By Lynn L. Bergeson and Carla N. Hutton
On June 24, 2021, a “unique and broad group” of chemical manufacturers, brand owners, environmental non-governmental organizations (NGO), states, and municipalities sent a letter to the leaders of the House and Senate Appropriations Subcommittees on Interior, Environment, and Related Agencies to express their “strong support” for the U.S. Environmental Protection Agency’s (EPA) Safer Choice Program and to encourage that the program be funded fully. The letter asks that the following language be included in the report:
The Committee supports the Safer Choice program and directs that the program be funded and operated at least at levels consistent with Fiscal Year 2014, adjusted for inflation.
According to the letter, in the last quarter of 2020, EPA reorganized the Office of Chemical Safety and Pollution Prevention (OCSPP), dissolving the Safer Choice branch and reassigning most staff to the areas of OCSPP. The letter states that “[a]s a result, the program is now severely under-resourced with approximately four full-time staff.” The Biden-Harris EPA has taken steps to restore the program, but EPA still faces resource constraints.
The letter describes how companies across the value chain use the Safer Choice brand to advance their individual safer chemical initiatives. Chemical manufacturers invested in developing safer chemicals now listed on the Safer Choice’s Safer Chemicals Ingredients List (SCIL). Brand owners and product manufacturers have reformulated products using the SCIL to obtain Safer Choice certification. Major retailers specify the Safer Choice label as a verifiable way to meet corporate goals laid out in public-facing chemicals policies.
According to the letter, the Safer Choice Program also provides value to entities outside of the supply chain. States and municipalities rely on the Safer Choice Program “because it is the only third-party program that requires all ingredients to be screened for hazards instead of simply using a restricted substances list.” NGOs and consumers “find significant value in an authoritative government program that can be trusted to vet safer chemicals and products.”
By Lynn L. Bergeson
On June 15, 2021, the U.S. Environmental Protection Agency (EPA) announced and recognized the winners of the 2021 Green Chemistry Challenge Awards. According to EPA’s announcement, this year’s winners have developed new and innovative green chemistry technologies that provide solutions to significant environmental challenges and spur innovation. The announcement was made during the American Chemical Society (ACS) Green Chemistry & Engineering Conference. Co-sponsored by EPA and ACS, the Green Chemistry Challenge Awards celebrated its 25th anniversary this year. Further details are available here.
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
On April 1, 2021, the U.S. Environmental Protection Agency (EPA) issued its final modifications of certain compliance dates under the Renewable Fuel Standard (RFS) program. The final rule extends the RFS compliance deadline for the 2019 and 2020 compliance years and its associated deadlines for submission of attest engagement reports for the 2019 and 2020 compliance years for small refineries. The new 2019 compliance year and attest engagement report deadlines are now November 30, 2021, and June 1, 2022, respectively. The new 2020 compliance year and attest engagement report deadlines are now January 31, 2022, and June 1, 2022, respectively. EPA has also extended the deadline for submission of attest engagement reports for the 2021 compliance year for obligated parties to September 1, 2022. The final rule became effective on March 20, 2021.
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.”
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
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.