66392 Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 

Dated: October 20, 2005. 

J. E. Leahy, Jr., 

Acting Director, Special Review and 

Reregistration Division, Office of Pesticide 

Programs. 

[FR Doc. 05–21626 Filed 11–1–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[OPP–2002–0311; FRL–7739–7] 

Endangered Species Protection 

Program Field Implementation 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This document describes how 

EPA’s Office of Pesticide Programs 

intends to implement its Endangered 

Species Protection Program (ESPP or the 

Program). The goal of the ESPP is to 

carry out responsibilities under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) in compliance 

with the Endangered Species Act (ESA), 

while at the same time not placing 

unnecessary burden on agriculture and 

other pesticide users. This document 

describes EPA’s approach to 

implementing its responsibilities under 

section 7(a)(2) of ESA subsequent to a 

determination by EPA that 

geographically specific risk mitigation is 

necessary to protect federally listed 

threatened or endangered species or 

their critical habitat. For purposes of the 

ESPP, the term ‘‘listed species’’ or 

‘‘endangered species’’ will encompass 

species listed as threatened or 

endangered, plus designated critical 

habitat of these species; the term 

‘‘county’’ will include counties, 

parishes, and similar political 

boundaries of U.S. Territories. The 

implementation approach relies on 

pesticide labels, as appropriate, 

referring the pesticide user to 

geographically specific Endangered 

Species Protection Bulletins that will 

contain enforceable use limitations for 

the pesticide necessary to ensure the 

pesticide’s use will not jeopardize the 

continued existence of a listed species. 

FOR FURTHER INFORMATION CONTACT: For 

technical information: Arthur-Jean B. 

Williams, Environmental Fate and 

Effects Division (7507C), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460; 

telephone number: (703) 305–7695; fax 

number: (703) 305–6309; e-mail address: 

williams.arty@epa.gov. 

For field implementation information: 

Mary Powell, Field and External Affairs 

Division (7506C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460; telephone 

number: (703) 305–7384; fax number: 

(703) 308–3259; e-mail address: 

powell.mary@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

This action is directed to the public 

in general, and may be of particular 

interest to State and Tribal regulatory 

partners, other interested Federal 

agencies, environmental or public 

interest groups, pesticide registrants and 

pesticide users. Since other entities may 

also be interested, the Agency has not 

attempted to describe all the specific 

entities that may be affected by this 

action. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

B. How Can I Get Copies of this 

Document and Other Related 

Information? 

1. Docket. EPA has established an 

official public docket for this action 

under docket identification (ID) number 

OPP–2002–0311. The official public 

docket consists of the documents 

specifically referenced in this action, 

any public comments received, and 

other information related to this action. 

Although a part of the official docket, 

the public docket does not include 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. The official public 

docket is the collection of materials that 

is available for public viewing at the 

Public Information and Records 

Integrity Branch (PIRIB), Rm. 119, 

Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

2. Electronic access. You may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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 

Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 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. 

66394 Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 

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-bycase basis with minimal impact on 

listed species, and assume some take 

would occur (1 commenter); consulting 

with as many State and federal agencies 

as possible to respond to the emergency 

(1 commenter); detailing a FWS person 

to EPA to work with EPA on requests for 

crisis exemptions (1 commenter); and, if 

no ESA review is done because of the 

extreme nature of the emergency, 

complete the listed species review as 

soon as possible afterward, without 

extending the emergency registration 

until the ESA review is completed (6 

commenters). 

Response: While EPA will endeavor 

to resolve concerns regarding listed 

species prior to taking an action, that 

may not always be possible for section 

18s, which by their very nature are time 

critical, especially those involving 

public health emergencies. When 

submitting a section 18 request States, 

Tribes and federal agencies will be 

expected to demonstrate they have 

made a credible effort to identify and 

address endangered species issues. The 

more thorough the approach of the 

submitter, the more likely it will be that 

EPA can conduct its endangered species 

Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 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 

66396 Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 

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 

Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 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 countylevel Bulletin. 

Comment: More than 110 commenters 

said mandatory protections for listed 

species must be on the pesticide label, 

not in a Bulletin or on a web site. Many 

indicated specific information they 

believed should be included on the 

label such as: The name of the species 

to be protected, what protections apply, 

where those protections apply, and 

penalties for failure to comply with the 

label restrictions. Eleven commenters 

said pesticide users should not have to 

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 

66398 Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 

critical habitat. Ten commenters said 

monitoring must involve the States, be 

done at the State level or be done by the 

States. In response to our proposal to 

augment monitoring data with targeted 

terrestrial residue monitoring, possibly 

to include post-registration monitoring 

by registrants or others, 13 commenters 

objected to registrants playing a role in 

any monitoring because of potential 

conflicts of interest or the added burden 

to the companies, while five 

commenters said the Services should 

play some role in monitoring, ranging 

from oversight of others to performing 

the monitoring themselves. Six 

commenters questioned the utility and 

applicability of incident data in risk 

assessments, largely because of qualitycontrol issues and the lack of a 

definition of best available data. Nine 

commenters agreed that EPA should 

make better use of existing monitoring 

programs, rather than adding additional 

monitoring schemes. 

Response: Given the comments 

received, the potential of budget 

considerations at the federal, State and 

Tribal levels of government, and the 

need to ensure that any new monitoring 

undertaken by the federal government is 

well defined and considers input of 

stakeholders, this notice does not 

include an EPA plan for new terrestrial 

monitoring. However, this is an area 

that EPA will continue to explore as the 

program moves forward, to determine 

whether it has broad utility in 

evaluating the effectiveness of the 

program. 

EPA will continue to consider and 

improve upon its use of existing 

monitoring and incident data in its 

analyses of potential effects to listed 

species. EPA continues to believe that 

the result of monitoring programs 

generally do not provide sufficient 

information on which to base a 

regulatory decision unless those 

programs are specifically designed to 

answer the particular questions being 

posed. However, both monitoring and 

incident data may, to varying degrees 

based on the quality of the information 

and the confidence in the information, 

be of value in characterizing the extent 

of potential exposure of a listed species 

to a pesticide. EPA will consider 

incident information reported to its 

incident monitoring programs and 

monitoring data conducted under the 

U.S. Geological Survey’s National Water 

Quality Assessment Program and 

monitoring data submitted to EPA’s 

Office of Water under the Clean Water 

and Safe Drinking Water Acts, to help 

characterize the extent of potential risk 

to listed species. Additionally, if OPP is 

aware of monitoring programs 

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 

Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 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 

66400 Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 

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 

http://www.epa.gov/espp. EPA is 

developing a web-based Bulletinretrieval system that will enable 

pesticide users to enter basic 

information such as their state, county, 

and month of anticipated pesticide use. 

The system will then display the 

appropriate Bulletin for printing. The 

printed Bulletin will display the month 

for which it is valid. These Endangered 

Species Protection Bulletins will be 

available on a distinct web site that will 

be referenced on the pesticide label to 

avoid possible confusion with the 

existing, voluntary county bulletins that 

will remain available for public 

reference but do not contain enforceable 

use limitations. 

Bulletins will generally be available 6 

months in advance of their effective 

date. Pesticide users should therefore 

check for availability of a relevant 

Bulletin no more than 6 months before 

applying a pesticide to ensure they are 

using the current Bulletin for the 

county. 

Those without access to the Internet 

may call EPA at 1–800–447–3813 to 

determine applicability and availability 

of Endangered Species Protection 

Bulletins. If a Bulletin does apply, it 

will be printed and mailed upon 

request. 

E. Pesticide Label Language 

When geographically specific use 

limitations are necessary to ensure legal 

use of a pesticide product will not result 

in jeopardy to the species, EPA will 

generally seek to ensure that registrants 

include the following statement on the 

product label at the beginning of the 

product’s Directions for Use: 

ENDANGERED SPECIES PROTECTION

REQUIREMENTS

This product may have effects on federally 

listed threatened or endangered species or 

their critical habitat in some locations. When 

using this product, you must follow the 

measures contained in the Endangered 

Species Protection Bulletin for the county or 

parish in which you are applying the 

pesticide. To determine whether your county 

or parish has a Bulletin, and to obtain that 

Bulletin, consult 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 

Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 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 sixphase process and generally provides 

one or two formal opportunities for 

public input. 

There are three major phases of a 

listed species assessment that may 

provide opportunity for public input: 

Prior to a ‘‘may affect determination’’ by 

EPA; identifying potential mitigation; 

and prior to issuance of a Biological 

Opinion to EPA by the Services. EPA 

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 manmade landmarks such as rivers, roads, 

and railways. 

• Review of use limitations to protect 

species. States and Tribes also will be 

requested to provide input to the 

Agency on any potential use limitations 

for species protection. The purpose of 

this review would be for the Agency to 

ascertain, based on local conditions, 

whether specific use limitations could 

be implemented. States and Tribes will 

also be sources of input on the 

technological and economic feasibility 

of implementing any proposed use 

limitations. 

3. Role of pesticide registrants. As 

with any potential change to a pesticide 

product label, the registrant of a product 

for which it has been determined the 

generic endangered species statement 

needs to be included, will have an 

opportunity to review the specific use 

limitations that may be included in the 

Bulletins, prior to Bulletin issuance. If 

once a product is labeled with the 

generic statement, changes in the 

Bulletin which would affect that 

product’s use are necessary, the 

registrant will have an opportunity to 

review the changes prior to issuance. 

Further, the registrants retain any rights 

they may have under FIFRA, regarding 

EPA’s determination that use of the 

product needs to be modified. 

EPA will publish specific details of 

this public participation process on its 

web site, 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 

66402 Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 

ensure the provisions of the plan can be 

implemented by EPA through the 

labeling and Bulletin approach 

discussed in this Notice. EPA will also 

determine whether the Services need to 

be consulted on the contents of the plan 

before EPA adopts the plan. After the 

necessary reviews EPA will approve or 

disapprove the plan. If approved, EPA 

would then adopt it and could require, 

through Bulletins, that users comply 

with the requirements of the plan, as 

appropriate. 

An alternative plan may be submitted 

to EPA at any time. However, once the 

federally initiated actions are 

implemented within an area, those 

requirements will be effective in that 

area until the alternative plan is 

approved for implementation and EPA 

implements the plan through changes to 

the appropriate Bulletins. Section 24(a) 

of FIFRA reserves to States the authority 

to impose different requirements on 

registered pesticides provided they do 

not permit any sale or use prohibited by 

FIFRA. Accordingly, this Notice is not 

intended to modify any State authority 

to impose additional State requirements 

regarding listed species. 

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 AgencyEndangered and Threatened Species 

Effects Determinations (http://epa.gov/ 

espp/consultation/ecoriskoverview.pdf). 

2. U.S. Environmental Protection 

Agency. 2002. Process for Assessing 

Potential Risks to Endangered and 

Threatened Species and Consultation 

with the National Marine Fisheries 

Service and the U.S. Fish and Wildlife 

Service. 

3. U.S. Department of the Interior, 

Fish and Wildlife Service; and U.S. 

Department of Commerce, National 

Oceanic and Atmospheric 

Administration, National Marine 

Fisheries Service. August 5, 2004. Joint 

Counterpart Endangered Species Act 

Section 7 Consultation Regulations; 

Final Rule. 69 FR 47732, codified at 45 

CFR part 402. 

4. U.S. Environmental Protection 

Agency; U.S. Department of the Interior, 

Fish and Wildlife Service; and U.S. 

Department of Commerce, National 

Oceanic and Atmospheric 

Administration, National Marine 

Fisheries Service. August 2004. 

Alternative Consultation Agreement for 

Implementation of Optional Alternative 

Consultation Procedures (ACA) (http:// 

www.epa.gov/espp/consultation/finalaca.pdf). 

5. U.S. Fish and Wildlife Service and 

National Marine Fisheries Service. 

March 1998. Endangered Species 

Consultation Handbook, Procedures for 

Conducting Consultation and 

Conference Activities Under Section 7 

of the Endangered Species Act (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 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL–7992–9] 

Safe Drinking Water Act 

Determination; Underground Injection 

Control Program, Determination of 

Indian Country Status for Purposes of 

Underground Injection Control 

Program Permitting 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of prospective 

determination. 

SUMMARY: EPA must determine whether 

any of the approximately 160 acres of 

land located in the southeast portion of 

Section 8, Township 16N, Range 16W, 

in the State of New Mexico, is part of 

a dependent Indian community under 

18 U.S.C. 1151(b) and, thus, considered 

to be ‘‘Indian country.’’ This 

determination is necessary in order to 

establish whether EPA or the New 

Mexico Environment Department is the 

appropriate agency to issue a particular 

underground injection control permit 

under the Safe Drinking Water Act. EPA 

is seeking comments and information 

from the public and all interested 

parties regarding the possible Indian 

country status of this land and is