[Federal Register Volume 67, Number 231 (Monday, December 2, 2002)]
[Notices]
[Pages 71549-71561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30463]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-0311; FRL-7283-7]
Endangered Species Protection Program Field Implementation
AGENCY: Environmental Protection Agency (EPA or Agency).
ACTION: Notice of proposed field implementation approach and request
for comment.
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SUMMARY: EPA's Office of Pesticide Programs is describing, and
requesting comment on, implementation of its Endangered Species
Protection Program (ESPP, or the Program). The goal of the ESPP is to
carry out responsibilities under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) in compliance with the Endangered Species
Act (ESA), while at the same time not placing unnecessary burden on
agriculture and other pesticide users. This Notice describes how EPA
proposes to implement its responsibilities under section 7(a)(2) of ESA
by completing and upgrading County Bulletins, amending pesticide labels
to reference County Bulletins, and enhancing monitoring programs.
Regulations found at 50 CFR part 402 acknowledge that there may be
Federal programs for which revisions to standard regulatory processes
could result in more effective and efficient coordination among Federal
agencies and thus, more effective and efficient protection of listed
species. As such, those regulations (50 CFR part 402) allow Federal
agencies to establish alternate procedures, applicable to specific
Federal programs, for satisfying the provisions of ESA section 7(a)(2).
Those alternate procedures are known as counterpart regulations.
Through a separate Advance Notice of Proposed Rulemaking (ANPR) to
be issued on or about the same date as this Notice, EPA, the Department
of the Interior (DOI), and the Department of Commerce (DOC) are seeking
public input on ways that such counterpart regulations could improve
the ESA consultation process with respect to pesticide registrations.
Similarly, implementing regulations under FIFRA may be revised to
ensure a more effective program.
The docket for this Notice (docket identification number OPP-2002-
0311) includes a summary of the current technical review and
consultation approaches employed by the Agency, and the standard
evaluation procedure used for ecological risk assessments. That
information has been subject to public comment in the past, has been
used during EPA's Interim Endangered Species Protection Program, and
will continue to be used until the Agency, DOI and DOC take comment on
these aspects of the Program through the ANPR and modify them as
appropriate.
DATES: Comments, identified by docket ID number OPP-2002-0311, must be
received on or before March 3, 2003.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of this Notice.
FOR FURTHER INFORMATION CONTACT: Mary Powell, Field and External
Affairs Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-7384; fax number: (703) 308-3259; e-mail
address: [email protected].
SUPPLEMENTARY INFORMATION: This Notice is organized into four units.
Unit I. provides general information about applicability of this
Notice, availability of additional information, and how to
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comment on the Notice. Unit II. provides background information,
including the Agency's legal authority for taking this action, the
Interim ESPP, and EPA's efforts to develop this proposed field
implementation approach. Unit III. describes the proposed field
implementation of the ESPP, and Unit IV. provides the references cited
throughout this Notice.
While the Agency seeks comments on any aspect of this Notice, it
also is hoping to obtain input on certain specific aspects. Within the
various units of this Notice, EPA has indicated specific issues on
which the Agency is particularly interested in obtaining comment. These
issues are noted within the appropriate units under a subheading of
``Specific Input Requested.'' Further, the Agency seeks comment on
whether any aspect of this field implementation proposal is more
appropriately addressed through the counterpart regulations that are
the subject of a separate ANPR, to be published by the Agency, DOI, and
DOC on or about the same date as this Notice.
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general, and may be of
particular interest to farmers; pesticide registrants; pesticide users;
agricultural trade associations; public interest groups; groups
involved in or interested in endangered species protection; and local,
State, Tribal, U.S. Territory, and Federal government agencies. Because
other entities may also 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?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2002-0311. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B. EPA intends to work towards
providing electronic access to all of the publicly available docket
materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and To Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number (in this case, number OPP-2002-0311) in
the subject line on the first page of your comment. Please ensure that
your comments are submitted within the specified comment period.
Comments received after the close of the comment period will be marked
``late.'' EPA is not required to consider these late comments. If you
wish to submit CBI or information that is otherwise protected by
statute, please follow the instructions in Unit I.D. Do not use EPA
Dockets or e-mail to submit CBI or information protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is
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EPA's preferred method for receiving comments. Go directly to EPA
Dockets at http://www.epa.gov/edocket, and follow the online
instructions for submitting comments. Once in the system, select
``search,'' and then key in docket ID number OPP-2002-0311. The system
is an ``anonymous access'' system, which means EPA will not know your
identity, e-mail address, or other contact information unless you
provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to [email protected],
Attention: Docket ID Number OPP-2002-0311. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB), Office of Pesticide Programs (OPP),
Environmental Protection Agency (7502C), 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2002-0311.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1921 Jefferson Davis Hwy., Arlington, VA., Attention:
Docket ID Number OPP-2002-0311. Such deliveries are only accepted
during the docket's normal hours of operation as identified in Unit
I.B.1.
D. How Should I Submit CBI To the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find these suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide any technical information and/or data you used that
support your views.
4. If you estimate potential burden or costs, explain how you
arrived at your estimate.
5. Provide specific examples to illustrate your concerns.
6. Offer alternatives.
7. Make sure to submit your comments by the comment period deadline
identified.
8. To ensure proper receipt by EPA, identify the appropriate docket
ID number (in this case, docket ID number OPP-2002-0311) in the subject
line on the first page of your response. It would also be helpful if
you provided the name, date, and Federal Register citation related to
your comments.
II. Background Information on the Endangered Species Protection Program
A. Authority and Responsibility under FIFRA and ESA
Since 1970, EPA has had responsibility for regulating the sale,
distribution and use of pesticides under the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA). EPA has granted registrations,
or licenses, to thousands of pesticides containing hundreds of active
ingredients and has continuing oversight over such actions. These
registrations encompass thousands of different use sites and practices
across the United States.
FIFRA as amended (7 U.S.C. 135 et seq.) governs the regulation of
pesticides in the United States. Under FIFRA, a pesticide product may
be sold or distributed in the United States only if it is registered or
exempted from registration by EPA. Before a product can be registered
unconditionally, it must be shown, among other things, that the
pesticide, when used in accordance with widespread and commonly
recognized practice, will not generally cause ``unreasonable adverse
effects on the environment'' (section 3(c)(5)). FIFRA defines this
standard to include ``any unreasonable risk to man or the environment,
taking into account the economic, social, and environmental costs and
benefits of the use of'' the pesticide (FIFRA section (2)(bb)(1)). This
is known as the FIFRA risk/benefit standard.
Amendments to FIFRA in 1988 required that in addition to the
original registration decision, all pesticides first registered before
November 1984 be reviewed against more up-to-date data requirements and
standards, and decisions made about whether these pesticides should be
``reregistered'' (FIFRA section 4(a)). FIFRA was amended again in 1996
with enactment of the Food Quality Protection Act. FQPA put into place
a new standard for assessing human dietary risk (FIFRA section
2(bb)(2)), but it did not alter the risk benefit-standard of section
2(bb)(1) for assessing ecological risk. It also required that EPA
periodically review pesticide registrations (establishing a goal of
such review every 15 years) to determine whether such registrations
meets the requirements of the Act (FIFRA section 3(g)(1)(A)).
Congress enacted the ESA (16 U.S.C. 1531 et seq.) to protect and
promote the recovery of animal and plant species that are threatened or
in danger of becoming extinct and to ensure that the critical habitat
upon which they depend is not destroyed or adversely modified. The ESA
institutes certain prohibitions against ``taking'' threatened or
endangered (listed) species.
Section 7(a)(1) of the ESA, 16 U.S.C. 1536(a)(1), requires Federal
agencies use their authorities in furtherance of the purposes of the
Act, by carrying out programs for the conservation of listed species.
Public Law 100-478, October 7, 1988, amended the ESA and states that
EPA should fulfill its obligation to conserve listed species, while at
the same time considering the needs of agriculture and other pesticide
users. Section 7(a)(2) of the ESA, 16 U.S.C. 1536, and the implementing
regulations at 50 CFR part 402, further require Federal agencies to
ensure that their
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actions are not likely to jeopardize the continued existence of any
endangered or threatened species or result in the destruction or
adverse modification of critical habitat. This duty extends to
licensing activities such as the registration of pesticides by EPA. In
meeting the section 7(a)(2) requirement, EPA must consult with the
Services regarding the effects of Agency actions on listed species. In
fulfilling this requirement, Federal agencies must use the best
scientific and commercial data available. The Secretary of the Interior
has delegated the interagency consultation responsibilities to the U.S.
Fish and Wildlife Service; the Secretary of Commerce has delegated the
interagency consultation responsibilities to the National Oceanic and
Atmospheric Administration.
EPA and the Services are currently engaged in a number of separate,
but related activities relative to EPA's responsibilities under the
ESA. First, under ESA section 7(a)(1), EPA and the Services are engaged
in an ongoing Proactive Conservation Review. This review of EPA's ESPP,
is intended to clarify for the Federal agencies, EPA's approach to risk
assessment, criteria that indicate a listed species may be at risk, and
the requirements imposed on EPA by the ESA regulations governing
consultation. The review will also identify areas or issues relative to
risk assessment, criteria and consultations that may require
modification to ensure an effective and efficient process of
consultation among EPA and the Services. While this review is conducted
under ESA section 7(a)(1), the outcomes of the review will likely be
used to help focus discussions on technical and science policy issues
that need to be addressed in order to effectively carry out
responsibilities under ESA section 7(a)(2).
As noted in the SUMMARY section of this Notice, EPA and the
Services are also publishing an ANPR, at or about the same time as
publication of this Notice. The purpose of the ANPR is to gain public
input relative to the consultation, technical, and science policy
issues that need to be addressed in order to effectively carry out
responsibilities under ESA section 7(a)(2).
As part of the ESPP, this Federal Register Notice proposes a field
implementation plan for putting in place any protection measures
necessary to ensure EPA's compliance with ESA section 7(a)(2). This
plan, once final, will be used to put in place protection measures
identified through consultations with the Services. EPA may also use
this implementation approach as appropriate, to put measures in place
necessary to protect listed species, even in the absence of a
Biological Opinion from the Services.
B. EPA's Role
1. ESA section 7(a)(1) obligations. As noted in Unit II.A. above,
EPA has responsibilities under both section 7(a)(1) and 7(a)(2) of the
ESA. Under section 7(a)(1), EPA uses its authorities to conserve listed
species, in consultation with the Services. The Proactive Conservation
Review discussed in Unit II.F.2. is being carried out under section
7(a)(1) of ESA. In addition, EPA has carried out a number of other
activities intended to conserve listed species including: Hosting a Wb
site that contains listed species fact sheets and a county-scale data
base of listed species occurrences; maintaining a toll-free telephone
number for public inquiries relative to pesticide use and listed
species protection; and producing and disseminating educational
materials for students. Additionally, EPA has worked with State
agencies responsible for pesticide programs, to ensure that pesticide
applicators certified by the States, receive information during their
certification training, relative to endangered species protection
needs.
2. ESA section 7(a)(2) obligations. Under section 7(a)(2) of ESA,
EPA must ensure that its actions are ``not likely to jeopardize the
continued existence of any'' listed species or ``result in the
destruction or adverse modification of'' their designated critical
habitat. In carrying out its responsibilities, EPA's challenge is how
to implement FIFRA, a risk/benefit statute, in a way that ensures
compliance with the requirements of the ESA mandate to protect listed
species and to do so at use sites that are geographically,
ecologically, agronomically, and economically diverse and changeable.
EPA seeks to carry out these protections for thousands of pesticide
products in ways that users can be expected to implement reliably and
routinely without unnecessary burden.
The Agency is responsible for reviewing information and data to
determine whether a pesticide product may be registered for a
particular use. As part of that determination, the Agency assesses
whether listed species or their designated critical habitat may be
affected by the use of the product. If EPA determines that the action
may affect a listed species, the interagency coordination regulations
require the Agency to enter into a process with the Services called
``consultation'' (50 CFR 402.14). The consultation process is designed
to ensure that the Agency action is not likely to jeopardize the
continued existence of a listed species or result in destruction or
adverse modification of its designated critical habitat (ESA section
7(a)(2)). Following consultation, the Agency is responsible for
implementing protections, if necessary, through its available
authority. More information on ``may affect determinations'' and
consultations may be found in Unit II.D. EPA must also ``confer'' with
the Services if its actions may jeopardize the continued existence of
species proposed for listing or result in destruction or adverse
modification of habitat proposed for designation as critical habitat.
Consultation is not necessary if EPA determines that a particular
action will have ``no effect'' on listed species or designated critical
habitat. (See Unit II.D.1.c. for a discusssion of ``no effect
determinations.''
C. The Roles of FWS and NOAA Fisheries
DOI's U.S. Fish and Wildlife Service (FWS) administers the ESA for
most species. DOC's National Marine Fisheries Service (NOAA Fisheries)
administers the ESA for certain listed marine and anadromous species.
Both FWS and NOAA Fisheries (jointly, the Services) enter into formal
or informal consultation or conference with EPA concerning effects to
listed species and species proposed for listing as well as effects on
critical habitat. The consultation process is described in Unit II.D.3.
below. The Services may determine whether an EPA action is likely to
cause jeopardy to the continued existence of a species and if so, the
Services may propose reasonable and prudent alternatives to the action
to avoid jeopardy. The Services may also issue incidental take
statements that authorize takings of listed species incidental to
certain Federal actions.
D. Effects Determinations and Consultations
In the past, EPA has conducted a number of consultations with the
Services. The Agency's experience with those has demonstrated that the
agencies need to reexamine their programs to improve both the
efficiency and effectiveness of consultation. EPA and the Services are
currently participating in a joint Proactive Conservation Review (see
Unit II.F.2.) to explore potential modifications for better integrating
the FIFRA and ESA processes. The Agency, DOI and DOC are seeking public
input on the consultation process and EPA's endangered species
assessment
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processes through a separate ANPR, to be published on or about the same
date as this Notice, and intend to address these provisions through
counterpart regulations. Similarly, subsequent to the ANPR, certain
FIFRA regulatory processes may be reviewed for possible revisions that
could make the program more efficient or effective.
While the Agency is not seeking comment on these aspects of its
protection efforts through this Notice, it is including a summary of
its current process for making effects determinations and consulting
with the Services in Unit II.D.2. below, for purposes of providing
context to the reader.
1. Effects determinations. To the degree possible, endangered
species issues are and will be addressed within the Agency's existing
processes of registration and reregistration. Concurrently, the Agency
will review those pesticides that have been through reregistration and
that may affect listed species, or did not undergo ESA review during
reregistration.
EPA has no standard data requirements for endangered species
effects determinations, beyond those normally required during
registration and reregistration. However, in making such effects
determinations in the past, the Agency has requested data for specific
listed species concerns, and may continue to do so in the future. As
the Proactive Conservation Review and ANPR move forward (see Unit
II.F.2.), and as EPA begins to meld the process for making these
determinations into existing registration and reregistration
activities, the Agency may revisit the necessity for identifying data
requirements specific to listed species.
The potential of a pesticide to directly affect any particular
species is based on two factors: The toxicity of the chemical to the
species, and exposure. The latter includes the estimated environmental
concentrations (EECs) that would result from labeled use of a pesticide
and the potential for actual exposure of the species of concern to
those EECs. Direct effects may be in either of two broad categories:
Acute effects or chronic effects, including both lethal and sublethal
effects. Species may also be affected indirectly through modification
of their habitat or through effects on their food supply. EPA relies on
a wide range of environmental data to assess the potential effects of
pesticides on listed species. These data include toxicological studies,
laboratory and field studies of the fate and transport of pesticides,
mathematical fate and transport models, and field studies monitoring
pesticide concentrations and adverse effects to non-target organisms.
a. Acute lethal and sublethal effects. Acute data are derived from
toxicity tests with lethality as the primary endpoint. The standard
acute tests submitted for pesticide registration also include analysis
of observable sublethal effects. For example, a typical acute test for
a fish will include concentrations that cause no mortality and often no
observable sublethal effects, as well as concentrations that would
cause 100% mortality. Sublethal effects may or may not be observed at
concentrations below that which cause 100% mortality. Where sublethal
effects are observed, the Agency includes such information in its
assessment of whether a pesticide may affect a listed species. The
effects at test concentrations can be used to statistically predict the
effects likely to occur at various pesticide concentrations; a well-
done test can even be extrapolated to concentrations below those tested
(or above the test concentrations, if the highest concentration did not
produce 100% mortality).
b. Chronic lethal and sublethal effects. Potential chronic effects
of a pesticide can be evaluated based on several types of tests and
conducted on one of several possible species, depending on the listed
species of interest. For example, chronic tests for a listed bird could
be conducted on the mallard or bobwhite quail, whereas such tests for a
listed estuarine species would be conducted on mysid shrimp. Chronic
tests primarily evaluate the potential for reproductive effects and
effects on the offspring. Other observed sublethal effects are also
required to be reported. An abbreviated chronic test is usually the
first chronic test conducted and will indicate the likelihood of
reproductive or chronic effects at relevant concentrations. If such
effects are found, then a full life-cycle test will generally be
required. If the nature of the chemical is such that reproductive
effects are expected, the abbreviated test may be skipped in favor of
the full life-cycle test. These chronic tests are designed to determine
a ``no observable effect level'' (NOEL) and a ``lowest observable
effect level'' (LOEL).
c. Assessment. EPA typically evaluates the potential of a pesticide
to affect listed species by conducting a screening level assessment
and, if necessary, a species-specific assessment. During the screening
level assessment process, the Agency generally does not determine
whether in fact any specific threatened or endangered species may be
affected by the pesticide, but merely whether a concern would exist if
a threatened or endangered species were exposed to the EECs, given the
toxicity of the specific pesticide to the species. The screening steps
start out very conservative and become more refined with each step. EPA
determines that there is ``no effect'' on listed species if, at any
step in the screening level assessment, no Levels of Concern (LOCs) are
exceeded. After EPA performs all the available steps in the screening
level assessment, a pesticide may still exceed the Agency's LOCs for
listed species (see Unit II.D.1.d.). The Agency will then conduct a
species-specific assessment to make effects determinations for
individual listed species and their designated critical habitat. Units
II.D.1.d. through II.D.1.g. provide an example of this process for
aquatic species. Similar steps are undertaken for terrestrial species.
d. Screening level assessment. EPA begins its screening level
assessments by conducting a basic ecological risk assessment that uses
available data and generally conservative assumptions to establish the
EEC. EPA then uses increasingly specific methods and data and more
refined exposure models to refine the EEC of the pesticide. Where
available, EPA may also use field monitoring data for a variety of
purposes. At each screening step, the more refined EEC is compared to
the toxicity of the pesticide active ingredient to determine whether
the pesticide exceeds LOCs established for listed aquatic and
terrestrial species. EPA's Standard Evaluation Procedure for Ecological
Risk Assessment (June, 1986. EPA-540/9-85-001) provides that LOCs are
exceeded for acute effects on listed species when the EEC of a
pesticide is greater than 1/20th the LC50 for appropriate
aquatic species or 1/10th the LC50 or LD50 for
appropriate terrestrial species. Thus, under current practices, the
LOCs for listed species incorporate an extra level of protection that
is not used in the LOCs for other non-target species. (LC50
is the statistically derived estimate of concentration expected to
cause 50% lethality. LD50 is the statistically derived
estimate of oral dose expected to result in 50% lethality.) LOCs are
exceeded for chronic and/or reproductive effects when the EEC exceeds
the NOEL in appropriate studies.
In the first step of EPA's screening level assessment, the Agency
uses a quantitative comparison between the default EEC and the toxicity
of the chemical. A default EEC is based on application rates from
pesticide labels and on extremely conservative assumptions of movement
of the pesticide to water rather than on actual
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chemical fate and transport data. Toxicity values for the pesticide are
taken from data submitted by pesticide registrants to support their
registration request. The application rate is determined from pesticide
labels. EPA then compares the toxicity values with the default EEC to
determine whether the pesticide exceeds EPA's endangered species LOCs.
If no LOCs are exceeded, the pesticide has ``no effect'' on listed
species and the analysis ends. However, if an LOC is exceeded, EPA may
proceed to the next screening step to refine its assessment.
In this next step, the Agency refines its ecological risk
assessment by running the GENEEC (generic EEC) model with a variety of
inputs on application methods and rates, and chemical fate and
transport data to calculate the EEC. Running this model provides a more
refined EEC for comparison with the toxicity data. Again, if an
endangered species' LOC is exceeded at this step, EPA may proceed to
the next step to further refine its assessment. If the model described
below is not available for the particular use scenario being evaluated,
EPA would typically move to a species-specific assessment as described
in Unit II.D.1.e. below.
In the next step, the Agency uses a much more sophisticated model
the Pesticide Root Zone Model-Exposure Analysis Modeling System (PRZM/
EXAMS) to calculate more refined EECs. This model includes more
chemical fate and transport data, and it involves selecting a use site
(e.g., wheat or apples) scenario and modifying the scenario to reflect
the nature of the pesticide use. These scenarios are based upon actual
field data on crop location, extent to which the crop is grown, soil
characteristics, climate, etc. Use site scenarios exist only for major
and a few minor crops, and would need to be developed to run this model
for other crops. If an endangered species LOC is exceeded at this step,
a species-specific assessment is conducted.
e. Species-specific assessment. To conduct a species-specific
assessment, EPA takes the basic quantitative information from its
screening level assessment developed for all non-target organisms and
puts that information in context for individual listed species and
their locations. Important ecological parameters such as stream flow
rates and soil types, pesticide use information, the geographic
relationship between specific pesticide uses and species locations, and
biological requirements and behavioral aspects of the particular
species are typically considered. Where reliable, published data are
not available, information for such parameters is typically obtained
through contacts with knowledgeable experts, including extension
agents, crop advisors, resource specialists, and watershed experts.
These steps enable the Agency to refine its generic assessment into one
specific to individual listed species and their designated critical
habitat. If LOCs are exceeded after this analysis, the Agency may work
with the registrant to determine whether sufficient protection measures
can be incorporated into the registration or reregistration to achieve
a no-effect determination. Only if those efforts are unsuccessful will
EPA declare a ``may affect determination.''
f. Use of field monitoring in assessing risks. Field monitoring
data can supplement modeling and provide a more direct means to assess
whether species may be exposed to the pesticide at a level sufficient
to cause an effect, if the monitoring program was designed or is
appropriate for this purpose. For example, using monitoring data where
water samples are obtained one time per quarter year does not
necessarily provide information from which exposure levels can be
determined, although data can alert EPA to locations where pesticide
exposure may be occurring to trigger further assessment or analysis.
However, even in cases where appropriately designed monitoring was
conducted, EPA would still typically conduct exposure modeling when
field monitoring data do not exist for all species locations, and EPA
would still typically conduct a species-specific assessment, as
described in Unit II.D.1.e. above, to determine whether a particular
species may be exposed to the monitored levels of the pesticide.
In summary, EPA typically evaluates the potential of a pesticide to
affect listed species by conducting increasingly refined screening
level assessments, and, if necessary, a final species-specific
assessment.
2. Consultation procedures. Service regulations provide for two
types of consultations once a ``may affect determination'' has been
made.
a. Informal consultation. Informal consultation is an option
available to an action agency (in this case EPA) to assist the action
agency in determining whether formal consultation is required. During
this process, the Services can suggest modifications to an EPA action
to avoid the likelihood of adverse effects to a listed species or its
designated critical habitat. The informal consultation process is
completed with a written concurrence by the Services with EPA's
determination that its action is ``not likely to adversely affect''
listed species or designated critical habitat. If the Services do not
concur with EPA's finding of ``not likely to adversely affect,'' then
formal consultation must be initiated.
b. Formal consultation. Formal consultation is required if the
Agency determines that a pesticide may affect or is likely to adversely
affect a listed species or critical habitat. In this case, EPA makes a
written request for formal consultation with the Services on a
particular Agency action (i.e., a pesticide registered for a specific
use).
Basically, a consultation package consists of EPA's assessment of
the potential for a listed species or designated critical habitat to be
adversely affected by the registration of a particular pesticide. More
specifically, the package includes a description of the action under
consideration, areas that may be affected, listed species or critical
habitats at issue, a description of the manner in which the action may
affect any listed species or critical habitat, and an analysis of
cumulative effects and any relevant reports. The consultation package
must use the best scientific and commercial data available.
In response, the Services develop and provide to EPA a Biological
Opinion, which provides the Services' opinion on whether the use of the
pesticide in question is ``likely to jeopardize the continued existence
of a listed species or result in the destruction or adverse
modification of designated critical habitat'' (50 CFR 402.14(g)).
If a Biological Opinion concludes that an action is likely to
jeopardize a listed species or adversely modify its designated critical
habitat, then the Biological Opinion will include ``reasonable and
prudent alternatives,'' if any, that EPA may undertake to avoid the
likelihood of jeopardy to the species or destruction or adverse
modification of critical habitat. Reasonable and prudent alternatives
(50 CFR 402.02) are actions that:
(1) The consulting agency is capable of implementing under its
authority and jurisdiction.
(2) Allow the agency action to be implemented in a manner
consistent with its intended purpose.
(3) Are economically and technologically feasible.
(4) Are not likely to jeopardize the continued existence of any
listed species or result in the destruction or adverse modification of
critical habitat.
Biological Opinions will frequently include information for use in
implementing protections. For those few species that the Services
determine are
[[Page 71555]]
subject to collection threats, the Services generally will encourage
development of alternative protections, such as landowner agreements
(see Unit II.E.3.b. for more information on landowner agreements).
Biological Opinions may also include an ``incidental take
statement.'' For listed species, to ``take'' means ``to harass, harm,
pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to
attempt to engage in any such conduct'' (ESA section 3). Incidental
take refers to takings that result from, but are not the purpose of,
carrying out an otherwise lawful activity (50 CFR 402.02). Incidental
take statements specify, among other things, the amount or extent of
any anticipated incidental taking (e.g., the number of individuals) and
the ``reasonable and prudent measures'' needed to minimize the impact
of such a taking. The Biological Opinion may contain reasonable and
prudent measures to reduce the impact of incidental take, even if no
jeopardy to the listed species is found. If the amount or extent of
taking specified in the incidental take statement is exceeded, EPA must
reinitiate formal consultation (50 CFR 402.16(a)). The incidental take
statement also conveys to the action agency, any applicant to the
agency, and any users of the product an exemption from the take
prohibitions of the ESA, provided that the action is implemented in a
manner consistent with the reasonable and prudent measures included
with the incidental take statement (ESA section 7(o)(2)).
Reinitiation of consultation must occur if new information reveals
effects of the action that may affect listed species or critical
habitat in a manner or extent not previously considered; if the
identified action is subsequently modified in a manner that causes an
effect to the listed species or critical habitat that was not
considered in the Biological Opinion; or if a new species is listed or
critical habitat designated that may be affected by the identified
action (50 CFR 402.16).
E. Initial Efforts at Program Implementation
EPA's past efforts to carry out its responsibilities under FIFRA
and ESA fall into three areas: Assessment and consultation;
implementation of protections; and an interim Program that relies on
education, cooperation and public outreach.
1. Assessment and consultation. EPA has been consulting with FWS on
endangered species issues since 1977, and has used a variety of
approaches to these consultations. The various approaches yielded
variable results in terms of efficiency, effectiveness at addressing
potential risk to a given species, and equity among pesticide
registrants and equity among pesticide users.
a. ``Case-by-case'' consultations. In more than 80 instances, the
Agency has assessed the potential effects of a pesticide on all listed
species, across all proposed uses of a single pesticide. The benefit to
this approach to consultation (one pesticide, all proposed uses) is
that it is comprehensive as to the agency action and manageable since
it involves a single pesticide. The major drawbacks to this approach
resulted from use limitations being proposed for a specific pesticide
while competing pesticides that may also pose risks to species had not
yet been reviewed.
b. ``Cluster'' consultations. In order to mitigate the potential
inequity to competing registrants from the case-by-case approach, the
Agency engaged the FWS in several ``cluster'' consultations. These
consultations were based on an assessment of all pesticides registered
for use on certain crops. For example, in the ``cotton cluster'' EPA
assessed and consulted as appropriate on any pesticide registered for
use on cotton. By approaching assessment and consultation in this
manner, the Agency alleviated the potential inequity of case-by-case
consultations since competitive products for the same use were assessed
at the same time. However, this approach carried with it certain other
problems. The consultations resulting from this approach were much
larger and more complex. At the request of the FWS, EPA reinitiated
consultation on portions of these ``clusters'' to address newly listed
species and obtain ``incidental take'' statements. The resulting
reinitiation encompassed certain uses of 112 pesticides that had the
potential to affect one or more of 165 different listed species. For
both the original consultations and the reinitiation, the statutory
time frame provided for the Services to complete a Biological Opinion
proved difficult to meet. This approach, while eliminating the inequity
among pesticide registrants, created a potential inequity among
pesticide users. In these cluster consultations, a pesticide was
assessed for one crop, but not for other crops for which it was
registered. If the assessed crop was grown adjacent to the unassessed
crop, growers of the one crop could face use limitations while growers
of the other did not.
c. ``Species-based'' consultations. A third approach to assessment
and consultation was intended to ensure that a species was completely
addressed at once. This ``species-based'' approach was used to request
formal consultation for 31 pesticides. Under this approach, the Agency
and the Services identified the species most vulnerable to effects from
exposure to pesticides; identified all the pesticides to which that
species might be exposed; and identified all other species that might
be exposed to those uses of these pesticides. The Agency's consultation
would encompass any combination of these factors that produced a ``may
affect determination.'' Because of the diversity of uses of these
pesticides and the large number of species potentially affected, it was
necessary to divide the consultation into two parts. FWS has completed
part I. EPA asked FWS to suspend work on part II while EPA and the
Services undertake the ESA Section 7(a)(1) Proactive Conservation
Review to facilitate the overall consultation process (see Unit II.F.2.
for more information on the Proactive Conservation Review). The
benefits of this approach appear to be that a particular species would
be protected from all pesticide exposures with a potential to harm the
species, at one time. However, because of the complexity of these
assessments, the time necessary to identify protections is protracted
significantly.
2. Implementation of protections. In the past, EPA has proposed
several approaches for implementing an endangered species protection
program (53 FR 7716, March 9, 1988; 54 FR 27984, July 3, 1989). Under
these previous proposals, product labels would have been amended, where
necessary, to instruct users to follow specific use limitations. These
limitations would have been described in County Bulletins developed by
EPA to protect listed species in their area. Bulletins would contain
general information about the ESPP, a map of the county depicting areas
in which limitations applied, and a table indicating the particular use
limitations for specific pesticides in specific areas of the county.
States and Tribes would have had the option to initiate and propose to
EPA alternative plans for protecting listed species in their area. If
EPA deemed these plans to be feasible, and the Services deemed them
protective of the species, EPA would adopt the provisions of the plan
as the Federal requirements for that State or Tribe.
Other elements of implementation would have included public
participation, to include the opportunity for comment on the maps and
County Bulletins and State-initiated plans (Unit III.F.).
[[Page 71556]]
Moving forward with a final program implementation scheme did not
seem feasible at those earlier points in the history of the program's
development. There remained significant issues with potential resulting
inequities and resource implications created by the variety of priority
setting schemes for assessment and consultation. There also was concern
that County Bulletins, enforceable under FIFRA misuse provisions, did
not provide sufficient flexibility for pesticide applicators to
exercise judgement based on local conditions, to protect listed species
in ways that posed the least burden. Consequently, EPA decided, for the
interim, to maintain its case-by-case approach to assessment and
consultation and to conduct a voluntary ESPP to protect listed species
and their habitats. As part of this interim program, EPA has undertaken
a number of activities designed to address efficiency, effectiveness
and equity issues and to develop an improved ESPP implementation plan.
3. Interim program. The interim ESPP relies on education,
cooperation and public outreach to achieve its goals. The interim ESPP
involves the voluntary participation of States and pesticide users,
typically through the use of Interim Pamphlets as described below. Some
States also have participated in the program by developing and piloting
State-initiated plans to protect listed species within that State. Key
components of the interim ESPP include:
a. Distributing Interim Pamphlets. These Pamphlets, which are
precursors to the County Bulletins, were developed for voluntary use
during the Interim ESPP to encourage the protection of listed species.
Based largely on Biological Opinions, the Pamphlets include the name of
the species of concern, a table of the pesticides that may harm that
species, a description of the use limitations necessary to protect the
species, and a county-level map showing the geographic areas associated
with these use limitations. The type of map and level of detail depends
in part on the sensitivity of the listed species to other factors, such
as collection. (See Unit III.B. for distribution procedures and more
information on County Bulletins.)
b. Developing State- and Tribe-specific approaches. Several States
have developed alternative approaches to protecting certain listed
species during the Interim Program. For example, Minnesota and
Wisconsin have succeeded in protecting listed plants by developing
landowner agreements with private individuals. These agreements
identify protective measures specific to the geographic area involved
in the agreement and are made with FWS and the appropriate State
agencies.
California has put a program in place whereby use of particular
pesticides requires a State permit, the provisions of which take into
account the proximity of use to a listed species. Still others have
proceeded under the general direction of the Agency's Interim Program
but have developed alternatives to county mapping that better
communicate protection measures to their citizens.
F. Development of this Implementation Proposal
In developing this implementation proposal, EPA considered
information and comments from a number of sources. Those sources
included public comments submitted in response to past proposals and
other information described below.
1. EPA initiatives. EPA has been working on the technical aspects
of the ESPP. These efforts include collecting additional data on
species biology and habitat locations, agricultural crop and other
pesticide use locations, and pesticide toxicity and exposure. In
certain cases, additional research was conducted that specifically
provided data needed to address risks to listed species. Examples
include studies on herbicide effects on cacti, and effects of
insecticide use on terrestrial snails.
As required by Public Law 100-478, October 7, 1988, EPA completed
and submitted a report to Congress titled ``Report to Congress on the
Endangered Species Protection Program as it Relates to Pesticide
Regulatory Activities.'' The report describes the joint efforts by EPA,
USDA, and FWS to determine the effects of pesticide use on listed
species. It also summarizes EPA's efforts to communicate use
limitations to pesticide users, to determine alternatives to outright
prohibitions, to develop and distribute accurate maps of use limitation
areas related to listed species, and to improve communications among
EPA, USDA, and FWS.
2. Proactive Conservation Review. In a joint effort with the
Services, the Agency has undertaken a Proactive Conservation Review,
authorized under ESA section 7(a)(1). EPA and the Services are
analyzing the processes EPA uses to determine whether a pesticide may
affect a listed species and to assess generic mitigation measures. The
Services and EPA have agreed to explore issues relative to five
specific areas: (1) EPA's test methodologies, (2) environmental
exposure assessment processes, (3) risk assessments, (4) conservation
measures, and (5) follow-up to EPA action to ensure continuing
protection and conservation of listed species. One product of the
Proactive Conservation Review will be a handbook setting forth the
processes and procedures that will be followed by EPA, NOAA Fisheries
and FWS relative to species conservation, pesticide consultations, and
protection measures for listed species deemed to be potentially
affected by pesticide exposure.
3. EPA Regional programs. EPA Regional offices continue to act as
liaisons with State lead agencies (SLAs) for pesticide regulatory
activities, Tribes and U.S. territories; train State representatives in
the ESPP; distribute program materials; contribute to the development
of educational and outreach materials; and work closely with States in
developing State-initiated plans.
4. State efforts. To ensure that the county maps delineating the
pesticide use limitation areas are precise and reflect the result of
assessments that were based on currently occupied habitat, EPA has
continued to work with the States, FWS, and USDA in developing,
reviewing and revising the maps. Opportunity also has been provided for
their comment on the specific pesticide use limitations for individual
species.
State involvement varies, but review usually includes participation
by the SLA responsible for pesticide programs at the State level
(usually the State Department of Agriculture), State heritage and
conservation agencies, the pesticide coordinator for pesticide
applicator certification and training, and others. EPA has encouraged
the States to include a balanced role for representatives of non-
government environmental groups and the pesticide user community as
well.
States continue to play an active role in other aspects of the
ESPP. Their efforts include developing State-initiated plans,
incorporating endangered species modules into pesticide applicator
certification and training programs, refining species location
information, and providing input on the future directions of the ESPP
and ways to achieve program goals more effectively.
5. National partners' workshops. As EPA began to revitalize the
ESPP, three national workshops were held (in 1997, 1999 and 2001). The
purpose of these workshops was to seek input on future directions of
the ESPP and on ways to achieve goals more effectively. These workshops
resulted in the formulation
[[Page 71557]]
of the framework for this final program proposal.
At the heart of each of these workshops was the discussion of a
range of practical, nuts-and-bolts solutions for furthering endangered
species protection consistent with the ESA. A few dominant themes were
apparent throughout: To better protect threatened and endangered
species, everyone involved needs to communicate better; to share
information, data and resources; and to identify and focus on
priorities to make better use of limited resources. While the use of
technology to foster endangered species protection is crucial,
consideration must also be given to non-technological alternatives and
innovative practices (see Unit III.E.3.b. for some examples).
III. The Endangered Species Protection Program - Field Implementation
Proposal
EPA's implementation proposal is based on two goals. The first is
to provide appropriate protection to listed species and their habitats
from potential harm due to pesticide use. The second is to avoid
placing unnecessary burden on pesticide users and agriculture.
The following sections describe the elements of EPA's proposed
approach to implementing endangered species protections under existing
ESA regulations. These elements include: Scope, approach to reviewing
pesticides, completing and upgrading County Bulletins, amending
pesticide labels to reference County Bulletins, enhancing monitoring
programs, compliance and enforcement, and public participation.
Finally, this section describes the role of States and Tribes in the
Program, implementation timing, and program maintenance.
A. Scope of the ESPP
All pesticide products for which EPA makes a ``may affect''
determination may be subject to the ESPP.
1. Indoor products determination. EPA has determined that pesticide
products bearing label directions only for use indoors, and where the
applied pesticide remains indoors, will not result in exposure to
listed species. Therefore, these products will have ``no effect'' on
listed species and generally would not be subject to the ESPP. Indoor
use includes application within transport vehicles and within any
structure with enclosed walls and a roof, such as buildings,
greenhouses, outbuildings, etc.
This ``no effect'' determination would not apply to a pesticide
that is applied indoors, but could expose outdoor environments (such as
pesticides applied in cooling towers or used as cattle dips). Whether
these products result in a ``may affect'' determination will be
assessed on a case-by-case basis. If a ``may affect'' determination is
made for these products, they would be subject to the ESPP.
2. Public health emergencies. Under section 18 of FIFRA (40 CFR
part 166), a State or Federal public health agency may request that EPA
grant an emergency exemption from pesticide registration requirements
for a public health emergency if the State or Federal agency can
demonstrate that:
a. An emergency, non-routine condition exists that requires the use
of a pesticide.
b. Effective registered pesticides or alternative practices are not
available or economically or environmentally feasible.
c. The situation will present significant risks to human health.
Public health emergencies, verified by State or Federal public
health authorities, include situations in which:
(1) A pest outbreak poses a significant risk to human health or in
which the elements for disease outbreak (i.e., virus activity, large
population of disease vectors either present or pending, or others) are
demonstrated to be in place and prompt action is required to avert an
actual disease outbreak, and
(2) An actual disease outbreak is in progress and immediate action
is essential to arrest the outbreak.
In the latter case, a crisis exemption under section 18 may be
appropriate, which allows a Federal or State agency to authorize the
emergency use of a pesticide if its use is critical and enough time is
not available for EPA to receive and complete a review of the specific
request for a public health exemption. Consultations on emergency
actions are conducted in accordance with Service regulations found at
50 CFR 402.05.
Generally, in accordance with the ESA, EPA does not authorize use
of a pesticide under section 18 if that pesticide will jeopardize a
listed species or adversely modify critical habitat. However, if no
practical alternative control measures are available, during a public
health emergency, a public health exemption under section 18 may be
sought for the use of a pesticide that was found to jeopardize listed
species or adversely modify its critical habitat.
Specific Input Requested - Public Health Emergencies
[sbull] Is the above section 18 approach the appropriate mechanism
to address potential intersections of public health and listed species
protections?
[sbull] Should actions relative to public health emergencies
require consultation with the Services, and if so, should it be an
emergency consultation?
[sbull] What specific alternatives might be appropriate? How do
these alternatives allow the appropriate weighing and balancing of
public health and listed species protection?
3. Review of pesticides. To the degree possible, endangered species
issues will be addressed within the Agency's existing review processes
of registration and reregistration so that when a registration or
reregistration decision is made, it fully addresses issues relative to
listed species protection. Concurrently, the Agency will begin a
process to review those pesticides that have been through
reregistration review and were found potentially to affect listed
species or their critical habitat, or where the potential for effects
on listed species or their critical habitat was not considered. This
does not limit EPA's ability to make changes in its technical approach
nor in its data requirements. EPA and the Services are seeking input
relative to the technical and consultation aspects of the program
through an ANPR.
EPA attempted several different approaches to prioritizing reviews
in the past (see Unit II.E.a. through II.E.c.), each resulting in a
different set of issues and each more or less effective in differing
ways. EPA's proposed approach of addressing potential effect to listed
species on a chemical-by-chemical basis, is not without issues. With
any approach, EPA believes the best way to address the issues is to
develop a technical and consultation process that allows the Federal
Government to make appropriate decisions in a timely manner. By
focusing our internal processes to address listed species concerns
during registration and reregistration where possible, and by
identifying and implementing improvements in the technical aspects of
review and in the consultation processes, EPA believes many of the
issues resulting from a chemical-by-chemical approach to review will be
resolved.
4. Effect determinations and consultations. EPA's technical review
policies (Unit II.D.) and the Services' technical information and
analysis requirements under the ESA section 7 consultation regulations
currently form the analytical and procedural bases of EPA's Interim
Endangered Species Protection Program. As noted in Unit II.F.2., EPA is
engaged in a Proactive Conservation Review with the Services under ESA
section 7(a)(1) to analyze, among other things, the processes EPA uses
to determine whether a pesticide may affect a listed species. Further,
EPA
[[Page 71558]]
and the Services will be taking comment through an ANPR on options for
counterpart regulations that could amend the existing ESA and FIFRA
regulatory regimes in a manner that improves consultations on pesticide
actions. Until these efforts are finalized, EPA's current procedures
and the Services' existing regulations at 50 CFR part 402 will continue
to form the analytical and procedural bases of the ESPP.
B. Completing and Upgrading County Bulletins
The Interim Pamphlets (Unit II.E.3.) have been the centerpiece of
the ESPP. As a top priority, EPA will update existing Pamphlets to
reflect all current Biological Opinions, including the identified
species of concern, a table of pesticides that may harm those species,
and current use limitations to protect listed species. EPA will then
convert these Pamphlets to County Bulletins. The Agency will continue
to provide access to the Bulletins through its home page on the
Internet (www.epa.gov/espp) and improve the distribution network.
The Bulletins will be developed by EPA in cooperation with the
Services, USDA, States and Tribes. EPA will generally determine
appropriate use limitations and recommendations in the Bulletins by
reviewing results of ESA section 7 consultations and any other relevant
information that addresses the needs of the listed species. The
Bulletins will only be maintained and issued for counties for which
protection measures have been deemed necessary. Bulletins will:
1. Identify the species of concern.
2. Name the pesticides that may harm the listed species.
3. Provide a description of the protection measures necessary to
protect the species. Where species or habitat descriptions are helpful
or necessary to identify use limitations, EPA will also include this
information.
4. Contain a county map showing the geographic area associated with
the protection measures, depending on the sensitivity of the species to
other factors such as collection. Typically, maps will show a shaded
area indicating the area where pesticide use should be modified to
protect that species. Within shaded areas on the maps, the specific
protection measures will be identified for the pesticide and the
species being protected.
To ensure precision, EPA has been working with other Federal
agencies and the States in revising the maps and the tables of
pesticide use. EPA will develop draft maps and tables of pesticide use
limitations and send them to the States, Services, and USDA for review
as EPA updates the information for the County Bulletins, or as
completion of consultations results in EPA's decision to include
additional pesticides or species, or delete currently included
pesticides or species. Based on comments from Federal agencies, States
and Tribes during the review process, EPA will work with the commenters
to resolve any problems and to make any necessary revisions to the
Bulletins.
EPA also is working on making the maps easier to use. For example,
EPA has been exploring various mapping formats in attempting to convey
information to pesticide users most effectively. In some cases,
township-range-section designation may be the best way to delineate the
habitat of a species, while in other situations, local landmarks such
as roads or streams may work more effectively.
The Bulletins also will contain a printing date to indicate the
date the Bulletin was issued. As new information becomes available and
a Bulletin is revised, EPA will issue a new, revised Bulletin with a
new printing date. This Bulletin will supersede the Bulletin previously
issued, as identified by the new printing date. EPA will review the
County Bulletins as necessary, but generally will not update them more
than once annually.
Specific Input Requested - County Bulletins
County Bulletins will be the main basis for conveying information
to pesticide users. The Agency is particularly interested in comment on
various aspects of these documents as detailed below. (To facilitate
comment, an Interim Pamphlet may be printed from the Web site at
www.epa.gov/espp/usa-map.htm.)
[sbull] Are there ways to make the instructions for use easier to
understand?
[sbull] Is the mapped information depicted in a way that is
understandable? For example, is the use of township-range-section
designations appropriate?
[sbull] Is the use of natural and man-made landmarks appropriate?
[sbull] Is it clear what pesticides are subject to what use
modifications to protect listed species?
[sbull] Are there ways to make the protection measures easier to
understand?
[sbull] Are the narrative descriptions of habitat or of species as
a map supplement helpful?
[sbull] How can the Agency make protection areas as specific as
possible without infringing on the privacy of individual landowners,
who may be the sole custodians of a species on their property, while
still protecting the species and not subjecting the species to
potential harm by revealing its specific location?
[sbull] How can EPA ensure that growers know they have the most
recent Bulletins?
[sbull] Is annual updating of the Bulletins the right frequency? If
not, how often should EPA update them?
[sbull] How can EPA work with States to improve the development of
Bulletins?
C. Bulletin Distribution Procedures
EPA has been developing its distribution plan for Bulletins and
other ESPP information. A key factor in developing this plan is to make
sources of Bulletins and other information convenient to pesticide
users. In addition, different mechanisms may be appropriate for
different States and Tribes. As a result, distribution mechanisms could
include several or all of the following methods, depending on the State
or Tribe:
1. Mechanisms identified by SLAs.
2. Direct mailing to pesticide applicators within an affected
county.
3. Pesticide dealers and distributors. Ideally, Bulletins will be
available when and where pesticide applicators buy or obtain their
pesticides.
4. Cooperative Extension Service, Natural Resources Conservation
Service, Agricultural Stabilization and Conservation offices, and USDA
county offices in the vicinity of affected counties.
5. The Services' regional and field offices, where appropriate.
6. EPA Headquarters, Regional offices, EPA's toll-free number and
Web site.
EPA plans to evaluate these mechanisms continually and to modify
any part of the distribution process as the need arises and as more is
learned about the effectiveness of the various mechanisms.
Specific Input Requested - Bulletin Distribution
[sbull] Are the mechanisms identified for Bulletin distribution
appropriate?
[sbull] What other mechanisms would be of value?
D. Amending Pesticide Labels to Reference County Bulletins
EPA proposes to request label amendments of pesticide products for
which protection measures have been identified. This amendment would
generally include a statement directing the user to follow the
information in the County Bulletin. The label also would include a
statement regarding the
[[Page 71559]]
potential for effects to listed species. Finally, the label would
include information on how the user can obtain the County Bulletin. The
County Bulletins, in turn, would contain specific information on
species and areas where protection measures were necessary. Such a
system would help ensure that pesticide users are aware, before
applying pesticides, of both the potential harm to listed species and
how they can obtain information necessary to protect listed species.
The Agency has several approaches to requesting label amendments
for currently registered pesticides. In Reregistration Eligibility
Decisions (REDs), the Agency can make clear its regulatory position on
listed species protection and indicate the labeling that would be
necessary for products to be considered eligible for reregistration.
The Agency also could issue a Pesticide Registration (PR) Notice
requesting amendments of pesticide labels for which limitations have
been identified to protect listed species or critical habitat. The
Agency also could determine that in the absence of the amended label
language, the pesticide would no longer meet the risk/benefit standard
of FIFRA and would, therefore, be subject to cancellation.
The Agency intends to use the first approach when completion of a
listed species and critical habitat assessment and the identification
of use limitations coincides with completion of a RED. However, this
approach will not work in those instances where these two activities
are not coincidental (i.e., the RED is completed ahead of the listed
species determinations or vice versa).
To facilitate label changes in these situations, the Agency would
first review the existing Interim Pamphlets to determine that the
information is current. The Agency then intends to prepare a PR Notice
that will generally request registrants of products in those Pamphlets
to make label changes relative to listed species. Specific suggested
label language would be articulated in the PR Notice. After passage of
the time frames that would be articulated in that Notice, products for
which revised label statements are requested, and which do not bear
that statement, may be considered misbranded under FIFRA section
12(a)(1)(E) and may be subject to a Notice of Intent to Cancel. If
necessary, subsequent PR Notices would generally be issued annually to
request label changes for additional products. These Notices will also
indicate any products that have been removed from the Program.
Because the label statements would not be county-specific or use-
site specific, registrants would not need to change their product label
once the appropriate changes have been made, if protection measures are
extended to new locations or new species need protection. Label changes
would be necessary only if the protective measures specified in the
Bulletin are rescinded for all uses of the product. As noted in Unit
III.H., the Agency intends to take public input on several phases of
listed species assessment before implementing new measures.
The Agency proposes the following generic label statement be
adopted for instructing pesticide users about listed species
protection:
This product may have effects on federally listed threatened and
endangered species or critical habitat in some counties. When using
this product, you must follow the measures contained in the County
Bulletin for the county in which you are applying the pesticide. To
determine whether your County has a Bulletin consult http://www.epa.gov/espp/usa-map.htm. Bulletins also may be available from
local pesticide dealers, extension offices, or State pesticide
agencies.
Specific Input Requested - Labels
The Agency specifically requests comment on how best to accomplish
label changes to protect listed species, where EPA, FWS or NOAA
Fisheries has identified use limitations to ensure protection. The
Agency also seeks suggestions for specific label language to relay the
information articulated in this section.
E. Enforcement
For pesticide products determined to affect listed species or
critical habitat, the Agency is proposing that the product labels carry
a statement directing users to follow the appropriate County Bulletin
in effect at the time of product application. Another option is that
all Bulletins published by an annual date certain will be in effect for
12 months. In either case, pesticide users who fail to follow
provisions applicable to their pesticide application, whether that
failure results in harm to a listed species or not, would be subject to
enforcement under the misuse provisions of FIFRA (section 12(a)(2)(G)).
Specific Input Requested - Enforcement
In connection with these approaches, EPA seeks public comment on
whether:
[sbull] Either or both of these approaches provide effective means
to implement species protection.
[sbull] There are alternative means to ensure appropriate
protection of species that may be adversely affected from the use of a
pesticide.
F. Enhancing Monitoring Programs
Evaluating the extent to which the ESPP is protecting and
contributing to the conservation of listed species can be accomplished
in several ways. Potential options include monitoring to determine the
degree to which pesticide users in affected areas are or are not
applying pesticides in accordance with the County Bulletins, best
management practices associated with landowner agreements, and State-
specific approaches.
To determine the feasibility of this type of monitoring, EPA
proposes several pilot studies. At least two States would conduct a
pilot study with the Agency regarding adherence to information in the
Bulletins. States selected for this pilot would be from among those
that are currently working on more efficient ways to distribute County
Bulletins. EPA also proposes that another State, from among those
currently employing landowner agreements in their endangered species
protection efforts, pilot a review of the effectiveness of landowner
agreements. Finally, the Agency proposes that two additional States
assist in piloting a review of the effectiveness of State-specific
approaches (Unit II.E.3.b.). Again, the States selected for this pilot
would be from among those that have implemented protection programs
that vary from EPA's proposal in some significant respect.
Also, it is important that data being collected through acceptable
sources be used to the fullest extent possible to maximize efficiencies
and minimize costs. EPA proposes to use more effectively the
information being obtained by the U.S. Geological Survey to detect
pesticides in surface and ground water, information provided to EPA's
Office of Water under the Clean Water Act, and State-level ground or
surface water monitoring resulting from State pesticide program
efforts. EPA will also use the technical data identified during section
7 consultations with the Services. EPA proposes to analyze this
information to determine if residues of pesticides are occurring at
levels of concern in aquatic environments. Further, EPA proposes to
augment these data with targeted terrestrial residue monitoring,
possibly to include post-registration monitoring by registrants or
others. Locations would be determined with input from the Services and
the appropriate State or Tribe, based on proximity of pesticide use
sites with species locations. If such pilots result in broader
monitoring, this would be conducted as part of the States' or Tribes'
ongoing enforcement efforts.
[[Page 71560]]
Finally, EPA would continue and improve upon its cooperation with
the Services, States, Tribes, and others to review reported incidents
in which pesticides have had an impact on listed species and critical
habitat. EPA has been working with FWS field offices throughout the
country, as well as other Federal and State agencies, to ensure that
EPA has the best possible information on incidents. EPA's Environmental
Fate and Effects Division maintains an Ecological Incidents Information
System. EPA also gathers incident information from registrant reports
submitted under FIFRA section 6(a)(2), or those in which pesticide
registrants report to the Agency on observed adverse effects.
Specific Input Requested - Enhanced Monitoring
In particular, the Agency is interested in obtaining public input
on the following issues:
[sbull] The appropriate role of pesticide registrants and
manufacturers in performing environmental monitoring.
[sbull] The role incident data could play in protecting listed
species and critical habitat.
[sbull] Whether there are other ongoing monitoring programs EPA
should consider reviewing routinely for information.
[sbull] The role the Services should play in monitoring programs.
[sbull] Other methods of monitoring that might be appropriate for
the agencies to implement.
[sbull] How to improve the quality of information on the effects of
pesticides on listed species and critical habitat.
G. Role of the States and Tribes
Because local and State and Tribal circumstances may influence the
effectiveness of different approaches to listed species protection,
States and Tribes will continue to be integral to the success of the
ESPP. Specific roles include review of county maps; review of use
limitations to protect species; determining the effectiveness of the
program; and, at their discretion, development of alternative
approaches for protecting listed species.
1. Review of county maps. States and Tribes will be requested to
provide input to the Agency on county maps to accomplish several
things. First, accuracy of the maps is key to success of relaying
information to pesticide users. Therefore, States and Tribes will be
requested to provide feedback on draft maps relative to whether they
accurately depict landmarks, rivers, roads, etc. Further, State and
Tribal input on how best to characterize use limitation areas on the
County maps will be sought. For example, some States believe that their
pesticide users would be best served by designating limitation areas
based on township-range-section mapping, while other States believe
their pesticide users would prefer designations based on natural and
man-made landmarks such as rivers, roads and railways.
2. Review of use limitations to protect species. States and Tribes
also will be requested to provide input to the Agency on any potential
use limitations for species protection. The purpose of this review
would be for the Agency to ascertain, based on local conditions,
whether specific use limitations could be implemented. States and
Tribes will also be sources of input on the technological and economic
feasibility of implementing any proposed use limitations.
3. Help determine the effectiveness of the program. Because States
and Tribes are in closer contact with pesticide users than is the
Agency, they will be requested to assist the Agency in determining
whether the ESPP as implemented is effective in protecting listed
species. They also will be requested to assist in determining whether
the limitations outlined in County Bulletins are being followed or
modified based on local conditions, and whether any generic changes in
the County Bulletins would improve the success of this program.
4. Develop alternative approaches to protect listed species. States
and Tribes may develop and propose alternative plans for protecting
listed species in their areas. Such a plan would recommend measures and
approaches that EPA could use to protect listed species in that area.
If these plans are submitted to EPA for review and approval, EPA will
coordinate with the Services and consult, as appropriate, to determine
that the provisions of the plan will provide adequate protections for
listed species within that State or Tribal land. If EPA approves the
plan following any necessary consultation with the Services, EPA would
then adopt it and could require, through Bulletins, that users comply
with the requirements of the plan. Alternative plans can be developed
for all or a portion of the species affected in that State or Tribal
land.
An alternative plan may be submitted to EPA at any time. However,
once the federally initiated actions are implemented within an area,
those requirements will be effective in that area until the alternative
plan is approved for implementation.
H. Public Participation
EPA has encouraged the involvement of Federal agencies, States,
Tribes and members of the public throughout the development of the ESPP
and will continue to provide opportunities for public participation
once the program is final. EPA intends the final ESPP to be as flexible
as possible and to modify it as necessary to achieve the goals of
protecting listed species and minimizing the impact on pesticide users.
Eventually, the ongoing program will meld its components of public
participation with existing practices in the registration and
reregistration processes.
EPA will always welcome comments from the public on the various
aspects of the program. EPA intends periodically to reevaluate the
Program, review public comments, and modify the ESPP to continually
improve protection of listed species while serving the public interest.
Additionally, there are several major phases of a listed species
assessment that have opportunity for public input: (1) Prior to a ``may
affect determination'' by EPA, (2) subsequent to such determination but
during development of information with which to consult with the
Services, and (3) prior to issuance of a Biological Opinion to EPA by
the Services. EPA proposes to engage the public in each of these phases
as noted below. When any of these phases corresponds with a public
participation phase under EPA's ongoing review processes (i.e,
reregistration review), that ongoing public process will be used.
1. Prior to a ``may affect determination.'' The Agency proposes to
notify affected pesticide registrants and provide them an opportunity
to update information or provide additional information relative to the
determination. Subsequently, the Agency will make public in draft, any
determination that a pesticide ``may affect'' a listed species. The
public will have a 30-day opportunity to provide input to that
determination.
2. Subsequent to a ``may affect determination.'' The Agency will
accept information provided for use during consultation with the
Services. Information provided subsequent to a ``may affect
determination'' being made will not be considered by the Agency alone
but will be shared with the Services for joint consideration during
consultation.
3. Public comment on draft Biological Opinion. The Agency intends
to request that the Services provide draft Biological Opinions to the
Agency upon
[[Page 71561]]
their development. The Agency will provide opportunity for public input
to any reasonable and prudent measures or alternatives recommended by
the Services in these draft Biological Opinions. The purpose of this
review would be to determine whether the alternatives or measures can
be reasonably implemented and whether there are alternative measures
that may provide similar protection but result in less impact. The
Agency will consider this input in developing its response to the draft
Biological Opinions.
Specific Input Requested - Public Participation
The Agency seeks specific suggestions on how the public could most
effectively be informed of the Agency's determinations and
consultations. The Agency also seeks other suggestions for enhancing
public involvement in the ESPP.
I. Implementation Timing
Once public comment on this Notice has been considered and a final
Notice issued, the Agency intends to begin field implementation of the
ESPP. At the same time, EPA recognizes that technical and consultation
process issues may change based on input in response to the ANPR the
Agency will issue with DOI and DOC on or about the same date as this
Notice, or changes to FIFRA implementation regulations. However, the
Agency believes the responsible approach is to implement in a timely
manner, those aspects of listed species protection that the Agency can,
while building modifications and efficiencies into the longer term
effort of a sustained approach to protecting listed species.
Within 6 months of reviewing existing Interim Pamphlets for
accuracy, the Agency intends to modify them as appropriate and issue
them as County Bulletins. While the Bulletins will be widely available,
they will be effective upon reference to them on pesticide labels. The
Agency also will develop for public comment a PR Notice that will
identify time frames in which the Agency anticipates that registrants
could modify labels for these products.
Upon issuance of a final Notice of Program Field Implementation,
the Agency will begin the process of reviewing, for endangered species
implications, those pesticides for which REDs have already been issued
but for which specific endangered species assessments were not
completed during the RED process.
As pesticides are reviewed and determinations made for listed
species, the Agency will begin creating Bulletins or preparing to
include these pesticides in existing Bulletins, as appropriate. EPA
will review the County Bulletins as necessary, but generally update
them not more than once annually.
Specific Input Requested - Implementation Timing
How can EPA time the release of County Bulletins to minimize the
potential disruption to pesticide users during a growing season?
J. Program Maintenance
To the degree possible, endangered species issues are and will be
addressed within the Agency's existing processes of registration and
reregistration. Concurrently, the Agency will review those pesticides
that have been through reregistration and were found potentially to
affect listed species, or did not undergo ESA review during
reregistration. Once all registered pesticides have been re-evaluated,
EPA's future obligations to consult under ESA will be fulfilled through
an ongoing process of evaluation and referral. If new, valid
information becomes available on existing pesticide registrations, or
if new species affected by specific pesticides are listed under the
ESA, EPA will re-evaluate its determinations and reinitiate
consultation when appropriate. EPA anticipates that reinitiation on the
basis of new information will occur on an annual or biannual basis, as
necessary. EPA will periodically reinitiate consultation, as
appropriate, on pesticides already included in the Program to obtain
Biological Opinions for newly listed species. It is not the Agency's
intent, however, to change product labels and County Bulletins
constantly; rather, EPA intends to maintain the ability to act on
listed species and critical habitat issues if a new body of data
becomes available.
IV. References
All references are available for public review in the public
docket. The references used in this document are:
1. U.S. Environmental Protection Agency. 2002. Process for
Assessing Potential Risks to Endangered and Threatened Species and
Consultation with the National Marine Fisheries Service and the U.S.
Fish and Wildlife Service.
2. U.S. Environmental Protection Agency. 1986. Hazard Evaluation
Division Standard Evaluation Procedure, Ecological Risk Assessment.
3. U.S. Environmental Protection Agency. 1991. Report to Congress
on the Endangered Species Protection Program as it Relates to Pesticide
Regulatory Activities.
List of Subjects
Environmental protection, Pesticides, Endangered species.
Dated: November 25, 2002.
James Jones,
Acting Director, Office of Pesticide Programs.
[FR Doc. 02-30463 Filed 11-29-02; 8:45 am]
BILLING CODE 6560-50-S