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EPA Draft FY 2022-2026 Strategic Plan Includes Ambitious Goals To Ensure Safety Of Chemicals For People And The Environment
On October 1, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of the Draft FY 2022-2026 EPA Strategic Plan. 86 Fed. Reg. 54448. The draft Strategic Plan communicates EPA’s priorities and provides the roadmap for achieving its mission to protect human health and the environment. The draft Strategic Plan outlines objectives with the following goals:
- Goal 1: Tackle the Climate Crisis;
- Goal 2: Take Decisive Action to Advance Environmental Justice and Civil Rights;
- Goal 3: Enforce Environmental Laws and Ensure Compliance;
- Goal 4: Ensure Clean and Healthy Air for All Communities;
- Goal 5: Ensure Clean and Safe Water for All Communities;
- Goal 6: Safeguard and Revitalize Communities; and
- Goal 7: Ensure Safety of Chemicals for People and the Environment.
Goal 7 includes two objectives. Objective 7.1, “Ensure Chemical and Pesticide Safety,” is intended to protect the health of families, communities, and ecosystems from the risks posed by chemicals and pesticides. It includes the following long-term goals:
- By September 30, 2026, complete annually at least eight High-Priority Substance (HPS) Toxic Substances Control Act (TSCA) risk evaluations within statutory timelines compared with the fiscal year (FY) 2020 baseline of one;
- By September 30, 2026, review 90 percent of risk mitigation requirements for TSCA new chemical substances compared to the FY 2021 baseline of none;
- By September 30, 2026, renew 40 percent of expiring lead-based paint Renovation, Repair, and Painting (RRP) firm certifications within 30 days compared to the FY 2021 baseline of 36 percent;
- By September 30, 2026, complete 78 pesticide registration review cases;
- By September 30, 2026, consider the effects determinations or protections of federally threatened and endangered species for new active ingredients in 90 percent of the risk assessments supporting pesticide registration decisions for new active ingredients compared to the FY 2020 baseline of 50 percent;
- By September 30, 2026, consider the effects determinations or protections of federally threatened and endangered species in 50 percent of the risk assessments supporting pesticide registration review decisions compared to the FY 2020 baseline of 25 percent; and
- By September 30, 2026, support Agricultural Worker Protection Standard (WPS) pesticide safety training for 20,000 farmworkers annually compared with the FY 2018-2020 annual average baseline of 11,000.
Objective 7.2, “Promote Pollution Prevention,” is intended to encourage the adoption of pollution prevention and other stewardship practices that conserve natural resources, mitigate climate change, and promote environmental sustainability. It includes the following long-term goals:
- By September 30, 2026, reduce a total of 1.5 million metric tons of carbon dioxide equivalent released attributed to EPA pollution prevention grants; and
- By September 30, 2026, EPA’s Safer Choice program will certify a total of 2,300 products compared to the FY 2021 baseline of 1,950 total certified products.
According to the notice, EPA is seeking comment from individual citizens, states, tribes, local governments, industry, the academic community, non-governmental organizations (NGO), and all other interested parties. Comments are due November 12, 2021. EPA states that it “anticipates the final Strategic Plan will be submitted to Congress in February 2022.”
EPA Announces BOSC CSS HERA Subcommittee Meeting
On October 1, 2021, EPA announced a series of virtual meetings of the Board of Scientific Counselors (BOSC) Chemical Safety for Sustainability and Health and Environmental Risk Assessment (CSS HERA) Subcommittee to review recent progress and activities of the Chemical Safety Analytics (CSA) and Emerging Materials and Technologies (EMT) research areas. Meetings are open to the public, and EPA accepted comments until November 3, 2021.
The initial meeting will be held over a two-day period via videoconference on November 4 and 5, 2021, 12:00 p.m. to 5:00 p.m. (EDT). Registration was required by November 3, 2021. The following meetings are also scheduled:
- BOSC Deliberation Videoconference: November 18, 2021, 11:00 a.m. to 2:00 p.m. (EST) — Registration is required by November 17, 2021.
- Final BOSC Deliberation Videoconference: December 10, 2021, 11:00 a.m. to 2:00 p.m. (EST) — Registration is required by December 9, 2021.
Meeting times are subject to change.
EPA Announces Steps Intended To Enhance Scientific Integrity And Strengthen New Chemical Safety Reviews
The 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 TSCA. OCSPP states that to date, NCD has inventoried and reviewed more than 100 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.
- 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.
- 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.
House Subcommittee Holds Hearing On “TSCA And Public Health: Fulfilling The Promise Of The Lautenberg Act”
The House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing on October 27, 2021, on “TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act.” The October 25, 2021, briefing memorandum notes that the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Lautenberg Act) comprehensively amended TSCA, “including key reforms to increase EPA’s authority to mandate testing, require EPA to make affirmative decisions about the safety of new chemicals, and require the evaluation, and where merited, the regulation of existing chemicals.”
Dr. Michal Ilana Freedhoff, Assistant Administrator for OCSPP, was the Subcommittee’s only witness. In her testimony, she emphasized several critical building blocks of a sustainable TSCA program:
- Resources: EPA needs meaningful new funding to reflect its new responsibilities under the Lautenberg Act. Freedhoff estimates that EPA has less than 50 percent of the resources necessary to review and approve new chemicals in the way Congress intended;
- Strong science and scientific integrity; and
- Policies and processes that will lead to legally and scientifically defensible and protective chemical safety actions. The previous Administration issued ten final risk evaluations. While some EPA policy changes made under the Biden Administration will require revision to some of these risk evaluations, EPA’s intent is to do only what is necessary. These policy changes include reversing the assumption that all workers always use personal protective equipment (PPE) and reversing the decision to exclude exposures to chemicals from air, drinking water, and disposal.
Freedhoff stated that EPA’s goal is to move to rulemaking as soon as possible. She expects that the proposed rule for asbestos will be the very first of the first ten chemicals assessed under the Lautenberg Act that will be sent to the Office of Management and Budget (OMB) for interagency review later in 2021. According to Freedhoff, the scope for the next part of the asbestos risk evaluation that addresses uses and fiber types that the previous Administration excluded will be ready “roughly” by the end of 2021. EPA expects to complete that risk evaluation by the end of 2024.
Freedhoff described EPA’s work to improve implementation of the new chemicals program. Freedhoff noted that EPA has made policy changes intended to protect workers and ensure that the scope of new chemical reviews aligns with Congress’s expectations. EPA has also revised the process for reviewing and issuing final human health risk assessments and established a new internal advisory body to review and consider scientific policy issues related to new chemical submissions. Freedhoff stressed that she does not believe ensuring that new chemicals be used safely and reviewing new chemicals quickly are mutually exclusive. EPA can do both, and the Lautenberg Act states that EPA should. When questioned about the delay in review of premanufacture notices (PMN) within the allotted 90 days, Freedhoff stated that EPA is operating under the typical workload, as has been the case the past few years. According to Freedhoff, when EPA takes more than 90 days, it is typically because the companies have asked EPA to do so. Sometimes that is because the companies are providing new information late in the process and sometimes, especially in the past few years, it is because they disagree with EPA’s risk assessment and want to change EPA’s mind. Freedhoff reiterated her earlier point about needing resources, noting that EPA is operating with less than 50 percent of the resources that it thinks it needs to operate the NCD in the way that Congress intended.
Freedhoff stated that in April 2021, she and the scientific integrity official found a way to initiate a review of a small number of human health assessments about which concerns were raised, and she shared the information with the Office of the Inspector General (OIG). She learned that sometimes very serious questions were raised about how hazardous a new chemical is found to be, even when there is agreement that hazard exists. She heard that changes to the scientific basis of the assessments is not always well explained or understandable. Freedhoff stated that there are legitimate questions about the process and science associated with reviewing new chemicals and that she takes these concerns seriously. She personally let the OIG know that OCSPP will cooperate fully with its investigation; launched a series of scientific integrity trainings; put into place new ways for scientists who believe that there is disagreement can elevate their concerns and obtain a review; and hired someone to come in and talk about ways to improve recordkeeping practices.
Freedhoff highlighted one of OCSPP’s contributions to the Biden Administration’s multi-agency plan to address PFAS contamination, the national PFAS testing strategy. According to Freedhoff, most of the thousands of PFAS have no toxicity data, and if EPA continues to work on one PFAS at a time, EPA will not get through them. Freedhoff stated that the first TSCA test orders to manufacturers for about 20 different PFAS in 20 different categories will go out in a matter of months. EPA expects to extrapolate the information that it receives to more than 2,000 other PFAS in similar categories. EPA is currently determining what tests to require. The timeline for industry to conduct the testing and provide results to EPA depends on what tests are required.
After Freedhoff completed her opening statement, Committee and Subcommittee members had an opportunity to ask questions. During the question and answer period, Freedhoff agreed that the Lautenberg Act requires that EPA make health and safety studies public, such as those for Colour Index (C.I.) Pigment Violet 29 (PV29) that were initially declared confidential, and EPA is going to do that. EPA has updated the confidential status of almost 400 chemicals and will include those chemicals on the next update of the TSCA Inventory. EPA is also working to provide more information about new chemicals and make it more public as quickly as possible.
To address risks to communities that live near industrial facilities, EPA is creating a fenceline screening methodology to ensure that communities are not inadvertently left out of the risk evaluation process. According to Freedhoff, EPA will release the methodology for public comment and peer review in fall 2021. EPA also expects to release a new draft systematic review methodology for both public comment and peer review later in 2021.
When asked about the final rules for five persistent, bioaccumulative, and toxic (PBT) chemicals — 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP), decabromodiphenyl ether (decaBDE), hexachlorobutadiene (HCBD), pentachlorothiophenol (PCTP), and phenol, isopropylated phosphate (3:1) (PIP (3:1)) — that have caused concerns about the supply chain, Freedhoff noted that these final rules were issued under the Trump Administration. She stated that she believes that the former Administration made every effort to reach out to industry, but industry realized what the implications would be on their supply chains only after the final rules were issued. The Biden EPA immediately took action to extend the PIP (3:1) compliance date and is still working to address industry’s concerns and will continue to do so.
Under the previous Administration, EPA completed the risk evaluation of methylene chloride and banned it in all paint removers for consumer use. According to Freedhoff, EPA is now considering its commercial uses and working to ensure that the rule will not leave fenceline communities with additional exposures. EPA expects to send a proposed rule addressing these uses for interagency review sometime in 2022.
There were not many surprises in the hearing. Freedhoff largely reiterated statements EPA has made in the past, rather than providing new information or additional clarity. Criticism from members followed fairly well-trodden lines of critique that have been raised since 2016, and Freedhoff responded predictably, asserting that EPA would follow the law and the science and urging repeatedly that EPA needs additional resources to fulfill its mission.
For critics on both sides, there was little assurance that OCSPP will take action timely on the many issues that have been delayed, including the Section 6 risk evaluations, new chemicals notices, and PBT regulations.
EPA Posts Recording Of Webinar On 2022 Green Chemistry Challenge Awards
EPA has posted a recording of the September 22, 2021, webinar that it hosted to educate stakeholders on the Green Chemistry Challenge Awards and the nomination process. The webinar reviewed the history of the awards, the categories within the awards, eligibility requirements, and what is needed to submit a nomination. As reported in our August 27, 2021, blog item, EPA is currently accepting nominations for the 2022 Green Chemistry Challenge Awards from companies or institutions that have developed a new green chemistry process or product that helps protect human health and the environment. Nominations are due December 10, 2021. An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2022 nominations and make recommendations to EPA for the 2022 winners. EPA anticipates giving awards to outstanding green chemistry technologies in six categories in June 2022.
DOE Issues Notice Of Intent To Issue FOA Titled “Scale-Up Of Integrated Biorefineries”
On October 29, 2021, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) issued a notice of intent to release a second Funding Opportunity Announcement (FOA) to accelerate the scale-up of biofuel and bioproduct refineries. Funded by DOE’s Bioenergy Technologies Office (BETO), this FOA will include efforts for pre-pilot, pilot, and demonstration scale projects. The FOA will fund projects in the planning phase, projects that already have a design package and are ready to construct, and projects that were funded by DOE previously for design work.
State
California DTSC Announces GRSP Meeting To Discuss Microplastic Research And Policy
On October 7, 2021, the California Department of Toxic Substances Control (DTSC) announced that the Green Ribbon Science Panel (GRSP) will hold a meeting from 12:00 p.m. to 3:00 p.m. (EDT) on November 5, 2021. The meeting will focus on microplastic research and policy.
GRSP was established to act as a resource for the implementation of California’s Green Chemistry Law. GRSP provides technical advice to the DTSC Director and the California Environmental Policy Council (CEPC) on scientific matters related to the development of policy recommendations and implementation strategies on green chemistry and chemicals through DTSC’s Safer Consumer Products (SCP) program. Additional topics covered by GRSP as the SCP program continues to expand include:
- Development and implementation of DTSC’s 2021-2023 Priority Product Work Plan;
- Development of information, guidance, and tools aimed to help stakeholders to perform the Alternatives Analysis (AA) process; and
- Program and stakeholder information needs and recommendations on how to meet those needs.
Research
Tokyo Tech Study Reveals That Bioplastics Can Be Transformed Into Fertilizers
On October 28, 2021, the Tokyo Institute of Technology (Tokyo Tech) announced that several of its scientists discovered in a study that bioplastics can be chemically recycled into nitrogen-rich fertilizers in an environmentally friendly manner. Assistant Professor Daisuke Aoki and Professor Hideyuki Otsuka led the study hoping to address plastic pollution, petrochemical resource depletion, and world hunger. In their novel method, plastics produced from biomass (bioplastics) are chemically recycled back into fertilizers.
The study was published in Green Chemistry, a Royal Society of Chemistry journal focused on innovation research on sustainable and eco-friendly technologies.
Other News
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