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By Lynn L. Bergeson and Carla N. Hutton
 
On March 2, 2021, the U.S. Government Accountability Office (GAO) published its latest High Risk List, which includes 36 areas across the federal government vulnerable to waste, fraud, abuse, and mismanagement or needing broad-based transformation.  According to GAO, five areas have regressed since 2019, including the U.S. Environmental Protection Agency’s (EPA) process for assessing and controlling toxic chemicals.  GAO’s report, High-Risk Series: Dedicated Leadership Needed to Address Limited Progress in Most High-Risk Areas, states that this high-risk area declined in the monitoring criterion from a partially met rating in 2019 to a not met rating in 2021; three criteria in each of the two segments declined to a not met rating in 2021.  GAO notes that the Integrated Risk Information System (IRIS) Program did not issue a completed chemical assessment between August 2018 and December 2020, and EPA (1) did not indicate how it was monitoring its assessment nomination process to ensure it was generating quality information about chemical assessment needs; and (2) lacked implementation steps and resource information in its strategic plan and metrics to define progress in the IRIS Program.  Additionally, according to GAO, EPA’s programs supporting the Toxic Substances Control Act (TSCA) (1) did not complete workforce or workload planning to ensure the agency can meet TSCA deadlines; and (2) did not meet initial statutory deadlines for releasing its first ten chemical risk evaluations.


 

In the 21st century, we take as given a continuous stream of new and better products. From electronics to building materials to transportation solutions, the flow of new and better products and applications seems unending. New chemical substances play a fundamental role in creating those products and making existing products better. If the pipeline of new chemicals were closed off, the flow of new products and applications would slow to a trickle and eventually dry up. Modern life as we know it would not exist without the continued invention, production and use of new chemicals.

In the US, all new chemicals must be reviewed by the US EPA before they can enter commerce. The agency looks at new chemicals to determine whether their manufacturing, processing and use would adversely affect people or the environment. If the EPA identifies risks that it determines to be unreasonable, then it either prohibits use of the chemical, or requires restrictions on the chemical to control for risks. Since the 1970s, tens of thousands of chemicals have come through the EPA for review and have been allowed into US commerce.

In this article, Richard E. Engler, Ph.D. and Jeffery T. Morris, Ph.D. write that more robust consideration of a new chemical’s potential to prevent pollution and lower risks could help achieve the right balance between safety and innovation. The full article is available at https://chemicalwatch.com/220164/guest-column-why-the-us-epa-can-and-should-evaluate-the-risk-reducing-role-a-new-chemical-may-play-if-allowed-on-the-market (subscription required).


 

By Lynn L. Bergeson and Carla N. Hutton
 
On February 16, 2021, the National Academies of Sciences, Engineering, and Medicine (National Academies) announced the availability of a report entitled The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations.  The U.S. Environmental Protection Agency (EPA) requested that the National Academies convene a committee to review EPA’s 2018 guidance document on Application of Systematic Review in TSCA Risk Evaluations and associated materials.  In its final report, the Committee to Review EPA’s Toxic Substances Control Act (TSCA) Systematic Review Guidance Document states that it “was in strong consensus that the processes used by [the Office of Pollution Prevention and Toxics (OPPT)] do not meet the evaluation criteria specified in the Statement of Task (i.e., comprehensive, workable, objective, and transparent).”  The Committee recognizes the “substantial challenges in implementing review methods on the schedule required by” the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), but concluded that those challenges “have not yet been successfully met.”  The final report includes the following summary of the Committee’s general recommendations:

  • OPPT’s approach to systematic review does not adequately meet the state of the practice.  The Committee suggests that OPPT comprehensively reevaluate its approach to systematic review methods, addressing the comments and recommendations provided in Chapter 2 of the final report.
     
  • With regard to hazard assessment for human and ecological receptors, the Committee comments that “OPPT should step back from the approach that it has taken and consider components” of the Office of Health Assessment and Translation (OHAT) of the National Toxicology Program, EPA’s Integrated Risk Information System (IRIS), and Navigation Guide methods that could be incorporated directly and specifically into hazard assessment.
     
  • The Committee finds that OPPT’s use of systematic review for the evidence streams, for which systematic review has not been previously adapted, “to be particularly unsuccessful.”  The Committee suggests that OPPT elaborate plans for continuing the refinement of methods, ideally in collaboration with internal and external stakeholders.  The Committee also suggests that OPPT evaluate how the existing OHAT, IRIS, and Navigation Guide methods could be modified for the other evidence streams.  In addition, according to the Committee, OPPT should use existing EPA guidance, such as the Guidelines for Human Exposure Assessment, the Guidelines for Ecological Risk Assessment, and the operating procedures for the use of the ECOTOXicology knowledgebase (ECOTOX).  Following these existing guidelines would improve transparency of the assessments.
     
  • The Committee recommends that EPA put together a handbook for TSCA review and evidence integration methodology that details the steps in the process.  Throughout the final report, the Committee points to problems of documentation.  The Committee “believes that the effort of developing and publicly vetting a handbook will pay off in the long run by making the process more straightforward, transparent, and easier to follow.”

The final report states that “[t]here is an ongoing cross-sector effort to develop and validate new tools and approaches for exposure, environmental health, and other new areas of application of systematic review,” and the Committee “strongly recommends that OPPT staff engage in these efforts.”  According to the final report, the approaches used for TSCA evaluation “would benefit from the substantial external expertise available,” as well as additional transparency and acceptance by the different stakeholders as these tools are developed.
 
EPA published a press release on February 16, 2021, in response to the Committee’s report, announcing that it “will refine its approach to selecting and reviewing the scientific studies that are used to inform” TSCA chemical risk evaluations.  According to EPA, its “ongoing effort to update its systematic review approach” is also part of its “broader efforts” to review the first ten TSCA risk evaluations.  EPA states that it “is not using, and will not again use, the systematic review approach that was reviewed by the Academies.”  The 2018 Application of Systematic Review document “represented EPA’s practices at that time.”  According to the press release, EPA has already begun to develop a TSCA systematic review protocol in collaboration with its Office of Research and Development to incorporate approaches from the IRIS Program.  EPA “expects to publish and take public comment on a TSCA systematic review protocol that will adopt many of the recommendations in the Academies’ report later this year.”


 

The American Law Institute Continuing Legal Education (ALI CLE) and the Environmental Law Institute’s (ELI) Environmental Law 2021 webcast educates lawyers on key current environmental law issues, including the latest developments in air, water, endangered species, climate change, chemicals, and renewable energy. A national faculty of seasoned private practitioners, governmental officials, law professors, and public interest advocates will cover what to expect from the change of administrations in Washington D.C., with Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), and Alexandra Dapolito Dunn, former Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency, presenting "Chemicals Regulation: Latest Developments" on February 25, 2021. This course will cover:

  • Biden-Harris Administration priorities with respect to chemical policy and regulation;
     
  • Potential likelihood of shifts in Toxic Substances Control Act (TSCA) implementation and agricultural chemical policy;
     
  • Key recent European Union (EU) initiatives expected to influence domestic initiatives; and
     
  • Anticipated changes with respect to emerging contaminants and environmental justice policy development.

Register online for the full three-part webcast, or register separately for Part 1 on February 24, Part 2 on February 25, and Part 3 on February 26.


 

This week's All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below.

This week I had my final visit with the U.S. Environmental Protection Agency’s (EPA) Assistant Administrator Alexandra Dunn.  As many of our listeners know, Alex Dunn lead the Office of Chemical Safety and Pollution Prevention and was responsible for implementing the nation’s industrial and agricultural chemical laws, the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), respectively.  Alex has done a superb job since taking office in early 2019, and her steady hand in managing TSCA implementation and a wide range of hot button pesticide issues has been effective and comforting.

Prior to Alex’s current role, she served as the Regional Administrator for EPA Region 1, and before Region 1, Alex served as the executive director and general counsel for the Environmental Council of the States.

We focused our discussion on a look back at Alex’s many achievements since taking office, including implementation of the amendments to TSCA, which Congress enacted in 2016.  Alex also addressed some of the most controversial pesticides -- glyphosate, dicamba, and chlorpyrifos, among others -- all the while implementing one of the most consequential pieces of environmental legislation ever passed by Congress.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2021 Bergeson & Campbell, P.C.  All Rights Reserved


 

By Lynn L. Bergeson and Carla N. Hutton
 
On November 30, 2020, Bloomberg Law Environment & Energy Report published a Practitioner Insight column entitled “The Toxic Substances Control Act Under Biden:  Impact on Tribal, Fenceline Populations” by Jeffery Morris, former Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) and founder of Jeff Morris Solutions LLC.  Morris examines how the Biden Administration could apply the Toxic Substances Control Act’s (TSCA) requirement to consider impacts on subpopulations in the evaluation of chemical risks.  Morris notes that fenceline communities and American Indian and Alaskan Natives (referred to as “tribes” in the article, “recognizing that not all native people are in federally recognized tribes”) have faced significant impacts from chemical exposure and should be priorities.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 10, 2020, that the Integrated Risk Information System (IRIS) Program released the ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook) for public comment.  EPA states that the IRIS Handbook provides operating procedures for developing IRIS assessments, including problem formulation approaches and methods for conducting systematic review, dose response analysis, and developing toxicity values.  The IRIS Handbook notes that it does not supersede existing EPA guidance and does not serve as guidance for other EPA programs.  EPA will publish a Federal Register notice announcing the beginning of a 90-day public comment period on the IRIS Handbook and on the draft charge questions for reviewers in advance of a National Academies of Sciences, Engineering, and Medicine (NASEM) peer review.  EPA will summarize comments received and provide them to the committee conducting the peer review.  EPA has posted a pre-publication version of the Federal Register notice.


 

By Lynn L. Bergeson and Carla N. Hutton

We are pleased to announce that the American Bar Association (ABA) Section of Environment, Energy, and Resources published an article written by Lynn L. Bergeson and Eve C. Gartner entitled “The essentials of TSCA practice” in the November/December 2020 issue of Trends.  According to the authors, legal practitioners should be aware of the commercial, legal, and reputational implications of the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act in 2016.  The authors state that TSCA’s expanded commercial reach “is an important, consequential, and growing practice area.”  The authors note that “[c]ommunity organizations representing populations at greater risk of harm from chemicals should also be aware that TSCA may offer much-needed protections.”


 

By Lynn L. Bergeson , Lisa M. Campbell, and Carla N. Hutton
 
Representatives Frank Pallone, Jr. (D-NJ), Chair of the House Committee on Energy and Commerce, and Jan Schakowsky (D-IL), Chair of the House Energy and Commerce Subcommittee on Consumer Protection and Commerce, wrote to Amazon Chief Executive Officer (CEO) and Chair Jeff Bezos on October 7, 2020, requesting that he launch an investigation into the safety of Amazon’s product line, AmazonBasics, and answer a series of questions pertaining to the company’s product safety and recall practices.  The Committee’s October 7, 2020, press release notes that the request comes after a CNN investigation found that many of AmazonBasics’ electronic products “have exploded, caught fire, sparked, melted, or otherwise created hazardous situations at rates well above comparable products.”  According to the press release, many of these products were never recalled and continue to be sold.
 
In addition to their request that Bezos initiate an investigation into the safety of AmazonBasics products, Pallone and Schakowsky also seek answers to a series of questions, including:

  • What Amazon-owned products are no longer for sale due at least in part to safety concerns?
     
  • What products -- both Amazon-owned and third party -- have been officially recalled?
     
  • What notification does Amazon provide to customers who have purchased products that are later recalled or found to be unsafe?
     
  • In addition to direct notification, what other kinds of consumer or public outreach does Amazon conduct to ensure consumers properly dispose of, repair, or replace an unsafe product?
     
  • How can consumers find information regarding recalled products? If information is not readily available, why not, and what plans exist to make it available?
     
  • How can consumers report product safety issues to Amazon?
     
  • How many staff does Amazon have devoted to ensuring that products sold on its platform follow all applicable laws and regulations, and that Amazon is in compliance with obligations to notify the U.S. Consumer Product Safety Commission (CPSC) when a product is suspected of being unsafe?

The letter requests a response no later than October 21, 2020.
 
The letter and request for answers to the questions noted above are another indication of the pressure certain Members in Congress are putting on Amazon to ensure the safety of the products the platform hosts.  Amazon is under increasing scrutiny by the U.S. Environmental Protection Agency (EPA) in this regard, as reported in our February 16, 2018, and June 17, 2020, blog items, and this Congressional inquiry seems more of the same.  These efforts will almost certainly cause more pressure on product manufacturers to ensure the products they offer for sale on Amazon are compliant.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) published on September 30, 2020, its audit of EPA’s Toxic Substances Control Act (TSCA) Service Fee Fund financial statements for the period from Inception (June 22, 2016) through September 30, 2018.  The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) requires EPA to prepare and OIG to audit the TSCA Service Fee Fund financial statements each year.  OIG states that its primary objectives were to determine whether the financial statements were fairly stated in all material respects; EPA’s internal controls over financial reporting were in place; and EPA management complied with laws and regulations.  OIG notes that the TSCA Service Fee Fund has been designed to defray up to 25 percent of the costs associated with implementing key TSCA provisions.  According to OIG, EPA overstated expenses from other appropriations by $8.4 million.  OIG states it found that EPA made errors in multiple iterations of its calculation for expenses from other appropriations.  No significant matters involving compliance with applicable laws and regulations, contracts, and grant agreements came to OIG’s attention during the course of the audit.
 
OIG recommends that the chief financial officer:  (1) improve the management review process for calculating expenses from other appropriations to be consistent with EPA component financial statement audits and to ensure that costs support the TSCA Service Fee Fund activities; and (2) establish written policies and procedures so that expenses from other appropriations in component audits reflect actual costs.  According to OIG, EPA concurred with its recommendations and provided “acceptable corrective actions and estimated completion dates.”  OIG states that it considers the recommendations resolved with corrective actions pending.


 
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