[Federal Register Volume 75, Number 210 (Monday, November 1, 2010)]
[Pages 67088-67090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27289]



[EPA-HQ-OPP-2010-0818; FRL-9218-6]

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of national meeting and request for public comment.


SUMMARY: 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.

DATES: 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.

ADDRESSES: 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 
    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: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web Site: [email protected]. Follow the instructions 
for submitting comments on the [email protected].
     E-mail: [email protected]. 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

[[Page 67089]]

Pennsylvania 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.

FOR FURTHER INFORMATION CONTACT: Joseph Beaman, Health and Ecological 
Criteria Division (4304T), Office of Water, U.S. EPA, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460; 202-566-0420; [email protected].
    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; [email protected]
    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; [email protected]


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 www.regulations.gov, 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 
    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 http://www.regulations.gov, 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: http://www.epa.gov/waterscience/criteria/aqlife/cem.html Office of Pesticide Programs 
link: http://www.epa.gov/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. (http://www.epa.gov/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

[[Page 67090]]

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 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, http://www.epa.gov/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 
    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 (http://www.epa.gov/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 
(http://www.epa.gov/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 (http://www.epa.gov/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 (http://cfpub.epa.gov.ecotox/). The ``OPP Aquatic Benchmarks,'' a Web site 
developed by OPP, contains the aquatic toxicity endpoints used in 
pesticide assessments (http://www.epa.gov/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 
    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.

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