By Lynn L. Bergeson
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.
Bergeson & Campbell, P.C. Commentary
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
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 published 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.”
March 31, 2021
1:30 p.m. - 3:00 p.m. EDT
The COVID-19 global pandemic has had far-reaching impacts on business operations. While we are all eager to put the pandemic behind us, other catastrophic events will inevitably occur. To strengthen organizational resilience going forward, we must examine lessons learned and position product stewardship as a key player in business continuity and crisis management.
This complimentary future-focused webinar, hosted by the Product Stewardship Society (PSS), will identify the broad range of complex, unresolved, and evolving issues product stewards have faced and continue to face because of the pandemic.
Tina Armstrong, Ph.D., Principal Scientist and Vice President at the global consultancy firm Arcadis
Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (moderator)
Jon Hellerstein, CIH, CSP, a career environmental health professional
Al Iannuzzi, Ph.D., Vice President, Sustainability, The Estée Lauder Companies
Louise Proud, leader of the Environment, Health, and Safety program for Pfizer Inc.
In addition to receiving 1.5 contact hours, participants will learn:
- How product stewards can integrate product stewardship into business continuity and crisis management.
- What issues a product steward needs to address when a COVID-19 outbreak occurs in a workplace, retail space, or upstream/downstream in the supply chain.
- How to leverage the experiences of the COVID-19 pandemic to influence senior leaders to think differently about product stewardship and environment, health, and safety in general.
Make sure to register now for what promises to be a timely, resourceful, and interesting event!
By Richard E. Engler, Ph.D.
In the 21st century, we take as given a continuous stream of new and better products. From electronics to building materials to transportation solutions, the flow of new and better products and applications seems unending. New chemical substances play a fundamental role in creating those products and making existing products better. If the pipeline of new chemicals were closed off, the flow of new products and applications would slow to a trickle and eventually dry up. Modern life as we know it would not exist without the continued invention, production, and use of new chemicals.
In the United States, all new chemicals must be reviewed by the U.S. Environmental Protection Agency (EPA) before they can enter commerce. The Agency looks at new chemicals to determine whether their manufacturing, processing, and use would adversely affect people or the environment. If EPA identifies risks that it determines to be unreasonable, then it either prohibits use of the chemical, or requires restrictions on the chemical to control for risks. Since the 1970s, tens of thousands of chemicals have come through EPA for review and have been allowed into U.S. commerce.
In this article, Richard E. Engler, Ph.D. and Jeffery T. Morris, Ph.D. write that more robust consideration of a new chemical’s potential to prevent pollution and lower risks could help achieve the right balance between safety and innovation. The full article is available at https://chemicalwatch.com/220164/guest-column-why-the-us-epa-can-and-should-evaluate-the-risk-reducing-role-a-new-chemical-may-play-if-allowed-on-the-market (subscription required).
By Lynn L. Bergeson
On February 1, 2021, the U.S. District Court for the District of Montana granted the U.S. Environmental Protection Agency’s (EPA) January 31, 2021, unopposed motion to vacate and remand its January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information” (86 Fed. Reg. 469). EDF v. EPA, No. 4:21-cv-03-BMM. On January 11, 2021, the Environmental Defense Fund (EDF), Montana Environmental Information Center (MEIC), and Citizens for Clean Energy (CCE) filed suit against EPA, claiming that the January 6, 2021, final rule was unlawful and that EPA’s decision to make the final rule effective on publication was unlawful. On January 27, 2021, the court granted summary judgment to the plaintiffs, finding that EPA did not provide good cause to exempt the final rule from the Administrative Procedure Act’s (APA) 30-day notice requirement. The court stated that “EPA’s decision to make the Final Rule immediately effective on publication was ‘arbitrary, capricious’ and ‘otherwise not in accordance with law.’” In its January 31, 2021, motion, EPA states based on the court’s conclusion that the final rule constitutes a substantive rule and that EPA “lacked authorization to promulgate the rule pursuant to its housekeeping authority.” According to EPA, where EPA lacked the authority to promulgate the final rule, “remand without vacatur would serve no useful purpose because EPA would not be able to cure that defect on remand.” EPA notes that because the final rule was in effect for less than a month, and it had not applied the rule in any circumstance while the rule was in effect, “there would be no disruptive consequences in remanding and vacating the rule.”
Prior to EPA’s motion to vacate and remand the final rule, on January 20, 2021, President Biden signed an Executive Order (EO) on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis. According to the EO, it is the policy of the Biden Administration “to listen to the science; to improve public health and protect our environment; to ensure access to clean air and water; to limit exposure to dangerous chemicals and pesticides; to hold polluters accountable, including those who disproportionately harm communities of color and low-income communities; to reduce greenhouse gas emissions; to bolster resilience to the impacts of climate change; to restore and expand our national treasures and monuments; and to prioritize both environmental justice and the creation of the well-paying union jobs necessary to deliver on these goals.” The EO directs all executive departments and agencies to review immediately and, as appropriate and consistent with applicable law, take action to address the promulgation of federal regulations and other actions during the Trump Administration that conflict with the Biden Administration’s national objectives, and to commence work immediately to confront the climate crisis. The EO calls for the heads of all agencies to review immediately “all existing regulations, orders, guidance documents, policies, and any other similar agency actions (agency actions) promulgated, issued, or adopted between January 20, 2017, and January 20, 2021, that are or may be inconsistent with, or present obstacles to,” the Biden Administration’s policy. For any identified actions, the EO directs the heads of agencies to “consider suspending, revising, or rescinding the agency actions.” In addition, for certain specified agency actions, the EO states that the head of the relevant agency “shall consider publishing for notice and comment a proposed rule suspending, revising, or rescinding the agency action within the time frame specified.” The specified agency actions include EPA’s January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.”
As reported in our January 11, 2021, memorandum, the origin of EPA’s January 6, 2021, final rule is rooted in legislative proposals more clearly intended to challenge important regulatory requirements, particularly related to EPA’s air program. We predicted that the final rule would likely be among the first items subject to reversal or “clarifying” guidance making it consistent with previously established science policies (see Bergeson & Campbell, P.C.’s (B&C®) Forecast 2021 memo). With Democratic control of both houses of Congress, there might also be attempts to repeal the rule via action under the Congressional Review Act (CRA) of recently promulgated regulations.
By Lynn L. Bergeson
On January 11, 2021, EPA published a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule. 86 Fed. Reg. 1890. Under TSCA, EPA collects fees from chemical manufacturers and processors to help fund implementation and to ensure that public health and the environment continue to be protected. TSCA requires EPA to review its fees every three years and, after consulting with parties potentially subject to the fees, to adjust the fees if necessary. The proposed rule describes the proposed modifications to the TSCA fees and fee categories for fiscal years 2022, 2023, and 2024 and explains the methodology by which these TSCA fees were determined. The proposed updates include:
- Regarding EPA-initiated risk evaluations, narrowing the scope of the TSCA fees rule by exempting from the requirement to pay fees importers of articles containing a chemical substance, companies that produce a chemical as a byproduct or manufacture or import as an impurity, companies that manufacture or import a chemical in de minimis amounts, companies that manufacture or import chemicals solely for R&D purposes, and companies that produce a chemical as a non-isolated intermediate;
- Using cost data gathered over the past two years, instead of estimates, to update the fee calculations;
- Ensuring fees are fairly and appropriately shared across companies by proposing a production-volume based fee allocation and including export-only manufacturers for EPA-initiated risk evaluations;
- Allowing for corrections to be made to the list of manufacturers subject to fees for EPA-initiated risk evaluations after the final list is published, ensuring the accuracy of the list;
- Increasing flexibility for companies by extending the amount of time to form consortia to share in fee payments;
- Ensuring that EPA can fully collect fees and enabling companies to prepare better for paying fees by allowing payments in installments for EPA-initiated and manufacturer-requested risk evaluations (MRRE); and
- Adding three new fee categories, two associated with new chemical activities and one associated with test orders.
Comments are due February 25, 2021. More information is available in our December 30, 2020, memorandum, “EPA Intends Proposed Rule to Increase Flexibility and Reduce Burdens under TSCA Fees Program.
By Lynn L. Bergeson
EPA announced on January 8, 2021, that it released an updated and improved version of OncoLogic™, a system used to evaluate a chemical’s potential to cause cancer. EPA states that, in partnership with the Organization for Economic Cooperation and Development (OECD), it developed “a more user-friendly version of the most widely used piece of this system, greatly expanding its usability across the agency and the scientific community.” According to EPA, the updated module (version 9) is used to analyze organic chemicals, the largest group of chemicals contained in this tool. It features:
- A streamlined interface that does not require expert knowledge to navigate;
- A standardized reporting format that allows users to view and export results quickly; and
- Increased transparency in the science behind the predictions provided by the model.
EPA notes that OncoLogic™ is one of many publicly available assessment methods, databases, and predictive tools it developed to estimate hazard to humans and the environment, particularly in the absence of test data. According to EPA, these tools and models support it in implementing programs and regulations, such as TSCA, and help external users assess and manage chemical risks. EPA states that version 8.0, which continues to include modules for fibers, metals, and polymers, will remain available to the public.
By Lynn L. Bergeson
On January 12, 2021, 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 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
Dan Utech, Incoming Chief of Staff for EPA, announced to EPA on January 21, 2021, that until Michael Regan, Secretary of the North Carolina Department of Environmental Quality, is confirmed as EPA Administrator, Jane Nishida will serve as Acting Administrator. According to Utech, EPA will be guided by science as it moves to achieve these goals and address other threats to public health and the environment.
Utech states that Biden also signed an Executive Order on Advancing Racial Equity and Support for Underserved Communities through the Federal Government. In addition to providing a framework for advancing equity, it revokes Executive Order 13950, “Combating Race and Sex Stereotyping.”
Utech’s announcement includes the following updated list of current and acting leaders, as well as a list of the incoming appointees who onboarded this week.
Current and Acting Leadership
- Acting Administrator: Jane Nishida
- Office of the Chief Financial Officer (OCFO): David Bloom
- Office of Air and Radiation (OAR): Joseph Goffman
- Office of Water (OW): Radhika Fox
- Office of Land and Emergency Management (OLEM): Barry Breen
- Office of Chemical Safety and Pollution Prevention (OCSPP): Michal Ilana Freedhoff (as of January 25, 2021)
- Office of Research and Development (ORD): Jennifer Orme-Zavaleta
- Office of General Counsel (OGC): Melissa Hoffer
- Office of Enforcement and Compliance Assurance (OECA): Larry Starfield
- Office of International and Tribal Affairs (OITA): Mark Kasman
- Office of Mission Support (OMS): Donna Vizian
- Office of Policy (OP): Victoria Arroyo
- Office of Congressional and Intergovernmental Relations (OCIR): Robin Richardson
- Office of Public Engagement and Environmental Education (OPEEE): Rosemary Enobakhare
- Office of Public Affairs (OPA): Lindsay Hamilton
- Region 1: Deb Szaro
- Region 2: Walter Mugdan
- Region 3: Diana Esher
- Region 4: John Blevins
- Region 5: Cheryl Newton
- Region 6: David Gray
- Region 7: Ed Chu
- Region 8: Deb Thomas
- Region 9: Deb Jordan
- Region 10: Michelle Pirzadeh
Members of the incoming EPA leadership team who onboarded this week:
- Radha Adhar, Deputy Associate Administrator for Congressional Affairs;
- Victoria Arroyo, Associate Administrator for Policy;
- Tomás Elias Carbonell, Deputy Assistant Administrator for Stationary Sources, OAR;
- Alison Cassady, Deputy Chief of Staff for Policy;
- Dimple Chaudhary, Deputy General Counsel for Nationwide Resource Protection Programs;
- Rosemary Enobakhare, Associate Administrator for Public Engagement and Environmental Education;
- Philip Fine, Principal Deputy Associate Administrator for Policy;
- Radhika Fox, Principal Deputy Assistant Administrator, OW;
- Michal Ilana Freedhoff, Principal Deputy Assistant Administrator for Chemical Safety and Pollution Prevention;
- Joseph Goffman, Principal Deputy Assistant Administrator, OAR;
- Lindsay Hamilton, Associate Administrator for Public Affairs;
- Sinceré Harris, White House Liaison;
- Melissa Hoffer, Principal Deputy General Counsel;
- Casey Katims, Deputy Associate Administrator for Intergovernmental Affairs; and
- John Lucey, Special Assistant to the Administrator.
By Lynn L. Bergeson
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 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.