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Clean Water Act (CWA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Common Aquatic Life Effects Assessment for Pesticides Using Available Data

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Environmental Protection Agency (EPA).


Notice of national meeting and request for public comment.


EPA will conduct a national stakeholders meeting to solicit input on methods being evaluated by the Office of Pesticide Programs (OPP) and the Office of Water (OW), with the support of the Office of Research and Development (ORD) to develop common characterizations of effects from pesticides on fish, other aquatic organisms, and aquatic plants in aquatic ecosystems. The national meeting will be held in Washington, DC, December 1, 2010. EPA has developed a set of draft white papers that explore: (1) The use of various tools to estimate aquatic toxicity data; (2) approaches for deriving community level benchmarks; and (3) procedures for better integrating plant effects data into community level assessments. EPA is soliciting stakeholder input on the tools and approaches presented in the draft white papers via public comment and at the national meeting.


The national stakeholders meeting will be held December 1, 2010; the agency must receive written requests (via e-mail or US Mail to one of the points of contact listed below) to deliver verbal comments at the National Stakeholder prior to the meeting on December 1, 2010. Written comments may be submitted to the docket (see instructions below) anytime between November 1, 2010 and prior to the close of the docket on January 15, 2010.


EPA will hold a national stakeholders meeting at the following address: USEPA East (EPA East) [Old ICC Building], 1201 Constitution Avenue, NW., Washington, DC 20004, Room # 1153 EPA East.

To request accommodation of a disability, please contact the person listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request.

You may submit comments, identified by the Docket ID: EPA-HQ-OW-2010-0818, by any of the following methods:

  • Federal Rulemaking Portal: Follow the instructions for submitting comments.
  • Agency Web Site: Follow the instructions for submitting comments on the
  • E-mail: Include EPA-HQ-OW-2010-0818 in the subject line of the message.
  • Mail: US Environmental Protection Agency, EPA Docket Center (EPA/DC) Water Docket, MC 4101T,1200 Start Printed Page 67089Pennsylvania Avenue, NW., Washington, DC 20460
  • Hand Delivery/Courier: Public Reading Room, Room B102, EPA West Building, 1301 Constitution Avenue, NW., Washington, DC. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.
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Joseph Beaman, Health and Ecological Criteria Division (4304T), Office of Water, U.S. EPA, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 202-566-0420;

Mark Corbin, Environmental Fate and Effects Division (7507P), Office of Pesticide Programs, U.S. EPA, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 703-605-0033;

Cindy Roberts, Office of Science Policy (8104R), Office of Research and Development, U.S. EPA, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 202-564-1999;

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I. General Information

A. Instructions: All submissions received must include the agency name and docket number for this notice. All comments received will be posted without change to, including any personal information provided.

B. Meeting: This meeting is open to the public; registration is not required for attending this meeting. Seats will be available on a first come, first served basis.

C. Does this Action Apply to Me? This action is directed to the public in general, and may be of interest to a wide range of stakeholders, including environmental, water resources professionals, and agricultural advocates, the chemical industry, pesticide users, and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

D. How Can I Get Copies of this Document and Other Related Information? EPA has established a docket for this action under docket ID number EPA-HQ-OW-2010-0818. Publicly available docket materials are available either in the electronic docket at, or, if only available in hard copy, at the Office of Water's (OW) Public Reading Room, Room B102, EPA West Building, 1301 Constitution Avenue, NW., Washington, DC. The hours of operation of this Docket Facility are from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (202) 566-2426.

Alternatively, the documents for this meeting as well as materials related to this action that have been previously developed can be found on the EPA Web site: Office of Water link:​waterscience/​criteria/​aqlife/​cem.html Office of Pesticide Programs link:​oppefed1/​cwa_​fifra_​effects_​methodology/​.

II. Background

Section 304(a)(1) of the Clean Water Act (CWA) requires EPA to develop, publish, and from time to time, revise criteria for water quality that accurately reflect the latest scientific knowledge. Water quality criteria are scientifically derived numeric values that measure the level beyond which pollutants in ambient water are expected to have deleterious effects on aquatic life or human health. Water quality criteria developed under Section 304(a) are based solely on data and scientific judgments on the relationship between pollutant concentrations and environmental and human health effects. Section 304(a) criteria do not reflect consideration of economic impacts or the technological feasibility of meeting the chemical concentrations in ambient water.

Section 304(a) criteria provide guidance to states and authorized tribes in adopting water quality standards that ultimately provide the basis for controlling discharges or releases of pollutants. The criteria also provide guidance to EPA when promulgating federal regulations under Section 303(c), when such action is necessary. Under the CWA and its implementing regulations, states and authorized tribes adopt water quality criteria to support designated uses (e.g., aquatic life, public water supply, recreational use). EPA's recommended criteria do not impose legally binding requirements. States and authorized tribes have the discretion to adopt, where appropriate, other water quality criteria based on scientifically defensible approaches that differ from EPA's recommended criteria.

FIFRA requires that all pesticides used in the U.S. be registered by EPA and thus ensures federal control of distribution, sale, and use of pesticides. Registration assures that pesticides will be properly labeled and that, if used in accordance with labeled specifications, will not cause unreasonable adverse effects on human health and the environment. FIFRA ecological risk assessments quantitatively evaluate reduced survival of aquatic animals from direct acute exposures and survival, growth, and reproductive impairment for aquatic animals from direct chronic exposures. Assessments for aquatic plants focus on growth rates and biomass (reproduction) measurements. Effects assessments are an important component of a FIFRA risk assessment.

For FIFRA ecological effects assessments, EPA reviews toxicity data provided by the registrant as required by regulation, as well as data from public sources obtained from EPA's ECOTOX database. Current testing requirements for aquatic organisms include toxicity studies containing information on survival, reproduction, and growth endpoints for freshwater and estuarine/marine animals and biomass and growth endpoints for aquatic plants. These test requirements are defined for each chemical class by use category in title 40 of the Code of Federal Regulations, Part 158. Studies are performed on laboratory test organisms in the following broad taxonomic groupings: freshwater fish and invertebrates, estuarine/marine fish and invertebrates, and aquatic plants. For screening-level assessments, OPP's effects assessments are based on the lowest acute and chronic toxicity values from the most sensitive species tested in acceptable studies. More refined assessments may use the full species sensitivity distribution for a given taxon or other toxicity endpoints, as for the variability and uncertainty of the data (probabilistic approaches). The “OPP Aquatic Benchmarks” is a web site developed by OPP that contains the aquatic toxicity endpoints used in EPA pesticide risk assessments. (​oppefed1/​ecorisk_​ders/​aquatic_​life_​benchmarks.htm).

OPP toxicity benchmarks and OW AWQC are both developed with high quality data pursuant to parallel but somewhat different rigorously peer-reviewed assessment methodologies. The opportunity being addressed by EPA is how best to build on the substantial high quality science developed under both programs to develop a consistent and common set of effects characterization methods that integrates these approaches for regulators to use in different programs at both the Federal and State level. Stakeholders have identified a need for Start Printed Page 67090consistent and timely federal input that will allow EPA, states, tribes, and the public to gauge whether pesticides represent a concern for aquatic life, for example, based on water monitoring results. To address these concerns, the Agency has begun a process to explore how to build on the high quality science in both OW and OPP to develop additional tools and approaches to support consistent and common effects characterizations using the best available information. If successful, this common tiered effects characterization methodology and resultant advisory values would allow Federal and State risk managers to make environmentally protective and scientifically defensible, timely decisions about chemicals that may be found in ambient water in a consistent manner while meeting the mandates of both CWA and FIFRA.

A scoping document was published in April 2009,​oppefed1/​cwa_​fifra_​effects_​methodology/​scope.html that described this effort in more detail and invited public participation in our collective efforts. Following through on this invitation, 6 regional stakeholders meetings where held in January 2010. The feedback received from stakeholders assisted EPA in crafting three draft white papers. Now, a national stakeholders meeting is being planned for October 29, 2010 to solicit input on the Agency's draft white papers that address the following topics:

(1) The use of various tools to estimate aquatic toxicity data;

(2) approaches for deriving community level benchmarks; and

(3) procedures for better integrating plant effects data into community level assessments.

These white papers also describe how the potential new tools, methods, and analytical approaches that may be used by the Agency, state pesticide and water quality agencies, and other stakeholders to gauge whether pesticides represent a concern for aquatic life. Following this meeting, the Agency plans to revise the white papers, based on public comments and feedback from the stakeholders. The white papers will then be reviewed by EPA's Science Advisory Board in summer 2011.

For more information about water quality criteria and Water Quality Standards, refer to the following: Water Quality Standards Handbook (EPA 823-B94-005a); Advanced Notice of Proposed Rule Making (ANPRM), (63 FR 36742); Water Quality Criteria and Standards Plan—Priorities for the Future (EPA 822-R-98-003); Guidelines and Methodologies Used in the Preparation of Health Effects Assessment Chapters of the Consent Decree Water Criteria Documents (45 FR 79347); Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health (2000), EPA-822-B-00-004); Guidelines for Deriving Numerical National Water Quality Criteria for the Protection of Aquatic Organisms and Their Uses (EPA 822/R-85-100); National Strategy for the Development of Regional Nutrient Criteria (EPA 822-R-98-002); and EPA Review and Approval of State and Tribal Water Quality Standards (65 FR 24641). You can find these publications through EPA's National Service Center for Environmental Publications (NSCEP, previously NCEPI) or on the Office of Science and Technology's home page (​waterscience).

For more information about the OPP Ecological Exposure Assessment Process under FIFRA, refer to the following: Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, which describes how pesticide data are used in ecological risk assessments (​oppfead1/​endanger/​consultation/​ecorisk-overview.pdf). The data requirements for aquatic non-target plants and animals for pesticides are described in title 40 of the Code of Federal Regulations, revised July 1, 2008 (158.660 Non-target Plant Protection Data Requirements). The required procedures for conducting the studies are described in OPPTS Harmonized Test Guidelines. Series 850 Ecological Effects Test Guidelines—Public Drafts (​opptsfrs/​publications/​OPPTS_​Harmonized/​850_​Ecological_​Effects_​Test_​Guidelines/​Drafts/​). Information on procedures used to evaluate these studies are described in: Standard Evaluation Protocols, the guidance document entitled the Rejection Rate Analysis: Ecological Effects (EPA 738-R-94-035), and in the OPP Overview Document. Public literature is accessed by OPP through EPA's ECOTOX database (​). The “OPP Aquatic Benchmarks,” a Web site developed by OPP, contains the aquatic toxicity endpoints used in pesticide assessments (​oppefed1ecorisk_​ders/​aquatic_​life_​benchmarks.htm).

III. What type of comments does EPA want to receive?

EPA would like the public to comment on the following:

1. The data, tools, and methods presented in the white papers;

2. Alternate tools or methods that EPA should consider for extrapolating or estimating aquatic toxicity data;

3. Alternate methods EPA should consider for developing community level benchmarks or aquatic life screening values when minimum data requirements for national recommended aquatic life criteria are not met;

4. The types of values that are used by states and/or regions for protecting aquatic life in the absence of ambient water quality criteria; and

5. Approaches to establishing plant-based criteria, or methods to better incorporate plant effects data in community level benchmarks.

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Dated: September 27, 2010.

Ephraim S. King,

Director, Office of Science and Technology, Office of Water.

Dated: September 29, 2010.

Steve Bradbury,

Director, Office of Pesticide Programs.

Dated: September 29, 2010.

Fred Hauchman,

Director, Office of Science Policy, Office of Research and Development.

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[FR Doc. 2010-27289 Filed 10-27-10; 8:45 am]