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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 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 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
 
On June 15, 2021, the U.S. Environmental Protection Agency (EPA) appointed nine new members to serve on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). Additionally, EPA appointed a new Chair and reappointed seven existing members. In EPA’s July 13, 2021, announcement, EPA notes that members of the TSCA SACC serve staggered terms of appointment, generally of three years. They possess expertise in scientific and technical fields relevant to chemical risk assessment and pollution prevention, including human health and ecological risk assessment and chemical exposure to susceptible life stages and subpopulations. EPA states that in addition to scientific expertise, members also have backgrounds and experiences that will contribute to the diversity of scientific viewpoints, including professional experiences in government, public health, industry, and other groups. According to EPA, TSCA SACC serves as a primary scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) and is structured to provide 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.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 8, 2021, that it is releasing an updated toxicity assessment for perfluorobutane sulfonic acid (PFBS), which is a member of the group of per- and polyfluoroalkyl substances (PFAS).  EPA states that this PFBS assessment is part of its commitment to restore scientific integrity to all of the Agency’s actions and increase the amount of research and information available to the public on PFAS.  According to EPA’s announcement, “EPA, federal agencies, states, tribes, and local communities can use the PFBS toxicity assessment, along with specific exposure and other relevant information, to determine if and when it is necessary to take action to address potential health risks associated with human exposures to PFBS under appropriate regulations and statutes.”  EPA notes that the updated assessment “has gone through all appropriate reviews, includes input EPA received from external peer review, upholds the tenants of scientific integrity, was authored by expert career scientists in EPA’s Office of Research and Development, and has not been compromised by political staff -- these were all issues with a version of the assessment that was posted during the previous administration.  The release of today’s PFBS assessment upholds the integrity of EPA’s science, which EPA, states, tribes, and more rely on to make decisions that protect the health of their communities.”
 
According to EPA’s fact sheet on the toxicity assessment, PFBS is a replacement chemical for perfluorooctanesulfonic acid (PFOS), a PFAS that was voluntarily phased out by the primary U.S. manufacturer by 2002.  PFBS has been identified in the environment and consumer products, including surface water, wastewater, drinking water, dust, carpeting and carpet cleaners, and floor wax.  The fact sheet states that the PFBS toxicity assessment is comparable to assessments developed under EPA’s Integrated Risk Information System (IRIS) and Provisional Peer-Reviewed Toxicity Value (PPRTV) Programs in that it provides hazard identification, dose-response information, and toxicity values.  EPA will continue to work with state, tribal, and local partners to provide technical assistance as they consider the final PFBS toxicity values in relevant exposure scenarios.  The fact sheet notes that at this time, EPA does not plan to issue a regulation for PFBS.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will host its first annual conference to discuss alternative test methods and strategies to reduce animal testing on December 17, 2019, in Washington, D.C.  According to EPA, the conference will bring together some of the leading voices in environmental and health research to discuss efforts to reduce testing on mammals.  The conference will focus on the New Approach Methods (NAM) and will feature presentations by U.S. and international scientific experts on advancements in the field.  On-site participants will have the opportunity to exchange information about scientific advancements in the NAMs field to develop a better understanding of the state of the science, discuss approaches for developing scientific confidence in using alternatives, and summarize existing studies characterizing the uncertainties in results from animal testing.  The public can register to participate via webinar.
 
As reported in our September 11, 2019, blog item, on September 10, 2019, EPA Administrator Andrew Wheeler signed a directive to prioritize efforts to reduce animal testing.  The directive states that EPA “will reduce its requests for, and [its] funding of, mammal studies by 30 percent by 2025 and eliminate all mammal study requests and funding by 2035.  Any mammal studies requested or funded by the EPA after 2035 will require Administrator approval on a case-by-case basis.”
 
EPA notes that over the past several years, it has made significant scientific advancements in NAMs and has led efforts to reduce, replace, and refine its animal testing requirements.  On December 5, 2019, EPA updated the list of NAMs that it developed pursuant to the Toxic Substances Control Act (TSCA), as amended by the 2016 Lautenberg Chemical Safety Act.  EPA states that it “will continue to lead the way among federal agencies in the United States and internationally.”


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On May 9, 2019, the U.S. Environmental Protection Agency (EPA) announced it will hold the first meeting of the Science Advisory Committee on Chemicals (SACC) under the Toxic Substances Control Act (TSCA), for Pigment Violet 29 (PV29), the first chemical of the initial ten chemicals undergoing review, on June 18-21, 2019, from 9:00 a.m. to 5:30 p.m. (EDT) at the Holiday Inn Rosslyn at Key Bridge, Rosslyn Ballroom, 1900 North Fort Myer Drive, Arlington, Virginia.  84 Fed. Reg. 20354.  The meeting may also be available via webcast.

EPA states that the purpose of the SACC meeting is for EPA “to get the independent review of the science underlying the PV29 risk assessment, including the hazard assessment, assessment of dose-response, exposure assessment, and risk characterization.”  Additionally, this meeting will include an orientation on TSCA and how EPA is evaluating chemicals in commerce as prescribed in amended TSCA.  EPA states that it will use the scientific advice, information, and recommendations from the SACC, as well as public comments, to inform the final risk evaluation.  Comments are still being collected on the PV29 risk assessment until May 17, 2019, in Docket No. EPA-HQ-OPPT-2018-0604 on www.regulations.gov.

More information about the June SACC meeting and peer review of PV29 is available on EPA’s website.


 

By Christopher R. Bryant and Lynn L. Bergeson

According to press reports, Nancy Beck, Ph.D., DABT has been hired as the Principal Deputy Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP).  Dr. Beck holds a doctorate in environmental health from the University of Washington.  For the past five years she served as the Senior Director for Regulatory Science Policy at the American Chemistry Council (ACC).  For a decade prior to ACC, she was an analyst within the White House’s Office of Management and Budget (OMB).

Despite Dr. Beck’s compelling credentials, the appointment has displeased some stakeholders.  Dr. Beck has been a staunch critic of how EPA conducts chemical risk assessments and its Integrated Risk Information System (IRIS).  President Trump is proposing to eliminate IRIS; it thus is unlikely that Dr. Beck would revive or rely upon it in implementing the recently revised Toxic Substances Control Act (TSCA).  Less than two months ago, Dr. Beck provided testimony before the Senate Homeland Security and Government Affairs Subcommittee on Regulatory Affairs and Federal Management calling for changes to EPA’s risk assessment processes. 


 

By Lynn L. Bergeson and Charles M. Auer

On November 29, 2016,  the U.S. Environmental Protection Agency (EPA) announced the initial ten chemical substances on which risk evaluations will be conducted under Toxic Substances Control Act (TSCA) Section 6(b)(2)(A).  The chemicals, all of which were to be drawn from the TSCA Work Plan for Chemical Assessments, are:

1,4-dioxane
1-bromopropane
Trichloroethylene (TCE)
Carbon tetrachloride
Hexabromocyclododecane (HBCD)
Methylene chloride
Pigment violet 29
Perchloroethylene (PERC)
N-methyl-2-pyrrolidone (NMP)
Asbestos

EPA is required under TSCA Section 6(b)(2)(A) to announce the chemicals within 180 days of enactment, or by December 19, 2016.

Interestingly, several of the chemicals are the subject of Section 6 rules that are currently undergoing review by the Office of Management and Budget (OMB).  These include TCE, methylene chloride, and NMP.  Assuming that EPA continues with these rules (relying on the savings provision at TSCA Section 26(p)(3) to use the completed risk evaluations on these chemicals in taking the Section 6 actions), the inclusion of the chemicals on the list may suggest that EPA will broaden the risk evaluations to include other conditions of use beyond those in the completed risk assessments.

For more on the chemicals listed and additional information: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/evaluating-risk-existing-chemicals-under-tsca.