Posted on April 11, 2023 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) will hold training on May 23, 2023, on Generalized Read-Across (GenRA), a publicly available tool that uses an automated approach to make reproducible read-across predictions of toxicity. EPA states that read-across “is a commonly used data gap filling technique whereby endpoint information for one substance is used to predict the same endpoint for another substance, supported by structural or other feature similarities.” According to EPA, while read-across sometimes relies on subjective or expert judgement, use of the GenRA tool could provide more objective and reproducible read-across predictions. Specifically targeted for decision-makers, this training will provide:
- A presentation overview of GenRA’s purpose and scope;
- A demonstration of GenRA’s interface and navigation; and
- Opportunities for participatory learning and engagement.
The virtual training will feature EPA’s Dr. Grace Patlewicz. The training will include a plenary presentation, small group discussions, and a chance to try out GenRA. EPA has divided the training into two parts to accommodate a variety of interests and schedules. Registration for one or both sessions is free but required.
This session will provide an overview of GenRA content and function with opportunities for participation and Q&A.
This session will break participants into breakout rooms to work on exercises in small groups, aided by facilitators.
Posted on March 29, 2023 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
On March 27, 2023, the U.S. Environmental Protection Agency (EPA) announced that its Safer Choice program is accepting submissions for its 2023 Safer Choice Partner of the Year Awards. 88 Fed. Reg. 18135. The Safer Choice program certifies products containing ingredients that have met the program’s specific and rigorous human health and environmental toxicological criteria. According to EPA, the Safer Choice program allows companies to use its label on certified products that contain safer ingredients and perform, as determined by expert evaluation. EPA states that it developed the Partner of the Year Awards to recognize the leadership contributions of Safer Choice partners and stakeholders who have shown achievement in the design, manufacture, selection, and use of products with safer chemicals that further outstanding or innovative source reduction.
Similar achievement in the design, manufacture, selection, and use of Design for the Environment (DfE)-certified products will also make an organization eligible for the Partner of the Year Awards. The DfE program is a companion program to Safer Choice and certifies antimicrobial products. EPA states that the DfE logo may be used on certified products and helps consumers and commercial buyers identify products that meet the health and safety standards of the pesticide registration process required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as well as the Safer Choice program’s stringent criteria for efficacy and effects on human health and the environment.
All Safer Choice stakeholders and program participants in good standing are eligible for recognition. Interested parties who would like to be considered for the award should submit to EPA an application detailing their accomplishments and contributions during calendar year 2022. EPA “especially encourages submission of award applications that show how the applicant’s work in the design, manufacture, selection, and use of those products promotes environmental justice, bolsters resilience to the impacts of climate change, results in cleaner air or water, improves drinking water quality, or advances innovation in packaging.” Submissions are due May 31, 2023. EPA will recognize award winners at a Safer Choice Partner of the Year Awards ceremony in fall 2023. More information on the 2023 Safer Choice Partner of the Year Awards, including the application form, submission process, and past winners, is available on EPA’s website.
Posted on January 12, 2023 by Lynn L Bergeson 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.
Posted on December 07, 2022 by Lynn L BergesonBy 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.
Posted on December 01, 2022 by Lynn L BergesonBy 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.
Posted on November 04, 2022 by Lynn L BergesonBy 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.
Posted on August 22, 2022 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on August 18, 2022, that it is accepting nominations for the 2023 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. The awards again include a category to recognize technology that reduces or eliminates greenhouse gas (GHG) emissions. EPA will hold a webinar on September 28, 2022, from 2:00 to 3:30 p.m. (EDT) to educate stakeholders on the Green Chemistry Challenge Awards and the nomination process. Registration for the webinar is open. Nominations are due to EPA by December 9, 2022.
EPA states that green chemistry is the design of chemical products and processes that reduce or eliminate the generation and use of chemicals that are hazardous to the environment and people’s health. According to EPA, its efforts to “speed the adoption of this revolutionary and diverse discipline” have led to significant environmental benefits, innovation, and a strengthened economy. Green chemistry aims to prevent pollution before it is created, making it the preferred approach for providing solutions to some of the most significant environmental challenges.
An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2023 nominations and make recommendations to EPA for the 2023 winners. EPA anticipates giving awards to outstanding green chemistry technologies in six categories in fall 2023.
Posted on August 08, 2022 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on August 1, 2022, a 15-day public comment period on two additional peer review candidates for the external peer review of the Biofuels and the Environment: Third Triennial Report to Congress (RtC3). 87 Fed. Reg. 46958. EPA previously requested comment on an initial pool of 20 candidates announced in a May 9, 2022, Federal Register notice. EPA states that after considering public comments and the balance and collective expertise of the reviewers, it asked ERG, the independent contractor organizing the peer review, to identify additional candidates to strengthen expertise gaps and allow a more balanced panel. EPA seeks public comment on additional peer review candidates to strengthen underrepresented areas of expertise, specifically economics, water quality, and ecology disciplines. According to EPA, ERG will ensure the peer reviewers’ combined expertise best spans the following disciplines: economics, engineering, agronomics, land use change, remote sensing, air quality, biogeochemistry, water quality, hydrology, conservation biology, limnology, and ecology. Comments are due August 16, 2022.
The first report to Congress (RtC1), completed in 2011, provided an assessment of the environmental and resource conservation impacts associated with increased biofuel production and use. The second report to Congress (RtC2) was completed in 2018 and reaffirmed the overarching conclusions of RtC1. RtC3 builds on the previous two reports and provides an update on the impacts to date of the RFS Program on the environment. It assesses air, water, and soil quality; ecosystem health and biodiversity; and other effects. RtC3 also includes new analyses not previously included in RtC1 and RtC2.
Posted on July 19, 2022 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, July 27, 2022, from 1:00 - 2:00 p.m. (EDT). During the webinar, EPA will provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) before taking questions from the audience. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemicals submissions under the Toxic Substances Control Act (TSCA) and common issues that cause EPA to have to rework risk assessments for these submissions.
Registration for the July 27, 2022, webinar is open. According to EPA, subsequent webinars over the coming months will communicate its considerations in evaluating qualitative claims or quantitative data, especially when they deviate from model defaults such as those used in the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER) and its considerations for evaluating information about sites not controlled by the submitter. EPA will release information about these webinars, including dates and instructions on how to register, as it becomes available.
Posted on June 16, 2022 by Lynn L BergesonBy Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On May 27, 2022, EPA announced that it is seeking nominations for technical experts to serve as Special Government Employees (SGE) to participate in the review of the New Chemicals Collaborative Research Program with the Board of Scientific Counselors (BOSC), a federal advisory committee to the Office of Research and Development (ORD). EPA will consider nominees from industry, business, public and private research institutes or organizations, academia, government (federal, state, local, and Tribal), non-governmental organizations, and other relevant interest areas. EPA notes that it values and welcomes diversity. EPA encourages all qualified candidates to apply regardless of gender, race, disability, or ethnicity. The deadline to submit nominations is June 30, 2022, and submissions should be made via the BOSC website. More information on EPA’s Draft Document on “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA” is available in Bergeson & Campbell, P.C.’s (B&C®) March 14, 2022, memorandum.
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