May 28,20 14
Certified Mai l UNITED STAT E S ENVIRONMENTAL PROTECTION AGEN C Y WASH I NGTON , D.C

. 20460

OFF I CE OF C H E MI C A L SAFETY AND POLLUTION PREVENTION

Ms. Heather Hansen, Executive Director, Wa s hin gton Fr i e n ds of Fa rm s & Forests 

### Mr. Ri ck Tomlinson , President , California Strawberr y Commi ss ion Joel Nel sen , President, Calif o rnia Citrus Hank Giclas, Senior Vic e President, We s tern Growers Scott Dahlman, Ex ecutive Director, O regonian s for Food & She lter
Re: Growers fo r ESA Tran s parency (G ET) Petition to th e Environmental Protection Agency for Rulemakin g to E stabli sh Procedures Consistent w ith Section 1010 of the 198 8 Amendment s to the Endangered Species Act, dated September 16, 2010.
Dear M s . Hansen, Mr. T om l i n son, 

### Mr
. Nel se n, Mr. Giclas, and Mr. Dahlman :
Th is l ette r co n stitute s th e E nv iro nmental Protection Agency' s (EPA's) respon se to the petition filed Sep t ember 16 , 2010 by Growers for ESA Transparency (GET or th e P etit io ner) on behalf of growers throughout the we stern United State s reques ting that EPA " e sta bli sh by ru lemaking clear and e quitable procedures for noti ce and comment on EPA's pesticide e ff ec t s determinati o n s for endangered species and s ubsequent actio n s, includin g draft Biological Opinions and po tential product restrictions. co n s is tent wi th Sect ion 1010 of the 1988 amendments to the Endangered Species Act."

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### 15I. The Petition

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The petition states that EPA and the US Fish and Wi ldli fe Service (FWS) and National Marine Fisheries Service (NMFS) (collectively, the Se r vices) "shou ld be open to receiving information from knowledgeable th ird parties, and to according them a greater r ole in indiv idual cons ultat ions from an early stage." The P etiti oner contend s that procedures in place at the time of the petition effectively bar agricultural producers, pesticide applicators, and other end users from the effects determin atio n s and consultations processes leaving EPA and the Services without valuab l e information o n which to base sound decisions.
The petition requests that prior to initiating informal or formal consultation , EPA shoul d p ermit affec t ed stake hold ers an opportunity to provide data and information r elevant to the effects determination and consultation processes. The petition further states that s takeho ld ers have a right to review and com m e nt on all aspects of draft Biological Opinions deve loped by the Services before EPA takes action and that Section 1010 of the Endangered Species Act amendments of 1988 1 (sectio n 10 10) requir es EPA to take comment on: an explanat i on of the proposed re s triction or prohibition on the use of the pesticide; an identification of the geographic a

reas affected by the re s triction , or prohibition; an identification of the effects of the pesticide on the li s ted species; and an identification of th e listed species with a general description of the g eographic areas where the species are located and pesticide application would be restricted , pro hibited , or otherwise limited in its use.
The petition request s that EPA promulgate a new section of Title 40 of the Code of Federal Regulations that set s forth clear procedures for the enforcement of Section 1010. GET requests that this new sectio n include confirmation that th e procedures described in Section 1010 will be invoked when EPA completes effects determination s or during informal and formal consultation with a Service that may result in an EPA action to amend lab eling of an ex i s ting product to address ESA concern s, or to impose ESA labeling requirements on a new product to address ESA co ncern s .

1 Pub. L. No. 100

- 478, 102 Stat. 2306, Section 1010 (1988); codified as a note to 7 U.S.C. Section 136a) Page 2 of 

### 15

### According to the petition , th e new regulation should include provi s ion s granting rights to agricultura l producers, pe stic id e applicator s , and other end u se rs for timely publi c no t ification regarding: 1) an in :ittial determination that informal or formal co n s ultation i s appropriate, 2) a draft Biological Opinion prior to final EPA action, and 3) impl e mentation procedures related to EPA 's final action.
In addition , Petitioners ask that the new regulation set forth the minimum content of suc h a notice, including: 1) the id e ntification of any pesticide affected by an EPA effects determination , draft Biological Opinion , and related EPA imp lementati on procedures; 2) a d e ta il ed exp l anation of the ba s is of the effects determination , including a clear del ineation of assumptions on which th e determination is ba sed; 3) a description of the spec ifi c geographic area relate d to the effects determinations; 4) identifi cation of the endangered or threaten ed species along with a general description of the geographi c areas in which s uch species are located where

_ in the applicati on of a pe s ticide will be restricted , prohibited , or its u se otherwise l imited, unle ss the Secr e tary of the Interior determines that the di s closure of s uch information may create a substantial ri s k of harm to such spec ies or its habitat ; 5) an explanation of the restri ction s or prohibitions on the user or applicator of any such pe s ticide; 6) an as sess ment of the impact of propo sed re s trictions on the produ c tion of agricultural food and fib er commo dities ; 7) not J ess than 90 da ys for agricultural producers, pes ticide applicators, and other end u sers to submit comment s; and 8) a commitment by EPA to evaluate and s ummari ze 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 s almon and stee lhead.
II. Legal Framework

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Federal In sec ti c id e, Fungicide, and Rodenticide Act (FIFRA) Standa rd for Regi st ration, Reregi s trati on, and R egistration Review Page 3 oflSEPA regul ates the di stribution , s ale and use of pe stic ide s und e r th e Federal In secticide , Fungicid e, and Rodenticide Act (FIFRA). Under Section 3 of FIFRA , s ubject to limited exceptions, a pe s ticide must be registered by the EPA prior to its di stribution or sale
. As p art of regi s tration , EPA evaluates the registrant' s proposed labeling and other materials su bmitted with the app li cation to determine whether u se of the pesticide will re s ult in unreasonable adverse effects on th e e nviro nment. If EPA concludes that the p es ticid e, together with it s accompanying lab e lin g and any terms and conditions, w ill not cause unreas onable adverse effects on the environment, EPA grants the registration and the labeling provisions approved by EPA become the e nfor ceab l e us e direc tions for the pesticide product. Po s t
- registration, EPA reviews and reevaluate s a pesticide to determine whether it continues to meet the FlFRA registration standard.
The c urrent po st-registration review process- known as r eg is tration review-- was created by se ction 3 (g ) of FIFRA and mandate s that EPA review pe s ticide s not later than every 15 years 2

. Und er section 3(g)(l)(A)(ii ), EPA has established procedure s for regi stration 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 codif ied 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 regi s tration review. Specifically, the EPA will initiate a pesticide's reevaluation by establishing a public do cket containing information that will as s is t 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 Regi ste r announcing the opening of the public docket for public review for a period of at lea st 60 calendar days during which the public may s ubmit information they belie ve to be relevant to the review for EPA 's consideration. If a new ri sk assessment has been conducted for a pe sti c id e under regi st ration review, EPA will generally ann ounce in the Federal Register the availabi lity of th e draft ri s k ass e ss ment for public review and co mment for at least 30 calendar day s (40 CFR 155.53(c). Before a final regi stration

2 FIFRA sec ti o n 3(g)( I )(A)(i ii ) provides that " The Admini s trator s hall co mplete the registration review of each p es tici de o r pe s ti c id e case, which may be composed of I o r mo r e active in gred ie nts and the products associated with the active ingred ie nt s, not later th an the later of ( I) October I. 2022; o r ( II) the date that is 15 years after the date o n whi c h th e fir s t p es ti c ide co ntaining a new active ingredient is reg is tere d ." Page 4 of 15review deci s ion is made , EPA will announce via a Federal Register notice the availabi l ity of the proposed registratio n review decision for public review and commen t for at least 60 calendar days (40 CF R Part 155.58). The proposed decision will , among other thin gs, contai n EPA 's proposed findin gs with re s pect to FIFRA 's no unreasonable adve rse effects on the environment standard, identify any nece ss ary risk mitigation, including proposed l abel changes, identify additional data that are needed, and identify deadlines for completing any required actions. EPA may also i ss ue an interim registration review deci sio n. Interi m deci s ion s may be u se d in appropriate situations and may involve ri sk reduction measures, and identify data, or information to compl e te the review, and also invo l ve propo sal and comme nt stages (40 CFR Part 155.56 and 155.58). In addition to the public review and co mment p eriod s outlined abov e, EPA may m eet w ith s take holders at any t ime during r egis tr atio n review , e ith er through Agency initiation , or sta ke hold er request, to di sc uss an ongoing registration review (40 CFR Part 155.52).
In the final rule dated Augu s t 9 , 2006 , EP A noted in its re s pon se to comments abo ut the operation of the regi stration review pro g ram that it intend s to incorporate endangered spec ies assessments into the registration review pro gram. Endangered Species Act CESA)
Under th e Endangered Species Act (ESA) of 1973 , as amended , all federal agencies have respon s ibility to ensure that any action authori zed, funded , or carried out by that agency is not likely to jeopardize the continued existence of any federa ll y li ste d endangered or threatened spec ies, or resu lt in the de s truction or adverse modification of d es ignated critical habitat. EPA is the federal agency authori zed to regulate pesticide use through ad ministration of FIFRA. Under ESA, EPA must ensure that its activities in administering FIFRA are not like ly to jeopardize the continued ex is tence of any f ederally li sted, threatened, or endan gere d spec i es and/or adver se ly modify d esignated critical habitat. Regulation s implementing Section 7 of th e ESA require that federa l agencie s initiate "consu lt ation " with the appropriate Service on certain acti ons that " may affect " li s ted species or designated c ritical habitat. The Service s conclude a formal consu ltation by issu ing a Biolo gica l Page 5 of 15Opinion that addresses th e federal agency action considered during consul tation. 

### In the Biological Opin ion , FWS or NMFS determines whethe r the proposed action is likely to jeopardize the co ntinued 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 jeopar dize the continued existence of the species, it must provide the federal agency with Reasonable and Prudent Alternatives (RPA to the action, if any exist, tha t 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 198 8 Amendments to the ESA was developed in response to concern over EPA's 1988 proposed Endangered Species Protection Progr am (ESPP). 

### In parti cular, concern was expressed over the lack of adequate public review and comment and the need for additional educat i on and training programs related to EPA's proposed use of county bulle tin s detailing u se limitations in specific geographic areas designed to protect listed species. Congress re sponded by enacting Section 1010. Congress mandated that EPA promptly conduct a program to inform and educate persons engaged in agricultural food and fib er commodity production on any proposed pesticide lab e ling program or requirements that may be impo sed by the Administrator in compliance with the ESA. The legislation al so called on EPA, USDA, and the Department of the Interior to eva luate 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 En d angered Species Protection Program (ESPP) i s the EPA program for addressing th e r equirements of the ESA in connection with EPA 's implementation of FIFRA. The ESPP is designed to determine whether pesticide u se in a certain geograph ic a r ea may affect any li sted species and/o r its designated critical habitat. I f limitations on pesticide use are necessary to

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### 15protect listed species in that area, the information is relayed through Endangered Species 

### Protection Bulletins that are referenced on pe sticide product labe lin g.
EPA first proposed th e 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 enfo rceable measures re su lting from future consultations with the Services. This interim , vo lu ntary program provided for unenforceable geographically specifi c pes ticide use limitation s in areas of concern based on previously i ss ued Biological Opinion s from the Services. In December 2002, EPA published for public comment a revised propo se d approach to field implementation of the ESPP and received comments from many sources including: industry, th e grower community, government entities, and public interest groups. After reviewing and considering these comments, EPA publi shed a description of its final process on November 2, 2005. As finalized, the program calls for an approach simi l ar to that originally set forth in EPA 1989 proposal. Specif ically , when EPA see ks to implement Reaso nable and Prudent A lternatives and Meas ure s (RPA/RPM) set forth in a Service Biological Opinion (or to impl ement EPA's own alternatives), it will request that re gistrants adopt labeling that requi re s 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 identifie s a listed spec ie s concern, and 3) prior to issuance of a Biologica l Opinion to EPA by the Services. Under the ESPP, EPA will generally engage the public in each of these three stages of it s ESA-related work. The fir st and seco nd opportunity for public review and comment me ld with existing procedures established for registration review. These opportunities for public input still exist and have been strengthened and enhanced through process improvement s jointly developed by EPA, the Services, and the USDA. These proc ess improvements affecting r eg i s tration rev iew and pesticide consultations are described later in this response.


### As described in th e public partic ip ation section of the 2005 ESPP 

### do cument, during the registration review ri sk assessment process, but prior to a "may affect" determination, anyone Page 7 of 

### 15ma y pro v ide additional or new information for EPA to con s id er as EPA de ve lop s it effects d e term ination s. In parti c ular , EPA is interes ted in inform ation o n pe sti c ide u se and use pattern s, appli cation s, and me thod s, a s well a s, s pecie s l o cation inf ormati o n . Thi s ne w information would fee d into and inf o rm EPA 's preliminary risk assess me nt f or re gi s tration rev iew , which i s publi s he d for publi c re view and comment for a period of at leas t 3 0 cal e ndar day s . Pub li c comme nt rece i ve d on the preliminary risk a s ses s ment i s c on s idered a s EPA finalizes its risk a ssess ment , work s with stakeholders to develop mitigation, and th e n propo s e s its registration review d e ci s ion concerning w hether or not the pes ticide' s regi s tration continues to meet the FIFRA s tandard for regi s tration.
Publi c input on any proposed risk mitigation inte nded to prote c t li sted speci es is sought during th e 60

- day public review and comment period on an EPA propo s ed interim or final decision. EPA is intere s te d in receiving input and di s cu ssi on during thi s c omment period about how prop os ed mitigation impacts the identified threat and the agri c ultur al c ommunity, and about altern ativ e mitigation. EPA believes that ri sk mitigation me a sures adopted early in the regi stration review proce ss may lead to s treamlined and more fo c u s ed c ons ultations with the S ervi ces . Publi c review and comment on draft Biological Opinion s de veloped by the Services is sought to estab lis h 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 s pecies, but result in fewer impact s on agriculture and other end users.
EPA u s e s Endangered Species Protection Bu ll etin s: 1 ) to id e nti f y th e li sted s pecies being prote cte d , 2) t o identify the geographic areas in whi ch li s ted s pe c ies are impacted by use re s tri c tion s, prohibition s, or other use limitation s, and 3) to explain prohibitions and restrictions on the u ser o f th e p es ticide s ubject to the Endangered Sp e ci es Prote ction Bulletin (Bulletins)
. EPA pro v id es draft bulletins to registrants, state s and trib es f or re view and comment. Under c urren t prac ti ce, EPA s eek s public comment on draft Biologi c al Opinion s and draft RPA/RPM and provides s ummarized comments to the Service s for th eir con s ideration. In addition , prior to finali z ing draft RPA/RPM , the Services and EPA evaluate input from the applicants (the Page 8 of 

### 15registr ants) and stakeholders to determ ine whether the RPA/RPM a r e reasonabl e and can be implemented. Bulletin s are the mean s EPA u ses to comm unicate RPA/RPM to the en d

- us er. S ince Bulletins refl ect RPAJRPM on which publi c co mment ha s already b een taken , EPA believes that additional p ub li c comment on Bull e tins is ge nerally only warra nte d if RPAJRPM diffe r s i gn ific a n t l y fr o m RPAJRPM provided in draft Biological Opinion s.
III. Regi st rati on Review and Consultation Proce ss Impro vements -
Existing proce sses for r eg is tration review and co n s ultation already provid e multiple op portunitie s for s takeholder engage ment. How eve r , EPA agrees with th e Petitioner that EPA and the Services s hould be op en to receivin g inform ation from knowledg eabl e third partie s, and to acco rd ing them a greate r role in indi v idu a l co n s ultati ons from an ea r ly stage. EPA beli eves th at increasing p ubl ic participation opportuniti es during the con s ultatio n process is an important goa l. EPA acknowled ges that many sta k e h o ld ers have ex pressed s imi lar concerns re garding th e appare nt lack of tran s parency surrounding ESA con s ultations on p es ti c id es, th e need for increased acce ss to th e d ec is ion-making process to g ive s tate s and other s takeholders increased opportunities to provide relevant data for cons id eratio n during consultation, and the need for ade quate time for publi c rev iew and co mm e nt.
In res ponse, EPA, th e Services , and the USDA h ave organ ized and participate d in stakehold e r meetings and workshop s with stakeholders affected by ESA determination s and deci s ion s in order to id enti fy improvement s to the registration review and consultation proce ss es that would mor e fully invo l ve s take hol ders. Specifically, EPA, the Services, and USDA helpe d organi ze and participated in the Minor Cr op Farmer Alliance (MCFA) Workshop in D e n ver in May 2011. Th e MCFA is an alliance of national and regional organizations and individual s repre senting growers, sh ipp ers, packers, h andlers, and pro cesso rs of various agricultural co mmoditi es, including food, fiber , nur se ry , and horticultural products, and organi zation s involved with public h ealth pesticide s . Th e M CFA Workshop focused o n opportunities for growe rs to become mor e in vo l ve d in EPA 's ESA-related work and activities under EPA 's regi stration revie w program. Growers d iscussed th e k ind s of information th ey co uld provide to refine endange r e d speci es' ri sk assessment s and where during regi st r ati on review they could submit th e ir information. There Pag e 9 of 

### 15wa s general agreement that information wa s n e ed e d to clarify and confirm product labels , identify where crop s are grown and that grower s need to be engaged early and continuously. Th e meeting minutes and material s provided for and di s cussed at the workshop can be found at: http://www. ffva.com/i m ispub I ic/Co ntent/N avigationMenu2/AgResou rces/Agl inks/Meetingma ter ials/default.htm
. Co pi es of th e individual pres entation s can be found on th e following web s ites : Flor ida Fru i t & Vege tabl e A ss ociation , www.ffva.com ; and the California C itru s Quality C ouncil, www.calcitrusquality.org
.
EPA and the Services have been workin g with the Pestic ide Program D ial ogue Committee ( PPDC) to provide bac k ground information to PPDC members on the s tatu s of ESA/FIFRA c on su ltati ons to dat e, and an opportunity for me mber s to discus s concern s related to the c on su ltation pro c e ss. Th e PPDC provide s a f orum for a divers e group of s takeho l ders to prov id e feedback to the pe sticid e program on variou s pes ticide regulatory, policy, and program implementation iss ue s . In addition, EPA has bee n working with a subgroup of the PPDC, the Pestici d e Registration Improvement Act (PRIA) Process Improvements Workgro up. Meeting s were held in July and S e ptember 2011 to di s cu ss opportuniti es for publi c participation on ESA

re lated work und er reg is tration review and to explore when and wh ere duri ng reg istration review to init iate cons ultati o n with the Service s. The me eting minutes can be f o und at: http://www .epa. gov /oppfcad l /cb/ppdc/prialindcx. html#meetings
As a result of the variou s meetings and workshops designed to reach out to s takeholders and gather their input , in mid

- to
- l ate 2012, EPA, USDA, and the Service s jointly developed a pap er de s cribing improveme nts to registration review and consu l tation process e s that enhance opportunities for s take holder participat i on . Th e p ap er entitled , " Enhan c ing Stakeholder Input in the Pesticide Regi s tr ati o n Review and ESA Con s ultation Proces ses and Development of Economically and T echnologically Feasible Re a sonab l e and Prudent A l t e rnatives" (Stakeh olde r Paper) was finalized in March 20 13 , and can be found at www . regu lat ions.gov in the fo ll owing docket: 

### EPA-HQ-OPP-2012-0442. The proce sses de s cribed in the Stake holder Paper supers e de s imilar pro v i s ion s in the 2005 ESPP docum e nt.

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### 15The Stakeho lder Paper describes modifications to EPA's current practice under the pesticide registration review program and when and how it condu cts consultation with the Services under Section 7 of the ESA. 

### In an effort to be re spon s ive to stakeholders ' desire s for a mechani s m to get information into the registration review process as early a s pos s ible, EPA is holding "Focu s" meetings at the s tart of registration review for each active ingredient. In response to stakeho ld er s' desires for a more open, reliable, and transparent pesticide con s ultation proces s, EPA generally intends to initiate any needed formal ESA con s ultations at a later s tage in the review process. Consulting later in the registration review process allows EPA to develop more refined eco l og i cal risk as s essments and to engage affected stakeho lders in discussions that should re s ult in more focu s ed consultation packages inclusive of mitigation for listed species. There is a cons e n s u s that EPA and the Servi c e s should engage informally and e arly in the consultation process, but that formal consultation should be re s erved until EPA ' s ecological ri s k 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 c ritical habitat , less en the impact s on agriculture , and narrow the scope of the Federal action. Additionally , the document describes EPA 's plans to reach out to pesticide u s er s po tentially affected to discuss the technological and economic feasibility of RPAs intended to avoid jeopardy to threatened and/or endangered s pecies and RPM s to minimize take. The USDA's relation ships with the agricultural community provide a critical link between EPA's expertise on pesticides and the Services' expertise on li s ted species' locations, status, and biology. Finally, the document de s cribes the proce ss by which public comments received on draft RPA s will be summa ri zed and organ ized by EPA and provided to the Services, who will prepare a document to be included in the administrative record of the consultation exp l aining how comment s were considered , and if appropriate , how the final bio l og i cal opinion was modified to addre s s the comments. The Serv i ces will provide the document to EPA, and both the Service s and EPA will make the document available to the public up on request. Th e s e process changes are intended to provide clar ity and transparency to the ESA Section 7 consultation process for pesticide s . Page 11 of 15IV. Putting It All Together
In s ummary , EPA inte nd s to incorporate ri s k a ssess m e nts for listed s pec ies into regi s tration review under th e ex ist ing legal framework and pro cesses de scrib ed above. EPA believes that existing process and recently-implemen ted proc ess improvements, taken together, enhance opportunities for growers to become involved in registration review and li s te d s pecies consu ltations. EPA is see king to engage stakeholders from an early stage of registration review and to increase access ibility and transparency during consu ltation
. Goi ng forward , EPA e n v is ions a process that is s upported by existing s tatute s and rul es that have been improved by recent changes de scribed in the Stakeholder Pap e r. As s uch, EPA posts it s publicly available registration review schedul e, which includes the s p ec ific tim e frame within a particular fiscal year when a pesticide will begin it s review. T his allow s s takeholders the ear liest opportunity to become engaged in the pro cess . Generally, EPA hold s Focus meeting s prior to opening publi c do cke ts fo r regi s tration re v iew chemicals. Minutes of th e meetings are posted in the publically

- available, chemical -s pecifi c docket. Stakeholders can access the minutes and request a meeting with EPA to discuss relevant iss ues addressed during the meetings at any time during registr a tion review. EPA is willing to hold additional Focu s meetings at any point during the regi stration review process. Stakeholders may contact EPA at any time during registration review to di sc u ss a chemical case, provide data and information about a pesticide 's u se that may help inform the re-evaluation. For example , end -u sers may ha ve relevan t information on which u ses of a pesticide product are critical versus those considered non-critical. In addition, end

- u se rs can c ontribute information on what use rates are n ecess ary.
EPA gives public notification of and invite s public review and comment about the Preliminary Work Plan (PWP) and s upporting documents w h e n a registration revi ew docket is opened. The PWP provide s s takeholders and the general publi c w ith information about, among other thing s, a p esticide 's identifi ca tion and registered uses at it s ea rlie st point in registrati on rev iew. EPA prepares its prelim in ary ri s k assessment and takes public comment about it. E PA finalize s its ri sk Page 12 of 15assess ment, and prepares it s proposed interim or final de ci s ion on wh e ther to con t inue the pes ticide ' s regi s tration. EPA pro v ide s the proposed dec i s ion containing , amon g other thing s, any proposed risk mitigation, including mitigation intend ed to protect li s ted specie s, to the public for revi e w and comment. To th e extent that any proposed ri sk mitigation re s ults in either "No Ef fe ct", or " Not Likely to Ad ve rsely Affe c t " determinations for li s te d s pecie s, the s cope o f formal consultation can be narrowed. During these early s tages of regi s tration rev iew, EPA e ngages with the Service s and USDA and
u s e s informal con s ultation increasingly as a means to s treamline forma l consultations and moves to formal con s ultation later in the regi s tration review pro c ess with a s maller con s ultation pac kage , as need e d. In keeping with the principles of Sec ti on 1010 of the 1988 Amendm e nts to th e ESA, EPA works with the Services, registrants, pe s ticide u sers , and other stakeholders and includes them in the development of pe s ticide use re s trictions that wi ll protect li s ted species with f ewe r restriction s on pesticide u s ers.
Where formal con s ultation i s necessary , the Service s pre pare a draft Biological Opinion. EPA make s the Service s ' draft Bio logical Opinion s containing RPAs/RPMs availabl e to the publi c f or review and comment. The Services will prepare a document and include it in the administrative re c ord that addre s ses how public comments were con s idered , and i f appropriate, how the fina l Biologica l Opinion was modified with re s pect to comments. During consultation , the Servi c e s will work w ith EPA and the USDA to engage registrants, growers and other product users , and other s takehold ers to discu ss po s sible label c hange s ne ed e d to avoid jeopardizing the continued exi s tence of li s te d species and destroying or ad vers ely modifying c ritical habitat. Prior to implementing any RP As and/or RPM, EPA determine s if they can reasonably be implemented and whether alternative miti g ation may provide adequ ate s pecies' protections with fewer con s equence s to agriculture
. Generally, when geographicall y expli c it u s e res trictions are necessary, EPA u s es Endangered Specie s Protection Bu ll etins and provides draft bulletins to s takeholders (regi s trants , s tat es, growers and applicators, and trib es ) for review and comment.

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### 15V. EPA Re spon se to the PetitionIn primary part , the GET petition's objective appears to be to ensure that growers and other stakeholders hav e an opportunity to provide input at three points in EPA 's ESA complianc e proc ess for pe sticid e re g i stration activiti es : ( 1) B efore any nece ss ary con s ultation i s initiate d ; (2) Wh e n draft Biolo g ical Opinion s and draft RPA s and RPM s ar e pro v id e d to EPA ; and (3 ) Pri o r to EPA implementation of limitation s to addre ss ri s k s to li sted species. It is important to unders tand that EPA is plannin g to conduct the large majority of future ESA complian c e activities in the course of registration r e view and that, as outlined above , EPA has already es tablished procedural re gulations for r e gi st r ation review that give s takehold ers, such as G ET , multiple opportuniti es to provide input into the deve lopment of EPA 's reg is tration rev iew de c is ion s . Th ese proce dure s pro v ide an opportunity for input at the very e arli es t s tages of re gi s tration r ev iew and continu e throughout the process as EPA initiates any ne c e ss ary consultation s and on any proposed regi stration revie w d e ci s ions that, among other things, may involve labeling changes to address impacts to listed s p e cie s . Further, as explain ed mo st recently in the 2013 Stakeholder Paper, EPA will seek publi c c omme nt on draft Biologi c al Opinions and on any proposed Service RPA s /RPM s in tho se draft Biological Opinion s as s oon a s they are r ece ive d. A s stated abov e, prior to finalizing a re gi stration review deci s ion , EPA pro v id es propo s ed d eci s ion s c ontaining ri sk mitigation , pote ntially including mitigation intended to protect li s ted species , for public comment. This is current practice. Accordingly , EPA believes it s existing practice largely give s the petitioners the v ery processes they are seeking. EPA will not, howev er , commit that all draft E SPP county bulletin s will necessarily be put out for public comme nt. Wh ere EPA is simply s eeking to impleme nt me a sure s provided in S er v ic e Biological Opinion s or that are propo se d for r eg i stration re v iew dec is ion s, it is not cl e ar that a nee d would exi s t for an additional round of public input on the s ame s et of measures upon whi c h EPA already re c eiv e d public comment. 

### In any case, EPA provide s draft bulletins to stakeholders, including regi s trants, s tates, growers and applicators, and tribe s ; therefore, there are opportunities for stakeholder input through that process. Where , how eve r, EPA is propo s ing RPA s and RPMs that dif fe r s igni f icantly from tho se pro po s ed b y the S e rv ices and EPA has no t oth erwi se s ought comme nt o n su c h measure s, EP A ag ree s th at publi c co mme nt on the bulletin s w ould likel y pro v ide me anin g ful additional inpu t. 

### In
s u c h situation s , EPA w ill generally seek addition al inp u t. It is important to e mphasize that prior Pag e 

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### 15to finalizing and/or implementing any RPNRPM, EPA is committed to organizing public comments and highlighting tho se of particular note before sending them on to the Services. EPA is co mmitted to working with the Service s, USDA, and s takeholders to determin e whether th e RPNRPM are reasonable and can be imp lemen ted. USDA will le nd it s expertise on f armin g/ pest management prac tices and the tech nologi cal or economi c feasibility of adopti n g pote ntial risk redu ction strategie s. Finally , beyond the existing registration review regulations and pro cess improv e ments, EPA doe s not prese ntly intend to further codify it s ESA implementation practices into regulation s. Nothing in FIFRA, Section 1010 of the 1988 Amendm e nts to the ESA, or the Ad mini strative Procedure Act co mpels t he development of additional procedural reg ul ations, and EPA believe s that it should retain some mea s ure of flexibility as it continues to imp lement the ESA. For example , EPA expects that as the program matures , the timing , conte nt and commen t period s for public notices may change to so me extent. EPA b e lieves it make s sense to maintain the ability to promptly adapt its practices where neces sa ry to me e t the pub lic interes t and that adopting additional procedural regu l ations now could impede s uch efforts.

Sincerely ,

# (Jj~f)5\~~ Jack Housenger

# y:~ctor Office of Pes ticide Program s US Environmental Protection Agency

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