Docket ID Number: EPA-HQ-OPP-2012-0442

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ENVIRONMENTAL PROTECTION AGENCY

Office of Chemical Safety and Pollution Prevention

Office of Pesticide Programs

Enhancing Stakeholder Input in the Pesticide Registration Review and ESA Consultation 

Processes and Development of Economically and Technologically Feasible Reasonable and 

Prudent Alternatives

Purpose of this Document: 

This document, which was developed jointly by the EPA, the U.S. Department of Agriculture 

(USDA), the National Marine Fisheries Service (NMFS) in the U.S. Department of Commerce and the 

Fish and Wildlife Service (USFWS) in the U.S. Department of Interior1

, provides guidance to staff and 

managers participating in the associated processes. It does not create or confer legal rights or impose any 

legally binding requirements on the agencies or any other party.

Table of Contents:

Table of Contents:................................................................................................................................. 1

1 Introduction......................................................................................................................................... 2

2 EPA’s Registration Review Program.................................................................................................. 2

Figure 1. Original Design of EPA’s Registration Review Program...................................................... 4

3 Process Improvement Discussions...................................................................................................... 4

Earlier involvement of stakeholders in the Registration Review Process .......................................... 5

Consideration of pesticide use and usage data.................................................................................... 7

Increased use of the informal (or early) consultation process ............................................................ 7

Figure 2. Revised Design for EPA’s Registration Review Process........................................................ 8

4 Service’s ESA Consultation Process .................................................................................................. 9

Figure 3. Services’ Formal Consultation Process................................................................................. 11

5 Conclusion ........................................................................................................................................ 11

___________________________________________________________________________

 1 NMFS and USFWS are referred to collectively as the Services.
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1 Introduction

This document pertains to Federal agency implementation of the Federal Insecticide, Fungicide 

and Rodenticide Act (FIFRA)2 and the Endangered Species Act (ESA)3

. This document describes how 

the agencies will implement the statutes in the context of pesticide registration review decisions. In 

August 2012, EPA published a draft proposal and solicited public comments for 60 days. EPA, USDA, 

and the Services subsequently revised the document after consideration of the public comments 

received. 

The process of assessing the potential effects of a pesticide to federally listed threatened and

endangered species (hereafter referred to as listed species), determining whether risk reduction measures 

are necessary to ensure these species are not likely to be jeopardized and critical habitat is not destroyed 

or adversely modified, and implementing such measures requires close coordination across multiple 

Federal agencies and impacts a variety of entities including state pesticide regulatory agencies, pesticide 

users and pesticide companies. The process of ensuring protection of these species is one that will 

benefit from input by these entities as well as the general public. There are multiple opportunities for 

soliciting and considering such input at various points in the process as noted below. Because 

stakeholders, including state governments, universities, and growers/users have significant amounts of 

relevant information and are the ultimate implementers of pesticide labels in the field, it is critical that 

they have a seat at the table during the development of any needed risk reduction measures to ensure that 

such measures are technologically and economically feasible.

Over the past several years, stakeholder groups have increasingly expressed interest in ESA 

issues involving pesticide registration. Furthermore, Congressional committees have also stressed the 

importance of an open and transparent process ensuring that at multiple stages of the process there are 

opportunities for broader public participation and that the economic impacts on agriculture are more 

fully integrated into the process before a final decision is made. This paper describes how the Federal 

agencies can clarify and/or modify their processes to address these concerns and increase the robustness 

of the overall process. This paper specifically describes changes to EPA’s registration review process 

and the Services’ Section 7 consultation process that are intended to facilitate ESA pesticide 

consultations and coordination across these Federal agencies. In addition, it calls for a greater role for 

USDA. 

These process changes recognize and acknowledge the respective expertise of the four agencies 

involved. USDA’s expertise on crop distribution and their relationships with the agricultural community 

are critical links between EPA’s expertise on pesticides and the Services’ expertise on listed species’ 

locations, status, and biology. Each agency’s expertise defines their respective roles and responsibilities 

during consultation.

2 EPA’s Registration Review Program

The Food Quality Protection Act (FQPA) of 1996 amended FIFRA to include a mandate that 

EPA establish a new program4

, called registration review5, so that, as the ability to assess risk evolves 

 2 7 U.S.C. 136a et seq. (http://www.epa.gov/lawsregs/laws/fifra.html). 3 16 U.S.C. §1531 et seq. (http://www.epa.gov/lawsregs/laws/esa.html). 4 FIFRA Section 3(g), 7 U.S.C. 136a(g).

5 For more information about EPA’s registration review program, go to http://www.epa.gov/oppsrrd1/registration_review/.
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and as policies and practices change, all registered pesticides continue to meet the statutory standard of 

no unreasonable adverse effects to human health and the environment. Changes in science, public 

policy, and pesticide use practices will occur over time. Through the registration review program, EPA

periodically reevaluates pesticides to ensure that as change occurs, products in the marketplace can still 

be used safely. The registration review program challenges EPA to continuously improve its processes, 

science, and information management while maintaining a collaborative and open process for decisionmaking. In general, EPA intends to accomplish its work relative to protection of listed species in the 

course of its registration review program. That work will include, where appropriate, consultation with 

the Services. 

Under EPA’s regulations, the registration review program is a multi-stage process, incorporating 

opportunities for public comment at critical points in the review process. As originally designed,

interested stakeholders can comment on and provide relevant information at three critical points during 

the registration review process: the initial docket opening, the preliminary risk assessment, and the 

proposed decision. These points in the process are publically announced and accompanied by time 

frames and deadlines for the submission of comments and relevant information. 

At the stage where EPA opens the registration review docket, the Agency issues a preliminary work plan 

and invites the public to provide feedback on how EPA will scope the review (i.e., problem formulation) 

and what data will be required as part of this review. Following the completion of the public comment 

period, EPA reviews the information submitted, develops a response to comments document, and issues 

a final work plan. After the required data have been submitted and evaluated, EPA develops a 

preliminary risk assessment that addresses potential human health and ecological exposures and issues 

that scientific analysis for public comment.6 EPA’s ecological risk assessments will become a 

“biological evaluation” during consultation with the Services. After reviewing public comments, EPA 

revises the risk assessment, as needed, develops a response to comments document, proposes risk 

reduction measures it believes are necessary to address risk concerns, and invites the public to provide 

feedback on its proposed decision. It is only after these multiple stages of public comment that the 

Agency issues its final registration review decision. Figure 1 provides an overview of the original

registration review program. 

 6 When originally designing the registration review program, EPA intended to initiate consultation with the Services (if 

needed) at the point in the registration review process where comments were being sought on the preliminary risk 

assessment. The concept was that while the Agency was soliciting public input on the preliminary assessment, EPA would 

also engage in consultation with the Services, resulting in a Biological Opinion that could be incorporated into a final risk 

assessment and proposed registration review decision at the next step in the process. 
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Figure 1. Original Design of EPA’s Registration Review Program

Over the past year, EPA has engaged in significant dialogue with the Services and other 

stakeholders regarding how to improve the registration review process. At a summary level, most 

stakeholder groups have recommended that EPA make changes to its process to accomplish several 

goals: 1) earlier stakeholder involvement in the scoping of the pesticide’s re-evaluation, 2) earlier 

adoption of risk reduction measures, including incorporation of clarifications and/or new restrictions on 

product labels, before initiation of any needed consultations with the Services and prior to completion of 

the registration review, and 3) a more focused consultation process (when and if necessary) that reflects 

the adoption of such measures.

3 Process Improvement Discussions

In May 2011, the Minor Crop Farmer Alliance (MCFA) convened a workshop in Denver, 

Colorado, with three primary goals:

• Provide grower representatives with an understanding of the processes and analyses leading 

to the identification of risk and risk reduction options by EPA and by the Services.

• Identify grower-level data that could potentially refine the risk assessment and enhance the 

risk identification and risk reduction decision processes.

• Initiate discussions on the mechanisms for providing such data.

Several questions emerged from these discussions and have served to inform potential 

improvements to the registration review and consultation processes: 
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• What are the appropriate points in the registration review process to initiate discussions with 

both the registrant and the user community to identify, describe and verify crop specific use 

and usage information?

• What data sources are most complete and relevant to the risk assessment process?

• How will commodity groups know when to engage in the process?

• How will the agencies ensure that information collected and submitted is considered?

Subsequent to the workshop, EPA solicited input from its Federal advisory committee, the 

Pesticide Program Dialogue Committee (PPDC), regarding potential process changes that would 

facilitate greater opportunities for public participation and transparency in the registration review 

process and have the additional benefit of streamlining ESA consultation with the Services.

After considering public feedback based on the August 2012 proposal, and advice from the 

PPDC, EPA has implemented changes to the registration review process further augmenting 

opportunities for public involvement in the process. These changes are described below.

Earlier involvement of stakeholders in the Registration Review Process

As part of the registration review process, EPA annually publishes a four-year schedule to 

communicate when individual pesticides will enter the registration review program. To enhance 

transparency in the process, EPA has begun including information on the specific timeframe 

within any fiscal year when a pesticide will begin its review. Having this information available 

in advance provides early notice for interested stakeholders to submit information to EPA in 

advance of the pesticide beginning its re-evaluation7

.

During FY12, EPA began holding “Focus” meetings during the early stage of registration 

review. EPA believes that these meetings increase efficiency and help to better inform the 

problem formulation and risk assessment phases of the registration review process. EPA uses

“Focus” meetings to begin initial outreach efforts to stakeholders. A “Focus” meeting is initiated 

by EPA with affected registrants and possibly other stakeholders via invitation8

. EPA will 

extend invitations to USDA, and, where applicable, to the Services, to attend “Focus” meetings. 

The USDA can help identify affected growers and ensure they are aware of time frames for 

registration review. The Services can respond to questions and concerns regarding any existing 

ESA issues, such as, ongoing litigation. 

In an effort to create a transparent process and broaden stake holder participation, EPA will place 

the “Focus” meeting minutes and related materials (the invitation letter, a sign-in sheet 

containing contact information for the meeting attendees, documents provided by the EPA, 

registrants, or other attendees, and any other related material) in the publically-available,

 7 For more on registration review schedules go to http://www.epa.gov/oppsrrd1/registration_review/schedule.htm 8 For more details on “Focus” meetings visit: http://www.epa.gov/oppsrrd1/registration_review/focus-meetings.html
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chemical-specific registration review dockets within 45 days9, but will strive to have those 

materials posted to the docket within 10 business days of the meeting. Additional follow-up 

meetings and calls will be held as needed. If upon reviewing the minutes and materials of the 

meeting, an interested stakeholder wishes to meet with EPA and discuss these issues, they can 

contact EPA and request a meeting. Contact information for EPA will be included in the 

chemical-specific docket materials. EPA can initiate discussions with registrants and other 

parties at any point in the registration review process. 

Similar to the “SMART” meetings that were held during reregistration, these “Focus” meetings 

provide the registrants and other interested stakeholders opportunities to: 1) identify the uses that 

the registrant intends to support for registration review, 2) address label language that is vague, 

insufficient, or inaccurate at an early stage of the review process, and 3) adopt risk reduction

measures before registration review begins.

Purpose #1: Define the use patterns supported by the registrants. Markets and the economic 

viability of certain pesticide uses change over time. Through the “Focus” meetings, EPA 

will ask the manufacturers to explicitly indicate which uses they intend to continue to support

for registration. This provides an opportunity to begin the process of defining the scope of 

the Federal action to be considered under the ESA.

Purpose #2: Ensure label language accurately reflects product use and usage. Inaccuracies, 

missing information, and vague or poorly worded label language should be identified. 

Confusion regarding label directions will be addressed at this stage in the process so that the

risk assessment more accurately reflects the intended use of the pesticide. One such example 

is inclusion of specificity on the maximum number and frequency of applications. Products 

and use patterns can be discussed to maximize the potential for species’ protections while 

maintaining a critical use. When applicable, EPA will follow-up with additional meetings 

with state regulators, USDA, and commodity groups on proposed use site/label changes.

Purpose #3: Identify potential risk drivers and potential risk reduction measures as early as 

possible. Previous risk assessments, conducted either to support reregistration decisions, new 

uses, or litigation, may have indicated potential ecological risks. Alternative chemicals may 

have been developed since those initial evaluations; as a result, the benefits of the pesticide 

beginning registration review may have changed. There may also be the potential, based 

upon further field experience with the pesticide, to identify the key efficacious rates critical 

for crop protection and/or existing conservation practices being employed that could be 

incorporated into labels as part of “early risk reduction.”

It is a common goal of the Federal agencies to have accurate use and usage language on product 

labels, and, when possible, agreed upon risk reduction measures incorporated onto product labels 

before the pesticide reaches the preliminary risk assessment stage. This saves valuable resources 

for all.

 9 Under the registration review rule (40 CFR 155.52), the EPA has 45 days to docket meeting minutes and related materials. 

A special Focus Meetings docket has been established for meeting material; visit EPA-HQ-OPP-2012-0778 at 

www.regulations.gov.
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Consideration of pesticide use and usage data

During a two to three-year period of time after completion of the final workplan, the registrant is 

often developing toxicity and exposure data to support the preliminary risk assessment for the 

pesticide’s registration review. As this information is being submitted to EPA, updated use data

(i.e., data identifying registered use sites) and usage information (i.e., information explaining 

how products are applied to specific use sites) will be solicited from a variety of sources, 

including USDA and grower organizations. These data, such as application methods, application 

rates, frequency of application, and application timing are critical pieces of information in 

developing EPA’s ecological risk assessment. For example, having more complete information 

on the times of the year when a pesticide is used may enable EPA to more accurately predict the 

potential exposure of listed species to pesticides.

EPA will incorporate these data, which may be national and/or local in scope, to refine the label

and/or identify typical use rates for risk characterization, to define the uses that will be supported 

for registration review, and to facilitate the potential adoption of any additional needed risk 

reduction measures with the possibility of reducing, or eliminating the number of “may affect, 

likely to adversely affect” determinations under the ESA. These data can also be used to 

describe the situations in which rates higher than “typical” rates are needed and under what 

conditions, allowing more prescriptive label language to be developed. Ultimately, these data 

should result in a refined preliminary (ecological) risk assessment.

EPA has a long history of using these data in making pesticide safety determinations. For 

example, pesticide usage data collected by USDA’s National Agricultural Statistics Service 

(NASS) have been found to be of exceptional quality and reliability in making food safety 

determinations (i.e., “reasonable certainty of no harm” determinations) under the FQPA. 

Congress has directed EPA to use data, such as those developed by NASS when EPA “finds that 

the data are reliable and provide a valid basis to show what percentage of the food derived from 

such crop is likely to contain such pesticide chemical residue,” provided that the Agency 

periodically reevaluates the estimate of the anticipated exposure in light of these data.

Increased use of the informal (or early) consultation process

A critical step in developing the preliminary ecological risk assessment is having reliable data on 

species habitat, diet, geographic range, and behavior. EPA will use the informal consultation 

process to work with the appropriate Service to gather this information for inclusion in a more 

refined ecological risk assessment. Collaborating with the Services to gather this information at 

an earlier stage in the process has a number of benefits, including 1) incorporation of more 

refined species biology and habitat information into EPA’s effects determinations, 2) potential 

reduction in the number of “may affect, likely to adversely affect” determinations, and 3) fewer 

resources (for both EPA and the Services) needed to complete consultations because the best 

available information has been incorporated into EPA’s preliminary ecological risk assessment. 

Early interaction under informal consultation will allow EPA and the Services to identify 

potential risk to listed species and their habitats and would position EPA to begin discussing 

potential risk reduction measures with the pesticide registrant. Even when this informal 

consultation does not eliminate the need for formal consultation, the work accomplished through 

informal consultation will inform and streamline the formal consultation.
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As a result of the process improvement discussions, EPA is making two significant changes to its 

registration review process: 1) hold “Focus” meetings at the start of the registration review for each 

active ingredient, and 2) consult informally with the Services early in the review process and initiate any 

needed formal consultations at a subsequent stage. Figure 2 outlines EPA’s revised registration review 

process.

Figure 2. Revised Design for EPA’s Registration Review Process

One major end result of these process changes is that through public involvement, particularly with 

growers who are responsible for “on the ground” implementation of pesticide product label language, 

risk reduction measures that achieve protection for listed species and designated critical habitat and that 

are technologically and economically feasible can be achieved, possibly through changes to labels, or 

via species’ bulletins10. The involvement of growers and state lead agencies will also ensure that the 

protection measures are economically and technologically feasible. 

 10 More on EPA’s Bulletins Live! can be found at http://www.epa.gov/oppfead1/endanger/bulletins.htm
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4 Services’ ESA Consultation Process

Under the Services’ ESA regulations11, when a Federal agency determines that its proposed 

action may adversely affect a listed species or critical habitat, the agency is obligated to enter into 

formal consultation with the Services to ensure that the action is not likely to result in jeopardy to the 

listed Species, or destroy and/or adversely modify critical habitat.

However, before initiating formal consultation under section 7 of the ESA, a Federal agency, or a 

designated non-Federal representative can consult “informally.”12 Informal consultation is an optional 

process that can be used to (1) clarify whether and what listed, proposed and candidate species, or 

designated, or proposed critical habitat may be in the action area; (2) determine what effect the action 

may have on these species and critical habitat; (3) explore ways to modify the action to reduce or 

remove adverse effects to the species and critical habitat; (4) determine the need to enter into formal 

consultation; and (5) explore modifications of an action to benefit listed species. Participants in 

informal consultation may include the (1) Federal action agency, (2) applicant, (3) non-Federal 

representative, or (4) consultant working on behalf of one of the first three. There is no overall timetable 

for informal discussions, and dialogue can continue as long as the parties are willing to participate and 

are actively working to complete the consultation. If during informal consultation the Federal agency 

determines, with written concurrence of the Services, that the action is not likely to adversely affect 

listed species or critical habitat, the consultation process is terminated. 

When EPA determines that formal consultation with one or both of the Services is necessary, 

continued engagement with registrants and interested stakeholders (e.g., growers, state agencies, 

conservation groups, and water quality groups) is vital. Under ESA regulations, registrants are 

considered “applicants.” Applicants have certain defined opportunities under the regulations, including 

the opportunity to submit information during the consultation and review draft biological opinions. 

Upon receiving a request to initiate formal consultation from EPA, the Service will convene a 

meeting with EPA and the applicant to identify what additional information – beyond that provided by 

EPA in its package initiating consultation – can be provided for consultation and subsequent drafting of 

the biological opinion. To ensure that all agency expertise is involved, EPA will extend an invitation to 

USDA to attend the applicant meetings. During consultation, the Services may discuss with EPA its risk 

assessment and effects determination to gain a better understanding and they may seek out additional 

information from other sources. If the Services believe that changes to the pesticide label may be 

necessary to avoid or reduce the extent of adverse effects to listed species or critical habitat, they will

work with EPA and USDA to engage the applicant, product users, and other stakeholders to discuss 

possible label changes needed to avoid jeopardizing the continued existence of listed species and 

destroying or adversely modifying critical habitat. Before analyzing the effects of the action, the 

Services, EPA, and applicants will review and agree upon the description of the action (e.g., use rates, 

registered uses, scope of the proposed action as described on pesticide labels).

The Services will prepare draft biological opinions that include their analyses and conclusions 

regarding whether use of the pesticide is likely to jeopardize the continued existence of a federally-listed 

 11 See 50 CFR Part 402. 12 Endangered Species Consultation Handbook, USFWS and NMFS March 1998; 50 CFR 402.13
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species or to destroy or adversely modify critical habitat under their purview. If FWS and/or NMFS

determine that jeopardy or adverse modification of critical habitat is likely, they are obligated to work 

with EPA and the applicant to identify Reasonable and Prudent Alternatives (RPAs), to the extent such 

measures exist, to insure that the action will avoid the likelihood of jeopardizing listed species or 

destroying or adversely modifying critical habitat. Service regulations require that these are measures 

that can be implemented in a manner consistent with the intended purpose of the action, can be 

implemented within the scope of EPA’s legal authority and jurisdiction, and are economically and 

technologically feasible. Where the Services anticipate “take”13 of listed species, the draft biological 

opinion(s) includes proposed Reasonable and Prudent Measures (RPMs) and terms and conditions to 

minimize the impact of the take.

The Services will provide EPA with the draft biological opinion for their review. EPA will make 

the draft biological opinion available for public comment. The public comment period provides another 

opportunity for stakeholders to provide valuable input on RPAs, RPMs, and terms and conditions, as 

well as to provide/suggest/propose alternate risk reduction measures that accomplish the same protection 

goals but may be easier/less costly for the grower/user community to implement. All comments will be 

submitted to EPA, although the applicant may send a copy of its comments directly to the Service. EPA 

will organize the comments and highlight those of particular note and provide them to the Services.

During the public comment period, EPA and the Services, supported by USDA, will solicit input 

from growers and other stakeholders on any technologically and economically feasible approaches that 

minimize the impact on growers and that allow them to meet their pest control needs while achieving the 

necessary protection goals to avoid jeopardy to threatened and/or endangered species. In particular, this 

process should offer stakeholders an opportunity to provide data and to identify practical considerations 

that affect the viability of different options for mitigating risks to species. EPA will provide a key role 

by focusing affected entities on the availability of the draft biological opinion and timeframes for 

submission of input.

Upon receipt of the organized public comments from EPA, each Service will prepare a document 

for their respective opinions, where applicable, and include it in the administrative record that addresses 

how comments were considered and, if appropriate, how the final document was modified to address the 

comments. Each Service will include this document in their respective administrative records and will 

provide it to EPA. Both the Services and EPA will make the document available to the public upon 

request. 

The ESA and section 7 regulations require that formal consultation be concluded within 90 

calendar days of initiation, and that the biological opinion be delivered to the action agency within 45 

days of the conclusion of formal consultation, unless an extension is agreed to by the agencies and any 

applicant. EPA will seek an extension to the consultation process when they determine that the statutory 

timeframes fail to provide adequate time for consideration of information obtained through this process. 

However, if the extension exceeds more than 60 days, i.e., 150 days from initiation of formal 

consultation, EPA and the Services must seek consent from the applicants. It should be recognized, 

however, that circumstances beyond the government’s control (e.g., the refusal of an applicant to agree 

to an extension) may force the process described above to be more truncated.

 13 Take – to pursue, hunt, shoot, wound, kill, trap, capture, or collect, or attempt to pursue, hunt, wound, kill, trap, capture, or 

collect. See 50 CFR§10.12.
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Throughout the consultation, it is critical that the established expertise of each agency is 

recognized and respected: the Services are the expert agencies regarding the species; EPA is the expert 

agency on pesticide risk assessment, regulation, and the enforceability of labels. USDA will lend its 

expertise on farming/pest management practices and the technological or economic feasibility of 

adopting potential risk reduction strategies. Therefore, in developing draft RPAs and RPMs, the 

Services should include only those risk reduction measures that EPA has the authority to impose and 

should then defer to EPA to implement these measures using its existing statutory authorities. For 

example, the Services might identify a level of exposure below which jeopardy would not occur. In 

response, EPA will implement changes to the pesticide registration that will reasonably ensure that the 

specified level of exposure is not exceeded. Figure 3 outlines the Service’s formal consultation process. 

Figure 3. Services’ Formal Consultation Process

5 Conclusion

In summary, the Services, EPA, and USDA intend that these changes will result in greater 

openness and transparency in the pesticide registration review process under FIFRA and in the 

consultation process under the ESA. Consistent with the statutory mandate to use the best available 

information, the goal of these changes is to improve stakeholder involvement in these processes and to 

improve the respective agencies’ understanding of how pesticides are used, the ways in which they may 

affect listed species, and how risks to listed species can be mitigated while preserving the beneficial uses 

of the pesticides to the extent possible.