By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced on March 7, 2023, that EPA did not follow the typical intra-agency review and clearance process during the development and publication of the January 2021 perfluorobutane sulfonic acid (PFBS) toxicity assessment. OIG conducted its evaluation to determine whether EPA followed applicable policies and procedures to develop and publish the PFBS toxicity assessment. OIG notes that two weeks after publication, EPA removed the toxicity assessment from its website, citing political interference and Scientific Integrity Policy violations. EPA republished the toxicity assessment in April 2021.
 
According to OIG, EPA did not follow the typical intra-agency review and clearance process during the development and publication of the January 2021 toxicity assessment. OIG states that during final clearance, “a political appointee directed that a last-minute review be conducted of the uncertainty factors used to calculate toxicity values, resulting in a scientific disagreement that caused delay, confusion, and significant changes to the near-final, peer-reviewed work product.” The changes included replacing single toxicity values with “unprecedented toxicity ranges.” Users of the toxicity assessment, including regulated entities cleaning up PFBS contamination, “could have selected a less stringent value within this range, which may have been less costly but also less protective of human health.” While EPA staff expressed scientific integrity concerns about the last-minute review and risks to public health, EPA lacked policies and procedures to address these concerns. According to OIG, without updates to policies and procedures, EPA cannot fulfill its commitment to scientific integrity and information quality.
 
OIG made five recommendations:

• Three to the Assistant Administrator for Research and Development to reduce procedural confusion and strengthen existing policies, procedures, and guidance by clarifying if and when comments expressing scientific disagreement can be expressed; making clear if and when toxicity ranges are acceptable; and using OIG as a resource for high-profile scientific integrity concerns that relate to political interference or that assert risk to human health or the environment;
• One to the Assistant Administrator for Mission Support to update policies and procedures on environmental information quality to require additional quality assurance reviews for EPA products; and
• One to the Deputy Administrator to strengthen EPA’s culture of scientific integrity, transparency, and accountability of political leadership actions when changes occur as a result of policy decisions.

OIG notes that “EPA disagreed with all five recommendations, which remain unresolved.”

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 13, 2023, that it will accept public comments on candidates under consideration for selection as ad hoc reviewers to assist the Science Advisory Committee on Chemicals (SACC) with peer review of two draft documents related to cumulative risk assessment under the Toxic Substances Control Act (TSCA). Biographies of these candidates are available on regulations.gov. If selected, candidates will serve as peer reviewers for two documents, which will be reviewed by the SACC at a public virtual meeting May 8-11, 2023. Comments on the candidates are due February 25, 2023.
 
EPA states that it plans to release the following documents for public comment in late February 2023:

• Draft Proposed Principles of Cumulative Risk Assessment under the Toxic Substances Control Act: According to EPA, this document will describe the fundamental principles of cumulative risk assessment of chemicals and how they may be applied within the regulatory requirements of TSCA to ensure TSCA risk evaluations are based on the best available science and are protective of human health; and
   
• Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer Requested Phthalate under the Toxic Substances Control Act: EPA states that this document will describe its proposed approach for evaluating a subset of high-priority and manufacturer-requested phthalates for cumulative risk to human health under TSCA based on the principles of cumulative risk assessment described in EPA’s draft principles document referenced above.

The SACC serves as a scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). It provides independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, pollution prevention measures, and approaches for chemicals regulated under TSCA.

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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 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).

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a webinar on October 27, 2022, in its Computational Toxicology and Exposure Communities of Practice (CompTox Communities of Practice) series on “Analysis of High-Throughput Profiling Assays in Chemical Safety Screening.” The abstract for the webinar states that recent technological advancements have led to the development of new high-throughput profiling methods, such as transcriptomics, that can be used to screen rapidly chemicals for potential hazards. Decreasing costs have made it feasible to profile all protein-coding genes across thousands of samples, allowing for broad evaluation of many target pathways and modes of action in a single screening assay. Similarly, it is now possible to apply high-content imaging across many different chemical exposures to capture a variety of changes in cell morphology. According to the abstract, such methods have been applied to in vitro chemical screening studies, including screening studies at EPA that were recently released on the CompTox Chemicals Dashboard. These types of data can be used for both hazard prediction and potency estimation, thereby informing risk assessments and prioritizing chemicals for further testing.
 
The abstract notes that assessing the reliability and reproducibility of these screening platforms is critical to their utility in regulatory applications. While these platforms often have lower signal-to-noise ratios compared to individual targeted assays, the resulting data are also high-dimensional, allowing for the analysis of consistent trends across many molecular endpoints. The webinar will provide an overview of computational methods and best practices for reliable analysis of high-throughput profiling data in a variety of use cases and will highlight the recent data release on the CompTox Chemicals Dashboard. Registration is open.

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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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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 10, 2022, that registration is now open for the April 19-21, 2022, virtual meeting of the Science Advisory Committee on Chemicals (SACC). During the meeting, SACC will peer review the draft Toxic Substances Control Act (TSCA) Systematic Review Protocol. SACC’s virtual meeting is open to the public, and registration is required. EPA states that the draft Protocol, released in December 2021 for public comment, incorporates changes to address the recommendations from the National Academies of Sciences, Engineering, and Medicine (NASEM), as well as comments received from SACC and the public. According to EPA, the SACC review “will provide a transparent process to ensure that the protocol follows sound science and incorporates independent scientific advice and recommendations.” Stakeholders wishing to provide oral comments during the virtual meeting must register by 12:00 p.m. (EDT) on April 4, 2022. Stakeholders may register as listen-only attendees at any time until the end of the meeting on April 21, 2022. More information on the draft Protocol is available in our December 21, 2021, memorandum.

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By Lynn L. Bergeson and Carla N. Hutton
 
According to an October 26, 2021, project notification memorandum, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) plans to begin fieldwork on an audit of EPA’s process for conducting reviews of new chemicals under the Toxic Substances Control Act (TSCA). The memorandum states that the audit “is self-initiated based on OIG’s oversight plan for fiscal year [(FY)] 2022 and to address complaints submitted to the OIG Hotline.” The audit also addresses the following FY 2022 top management challenge for EPA: ensuring safe use of chemicals.
 
OIG states that its objective is to determine the extent to which EPA uses and complies with applicable records management requirements, quality assurance requirements, and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks. OIG plans to conduct work with the Office of Chemical Safety and Pollution Prevention (OCSPP) in EPA headquarters. According to OIG, the anticipated benefits of the audit are “improved operational efficiency and greater human health and environmental protections.”
 
To expedite the audit, OIG asks that OSCPP provide the following information:

• Any training materials, handbooks, or other materials related to the review of new chemicals;
• Resource allocations for the New Chemicals Review Program for FYs 2018 through 2021;
• Scopes of work for any contracts related to the new chemicals review process;
• Any OCSPP guidance under which products developed during the review of new chemicals would constitute records and how the records should be managed; and
• New Chemicals Review Program organization charts before and after the October 2020 reorganization.

As reported in our October 28, 2021, memorandum, “House Committee Holds Hearing on ‘TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act,’” Dr. Michal Ilana Freedhoff, OCSPP Assistant Administrator, has let OIG know that OCSPP will cooperate fully with its investigation.

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By Lynn L. Bergeson and Carla N. Hutton
 
On July 14, 2021, the U.S. Environmental Protection Agency (EPA) announced a stewardship program to encourage the voluntary withdrawal of previously granted low volume exemptions (LVE) for per- and polyfluoroalkyl substances (PFAS). According to EPA, the goal of the PFAS LVE Stewardship Program is to stop the ongoing manufacture of PFAS under previously approved LVEs that have not gone through the full pre-manufacture review process under the Toxic Substances Control Act (TSCA). EPA will hold a webinar on July 29, 2021, to provide an overview of the program.
 
EPA states that there are approximately 600 PFAS with currently granted LVEs. Through the program, EPA intends to work with trade associations, non-governmental organizations (NGO), and companies to encourage voluntary withdrawal of the LVEs. According to EPA, it based the new program on a 2016 outreach effort that resulted in companies withdrawing more than half of the 82 long-chain PFAS LVEs that were targeted for voluntary withdrawal at the time.
 
To participate in the program, companies with previously granted PFAS LVEs may choose to withdraw voluntarily their LVEs and certify that they will no longer manufacture or import those PFAS. Alternatively, companies may choose to withdraw voluntarily their LVEs following submission and review of a pre-manufacture notice (PMN), “which will provide for a robust safety review and the imposition of appropriate and enforceable protections for human health and the environment.” EPA states that it will provide recognition of program participants on its website.

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