Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.

Register now to join B&C for “FIFRA Hot Topics,” a complimentary webinar covering key priorities of Office of Pesticide Programs (OPP) and what companies should know to avoid market delays. With year one of the Biden Administration’s term in the history books, we have a clearer sense of how EPA is proceeding on all fronts. EPA’s OPP is focusing on long-standing challenges, especially a renewed effort to meet Endangered Species Act (ESA) consultation requirements and determining how best to meet core pesticide registration review obligations in 2022. These program priorities must reflect special considerations for environmental justice and climate change, advance critical science and policy issues, develop a fifth Pesticide Registration Improvement Act (PRIA) implementation framework, and display a renewed commitment to working collaboratively with state partners and other stakeholders to implement the program.

Speakers include:

Tags: Webinar, FIFRA

 

By Lynn L. Bergeson 

On February 24, 2022, EPA announced the selection of 11 organizations to receive a total of approximately $2 million in funding to divert food waste from landfills by expanding anaerobic digester capacity nationwide. Anaerobic digestion (AD) produces biogas that can be captured and used for energy production and digestate (a fertilizer product) by using microorganisms to break down organic materials, such as food scraps and manure, in the absence of oxygen. By reducing the amount of wasted food in landfills and consequently methane emissions, AD may reduce significantly the impacts of climate change. EPA’s food recovery hierarchy includes AD as a strategy that is preferable to landfilling and incineration, because it contributes to building a circular economy. Each of the selected organizations will receive between $150,000 and $200,000 over two years. A list of the selected projects is available here.


 

By Lynn L. Bergeson and Carla N. Hutton

On February 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on requirements under the Toxic Substances Control Act (TSCA) and the premanufacture notice (PMN) process for biofuels. As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. According to EPA, it has received more than 30 biofuel PMNs “that collectively describe plans for close to 800 million gallons per year of production of advanced biofuels, that could contribute to annual volume mandates under the [Renewable Fuel Standard (RFS)] program and help support the goals of energy security through increasing domestic production” within the United States. Future webinars will cover the TSCA Inventory, nomenclature, and Bona Fide process; new chemicals risk assessments, including applications of the tools, models, and databases; and new chemicals risk management actions, including TSCA Section 5 orders and significant new use rules (SNUR).

More information on webinar is available in our March 1, 2022, memorandum.

Tags: TSCA, EPA, Biofuel, PMN

 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency will hold a virtual public meeting April 20-21, 2022, to seek individual input on the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. In addition, EPA announced the availability of and is soliciting public comment on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” EPA states that the Office of Chemical Safety and Pollution Prevention (OCSPP) is proposing to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. According to EPA, the effort will be performed in partnership with its Office of Research and Development (ORD) and other federal entities to leverage their expertise and resources. Written comments are due April 26, 2022. Registration for the meeting is now open.

According to EPA, the research program will refine existing approaches and develop and implement new approach methodologies (NAM) to ensure the best available science is used in TSCA new chemical evaluations. Key areas proposed in the TSCA New Chemicals Collaborative Research Program include:

  • Updating OCSPP’s approach to using data from structurally similar chemicals to determine potential risks from new chemicals, also known as read-across. According to EPA, this will increase the efficiency of new chemical reviews, promoting the use of the best available data to protect human health and the environment.
  • Digitizing and consolidating information on chemicals to include data and studies that currently exist only in hard copy or in various disparate TSCA databases. EPA will combine the information with publicly available sources to expand the amount of information available, enhancing chemical reviews and enabling efficient sharing of chemical information across EPA. Safeguards for confidential business information (CBI) will be maintained as appropriate in this process.
  • Updating and augmenting the models used for predicting a chemical’s physical-chemical properties and environmental fate/transport, hazard, exposure, and toxicokinetics to provide a suite of models to be used for new chemicals assessments. The goal of this effort is to update the models to reflect the best available science, increase transparency, and establish a process for updating these models as science evolves.
  • Exploring ways to integrate and apply NAMs in new chemicals assessments, reducing the use of animal testing. EPA states that as this effort evolves, the goal is to develop a suite of accepted, fit-for-purpose NAMs that could be used by external stakeholders for data submissions under TSCA, as well as informing and expanding new chemical categories.
  • Developing a decision support tool that integrates the various information streams specifically used for new chemical risk assessments. The decision support tool will integrate more efficiently all the data streams (e.g., chemistry, fate, exposures, hazards) into a final risk assessment and transparently document the decisions and assumptions made. Simply put, this will facilitate the new chemicals program tracking decisions over time and evaluating consistency within and across chemistries.

EPA states that additional information on each of these areas will be provided in the draft collaborative research plan that will be available in the docket by March 14, 2022. Later in 2022, EPA plans to engage its Board of Scientific Counselors (BOSC), a federal advisory committee, for peer review. EPA also intends to issue a Federal Register notice announcing the BOSC meeting and to open a docket for public comments.

Although the notice states that EPA’s background documents and the related supporting materials to the draft are available in the docket established for this meeting, Docket ID Number EPA-HQ-OPPT-2022-0218, nothing is available at this time. EPA states that it will provide additional background documents as the materials become available. After the virtual public meeting, EPA will prepare meeting minutes summarizing the individual comments received at the meeting. EPA will post the meeting minutes on its website and in the relevant docket.


 

By Lynn L. Bergeson 

On December 28, 2021, EPA announced that it will hold a public virtual meeting to discuss biofuel greenhouse gas (GHG) modeling. EPA is soliciting information on the current scientific understanding of GHG modeling of land-based biofuels used in the transportation sector. According to EPA, the information gathered during this meeting will be used to inform current and future EPA actions, including the method for quantifying GHG emissions under RFS. Of particular interest to EPA, is input on:

  • How to incorporate the best available science into an update of EPA’s biofuels lifecycle analysis (LCA); and
  • The next steps EPA should take in this work area.

Hosted by EPA’s Office of Transportation and Air Quality in consultation with USDA and DOE, the virtual public meeting is scheduled for February 28, 2022, and March 1, 2022, from 12:00 p.m. to 4:00 p.m. (EST). EPA will also be accepting comments on these topics until April 1, 2022.


 

By Lynn L. Bergeson 

On December 10, 2021, the Biden Administration released its Fall 2021 Unified Agenda of Regulatory and Deregulatory Actions. According to EPA’s rule list, the Office of Chemical Safety and Pollution Prevention (OCSPP) is working on the following rulemakings under the Toxic Substances Control Act (TSCA). Rulemakings at the proposed stage include:

  • Tiered Data Reporting to Inform Prioritization, Risk Evaluation, and Risk Management Under TSCA (2070-AK62): EPA is developing this rule to obtain information about potential hazards and exposure pathways related to certain chemicals, particularly occupational, environmental, and consumer exposure information. EPA states that this information is needed to inform prioritization, risk evaluation, and risk management of the chemical substances under TSCA Section 6. EPA intends to publish a notice of proposed rulemaking (NPRM) in July 2022 and a final rule in March 2023. More information on the rulemaking is available in our July 29, 2021, memorandum;
     
  • Revisions to the TSCA Fees Rule (2070-AK64): In January 2021, EPA proposed updates and adjustments to the 2018 TSCA Fees Rule. EPA proposed to add three new fee categories: a Bona Fide Intent to Manufacture or Import Notice, a Notice of Commencement of Manufacture or Import, and an additional fee associated with test orders. In addition, EPA proposed exemptions for entities subject to certain fee triggering activities, including: an exemption for research and development activities; an exemption for entities manufacturing less than 2,500 pounds of a chemical subject to an EPA-initiated risk evaluation fee; an exemption for manufacturers of chemical substances produced as a non-isolated intermediate; and exemptions for manufacturers of a chemical substance subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, produced as a byproduct, or produced or imported as an impurity. EPA proposed a volume-based fee allocation for EPA-initiated risk evaluation fees in any scenario where a consortium is not formed and proposed to require export-only manufacturers to pay fees for EPA-initiated risk evaluations. EPA states that in light of public comments, it has decided to issue a supplemental proposal and seek additional public comment on changes to the January 2021 proposal. EPA intends to issue a supplemental NPRM in February 2022. EPA has not determined when it will issue a final rule. More information on the proposed rule is available in our December 30, 2020, memorandum;
     
  • New Chemicals Procedural Regulations to Reflect Amendments to TSCA (2070-AK65): This rulemaking seeks to revise the new chemicals procedural regulations in 40 C.F.R. Part 720 to improve the efficiency of EPA’s review process and to align its processes and procedures with the new statutory requirements. According to EPA, this rulemaking seeks to increase the quality of information initially submitted in new chemicals notices and improve its processes “to reduce unnecessary rework in the risk assessment and, ultimately, the length of time that new chemicals are under review.” EPA intends to publish an NPRM in September 2022. EPA has not determined when it will issue a final rule;
     
  • Procedures for Submitting Information Subject to Business Confidentiality Claims Under TSCA (2070-AK68): EPA states that it is considering proposing new and amended rules concerning the assertion and maintenance of claims of business confidentiality (i.e., confidential business information (CBI)) under TSCA. The 2016 TSCA amendments included several new provisions concerning the assertion and EPA review and treatment of confidentiality claims. EPA is considering procedures for submitting and supporting such claims in TSCA submissions, including substantiation requirements, exemptions, electronic reporting enhancements, and maintenance or withdrawal of confidentiality claims. EPA is also considering whether the proposed rule should elaborate on EPA’s procedures for reviewing and communicating with TSCA submitters about confidentiality claims. According to EPA, it expects the proposed rule to include new provisions, as well as revisions to existing rules on asserting confidentiality claims to conform to the 2016 amendments. EPA intends to issue an NPRM in April 2022; and
     
  • Reconsideration of Procedures for Chemical Risk Evaluation Under the Amended TSCA (2070-AK90): EPA published a final rule on July 20, 2017, that established a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. This process incorporates the science requirements of the amended statute, including best available science and weight of the scientific evidence. The final rule established the steps of a risk evaluation process, including: scope, hazard assessment, exposure assessment, risk characterization, and risk determination. EPA states that it is now in the process of reconsidering the final rule in keeping with new EOs concerning the advancement of racial equity and support for underserved communities through the federal government (EO 13985), the protection of public health and the environment and restoring science to tackle the climate crisis (EO 13990), tackling the climate crisis at home and abroad (EO 14008), and other Administration priorities (such as the Presidential memorandum on restoring trust in government through scientific integrity and evidence-based policymaking). If EPA determines to amend the 2017 final rule based on its reconsideration, it will solicit public comment through an NPRM. EPA intends to publish an NPRM in September 2022.

The Unified Agenda lists the following TSCA rulemaking at the final stage:

  • Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (PMN) (2070-AJ94): EPA proposed amending components of the Significant New Uses of Chemical Substances regulations at 40 C.F.R. Part 721, specifically the “Protection in the Workplace” (40 C.F.R. Section 721.63) and “Hazard Communication Program” (40 C.F.R. Section 721.72). 81 Fed. Reg. 49598. The proposed changes are intended to align, where possible, EPA’s regulations with the revised Occupational Safety and Health Administration (OSHA) regulations at 29 C.F.R. Section 1910.1200. OSHA issued a final rule on March 26, 2012 (77 Fed. Reg. 17573), that aligns OSHA’s Hazard Communication Standards with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). EPA states that it is reviewing the comments received and is planning to issue a final rule. EPA intends to issue a final rule in September 2022. More information on EPA’s 2016 proposed rule is available in our July 29, 2016, memorandum.
Tags: TSCA

 

Bergeson & Campbell, P.C. (B&C®) is pleased to provide our Forecast 2022 to readers of the Biobased and Renewable Products Update, offering our best informed judgment as to the trends and key developments we expect to see in the new year. Global and national policy reforms continue to focus increasingly on a circular economy as a critical part of addressing climate change. In 2022, industry stakeholders can expect the U.S. Department of Energy (DOE) to announce funding opportunities for efforts focused on the development of novel biobased chemistry. Stakeholders in the biobased chemical industry should also plan to monitor activities on Capitol Hill, including the Sustainable Chemistry Research and Development Act, passed in July 2020 as part of the National Defense Authorization Act for fiscal year (FY) 2021. More details on this, and expected regulatory changes of all varieties, are available in our Forecast for U.S. Federal and International Chemical Regulatory Policy 2022.

WEBINAR
What to Expect in Chemicals in 2022
January 26, 2022, 12:00 p.m. EST
Register Now

B&C will be presenting a complimentary webinar, “What to Expect in Chemicals in 2022,” focusing on themes outlined in the forecast. Join Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Director of Chemistry; and James V. Aidala, Senior Government Affairs Consultant, for this informative and forward-looking webinar.


 

By Lynn L. Bergeson 

According to an October 26, 2021, project notification memorandum, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) plans to begin fieldwork on an audit of EPA’s process for conducting reviews of new chemicals under the Toxic Substances Control Act (TSCA). The memorandum states that the audit “is self-initiated based on OIG’s oversight plan for fiscal year [(FY)] 2022 and to address complaints submitted to the OIG Hotline.” The audit also addresses the following FY 2022 top management challenge for EPA: ensuring safe use of chemicals.

OIG states that its objective is to determine the extent to which EPA uses and complies with applicable records management requirements, quality assurance requirements, and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks. OIG plans to conduct work with the Office of Chemical Safety and Pollution Prevention (OCSPP) in EPA headquarters. According to OIG, the anticipated benefits of the audit are “improved operational efficiency and greater human health and environmental protections.”

To expedite the audit, OIG asks that OSCPP provide the following information:

  • Any training materials, handbooks, or other materials related to the review of new chemicals;
     
  • Resource allocations for the New Chemicals Review Program for FYs 2018 through 2021;
     
  • Scopes of work for any contracts related to the new chemicals review process;
     
  • Any OCSPP guidance under which products developed during the review of new chemicals would constitute records and how the records should be managed; and
     
  • New Chemicals Review Program organization charts before and after the October 2020 reorganization.

As reported in Bergeson & Campbell, P.C.’s (B&C®) October 28, 2021, memorandum, “House Committee Holds Hearing on ‘TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act,’” Dr. Michal Ilana Freedhoff, OCSPP Assistant Administrator, has let OIG know that OCSPP will cooperate fully with its investigation.
 


 

By Lynn L. Bergeson and Carla N. Hutton
 
According to an October 26, 2021, project notification memorandum, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) plans to begin fieldwork on an audit of EPA’s process for conducting reviews of new chemicals under the Toxic Substances Control Act (TSCA). The memorandum states that the audit “is self-initiated based on OIG’s oversight plan for fiscal year [(FY)] 2022 and to address complaints submitted to the OIG Hotline.” The audit also addresses the following FY 2022 top management challenge for EPA: ensuring safe use of chemicals.
 
OIG states that its objective is to determine the extent to which EPA uses and complies with applicable records management requirements, quality assurance requirements, and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks. OIG plans to conduct work with the Office of Chemical Safety and Pollution Prevention (OCSPP) in EPA headquarters. According to OIG, the anticipated benefits of the audit are “improved operational efficiency and greater human health and environmental protections.”
 
To expedite the audit, OIG asks that OSCPP provide the following information:

  • Any training materials, handbooks, or other materials related to the review of new chemicals;
  • Resource allocations for the New Chemicals Review Program for FYs 2018 through 2021;
  • Scopes of work for any contracts related to the new chemicals review process;
  • Any OCSPP guidance under which products developed during the review of new chemicals would constitute records and how the records should be managed; and
  • New Chemicals Review Program organization charts before and after the October 2020 reorganization.

As reported in our October 28, 2021, memorandum, “House Committee Holds Hearing on ‘TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act,’” Dr. Michal Ilana Freedhoff, OCSPP Assistant Administrator, has let OIG know that OCSPP will cooperate fully with its investigation.


 

By Lynn L. Bergeson 

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.


 
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