmental release) of...

From new product or new use approvals, to impact on chemical supply chains, Bergeson & Campbell, P.C. (B&C®) monitors key federal and international chemical legislative and regulatory initiatives to keep firm clients and friends informed. We have compiled a comprehensive and frequently updated listing of our content related to the coronavirus crisis that we hope will serve as a useful, one-click source of information: www.lawbc.com/uploads/docs/COVID-19.pdf....

The Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP), issued the long-awaited revision of MEP Order No. 7 in final, “Measures on the Environmental Management of New Chemical Substances” (MEE Order No. 12), on April 29, 2020, which will become effective January 1, 2021. MEE Order No. 12 is generally the same as the Notification Draft that MEE notified to the World Trade Organization (WTO) on September 2, 2019, except that...

On May 5, 2020, the U.S. Government Accountability Office (GAO) released a report updating its open priority recommendations for the U.S. Environmental Protection Agency (EPA). According to GAO, in April 2019, it identified 17 priority recommendations for EPA. Since then, EPA has implemented three of those recommendations by, among other things, assessing established timeframes for each step in the Integrated Risk Information System (IRIS) process and publishing current information...

On April 27, 2020, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluation of perchloroethylene. According to EPA, it reviewed 68 conditions of use and preliminarily found unreasonable risk to workers, occupational non-users (ONUs), consumers, bystanders, and the environment from certain uses. EPA will use feedback received from the peer review and public comment process to inform the final risk evaluation. EPA notes that if its final risk evaluation finds there...

Under the amended Toxic Substances Control Act (TSCA), the U.S. Environmental Protection Agency (EPA) has authority to collect fees from chemical manufacturers and importers to defray a portion of the EPA costs associated with implementation efforts. The EPA fees rule, which became effective on October 18, 2018, required payment of fees for eight categories of fee-triggering events under TSCA, including EPA-initiated risk evaluations under TSCA Section 6. As part of the final fees rule, EPA...

On April 17, 2020, the U.S. Environmental Protection Agency (EPA) released the draft scope documents for the remaining seven of the 20 chemicals designated as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA). The draft scope documents include the proposed conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations EPA expects to consider in the risk evaluations. The documents also include: a description of...

The U.S. Food and Drug Administration (FDA) issued on April 18, 2020, an Emergency Use Authorization (EUA) for manufacturers and distributors of face masks in response to the ongoing efforts for prevention of the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As discussed below, in issuing this EUA, the FDA is effectively allowing manufacturers and distributors to address well-publicized concerns relating to national personal protective equipment (PPE)...

The U.S. Environmental Protection Agency (EPA) announced on April 6, 2020, that the first set of draft scope documents for the next group of chemicals undergoing risk evaluation under the Toxic Substances Control Act (TSCA) is available for comment. EPA released draft scope documents for 13 of the next 20 chemicals undergoing risk evaluation, and stated that it will soon release and accept public comments on the seven remaining draft scope documents. According to EPA, the scope...

The Russia Federation issued in final the Technical Regulation on the Safety of Chemical Products (TRSCP; Decree No. 1019) in October 2016 to establish a framework for regulation of chemical substances. Its implementation created a chemical inventory to include chemicals and mixtures in circulation and those intended for circulation in the territory of the Russian Federation. Inventory information is to be submitted online to the Russian Federation’s Governmental Industry Information Exchange...

The U.S. Environmental Protection Agency (EPA) published the draft risk evaluation of asbestos on March 30, 2020. EPA will publish a notice of availability in the Federal Register, beginning a 60-day comment period. EPA will hold a virtual peer review meeting of the Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation April 27-30, 2020. The virtual peer review meeting is open to the public to attend and provide comments. EPA will hold a...

On March 30, 2020, the U.S. Environmental Protection Agency (EPA) published the 2020 Mercury Inventory Report on the supply, use, and trade of mercury in the United States. The report presents aggregated data submitted on imported mercury, mercury manufactured in the United States, imported mercury-added products, mercury-added products made in the United States, and mercury used in manufacturing processes. The inventory report also provides a broad view of U.S. mercury stored, sold,...