[MPWG] Fw: [epa-species] Endangered Species Protection Program Field Implementation
Patricia_DeAngelis at fws.gov
Patricia_DeAngelis at fws.gov
Wed Nov 2 15:10:56 CST 2005
The announcement below..."describes how EPA's Office of Pesticide Programs
intends to implement its Endangered Species Protection Program (ESPP or
the Program)" given its "responsibilities under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA)
in compliance with the Endangered Species Act (ESA)."
"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."
Based on past MPWG listserve member input, it is possible
that the following section may be of particular interest to you:
"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 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."
More information is provided below.
-Patricia
Patricia S. De Angelis, Ph.D.
Botanist - Division of Scientific Authority
Chair - Plant Conservation Alliance - Medicinal Plant Working Group
US Fish & Wildlife Service
4401 N. Fairfax Dr., Suite 750
Arlington, VA 22203
703-358-1708 x1753
FAX: 703-358-2276
Working for the conservation and sustainable use of our green natural
resources.
<www.nps.gov/plants/medicinal>
----- Forwarded by Patricia De Angelis/ARL/R9/FWS/DOI on 11/02/2005 03:58
PM -----
envsubset at epamail
.epa.gov
To
11/02/2005 12:10 "Federal Register SPECIES
PM documents"
<epa-species at lists.epa.gov>
cc
Please respond to
envsubset at epamail Subject
.epa.gov [epa-species] Endangered Species
Protection Program Field
Implementation
http://epa.gov/EPA-SPECIES/2005/November/Day-02/
=======================================================================
[Federal Register: November 2, 2005 (Volume 70, Number 211)]
[Notices]
[Page 66392-66402]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no05-80]
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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: <A HREF="
mailto:williams.arty at epa.gov">williams.arty at epa.gov</A>.
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: <A HREF="mailto:powell.mary at epa.gov
">powell.mary at epa.gov</A>.
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 <A HREF="http://www.epa.gov/fedrgstr/
">http://www.epa.gov/fedrgstr/</A>.
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 <A HREF="http://www.epa.gov/edocket/
">http://www.epa.gov/edocket/</A> 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, <A HREF="
http://www.epa.gov/espp">http://www.epa.gov/espp</A>, 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
<A HREF="http://www.epa.gov/espp">http://www.epa.gov/espp</A>. 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
[[Page 66399]]
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
[[Page 66400]]
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 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 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 <A HREF="
http://www.epa.gov/espp">http://www.epa.gov/espp</A>. EPA is developing a
web-based Bulletin-
retrieval 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 <A HREF="http://www.epa.gov/espp/">http://www.epa.gov/espp/</A>, 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
[[Page 66401]]
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 six-phase 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 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
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 man-made 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, <A HREF="http://www.epa.gov/espp
">http://www.epa.gov/espp</A>, 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
[[Page 66402]]
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.
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 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.
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.
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 Agency-Endangered and
Threatened Species Effects Determinations
(<A HREF="http://epa.gov/espp/consultation/ecorisk-overview.pdf
">http://epa.gov/espp/consultation/ecorisk-overview.pdf</A>).
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. Alternative Consultation Agreement for
Implementation of Optional Alternative Consultation Procedures (ACA)
(<A HREF="http://www.epa.gov/espp/consultation/final-aca.pdf
">http://www.epa.gov/espp/consultation/final-aca.pdf</A>).
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
(<A HREF="http://www.fws.gov/endangered/consultations/s7hndbk/s7hndbk.htm
">http://www.fws.gov/endangered/consultations/s7hndbk/s7hndbk.htm</A>.)
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
(<A HREF="
http://www.fws.gov/endangered/consultations/pesticides/evaluation.pdf
">http://www.fws.gov/endangered/consultations/pesticides/evaluation.pdf</A>).
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
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