2024-31086. Comparison of Aquatic Life Protective Values Developed for Pesticides Under the FIFRA and the CWA

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Environmental Protection Agency

1. [EPA-HQ-OW-2023-0107; FRL 10680-01-OW]

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of availability.

SUMMARY:

The U.S. Environmental Protection Agency (EPA) is announcing the availability of draft analyses comparing aquatic life benchmarks developed by the EPA's Office of Pesticides Programs (OPP) in support of registration decisions for pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) to existing national recommended aquatic life Ambient Water Quality Criteria and criteria-related values developed under the Clean Water Act (CWA) for the protection of aquatic life from pesticides. The EPA's draft analyses show that the values developed under these statutes are similarly protective of aquatic life and that the most sensitive OPP aquatic life benchmarks, which are updated regularly to include the latest science, could also serve as CWA section 304(a)(1) recommended aquatic life criteria or 304(a)(2) informational benchmarks for pesticides. The EPA will accept public comments on the draft analyses and potential application of OPP aquatic life benchmarks for CWA 304(a) purposes for 30 days upon publication in the Federal Register .

DATES:

Comments must be received on or before January 27, 2025.

ADDRESSES:

You may send comments, identified by Docket ID No. EPA-HQ-OW-2023-0107, by any of the following methods:

• Federal eRulemaking Portal: https://www.regulations.gov/​ (our preferred method). Follow the online instructions for submitting comments.
• Agency website: https://www.epa.gov/​wqc/​common-effects-methodology-pesticides. Follow the online instructions for submitting comments.
• Mail: U.S. Environmental Protection Agency, EPA Docket Center, Office of Water Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
• Hand Delivery or Courier: EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket Center's hours of operations are 8:30 a.m.—4:30 p.m., Monday—Friday (except Federal Holidays).

Instructions: All submissions received must include the Docket ID No. for this Notice of Availability. Comments received may be posted without change to https://www.regulations.gov/​, including any personal information provided. For detailed instructions on sending comments and additional information on the public comment, see the “Public Participation” heading of the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:

Christine Bergeron, Health and Ecological Criteria Division, Office of Water (Mail Code 4304T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: [phone]; email: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Public Participation

Submit your comments, identified by Docket ID No. EPA-HQ-OW-2023-0107, at https://www.regulations.gov (our preferred method)), or the other methods identified in the ADDRESSES section. Once submitted, comments cannot be edited or removed from the docket. The EPA may publish any comment received to its public docket. Do not submit to EPA's docket at https://www.regulations.gov any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e., on the web, cloud, or other file sharing system). Please visit https://www.epa.gov/​dockets/​commenting-epa-dockets for additional submission methods; the full EPA public comment policy; information ( print page 105568) about CBI or multimedia submissions; and general guidance on making effective comments.

II. Purpose and Background

A. What is the purpose of this action?

The purpose of this action is to request comment on: (1) the EPA's draft analyses comparing aquatic life benchmarks developed by the EPA's Office of Pesticides Programs (OPP) in support of registration decisions for pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to existing national recommended aquatic life Ambient Water Quality Criteria (AWQC) and criteria-related values ( e.g., values developed using assessment or safety factors) developed under the Clean Water Act (CWA) for the protection of aquatic life from pesticides, and (2) the potential application of OPP aquatic life benchmarks for CWA 304(a) purposes, either as 304(a)(1) recommended criteria or 304(a)(2) informational benchmarks, and 3) whether the eight current pesticide criteria values that also have OPP benchmarks should be updated with the most sensitive OPP benchmark value and retained as CWA section 304(a)(1) aquatic life AWQC. The EPA prepared these draft analyses to support the agency's effort to harmonize aquatic life effects assessment methods for pesticides across statutes and to provide a common basis for achieving water quality protection under the FIFRA and the CWA by leveraging work across the agency. This collaborative effort promotes consistency and efficiency in the EPA's effects assessments for pesticides to protect aquatic life.

B. Background

1. CWA section 304(a)(1) National Recommended Ambient Water Quality Criteria for Aquatic Life

National recommended AWQC for the protection of aquatic life are numeric concentrations of pollutants in surface waters that are expected to protect against unacceptable adverse ecological effects to aquatic life resulting from exposure to pollutants found in water with specific recommendations on the duration and frequency of those concentrations ( https://www.epa.gov/​wqc/​national-recommended-water-quality-criteria-aquatic-life-criteria-table). CWA section 304(a)(1) directs the EPA to develop and publish AWQC recommendations that reflect the latest scientific knowledge. Generally, the EPA develops 304(a)(1) aquatic life AWQC recommendations following the “Guidelines for Deriving Numerical Water Quality Criteria for the Protection of Aquatic Organisms and Their Uses” (U.S. EPA 1985) (“Guidelines”), an approach that encourages collecting toxicity data for a broad range of aquatic organisms, specified by the recommended eight Minimum Data Requirements (MDRs), to ensure, with high confidence, that the AWQC will be protective of aquatic communities. AWQC are based solely on data and scientific judgments about the relationship between pollutant concentrations and the potential effects on aquatic organisms. The EPA's recommended AWQC are not regulatory, nor do they automatically become part of a State's water quality standards. States and authorized Tribes may adopt these criteria into their water quality standards (WQS) to protect the designated uses of water bodies. States and authorized Tribes may also modify these criteria to reflect site-specific conditions before adopting these into standards or use other scientifically defensible methods to develop criteria.

2. CWA Section 304(a)(2) Aquatic Life Benchmarks

Aquatic life benchmarks, developed under CWA section 304(a)(2), are informational values that the EPA generates when there are limited high-quality data available to develop 304(a)(1) AWQC, because data gaps exist for several aquatic organism families. These data gaps can be addressed using new approach methods, such as mathematical extrapolation tools, read-across from other chemicals with similar structures, or other information. The EPA develops aquatic life benchmarks to provide information that States and Tribes may consider in their water quality protection programs including development of water quality criteria. Like AWQC, the EPA's CWA section 304(a)(2) aquatic life benchmark values are not regulatory, nor do they automatically become part of a State's or Tribe's water quality standards.

3. OPP Aquatic Life Benchmarks

Aquatic life benchmarks developed by OPP are based on the EPA's analysis of available high-quality data on the potential effects of pesticides on the aquatic community and support registration decisions for pesticides under the FIFRA. These benchmarks are estimates of the concentrations below which pesticides are not expected to present a risk of concern for aquatic organisms ( https://www.epa.gov/​pesticide-science-and-assessing-pesticide-risks/​aquatic-life-benchmarks-and-ecological-risk). EPA regularly updates the benchmarks to reflect the latest scientific information submitted under FIFRA. Federal, State, Tribal and local governments use these benchmarks in their interpretation of water monitoring data.

III. Overview of Harmonized Approach and Draft Comparative Analysis

The EPA has been working since 2009 to harmonize OPP's benchmarks and CWA section 304(a) aquatic life effects assessments in response to States and other stakeholders questioning the differences between these two approaches. In 2010, the EPA notified the public of multiple stakeholder meetings held when the agency first considered harmonizing aquatic effects assessments for pesticides under the FIFRA and the CWA. See https://www.regulations.gov/​docket/​EPA-HQ-OPP-2009-0773. In 2011, the agency solicited public comments as part of the 2012 FIFRA Scientific Advisory Panel (SAP) review of the EPA analyses regarding potential approaches. See https://www.regulations.gov/​docket/​EPA-HQ-OPP-2011-0898. The SAP made recommendations to develop an approach to harmonize OPP's benchmarks and CWA section 304(a) aquatic life criteria recommendations. The EPA focused on comparing the relative magnitude of the values derived using the respective FIFRA and CWA methods to examine whether the different effects assessment approaches yield similar results. This approach facilitates an efficient harmonization outcome of adopting the OPP benchmark values for the protection of aquatic life. For the draft comparative analyses, the EPA evaluated aquatic toxicity data for select insecticides and herbicides from different chemical classes and with different modes of action to compare the protective aquatic effect values developed by OPP and OW. These draft analyses are described in the “Comparison of Aquatic Life Protective Values Developed for Pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Clean Water Act (CWA)” (US EPA 2024, EPA-820-D-24-002), which is being made available for public comment in this notice of availability. The draft analyses demonstrate that the OPP benchmarks are similarly protective of aquatic life as the EPA's existing national recommended AWQC for pesticides, as well as criteria-related values developed for CWA purposes. For example, the most sensitive OPP benchmark for a given pesticide is generally lower than the corresponding current nationally recommended CWA 304(a)(1) criterion for that pesticide, with the OPP benchmarks being within a factor of two of the current 304(a)(1) ( print page 105569) criteria. The differences between the most sensitive OPP benchmarks and criteria-related values developed when toxicity data are limited are generally within the variability reported in the literature for toxicity tests repeated within a laboratory and tests conducted in different laboratories (5-10X).

The OPP benchmarks reflect the latest scientific knowledge regarding the effects of a given pesticide on the aquatic environment, consistent with the requirement under CWA section 304(a) for establishing recommended AWQC. Most of the pesticides with OPP benchmarks do not have sufficient data available to meet the Guidelines' recommended eight MDRs for aquatic life AWQC development. Accordingly, strict adherence to the MDR recommendations in the Guidelines would result in far fewer AWQC for pesticides for which OPP has developed robust benchmarks. Thus, in this action, the EPA is proposing to rely on these available, science-based OPP values for pesticides to develop 304(a) values for pesticides for future consideration and potential use by States and Tribes in establishing water quality standards for their waters.

IV. Development of CWA 304(a) Values for Pesticides

In light of these comparative analyses showing that OPP benchmarks are similarly protective of aquatic life as the EPA's existing CWA section 304(a) national recommended AWQC and criteria-related values, the EPA is considering recommending these OPP benchmarks as CWA section 304(a) aquatic life values. A list of the 757 anticipated CWA 304(a) aquatic life protective values based on the OPP pesticide benchmarks is presented in Table 1. Specifically, the EPA is requesting comment on whether to utilize the most sensitive OPP aquatic life benchmarks across all tested species for each pesticide as CWA 304(a)(1) recommended AWQC or 304(a)(2) informational aquatic life benchmarks, with the following exceptions:

• When plants are the most sensitive taxonomic group overall for a given pesticide, the EPA would include protective values for both the plant and most sensitive animal (vertebrate or invertebrate). If the lowest OPP benchmark is a freshwater or estuarine/marine nonvascular plant, the CWA value will be identified accordingly.
• CWA values for pesticide mixtures are not included.

Consistent with the EPA's current approach for AWQC for the protection of aquatic life, the agency intends to recommend use of standard parameters for duration (one hour for acute effects, 4-day for chronic effects) and frequency (not to be exceeded more than once in three years) for the CWA 304(a) aquatic life value.

V. The EPA's Request for Comments and Next Steps

The EPA will consider and evaluate all public comments and is most interested in receiving comments regarding the following three topics: 1) the comparison of approaches outlined in “Comparison of Aquatic Life Protective Values Developed for Pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Clean Water Act (CWA),” 2) whether the CWA values should be accepted as CWA section 304(a)(1) aquatic life AWQC or as CWA section 304(a)(2) informational aquatic life benchmarks for pesticides if the agency concludes it will use OPP benchmarks as CWA 304(a) values, and 3) whether the eight current pesticide criteria values that also have OPP benchmarks should be updated with the most sensitive OPP benchmark value and retained as CWA section 304(a)(1) aquatic life AWQC. Updating these eight data-rich pesticides with the OPP benchmark information would reflect the latest scientific knowledge.

If the EPA pursues this approach, the agency would undertake subsequent efforts to publish CWA 304(a) aquatic life values for over 750 pesticides that States and Tribes may consider in their water quality protection programs. The CWA 304(a) values would be regularly updated to reflect the latest scientific information submitted under FIFRA and would represent the best available science regarding the aquatic life effects of pesticides.

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Bruno Pigott,

Principal Deputy Assistant Administrator.