[Federal Register Volume 70, Number 211 (Wednesday, November 2, 2005)]
[Notices]
[Pages 66392-66402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-21838]


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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.

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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="/cdn-cgi/l/email-protection#9aedf3f6f6f3fbf7e9b4fbe8eee3daffeafbb4fdf5ec"><span class="__cf_email__" data-cfemail="8ff8e6e3e3e6eee2fca1eefdfbf6cfeaffeea1e8e0f9">[email protected]</span></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="/cdn-cgi/l/email-protection#96e6f9e1f3fafab8fbf7e4efd6f3e6f7b8f1f9e0"><span class="__cf_email__" data-cfemail="bacad5cddfd6d694d7dbc8c3fadfcadb94ddd5cc">[email protected]</span></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 <greek-i>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 http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to 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, http://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 
http://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

[[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:
    <bullet> Identify the species of concern.
    <bullet> Name the active ingredient(s) for which use limitations 
apply.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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 http://www.epa.gov/espp. 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 http://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

[[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--
    <bullet> 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.
    <bullet> Potential mitigation. Provide suggestions on use practice 
changes, how certain changes may impact the pesticide user community, 
and input on risk mitigation scenarios.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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, http://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

[[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 (http://epa.gov/espp/consultation/ecorisk-overview.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. Alternative Consultation Agreement for 
Implementation of Optional Alternative Consultation Procedures (ACA) 
(http://www.epa.gov/espp/consultation/final-aca.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 (http://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 (http://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


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