By Lynn L. Bergeson and Carla N. Hutton
 
On December 2, 2022, the U.S. Environmental Protection Agency (EPA) published a final rule determining that renewable diesel, jet fuel, heating oil, naphtha, and liquefied petroleum gas (LPG) produced from canola/rapeseed oil via a hydrotreating process all meet the lifecycle greenhouse gas (GHG) emissions reduction threshold of 50 percent required for advanced biofuels and biomass-based diesel (BBD) under the Renewable Fuel Standard (RFS) program. 87 Fed. Reg. 73956. EPA states that based on the analyses described in the earlier notice of proposed rulemaking associated with this action, it is adding these pathways to the list of approved pathways in the RFS regulations, making them eligible to generate Renewable Identification Numbers (RIN), provided they satisfy the other definitional and RIN generation criteria for renewable fuel specified in the RFS regulations. EPA also amended the RFS regulations by adding a new definition of “canola/rapeseed oil.” The final rule was effective on January 3, 2023.

By Lynn L. Bergeson and Carla N. Hutton
 
On January 3, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of a draft document entitled Biofuels and the Environment: Third Triennial Report to Congress (External Review Draft) for public comment. 88 Fed. Reg. 72. EPA’s Office of Research and Development (ORD) and Office of Air and Radiation (OAR), in consultation with the U.S. Departments of Agriculture (USDA) and Energy (DOE), prepared the document. The draft report is responsive to Section 204 of the 2007 Energy Independence and Security Act (EISA). The purpose of the report is to examine the effects of the Renewable Fuel Standard (RFS) Program on the environment, including the impacts to date and likely future impacts to the nation’s air, land, and water resources. It focuses on the dominant biofuel sources in the United States: (1) domestic corn ethanol from corn starch; (2) domestic biodiesel from soybean oil; (3) domestic biodiesel from fats, oils, and greases (FOG); and (4) imported ethanol from Brazilian sugarcane. The draft report concludes that the RFS Program likely played a relatively minor role (0-0.4 billion gallons per year) in the growth of corn ethanol in the United States from 2002-2012 and may have played a more important role (0-2.1 billion gallons per year) since 2013. According to the draft report, the more prominent role of the RFS Program on corn ethanol production in the United States in more recent years is consistent with the methyl-tert-butyl-ether (MTBE) phaseout by 2006, expiration of the Volumetric Ethanol Excise Tax Credit (VEETC) at the end of 2010, and lower oil prices after 2015. For biodiesel and renewable diesel, which may be produced from a variety of feedstocks (e.g., soybean, FOGs), the draft report states that the conclusion on the attributional effect of the RFS Program is different. There is evidence that the RFS Program has driven a significant portion of the use of these biofuels since 2010; there is insufficient information available to quantify the attributional effect of the RFS Program, however. The draft report notes that despite the finding of relatively modest effects of the RFS Program nationally for the environmental impacts assessed, these may have important cumulative impacts on the environment. The draft report states that international effects associated with imported biofuels are even more uncertain than national effects but are likely modest as well given the relatively small quantity of imports relative to domestic biofuel production since the RFS Program went into effect.
 
The draft report reinforces the broad conclusions from the first and second Reports to Congress on biofuels in general and further evaluates attribution of those effects to the RFS Program more specifically. According to the draft report, biofuels continue to have the potential for both positive and negative environmental effects, depending on the many factors identified in the report. The draft report notes that at the time of writing, the likely future effects of the RFS Program are highly uncertain. The first and second Reports to Congress “had the benefit of statutory biofuel volumes established by EISA as a guideline for the likely future,” but these statutory volumes ended in 2022. EPA continues to work on issuing final annual biofuel standards under the RFS Program for future years. These standards are critical to estimating accurately the likely future effects of the RFS Program. Since these final standards for future years are not yet available, they are not included in this report. The draft report notes that several other factors contribute to additional uncertainty, including ongoing recovery from the global COVID-19 pandemic, uncertainty in the penetration of E15 in the marketplace, competition with other technologies such as electric vehicles, and continued but slow growth of cellulosic ethanol production from agricultural or marginal lands. As policy and market conditions change, so may the factors to consider and the estimate of the likely future effects of the RFS Program.
 
EPA states that it is releasing the draft document to seek review by a contractor-led peer review panel. EPA will post the external peer review panel, peer review meeting dates, and registration information on its website. Comments on the draft report are due March 6, 2023.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 27, 2022, that it is extending the deadline for applications from managers of standards development organizations, ecolabel programs, and other similar organizations for assessment and inclusion in the Environmentally Preferable Purchasing (EPP) program’s Recommendations of Specifications, Standards and Ecolabels for Federal Purchasing, a resource intended to help federal purchasers identify and procure environmentally preferable products and services. To apply to have a standard or ecolabel included in the Recommendations, applicants must submit responses to the scoping questions to .(JavaScript must be enabled to view this email address) by January 24, 2023. EPA notes that responses to the scoping questions may be high level and do not need to include detailed information or justifications. EPA will use the responses to determine the applicant's eligibility and scope of assessment. EPA states that it will review applications by product categories. In spring 2023, EPA will announce the order in which product categories will be assessed. In fall 2023, EPA will notify the first round of applicants of the results of its assessment. More information on the new process to expand the Recommendations is available in our November 7, 2022, blog item.

By Lynn L. Bergeson and Carla N. Hutton
 
On December 20, 2022, the Federal Trade Commission (FTC) requested public comment on its Guides for the Use of Environmental Claims (Green Guides). FTC intends the Green Guides to help marketers avoid making environmental marketing claims that are unfair or deceptive under Section 5 of the FTC Act. 87 Fed. Reg. 77766. FTC states in its December 14, 2022, news release that it seeks to update the Green Guides “based on increasing consumer interest in buying environmentally friendly products.” As noted in our December 16, 2022, memorandum, publication of the notice in the Federal Register began a 60-day comment period. Comments are due February 21, 2023.
 
FTC states that it expects “many public comments” on the following specific issues:

• Carbon Offsets and Climate Change: The current Green Guides provide guidance on carbon offset and renewable energy claims. FTC invites comments on whether the revised Green Guides should provide additional information on related claims and issues;
   
• The Term “Recyclable”: Among other things, FTC seeks comments on whether it should change the current threshold that guides marketers on when they can make unqualified recyclable claims, as well as whether the Green Guides should address in more detail claims for products that are collected (picked up curbside) by recycling programs but not ultimately recycled;
   
• The Term “Recycled Content”: FTC requests comments on whether unqualified claims about recycled content -- particularly claims related to “pre-consumer” and “post industrial” content -- are widely understood by consumers, as well as whether alternative methods of substantiating recycled content claims may be appropriate; and
   
• The Need for Additional Guidance: FTC also seeks comment on the need for additional guidance regarding claims such as “compostable,” “degradable,” ozone-friendly,” “organic,” and “sustainable,” as well as those regarding energy use and energy efficiency.

More information and an insightful commentary are available in our December 16, 2022, memorandum.

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative (NBBI) to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. On December 20, 2022, the White House Office of Science and Technology Policy (OSTP) published two requests for information (RFI) related to the NBBI. In the first one, OSTP, on behalf of the primary agencies that regulate the products of biotechnology -- the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) -- requests relevant data and information, including case studies, that may assist in identifying any regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology, particularly with regard to new and emerging biotechnology products. 87 Fed. Reg. 77900. According to the RFI, the information provided will inform regulatory agency efforts to improve the clarity and efficiency of the regulatory processes for biotechnology products. The RFI includes the following questions:

1. Describe any ambiguities, gaps, inefficiencies, or uncertainties regarding statutory authorities and/or agency roles, responsibilities, or processes for different biotechnology product types, particularly for product types within the responsibility of multiple agencies.
    
   1. Describe the impact, including economic impact, of these ambiguities, gaps, inefficiencies, or uncertainties.
       
2. Provide any relevant data or information, including case studies, that could inform improvement in the clarity or efficiency (including the predictability, transparency, and coordination) of the regulatory system and processes for biotechnology products.
    
3. Describe any specific topics the agencies should address in plain language on the regulatory roles, responsibilities, and processes of the agencies.
    
4. Describe any specific issues the agencies should consider in developing a plan to implement regulatory reform, including any updated or new regulations or guidance documents.

5. Describe any new or emerging biotechnology products (e.g., microbial amendments to promote plant growth; food plants expressing non-food substances or allergens from non-plant sources) that, based on lessons learned from past experiences or other information, the agencies should pay particular attention to in their evaluation of ambiguities, gaps, or uncertainties regarding statutory authorities and/or agency roles or processes.

6. Describe any new or emerging categories of biotechnology products on the horizon that the regulatory system and processes for biotechnology products should be preparing to address. Describe any specific recommendations for regulating these new or emerging categories of biotechnology products to guide agency preparations.

7. What is the highest priority issue for the agencies to address in the short term (i.e., within the next year) and in the long term.

OSTP, EPA, FDA, and USDA will host a virtual public listening session on January 12, 2023. The virtual listening session will allow OSTP, EPA, FDA, and USDA to hear, firsthand, from stakeholders who wish to provide feedback on any of the seven questions outlined in the RFI. Comments are due on or before 5 p.m. (EST) February 3, 2023. More information on the Coordinated Framework for the Regulation of Biotechnology is available in our January 9, 2017, memorandum.
 
The second RFI seeks public input on how advances in biotechnology and biomanufacturing can help achieve goals that were previously out of reach and what steps can be taken to provide the right research ecosystem, workforce, data, domestic biomanufacturing capacity, and other components to support a strong bioeconomy. 87 Fed. Reg. 77901. OSTP invites input from interested stakeholders, including industry and industry association groups; academic researchers and policy analysts; civil society and advocacy groups; individuals and organizations that work on biotechnology, biomanufacturing, or related topics; and members of the public. OSTP seeks responses to one, some, or all of the following questions:

Harnessing Biotechnology and Biomanufacturing Research and Development (R&D) to Further Societal Goals

1. For any of the four categories outlined above (health, climate and energy, food and agriculture, and supply chain resilience):
    
   1. What specific bold goals can be achieved through advances in biotechnology and biomanufacturing in the short term (five years) and long term (20 years)? In your answers, please suggest quantitative goals, along with a description of the potential impact of achieving a goal. Listed below are illustrative examples of quantitative goals:
       
      1. Develop domestic bio-based routes of production, including the entire supply chain, for X percent of active pharmaceutical ingredients.
          
      2. Utilize X tons of sustainable biomass annually as input to biomanufacturing processes to displace Y percent of U.S. petroleum consumption.
         ​
   2. What R&D is needed to achieve the bold goals outlined in (a), with a focus on cross-cutting or innovative advances? How would the government support this R&D, including through existing federal programs, creation of new areas of R&D, and/or development of new mechanisms?
       
   3. How else can the government engage with and incentivize the private sector and other organizations to achieve the goals outlined in (a)?
       
2. Public engagement and acceptance are of critical importance for successful implementation of biotechnology solutions for societal challenges. How might social, behavioral, and economic sciences contribute to understanding possible paths to success and any hurdles? What public engagement and participatory models have shown promise for increasing trust and understanding of biotechnology?

Data for the Bioeconomy

3. What data types and sources, to include genomic and multiomic information, are most critical to drive advances in health, climate, energy, food, agriculture, and biomanufacturing, as well as other bioeconomy-related R&D? What data gaps currently exist?

4. How can the federal government, in partnership with private, academic, and non-profit sectors, support a data ecosystem to drive breakthroughs for the U.S. bioeconomy? This may include technologies, software, and policies needed for data to remain high-quality, interoperable, accessible, secure, and understandable across multiple stakeholder groups.

Building a Vibrant Domestic Biomanufacturing Ecosystem

5. What is the current state of U.S. and global biomanufacturing capacity for health and industrial sectors, and what are the limits of current practice?

6. What can the federal government do to expand and scale domestic biomanufacturing capacity and infrastructure? What level of investment would be meaningful, and what incentive structures could be employed?

7. What are barriers that must be addressed to enable better domestic supply chains for biomanufacturing (e.g., feedstocks, reagents, consumables)?

8. How can the federal government partner with state and local governments to expand domestic biomanufacturing capacity, with a particular focus on underserved communities?

Biobased Products Procurement

9. What are new, environmentally sustainable biobased products that the federal government could purchase through its BioPreferred Program? How can the federal government incentivize development of new categories of sustainable biobased products?

   Biotechnology and Biomanufacturing Workforce

10. How can the U.S. strengthen and expand the biotechnology and biomanufacturing workforce to meet the needs of industry today and in the future? What role can government play at the local, state, and/or federal level?

11. What strategies and program models have shown promise for successfully diversifying access to biomanufacturing and biotechnology jobs -- including those involving Historically Black Colleges and Universities (HBCU), Tribal Colleges and Universities, and other Minority Serving Institutions? What factors have stymied progress in broadening participation in this workforce?

Reducing Risk by Advancing Biosafety and Biosecurity

12. What can the federal government do to support applied biosafety research and biosecurity innovation to reduce risk while maximizing benefit throughout the biotechnology and biomanufacturing life cycles?
     
13. How can federal agencies that fund, conduct, or sponsor life sciences research incentivize and enhance biosafety and biosecurity practices throughout the United States and international research enterprises?

 Measuring the Bioeconomy

14. What quantitative indicators, economic or otherwise, are currently used to measure the contributions of the U.S. bioeconomy? Are there new indicators that should be developed?

15. How should the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS) be revised to enable characterization of the economic value of the U.S. bioeconomy? Specifically, which codes or categories do not distinguish between functionally identical biobased and fossil fuel-based commodities?

International Engagement

16. What are opportunities for the U.S. government to advance R&D, a skilled workforce, regulatory cooperation, and data sharing for the bioeconomy through international cooperation? Which partnerships and fora are likely keys to advance these priority areas?
     
17. What risks are associated with international biotechnology development and use, and how can the U.S. government work with allies and partners to mitigate these risks?

Comments are due on or before 5:00 p.m. (EST) on January 20, 2023.

By Lynn L. Bergeson and Carla N. Hutton
 
On December 1, 2022, the U.S. Environmental Protection Agency (EPA) announced a multi-part proposal that will build on the Renewable Fuel Standard (RFS) program and seek to advance the priorities of energy security, less pollution, and consumer protection. The RFS “Set” proposal requests public input on required volumes of biofuel for the next one to three years and on a series of modifications intended to strengthen and expand the program. EPA states that this proposal includes steady growth of biofuels for use in the nation’s fuel supply for 2023, 2024, and 2025. EPA notes that because the Energy Independence and Security Act of 2007 (EISA) does not include volumes after 2022, this is the first time that EPA is setting these proposed biofuel volume targets without using those outlined in statute. According to EPA, when setting biofuel volumes for years after 2022, EPA must consider a variety of factors specified in the statute, including costs, air quality, climate change, implementation of the program to date, energy security, infrastructure issues, commodity prices, and water quality and supply.
 
EPA is seeking comment on the proposed volumes and how to balance appropriately these factors so that the program works for renewable fuel growers and producers, refiners and the union workers who operate these facilities, and fuel consumers. According to EPA, because the rule is an opportunity to take a “fresh look” at many aspects of the program, EPA is also seeking comment on how the rule can intersect with continued viability of domestic oil refining assets, including merchant refineries, how best to support novel fuels like sustainable aviation fuels and clean hydrogen, and how to account for the new and updated incentives in the Inflation Reduction Act.
 
EPA will also propose new regulations governing the generation of qualifying renewable electricity made from renewable biomass that is used for transportation fuel in electric vehicles. EPA seeks comment on this new component of the RFS program that would tie electricity generation from renewable biomass into the program for the first time. EPA has posted a pre-publication version of the proposed rule. Comments on the proposed rule are due February 10, 2023.
 
EPA will hold a virtual public hearing on January 10, 2023, on its proposed rule. 87 Fed. Reg. 76194. If necessary, EPA will hold an additional session on January 11, 2023. EPA asks that all attendees register by January 3, 2023.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy (DOE) Bioenergy Technologies Office (BETO) has postponed the webinar originally scheduled for December 13, 2022, on the “SAF Grand Challenge Roadmap: Soaring Towards Sustainable Fuel Production Goals.” According to BETO, the webinar will take place in early 2023. As reported in our November 29, 2022, blog item, the webinar will cover the six action areas that support the Grand Challenge’s goals of:

• Reducing life cycle greenhouse gas emissions (GHG) by 50 percent compared to conventional fuel;
• Producing enough sustainable aviation fuels (SAF) to meet 100 percent of aviation fuel demand by 2050; and
• Enhancing fuel sustainability.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy (DOE) Bioenergy Technologies Office’s (BETO) Chemical Catalysis for Bioenergy Consortium (ChemCatBio) will hold a webinar on December 14, 2022, on what is ahead for the consortium. From 2020 to 2022, ChemCatBio’s research and development (R&D) focus was on improving carbon efficiency during catalytic conversion to drive down minimum fuel selling price. ChemCatBio states that now, with three more years of funding, it aims to develop and advance biomass and waste conversion technologies for hard-to-decarbonize fuels and chemicals to achieve greater than 70 percent greenhouse gas (GHG) emissions reduction, and to provide foundational knowledge to address risks associated with catalyst/process durability and carbon efficiency. During the webinar, ChemCatBio Deputy Director Dan Ruddy will share highlights from the last three years of consortium R&D. He will then present plans for the next three years, focusing on process integration and fuel production with engineered catalysts.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 7, 2022, that the final video recording, slide deck, and case study worksheets from the CompTox Chemicals Dashboard virtual training are now available. EPA also announced that the Dashboard recently released a new version (v2.1.1). New features include:

• A new link to an updated set of Help Pages containing new information;
• Ability to visualize structures in Batch Search;
• Ability to filter out chemicals that are structures;
• Moving the chemistry-related data tabs under a single tab;
• reCAPTCHA implementation to ensure continued functionality;
• Updating the Production Volume data;
• Updating the ADME > IVIVE table using the latest HTTK R-package v2.2.1 algorithm; and
• Several bug fixes.

EPA suggests that if users do not see these updates to try clearing the cache.

The recordings and slides from the October 12-13, 2022, EPA New Approach Methods (NAM) Conference are available on the conference web page. Conference topics included:

• Variability and Relevance of Traditional Toxicity Tests;
• Evolution of Validation and Scientific Confidence Frameworks to Incorporate 21st Century Science; and
• Breakout groups discussing Variability of Traditional Toxicity Tests, Relevance of Traditional Toxicity Tests, and Feedback on EPA Scientific Confidence Framework.

By Lynn L. Bergeson and Carla N. Hutton
 
Under the Reports Consolidation Act of 2000, each agency’s inspector general must prepare an annual statement summarizing what the inspector general considers to be “the most serious management and performance challenges facing the agency” and to assess briefly the agency’s progress in addressing those challenges. On November 29, 2022, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released its report regarding EPA’s fiscal year (FY) 2023 top management challenges. According to the report, the eight top management challenges for EPA in FY 2023 include:

• Providing for the Safe Use of Chemicals: The public must be able to depend on the EPA’s ability to conduct credible and timely assessments of the risks posed by pesticides, toxic chemicals, and other environmental chemicals.

OIG states in its full report that an audit of the Toxic Substances Control Act’s (TSCA) New Chemicals Review Process is currently ongoing as part of its FY 2022 Oversight Plan. According to OIG, the objective of that review is to determine the extent to which EPA is using and complying with applicable records-management and quality-assurance requirements and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks.
 
OIG concludes that many of the Biden Administration’s top priorities rely on the work of the Office of Chemical Safety and Pollution Prevention (OCSPP). Both EPA OIG and EPA have noted that key OCSPP programs face a steep staffing shortage and a lack of planning that could negatively impact critical chemical work, however. Absent the resources OCSPP needs for its TSCA programs, EPA “will remain challenged with meeting its statutory deadlines.” OIG states that if OCSPP is unable to balance the workload with its resource needs, EPA “will continue to face the key challenge of ensuring the safety of chemicals.”

 By Lynn L. Bergeson and Carla N. Hutton
 
On November 30, 2022, the U.S. Department of Agriculture’s (USDA) Agricultural Research Service (ARS) announced that its scientists have determined that plants could be used to produce nanobodies that quickly block emerging pathogens in human medicine and agriculture. The nanobodies are small antibody proteins naturally produced in specific animals like camels, alpacas, and llamas. ARS researchers evaluated nanobodies to prevent and treat citrus greening disease in citrus trees. The scientists are now using their newly developed and patented Symbiont^TM technology to show that nanobodies can be easily produced in a plant system with broad agricultural and public health applications. According to ARS, as a proof-of-concept, researchers showed that nanobodies targeting the SARS-CoV-2 virus could be made in plant cells and remain functional in blocking the binding of the SARS-CoV-2 spike protein to its receptor protein: the process responsible for initiating viral infection in human cells.
 
AgroSource, Inc. collaborated with ARS to develop the plant-based production system. According to ARS, they are currently taking the necessary steps to see how they can move this advancement into the commercial sector. ARS notes that this research collaboration is in response to the White House’s Executive Order on advancing biotechnology and biomanufacturing innovation for a sustainable, safe, and secure American bioeconomy.

By Lynn L. Bergeson and Carla N. Hutton
 
EuropaBio announced on November 14, 2022, a new cross-sectoral Biomanufacturing Platform. EuropaBio states that the Platform has the mission to represent biomanufacturing at the highest policy levels in Europe and to ensure that it is visible and recognized within the industrial strategy and Europe’s green and digital transitions. The Platform will address the policy and wider frameworks through which biomanufacturing is delivered. EuropaBio states that together with members and stakeholders, the Platform will address how economic growth, employment, and resilience are achieved through policy, legal frameworks, and regulation at the European Union (EU) and national levels. Platform activities will build an economic evidence base for biomanufacture across sectors; reflect policy priorities from EuropaBio’s Healthcare, Industrial Biotechnology, and National Association Councils; and build case studies to demonstrate diversity and impact of biomanufacture.
 
The Biomanufacturing Platform will host its first policy summit on March 15, 2023, in Brussels. The summit will set the vision for Europe’s global innovation, competitiveness, and sustainability through the lens of biomanufacturing and set a baseline for its understanding and recognition within policy.

By Lynn L. Bergeson and Carla N. Hutton
 
Research in the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) is organized around six highly integrated and transdisciplinary national research programs that are closely aligned with EPA’s strategic goals and cross-EPA strategies. Each program is guided by a Strategic Research Action Plan (StRAP) developed by EPA with input from its many internal and external partners and stakeholders. In October 2022, EPA published six StRAPs for fiscal years (FY) 2023-2026. EPA states that the StRAP for Chemical Safety for Sustainability (CSS) “is focused on addressing the pressing environmental and health challenge of a lack of sufficient information on chemicals needed to make informed, risk-based decisions.” The StRAP for CSS states that CSS will continue to:

• Develop the science needed to reduce, refine, and replace vertebrate animal testing consistent with EPA policies;
• Accelerate the pace of chemical assessment to enable our partners to make informed and timely decisions concerning the potential impacts of environmental chemicals on human health and the environment; and
• Provide leadership to transform chemical testing, screening, prioritization, and risk assessment practices.

Topic 1, Chemical Evaluation, includes three research areas, including emerging materials and technologies. The StRAP states that emerging materials and technologies often have unique physicochemical properties, warranting specialized approaches for evaluating hazard and exposure, and necessitating an evaluation of the environmental impacts of their use. In addition, investigation of novel products of synthetic biology, genome editing, and metabolic engineering is needed to support risk assessment of emerging biotechnology products. The emerging materials and technologies research area will develop, collate, mine, and apply information on emerging materials and technologies to support risk-based decisions, including potential impacts of disproportionately affected populations. It will address the additional data needed to characterize potential release of and exposure to these chemicals and materials, and subsequent environmental impacts of emerging materials on humans and ecological species. The research area will also address relevant cross-cutting priorities related to cumulative impacts and environmental justice potentially associated with incidental exposures.

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) will hold a webinar on December 6, 2022, to provide an overview to stakeholders about its November 16, 2022, supplemental proposed rule modifying and adjusting certain aspects of the fees rule established under the Toxic Substances Control Act (TSCA). EPA states that it is publishing these changes to ensure that collected fees provide it with 25 percent of authorized TSCA costs consistent with direction in the fiscal year 2022 appropriations bill to consider the “full” implementation costs of the law. According to EPA, updating TSCA fees will strengthen its ability to implement successfully TSCA in a way that is both protective and sustainable and significantly improve on-time performance and quality. The webinar will provide stakeholders an opportunity to provide comment to EPA on the supplemental proposed rule. Registration for the webinar is open. Stakeholders who wish to provide oral comments during the webinar are asked to register by December 1, 2022. Comments on the supplemental proposed rule are due January 17, 2023. More information on the supplemental proposed rule is available in our November 18, 2022, memorandum.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 10, 2022, that it is requesting nominations of prospective candidates for membership on the Science Advisory Committee on Chemicals (SACC) established under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 67898. Any interested person or organization may nominate qualified persons to be considered for appointment to the SACC. Individuals may also self-nominate. Nominations are due December 12, 2022.
 
SACC serves as a scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). According to EPA, SACC provides independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA. Currently, there are 17 SACC members, with eight membership terms that will expire over the next year.
 
EPA states that its “rigorous scientific peer review processes ensure all Agency decisions are founded on credible science and data. Science provides the foundation for EPA policies, actions and decisions made on behalf of the American people.”
 
To be considered, all nominations should include the following information:

• Current contact information for the nominee (including the nominee’s name, organization, current business address, e-mail address, and daytime telephone number);
• The nominee’s disciplinary and specific areas of expertise;
• Research activities;
• Recent service on other federal advisory committees and national or international professional organizations; and
• When available, a biographical sketch of the nominee, indicating current position and educational background.

EPA states that it is seeking nominations from individuals who have demonstrated high levels of competence, knowledge, and expertise in scientific and other technical fields relevant to chemical safety and risk assessment. EPA seeks nominees with expertise in a variety of disciplines and focus areas, including human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically based pharmacokinetics (PBPK), toxicology and pathology (including neurotoxicology, developmental/reproductive toxicology, and carcinogenesis), and chemical exposure pathways to susceptible life stages and subpopulations (women, children, and other potentially exposed subpopulations).
 
EPA states that nominees should have backgrounds and experiences that would contribute to the diversity of scientific viewpoints on the committee -- including professional experiences in government, labor, public health, public interest, animal protection, industry, and other groups -- and as the EPA Administrator determines to be advisable (e.g., geographical location; social and cultural backgrounds; and professional affiliations).