`[Federal Register Volume 89, Number 248 (Friday, December 27, 2024)]
[Notices]
[Pages 105567-105604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31086]


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ENVIRONMENTAL PROTECTION AGENCY

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


Comparison of Aquatic Life Protective Values Developed for 
Pesticides Under the FIFRA and the CWA

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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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: (202) 566-0629; email: 
[email protected].

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

[[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)

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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.
[FR Doc. 2024-31086 Filed 12-26-24; 8:45 am]
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