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By Lynn L. Bergeson and Carla N. Hutton
 
On January 21, 2022, the U.S. Environmental Protection Agency (EPA) announced a new effort under the Toxic Substances Control Act (TSCA) to streamline the review of new chemicals that could be used to displace current, higher greenhouse gas (GHG) emitting transportation fuels. The Office of Chemical Safety and Pollution Prevention’s (OCSPP) New Chemicals Division (NCD) has implemented a “robust, consistent, and efficient process to assess the risk and apply mitigation measures, as appropriate, for substitutes to petroleum-based fuels and fuel additives that use biobased or waste-derived sources to produce biofuels.” EPA states that this effort supports its goals under the Renewable Fuel Standard (RFS) program, as well as its 2021 Climate Adaptation Action Plan. According to the announcement, EPA has received over 30 biofuel premanufacture notices (PMN) “that collectively describe plans for close to 800 million gallons per year of production of advanced biofuels, that could contribute to annual volume mandates under the RFS program and help support the goals of energy security through increasing domestic production” within the United States.
 
The announcement includes:
 
New Chemicals Division Integrated Approach to Biofuels
 
Under this effort, NCD formed a dedicated team to collaborate on the review of PMNs for biobased or waste-derived feedstocks used to make transportation fuel substitutes with the goals to use the best available science while creating a consistent and efficient review process. EPA states that NCD developed a standardized process for the way biofuel PMNs are reviewed. For example, the same dedicated team will be conducting reviews for all biofuels PMNs, helping to ensure the assessments and determinations are consistent and aligned with requirements. Further, NCD will generate one report for biofuels PMNs that combines the six different risk assessments typically conducted for PMNs, helping to provide a clearer summary explanation of how EPA conducted its assessment and made its determination.
 
For risk management actions, NCD will apply appropriate mitigation measures to address any potential for unreasonable risk identified in an efficient and consistent manner within TSCA consent orders and significant new use rules (SNUR).
 
Outreach and Training
 
According to the announcement, OCSPP is launching outreach and training for interested stakeholders in the biofuels sector to review TSCA requirements, outline the streamlined approaches for risk assessments and risk management actions, and provide information on how to navigate the new chemicals PMN process.
 
OCSPP will hold a kick-off meeting on February 9, 2022, to provide an overview of this initiative and answer questions from stakeholders. Registration for the meeting is open.
 
Other planned outreach and training related to this biofuels initiative include webinars on:

  • TSCA requirements and the PMN process;
  • The TSCA Inventory, nomenclature, and Bona Fide process;
  • New chemicals risk assessments, including applications of the tools, models, and databases; and
  • New chemicals risk management actions, including TSCA Section 5 orders and SNURs.

EPA states that it may add additional outreach and training sessions, including training opportunities applicable to all new chemical submitters, based on stakeholder interest and feedback.


 

By Lynn L. Bergeson and Carla N. Hutton

On January 21, 2022, the U.S. Environmental Protection Agency (EPA) announced that it will hold a virtual peer review meeting of the Science Advisory Committee on Chemicals (SACC) to consider and review the “Draft TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0.” 87 Fed. Reg. 3294. The meeting will be held March 15-17, 2022, and will be open to the public. Along with presenting the methodology, EPA will also present results of applying the screening methodology (case studies) to 1-bromopropane (1-BP) (air pathway), N-methylpyrrolidone (NMP) (water pathway), and methylene chloride (MC) (air and water pathway). In addition, EPA announced the availability of and solicited public comments on the draft approach, which will be presented as a screening level methodology for assessing potential air and water chemical exposures to fenceline communities. Comments are due February 22, 2022.

EPA's background documents, related supporting materials, and draft charge questions to the SACC are available in Docket ID EPA-HQ-OPPT-2021-0415 and on the SACC website. EPA will provide additional background documents (e.g., SACC members and consultants participating in this meeting and the meeting agenda) as the materials become available. Registration is required to receive the webcast meeting link and audio teleconference information. EPA states that it intends to announce registration instructions on the SACC website by early February 2022.

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 January 13, 2022, that it is accepting public comments on candidates under consideration for selection as ad hoc peer reviewers assisting the Science Advisory Committee on Chemicals (SACC) with its review of the Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances. This comment period follows a previous 30-day call for nominations that ended on November 17, 2021. EPA will use comments on the potential candidates to assist it in selecting approximately six to eight ad hoc reviewers, depending on a balance of experience, to assist SACC with its review. Biographies of the candidates are available at regulations.gov. Comments are due January 28, 2022, to Docket ID EPA-HQ-OPPT-2021-0414.
 
As reported in our December 21, 2021, memorandum, the draft protocol incorporates changes to address recommendations from the National Academies of Sciences, Engineering, and Medicine, as well as comments received from SACC and the public. The SACC review of the protocol will take place during a public meeting April 19-21, 2022. According to EPA, this review “will provide a transparent process to ensure that the protocol follows sound science and incorporates independent scientific advice and recommendations.” EPA will announce registration instructions on the SACC website in early March.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On January 11, 2022, the White House Office of Science and Technology Policy (OSTP) released the report of its Scientific Integrity Task Force on protecting the integrity of government science. According to OSTP, the scientific integrity principles and best practices identified in the report “aim to ensure that science is conducted, managed, communicated, and used in ways that preserve its accuracy and objectivity and protect it from suppression, manipulation, and inappropriate influence -- including political interference.” The report finds that:

  • While violations of scientific integrity are small in number compared to the magnitude of the federal government’s scientific enterprise, they can significantly undermine federal decision-making and public trust in science;
  • Existing federal scientific integrity policies are responsive to previous Executive actions but need to be strengthened to deter better inappropriate influence in the conduct, management, communication, and use of science; and
  • Supporting scientific integrity requires attention to other policy areas, including greater transparency into research processes and outputs; clear guidelines for data and information that agencies release; and policies that promote safe, equitable workplaces free from harassment and discrimination.

OSTP notes that the Obama Administration identified six principles of scientific integrity in 2009. To not only restore, but to strengthen the integrity of federal science beyond the efforts of any previous Administration, the Task Force makes the following additional recommendations to guide policymaking and foster a culture of scientific integrity in federal agencies:

  • All federal agencies -- not just those that fund and conduct scientific research -- should develop, implement, and periodically update scientific integrity policies. Protecting scientific integrity is essential for any federal agency or entity that communicates or makes use of scientific and technical information in decision-making;
  • Scientific integrity policies should apply to all those in federal agencies who manage, communicate, or use science, not just to scientists and engineers who conduct research, and not just to career employees, but contractors and political appointees as well. All must be trained in scientific integrity and their roles in upholding it;
  • Scientific integrity policies should be modernized to address important, emergent issues. They must advance diversity, equity, inclusion, and accessibility; address new concerns arising from the use of emerging technologies such as artificial intelligence and machine learning; and apply to emerging modes of science, such as citizen science and community-engaged research with federal involvement;
  • There should be broader dissemination and adoption of good scientific integrity practices across the federal government, a task that could be facilitated by more formalized interagency collaboration; and
  • There should be widespread training for agency scientists so they can communicate scientific findings effectively to nonscientists in their agencies and to lay audiences, with the idea of helping to ensure that policies and actions are based on an accurate understanding of the science.

OSTP states that in the coming months, it will draw upon the findings of the Task Force to develop a plan for the regular assessment and iterative improvement of scientific integrity policies and practices. In addition, agency leadership, working closely with OSTP, will deploy this framework to ensure that their scientific integrity policies are informed by the Task Force report and adhere to scientific integrity principles.


 

By Lynn L. Bergeson and Carla N. Hutton

Public Employees for Environmental Responsibility (PEER) announced on January 5, 2022, that it filed suit in the U.S. District Court for the District of Columbia to compel the U.S. Environmental Protection Agency (EPA) to disclose reports submitted pursuant to Section 8(e) of the Toxic Substances Control Act (TSCA). According to the complaint, PEER submitted a Freedom of Information Act (FOIA) request in November 2021 seeking records demonstrating how EPA deals with Section 8(e) reports. PEER states that it requested both Section 8(e) reports submitted to EPA and internal policies regarding publicly posting and using Section 8(e) reports. PEER notes that its FOIA request “built upon information reported in a November 2021 article in The Intercept noting that EPA had only posted one 8(e) report publicly since 2019 and describing disagreement over how the EPA processes 8(e) reports internally.”

In its announcement, PEER states that TSCA requires industry to notify EPA within 30 days when it obtains information that reasonably supports the conclusion that a chemical substance presents a substantial risk of injury to health or the environment. According to PEER, in early 2019, EPA stopped posting these industry reports in its public-facing database or on an easily searchable internal database. While industry submitted and EPA published more than 1,000 substantial risk reports from 2017 through 2018, PEER states that since 2019, EPA has posted only one to the public database. EPA scientists informed PEER that another approximately 1,240 reports have been received but sequestered.

PEER states that “[a]n EPA spokesperson told a news reporter that the person who had been responsible for posting these reports had retired in December 2018; and the agency lacked fundings to replace this single employee. However, at the same time, the agency finances an online tool enabling chemical companies to track their products through the approval process – internally called the ‘pizza tracker.’”

PEER asks the court to enter an order declaring that EPA wrongfully withheld requested documents and to issue a permanent injunction directing EPA to disclose all wrongfully withheld documents.


 

Bergeson & Campbell, P.C. (B&C®) is pleased to provide our Forecast 2022 to TSCAblog® readers, offering our best informed judgment as to the trends and key developments we expect to see in the new year. In 2022, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) will continue to focus on implementing the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) amendments to the Toxic Substances Control Act (TSCA), including the development of required risk evaluations and risk management actions on certain existing chemicals, review of and determinations on new chemical premanufacture notices (PMN), and issuance of a final rule requiring the reporting of hazard and exposure information on per- and polyfluoroalkyl substances (PFAS). In 2022, OPPT is also expected to initiate the prioritization for risk evaluation of certain chemicals to replace in the TSCA risk evaluation pipeline those “high-priority” chemicals for which risk evaluations may be completed in late 2022 or 2023. More details on this, and expected regulatory changes of all varieties, are available in our Forecast for U.S. Federal and International Chemical Regulatory Policy 2022.

WEBINAR
What to Expect in Chemicals in 2022
January 26, 2022, 12:00 p.m. EST
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B&C will be presenting a complimentary webinar, “What to Expect in Chemicals in 2022,” focusing on themes outlined in the forecast. Join Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Director of Chemistry; and James V. Aidala, Senior Government Affairs Consultant, for this informative and forward-looking webinar.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on December 28, 2021, it is granting a petition from six North Carolina public health and environmental justice organizations filed under Section 21 of the Toxic Substances Control Act (TSCA) to compel companies to conduct testing of certain per- and polyfluoroalkyl substances (PFAS). The previous Administration denied the petition on January 22, 2021. 86 Fed. Reg. 6602. The petition sought issuance of a rule or order under TSCA Section 4 compelling The Chemours Company to fund and carry out this testing under the direction of a panel of independent scientists. The petitioners requested that EPA reconsider its denial in March 2021, which EPA agreed to do in September 2021, in light of the change in Administration and attendant change in policy priorities concerning PFAS. As reported in our October 19, 2021, memorandum, EPA published a National PFAS Testing Strategy (Testing Strategy) that identifies priority substances for the first of several described phases of an iterative testing approach based on grouping of chemicals by chemistry features and available toxicity data. EPA states that these substances include many of the chemicals identified in the petition, as well as additional PFAS that will inform a wider universe of categories of PFAS where key data are lacking. For example, according to EPA, the first phase of testing on 24 PFAS is expected to provide data that can be extrapolated to 2,950 PFAS that belong to the same categories as the 24 individual substances.

EPA states that it has granted the petition and will use its TSCA Section 4 order authority to require PFAS manufacturers to conduct and fund the following studies that will provide toxicity data and information on categories of PFAS:

  • Near-Term Testing Covers 30 of 54 Petition Chemicals -- Under the Testing Strategy, EPA’s first test orders for 24 categories of PFAS about which the least is known will provide human health hazard data that cover 30 of the 54 petition chemicals;
  • Subsequent Testing May Cover Nine of 54 Petition Chemicals -- An additional nine PFAS identified in the petition belong to one other category included in the Testing Strategy. EPA is conducting more in-depth analyses of the sufficiency of the existing data, which will inform later phases of testing;
  • Remaining 15 of 54 Petition Chemicals -- According to EPA, 15 chemicals identified in the petition do not fit the definition of PFAS used in developing the Testing Strategy. EPA has determined that there are robust data on some of them available to it. EPA is conducting more in-depth analyses of the existing data, which will inform later phases of testing;
  • Mixtures Studies -- EPA will address PFAS mixtures by using the toxicity of the individual substances to predict the toxicity of the mixture, an approach which is consistent with the current state-of-science on PFAS. EPA is proceeding with development and peer review of these methods as specifically applied to PFAS;
  • Human Studies -- EPA is contributing to and reviewing numerous existing ongoing human studies, including studies on potentially exposed workers and communities in North Carolina, and is evaluating how to advance and expand on these efforts further. These include studies of health outcomes for people in communities impacted by industrial PFAS releases, as well studies that explore the connection between chronic health outcomes and PFAS exposures in North Carolina; and
  • Analytical Standards -- EPA does not believe it is appropriate to require the development or submission of analytical standards with the initial test orders that will be issued under the Testing Strategy and lacks the ability to order the submission of all analytical standards in the manner requested. Nonetheless, EPA has requested comment on whether to require the submission of existing analytical methods for PFAS under a separate rulemaking that the Agency expects to issue in final next year.

Commentary

EPA’s reversal is hardly surprising. The Biden Administration’s commitment to obtaining information on PFAS is clear and has been reinforced in many contexts. In her remarks before the Committee on Energy and Commerce on October 27, 2021, for example, Assistant Administrator Freedhoff stated that EPA is “scouring all sources of information to identify important gaps in existing data and to select representative chemicals within identified categories or additional testing.” Reconsidering the prior Administration’s denial of the Section 21 petition seems like a no-brainer.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 27, 2021, that it is expanding the scope of Toxics Release Inventory (TRI) reporting requirements to include certain contract sterilization facilities that are not currently reporting on ethylene oxide releases. EPA states that under the Emergency Planning and Community Right-to-Know Act (EPCRA), “the EPA Administrator has the discretionary authority to extend TRI reporting requirements to specific facilities based on a chemical’s toxicity, the facility’s proximity to other facilities that release the chemical or to population centers, any history of releases of the chemical at the facility, or other factors the Administrator deems appropriate.” According to EPA, exposure to ethylene oxide can cause cancer in humans and damage DNA. Other effects include eye, skin, nose, throat, and lung irritation, as well as harm to the brain and nervous system. Workers in facilities that use ethylene oxide and people in communities located adjacent to these facilities, including historically underserved communities, have the highest chance of being exposed to ethylene oxide. EPA notes that because their bodies are still growing, children are expected to be more susceptible to the toxic effects caused by ethylene oxide.
 
In October 2021, EPA sent letters to 31 facilities providing notice that EPA was considering exercising its discretionary authority. After corresponding with many of the facilities, EPA has issued a determination extending TRI reporting requirements to 29 of the 31 facilities for ethylene oxide and to 16 of the 31 facilities for ethylene glycol. According to EPA, because ethylene glycol is produced using ethylene oxide, these chemicals may co-occur at facilities. EPA states that it believes these 29 contract sterilization facilities, which do not currently report to TRI, use the highest amounts of ethylene oxide in the contract sterilization sector. The facilities are likely to exceed the 10,000 pounds per year “otherwise used” TRI reporting threshold for ethylene oxide. EPA notes that it considered additional factors, such as the facilities’ proximity to a population center (e.g., the number of people, including children under the age of five living near the facilities), their history of releases of ethylene oxide and ethylene glycol (e.g., past receipt of TRI reporting forms on ethylene oxide and ethylene glycol from these facilities), and other factors the Administrator deemed appropriate (e.g., proximity of the facilities to nearby schools and communities, especially those with potential environmental justice concerns and concerns for facility workers).
 
EPA did not to extend TRI reporting requirements to two of the 31 facilities initially contacted. According to EPA, one of the facilities conveyed to EPA that they had sold the establishment they previously used for sterilization and no longer perform sterilization work at that facility. Another facility informed EPA that their facility uses ethylene oxide in quantities far below the amount that would trigger TRI reporting in a year due to their sterilization technology and scale of operations.
 
Beginning in January 2022, these 29 facilities should start tracking their activities involving ethylene oxide (and ethylene glycol, if applicable) releases and other waste management quantities as required by EPCRA, similar to any other facility subject to TRI reporting requirements. If reporting thresholds are met, the facilities must submit TRI data beginning in 2023.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has reopened the online dockets for 20 high-priority substances. According to the December 9, 2021, memorandum authorizing the re-opening of the dockets, EPA is re-opening these dockets to receive use, hazard, exposure, and any other information that can help inform their risk evaluations. Information must be submitted by June 9, 2022, when EPA will close the dockets. Information submitted to the docket should be identified by the docket identification (ID) number associated with the relevant chemical. The 20 high-priority chemicals are:

  • p-Dichlorobenzene;
  • 1,2-Dichloroethane;
  • trans-1,2-Dichloroethylene;
  • o-Dichlorobenzene;
  • 1,1,2-Trichloroethane;
  • 1,2-Dichloropropane;
  • 1,1-Dichloroethane;
  • Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2-dibutyl ester);
  • Butyl benzyl phthalate (BBP) (1,2-Benzene-dicarboxylic acid, 1-butyl 2-(phenylmethyl) ester);
  • Di-ethylhexyl phthalate (DEHP) (1,2-Benzene-dicarboxylic acid, 1,2-bis(2-ethylhexyl) ester);
  • Di-isobutyl phthalate (DIBP) (1,2-Benzene-dicarboxylic acid, 1,2-bis-(2-methylpropyl) ester);
  • Dicyclohexyl phthalate;
  • 4,4'-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA);
  • Tris(2-chloroethyl) phosphate (TCEP);
  • Phosphoric acid, triphenyl ester (TPP);
  • Ethylene dibromide;
  • 1,3-Butadiene;
  • 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB);
  • Formaldehyde; and
  • Phthalic anhydride.

The docket ID number and contact information for each chemical lead is available in the memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) is accepting public comments on candidates under consideration for selection as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with their review of the draft EPA Toxic Substances Control Act (TSCA) Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities. EPA will use the comments to assist it in selecting approximately six to eight ad hoc reviewers to assist the SACC with its review. Biographies of the candidates are available online. Comments are due January 5, 2022. Comments can be submitted through Docket ID EPA-HQ-OPPT-2021-0415. Information considered to be confidential business information (CBI) or other information whose disclosure is restricted by statute should not be submitted electronically. EPA notes that it will not post copyrighted material without explicit permission of the copyright holder.
 
EPA notes that it published ten final risk evaluations between 2020 and 2021 under TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. During the course of preparing many of these final risk evaluations, the previous Administration made a policy decision that EPA not assess air and water exposure pathways that fall under the jurisdiction of other EPA-administered laws. This policy decision was reversed in June 2021. EPA states that it is presenting Version 1.0 of a screening level methodology for assessing potential air and water pathway chemical exposures to fenceline communities. Along with presenting this methodology, EPA will also present results of applying the screening methodology (case studies) to 1-bromopropane (air pathway), N-methylpyrrolidone (water pathway), and methylene chloride (air and water pathway). The review will take place during a public meeting anticipated for March 15-17, 2022. Registration instructions will be announced on the SACC website in early February 2022.


 
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