Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) is scheduled to publish a final rule on May 18, 2021, that will rescind the October 18, 2020, rulemaking that established procedures for issuing, modifying, withdrawing, and using guidance documents. According to the final rule, after consideration and review, “EPA has concluded that the internal rule on guidance deprives the EPA of necessary flexibility in determining when and how best to issue public guidance based on particular facts and circumstances, and unduly restricts the EPA's ability to provide timely guidance on which the public can confidently rely.” EPA states that it will continue to make Agency guidance available to the public at https://www.epa.gov. In addition, EPA will comply with all statutory obligations pertaining to posting documents for public accessibility. EPA will also continue its practice, as appropriate, of soliciting stakeholder input on guidance of significant stakeholder and public interest. EPA notes that consistent with the Administrative Procedure Act (APA), stakeholders may still petition EPA at any time regarding its regulatory programs, including requests to issue, amend, or repeal EPA guidance. The final rule will be effective when published in the Federal Register.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on May 11, 2021, that it has launched a new application in the Central Data Exchange (CDX), EPA’s electronic reporting site, that will allow users to submit electronically certain communications under the Toxic Substances Control Act (TSCA).  According to EPA, the new application provides users with a faster, secure, and more convenient way to comply with TSCA reporting requirements and is “expected to be used for hundreds of individual communications every year.”
 
EPA states that the application is located within the Chemical Safety and Pesticide Programs (CSPP) data flow and supports numerous types of communications, including General Confidential Correspondence, Requests for Chemical Information, Pre-manufacture Notice (PMN) Corrections for Submissions made Prior to 2016, and Copy of Record Requests.  Previously, these types of communications were required to be sent to EPA in hard copy.  EPA will continue to accept paper documents, but recommends submitting TSCA communications electronically when possible “since paper communications could take longer to process.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The Senate Committee on Environment and Public Works will hold a hearing on May 12, 2021, on several nominations, including that of Michal Freedhoff to be Assistant Administrator for Chemical Safety and Pollution Prevention of the U.S. Environmental Protection Agency (EPA).  As reported in our January 22, 2021, blog item, Freedhoff was onboarded in January 2021 as Principal Deputy Assistant Administrator for Chemical Safety and Pollution Prevention.  On April 14, 2021, President Joseph Biden nominated Freedhoff for Assistant Administrator for Chemical Safety and Pollution Prevention.  According to Biden’s announcement, Freedhoff has more than 20 years of government experience, most recently as the Minority Director of Oversight for the Senate Environment and Public Works Committee.  She began her Congressional service in 1996 in then-Representative Ed Markey’s (D-MA) office as a Congressional Science and Engineering fellow after receiving a Ph.D. in physical chemistry at the University of Rochester.  Freedhoff also served on the staffs of the House Science Committee, the House Select Committee on Energy Independence and Global Warming, the House Energy and Commerce Committee, and the House Natural Resources Committee.  The announcement states that Freedhoff’s legislative work includes the 2016 re-authorization of the Toxic Substances Control Act (TSCA), 2019 legislation to address per- and polyfluoroalkyl substances (PFAS) contamination, the fuel economy provisions in the 2007 Energy Independence and Security Act, and a law requiring the creation of an online database of potential consumer product safety defects.
 
The Committee will also consider several other nominations, including that of Radhika Fox to be EPA Assistant Administrator for Water.  Like Freedhoff, she was onboarded at EPA in January 2021.  More information on Fox is available in President Biden’s April 14, 2021, announcement.


 
 
SAVE THE DATE
NEW TSCA AT FIVE
Virtual Conference
June 30, 2021
 
This June marks the fifth anniversary of the enactment of the game-changing Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) that amended the Toxic Substances Control Act (TSCA). With a new Administration and the relentless pace of regulatory developments related to Lautenberg implementation, there are many issues to consider and problems to solve.

The Environmental Law Institute (ELI), the George Washington University Milken Institute School of Public Health, and Bergeson & Campbell, P.C. (B&C®) are pleased to announce the fifth annual conference providing updates and insights regarding the current state of TSCA implementation, ongoing and emerging issues, and related developments. Topics will include how EPA is implementing Section 6 risk evaluation provisions, changes in new chemical review, existing chemical risk management provisions, and TSCA’s role in achieving environmental justice, among other topics.

As with our previous TSCA anniversary events, a stellar faculty of speakers from government, non-governmental organizations, industry, and academia will convene to inform, analyze, discuss, and debate the most pressing issues related to TSCA with regulatory practitioners and other stakeholder attendees.

Detailed program and registration information to come. SAVE THE DATE!


 

March 31, 2021
1:30 p.m. - 3:00 p.m. EDT
Register here

The COVID-19 global pandemic has had far-reaching impacts on business operations. While we are all eager to put the pandemic behind us, other catastrophic events will inevitably occur. To strengthen organizational resilience going forward, we must examine lessons learned and position product stewardship as a key player in business continuity and crisis management.

This complimentary future-focused webinar, hosted by the Product Stewardship Society (PSS), will identify the broad range of complex, unresolved, and evolving issues product stewards have faced and continue to face because of the pandemic.

SPEAKERS:

 

Tina Armstrong, Ph.D., Principal Scientist and Vice President at the global consultancy firm Arcadis

 

 Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (moderator)

 

Jon Hellerstein, CIH, CSP, a career environmental health professional 

 

Al Iannuzzi, Ph.D., Vice President, Sustainability, The Estée Lauder Companies

 

Louise Proud, leader of the Environment, Health, and Safety program for Pfizer Inc.

 

In addition to receiving 1.5 contact hours, participants will learn:

  • How product stewards can integrate product stewardship into business continuity and crisis management.
     
  • What issues a product steward needs to address when a COVID-19 outbreak occurs in a workplace, retail space, or upstream/downstream in the supply chain.
     
  • How to leverage the experiences of the COVID-19 pandemic to influence senior leaders to think differently about product stewardship and environment, health, and safety in general.

Make sure to register now for what promises to be a timely, resourceful, and interesting event!


 

By Lynn L. Bergeson and Carla N. Hutton
 
The House Science, Space, and Technology Subcommittee on Investigations and Oversight held a hearing on March 17, 2021, on “Brain Drain:  Rebuilding the Federal Scientific Workforce.”  The Subcommittee heard from the following witnesses:

  • Ms. Candice Wright, Acting Director, Science, Technology Assessment, and Analytics, U.S. Government Accountability Office (GAO);
     
  • Mr. Max Stier, President and Chief Executive Officer (CEO), Partnership for Public Service;
     
  • Dr. Andrew Rosenberg, Director of the Center for Science and Democracy, Union of Concerned Scientists; and
     
  • Dr. Betsy Southerland, Former Director of Science and Technology, Office of Water, U.S. Environmental Protection Agency (EPA).

During the hearing, Subcommittee Chair Bill Foster (D-IL) submitted a Majority staff report into the record on “trends in the Science, Technology, Engineering and Mathematics (STEM) workforce within federal science agencies following the sequestration in the early 2010s that impacted staffing within federal agencies and workforce-related actions taken by the Trump Administration that contributed to destabilizing the federal STEM workforce over the last four years.”  The staff report, “Scientific Brain Drain:  Quantifying the Decline of the Federal Scientific Workforce,” evaluates how STEM civil service employment has expanded or contracted over the past decade at several federal agencies, including EPA.  According to the Committee’s press release, the report finds significant declines in the STEM workforce at EPA, particularly within the Office of Research and Development, the Department of Energy (DOE), and the National Oceanic and Atmospheric Administration (NOAA), as well as that racial and ethnic employment gaps are significant in STEM fields compared to the total federal workforce.  The press release states that “[t]hese trends suggest the United States may need to recommit to promoting U.S. competitiveness in science and innovation, especially as China redoubles its investments in advanced technology and commitment to a pipeline of highly educated STEM workers.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On March 3, 2021, Representatives Frank Lucas (R-OK), Ranking Member of the House Science, Space, and Technology Committee; Stephanie Bice (R-OK), Ranking Member of the Environment Subcommittee; and Jay Obernolte (R-CA), Ranking Member of the Investigations and Oversight Subcommittee, sent a letter to the U.S. Environmental Protection Agency (EPA) urging EPA to expedite any reevaluation of the Toxic Substances Control Act’s (TSCA) systematic review methods.  As reported in our February 17, 2021, blog item, 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.  In its final report, the Committee to Review EPA’s 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).”  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 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 Integrated Risk Information System (IRIS) Program.  In their March 4, 2021, press release, the Republicans state that the IRIS Program “has come under fire from Congress and independent reviewers like the National Academies for its inconsistent process, lack of transparency, and failure to complete assessments in a timely fashion.”  The Republicans ask for EPA’s commitment that, “in accordance with congressional intent to operate with flexibility and speed, TSCA does not fully or consistently adopt program processes or procedures implemented by IRIS.”  If EPA incorporates elements developed by the IRIS Program into TSCA, the Republicans “expect the Agency to assess their benefits and impacts thoroughly, while also adhering to the statutorily prescribed deadlines and scientific standards mandated.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The House Energy and Commerce Subcommittee on Oversight and Investigations will hold a fully remote hearing on March 10, 2021, on “The Path Forward:  Restoring the Vital Mission of EPA.”  According to the House Energy and Commerce Committee’s March 3, 2021, press release, the hearing will examine the “critical need to restore the mission” of the U.S. Environmental Protection Agency (EPA) and how EPA “can address climate change and other urgent challenges to the nation’s environment and public health.”  Subcommittee members will hear “from former EPA leaders about what steps must be taken to undo the damage done to the agency over the last four years and to re-empower it to fulfill its mission.”  The hearing will be available via live webcast.


 

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).


 
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