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Clean Water Act and Federal Insecticide, Fungicide, and Rodenticide Act Common Effects Aquatic Life Assessment for Pesticides Using Available Data: Regional Stakeholder Meetings

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Environmental Protection Agency (EPA).


Notice of Public Meetings.


EPA will conduct six public meetings 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 characterize effects from pesticides on fish, other aquatic organisms, and aquatic plants in aquatic ecosystems. These public meetings will be held in Chicago, IL (Region 5), Edison, NJ (Region 2), Kansas City, KS (Region 7), Atlanta, GA (Region 4), San Francisco, CA (Region 9), and Seattle, WA (Region 10), starting in January 2010. At the public meetings, EPA will provide presentations that detail its initial thinking on how to ensure that pesticide effects are characterized consistently by both OPP and OW.


The public meetings will be held on the following dates: January 11, 2010; January 12, 2010; January 14, 2010; January 19, 2010; January 21, 2010; and January 22, 2010.


The meetings will be held at the following locations and times:

January 11, 20101 p.m. to 5 p.m.EPA Region 2 2890 Woodbridge Ave. Building 205 Main Conference Room Edison, NJ 08837
January 12, 20101 p.m. to 5 p.m.EPA Region 4 Sam Nunn Atlanta Federal Center Augusta Conference Room 61 Forsyth St., SW Atlanta, GA 30303
January 14, 20109 a.m. to 1 p.mEPA Region 5 Ralph Metcalfe Federal Building Valdas V. Adamkus Resource Center - 12th Floor Lake Michigan Room 77 W. Jackson Boulevard Chicago, IL 60604
January 19, 20109 a.m. to 1 p.mEPA Region 7 901 North 5th St. Room 2240 A Kansas City, KS 66101
January 21, 20109 a.m. to 1 p.mEPA Region 10 1200 Sixth Ave., Suite 900 Seattle, WA 98101
January 22, 20101 p.m. to 4 p.m.EPA Region 9 Ronald V. Dellums Federal Building Edward R. Roybal Auditorium and Conference Center 1301 Clay St. Oakland, CA 94612

Additional information concerning these meetings will be available on December 1, 2009 at the following web site:​oppefed1/​cwa_​fifra_​effects_​methodology/​index.html.

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.

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Jane Hopkins, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, D.C. 20460; telephone number: (703) 305-7195; e-mail address:

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I. General Information

A. 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.

B. 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-OPP-2009-0773. Publicly available docket materials are available either in the electronic docket at, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

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 accurately reflecting the latest scientific knowledge. Water quality criteria are scientifically derived numeric values that measure the level beyond which pollutants in ambient water will 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 measure attainment of designated uses (e.g., public water supply, recreational use, industrial use). EPA’s recommended criteria do not impose legally binding requirements. States and authorized tribes have the discretion to adopt, where appropriate, other scientifically defensible water quality criteria that differ from EPA’s recommended criteria.

FIFRA requires that all pesticides used in the United States be registered by EPA for use 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. Risk management decisions for pesticide registration under FIFRA take into consideration benefits in addition to risks of pesticides used; however, benefits are not considered in characterizing ecological effects under FIFRA or in deriving ambient water quality criteria (AWQC) values under CWA.

For FIFRA ecological effects assessments, EPA peer 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 taxa 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).

Although both OPP’s and OW’s approaches afford a high degree of protection for aquatic life, stakeholders have identified a need for consistent 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 a consistent and common set of effects characterization methods using best available information. A Scoping Document has been developed that describes this effort in more detail. A letter signed by the Office Directors of OPP and OW, and reinforced by the Scoping Document, has invited public participation in our collective efforts. Following through on this invitation, regional public meetings are being planned for January 2010 to solicit input on the Agency’s initial thinking regarding methods, tools, and approaches that are being developed and evaluated by OPP and OW, with the support of ORD, to assure that pesticide ecological effects are characterized consistently. The areas for consideration under this effort include:

  • Development and evaluation of predictive tools for use in development of community level benchmarks
  • Development of aquatic life community level benchmarks with datasets that do not conform to the “1985 Guidelines”
  • Derivation of aquatic life screening values for aquatic plants

The tools and approaches developed by EPA will:

  • Continue to be based upon sound science and utilize the available data,
  • Be legally defensible under our statutory mandates,
  • Be based upon methodologies that are as consistent and practical as possible,
  • Be implementable at the Federal and State level.
  • Be developed as quickly and efficiently as possible, and
  • Reflect stakeholder input and comments.Start Printed Page 61681

During these meetings, EPA will also solicit input from Regional stakeholders regarding the following:

1. Additional sources of pesticide data and relevant reports.

2. The white paper topics.

3. The availability of data, tools, approaches, and data sets on aquatic toxicity that may be useful for this effort.

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.

5. Examples of situations in which differences between OW and OPP assessment approaches were an issue.

Following these meetings, the Agency plans to develop a set of white papers, describing potential new tools and analytical approaches that may be used by the Agency, state pesticide and water quality agencies, and other stakeholders.

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 (Http://​oppefed1ecorisk_​ders/​aquatic_​life_​benchmarks.htm).

III. How Can I Request to Participate in this Meeting?

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

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List of Subjects

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Dated: November 13, 2009.

Debra Edwards,

Director, Office of Pesticide Programs.

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[FR Doc. E9-28059 Filed 11-24-09; 8:45 am]