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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 7, 2022, that registration is now open for the March 15-17. 2022, meeting of the Science Advisory Committee on Chemicals (SACC) to peer review EPA’s “Draft TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0” (screening level methodology). As reported in our January 24, 2022, memorandum, EPA will use the screening level methodology to evaluate potential chemical exposures and associated potential risks to fenceline communities in its Toxic Substances Control Act (TSCA) risk evaluations. EPA has extended the comment period to March 22, 2022, to give stakeholders additional time to provide input. EPA “encourages” written comments for consideration by SACC during its peer review be submitted by the original deadline of February 22, 2022. EPA states that it will provide comments submitted after this date to the SACC members, but notes that members “may not have adequate time to consider those comments prior to the meeting’s discussions.” While SACC is unable to consider comments submitted after the March 15-17, 2022, meeting, EPA will consider all comments submitted by March 22, 2022.
 
To provide oral comments during the virtual peer review meeting, registration must be received by 12:00 p.m. (EST) on February 25, 2022. Stakeholders may register as a listen-only attendee at any time until the end of the meeting on March 17, 2022.


 

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
 
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.


 
By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced the availability of the Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances (Draft Protocol) on December 20, 2021. 86 Fed. Reg. 71891. According to EPA, the Draft Protocol includes a revised generic approach for Toxic Substances Control Act (TSCA)-related approaches accounting for previous peer review comments from the Science Advisory Committee on Chemicals (SACC) reviews of risk evaluations on the first ten chemical assessments and more recent recommendations from the National Academies of Sciences, Engineering, and Medicine (NASEM) review of the Application of Systematic Review in TSCA Risk Evaluations. EPA states that in addition to the revised, generic approach, the peer review package will include appendices containing chemical-specific information that is relevant for search strings and screening statements and data evaluation criteria for the next chemical risk evaluations being conducted by the Office of Pollution Prevention and Toxics (OPPT). The Draft Protocol provides specific details of the systematic reviews for the individual chemicals listed below:

o-Dichlorobenzene
p-Dichlorobenzene
1,2-Dichloroethane
trans-1,2- Dichloroethylene
1,1,2-Trichloroethane
1,2-Dichloropropane
1,1-Dichloroethane
Ethylene dibromide
1,3-Butadiene
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB)
4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA)
Tris(2-chloroethyl) phosphate (TCEP)
Phosphoric acid, triphenyl ester (TPP)
Formaldehyde
Phthalic anhydride
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
Diisodecyl phthalate (DIDP)
Diisononyl phthalate (DINP)
Octamethylcyclotetra-siloxane (Cyclotetrasiloxane, 2,2,4,4,6,6,8,8-octamethyl-) (D4)
Asbestos 2 (including Libby Amphibole Asbestos [LAA] and its tremolite, winchite, and richterite constituents)
1,4-Dioxane supplement
 
EPA invites the public to provide input on the Draft Protocol via Docket No. EPA-HQ-OPPT-2021-0414. Comments are due February 18, 2022.
SACC will hold a virtual three-day peer review public meeting to consider and review the Draft Protocol on April 19-21, 2022. Stakeholders must register online to receive the webcast meeting link and audio teleconference information. Registration instructions will be announced on the SACC website by early March 2022. After the public meeting, SACC will prepare meeting minutes summarizing its recommendations to EPA. The meeting minutes will be posted on the SACC website and in the relevant docket.
 
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) Office of Inspector General (OIG) announced the availability of its fiscal year (FY) 2022 oversight plan on December 14, 2021. According to OIG, the plan reflects the priority work that the OIG believes is necessary to keep EPA, the U.S. Chemical Safety and Hazard Investigation Board (CSB), and Congress fully informed about issues relating to the administration of EPA programs and operations. The planned oversight projects concerning Ensuring the Safe Use of Chemicals include:

  • Audit of EPA’s Management of New Chemical Risk Assessments Conducted under the Toxic Substances Control Act (TSCA): Determine the extent to which EPA is using and complying with applicable records-management and quality-assurance requirements and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks;
     
  • Evaluation of EPA Regions’ Oversight Responsibilities for State and Tribal Drinking Water Certification Programs: Determine whether select EPA regions are fulfilling oversight responsibilities for drinking water certification programs in states and tribal nations;
     
  • Evaluation of EPA’s Use of Pesticide Incident-Reporting Data: Determine whether EPA uses pesticide incident-reporting data to prevent unreasonable adverse effects on human health and the environment;
     
  • Evaluation of Implementation of EPA’s Federal Certification for Applicators and Dealers of Restricted-Use Pesticides within Indian Country: Determine how EPA monitors and enforces the requirements for restricted-use pesticide applicators (private and commercial) and restricted-use pesticide dealers in Indian Country;
     
  • Evaluation of EPA’s Progress toward Providing States with Clear Benchmarks to Address Per- and Polyfluoroalkyl Substances (PFAS) in Drinking Water: Determine why EPA has not established a mandatory limit for PFAS in drinking water; what challenges may prevent EPA from setting such a limit; and what EPA’s plan -- if one exists -- is for implementing such a limit; and
     
  • Evaluation of EPA’s Progress to Identify Key Regulatory Stakeholders for TSCA Existing Chemical Risk Management: Determine whether EPA identified and partnered with key regulatory stakeholders and developed a process to coordinate the regulation of occupational exposures from existing chemicals under TSCA.

Ongoing projects concerning Ensuring the Safe Use of Chemicals include:

  • Evaluation of EPA’s Cancer Assessment Review for Pesticide 1,3-Dichloropropene: Evaluate the extent to which EPA followed policies and procedures in developing the cancer assessment for the 1,3-dichloropropene pesticide registration review decision to prevent unreasonable adverse effects on human health; and
     
  • Evaluation of EPA’s Overdue Residual Risk and Technology Reviews: Evaluate whether EPA has conducted residual risk and technology reviews in a timely manner, as required for EPA to revise standards, as needed, to protect the public from air toxics emitted by stationary sources.

Planned and ongoing projects concerning Safeguarding Scientific Integrity Principles include:

  • Congressional Request: Evaluation of EPA’s Changes to Final Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Significant New Use Rule (SNUR): Determine the extent to which EPA followed applicable policies, procedures, and guidance for the changes made to the Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances SNUR between the EPA Administrator’s signing of the final SNUR on June 22, 2020, and the publication of the final SNUR in the Federal Register on July 27, 2020; and
     
  • Evaluation of EPA’s January 2021 Perfluorobutane Sulfonic Acid (PFBS) Toxicity Assessment: Determine whether EPA’s Office of Research and Development (ORD) and Office of Chemical Safety and Pollution Prevention (OCSPP) followed applicable policies and procedures in the development and publication of the January 19, 2021, PFBS toxicity assessment.

OIG states that it is important to note that its planning efforts “are not static and that the projects included herein may be modified throughout the year as challenges and risks for the EPA and the CSB evolve and emerge.”


 

By Lynn L. Bergeson and Carla N. Hutton

On December 10, 2021, the Biden Administration released its Fall 2021 Unified Agenda of Regulatory and Deregulatory Actions. According to the U.S. Environmental Protection Agency’s (EPA) rule list, the Office of Chemical Safety and Pollution Prevention (OCSPP) is working on the following rulemakings under the Toxic Substances Control Act (TSCA). Rulemakings at the proposed stage include:

  • Tiered Data Reporting to Inform Prioritization, Risk Evaluation, and Risk Management Under TSCA (2070-AK62): EPA is developing this rule to obtain information about potential hazards and exposure pathways related to certain chemicals, particularly occupational, environmental, and consumer exposure information. EPA states that this information is needed to inform prioritization, risk evaluation, and risk management of the chemical substances under TSCA Section 6. EPA intends to publish a notice of proposed rulemaking (NPRM) in July 2022 and a final rule in March 2023. More information on the rulemaking is available in our July 29, 2021, memorandum;
     
  • Revisions to the TSCA Fees Rule (2070-AK64): In January 2021, EPA proposed updates and adjustments to the 2018 TSCA Fees Rule. EPA proposed to add three new fee categories: a Bona Fide Intent to Manufacture or Import Notice, a Notice of Commencement of Manufacture or Import, and an additional fee associated with test orders. In addition, EPA proposed exemptions for entities subject to certain fee triggering activities, including: an exemption for research and development activities; an exemption for entities manufacturing less than 2,500 pounds of a chemical subject to an EPA-initiated risk evaluation fee; an exemption for manufacturers of chemical substances produced as a non-isolated intermediate; and exemptions for manufacturers of a chemical substance subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, produced as a byproduct, or produced or imported as an impurity. EPA proposed a volume-based fee allocation for EPA-initiated risk evaluation fees in any scenario where a consortium is not formed and proposed to require export-only manufacturers to pay fees for EPA-initiated risk evaluations. EPA states that in light of public comments, it has decided to issue a supplemental proposal and seek additional public comment on changes to the January 2021 proposal. EPA intends to issue a supplemental NPRM in February 2022. EPA has not determined when it will issue a final rule. More information on the proposed rule is available in our December 30, 2020, memorandum;
     
  • New Chemicals Procedural Regulations to Reflect Amendments to TSCA (2070-AK65): This rulemaking seeks to revise the new chemicals procedural regulations in 40 C.F.R. Part 720 to improve the efficiency of EPA’s review process and to align its processes and procedures with the new statutory requirements. According to EPA, this rulemaking seeks to increase the quality of information initially submitted in new chemicals notices and improve its processes “to reduce unnecessary rework in the risk assessment and, ultimately, the length of time that new chemicals are under review.” EPA intends to publish an NPRM in September 2022. EPA has not determined when it will issue a final rule;
     
  • Procedures for Submitting Information Subject to Business Confidentiality Claims Under TSCA (2070-AK68): EPA states that it is considering proposing new and amended rules concerning the assertion and maintenance of claims of business confidentiality (i.e., confidential business information (CBI)) under TSCA. The 2016 TSCA amendments included several new provisions concerning the assertion and EPA review and treatment of confidentiality claims. EPA is considering procedures for submitting and supporting such claims in TSCA submissions, including substantiation requirements, exemptions, electronic reporting enhancements, and maintenance or withdrawal of confidentiality claims. EPA is also considering whether the proposed rule should elaborate on EPA’s procedures for reviewing and communicating with TSCA submitters about confidentiality claims. According to EPA, it expects the proposed rule to include new provisions, as well as revisions to existing rules on asserting confidentiality claims to conform to the 2016 amendments. EPA intends to issue an NPRM in April 2022;
     
  • Cyclic Aliphatic Bromide Cluster (HBCD); Rulemaking Under TSCA Section 6(a) (2070-AK71): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for HBCD, EPA initiated rulemaking to address unreasonable risks of injury to health and the environment identified in the final risk evaluation. EPA intends to publish an NPRM by September 2022 and a final rule by April 2024. More information on the final risk evaluation is available in our September 28, 2020, memorandum;
     
  • 1-Bromopropane; Rulemaking Under TSCA Section 6(a) (2070-AK73): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for 1-bromopropane, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in May 2024. More information on the final risk evaluation is available in our August 11, 2020, memorandum;
     
  • Carbon Tetrachloride; Rulemaking Under TSCA Section 6(a) (2070-AK82): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for carbon tetrachloride, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in June 2024. More information on the final risk evaluation is available in our November 4, 2020, memorandum;
     
  • Trichloroethylene (TCE); Rulemaking Under TSCA Section 6(a) (2070-AK83): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for TCE carried out under the authority of TSCA Section 6, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in June 2024. More information on the final risk evaluation is available in our November 24, 2020, memorandum;
     
  • Asbestos (Part 1: Chrysotile Asbestos); Rulemaking under TSCA Section 6(a) (2070-AK86): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a TSCA Section 6 risk evaluation for chrysotile asbestos, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM by April 2022 and a final rule by November 2023. More information on the final risk evaluation is available in our January 4, 2021, memorandum;
     
  • Reconsideration of Procedures for Chemical Risk Evaluation Under the Amended TSCA (2070-AK90): EPA published a final rule on July 20, 2017, that established a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. This process incorporates the science requirements of the amended statute, including best available science and weight of the scientific evidence. The final rule established the steps of a risk evaluation process, including: scope, hazard assessment, exposure assessment, risk characterization, and risk determination. EPA states that it is now in the process of reconsidering the final rule in keeping with new executive orders (EO) concerning the advancement of racial equity and support for underserved communities through the federal government (EO 13985), the protection of public health and the environment and restoring science to tackle the climate crisis (EO 13990), tackling the climate crisis at home and abroad (EO 14008), and other Administration priorities (such as the Presidential memorandum on restoring trust in government through scientific integrity and evidence-based policymaking). If EPA determines to amend the 2017 final rule based on its reconsideration, it will solicit public comment through an NPRM. EPA intends to publish an NPRM in September 2022;
     
  • Regulation of Persistent, Bioaccumulative, and Toxic (PBT) Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1) (PIP (3:1)); Further Compliance Date Extension (2070-AK95): EPA proposed in October 2021 to amend the regulations applicable to PIP (3:1) promulgated under TSCA. Specifically, EPA proposes 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 notes that the articles covered by the proposed rule include a wide range of key consumer and commercial goods such as cellular telephones, laptop computers, and other electronic and electrical devices and industrial and commercial equipment used in various sectors, including transportation, construction, agriculture, forestry, mining, life sciences, and semiconductor production. The proposed rule follows a recently-issued final rule that extended 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, from March 8, 2021, to March 8, 2022, along with the associated recordkeeping requirements. Comments on the proposed rule are due December 27, 2021. EPA intends to issue a final rule in March 2022. More information on the proposed rule is available in our October 25, 2021, memorandum; and
     
  • TSCA Section 8(a) Reporting and Recordkeeping Requirements for Asbestos (2070-AK99): This rulemaking, under the authority of TSCA Section 8(a), would require the maintenance of records and submission to EPA of reports by manufacturers, importers, and processors of asbestos and mixtures and articles containing asbestos (including as an impurity). EPA states that the information sought includes data on the quantities of asbestos used in making products, employee exposure data, and waste disposal data. Reported information would be used by EPA and other federal agencies in considering the regulation of asbestos. EPA intends to issue an NPRM in March 2022 and a final rule in November 2022.

The Unified Agenda lists the following TSCA rulemaking at the final stage:

  • Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (PMN) (2070-AJ94): EPA proposed amending components of the Significant New Uses of Chemical Substances regulations at 40 C.F.R. Part 721, specifically the “Protection in the Workplace” (40 C.F.R. Section 721.63) and “Hazard Communication Program” (40 C.F.R. Section 721.72). 81 Fed. Reg. 49598. The proposed changes are intended to align, where possible, EPA’s regulations with the revised Occupational Safety and Health Administration (OSHA) regulations at 29 C.F.R. Section 1910.1200. OSHA issued a final rule on March 26, 2012, (77 Fed. Reg. 17573) that aligns OSHA’s Hazard Communication Standards with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). EPA states that it is reviewing the comments received and is planning to issue a final rule. EPA intends to issue a final rule in September 2022. More information on EPA’s 2016 proposed rule is available in our July 29, 2016, memorandum.

 

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.


 
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