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.”
By Lynn L. Bergeson, Scott J. Burya, Ph.D., and Carla N. Hutton
Under Canada’s New Substances Fees Regulations, fees must be provided with each New Substance Notification (NSN) package submitted under the New Substance Notification Regulations (Chemicals and Polymers). The amount of the fee is dependent on the annual sales in Canada for the notifier, the specific Schedule being submitted, and other services being requested (e.g., confidential search on the Domestic Substances List (DSL) or Non-Domestic Substances List (NDSL) or masked name application). As of April 1, 2019, Environment and Climate Change Canada (ECCC) modifies NSN fees annually based on the country’s Consumer Price Index (CPI). Based on a decrease in Canada’s CPI over the past 12 months, fees for NSN submissions will decrease by 0.2% starting April 1, 2021. ECCC has posted a revised fee table, effective April 1, 2021, to March 31, 2022.
By Lynn L. Bergeson and Carla N. Hutton
On February 23, 2021, the European Agency for Safety and Health at Work (EU-OSHA) announced that in association with other relevant Directorates-General (DG) of the European Commission (EC), DG Environment has opened a call for applications to select members for an expert group, the High-Level Roundtable on Implementation of the Chemicals Strategy for Sustainability. According to EU-OSHA, the expert group’s mission “is to set the Chemicals Strategy for Sustainability objectives and monitor its implementation in dialogue with the stakeholders concerned.” Specific tasks include contributing to identifying and addressing social, economic, and cultural barriers to the transition toward safe and sustainable chemicals. The expert group will act as a core group of ambassadors to facilitate discussions and promote this transition in the economy and society, developing a regular exchange of views, experiences, and good practices between the EC and stakeholders on the main objectives of the Strategy, namely:
- Innovating for safe and sustainable chemicals, including for materials and products;
- Addressing pressing environmental and health concerns;
- Simplifying and consolidating the legal framework;
- Providing a comprehensive knowledge base on chemicals; and
- Setting the example for global sound management of chemicals.
The expert group will consist of up to 32 members, with a maximum of:
- The Member State holding the Presidency of the Council of the European Union;
- Ten third-sector organizations in the following areas: health protection, environmental protection, human rights, animal protection, consumer rights, and workers’ rights;
- Eight scientific organizations, academia, and research institutes providing a suitable balance between expertise in fundamental research, applied research, and training/education;
- Ten industries, including small- and medium-sized enterprises (SME) or associations of enterprises, including an adequate representation of frontrunners in the production and use of safe and sustainable chemicals. Those should include chemical industries, downstream users (from different sectors), and retailers; and
- Three international organizations -- the Organization for Economic Cooperation and Development (OECD), the World Health Organization (WHO), and the United Nations Environment Program (UNEP).
Interested organizations are invited to submit their applications before March 18, 2021.
By Lynn L. Bergeson and Carla N. Hutton
On January 12, 2021, the U.S. Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA) announced a memorandum of understanding (MOU) that advances collaboration and communication on EPA’s review of new chemicals under the Toxic Substances Control Act (TSCA). EPA states that the MOU provides a framework for coordination and communication between the two agencies on exposure to new chemicals in the workplace and will help achieve the agencies’ shared goal of ensuring workers are protected from potential health and environmental risks. As required by TSCA, EPA and OSHA are collaborating on workplace exposures as part of EPA’s review of new chemicals. The MOU formalizes coordination efforts that EPA and OSHA have already implemented and provides a framework for additional opportunities for collaboration. Highlights of the MOU include:
- Establishing designated staff and management points of contact from each agency to discuss and resolve workplace exposure issues related to EPA’s review of new chemicals;
- Providing OSHA with regular updates on EPA’s new chemical determinations, including any necessary worker protection identified during EPA’s review; and
- Documenting EPA’s role in identifying and notifying OSHA of the need for formal consultation on EPA’s review of new chemicals.
More information will be available in a forthcoming memorandum that will be posted on our website.
By Lynn L. Bergeson, Carla N. Hutton, and Richard E. Engler, Ph.D.
The U.S. Environmental Protection Agency (EPA) has posted a Compliance Advisory entitled “Applicability of the Toxic Substances Control Act to Chemicals made from Petroleum and Renewable Sources Used as Fuels and Fuel Additives and Distillates.” The Compliance Advisory states that EPA is reaffirming that chemical substances used as fuels, fuel additives, and distillates made from either petroleum or renewable sources are subject to the Toxic Substances Control Act (TSCA). Anyone who plans to manufacture (including import) a chemical made from petroleum or renewable sources must comply with the statutory and regulatory new chemical requirements under TSCA Section 5. According to the Compliance Advisory, EPA has received stakeholder inquiries “as to whether fuel and fuel additives made from renewable sources (such as renewable naphtha) are subject to the TSCA new chemicals requirements under section 5.” EPA states that it is issuing the Compliance Advisory “to affirm that fuel and fuel additives either made from petroleum or renewable sources are subject to TSCA and have been subject to its requirements since 1976.”
According to the Compliance Advisory, there are about 142 “naphthas” and 178 “distillates” (that compositionally can qualify as naphthas) currently on the TSCA Inventory, and they are considered Unknown, Variable composition, Complex, or Biological (UVCB) substances. Any substance that is not on the TSCA Inventory is a new chemical under TSCA Section 5(a)(1)(A). Prior to manufacture (including import) of a new chemical for commercial use, a premanufacture notice (PMN) must be filed with EPA under TSCA Section 5. The Compliance Advisory includes several questions and answers (Q&A), including:
Can you manufacture or import a chemical substance made from a renewable source if it is not listed on the TSCA Inventory?
No. Anyone who intends to manufacture (including import) a new chemical substance that is subject to TSCA for a non-exempt commercial purpose is required to submit a PMN at least 90 days prior to the manufacture of the chemical. Manufacturers (importers) are in violation of TSCA if they fail to comply or are late in complying with TSCA notice requirements. If you are required to submit a PMN, failure to do so is a violation of TSCA Section 15 and you may be subject to penalties. PMN submissions must include all available data, pursuant to 40 CFR 720.45 and 720.50. TSCA requires EPA to review the notice and make a determination; and, if appropriate, regulate the proposed activity.
EPA’s “compliance advisory” is disappointing. It signals this EPA is disinclined to promote renewable petroleum cuts and essentially (and emphatically) reaffirms what we believe to be EPA’s inflexible and unimaginative stance on “source” being determinative in petroleum cut UVCBs. This position, as we have noted in a variety of regulatory contexts, is a substantial disincentive to commercializing renewable petroleum cuts. EPA’s view is especially problematic when a refinery might wish to use a combination of petroleum and renewable feedstocks to make a single naphtha (or other distillate) cut.
For example, to avail itself of the equivalence determination, a company would have to submit a PMN for the renewable equivalent of a petroleum cut, sign the almost certain resultant consent order (EPA will undoubtedly identify aquatic toxicity concerns and may also identify health concerns), commence manufacture, file a Notice of Commencement of Manufacture or Import (NOC), and then request an equivalency determination. If EPA denies the equivalency determination, any downstream processor or user will have to either segregate the renewable products from the petroleum products so that the downstream entity can maintain records of compliance with the consent order or treat both the renewable and petroleum products as being subject to the order. Neither option is commercially feasible or sustainable.
This sequence of events illustrates why commercial entities are disinclined to avail themselves of renewable sources in the distillate space. EPA’s “compliance advisory” is an unexpected and, to many, unwanted parting gift from the Trump Administration. The Biden Administration may wish to revisit the wisdom and prudence of this inflexible, antiquated, and inequitable view.