The U.S. Environmental Protection Agency (EPA) has postponed the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) peer review virtual meeting scheduled for April 27-30, 2020, due to recent changes in the availability of SACC members for the review. EPA states that given the importance of the draft risk evaluation for asbestos, it believes that “rescheduling for a time when more members are available is critical and will allow for a more robust...
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On April 17, 2020, the U.S. Environmental Protection Agency (EPA) released the second set of draft scope documents for the seven remaining chemicals designated as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA). As reported in our December 20, 2019, memorandum, EPA designated these chemicals as a high priority for risk evaluation in December 2019. According to EPA, seeking public input on the conditions of use to be included in the risk...
On April 16, 2020, the U.S. Environmental Protection Agency (EPA) hosted a call on its recently announced plan to reduce the burden for certain stakeholders subject to the Toxic Substances Control Act (TSCA) fees rule requirements for EPA-initiated risk evaluations. The call covered: EPA announced on March 25, 2020, that plans to initiate a new rulemaking process to consider proposing exemptions to the current rule’s self-identification requirements associated with...
The U.S. Environmental Protection Agency (EPA) will hold a call on April 16, 2020, from 1:00 p.m. to 2:00 p.m. (EDT) on its recently announced plan to reduce burden for certain stakeholders subject to the Toxic Substances Control Act (TSCA) fees rule requirements for EPA-initiated risk evaluations. The call will cover: EPA asks stakeholders to submit questions by April 14, 2020, to Ben Dyson, dyson.benjamin@epa.gov, and EPA will address them during the call. ...
The U.S. Environmental Protection Agency (EPA) announced on April 8, 2020, that it received a complete manufacturer request for EPA to conduct a risk evaluation of octamethylcyclotetrasiloxane (D4) from Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center. EPA states that...
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. As reported in our December 20, 2019, memorandum, EPA designated these chemicals as a high priority for risk evaluation in December 2019. According to EPA, seeking public input on the conditions of use to be included in...
The U.S. Environmental Protection Agency (EPA) published the draft risk evaluation of asbestos on March 30, 2020. EPA reviewed a suite of potential asbestos exposures and made the following initial determinations on risk: EPA states that these initial determinations are based on a draft risk evaluation of the reasonably available information and are not final determinations on whether asbestos presents unreasonable risks under the conditions of use. EPA will use feedback...
By Lynn L. Bergeson The U.S. Environmental Protection Agency (EPA) announced on March 25, 2020, that it will consider a proposed rule that would look at providing exemptions to the Toxic Substances Control Act (TSCA) fees rule in response to stakeholder concerns about implementation challenges. EPA states that by considering a proposal to narrow the broad scope of the current requirements, it “could significantly reduce burden on potentially thousands of businesses across the country while...
The U.S. Environmental Protection Agency (EPA) announced on March 25, 2020, that it will consider a proposed rule that would look at potential exemptions to the Toxic Substances Control Act (TSCA) fees rule in response to stakeholder concerns about implementation challenges. EPA states that by considering a proposal to narrow the broad scope of the current requirements, it “could significantly reduce burden on potentially thousands of businesses across the country while...
In a Federal Register notice published on March 20, 2020, the U.S. Environmental Protection Agency (EPA) announced that the March 24-26, 2020, Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) meeting to review the draft risk evaluation for trichloroethylene (TCE) is being changed to a virtual public meeting. 85 Fed. Reg. 16096. Participation will be by telephone and webcast only. EPA states the meeting times and...
Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), sat down with Dr. Richard Engler, Director of Chemistry at B&C, to bring everyone up to date on the U.S. Environmental Protection Agency’s (EPA) implementation of the Toxic Substances Control Act (TSCA) fee rule and how it applies to entities obligated to pay a portion of the $1,350,000 per chemical fee for preparing an EPA-initiated risk evaluation, the legal and regulatory significance of the supplemental...
March 9, 2020
EPA Extends Deadline to Self-Identify as a Manufacturer or Importer of a High-Priority Chemical to May 27
On March 9, 2020, the U.S. Environmental Protection Agency (EPA) announced that it has extended the deadline to self-identify as a manufacturer or importer of a high-priority chemical to May 27, 2020. EPA states that it is working to address issues identified with implementation of the Toxic Substances Control Act (TSCA) Fees Rule and EPA-initiated risk evaluations. EPA “is actively seeking ways to address the many implementation impracticalities that have been...
On March 2, 2020, at ChemCon The Americas 2020 in Philadelphia, Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), and Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention, sat down with Tjeerd Bokhout to discuss the implementation of Lautenberg and what can be expected through 2020. Ms. Dunn started off the discussion, noting that EPA is “getting our sea legs under us; we spent the first...
The U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register on February 26, 2020, announcing the availability of the draft risk evaluation for 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.” 85 Fed. Reg. 11079. EPA assessed 54 conditions of use of...
The U.S. Environmental Protection Agency (EPA) released on February 21, 2020, the draft risk evaluation for 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.” EPA assessed 54 conditions of use of TCE, and the draft risk evaluation includes the following findings: EPA notes that the draft risk...
On February 20, 2020, the U.S. Environmental Protection Agency (EPA) published a list of 20 chemical substances identified as low-priority for risk evaluation under the amended Toxic Substances Control Act (TSCA), completing another TSCA requirement. EPA notes that a final designation as “low-priority” means that risk evaluations are not warranted at this time. EPA states that it considered reasonably available information for each chemical substance under its...
The U.S. Environmental Protection Agency (EPA) will host a conference call on February 24, 2020, from 12:30 to 1:00 p.m. (EST) to review certain provisions of the final rule on fees for the administration of the Toxic Substances Control Act (TSCA). In light of the recent publication of the preliminary list of manufacturers/importers subject to risk evaluation fees, as reported in our January 29, 2020, blog item, EPA states that it will give a brief overview of the...
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) 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) 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 20, 2019
NAS Will Peer Review EPA’s TSCA Systematic Review Approach
By Lynn L. Bergeson On December 13, 2019, EPA announced that it has contracted the National Academies of Science (NAS) to conduct a peer review of its Application of Systematic Review in TSCA Risk Evaluations. According to EPA, this review will help provide it with important feedback on its approach to selecting and reviewing the scientific studies that are used to inform Toxic Substances Control Act (TSCA) risk evaluations. EPA states that “integrating systematic review principles...
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
NAS Will Peer Review EPA’s TSCA Systematic Review Approach
The U.S. Environmental Protection Agency (EPA) announced on December 13, 2019, that it contracted the National Academies of Science (NAS) to conduct a peer review of its Application of Systematic Review in TSCA Risk Evaluations. According to EPA, this review will help provide it with important feedback on its approach to selecting and reviewing the scientific studies that are used to inform Toxic Substances Control Act (TSCA) risk evaluations. EPA states that “[i]ntegrating...
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 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) 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 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...
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...
The U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act Science Advisory Committee on Chemicals (TSCA SACC) will peer review EPA’s draft risk evaluation for 1-bromopropane (1-BP) on September 10-12, 2019. The meeting will be held at the Hyatt Regency Crystal City at Reagan National Airport, 2799 Jefferson Davis Highway, Arlington, Virginia. As reported in our August 9, 2019, blog item, EPA released the draft risk evaluation for...
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 17, 2019
EPA Begins Public Comment Period for Manufacturer Requests for Risk Evaluations of DIDP and DINP
The U.S. Environmental Protection Agency (EPA) announced on August 16, 2019, that it is opening a public comment period for manufacturer requests for the risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP), two chemicals used in plastic production. EPA notes that the manufacturer-requested risk evaluations “are among the first such evaluations of this kind to be requested” under the Toxic Substances Control Act (TSCA). EPA is also taking public...
The U.S. Environmental Protection Agency (EPA) released on August 9, 2019, the draft risk evaluation for 1-bromopropane (1-BP), the fourth of the first ten chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA). EPA made the following initial determinations on risk: EPA states that these initial determinations may change as its evaluation becomes more refined through the public and peer review process. The draft risk evaluation, including...
On June 28, 2019, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluations for cyclic aliphatic bromide cluster (HBCD) and 1,4-dioxane, two of the first ten chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA). In its June 28, 2019, press release, EPA states in the draft risk evaluation for HBCD, it did not find unreasonable risk to the general population, consumers, workers, or the environment. According to EPA, in...
June 26, 2019
Court Hears Oral Argument in Case Challenging EPA’s Prioritization and Risk Evaluation Rules
On May 16, 2019, the U.S. Court of Appeals for the Ninth Circuit heard oral arguments in a case filed by non-governmental organizations (NGO) challenging the U.S. Environmental Protection Agency’s (EPA) prioritization and risk evaluation rules. Safer Chemicals, Healthy Families v. EPA, No. 17-72260. During oral arguments, the court asked the Natural Resources Defense Council (NRDC) whether it had standing to be before the court. NRDC responded that it does, arguing that EPA’s rules...
June 26, 2019
Court Hears Oral Argument in Case Challenging EPA’s Prioritization and Risk Evaluation Rules
On May 16, 2019, the U.S. Court of Appeals for the Ninth Circuit heard oral arguments in a case filed by non-governmental organizations (NGO) challenging the U.S. Environmental Protection Agency’s (EPA) prioritization and risk evaluation rules. Safer Chemicals, Healthy Families v. EPA, No. 17-72260. During oral arguments, the court asked the Natural Resources Defense Council (NRDC) whether it had standing to be before the court. NRDC responded that it does, arguing that...
On June 14, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 24, 2019, EPA received manufacturer requests for EPA to conduct risk evaluations of diisodecyl phthalate (DIDP) from ExxonMobil Chemical Company and diisononyl phthalate (DINP) from ExxonMobil Chemical Company, Evonik Corporation, and Teknor Apex, both through the American Chemistry Council’s High Phthalates Panel. EPA states that both DIDP and DINP belong to a family of chemicals commonly referred to...
April 17, 2019
EPA Releases Updated Systematic Review Supplemental Files for CI PV29 Risk Evaluation; Reopens Comment Period
On April 17, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of updated systematic review supplemental files with data evaluation scoring sheets as supporting documents for the draft risk evaluation for Colour Index (C. I.) Pigment Violet 29 (PV29) under the Toxic Substances Control Act (TSCA). 84 Fed. Reg. 16011. EPA states it is “seeking public comment on the draft risk evaluation for PV29 in light of the additional materials already made...
On March 20, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing a list of 40 chemicals to begin the prioritization process required by the amended Toxic Substances Control Act (TSCA). New TSCA requires EPA to designate 20 chemicals as “high-priority” for subsequent risk evaluation and 20 chemicals as “low-priority,” meaning that risk evaluation is not warranted at this time. The 20 high priority candidate chemicals include: EPA is also...
December 19, 2018
Ninth Circuit Issues Order Partially Granting EPA’s Request for Remand of Certain Provisions of Risk Evaluation Final Rule
On December 18, 2018, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order granting in part respondent U.S. Environmental Protection Agency’s (EPA) motion for partial voluntary remand of certain provisions of its final rule on Procedures for Chemicals Risk Evaluation under the Toxic Substances Control Act (TSCA). Specifically, EPA’s motion for partial voluntary remand, filed August 6, 2018, sought remand with vacatur of 40 C.F.R. Section 702.31(d) (Penalty...
On November 29, 2019, the U.S. Environmental Protection Agency (EPA) announced that it has scheduled the first public meetings of the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). The first meeting, a preparatory virtual meeting, and will be held on January 8, 2019, from 2:00 p.m. to 4:00 p.m. (EST). The second meeting, a four-day in-person meeting, will be held on January 29, 2019, from 1:00 p.m. (EST) to 5:30 p.m. and...
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 15, 2018, announcing the availability of and seeking public comment on the first draft chemical risk evaluation under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). The draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 is intended to determine whether C.I. Pigment Violet 29 presents an...
On August 7, 2018, EPA is expected to announce the extension of the comment period on the problem formulations for the risk evaluations for the first 10 chemicals under Toxic Substances Control Act (TSCA) Section 6. The notice extends the comment period on the problem formulations and the document titled Application of Systematic Review of TSCA Risk Evaluations, an additional 21 days, until August 16, 2018. Reportedly EPA received several requests to extend the deadline....
On January 31, 2018, the U.S. Environmental Protection Agency (EPA) announced the release of its 2018 Annual Report on Risk Evaluations. Pursuant to Section 26(n)(2) of the amended Toxic Substances Control Act (TSCA), EPA is directed to publish an annual plan at the beginning of each calendar year identifying the chemical substances that will undergo risk evaluations during that year. The plan is to include both risk evaluations that will be initiated and that will be...
On January 5, 2018, the Natural Resources Defense Council (NRDC) filed a Petition for Review in the U.S. Court of Appeals for the Second Circuit (Second Circuit) of what is characterized as a U.S. Environmental Protection Agency (EPA) “final rule” issued November 7, 2017, entitled “New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA.” The Framework Document, as it has come to be called, is the “final rule” at issue...
On December 11, 2017, in the U.S. Court of Appeals for the Fourth Circuit (Fourth Circuit) case on the petition for review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Chemical Risk Evaluation under TSCA (Alliance of Nurses for Healthy Environments v. EPA, Case Nos. 17-1926, 17-2040, and 17-2244 (consolidated)), the Fourth Circuit granted the petitioners’ motions to transfer to the Ninth Circuit. This was not entirely unexpected, as the U.S. Court...
On November 27, 2017, in the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) case on the petition for review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Prioritization of Chemicals for Risk Evaluation (Safer Chemicals, Healthy Families v. EPA, Case Nos. 17-72260, 17-72501, and 17-72968 (consolidated)), the Ninth Circuit issued an order on several pending motions. It granted the American Chemistry Council’s (ACC) (and other industry groups) motion...
On September 25, 2017, Petitioners Safer Chemicals Healthy Families and Environmental Defense Fund (EDF) (collectively Petitioners) in Ninth Circuit Case Nos. 17-72260 and 17-72501 (regarding review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Prioritization of Chemicals for Risk Evaluation) filed a joint opposition to the U.S. Environmental Protection Agency’s (EPA) motion to transfer to the Fourth Circuit and hold cases in abeyance. On September 14, 2017,...