Memoranda

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:...

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: Establish the first formal petition process for the public to request that EPA modify or withdraw a guidance document;  Ensure...

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 the exclusion...

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,...

India released the fourth draft Chemicals (Management and Safety) Rules to select groups on March 16, 2020. This fourth draft is believed to be the final draft, despite assurances in February that the third draft was the final draft. The government is accepting comments until March 31, 2020. The draft Rules include significant revisions to the list of priority substances that are subject to importation notifications, and hazard communication obligations (i.e., safety data sheets,...

On March 18, 2020, a coalition of non-governmental organizations (NGO) filed suit in the U.S. District Court for the District of Columbia against the U.S. Environmental Protection Agency (EPA), claiming that EPA fails to disclose information about new chemical substances under the Toxic Substances Control Act (TSCA). According to the plaintiffs’ complaint, EPA fails to publish full and complete notices of its receipt of new chemical applications in a timely fashion and does not disclose...

On March 17, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a final rule amending the Chemical Data Reporting (CDR) rule. According to EPA, the amendments are intended to reduce the burden for certain CDR reporters, improve the quality of CDR data collected, and align reporting requirements with the Frank R. Lautenberg Chemical Safety for the 21st Century Act’s (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA). EPA states that...

On March 3, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a supplemental notice of proposed rulemaking (SNPRM) to the Strengthening Transparency in Regulatory Science proposed rule. EPA notes that the SNPRM “is not a new rulemaking; rather, it provides clarifications on certain terms and aspects of the 2018 proposed rule.” The SNPRM: Proposes that the scope of the rulemaking applies to influential scientific information, as well as significant...

Given the considerable industry stakeholder confusion and angst that has arisen related to the January 27, 2020, U.S. Environmental Protection Agency (EPA) Federal Register notice on identifying the preliminary lists of manufacturers (including importers) of the 20 chemical substances that EPA designated as high-priority substances for risk evaluation and for which fees will be charged (85 Fed. Reg. 4661), EPA leadership has repeatedly stated that EPA is considering options to...

In a recent Bergeson & Campbell, P.C. (B&C®) advisory memorandum, we noted that enforcement activity under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) has been increasing during the last couple of years. That memorandum provides guidance to TSCA stakeholders on how to respond to a typical U.S. Environmental Protection Agency (EPA) TSCA inspection letter, and notes that it is often unclear why a particular manufacturer...

Today as never before, the old adage “there is strength in numbers” rings true. As the U.S. Environmental Protection Agency (EPA) continues to implement the amended Toxic Substances Control Act (TSCA), industry stakeholders are recognizing the immense importance of working within consortia to leverage resources, reduce cost, and increase opportunities for successful results. EPA statements in connection with TSCA implementation have repeatedly reinforced its expectation that industry will...

The U.S. Environmental Protection Agency (EPA) released on February 20, 2020, a proposed supplemental significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances that would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles. Under the proposed supplemental SNUR, issued under Section 5(a)(2) of the Toxic Substances Control Act (TSCA), this subset of LCPFAC chemical...

On February 19, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication version of its final rule on procedures for review of confidential business information (CBI) claims made under the Toxic Substances Control Act (TSCA). The final rule includes the requirements for regulated entities to substantiate certain CBI claims made under TSCA to protect the specific chemical identities of chemical substances on the confidential portion of the TSCA Inventory, and...

On February 21, 2020, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluation of trichloroethylene (TCE), “a chemical used as a solvent and an intermediate for refrigerant manufacture in industrial and commercial processes, and with limited consumers uses like as a spot cleaner in dry cleaning facilities.” The Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) will meet on March 24-26, 2020, to peer review the...

On February 24, 2020, the U.S. Environmental Protection Agency (EPA) hosted a conference call to review certain provisions of the final rule on fees for the administration of the Toxic Substances Control Act (TSCA), particularly those related to EPA-initiated risk evaluations. EPA published a Federal Register notice on January 27, 2020, identifying the preliminary lists of manufacturers (including importers) of the 20 high-priority chemical substances for risk evaluation for...

The U.S. Environmental Protection Agency (EPA) announced on February 20, 2020, the final list of 20 chemical substances designated as low-priority substances for which risk evaluation under the Toxic Substances Control Act (TSCA) is not warranted at this time. EPA has posted a pre-publication version of the Federal Register notice. The notice includes the final designation for each of the chemical substances and instructions on how to access the chemical-specific...

Federal enforcement of chemical product laws is alive and well, despite a broadly held misconception to the contrary. We have seen over the past 18 months or so an uptick in federal enforcement under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). We write to alert you to this fact and focus here on TSCA enforcement, as we believe we will see this trend continue in 2020. We will devote a second client alert to FIFRA enforcement. What...

On December 10, 2019, the U.S. Senate received and read twice the Sustainable Chemistry Research and Development Act of 2019 (Act). Passed by the U.S. House of Representatives one day prior to the Senate’s review, the Act -- H.R. 2051 -- if approved, will establish an interagency working group led by the Office of Science and Technology Policy (OSTP) to coordinate federal programs and activities in support of sustainable chemistry. This is an exciting development and, for sustainable...

On January 24, 2020, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluation of carbon tetrachloride, “a solvent primarily used in the manufacturing of chlorinated compounds and petrochemicals.” Carbon tetrachloride is the seventh of the first ten chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA). EPA published a Federal Register notice on January 27, 2020, announcing the availability of the draft risk...

On January 14, 2020, California’s Office of Environmental Health Hazard Assessment (OEHHA) adopted amendments it proposed on November 16, 2018, and modified on October 4, 2019, to the Proposition 65 (Prop 65) regulations setting forth the circumstances when a “retail seller” is responsible for providing consumer product exposure warnings. The amendments are effective on April 1, 2020. The amendments adopted have not changed since OEHHA’s October 4, 2019, modifications. A...

Click here for a PDF brochure of the memorandum, and click here to listen to the special Forecast 2020 edition of the All Things Chemical podcast. Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) are pleased to offer you our Forecast 2020. In this detailed and comprehensive document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and policy, and provide our...

The U.S. Environmental Protection Agency (EPA) released on December 20, 2019, an updated version of the “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA.” EPA states that the updated document, “TSCA New Chemical Determinations: A Working Approach for Making Determinations under TSCA Section 5,” explains its approach for making one of the five affirmative...

The U.S. Environmental Protection Agency (EPA) published on December 20, 2019, the final list of high-priority chemicals. These chemicals will be the next 20 chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA). According to EPA, issuing the final list of high-priority chemicals for risk evaluation “represents the final step in the prioritization process outlined in TSCA and marks another major TSCA milestone for EPA in its efforts to ensure the safety of...

As part of its Fitness Check of European Union (EU) legislation regarding endocrine disruptors, the European Commission (EC) has begun two public consultations: a public consultation (designed from a citizen’s perspective), and a stakeholder consultation (designed for stakeholders and experts). The public consultation will close March 9, 2020, and targets the general public. The stakeholder survey will close on January 31, 2020, and targets stakeholder...

The results of the United Kingdom’s December 12, 2019, elections give the Conservative Party under the leadership of Boris Johnson a clear mandate to withdraw from the European Union (EU), a process colloquially known as “Brexit,” by the January 31, 2020, deadline agreed with the EU. The mandate is clear, the details of withdrawal are not, and the forthcoming negotiation with the EU promises to be challenging. Brexit has attracted unparalleled levels of attention from the global...

The latest revisions to the Act on Registration, Evaluation, etc. of Chemicals [Act No. 15844, October 16, 2018] in South Korea (K-REACH) entered into force on January 1, 2019. Its first significant compliance deadline required manufacturers and importers to pre-register existing substances by June 30, 2019. The industry is now shifting its focus to registration requirements that provide the following phase-in timelines. Substances imported or manufactured > 1,000 tons/year and...

On December 4, 2019, the U.S. Environmental Protection Agency (EPA) published an advance notice of proposed rulemaking (ANPRM) soliciting information as EPA considers a future rulemaking to add certain per- and polyfluoroalkyl substances (PFAS) to the list of toxic chemicals subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and Section 6607 of the Pollution Prevention Act (PPA) (more commonly known as the Toxics Release Inventory...

There is less than one month before the effective date of the online requirements set forth in California’s Cleaning Product Right to Know Act of 2017 (S.B. 258). S.B. 258 sets forth new requirements on manufacturers of “designated products” to disclose certain chemical ingredients on the manufacturer’s website and product label. The online ingredient disclosure requirements set forth under California’s law are applicable to designated products sold in California as of January 1,...

On November 13, 2019, the House Committee on Science, Space, and Technology held a hearing on “Strengthening Transparency or Silencing Science? The Future of Science in EPA Rulemaking.” The hearing focused on the U.S. Environmental Protection Agency’s (EPA) April 30, 2018, proposed rule on “Strengthening Transparency in Regulatory Science,” as well as a leaked copy of EPA’s supplemental proposed rule that was published by the New York Times on November 11, 2019. Dr....

On November 4, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the draft risk evaluation for N-methylpyrrolidone (NMP), which includes more than 30 uses of NMP in adhesives, sealants, paints and arts and craft paints, paint and coating removers, adhesive removers, and degreasers. In the draft risk evaluation, EPA has made a preliminary determination that NMP does not present risks to the environment, bystanders, or occupational non-users (ONU)....

On October 29, 2019, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing the availability of the draft Toxic Substances Control Act (TSCA) risk evaluation for methylene chloride (MC). 84 Fed. Reg. 57866. As reported in our October 25, 2019, memorandum, EPA is submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review. SACC will convene an in-person public meeting to consider and review the...

The U.S. Environmental Protection Agency (EPA) will publish a Federal Register notice on October 29, 2019, announcing the availability of and soliciting public comment on the draft Toxic Substances Control Act (TSCA) risk evaluation of methylene chloride (MC). EPA states that it is also submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review and that SACC will convene an in-person public meeting to consider and review the draft risk...

On October 11, 2019, New York Governor Andrew M. Cuomo (D) signed legislation (S.2387-B/A.164-B) requiring menstrual product packages or boxes sold in New York State to contain a “plain and conspicuous printed list of all the ingredients in the products.” According to Cuomo’s October 11, 2019, press release, the new law makes New York the first state to require ingredient labels on menstrual products. The legislation will take effect in 180 days, and product manufacturers will...

On October 4, 2019, California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed modifications to amendments it proposed on November 16, 2018, to the Proposition 65 (Prop 65) regulations setting forth the circumstances when a “retail seller” is responsible for providing consumer product exposure warnings. As discussed below, OEHHA first proposed amendments clarifying retail seller responsibilities in response to questions and requests for clarification it...