By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on September 7, 2023, that the upcoming 2023 Safer Choice Partner of the Year Awards Ceremony will be held October 2, 2023, and the Partner and Stakeholder Summit will be held October 3-4, 2023. EPA states that during the Partner of the Year Awards Ceremony, it will recognize the 2023 Safer Choice Partners of the Year “for their outstanding achievement in the design, manufacture, selection and use of products that meet the Safer Choice program’s stringent health and environment standards.” The Partner and Stakeholder Summit is a two-day meeting that will include informational sessions, panelist discussions, and networking opportunities with a focus on dialogue and developing solutions, which will help advance the Safer Choice program. Both events will be held at the Cooperative Plaza Conference Center in Arlington, Virginia, with virtual attendance options available. The events are free to attend, but registration is required. Registration is now open.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency announced on August 4, 2023, that it is providing resources to help biotechnology developers exercise the full benefits of the exemptions available under the Plant Incorporated Protectants (PIP) exemption rule. These resources are available on EPA’s public website and include the following:

• Fact sheet and background information on PIPs rule;
• Examples of genetic modifications that are exempt under the rule;
• Description of how to submit a self-determination or a request for EPA confirmation of exemption under the rule; and
• Sample documents for submitting a self-determination or request for confirmation.

The PIPs Exemption Final Rule went into effect on July 31, 2023.  More information on the final rule is available in our June 2, 2023, memorandum.

Background

On May 31, 2023, EPA released a final rule exempting two categories of PIPs created using genetic engineering from certain registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. EPA states that the rule ensures that human health and the environment are protected while reducing costs for the regulated community, consistent with the September 2022 Executive Order 14081 on Advancing Biotechnology. According to EPA, the rule may also result in increased research and development activities, commercialization of new pest control options for farmers, and reduced use of conventional pesticides.
 
EPA notes that the final rule reflects the biotechnological advances made since 2001, when it first exempted PIPs derived through conventional breeding from FIFRA registration and FFDCA tolerance requirements, but did not at that time exempt PIPs created through biotechnology. Specifically, the final rule exempts PIPs derived through genetic engineering from FIFRA registration and FFDCA tolerance requirements in cases where the PIPs are essentially equivalent to those exempted by the 2001 rule.
 
The rule contains conditions for exempting:

• PIPs in which genetic engineering has been used to insert a gene from a sexually compatible plant or to modify a gene to match a gene found in a sexually compatible plant. This category of PIPs requires EPA confirmation of eligibility for the exemption; and 
   
• Loss-of-function (LoF) PIPs, in which a gene is modified through genetic engineering to reduce or eliminate the activity of that gene. The loss of the activity of that gene then results in the pesticidal effect. EPA states that for this category of PIP, “biotechnology developers can make a self-determination that their PIP meets the exemption criteria, which requires notification but no EPA review, or request EPA confirmation of eligibility for the exemption.”

EPA notes that it indicated in the preamble to the final rule that it would consider exempting additional categories of PIPs from both FIFRA registration and FFDCA tolerance requirements and expanding the categories of PIPs that are allowed the option to self-determine and do not require EPA confirmation of eligibility for the exemption.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a two-day training on its high throughput toxicokinetic (HTTK) R package as part of its New Approach Methods (NAM) Training Program:

• Day 1: Presentation and demo: Wednesday, November 8, 2023, 10 a.m. - 12 p.m. (EST); and
• Day 2: Expert-led hands-on learning activity: Thursday, November 9, 2023, 10 a.m. - 12 p.m. (EST).

According to EPA, toxicokinetics (TK) provides a bridge between toxicity and exposure assessment by predicting tissue concentrations due to exposure. EPA notes that traditional TK methods can be resource intensive and require chemical-specific data. EPA states that its freely available HTTK R package uses data from in vitro high-throughput screening data sets, which can be used to fill data gaps in traditional TK methods.
 
EPA’s goal for the two-day training is to familiarize those engaged in chemical exposure assessment, including researchers, regulators, and health and environmental safety professionals, with EPA’s generic and open-source models and data for toxicokinetics, including reverse dosimetry and physiologically based pharmacokinetic (PBPK) modeling for internal dose calculation. The training will include an application-oriented presentation and demonstration (Day 1), as well as opportunities for participatory learning and engagement (Day 2).

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By Lynn L. Bergeson and Carla N. Hutton
 
On July 25, 2023, the U.S. Environmental Protection Agency (EPA) announced an opportunity for public input on the potential expansion of the Safer Choice and Design for the Environment (DfE) programs’ certification to new product categories. EPA notes in its July 27, 2023, Federal Register notice that Safer Choice “helps consumers, businesses, and purchasers find products that perform and contain ingredients that are safer for human health and the environment.” 88 Fed. Reg. 48463. DfE “is a similar program currently used by EPA for the purpose of helping consumers and commercial buyers identify antimicrobial products that meet the health and safety standards of the normal pesticide registration process required by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA),” as well as other rigorous criteria required by EPA. EPA will hold a listening session webinar on August 29, 2023, and request stakeholder comment on which new product categories Safer Choice and DfE could expand into and how the potential expansion could offer significant benefits to human health and the environment. To receive the webcast meeting link and audio teleconference information before the webinar, the notice states that stakeholders must register by 5:00 p.m. (EST) on August 28, 2023. Comments are due September 11, 2023.
 
During the listening session, EPA will present its proposed plans to expand Safer Choice and DfE certification to new product categories. According to EPA, Safer Choice and DfE certifications “would likely not expand to certify materials.” EPA states that “the availability of EPA certified products would help give consumers a choice of products that meet EPA’s high standard for human and environmental health and, as part of meeting these criteria, would not contain intentionally added per- and polyfluoroalkyl substances (PFAS).” After the presentation, there will be time for attendees to submit questions and comments. EPA states that it will respond to the questions and comments as time allows during the listening session. EPA asks for written submission of all comments after the listening session.

Background

EPA states that as part of its human health and environmental mission, the Safer Choice program partners with businesses to help consumers and commercial buyers identify products containing chemical ingredients meeting EPA’s criteria for being “safer” without sacrificing quality or performance criteria set by EPA. The Safer Choice program certifies products containing ingredients that have met the program’s criteria and allows companies to use its label on certified products that contain safer ingredients and perform, as determined by expert evaluation. EPA notes that the Safer Choice program certification “represents a high level of achievement in formulating products made with safer ingredients for people and the environment.” More information is available on the Safer Choice website.
 
EPA currently uses the DfE program to help consumers and commercial buyers identify antimicrobial products that meet the health and safety standards of the typical pesticide registration process required by FIFRA, as well as the DfE certification criteria (as described in the Safer Choice Standard). More information is available on EPA’s website. 

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By Lynn L. Bergeson and Carla N. Hutton
 
On July 19, 2023, the U.S. Environmental Protection Agency (EPA) extended the comment period on proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 46125. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Lautenberg Act), improve EPA’s efficiency in the review process, and “update the regulations based on existing policies and experience implementing the New Chemicals Program.” EPA states that the proposed rule includes amendments that would “reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review.” EPA proposed several amendments to the regulations for low volume exemptions (LVE) and low release and exposure exemptions (LoREX), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, and toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA’s 1999 PBT policy. Comments are due August 8, 2023. More information on the proposed rule is available in our May 24, 2023, memorandum.

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By 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.

• Session 1 (Presentation and Questions and Answers (Q&A)) 11:00 a.m. - 12:30 p.m. (EDT)

This session will provide an overview of GenRA content and function with opportunities for participation and Q&A.

• Session 2 (Breakout Sessions) 12:30 - 1:30 p.m. (EDT)

This session will break participants into breakout rooms to work on exercises in small groups, aided by facilitators.

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By 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.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has posted the justification for its fiscal year (FY) 2024 appropriation estimates for the Committee on Appropriations (Congressional Justification (CJ)). According to the CJ, work in the Pollution Prevention (P2) Program supports Objective 7.2: Promote Pollution Prevention (P2) under Goal 7: Ensure Safety of Chemicals for People and the Environment. The FY 2024 budget includes $29 million and 69.2 full-time equivalents (FTE) to support the P2 Program in the Environmental Program and Management (EPM) appropriation, an increase of $16 million and 18 FTEs above the FY 2023 enacted budget. The CJ states that FY 2024 funding will continue to support the following P2 programs.
 
Safer Choice Program
 
The CJ states that Safer Choice is a voluntary program that certifies safer products so consumers, businesses, and purchasers can find products that work well and contain ingredients safer for human health and the environment. EPA certifies and allows use of the Safer Choice label on products containing ingredients that meet stringent health and environmental criteria. Under the same stringent criteria, EPA certifies disinfectant products registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) using the Design for the Environment logo. According to the CJ, the Safer Choice Program will expand into additional product categories and seek to increase consumer and commercial recognition of Safer Choice products. In FY 2024, EPA will continue its Partner of the Year Awards Program, recognizing organizations and companies for their leadership in formulating products made with safer ingredients and making them available to communities.
 
The CJ states that in FY 2024, Safer Choice will integrate and address environmental justice (EJ) concerns through outreach and partnership activities. Efforts to make Safer Choice-certified products more accessible to communities with EJ concerns will expand, with particular focus on low-income, Tribal, and indigenous populations and other vulnerable populations such as the elderly, children, and those with pre-existing medical conditions. According to the CJ, Safer Choice will work with retailers and product manufacturers to help them develop more products containing safer chemical ingredients that are easy to identify and purchase. Safer Choice will also work to empower custodial staff and house cleaning companies and enable facilities through education to gain access to Safer Choice-certified products to improve indoor air quality and reduce exposure-related asthma.
 
Environmentally Preferable Purchasing (EPP) Program
 
The EPP Program implements direction provided to EPA in several statutes and Executive Orders that mandate sustainable federal procurement, including through development and use of sustainability standards, specifications, and ecolabels. Beginning in FY 2023, the EPP Program is expanding the EPA Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing in new categories to support the Biden Administration’s environmental and human health goals and mandates, including net-zero emissions procurement, low embodied carbon construction materials, and products that do not contain per- and polyfluoroalkyl substances (PFAS). According to the CJ, the EPP Program has received applications for over 70 standards/ecolabels from 29 organizations to be considered for assessment and recommendation in federal purchasing. These cover the following high-impact federal procurement sectors: food and cafeteria services; uniforms/clothing; professional services; laboratories and healthcare; building/construction; infrastructure; and landscaping.
 
The CJ notes that EPA is characterizing PFAS provisions of existing private-sector sustainability standards, ecolabels, and certifications to identify products and purchase categories associated with key PFAS use and to prioritize PFAS conditions of use. In FY 2024, EPA will enhance public protection from potential effects of PFAS through recommendations of additional standards/ecolabels to help purchasers identify products that meet specific environmental performance criteria. EPA will conduct the following activities:

• Assess and recommend additional ecolabels and standards with criteria specifically supporting reduction or elimination of PFAS use in key product categories not yet covered by the EPA Recommendations for Standards, Specifications, and Ecolabels for Federal Purchasing.
• Build, implement, maintain, and update tools for integrating EPA recommendations into federal e-procurement systems, initiate identification and monitoring of relevant government contracts for sustainable purchasing requirements, and develop tools to ensure that PFAS data are captured for compliance in the Federal Procurement Data System (FPDS).
• Initiate and engage in private-sector standards development activities that address product categories known to contain PFAS.
• Work with the General Services Administration (GSA) and others to create a central product registry to identify products that meet EPA’s assessment of PFAS specifications.
• Collaborate with the Department of Defense (DOD) on performance-based, rather than material-based, specifications and standards for equipment (e.g., textiles, coatings, firefighting foam) for DOD and Department of Homeland Security (DHS) uses.
• Work with other federal agencies and the private sector to initiate a performance-based technology innovation challenge for a set of PFAS-free product categories for which use of non-PFAS options could be technically and economically feasible with respect to key federal purchasing categories.

According to the CJ, to support further EPA’s goals for equity and EJ, the EPP Program will begin to develop and implement training and outreach for disadvantaged communities, as well as state, Tribal, and local governments, to assist in facilitating product and service procurement choices that are environmentally sound and promote human and environmental health.
 
Green Chemistry Program
 
According to the CJ, the Green Chemistry Program fosters the sustainable design of chemical products and processes. It also analyzes green chemistry innovations and works with partners and external stakeholders to facilitate market adoption and penetration of new commercially successful chemistries and technologies. The CJ states that the program’s Green Chemistry Challenge Awards serve a critical role in raising the profile, importance, and credibility of innovative and market-ready green and sustainable chemistry technologies. In FY 2024, the Green Chemistry Program will begin to work with awardees and nominees to pursue the goal of market-oriented environmental and economic progress through increased adoption of these innovations. The CJ notes that EPA will support and lead portions of EPA’s responsibilities for implementation of the Sustainable Chemistry Research and Development Act of 2020. More information on the Sustainable Chemistry Research and Development Act of 2020 is available in our January 19, 2021, memorandum.

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 By Lynn L. Bergeson and Carla N. Hutton
 
On March 8, 2023, the U.S. Environmental Protection Agency (EPA) announced the availability of $16 million for two new grant opportunities to support states and Tribes in providing technical assistance to businesses seeking to develop and adopt pollution prevention (P2) practices that advance environmental justice in underserved communities. The Request for Applications for P2 investments include the Pollution Prevention Grant: Environmental Justice Through Safer and More Sustainable Products. The goal of this grant is to address environmental justice by providing P2 technical assistance to businesses (e.g., information, training, expert advice) to improve human health and the environment in disadvantaged communities by increasing the supply, demand, and use of safer and more sustainable products, such as those that are certified by EPA’s Safer Choice Program, or those that conform to EPA’s Recommendations for Specifications, Standards and Ecolabels for Federal Purchasing (EPA Recommendations).
 
To allow a greater number of disadvantaged communities to benefit from the results and lessons learned from projects funded by these grants, EPA states that it is requiring recipients to develop P2 case studies on approaches to make safer and sustainable products more available in disadvantaged communities where the approaches are new, not widely known or adopted, or where the recipient believes detailed information on the project could support more widespread project replication. Recipients must develop at least one case study during the grant period. According to EPA, it will use these case studies to build and share a body of knowledge about P2 approaches to make safer and sustainable products more available in disadvantaged communities that could be implemented by other enterprises.
 
Eligible entities include the 50 states, the District of Columbia, the U.S. Virgin Islands, the Commonwealth of Puerto Rico, any territory or possession of the United States, any agency or instrumentality of a state or Tribe, including colleges and universities, and federally recognized Tribes and intertribal consortia. EPA “strongly” encourages applicants to develop partnerships where they can strengthen their ability to provide P2 technical assistance to businesses in disadvantaged communities.
 
EPA will hold informational webinars on March 21, March 23, March 28, and March 30, 2023. Although EPA’s press release states that applications for the grant are due June 6, 2023, the information on grants.gov states that the closing date for applications is June 20, 2023.

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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.

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