By Lynn L. Bergeson and Carla N. Hutton
On January 21, 2022, the U.S. Environmental Protection Agency (EPA) announced a new effort under the Toxic Substances Control Act (TSCA) to streamline the review of new chemicals that could be used to displace current, higher greenhouse gas (GHG) emitting transportation fuels. The Office of Chemical Safety and Pollution Prevention’s (OCSPP) New Chemicals Division (NCD) has implemented a “robust, consistent, and efficient process to assess the risk and apply mitigation measures, as appropriate, for substitutes to petroleum-based fuels and fuel additives that use biobased or waste-derived sources to produce biofuels.” EPA states that this effort supports its goals under the Renewable Fuel Standard (RFS) program, as well as its 2021 Climate Adaptation Action Plan. According to the announcement, EPA has received over 30 biofuel premanufacture notices (PMN) “that collectively describe plans for close to 800 million gallons per year of production of advanced biofuels, that could contribute to annual volume mandates under the RFS program and help support the goals of energy security through increasing domestic production” within the United States.
The announcement includes:
New Chemicals Division Integrated Approach to Biofuels
Under this effort, NCD formed a dedicated team to collaborate on the review of PMNs for biobased or waste-derived feedstocks used to make transportation fuel substitutes with the goals to use the best available science while creating a consistent and efficient review process. EPA states that NCD developed a standardized process for the way biofuel PMNs are reviewed. For example, the same dedicated team will be conducting reviews for all biofuels PMNs, helping to ensure the assessments and determinations are consistent and aligned with requirements. Further, NCD will generate one report for biofuels PMNs that combines the six different risk assessments typically conducted for PMNs, helping to provide a clearer summary explanation of how EPA conducted its assessment and made its determination.
For risk management actions, NCD will apply appropriate mitigation measures to address any potential for unreasonable risk identified in an efficient and consistent manner within TSCA consent orders and significant new use rules (SNUR).
Outreach and Training
According to the announcement, OCSPP is launching outreach and training for interested stakeholders in the biofuels sector to review TSCA requirements, outline the streamlined approaches for risk assessments and risk management actions, and provide information on how to navigate the new chemicals PMN process.
OCSPP will hold a kick-off meeting on February 9, 2022, to provide an overview of this initiative and answer questions from stakeholders. Registration for the meeting is open.
Other planned outreach and training related to this biofuels initiative include webinars on:
- TSCA requirements and the PMN process;
- The TSCA Inventory, nomenclature, and Bona Fide process;
- New chemicals risk assessments, including applications of the tools, models, and databases; and
- New chemicals risk management actions, including TSCA Section 5 orders and SNURs.
EPA states that it may add additional outreach and training sessions, including training opportunities applicable to all new chemical submitters, based on stakeholder interest and feedback.
Bergeson & Campbell, P.C. (B&C®) is pleased to provide our Forecast 2022 to TSCAblog® readers, offering our best informed judgment as to the trends and key developments we expect to see in the new year. In 2022, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) will continue to focus on implementing the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) amendments to the Toxic Substances Control Act (TSCA), including the development of required risk evaluations and risk management actions on certain existing chemicals, review of and determinations on new chemical premanufacture notices (PMN), and issuance of a final rule requiring the reporting of hazard and exposure information on per- and polyfluoroalkyl substances (PFAS). In 2022, OPPT is also expected to initiate the prioritization for risk evaluation of certain chemicals to replace in the TSCA risk evaluation pipeline those “high-priority” chemicals for which risk evaluations may be completed in late 2022 or 2023. More details on this, and expected regulatory changes of all varieties, are available in our Forecast for U.S. Federal and International Chemical Regulatory Policy 2022.
“What to Expect in Chemicals in 2022”
January 26, 2022, 12:00 p.m. EST
B&C will be presenting a complimentary webinar, “What to Expect in Chemicals in 2022,” focusing on themes outlined in the forecast. Join Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Director of Chemistry; and James V. Aidala, Senior Government Affairs Consultant, for this informative and forward-looking webinar.
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
According to an October 26, 2021, project notification memorandum, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) plans to begin fieldwork on an audit of EPA’s process for conducting reviews of new chemicals under the Toxic Substances Control Act (TSCA). The memorandum states that the audit “is self-initiated based on OIG’s oversight plan for fiscal year [(FY)] 2022 and to address complaints submitted to the OIG Hotline.” The audit also addresses the following FY 2022 top management challenge for EPA: ensuring safe use of chemicals.
OIG states that its objective is to determine the extent to which EPA uses and complies with applicable records management requirements, quality assurance requirements, and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks. OIG plans to conduct work with the Office of Chemical Safety and Pollution Prevention (OCSPP) in EPA headquarters. According to OIG, the anticipated benefits of the audit are “improved operational efficiency and greater human health and environmental protections.”
To expedite the audit, OIG asks that OSCPP provide the following information:
- Any training materials, handbooks, or other materials related to the review of new chemicals;
- Resource allocations for the New Chemicals Review Program for FYs 2018 through 2021;
- Scopes of work for any contracts related to the new chemicals review process;
- Any OCSPP guidance under which products developed during the review of new chemicals would constitute records and how the records should be managed; and
- New Chemicals Review Program organization charts before and after the October 2020 reorganization.
As reported in our October 28, 2021, memorandum, “House Committee Holds Hearing on ‘TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act,’” Dr. Michal Ilana Freedhoff, OCSPP Assistant Administrator, has let OIG know that OCSPP will cooperate fully with its investigation.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) has posted a recording of the September 22, 2021, webinar that it hosted to educate stakeholders on the Green Chemistry Challenge Awards and the nomination process. The webinar reviewed the history of the awards, the categories within the awards, eligibility requirements, and what is needed to submit a nomination. As reported in our August 27, 2021, blog item, EPA is currently accepting nominations for the 2022 Green Chemistry Challenge Awards from companies or institutions that have developed a new green chemistry process or product that helps protect human health and the environment. Nominations are due December 10, 2021. An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2022 nominations and make recommendations to EPA for the 2022 winners. EPA anticipates giving awards to outstanding green chemistry technologies in six categories in June 2022.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced on October 14, 2021, several actions intended to enhance scientific integrity, including establishing two internal science policy advisory councils, creating a new senior-level career position to serve as a science policy advisor to the Assistant Administrator, and making further improvements to policies and procedures. The announcement includes the following actions:
- New OCSPP Science Policy Council and New Science Policy Advisor Position: OCSPP is forming a new internal advisory group, the OCSPP Science Policy Council, to provide advisory support and recommendations on science policy and scientific integrity issues that arise within its Office of Pollution Prevention and Toxics (OPPT) and Office of Pesticide Programs (OPP). The OCSPP Science Policy Council will be chaired by a science policy advisor, a newly created position. The science policy advisor will report to the OCSPP Assistant Administrator, provide guidance on emerging science policy and scientific integrity matters, and serve as the deputy scientific integrity official for OCSPP. OCSPP states that the OCSPP Science Policy Council will provide an advisory perspective on matters related to scientific integrity; identify scientific questions that are of broad interest within OCSPP for informal review and, as appropriate, recommend a process for further addressing them; and foster informal opportunities for scientific collaboration within OCSPP. Members chosen to address specific issues or questions will be selected based on their expertise and impartiality on the issue or question, and they may include EPA experts outside of OCSPP. OCSPP notes that the group is not intended to replace or otherwise interfere with EPA’s Scientific Integrity Policy, the Scientific Integrity Official’s role, or the Inspector General’s role.
- Strengthening New Chemical Safety Reviews: According to OCSPP, as part of its broader review of policies and procedures to ensure the program effectively implements the Biden Administration’s executive orders, other directives, and principles of scientific integrity, OCSPP’s New Chemicals Division (NCD) engaged in a top-to-bottom effort to catalogue, prioritize, and improve its standard operating procedures (SOP), decision making, and recordkeeping practices related to review and management of new chemicals under the Toxic Substances Control Act (TSCA). OCSPP states that to date, NCD has inventoried and reviewed over 100 different SOPs, guidances, and science policies, and prioritized those that NCD expects to be updated over the next year. Several policy changes have already been implemented, including stopping harmful new per- and polyfluoroalkyl substances (PFAS) from entering the market and procedures to strengthen the review of new chemicals and ensure worker safety.
- New Chemicals Advisory Committee: According to OCSPP, NCD has formed the New Chemicals Advisory Committee (NCAC) that, similar to other long-standing internal advisory bodies within OCSPP, will serve as an advisory body to review both scientific and science policy issues related to new chemical submissions subject to TSCA. If differing opinions cannot be resolved through the human health risk assessment process improvements described below, the NCAC and OCSPP Science Policy Council could provide additional opportunities for further consideration.
- Human Health Risk Assessment Process Improvements: According to OCSPP, NCD solicited feedback from staff and implemented important changes to its process for reviewing and issuing final human health risk assessments. The new process provides additional opportunities for resolution of differing scientific opinions and invites input to the decision-making process to be provided by EPA subject matter experts outside of NCD.
- Enhanced Recordkeeping Requirements: Proper documentation of decisions and of any differing scientific opinions of those decisions is a significant component of EPA’s Scientific Integrity Policy. OCSPP states that it has implemented some changes to its procedures to ensure improved documentation of decisions and is in the process of further review to identify additional improvements, if any, including for new chemicals human health risk assessments.
- Workplace Climate Assessment: In September 2021, with the support of an independent contractor, OCSPP launched a workplace climate assessment of the NCD to obtain feedback from employees and management about any potential workplace barriers and opportunities for organizational improvement. OCSPP states that this effort will expand to other parts of OCSPP over the coming months. OCSPP leadership will use the feedback collected to understand, evaluate, and, if necessary, make changes in its work practices and culture to promote collaboration and enhance the science used in its program decision making.
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
The U.S. Government Accountability Office (GAO) posted a WatchBlog item entitled “Can Chemical Recycling Reduce Plastic Pollution?” on October 5, 2021. The item looks at GAO’s September 2021 Science & Tech Spotlight: Advanced Plastic Recycling. According to GAO, chemical recycling could reduce the amount of plastic that ends up in landfills, potentially reducing the release of chemicals into the environment. Chemical recycling can produce high-quality raw materials, decreasing the demand for fossil fuels and other natural resources. GAO states that the obstacles to using chemical recycling include process and technology challenges, high startup and operating costs, and limited incentives for recycling innovation and investment. GAO notes that new plastics produced from fossil fuels are typically cheaper to produce than recycled plastics, in part due to transportation costs and limited recycling infrastructure, making recycled plastics less marketable. Key questions for policymakers include:
- What steps could the federal government, states, and other stakeholders take to further incentivize chemical recycling rather than disposal? What are the potential benefits and challenges of these approaches?
- What steps could policymakers take to support a transition toward a circular economy -- one in which products are not disposed of but are recycled for reuse including innovation -- and investment in manufacturing and recycling capacity?
- What might policymakers do to promote advanced recycling technologies while also reducing the hazards associated with existing plastic production and recycling methods?
One issue that GAO fails to consider is the regulatory status of depolymerized plastic. If a polymer cannot be reduced back to the exact starting monomers, the U.S. Environmental Protection Agency (EPA) views the depolymerized plastic as a substance that is different from the starting monomers. Furthermore, making a polymer with depolymerized plastic is, according to the Toxic Substances Control Act (TSCA) nomenclature rules, different than the virgin polymer. These nomenclature complications will likely be a barrier to the commercialization of the closed-loop chemical recycling of plastics.
By Lynn L. Bergeson and Carla N. Hutton
On September 22, 2021, the U.S. Environmental Protection Agency (EPA) recognized 33 Safer Choice Partner of the Year award winners across 16 states and the District of Columbia for achievement in the design, manufacture, selection, and use of products with safer chemicals. The Safer Choice program helps consumers and purchasers for facilities, such as schools and office buildings, find products that perform and are safer for human health and the environment. According to EPA, the work of many of the organizations being recognized addressed climate change, including by reducing greenhouse gas emissions. Additionally, several awardees have worked to increase access to products with safer chemical ingredients in underserved communities. EPA states that in the coming year, it hopes to build on this work by expanding the Safer Choice program to make products containing safer chemicals increasingly available to underserved communities, including communities of color and low-income communities. The 2021 Partner of the Year award winners include:
- Albertsons Companies, Safer Choice Retailer: Albertsons expanded their line of Safer Choice-certified products by adding six laundry detergent products that have SmartLabels that allow customers to scan a product quick response (QR) code and learn more about the Safer Choice certification. Albertsons also worked with cities and counties to identify opportunities to educate underserved households about safer cleaning and disinfecting products.
- American Cleaning Institute (ACI), Safer Choice Supporter: ACI contributed toxicological reviews that resulted in eight chemicals being added to EPA’s Safer Chemical Ingredients List (SCIL) and was the first non-manufacturer to do so. ACI’s news media coverage featuring the Safer Choice program generated a total potential reach of 11.2 million in 2020 and highlighted that “Adding chemicals to SCIL encourages innovation and growth in safer products, increases markets for manufacturers and helps protect people and the environment.”
- Apple, Safer Choice Supporter: Apple uses internal Apple Safer Cleaner Criteria based on Safer Choice criteria, among other assessment tools, to determine the safer chemical status of chemicals used in its manufacturing processes. Apple assessed 54 new cleaners, bringing the total to more than 80 safer cleaner and degreaser alternatives approved for use by more than 80,000 employees in their supply chain.
- The Ashkin Group, Safer Choice Supporter: The Ashkin Group included Safer Choice in training programs for frontline cleaning workers, training more than 30,000 workers to date, the majority of whom are from underserved communities.
- BASF Home Care and I&I Cleaning Solutions (BASF), Safer Choice Innovator: BASF added 13 and renewed 25 safer ingredients on CleanGredients, a database of chemical ingredients pre-approved for use in Safer Choice-certified products. This brought their total to 74 ingredients across seven functional class categories.
- Bona, Safer Choice Formulator-Product Manufacturer: Achieving Safer Choice-certification is a companywide objective for Bona. Since becoming a Safer Choice partner in 2020, Bona has certified 13 products. Bona has reformulated more than 90 percent of their current cleaner line for Safer Choice certification.
- Case Medical, Safer Choice Formulator-Product Manufacturer: Case Medical broadened the availability of their line of Safer Choice-certified products to additional markets. They built these formulations with ingredients from the SCIL and from CleanGredients.
- Church & Dwight Co., Inc. (CHD), Safer Choice Formulator-Product Manufacturer: CHD had a new product certified by Safer Choice. CHD’s advertising of this new Safer Choice-certified product included national television, digital, and print ads, and social media, with a potential reach of 169 million. CHD partnered with Safer Choice to develop and implement an in vitro testing strategy to meet Safer Choice pH criteria for laundry detergents.
- The Clorox Company, Safer Choice Formulator-Product Manufacturer: Clorox updated ten formulations and added a new product to their offering of Safer Choice- and Design for the Environment (DfE)-certified products, bringing the total to 37 Stock Keeping Units (SKU) spanning 19 retail and 18 industrial and institutional products. They also increased the percentage of Safer Choice-certified products displaying the Safer Choice label prominently on the front product label from 57 percent of products in 2019 to 70 percent of products in 2020.
- Defunkify, Safer Choice Formulator-Product Manufacturer: Defunkify has 15 Safer Choice-certified products, a 67 percent increase over 2019. Defunkify centers their communications strategy on emphasizing product performance and Safer Choice certification.
- Dirty Labs Inc., Safer Choice Formulator-Product Manufacturer: Dirty Labs’ first two commercial products are Safer Choice-certified, and every ingredient in these products is listed on CleanGredients. The lifecycles and sources for these ingredients are mapped on Dirty Labs’ website.
- ECOS, Safer Choice Formulator-Product Manufacturer: ECOS added four new products, renewed four products, and updated 11 product formulations. In total, ECOS offers more than 150 products that are Safer Choice-certified, which represents 79 percent of all ECOS product offerings.
- Grove Collaborative, Safer Choice Formulator-Product Manufacturer: Grove Collaborative expanded beyond the hand soap category to certify their entire liquid laundry and dishwasher detergent collections. Grove Collaborative made it easier for customers to learn about the Safer Choice program and find certified products on their website by creating an EPA Safer Choice Spotlight store.
- Hazardous Waste Management Program, King County, Washington, Safer Choice Supporter: The program featured Safer Choice in presentations at virtual webinars, as well as in publications and educational materials available in more than a dozen languages. The program also piloted a Safer Choice retail product mapping database that lists Safer Choice-certified products and information on the store where each product is sold, with the goal of increasing access to Safer Choice-certified products.
- The Home Depot, Safer Choice Retailer: In 2020, Home Depot carried 173 Safer Choice-certified products. These products are featured in a callout on Home Depot’s Eco Options website, which had more than 410,000 views in 2020.
- Household & Commercial Products Association (HCPA), Safer Choice Supporter. HCPA continued its support of the Safer Choice program by bringing stakeholders together from across HCPA’s membership virtually to strengthen Safer Choice, encourage more HCPA members to get their products certified by Safer Choice, and engage in discussions with Safer Choice staff about improvements to the program.
- Jelmar, LLC, Safer Choice Formulator-Product Manufacturer: Jelmar added three new products to its Safer Choice partnership. Jelmar displays the Safer Choice label to consumers on 100 percent of its Safer Choice-certified products. In addition to its product labels, Jelmar features the Safer Choice label in advertisements for television, social media, online video, podcasts, and at trade shows.
- Lake Monroe Sailing Association (LMSA), Safer Choice Supporter: The City of Bloomington, Indiana, relies on the Lake Monroe watershed for drinking water, recreation, and supporting the local economy. LMSA uses Safer Choice-certified products on facility-owned boats and makes these products easily accessible at no cost to their 200 members by placing them at boat cleaning stations.
- Lemi Shine, Safer Choice Formulator-Product Manufacturer: Lemi Shine added three products and updated five Safer Choice-certified formulations in 2020. Currently, 18 of their 21 products are Safer Choice-certified, and Lemi Shine prioritizes formulating with chemicals from the SCIL in over 99 percent of their materials.
- LightHouse for the Blind and Visually Impaired, Safer Choice Formulator-Product Manufacturer: LightHouse is a non-profit that has programs to help blind and visually impaired employees get experience in many areas, including chemical manufacturing, chemical blending, and quality assurance and control. LightHouse had record sales for their Safer Choice-certified products in 2020, with all proceeds going directly to the blind and visually impaired community.
- LSI, Innovator: LSI developed a formula for a DfE-certified, fast-acting hydrogen peroxide-based disinfectant that combats SARS-CoV-2, the virus that causes COVID-19. This base formulation is registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and certified under the DfE program.
- Novozymes North America, Safer Choice Innovator: In 2020, Novozymes added six enzyme ingredients to CleanGredients. Novozymes also supported 25 requests made by formulators and brand owners for certification of formulations by the Safer Choice program.
- Oregon Department of Environmental Quality (DEQ)-Toxics Use Reduction Program, Safer Choice Supporter: Oregon DEQ developed innovative projects with goals of building a community that purchases safer products and of directly supporting businesses in obtaining Safer Choice certification. In partnership with the Pollution Prevention Resource Center, Oregon DEQ’s team developed and implemented a Safer Chemical Alternatives Training Program that focused on increasing knowledge about Safer Choice-certified products.
- The Procter & Gamble Company (P&G), Safer Choice Formulator-Product Manufacturer: P&G added 12 products to their Safer Choice-certified line and updated two formulations. P&G designed, formulated, and manufactured their first complete Safer Choice-certified brand portfolio that is a collection of fabric and home care products.
- PurposeBuilt Brands, Safer Choice Formulator-Product Manufacturer: PurposeBuilt Brands added 12 products (with 27 SKUs) to their line of Safer Choice-certified products.
- Roger McFadden and Associates, LLC, Safer Choice Supporter: McFadden and Associates designed 21 products to meet Safer Choice criteria. Based on their pro bono technical recommendations, three health care facilities replaced eight cleaning products, amounting to 84,500 pounds, with Safer Choice-certified products.
- Rust-Oleum Corporation, Safer Choice Formulator-Product Manufacturer: Rust-Oleum increased their offering of Safer Choice-certified products by 19 percent to 16 products (with 42 SKUs). They also began focusing on using concentrates and refillable bottles to reduce plastic use and emissions, contributing to EPA’s goal of addressing climate change.
- Sea Mar Community Health Centers, Safer Choice Supporter: Sea Mar continued to act on the top two concerns for the Hispanic/Latino community identified during an earlier stakeholder meeting: the overuse of disinfectants and the common and dangerous practice of mixing cleaning products. Sea Mar conducted 100 trainings with Spanish-speaking households on safer cleaning practices, reaching 369 people with their training.
- Sensitive Home, Safer Choice Formulator-Product Manufacturer: All of Sensitive Home’s 14 dish, laundry, and surface cleaners became Safer Choice-certified in 2020. Sensitive Home designed their products for sensitive people, including those with skin sensitivities, compromised immune systems, and respiratory issues.
- Seventh Generation, Safer Choice Formulator-Product Manufacturer: Seventh Generation added 16 products, bringing their total to 66 Safer Choice-certified products. Seventh Generation also promoted their Safer Choice-certified products through digital and print marketing materials, including Safer Choice promotions through major e-commerce retail partners.
- University of Washington Department of Environmental and Occupational Health Sciences (UW DEOHS) Continuing Education Programs, Safer Choice Supporter: In response to a surge in calls to the Poison Control Center because of increased misuse of cleaning and disinfecting products in 2020, a team at the UW DEOHS collaborated with the Occupational Health and Safety Section of the American Public Health Association to publish a fact sheet on best practices for safer cleaning and disinfecting to prevent the spread of COVID-19. In both English and Spanish, the fact sheet highlights certified safer cleaning products, including those with the Safer Choice label and DfE-certified disinfectants and products with DfE-approved active ingredients.
- Wegmans Food Markets, Safer Choice Retailer: Wegmans added nine products (with 16 different SKUs) to their line of Safer Choice-certified products. Wegmans offers more than 70 SKUs of national brand Safer Choice-certified products.
- Wexford Labs, Inc., Formulator-Product Manufacturer: Wexford Labs has three DfE-certified products, after bringing on a new brand of disinfecting wipes in 2020. They also assisted their partners in obtaining DfE certifications for seven new private-label products.
By Lynn L. Bergeson and Carla N. Hutton
On August 17, 2021, Representatives Frank Pallone, Jr. (D-NJ), Chair of the House Energy and Commerce Committee, Diana DeGette (D-CO), Chair of the Subcommittee on Oversight and Investigations, and Paul Tonko (D-NY), Chair of the Subcommittee on Environment and Climate Change, sent a letter to U.S. Environmental Protection Agency (EPA) Administrator Michael Regan to request information regarding “concerning reported irregularities” in EPA’s chemical review program. The Committee’s August 17, 2021, press release states that “[a]ccording to recent allegations made by four whistleblowers -- each a current or former staffer in EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) -- the OCSPP has for many years downplayed the dangers of new chemicals and inappropriately interfered with risk assessments conducted pursuant to the Toxic Substances Control Act (TSCA).” The press release states that additional reports “have described the interference alleging that OCSPP manipulated the review of dozens of chemicals” to make the chemicals appear safer. EPA employees “were reportedly pressured to downplay evidence of chemicals’ potential adverse effects such as cancer, birth defects, and neurological effects,” and “EPA’s scientific staff were subject to retaliation.”
The August 17, 2021, letter requests a briefing from EPA, as well as written responses to the following issues:
- Describe EPA’s understanding as to the veracity of the complaints raised by whistleblowers regarding interference in the chemical program. Explain what actions, if any, EPA has taken to look into these allegations.
- Is EPA considering reevaluating any chemicals in light of concerns that their review process may have been subject to interference or that they may include precursors to per- and polyfluoroalkyl substances (PFAS)? If so, describe the process and timeline for any reevaluation.
- Does EPA have any ongoing or planned efforts to review and strengthen whistleblower protections? If so, describe these efforts, including the EPA office responsible for these improvements and any associated timelines.
Wednesday, June 30, 2021
9:00 a.m. - 4:30 p.m. (EDT)
Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present “TSCA Reform - Five Years Later.” This complimentary virtual conference marks the fifth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers will dive into a host of topics, including the systems of risk evaluation and risk management, environmental justice, regulating per- and polyfluoroalkyl substances (PFAS), new chemicals, and more. Register online.
9:00 a.m. - 9:30 a.m.
|Welcome and Overview of Virtual Forum
Lynn R. Goldman, M.D., M.S., M.P.H., Michael and Lori Milken Dean, Milken Institute School of Public Health, Professor of Environmental and Occupational Health, George Washington University
|9:30 a.m. - 10:00 a.m.
||Morning Keynote Discussion
Michal Freedhoff, Assistant Administrator, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA)
10:00 a.m. - 10:45 a.m.
|Panel 1: Risk Evaluation under TSCA
With the EPA under the Trump Administration completing 10 evaluations and the EPA conducting another 23 under the Biden Administration, there are differences of opinion over what the law requires and the best way to assess chemical risks. This panel will share perspectives on these issues and discuss whether and how the new Administration might revisit the 10 completed evaluations.
Robert M. Sussman, Principal, Sussman & Associates, Moderator
Ryan J. Carra, Ph.D., Principal, Beveridge & Diamond, P.C.
Penny Fenner-Crisp, Ph.D., Environmental Protection Network
Suzanne Hartigan, Ph.D., Senior Director, Regulatory and Technical Affairs, American Chemistry Council
Jon Kalmuss-Katz, Supervising Senior Attorney, Earthjustice
11:00 a.m. - 11:45 a.m.
|Panel 2: Risk Management under TSCA
The new regulatory frontier associated with the 2016 TSCA amendments is determining how best to manage chemical risks found to be unreasonable. This panel will discuss EPA’s authority under the Lautenberg amendments and options for deploying its risk management authority.
Jeffery T. Morris, Ph.D., Jeff Morris Solutions, LLC, Moderator
Eve C. Gartner, Managing Attorney, Toxic Exposure & Health Program, Earthjustice
Randy S. Rabinowitz, Executive Director, OSH Law Project LLC
Sara Beth Watson, Of Counsel, Steptoe & Johnson LLP
Kimberly Wise White, Ph.D., Vice President, Regulatory and Technical Affairs, American Chemistry Council
11:45 a.m. - 12:30 p.m.
|Panel 3: TSCA and Environmental Justice
The TSCA amendments offer enormous opportunities to help eliminate environmental injustice by evaluating and managing chemical risks. This panel will consider how TSCA can be leveraged to address concerns regarding environmental justice.
Lynn L. Bergeson, Managing Partner, Bergeson & Campbell P.C., Moderator
Dianne Barton, Council Chair, National Tribal Toxics Council
Marianne Engelman Lado, Deputy General Counsel, Environmental Initiatives, Office of General Counsel, U.S. Environmental Protection Agency
Timothy W. Hardy, Partner, Breazeale, Sachse & Wilson, L.L.P.
Adrienne Hollis, Senior Climate Justice and Health Scientist, Union of Concerned Scientists
|12:30 p.m. - 1:30 p.m.
Hon. Jeffrey Alan Merkley, U.S. Senator, Oregon (invited)
1:45 p.m. - 2:45 p.m.
|Panel 4: New Chemicals Review
The TSCA New Chemicals Program was modified in the 2016 amendments and what the law requires has been vigorously debated. This panel will discuss the evolution of EPA’s implementation of Section 5 under the past Administration and now under the Biden Administration.
Lawrence E. Culleen, Partner, Arnold & Porter Kaye Scholer LLP, Moderator
Alexandra Dapolito Dunn, Partner, Baker Botts L.L.P.
Richard A. Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund
Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C.
Daniel Rosenberg, Director, Federal Toxics Policy, Healthy People & Thriving Communities Program, Natural Resources Defense Council
3:00 p.m. - 3:45 p.m.
|Panel 5: TSCA and PFAS
This panel will address how TSCA authorities can be used to address concerns about both new and existing PFAS, as this class of substances continues to gain significant attention.
Robert M. Sussman, Principal, Sussman & Associates, Moderator
Dennis R. Deziel, Bergeson & Campbell, P.C. and former Administrator, Region I, U.S. Environmental Protection Agency
Liz Hitchcock, Director, Safer Chemicals, Healthy Families
Robert J. Simon, Vice President, Chemical Products and Technology and Chlorine Chemistry, American Chemistry Council
Betsy Southerland, Issue Team, Toxic Substances Control Act (TSCA), Environmental Protection Network
3:45 p.m. - 4:15 p.m.
|Panel 6: TSCA Litigation Update
Unsurprisingly, TSCA litigation is on the rise five years into implementation of the new law. This panel will discuss key issues in dispute and where the courts might be headed.
Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C., Moderator
Martha E. Marrapese, Partner, Wiley Rein LLP
Gavin McCabe, Special Assistant Attorney General, New York State Office of Attorney General
4:15 p.m. - 4:30 p.m.
|Concluding Remarks and Adjournment
Scott Fulton, President, Environmental Law Institute
John Pendergrass, Vice President, Programs & Publications, Environmental Law Institute
Join ELI, Bergeson & Campbell, P.C., the George Washington University Milken Institute School of Public Health, leading experts, and distinguished keynote speakers for a robust exploration of the issues and regulations surrounding TSCA. Full program and registration available online.