May 28,2014 

Certified Mail 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Ms. Heather Hansen, Executive Director, Washington Friends of Farms & Forests 

Mr. Rick Tomlinson, President, California Strawberry Commission 

Joel Nelsen, President, California Citrus 

Hank Giclas, Senior Vice President, Western Growers 

Scott Dahlman, Executive Director, Oregonians for Food & Shelter 

Re: Growers for ESA Transparency (GET) Petition to the Environmental Protection Agency for 

Rulemaking to Establish Procedures Consistent with Section 1010 of the 1988 Amendments to 

the Endangered Species Act, dated September 16, 2010. 

Dear Ms. Hansen, Mr. Tomlinson, Mr. Nelsen, Mr. Giclas, and Mr. Dahlman: 

This letter constitutes the Environmental Protection Agency's (EPA's) response to the petition 

filed September 16, 2010 by Growers for ESA Transparency (GET or the Petitioner) on behalf of 

growers throughout the western United States requesting that EPA "establish by rulemaking 

clear and equitable procedures for notice and comment on EPA's pesticide effects determinations 

for endangered species and subsequent actions, including draft Biological Opinions and potential 

product restrictions. consistent with Section 1010 of the 1988 amendments to the Endangered 

Species Act." 

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I. The Petition -

The petition states that EPA and the US Fish and Wildlife Service (FWS) and National Marine 

Fisheries Service (NMFS) (collectively, the Services) "should be open to receiving information 

from knowledgeable third parties, and to according them a greater role in individual 

consultations from an early stage." The Petitioner contends that procedures in place at the time of 

the petition effectively bar agricultural producers, pesticide applicators, and other end users from 

the effects determinations and consultations processes leaving EPA and the Services without 

valuable information on which to base sound decisions. 

The petition requests that prior to initiating informal or formal consultation, EPA should permit 

affected stakeholders an opportunity to provide data and information relevant to the effects 

determination and consultation processes. The petition further states that stakeholders have a 

right to review and comment on all aspects of draft Biological Opinions developed by the 

Services before EPA takes action and that Section 1010 of the Endangered Species Act 

amendments of 19881 (section 10 10) requires EPA to take comment on: an explanation of the 

proposed restriction or prohibition on the use of the pesticide; an identification of the geographic 

areas affected by the restriction, or prohibition; an identification of the effects of the pesticide on 

the listed species; and an identification of the listed species with a general description of the 

geographic areas where the species are located and pesticide application would be restricted, 

prohibited, or otherwise limited in its use. 

The petition requests that EPA promulgate a new section of Title 40 of the Code of Federal 

Regulations that sets forth clear procedures for the enforcement of Section 1010. GET requests 

that this new section include confirmation that the procedures described in Section 1010 will be 

invoked when EPA completes effects determinations or during informal and formal consultation 

with a Service that may result in an EPA action to amend labeling of an existing product to 

address ESA concerns, or to impose ESA labeling requirements on a new product to address 

ESA concerns. 

1 Pub. L. No. 100-478, 102 Stat. 2306, Section 1010 (1988); codified as a note to 7 U.S.C. 

Section 136a) 

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According to the petition, the new regulation should include provisions granting rights to 

agricultural producers, pesticide applicators, and other end users for timely public notification 

regarding: 1) an in:ittial determination that informal or formal consultation is appropriate, 2) a 

draft Biological Opinion prior to final EPA action, and 3) implementation procedures related to 

EPA's final action. 

In addition, Petitioners ask that the new regulation set forth the minimum content of such a 

notice, including: 1) the identification of any pesticide affected by an EPA effects determination, 

draft Biological Opinion, and related EPA implementation procedures; 2) a detailed explanation 

of the basis of the effects determination, including a clear delineation of assumptions on which 

the determination is based; 3) a description of the specific geographic area related to the effects 

determinations; 4) identification of the endangered or threatened species along with a general 

description of the geographic areas in which such species are located where_in the application of a 

pesticide will be restricted, prohibited, or its use otherwise limited, unless the Secretary of the 

Interior determines that the disclosure of such information may create a substantial risk of harm 

to such species or its habitat; 5) an explanation of the restrictions or prohibitions on the user or 

applicator of any such pesticide; 6) an assessment of the impact of proposed restrictions on the 

production of agricultural food and fiber commodities; 7) not Jess than 90 days for agricultural 

producers, pesticide applicators, and other end users to submit comments; and 8) a commitment 

by EPA to evaluate and summarize all comments prior to formally or informally requesting ESA 

consultation from FWS and/or NMFS, and to share all comments with FWS and/or NMFS. 

The petition asserts that EPA had failed to meet these requirements, and EPA had not sought 

input from concerned user interests on the specific elements identified in Section 1010 for the 

series of NMFS' Biological Opinions on pacific salmon and steelhead. 

II. Legal Framework -

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Standard for Registration, 

Reregistration, and Registration Review 

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EPA regulates the distribution, sale and use of pesticides under the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA). Under Section 3 of FIFRA, subject to limited 

exceptions, a pesticide must be registered by the EPA prior to its distribution or sale. As part of 

registration, EPA evaluates the registrant's proposed labeling and other materials submitted with 

the application to determine whether use of the pesticide will result in unreasonable adverse 

effects on the environment. If EPA concludes that the pesticide, together with its accompanying 

labeling and any terms and conditions, will not cause unreasonable adverse effects on the 

environment, EPA grants the registration and the labeling provisions approved by EPA become 

the enforceable use directions for the pesticide product. Post-registration, EPA reviews and 

reevaluates a pesticide to determine whether it continues to meet the FlFRA registration 

standard. 

The current post-registration review process- known as registration review-- was created by 

section 3(g) of FIFRA and mandates that EPA review pesticides not later than every 15 years2

. 

Under section 3(g)(l)(A)(ii), EPA has established procedures for registration review in its final 

rule published in the Federal Register (71 FR 45,732, Aug. 9, 2006, as amended at 73 FR 75595, 

Dec. 12, 2008) and codified at 40 CFR Part 155 Subpart C- Registration Review Procedures. 

Under the procedures established per 40 CFR part 155 Subpart C, three specific time points are 

identified for public notification and comment during registration review. Specifically, the EPA 

will initiate a pesticide's reevaluation by establishing a public docket containing information that 

will assist the public in understanding the basis for EPA's review (40 CFR Part 155.50). Per 40 

CFR Part 155.50(b), EPA will publish a notice in the Federal Register announcing the opening of 

the public docket for public review for a period of at least 60 calendar days during which the 

public may submit information they believe to be relevant to the review for EPA's consideration. 

If a new risk assessment has been conducted for a pesticide under registration review, EPA will 

generally announce in the Federal Register the availability of the draft risk assessment for public 

review and comment for at least 30 calendar days (40 CFR 155.53(c). Before a final registration 

2 FIFRA section 3(g)( I )(A)(iii) provides that " The Administrator shall complete the registration review of each 

pesticide or pestic ide case, which may be composed of I or more active ingredients and the products associated with 

the active ingredients, not later than the later of (I) October I. 2022; or (II) the date that is 15 years after the date on 

which the first pesticide containing a new active ingredient is registered." 

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review decision is made, EPA will announce via a Federal Register notice the availability of the 

proposed registration review decision for public review and comment for at least 60 calendar 

days (40 CFR Part 155.58). The proposed decision will, among other things, contain EPA's 

proposed findings with respect to FIFRA's no unreasonable adverse effects on the environment 

standard, identify any necessary risk mitigation, including proposed label changes, identify 

additional data that are needed, and identify deadlines for completing any required actions. EPA 

may also issue an interim registration review decision. Interim decisions may be used in 

appropriate situations and may involve risk reduction measures, and identify data, or information 

to complete the review, and also involve proposal and comment stages (40 CFR Part 155.56 and 

155.58). In addition to the public review and comment periods outlined above, EPA may meet 

with stake holders at any time during registration review, either through Agency initiation, or 

stake holder request, to discuss an ongoing registration review (40 CFR Part 155.52). 

In the final rule dated August 9, 2006, EPA noted in its response to comments about the 

operation of the registration review program that it intends to incorporate endangered species 

assessments into the registration review program. 

Endangered Species Act CESA) 

Under the Endangered Species Act (ESA) of 1973, as amended, all federal agencies have 

responsibility to ensure that any action authorized, funded, or carried out by that agency is not 

likely to jeopardize the continued existence of any federally listed endangered or threatened 

species, or result in the destruction or adverse modification of designated critical habitat. EPA is 

the federal agency authorized to regulate pesticide use through administration of FIFRA. Under 

ESA, EPA must ensure that its activities in administering FIFRA are not likely to jeopardize the 

continued existence of any federally listed, threatened, or endangered species and/or adversely 

modify designated critical habitat. 

Regulations implementing Section 7 of the ESA require that federal agencies initiate 

"consultation" with the appropriate Service on certain actions that "may affect" listed species or 

designated critical habitat. The Services conclude a formal consultation by issuing a Biological 

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Opinion that addresses the federal agency action considered during consultation. In the 

Biological Opinion, FWS or NMFS determines whether the proposed action is likely to 

jeopardize the continued existence of any listed species or destroy or adversely modify the 

designated critical habitat of such species. If the FWS or NMFS determines that a proposed 

action is likely to jeopardize the continued existence of the species, it must provide the federal 

agency with Reasonable and Prudent Alternatives (RPA to the action, if any exist, that the 

Service determines will preclude likely jeopardy. If take is anticipated and the Services conclude 

that such take will not violate section 7(a)(2), the Services must also provide the federal agency 

with an incidental take statement (ITS) specifying the legal terms and conditions ( reasonable 

and prudent measures or RPMs) under which any incidental take of individual members of a 

species is permitted. 

Section 1010 of the 1988 Amendments to the ESA was developed in response to concern over 

EPA's 1988 proposed Endangered Species Protection Program (ESPP). In particular, concern 

was expressed over the lack of adequate public review and comment and the need for additional 

education and training programs related to EPA's proposed use of county bulletins detailing use 

limitations in specific geographic areas designed to protect listed species. Congress responded by 

enacting Section 1010. Congress mandated that EPA promptly conduct a program to inform and 

educate persons engaged in agricultural food and fiber commodity production on any proposed 

pesticide labeling program or requirements that may be imposed by the Administrator in 

compliance with the ESA. The legislation also called on EPA, USDA, and the Department of 

the Interior to evaluate possible approaches to implement the ESA in ways that would allow 

persons to continue production of agricultural food and fiber commodities. 

Endangered Species Protection Program (ESPP) 

EPA's Endangered Species Protection Program (ESPP) is the EPA program for addressing the 

requirements of the ESA in connection with EPA's implementation of FIFRA. The ESPP is 

designed to determine whether pesticide use in a certain geographic area may affect any listed 

species and/or its designated critical habitat. If limitations on pesticide use are necessary to 

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protect listed species in that area, the information is relayed through Endangered Species 

Protection Bulletins that are referenced on pesticide product labeling. 

EPA first proposed the ESPP in 1988 and again in 1989 as the approach for implementing 

regulatory restrictions to meet its obligations under the ESA. At that time, EPA announced the 

implementation of an interim voluntary program pending the development of enforceable 

measures resulting from future consultations with the Services. This interim, voluntary program 

provided for unenforceable geographically specific pesticide use limitations in areas of concern 

based on previously issued Biological Opinions from the Services. In December 2002, EPA 

published for public comment a revised proposed approach to field implementation of the ESPP 

and received comments from many sources including: industry, the grower community, 

government entities, and public interest groups. After reviewing and considering these 

comments, EPA published a description of its final process on November 2, 2005. As finalized, 

the program calls for an approach similar to that originally set forth in EPA 1989 proposal. 

Specifically, when EPA seeks to implement Reasonable and Prudent Alternatives and Measures 

(RPA/RPM) set forth in a Service Biological Opinion (or to implement EPA's own alternatives), 

it will request that registrants adopt labeling that requires applicator compliance with limitations 

found in the ESPP bulletins. 

The 2005 ESPP document outlines three opportunities for public input and participation during 

registration review: I) prior to a "may affect" determination by EPA, 2) when identifying 

potential mitigation if a risk assessment identifies a listed species concern, and 3) prior to 

issuance of a Biological Opinion to EPA by the Services. Under the ESPP, EPA will generally 

engage the public in each of these three stages of its ESA-related work. The first and second 

opportunity for public review and comment meld with existing procedures established for 

registration review. These opportunities for public input still exist and have been strengthened 

and enhanced through process improvements jointly developed by EPA, the Services, and the 

USDA. These process improvements affecting registration review and pesticide consultations are 

described later in this response. 

As described in the public participation section of the 2005 ESPP document, during the 

registration review risk assessment process, but prior to a "may affect" determination, anyone 

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may provide additional or new information for EPA to consider as EPA develops it effects 

determinations. In particular, EPA is interested in information on pesticide use and use patterns, 

applications, and methods, as well as, species location information. This new information would 

feed into and inform EPA's preliminary risk assessment for registration review, which is 

published for public review and comment for a period of at least 30 calendar days. Public 

comment received on the preliminary risk assessment is considered as EPA finalizes its risk 

assessment, works with stakeholders to develop mitigation, and then proposes its registration 

review decision concerning whether or not the pesticide's registration continues to meet the 

FIFRA standard for registration. 

Public input on any proposed risk mitigation intended to protect listed species is sought during 

the 60-day public review and comment period on an EPA proposed interim or final decision. 

EPA is interested in receiving input and discussion during this comment period about how 

proposed mitigation impacts the identified threat and the agricultural community, and about 

alternative mitigation. EPA believes that risk mitigation measures adopted early in the 

registration review process may lead to streamlined and more focused consultations with the 

Services. 

Public review and comment on draft Biological Opinions developed by the Services is sought to 

establish whether any mitigation measures outlined in the draft Biological Opinion can be 

reasonably implemented and whether different mitigation measures will provide the same level 

of protection for listed species, but result in fewer impacts on agriculture and other end users. 

EPA uses Endangered Species Protection Bulletins: 1) to identify the listed species being 

protected, 2) to identify the geographic areas in which listed species are impacted by use 

restrictions, prohibitions, or other use limitations, and 3) to explain prohibitions and restrictions 

on the user of the pesticide subject to the Endangered Species Protection Bulletin (Bulletins). 

EPA provides draft bulletins to registrants, states and tribes for review and comment. Under 

current practice, EPA seeks public comment on draft Biological Opinions and draft RPA/RPM 

and provides summarized comments to the Services for their consideration. In addition, prior to 

finalizing draft RP A/RPM, the Services and EPA evaluate input from the applicants (the 

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registrants) and stakeholders to determine whether the RPA/RPM are reasonable and can be 

implemented. Bulletins are the means EPA uses to communicate RP A/RPM to the end-user. 

Since Bulletins reflect RPAJRPM on which public comment has already been taken, EPA 

believes that additional public comment on Bulletins is generally only warranted if RPAJRPM 

differ significantly from RPAJRPM provided in draft Biological Opinions. 

III. Registration Review and Consultation Process Improvements -

Existing processes for registration review and consultation already provide multiple 

opportunities for stakeholder engagement. However, EPA agrees with the Petitioner that EPA 

and the Services should be open to receiving information from knowledgeable third parties, and 

to according them a greater role in individual consultations from an early stage. EPA believes 

that increasing public participation opportunities during the consultation process is an important 

goal. EPA acknowledges that many stakeholders have expressed similar concerns regarding the 

apparent lack of transparency surrounding ESA consultations on pesticides, the need for 

increased access to the decision-making process to give states and other stakeholders increased 

opportunities to provide relevant data for consideration during consultation, and the need for 

adequate time for public review and comment. 

In response, EPA, the Services, and the USDA have organized and participated in stakeholder 

meetings and workshops with stakeholders affected by ESA determinations and decisions in 

order to identify improvements to the registration review and consultation processes that would 

more fully involve stakeholders. Specifically, EPA, the Services, and USDA helped organize and 

participated in the Minor Crop Farmer Alliance (MCFA) Workshop in Denver in May 2011. The 

MCFA is an alliance of national and regional organizations and individuals representing 

growers, shippers, packers, handlers, and processors of various agricultural commodities, 

including food, fiber, nursery, and horticultural products, and organizations involved with public 

health pesticides. The MCFA Workshop focused on opportunities for growers to become more 

involved in EPA's ESA-related work and activities under EPA's registration review program. 

Growers discussed the kinds of information they could provide to refine endangered species' risk 

assessments and where during registration review they could submit their information. There 

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was general agreement that information was needed to clarify and confirm product labels, 

identify where crops are grown and that growers need to be engaged early and continuously. The 

meeting minutes and materials provided for and discussed at the workshop can be found at: 

http://www. ffva.com/i m is pub I ic/Content/N avigationMenu2/AgResou rces/ Agl inks/Meetingma ter 

ials/default.htm. Copies of the individual presentations can be found on the following websites: 

Florida Fruit & Vegetable Association, www.ffva.com; and the California Citrus Quality 

Council, www.calcitrusquality.org. 

EPA and the Services have been working with the Pesticide Program Dialogue Committee 

(PPDC) to provide background information to PPDC members on the status of ESA/FIFRA 

consultations to date, and an opportunity for members to discuss concerns related to the 

consultation process. The PPDC provides a forum for a diverse group of stakeholders to provide 

feedback to the pesticide program on various pesticide regulatory, policy, and program 

implementation issues. In addition, EPA has been working with a subgroup of the PPDC, the 

Pesticide Registration Improvement Act (PRIA) Process Improvements Workgroup. Meetings 

were held in July and September 2011 to discuss opportunities for public participation on ESArelated work under registration review and to explore when and where during registration review 

to initiate consultation with the Services. The meeting minutes can be found at: 

http://www .epa. gov /oppfcad l /cb/ppdc/prialindcx. html#meetings 

As a result of the various meetings and workshops designed to reach out to stakeholders and 

gather their input, in mid-to-late 2012, EPA, USDA, and the Services jointly developed a paper 

describing improvements to registration review and consultation processes that enhance 

opportunities for stakeholder participation. The paper entitled, "Enhancing Stakeholder Input in 

the Pesticide Registration Review and ESA Consultation Processes and Development of 

Economically and Technologically Feasible Reasonable and Prudent Alternatives" (Stakeholder 

Paper) was finalized in March 2013, and can be found at www.regulations.gov in the following 

docket: EPA-HQ-OPP-2012-0442. The processes described in the Stakeholder Paper supersede 

similar provisions in the 2005 ESPP document. 

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The Stakeholder Paper describes modifications to EPA's current practice under the pesticide 

registration review program and when and how it conducts consultation with the Services under 

Section 7 of the ESA. In an effort to be responsive to stakeholders' desires for a mechanism to 

get information into the registration review process as early as possible, EPA is holding "Focus" 

meetings at the start of registration review for each active ingredient. In response to 

stakeholders' desires for a more open, reliable, and transparent pesticide consultation process, 

EPA generally intends to initiate any needed formal ESA consultations at a later stage in the 

review process. Consulting later in the registration review process allows EPA to develop more 

refined ecological risk assessments and to engage affected stakeholders in discussions that 

should result in more focused consultation packages inclusive of mitigation for listed species. 

There is a consensus that EPA and the Services should engage informally and early in the 

consultation process, but that formal consultation should be reserved until EPA's ecological risk 

assessment and proposed decision are more fully formed. This approach has the potential to 

maximize the opportunity to effect changes that provide protections for species and their 

designated critical habitat, lessen the impacts on agriculture, and narrow the scope of the Federal 

action. 

Additionally, the document describes EPA's plans to reach out to pesticide users potentially 

affected to discuss the technological and economic feasibility of RPAs intended to avoid 

jeopardy to threatened and/or endangered species and RPMs to minimize take. The USDA's 

relationships with the agricultural community provide a critical link between EPA's expertise on 

pesticides and the Services' expertise on listed species' locations, status, and biology. 

Finally, the document describes the process by which public comments received on draft RPAs 

will be summarized and organized by EPA and provided to the Services, who will prepare a 

document to be included in the administrative record of the consultation explaining how 

comments were considered, and if appropriate, how the final biological opinion was modified to 

address the comments. The Services will provide the document to EPA, and both the Services 

and EPA will make the document available to the public upon request. These process changes 

are intended to provide clarity and transparency to the ESA Section 7 consultation process for 

pesticides. 

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IV. Putting It All Together 

In summary, EPA intends to incorporate risk assessments for listed species into registration 

review under the existing legal framework and processes described above. EPA believes that 

existing process and recently-implemented process improvements, taken together, enhance 

opportunities for growers to become involved in registration review and listed species 

consultations. EPA is seeking to engage stakeholders from an early stage of registration review 

and to increase accessibility and transparency during consultation. 

Going forward, EPA envisions a process that is supported by existing statutes and rules that 

have been improved by recent changes described in the Stakeholder Paper. As such, EPA posts 

its publicly available registration review schedule, which includes the specific time frame within 

a particular fiscal year when a pesticide will begin its review. This allows stakeholders the 

earliest opportunity to become engaged in the process. Generally, EPA holds Focus meetings 

prior to opening public dockets for registration review chemicals. Minutes of the meetings are 

posted in the publically-available, chemical-specific docket. Stakeholders can access the minutes 

and request a meeting with EPA to discuss relevant issues addressed during the meetings at any 

time during registration review. EPA is willing to hold additional Focus meetings at any point 

during the registration review process. Stakeholders may contact EPA at any time during 

registration review to discuss a chemical case, provide data and information about a pesticide's 

use that may help inform the re-evaluation. For example, end-users may have relevant 

information on which uses of a pesticide product are critical versus those considered non-critical. 

In addition, end-users can contribute information on what use rates are necessary. 

EPA gives public notification of and invites public review and comment about the Preliminary 

Work Plan (PWP) and supporting documents when a registration review docket is opened. The 

PWP provides stakeholders and the general public with information about, among other things, 

a pesticide's identification and registered uses at its earliest point in registration review. EPA 

prepares its preliminary risk assessment and takes public comment about it. EPA finalizes its risk 

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assessment, and prepares its proposed interim or final decision on whether to continue the 

pesticide's registration. EPA provides the proposed decision containing, among other things, any 

proposed risk mitigation, including mitigation intended to protect listed species, to the public for 

review and comment. To the extent that any proposed risk mitigation results in either "No 

Effect", or "Not Likely to Adversely Affect" determinations for listed species, the scope of 

formal consultation can be narrowed. 

During these early stages of registration review, EPA engages with the Services and USDA and 

uses informal consultation increasingly as a means to streamline formal consultations and moves 

to formal consultation later in the registration review process with a smaller consultation 

package, as needed. In keeping with the principles of Section 1010 of the 1988 Amendments to 

the ESA, EPA works with the Services, registrants, pesticide users, and other stakeholders and 

includes them in the development of pesticide use restrictions that will protect listed species with 

fewer restrictions on pesticide users. 

Where formal consultation is necessary, the Services prepare a draft Biological Opinion. EPA 

makes the Services' draft Biological Opinions containing RPAs/RPMs available to the public for 

review and comment. The Services will prepare a document and include it in the administrative 

record that addresses how public comments were considered, and if appropriate, how the final 

Biological Opinion was modified with respect to comments. During consultation, the Services 

will work with EPA and the USDA to engage registrants, growers and other 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. Prior to 

implementing any RP As and/or RPM, EPA determines if they can reasonably be implemented 

and whether alternative mitigation may provide adequate species' protections with fewer 

consequences to agriculture. Generally, when geographically explicit use restrictions are 

necessary, EPA uses Endangered Species Protection Bulletins and provides draft bulletins to 

stakeholders (registrants, states, growers and applicators, and tribes) for review and comment. 

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V. EPA Response to the PetitionIn primary part, the GET petition's objective appears to be to ensure that growers and other 

stakeholders have an opportunity to provide input at three points in EPA's ESA compliance 

process for pesticide registration activities: ( 1) Before any necessary consultation is initiated; (2) 

When draft Biological Opinions and draft RPAs and RPMs are provided to EPA; and (3) Prior to 

EPA implementation of limitations to address risks to listed species. It is important to understand 

that EPA is planning to conduct the large majority of future ESA compliance activities in the 

course of registration review and that, as outlined above, EPA has already established procedural 

regulations for registration review that give stakeholders, such as GET, multiple opportunities to 

provide input into the development of EPA's registration review decisions. These procedures 

provide an opportunity for input at the very earliest stages of registration review and continue 

throughout the process as EPA initiates any necessary consultations and on any proposed 

registration review decisions that, among other things, may involve labeling changes to address 

impacts to listed species. Further, as explained most recently in the 2013 Stakeholder Paper, 

EPA will seek public comment on draft Biological Opinions and on any proposed Service 

RPAs/RPMs in those draft Biological Opinions as soon as they are received. As stated above, 

prior to finalizing a registration review decision, EPA provides proposed decisions containing 

risk mitigation, potentially including mitigation intended to protect listed species, for public 

comment. This is current practice. Accordingly, EPA believes its existing practice largely gives 

the petitioners the very processes they are seeking. EPA will not, however, commit that all draft 

ESPP county bulletins will necessarily be put out for public comment. Where EPA is simply 

seeking to implement measures provided in Service Biological Opinions or that are proposed for 

registration review decisions, it is not clear that a need would exist for an additional round of 

public input on the same set of measures upon which EPA already received public comment. In 

any case, EPA provides draft bulletins to stakeholders, including registrants, states, growers and 

applicators, and tribes; therefore, there are opportunities for stakeholder input through that 

process. Where, however, EPA is proposing RPAs and RPMs that differ significantly from those 

proposed by the Services and EPA has not otherwise sought comment on such measures, EPA 

agrees that public comment on the bulletins would likely provide meaningful additional input. In 

such situations, EPA will generally seek additional input. It is important to emphasize that prior 

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to finalizing and/or implementing any RP NRPM, EPA is committed to organizing public 

comments and highlighting those of particular note before sending them on to the Services. EPA 

is committed to working with the Services, USDA, and stakeholders to determine whether the 

RP NRPM are reasonable and can be implemented. USDA will lend its expertise on farming/pest 

management practices and the technological or economic feasibility of adopting potential risk 

reduction strategies. 

Finally, beyond the existing registration review regulations and process improvements, EPA 

does not presently intend to further codify its ESA implementation practices into regulations. 

Nothing in FIFRA, Section 1010 of the 1988 Amendments to the ESA, or the Administrative 

Procedure Act compels the development of additional procedural regulations, and EPA believes 

that it should retain some measure of flexibility as it continues to implement the ESA. For 

example, EPA expects that as the program matures, the timing, content and comment periods for 

public notices may change to some extent. EPA believes it makes sense to maintain the ability to 

promptly adapt its practices where necessary to meet the public interest and that adopting 

additional procedural regulations now could impede such efforts. 

Sincerely, 

(Jj~f)5\~~ 

Jack Housenger y:~ctor 

Office of Pesticide Programs 

US Environmental Protection Agency 

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