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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has opened registration for the second ECOTOXicology Knowledgebase (ECOTOX) virtual training on February 7, 2023. ECOTOX is a comprehensive, publicly available tool providing environmental toxicity data on aquatic life, terrestrial plants, and wildlife.  EPA states that the virtual training, which is specifically targeted for decision-makers, will provide:

  • An overview of the database content and function;
     
  • Application-oriented use case demonstrations; and
     
  • Opportunities for participatory learning and engagement.

According to EPA, the virtual training will be a live encore of the training offered in May 2022, presenting the same material and featuring expanded opportunity for live interaction in Session 2. Participants may register for one or both sessions; registration is free but required to attend each session.
 
Session 1 (Presentation and Questions and Answers (Q&A))
11:00 a.m.-12:30 p.m. (EST)
This session will provide an overview of the knowledgebase content and function with opportunities for participation and Q&A.
 
Session 2 (Breakout Sessions)
12:30-1:30 p.m. (EST)
This session will break participants into breakout groups to work on case study exercises in small groups, aided by facilitators.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On January 12, 2023, the White House Office of Science and Technology Policy (OSTP) announced the release of A Framework for Federal Scientific Integrity Policy and Practice, “a roadmap that will help strengthen scientific integrity policies and practices across the federal government.” The framework builds on the assessment of federal scientific integrity policies and practices described in the January 2022 report, Protecting the Integrity of Government Science, and draws from extensive input from federal agencies, as well as from across sectors, including academia, the scientific community, public interest groups, and industry. According to OSTP, the framework has several key components that federal departments and agencies will use to improve scientific integrity policies and practices, including:

  • A consistent definition of scientific integrity for all federal agencies;
  • A model scientific integrity policy to guide agencies as they build and update their policies; and
  • A set of tools to help agencies regularly assess and improve their policies and practices.

The framework requires all agencies to designate a Scientific Integrity Official (SIO) and agencies that fund, conduct, or oversee research to designate a Chief Science Officer (CSO), and it establishes the National Science and Technology Council (NSTC) Subcommittee on Scientific Integrity to oversee implementation of the framework and evaluate agency progress. Agencies are directed to adopt the following timeline:

  • Within 60 days from public posting of the framework: Agencies should submit new or updated agency and department draft scientific integrity policies for review by OSTP and the Subcommittee via the mailbox .(JavaScript must be enabled to view this email address);
  • Within 120 days from public posting of the framework: OSTP and the Subcommittee will complete the reviews using the framework’s critical policy features for assessment;
  • Within 180 days after public posting of the framework: Each agency should provide an opportunity for public input on its scientific integrity policies and practices, such as through a listening session or request for comment on its draft policy;
  • Within 270 days from public posting of the framework: Final policies are due to OSTP. OSTP will compile and make public all agency policies, as well as all agencies’ designated CSOs and SIOs on a federal web page;
  • Within 360 days from public posting of the framework and every two years thereafter: All agencies report to OSTP on their progress toward implementing the Framework; and
  • For calendar year 2023 and annually thereafter: Each agency should publish, consistent with any requirements related to national security and privacy as well as any other applicable law, an annual report on the agency’s website.

 

 By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on January 12, 2023, that it is updating the Safer Chemical Ingredients List (SCIL), “a living list of chemicals organized by functional-use class that EPA’s Safer Choice program has evaluated and determined meet Safer Choice criteria.” EPA is adding nine chemicals to the SCIL. EPA states that to expand the number of chemicals and functional-use categories on the SCIL, it encourages manufacturers to submit their safer chemicals for review and listing on the SCIL. In support of the Biden Administration’s goals, the addition of chemicals to the SCIL “incentivizes further innovation in safer chemistry, which can promote environmental justice, bolster resilience to the impacts of climate change, and improve water quality.” According to EPA, chemicals on the SCIL “are among the safest for their functional use.”
 
EPA changed the status for one chemical (1-octanesulfonic acid, 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-) that has recently been identified on the SCIL as a per- or polyfluoroalkyl substance (PFAS). According to EPA, the chemical is not used in any Safer Choice-certified products. It was added to the SCIL in 2012 based on the data available and the state of EPA’s knowledge at the time. EPA has now updated the SCIL listing for this chemical to a grey square because of a growing understanding of the toxicological profiles for certain PFAS and incomplete information on the potential health and environmental effects of these substances. A grey square notation means that the chemical may not be allowed for use in products that are candidates for the Safer Choice label, and any current Safer Choice-certified products that contain this chemical must be reformulated unless relevant health and safety data are provided to justify continuing to list this chemical on the SCIL. EPA will determine the data required on a case-by-case basis. According to EPA, in general, data useful for making such a determination would provide evidence of low concern for human health and environmental impacts. Unless information provided to EPA adequately justifies continued listing, EPA will remove the chemical from the SCIL 12 months after the grey square designation.
 
EPA states that after this update, there are 1,064 chemicals listed on the SCIL. The SCIL is a resource that can help many different stakeholders:

  • Product manufacturers use the SCIL to help make high-functioning products that contain safer ingredients;
  • Chemical manufacturers use this list to promote the safer chemicals they manufacture;
  • Retailers use the list to help shape their sustainability programs; and
  • Environmental and health advocates use the list to support their work with industry to encourage the use of the safest possible chemistry.

EPA’s Safer Choice program certifies products containing ingredients that have met the program’s rigorous human health and environmental safety criteria. The Safer Choice program allows companies to use its label on products that meet the Safer Choice Standard. The EPA website contains a complete list of Safer Choice-certified products.


 

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.

Tags: RFS, GHG, Biofuel, BBD

 

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
 
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
 
On November 1, 2022, the U.S. Environmental Protection Agency (EPA) announced 26 Safer Choice Partner of the Year award winners, recognizing their achievements in the design, manufacture, selection, and use of products with safer chemicals. The awardees represent a wide variety of organizations, including small- and medium-sized businesses, women-owned companies, state and local governments, non-governmental organizations, and trade associations.
 
EPA encouraged applicants for the 2022 awards to show how their work advances environmental justice, bolsters resilience to the impacts of climate change, results in cleaner air or water, or improves drinking water quality. According to EPA, many of the organizations being recognized are working to reduce greenhouse gas (GHG) emissions and combat the climate crisis. For example, several winners offer products with concentrated formulas that reduce water consumption and plastic use. This practice also lowers GHG emissions by reducing the amount of product that must be transported.
 
EPA states that additionally, many awardees increased access to products with safer chemical ingredients in underserved and overburdened communities. For example, one nonprofit winner conducted targeted outreach in both English and Spanish to promote safer cleaning techniques and products, including Safer Choice-certified products, in food trucks. Many of these businesses are owned and operated by immigrant entrepreneurs. Another winner made its Safer Choice-certified product line more accessible to lower income shoppers by offering affordable prices and making these products available at retailers that often serve low-income communities.
 
In early 2023, EPA intends to build on this work by announcing a grant opportunity for projects that can increase supply and demand for safer, environmentally preferable products such as those certified by the Safer Choice program or identified by EPA’s Environmentally Preferable Purchasing program.
 
The 2022 winners include:

  • American Cleaning Institute, District of Columbia;
  • The Ashkin Group, LLC, Channel Islands Harbor, California;
  • Bona US, Englewood, Colorado;
  • Case Medical, Bloomfield, New Jersey;
  • Church & Dwight Co., Inc., Ewing, New Jersey;
  • Clean Safety & Health in Food Trucks (CleanSHiFT) Team, Seattle, Washington;
  • The Clorox Company, Oakland, California;
  • Colgate-Palmolive, New York, New York;
  • Design for the Environment Logo Redesign Coalition: Environmental Defense Fund, The Natural Resources Defense Council, The Clorox Company, The Procter & Gamble Company, and Reckitt;
  • Dirty Labs Inc., Portland, Oregon;
  • ECOS, Cypress, California;
  • Grove Collaborative, San Francisco, California;
  • The Hazardous Waste Management Program, Seattle, Washington;
  • Holloway House, Inc., Fortville, Indiana;
  • The Home Depot, Atlanta, Georgia;
  • Household & Commercial Products Association, District of Columbia;
  • Jelmar, LLC, Skokie, Illinois;
  • Lemi Shine, Austin, Texas;
  • LightHouse for the Blind and Visually Impaired, San Francisco, California;
  • Mother Africa, Kent, Washington;
  • Novozymes North America, Raleigh, North Carolina;
  • The ODP Corporation, Boca Raton, Florida;
  • The Procter & Gamble Company, Cincinnati, Ohio;
  • PurposeBuilt Brands, Gurnee, Illinois;
  • Sensitive Home, Greenbrae, California; and
  • Solutex, Sterling, Virginia.

 

By Lynn L. Bergeson and Carla N. Hutton

Come learn about the 2023 Green Chemistry Challenge Awards program and the nomination process. This year the program will recognize winners in six categories, including: Greener Synthetic Pathways; Greener Reaction Conditions; The Design of Greener Chemicals; Specific Environmental Benefit: Climate Change; Small Business; and Academic.

Registration is open.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that registration was open for the 2022 Conference on the State of the Science on Development and Use of New Approach Methods (NAM) for Chemical Safety Testing. EPA notes that there will be limited availability in person at EPA headquarters in Washington, DC, on October 12-13, 2022, and a virtual option will also be available. Conference topics include:

  • 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.

EPA asks that attendees register for the NAMs conference before October 7, 2022.
 
On October 18, 2022, EPA will provide training on the Computational Toxicology (CompTox) Chemicals Dashboard, which is part of a suite of databases and web applications developed by EPA to support the development of innovative methods to evaluate chemicals for potential health risks. The computational toxicology tools and data in the Dashboard help prioritize chemicals based on potential health risks. Specifically targeted for decision-makers, the training will provide:

  • An overview of the Dashboard content and function;
  • Application-oriented use-case demonstrations in the areas of general use, hazard/bioactivity, exposure/absorption, distribution, metabolism, and excretion (ADME)-in vitro to in vivo extrapolation (IVIVE), and chemistry; and
  • Opportunities for participatory learning and engagement.

The training will offer information about the latest release of the Dashboard and how it can be used to gather actionable information about chemical properties and risks through case examples, demonstrations, and hands-on exercises. Registration is now open (attendees must register for the training portions individually):


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 22, 2022, that as part of its commitment to re-evaluate policies and practices under the Toxic Substances Control Act (TSCA) New Chemicals Program to ensure they adhere to statutory requirements and the Biden Administration’s executive orders and directives, it has updated its policy to discontinue the use of exposure modeling thresholds when assessing the health and environmental risks of new chemicals under TSCA. According to EPA, due in part to the automation of modeling, it has become less burdensome to complete these calculations. Furthermore, according to EPA, removing the thresholds supports President Biden’s Executive Order 13985, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,” which calls on federal agencies to advance equity, including by reviewing and revising as needed government policies and programs impacting underserved communities.
 
The New Chemicals Program will implement this change by making minimal changes to the coding in the New Chemical Review application to remove the thresholds and will update standard operating procedures and training materials for exposure and human health risk assessors. EPA states that it will implement this policy change “as soon as feasible.” According to EPA, despite the resource challenges it is currently facing in the TSCA program, it anticipates that the change “will have minimal impact on the amount of time it takes to complete new chemical reviews and that the benefits gained from a more comprehensive accounting of all potential air and water releases will help ensure any needed protections are in place before a new chemical can come to market.”
 
More information and a detailed commentary that discusses thresholds of toxicological concern (TTC) are available in our August 22, 2022, memorandum.


 
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