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.

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) published a supplemental proposed rule that would add the diisononyl phthalate (DINP) category to the list of toxic chemicals subject to the reporting requirements under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). 87 Fed. Reg. 48128. EPA previously issued a proposed rule on September 5, 2000, in response to a petition filed under EPCRA, to add a DINP category to the list of toxic chemicals subject to the reporting requirements under EPCRA and the PPA. EPA proposed to add this chemical category to the EPCRA toxic chemical list based on its preliminary conclusion that this category met the EPCRA toxicity criterion. According to the supplemental proposed rule, EPA has updated its hazard assessment for DINP and is proposing to add DINP as a category defined to include branched alkyl di-esters of 1,2 benzenedicarboxylic acid in which alkyl ester moieties contain a total of nine carbons. EPA states that the updated hazard assessment “demonstrates that the proposed DINP category meets the EPCRA toxicity criterion because the members of the category can reasonably be anticipated to cause cancer and serious or irreversible chronic health effects in humans; specifically, developmental, kidney, and liver toxicity.” EPA is proposing to add the DINP category to the toxic chemical list on this basis and requests comment on the updated DINP hazard assessment and associated updated economic analysis. Comments are due October 7, 2022.

Tags: DINP, EPCRA, PPA

 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) will hold a webinar on August 17, 2022, on the “EPA PFAS Strategic Roadmap: Research Tools and Resources.” EPA states that “[a] growing body of scientific evidence suggests that exposure at certain levels to specific [per- and polyfluoroalkyl substances (PFAS)] can adversely impact human health and other living things.” The webinar will provide a brief overview of EPA’s PFAS Strategic Roadmap and ongoing efforts by EPA’s Office of Research and Development (ORD) to address key PFAS research needs for environmental decision-making. During the webinar, ORD scientists will highlight two recently released data sources: EPA’s PFAS Thermal Treatment Database (PFASTT), which contains information on the treatability of PFAS via various thermal processes, and Systematic Evidence Map for PFAS, which summarizes available toxicity evidence for approximately 150 different PFAS. Recent updates to other PFAS resources will also be shared. Registration is now open.

Tags: ORD, PFAS, PFASTT

 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) has posted two new resource documents for recipients of test orders under Section 4 of the Toxic Substances Control Act (TSCA). The August 5, 2022, policy document entitled “Policies Regarding Manufacturers and Processors Subject to TSCA Section 4(a) Testing” provides two policies:

  • Policy 1: Companies engaged in manufacturing activities for a chemical substance during the five years prior to the projected signature date or effective date of a Section 4(a) action (i.e., a rule, consent agreement, or order) will generally be included in the scope of the action. EPA may apply a longer or shorter period of time when appropriate in specific cases, however. EPA states that “[w]here (1) a five-year period fails to identify a sufficient number of manufacturers, (2) fairness reasons warrant inclusion of a manufacturer, especially a high-volume manufacturer, of the chemical substance with less recent manufacturing, (3) a chemical substance has persistence and/or bioaccumulative properties that warrant inclusion of companies that contributed to potential exposures associated with such substance, or (4) where warranted for other reasons, which the Agency would explain as part of the Section 4(a) action, EPA will consider a longer manufacturing period than five years for the identification of companies as manufacturers subject to TSCA Section 4 testing obligations for a given chemical substance.” According to EPA, an example of where it may not include a company that has manufactured in the past five years as a manufacturer subject to testing requirements in a specific Section 4(a) action would be a company that “may have gone into bankruptcy and be in the hands of receivers who do not seek to continue the company’s manufacturing activities involving the chemical substance subject to the testing requirements.”
  • Policy 2: Section 4 actions will not include an option to cease manufacturing as a means to satisfy the requirements of the action. Test orders issued in January 2021 included this option. EPA removed this response option to ensure that a sufficient number of entities remained subject to an order (e.g., for one 2021 order, no manufacturers identified by the order remained available to conduct the testing due to their use of the cease manufacture response option). According to EPA, were all entities subject to the testing requirements able to exit the market to forgo producing the required data, EPA would be unable to seek and obtain data under Section 4(a) to support better its assessments and action. EPA states that where it is conducting a risk evaluation on chemical substances that have conditions of use that “are not currently ongoing but are reasonably foreseen to reoccur or for which the effects and exposures are ongoing, EPA generally believes it is appropriate to include companies responsible for those activities in testing obligations.”

The August 5, 2022, policy document entitled “Removal of Certain Companies from Seven TSCA Section 4(a)(2) Orders Issued in 2022” states that although EPA’s policy is that it will no longer provide a “cease manufacture” response option for a company to cease its manufacture of a chemical substance to satisfy the requirements of an order, EPA recognizes that a company that ceased its manufacture of a chemical substance in response to a 2021 order “forewent a business opportunity in reliance upon EPA’s representation that testing on the chemical substance would not be required by the company.” EPA will remove from a 2022 order on a chemical substance any company that made successful use of the cease manufacture response option for a 2021 order on that same chemical substance, “provided the company has not, and does not, recommence its manufacture of the chemical substance while testing obligations remain in effect for that chemical substance under the applicable 2021 Order and/or 2022 Order.” According to EPA, removal of such companies due to EPA’s approval of the “cease manufacture” response option provided in the 2021 order applies only to the 2022 orders issued for the eight subject chemical substances. EPA notes that any future Section 4 action involving the applicable chemical substance will include manufacturers and/or processors as EPA deems to be appropriate upon any final future action (e.g., should such companies resume their manufacturing and/or processing of the chemical substance following the completion of the testing requirements in the 2021 and 2022 orders).

EPA states in each document that the policy document is not intended to bind EPA or members of the public. EPA “may revisit and depart from these policies based on reasoned consideration as it deems appropriate in the future.”


 

By Lynn L. Bergeson and Carla N. Hutton

The White House Office of Science and Technology Policy (OSTP) released on August 5, 2022, a new report on the National Emerging Contaminants Research Initiative (NECRI). The report outlines a federal strategy to address critical research gaps related to detecting and assessing emerging contaminants in drinking water, as well as identifying and mitigating the adverse health effects those contaminants cause. The report also outlines strategic steps needed to more effectively track, identify, and mitigate contaminants of emerging concern (CEC), which have been traditionally difficult to detect in drinking water.

The report outlines five research goals:

  • Decrease the time from drinking water CEC identification to risk mitigation;
  • Promote technological innovation in tools to discover, track, and mitigate drinking water CECs;
  • Develop and deploy tools and approaches for drinking water CEC decision making;
  • Coordinate transdisciplinary drinking water CEC research activities among federal and non-federal partners; and
  • Foster transparency and public trust when communicating about drinking water CECs.

According to the report, over the next year, the CEC Strategy Team “will operationalize the NECRI through an implementation framework that organizes and coordinates the strategic goals, harnesses existing research, and fuels transformative advancements.” The information derived from these actions will, in turn, inform drinking water advisories, standards, and public health actions and “help our Nation to realize the vision of safe and plentiful [drinking water] for every person.”

Tags: CEC, OSTP

 

Bergeson & Campbell, P.C.’s (B&C®) August 3, 2022, webinar “TSCA New Approach Methodologies” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/8166994675079284995.

During this one-hour webinar, panelists shared a comprehensive review of the U.S. Environmental Protection Agency’s (EPA) use of New Approach Methodologies (NAM) in evaluating chemicals under the Toxic Substances Control Act (TSCA). Kristie Sullivan, MPH, Vice President of Research Policy with the Physicians Committee for Responsible Medicine (PCRM), Richard E. Engler, Ph.D., Director of Chemistry, B&C, and James W. Cox, M.S., Senior Scientist, B&C, discussed examples of EPA’s use and development of non-vertebrate testing strategies, successful collaborations between EPA and external partners to advance understanding and use of NAMs, and the need for EPA and stakeholders to approach implementation of NAMs with an “innovation mindset” that fulfills the requirements under TSCA. Lynn L. Bergeson, Managing Partner, B&C, moderated.

We encourage you to view the webinar, listen to the All Things Chemical® episode “Animal Testing and New TSCA,” and subscribe to B&C’s informative blogs and newsletters.

Tags: NAM, webinar

 

By Lynn L. Bergeson and Carla N. Hutton
 
On July 28, 2022, the National Toxicology Program (NTP) announced that the following revised Technical Reports on the Toxicity Studies are available on the NTP website:

  • Perfluoroalkyl Sulfonates (Perfluorobutane Sulfonic Acid, Perfluorohexane Sulfonate Potassium Salt, and Perfluorooctane Sulfonic Acid) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Revised TOX-96); and
     
  • Perfluoroalkyl Carboxylates (Perfluorohexanoic Acid, Perfluorooctanoic Acid, Perfluorononanoic Acid, and Perfluorodecanoic Acid) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Revised TOX-97).

According to NTP, transcription errors were identified in these reports, and an audit was conducted. NTP revised and republished the reports with an appendix that identifies the corrections. NTP notes that the final tables are available in the Chemical Effects in Biological Systems (CEBS) database.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Government Accountability Office (GAO) published a report on July 28, 2022, entitled Persistent Chemicals: Technologies for PFAS Assessment, Detection, and Treatment. GAO was asked to conduct a technology assessment on per- and polyfluoroalkyl substances (PFAS) assessment, detection, and treatment. The report examines the technologies for more efficient assessments of the adverse health effects of PFAS and alternative substances; the benefits and challenges of current and emerging technologies for PFAS detection and treatment; and policy options that could help enhance benefits and mitigate challenges associated with these technologies. GAO assessed relevant technologies; surveyed PFAS subject matter experts; interviewed stakeholder groups, including government, non-governmental organizations (NGO), industry, and academia; and reviewed key reports. GAO identified three challenges associated with PFAS assessment, detection, and treatment technologies:

  • PFAS chemical structures are diverse and difficult to analyze for health risks, and machine learning requires extensive training data that may not be available;
     
  • Researchers lack analytical standards for many PFAS, limiting the development of effective detection methods; and
     
  • The effectiveness and availability of disposal and destruction options for PFAS are uncertain because of a lack of data, monitoring, and guidance.

GAO developed the following three policy options that could help mitigate these challenges:

  • Promote research: Policymakers could support development of technologies and methods to more efficiently research PFAS health risks. This policy option could help address the challenge of limited information on the large number and diversity of PFAS, as well as a lack of standardized data sets for machine learning;
     
  • Expand method development: Policymakers could collaborate to improve access to standard reference samples of PFAS and increase the pace of method and reference sample development for PFAS detection. This policy option could help address the challenges of a lack of validated methods in media other than water, lack of analytical standards, and cost, which all affect researchers’ ability to develop new detection technologies; and
     
  • Support full-scale treatment: Policymakers could encourage the development and evaluation of full-scale technologies and methods to dispose of or destroy PFAS. This policy option could help address the challenges of cost and efficiency of disposal and destruction technologies and a lack of guidance from regulators.

GAO notes that these policy options involve possible actions by policymakers, which may include Congress, federal agencies, state and local governments, academia, and industry.


 

By Lynn L. Bergeson 

Since the U.S. Supreme Court issued its blockbuster ruling in West Virginia v. EPA, 597 US _ 2022 WL 2347278 (June 30, 2022), many are asking whether the Court’s amplification of the “major questions doctrine” (MQD) might be used to seek to limit the U.S. Environmental Protection Agency’s (EPA) authority in implementing Congress’s 2016 amendments to the Toxic Substances Control Act (TSCA), the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act).
 
The answer is yes. West Virginia will henceforth be cited with predictable regularity in claiming that EPA, or any federal agency for that matter, has taken final agency action in what detractors will claim is an “extraordinary case” with outsized “economic and political significance” that, as Chief Justice John Roberts somewhat glibly noted, “raise[s] an eyebrow.” The full text of this article, written by Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®) for Chemical Watch, is available here.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The National Academies of Sciences, Engineering, and Medicine (NASEM) announced on July 21, 2022, publication of a new report entitled The Importance of Chemical Research to the U.S. Economy. The National Science Foundation (NSF), the Department of Energy (DOE), the National Institute of Standards and Technology (NIST), and the American Chemical Society (ACS) asked NASEM to convene a committee to consider strategies to sustain and enhance the economic activity driven by fundamental research investments in the chemical sciences. According to NASEM, “a new and evolving chemistry landscape requires changes with regard to funding, training, and a focus on integrating sustainability into manufacturing, product usage, and product disposal.” NASEM states that the report identifies strategies and options for research investments intended to support U.S. leadership “while considering environmental sustainability and developing a diverse chemical economy workforce with equitable opportunities for all chemistry talent.” The report recommends that funding agencies and philanthropic organizations that support the chemical sciences “fund as large a breadth of fundamental research projects as possible.” The chemical industry and their partners at universities, scientific research institutions, and national laboratories “should align the objectives of fundamental research” to assist directly with new practices toward environmental stewardship, sustainability, and clean energy. Additionally, the report recommends that funding agencies “make substantial investment toward education research to enable innovative ways of teaching about emerging concepts, tools and technologies.”

Tags: DOE, NSF, NIST, ACS, NASEM, Research,

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on July 21, 2022, that the meeting minutes and final report (final report) are now available for the April 19-21, 2022, Science Advisory Committee on Chemicals (SACC) virtual meeting regarding EPA’s proposed Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances Version 1.0 (Draft Protocol). As reported in our December 21, 2021, memorandum, EPA released the Draft Protocol for public comment on December 20, 2021. 86 Fed. Reg. 71891. According to EPA’s December 20, 2021, press release, the Draft Protocol will strengthen EPA’s approach to reviewing and selecting the scientific studies that are used to inform Toxic Substances Control Act (TSCA) chemical risk evaluations and ensure that EPA has the best tools under TSCA to protect human health and the environment. EPA intends to issue its response to the SACC’s recommendations along with any revisions to the approach in 2023.

Charge Question 1: TSCA Systematic Review Protocol Document (Chapters 1-7)

The final report states that the SACC raised some substantive comments that require edits or explanation from EPA. According to the SACC, the Draft Protocol “is closer to a framework to carry out systematic review and other evaluation processes for TSCA risk evaluation.” Multiple SACC members recommended specifying systematic review and non-systematic review processes (e.g., risk assessment) within the Draft Protocol. To increase transparency, the Draft Protocol needs to: (1) start with the problem formulation; (2) describe how Populations, Exposures, Comparators, and Outcomes (PECO) or Receptors, Exposure, Setting or Scenario, and Outcomes (RESO) statements are developed and refined through the process; (3) describe the process of systematic review, evidence synthesis, and integration; and (4) clearly link the steps of the systematic review back to the larger risk evaluation process.

Charge Question 2: Strategies for Literature Search and Screening (Chapter 4)

According to the final report, overall, the SACC found the methods for searching and screening well described in Chapter 4. The general process for searching the peer-reviewed literature was considered robust, but the SACC noted concerns that methods for searching gray literature were neither robust nor complete. The method for searching gray literature does not currently find relevant information from states, non-governmental organizations (NGO), or community groups. The SACC recommends EPA identify authoritative reviews from government agencies and begin with these as a starting point to make more efficient use of time and resources.

Charge Question 3: Method to Assess the Quality of Evidence (Chapter 5)

The final report states that in general, the SACC noted that the Draft Protocol is an improved approach compared with the 2018 method. There was greater transparency and clarity in the data evaluation methods, as EPA’s process for evaluating the data across various evidence streams was well described and explained. The SACC made several recommendations to include more detail regarding the role of certain evidence types, such as biochemical and cellular-level outcomes, and to describe how supplemental data sources will be reviewed, evaluated, and incorporated into the systematic review or what criteria will be used to make the determination to consider/incorporate these data. In addition, EPA should re-evaluate the domain “accessibility” and identify whether an alternative term or phrase would be more appropriate to capture the elements under consideration. The SACC stated that EPA should be specific about the types of quality and validity issues it is considering and maintain appropriate categorizations of each instead of referring to them collectively under a blanket term.

Charge Question 4: Approaches for Integrating Evidence in Exposure and Hazard (Chapter 7)

According to the final report, SACC agreed this is a difficult and multi-faceted task and generally found that several aspects of the chapter were helpful, such as the hierarchies of data and the documentation on integration. As written, the Draft Protocol presents a complicated and potentially inefficient method for integrating data within the various disciplines, however. The final report states that many SACC members were concerned that criteria used to judge quality may exclude useful data that are not of high quality but nevertheless may have specific value for other downstream applications (e.g., corroboration of results or to assist with coherence of a data stream). In addition, the evidence integration process inappropriately introduces criteria for data selection that should be specified earlier in the process.


 
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