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
 
Effective May 21, 2021, Yvette T. Collazo has resigned as the Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT). Collazo began as OPPT Director in March 2020. During her tenure, OPPT’s accomplishments include:

  • Publishing final risk evaluations for the first ten chemicals reviewed under the amended Toxic Substances Control Act (TSCA) and initiating the risk evaluation process for the next 20 high-priority chemicals;
  • Beginning risk management activities for the first ten chemicals, including public engagement and consultations with tribal and environmental justice communities;
  • Issuing final rules to reduce exposures to five persistent, bioaccumulative, and toxic (PBT) chemicals;
  • Proposing revisions to the TSCA fees rule;
  • Increasing transparency by conducting and updating data on TSCA Confidential Business Information reviews, publishing updated 2016 Chemical Data Reporting (CDR) information, updating the TSCA Inventory, and making additional information on new chemical submissions available in ChemView;
  • Recognizing significant stakeholder achievements through the 2020 Safer Choice and Green Chemistry Awards;
  • Re-organizing OPPT to align new chemicals, existing chemicals, confidential information/transparency, and “forward-looking” data collection functions structurally; and
  • Establishing an Office for Project Management and Operations that is intended to manage effectively and efficiently the TSCA Program.

More information on these developments is available on our website in our TSCA memoranda.


 

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.


 

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

Dan Utech, Incoming Chief of Staff for the U.S. Environmental Protection Agency (EPA), announced to EPA on January 21, 2021, that until Michael Regan, Secretary of the North Carolina Department of Environmental Quality, is confirmed as EPA Administrator, Jane Nishida will serve as Acting Administrator.  In his announcement, Utech notes that on January 20, 2021, President Biden signed an Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis, which states that it is the policy of the Biden Administration “to listen to the science; to improve public health and protect our environment; to ensure access to clean air and water; to limit exposure to dangerous chemicals and pesticides; to hold polluters accountable, including those who disproportionately harm communities of color and low-income communities; to reduce greenhouse gas emissions; to bolster resilience to the impacts of climate change; to restore and expand our national treasures and monuments; and to prioritize both environmental justice and the creation of the well-paying union jobs necessary to deliver on these goals.”  According to Utech, EPA will be guided by science as it moves to achieve these goals and address other threats to public health and the environment.

Utech states that Biden also signed an Executive Order on Advancing Racial Equity and Support for Underserved Communities through the Federal Government.  In addition to providing a framework for advancing equity, it revokes Executive Order 13950, “Combating Race and Sex Stereotyping.”

Utech’s announcement includes the following updated list of current and acting leaders, as well as a list of the incoming appointees who onboarded this week.

Current and Acting Leadership

  • Acting Administrator:  Jane Nishida
  • Office of the Chief Financial Officer (OCFO):  David Bloom
  • Office of Air and Radiation (OAR):  Joseph Goffman
  • Office of Water (OW):  Radhika Fox
  • Office of Land and Emergency Management (OLEM):  Barry Breen
  • Office of Chemical Safety and Pollution Prevention (OCSPP):  Michal Ilana Freedhoff  (as of January 25, 2021)
  • Office of Research and Development (ORD):  Jennifer Orme-Zavaleta
  • Office of General Counsel (OGC):  Melissa Hoffer
  • Office of Enforcement and Compliance Assurance (OECA):  Larry Starfield
  • Office of International and Tribal Affairs (OITA):  Mark Kasman
  • Office of Mission Support (OMS):  Donna Vizian
  • Office of Policy (OP):  Victoria Arroyo
  • Office of Congressional and Intergovernmental Relations (OCIR):  Robin Richardson
  • Office of Public Engagement and Environmental Education (OPEEE):  Rosemary Enobakhare
  • Office of Public Affairs (OPA):  Lindsay Hamilton
  • Region 1:  Deb Szaro
  • Region 2:  Walter Mugdan
  • Region 3:  Diana Esher
  • Region 4:  John Blevins
  • Region 5:  Cheryl Newton
  • Region 6:  David Gray
  • Region 7:  Ed Chu
  • Region 8:  Deb Thomas
  • Region 9:  Deb Jordan
  • Region 10:  Michelle Pirzadeh

Members of the incoming EPA leadership team who onboarded this week:

  • Radha Adhar, Deputy Associate Administrator for Congressional Affairs;
  • Victoria Arroyo, Associate Administrator for Policy;
  • Tomás Elias Carbonell, Deputy Assistant Administrator for Stationary Sources, OAR;
  • Alison Cassady, Deputy Chief of Staff for Policy;
  • Dimple Chaudhary, Deputy General Counsel for Nationwide Resource Protection Programs;
  • Rosemary Enobakhare, Associate Administrator for Public Engagement and Environmental Education;
  • Philip Fine, Principal Deputy Associate Administrator for Policy;
  • Radhika Fox, Principal Deputy Assistant Administrator, OW;
  • Michal Ilana Freedhoff, Principal Deputy Assistant Administrator for Chemical Safety and Pollution Prevention;
  • Joseph Goffman, Principal Deputy Assistant Administrator, OAR;
  • Lindsay Hamilton, Associate Administrator for Public Affairs;
  • Sinceré Harris, White House Liaison;
  • Melissa Hoffer, Principal Deputy General Counsel;
  • Casey Katims, Deputy Associate Administrator for Intergovernmental Affairs; and
  • John Lucey, Special Assistant to the Administrator.

 

By Lynn L. Bergeson and Carla N. Hutton

Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) published on January 9, 2020, our “Forecast for U.S. Federal and International Chemical Regulatory Policy 2020.”  In this richly detailed and comprehensive document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and policy, and provide our best informed judgment as to the shape of key developments we are likely to see in the New Year.  The document includes a list of B&C speeches and writings, as well as a list of B&C webinars and podcasts available on demand.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On Wednesday, November 13, 2019, at 3:00 p.m. (EST), the U.S. Environmental Protection Agency (EPA) will hold a webinar on the Green Chemistry Challenge Awards Program.  Participants will learn more about applying for the 2020 Green Chemistry Challenge Awards.  The webinar presentation will cover award eligibility, the application process, and evaluation criteria.  There will also be time for questions from the webinar participants.
 
As reported in our September 20, 2019, blog item, EPA is now accepting nominations for the 2020 Green Chemistry Challenge Awards for companies or institutions that have developed a new process or product that helps protect public health and the environment.  EPA defines green chemistry as the design of chemical products and processes that reduce both the generation and use of chemicals that are hazardous to the environment and people’s health.  Nominations for innovative technologies featuring the design of greener chemicals and products, greener chemical syntheses and reactions, or greener chemical processes are due to EPA by December 31, 2019.  EPA anticipates giving awards to outstanding green chemistry technologies in five categories in June 2020


 

By Lynn L. Bergeson

On June 10, 2019, at 5:00 p.m., the American Chemical Society (ACS) will hold the 2019 Green Chemistry Challenge Awards ceremony in Washington, D.C.  Sponsored by the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP), in partnership with the ACS Green Chemistry Institute® and members of the chemical community, these prestigious annual awards recognize chemical technologies that incorporate the principles of green chemistry into chemical design, manufacture, and use. 

EPA usually presents one Green Chemistry Challenge Award in each award category.  For the 2019 competition, there are five award categories:

  • Focus Area 1:  Greener Synthetic Pathways;
  • Focus Area 2:  Greener Reaction Conditions;
  • Focus Area 3:  The Design of Greener Chemicals;
  • Small Business (for a technology in any of the three focus areas developed by a small business); and
  • Academic (for a technology in any of the three focus areas developed by an academic researcher).

If you are interested in attending this event, please RSVP to .(JavaScript must be enabled to view this email address) for more information.


 

By Lynn L. Bergeson and Richard E. Engler, Ph.D.

On May 20, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 30, 2019, it will begin publishing Toxic Substances Control Act (TSCA) Section 5 notices including premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN), their attachments, including any health and safety studies, any modifications thereto, and all other associated information in ChemView -- in the form they are received by EPA, without review by EPA.  EPA states that it will not be reviewing confidential business information (CBI)-sanitized filings before publishing.  EPA states that this announcement will be the first of several reminders that EPA sends and, in addition, EPA has incorporated a reminder to check accompanying sanitized submissions as part of the Central Data Exchange (CDX) reporting module for TSCA Section 5 notices.

EPA’s announcement states the following as guidance for submitters to take heed of before submitting their TSCA Section 5 notices:

  1. Verify the asserted CBI claims are correct and consistent; and
  2. Verify the sanitized versions of the form, attachments, and file names are checked for proper and consistent CBI redactions and that watermarks or stamps indicating CBI are removed.  

Commentary

EPA does not specify how long after submission the documents may be posted, but submitters should expect a very short turn-around.  Bergeson & Campbell, P.C. (B&C®) has addressed the topic of CBI before, most recently on our podcast, All Things Chemical™.  When completing a PMN, a submitter must take care to ensure that all information that must be protected as CBI is marked as such.  A submitter cannot expect EPA to extrapolate a claim for CBI in one part of a form to the rest of the document and its attachments.  B&C strongly suggests that a submitter review the sanitized form of an entire document (e.g., a PMN and its attachments) to ensure that all sensitive information is redacted before submitting the document to EPA.

Do not wait until May 30.  Begin developing and practicing good CBI practices today.


 

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

On May 16, 2019, the U.S. Environmental Protection Agency (EPA) announced that it has updated its Statistics for the New Chemicals Review Program under TSCA web page, which is under EPA’s Reviewing New Chemicals under the Toxic Substances Control Act (TSCA) section, to make it easier to find and understand how many chemicals are in each stage of the new chemicals review process.  The revised web page now includes a flow chart showing the number of new chemicals cases (premanufacture notices (PMN), significant new use notices (SNUN), and microbial commercial activity notices (MCAN)) at each stage of review and detailed descriptions of each step in the process.

EPA states that these changes “are the first step in a larger effort to increase the transparency of the new chemicals program and ensure stakeholders and the public can quickly and easily view EPA’s progress in reviewing new chemicals submissions as the Agency receives them.”  EPA Assistant Administrator Alexandra Dunn has repeatedly expressed her and EPA’s commitment to enhance the transparency of EPA’s operations, and this latest development reflects that commitment.


 
 1 2 3 >  Last ›