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.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on June 15, 2021, the winners of the 2021 Green Chemistry Challenge Awards. EPA states that “[g]reen chemistry is the design of chemical products and processes that reduce or eliminate the generation and use of hazardous substances.” According to EPA, the 2021 winners “developed new and innovative green chemistry technologies that provide solutions to significant environmental challenges, and spur innovation and economic development.” The 2021 winners are:
- Professor Srikanth Pilla of Clemson University, South Carolina, for creating the first nonisocyanate polyurethane foam. Traditional polyurethane foams are widely used in the plastics industry and are typically manufactured from diisocyanates, a potential human carcinogen. This new foam is made using lignin, a natural polymer from pulp and paper waste that is derived from vegetable oils and uses no isocyanates. According to EPA, the lignin-based foams have the same mechanical properties as traditional polyurethane foams and were specifically designed for chemical recycling at the end of their life, making the foam a more environmentally friendly option.
- XploSafe, Oklahoma, for creating PhosRox, a novel sorbent used to make fertilizer. The product simultaneously removes ammonia, phosphate, and nitrate from contaminated waters. The resulting material is a granulated time-release fertilizer that can help lower dependence on manufactured fertilizers by recycling nutrients. According to EPA, this product will also help wastewater treatment operators maintain compliance with regulations and potentially generate revenue from the sale of the resulting fertilizer. EPA states that when this is added to agricultural soils, it will not only release plant nutrients slowly but, in future years, could enhance the nutrient-holding capacity of the soil, preventing fertilizer runoff and protecting the watershed.
- Colonial Chemical, Tennessee, for developing environmentally friendly, high performing Suga®Boost surfactants. While many surfactants used in traditional cleaners are made from petroleum-based materials and can be highly toxic, EPA states that SugaBoost surfactants are plant-based, biodegradable, generate no air emissions or wastewater discharges, and do not contain known carcinogens or endocrine disruptors. According to EPA, they perform as well as or better than “toxic, energy-intensive petroleum-based surfactants, creating the potential to yield huge environmental improvements in the cleaning industry.”
- Bristol Myers Squibb, New York, for a new class of sustainable reagents -- substances used to cause a chemical reaction. The new reagents use less solvent and are derived from limonene, a waste product from discarded citrus peels, which increases sustainability and decreases environmental impact. They also can tolerate air and moisture better than traditional reagents, eliminating the need for expensive technology and specialized shipping and storage.
- Merck, New Jersey, for developing a green and sustainable manufacturing process for a drug used to treat chronic coughs. According to EPA, by incorporating green chemistry techniques into the manufacturing process, the team not only replaced two highly toxic and hazardous chemicals, it also reduced carbon monoxide and carbon dioxide emissions. According to EPA, life-cycle assessment data show that these changes are expected to decrease the carbon footprint of manufacturing this drug by more than 80 percent.
EPA recognized the winners during the virtual American Chemical Society Green Chemistry & Engineering Conference. EPA states that the 2021 awards have special meaning because it is also the 25th anniversary of the Green Chemistry Challenge Awards. During the quarter century of the Green Chemistry program, EPA and the American Chemical Society, which co-sponsor the awards, have received more than 1,800 nominations and presented awards to 128 technologies that decrease hazardous chemicals and resources, reduce costs, protect public health, and spur economic growth. According to EPA, winning technologies are responsible for annually reducing the use or generation of hundreds of millions of pounds of hazardous chemicals and saving billions of gallons of water and trillions of BTUs in energy. An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute formally judged the 2021 submissions and made recommendations to EPA for the 2021 winners.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) has prepared a strategic plan for the Office of Pollution Prevention and Toxics (OPPT) for fiscal years (FY) 2021-2023. The strategic plan outlines how OPPT intends to fulfill its obligations under the Toxic Substances Control Act (TSCA), the Emergency Planning and Community Right-to-Know Act (EPCRA), the Pollution Prevention Act (PPA), and related EPA policies and procedures “in ways that value science, protect people and the environment, and increase transparency for stakeholders and the general public.” The strategic plan includes new vision, mission, and values statements for OPPT. Priority areas include:
- New Chemicals: The New Chemicals Program manages potential risks to human health and the environment from chemicals new to the marketplace. The program identifies conditions to be placed on the use of new chemicals before they enter into commerce;
- Existing Chemicals: TSCA requires EPA to evaluate the safety of existing chemicals through prioritization, risk evaluation, and risk management. Ensuring the safety of existing chemicals requires collecting and analyzing information about the chemicals, developing additional information, conducting analyses to evaluate risk, and taking regulatory action on proper conditions of use for each chemical;
- Pollution Prevention/Safer Choice/Toxics Release Inventory (TRI): OPPT supports a suite of programs that are intended to reduce, eliminate, or prevent pollution at its source as an alternative to pollution control and waste disposal. Safer Choice helps consumers, businesses, and purchasers find products that contain ingredients that are safer for human health and the environment. The TRI Program collects information to track industry progress in reducing waste generation and moving toward safer waste management alternatives;
- Transparency and Stakeholder Engagement: OPPT is committed to providing the public with the information needed to understand EPA’s chemical evaluations. It continually seeks more productive means of engaging with interested stakeholders through public comment during rulemaking, Federal Advisory Committee Act (FACA) workgroups, and other means;
- Human Capital: OPPT strives to provide a healthy and supportive working environment, support for career development, and communication on issues that are important to its colleagues. It closely collaborates with its partners in the Office of Chemical Safety and Pollution Prevention’s (OCSPP) Office of Program Support to ensure that the basics of being an OPPT employee, such as timekeeping, personnel actions, and equipment, are easy to manage; and
- Efficiency and Enabling Tools: OPPT’s priority areas depend on a wide range of data from manufacturers, researchers, and the public. Its employees need to know how to work with these data and to have access to tools that facilitate access to and analysis of these data. OPPT is committed to increasing its ability to manage projects effectively through a unified approach that ensures timely deliverables, increases its ability to track its work, and simplifies its processes.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on April 27, 2021, “important policy shifts in its review of new [per-and polyfluoroalkyl substances (PFAS)] before they can enter the market.” According to EPA, although some new PFAS have been allowed to enter the market through low volume exemptions (LVE), EPA’s New Chemicals Program is implementing a new strategy for reviewing and managing LVE requests for PFAS. EPA states that due to the scientific complexities associated with assessing PFAS, and the hazard potential associated with various sub-classes of PFAS, “it is challenging to conduct an appropriately robust review of LVE requests for PFAS in the 30 days the regulations allow.” Under the regulations, EPA can deny LVE requests if it finds the chemical may cause serious human health effects or significant environmental effects or when issues concerning toxicity or exposure require review that cannot be completed in 30 days. According to EPA, “[g]iven the complexity of PFAS chemistry, potential health effects, and their longevity and persistence in the environment, an LVE submission for a PFAS is unlikely to be eligible for this kind of exemption under the regulations.” While EPA will consider each LVE application individually, it “generally expects” that it will deny pending and new LVE submissions for PFAS. This will allow EPA more time to conduct a more thorough review and, as appropriate, “put measures in place to mitigate the potential risk of these chemicals as the agency determines whether to allow them to enter commerce.” EPA states that in addition, it is “exploring ways to work cooperatively with companies to voluntarily withdraw previously granted LVEs.” EPA states that this “would build upon a 2016 outreach effort that resulted in companies withdrawing more than half of the 82 long-chain PFAS LVEs that existed at the time.”
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on March 29, 2021, that it is evaluating its policies, guidance, templates, and regulations under the Toxic Substances Control Act (TSCA) new chemicals program to ensure they “adhere to statutory requirements,” the Biden-Harris Administration’s executive orders, and other directives. EPA identified several instances where its approach for making determinations and managing risks associated with new chemicals can, according to EPA, more closely align with TSCA’s requirements to ensure protections for human health and the environment, including the use of significant new use rules (SNUR) and assumptions related to worker exposures. EPA states that it will stop issuing determinations of “not likely to present an unreasonable risk” based on the existence of proposed SNURs. According to EPA, “[r]ather than excluding reasonably foreseen conditions of use from EPA’s review of a new substance by means of a SNUR, Congress anticipated that EPA would review all conditions of use when making determinations on new chemicals and, where appropriate, issue orders to address potential risks.” Going forward, when EPA concludes that one or more uses may present an unreasonable risk, or when EPA believes that it lacks the information needed to make a safety finding, EPA will issue an order to address those potential risks.
EPA states that as has been the “long-standing practice,” it intends to continue issuing SNURs following TSCA Section 5(e) and 5(f) orders for new chemicals to ensure the requirements imposed on the submitter via an order apply to any person who manufactures or processes the chemical in the future. EPA notes that this ensures that other manufacturers of the same new chemical substance are held to the same conditions as the submitter subject to the TSCA Section 5(e) or 5(f) order.
EPA states that it now intends to ensure necessary protections for workers identified in its review of new chemicals through regulatory means. According to the announcement, where EPA identifies a potential unreasonable risk to workers that could be addressed with appropriate personal protective equipment (PPE) and hazard communication, EPA will no longer assume that workers are protected adequately under the Occupational Safety and Health Administration’s (OSHA) worker protection standards and updated safety data sheets (SDS). Instead, EPA will identify the absence of worker safeguards as “reasonably foreseen” conditions of use, and mandate necessary protections through a TSCA Section 5(e) order, as appropriate.
The first policy change -- that the Office of Pollution Prevention and Toxics (OPPT) will no longer employ the “non-order SNUR” construction to regulate new chemicals without an order -- was somewhat predictable. This construction, since its inception, has led to questions about whether this interpretation meets the requirements under TSCA Section 5. In our view, EPA issuing a SNUR to prohibit conditions of use that EPA identifies as potentially leading to an unreasonable risk was an appropriate and expeditious means to achieve the protective end (the TSCA regulation) without the inefficiency and delays associated with the development of a consent order. EPA would only use this option when EPA concluded the intended conditions of use were not likely to present an unreasonable risk. It is not clear why a SNUR is viewed as being less protective than an order, when an order applies only to the premanufacture notice (PMN) submitter and a SNUR applies to all actors in the supply chain. EPA is required to promulgate a SNUR that conforms to an order absent a reason otherwise. The claim that undertaking a condition of use that is defined in a SNUR as a significant new use “requires only notification to EPA” misrepresents the rigor of the significant new use notice (SNUN) process. A SNUN functions just like a PMN, with a similar level of effort required on the submitter’s and EPA’s parts and nearly identical determination outcomes (a consent order, modification of the existing SNUR, or revocation of the existing SNUR if warranted), so saying that a SNUN is “just a notification to EPA” is the equivalent of stating that a PMN is “just a notification to EPA.” Detractors might also claim that orders include testing, but that presumes that testing is required for EPA to make an informed decision. If EPA can, as it routinely does, make a decision based on conservative assumptions with analogs, models, and information provided by the submitter, EPA can similarly make an informed decision about what measures are necessary to achieve its protective goal without new test data. In Bergeson & Campbell, P.C.’s (B&C®) view, this policy change will add marginal, if any, protective benefit at a significant increase in effort by both EPA and the submitter.
EPA’s decision that it no longer views use of PPE as reasonably foreseeable is an unwelcome and unprincipled development. B&C, on behalf of the TSCA New Chemicals Coalition (NCC), provided, at OPPT’s request, a robust data set that demonstrated that proper PPE is rarely not used in an industrial/commercial setting. A database of 40 years of OSHA violations contained very few glove, goggle, and general dermal protection violations -- all obvious violations to any inspector. The marginal number of OSHA violations supports the NCC’s view that standard PPE use is both reasonably foreseeable and highly likely and demonstrably so. Today’s unexplained reversal is difficult to reconcile with these facts. If EPA proceeds to issue orders for every PMN that may present a risk if workers do not take routine protective measures, then EPA will be required to regulate nearly every PMN in which EPA identifies a hazard other than “low hazard” for health and ecotoxicity, as was EPA’s practice when the Lautenberg amendments were passed in 2016. As we have stated previously, that would mean that EPA will be implementing TSCA as a hazard-based law, instead of the clear risk-based law that it is.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on March 23, 2021, that it is now accepting nominations for the 2021 Safer Choice Partner of the Year Awards. According to a Federal Register notice scheduled for publication on March 24, 2021, the awards will recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown achievement in the design, manufacture, selection, and use of products with safer chemicals that further outstanding or innovative source reduction. EPA “especially encourages” award applications that show how the applicant’s work in the design, manufacture, selection, and use of those products promotes environmental justice, bolsters resilience to the impacts of climate change, results in cleaner air or water, or improves drinking water quality. All Safer Choice stakeholders and program participants in good standing are eligible for recognition. Interested parties should submit to EPA information about their accomplishments and contributions during 2020. Submissions are due May 31, 2021. EPA will recognize award winners at a ceremony in fall 2021.
Safer Choice is an EPA Pollution Prevention (P2) program, which includes practices that reduce, eliminate, or prevent pollution at its source, such as using safer ingredients in products. The Safer Choice program certifies products containing ingredients that have met its “specific and rigorous” human health and environmental toxicological criteria. EPA notes that the Safer Choice program allows companies to use its label “on certified products that contain safer ingredients and perform, as determined by expert evaluation.” EPA states that the Safer Choice program certification “represents a high level of achievement in formulating products that are safer for people and the environment.”