All Knowledge & Insights By Date

On August 17, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) published a report entitled Lack of Planning Risks EPA’s Ability to Meet Toxic Substances Control Act Deadlines.  OIG conducted the audit to determine whether EPA met the deadlines already imposed by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) in 2016, which amended the Toxic Substances Control Act (TSCA), and has the staff, resources, and...

On August 12, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of the final risk evaluation for 1-bromopropane (1-BP).  85 Fed. Reg. 48687.  After evaluating 25 conditions of use, EPA determined that 16 present an unreasonable risk to workers, occupational non-users (ONU), consumers, and bystanders.  For those conditions of use for which EPA has found an unreasonable risk, EPA states that it must take regulatory action to address that...

On July 16, 2020, a coalition of non-governmental organizations (NGO) filed a petition in the U.S. Court of Appeals for the Ninth Circuit, challenging the U.S. Environmental Protection Agency’s (EPA) final risk evaluation for methylene chloride.  The NGOs seek review of EPA’s determination “that the chemical methylene chloride does not present an unreasonable risk of injury to health or the environment under certain conditions of use” and its decision not to consider “certain uses...

On June 30, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report on its audit to determine whether the Safer Choice program effectively meets its goals and whether the program achieves quality standards through its product qualification, renewal, and required audit processes.  OIG states that EPA’s Safer Choice program does not have formal goals included in the fiscal year (FY) 2018-2022 EPA Strategic Plan, and the program has not reported...

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 petitioned the U.S. Environmental Protection Agency (EPA) to develop a risk management procedural rule under the Toxic Substances Control Act (TSCA).  According to ACA’s June 15, 2020, press release, ACA “believes that a procedural rule would provide guard rails to ensure consistency, transparency and effective...

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...

During the week of June 15, 2020, the U.S. District Court for the Northern District of California heard from the U.S. Environmental Protection Agency’s (EPA) final three witnesses:  Dr. Joyce Tsuji, Dr. Ellen Chang, and Dr. Tala Henry.  Food & Water Watch, Inc. v. EPA, Case No. 3:17-cv-02162-EMC.  Dr. Tsuji did not dispute that fluoride can be a neurotoxin at “high enough levels.”  Dr. Tsuji contended that the scientific literature remains too limited to establish...

The U.S. Environmental Protection Agency (EPA) announced on June 12, 2020, that it is opening a public comment period for a manufacturer-requested risk evaluation of octamethylcyclotetra-siloxane (D4), a chemical used to make other silicone chemicals and as an ingredient in some personal care products.  EPA states that the manufacturer-requested risk evaluation of D4 is the third evaluation of this kind to be requested under the amended Toxic Substances Control Act (TSCA).  EPA...

The U.S. Environmental Protection Agency (EPA) recently published its 2020 Annual Plan for Chemical Risk Evaluations under TSCA (Annual Plan).  Section 26(n) of the Toxic Substances Control Act (TSCA) requires EPA to publish an annual plan at the beginning of each calendar year that identifies the chemical substances for which EPA expects to initiate or complete risk evaluations that year and the resources necessary for their completion, describes the status of each risk evaluation that has...

On May 20, 2020, the Senate Environment and Public Works Committee held an oversight hearing on the U.S. Environmental Protection Agency (EPA).  EPA Administrator Andrew Wheeler was the only witness.  During the hearing, Senator Jeff Merkley (D-OR) questioned Wheeler about the risk evaluations being done under the amended Toxic Substances Control Act (TSCA), particularly the risk evaluation of asbestos.  Wheeler acknowledged that EPA probably will not meet the June 22, 2020, deadline for...

As we noted in our May 15, 2020, blog item “NGOs Ask EPA to Revise Draft Scope Documents to Comply with TSCA and EPA Regulations,” Environmental Defense Fund (EDF), Earthjustice, Natural Resources Defense Council (NRDC), and Safer Chemicals, Healthy Families filed comments on May 13, 2020, stating that the U.S. Environmental Protection Agency’s (EPA) 20 draft scope documents released on April 9 and April 23, 2020, fail to meet Toxic Substances Control Act (TSCA) and EPA...

Environmental Defense Fund (EDF), Earthjustice, Natural Resources Defense Council (NRDC), and Safer Chemicals, Healthy Families filed comments on May 13, 2020, stating that the U.S. Environmental Protection Agency’s (EPA) 20 draft scope documents released on April 9 and April 23, 2020, fail to meet Toxic Substances Control Act (TSCA) and EPA regulatory requirements.  According to EDF’s May 14, 2020, blog item, the non-governmental organizations (NGO) called on EPA to revise the...

The U.S. Environmental Protection Agency (EPA) announced on May 11, 2020, that the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) will meet from June 8 to 11, 2020, to peer review the draft risk evaluation for asbestos.  The public meeting will be virtual, with participation by phone and webcast only.  There will be no in-person gathering for this meeting.  EPA postponed the previously announced virtual meeting for SACC to review...

 The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 4, 2020, announcing the availability of and soliciting public comment on the draft Toxic Substances Control Act (TSCA) risk evaluation of perchloroethylene.  85 Fed. Reg. 26464.  EPA states that it is also submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review and is announcing that there will be two virtual public meetings of the TSCA SACC, with...

On April 27, 2020, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluation of perchloroethylene.  Perchloroethylene is the last of the first ten chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA).  EPA’s draft risk evaluation preliminarily found unreasonable risk to workers, occupational non-users, consumers, bystanders, and the environment from certain uses.  EPA states that the primary health risk identified in the draft...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on April 23, 2020, announcing the availability of the draft scope documents for the risk evaluations to be conducted for the remaining seven of the 20 high-priority substances designated in December 2019.  85 Fed. Reg. 22733.  The draft scope document for each chemical substance includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to...

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...

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: How EPA’s plan to initiate a rulemaking to consider proposing exemptions to the current rule’s requirements impacts manufacturers and other businesses;  What the “No Action Assurance” means for...

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: TSCA fees rule requirements and processes associated with EPA-initiated risk evaluations;  EPA’s March 25, 2020, rulemaking announcement and “No...

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 risk...

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 did not find risk to the environment.  For all the conditions of use included in the draft risk evaluation, EPA has preliminarily found no unreasonable risks to the environment under any of the conditions of use.  EPA’s draft risk evaluation...

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...

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 did not find risk to the...

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 fees...

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...

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 evaluation for...

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...

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. ...

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...

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: EPA did not find risk to the environment, bystanders, or occupational non-users.  For all the conditions of use included in the draft risk evaluation, EPA has preliminarily...

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 did not find risk to the environment, bystanders, or occupational non-users.  For all the conditions of use included...

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 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,...

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...