Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 21, 2022, that it seeks public nominations of scientific and technical experts whom EPA can consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with the peer review of two draft documents entitled “Draft Proposed Principles of Cumulative Risk Assessment Under the Toxic Substances Control Act” and “Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer Requested Phthalate Under the Toxic Substance Control Act.” 87 Fed. Reg. 78103. EPA states that it will submit the two draft documents to SACC and release them for public review and comment in late February 2023. EPA will solicit comments from SACC on issues related to chemical grouping for purposes of cumulative risk assessment (CRA), health outcomes related to phthalate syndrome, and possible approaches to developing the cumulative hazard and exposure assessment for high-priority phthalates and a manufacturer-requested phthalate. EPA also announced the scheduling of a four-day virtual public meeting for SACC to consider and review the two draft documents. EPA provides the following chronological listing of the dates for the specific activities:

  • January 20, 2023 -- Deadline for submitting all nominations to EPA;
     
  • April 24, 2023 -- Deadline for submitting a request for special accommodations to allow EPA time to process the request before the meeting; and
     
  • May 8 to 11, 2023, from 10:00 a.m. to approximately 5:30 p.m. (EDT) -- The public virtual meeting will be held via a webcast platform such as “Zoom.gov” and audio teleconference, and you must register to receive the links.

 
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By Lynn L. Bergeson and Carla N. Hutton
 
On December 15, 2022, the U.S. Environmental Protection Agency (EPA) announced a redesign and updates to the statistics web page for the New Chemicals Review Program. According to EPA, the update includes additional information and metrics on the Agency’s review of new chemicals under the Toxic Substances Control Act (TSCA), increasing transparency for the public, the regulated community, and other stakeholders.
 
According to EPA, before TSCA was amended in 2016 by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), EPA issued formal risk determinations for approximately 20 percent of new chemical submissions. EPA states that in 80 percent of the cases, EPA dropped the chemical from further review, which under the prior law would allow the manufacturer to take the chemical to market.
 
Under the Lautenberg Act amendments, EPA is required to make an affirmative determination on all new chemical notices submitted under TSCA, “substantially increasing the Agency’s workload.” EPA notes that despite the “dramatic increase in responsibility,” its budget for the TSCA program has remained essentially flat over the past six years.
 
To address resource limitations, EPA has taken several significant steps over the past year to create a sustainable program that follows the science and the law. EPA states that the redesigned and updated web page represents another important step in that process. EPA will update the data displayed on the enhanced web page monthly. According to EPA, the data show that EPA “continues to make positive progress on reviewing new chemicals and managing risks to human health and the environment. With more funding and resources, EPA could further increase the efficiency, effectiveness and transparency of its work.”
 
More Detailed Breakdown of New Chemical Submissions
 
EPA states that the web page now contains month-by-month counts of new chemical submissions, completed risk assessments, and completed risk management actions for all notices and exemptions, allowing users to track monthly progress on EPA’s new chemicals workload.
 
EPA notes that the new monthly statistics table “shows recent improvement in EPA’s ability to conduct risk assessments efficiently -- in October and November, EPA completed 99 risk assessments, more than double from the prior two-month period.” According to EPA this progress “is a result of EPA’s aggressive recruitment and training for scientists with relevant experience and background to conduct risk assessments and efforts to continuously improve the program’s review process and procedures.”
 
Additionally, new tables and graphs on the web page visualize new chemicals submission trends and changes from fiscal years (FY) 2010-2022. Previously, the web page included a count of the total number of completed actions since the 2016 TSCA amendments, but it did not break this information down by FY.
 
Status Tracker for New Chemical Exemptions
 
The revised web page now also includes a tracker for other applications submitted to the New Chemicals Program, including low volume exemptions (LVE), low release and low exposure exemptions (LoREX), test market exemptions (TME), TSCA environmental release applications (TERA), and Tier II exemptions for microorganisms (Tier II). EPA notes that previously, the web page only included this kind of tracking for premanufacture notices (PMN), significant new use notices (SNUN), and microbial commercial activity notices (MCAN).
 
According to EPA, exemptions represent over 50 percent of the new chemical notices submitted to EPA. EPA states that the new tracker “makes it easy for users to monitor the number of active exemption cases currently under review by EPA and their review status, giving stakeholders greater insight into the status of a significant portion of the program’s workload.”
 
Information on the New Chemicals Review Process
 
The new web page provides greater detail about the new chemicals review process, including explanations of each step of the review process for notices and exemptions. Also new to the web page is an explanation of the factors that EPA considers when triaging new chemical submissions for review. EPA states that these factors include the date of receipt of submission, statutory and regulatory deadlines, the level of effort needed to rework potentially some or all of the risk assessment, and the applicability of new approaches that EPA has developed to standardize reviews for certain new chemicals. EPA states that providing this information helps submitters understand how EPA manages its large workload within limited resource constraints and helps them submit complete notices in the order that matters most for their business.
 
Other New Chemicals Improvements
 
EPA states that the New Chemicals Program has taken several steps this year to enhance the review process for new chemicals, resulting in 480 risk assessments completed and 447 risk management actions issued in FY 2022. These efforts include:

  • Launching innovative approaches to reviewing new biofuels and mixed metal oxides (MMO) used in new and modified cathode active materials (CAM), which have helped increase the program’s capacity by standardizing the review process for these chemicals;
  • Conducting an outreach initiative consisting of several webinars with stakeholders to explain how EPA evaluates engineering data for new chemical submissions, with the goal of preventing common issues that contribute to delays in new chemical reviews and stretch limited resources;
  • Developing a multi-year collaborative research program with the Office of Research and Development (ORD) and other federal entities to bring innovate science to new chemical reviews before they can enter the marketplace; and
  • Aggressively recruiting, onboarding, and training new staff to conduct risk assessments and developing new policies, guidance, and standard operating procedures.

We applaud EPA’s efforts to improve the efficiency and transparency of its operations. We appreciate that EPA is working hard, with too few resources and staff, and welcome these enhancements to the EPA website.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The New York State Department of Environmental Conservation (NYS DEC) will hold a virtual public meeting on January 10, 2023, on the chemicals under consideration for listing as Chemicals of Concern (COC) and High Priority Chemicals (HPC) for the Toxic Chemicals in Children’s Products (TCCP) program. NYS DEC will present an overview of the enacted TCCP law and discuss the chemicals under consideration for listing as COCs and HPCs that manufacturers will be required to report if present in children’s products. NYS DEC asks that stakeholders note that it “is soliciting feedback on these chemicals under consideration and will post them on our website in advance of the meeting. Additionally, please note that this will be a pre-rulemaking meeting and DEC anticipates releasing a proposed rule with additional public comment opportunities after feedback at this meeting is obtained.” Registration for the January 10, 2023, meeting is required.
 
As reported in our September 16, 2021, blog item, NYS DEC held a virtual public meeting on September 15, 2021, on its forthcoming regulations to implement the TCCP law. New York’s Environmental Conservation Law (ECL) Article 37 Title 9 establishes an ingredient disclosure program and prohibits certain chemicals in children’s products. ECL Article 37 instructs NYS DEC to promulgate lists of COCs and high priority chemicals that must be disclosed if present in children’s products by March 1, 2022. ECL Article 37 also prohibits the sale of children’s products containing benzene, asbestos, or tris(1,3-dichloro-2-propyl) phosphate effective January 1, 2023. NYS DEC has posted a list of chemicals under consideration and their practical quantification limits.

Tags: New York, TCCP

 
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By Lynn L. Bergeson and Carla N. Hutton
 
On December 2, 2022, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMN) and are also subject to Orders issued by EPA pursuant to TSCA. 87 Fed. Reg. 74072. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required by that determination. Comments are due January 3, 2023.
 
According to EPA, during review of the PMNs submitted for the chemical substances that are the subject of the proposed SNURs, EPA concluded that regulation was warranted under TSCA Section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. Based on its findings, EPA negotiated TSCA Section 5(e) Orders requiring the use of “appropriate exposure controls” with the PMN submitters. EPA states that as a general matter, it “believes it is necessary to follow the TSCA Orders with a SNUR that identifies the absence of those protective measures as significant new uses to ensure that all manufacturers and processors -- not just the original submitter -- are held to the same standard.” The proposed SNURs also include significant new uses that EPA proposes to determine are not ongoing based either on information showing that the chemical is not on the TSCA Inventory or based on EPA’s review of Chemical Data Reporting (CDR) submissions under TSCA Section 8(a). EPA states that it “believes that these uses could significantly increase the magnitude and duration of exposure to humans and the environment to these chemical substances. Accordingly, EPA wants the opportunity to evaluate and manage risks, where appropriate, from activities associated with those uses, before manufacturing or processing for those uses were to begin.”
 
EPA states that the SNURs advance one of the “key actions” in the PFAS Strategic Roadmap where EPA stated it plans to revisit past regulatory decisions concerning per- and polyfluoroalkyl substances (PFAS) and address those that are insufficiently protective by imposing additional notification requirements. According to EPA, in this way, it “can ensure it has the opportunity to review PFAS before they are used in new ways that might present concerns.” More information on the PFAS Strategic Roadmap is available in our October 19, 2021, memorandum.

Tags: SNUR, PFAS

 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 7, 2022, that the final video recording, slide deck, and case study worksheets from the CompTox Chemicals Dashboard virtual training are now available. EPA also announced that the Dashboard recently released a new version (v2.1.1). New features include:

  • A new link to an updated set of Help Pages containing new information;
  • Ability to visualize structures in Batch Search;
  • Ability to filter out chemicals that are structures;
  • Moving the chemistry-related data tabs under a single tab;
  • reCAPTCHA implementation to ensure continued functionality;
  • Updating the Production Volume data;
  • Updating the ADME > IVIVE table using the latest HTTK R-package v2.2.1 algorithm; and
  • Several bug fixes.

EPA suggests that if users do not see these updates to try clearing the cache.

The recordings and slides from the October 12-13, 2022, EPA New Approach Methods (NAM) Conference are available on the conference web page. Conference topics included:

  • Variability and Relevance of Traditional Toxicity Tests;
  • Evolution of Validation and Scientific Confidence Frameworks to Incorporate 21st Century Science; and
  • Breakout groups discussing Variability of Traditional Toxicity Tests, Relevance of Traditional Toxicity Tests, and Feedback on EPA Scientific Confidence Framework.

 
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By Lynn L. Bergeson and Carla N. Hutton
 
Under the Reports Consolidation Act of 2000, each agency’s inspector general must prepare an annual statement summarizing what the inspector general considers to be “the most serious management and performance challenges facing the agency” and to assess briefly the agency’s progress in addressing those challenges. On November 29, 2022, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released its report regarding EPA’s fiscal year (FY) 2023 top management challenges. According to the report, the eight top management challenges for EPA in FY 2023 include:

  • Providing for the Safe Use of Chemicals: The public must be able to depend on the EPA’s ability to conduct credible and timely assessments of the risks posed by pesticides, toxic chemicals, and other environmental chemicals.

OIG states in its full report that it conducted an evaluation in 2020 of EPA’s progress toward meeting deadlines established by the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), focusing primarily on TSCA’s existing chemicals program. OIG recommended that the Office of Chemical Safety and Pollution Prevention (OCSPP) assistant administrator publish the annual existing chemicals plan, including the anticipated implementation efforts and required resources; conduct a workforce analysis to assess the Office of Pollution Prevention and Toxics’ (OPPT) capability to implement TSCA; and specify what skill gaps had to be filled in FY 2021 to meet the TSCA requirements. According to OIG, on February 7, 2022, OCSPP certified that it had completed all corrective actions for the recommendations in its report. More information on OIG’s 2020 report is available in our August 18, 2020, blog item.
 
OIG notes that an audit of TSCA’s New Chemicals Review Process is currently ongoing as part of its FY 2022 Oversight Plan. According to OIG, the objective of that review is to determine the extent to which EPA is using and complying with applicable records-management and quality-assurance requirements and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks.
 
According to OIG, per EPA, “an increased workload and the need for resources -- especially staff trained in specific science skills -- are major factors in not being on track to meet many of the EPA’s statutory deadlines.” Citing a trade press article, OIG states that “[s]pecifically, the OCSPP stated that it does not have the resources to address statutory requirements. The OCSPP also stated that it has not received the necessary funding to complete its mission.” For example, OCSPP reports that it has approximately 310 full-time equivalent staff but estimates that it needs about 500 full-time equivalents for its mission. EPA also cited a lack of resources for its failure to post publicly the risk reports for 1,240 new chemicals.
 
In FY 2022, EPA requested an additional $15 million and 87.6 full-time equivalents -- a 35 percent increase from the FY 2021 enacted full-time equivalent level -- to meet the increased responsibilities from the Lautenberg Act. The FY 2022 enacted budget provided for 25.6 full-time equivalents for TSCA programs, however. Furthermore, according to OIG, OCSPP conducted a recent assessment that recommended that the office hire more staff, mitigate the workload to manage the workforce’s daily stress, modernize information technology (IT) systems, and eliminate the use of multiple tracking systems.
 
OIG concludes that many of the Biden Administration’s top priorities rely on the work of the OCSPP. Both EPA OIG and EPA have noted that key OCSPP programs face a steep staffing shortage and a lack of planning that could negatively impact critical chemical work, however. Absent the resources OCSPP needs for its TSCA programs, EPA “will remain challenged with meeting its statutory deadlines.” OIG states that if OCSPP is unable to balance the workload with its resource needs, EPA “will continue to face the key challenge of ensuring the safety of chemicals.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On November 21, 2022, the U.S. Environmental Protection Agency (EPA) announced that it has improved public access to certain reports submitted by chemical companies in ChemView, EPA’s web application for public access to non-confidential business information (non-CBI) on chemicals regulated under the Toxic Substances Control Act (TSCA), including new chemical notices and notices of substantial risk. EPA has published previously unpublished new chemical notices received under TSCA Section 5 and notices of substantial risk provided by companies under TSCA Section 8(e). EPA states that going forward, it will continue to identify older, previously submitted unpublished information to make available in ChemView and will publish newly received TSCA Section 5 notices and TSCA Section 8(e) reports on a “near real-time basis.” EPA has also published in ChemView chemical health and safety studies received under TSCA Section 8(d).
 
New Chemical Submissions
 
TSCA Section 5 requires EPA to publish a list of new chemical submissions it has received, including premanufacture notices (PMN), significant new use notices (SNUN), microbial commercial activity notices (MCAN), test market exemption (TME) applications, notices of commencement of manufacture or import (NOC), and test information submitted under Section 5. According to EPA, in 2022 it made available in ChemView more than 25,000 new chemical notice records received under TSCA Section 5, including notices received between 2014 and 2019 that had not been published previously. In 2019, EPA began publishing non-CBI notices on an ongoing basis, and “new records are now generally published within five days of receipt.” EPA states that it will also continue to identify and make public older, previously unpublished new chemicals notices.
 
Notices of Substantial Risk
 
TSCA Section 8(e) requires chemical companies to inform EPA of information that reasonably supports the conclusion that a chemical may present a substantial risk of injury to health or the environment. EPA uses these notices to inform new and existing chemical risk assessment activities. According to EPA, in 2022 it has published 3,900 notices of substantial risk records received under TSCA Section 8(e) in ChemView, including more than 3,300 non-CBI notices submitted between January 1, 2019, and December 20, 2021, that were not previously published due to resource limitations. EPA states that over the next several months, it will publish all non-CBI versions of Section 8(e) notices received from December 20, 2021, to the present. Going forward, “EPA will strive to publish 8(e) notices deemed complete within a week of receiving them from companies.” Additionally, EPA will work to identify and publish Section 8(e) notices received before 2019 as resources allow.
 
Health and Safety Data Reporting
 
Regulations promulgated under TSCA Section 8(d) require chemical companies to submit lists and copies of health and safety studies relating to the health and/or environmental effects of specified chemical substances and mixtures. According to EPA, in 2022 it published more than 1,700 health and safety study records received since September 2021 under TSCA Section 8(d) in ChemView. EPA notes that many of these records were in response to EPA’s 2021 Section 8(d) rulemaking, Health and Safety Data Reporting; Addition of 20 High-Priority Substances and 30 Organohalogen Flame Retardants. EPA states that it expects to publish additional Section 8(d) records “in the future.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a webinar on December 6, 2022, to provide an overview to stakeholders about its November 16, 2022, supplemental proposed rule modifying and adjusting certain aspects of the fees rule established under the Toxic Substances Control Act (TSCA). EPA states that it is publishing these changes to ensure that collected fees provide it with 25 percent of authorized TSCA costs consistent with direction in the fiscal year 2022 appropriations bill to consider the “full” implementation costs of the law. According to EPA, updating TSCA fees will strengthen its ability to implement successfully TSCA in a way that is both protective and sustainable and significantly improve on-time performance and quality. The webinar will provide stakeholders an opportunity to provide comment to EPA on the supplemental proposed rule. Registration for the webinar is open. Stakeholders who wish to provide oral comments during the webinar are asked to register by December 1, 2022. Comments on the supplemental proposed rule are due January 17, 2023. More information on the supplemental proposed rule will be available in our forthcoming memorandum.


 
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This webinar has been rescheduled from December 7, 2022. The new and correct date and time is December 14, 2022, 12:00 p.m. – 1:00 p.m. (EST).

Registration is open for the "Articles under TSCA" webinar on December 14, 2022, 12:00 p.m. - 1:00 p.m. (EST).

When the Toxic Substances Control Act (TSCA) was enacted in 1976, the U.S. Environmental Protection Agency (EPA) focused its attention on chemical substances and chemical mixtures, while largely exempting the regulation of chemicals in “articles,” generally meaning finished products or manufactured goods. EPA’s more recent announcement of its intent to regulate chemicals in articles to a much greater extent has caught many in the regulated industries off guard and reflects a significant shift in U.S. chemical regulation policy. This change in policy affects all commercial entities that deal with a physical product, as they must now become familiar with the law, its requirements, and the chemical makeup of their finished goods. This webinar will cover the policy changes that led to the regulation of articles, EPA’s authority to regulate these articles, and what companies need to know to stay in compliance.
 
Register now to join Richard E. Engler, Ph.D., Eve Gartner, and Lynn L. Bergeson for the Bergeson & Campbell, P.C. (B&C®) webinar “Articles under TSCA.”

Topics Covered:  

  • What products in commerce qualify as articles;
     
  • What EPA’s change in approach means as a practical matter for the supply chain; and
     
  • The importance and challenges of transparency in product sourcing.

Speakers Include:

Richard E. Engler, Ph.D. is Director of Chemistry with B&C. Dr. Engler is a 17-year veteran of EPA and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA’s Office of Pollution Prevention and Toxics (OPPT) and leader of EPA’s Green Chemistry Program. He has participated in thousands of TSCA substance reviews at EPA, as well as pre-notice and post-review meetings with submitters to resolve complex or difficult cases, and he draws upon this invaluable experience to assist B&C clients as they develop and commercialize novel chemistries.
 
Eve Gartner is the Managing Attorney for the Toxic Exposure and Health Program at Earthjustice, where she leads a team of professionals charged with protecting human health from toxic chemicals. Ms. Gartner works with groups around the country to develop state policies that will reduce exposures to chemicals and pesticides. She also serves as part of Project TENDR, a collaboration of scientists, health professionals, and children’s health advocates working to develop policy approaches to address the link between environmental exposure and neurodevelopmental disorders.
 
Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Ms. Bergeson counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.


 
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 By Lynn L. Bergeson and Carla N. Hutton
 
On November 15, 2022, a coalition petitioned the U.S. Environmental Protection Agency (EPA) under Section 21 of the Toxic Substances Control Act (TSCA) to require human and environmental health and safety testing for polyvinyl alcohol (PVA/PVOH) as it is used in consumer-packaged goods, “with particular attention to the use of PVA in laundry and dishwasher detergent pods and sheets.” The petitioners request that until such testing is completed, EPA remove PVA/PVOH from its Safer Choice Program “to curb plastic pollution.”
 
The coalition was filed on behalf of Blueland and Plastic Pollution Coalition, as well as the following “leading nonprofit organizations fighting plastic pollution and climate change”: Beyond Plastics; Plastic Oceans International; The Shaw Institute; Lonely Whale; 5 Gyres; GAIA (Global Alliance for Incinerator Alternatives); Oceanic Global Foundation; The Last Beach Cleanup; Rio Grande International Study Center; Inland Ocean Coalition; Occidental Arts and Ecology Center; Turtle Island Restoration Network; Friends of the Earth; Surfrider; and Made Safe.
 
The American Cleaning Institute (ACI) released a statement on November 15, 2022, regarding the “misinformation that is being spread about PVA/PVOH.” ACI states that it “believe[s] this recent effort by NGOs to petition the EPA is part of an ongoing marketing campaign funded by a company with an interest in preventing other companies from using this technology.” According to ACI, the marketing campaign “ignores decades of science and research demonstrating the biodegradability of this chemistry.”
 
EPA is required to grant or deny TSCA Section 21 petitions within 90 days from the day the petition is filed with EPA. If EPA grants the petition, EPA must promptly commence an appropriate proceeding. If EPA denies the petition, EPA must publish the reasons for its denial in the Federal Register.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On November 10, 2022, California filed suit in California Superior Court against the manufacturers of per- and polyfluoroalkyl substances (PFAS) “for endangering public health, causing irreparable harm to the state’s natural resources, and engaging in a widespread campaign to deceive the public.” According to California Attorney General Rob Bonta’s November 10, 2022, press release, California “alleges that these manufacturers, including 3M and DuPont, knew or should have known that PFAS are toxic and harmful to human health and the environment, yet continued to produce them for mass use and concealed their harms from the public.” California claims that as a result, “these toxic ‘forever chemicals’ are pervasive across California’s bays, lakes, streams, and rivers; in its fish, wildlife, and soil; and in the bloodstream of 98% of Californians.” The complaint claims that the manufacturers “created and/or contributed to a public nuisance, harmed and destroyed natural resources, marketed defective products, failed to provide adequate warnings concerning the use of their products, and engaged in unlawful business practices.”
 
The press release states that the lawsuit concerns seven common PFAS that have been detected in drinking water supplies, surface waters, and groundwater in California: perfluorooctanoic acid (PFOA); perfluorooctanesulfonic acid (PFOS); perfluorobutanesulfonic acid (PFBS); perfluorohexanesulfonic acid (PFHxS); perfluorohexanoic acid (PFHxA); perfluoroheptanoic acid (PFHpA); and perfluorononanoic acid (PFNA). California requests statewide treatment and destruction of PFAS, including, but not limited to, the treatment of drinking water by regulated water systems; water drawn from private wells and unregulated systems used for drinking water and irrigation; and water from other wastewater treatment plants and systems. California also seeks payment of funds necessary to mitigate the impacts to human health and the environment through environmental testing, medical monitoring, public noticing, replacement water (for period between testing and installation of treatment), and safe disposal and destruction.


 
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By Lynn L. Bergeson and Carla N. Hutton

Research in the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) is organized around six highly integrated and transdisciplinary national research programs that are closely aligned with EPA’s strategic goals and cross-EPA strategies. Each program is guided by a Strategic Research Action Plan (StRAP) developed by EPA with input from its many internal and external partners and stakeholders. In October 2022, EPA published six StRAPs for fiscal years (FY) 2023-2026. EPA states that the StRAP for Chemical Safety for Sustainability (CSS) “is focused on addressing the pressing environmental and health challenge of a lack of sufficient information on chemicals needed to make informed, risk-based decisions.” The StRAP for CSS states that CSS will continue to:

  • Develop the science needed to reduce, refine, and replace vertebrate animal testing consistent with EPA policies;
  • Accelerate the pace of chemical assessment to enable our partners to make informed and timely decisions concerning the potential impacts of environmental chemicals on human health and the environment; and
  • Provide leadership to transform chemical testing, screening, prioritization, and risk assessment practices.
Tags: CSS, ORD, StRAP

 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 10, 2022, that it is requesting nominations of prospective candidates for membership on the Science Advisory Committee on Chemicals (SACC) established under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 67898. Any interested person or organization may nominate qualified persons to be considered for appointment to the SACC. Individuals may also self-nominate. Nominations are due December 12, 2022.
 
SACC serves as a scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). According to EPA, SACC provides independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA. Currently, there are 17 SACC members, with eight membership terms that will expire over the next year.
 
EPA states that its “rigorous scientific peer review processes ensure all Agency decisions are founded on credible science and data. Science provides the foundation for EPA policies, actions and decisions made on behalf of the American people.”
 
To be considered, all nominations should include the following information:

  • Current contact information for the nominee (including the nominee’s name, organization, current business address, e-mail address, and daytime telephone number);
     
  • The nominee’s disciplinary and specific areas of expertise;
     
  • Research activities;
     
  • Recent service on other federal advisory committees and national or international professional organizations; and
     
  • When available, a biographical sketch of the nominee, indicating current position and educational background.

EPA states that it is seeking nominations from individuals who have demonstrated high levels of competence, knowledge, and expertise in scientific and other technical fields relevant to chemical safety and risk assessment. EPA seeks nominees with expertise in a variety of disciplines and focus areas, including human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically based pharmacokinetics (PBPK), toxicology and pathology (including neurotoxicology, developmental/reproductive toxicology, and carcinogenesis), and chemical exposure pathways to susceptible life stages and subpopulations (women, children, and other potentially exposed subpopulations).
 
EPA states that nominees should have backgrounds and experiences that would contribute to the diversity of scientific viewpoints on the committee -- including professional experiences in government, labor, public health, public interest, animal protection, industry, and other groups -- and as the EPA Administrator determines to be advisable (e.g., geographical location; social and cultural backgrounds; and professional affiliations).

Tags: SACC, OCSPP, Review

 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 9, 2022, that it awarded $7,770,044 in research grant funding to 11 institutions to develop and evaluate innovative methods and approaches to inform its understanding of the human health risks that may result from exposure to chemical mixtures in the environment. EPA states that toxicology studies have traditionally focused on the effects of single chemicals on human health. Chemicals in the environment are often present as mixtures in the air, water, soil, food, and products in commerce, however, and these chemical mixtures include per- and polyfluoroalkyl substances (PFAS), phthalates, polycyclic aromatic hydrocarbons (PAH), disinfection byproducts (DBP), and other well-characterized mixtures. According to EPA, there is a need to assess the toxicity of chemical mixtures to understand how their combined effects on human health and the environment differ from what is known about individual chemicals. Due to their lower cost and higher throughput, new approach methods (NAM) and use of alternative animal models have emerged as potential approaches to advance the risk assessment of mixtures.
 
To help address this research need, the institutions receiving these grants will conduct research focused on the development, improvement, evaluation, and integration of predictive toxicology methods to evaluate environmental chemical mixtures. The grantees and their project titles include:

  • Georgia Institute of Technology, Atlanta, Georgia -- High-Throughput Lung Damage and Inflammation Assessment of Polyaromatic Hydrocarbon Mixtures;
     
  • Medical University of South Carolina, Charleston, South Carolina -- Developing an Integrated Framework for Evaluating Toxicity of Real-life Chemical Mixtures;
     
  • Purdue University, West Lafayette, Indiana -- Protein Binding Affinity as the Driver for Studying PFAS Mixture Toxicity;
     
  • The Research Foundation of CUNY, New York, New York -- Innovative Approach to Assess the Effect of Metal Mixtures from Infant Meconium Associated with Adverse Infant Outcomes by Identifying Methylation Loci in Mothers and Infants;
     
  • Texas A&M University, College Station, Texas -- A Tiered Hybrid Experimental-Computational Strategy for Rapid Risk Assessment of Complex Environmental Mixtures Using Novel Analytical and Toxicological Methods;
     
  • University at Buffalo, Buffalo, New York -- Assessment of Neurotoxicity of Mixtures of PFAS and Other Neuroactive Organic Pollutants through Integrated in Silico, in Vitro Cellular, and in Vivo Models;
     
  • University of Georgia Research Foundation, Inc., Athens, Georgia -- Development of a Quantitative Adverse Outcome Pathway Network to Assess Neurodevelopmental Toxicity of PFAS Mixture in C. Elegans;
     
  • University of Houston, Houston, Texas -- Oral Toxicity Assessment of PAH Mixtures Using an in Vitro 3D Cell Culture Bioreactor Mimicking the in Vivo Intestinal Tract Environment;
     
  • University of Massachusetts Boston, Boston, Massachusetts -- Whole Animal New Approach Methodologies for Predicting Developmental Effects of Air Pollutant Mixtures;
     
  • University of North Carolina at Chapel Hill, Chapel Hill, North Carolina -- Wildfire Smoke Mixtures Toxicity Testing; and
     
  • Wayne State University, Detroit, Michigan -- Assessment of Underlying Molecular Mechanisms Promoting Adipogenic Outcomes in Complex Mixtures.

 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 4, 2022, that it will hold the first of a two-part webinar series on November 17, 2022, on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). As reported in our October 11, 2022, memorandum, in October 2022, EPA announced an innovative effort intended to help make its review of new MMOs, including new and modified CAMs, more efficient. According to EPA, MMOs are used in batteries, electric vehicles, semiconductors, and renewable energy generation, making them a vital part of clean energy sectors.
 
EPA states that the kickoff webinar will provide statutory and regulatory background, including the related compliance advisory, a broad overview of the approach for risk assessment and risk management, and information on the Toxic Substances Control Act (TSCA) Inventory, nomenclature, and the bona fide process for those seeking to find out if their MMOs are already on the Inventory.
 
According to EPA, the second webinar, currently targeted for early 2023, will go into greater detail on the standardized risk assessment approach, present various case scenarios and a decision tree for identifying potential hazards and risks, and provide tips on risk calculators, tools, and models that are used for the risk assessment.
 
EPA encourages stakeholders to provide feedback, ideas, and questions at the kickoff webinar. This will help EPA supplement the information that will be shared at the second webinar and any follow-up communication on the new approach.


 
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