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Page 1 of 11 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:

Th is 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 Interior 1

, provide s guidance to staff and managers participating in the associated processes . It d oes not create or confer legal rights or impose any legally binding requiremen ts on the agencies or any other party.

Table of Contents : Table of Contents :

................................ ................................ ................................ ................................ . 1

1 Introduction

................................ ................................ ................................ ................................ ......... 2

2 EPA’s Registrati on 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.Docket ID Number: EPA

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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, E PA published a draft proposal and solicited public comments for 60 days

. EPA, USDA, and the Services subseque ntly 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 adverse ly modifi ed

, and implementing such measures requires close coordination across multiple

F ederal 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 publi c. 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 informat ion 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 feasibl e.

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 tha t 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

agen cies can clarify and/or modify their processes to address these concerns and increase the robustness of the overall process

. Th is paper specifically describes changes to EPA’s r egistration r eview process and the Services’ Section 7 consultation process that are intended to facilitate ESA pesticide

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

USDA.

The se process changes recognize and acknowledge the respective expertise of the four agencies

i nvolved. U SDA’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 agenc y’s exp ertise defines their respective roles and responsibilities during consultation.



### 2 EPA’s Registration Review Program

T he Food Quality Protection Act (FQPA) of 1996 amended FIFRA to include a mandate that EPA establish a new program 4 , called registration review 5 , 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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Page 3 of 11 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 . C hanges in science, pub lic 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 pr ogram challenges EPA to continuously improve its processes, science, and information management while maintaining a collaborative and open process for decision

making. 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 comme nt 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 sta ge 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. Fol lowing 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 a ssessment that addresses potential human health and ecological exposures and issues that scientific analysis for public comment. 6 EPA’s ecological risk assessment s will become a “biological evaluation” during consultation with the Services. After reviewing public comments, EPA

revi ses 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

r egistration review pro gram

.

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, r esulting 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.Docket ID Number: EPA

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Page 4 of 11 Figure 1. Original Design of EPA’s Registratio n 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 proces s to accomplish several goals: 1) earlier stakeholder involvement in the scoping of the pesticide’s re

- evaluation, 2) earlier adoption of risk reduction measures , i ncluding incorporation of clarifications and/or new restrictions on product labels, before i nitiation 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) th at 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:Docket ID Number: EPA

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Page 5 of 11 • 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 t hat 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 h as begun including information on the specific timeframe within any fiscal year when a pesticide will begin its review

. Having this information available in advance provide s early notice for interested stakeholders to submit information to EPA in

advance of the pesticide beginning its re

- evaluation 7

.

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 invitation 8

. EPA will

extend invitation s 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 concern s 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 shee t 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

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Page 6 of 11 chemical

- specific registration review dockets within 45 days 9

, 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 t o meet with EPA and discuss these issues, they can contact EPA and request a meeting. C ontact 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 t he 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 s upport 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. M arkets 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 registratio n. T his 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

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

C onfusion 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 inclusi on of specificity on the maximum number and frequency of applications. P roducts 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 mee tings 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 pes ticide 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 material s. A special Focus Meetings docket has been established for meeting material; visit EPA

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Page 7 of 11 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 applica tion 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 ne eded 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 cer tainty 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 li kely 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 developi ng the preliminary ecological risk assessment is having reliable data on species habitat, diet, geographic range, and behav ior. 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 EP A ’s effects determinations , 2) potential reduction in the number of “may a ffect, likely to adversely affect” determinations, and 3) fewer

resources (for both EPA and the Services) needed to complete consultation s 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.Docket ID Number: EPA

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Page 8 of 11 As a result of the process improvement discussions , EPA is mak ing two significant changes to its registration review process: 1) hold “Focus” meetings at the start of the registration review for each

active i ngredient

, 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’ bulletins 10 . The involvement of growers and state lead a gencies 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.htmDocket ID Number: EPA

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### 4 Service s’ ESA Consultation Process

Under the Services’ ESA regulations 11

, 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 S pecies , or destroy and/ or adversely modify critical habi t at

.

However, b efore 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 an d 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

re move 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 act ion 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 a nd 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 consul tation 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 qu ality groups) is vital. U nder ESA regulations, registrants are considered “applicants.” A pplicant s 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 conv ene 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 a gency expertise is involved, EPA will extend an invitation to USDA to attend the applicant meetings. During consultation, the S ervices may discuss with EPA its risk

assessment and eff ects determination to gain a better understanding and they may seek out a dditional

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 , t he Services, EPA, and applicants will review and agree upon the d escription of the a ction (e.g., use rates, registered uses, scope of the proposed action as described on pesticide labels ).

The Services will prepare draft biological opinion s 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 En dangered Species Consultation Handbook, USFWS and NMFS March 1998; 50 CFR 402.13Docket ID Number: EPA

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Page 10 of 11 species or to destroy or adversely modify critical habitat under their purview

. If FWS and/or NMFS determine that j eopardy or adverse modification of critical habitat is likely, they are obligated to work with EPA and the applicant to identify R easonable and P rudent A lternatives (RPAs), to the extent such measures exist, to insure that the action will avoid the likelih ood of jeopardizing listed species or destroying or adverse ly modif ying 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) include s proposed Reasonable and Prudent Me asures (RPMs) and terms and conditions to minimize the impact of the take

.

T he Service s will provide EPA with the draft biological opinion for their review . EPA will make

th e draft b iological o pinion available for public comment. The public comment period provides another opportunity for stakeholders to provide valuable input on RPAs , RPMs, and terms and con d itions, 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 t hem 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 s pecies. 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 administrat ive 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 record s 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 biolo gical 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.Docket ID Number: EPA

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Page 11 of 11 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

Service s 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 Service s 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 form al 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 mandat e 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.