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...
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on January 27, 2020, 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. During the comment period, manufacturers (including importers) are required to self-identify as manufacturers of a high-priority substance irrespective of whether...
The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on January 27, 2020, 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. Publication of the Federal Register notice will begin a 60-day comment period during which manufacturers (including importers) will be required...
Bergeson & Campbell, P.C. (B&C®) is pleased to announce the release of the complete suite of TSCA Tutor™ regulatory training courses online and on-demand at www.TSCAtutor.com. Professionals seeking expert, efficient, essential training can preview and enroll in on-demand classes to complete at their own pace and timing. In addition to the newly released online e-learning courses, B&C’s TSCA Tutor™ training platform offers live in-person training at a...
The U.S. Environmental Protection Agency (EPA) will hold its next Enforcement and Compliance History Online (ECHO) webinar on February 18, 2020, at 1:30-2:30 PM (EST). The webinar will provide an overview of the data in ECHO and guide users through using the site to answer environmental compliance and enforcement questions. EPA states that the focus of this session will be a collection of short, step-by-step demonstrations geared toward new and infrequent users. EPA will...
The U.S. Environmental Protection Agency (EPA) announced on January 15, 2020, that it is partnering with People for the Ethical Treatment of Animals (PETA) and Physicians for Responsible Medicine (PCRM) to host public webinars on various topics related to reducing, refining, or replacing vertebrate animal testing. A webinar will be held on January 22, 2020, covering the use and application of the Collaborative Acute Toxicity Modeling Suite (CATMoS), a free resource for screening organic...
The U.S. Environmental Protection Agency (EPA) promulgated a final rule on January 13, 2020, to adjust the level of the maximum (and minimum) statutory civil monetary penalty amounts under the statutes it administers, including the Toxic Substances Control Act (TSCA). 85 Fed. Reg. 1751. EPA states that this action is mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the...
January 10, 2020
B&C Publishes Forecast for U.S. Federal and International Chemical Regulatory Policy 2020
Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) published on January 9, 2020, our “Forecast for U.S. Federal and International Chemical Regulatory Policy 2020.” In this richly 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 best informed judgment as to the shape of key developments we are likely to see...
January 2, 2020
Comments on Updated Version of “Working Approach” Document for New Chemicals Review Due February 18
As reported in our December 20, 2019, blog item, 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.” On January 2, 2020, EPA published a Federal Register notice announcing the availability of the updated document and beginning a 45-day...
Kevin L. Bromberg, Assistant Chief Counsel for Environmental Policy for the U.S. Small Business Administration’s (SBA) Office of Advocacy, will retire from federal service on January 3, 2020. Bromberg served two terms in the Office of Advocacy, from 1979 to 1991 and from 1994 to the present. Prior to rejoining the Office of Advocacy in 1994, Bromberg represented small business trade associations in regulatory matters dealing with the U.S. Environmental Protection Agency...
December 20, 2019
Updated Version of “Working Approach” Document for New Chemicals Review Available for Public Comment
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 discussed the updated document, “TSCA New Chemical Determinations: A Working Approach for Making Determinations under TSCA Section 5,” at a public meeting on December 10, 2019. ...
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...
December 19, 2019
Updated Version of “Working Approach” Document for New Chemicals Review Available for Public Comment
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 discussed the updated document, “TSCA New Chemical Determinations: A Working Approach for Making Determinations under TSCA Section 5,” at a public meeting on December 10, 2019. ...
The U.S. Environmental Protection Agency (EPA) announced on December 18, 2019, that it is extending the public comment period for the draft risk evaluation of N-methylpyrrolidone (NMP) to give stakeholders more time to review and comment on the draft document. Comments are now due January 21, 2020. EPA states that it will use feedback received from the public comment process, along with input from the Science Advisory Committee on Chemicals (SACC), to inform the final risk...
December 16, 2019
EPA Will Host Conference Call on Fee Obligations for EPA-Initiated Risk Evaluations
On December 19, 2019, from 2:00 p.m. to 2:30 p.m. (EST), the U.S. Environmental Protection Agency (EPA) will host a conference call to review certain provisions of the final rule on fees for the administration of the Toxic Substances Control Act (TSCA). EPA states that it will provide a brief overview of the fees associated with an EPA-initiated risk evaluation, the creation of the preliminary list that identifies manufacturers and importers subject to fees, and how it...
December 11, 2019
EPA Will Host First Annual Conference on New Approach Methods for Reducing Animal Testing for Chemical Safety on December 17
The U.S. Environmental Protection Agency (EPA) will host its first annual conference to discuss alternative test methods and strategies to reduce animal testing on December 17, 2019, in Washington, D.C. According to EPA, the conference will bring together some of the leading voices in environmental and health research to discuss efforts to reduce testing on mammals. The conference will focus on the New Approach Methods (NAM) and will feature presentations by U.S. and...
The U.S. Environmental Protection Agency (EPA) announced on December 2, 2019, that it granted the first two manufacturer requests for risk evaluations for diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP), two chemicals used in plastic production. EPA states that if the requests are not withdrawn within 30 days, both DIDP and DINP will enter the risk evaluation process under the Toxic Substances Control Act (TSCA). Manufacturer-requested risk evaluations are conducted in the same...
November 22, 2019
Ban on Retail Distribution of Methylene Chloride to Consumers for Paint and Coating Removal Begins November 23
The U.S. Environmental Protection Agency (EPA) issued a press release on November 22, 2019, reminding stakeholders that its regulations to prohibit the manufacture (including import), processing, and distribution of methylene chloride in all paint removers for consumer use will go into effect after November 22, 2019. Beginning November 23, 2019, it will be unlawful for any person or retailer to sell or distribute paint removal products containing methylene chloride for...
November 22, 2019
“Value Chain Communications Required under TSCA Consent Orders and SNURs: How to Formulate Them and Optimize Their Value” Recording Available Now
On November 13, 2019, Bergeson & Campbell, P.C. (B&C®), presented “Value Chain Communications Required under TSCA Consent Orders and SNURs: How to Formulate Them and Optimize Their Value,” a complimentary webinar for our clients and friends. Richard E. Engler, Ph.D., Director of Chemistry, B&C, outlined the categories of legally required risk communications to value chain participants required under TSCA Consent Orders and significant new use rules...
November 21, 2019
Ninth Circuit Issues Decision in Case Challenging EPA’s Prioritization and Risk Evaluation Rules
On November 14, 2019, the U.S. Court of Appeals for the Ninth Circuit issued its decision in a case challenging the U.S. Environmental Protection Agency’s (EPA) prioritization and risk evaluation rules. Safer Chemicals, Healthy Families v. EPA, No. 17-72260. Petitioners argued that provisions in the risk evaluation rule relating to EPA’s evaluation of the risks from a substance’s “conditions of use” violate several of the Toxic Substances Control Act’s (TSCA) requirements. ...
November 15, 2019
Comments on EPA’s 20 Proposed Low-Priority Chemical Substances Due November 13, 2019
On August 13, 2019, the U.S. Environmental Protection Agency (EPA) released the list of 20 chemical substances that it proposes to designate as low-priority substances for which risk evaluation under the Toxic Substances Control Act (TSCA) is not warranted at this time. EPA’s August 15, 2019, proposed rule provides a summary of the approach used by EPA to support the proposed designations, the proposed designations for each of the chemical substances, and instructions on how to access...
The U.S. Environmental Protection Agency (EPA) will hold a public meeting on December 10, 2019, to engage with interested stakeholders on the implementation of EPA’s Toxic Substances Control Act (TSCA) New Chemicals program. At the meeting, EPA will: By the end of 2019, EPA intends to announce the availability of the updated “Working Approach” document and provide an opportunity for written public comment. EPA states that feedback from the public meeting and comments...
November 13, 2019
EPA Denies Petition for TSCA Rule Prohibiting Oil Refineries from Using Hydrofluoric Acid in Manufacturing Processes
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 12, 2019, announcing the availability of its response to a petition it received under Section 21 of the Toxic Substances Control Act (TSCA) from Public Employees for Environmental Responsibility (PEER). 84 Fed. Reg. 60986. As reported in our August 23, 2019, blog item, PEER petitioned EPA under TSCA Section 21 to prohibit the use of hydrofluoric acid in manufacturing processes at oil refineries...
On Wednesday, November 13, 2019, at 3:00 p.m. (EST), the U.S. Environmental Protection Agency (EPA) will hold a webinar on the Green Chemistry Challenge Awards Program. Participants will learn more about applying for the 2020 Green Chemistry Challenge Awards. The webinar presentation will cover award eligibility, the application process, and evaluation criteria. There will also be time for questions from the webinar participants. As reported in our September 20, 2019, blog item, EPA...
November 8, 2019
Comments on Proposed Revisions to the CBI Substantiation Requirements Due December 9
On November 8, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a supplemental notice of proposed rulemaking regarding revisions to the confidential business information (CBI) substantiation requirements under the Toxic Substances Control Act (TSCA). 84 Fed. Reg. 60363. EPA states that in response to a recent federal circuit court decision, it is proposing revisions to existing and proposed substantiation requirements for...
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 7, 2019, announcing the availability of the draft risk evaluation for N-methylpyrrolidone (NMP) and soliciting public comment. 84 Fed. Reg. 60087. EPA’s draft risk evaluation findings include: The draft risk evaluation will be peer reviewed by the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) on December 5-6, 2019. EPA...
On November 13, 2019, at 10:00 a.m. (EST), the House Committee on Science, Space, and Technology will hold a hearing on “Strengthening Transparency or Silencing Science? The Future of Science in EPA Rulemaking.” The Committee will hear from the following witnesses: Panel 1 Panel 2...
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. EPA’s draft risk evaluation findings include: EPA notes that these initial determinations are based on a draft risk evaluation of the reasonably available information and...
On October 29, 2019, the U.S. Environmental Protection Agency 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 26, 2019, blog item, 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...
On October 30, 2019, the U.S. Environmental Protection Agency (EPA) announced that in response to an April 2019 court decision on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements Final Rule, EPA will publish a supplemental notice of proposed rulemaking that includes two additional questions about “reverse engineering” that manufacturers and processors would be required to answer when making confidential business information (CBI)...
October 26, 2019
Draft Risk Evaluation of Methylene Chloride Will Be Published on October 29; SACC Will Review It in December
The U.S. Environmental Protection Agency 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 hold an in-person public meeting to consider and review the draft risk evaluation...
October 26, 2019
Draft Risk Evaluation of Methylene Chloride Will Be Published on October 29; SACC Will Review It in December
The U.S. Environmental Protection Agency 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 hold an in-person public meeting to consider and review the draft...
The U.S. Environmental Protection Agency (EPA) announced on October 23, 2019, that it settled with Miles Chemical Company Inc. for failing to report timely chemical substances it imported. Under the settlement, the company will pay a $45,000 penalty. According to EPA, between 2012 and 2015, Miles Chemical Company failed to submit timely forms to EPA documenting the import of large quantities of two chemicals. EPA notes that under the Toxic Substances Control Act (TSCA), chemical...
October 15, 2019
EPA OIG Will Evaluate Implementation of 2009 TSCA PMN Consent Order with DuPont [Chemours]
The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced on September 23, 2019, that it plans to begin an evaluation of EPA’s implementation of the 2009 Toxic Substances Control Act (TSCA) premanufacture notice (PMN) consent order with DuPont [Chemours]. According to OIG, its objective is to determine what actions EPA took to verify compliance with the requirements of the consent order to prevent release of the chemical GenX into the Cape Fear...
October 3, 2019
EPA Publishes TSCA SACC Meeting Minutes and Final Report on Draft Risk Evaluation for PV29
On September 30, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the meeting minutes and final report for the June 18-21, 2019, meeting of the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation for Pigment Violet 29 (PV29). SACC’s report addresses the scientific issues being considered by EPA regarding the peer review for the draft risk evaluation. As reported in our...
On September 25, 2019, the U.S. Environmental Protection Agency (EPA) submitted a proposed significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances to the Office of Management and Budget (OMB) for review. The item on the rulemaking in EPA’s Spring 2019 Regulatory Agenda states that in 2015, EPA proposed amending the SNURs under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for LCPFAC...
On September 25, 2019, the U.S. Environmental Protection Agency (EPA) recognized 14 Safer Choice Partner of the Year award winners for outstanding achievement in 2018 for the design, manufacture, selection, and use of products with safer chemicals for use in households and facilities nationwide. The Safer Choice program partners with businesses and others to help consumers and commercial buyers identify products with safer chemical ingredients, without sacrificing quality or...
The U.S. Environmental Protection Agency (EPA) announced on September 20, 2019, that it will extend the public comment period for its proposed rule intended to reduce exposures to certain chemicals that are persistent, bioaccumulative, and toxic (PBT). 84 Fed. Reg. 36728. EPA identified five chemicals pursuant to Section 6(h) of the Toxic Substances Control Act (TSCA): decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)), also known as...
September 24, 2019
Latest Version of TSCA Inventory Includes Unique Identifier Information
The U.S. Environmental Protection Agency (EPA) announced on September 19, 2019, that it posted the first public Toxic Substances Control Act (TSCA) Inventory to include unique identifier (UID) information. EPA states that the UID is a numerical identifier assigned to a chemical substance when EPA approves a confidential business information (CBI) claim for specific chemical identity. When EPA approves such a claim, it assigns a UID to that chemical identity; applies the UID...
The Environmental Defense Fund (EDF) published a September 16, 2019, blog item entitled “EPA’s latest move to deflect criticism of its TSCA risk evaluations: Muzzle its science advisors.” EDF notes that it has opposed a number of recent decisions made by the U.S. Environmental Protection Agency (EPA) “that aim to limit the risks it finds when evaluating the safety of chemicals under the Toxic Substances Control Act (TSCA),” including: EDF states that through these decisions,...
September 13, 2019
Earthjustice Claims EPA Fails to Disclose Information about New Chemical Substances
On September 3, 2019, Earthjustice filed with the U.S. Environmental Protection Agency (EPA) a notice of intent to sue EPA under Section 20(a)(2) of the Toxic Substances Control Act (TSCA) for “EPA’s repeated and ongoing failures to comply with TSCA’s nondiscretionary mandates to disclose to the public information about new chemical substances reviewed by EPA.” According to Earthjustice, EPA “routinely fails to disclose” certain information regarding the submission and review of...
September 11, 2019
EPA Administrator Signs Directive Intended to Reduce Animal Testing, Awards $4.25 Million for Research on Alternative Methods to Animal Testing
The U.S. Environmental Protection Agency (EPA) issued a press release on September 10, 2019, announcing that EPA Administrator Andrew Wheeler signed a directive to prioritize efforts to reduce animal testing. Administrator Wheeler also announced $4.25 million in funding to five universities to research the development and use of alternative test methods and strategies that reduce, refine, and/or replace vertebrate animal testing. Administrative Wheeler directs the Office of Chemical...
September 5, 2019
EPA Publishes Compliance Guide to Assist Small Entities to Comply with TSCA Section 6(a) Methylene Chloride Rule
On September 4, 2019, the U.S. Environmental Protection Agency (EPA) released new guidance intended to help methylene chloride processors and distributors comply with EPA’s March 2019 rule issued under Section 6(a) of the Toxic Substances Control Act (TSCA) prohibiting the manufacture (including import), processing, or distribution in commerce of methylene chloride for consumer paint and coating removal. The final rule became effective on May 28, 2019. Each person who...
September 4, 2019
Court Rules NYDEC Household Cleansing Product Information Disclosure Program Is “Null and Void”
In a significant victory for industry, on August 27, 2019, the State of New York Supreme Court invalidated the New York Department of Environmental Conservation (NYDEC) Household Cleansing Product Information Disclosure Program (Disclosure Program). Information related to NYDEC’s prior delay of its enforcement of its Disclosure Program is available here, and general information regarding the Program and its extensive requirements for manufacturers of certain consumer cleaning products to...
September 4, 2019
Court Hears Oral Argument in Case Challenging EPA’s Prioritization and Risk Evaluation Rules
In a significant victory for industry, on August 27, 2019, the State of New York Supreme Court invalidated the New York Department of Environmental Conservation (NYDEC) Household Cleansing Product Information Disclosure Program (Disclosure Program). Information related to NYDEC’s prior delay of its enforcement of its Disclosure Program is available here, and general information regarding the Program and its extensive requirements for manufacturers of certain consumer cleaning products to...
September 4, 2019
Court Rules NYDEC Household Cleansing Product Information Disclosure Program Is “Null and Void”
In a significant victory for industry, on August 27, 2019, the State of New York Supreme Court invalidated the New York Department of Environmental Conservation (NYDEC) Household Cleansing Product Information Disclosure Program (Disclosure Program). Information related to NYDEC’s prior delay of its enforcement of its Disclosure Program is available here, and general information regarding the Program and its extensive requirements for manufacturers of certain consumer...
August 30, 2019
B&C-Authored Article “Protecting the Value of Health, Safety Studies—Emerging TSCA Issues” Published in Bloomberg Environment Insights
The cost of generating health and safety studies is considerable and data owners have every right to expect some protection from disclosure to preserve the value of their intellectual property. This is no longer guaranteed as Lynn L. Bergeson, Richard E. Engler, Ph.D., and Kathleen M. Roberts wrote in a two-part article in Bloomberg Environment Insights. The authors propose that the U.S. Environmental Protection Agency’s (EPA) practice of...
The U.S. Environmental Protection Agency (EPA) announced on August 22, 2019, the appointment of Dennis Deziel as Regional Administrator for Region 1. Mr. Deziel will oversee environmental protection efforts in the states of Maine, New Hampshire, Vermont, Massachusetts, Rhode Island, and Connecticut and in ten Tribal Nations. According to EPA, Mr. Deziel has spent much of his life working in public service in Washington, D.C. He most recently worked at Dow as the...
On August 23, 2019, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice proposing to designate 20 chemical substances as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA). 84 Fed. Reg. 44300. The notice includes a summary of the approach used by EPA to support the proposed designations, the proposed designation for each of the chemical substances, and instructions on how to access the chemical-specific information,...
August 23, 2019
PEER Petitions EPA for TSCA Rule Prohibiting Oil Refineries from Using Hydrofluoric Acid in Manufacturing Processes
The U.S. Environmental Protection Agency (EPA) posted an August 7, 2019, petition for rulemaking submitted by the Public Employees for Environmental Responsibility (PEER) under Section 21 of the Toxic Substances Control Act (TSCA). PEER asks that oil refineries be prohibited from using hydrofluoric acid in their manufacturing processes and that oil refineries be required to phase out the use of hydrofluoric acid within two years. According to PEER, TSCA and the Clean Air...