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.

• Email This
• Print
• Comments

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).

• Email This
• Print
• Comments

By Lynn L. Bergeson and Carla N. Hutton
 
On July 12, 2023, the U.S. Environmental Protection Agency (EPA) published a final rule establishing the applicable volumes and percentage standards for 2023 through 2025 for cellulosic biofuel, biomass-based diesel (BBD), advanced biofuel, and total renewable fuel. 88 Fed. Reg. 44468. The final rule also establishes the second supplemental standard addressing the judicial remand of the 2016 standard-setting rulemaking. Finally, according to EPA, the rule makes several regulatory changes to the Renewable Fuel Standard (RFS) program, including changes related to the treatment of biogas and other modifications to improve the program's implementation. As reported in our June 28, 2023, blog item, the final volume targets (billion Renewable Identification Numbers (RIN)) are as follows:
 

 
^a BBD is given in billion gallons.
 
The rule will be effective September 11, 2023, except for amendatory instruction 30, which will be effective February 1, 2024, and amendatory instructions 41 and 42, which will be effective April 1, 2024.

• Email This
• Print
• Comments

By Lynn L. Bergeson and Carla N. Hutton
 
On June 21, 2023, the U.S. Environmental Protection Agency (EPA) announced a final rule under the Renewable Fuel Standard (RFS) program that will establish the biofuel volume requirements from 2023 to 2025. According to EPA, the final rule “builds on the RFS program’s progress over the previous two years and reflects the Biden-Harris Administration’s commitment to strengthen the nation’s energy independence, advance low-carbon fuels, and support agricultural communities.” EPA states that the final rule strengthens U.S. energy security by reducing reliance on foreign sources of oil by roughly 130,000 to 140,000 barrels of oil per day over the time frame of the final rule, 2023-2025. The final rule also discusses EPA’s intent to monitor the ongoing implementation of the RFS program and its impacts on domestic refineries, “which have a critical role to play in our energy security.”
 
The final rule will establish the biofuel volume requirements and associated percentage standards for cellulosic biofuel, biomass-based diesel (BBD), advanced biofuel, and total renewable fuel for 2023-2025. EPA notes that the final rule also completes its response to a court remand of the 2016 annual rule by establishing a supplemental volume requirement of 250 million gallons of renewable fuel for 2023. The final volume targets (billion Renewable Identification Numbers (RIN)) are as follows:
 

 ^a BBD is given in billion gallons.
 
According to EPA, the final rule includes steady growth of biofuels for use in the nation’s fuel supply for 2023, 2024, and 2025. EPA notes that the Energy Independence and Security Act (EISA) of 2007 does not specify statutory volumes after 2022, and EPA in this rule will establish final biofuel volume targets for all categories under the “set” authority provided by the Clean Air Act. When determining biofuel volumes for years after 2022, EPA states that it 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, water quality, and supply.
 
In addition to setting the volume requirements, EPA will make several regulatory changes intended to expand the use of biogas under the program while, at the same time, putting in place provisions that will improve the operation of the RFS program.

• Email This
• Print
• Comments

By Lisa R. Burchi, James V. Aidala, and Heather F. Collins, M.S.

On May 31, 2023, the U.S. Environmental Protection Agency (EPA) released a final rule exempting a class of plant-incorporated protectants (PIP) created using genetic engineering, from 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. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. According to EPA’s May 25, 2023, press release, this rule will reduce costs for the regulated community and result in increased research and development activities, consistent with Executive Order 14081 on advancing biotechnology. EPA states that the rule also may result in the commercialization of new pest control options and reduced use of conventional pesticides. The final rule will be effective on July 31, 2023.

EPA states the final rule will allow PIPs to be exempt from FIFRA registration and FFDCA tolerance requirements in cases where they both pose no greater risk than PIPs that EPA has already concluded meet safety requirements, and when they could have otherwise been created through conventional breeding. The final rule reflects the biotechnological advances made since 2001, when EPA 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.

In the rule, EPA provides criteria and definitions that identify two categories of PIPs that are exempted through this action from FIFRA registration and FFDCA tolerance requirements:

• “PIPs created through genetic engineering from a sexually compatible plant” in which genetic engineering has been used to insert or modify a gene to match a gene found in a sexually compatible plant (to be codified at 40 C.F.R. Section 174.26); and
• “Loss-of-function PIPs” in which the genetically engineered modification reduces or eliminates the activity of a gene, which then helps make the plant resistant to pests (to be codified at 40 C.F.R. Section 174.27).

For the first exempted category, EPA will require a notification process for EPA to confirm that the PIP is eligible for the exemption. For the second exempted category (loss-of-function PIPs), developers of PIPs can submit to EPA a self-determination letter that the exemption applies. EPA also is establishing recordkeeping requirements for these exempted PIPs, clarifying general qualifications for exemption at 40 C.F.R. Section 174.21; clarifying the relationship between the existing exemptions for PIPs from sexually compatible plants (40 C.F.R. Section 174.25) and the newly issued exemption for “PIPs created through genetic engineering from a sexually compatible plant” (40 C.F.R. Section 174.26); and allowing the existing inert ingredient exemption at 40 C.F.R. Section 174.705 to include genetic engineering.

EPA notes that in the future, as biotechnology advances further, it intends to consider exempting additional categories of PIPs from both FIFRA registration and FFDCA tolerance requirements as well as adding categories of exempted PIPs to the list of categories that do not require EPA confirmation of eligibility.

Additional information, including the response to comment document, is available in docket EPA-HQ-OPP-2019-0508.

Commentary

This final rule is the next step for EPA’s Office of Pesticide Programs (OPP) on the path of EPA’s regulation of biotechnology pesticide products. It sets forth how OPP will handle products created by “Clustered Regularly Interspaced Short Palindromic Repeats” (CRISPR). In more general terms, CRISPR refers to manipulating plant genes with a method that was not available at the time the first biotechnology regulations were developed by EPA in the mid-1990s. This is why EPA needs to “update” its regulations, which is the purpose of the final rule.

Proponents of biotechnology methods argue that CRISPR allows the genes of plants to be manipulated more precisely and can be used to “simply” drop out a gene or add one from the same -- sexually compatible -- genome of the target plant. It follows that this is much like “traditional plant breeding” only done more precisely and more rapidly. Critics will likely raise questions about whether any product using this method, and not using traditional methods, might have some kind of unexpected result or unintended eventual effect. One can expect some adverse comments regarding these products even though EPA (among many others) lays out a rationale that this is an extension of its current regulations exempting products of traditional plant breeding from regulation under FIFRA/FFDCA (and not exempting such products from other regulatory authorities).

There also were concerns raised in comments submitted in response to the October 9, 2020, proposed rule. In particular, some in industry remain concerned that the final rule creates differential treatment for products due solely to the methods of development (i.e., biotechnology vs. conventional), thus subjecting products created using biotechnology to additional regulatory and recordkeeping requirements, even in cases when those products could have been created using older research and development approaches.

EPA’s basic requirements for biotechnology products that regulate inter-species gene manipulation would not change. Also worth noting is that the rule also would allow a developer to submit the product for EPA review to affirm that it qualifies for the exemption (i.e., a M009 Pesticide Registration Improvement Act (PRIA) action, which can lead to EPA delays in processing). The EPA docket includes a slide deck with a helpful summary of the final rule and its rationale.

• Email This
• Print
• Comments

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.

• Email This
• Print
• Comments

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.

• Email This
• Print
• Comments

 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.

• Email This
• Print
• Comments

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.

• Email This
• Print
• Comments

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.

• Email This
• Print
• Comments