By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 30, 2021, the release of the National Academies of Sciences, Engineering, and Medicine’s (NASEM) external peer review report of the Office of Research and Development (ORD) Staff Handbook for Developing Integrated Risk Information System (IRIS) Assessments (IRIS Handbook). EPA states that the IRIS Handbook provides standard operating procedures for staffers developing IRIS assessments and includes systematic review approaches that promote consistency and ensure that contributors understand how the assessment components are developed.
 
The NASEM committee found that the IRIS Handbook “reflects the significant improvements that EPA has made in its IRIS assessment process.” For instance, according to the report, the IRIS Handbook describes the inclusion of “sophisticated, state-of-the-art methods that use systematic evidence maps to summarize literature characteristics for scoping and systematic review methods for hazard identification.” The committee acknowledges that the IRIS program is “clearly helping” to advance the science of systematic review as applied to hazard identification. The report states that the committee “recognizes that EPA faces challenges in implementing many of the methods for the IRIS assessment process and is impressed and encouraged by the progress that the IRIS program has made to date.” The committee suggests that the methods for developing IRIS assessments can serve as a model for other EPA programs implementing systematic review methods.
 
The committee found that the Handbook does not consistently convey the strengths and advances in methodology for the IRIS assessment process in an even and clear manner, however. The report includes the committee’s recommendations to ensure the IRIS Handbook meets its objectives of providing transparency about the IRIS assessment process and providing operational instructions for those conducting the assessments.

By Lynn L. Bergeson and Carla N. Hutton
 
On November 17, 2021, the U.S. Environmental Protection Agency announced the availability of its response to an August 16, 2021, petition filed under Section 21 of the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 64129. William D. Bush requested that EPA determine that the “chemical mixtures contained within cosmetics present an unreasonable risk of injury to health and the environment,” and issue a rule or order under TSCA to “eliminate the hazardous chemicals used in mixtures [in cosmetics].” EPA states that after “careful consideration,” it has denied the petition. EPA notes that TSCA Section 3(2)(B) excludes “cosmetic” from the definition of “chemical substance” when manufactured, processed, or distributed in commerce for use as a cosmetic. Cosmetics, and any combination of chemicals contained therein, are thus not chemical substances under TSCA when manufactured, processed, or distributed in commerce for use as a cosmetic. EPA states that to the extent the petition seeks a TSCA Section 6 action on “cosmetics” when manufactured, processed, or distributed in commerce as cosmetics, the requested actions are not within its jurisdiction under TSCA. In addition, according to EPA, to the extent the petition seeks action on “chemical substances” within the TSCA Section 3(2) definition of that term, EPA finds that the petition did not set forth facts establishing that it is necessary for EPA to initiate an appropriate proceeding pursuant to TSCA Section 21. In particular, according to EPA, the petition did not identify the disposal of any particular chemical substance(s) or mixture(s) that could support a determination of unreasonable risk to the environment and, therefore, did not set forth sufficient facts establishing that it is necessary to issue a TSCA Section 6(a) rule addressing cosmetic disposal.

By Lynn L. Bergeson and Carla N. Hutton

On November 15, 2021, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced the availability of its annual report summarizing what OIG considers the “most serious management and performance challenges facing the agency.” According to OIG, EPA’s top management challenges in fiscal year (FY) 2022 include:

• Mitigating the Causes and Adapting to the Impacts of Climate Change: EPA must take a leadership role in limiting climate change and mitigating its effect on human health and the environment;
   
• Integrating and Leading Environmental Justice across EPA and the Government: As part of its effort to integrate environmental justice across its programs, EPA must address the environmental hazards and cumulative risk facing at-risk communities and effectively communicate that risk to those communities;
   
• Ensuring the Safe Use of Chemicals: OIG states that to protect effectively public health and the environment, EPA must be able to depend on its ability to conduct credible and timely assessments of the risks posed by pesticides, toxic chemicals, and other environmental chemical risks. According to OIG, the 2016 expansion of EPA’s regulatory authority under the Toxic Substances Control Act (TSCA) has increased the need for conducting rapid and accurate risk assessments. OIG notes that EPA must also continue to conduct registration and reregistration of “hundreds of pesticides per year, as well as assure that it is setting appropriate exposure levels for contaminants in drinking water.” Without appropriate resource and implementation plans in place to demonstrate that EPA can accomplish this work, and without the ability to conduct scientifically sound risk assessments accurately, the public’s trust and confidence in EPA’s ability to accomplish its mission of protecting human health and the environment will be at risk;
   
• Safeguarding Scientific Integrity Principles: Science-based decisions at EPA must be based on principles of scientific integrity to ensure that human health and the environment are protected by using the best available science. EPA must develop new processes and update its regulations, policies, and guidance to protect scientific integrity. According to OIG, taking these actions will help make EPA decisions more legally defensible and maintain public trust in its decision making;
   
• Ensuring Information Technology and Systems Are Protected against Cyberthreats: Information technology is a fundamental and essential resource for EPA to carry out its mission;
   
• Managing Infrastructure Funding and Business Operations: EPA must effectively oversee the funding and operation of America’s water, wastewater, and other environmental infrastructure; and
   
• Enforcing Environmental Laws and Regulations: Through enforcement, EPA ensures that regulated entities are following environmental laws and will continue to do so, as enforcement actions effectively deter future noncompliance. According to OIG, considering EPA’s limited resources, and despite potential funding increases in FY 2022, “EPA is challenged to assess its resource requirements for the enforcement program and identify innovative and cost-effective means of detecting and deterring noncompliance in the future.”

By Lynn L. Bergeson and Carla N. Hutton
 
On November 8, 2021, the U.S. Environmental Protection Agency (EPA) published a final rule revising the regulations associated with persons who must report data to the mercury inventory established under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 61708. The revisions implement an order issued by the U.S. Court of Appeals for the Second Circuit on June 5, 2020, that vacated the exemption at 40 C.F.R. Section 713.7(b)(2) for persons who import pre-assembled products that contain a mercury-added component. As a result, such persons are now required to report pursuant to 40 C.F.R. Section 713.7(b). EPA states that the rule is effectuating the vacatur ordered by the Second Circuit by making necessary amendments to the corresponding text in 40 C.F.R. Section 713.7(b). The final rule will be effective on December 8, 2021. EPA states in its November 2, 2021, press release that the final rule “offers impacted communities adequate notice of the amended reporting requirements, as the deadline for reporting 2021 data is July 1, 2022.” EPA will update the mercury inventory reporting rule compliance guide and other supporting materials to reflect these new reporting requirements.
 
As reported in our June 25, 2018, memorandum, “EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory,” the mercury rule and its reporting requirements apply to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process (including processes traditionally not subject to TSCA, such as for the manufacture of pharmaceuticals and pesticides).

By Lynn L. Bergeson and Carla N. Hutton
 
On October 29, 2021, the U.S. Environmental Protection Agency (EPA) announced its response to a petition submitted under Section 21 of the Toxic Substances Control Act (TSCA) seeking a rule requiring cigarette manufacturers to eliminate the hazardous chemicals used and to develop new product designs that eliminate or reduce the cigarette butt disposal risks to the environment. 86 Fed. Reg. 59931. EPA states that TSCA Section 6(a) authorizes it to determine if a chemical substance or mixture in manufacturing, processing, distribution in commerce, use, disposal, or any combination of these activities presents an unreasonable risk of injury to health or the environment. If EPA determines that there is unreasonable risk to health or the environment, then EPA must, by rule, issue regulations to the extent necessary so that the chemical substance no longer presents such risk. EPA notes that TSCA Section 3(2)(B), which defines “chemical substance,” excludes “tobacco or any tobacco product,” however. Under Section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FFDCA), “tobacco product” means “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” EPA states that it finds that the petitioner has not met its burden as defined in TSCA Sections 6(a) and 21(b)(1) “because cigarettes are not a product that can be regulated under TSCA section 6(a).”

By Lynn L. Bergeson and Carla N. Hutton
 
On October 28, 2021, the U.S. Environmental Protection Agency (EPA) proposed to amend the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 59684. Specifically, EPA is proposing to extend the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles until October 31, 2024, along with the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles. EPA also announced its intention to commence a new rulemaking effort on PIP (3:1) and four other persistent, bioaccumulative, and toxic (PBT) chemicals that have been regulated under TSCA Section 6(h). EPA states that it is anticipating issuing a proposal to this end in 2023. Comments on the proposed rule are due December 27, 2021. More information is available in our October 25, 2021, memorandum, “EPA Proposes Further Extension of Compliance Dates for PIP (3:1)-Containing Articles.”

Commentary

As anyone in this commercial space will attest, the proposal to extend the compliance date is good news. The deadline is still very aggressive for many, and case-specific requests for time beyond that deadline are essential. A thorough review of the notice is essential and urged.

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.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on October 26, 2021, that it is acting upon a petition from New Mexico Governor Michelle Lujan Grisham (D) to address per- and polyfluorinated substances (PFAS) under the Resource Conservation and Recovery Act (RCRA). EPA states that in responding to the petition, it outlined plans to initiate the rulemaking process for two new RCRA actions, “reflecting the agency’s focus on using best available science and leveraging authorities to combat this shared challenge.” First, EPA will initiate the process to propose adding four PFAS as RCRA Hazardous Constituents under Appendix VIII, by evaluating the existing data for these chemicals and establishing a record to support such a proposed rule. The four PFAS that EPA will evaluate are perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorobutane sulfonic acid (PFBS), and GenX. EPA states that adding these chemicals as RCRA Hazardous Constituents “would ensure they are subject to corrective action requirements and would be a necessary building block for future work to regulate PFAS as a listed hazardous waste.” The second rulemaking effort will clarify in EPA’s regulations that the RCRA Corrective Action Program has the authority to require investigation and cleanup for wastes that meet the statutory definition of hazardous waste, as defined under RCRA Section 1004(5). According to EPA, this modification would clarify that emerging contaminants such as PFAS can be cleaned up through the RCRA corrective action process.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has posted a recording of the September 22, 2021, webinar that it hosted to educate stakeholders on the Green Chemistry Challenge Awards and the nomination process. The webinar reviewed the history of the awards, the categories within the awards, eligibility requirements, and what is needed to submit a nomination. As reported in our August 27, 2021, blog item, EPA is currently accepting nominations for the 2022 Green Chemistry Challenge Awards from companies or institutions that have developed a new green chemistry process or product that helps protect human health and the environment. Nominations are due December 10, 2021. An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2022 nominations and make recommendations to EPA for the 2022 winners. EPA anticipates giving awards to outstanding green chemistry technologies in six categories in June 2022.

By Lynn L. Bergeson and Carla N. Hutton
 
On October 27, 2021, the U.S. Environmental Protection Agency (EPA) requested public nominations of scientific experts to consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with two peer review topics anticipated for early 2022: the draft EPA Toxic Substances Control Act (TSCA) Systematic Review Protocol and the draft EPA TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities. 86 Fed. Reg. 59382. EPA states that individuals nominated should have expertise in one or more of the following areas:

• Systematic review: Individuals nominated for peer review of the draft systematic review protocol should have expertise in one or more of the following areas: systematic review approaches of human health and ecological hazard, exposure topics, and fate. All experts, including those representing other fields of interest, who have experience with engineering, machine learning, artificial intelligence techniques, and natural language processing approaches as applied to systematic review are also needed. EPA states that understanding the TSCA risk evaluation process “is highly desirable for the context of this peer review.”
• Exposures to fenceline communities: Individuals nominated for peer review of the draft EPA TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities should have expertise in one or more of the following areas: chemical fate and transport via ambient air and water pathways; atmospheric modeling of fate, transport, and human exposures; human health, exposure, and risk assessment for airborne and/or waterborne chemicals; expertise estimating environmental air releases of chemicals from a variety of sources and databases such as Chemical Data Reporting (CDR); experience developing air dispersion methodologies and/or models to estimate ambient air concentrations and impacts to human populations; expertise estimating environmental water releases of chemicals from a variety of sources and databases such as CDR, Toxics Release Inventory (TRI), and Discharge Monitoring Report; experience developing methodologies and/or models to estimate chemical concentrations in ambient/source/drinking water and impacts to human populations; and public health protection for at-risk communities.

EPA states that any interested person or organization may nominate qualified individuals to be considered prospective candidates for these reviews. Individuals may also self-nominate. Nominations are due November 17, 2021.

By Lynn L. Bergeson and Carla N. Hutton
 
According to an October 25, 2021, project notification memorandum, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) plans to begin an evaluation to determine the extent to which EPA followed applicable policies, procedures, and guidance for the changes made to the significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances between the EPA Administrator’s signing of the final rule on June 22, 2020, and the publication of the final rule in the Federal Register on July 27, 2020. The memorandum states that the anticipated benefits of the evaluation include greater assurance that EPA “has controls in place to maintain the integrity of signed final rules prior to final publication in the Federal Register.”
 
The memorandum states that the evaluation is the result of a Congressional request. The evaluation is part of OIG’s oversight plan for fiscal year (FY) 2022 and addresses the following FY 2022 top management challenge for EPA: ensuring safe use of chemicals.
 
More information on EPA’s July 27, 2020, final SNUR is available in our July 27, 2020, memorandum, “EPA Issues Final SNUR for LCPFAC and Perfluoroalkyl Sulfonate Chemical Substances.”

By Lynn L. Bergeson and Carla N. Hutton
 
The House Energy and Commerce Subcommittee on Environment and Climate Change will hold a hearing on October 27, 2021, on “TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act.” According to the October 20, 2021, press release issued by the House Committee on Energy and Commerce, Representatives Frank Pallone, Jr. (D-NJ), Chair of the Committee, and Paul Tonko (D-NY), Chair of the Subcommittee, stated that the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) made “crucial” reforms to the Toxic Substances Control Act (TSCA) “that improve how the federal government protects Americans from dangerous chemicals, and now we must ensure those reforms are implemented effectively and honestly.” Pallone and Tonko stated that during the previous administration, “chemical risk evaluations were skewed in favor of industry to the detriment of workers and communities. We must protect consumers from exposure to toxic substances and ensure the Environmental Protection Agency is using the tools Congress granted it to protect public health.” The Subcommittee will discuss the implementation of the Lautenberg Act and the U.S. Environmental Protection Agency’s (EPA) “efforts to get TSCA back on track.”

By Lynn L. Bergeson and Carla N. Hutton
 
As part of a multi-agency effort to address pollution from per- and polyfluoroalkyl substances (PFAS), the U.S. Environmental Protection Agency (EPA) released on October 18, 2021, the PFAS Strategic Roadmap: EPA’s Commitments to Action 2021-2024. The Strategic Roadmap includes:

• Timelines to set enforceable drinking water limits under the Safe Drinking Water Act (SDWA) to ensure water is safe to drink in every community;
• A hazardous substance designation under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) to strengthen the ability to hold polluters financially accountable;
• Timelines for action -- whether it is data collection or rulemaking -- on Effluent Guideline Limitations under the Clean Water Act (CWA) for nine industrial categories;
• A review of past actions on PFAS taken under the Toxic Substances Control Act (TSCA) to address those that are insufficiently protective;
• Increased monitoring, data collection, and research so that EPA can identify what actions are needed and when to take them;
• A final toxicity assessment for GenX that can be used to develop health advisories that will help communities make informed decisions the better to protect human health and ecological wellness; and
• Continued efforts to build the technical foundation needed on PFAS air emissions to inform future actions under the Clean Air Act (CAA).

EPA also released a national PFAS testing strategy that will require PFAS manufacturers to provide toxicity data and information on categories of PFAS chemicals to inform future regulatory efforts. EPA states that it will select the PFAS to be tested “based on an approach that breaks the large number of PFAS into smaller categories based on similar features and considers what existing data are available for each category.” According to EPA, it will “strategically” select the initial set of test orders from more than 20 different categories of PFAS. EPA expects to use its TSCA Section 4 order authority to require PFAS manufacturers to conduct and fund the studies. EPA plans to issue the first round of test orders by the end of 2021 with additional phases thereafter. More information and a detailed commentary will be available in a forthcoming memorandum that will be posted on our website.

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on October 15, 2021, that it is updating the confidential status of 377 chemical identities and will include these chemical identities on the next update of the Toxic Substances Control Act (TSCA) Inventory, planned for winter 2022. The TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States. According to EPA, the Inventory contains 86,607 chemicals, of which 41,953 are active in U.S commerce.

As reported in our April 30, 2021, blog item, in April 2021, EPA announced its review of 390 specific chemical identities that were expected to lose their confidential status on the TSCA Inventory. Of the 390 chemicals under review, EPA states that it found that 13 accession numbers corresponded to substances that are already on the public portion of the Inventory or to substances reported using an invalid accession number (which was later corrected and/or the confidentiality claim was withdrawn). The remaining 377 chemical identities were reported as non-confidential by one or more manufacturers during the 2012, 2016, and/or 2020 Chemical Data Reporting (CDR) periods -- “meaning that at least one manufacturer did not request that each of these chemical identities be kept confidential, effectively saying it is not a secret that the chemical is in U.S. commerce. Therefore, these substances are no longer eligible for continued confidential Inventory status.”

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced on October 14, 2021, several actions intended to enhance scientific integrity, including establishing two internal science policy advisory councils, creating a new senior-level career position to serve as a science policy advisor to the Assistant Administrator, and making further improvements to policies and procedures. The announcement includes the following actions:

• New OCSPP Science Policy Council and New Science Policy Advisor Position: OCSPP is forming a new internal advisory group, the OCSPP Science Policy Council, to provide advisory support and recommendations on science policy and scientific integrity issues that arise within its Office of Pollution Prevention and Toxics (OPPT) and Office of Pesticide Programs (OPP). The OCSPP Science Policy Council will be chaired by a science policy advisor, a newly created position. The science policy advisor will report to the OCSPP Assistant Administrator, provide guidance on emerging science policy and scientific integrity matters, and serve as the deputy scientific integrity official for OCSPP. OCSPP states that the OCSPP Science Policy Council will provide an advisory perspective on matters related to scientific integrity; identify scientific questions that are of broad interest within OCSPP for informal review and, as appropriate, recommend a process for further addressing them; and foster informal opportunities for scientific collaboration within OCSPP. Members chosen to address specific issues or questions will be selected based on their expertise and impartiality on the issue or question, and they may include EPA experts outside of OCSPP. OCSPP notes that the group is not intended to replace or otherwise interfere with EPA’s Scientific Integrity Policy, the Scientific Integrity Official’s role, or the Inspector General’s role.
• Strengthening New Chemical Safety Reviews: According to OCSPP, as part of its broader review of policies and procedures to ensure the program effectively implements the Biden Administration’s executive orders, other directives, and principles of scientific integrity, OCSPP’s New Chemicals Division (NCD) engaged in a top-to-bottom effort to catalogue, prioritize, and improve its standard operating procedures (SOP), decision making, and recordkeeping practices related to review and management of new chemicals under the Toxic Substances Control Act (TSCA). OCSPP states that to date, NCD has inventoried and reviewed over 100 different SOPs, guidances, and science policies, and prioritized those that NCD expects to be updated over the next year. Several policy changes have already been implemented, including stopping harmful new per- and polyfluoroalkyl substances (PFAS) from entering the market and procedures to strengthen the review of new chemicals and ensure worker safety.
  • New Chemicals Advisory Committee: According to OCSPP, NCD has formed the New Chemicals Advisory Committee (NCAC) that, similar to other long-standing internal advisory bodies within OCSPP, will serve as an advisory body to review both scientific and science policy issues related to new chemical submissions subject to TSCA. If differing opinions cannot be resolved through the human health risk assessment process improvements described below, the NCAC and OCSPP Science Policy Council could provide additional opportunities for further consideration.
  • Human Health Risk Assessment Process Improvements: According to OCSPP, NCD solicited feedback from staff and implemented important changes to its process for reviewing and issuing final human health risk assessments. The new process provides additional opportunities for resolution of differing scientific opinions and invites input to the decision-making process to be provided by EPA subject matter experts outside of NCD.
  • Enhanced Recordkeeping Requirements: Proper documentation of decisions and of any differing scientific opinions of those decisions is a significant component of EPA’s Scientific Integrity Policy. OCSPP states that it has implemented some changes to its procedures to ensure improved documentation of decisions and is in the process of further review to identify additional improvements, if any, including for new chemicals human health risk assessments.
• Workplace Climate Assessment: In September 2021, with the support of an independent contractor, OCSPP launched a workplace climate assessment of the NCD to obtain feedback from employees and management about any potential workplace barriers and opportunities for organizational improvement. OCSPP states that this effort will expand to other parts of OCSPP over the coming months. OCSPP leadership will use the feedback collected to understand, evaluate, and, if necessary, make changes in its work practices and culture to promote collaboration and enhance the science used in its program decision making.