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).
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:
- Verify the asserted CBI claims are correct and consistent; and
- 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.
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.
By Lynn L. Bergeson and Margaret R. Graham, M.S.
On May 9, 2019, the U.S. Environmental Protection Agency (EPA) announced that it would soon be making available a signed action signed on May 6, 2019, that identifies chemical substances for inactive designation according to the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements rule. The pre-publication version of the notice is available here. Specifically, EPA states that the signed action is a companion to the first version of the TSCA Chemical Substance Inventory with all listings designated as active or identified as inactive, which was posted on the EPA TSCA Inventory web page on February 19, 2019, and it will initiate a 90-day period after which substances identified as inactive will be designated as inactive. Because the action was signed on May 6, 2019, inactive designations will become effective on Monday, August 5, 2019.
Starting on August 5, 2019, manufacturers and processors are required to notify EPA before reintroducing into commerce a substance designated as inactive on the TSCA Inventory. Manufacturers and processors can notify EPA via a Notice of Activity Form B, found in EPA's Central Data Exchange (CDX). Upon receiving such notification, EPA will change the designation of substances from inactive to active.
For more information, visit EPA’s TSCA Inventory Notification (Active-Inactive) Rule site.
By Lynn L. Bergeson and Margaret R. Graham, M.S.
On April 26, 2019, the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) issued its order on petition for review of the U.S. Environmental Protection Agency’s (EPA) final rule on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements (82 Fed. Reg. 37520 (Aug. 11, 2017)), which denied the petition for review on all but one claim. Petitioner Environmental Defense Fund (EDF) challenged five distinct features of the Inventory final rule: (i) EPA’s exclusion of substantiation questions regarding reverse engineering; (ii) the final rule’s criteria for “maintaining” a confidentiality claim; (iii) EPA’s choice not to incorporate certain regulatory requirements into the final rule; (iv) EPA’s failure to implement the Act’s “unique identifier” requirements in this rulemaking; and (v) the final rule’s exemption of exported chemicals from its notification requirements.
The D.C. Circuit’s order states that only the first claim succeeds past the standard of review required under both the Administrative Procedure Act (APA) and TSCA, however; specifically, EPA acted arbitrarily and capriciously via its “omission of any inquiry into a chemical identity’s susceptibility to reverse engineering [which] effectively excised a statutorily required criterion from the substantiation process.” Even though EPA included several substantiation questions to address reverse engineering in the proposed rule, EPA did not include any “substantiation questions related to the requirement that a substance’s chemical identity not be susceptible to reverse engineering” and declined altogether to “‘secure answers’ substantiating a company’s ‘assertion’ that its chemical product cannot be reverse engineered” in the final rule. The court states that this error was “fatal” and remands this issue back to EPA for EPA to “address its arbitrary elimination of substantiation questions regarding reverse engineering.”
Regarding the other four claims that it denied, the court made the following statements:
- “EPA acted well within its discretion in concluding that, as part of the Inventory update, any manufacturer or processor of a chemical substance can file a claim to maintain the chemical substance’s confidentiality”;
- “There is nothing facially troubling about the failure to copy every relevant statutory obligation into the regulation”;
- “Agencies need not address all regulatory obligations ‘in one fell swoop’ … nothing in [TSCA] requires the EPA to develop and implement the unique identifier system alongside its Inventory review process”; and
- “EPA’s decision [to exclude export-only chemicals from the final rule’s requirement that chemical companies notify EPA of chemical substances being manufactured or processed] reflected a reasonable interpretation of [TSCA].”
By Lynn L. Bergeson, Kathleen M. Roberts, and Carla N. Hutton
On April 25, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule that would amend the Toxic Substances Control Act (TSCA) Section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA Section 8(a) size standards for small manufacturers. 84 Fed. Reg. 17692. The current CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on chemical manufacturing, processing, and use every four years. EPA is proposing several changes to the CDR rule to make regulatory updates to align with new statutory requirements of TSCA, improve the CDR data collected as necessary to support the implementation of TSCA, and potentially reduce the burden for certain CDR reporters. Proposed updates to the definition for small manufacturers, including a new definition for small governments, are being made in accordance with TSCA Section 8(a)(3)(C) and impact certain reporting and recordkeeping requirements for TSCA Section 8(a) rules, including CDR. EPA states that the definitions may reduce the burden on chemical manufacturers by increasing the number of manufacturers considered small. Overall, according to EPA, the regulatory modifications may better address EPA and public information needs by providing additional information that is currently not collected; improve the usability and reliability of the reported data; and ensure that data are available in a timely manner. Comments are due by June 24, 2019. More information on the proposed rule is available in our full memorandum.