Endangered Species Protection Program Field Implementation, 66392-66402 [05-21838]
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66392
Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices
Dated: October 20, 2005.
J. E. Leahy, Jr.,
Acting Director, Special Review and
Reregistration Division, Office of Pesticide
Programs.
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2002–0311; FRL–7739–7]
Endangered Species Protection
Program Field Implementation
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: This document describes how
EPA’s Office of Pesticide Programs
intends to implement 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 document
describes EPA’s approach to
implementing its responsibilities under
section 7(a)(2) of ESA subsequent to a
determination by EPA that
geographically specific risk mitigation is
necessary to protect federally listed
threatened or endangered species or
their critical habitat. For purposes of the
ESPP, the term ‘‘listed species’’ or
‘‘endangered species’’ will encompass
species listed as threatened or
endangered, plus designated critical
habitat of these species; the term
‘‘county’’ will include counties,
parishes, and similar political
boundaries of U.S. Territories. The
implementation approach relies on
pesticide labels, as appropriate,
referring the pesticide user to
geographically specific Endangered
Species Protection Bulletins that will
contain enforceable use limitations for
the pesticide necessary to ensure the
pesticide’s use will not jeopardize the
continued existence of a listed species.
FOR FURTHER INFORMATION CONTACT: For
technical information: Arthur-Jean B.
Williams, Environmental Fate and
Effects Division (7507C), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460;
telephone number: (703) 305–7695; fax
number: (703) 305–6309; e-mail address:
williams.arty@epa.gov.
For field implementation information:
Mary Powell, Field and External Affairs
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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.1. Once in
the system, select ‘‘search,’’ then key in
the appropriate docket ID number.
I. General Information
[FR Doc. 05–21626 Filed 11–1–05; 8:45 am]
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:
powell.mary@epa.gov.
SUPPLEMENTARY INFORMATION:
A. What Action is the Agency Taking?
A. Does this Action Apply to Me?
This action is directed to the public
in general, and may be of particular
interest to State and Tribal regulatory
partners, other interested Federal
agencies, environmental or public
interest groups, pesticide registrants and
pesticide users. Since 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
technical person listed under FOR
FURTHER INFORMATION CONTACT.
This Notice describes EPA’s field
implementation plan for putting in
place any geographically specific
pesticide use limitations EPA deems
necessary to ensure EPA’s compliance
with ESA section 7(a)(2). This approach
will be used to put in place pesticide
use limitations identified as necessary
by EPA during the course of its
endangered species risk assessment
process or through consultations with
the U.S. Fish and Wildlife Service
(FWS) and the National Marine
Fisheries Service (NMFS) . These
protections or use limitations will be
enforceable by EPA under section 12 of
FIFRA.
This Notice is organized into four
units. Unit I. provides general
information about applicability of this
document and the availability of
additional information. Unit II. provides
background information, including the
Agency’s legal authority for taking this
action, and a summary of public
comments on EPA’s proposed approach
(67 FR 71549, December 2, 2002) (FRL–
7283–7) and its response to those
comments. Unit III. describes the
Program, including its scope, overall
approach, and Endangered Species
Protection Bulletins. Unit IV. contains
references to other documents used in
the development of and referenced in
this Notice.
EPA will begin using this approach to
implement geographically specific risk
mitigation for the protection of listed
species or their critical habitat upon
publication of this Notice. EPA’s plan as
described in this document, however, is
not a legally binding regulation and EPA
may decide to revise, amend, or act at
variance with the terms of this
document without providing notice and
comment under section 553 of the
Administrative Procedure Act.
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, 1801 S. Bell St.,
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
https://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 https://www.epa.gov/edocket/
to view public comments, to 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.
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II. Background
B. What is the Agency’s Authority for
Taking this Action?
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, for
thousands of pesticides containing
hundreds of active ingredients. These
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registrations encompass thousands of
different use sites and practices across
the United States.
FIFRA as amended (7 U.S.C. 136 et
seq.) governs the regulation of pesticides
in the United States. Under FIFRA, a
pesticide product generally may be sold
or distributed in the United States only
if it is registered 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
practices, will not generally cause
‘‘unreasonable adverse effects on the
environment’’ (FIFRA 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 be 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). 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
review every 15 years) to determine
whether such registrations meet the
requirements of the Act (FIFRA section
3(g)(1)(A)). This latter requirement is
known as registration review. EPA
recently published a Notice of Proposed
Rulemaking (NPRM) to establish
procedural regulations for conducting
registration review (70 FR 40251, July
13, 2005) (FRL–7718–4).
The purpose of the Endangered
Species Act (ESA) (16 U.S.C. 1531 et
seq.) is 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.
Section 7(a)(1) of the ESA, 16 U.S.C.
1536(a)(1), requires federal agencies to
use their authorities in furtherance of
the purposes of the ESA by carrying out
programs for the conservation of listed
species.
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Section 7(a)(2) of the ESA, 16 U.S.C.
1536(a)(2), and the implementing
regulations at 50 CFR part 402, further
require federal agencies to ensure that
their actions are not likely to jeopardize
the continued existence of any listed
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, under certain
circumstances, consult with the
Secretary of the Interior (which has
delegated the interagency consultation
responsibilities to the FWS) and the
Secretary of Commerce (which has
delegated the interagency consultation
responsibilities to the NMFS within the
National Oceanic and Atmospheric
Administration), regarding the effects of
Agency actions on listed species or
designated critical habitat. In fulfilling
this requirement, federal agencies must
use the best scientific and commercial
data available.
Section 7(a)(4) of the ESA, 16 U.S.C.
1536(a)(4), requires federal agencies to
confer with the Services (jointly, FWS
and NMFS) on any agency action that
will likely jeopardize the continued
existence of any species proposed to be
listed as threatened or endangered, or
adversely modify critical habitat
proposed to be designated for
endangered species.
In 1988, Congress addressed the
relationship between the ESA and EPA’s
pesticide labeling program in section
1010 of Public Law 100–478 (October 7,
1988), which required EPA to conduct
a study and to provide Congress with a
report of the results (U.S. EPA’s 1991
report to Congress: Endangered Species
Protection Program as it Relates to
Pesticide Regulatory Activities, EPA
540–09–91–120, May 1991) on ways to
implement EPA’s endangered species
pesticide labeling program in a manner
that both promotes the conservation of
listed species and minimizes the
impacts to persons engaged in
agricultural food and fiber commodity
production and other pesticide users
and applicators. This law provided a
clear sense that Congress desires that
EPA should fulfill its obligation to
conserve listed species, while at the
same time considering the needs of
agriculture and other pesticide users.
Further, section 1010 subsection (a)
directs EPA to take public comment on
any proposed pesticide labeling
program imposed in order to comply
with the ESA. Pursuant to that
provision, EPA issued and sought
public comment on its Endangered
Species Protection Program in December
2002 (67 FR 71549, December 2, 2002).
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The Services have promulgated
regulations at 50 CFR part 402
addressing the means by which all
federal agencies may satisfy their ESA
section 7(a)(2) consultation obligations.
In 2004, the Services published
Counterpart Regulations (69 FR 47732,
August 5, 2004) that provide additional
alternative procedures that EPA may use
to meet its ESA section 7(a)(2)
obligations for pesticide regulatory
actions under FIFRA. In order to use the
Counterpart Regulations, EPA entered
into an Alternative Consultation
Agreement (ACA) (Ref. 4) with the
Services. This ACA establishes the
interagency process for implementing
and ensuring compliance with the
Counterpart Regulations. In connection
with the development of the
Counterpart Regulations and the ACA,
EPA developed its Technical Overview
of Ecological Risk Assessment (Ref. 1),
detailing EPA’s approach to ecological
risk assessment for endangered species.
This ‘‘Overview’’ document and the
processes it describes were reviewed by
the Services and deemed to be processes
that will result in ESA-compliant risk
determinations (Ref. 6).
C. EPA’s Role
1. ESA section 7(a)(1) obligations. As
noted in Unit II.B., 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. EPA’s
Office of Pesticide Programs (OPP) has
carried out a number of activities
intended to conserve listed species,
including: Hosting a web site that
contains listed species fact sheets and a
county-scale data base of listed species
locations by county, and producing and
disseminating informational and
educational materials. Additionally,
EPA has worked with State agencies
responsible for pesticide programs and
extension services to ensure that
pesticide applicators certified by the
States receive, during their certification
training, information on listed species’
protection needs. Listed species issues
and concerns are included as part of the
testing requirements for State-certified
applicators in many States.
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. The
ESA does not, however, provide action
agencies, such as EPA, with
independent authority to modify agency
actions for the benefit of listed species.
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Rather, action agencies must utilize
their existing authorities, such as EPA’s
authority under FIFRA, to the extent
permissible, to provide such
protections. Accordingly, EPA’s
challenge is to implement FIFRA, a risk/
benefit statute, in a way that harmonizes
with the ESA, to the fullest extent
possible, 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 under FIFRA 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 a proposed
pesticide registration action will have
no effect on any listed species or
designated critical habitat, consultation
under ESA section 7(a)(2) is not
required. A determination that a
proposed pesticide registration action is
not likely to adversely affect any listed
species or designated critical habitat is
subject to the Services’ consultation
regulations regarding ‘‘informal
consultation.’’ EPA may either utilize
the provisions of the Counterpart
Regulations at 50 CFR part 402, subpart
D, and complete this determination
without obtaining Service concurrence,
or EPA may choose to seek the written
concurrence of the Services on this
finding under the Services’ regulations
at 40 CFR part 402, subpart B, that apply
to all federal agencies. If EPA
determines that a proposed pesticide
registration action is likely to adversely
affect a listed species or designated
critical habitat, EPA is required to enter
into a process with the Services called
‘‘formal consultation.’’ The consultation
process is designed to assist federal
agencies in developing actions that will
not jeopardize the continued existence
of any listed species or result in
destruction or adverse modification of
any designated critical habitat (ESA
section 7(a)(2)). Following consultation,
the Agency is responsible for
implementing protections, if necessary,
through its available authority.
D. The Roles of FWS and NMFS
The Department of the Interior’s U.S.
Fish and Wildlife Service (FWS)
administers the ESA for most species.
The Department of Commerce’s
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National Marine Fisheries Service
(NMFS) administers the ESA for certain
marine and anadromous species. EPA
may enter into informal or formal
consultation with the Services
concerning effects to listed species or
critical habitat (or confer on proposed
species). At the conclusion of formal
consultation, the Services determine
whether an EPA action is likely to
jeopardize the continued existence of a
species or destroy or adversely modify
designated critical habitat. If the action
is likely to cause jeopardy, the Services
propose reasonable and prudent
alternatives, to the extent available, to
avoid jeopardy. In connection with
consultation, the Services’ Biological
Opinion will also address whether
incidental take is anticipated from the
Agency’s action. If so, the Services may
authorize a certain amount of incidental
take, provided any reasonable and
prudent measures identified by the
Services are adopted by the Agency and
followed by pesticide users. Take, as
defined in section 3(18) of the ESA, is
unlawful unless the Services issue an
incidental take statement that provides
an exemption to the prohibitions on
take of listed wildlife, incidental to
certain federal actions. The Services
maintain enforcement authority
regarding the unlawful take of listed
species under section 9 of the ESA.
E. Summary of Comments on EPA’s
ESPP Proposal
On December 2, 2002, EPA published
a Federal Register Notice soliciting
public comment on its proposed field
implementation program (67 FR 71549).
EPA received 228 letters in response.
Most of the letters (143) were from
private citizens. Letters were also
received from agricultural and pesticide
associations (55), State and federal
agencies and their representatives (18),
and environmental groups (12). When
broken out into individual topics, the
comments within these letters totaled
more than 600.
Commenters were fairly evenly split
between those who generally supported
the proposal and those who generally
opposed it. Supportive commenters said
the proposal was an appropriate balance
of Program goals that makes efficient
use of resources and Agency expertise
in pesticide regulation. Opposing
commenters said the proposal was
inadequate to protect listed species,
weakened existing laws, and should in
no way consider economics in
determining protections for listed
species.
Numerous comments were received
on consultation, technical, and science
policy issues that were outside the
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scope of the ESPP. While the proposal
included a summary of EPA’s processes
for making effects determinations and
consulting with the Services, that
information was included solely to
provide context to the reader. For more
information about the technical aspects
of endangered species risk assessment
and consultation with the Services,
readers are referred to the Counterpart
Regulations at 50 CFR part 402 (69 FR
47732, August 5, 2004), EPA’s Overview
Document (Ref. 1), and the Alternative
Consultation Agreement (Ref. 4).
All comments submitted in response
to the proposal are available in docket
ID number OPP–2002–0311 as described
in Unit I.B. A summary of the specific
areas on which EPA requested
comment, follows below.
1. FIFRA section 18 emergency
exemptions. The Agency requested
comment on how it proposed to address
endangered species in the context of
FIFRA section 18 emergency
exemptions in general and specifically
for public health emergencies.
Comment: Most of 24 commenters
acknowledged the necessity for a rapid
response in public health emergencies,
but differed on the point at which an
endangered species review should be
carried out, if at all, and whether
consultation may be appropriate in such
situations. Suggested alternatives to the
proposed approach included requiring
that FWS and State, Tribal and local
officials establish a balanced program to
solve health emergencies on a case-bycase basis with minimal impact on
listed species, and assume some take
would occur (1 commenter); consulting
with as many State and federal agencies
as possible to respond to the emergency
(1 commenter); detailing a FWS person
to EPA to work with EPA on requests for
crisis exemptions (1 commenter); and, if
no ESA review is done because of the
extreme nature of the emergency,
complete the listed species review as
soon as possible afterward, without
extending the emergency registration
until the ESA review is completed (6
commenters).
Response: While EPA will endeavor
to resolve concerns regarding listed
species prior to taking an action, that
may not always be possible for section
18s, which by their very nature are time
critical, especially those involving
public health emergencies. When
submitting a section 18 request States,
Tribes and federal agencies will be
expected to demonstrate they have
made a credible effort to identify and
address endangered species issues. The
more thorough the approach of the
submitter, the more likely it will be that
EPA can conduct its endangered species
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assessment and consult with the
Services, as necessary, within the time
constraints for review of FIFRA section
18 applications. However, under the
Counterpart Regulations, the Services
have indicated that emergencies under
section 18 of FIFRA may be treated as
‘‘emergencies’’ under the Services’
consultation regulations. As a result, if
EPA cannot perform a comprehensive
endangered species assessment or, if
applicable, initiate and complete formal
consultation within the time constraints
for review of a section 18 application,
EPA may use the emergency informal
consultation procedures described in
the Services’ Endangered Species
Consultation Handbook (Ref. 5) and
complete any necessary formal
consultation as soon as practicable after
the emergency.
2. County Bulletins. The proposal
described the substance of county-level
Endangered Species Protection Bulletins
(Bulletins) that would be the
mechanism to inform pesticide users of
any specific changes to pesticide use
required to protect a listed species. The
Agency requested comment on a variety
of aspects of the Bulletins, ranging from
how to make them more understandable
to frequency of updates and distribution
mechanisms. EPA received about 150
comments on a range of issues about the
Bulletins, including when their use is
appropriate, how to make them easier to
use, when to update them, and how to
work more effectively with States in
Bulletin development.
Comment: General--Bulletins were
viewed by some as either inadequate to
protect listed species (5 commenters) or
as providing a practical, site-specific
mechanism for protecting listed species
that may be affected by pesticide use (20
commenters). About 40 commenters
said Bulletins should not be required if
alternative protection measures for
listed species exist, such as landowner
or conservation agreements; most of
those same commenters said growers
and their consultants should have the
right to use alternative mitigation
measures to protect listed species if
their methods are scientifically
defensible. Other commenters
supported the Bulletins, but expressed
concerns about privacy, frequency and
notification of updates, and methods
used to determine areas requiring
protections for listed species.
Response: EPA continues to believe
that Bulletins offer the best compromise
between the lengthy time required to
change product labels and being able to
more quickly inform pesticide users of
any required use limitations to protect
listed species or critical habitat. Under
the Agency’s approach, the label will
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carry a generic label statement referring
pesticide users to the Bulletin. The
Bulletins will carry the same weight for
enforcement purposes as information on
the label, and failure to follow the
appropriate Bulletin would be subject to
enforcement action under FIFRA.
The ESA requires EPA to ensure that
the pesticide registration actions it
authorizes are not likely to jeopardize
the continued existence of listed species
or adversely modify the designated
critical habitat of such species. The
Services have endorsed EPA’s risk
assessment process for pesticides, as
outlined in the Agency’s Overview
Document (Ref. 1), as an appropriate
means of assessing risks and making
effects determinations for listed species
and designated critical habitat. Before
EPA could consider an alternative
protective measure, it would need to
ensure that the assessment methods
used by the State or Tribe were adequate
to evaluate risks to the species and
critical habitat and that any alternative
measures would provide adequate
protection. EPA cannot, therefore, omit
from consideration lands subject to
landowner or conservation agreements
when assessing risks to listed species.
However, if EPA’s risk assessment
concludes that such agreements are an
appropriate and effective means to
protect listed species, EPA could adopt
those measures by stating in the Bulletin
itself that a pesticide user must apply
the pesticide only under the terms and
conditions of the agreement.
EPA will seek input, as appropriate,
from stakeholders on use limitations it
includes in the Bulletins prior to
adopting them. It would be appropriate
to bring to EPA’s attention any
alternative protective methods the user
community believes exist at that time.
Opportunities for public participation
exist throughout EPA’s decision
process. Therefore, users are
particularly encouraged to stay involved
in that decision process so that EPA can
incorporate practical measures into its
decisions and Bulletins as early as
possible.
Comment: Ease of use--EPA should
use clear, consistent, plain-language
statements and formats throughout all
Bulletins and, in particular, in pesticide
use restrictions (44 commenters). Use a
pesticide’s common, trade or brand
name instead of active ingredient name
in the table of pesticides (11
commenters).
Response: Bulletins will convey
geographically specific pesticide use
information to pesticide users, so it is
crucial that they understand and can
easily use the information the Bulletins
present. EPA agrees that language,
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terminology, format, etc., must be as
clear, concise, and uniform as possible.
EPA has been working with other
federal agencies, States, Tribes, and
other stakeholders to revise and
improve the Bulletins, especially the
maps and tables of pesticide use
restrictions, with the goal of achieving
consistency and ease of use of all
information presented.
Maintaining Bulletins and the
information appropriate to each county
where a geographically specific use
limitation is needed will be a significant
undertaking. EPA is disinclined to add
to this undertaking the challenge of
keeping current all the product names
for each active ingredient subject to one
or more Bulletins across the country.
Therefore, EPA does not intend to
include trade or product names in the
Bulletins but instead intends to use the
active ingredient name.
Comment: Maps and private lands-Suggestions varied for how EPA can
make protection areas as specific as
possible without infringing on
individual landowners’ privacy. The
largest number of comments on this
topic (14 commenters) concerned
respect of private property rights in
developing county maps. Thirteen
commenters suggested that in cases
where a listed species occurs only on
privately owned lands, landowner
agreements be used in lieu of publishing
a Bulletin that would identify those
lands.
Response: EPA agrees that it is
important to respect the privacy of
individuals. However, EPA is not in a
position to enter into landowner
agreements with all individuals
regarding their use of pesticides.
Further, concern regarding the
enforcement of any such agreements if
landownership changes is one of the
many complex implementation issues
that EPA would have to resolve to adopt
such an approach. Additionally, while a
species may be located only on lands
owned by a single individual, use of
pesticides adjacent to that land or
upstream from a particular geographic
location could also have effects on the
listed species or its critical habitat. For
these reasons, EPA does not intend to
forego Bulletin development in favor of
landowner agreements.
Comment: Maps and delineation of
use limitation areas--Nine commenters
said township-range-section
designations alone, or in conjunction
with natural and man-made landmarks
and boundaries, should be used to
delineate species protection areas. Nine
other commenters said map locations
alone, not natural boundaries, habitat
types, etc., should be used because
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those designations can result in larger
restricted areas than warranted by
sound science. Seven commenters said
protection areas should be referenced by
Geographic Positioning System (GPS)compatible points. Eight commenters
supported the use of narrative
descriptions of listed species and/or
habitat to explain use restrictions in a
Bulletin.
Response: EPA acknowledges that
State, Tribal and local situations greatly
influence the most appropriate
designation to use in producing maps
and protection boundaries. The Agency
will be flexible in its choices when
preparing draft maps for State and
Tribal input. EPA will use both natural
and man-made boundaries as
appropriate and necessary with the goal
of identifying the geographic area where
any use limitation applies but without
unnecessarily enlarging that area.
Bulletins will generally 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
patterned or shaded area indicating
where pesticide use must be limited to
protect that species. Within patterned or
shaded areas on the maps, the specific
protection measures will generally be
identified for each pesticide and the
species being protected. Where species
or habitat descriptions are helpful or
necessary to identify use limitations,
EPA will include that information in
Bulletins. Also, where possible without
causing further threat to a species, the
Bulletins will provide a picture and
description of the species. While it is
EPA’s intention to use geographic
information systems to develop and
produce the maps that will be included
in Bulletins, we do not intend to
provide specific GPS coordinates in the
Bulletins.
Comment: Notifying users when a
Bulletin applies--EPA requested
comment on how the Agency could
ensure that growers know they have the
most recent Bulletins. Seven
commenters said there must be a
uniform mechanism for informing
pesticide users of when a Bulletin is
available; five of those commenters
suggested computer-generated Bulletins
at the time of sale as the appropriate
mechanism. Three other commenters
suggested placing a notice on EPA’s web
site.
Response: EPA has developed a
uniform mechanism for notifying
pesticide users when a Bulletin may
apply to their pesticide application; that
is, through placement of a generic
statement on the pesticide label
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directing pesticide users to follow the
Bulletin for their county if one is
available. Pesticide users may access the
appropriate Bulletin for their pesticide
use in one of two ways: Either by
checking EPA’s web site, https://
www.epa.gov/espp, or if Internet access
is not available, users may determine
whether a Bulletin exists for their
pesticide use by calling 1–800–447–
3813, and if a Bulletin is available it can
be mailed to the caller. Pesticide users
should check for availability of a
relevant Bulletin no more than 6 months
before applying a pesticide to ensure
they are using the current Bulletin for
the county.
Comment: Updating frequency and
effective date of Bulletins--EPA
requested comment on whether annual
updating of the Bulletins is the
appropriate frequency and, if so, what
an appropriate effective date would be.
Fifteen commenters said Bulletins
should be updated annually. Other
suggestions ranged from, simply,
‘‘regular updating,’’ to ‘‘as soon as
consultations are completed and use
limitations put in place,’’ to ‘‘a 3–year
schedule.’’ Ten commenters said
Bulletins also need to be dated so
pesticide users can be assured they are
using the current version of the Bulletin.
Response: It is not EPA’s intent to
constantly seek changes to product
labels and make Bulletin changes. At
the same time, EPA intends to maintain
the ability to act on listed species and
critical habitat issues when protection
decisions are made or when a new body
of data becomes available. EPA believes
the best compromise between acting
quickly to protect listed species and not
engendering confusion with constant
changes in label instructions can be
reached by providing Bulletins via a
web-based system, as described below.
The generic statement on the label will
direct pesticide users to follow the use
limitations in a Bulletin applicable to
their county and their pesticide
application; pesticide users may
generally obtain this information 6
months before the date on which they
intend to apply the pesticide.
Bulletins will be available for viewing
and printing on the web at https://
www.epa.gov/espp. Those without
access to the Internet may call EPA at
1–800–447–3813 to determine
applicability and availability of a
Bulletin. Bulletins will be printed and
mailed upon request. Bulletins obtained
either from the web or from EPA will
indicate the time frame for which they
apply.
Comment: EPA and the States and
Tribes working together to improve the
development of Bulletins--EPA
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proposed specific roles for States and
Tribes that would 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 in the form of State or
Tribal initiated plans. Several
commenters supported this proposed
approach, but expressed concern about
having the resources to undertake such
a program. One suggestion was to
incorporate Bulletin development into
performance partnership grant
agreements.
Other comments received were not
necessarily specific to Bulletin
development, but still addressed how
EPA, States and Tribes should work
together to protect listed species. About
50 commenters said EPA should broadly
define the Program goals and help
develop a general process, but then
allow programs to be fully developed
and tailored at the State and Tribal
level.
Response: Given the specifics of the
program as articulated, EPA believes it
will not result in significant additional
resource needs on the part of States and
Tribes. EPA will provide Bulletins via
the web or through a toll-free number,
thus eliminating the proposed role of
the States and Tribes in Bulletin
distribution. Enforcement actions will
be carried out through existing methods
of FIFRA inspection, investigation and
enforcement, just as all pesticide use
requirements are enforced. EPA is not
requiring States, Tribes, local
governments or others to participate in
Bulletin review; rather, the Agency will
provide an opportunity for review at
appropriate points in the risk
assessment process and prior to
publishing Bulletins on the web. This
cooperative activity may be
incorporated into performance
partnership grant agreements so that
EPA and the States and Tribes can
effectively negotiate resources and
clearly define outputs and outcomes.
The ESPP continues to provide States
and Tribes an opportunity to develop
State or Tribal initiated plans. Again,
these plans are not a requirement but an
option in which they may choose to
engage.
Comment: Bulletin Distribution-When the ESPP was proposed for
comment, EPA had been developing a
broad-based distribution plan for
Bulletins and other ESPP information
that was based on availability of both
paper and electronic copies of Bulletins.
A key factor in developing that plan was
to make sources of Bulletins and other
information convenient to pesticide
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users. The overwhelming sense of more
than 50 comments received on this topic
was that Bulletins must be easily and
readily accessible. About a dozen
commenters preferred availability on
the web, although concerns were
expressed regarding web access and
ease of printing (3 commenters), as well
as possibly publicizing exact species
locations when specific farms or
ranches might be identified in county
maps (5 commenters). Other suggested
distribution mechanisms for paper
copies of Bulletins included points of
sale such as pesticide dealers,
distributors and retail stores; State lead
agencies; U.S. Department of
Agriculture’s Cooperative Extension
Service; the Services; and applicator
training programs.
Response: In the time since EPA
proposed the ESPP, EPA’s ability to
utilize web-based technology has
evolved and funding situations have
changed. These factors, combined with
the public comment on the proposal and
EPA’s desire to minimize label changes
while providing timely protection to
listed species, have led to EPA’s
decision to use a web-based system as
the main route of Bulletin distribution.
EPA believes web-based Bulletin
distribution provides the best
compromise between the time required
to change product labels and being able
to more quickly inform pesticide users
of any required use restrictions to
protect listed species or critical habitat.
The Agency also believes such a system
is more cost-effective than printing
paper copies and will eliminate possible
confusion about whether pesticide users
have the current version of a Bulletin.
Therefore, EPA will provide Bulletins
via a web-based system or, if a pesticide
user does not have access to the
Internet, through calling a toll-free
number, as described above.
3. Labels and Bulletins. EPA proposed
to use a generic label statement that
would be included on the labels of
products for which pesticide use
limitations were necessary to ensure
protection of listed species. This generic
statement would refer the pesticide user
to further use limitations in a countylevel Bulletin.
Comment: More than 110 commenters
said mandatory protections for listed
species must be on the pesticide label,
not in a Bulletin or on a web site. Many
indicated specific information they
believed should be included on the
label such as: The name of the species
to be protected, what protections apply,
where those protections apply, and
penalties for failure to comply with the
label restrictions. Eleven commenters
said pesticide users should not have to
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go to more than one source to obtain
compliance information. Seventeen
commenters expressed some level of
support for a generic label statement
directing pesticide users, when
necessary, to follow a Bulletin.
Response: EPA has considered again
the feasibility and desirability of
including all pertinent information
regarding listed species protection on
the actual pesticide product label itself.
EPA continues to believe this approach
is not feasible, would not result in better
protection for listed species, and would
by necessity be overbroad in terms of
geographic areas in which limitations
on pesticide use are necessary to protect
listed species. EPA intends to provide
protection for listed species while
minimizing any unnecessary burden on
pesticide users, as we believe was the
intent of Congress in passing section
1010 of Public Law 100–478 (October 7,
1988). While geographically specific use
limitations may certainly be described
in text, such description could be very
lengthy consisting of numerous
coordinates of many geographic points.
This type of information is more
amenable to portrayal through graphic
methods. Further, should changes be
necessary as a result of additional
species being listed etc., changes to the
Bulletin could be accomplished more
readily than further changes to a
pesticide label. Therefore, by using
Bulletins rather than the pesticide
product label to relay the specific use
limitations, protection will be more
timely for the listed species.
4. Enforcement. For pesticide
products determined to affect listed
species or critical habitat, the Agency
proposed that the product labels carry a
statement directing users to follow the
appropriate Bulletin in effect at the time
of product application or that all
Bulletins published by an annual date
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)).
Comment: Liability and incidental
take--Most of about 18 commenters in
this area were concerned with liability
and incidental take. Fourteen
commenters said those who follow label
instructions and accidentally harm a
listed species should not be subject to
any liability, and any enforcement of the
ESPP should be done through FIFRA,
not the ESA.
Response: The obligation of pesticide
users under FIFRA to comply with a
pesticide product’s label will not change
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under the Program. Bulletins will be
enforced as are pesticide labels since
compliance with the Bulletins will be a
labeling requirement. As for the ESA,
the Services may under some
circumstances issue what is called an
‘‘incidental take statement’’ which
authorizes take of species under certain
circumstances. If such a statement
authorizes take that may result from the
use of a pesticide in compliance with
FIFRA, a pesticide user applying the
pesticide consistent with the labeling
would not be subject to enforcement
action under the ESA for taking a listed
species. However, if the Services have
not authorized take by issuance of an
incidental take statement, and take
occurs from use of the pesticide, a
pesticide user could be liable for take
under section 9 of the ESA, regardless
of whether they complied with the use
requirements for the pesticide or not. In
situations where EPA’s analysis results
in a determination that a pesticide’s use
is ‘‘likely to adversely affect’’ a species,
EPA will be consulting with the
Services. If the pesticide’s use will not,
in the opinion of the Services, result in
jeopardy to the species, they may
develop and issue an incidental take
statement. In situations where EPA’s
analysis results in a determination that
use of the pesticide with any use
limitations in the Bulletin is ‘‘not likely
to adversely affect’’ the species, further
consultation with the Services may not
occur. In these situations, there is by
definition, no incidental take
anticipated since the pesticide is ‘‘not
likely to adversely affect’’ a species.
Thus, while a pesticide user could be
liable for take under the ESA of a listed
species even when following all the
appropriate use requirements, including
those articulated through a Bulletin, this
scenario is highly unlikely to occur.
5. Enhanced monitoring. EPA
proposed several ways to evaluate the
extent to which the ESPP is protecting
and contributing to the conservation of
listed species. EPA proposed to use
existing monitoring and incident data
more effectively, to monitor
effectiveness of Bulletins after they have
been used for a time, and to sponsor
some limited terrestrial monitoring to
better understand whether specific
provisions in Bulletins were resulting in
decreased potential for a listed species
to be exposed at levels of concern.
Comment: Nearly 60 comments were
received on this broad area of
discussion. More than 30 commenters
said any monitoring data should be used
either to refine the endangered species
risk assessment or to minimize the areas
affected by pesticide use limitations
designed to protect listed species or
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critical habitat. Ten commenters said
monitoring must involve the States, be
done at the State level or be done by the
States. In response to our proposal to
augment monitoring data with targeted
terrestrial residue monitoring, possibly
to include post-registration monitoring
by registrants or others, 13 commenters
objected to registrants playing a role in
any monitoring because of potential
conflicts of interest or the added burden
to the companies, while five
commenters said the Services should
play some role in monitoring, ranging
from oversight of others to performing
the monitoring themselves. Six
commenters questioned the utility and
applicability of incident data in risk
assessments, largely because of qualitycontrol issues and the lack of a
definition of best available data. Nine
commenters agreed that EPA should
make better use of existing monitoring
programs, rather than adding additional
monitoring schemes.
Response: Given the comments
received, the potential of budget
considerations at the federal, State and
Tribal levels of government, and the
need to ensure that any new monitoring
undertaken by the federal government is
well defined and considers input of
stakeholders, this notice does not
include an EPA plan for new terrestrial
monitoring. However, this is an area
that EPA will continue to explore as the
program moves forward, to determine
whether it has broad utility in
evaluating the effectiveness of the
program.
EPA will continue to consider and
improve upon its use of existing
monitoring and incident data in its
analyses of potential effects to listed
species. EPA continues to believe that
the result of monitoring programs
generally do not provide sufficient
information on which to base a
regulatory decision unless those
programs are specifically designed to
answer the particular questions being
posed. However, both monitoring and
incident data may, to varying degrees
based on the quality of the information
and the confidence in the information,
be of value in characterizing the extent
of potential exposure of a listed species
to a pesticide. EPA will consider
incident information reported to its
incident monitoring programs and
monitoring data conducted under the
U.S. Geological Survey’s National Water
Quality Assessment Program and
monitoring data submitted to EPA’s
Office of Water under the Clean Water
and Safe Drinking Water Acts, to help
characterize the extent of potential risk
to listed species. Additionally, if OPP is
aware of monitoring programs
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conducted by OPP’s State or Tribal
regulatory partners, EPA will assess the
utility of the data resulting from those
programs and use those data, as
appropriate. Finally, there may be
specific targeted monitoring conducted
by the regulated industry at EPA’s
request. These data too will be used, as
appropriate, to help characterize the
extent of potential exposure of listed
species to pesticides.
6. Public participation. The proposal
articulated EPA’s commitment to
appropriate public participation and
outlined three general stages at which
public input could be of particular
value: During analysis of a pesticide’s
potential effects, subsequent to a
determination of potential effect, and
subsequent to development of a draft
Biological Opinion on the part of the
Services, if appropriate. EPA proposes
that when any of these phases
corresponds with a public participation
phase under EPA’s ongoing review
processes (e.g., reregistration), that
ongoing public process will be used.
Comment: Virtually all commenters
agreed that more opportunities must be
available for public participation in all
areas of listed species protection, from
the initial risk assessment through
determining mitigations where needed
and developing appropriate Bulletins.
Response: Endangered species risk
assessment processes and risk
management decisions are being
incorporated into EPA’s existing
processes of registration, reregistration
and registration review, and will
generally be afforded the same level of
transparency and opportunity for
comment as provided in those
processes. EPA has discussed public
participation with its Federal Advisory
Committee (the Pesticide Program
Dialogue Committee) on several
occassions and will continue to work
with that committee to further define
specific aspects of public participation
relative to listed species concerns. EPA
is committed to a transparent and
participatory process to the extent that
can be accomplished in a manner that
continues to allow EPA to meet its
statutory obligations.
7. Implementation timing. EPA
solicited comment on ways to time the
release of Bulletins to minimize the
potential disruption to pesticide users
during a growing season. Among other
details, the Agency proposed to begin
reviewing existing Bulletins within 6
months of publication of this final
Program notice to ensure they are still
valid, and to update each Bulletin no
more than once annually.
Comment: Eight commenters said
Bulletins should be updated annually,
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in time for growers to plan for the
upcoming season. Suggestions for when
to update them ranged from the end of
the fall growing season to January of
each year.
Response: Given a web-based
approach to Bulletin production and
distribution as articulated in this Notice,
EPA intends to update Bulletins as
protection decisions are made or when
a new body of data becomes available.
However, this web-based system is
designed so that a pesticide user may
obtain any applicable pesticide use
limitations for a particular use in a
particular location, up to 6 months prior
to the application date. EPA believes
this 6–month window will allow
adequate time in most cases, for a
pesticide user to plan their application
of a pesticide. Further, EPA believes
that this will allow protections to be
implemented in a more timely manner
than if EPA were to select one date per
year on which all changes would
become effective.
All of the submitted comments are
available in docket ID number OPP–
2002–0311, as described in Unit I.B.
III. The Endangered Species Protection
Program Field Implementation
EPA’s implementation plan is based
on two goals. The first is to provide
appropriate protection to listed species
and their designated critical habitat
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 approach
to implementing listed species
protections where such protections are
deemed necessary.
EPA’s plan as described in this
document is not a legally binding
regulation and EPA may decide to
revise, amend, or act at variance with
the terms of this document without
providing notice and comment under
section 553 of the Administrative
Procedure Act.
A. Scope of the ESPP
All pesticide products that EPA
determines ‘‘may affect’’ a listed species
or its designated critical habitat may be
subject to the ESPP. The scope
potentially includes pesticide actions
under sections 3, 5, 18, and 24(c) of
FIFRA.
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 would not
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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 does
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. FIFRA section 18s. Section 18 of
FIFRA authorizes EPA to issue
‘‘emergency exemptions’’ to States and
federal agencies to use a pesticide for an
unregistered use for a limited time if
EPA determines that emergency
conditions exist. While EPA will
endeavor to resolve concerns regarding
listed species prior to taking an action,
that may not always be possible for
section 18s, which by their very nature
are time critical, especially those
involving public health emergencies.
When submitting a section 18 request to
EPA, States, Tribes and federal agencies
will be expected to demonstrate they
have made a credible effort to identify
and address endangered species issues.
The more thorough the approach of the
submitter, the more likely it will be that
EPA can conduct its endangered species
assessment and consult with the
Services, as necessary, within the time
constraints for review of FIFRA section
18 applications. However, under the
Counterpart Regulations, the Services
have indicated that emergencies under
section 18 of FIFRA may be treated as
‘‘emergencies’’ under the Services’
consultation regulations. As a result, if
EPA cannot perform a comprehensive
endangered species assessment or, if
applicable, initiate and complete formal
consultation prior to the emergency,
EPA may use the emergency informal
consultation procedures described in
the Services’ Endangered Species
Consultation Handbook (Ref. 5) and
complete any necessary formal
consultation as soon as practicable after
the emergency.
B. Overall Approach
The task of assessing pesticide
registrations’ potential effects to listed
species has the potential to be quite
significant. There are more than 900
active ingredients used in more than
19,000 formulated products registered
under FIFRA. Each product is registered
for one to potentially many use sites.
Each use site and its specific use
instructions have different potentials to
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affect a listed species or critical habitat.
With more than 1,200 listed species in
one or more of over 2,000 counties
throughout the United States, the job of
determining what use patterns of each
pesticide have the potential to affect
which species, is not a task that can be
accomplished quickly.
EPA’s overall strategy is to address
listed species concerns within the
context of the pesticide registration,
reregistration, and registration review
processes. As explained in the Agency’s
risk assessment Overview Document
(Ref. 1), endangered species assessments
are, essentially, geographic and
biological refinements of the core
environmental risk assessment
performed to support a registration,
reregistration or, in the future,
registration review decision. Since the
refinements to assess the potential
effects of a pesticide’s use to a listed
species stem from this core assessment,
and since that core assessment feeds
into a decision regarding the registration
status of a pesticide, it seems both
logical and efficient to develop
processes to accomplish the endangered
species refinements within the context
of the broader activities of registration,
reregistration and, in the future,
registration review. FIFRA section 3(g)
requires the Agency to periodically
review pesticide registrations. After
establishing procedures for registration
review, EPA’s goal is to review the
registration of each pesticide every 15
years. The purpose of this review is to
assess whether a pesticide continues to
meet FIFRA requirements for
registration. During a pesticide’s
registration review, the Agency would,
among other things, determine whether
endangered species assessments must be
conducted. If so, such assessments
would generally be conducted as part of
the pesticide’s registration review where
possible.
While it is OPP’s intent to accomplish
endangered species assessments through
these processes, there may be situations
in which the potential risks to a listed
species are addressed apart from these
processes. For example, there may be
situations in which new, valid
information becomes available on
existing pesticide registrations, or on a
listed species, that will compel EPA to
re-evaluate its determinations and
reinitiate consultation, as appropriate,
outside those existing processes. In
those circumstances, case-by-case
decisions will be made on whether to
review a pesticide prior to its scheduled
review time.
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C. Results of Endangered Species
Assessments: ‘‘Effect Determinations’’
The result of EPA’s assessment of a
pesticide use’s potential effects to listed
species is an effects determination. This
determination will generally be
included in the ecological risk
assessment conducted to support a
decision regarding the registration status
of the pesticide (see Unit III.B.). EPA
will make one of three determinations
regarding the potential of a pesticide to
have an effect on listed species: (1) The
pesticide will have ‘‘no effect’’ on the
species, (2) the pesticide ‘‘may affect but
is not likely to adversely affect’’ the
species, or (3) the pesticide is ‘‘likely to
adversely affect’’ the species. The
processes by which these
determinations are made are described
in the Agency’s Overview Document
(Ref. 1). Each determination may relate
to a specific use of a particular pesticide
and a particular listed species. Based on
these determinations and any required
consultation under section 7(a)(2) of the
ESA, some pesticides will likely require
changes to their use instructions in
particular geographic areas to ensure
protection of listed species.
Decisions that change the use
instructions on a pesticide and
subsequent implementation of those
changes can occur in several ways. If
EPA’s listed species assessment results
in a determination that the pesticide
‘‘may affect but is not likely to adversely
affect’’ or that it is ‘‘likely to adversely
affect’’ a listed species, EPA will
address its consultation obligations as
described in the Services consultation
regulations at 50 CFR part 402, unless
the applicant or registrant adopts
changes to product labeling that allow
EPA to make a ‘‘no effect’’
determination for the pesticide. If EPA
makes a ‘‘not likely to adversely affect’’
determination for the pesticide under
the procedures of the Counterpart
Regulations at 50 CFR part 402, subpart
D, no further consultation or written
concurrence from the Services is
required. EPA may, however, choose to
utilize the informal consultation
procedures of the Services regulations
applicable to all federal agencies by
seeking the written concurrence of the
Services on this finding. The result of
formal consultation following a ‘‘likely
to adversely affect’’ determination will
be a Biological Opinion issued to EPA
by the Services. This Opinion will
contain the Services’ determination of
whether the pesticide’s use could
jeopardize the continued existence of
the species. If the Services believe that
the action will likely jeopardize listed
species or destroy or adversely modify
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designated critical habitat, then the
Services will include changes to the
pesticide registration in the Biological
Opinion that EPA may consider
adopting to avoid jeopardizing the
continued existence of listed species or
the destruction or adverse modification
of designated critical habitat (called
reasonable and prudent alternatives). If
the Services determine that jeopardy to
the species will not result from use of
the pesticide and authorizes incidental
take of the species, the Biological
Opinion will contain measures that
must be followed in order for any take
of the species to be authorized by the
ESA (reasonable and prudent measures).
These alternatives and measures may
form the basis for specific changes to the
use instructions for a particular
pesticide in a particular geographic
location.
Finally, EPA may identify a potential
risk to a listed species and request
public input to suggest ways in which
the pesticide use instructions could be
modified to reduce the potential risk.
This public input could form the basis
for EPA exploring a variety of potential
changes to the pesticide’s use in order
to ensure it is in compliance with the
ESA.
By their very nature, the geographic
range of each listed species and the area
required to support each species is
usually quite limited; therefore, changes
to use instructions to protect listed
species will also, where appropriate, be
geographically limited even for a
particular use of the pesticide. For
example, in order to ensure protection
of a listed species, EPA may determine
that use of a pesticide for a particular
crop need be changed only in a small
geographic area within a county, rather
than for the crop nationwide.
When changes to a pesticide’s use are
necessary to protect a listed species, and
those changes are geographically
specific, EPA intends to implement
those changes through Endangered
Species Protection Bulletins (Bulletins).
The Bulletins will be at a county scale,
with specific geographic areas indicated
within the county where use limitations
exist. In these cases, the Bulletin will be
referenced on the pesticide label by a
generic statement that tells the pesticide
user that the product may harm some
endangered or threatened species or
their critical habitat; that the user must
follow the use limitations in the
Bulletin for the county in which they
intend to apply the pesticide; and how
they may access the Bulletin for their
county and pesticide use.
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D. Endangered Species Protection
Bulletins and County Bulletins
1. Endangered Species Protection
Bulletins (Bulletins). If as a result of
EPA’s review of a pesticide, or as a
result of consultation with the Services,
geographically specific use limitations
are necessary to ensure a pesticide
registration complies with the ESA and
FIFRA, those use limitations will be
relayed to pesticide users through
Bulletins referenced on the labels of
affected pesticide products. Bulletins
will become enforceable use
requirements once referenced on the
pesticide label.
Endangered Species Protection
Bulletins will:
• Identify the species of concern.
• Name the active ingredient(s) for
which use limitations apply.
• Describe the use limitation
necessary for protection of the species.
Where species or habitat descriptions
are helpful or necessary to identify use
limitations, EPA will also include this
information.
• Contain a county map on which is
shown the specific geographic area in
which the use limitations apply,
depending on the sensitivity of the
species to other factors such as
collection. Typically, maps will show a
patterned or shaded area indicating
where pesticide use must be modified to
protect the listed species and to ensure
the pesticide user is not violating the
misuse provisions of FIFRA. Within
patterned or shaded areas on the maps,
the specific use limitations will be
identified for the pesticide and the
species being protected.
• Where possible without causing
further threat to a species, provide a
picture and description of the species.
2. Voluntary County Bulletins. There
are a number of county bulletins that
EPA has developed in the past based on
consultations with the Services. These
county bulletins have been posted on
EPA’s web site for voluntary use by
pesticide applicators but are not
required to be followed to comply with
the pesticide use requirements. EPA is
pursuing whether a method exists, short
of a full re-evaluation of each pesticide’s
use included in existing county
bulletins, to validate the information
contained in these voluntary county
bulletins. If that proves to be possible,
EPA intends to pursue public comment
on the process before finalizing the
method. EPA then intends to
incorporate the validated information
into new Endangered Species Protection
Bulletins, as resources permit. EPA
would then request that applicants and
registrants reference these Bulletins on
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their affected product labels using the
label statement identified in Unit III.E.
3. Access to Endangered Species
Protection Bulletins. Endangered
Species Protection Bulletins will be
available for printing on the web at
https://www.epa.gov/espp. EPA is
developing a web-based Bulletinretrieval system that will enable
pesticide users to enter basic
information such as their state, county,
and month of anticipated pesticide use.
The system will then display the
appropriate Bulletin for printing. The
printed Bulletin will display the month
for which it is valid. These Endangered
Species Protection Bulletins will be
available on a distinct web site that will
be referenced on the pesticide label to
avoid possible confusion with the
existing, voluntary county bulletins that
will remain available for public
reference but do not contain enforceable
use limitations.
Bulletins will generally be available 6
months in advance of their effective
date. Pesticide users should therefore
check for availability of a relevant
Bulletin no more than 6 months before
applying a pesticide to ensure they are
using the current Bulletin for the
county.
Those without access to the Internet
may call EPA at 1–800–447–3813 to
determine applicability and availability
of Endangered Species Protection
Bulletins. If a Bulletin does apply, it
will be printed and mailed upon
request.
E. Pesticide Label Language
When geographically specific use
limitations are necessary to ensure legal
use of a pesticide product will not result
in jeopardy to the species, EPA will
generally seek to ensure that registrants
include the following statement on the
product label at the beginning of the
product’s Directions for Use:
ENDANGERED SPECIES PROTECTION
REQUIREMENTS
This product may have effects on federally
listed threatened or endangered species or
their critical habitat in some locations. When
using this product, you must follow the
measures contained in the Endangered
Species Protection Bulletin for the county or
parish in which you are applying the
pesticide. To determine whether your county
or parish has a Bulletin, and to obtain that
Bulletin, consult https://www.epa.gov/espp/,
or call 1-800-447-3813 no more than 6
months before using this product.
Applicators must use Bulletins that are in
effect in the month in which the pesticide
will be applied. New Bulletins will generally
be available from the above sources 6 months
prior to their effective dates.
Absent the appropriate label
statement, EPA believes a pesticide
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generally will not meet the FIFRA risk/
benefit standard. EPA may, therefore,
initiate cancellation or denial
proceedings under FIFRA against any
product for which EPA has determined
this label statement is necessary and for
which the applicant or registrant refuses
to adopt such restrictions.
Note that a more specific web-site
address will be included in this
language once a permanent web address
is secured for enforceable Endangered
Species Protection Bulletins.
F. Enforcement
Pesticide users who fail to follow
label 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)). Products that do
not bear appropriate endangered species
labeling may be subject to enforcement
under the misbranding provisions of
FIFRA (section 12(a)(1)(E)). Absent an
incidental take statement issued by the
Services that authorizes take that may
occur from the use of a pesticide
consistent with its labeling, users
maintain liability under section 9 of the
ESA for any take that occurs as a result
of pesticide application, regardless of
whether label provisions were followed.
While enforcement actions under FIFRA
are brought by EPA and the States,
enforcement of the ESA is the
responsibility of the Services.
G. Public Participation
1. General. 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.
EPA intends the 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. The ongoing program
will meld its components of public
participation with existing practices in
the registration, reregistration, and
registration review processes. The
processes for public participation
during registration and registration
review are under development.
Reregistration generally is a four- or sixphase process and generally provides
one or two formal opportunities for
public input.
There are three major phases of a
listed species assessment that may
provide opportunity for public input:
Prior to a ‘‘may affect determination’’ by
EPA; identifying potential mitigation;
and prior to issuance of a Biological
Opinion to EPA by the Services. EPA
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will generally engage the public in each
of these phases as outlined below. When
any of these phases corresponds with a
public participation phase under EPA’s
ongoing review processes (e.g.,
reregistration), that ongoing public
process generally will be used.
In general-• Prior to a ‘‘may affect
determination.’’ During the risk
assessment process, anyone may
provide additional or new information
for the Agency to consider. Of particular
use would be information on local use
practices and use site locations.
• Potential mitigation. Provide
suggestions on use practice changes,
how certain changes may impact the
pesticide user community, and input on
risk mitigation scenarios.
• Draft Biological Opinion. If EPA
must formally consult with the Services,
after the Services issue a draft Biological
Opinion, EPA will welcome input from
State, Tribal and local governments on
draft reasonable and prudent measures
and alternatives. The purpose of this
review would be to determine whether
the alternatives or measures can be
reasonably implemented and whether
there are different measures that may
provide adequate protection but result
in less impact to pesticide users. The
Agency will consider this input in
developing its response to draft
Biological Opinions.
2. Role of the States and Tribes. States
and Tribes will continue to be integral
to the success of the ESPP. Local, State
and Tribal circumstances may influence
the effectiveness of different approaches
to listed species protection; therefore,
local, State and Tribal governments may
be afforded specific opportunities for
Bulletin review. Also, at their
discretion, States and Tribes may
initiate alternative approaches for
protecting listed species (Unit III.H.)
that EPA could adopt as the EPA
approach in that jurisdiction. States and
Tribes may also assist in determining
the effectiveness of the ESPP via
enforcement and inspection activity.
Opportunities for State and Tribal
review of Bulletins may include:
• Review of maps. States and Tribes
generally may be requested to provide
input to the Agency on maps that will
be incorporated into Endangered
Species Protection Bulletins, 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
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66401
limitation areas on the 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 manmade landmarks such as rivers, roads,
and railways.
• 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. Role of pesticide registrants. As
with any potential change to a pesticide
product label, the registrant of a product
for which it has been determined the
generic endangered species statement
needs to be included, will have an
opportunity to review the specific use
limitations that may be included in the
Bulletins, prior to Bulletin issuance. If
once a product is labeled with the
generic statement, changes in the
Bulletin which would affect that
product’s use are necessary, the
registrant will have an opportunity to
review the changes prior to issuance.
Further, the registrants retain any rights
they may have under FIFRA, regarding
EPA’s determination that use of the
product needs to be modified.
EPA will publish specific details of
this public participation process on its
web site, https://www.epa.gov/espp, as
they are developed and refined.
H. State- and Tribal-initiated Plans
States and Tribes may develop and
propose plans for their specific
involvement in protecting listed species
beyond the involvement outlined in this
Notice. For example, such a plan could
include varying provisions for how use
limitations are articulated in a Bulletin;
actual development of maps for
inclusion in Bulletins; provisions for
specific information a State or Tribe
may provide to EPA to consider during
its risk assessment process (for example,
specific information regarding
geographic location of certain crop
types); or could recommend specific
approaches that EPA could use to
protect listed species in a specific area,
such as State-administered land owner
agreements.
If such plans are submitted by a State
or Tribe, EPA will review the plan to
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Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices
ensure the provisions of the plan can be
implemented by EPA through the
labeling and Bulletin approach
discussed in this Notice. EPA will also
determine whether the Services need to
be consulted on the contents of the plan
before EPA adopts the plan. After the
necessary reviews EPA will approve or
disapprove the plan. If approved, EPA
would then adopt it and could require,
through Bulletins, that users comply
with the requirements of the plan, as
appropriate.
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 and EPA
implements the plan through changes to
the appropriate Bulletins. Section 24(a)
of FIFRA reserves to States the authority
to impose different requirements on
registered pesticides provided they do
not permit any sale or use prohibited by
FIFRA. Accordingly, this Notice is not
intended to modify any State authority
to impose additional State requirements
regarding listed species.
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
to house and retrieve this information.
EPA also gathers incident information
from registrant reports that are required
to be submitted under FIFRA section
6(a)(2).
EPA also intends to develop a process
for monitoring the effectiveness of
Bulletins after the Program has been in
effect for some time. At that time, the
Agency will solicit public comment on
ways to determine whether Bulletins are
effective at protecting listed species and
critical habitat.
I. Monitoring
EPA is committed to improved use of
existing monitoring data in our risk
assessments. Federal and State budget
outlooks make it important that data
being collected through appropriate
sources be used to the fullest extent
possible to maximize efficiencies and
minimize costs. EPA will continue to
use, in the most effective manner
possible, the information being obtained
by the U.S. Geological Survey to detect
pesticides in surface water and ground
water, information provided to EPA’s
Office of Water under the Clean Water
and Safe Drinking Water Acts, and
State- or Tribal-level ground water or
surface water monitoring resulting from
State or Tribal pesticide program efforts
where those results are known to OPP.
EPA will also use the technical data
identified during ESA section 7
consultations with the Services to assist
in determining if pesticide residues are
occurring at levels of concern in the
environment. Where appropriate
terrestrial monitoring is known to EPA,
that too will be used in the most
effective manner possible, to inform
EPA’s assessments.
EPA will continue and improve upon
its cooperation with the Services, States,
Tribes, and others to use reported
incidents in which pesticides may 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
IV. References
All references are available for public
review in the public docket as described
in Unit I.B. The references used in this
document are:
1. U.S. Environmental Protection
Agency. January 23, 2004. Overview of
the Ecological Risk Assessment Process
in the Office of Pesticide Programs, U.S.
Environmental Protection AgencyEndangered and Threatened Species
Effects Determinations (https://epa.gov/
espp/consultation/ecoriskoverview.pdf).
2. 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.
3. U.S. Department of the Interior,
Fish and Wildlife Service; and U.S.
Department of Commerce, National
Oceanic and Atmospheric
Administration, National Marine
Fisheries Service. August 5, 2004. Joint
Counterpart Endangered Species Act
Section 7 Consultation Regulations;
Final Rule. 69 FR 47732, codified at 45
CFR part 402.
4. U.S. Environmental Protection
Agency; U.S. Department of the Interior,
Fish and Wildlife Service; and U.S.
Department of Commerce, National
Oceanic and Atmospheric
Administration, National Marine
Fisheries Service. August 2004.
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17:22 Nov 01, 2005
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J. Implementation Timing
Endangered Species Protection
Bulletins will be effective and
enforceable upon reference to them on
a product label. EPA will be establishing
a web site prior to enforceable label
references appearing on products in the
market place, that will allow pesticide
users to determine the appropriate
Bulletin to follow, if any, as described
in Unit III.D.
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Fmt 4703
Sfmt 4703
Alternative Consultation Agreement for
Implementation of Optional Alternative
Consultation Procedures (ACA) (https://
www.epa.gov/espp/consultation/finalaca.pdf).
5. U.S. Fish and Wildlife Service and
National Marine Fisheries Service.
March 1998. Endangered Species
Consultation Handbook, Procedures for
Conducting Consultation and
Conference Activities Under Section 7
of the Endangered Species Act (https://
www.fws.gov/endangered/
consultations/s7hndbk/s7hndbk.htm.)
6. Letter of January 26, 2004 from
Steve Williams, U.S. Fish and Wildlife
Service and William Hogarth, National
Marine Fisheries Service to Susan B.
Hazen, U.S. Environmental Protection
Agency (https://www.fws.gov/
endangered/consultations/pesticides/
evaluation/pdf).
List of Subjects
Environmental protection, Pesticides,
Endangered species.
Dated: October 25, 2005.
Susan B. Hazen,
Acting Assistant Administrator, Office of
Prevention, Pesticides and Toxic Substances.
[FR Doc. 05–21838 Filed 11–1–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–7992–9]
Safe Drinking Water Act
Determination; Underground Injection
Control Program, Determination of
Indian Country Status for Purposes of
Underground Injection Control
Program Permitting
Environmental Protection
Agency (EPA).
ACTION: Notice of prospective
determination.
AGENCY:
SUMMARY: EPA must determine whether
any of the approximately 160 acres of
land located in the southeast portion of
Section 8, Township 16N, Range 16W,
in the State of New Mexico, is part of
a dependent Indian community under
18 U.S.C. 1151(b) and, thus, considered
to be ‘‘Indian country.’’ This
determination is necessary in order to
establish whether EPA or the New
Mexico Environment Department is the
appropriate agency to issue a particular
underground injection control permit
under the Safe Drinking Water Act. EPA
is seeking comments and information
from the public and all interested
parties regarding the possible Indian
country status of this land and is
E:\FR\FM\02NON1.SGM
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Agencies
[Federal Register Volume 70, Number 211 (Wednesday, November 2, 2005)]
[Notices]
[Pages 66392-66402]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21838]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-0311; FRL-7739-7]
Endangered Species Protection Program Field Implementation
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This document describes how EPA's Office of Pesticide Programs
intends to implement 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 document describes EPA's approach to implementing its
responsibilities under section 7(a)(2) of ESA subsequent to a
determination by EPA that geographically specific risk mitigation is
necessary to protect federally listed threatened or endangered species
or their critical habitat. For purposes of the ESPP, the term ``listed
species'' or ``endangered species'' will encompass species listed as
threatened or endangered, plus designated critical habitat of these
species; the term ``county'' will include counties, parishes, and
similar political boundaries of U.S. Territories. The implementation
approach relies on pesticide labels, as appropriate, referring the
pesticide user to geographically specific Endangered Species Protection
Bulletins that will contain enforceable use limitations for the
pesticide necessary to ensure the pesticide's use will not jeopardize
the continued existence of a listed species.
FOR FURTHER INFORMATION CONTACT: For technical information: Arthur-Jean
B. Williams, Environmental Fate and Effects Division (7507C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460; telephone number: (703) 305-7695; fax
number: (703) 305-6309; e-mail address: williams.arty@epa.gov.
For field implementation information: 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: powell.mary@epa.gov.
SUPPLEMENTARY INFORMATION:
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 State and Tribal regulatory partners, other
interested Federal agencies, environmental or public interest groups,
pesticide registrants and pesticide users. Since 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 technical 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,
1801 S. Bell St., 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 https://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 https://www.epa.gov/edocket/ to view public comments,
to 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. 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.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background
A. What Action is the Agency Taking?
This Notice describes EPA's field implementation plan for putting
in place any geographically specific pesticide use limitations EPA
deems necessary to ensure EPA's compliance with ESA section 7(a)(2).
This approach will be used to put in place pesticide use limitations
identified as necessary by EPA during the course of its endangered
species risk assessment process or through consultations with the U.S.
Fish and Wildlife Service (FWS) and the National Marine Fisheries
Service (NMFS) . These protections or use limitations will be
enforceable by EPA under section 12 of FIFRA.
This Notice is organized into four units. Unit I. provides general
information about applicability of this document and the availability
of additional information. Unit II. provides background information,
including the Agency's legal authority for taking this action, and a
summary of public comments on EPA's proposed approach (67 FR 71549,
December 2, 2002) (FRL-7283-7) and its response to those comments. Unit
III. describes the Program, including its scope, overall approach, and
Endangered Species Protection Bulletins. Unit IV. contains references
to other documents used in the development of and referenced in this
Notice.
EPA will begin using this approach to implement geographically
specific risk mitigation for the protection of listed species or their
critical habitat upon publication of this Notice. EPA's plan as
described in this document, however, is not a legally binding
regulation and EPA may decide to revise, amend, or act at variance with
the terms of this document without providing notice and comment under
section 553 of the Administrative Procedure Act.
B. What is the Agency's Authority for Taking this Action?
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, for thousands of pesticides containing hundreds of active
ingredients. These
[[Page 66393]]
registrations encompass thousands of different use sites and practices
across the United States.
FIFRA as amended (7 U.S.C. 136 et seq.) governs the regulation of
pesticides in the United States. Under FIFRA, a pesticide product
generally may be sold or distributed in the United States only if it is
registered 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 practices, will not
generally cause ``unreasonable adverse effects on the environment''
(FIFRA 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 be 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).
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 review every 15 years) to determine whether
such registrations meet the requirements of the Act (FIFRA section
3(g)(1)(A)). This latter requirement is known as registration review.
EPA recently published a Notice of Proposed Rulemaking (NPRM) to
establish procedural regulations for conducting registration review (70
FR 40251, July 13, 2005) (FRL-7718-4).
The purpose of the Endangered Species Act (ESA) (16 U.S.C. 1531 et
seq.) is 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.
Section 7(a)(1) of the ESA, 16 U.S.C. 1536(a)(1), requires federal
agencies to use their authorities in furtherance of the purposes of the
ESA by carrying out programs for the conservation of listed species.
Section 7(a)(2) of the ESA, 16 U.S.C. 1536(a)(2), and the
implementing regulations at 50 CFR part 402, further require federal
agencies to ensure that their actions are not likely to jeopardize the
continued existence of any listed 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, under certain
circumstances, consult with the Secretary of the Interior (which has
delegated the interagency consultation responsibilities to the FWS) and
the Secretary of Commerce (which has delegated the interagency
consultation responsibilities to the NMFS within the National Oceanic
and Atmospheric Administration), regarding the effects of Agency
actions on listed species or designated critical habitat. In fulfilling
this requirement, federal agencies must use the best scientific and
commercial data available.
Section 7(a)(4) of the ESA, 16 U.S.C. 1536(a)(4), requires federal
agencies to confer with the Services (jointly, FWS and NMFS) on any
agency action that will likely jeopardize the continued existence of
any species proposed to be listed as threatened or endangered, or
adversely modify critical habitat proposed to be designated for
endangered species.
In 1988, Congress addressed the relationship between the ESA and
EPA's pesticide labeling program in section 1010 of Public Law 100-478
(October 7, 1988), which required EPA to conduct a study and to provide
Congress with a report of the results (U.S. EPA's 1991 report to
Congress: Endangered Species Protection Program as it Relates to
Pesticide Regulatory Activities, EPA 540-09-91-120, May 1991) on ways
to implement EPA's endangered species pesticide labeling program in a
manner that both promotes the conservation of listed species and
minimizes the impacts to persons engaged in agricultural food and fiber
commodity production and other pesticide users and applicators. This
law provided a clear sense that Congress desires that EPA should
fulfill its obligation to conserve listed species, while at the same
time considering the needs of agriculture and other pesticide users.
Further, section 1010 subsection (a) directs EPA to take public comment
on any proposed pesticide labeling program imposed in order to comply
with the ESA. Pursuant to that provision, EPA issued and sought public
comment on its Endangered Species Protection Program in December 2002
(67 FR 71549, December 2, 2002).
The Services have promulgated regulations at 50 CFR part 402
addressing the means by which all federal agencies may satisfy their
ESA section 7(a)(2) consultation obligations. In 2004, the Services
published Counterpart Regulations (69 FR 47732, August 5, 2004) that
provide additional alternative procedures that EPA may use to meet its
ESA section 7(a)(2) obligations for pesticide regulatory actions under
FIFRA. In order to use the Counterpart Regulations, EPA entered into an
Alternative Consultation Agreement (ACA) (Ref. 4) with the Services.
This ACA establishes the interagency process for implementing and
ensuring compliance with the Counterpart Regulations. In connection
with the development of the Counterpart Regulations and the ACA, EPA
developed its Technical Overview of Ecological Risk Assessment (Ref.
1), detailing EPA's approach to ecological risk assessment for
endangered species. This ``Overview'' document and the processes it
describes were reviewed by the Services and deemed to be processes that
will result in ESA-compliant risk determinations (Ref. 6).
C. EPA's Role
1. ESA section 7(a)(1) obligations. As noted in Unit II.B., 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. EPA's Office of Pesticide
Programs (OPP) has carried out a number of activities intended to
conserve listed species, including: Hosting a web site that contains
listed species fact sheets and a county-scale data base of listed
species locations by county, and producing and disseminating
informational and educational materials. Additionally, EPA has worked
with State agencies responsible for pesticide programs and extension
services to ensure that pesticide applicators certified by the States
receive, during their certification training, information on listed
species' protection needs. Listed species issues and concerns are
included as part of the testing requirements for State-certified
applicators in many States.
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. The ESA does not, however, provide action agencies, such as
EPA, with independent authority to modify agency actions for the
benefit of listed species.
[[Page 66394]]
Rather, action agencies must utilize their existing authorities, such
as EPA's authority under FIFRA, to the extent permissible, to provide
such protections. Accordingly, EPA's challenge is to implement FIFRA, a
risk/benefit statute, in a way that harmonizes with the ESA, to the
fullest extent possible, 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 under FIFRA 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 a proposed
pesticide registration action will have no effect on any listed species
or designated critical habitat, consultation under ESA section 7(a)(2)
is not required. A determination that a proposed pesticide registration
action is not likely to adversely affect any listed species or
designated critical habitat is subject to the Services' consultation
regulations regarding ``informal consultation.'' EPA may either utilize
the provisions of the Counterpart Regulations at 50 CFR part 402,
subpart D, and complete this determination without obtaining Service
concurrence, or EPA may choose to seek the written concurrence of the
Services on this finding under the Services' regulations at 40 CFR part
402, subpart B, that apply to all federal agencies. If EPA determines
that a proposed pesticide registration action is likely to adversely
affect a listed species or designated critical habitat, EPA is required
to enter into a process with the Services called ``formal
consultation.'' The consultation process is designed to assist federal
agencies in developing actions that will not jeopardize the continued
existence of any listed species or result in destruction or adverse
modification of any designated critical habitat (ESA section 7(a)(2)).
Following consultation, the Agency is responsible for implementing
protections, if necessary, through its available authority.
D. The Roles of FWS and NMFS
The Department of the Interior's U.S. Fish and Wildlife Service
(FWS) administers the ESA for most species. The Department of
Commerce's National Marine Fisheries Service (NMFS) administers the ESA
for certain marine and anadromous species. EPA may enter into informal
or formal consultation with the Services concerning effects to listed
species or critical habitat (or confer on proposed species). At the
conclusion of formal consultation, the Services determine whether an
EPA action is likely to jeopardize the continued existence of a species
or destroy or adversely modify designated critical habitat. If the
action is likely to cause jeopardy, the Services propose reasonable and
prudent alternatives, to the extent available, to avoid jeopardy. In
connection with consultation, the Services' Biological Opinion will
also address whether incidental take is anticipated from the Agency's
action. If so, the Services may authorize a certain amount of
incidental take, provided any reasonable and prudent measures
identified by the Services are adopted by the Agency and followed by
pesticide users. Take, as defined in section 3(18) of the ESA, is
unlawful unless the Services issue an incidental take statement that
provides an exemption to the prohibitions on take of listed wildlife,
incidental to certain federal actions. The Services maintain
enforcement authority regarding the unlawful take of listed species
under section 9 of the ESA.
E. Summary of Comments on EPA's ESPP Proposal
On December 2, 2002, EPA published a Federal Register Notice
soliciting public comment on its proposed field implementation program
(67 FR 71549). EPA received 228 letters in response. Most of the
letters (143) were from private citizens. Letters were also received
from agricultural and pesticide associations (55), State and federal
agencies and their representatives (18), and environmental groups (12).
When broken out into individual topics, the comments within these
letters totaled more than 600.
Commenters were fairly evenly split between those who generally
supported the proposal and those who generally opposed it. Supportive
commenters said the proposal was an appropriate balance of Program
goals that makes efficient use of resources and Agency expertise in
pesticide regulation. Opposing commenters said the proposal was
inadequate to protect listed species, weakened existing laws, and
should in no way consider economics in determining protections for
listed species.
Numerous comments were received on consultation, technical, and
science policy issues that were outside the scope of the ESPP. While
the proposal included a summary of EPA's processes for making effects
determinations and consulting with the Services, that information was
included solely to provide context to the reader. For more information
about the technical aspects of endangered species risk assessment and
consultation with the Services, readers are referred to the Counterpart
Regulations at 50 CFR part 402 (69 FR 47732, August 5, 2004), EPA's
Overview Document (Ref. 1), and the Alternative Consultation Agreement
(Ref. 4).
All comments submitted in response to the proposal are available in
docket ID number OPP-2002-0311 as described in Unit I.B. A summary of
the specific areas on which EPA requested comment, follows below.
1. FIFRA section 18 emergency exemptions. The Agency requested
comment on how it proposed to address endangered species in the context
of FIFRA section 18 emergency exemptions in general and specifically
for public health emergencies.
Comment: Most of 24 commenters acknowledged the necessity for a
rapid response in public health emergencies, but differed on the point
at which an endangered species review should be carried out, if at all,
and whether consultation may be appropriate in such situations.
Suggested alternatives to the proposed approach included requiring that
FWS and State, Tribal and local officials establish a balanced program
to solve health emergencies on a case-by-case basis with minimal impact
on listed species, and assume some take would occur (1 commenter);
consulting with as many State and federal agencies as possible to
respond to the emergency (1 commenter); detailing a FWS person to EPA
to work with EPA on requests for crisis exemptions (1 commenter); and,
if no ESA review is done because of the extreme nature of the
emergency, complete the listed species review as soon as possible
afterward, without extending the emergency registration until the ESA
review is completed (6 commenters).
Response: While EPA will endeavor to resolve concerns regarding
listed species prior to taking an action, that may not always be
possible for section 18s, which by their very nature are time critical,
especially those involving public health emergencies. When submitting a
section 18 request States, Tribes and federal agencies will be expected
to demonstrate they have made a credible effort to identify and address
endangered species issues. The more thorough the approach of the
submitter, the more likely it will be that EPA can conduct its
endangered species
[[Page 66395]]
assessment and consult with the Services, as necessary, within the time
constraints for review of FIFRA section 18 applications. However, under
the Counterpart Regulations, the Services have indicated that
emergencies under section 18 of FIFRA may be treated as ``emergencies''
under the Services' consultation regulations. As a result, if EPA
cannot perform a comprehensive endangered species assessment or, if
applicable, initiate and complete formal consultation within the time
constraints for review of a section 18 application, EPA may use the
emergency informal consultation procedures described in the Services'
Endangered Species Consultation Handbook (Ref. 5) and complete any
necessary formal consultation as soon as practicable after the
emergency.
2. County Bulletins. The proposal described the substance of
county-level Endangered Species Protection Bulletins (Bulletins) that
would be the mechanism to inform pesticide users of any specific
changes to pesticide use required to protect a listed species. The
Agency requested comment on a variety of aspects of the Bulletins,
ranging from how to make them more understandable to frequency of
updates and distribution mechanisms. EPA received about 150 comments on
a range of issues about the Bulletins, including when their use is
appropriate, how to make them easier to use, when to update them, and
how to work more effectively with States in Bulletin development.
Comment: General--Bulletins were viewed by some as either
inadequate to protect listed species (5 commenters) or as providing a
practical, site-specific mechanism for protecting listed species that
may be affected by pesticide use (20 commenters). About 40 commenters
said Bulletins should not be required if alternative protection
measures for listed species exist, such as landowner or conservation
agreements; most of those same commenters said growers and their
consultants should have the right to use alternative mitigation
measures to protect listed species if their methods are scientifically
defensible. Other commenters supported the Bulletins, but expressed
concerns about privacy, frequency and notification of updates, and
methods used to determine areas requiring protections for listed
species.
Response: EPA continues to believe that Bulletins offer the best
compromise between the lengthy time required to change product labels
and being able to more quickly inform pesticide users of any required
use limitations to protect listed species or critical habitat. Under
the Agency's approach, the label will carry a generic label statement
referring pesticide users to the Bulletin. The Bulletins will carry the
same weight for enforcement purposes as information on the label, and
failure to follow the appropriate Bulletin would be subject to
enforcement action under FIFRA.
The ESA requires EPA to ensure that the pesticide registration
actions it authorizes are not likely to jeopardize the continued
existence of listed species or adversely modify the designated critical
habitat of such species. The Services have endorsed EPA's risk
assessment process for pesticides, as outlined in the Agency's Overview
Document (Ref. 1), as an appropriate means of assessing risks and
making effects determinations for listed species and designated
critical habitat. Before EPA could consider an alternative protective
measure, it would need to ensure that the assessment methods used by
the State or Tribe were adequate to evaluate risks to the species and
critical habitat and that any alternative measures would provide
adequate protection. EPA cannot, therefore, omit from consideration
lands subject to landowner or conservation agreements when assessing
risks to listed species. However, if EPA's risk assessment concludes
that such agreements are an appropriate and effective means to protect
listed species, EPA could adopt those measures by stating in the
Bulletin itself that a pesticide user must apply the pesticide only
under the terms and conditions of the agreement.
EPA will seek input, as appropriate, from stakeholders on use
limitations it includes in the Bulletins prior to adopting them. It
would be appropriate to bring to EPA's attention any alternative
protective methods the user community believes exist at that time.
Opportunities for public participation exist throughout EPA's decision
process. Therefore, users are particularly encouraged to stay involved
in that decision process so that EPA can incorporate practical measures
into its decisions and Bulletins as early as possible.
Comment: Ease of use--EPA should use clear, consistent, plain-
language statements and formats throughout all Bulletins and, in
particular, in pesticide use restrictions (44 commenters). Use a
pesticide's common, trade or brand name instead of active ingredient
name in the table of pesticides (11 commenters).
Response: Bulletins will convey geographically specific pesticide
use information to pesticide users, so it is crucial that they
understand and can easily use the information the Bulletins present.
EPA agrees that language, terminology, format, etc., must be as clear,
concise, and uniform as possible. EPA has been working with other
federal agencies, States, Tribes, and other stakeholders to revise and
improve the Bulletins, especially the maps and tables of pesticide use
restrictions, with the goal of achieving consistency and ease of use of
all information presented.
Maintaining Bulletins and the information appropriate to each
county where a geographically specific use limitation is needed will be
a significant undertaking. EPA is disinclined to add to this
undertaking the challenge of keeping current all the product names for
each active ingredient subject to one or more Bulletins across the
country. Therefore, EPA does not intend to include trade or product
names in the Bulletins but instead intends to use the active ingredient
name.
Comment: Maps and private lands--Suggestions varied for how EPA can
make protection areas as specific as possible without infringing on
individual landowners' privacy. The largest number of comments on this
topic (14 commenters) concerned respect of private property rights in
developing county maps. Thirteen commenters suggested that in cases
where a listed species occurs only on privately owned lands, landowner
agreements be used in lieu of publishing a Bulletin that would identify
those lands.
Response: EPA agrees that it is important to respect the privacy of
individuals. However, EPA is not in a position to enter into landowner
agreements with all individuals regarding their use of pesticides.
Further, concern regarding the enforcement of any such agreements if
landownership changes is one of the many complex implementation issues
that EPA would have to resolve to adopt such an approach. Additionally,
while a species may be located only on lands owned by a single
individual, use of pesticides adjacent to that land or upstream from a
particular geographic location could also have effects on the listed
species or its critical habitat. For these reasons, EPA does not intend
to forego Bulletin development in favor of landowner agreements.
Comment: Maps and delineation of use limitation areas--Nine
commenters said township-range-section designations alone, or in
conjunction with natural and man-made landmarks and boundaries, should
be used to delineate species protection areas. Nine other commenters
said map locations alone, not natural boundaries, habitat types, etc.,
should be used because
[[Page 66396]]
those designations can result in larger restricted areas than warranted
by sound science. Seven commenters said protection areas should be
referenced by Geographic Positioning System (GPS)-compatible points.
Eight commenters supported the use of narrative descriptions of listed
species and/or habitat to explain use restrictions in a Bulletin.
Response: EPA acknowledges that State, Tribal and local situations
greatly influence the most appropriate designation to use in producing
maps and protection boundaries. The Agency will be flexible in its
choices when preparing draft maps for State and Tribal input. EPA will
use both natural and man-made boundaries as appropriate and necessary
with the goal of identifying the geographic area where any use
limitation applies but without unnecessarily enlarging that area.
Bulletins will generally 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 patterned or shaded area indicating where
pesticide use must be limited to protect that species. Within patterned
or shaded areas on the maps, the specific protection measures will
generally be identified for each pesticide and the species being
protected. Where species or habitat descriptions are helpful or
necessary to identify use limitations, EPA will include that
information in Bulletins. Also, where possible without causing further
threat to a species, the Bulletins will provide a picture and
description of the species. While it is EPA's intention to use
geographic information systems to develop and produce the maps that
will be included in Bulletins, we do not intend to provide specific GPS
coordinates in the Bulletins.
Comment: Notifying users when a Bulletin applies--EPA requested
comment on how the Agency could ensure that growers know they have the
most recent Bulletins. Seven commenters said there must be a uniform
mechanism for informing pesticide users of when a Bulletin is
available; five of those commenters suggested computer-generated
Bulletins at the time of sale as the appropriate mechanism. Three other
commenters suggested placing a notice on EPA's web site.
Response: EPA has developed a uniform mechanism for notifying
pesticide users when a Bulletin may apply to their pesticide
application; that is, through placement of a generic statement on the
pesticide label directing pesticide users to follow the Bulletin for
their county if one is available. Pesticide users may access the
appropriate Bulletin for their pesticide use in one of two ways: Either
by checking EPA's web site, https://www.epa.gov/espp, or if Internet
access is not available, users may determine whether a Bulletin exists
for their pesticide use by calling 1-800-447-3813, and if a Bulletin is
available it can be mailed to the caller. Pesticide users should check
for availability of a relevant Bulletin no more than 6 months before
applying a pesticide to ensure they are using the current Bulletin for
the county.
Comment: Updating frequency and effective date of Bulletins--EPA
requested comment on whether annual updating of the Bulletins is the
appropriate frequency and, if so, what an appropriate effective date
would be. Fifteen commenters said Bulletins should be updated annually.
Other suggestions ranged from, simply, ``regular updating,'' to ``as
soon as consultations are completed and use limitations put in place,''
to ``a 3-year schedule.'' Ten commenters said Bulletins also need to be
dated so pesticide users can be assured they are using the current
version of the Bulletin.
Response: It is not EPA's intent to constantly seek changes to
product labels and make Bulletin changes. At the same time, EPA intends
to maintain the ability to act on listed species and critical habitat
issues when protection decisions are made or when a new body of data
becomes available. EPA believes the best compromise between acting
quickly to protect listed species and not engendering confusion with
constant changes in label instructions can be reached by providing
Bulletins via a web-based system, as described below. The generic
statement on the label will direct pesticide users to follow the use
limitations in a Bulletin applicable to their county and their
pesticide application; pesticide users may generally obtain this
information 6 months before the date on which they intend to apply the
pesticide.
Bulletins will be available for viewing and printing on the web at
https://www.epa.gov/espp. Those without access to the Internet may call
EPA at 1-800-447-3813 to determine applicability and availability of a
Bulletin. Bulletins will be printed and mailed upon request. Bulletins
obtained either from the web or from EPA will indicate the time frame
for which they apply.
Comment: EPA and the States and Tribes working together to improve
the development of Bulletins--EPA proposed specific roles for States
and Tribes that would 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 in the form of State or Tribal
initiated plans. Several commenters supported this proposed approach,
but expressed concern about having the resources to undertake such a
program. One suggestion was to incorporate Bulletin development into
performance partnership grant agreements.
Other comments received were not necessarily specific to Bulletin
development, but still addressed how EPA, States and Tribes should work
together to protect listed species. About 50 commenters said EPA should
broadly define the Program goals and help develop a general process,
but then allow programs to be fully developed and tailored at the State
and Tribal level.
Response: Given the specifics of the program as articulated, EPA
believes it will not result in significant additional resource needs on
the part of States and Tribes. EPA will provide Bulletins via the web
or through a toll-free number, thus eliminating the proposed role of
the States and Tribes in Bulletin distribution. Enforcement actions
will be carried out through existing methods of FIFRA inspection,
investigation and enforcement, just as all pesticide use requirements
are enforced. EPA is not requiring States, Tribes, local governments or
others to participate in Bulletin review; rather, the Agency will
provide an opportunity for review at appropriate points in the risk
assessment process and prior to publishing Bulletins on the web. This
cooperative activity may be incorporated into performance partnership
grant agreements so that EPA and the States and Tribes can effectively
negotiate resources and clearly define outputs and outcomes.
The ESPP continues to provide States and Tribes an opportunity to
develop State or Tribal initiated plans. Again, these plans are not a
requirement but an option in which they may choose to engage.
Comment: Bulletin Distribution--When the ESPP was proposed for
comment, EPA had been developing a broad-based distribution plan for
Bulletins and other ESPP information that was based on availability of
both paper and electronic copies of Bulletins. A key factor in
developing that plan was to make sources of Bulletins and other
information convenient to pesticide
[[Page 66397]]
users. The overwhelming sense of more than 50 comments received on this
topic was that Bulletins must be easily and readily accessible. About a
dozen commenters preferred availability on the web, although concerns
were expressed regarding web access and ease of printing (3
commenters), as well as possibly publicizing exact species locations
when specific farms or ranches might be identified in county maps (5
commenters). Other suggested distribution mechanisms for paper copies
of Bulletins included points of sale such as pesticide dealers,
distributors and retail stores; State lead agencies; U.S. Department of
Agriculture's Cooperative Extension Service; the Services; and
applicator training programs.
Response: In the time since EPA proposed the ESPP, EPA's ability to
utilize web-based technology has evolved and funding situations have
changed. These factors, combined with the public comment on the
proposal and EPA's desire to minimize label changes while providing
timely protection to listed species, have led to EPA's decision to use
a web-based system as the main route of Bulletin distribution. EPA
believes web-based Bulletin distribution provides the best compromise
between the time required to change product labels and being able to
more quickly inform pesticide users of any required use restrictions to
protect listed species or critical habitat. The Agency also believes
such a system is more cost-effective than printing paper copies and
will eliminate possible confusion about whether pesticide users have
the current version of a Bulletin. Therefore, EPA will provide
Bulletins via a web-based system or, if a pesticide user does not have
access to the Internet, through calling a toll-free number, as
described above.
3. Labels and Bulletins. EPA proposed to use a generic label
statement that would be included on the labels of products for which
pesticide use limitations were necessary to ensure protection of listed
species. This generic statement would refer the pesticide user to
further use limitations in a county-level Bulletin.
Comment: More than 110 commenters said mandatory protections for
listed species must be on the pesticide label, not in a Bulletin or on
a web site. Many indicated specific information they believed should be
included on the label such as: The name of the species to be protected,
what protections apply, where those protections apply, and penalties
for failure to comply with the label restrictions. Eleven commenters
said pesticide users should not have to go to more than one source to
obtain compliance information. Seventeen commenters expressed some
level of support for a generic label statement directing pesticide
users, when necessary, to follow a Bulletin.
Response: EPA has considered again the feasibility and desirability
of including all pertinent information regarding listed species
protection on the actual pesticide product label itself. EPA continues
to believe this approach is not feasible, would not result in better
protection for listed species, and would by necessity be overbroad in
terms of geographic areas in which limitations on pesticide use are
necessary to protect listed species. EPA intends to provide protection
for listed species while minimizing any unnecessary burden on pesticide
users, as we believe was the intent of Congress in passing section 1010
of Public Law 100-478 (October 7, 1988). While geographically specific
use limitations may certainly be described in text, such description
could be very lengthy consisting of numerous coordinates of many
geographic points. This type of information is more amenable to
portrayal through graphic methods. Further, should changes be necessary
as a result of additional species being listed etc., changes to the
Bulletin could be accomplished more readily than further changes to a
pesticide label. Therefore, by using Bulletins rather than the
pesticide product label to relay the specific use limitations,
protection will be more timely for the listed species.
4. Enforcement. For pesticide products determined to affect listed
species or critical habitat, the Agency proposed that the product
labels carry a statement directing users to follow the appropriate
Bulletin in effect at the time of product application or that all
Bulletins published by an annual date 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)).
Comment: Liability and incidental take--Most of about 18 commenters
in this area were concerned with liability and incidental take.
Fourteen commenters said those who follow label instructions and
accidentally harm a listed species should not be subject to any
liability, and any enforcement of the ESPP should be done through
FIFRA, not the ESA.
Response: The obligation of pesticide users under FIFRA to comply
with a pesticide product's label will not change under the Program.
Bulletins will be enforced as are pesticide labels since compliance
with the Bulletins will be a labeling requirement. As for the ESA, the
Services may under some circumstances issue what is called an
``incidental take statement'' which authorizes take of species under
certain circumstances. If such a statement authorizes take that may
result from the use of a pesticide in compliance with FIFRA, a
pesticide user applying the pesticide consistent with the labeling
would not be subject to enforcement action under the ESA for taking a
listed species. However, if the Services have not authorized take by
issuance of an incidental take statement, and take occurs from use of
the pesticide, a pesticide user could be liable for take under section
9 of the ESA, regardless of whether they complied with the use
requirements for the pesticide or not. In situations where EPA's
analysis results in a determination that a pesticide's use is ``likely
to adversely affect'' a species, EPA will be consulting with the
Services. If the pesticide's use will not, in the opinion of the
Services, result in jeopardy to the species, they may develop and issue
an incidental take statement. In situations where EPA's analysis
results in a determination that use of the pesticide with any use
limitations in the Bulletin is ``not likely to adversely affect'' the
species, further consultation with the Services may not occur. In these
situations, there is by definition, no incidental take anticipated
since the pesticide is ``not likely to adversely affect'' a species.
Thus, while a pesticide user could be liable for take under the ESA of
a listed species even when following all the appropriate use
requirements, including those articulated through a Bulletin, this
scenario is highly unlikely to occur.
5. Enhanced monitoring. EPA proposed several ways to evaluate the
extent to which the ESPP is protecting and contributing to the
conservation of listed species. EPA proposed to use existing monitoring
and incident data more effectively, to monitor effectiveness of
Bulletins after they have been used for a time, and to sponsor some
limited terrestrial monitoring to better understand whether specific
provisions in Bulletins were resulting in decreased potential for a
listed species to be exposed at levels of concern.
Comment: Nearly 60 comments were received on this broad area of
discussion. More than 30 commenters said any monitoring data should be
used either to refine the endangered species risk assessment or to
minimize the areas affected by pesticide use limitations designed to
protect listed species or
[[Page 66398]]
critical habitat. Ten commenters said monitoring must involve the
States, be done at the State level or be done by the States. In
response to our proposal to augment monitoring data with targeted
terrestrial residue monitoring, possibly to include post-registration
monitoring by registrants or others, 13 commenters objected to
registrants playing a role in any monitoring because of potential
conflicts of interest or the added burden to the companies, while five
commenters said the Services should play some role in monitoring,
ranging from oversight of others to performing the monitoring
themselves. Six commenters questioned the utility and applicability of
incident data in risk assessments, largely because of quality-control
issues and the lack of a definition of best available data. Nine
commenters agreed that EPA should make better use of existing
monitoring programs, rather than adding additional monitoring schemes.
Response: Given the comments received, the potential of budget
considerations at the federal, State and Tribal levels of government,
and the need to ensure that any new monitoring undertaken by the
federal government is well defined and considers input of stakeholders,
this notice does not include an EPA plan for new terrestrial
monitoring. However, this is an area that EPA will continue to explore
as the program moves forward, to determine whether it has broad utility
in evaluating the effectiveness of the program.
EPA will continue to consider and improve upon its use of existing
monitoring and incident data in its analyses of potential effects to
listed species. EPA continues to believe that the result of monitoring
programs generally do not provide sufficient information on which to
base a regulatory decision unless those programs are specifically
designed to answer the particular questions being posed. However, both
monitoring and incident data may, to varying degrees based on the
quality of the information and the confidence in the information, be of
value in characterizing the extent of potential exposure of a listed
species to a pesticide. EPA will consider incident information reported
to its incident monitoring programs and monitoring data conducted under
the U.S. Geological Survey's National Water Quality Assessment Program
and monitoring data submitted to EPA's Office of Water under the Clean
Water and Safe Drinking Water Acts, to help characterize the extent of
potential risk to listed species. Additionally, if OPP is aware of
monitoring programs conducted by OPP's State or Tribal regulatory
partners, EPA will assess the utility of the data resulting from those
programs and use those data, as appropriate. Finally, there may be
specific targeted monitoring conducted by the regulated industry at
EPA's request. These data too will be used, as appropriate, to help
characterize the extent of potential exposure of listed species to
pesticides.
6. Public participation. The proposal articulated EPA's commitment
to appropriate public participation and outlined three general stages
at which public input could be of particular value: During analysis of
a pesticide's potential effects, subsequent to a determination of
potential effect, and subsequent to development of a draft Biological
Opinion on the part of the Services, if appropriate. EPA proposes that
when any of these phases corresponds with a public participation phase
under EPA's ongoing review processes (e.g., reregistration), that
ongoing public process will be used.
Comment: Virtually all commenters agreed that more opportunities
must be available for public participation in all areas of listed
species protection, from the initial risk assessment through
determining mitigations where needed and developing appropriate
Bulletins.
Response: Endangered species risk assessment processes and risk
management decisions are being incorporated into EPA's existing
processes of registration, reregistration and registration review, and
will generally be afforded the same level of transparency and
opportunity for comment as provided in those processes. EPA has
discussed public participation with its Federal Advisory Committee (the
Pesticide Program Dialogue Committee) on several occassions and will
continue to work with that committee to further define specific aspects
of public participation relative to listed species concerns. EPA is
committed to a transparent and participatory process to the extent that
can be accomplished in a manner that continues to allow EPA to meet its
statutory obligations.
7. Implementation timing. EPA solicited comment on ways to time the
release of Bulletins to minimize the potential disruption to pesticide
users during a growing season. Among other details, the Agency proposed
to begin reviewing existing Bulletins within 6 months of publication of
this final Program notice to ensure they are still valid, and to update
each Bulletin no more than once annually.
Comment: Eight commenters said Bulletins should be updated
annually, in time for growers to plan for the upcoming season.
Suggestions for when to update them ranged from the end of the fall
growing season to January of each year.
Response: Given a web-based approach to Bulletin production and
distribution as articulated in this Notice, EPA intends to update
Bulletins as protection decisions are made or when a new body of data
becomes available. However, this web-based system is designed so that a
pesticide user may obtain any applicable pesticide use limitations for
a particular use in a particular location, up to 6 months prior to the
application date. EPA believes this 6-month window will allow adequate
time in most cases, for a pesticide user to plan their application of a
pesticide. Further, EPA believes that this will allow protections to be
implemented in a more timely manner than if EPA were to select one date
per year on which all changes would become effective.
All of the submitted comments are available in docket ID number
OPP-2002-0311, as described in Unit I.B.
III. The Endangered Species Protection Program Field Implementation
EPA's implementation plan is based on two goals. The first is to
provide appropriate protection to listed species and their designated
critical habitat 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
approach to implementing listed species protections where such
protections are deemed necessary.
EPA's plan as described in this document is not a legally binding
regulation and EPA may decide to revise, amend, or act at variance with
the terms of this document without providing notice and comment under
section 553 of the Administrative Procedure Act.
A. Scope of the ESPP
All pesticide products that EPA determines ``may affect'' a listed
species or its designated critical habitat may be subject to the ESPP.
The scope potentially includes pesticide actions under sections 3, 5,
18, and 24(c) of FIFRA.
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 would not
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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 does 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. FIFRA section 18s. Section 18 of FIFRA authorizes EPA to issue
``emergency exemptions'' to States and federal agencies to use a
pesticide for an unregistered use for a limited time if EPA determines
that emergency conditions exist. While EPA will endeavor to resolve
concerns regarding listed species prior to taking an action, that may
not always be possible for section 18s, which by their very nature are
time critical, especially those involving public health emergencies.
When submitting a section 18 request to EPA, States, Tribes and federal
agencies will be expected to demonstrate they have made a credible
effort to identify and address endangered species issues. The more
thorough the approach of the submitter, the more likely it will be that
EPA can conduct its endangered species assessment and consult with the
Services, as necessary, within the time constraints for review of FIFRA
section 18 applications. However, under the Counterpart Regulations,
the Services have indicated that emergencies under section 18 of FIFRA
may be treated as ``emergencies'' under the Services' consultation
regulations. As a result, if EPA cannot perform a comprehensive
endangered species assessment or, if applicable, initiate and complete
formal consultation prior to the emergency, EPA may use the emergency
informal consultation procedures described in the Services' Endangered
Species Consultation Handbook (Ref. 5) and complete any necessary
formal consultation as soon as practicable after the emergency.
B. Overall Approach
The task of assessing pesticide registrations' potential effects to
listed species has the potential to be quite significant. There are
more than 900 active ingredients used in more than 19,000 formulated
products registered under FIFRA. Each product is registered for one to
potentially many use sites. Each use site and its specific use
instructions have different potentials to affect a listed species or
critical habitat. With more than 1,200 listed species in one or more of
over 2,000 counties throughout the United States, the job of
determining what use patterns of each pesticide have the potential to
affect which species, is not a task that can be accomplished quickly.
EPA's overall strategy is to address listed species concerns within
the context of the pesticide registration, reregistration, and
registration review processes. As explained in the Agency's risk
assessment Overview Document (Ref. 1), endangered species assessments
are, essentially, geographic and biological refinements of the core
environmental risk assessment performed to support a registration,
reregistration or, in the future, registration review decision. Since
the refinements to assess the potential effects of a pesticide's use to
a listed species stem from this core assessment, and since that core
assessment feeds into a decision regarding the registration status of a
pesticide, it seems both logical and efficient to develop processes to
accomplish the endangered species refinements within the context of the
broader activities of registration, reregistration and, in the future,
registration review. FIFRA section 3(g) requires the Agency to
periodically review pesticide registrations. After establishing
procedures for registration review, EPA's goal is to review the
registration of each pesticide every 15 years. The purpose of this
review is to assess whether a pesticide continues to meet FIFRA
requirements for registration. During a pesticide's registration
review, the Agency would, among other things, determine whether
endangered species assessments must be conducted. If so, such
assessments would generally be conducted as part of the pesticide's
registration review where possible.
While it is OPP's intent to accomplish endangered species
assessments through these processes, there may be situations in which
the potential risks to a listed species are addressed apart from these
processes. For example, there may be situations in which new, valid
information becomes available on existing pesticide registrations, or
on a listed species, that will compel EPA to re-evaluate its
determinations and reinitiate consultation, as appropriate, outside
those existing processes. In those circumstances, case-by-case
decisions will be made on whether to review a pesticide prior to its
scheduled review time.
C. Results of Endangered Species Assessments: ``Effect Determinations''
The result of EPA's assessment of a pesticide use's potential
effects to listed species is an effects determination. This
determination will generally be included in the ecological risk
assessment conducted to support a decision regarding the registration
status of the pesticide (see Unit III.B.). EPA will make one of three
determinations regarding the potential of a pesticide to have an effect
on listed species: (1) The pesticide will have ``no effect'' on the
species, (2) the pesticide ``may affect but is not likely to adversely
affect'' the species, or (3) the pesticide is ``likely to adversely
affect'' the species. The processes by which these determinations are
made are described in the Agency's Overview Document (Ref. 1). Each
determination may relate to a specific use of a particular pesticide
and a particular listed species. Based on these determinations and any
required consultation under section 7(a)(2) of the ESA, some pesticides
will likely require changes to their use instructions in particular
geographic areas to ensure protection of listed species.
Decisions that change the use instructions on a pesticide and
subsequent implementation of those changes can occur in several ways.
If EPA's listed species assessment results in a determination that the
pesticide ``may affect but is not likely to adversely affect'' or that
it is ``likely to adversely affect'' a listed species, EPA will address
its consultation obligations as described in the Services consultation
regulations at 50 CFR part 402, unless the applicant or registrant
adopts changes to product labeling that allow EPA to make a ``no
effect'' determination for the pesticide. If EPA makes a ``not likely
to adversely affect'' determination for the pesticide under the
procedures of the Counterpart Regulations at 50 CFR part 402, subpart
D, no further consultation or written concurrence from the Services is
required. EPA may, however, choose to utilize the informal consultation
procedures of the Services regulations applicable to all federal
agencies by seeking the written concurrence of the Services on this
finding. The result of formal consultation following a ``likely to
adversely affect'' determination will be a Biological Opinion issued to
EPA by the Services. This Opinion will contain the Services'
determination of whether the pesticide's use could jeopardize the
continued existence of the species. If the Services believe that the
action will likely jeopardize listed species or destroy or adversely
modify
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designated critical habitat, then the Services will include changes to
the pesticide registration in the Biological Opinion that EPA may
consider adopting to avoid jeopardizing the continued existence of
listed species or the destruction or adverse modification of designated
critical habitat (called reasonable and prudent alternatives). If the
Services determine that jeopardy to the species will not result from
use of the pesticide and authorizes incidental take of the species, the
Biological Opinion will contain measures that must be followed in order
for any take of the species to be authorized by the ESA (reasonable and
prudent measures). These alternatives and measures may form the basis
for specific changes to the use instructions for a particular pesticide
in a particular geographic location.
Finally, EPA may identify a potential risk to a listed species and
request public input to suggest ways in which the pesticide use
instructions could be modified to reduce the potential risk. This
public input could form the basis for EPA exploring a variety of
potential changes to the pesticide's use in order to ensure it is in
compliance with the ESA.
By their very nature, the geographic range of each listed species
and the area required to support each species is usually quite limited;
therefore, changes to use instructions to protect listed species will
also, where appropriate, be geographically limited even for a
particular use of the pesticide. For example, in order to ensure
protection of a listed species, EPA may determine that use of a
pesticide for a particular crop need be changed only in a small
geographic area within a county, rather than for the crop nationwide.
When changes to a pesticide's use are necessary to protect a listed
species, and those changes are geographically specific, EPA intends to
implement those changes through Endangered Species Protection Bulletins
(Bulletins). The Bulletins will be at a county scale, with specific
geographic areas indicated within the county where use limitations
exist. In these cases, the Bulletin will be referenced on the pesticide
label by a generic statement that tells the pesticide user that the
product may harm some endangered or threatened species or their
critical habitat; that the user must follow the use limitations in the
Bulletin for the county in which they intend to apply the pesticide;
and how they may access the Bulletin for their county and pesticide
use.
D. Endangered Species Protection Bulletins and County Bulletins
1. Endangered Species Protection Bulletins (Bulletins). If as a
result of EPA's review of a pesticide, or as a result of consultation
with the Services, geographically specific use limitations are
necessary to ensure a pesticide registration complies with the ESA and
FIFRA, those use limitations will be relayed to pesticide users through
Bulletins referenced on the labels of affected pesticide products.
Bulletins will become enforceable use requirements once referenced on
the pesticide label.
Endangered Species Protection Bulletins will:
Identify the species of concern.
Name the active ingredient(s) for which use limitations
apply.
Describe the use limitation necessary for protection of
the species. Where species or habitat descriptions are helpful or
necessary to identify use limitations, EPA will also include this
information.
Contain a county map on which is shown the specific
geographic area in which the use limitations apply, depending on the
sensitivity of the species to other factors such as collection.
Typically, maps will show a patterned or shaded area indicating where
pesticide use must be modified to protect the listed species and to
ensure the pesticide user is not violating the misuse provisions of
FIFRA. Within patterned or shaded areas on the maps, the specific use
limitations will be identified for the pesticide and the species being
protected.
Where possible without causing further threat to a
species, provide a picture and description of the species.
2. Voluntary County Bulletins. There are a number of county
bulletins that EPA has developed in the past based on consultations
with the Services. These county bulletins have been posted on EPA's web
site for voluntary use by pesticide app