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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,...
March 23, 2020
NGOs File Suit against EPA for Failing to Disclose Information about New Chemical Substances
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...
March 9, 2020
EPA Releases Supplemental Proposed Rule to the Proposed Rule on Strengthening Transparency in Regulatory Science
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: EPA posted a pre-publication version of the SNPRM. Publication of the SNPRM in the Federal...
March 4, 2020
EPA Plans to Provide Additional Clarification on Self-Identifying as a Manufacturer or Importer of a High-Priority Chemical
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...
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...
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...
February 28, 2020
Proposed Supplemental SNUR Would Remove Exemption for LCPFAC Chemical Substances Used as Surface Coatings on Articles
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...
February 28, 2020
EPA Releases Final Rule on Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory
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...
February 26, 2020
EPA May Extend March 27 Deadline to Self-Identify as a Manufacturer or Importer of a High-Priority Chemical
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...
January 28, 2020
Senate Refers Sustainable Chemistry Research and Development Act of 2019 to Committee on Commerce, Science, and Transportation
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,...
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...
December 20, 2019
EPA Releases Updated Version of “Working Approach” Document for New Chemicals Review
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...
December 20, 2019
Final List of High-Priority Chemicals Will Be Next to Undergo Risk Evaluation under TSCA
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...
December 18, 2019
EC Begins Public Consultations on Fitness Check of EU Legislation Regarding Endocrine Disruptors
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...
On June 23, 2016, more than 30 million people voted in a referendum to decide whether the UK should remain in, or depart from, the EU. The “Leave Campaign” won the referendum by 52 percent to 48 percent, and since then “Brexit” has become an important matter globally with a wide range of stakeholders. Brexit has attracted unparalleled levels of attention from the global chemicals industry due to its significant implications for business operations. Brexit...