UNITED STATES ENVIRONMENTAL PROTE C TION AGEN CY WASH I NGTON , D
. C
. 20460


## MAR 3 1 

## 2014
OFFICE OF CHEMICAL S AFETY .AND POLLUTION PREVENTION VIA EMA J[L AND POST To Addre ssees Listed in the Enclosure to thi s Letter Subject: EPA Respo n se to ·'Pes ti cides in the Air- Kids at Ri sk: Petition to EPA to Protect Children from Pestici de Drift" Dear Petitioners: Enclosed please find the Agency"s response to your petition. "Pesticides in the Air

- Kid s at Ri s k: Petition to EPA to Protect Children from Pesticide D rift.'' subm itted in October 2009 on behalf of a number of he alth and enviromnemal organizations.' As you may recal l. EPA posted the petition to the public docket ( ww w.regulation s .Qo v , docket ID EPA-HQ-OPP

- 2009-0825) in November 2009 and opened a comment per i od that r an 120 days in its entirety. 

### In su m mary, and as re l ated more specificall y in our response, the petit i on asked EPA to account for children's exposures t:o pesticide drift and volatilization in its ri s k assessments and to take certain steps to reduce the risks from these expos ures.



## . · On July 24 ,2013, you filed a writ of mandamus lawsuit against EPA alleging that EPA bad unreasonably de l ayed respo nd ing to the petition. The parties agreed to stay th e case as long a s EPA promised to is s u e a final re s ponse to th e Pet ition by March 31, 2014. 2 The e nclosed response fudfills that pr omise. During the several years that passed between the time the petition was submitted and the present. the Agency was actively developing drift and volatilization assessment methodologies, applying th ose meth•odolog ies to both fumigant and conventi011al pesti ci des, and finding ways to mitigate the risks to adults and c hildren posed by pe s ti c ide drift and volati l ization. Rece ntl y the Agency posted to the docket a nd so licited comments on the m e th odo logies it has de veloped fo r assessing the risks from pesticide drift and volatilization. The comment period s

1 The organizati ons were Pes t i c ide Ac ti on Network of North Ameri ca (PANNA), Un ited Farm work er s, Pinero s y Campesi n os U ni do s De l Noroeste, MomsRising, Sea Mar Community H ea lth Center, Ca l ifornia Rur al Legal Ass i s tance Foundatio n , Farm L abo r O r ganizing Committee, and Phy s i c ian s for Social Re spo n s ibility

. 2 ln re : P es ti cide Actio n Netwo rk North America, et al. v. EPA, No. 13-7261 6 (9 1 h Circuit) 1

### for both mc :thodologi es arc open at thi s time (at www.regu la t t ons.gov ; the docket ID for the drift me t hod o lo gy is EPA-HQ

-OPP

-2013- 0676 ; for the volatilization methodology , EPA-HQ-OPP



### 20 1 4-0219 ). The enclo s ed response di scu sses background on the petition, the pending law s uit , the s tatutory and r egu lattory framework for EPA's pesticide programs, how these program s are implemented , and how EPA assesses and manages the ri s k s associated with pesticide use , including risks from spray dr ift and volatilization. The respon se also directly addresses the three major changes to current practices that were requested by the petitioners, that the Agency 1) assess the potential risks po sed by drift and vo l ati l ization for c hi ldren in places where they li ve and play , 2) accelera te the assessment of th ese potential r is ks, and 3) a dopt uniform buffers for pe st icides of s p ecial con,cern in the interim while th e risk assessmen t s are being conducted. EPA shares . the concerns expressed by the p e titioners , and agrees that the risks from drift and volati li zation must be accounted for, for both children and adults , and that action must be taken to mitigate any such ri s k s . T h e Agency beli eves that the regi s tration review program already in place is a timely, efficient , and effective wa y to assess and take action on the se ri sks, and doe s not believe that imposing requirements for uniform, interim buffers is scientif ica ll y supportab le or defensib.le. Thus the Agency grants in part a nd de n ies in part the petitioner s' reques ts. We thank you for your intere s t and for your role in advancing awareness o f the risks that pesticide drift and vo l atilization can pose to c hildren. We hope that you will rev iew and pro v id e constructive co mm ents on the newly publi s hed a sse s s ment methodologies for add ressi ng tho se tisks. Should you desire fmther informati on on the Agency 's approach to as sess ing drift and volatilization , please contact Jill Bloom of my s taff , at bloom.jill@epa.!WV or (703) 308- 8019 , and s h e will do her be st to ass i st you.

Enclosures: List of addressees Agency Response to "Pesticides in 

### the Air

- Kids at Risk: Petition to EPA to Protect Children from Pesticide Drift (2009)"



### 2cc: Ms
. V irg ini a Ru iz Dir ec tor of Occupati onal and Environme nt a l Health Farmworke r Ju s ti ce 1 1 2 6 1 6th S treet , N.W ., S u it e 270 Washington , DC 20036 vruiz@ farn1workerjusttce.org Ms. Patti Go ld man Ms. Janette K. Brimm e r 

### Earth justice 705 Second A venu e, Suite 203 Se attle , WA 98 104 

### j brimmcr @ earth justice .org pgoldman 

### @e arthjustice.org

3

### Addressees : Erik Nicholson Na ti onal Vi1ce Pr es id e n t U nite d Farm Workers PO Box 8337 Tacoma, WA 98418 enicho l son 

### @ufw

. org Paul T owers Organizing & 

### Media D irector Pes tic id e Action Network of North America 1611 Te l egraph Avenu e , S uite 1200 Oakland, CA 94612 plower!'>@ _panna.org Barbara Go ttlieb Program Dir ecto r Physicians for Social R espo nsibility llll-14th Street , N.W. , Suite 700 Washingtom, D. C. 20009 bgottl ieb@ p sr.org Ariana Kelly Cam pai g n Director Moms Ri s in g .or g Fami l y Env ir onmenta l H ealt h (no mailing addr ess available ari:ma @moms r i..,ini!.org Ramo n Ramirez President Pineros y Campesino s Un id os del Noroeste 300 Young St. W oo dburn, OR 97071-4818 ramonrarnii ez@ pcun.org Baldemar Velasquez President Farm Labor Organizing Co mmittee 3352 Plainview Dr
. Toledo , OHl 43615 bve lasq @floc. com Anne Katten C alifornia Rural Lega l A ssis tance Foundation 22 10 K Street Suite 20 1 Sacramento, CA 958 1 6 akatten @crlaf.org Michael Leong Vice President Corp. and Lega l Affairs Sea Mar Community Health Ce nter 10 40 S
. He nd erson Str eet Seatt l e, W A 98108 mike leong@seamarchc.org



### 4**A~en~y** 

### Response to "Pesticides in the Air

- Kids at Risk : Petition to EPA to Pr·otcct {'hildrrn from Pesticide Drift (20U9 l' ' Table of l 

### on

**tent~** I. Exe c u1tive Su mm ary ........... . .. . ... .. ... .. . ... ... . ........... . . ... . ... . ....... .. .. .. .......... . ..... .. ... . . ..... .. ... . ... .. . ... .. ...... ...... 2 II
. Backg round

... .. . .. ..... ... . . ... ......... .. ...... .. ......... . .. .. .. . .... . . .. . .. ... . .... ...... . ... ............ . .... . ............. . . ... .. ... . ... . .... 3 A. Petition Hi sto r y a nd Major Claim s by Pe titioners ... . ...... ... . ........ . ... .. .. ... ....... ...... . ....... . ... .. ....... .. 3 B
. Lawsu it

. ............................ . ............................................................. .. . ... ........ .. .......... . ................ 4 Ill. Statutory a n d R egu l atory B ac kgro und/Fra mework ............................... .. ......................................... 4 A. Th e Federal In sec ti c id e, Fu ng i c ide, an d R o de n tic ide A c l...
......... . .. .... ....... . ............ ....... ........... 4 B
. T h e Federal F ood, Drug, a nd Cos me ti c Act.. ........................... ........ . .. ................ . .. . . .. ... ...... ...... 5 C. Exec uti ve O rd e r s C it e d in P e titi on . ... . .. .. .... ... .. .. ........ ...... . .... . .. . .. ... .. .. .. ... ... .. .. .. ... . .... . .. . . ... .. .. .... . . 7 i. 1 994 Environme nt a l Ju s ti ce Exec ut i ve Ord e r ... ... . ..... .... . ... . .. ....... . ... ... .................. ...... . ... . ... .. . ... 7 ii. I 997 C hildre n 's Hea lth Executive Orde r . ... . ... . . .. . ....... .. ........... ....... .. .. ... . ............ ..... .. ........ . .. ... . 8 IV
. EPA 's P es tic id e Regula t ory Program s .................... . .. ... . .. .. . .......... ............. . ............ ...... ... . ............... 8 A. E PA's R eview of Pes ticide R eg i s tratio n A ppli cat io ns ......... . .... .. ... . ....................... .. ................ 9 B
. To l erance S e tt in g ... . ...... ... .. . .......................... . . . ............... . ........... . ..... .. ...... . ................. .. .. ... ..... I 0 1
. Proc ess o verv i e w .... .. . ..... .. . ... .. .. ....... . .. .. .. .. . ... .. .. ...... . ........ .. . ... .. .. .. . .... ... .. .. .. ... .. .. ........ . . .... . ... ... . . I O 11. T h e To l e ran ce P e t ition and Require d Documentation

. ........... ........... ... . ...... .... .. ...... . . . ... .. .. .. ... II ii i. H ow the Propo se d To l eranc e A c ti o n is Assessed

. ... . ... .. . ......... .. . ... ..... ....... . . .... .. ..... .. .......... .... I I C. P es ticide R e - ev a lu ation Proc esses ................. ... . . ..................... . .. .. .... . .......... . .. . . ... ... .. .. ... . ... ..... 1 2 1. R e r eg i stration
.... . ......... . . . . .. ... . ...................... . .. . .. . . ................. ............ .............. .... .... ..... ............ 1 2 11
. R eg i s tratio n R eview
....... . .............................. . . ............... . ........... .. ...... . ........... . ...... ....... ........... 1 3 111. Re gu lator y Respo n ses to U nacceptab le Risks

. .. . .......................... . . ......... ................ .......... .. .. . . 1 6 V. How Pes ti c ide Risk s A re Assessed

.. .. . ........... . . ...... ... .. . ........ . . ............ ... .. .. .... . ........... . ... ... .. .. . . .. ....... 1 7 A. Hazar d ide ntifi ca ti o n ..... ..... .. . ..... . .. . .. ...... .. . . .. . .. . .. .. . ....... .. ........ ... . .. . ... .. .. .. ........ . ..... . . .... . .. .. ... . ..... I 8 B
. Do se- res pon se ........ . ... .. . ... .. . .. .. .. . ...... .. ... .. .. .. . ... .. .. ...... .. ....... . ... .. ... . . . ... ................ ... . ..... ............. 1 9 C
. Expo s ure ............. .. .. .. .. ........... ................. . .. ... . . . .... . .................. .. ... ... ............. . .......... .. .... . .......... 20 D
. Ri s k ch arac terization ...................................... . ..... . .................... . . ...... ....... . .......... . ........ . .......... 20 E. C hildre n and p es ticide s .... . . ..... ..... ... .............. . . . ...... ................... ... . ... .. ... .. .. ............... ... .. ... . ... . . . 2 1 VI. Nomenclatu re A ssoc i ate d wit h P es ti c ide Drift an d Vo l at ili zation

... ... .. .. .. ... .. ....... .. ...... . .. .. . .... . ...... 22 VII. Assess ing and Ma n ag in g Risks from Spray Drift..

. . ... ..... .. ... .. .. . .. . ..... ... . ... .. .. ....... .. . .. . .... . .. ............ 23 A. Es timating Spray Drift and Potenti a l Expos u res to By s ta nd e rs .. ....... . ........ ... . ... .. ... ................ 23 B
. A ss ess men t of Ri s k to Bystande rs fro m S pra y Drift

.. ............. . .. . ................... . ....... . .. ....... . .. ... . 24 C. How EPA Miti ga tes P o tenti a l Ri s ks Assoc iat e d with Spray Dri:ft

.. ...... ............... .... . ..... . . ....... 2 6 V ill

. Assessi n g a nd Man agi ng th e Ri s ks Due to P es ticid e Volatilizati on ............................ . ... .. .......... 27 A
. Quan ti fying Volatilization Fo r Co nve ntional Pesticid es ... .. ............ ................ . ... .. .. .. ......... . .... 28 B. Estimati o n of Ri s ks Assoc iat ed w ith Pestici de Vo l atili za tion
..... .. . . ............................ .. ......... 3 0 C. How EPA Miti ga tes Pot e ntial R is ks A s soc iat e d with Vo lati li za tion

. .. . .................. . ... . . .... . ..... 3 1 IX. R es po n ses to Requ es t s Made by Petiti o n e r s ...... .. .. .. .. .. ......... .. ... .... . .... .. . ... ... .. .. ....... . .......... . . . ... . ... .. 32 A. EPA W ill Eva lu ate the Ri s k s to Chi ldr e n Associated wit h Spray Drift and Volatilization Ex po s ures....... .......... ... .... ................. . ..................... . ...... . . .... ...... .. ............................................................ 32 B
. Expe ditin g Assess m e nt s of Spray Drift an d Vo lat il izati o n Outside of t he R eg is tration R ev i ew Sc h e dul e is not Necessary
............. . ........................ . ....... . . ..... . ....... ... . ....... . ...... .... ..... ......... .. . ... . .. ...... . . .. . .. 3 4 C
. Immediat e Ado ption of Generic , In te rim No-Spray Buff e r s Aro und Hom es, Sc hoo ls, Daycare Ce nt e rs, a nd Park s to Pro tec t C hildre n f rom Drift I s Not App ro priat e ...... .. .. ... . ...... ........ .. .... ..... .. . ......... 36 X
. Co nc lu s i o n . .. ........................ .. . .. .................. . .. .............. ........ . .. .. .. . .. ...... .................... ................ ... . .... 38 APPENDIX

.... . .. . .... . .... .. ........... . ..... . .... .. ............... . ... . .. . ......................................................... . .............. 40

1

### I. 

### Executive

**Summar~**

**·** 

### This document pre se nts EPA's response to a petition that asked the agency to: I ) 

### evaluate the risk s to chddren expo sed to pesticides through drift and volatilization, 2) establish a separate process or modify its pesticide re-evaluation process to expedite assessment and management of these risks. and 3) for ce rtain types of pesticides, require the ado ption of ''o ne s ize fits all'' buffer zones between treated areas and places whe re c hildren congregate. EPA grants in part and denies in part thi s petition. EPA ag ; ree s with P etitioners that individuals includjng c hildren may be exposed to pe sticides through drift and/or vo latiliz ation; that the se exposures can occur in place s where c hildren liv e, go to schoetl, play , or are otherwise present ; and that, apart from occupationa l activi ti es, children (depending on certain factors, including age) may experience higher levels of pesticide exposure rel ative to their s ize than do adults. Furthennore, the Agency agrees with the petitioners that it shou ld cond uct pesticid e-specific assessments of the risks that include drift and vo latilizati on exposure s, as appropriate , and that if warranted , the Age ncy will take action to mitigate tho se risks

. The s. teps the Agency has been taking to address these expos ures are di sc ussed later in this do c ument. Petitio111ers define the term drift to include "any airborne movement of pe s ticides away from a target s ite during and/or after app li cation , in cluding the airborne mo vemen t of pesticide droplet s, pe s ticide powders, vo lati li zed vapor-pha se pe s ticides, and pesticide contaminated so il particles." In Section s VI through VIli of thi s response, EPA define s drift and volatilization as they relate to our risk a ss essments. The definitions differ mainly becau se the Agency dr aws a distinction between

**th1~** 

### off-site movement of spray droplets or pesticide patticles durin g an d s hortly after the applica1tion proces s ("pe s ticide drift ") and the movement of p estici de active ingredients a s a vapor or gas that can occur for longer time a fter application is completed ("volatil ization "). Both proces ses de sc ribe mo ve ment of pesticide s through the air. T he type of pe s ticide drift on which this response focuses i s "sp ray " drift, the off -s ite movement of aerosols originating with pe s ticide s app li ed as liquid s , because s pray drift is more lik e ly to occur tha n th e drift of pe s ticides in so lid form , and when it doe s, it generally po ses greater risk. EPA 's effo rts to asse ss and manage pesticide drift conse quently are concentrated on s pray drift. EPA denies the Petitioners ' request that EPA use a proce ss o ut side of the ongoing pesticide re-evaluation proces s, a s currently schedul ed, to assess and manage spray drift and volati li zation ri sks. The Petiti oners s uggest that the Agency s hould u se alternative approach es that reprioriti ze pe s ti ci de s for registration review or speed up ri sk assessments. The Agency believes that suc h adjustment s to the registration review proce ss are not needed and do not represent a n efficient use of limi ted Agency resources . 1

1 If s pec ific and signi ficant co nc e rns arise about an individual pesticide not in r eg is tration revi ew at the time , th e: Agency can utili ze ot h er proce sses a s appropriate to assess and mitigate ri s ks (as needed). These proc esses are de scribed lat e r in thi s docum e nt and are not intended to repl ace the sys tematic and r eg ul ar ac ti o n s th at con s t itut e regi s tration revi ew. See IV .C.iii, wh i ch discusses reg ulatory optio n s for cases in which the Agency ha s determined that a r eg i s te red pe s ti c id e no longer sa ti s fi es th e s tatutory sta ndard

.EPA also denies t he p etition as it relates to Petitioners' request that EPA imm ed iat e ly adopt int e rim proh ibitions on the use of certain pe s ticides t ha t they allege are toxic a nd may be pron e to 

### drift or vo latilization , near homes, schools, parks , and daycare centers or whe rever children congregate. EPA instead b e l ieves that case-by-case, chemical-specific ri sk assessment is a sound , science-based appr oach, consistent with the Agency's mandat e, that yields a more real is ti c representation of actu a l ri s k s and facilitate s the identification of wha t , if any , mitigation measures ()potentially including no-spray buffers) are needed to protect potenti a lly ex posed in

d i victuals.

The res pon se to the petition is organized in the following manner. Afte r th i s executive s ummary , EPA follows with two se ction s 

### ( II and 

### III) that di sc u ss background on the petition , th e pending law s uit brought by the Petitioners, and the s tatutory and regulatory framework as it relate s to EPA's implem entat ion of it s pe stic ide program s. The next two section s of the re spo n s e (IV and V) outline the Agency 's pesticide regulatory programs and how EPA assesses and manage s th e ri sks ass oc iated with pesticide use . The following sec tions 

### (VI through 

### VIII) revi s it the Age ncy's termin ology for describing the off- s ite mov e m en t of pe s ticide s through the air v ia spray drift and volati lization and explain how the ri s k s of eac h are a ssessed and managed. The next sect io111 (IX) con tain s EPA's response to the Petitioners' request for three changes to the Agency 's c : urrent pract ice s . The last section (X) provide s EPA 's conclusion. 

### II

. **Back~roond** A. Pel l t iun H h.tor;

**1d** M ajor Claim' by Petmon ep. In October 2009, a gro up of health and env ironm e n ta l orga ni z ations 2 ( " P e titioner s ") jointly filed a p e tition entit led, '' Pes ti cides in th e Air

- Kids a t Ri sk: P e tition to EPA to Protect Children Erom Pestic:ide Drift (''Pe titio n "). The P etiti on alleged th at EPA has failed to address children'!\ exposure s to and potential ri sks from pesticide drift and vola tili za tion. M o re speci fi ca ll y the Pe t ition e r s ask EPA to: 1
. fu lly and expeditiou s ly evaluate th e e xposure of c hil dre n to pesticide drift or vapors that orig inat e from agricultural a pplication s and travel to areas where chi ldren co n g rega te , s uch 

### as ho m e s, p a rk s, school s, and daycare centers. Funhermore , the P e titioners a sk that the Agency act to ensure that children are protected from aggrega te pe s ti ci d e ex po s ure s, including exposures t o drift: 2. impi lcment 

### an a ccelerated schedule (r e lativ e to the sch e dule for regi stration review) for completing drift

**asses ment** 

**s** and modifyin g registrations that prioritizes ass ess m e nt s ba sed on the suspcct, e d degree of ri s k po se d by th e pe s ticide drift and vo latilization; and

2 Thc o rga ni za tions includ e Pesticide Action Ne t work North Am e ri ca ( PANNA), United Farm Worke r s, Pi tnero s Y Campe s in os Unidos D e l N oroes te, Mom s Ri s in g, Sea Mar Co mmunit y H ea lth C e nte r , Californ ia Rur al L ega l Assistance F o undation , Farm Lab o r Organizing Committ ee, and Ph ys ician for Socia l Re s pon s ibility

. 33. im med iat e l y adopt int eri m prohibit io n s o n th e u se o f tox ic drift

- pron e pesticides suc h 

### as organophosphat es and n-m ethyl carbamat es a nd ce rt ai n other pesticides that arc u se d n e ar homes, sc h oo l s, parks, and daycare center s o r whereve r ch il dren cong re gate. 3 On Novembe r 4, 2009, EPA issued a Fede ral Register Notice requesting public comment on the assertio n s and requests made in the October 2009 petition. T h e c omment period f or tb e petiti o n cl ose d on January 4 , 2 010. EPA 

### ha s r ev ie wed th e comments rece i ved: ' 

### B
. Laws uil On Jul y 24,20 1 3, the Petitioners filed a w rit of mandamus lawsu it against EPA alleging th at EPA had u nreaso nabl y delayed responding to their 2009 Pet itio n . EPA a nd th e Petitioners agr ee d to s ta y the case . ln EPA's u n o pp ose d moti on lo st ay th e case, th e Agency promised to issue 

### a fi nal re sponse to th e P e titi o n b y March 3 1 ,20 1 4. 5 This respo n se fulfill s that promi se.
III. Statut • ory and Regulutury Background/Framen ork EPA regu la te s p estic id es under th e F e d e ral In s ect i c id e, F ungicide, and Rod e nti c ide Act ("FIFRA") , 7 U.S.C. 

### §§ 1 36- 1 36y, and t h e F e d eral F o od, Drug , and Cosmetic Ac t (" FFD CA''), 21 U.S.C. §346a. F IFRA sets forth a f e d e r a l li cen s ing sch e m e for the sa l e, di s tribut i on and use of pe stic ide s; FFDCA es t a bl ish es the mechani s m and standard s by w h ich EPA mu s t set tol erances (a llo wab le leve l s) for pe stic ide resi du es in food. As a general m a tter , under FTFRA s e c tion 3, before a pe s ti c ide can be d ist ributed or so ld in th e United States, it mu st be r eg i s te r e d. Pe t ition e rs" admi ni s trati ve p e tition implicate s both s tatu tes
.

Th e principal purp ose of F I F RA i s to regulate the sale, distribution and u se of pes ticid es (through reg i s tration s) whil e protecting human health and th e e nvironme nt from umea s on ab l e ad v erse effec t s a ss oci ate d w ith pes t ici d es. 

### See ge nerall y FI FRA sec tion 3. Under FIFRA, E PA regis te r a ]p es ti c ide on l y after conducting a sc ient ifi c revi ew of th e ri sks, and whe n appropri ate, benef it s of th at pesti ci d e to determine wheth e r the u se of th e pestici d e cause s " unreaso n able adve rse effects" to human h ea lth or th e environ ment. 6 Regi s tration and re g i s tratio n re view deci s ions unde r s ection 3, reregistrat i on decis io n s u nder section 4 , an d cance ll ation deci sio n s un d er sec tion 6 are go ve rn e d by the same statutory s tand a rd , which generally i s referred to a s " ri s k-b en efit" balancing, 

### i.e., a pesticide mu s t not po se "any unrea so nabl e ri sk to man or tb e

3 The pe ti tio ne r s bel i eve th ese interim mea s ures a l so s hou ld apply to " all o th er p es ticides that are ( I ) r eg i s tered for applic ation by gro und spra yers, broadcast equipmen t , a nd/or aerial equ ipme nt ; and (2) s u s pected o f c au s in g acute poi so nin gs, ca nce r , e ndo c rin e di s rupti o n, developmental e ff ec t s, and/or repro du c tiv e e ffect s. 4 The Pe tition docket is fou nd at htt p://www

. regulations.2ov/#!dockLLDetaii:D=EPA-HO -O PP-2009

- 08 2 5
.

-- 5 In re: Pe s ticide Ac t ion Net wo rk North America, et al. v. EPA, No. 1 3-72616 (91h Ci rc ui t)

4envirorunent, t aking into accoun t the economic, social , and enviro nm enta l cos t s and benefits of the use of any pesticid e." FIFRA 

### §§ 3(c)(5) & 2(bb); 7 U.S

. C. 

### §§ l36a (c)(5) & l36(bb)

. 

### If thi s s tandard i s not sa tisfied, EPA may not regi s ter the pesticide and existing pesticides are subject to modification or cancellation. 

### See FIFRA 

### §§ 3(c)(5) & 6 (b); 7 U.S.C. 

### §§ 136a(c)(5), & 136d(b ). In order to properl y evaluate pesticide applications, FIFRA and its impl e m enti ng regulation s generally rcequire applicants for reg i stratio n to subm it o r cite to a sig nifi can t body of toxicity a nd exposure data for the pesticides for which they are seeking regi s tration. 

### See 7 U.S.C. § l3 6 a(c) (2)('A) (directing EPA to publish guidelines f o r s ubmi ssio n s by applic ants); 40 C.F.R. 

### §§ 15 8 .1 

### et se q . l6l.20 et seq. (setti ng forth information to be provided by applicants ). Whi le EPA must consider a broad range of factors in determining whether a pesticide meets thi s standard , the balancing of the various ri s k s and ben efi ts of the pesticide, and co n si d eration of inh erent p o, Ji cy question s, 

### is left larg e l y to th e discretion of EPA: ''[W]ithin broad limit s, the [Ajdrnini strator has latitud e not merely to find facts, but also to set policy in the public intere s t. Like most reg ulatory s tatut es, ... FTFRA confers b road discretion on the [Administrato r]. " 

### Wellford v. Ruckelshaus , 439 F.2d 598 , 601 ( D.C

. Cir. 1 971); 

### See also Envtl. 

### De.f Fund v. EPA , 465 P.2d 528 , 538 (D.C. Cir. 1972) (FIFRA em powers EPA to " take account of benefits or their ab se nce as affecti ng imminency of hazard "). As part of the proce ss of EPA's approval of a pesticide reg i stra tion, the agency must revi ew and ultimately approve proposed labeling and directi ons for u se for each pe stici de. 

### See FIFRA 

### § 3(c)(5)(B). The approved pe s ticide l abel sets f01th the la wful con dition s of 

### use for a pesticide, 

### i.e., those mandated b y EPA in order to ensure that the pe st icid e will not cause umeasonable ad ve rse effects to human health or th e environ m e nt. 

### See / d. § 3(d). Indeed, it i s 

### a v iolat ion of FIFRA for any person to u se a pesticide in a manner incon s i sten t with the EPA

- approved labeling. 

### St ? e l ei. § 12(a)(2)(G). B. fiJL' federal Food. Drug. and Ct)\Jllelic

**A~l** ln 1996, the Foo d Qua lit y Pro tection Act ("FQPA") was enacted , amending FFDCA and FIFRA to r e quire all pe s ticide s the use of which results in res idues on food to meet new dietary r isk s tanda1 r ds. The FQPA amended the FIFRA risk-benefit standa rd ("any unreaso nable risk to m an or the env irorunent " ) to add another eleme nt to the d efini tion of that ter m : "a human dietary risk f r om resi dues that result from a use of a pesticide in or on any food incons i ste nt with the s tandard under lFFDCA section 408]. " 

### See FIFRA 

### § 2(bb); FFDCA 

### § 408 ( b)(l)

. In other words , th e reg i st ration of a pesticide i s co ntin gen t up o n its meeting the food safety s tandard established under FFDCA section 408, if u se of the pe st icide results in re s idue s on food. Section 408 a l so was amended by FQPA to add protections for infants and ch ildren and to establ i s h the estrogenic su b s tance s sc reening p rogram .

7 Public Law 10 4- I 70 , I 10 Stat. 1489 (1996). 5Sectio111 408 of the FFDCA authorize s EPA to establish by regulation ''to le r a n ces" se ttin g th e m a ximum permissible l eve l s of pesticide r esidues in foods. 8 FFDCA §§ 30l(a) , 408(a). Toleran ce se tting i s di scu ssed in more detail in Secti o n IV
. B
. EPA m ay only promulgat e a pesticide tolerance, if the to l era nce i s "safe." FFDCA § 40 8( b)(2)(A )( i). " Safe ' ' i s defined by the FFDCA section 408 to mean that "there is a reasonabl e certainty that no harm will res ult from aggregate exposure to th e pesticide chemical re sid u e, including a ll anticipat ed dietary exposures and all other exposures for w hi ch there is reliable informatiOJ }." /d. 

### § 40 8( b) (2)( A )( ii) [emphas i s added]

. Sectio n 408's reasonab le certainty o f n o harm s tandard is a risk-only s t a ndard , which ge nerally do es not allow cons id e ra t io n ofbenefits. 9 C o ngre ss also amended the FFDCA to require that EPA re -assess, using th e n ew safety standard, the existing tolerance s and e xemption s for all pe s ticide chemical re s idue s that were in effect on August 3, J l996. 

### ld. § 408(q)(l). Congres s directed EPA to comp le te the rea ssess ments by A ugu st 3, 2006. Congress instructed EPA, w hen applying th e new safety s t andard, to a ssess, among other things, the risks of p es tici d e c hemical s bas e d on available information conceming the special susceptibililty of infant s and ch ildren to pe s ti c ide chemical res idu es. FFDCA 

### § 408(b)(2)(C). To en s ure that there i s 

### a reasonable certainty that no harm will r es ult to infant s and c hildren from aggrega te ex posure to pe s ticid e chemical re s idue s, C o ngre ss mandated that EPA ap ply 

### an addition al te n-fold margi n of safe ty (known as the FQPA safety factor) in se ttin g tolerances u nless reliable data s h ow that a different m arg in of safet y will be sa fe for i nfant s a nd c hildren

. /d. Th e ad dl itional ten
- fold ma rgin of safe ty ca n be reduced o r removed ba sed on s u ch a finding. The FQP A amendment s to the FFDCA a l so directed EPA to consider "aggregate expo s ure" in its deci silo n-making

. EPA has intetpr e ted "aggregate exposure" to refer to th e co mbined exposures-to a s ingle chemical across muJ tiple routes (oral , dermal, inhalation) and across mu lti ple p a thways (food , drinking water, re s id e ntial)

. As amended by FQP 

### A , sect ion 40 8(b ) (2)( ii ) of FFDCA requires the Agency to make a findin g for each tol e ra nce or toleranc e exemption " that there i s a reas onable certainty that n o harm will re s ult from aggregate expo s ure to the pe stkide chemical res idue, includin g all anticip ated di e tary exposure s and a ll other expo s ures for which there i s reliable infOimation " {emphas i s added]. Section 408(b)(2)(C)( ii )(O of FFDCA s tat es that the Agency mu st find " th e re i s a reasonable certa inty that no harm wiJI result to in fants and children from aggrega te ex po s ure to th e p esticide c he mi ca l res idue s." Finally , secti on 408(b)(2)(D)(vi) direct s th e Agency, when m ak ing tolerance d ec i s i ons, to consider ''aggregate exposure level s .. . to the p es ticide chemical res idue

.. .includin g dietary exposure and exposur e from o ther non-occupational s ource s." EPA reaffirms its co n sistent interpre t a ti on of FFDCA sec t ion 408 as requiring considerati on o f all exposures to pes t icide residues and other re lated sub s t a n ces o ther than those exposures

8 Without s u c h a tol e ranc e or an exe mpti o n from th e req uirement of a tol e ran ce, a food conta· inin g a pe s ti ci d e res idue is "adulterated" under section 402 o f the FFDCA and may n ot b e l ega lly moved in i nterstate com m e rce. <> B e n ef its may only be consi d e re d under sectio n 408 in one very n arrow circu m s ta nce n o t applicable in thi s case. 6

### occurring 1111 

### the occupational se tting. 1 0 

### Relevant expos ures in cl ude pesticid e residues in foo d and water and •expos ure s t o pesticides around the home or in 

### publi c from source s other th an 

### food and water. It is important to 

### note th at Congress has expressly provid ed that any i ssue that can be rai sed through th•e FFDCA review process can only be reviewed through that proce ss . 11 

### According l y, to the extent a petition to revok e to le ran ces and ca nce l registrations rai ses i ss ues r e l evant to th e es t ab lishment o r revocation of tolerances , EPA's respon se to tho se iss u es may b e challenged on ly throu gh the administrative and judicia l review procedures provided in sec ti o n 408 of the FFDCA and are not reviewable under FIFRA or any other prov i sio n of law.

EPA inc lu des the following general discussion on two Execu tive Orders ment io ned by Petitioners as s upport to their claims. 1 2

1. 

### Executive Order 12898: Federal Ac ti ons to Address Environmen t a l Justice in Mi norit y Popu lation s and Low

- In come Populations On February 11, 1994, President Clinton iss ued Executive Order 12898 on Federal Actions to Address Environmental Justice 

### in Minority Populations and Low

- Income Populations. 1 3 

### This Order focUises federal attention on the environmental and human hea lth conditions of minority and l ow - income communities an d calls on agencies to 

### make ac hieving environmental justice (" EJ ") part: of the ir mi ss ion. S ince the i ss u ance of th at Execut ive Order , EPA h as been actively working to ensure tha t EJ iss ue s are considered in its d ecision-making processes. In 

### Septemb er 2011, EPA issued its Plan 

### EJ 20 14 strategy. 14 

### The strategy is the Agency's roadmap for advancing environmental just ice. Ba sed on this strategy, th e Agency seeks to:
• Protect: the env ironment and hea lth in overb urdened communities.

10 See Jmida c loprid ; Order Denying Objectio ns t o Issua nce of T olerance 69 Federal Regis t er 30042, 30073 (May 26, 2004). 11 FFD C A § 408(h) (5); NRDC v. John son, 461 F.3d 164 , 176 (2d Cir. 2006). 12 These

. Execut ive Orders do not cr eate an ind epen dent right of actio n against the Uni t ed States. 13 http:/ /www2.epa.gov/la w..,- r egulationsh;ummary-executi ve-order-12898

-federa l -ne t i ons-address

env i ronmema l -jus ttce 14 See http://www.epa.gov/compliancdej/plan

-ej/for more informat ion. Th e plan is not a ru le o r r egulation. I t i s a str ategy to help int egrate environmen t al justice i nto EPA's day -to-day activi ti es. Plan EJ 2014 ha s three major sections: Cross-Agency Focus Areas, Tool s Develop m ent Area s, and Program Initiatives. Within th ese areas, EPA plans to m ore effecti vely protect human hea lth and the environmen t for overburde ned pop ul ati o ns by deve lo pin g and impl e m enti n g gu id ance on incorporating e n v iron m e ntal ju stic e int o EPA's rul e m ak in g process . EPA a l so plan s to enabl e ove rburde ned commu niti es to ha ve fu ll and m ea ningful access to t he permitting proces s and to deve lop permits that address e nvironmental justice i ssues to t he greates t exte nt practicable under existin g env ir o nm enta l law s. Under the two s tat utes at i ss ue he r e, FIFRA and the FFDCA , EPA has a lready beg un to i ncorp orate these considerations into its lice nsing program. 7

### • Empower co mmunitie s to take action to improv e their health and environment. • Estab li s h partners h ips with local, state, tribal , and federal governments and o rga nization s to achieve healthy and s u stainab le communities. 15 

### EPA is committed to addressing ri s k s to population groups with unique expo s ure pathway s, s uc h as ch il dren , farm and migrant worker s, urban poor population s, rural or isolated popu lat ion s, and Native Americans and Alaskan Nattves [emphasis added]. 1 6 

### EPA's Office of Pe s ticide Programs has dev e loped an int e rnal training prog r am for staff that provides an ov e rview of environmental justice issues to be considered in risk assessment. Guidance mate rials and the templates for ri s k asses s ment docum ents direct risk assessors to address environmental justice concerns speci fi cal l y as a basic element of pe sticide risk a ss essment and th e Agency risk management decision-mak ing proce ss includes con s ideration of any such concerns id entified for the s ubject pesticide.

11. 

### Execu6ve Order 13045: Protection of C hildren from Environmental Health Ri s ks and Safety Risks On April 2 1 , 1997

. President Clinton signed Executive Order 13045 on the Protection of Chil dren from Environmental Health Ri s ks and Safety Risks. 1 7 

### This Executive Order requires all federal agencies to assign a high priority to addressing health and safety risks to c hildren, coordinate research priorities on children's health, and ensure that their standards take into account sp<::cial risks to children. While not directly c ited in the Petition, it should also be noted th at on Octob er 

### 20 , 1995, EPA adopted th e Policy on Evaluating Health Ri sks to 

### Chi ld ren (predating the Executive Order). This poli cy require s the EPA to consi der the risks to infant s and chi ldren consistently and exp licitly as part of risk assessments generated during its deci s ion m aking proces s, including the setting of standards to protect publi c h ea lth and the environme nt. 1 8 

# rn respon se to Exec ut ive Order 13045, EPA establi s hed the Office of Children's Health Protection r(''OCHP") i n May 1997. The focus of this office is to make the protection of child re n 's health 

### a fundamenta l goal of public health and env ir onmental protection in th e United States. The Agency 's Office of Pesticide Programs and OCHP are committed to ensuring that th e Agency's ri sk a ssess ments for pesticides are protecti ve of children's health. 1 9



### I V. 

### EPA •s

**es ti**  **ci ~**  **e~u atory**  

### Pr og r amo.,

15 Peti ti oners c l aim that EPA's pesticide assessments do not adequately address environmental justice issues as dir ected by the 1994 EJ Executive Order (Exec. Order No. 12,898 , 59 Fed

. R eg. 7,629 ( F eb. II , 1994)). EPA disagrees. EPA 's co mmitm e nt to EJ i ssues i s clear from it s recent pronouncements on these is u es. 16 http://: t![?h .a pha p ubl ica t io ns.org/d oi/f ull/ I 0.2 1 05/ A

J PH .20 1 1 .300 1 1 1 17 

### htt p://yoscmite.epa.gov/oc hp/oc hpweb.nsf/content/whatwe execut iv

. htm 18 ht tp ://yo:-.e mite.epa.gov/ochp/ochpweb.m.f/contenUpo licv-evaJ risb chi ld re n . htm 1 9 hUp:/1

**~ao.go\/product!-./GAO-** J 3-254 8The fo l llowing s ec t ions di s cuss how EPA implement s its statutory obligation s under FIFRA and the FFDCA. A.

**EPA·~ R~v1ew**  nf Pl!-.ttuue

**Rcg ~lmt**  **on** App

_ li

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t:a

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**iL '~n** 
**:-**______________ . EPA p r ovid es an a pplication kit 20 t o ass i s t in pr eparation of an applicati o n to re g i s ter a pe s ti c ide. The applicant i s re s ponsible for s ubmittin g or citing all of the information and dat a that are required to sup port the registration , includin g proposed product labeling, and scientific data th at meet the data requirements re lated to the specific product the app li cant int ends to re g i s ter. In addition , the app l icant prov ides a Confi de ntial Stateme nt of Formula that detail s the compo s it i on of th e pe s ticid e product , i. e., 1) all acti ve ingredient s, 2) all inert ingredient s, 3) all impurit ie s of toxi c ological s ignificance a ss ociated with the activ e ingredient , and 4) all impurities found to be pres ent a t a leve l equal to or gr e ater than 

### 0.1 percent by weight of the t echnical g;rade active ingredi e nt. 2 1 Th e applic ant will al s o prov ide 

### EPA with draft l ab e ling. FIFRA s e c tion 2 ( p) (1) define s " label " as ' ·'the written, print e d or graphi c material on, or attached to , the pe s ticid e or device or any of its containe rs or wrappers." The term "labeling" i s defined a s "all label s and a ll other written , pri inted , or graphic matter

- ( A ) accompanying the p es ticide or devi ce at any time ; or (B) to which reference is made on the label or in lit e rature accompanying the pesticide or device

. " 

### S ee F IFRA § 2 ( p ) (2) Labeling includes detailed information s uch a s th e ingredients s tat e ment, w arnings and pr

ec autionary s tatements, and direction s for u s e. It i s un lawful to sell or distribute a pesticid e if any claims made for it diff e r from claim s made on lab e lin g required for registration. 

### See FIFRA § 12( a) (l)(B )
. Therefore , adv e rti s ing claim s for a pe s ticide product mu s t not c ontradict claim s mad e in 

### th e produ c t 's lab e l ing. Labeling re quiremen ts are codified in 

### 40 CFR 

### Part 156

. EPA ha s de ve loped a Lab e l Rev iew Manuat2 2 a s g uidance to it s s taff on revi e wing label s. App l icants are res p onsibl e for citing or generating all data to me e t data requir e ments
. Th e purpo se of the s e data requir e m e nts i s to d e monstrate that the produ c t will not cau s e unreaso nable ad verse effec ts o n the envi ronment. [n g e n e ral, thes e data are used to evaluat e wh e ther a pe ticide has th e potential to cause advers e effects on humans, non - target wildlife, and plants, a s w e ll as po s sible contaminat ion of surfa c e water or groundwater from l eaching, run-off, and s pray drift. For pe s ti c ide s that will need a tolerance or tol eran c e exemption to demon st rate 

### a reas onable cert aint y of n o harm , additional data are n e eded. Requ irem ents may include, as app1icable, data on: • spr:ay drift, • residue chemi s try , 20 h ttp://ww w.c p: u .?o v/pes ticides/ r e g i s tr at io nkt tl 2 1 http ://www

**gp o.**  **go y~/pkg/CFR** 

**-2 0**  I 1

- LiLl e40- vo l 2 4/ p df/CFR

- 20 ll

- tlt l e40 -vo i2..J.-sec 1 58

- 32 0
. pdf 2 2 htt p :/l\\ ww .e pa . !! ov/o ppf ca d l/labe l tn!! / lnnl 9

### • environmental fate, • toxicolo gy, • applicator exposures • reentry protec tion , • w ildlif e and aquatic o rganism s, • plant prot ecti on , • nontarget i n sects, • produ ct perfonnance , and • produ c t c he mi s try. Data requirem e nt s 

### in s upport of appli cati on s for registratio n of a pest icid e pro duct are s pec i f ie d in 40 CFR P art 1 58Y EPA's r eview of the application include s the asse ss ment of t h e risk s to hum a n health and the environmen t th at may b e p osed b y th e pestici d e?4 

### B.

**Toleran~r** 

### Setting

1.

**Pr oces~**  

### overview 

### A toleranc e is the maximum allowabl e concentra t ion of a pe s ti ci d e on a p ar ti c ular food ite m . Th e tolerance i s t h e residue leve l that triggers enforc eme nt action s. That is , 

### if res idues are fou nd above that level , the commodity will b e s ubject to se i zu re by the governmen t. EPA must consi de r a nu mber of factor s when 

### it estab li s hes, modifies, leaves 

### in ef f ect , or revokes a tol e ran ce for a pesticide chemical re s idu e . FFDCA § 408(b)(2)(D). The process for the es tabli s hm e nt , modification, o r revocation o f tole ran ces, is d escri b ed directl y below

. A 

### tolerance action may be initiated by E PA of its own accord25 

### o r in response to an administrative petition. /d. § 

### 408(d)(l), (e)(l). "A n y per so n may fil e with lEP A] a petition proposing t he iss uance of a regulation

. .. es tablishin g, modifyin g, or re voking a tolerance for 

### a pes ti c id e chemical res i due in or o:n a food." /d

. § 

### 408(d)( 1 

### )(A). If EPA determines that an a d min ist rativ e pe ti tion meet s the s tatutory and regulatory r e quirements governing peti tion con tents, EPA publis hes a notice of the admini st rati ve petition's fi l ing. 

### !d. § 408(d)(3)

. (The Agency will al so publ is h a n o tice when the action i s Age ncy - initiat ed .) After th e publ i cation of the 

### notice , EPA mu st g i ve " due con s id eration" to th e petitio n and che n : i) 

### iss u e a fi n al regulati on es tabli s hing, modifying , or revoking a tolerance ; ii ) 

### i ss u e a pro po se d re g ul atio n under the s eparate provisions of the FFDCA § 408(e), and thereafter issue a

23 Data r equ ir e me nts ar e desc ribe d at http ://ww w . gpp .go v/fd sys/pk g/CFR- 2 0 ll-lll l1!40- vo l24/ pdf / CFR

- 20 II-Litle40

- vol 2 4

- part 15 8. pdf ; links to gui de lin es for th e cond uct of r e quired studies ar e l oca te d at

**tp ww**  **w.e pa.go** 

**/p es** 

**id es/** 

**cc /g**  **ide**
**li i.!s**  **.h m**  14 Fo r flllrther details on the pesti ci de r eg is tration see

**hltp ://epa.l!o**  **/pes**
**ki es/f**  **cts ee** 
**eg**

**tr**
**ti on.**  **htm**

**.** 2 5 Whe n , for exa mp le, 

### th e tolerance ac t ion f o llows 

### a cance llation ac ti o n . 10

### final regulation after add iti onal public notice and comment; or iii) issue an order denying the pe t iti on. FFDCA § 408(d)(4)(A). See NRDC v. Johnson, 

### 461 F.3d atl73-74. After EPA issues a regulation or order establis hin g, modifying, or revoking a tolerance for a pe s ticide c hemica l residue on food, any person may fi le objections with EPA and request an evidentiary hearing on those objections. FFDCA § 408(g)(2). After consideration of any such objections, EPA must issue a fina l order se parat e ly stat ing the action taken on eac h objection and whether 

### any hearing i s appropriate. ld

. § 408(g)(2)(C). Then the Agency can conclude its deliberations and grant, modify, or deny the tolerance, as appropriate

.
ii. 

### The Tolerance Petition and Required Docwnentation As discussed above, a determination on the proposed tolerance relie s on the risk-only standard from FFDCA section 408
. EPA mu s t e n s ure that the use associated with the tolerance will not pose unreasonable risks to human health

. Except in ce11ain instances, 26 

### a tolerance petition request is u s u ally accompanied by an application for reg istration , an app l ication to amend the registration of a cutTently regi ster ed product, or an experimental u se permit for the us e s proposed in th e petition. As risk assessments are a com ponent of the s tandards for evaluating both tolerance proposals and regi s tration ac tions, EPA determines whether any meaningful risks exist for the proposed uses, ba se d on an evaluation of the applicant's petition fo r a toleratnce. T h e Agency bases its tolerance deci s ion on the aggregate exposures and risks associa ted with the pesticide and the u se to wh ich the petition applies. Aggregate exposure is the combined 'exposures to a s ingle chemical across mul t iple routes (oral, dermal , inhalation) and across multiple pathw ays (food, drinking water, residential). 27
iii. 

### How the Propo sed Toleranc e A c tion is Assessed The risks of concern that are co n sidered in the setting of tolerance s are the human health risks from aggregate expos ur es, which are the s um of ex po s ures from each relevant pathwa y-- food, drinking water, and/or residential. The assessment of human health ri s k s is described in more detail in Section V. Aggregate risks are calcu l a ted based on varying durations of exposure. When no r , es id entiaJ u s es ex ist, aggregate risks are b as ed on exposure contributions from food and drinking water for the acute and chronic duratio n s. For residential-u se pesticides, residential exposures are comb in ed with food and drinking water exposures for each applicable duration of exposure. As discussed above, a determination on the proposed tolerance will be based on the risk-only s tand ard from FFDCA section 408.

26 A request for an import tolerance genera l ly would not require an accompanying applica t ion for registration. 27 Re s idential expos u re s inc lude expos ures as soc iat ed with home s, home lawn s, ya rd s , gardens , apartments and grounds arou nd apartment buildin gs, sc hoo ls, schoolyards , day care facilities, pl aygro unds , athleti c field s , a nd parks and other publi c s pace s . 11In 1997, EPA issued " HED SOP 97.2 Inte rim Gu idance for Conduct i ng Agg rega te Exposure an d R i sk Assess m e nt s (11/26/97)." 28 Th e Agency co ntinue d to work on m ore so phisticated m et hod s for estimat in g aggregate expo s ures to pe s tic id es, an d 

### in 2001, r e lease d " General P rin ci ple s for Perfo rm in g Aggregate Exposure a nd R i s k Assessments ," 29 to a u gme nt the gu idan ce dlocu m e nt
. The aggregate ri s k assessment p rocess rel ies on ava il a b le data , ass umpt io n s d esigned to be protec ti v e of public h ea lth , stand ard analytical methods and Agency SOPs to estimate ex po s ures to a pesticide for each potential pathw ay and route of ex p osure. EPA co mbin es the se se parat e exposure estimates to calcul ate potent i al aggregate ex po s ure and risk; aggregate exposures es t imated im this way reflect upp er- bound or hi gh -e nd of exposu r es for eac h route/pathway. The most highly ex p osed &rro up , which genera ll y al s o ha s the highest associated risk, i s u se d a s the bas i s for d1eci s i o n - m aki n g purpo ses . Aggrega te ri s k assess ment s conduc t ed in this manner t yp ically can b e ref in e d by th e use o f additional ex po s ure data and d ata s p ec ifi call y d esigned to address th e uncertainti es within an individ ua l aggrega te a nal ysis, as we ll as mor e sop h isticated analysis techniques. The assumption implicit in thi s approach i s th at indiv idual s c an encoumte r th e h igh

- end exposures from the di fferent pathwa ys all at one tim e. In actu a lit y, co-occu rrence of high -end food, drinkin g water. a nd r es idential exposure sce nar ios i s very unlikely. Thus, in u si ng thi s ap proach , E P A i s conf id e nt that aggregate expos ure es timates w ill overstate , so metimes s i g nifi cantly , th e amount of a pe s ticide to w hi ch p eopl e actual ly are exposed. Th e primary advantage to relying o n th ese highly conservat ive assess ments i s that th ey requi re rela tivel y fewer data and ana l ytical resources and l ess time to co ndu ct. In addition , an a gg rega te ri sk assess ment of this typ e may be enough to indi cate tha t a particular pesticide use sati sf ie s the a ppropriate regulatory s tandards.

1. Re reg is tr a ti on FIFRA require s the p eri o dic re -evaluation of cune ntl y re gistered p estic id es. In 1988 , Co ng ress amended FlFRA sect ion 4 to include a s pe c ific proce ss for the "reregistrat ion " of p estici de s containing ac ti ve ingredients fir s t regi s tered b e fore November I , 1984. Pub. L. 100- 532, title I , 

### § 102(a) , 102 Stat. 2655 , 2683( 1 988). To make a Reregis tra tion E li gib ilit y De c i s ion ( RED), 30 EPA reviewed a ll the s tudi es that we re s u bmitted by the pesticide reg i s tr ants for a

28 U
.S. Env ironmenta l Protection Ag e n cy. 1997e. Me m o r

an dum from Margar et S tas ikow sk i , Hea lth Ef fec t s Divi s io n to Hea lth Effects Di vi sio n Sta f f. "HED SO P 97.2 Inte rim G uid ance for Con ducti ng Aggr egate Expos ur e and Ri sk Assessme nts (J 1 /26/97) ;" Nove mber 26, I 99 7. Office of P esticid e Pr

og rams, Off ice of Preve ntion, Pesticides , and T oxic S ubstances, Wash in gto n , D.C. Ava ilabl e upon req uesL 29 Imp://www

**.epa.go\/~~tic ide~trac/..,cleoce/al!1!regate**  .pdf 30 In parti cular cases, th e Agency issue d a variatio n on the RED, i.e ., a To l eran ce R eassess m ent Dec i sion , or, for individual ac ti ve ingredients ide nti fied as be long i ng to a grou p of pest i c id es w ith a com mon m echani s m of actio n , an Interi m Reregistration Dec i s i on ma y ha ve bee n i ssued befor e the RED. 12pesticide active ingred ie nt, as well a.;; other rele vant i nformation, develop ed the appropriate risk assessments, and decided whether or not the pesticide active ingredient satisfied the risk-benefit s t a ndard of FIFRA section 3(c)(5). After determining eligibi lit y of the active ingredient, EPA de te rmined whether to reregister products contain in g th e active ingredient ?' 

### See FlFRA § 4(g)(2)(B)

.. In conj un ction with most REDs , the Agency "called- in " active ingredient- or product-specific data considered necessary to reduc e uncettainty in the RED risk assessments. Reregi st ration wa an open and transparent proc ess. Before fina l izing it s dec i sion on the e li gibiHty f or reregistrat ion of a pesticide , EPA mad e the supporting risk assessments available fo r public comment, although it was not required to do so. Comments were so licited particularly on the factual basis of the risk assessments and also on options for mitjgating the risks posed by the subject pesticide. These comments were cons id ered in the Agency's decision-making. Most of the pestici de s spec ifically nam ed in the Petition went through the reregistration process . Information o n the reregistration s tatus and l inks to the reregi st r at ion dockets for any pesticide can b e accessed v ia the Agency's Chemsearch database

. 32 And, as expla in ed more fu ll y below , they have also been scheduled for revi ew early in the current re-evaluation process , known as Regi s tration R eview. 

### See FlFRA 

### § 3(g).


### ii. Registration Review Once the reregi st ration decisions for all the s ubject active ingred i ents were completed, the Agency began the next re -eva lu ation proce ss unde r FIFRA, which requir es EPA to regularly review pesticides to ensure that they continue to sa ti sfy the statutory standard for reg i stration. The ongoing re -eva luation proces s is called registrat ion review. Section 3(g) of FIFRA requires EPA to comp lete its initial registration review cycle by October 1, 2022, fo r a ll pe s ticide s registered J prior to October 1, 2007, and by 15 years after the date of initia l registration for pesticides registered after that date. 

### /d. 33 Follow in g the initial review of the pesticide, EPA mu st conduct subsequent reviews of each registered pe s ticide every 15 years thereafter. The registration review program34 makes s ure that, as the ability to assess risk evo lve s and as policies and practices change , all registered pe s tjcid es continue to meet the s t atutory standard of no unreasonable adverse effects. Through reg i st ration review, the Agency i s ensuring that regi s tered jpes ticide s do not cause unreasonab l e ri s k s to human health or the environment when used as directed on pro duct l abeling. Changes in science , public policy , and pesticide u se practices will occur over time, and the cyclica l nature of registration review wi!J enable the

31 While the Agency has comp leted its s tarutory requirement to make el ig ibili ty determinations on the subject active ingredi ents, product reregistration is s till ongoing for some reregistration cases. 32

**ll p://iaspub.epa.gov/npc>./Qe~1ic**  **deslf?p=chemicab,earc**

**:** I ; se arch by active ingredient name , PC Code , or CAS number

. 33 See also 40 CFR Pa n 1 55 for the implementing regulations. An overview of rhe process is found at hllp:l/\\ '""
. cpa.gov/oppsrrd l/reg1strntion review/highlight'\ htm

.

**~** Unlike earlier re- e va lua tion program s, regi s tration r eview operates co ntinuou sly, and provide s for th e r eview of a ll regi s t ered pesticides. 13

### Age ncy t o co n s i de r upd a te d info rm ation ever y time a pes ti c ide co mes up for reg is tra ti o n review. 35 

### In co nd uc ting th e r egi s trati o n r ev iew prog ram , EPA ge nerally is reviewin g p es ti ci de s in chr o no lo gical orde r ac cordin g to the ir b ase lin e dates ; 3 6 

### that i s , o ld er c a ses a re being r ev iewe d fir t. 

### In a dditi on, m an y pesticides t hat rece ived p ri ori t y

**sc ed**  **n~** 

### for re r egisn·ation h ave been schedu l ed e ar l y in r eg istratio n rev iew. Th us, f o o d

- u se chemi cals that were ident i fied a s or suspec t e d o f h aving r i s k co ncerns at th e o u tset of rereg ist r ation genera ll y a re sc h e dul e d ea rl y i n th e reg is tration r ev iew pro cess. Additi o n a ll y, within thi s s tructure, E PA plan s t o rev ie w certa in re lated pestici d es at t h e same tim e, p artic ularl y p esticides in th e same fa m i ly, with th e same general stru cture an d mo de o f actio n . In re re gi s tr ati o n , E PA gain e d experi e nce and b en e fite d from e fficie nc i es in the c on c urrent r evie w of p es ti c i des in fa mili es l ik e the orga no phosph ates ( OP s). N- met h y l carbamates (NMCs) , t ri az ines, and ch l oroacetaniJides. T h e rodent icides and s o il fu mi gants wer e also rev iewed concurrently. EPA

**s** 

### to co ntin ue the practice of groupi ng re lated pes t ici des d urin g r egistration rev i ew. 8 

### Pote nt ia l ef fi c iencies f rom thi s prac tic e i nclu de:
• T ec hnica l an d regu l ator y iss ues may be r eso lved more eas il y l oo ki ng across an e ntire c hemical class or gr o up; • R e so urce s can be optimized w ith in E P A, among s take h olders , an d within other fe d era l a

g e nci es; and • l n d evelop in g d e ci s i ons, a "le ve l p l ay in g fi e ld " amo n g c h e mi ca l s in t h e gro up m ay b e assme d s o th at E P A 's acti ons d o no t i nad verten tl y cause increased risks. EPA com p leted c umul a ti ve ris k assess ments a n d r ereg is tration r isk ma n a ge m e nt dec i s ions fo r the OP p es ti c id es in A ug u s t 200 6 a n d th e NMC pes ti c id es in Sep te mber 2 007

. I n re ce nt years, E P A a n d s takeh o ld ers have invested s ignifi cant resources in 

### gaini ng a b etler under s tan din g of these cla sses of pestic ide s. T h e regi s trat io n r eview of the OP s began in 

### 2008 , and th e N -methy l ca rbam ate rev ie w bega n i n 2010

. The P etitio ne rs a r e re questin g exp edi t ed r ev iews for bo th classes o f c he mic al s. T h ese class e s of pes ticid es w ere am o n g th e first p e s t ici d es t o en te r th e r eg is t rat io n rev i ew pr ogr a m , so the assess ment of ri s k s associate d w ith th e ir use (incl u d in g ri sks to ch i ld r en , and r isks from s pray d ri f t) , and th e management o f tho s e ri sks

. sho ul d b e accompl is he d ea rl y in the curren t regi s tra ti on review cycl e, and i n su b sequent cycles as w ell

. Volatil i za ti o n w ill al s o b e ad dresse d ba sed o n th e r esul t s o f the scree nin g an a l ys is a nd th e s ub se qu e nt ava i lability of pertin e nt data, s h o uld the y b e re quir e d fo r in di v idual pe s ticides

. T he schedul in g of these cl asses of pesticides in registrat io n rev i ew reflects an tmderstan ding of t h e i mp orta n ce o f ad dre ss ing the toxicity , die tary and aggr egate r isks, and the

JS The A ge n cy u ses t he b es t , m os t rece nt inf o rmati o n i n a ny ri s k a ssess me nt , but th e cy cli c al n at ure of regi s tra tion r eview ass u res that assess ments fo r a n y one pe s ticide w ill be up da ted at lea s t eve r y 15 years . 36 The base li ne da te is the date w hen a RED was co mpl ete d, o r for a pes ti cide not s ubject to

**rer e~**  **istra tio** 

**,** the d ate w hen t h e pe s t icide wa s firs t registered

. 7 Pes ti c i de s u se d o n foo d c ro p s w e re g i ven h ig h pri or it

y bec au se th ey h ave p o te ntial to aff ec t th e p op ul a ti o n 2 1t

- l arge v i a di e t ary ex p os ure. 38 T he ov e r v i ew at http://\'-'WW.epa.gov/orm.rrd 1 /regJ!-.L ratt on

**rev1e\~ /h1ghli~hts.htm**  p rovi des li n ks to i n f

o rmation o n the p estic i de famil y group in gs. 14

### vo lum e of use for these pesticides. See 

### Appendix to thi s response for the registra ti o n review sch ed ules for the OPs and NMCs. EPA initiates a registration r ev iew by establishing a docket for a pesticide registration review case and opening the docket for public review and comment. The Agency publi s hes a F e d era l Register notice that anno un ces the availability of a P re liminary Work Plan (PWP) and provides a comment period of at least 60 days. Anyone may subm it data or info rm ation in response. EPA wi ll co n si d er information received during the comment period in cond ucting a pe s ticide's regi s tration rev i ew. The PWP:

• explain s what E PA knows about the pe s ticide from previou s ri s k assessments including hazard and exposure in fonnation related to chi ld re n. when availab le , and app li cation of uncertainty factors including the FQPA safety factor; • tentative ly identifies what kind of ri s k assessments are needed; • tentatively identifie s what data wi ll be needed to co nd uct the assessments; • addres ses the uncertainties in the database th at w ill impact the risk asse ss ments (paJrticularly mi ssing or unclear use paramet ers); • provides basic u se and u sage inf ormation and o th e r background information on the pesticide ; and • provides a proposed sc hedule that lays o ut mi lestones up unti l th e r egistration review decision is made. Information from registration review dockets that have opened is readily acc essi ble via Chemica l Search o n a chemical-by-chemica l basis. Regis t ration r eview , as set forth in th e regulation s, is a transparent process in which stakeho lde1 rs of a ll types are invited to provide rel evant data and commen ts. At the beginning of r eg is tration review , the public is asked to comment on the PWP and it s s upporting document s; by so liciting the se comments, EPA aims to gather additional information that can enhance reg is tration review planning and deci sion-ma king. Othe r r egi stratio n review documents also are s ubjec t to aL 

### public co mment period, such as when th e preliminary ri s k assessments are posted to th e docket lat er in the process. Similar approac h es to publi c notification and comment were used du r ing reregi s tration and can be used in decision-making about new active ingredients. E PA may also. as needed, co nsult with reg istrants, th e U.S. Departme nt of Agriculture. and other stakelhold ers to reso l ve an y uncertai nt ies about how the product is used, particularly 

### if u se parameters are not clear from product l abeling, or 

### if the regi st rant may have data not already s ubmitted to th e Agency that cou ld inform the process. For example , some l abels are not specif ic about retreatment intervals or seasonal maximum appl ication rates. Without actual use parameters, th e Agency i s forced to make conserva ti ve ass umption s that can re s ult in overly conservati ve risk assessment results. Th e Agency may so licit such in for mat ion in a "Focus Meeting." The se meetings can be held w henever in the reg i strati on p rocess they might be helpful. To ensure transparency. materials associated with Focus Meetings are avai lable in the pest icide -specific regi s tration r eview dockets. If a focus meetin g i s held pr ior to the docket

15opening, these materi a l s are posted to se p a rat e do c ket. 39 O nce the do c ket open s, a co py of th e focu s m eet in g notes will b e posted to the case-specif i c docket. Afte r th e close of the in itial co mment period, EPA revi ses its work pl an as neede d based on public input and any add itional information that ha s becom e avai l able i n the interim. The Fina l Work Pl an i s then posted to the do cket, and EPA prepares to ca ll -in any dat a needed f or the ri sk assessment s . Once th e registrants s ubmit th e r e quired data, work on the risk assess m e nt s be g in s. As not ed above, EPA mak es the draft ri s k assess ments ava ilab le for publi c rev iew and comment, and s ub sequent to rev iew of public co mm e nt s, the Agency posts the revi se d assessme nts. 

### If the revi sed assessments indi cate that there are ri sks of con cern, EPA may in vite the public t o s ubmi t s u ggestion s fo r miti gatin g those risks. These s uggestion s are u sed in the deve lopment of a proposed n egistration review dec i s io n. EPA will announc e th e ava ilability of 

### a proposed re g i strat i on review d ec i s io n on the do cket and w ill provide 

### a pu blic comment period of at leas t 

### 60 day s . The process culmi n ates with a fina l re gist rat ion revi ew dec i s i on- E P A's determination on whethe r the pesticide in qu estion meets or d oes no t m ee t th e standards for registration. The fina l r egistratio n review d ec i sion di scus ses any c h anges th a t are need e d to the pesticide's reg i st ra tion or lab els to add re ss the ri s ks of concern . If a reg i s trant fails to tak e ac ti on to impl e m e nt these changes, EPA may tak e appro priate action und er 

### FIFRA. To meet its s tatutory obl igat i ons for regi s tration review , EPA is opening 70 or more do ckets armuall y continu ing th ro u gh 20 1 7, and almo s t a ll of the pe st icid es regi s tered at th e s tart of the program will have do c kets ope ned by 2017. The Agency 

### is directed to complete th e f irs t round of regi stration review s by October 1 , 2022; during that tim e the Agency will co mpl e te th e re g i s tration re v iew s of at least 744 pe s ti ci de cases co mpri s in g I , 165 active in gred ient s. Pe s ticide s 1registered afte r 2007 will b e fo ld e d 

### in each year. 40
iii. Regula tory Responses to Unacceptable Ri s ks 

### If EPA determines th a t 

### a pesticide product do es not meet the s tatutory s tandard, the Agency m ay tak e "appropriate regu l atory actio n .' ' S u ch regu lat ory actio n s can include , but are not limi ted to, rest ricting p estic i de u ses or canceling the pesticide's registratio n. 

### See FlFRA §§ 3(d) & 6(b). 

### If EPA chooses to cancel a pesticide regi s tration , EPA must first i ss ue a Notice of Int e nt to C anc e l and hold a formal adminis trati ve hearing, if one i s requested b y a perso n a d versel y affected by th e notice. 

### See F fFRA 

### § 6(b)
. If the Agency determine s that 

### an " imminent hazard" ex i sts from the use o f a pes ticid e ( in cluding 

### a pesticide that was not eligib le fo r reregi s trati o n ), EPA m ay commence proceedin gs
39 Ge n e1ral informati o n abo ut focus meet in gs i s at http.//www .epa.gov/opp s n ·d 1/r ee i s trat• on revJew/focus-meetings.htm l ; th e do c k e t it se lf is a t http.//www. regulations .l! ov/#!docketDeta il , D=EP A

- HQ-OPP-20 12-0778

. 40 Th e sta tus of all compl ete d and ongo in g reg i strati on rev i ews ca n be found at hllp://v. W\\

**.cp .!mv/o**  **pp~rrd** I /re!!JS. lr ati on rev1ew / ree re\1 ie,., !>lai U 'i.hlm

. 16to suspend the registration of a pesticide during the time needed to complete cance llation proceeding ; s. See FIFRA § 6(c). Section 2(1) of FIFRA defines imminent hazard as: 

## laJ s ituation which ex i sts when the con tinued use of a pesticide during the time required for cancellation proceeding would be likely to result in unreasonable adverse effects on the environmen! or will involve unreasonable hazard to the survival of a species declared endange red or threatened 

### by the Secretary pursuant to the Endangered Spec ies 

### Act.
... If the 

### EPA determines that an emergency exists such that the imminent hazard wiJI occur during the period nece ssary to comp lete normal s u spension proceedings , th e 

### EPA may is s ue an immediate l y-effective emergency suspe n sio n order in advance of comp l eting suspens i on proceeding ,s. 

### !d.§ 6(c)(3). Courts addressing the s u s pension provi s ions ha ve held that an immin ent hazard exists if there is "a s ub st antial likelihood tha t serious harm will be experienced during the year or two required in any realms tic projection of the adm ini strative process." Love v. Thomas, 858 F.2d 1347 , 1350 (9l11 Cir. 1988) (quoting Environmental D efe n se Fund v . EPA, 465 F.2 d 528, 540 (D.C. Cir. 1972). In the case of an emer ge ncy s u s pension, one court has found by ana logy that s uspension is appropriate if there is a "s ub sta ntial like lih ood that seriou s harm will be experienced during the thre e or four months required in any realistic projection of the a dministrati ve s u s pension proce ss." Dow v. Blum , 469 F.Supp. 892 , 90 l (E. D. Mich. 1979). Thus, courts interpreting the FIFRA u s pen sio n standard have made clear that an immi n ent hazard finding requires a greater degree of 

### I ike lihood , immediacy, and severity of harm than i s otherwise required to take a cance ll ation action under FIFRA. And in evaluating the nature an d extent of inf01mation before 

### EPA, the co urt s hav e instructed the Agency to co nsider ( 

### 1) the serious ne ss of the threatened hru.m , (2) tlhe immediacy of the threatened harm, (3) the probability that the threatened harm will occ ur, and (4) the benefit s to th e public of the con t inued u se of the pesticide 

### !d

. at 902. 

### EPA's review and re -eva luation proces ses for pesticides have been d eveloped to account for advancements in science so that risks ca n be identified and managed before a pesticide is regi stered and at regul ar intervals thereafter. Through these processes, the Agency can anticipate and correct problems with the use of pesticides as time goes on, and, ideally, reduce the chances that a pe stic ide would pose risks of an immediacy and magnitude like tho se associated with an imminent harm finding.



### V. How Pesticide Risks

. \reAssessed The type of asses sme nt pertinent to thi s Petition is the human health ri sk assessment 41 (eco l ogical risk assessments are not discu ssed in the Petition). 

### EPA uses a scie nce-based risk as sess ment. approach. Risk is a function of both the hazard a ssoc iated with a pesticide and how mu ch exposure occurs to that pesticide. Hazard is th e innate ab ility of a pesticide or other stressor to cause an adverse effect (its to xicity). At EPA, h azards are typically identified from the resu lts of te s ting on seve ral animal species and typically the most sensitive effect is used as

· II See

**hllp://www.epa gov/oe~ttcJde<Jnboutlovcr**  viev

.. rbk

**ns~C!>S.htm** 17

### the basi s for risk assessment. Expos ure is th e amount or concentration of a s t ressor with which an affected. individual or group interacts. Ri sk is a function of both hazard and exposure and repre se nt s the likeli ho o d that an individual or g roup will b e adversely affect e d by that s tres s or. B o th ha zard and exposure can differ according to a person 's age, thu s EPA u ses age-appropria te be h av iors t:o 

### determin e ex po s ure s and al so l ooks at any s pe c ial sen s itivity to p est i c ides as s ociated with the age of the exposed parti es. EPA use s the National Re searc h Counci l 's four

step proce ss 42 

### for its human health risk a ssess ments. The four steps include: 1) 

### hazard identifi cation, 2) do se - re s pon se assessment, 3) exposure as sess ment , and 4) ri s k c haracterization. Each of th ese ste ps is s ummarized below

. It is important to not e that ri s k as s e ss me nt and risk man age ment are s eparat e activitie s. Ri s k manage ment relates to the ways in which the ri s ks charact e rized in the asse ss ment may be reduced or e liminated

. Ri s k management measures can include tolerance revocation or the cancell ation of registrat ion s, termination of s ome u ses of a p e sticide, change s to a pesticide 's u se parameter s, and risk r e duction training for p eo pl e who are o ccupationally exposed, s uch as pe s ticid e ap plicators .

The fir s t s tep in the ri s k assessme nt i s to id en tify potential heal th effects that may occur from different typ es of pe st 1 cide ex posure . EPA cons id ers th e full spec trum of a p es ti c ide 's potenti al health effects. Typically, a pesticide active ingredient is s ubjected to many toxicity studi es, and the data fr o m the se s tudies (if 

### determined to be acceptable) are used in ri s k assessment. Requirement s for the relevant data are typically imposed on the pesticide applicant or registrant , and the s tudi es are typicall y co ndu cted b y ind epe ndent laborat ories, w ith strict s tand ards for data s ure ty. 4 3 

### The data are evaluat e d f or accep tabi li ty by EPA sc ienti s t s. Th e toxi c ity s tudies primaril y are performed on laboratory animal s or 

### in vitro, although so me of the requir e d st udies are condu c te d in the field

. The Ag e nc y will also review human toxicity s tudies, with qualifications , a s di sc us s ed below, but doe s not re : quire them. EPA

**evaluat~s** 

### p estici des for a wide ran ge of potential toxic effects includin g eye and skin irritation , neurologi cal effects, cancer , and birth de fe c t s . ln addition to re v iewi ng the require d s tudi es, EPA al so co n s ult s the public lit e rature or other s ources of s up porting information. The re quired tests are u se d in the as s es s me nt of potenti al health effects in infant s , children , and adults

. They are c o ndu c te d for expo s ur es of different duration s , as appropriate to repre se nt the duration s of exposure anticipated for various life stages and behaviors

. Exposures may be of s ingle day or longer duration s, up to a nd in cludi ng duration s s parming a lifetime. Add itionall y, EPA cons iders the route by which the s e exposures ma y occur-ora ll y, e.g., through the diet o r vi a chi ld re " n 's mouthi ng b ehav iors; through the s kin; or by inhalation.

42 Th e Nationa l Re se ar c h Co uncil produc es re ports for the National Academy o f Sciences. Th e process i s e xplained at

**llup ://~**  **jU! v/ris**  **assess mentJh**  **allh rh.l-**  **htm**

**.** 43 R eq uire d laborat ory pra c ti ces for s tudi es u sed to support pe s ti c ide registration are detailed at htt p://wW\ \

.

**gpo.~rov/**

**fd sv~/**  **pl,. !!/C**  **FR- ?0**  J

**titl O-vo**  **xmi CFR**  **-:?. 0**  I l
-t l l l e40 -vol:?.4-pa nl6 0. xml 18To address ri s k s to infant s , chi ld ren, and adults, EPA typi cally requires animal te s ting at mttltipl e lif e s tages, includin g during gestation and s hortl y after. The effect s that are observ e d in this typ e of testing are fetal development ( including birth d e f ec t s) and reproductive s u ccess. The resu lt s o f these stud i es are parti c ul arly a p plicab le to the a sse ss ment of ri sks to the fet u s and yo ung c hildre n and, w h en co mpared to s tu d ie s with adult a nimal s, provide a basis for evaluating the relative sensitivity of the you ng to adults. In ord e r to develop a ri s k assessment th at i s protectiv e of human h ealth , th e Agency wi ll s e lect th e ' ' ' mo s t sensit ive " en dpoints and th e co rrespondin g po int of departure ( POD) from among these different s tudi es for the rele van t population s , t akin g into a cco un t th e d ura tion s a nd route s of ex posure. T he endpo int can be de s c rib e d a s the tox ic effect itsel f. The POD i s t y

pi ca ll y th e dose level bel o w the lo west d ose a t which the adverse effect i s manifested.

A s an exa mp le , co n s id e r a n endpoint th a t was se lecte d from a s horter-term an imal st udy in which th e :animals were exposed v ia the der mal route, for a pesticide that i s reg i s tered for use o n lawn s. In n his exam pl e , t h e POD based o n th i s e ndpo int wo uld be u sed to est im ate 1is k s to adults and to c hil dren aged 1 to 2 years old. Children in thi s age group typicall y a r e the most highl y expo sed re lative to ch i ldren of all ages for p es ticide residue s on turf b y weight a nd becau se o f th ei r b ehav ior on law ns, a s they are expo sed to residues through contact w ith their s kin wh e n th ey play i :n their yard s or in parks and playgrounds , and are al so expose d orall y, predominantly v

ia hand -to- mouth behavi o rs. As not ed prev iou s l y, th e Agency al s o will con s ider r e leva nt d ata from sources other than re quired s tudie s, including data from pro s p ec tive and retro spective epidemiologic s tudie s, incident r eports, 44 a nd s tudi es in which hum an s ubjects have been exposed int e ntionally to a pesticide (a lthough the latter mu st unde rgo an s p eciali zed rev ie w to en s ur e that the Agency d oes n ot rely o n data f rom s tudi es that violate estab li s hed et hi cal s ta nd ard s)
.45 EPA uses its draft " Frarnewot r k for In corp o rat ing Human Epi d e miologic & In c id ent D ata in Ri s k Assess m ents " when cons id ering those types of dat a. 46

Th e seco nd s tep 

### in the risk a ss es sme n t pro cess i s to con s ider the do se l evels 

### at wh i ch adverse effe c t s were observed in test ani mals and to extr apolate th ose dose leve l s to a n e qui va lent d ose in human s. Fo r animal studies, the uncertaint y arou nd the ex trapolation from tes t animals to human s a nd the variabi lity of se n s itivity in t h e human popul a ti on are accounted for by uncertainty factors

. The de fault factor s a ss um e there cou ld b e up to a ten
- fold difference be tween a nim a ls and human s and up to a ten
- f o ld di fference between th e average person and t h e m ost sensi 1 t ive people in the p o pul ation. T h at i s, human s ge ne rally are ass um e d to be 10 times more sen s iti ve than animal s, and the mo st sen s itive indi vidu a l s ge ner a ll y are assume d to be 1 0 time s more sen si ti ve tha n that. The se un certa inty fac tors c reate a margin of s afet y fo r protec ting
44 For e:x ampl e , pe r a na lys is of pe stic id e ac ute illn esses ba se d o n 1 998-2006 NIOSH SENSOR d at a, see

**http:/l<:litp03.meh~>-Ilih.gov/anicl**

**e/ in**  **fo'k** 3Ado,r/c 2Ft 0. 1 289% 2Fehp. l 00284.3 , r efe r e nce d i n th e P et iti on. 45 http://www .cpa.gov/oppfead 1/iwidance / human

-tel>L.hLm 4 6 hnp://www

**.regulatlon~.go,J#!documcnt.DeLaii:D=EP**A-HQ-OP P-2009-0851-(XJO-l 19

### people who may be exposed to the pesticide s. The FFDCA requi res EPA to u se an extra 10-fold s afety factor to protec t infants and children from effects of th e pesticide, unless re liable data show that a different (larger or s maller) factor would protect th e safety of inf ants and children. 47



### The third step in the risk asse ss ment proce ss is to addre ss how long, and at 

### what level peopl e are exposed to a pesticide , a critical consideration when se lect ing endpoints and also for calculating

. r isks. For spray drift, exposures are assessed for contact with pr ev ious ly contaminated s urface s s uch as lawns adjacent to treatment areas. More spec i f ica ll y, the Agency assesses exposures from dermal contact (e.g., children pla yi ng on lawns) and also non-dietary inge stion from mouthing behaviors of young c hildren. Adult s also are expected to have exposure s from dermal contact. For volatili zation exposure, the primary exposures result from inhalation s ince exposure is to the gas or vapor form of a pesticide. 

### In general, pesticide re sidues depo sited on surfaces (such as grass or the leaves o f treated crop plants.) remain availab le for exposure to people entering treated area 'i, or areas in which spray drift re s idues hav e se ttJed, for more than a single day , so su bchronic studies are used to de r ive endjpoints and PODs. Single day (acute toxicity) stud i es al so may b e co n s idered in order to evaluate risks on th e day of applicatjon (when the greatest expos ures are like ly)

. Impacts on fetuse s due to the exposure of pregnant women are included in the risk assessments when information on reprodu ctive and deve lopmental toxicities is available. If 

### informat i on on reprodu ctive and de velopm e ntal toxicities is not availab l e, an uncertainty factor may be u sed to account fo1r the possibility of the special sensitiv ity of children not apparent from available d ata. More details are provided in Sections 

### VIT and 

### VIII below on how expo s ures to spray drift and volatilization are determined. 

### D
. Risk \.'h,trncteruauon The last step in the risk assess ment proce ss is to combi ne the hazard and exposure assessments to describe th e overall risk from a pesticide. Ri sk c haracterization ex plains the assumptions used in assessing exposure as well as the un certain tie s 48 

### that are built into the dosere sponse assessment, and whether or not the assumptions and uncertainties used are likely to overstate or understate p o tential risks. The stre ngth of the overall database is cons idered , and broad concl usions are mad e. In su mmary, the ri sk s to human health from a pesticide depend on both the toxicity of the pe s tic ide and the likelihood of people coming into contact with it. At least some 

### expos ure and some 

### toxic it y are required to result in a ri sk. For example, if th e pesticide is very toxic, but no pe op le are exposed, there is no risk. Likewise , if there is ample exposure but the c he mical is nonto x ic, there: is no risk.
4 7 EPA may modify th ese un ce rtainty factors o n a case-by-case basis w hen s upp o rted by chemicalspec ifi c be ha vior. 48 The se are uncertaintie s not covere d by FQPA or other un certainty factor s, e.g. deriving fr om an incomplete database

. 20E

. Ch ilclrcn and

**p~-..tkldc-.**

**--~------------------**

**---- ----------** 

**-- --------**  **-----------** EPA has developed methods for estimating pesticide expo sures to ch ildr en through the diet and via non-dietary sources suc h as residential exposures. The se methods rely on the be st available scientific sources, such as EPA' s "Exposure Factor 's Handbook

...49 Dietary exposures are based on consumption data for children , and residential exposures are ba s ed on methods outlined in the ' 'Standard Operating Procedures (or SOPs) for Residential Expo s ure A ssess me111t. " 50 The SOPs address exposures for various life s tages, and allow for the identification of the mo st h ighly exposed lifestage. The SOPs, including the concept of lifestage , have been di scussed extensively by the FIFRA Scientific Advi so ry Panel (SAP). 5 1 The 2012 revision of the SOPs reflect the input of the SAP. 52 Young c hildren may have unique exposures that adults do not ha ve becau se of age-specific behaviors, for exampl e, picking things up from the ground and mouthing them , or putting their hand s

**(pott ntially**  contaminated with pesticide residues) in their mouths. They may also come into contact with pesticide s when crawling o r at play on treated or contaminated s urfaces. Children up to adolescence have a higher surface to weight ratio than adult s, so they may also be proporti onate ly more highly exposed via the dermal route. C hildren can al so be more highly exposed via the dietary route because they cons ume more food and water in proportion to body size than adults, and the type s of food they e at a lot of tend to contain more pe st icide residue s. Avai lab le data pertinent to children's health risks are eva lu ated along with data on adults and the mo s t sensitive, appropriate POD is defined (e.g., NOAEL or no observed adverse effect level) for 1 r h e most sensitive critical effect( s ) based on consideration of all h ea lth effects. By doing thi s, protection of the health of chi ldr en will be considered along with that of other potentially se nsitive populations. In most cases, it is appropriate t o evaluate the potential hazard to children se parately fr om the assessment for the general population or other population subgroups. T h e apjproach use d by EPA to account for pesticide exposures in children i s co nsistent with EPA 's genera l risk as s essment methods 5 3 and follows the Agency's age group in g gu idanc e. 54 The approach is also consistent w ith r ecommendations from the National Academy of Scienc e 49 http:/ / cfpub.epa.l!ov/ncea/rislJrecordi spl ny.c f m? deid=236252

. 50

**http./ www.epn.gov/pesticJde~/!\cicncc/rc-.ide**  **ial-exposure-sop**

**ml** 5 1 The SAP is a federal advisory committe e co n s is ting of ind ependent, external scie nt ific experts that a

d v ises th e Agency's Offic e of Pesticide Progr a m s (OPP) on technical i ss ues. 51 The SAP meeting report is at http://www

**.~:pa gov/sc**  **poly/sap/mcc.>ting,s/2009/1** 00609meetmg.lnml. 53 EPA' s ri s k assessment m e thods can be fo un d at

**tt p://w~w.cpa**  **gov/risk/guidan e.htm** 

**:** An overview o f EPA's appr oach to assess ing and m anag ing these ri s ks is provided in th e 20 I0 report " P r otecti ng Chi ldren's Health ," found at

**tt p://www.epa.~rov/pes**  **icides/health/protecting-children.pdL** 54 An overv iew of EPA's app r oac h to as sess in g and manag in g the se risks i s provided in the 2010 report "Protect ing Children 's Health," found at htt p://www .epa.gov/pesticides/health/protecting

chiiJrt:n.pdf

. : the 2005 p ape r "Gu idanc e on Selecting Age Groups for Monitoring and Assessing Childhood Exposures to Environmental Contaminants, at http://www

. epa . gov/raflpublkauonslpdfs/AGEGROUPS

.PDF , ad v ises r isk assessors o n se lecting appropriate age ranges for use in imp l ementing th e Agency 's initiatives on pr 21

### 19 93 report, "Pesticides in the Diets of Inf ants and Children," 55 

### c ited exten s iv e ly by the Pe t ition e r s . EPA ha s adopted many of th e recommendations from that r eport into its current ri s k as s essment' procedures. 

### \!1 . omcndature Associ:Jtcd

**'~ith Spra~**  

### Drift and Volatilization EPA w;es an informative nomenclature that allows for a clear delineation b e tw een the po ss ibl e forms and/or so urces of pe sticid e movement th ro u gh t h e air and away fro m treated field s. T hi s approac h provides for a mean s of avo idin g conf u sion w hen describing the un ique pro cesses and factors that ca n co ntribu te to pe st icide mo vement. Wh ether o r not pesticide drift occurs duri , ng o r after application is an importa nt factor , as i s whether o r not pesticides are applied in )l iquid form or a s so lid material. As indicated prev io u s ly , for thi s respon se, the Agency focuses on "s pra y" dri ft , the off-site mo veme nt of aerosols or ig inatin g with pe stic ides applied as liquid s, rather than dust drift, because s pray drift i s more like ly to occur and genera ll y po ses greater risk

. Also as noted pr eviously , , the Petit ioners do not appear to differen tiate between drift and vo l ati li zation. Although there ar e s imil arities in the mod e of transport (through the air) associated with vo latili zat i o n and s pra y drift , EPA assesse s s pray drift and vo latili zation separate l y, for several re asons:
• They a1re two distinctly differ en t proces ses . Spray drift is dependent on how application s are mad e and on the form in which the pestic id e is applied, while volatilization is driven b y th e phy s ica l and chemical c haracteristic s of th e pe sticide a c tiv e ingredient (especially it s vapor pr

ess ur e). • Spray d rift occur s at the tim e of applica t ion and s hortl y thereafter, for as long as droplets remain aloft

. Vol atili zation , on the other hand, can occur dur i ng the application pro cess and al so ove r longer period s of time d epending upon the phy sica l and chem ical characte ri stics of th e p es ti c ide and how it was appli e d. • The rou te of expo s ur e that the Agen cy assesses for volatilization is inh alati o n. The Agency 's assessment of spray drift fo c u ses on d ermal ex po sures and exposures from non- dietary ora l ingestio n (predom ma ntl y from hand

- to -mo uth behaviors in young children). Inhalation exposures a r e n ot include d in the Agen cy's spr ay drift assessme nts f or the following reasons: • Most, but not all, of the droplets in spray drift are too large to b e re s pirable. • For agricultural pesticides, the Worker Protecti o n Standard (WPS) prohibits th e application of a pesticide s uch that it contacts , e ith er directly or through drift , any worker or othe r person. 5 6 

### T hi s WPS prohibition mitigates the potential for bystander exposure to active drift , bu t not the resid ues of drift that are depo s it ed on s urfa ces to wh ich byst anders may be exposed. Th e Ag:ency at present lacks an assessment methodology for drift inhalation exposures. • The wa.ys that the r i s k from volatilization and s pray dri f t can be mitigat ed a r e different.

55 hllp.//w\H\ .nap.edulopcnbook..php?record •d =2126&page= I
. 56

**hUp://www.epa.gov/pcsucade~health/IA** orJ...er. htm 22

### The opterating definitions of "spray drift " and "volatilization" are discussed in detail 

### in Sections 

### VII and 

### VIII, respectively. 

### V

U
.

**As~e.c;..., in~ot**  

### u nd

**~1ana**

**in g**  

### Ri s k>i fro m

**pnl ~**  

### Drift

EPA has been working w i th a broad range of public and private stakeholders to addres s concerns related to spray drift and the potential for adverse effects related to drift expos ure. 57 

### EPA ' s goa l l is to asses s, and if necessary , to mitigate spray drift via a science

- ba s ed approach relying on , c a s e-specific information. Spray drift is influe n c ed primari l y by en v ironmental cond i tion s (such a s wind s peed) and application parameters (such as formulation type, application method, app li cation rate, droplet/particle s ize, a p plication release height). Some degree of pesticide drift is an i nevitab l e result of ne :arly all type s of pe s ticide application. Even under the best of circum s tances, a minute amount of pes ticide can move out of the treatment area for a short distance . When the amount of drift i s s u ch that it po ses ri s ks of concern , the Agency will t a k e a c tion to mitigate those ri s k s . 5 8 

### Quantifying the potential ri s ks of spray drift is a complex process that involves predicting the amount of drift associated with variou s type s of application equipment, estimating potential exposur es, and consid e ring the potential health effects from s uc h exposure s . Managing the ri s k s as s ociat e d with spray drift c an be complex as well and there are a variety of p o tential approach es that can b e u s ed , 

### as di s cu sse d more thorou g hly below. 

### A
.

**E~lllllltll mg**  

### Spray 

### Dril t 

### u11d PutentrJI

**Exposure~** to

**By~laml~:r:-.**

**~\J** 

# -------------------------- Since the early 1980 's, EPA has been w o rking to better under s tand s pray drift. Information key to thi s effort was develop e d by a group of pe s ticide registrant s workin g coll a borativel y to create a da t aba s e that address ed s pray drift data requirement s under 40 CFR 1 5 8.440. 60 

### Thi s group i s rc 1f erred to as the Spray Drift Ta s k Force (SDTF)

. 6 1 

### Since its formati o n in 1990 , the SDTF has generated standardized data on s pray drift levels a ss ociated with a variety of application methods u nder varying field and meteorological cond ition s. The database was reviewed by EPA internally , through external peer review works hops, and by the SAP

. 62 

### U s ing the databa se, the SDTF b e gan working with EPA 's Office of Research and D eve lopment and th e USDA 's Agricultural Re s ear ch Service and Fores t Service in 2000 to de velop and valida te a

57 The P es ti cide Program Committee (PPDC) i s a federa l advi s ory com mittee that incl udes representative s from a broad variety of s takehold e rs interested in pes ticide regulation

. See htt p://www

. cpa .l!ov/ oppfead 1 /c b/ppd c/ .The PPDC' s Spray Drift W o rkgroup ha s p rovid e d va lu abl e input on th e Age n cy's approac h to a ssess ing and miti g atin g spray drift. M e mbership of th e Workgroup includes e nv iro n me n ta l ad v ocacy g roup s, grower a ss o c iati o n s, registrants, a nd s tate officia l s. See http ://www. e pa.gov/oppf en u I/c b/ppd c/spra y d ri ftlm e mbe r s. htm

. SR hllp://www

**.e pa**  **go /p**  **e~ ic**  **id e~/**  **fact**
**he**

**l!I pra**  ydrifLhlm

. 59 For PIJrposes of this res po n se, bystanders are defined as peopl e w h o, live, play, o r work in area s at proximity to pesticide-tr e at e d ar e as. 60 S ee b llp :// www .e p a.gov/ocspp/ pub s/f rslpubli<.:atiom,ff es t G u ide line!>/se n es840.lllm 61 Th e Ta s k Forc e's w e b s it e is at http ://www.a gdrift. co m/ 62 S ee hl.lp:/1\\ ww .epa.go\/scipo l y/

...ap / me e tln gs/ 1 997/dece mbe r /sprav drift.ht m . 23

### model for pr e dicting the magnitude of off-target movement of p es ticide s via s pray drift , called th e "AgDrift' ' mode l. Th e Ag;D rift mod el was developed to assess s pr ay dri ft under a var i ety of di ffere nt condition s for aerial, g rou nd , and orchard a ir-blast applicatio ns. Inpu t features provide the cap a bilit y to alter ove r 30 parameters related to the aerial appli cation method incl uding types a nd numbers of n ozzles, weather co nd 1 ti ons, and terrain f ea tur es . AgDRIFT al so can prov id e e mpirically based pr e di ction s for ground and a irbla s t appli cati ons made und er var ious c ondition s, and c an accommodate differ ences in 

### u se patterns th at re late to crop -spec ifi c pest management need s. In addition , user s can run the Ag D1ift model to estimate th e amoun t o f spray d rift at s pecified di stances from the app l ication s ite. Sp r ay dl rift ass ociated wi th a e rial appli ca tion has bee n e v a luat e d exten s iv e ly by the U .S. Army and th e USDA For est Serv ice, so the drift database is more extensive for aer ial ap pli catio n s com pared to groun d appl icatio n s. For orchard a irb l ast and gro und boo m sp rayer estima tes, AgD rift is more lim ite d ; unlike estimates fo r ae ri a l appl ications, th ere is no mechani stic op tion for these gro und appli cati ons. Rather, an empi rkal appr oach based on the available d .ata i s u sed , and u se rs are more limited in th e numb er of factors that ca n be co n s idered (e.g., orchard ca nopy typ e f o r airbla s t sprayers). Even so, AgD rift is a po werfu l too l for quant ify in g s pray dri ft for th ese applicati on me thod s . For aeria l applications , E PA u ses AgDrift to predict conservati ve estim ates o f the amount of spra y drift g iven th e conditio n s specified o n p est ici de label s (w he n such cond i tions a re not s pe c if ied O i n 

### the propo se d labe l , the Agency u s es c on s erv at i ve ass umption s). AgD RIFT has mo re limit e d ca pabilit i e s to reflect lab e l s p ec ifi cation s for g ro und application s. AgD rift ca n b e u se d to es timate the ri s k reductio n attribut ab le to buffer zones of s pecifi ed widths (essenti a ll y by estimat ing the differen ces in th e amount o f s pr ay drift at different di s tan ces from the appli cati o n sit e). In additio n to it s use in assessing by s t ander risks, AgD rif t c an be used in e n v ironm enta l assessme nt s to estimate the potentia l spray drift ex po s ure s to non-target an i ma l s and plants. It 

### al so is u se d to estimate t h e p ote ntial contribution of s pray drift to pe s ticid e re s idues in drinkin g water
. Re su lt s from the u se of Ag Drift represen t a range of po ssi ble outcomes that are refl ective of c ultural practices tied to h ow the target crop are produ ced and t h e nature of th e pestici de being applied. For example , a contact insect i c ide applic ation to 

### dense-ca nopy field c r ops may be most efficacious when the spray 

### is co mpo sed of finer ae ro sols , while a sys tem ic he rbicide applied to a fi e ld crop c: anopy of lesser den s ity, where co mplet e s pray cove rage i s not n eeded to achie ve th e de s ir e d d egree of efficacy, ca n contain dropl e t s of a larger s ize (as an aside, l arge r s i ze or coarse dropl ets tend to drift less, all o th er facto rs being equal). EPA acknow ledges that there is 

### some potential fo r drift ex p os ures to 

### occ ur ind oo rs, b ut beli eves tha t th e amount of drift e ntering e nclose d s tructures i s ver y s mall re lat i ve to the amount pr ese nt o ut-o f-doors. 

### Th e Age ncy's effort s to unde rstand th e human heal th dsks posed b y drift are fo c u sed! on outdoor exposures. B
.

**As**
**l:** ... .,llletlt ofR1

... 1. to 

### B}'tander:-. from Sp1:.1_ 

### Dntl

**---------- ~------**  **-------- -------------------**  2 4EPA ha s been workin g to refine and s tandardize the way it assesses th e ri s ks to bystanders from s pray 

### drift

. On December 5, 2013 , EPA presented its approach to asse ss in g s pray drift to the PPD C. EPA made thi s new methodology for assessing s pr ay drift availabl e for public comment o n January 2 9 , 2014. The announc e ment and direction s on ho w to s ubmit comments on the pro p osa l can be acce sse d on the public docket. 63 EPA will continue to co ndu ct spray drift ris k assessments under it s current proce ss while it reviews and analyzes comments received dur ing t he public comm e nt p e riod , which originall y was sche duled to end on March 31, 2014, bu t i s being ex te nd e d b y 

### 30 days. After reviewing public comments, EPA plan s to finalize its m etho d o logy and con s ider it in cases tha t warra nt spra y drift ri s k a ss es s ment. The m e thodology f or a ssess ing spray drift ex po s ure s 

### is b ase d in part on the methodology for as s essing r' es idential exposures to pesticid es on 

### turf , as explained be1ow, 64 coupled with estimate s 

### o f the amount of s pray drift reachin g the area in qu estion, w hi ch are derived a s de sc ribed in Section A., above. E P A ha s d evelop ed m ethods for estimating ri s k s for re s idential scen arios in whic h people may be expo s ed throu g h their u se of a pe s ti c ide or becau s e th ey l ive, w o rk , or pl ay in place s where pesticide u se occ urs. As noted previously, EPA uses its SOPs f o r residential ex po su re a ssess ment as the basis for estimating expos ure s in th ese s ituations. These SOPs hav e undergone extens ive external pe e r rev ie w by the SAP. 65 SOPs ex i s t for a wide ran ge of po ss ib le ex posure sce n ar io s . The Agency assesses by s tander ri sk s from s pray drift based on the r esident ia l turf sce nari o, in wh ic h people ( includin g c hildren) are expose d to pesticide re s idues on l aw n s. 66 

### If an agricultura

. l pe s ticide is a l so regi s tered for u se on residential turf , E PA ha s d ete rmined that an add iti onal drift assessment i s not neces s ary b e yond that of th e re s idential turf. For an agricultural pe s ticid e n Qt also regi s tered for u s e on turf, the Age n cy c an u s e the s cr een in g m e thodology that is include d in the new drift methodology, and may be able to co nclude , qualitatively , that drift does not po se risks of c oncern for b ystande r s, so a quantitati ve a ss e ss m ent 

### i s not n ee ded

. Wh e n a quantita ti ve assessme nt is needed , the m etho dology cal l s for th e use o f the AgD rift mod el to estimate th e a mount of pe s ti c id e re s idue available on turf for th e ex po sures of adult and child by s tand e r s. The estimated amount of residue and the exposure factors for adu lt s' and chi ldren s' time and activities on l awn s are used to calculate exposures through th e skin and from the m o uthin g behaviors (predom in antly hand-t o- mouth) of ch ildr e n of appropriat e d evelop m enta l age . The se e xpo s ure s are co mpared to the appro pri ate endpoint and POD , as di sc u ss ed in V.B

. " Ha zard Id e n tifi cation" above. The d eve lopment of th e SOPs for evaluating lawn pesticid es consider ed a number of factors rel a t e d to how residu es should be quantifi ed, the appropriate b e ha v ioral con s id e rations for ad ults

63 http :// \\ ww.re gul at to n.. I!O\/#! d oc k e cD eta ii ; D =E PA

- H Q-OPP

- 20 IJ-06 76 64

**ht ://www.e**  **a.gov/pe~**

**tt ic.l**  **e..Jsc ce/res** 

**icl nti** 
**-e xpo** 

**re ~o**  **hlml** bS http :/ / www.e pa . goy/sc tp ol y/sa p/too ls/at oz index/res id e nt ex p.htm and hnp :/ / www . 1 e pa. gov / sc ip o l y

/ s ap / m eetin gs/2009/ 1 00609mee ting

. h t ml 66 See particularly th e Lawns/Turf SOP at

**hl //www** 

**.e a.gov/pe~** 

**li id**  **es/scie cdres**  **tdcn** expo:-. u re-..,op. ht ml. Th e SOP id ent ifi es default va lu es for expo s ur e parameters e .g . , tim e that a c hild s pend s on th e lawn, how often c hildren will put th e ir hands in th ei r mouth s, e t c. Th ese v alu es have bee n selec t e d so that ex po s ur e estimat es overall wi ll be con servative. 25

### and children, development of appropriate exposure metri cs, how exposures shou ld be combined, and what age groups shou ld be con sidered as the basis for ri sk management. EPA cons id ers adults involved 

### in hea vy yardwork and children ages 

### 1 to 

### 2 (based on both body weight and play behavior) as the two groups mo s t highly exposed to turf-appl ied pesticides. EPA has extensively considered children of varying ages in order to ascertain which lif estage (referred to as index Ii festage in the SOPs) has the highe st relative exposure given behavior s that occur at various s tages of deve lopment. Children between 1 and 2 yea rs old routinely and very active) y engage in outdoor play, and they exhibit mouthing behaviors (predominant ly hand -t o-mouth) which contribute to th e overall exposure level s . EPA relics on a number of assumptions when using the SOPs in the calculatio n of risks from spray drift. Risks are based on residue level s present on the day of application when they are at th eir hi ghest leve l s becau se they have not had 

### a cha nce to dissipate. Risks are al so estimated based on a s tandardized l awn width of 

### 50 feet. T h e standardized lawn was deriv e d fro m U.S. Census information for sing l e- and multi

- unit dwellings-it is the mean lo t width f or multi

- unit hou s ing and also is a reasonable representation for single-un it housing with s maller lots. A low

end lot size is used because the concentration of sp ray drift residues is assumed to be inversely correlated to lot size due to 

### lhe effects of residue dilution in larger lot sizes. 67 

### U se of "day of application " residues and the sta ndardi zed lawn s ize contribute to a data

- infonned co n servativ e estimate of ri s k. 

### C
. il<m EPA Mitig ate' Po t ential Risk' A"'l..lCi::tted 

### \vith Spr:ty 

### Dnft Unacce:ptable risk s assoc iated with spray drift can be mitigated in a number of ways, includin g c h anges to application paramet ers, use of drift reduction techno l ogies, 68 

### changes to formula t ions, and no-spray buffer zones, either in combination or by them se lv es. 69 

### While the use of buff,er zones is one of the key iss ue s raised by the petiti o ners, other mea s ures also can be used to manage potential ri s ks as soc iated with s pray drift

. Changes to application parameters and pesticide labels that may mitigate drift ri s k s include reduced application rate s; prohibition of certain application method s; so il-incorporation of pesticides a t the time of application; and

**prescriptiv~**

**~.** 

### product-specific labeling that requires a pat1icular spray quality (i.e., droplet s izes) or climatic co nditions . The Agency may al so undertake cance ll ation of specific uses, in those rare cases where spray drift causes unreasonable risks that cannot otherwise be mitigated. There i s a s ignificant leve l of effort w ith in the agr i cultural engineering commun ity to develop both drift redu ction technologies and best management practices to reduce spray drift. Useful drift reduction technologies include different forms of s pray nozzle s and other sophi sticated ap pli cation equipment (e.g., sensors for canopy identification that turn off nozzle s

67 More information on th e standardized lawn is fou nd in the proposed m eth odo l ogy at http ://www. r cg ul att o ns.gov/#! J ocke lD e ta•I ;D=EPA

- H Q

- OPP

- 20 13

- 0676

. 68 ht t p ;/ /'www .e p a.gov/e t o p /e t c at ps dt.html and http :/ /www.t:pa.gov/e t op/ct c < H prop psdt. h t m l

. An ins t ructiv e pr esen tation on th e Drift Reduction Techno logy Program is l ocated at ht tp://www

. cpa. gov/oppfead 1/ c b/pp dc/ 20

**/m:~y ~sJOn-7**  - drift

-ri!UliC l iO n . pdf 6 Q When approp ri ate , EPA con siders the pot ential conseque nces of mitigatio n measu r es in light of the impact on p1roducers and o n th e potential for unde si rable risk trad e-offs. 26at ends of rows), and the u se of adjuvants. 70 EPA, working with academia and industry, has developed a program to rate drift reduction technologies , and plans to id en tify on its website tested technologies and the risk reduction potential attributabl e to them. 71 O th er potential mean s of redu c ing exposures to s pray drift are already common l y accep ted, 72 for example, the ad

j ustm en t of release height in ground appl ications. Some formulati on types are less prone to drift than others; for examp le, s witching to a dry (soil-incorporated) formulation from one that i s applied a s :a liquid ma y reduce drift potential. A series of po ss ible drift redu ction measures are already included in the prop osed EPA m eth od for calc ulatin g risks from spray drift as a sta1ting po int for co n s idering mitigation options shou ld they be required. Th i s element of the method will facilitate c on s ist e ncy in the Agency' s d ec i s ion-making p rocess for mana g ing s pray drift ri sks. The Age n cy has u se d th e proposed as s essment approach to s upport pe s ti cide drift ri sk mitigation in past deci s ion

- making. The Agency completed its Preliminary Human Health Ri s k Asse ss ment for

**chlo~yrifo**

**s** (an orgar10p h osphate pesticide) under the regi st ration review proce ss in Jul y 201 1
. 3 That assessment id entified risk concern s for by s tand e r s from exposure t o spray drift from agricu ltural applications of c hlorpyrifo s and provided estimates of the potenti a l ris k redu c t iion s associated with various drift mitigation option s . In the Spray Drift Mitigatio n Decision for C hlorpyrifo s (J ul y 2012), 7 4 EP A annOtmced an agreement with the ch lorp y rifos registrants for implem enting u se re strictions intended to reduc e s pray drift ri s ks to by s tand e r s. 

### In accordan ce with the agreem en t , ri s k miti gat ion was accomp l i sh ed through am e ndments to chlorpyrifos product label s, w hich were put in place by the end of the s ame year. Mitigation measure s were: buffer zones for groundboom, ai rblast, and aerial applications of chlorpyrifos around s ites s uch as hom es, s idewalk s, and recreational areas; and a reduced application rate for aerial applications of c hlorpyrifo s (from 6 to 2 pounds active ingredient tpe r acre). VIII.

**A~sto;**

**,** ing and

**Mana~ing** 

### the Risks

**I>u~** 

### tn Pestiddc Volatilization Pesticide volatHiz a tion can be defined as the change of 

### a pesticide in solid or liquid form to a gas or vapor af ter appli cation has occurred. 75 Volatilized pe s ticides can mov e off-si te resulting in t he potential fo r expo s ure outside the treat ment area. Th e volatiliza ti on pro cess i s comp lex and depen ds o n many factor s that include the innate phy s i ca l and chemica l prope rti e s of the pe s ticid e, tihe innate characteristics of the s i t e where 

### it i s applied, and the atmo s pheric conditi o n s at the time of application. Other factors that impact volatilization , particu larl y those associated wi t h application parameters, directions for u se, and best mana ge ment pra ct ices are under the

70 An ad juvant i s broadl y defined as an y non-pe s ticide mate rial added to a pe s ticide product or pe stic id e s pray mi xtu r e to e nha nce th e pe s ti c ide's performan ce and/or the phy s ic al properti es of the s pray mi xtur e . 71 htl p://www .epa. !!ov/pcstic illrs/f act1>ht.!ets/spra ydrift.htm#othc r 72 For e Mmple,

**http://pe~ticidcs ewardship.org/drift!Pages/defauiLaspx**  provid es 

### a ge neral overvi e w of existin g t · ec hnologies. 73 See hup://www.regulations.gov/#!documemDetaiLD=EPA-HQ-OPP-2008-0850-00 1 5
. 7 4See hltp.//www.regulatiom •. gov/# !documcntDetai l:D=EPA

- HO-OPP-2008-0850-0 I OJ 75 S ee hup://www .epa.gov/oppOOOO 1/about/intheworks/volattlizatiOn.htm 

### 27control of the user and can be manipulated to reduce off-site movement. 76 For exa mple, soil incorporation of the pesticide , co mpaction of the so il , and (particularly in the case of fumigant pe s ticide s) tarping and tenting can reduce volatilization from so il- app li ed pesticides. The u se of certain adjuvants may reduce vo latilization from pesticides applied to foliage

. Fumig a mt pesticid es are highly volatil e. 77 Once applied , they will change in to a gaseous form th at works by filling the application space or by permeating the so il to kill a wide array of pests. Efficacy i s achieved by e n s uring that the appropriate air concentration i s maintained for the neces sa ry time in order to co ntrol the pe st of c oncern. 78 Practices that are u se d to reduce exposure to (w hile a l s o impro v ing the efficacy of) fumigant appli c ation s include the use of tar ps, field condinions mana ge m e nt (e.g., soi l moi s ture le vels), and the u s e of special ized application implem e nts (e .g., specially de s igned shanks for closing up and c ompacting th e s oil disturbance s to r etain 

### th1 e fum igant i n soi l). Conv e ntional pesticides (pesticides oth e r than fumigant s) t e nd to be much less volatile than fumiga nts becau s e of dif fe re n ces in their phy s ica l

- chemical properties, although s ome conventional pesticide s volatilize under s om e circumstances. Conventional pe s ti ci des al s o are de s igned to achieve efficacy via different mechanisms so volati l ity i s not a key required characteri s 1 t ic . When conventional pe s ticides do vo l atilize in the field, they too ca n move out s id e of t he treatment area .

. Qu:mtrfymg \'lllrnilu:JLion 

### for

**Ctli1Vl'lltH.""~Hal Pc~til:idc!o.**  EPA ha s developed a good understanding of th e volatilization of fumigant p es ticides, as no ted above and discu s sed by the SAP, 7 9 including an understan ding of how u se s ite condition s can impact volatilization

. The volatilization of conventiona l p es ticides has not been stu died to the s ame eKte nt. A numb e r of entities are n ow focu s ing on th e volati l ization of co nventional pe s ti c id es. Re se arch to enhance our under sta nding of the volat ili zation of co n ventional pe s ticides c ould include wo rk on the impact of a crop canopy or leaf type on the vo l atilization proce ss. Air monitoring data are also important in efforts to c haracterize how much of a pe s ticid e will vo l atihze and tra ve l out of the treatm e nt area. The approach used 

### in th e pas t fumigant ri s k assessment s and EPA's propo sed ap pro ach for conducting volatil iz ation e xpo s ure asse ss m e nt s for conventional pe s ticide s consider both s in gle application event s and the contamination of amb ient air within a local community , region , or th e

76 As in co ntrolling drift, prac tices that limit th e of f- s ite mo ve m e nt of volatilized pes ticide s can impro ve Lh e ef fi c acy of a n app l i c ation by k ee pin g more pesticid e w h e r

e it i s needed to co ntr ol the targe t pe s ts. 77 Bac k g round and st atu s of th e Agency 's r e-e valuation of the fumigants is found at httpJ 

### /www .I.!D"· gov/pest1c ides/rcreg i strat ion/so 1 l fumig an ts/so i 

### 1

-fum -reg- bac "-gmd. html 78 Th e int erac tion of co nce ntration and tim e to achieve efficacy is co mmonly r ef

e rred to as the required c om ce ntration x tim e sc h edu le (CxT). 7 9 Supporti ng docum e nt s and the final r e port fr o m the Decemb e r 1-4 , 2009 SAP m eeti ng o n

· ·sc i entific I ss u es Assoc i ate d w ith Field Vo lat ili zati o n of Con ve ntional Pesricides are locate d in th e do c ke t at http.//wW\\ .1-eeulaLions. gov/# 1 docketDctaii:D:EPA-HO-OPP-2009-0687. 28

### airshed (the ai r supply fo r a defined geographical re gion) from multiple applications w ith in th e same area . P otential impacts associated w ith ind ividual appl ication eve nts can b e managed more di rec tl y through p estic ide labe ls than potential exposures to ambient air. Also, more information can be col lected to quantify the vo l at iliz ati on a ss ociated with a sing le pesticide ap pli c ation event than the co n ce nltr a tion s expected in ambi ent air. " Flux " i s the t er

m u s ed to describ e how much vo l ati li zation (or emi ss ion) of a pesticid e ca n occ ur acro ss a g i ven a rea for spec ific period of time

. Fie ld data can b e collected for empiri cal u se in ri s k assess ment and al so as the basis for empirically ba se d di spersion model ing. T here are a number of recognized flux met hod s in th e peer-revie wed l iteratme. 80 

### A l ong with air co ncentration meas ure ment s each method r e qui res th at detailed meteorolog ical d ata be co ll ected and that th e co ndition s of the app l ication are al so well- do c um en ted. A l arge number of flu x s tudies hav e been co mplet ed for fumi gants, so th e ir behavior under various field cond iti ons is re l atively we ll unders tood. Flux data have been also gene r ated fo r a li mited number of conv e ntional pes ti cides including c hlorp yrif os, 81 

### b ut in 

### genera l , they are no t available fo r con vention a l pesticides. T hi s lack of flux data for conventiona l pestic id es was a primary focus of the 200 9 SAP revie w. EPA pre se nted a number of o pti ons fo r predicting tlux in li e u of data which would a ll ow EPA to sc reen conventional pe s ticides for p o tential ri s k co n cerns. Building on advice f ro m th e SAP, 82 

### the Agency developed a sc reeni ng methodology us ing a preferred approach known as the Wo odro w equati on. 83 

### EPA ha s recentl y a nn ounced the availability of thi s scree nin g metbodolo gy 84 

### and is so li ci tin g pub li c inputt on the new m e thodology and th e proposed approach for asse ss ing vo l at ilization f o r conventiona l pe s ticide s. EPA w ill finali ze th e a pproach after co n si dering publi c co mment. Along with d is tin ct applicatio n events, E PA also considers p otentia l expo s ures to ambient a ir th at m ay represent tho se w ithin a co mm unity, region, or widesp read airshed depending upon where , w he n , and how such monitoring data were collected. Such data ha ve been used empirically and EPA c h aracteri zes s uch dat a to the extent p oss ibl e given avai l ab le resource s. T he 2009 EPA SAP an a l y s is provides a n exa mple of how an air monitorin g res ult could b e characteri zed by risk assessors based on use infmmation and know l edge of the ap plicatio n s ite rel ati ve to w h e r e monito rs are pl aced

. To 

### d ate , EPA has not att e mpted a modeling approac h for
80 Rel eva nt c ita t ion s ca n be found in th e bib li og raph y to "Scie nt ifi c I ss ues A ssociate d with Field Volatili za ti o n of Conventi o n a l Pestic ides Pr ese nted Jointly to th e FIFRA Sc i e ntifi c Adv i s o r y Panel , USEPA , 2009" at http ://www .reg ulation ;)
. gov/#!tlocumen tD e ttJ il :D-EPA-HQ -OPP-200Y-0687 -0006

. Th ey in c lud e: USEPA , 2 008 ; Majewski and Cape l , 1995; Lenoir et al., 1999; Majew ski and Ba s ton, 2002; M cCon nell et al., 1998; Za mo r a e t al., 2003; Glotfelty eta/., I 990; Schombur g e ta/. , 1991. 8 1 The p re liminary vo latili zat ion evaluatio n fo r c hlorpyrifo s i s fou nd at http://www

. regulation!-..gQv/#!documentDetat i :D=EPA- HQ -OPP-2008-0850-0 I 14 ; s upporting docum e nts po s te d in th e s ame dock e t di sc u ss th e modeli ng of flux rat es. 82 T he fima l report of th e S AP i s found at http ;//www.reg ulati o ns.gov/#! do cumcnLDem ti.D= EPA

- 110- 0PP-2009-0687-0037

. 8 3 See Woo d row eta/., 1997 a nd 2001. Citati ons found at http://v. '' w.rei!ulations gov/#!documentDetai l :D=EPA- HQ -OPP-::!009-0687-0006

. 84 http://www .rcgulaLtOfl'>

. gov/#!dockelDetaii ;D=EP A-110-0PP-2014-0:219 

### 29predicting :ambient expo s ure s to pesticides for these types of circumsta n ce s , but plans o n exp loring s u c h ap proa c h es in th e future. A i r monitori n g data f o r co n ventional pe s ticide s are limit e d and the qu a lity is generally Jacking co mpared to c urren t protocol s . Th e data that do e xi s t mo s tly come from Ca li fornia ; d a t a collection under au th ority o f California 's Toxic Air Contaminant statute85 bega n in the mid1980s and tContinues in the pre s e nt time. T h e Was hington Departm ent of Health has co llected air m onitoring data wit h a focu s on organopho s phates inv o lved in agr i cultura l production. 86 PANN A (one of the P e tition e r s ) has al s o c oll ected air mon it oring data for a number of pe s ticid es in v ariou s lo c ations th rou g hout the United State s . 87 The A gen cy doe s cons id e r the se " Drift Catcher" d :ata fo r risk c harac t e r ization , de s pite c ertain limit ation s, and has conclude d that the data thu s far are ; no t s uggestiv e of concentration s of pesticides 

### in th e air that po s e s ignificant ri s k s t o human h ea lth. Other sourc es of ai r mo nitoring data are found in the scientifi c li terature.

At thi s time , E PA h a s conducted at l ea s t one volatilizati on as s e s sment for a c on v enti ona l pe s ti cide u s ing the fumigant methodology approach

. 88 Volatilization risk a ss e ss ments for the fumigant s a nd co nv en tional pesticides cons ider distinct, individual pesticide app li cation s as well as ambi e nt air co ntami n ation from mu lti p l e app li cati ons of the s ame pesticid e in the same general ar e a . Wh il e s ingl e application e v ent ri s k e s timate s are ba s ed on model e d v alues , ambient air anal ys e s are ba s ed o n e mpirical value s; for ambient ri s k es timation the mo s t representati ve expo s ure s tat is tic i s sele c te d and compared to the appropriate tox icologica l value

. Additionally , ri s k ass e ss m e nts for both ambient air and s ingl e application event s are inform e d by inc ident information. Look in g fo r co mmonaliti e s in the incid ent information and the predictive risk estimate s is a critica l con s ideration for re gulatory decision

- making. Th e A gen c y ' s app roac h to a ss e s sing ri s k s a ss ociated wit h s ingle appl icat i on ev ents i s multi

faceted

. It includes the u se o f information on how the pe s ti c ide i s u s ed ; flux data , which are needed for use of the Woodrow equati on 89 ( o r , if flux data are not available , information on ph ys ica l an d ch e mic a l properties of the pe s ticide); and information on th e toxicology of th e pe s ticide from the inhalation route of admini s tration (if inhalation toxicity data are not ava il ab le, oth er to x ic ii ty data ma y be used). An air di s pers ion model i s u se d to estimate air concentration s

85 http://www

. cdpr.ca.gov/doc<./emon/pubs!Lacmenu.htm , and

**http://www. cdpr.ca.gov/doc~/emon/pubs/~c/tacstdys.htm**  11 6 http:// w\\ w .doh. wa.gov/dtp/Pest/dnft htrn 8 7 S ee l mp://www

. panna.org/srience/drift ; the Age ncy co n s ide rs Drift Cat ch e r d ata whe n a v ai l abl e an d uses th e m in ri s k charac t e rization. Unfortunate l y , the raw data that EPA pr e f

e rs ar e n ot alway s av a ilabl e and the timin g int e rvals for air samp les under th e PANNA protocol t e nd not to pe rmit association wit h particular applications of the pes ticides detected

. 8 8 Re f e r t o the fumigant ri s k a ss essment do cum ents for a detai led overview of the ri s k ass e s sment pr oc ess ava ilabl e: htlp://w\-\ w .eoa gov/pesticides/rerel!istration/soil fumigams/soil-fum-reg

**baLk~rnd.html#infomlatton** 8 http://www.rel!ulauons.gov/#!documentDetail : D=EPA-HQ
- OPP-2009-0687-0006 30of vo lati lized pesticid es s unounding treated fie ld s. 90 Model input s incJude sta ndard assumption s about field sizes and the s urrounding tenain, and weather data for representative locations. Di s pers ion mode lin g i s a two -s te p proce ss . Firs t, flux inf ormation i s u se d to c h ara cte rize how m uch applied pesticid e wi ll vo l atilize from a tr ea tm e nt area, and th en th e di s p e r s ion of the vo l atilized pe sticid e a r ound the treatment area i s c haracteri z ed. Changing w ea the r pattern s over tim e are considered. Th e mathematical approach to co mpute ho w vo l a tili zed residues will di ss ipat e is based on a construct known as a Gaus s ian plume. 9 1 E P A has data require m e nt s for infor mation needed to s upport reg i s u·at io n s of p esticid es that m ay result in inha latio n exposur es. 92 Such d ata a r e stro n gly pr efened fo r use in volati lization ri sk assess ment s, but if n ecessa ry oral toxicity data can be u sed. I ss u es related to the u se of ora l data for inhalation expos ure s were di scu ssed by the SA P 

### in 2009. As noted previ o u sly, EPA ha s recently rel ease d a sc reening methodol ogy for characterizing the potentia l ri sks assoc i ate d with volatilization of conventional p es ti c id es. T h e Agency has u sed th e methodology to conduct a screen ing lev el assessment of 

### all currently

- registered conventional p es ticides , and found that o nl y about 20 percent of co n ventional pe stic ide s need to be evaluated further so that the Agency can better unders t and th e potential risks associ ated w ith thei r volati lizati o n and off- s ite movement. Th e results of this sc r eening exe rc i se wi ll b e released alo n g with th e methodology. The Agen cy may need additional information to p erfonn more detailed as sess ment s , s u c h as data that are n ee d ed to model flux , inhalati o n tox i c it y data , and in fo rmation on th e p es ti c ide 's use paramet e r s. Co mment s submitted by th e public on the sc reening ana ly s i s and it s con clusions wi ll b e co n s id ered as the Age ncy d ete nnine s how to proceed. A lso as not ed previous l y, th e Agency ha s already conducted at l east one volatili zation ri sk assessment for a co nv entio nal pe s ti cide, and it can be viewed o n the public docket. 93 C. 

### HO\
. ., EPA Mttig'-llC' PNcmiat 

### R isk A-.sociat cd " i t h 

### Vo l auliza t ion After clhemical ri s k assess m en ts are compl eted, E PA must determin e w het h er there are risks to b e mitigated, and 

### i f so , how tha t should be acco mpli s hed. EPA has u se d thi s proces s to address ris] ks posed by th e vo l ati li zation of a pe s ti c id e and i ts off -s ite mov e m e nt. Options that c an be e ffective inclu de: buff e r zone s , reduce d a pplication rates , low vo l at il ity f o rmulation s or ad

j uvants, tarpin g and tenting of treated field s, a nd cro p managem en t practice s . 

### The fumig ants as s ess m ent and mitigation mea s ures provide a framew or k for cons id eri ng how to manage potential vo latility risks as s ociated with conventi onal pe stici de s. For the fumig ant s, EPA required a s uite of comp l ementary m itigation m eas ures to protect hand l e r s, worke rs , and bystanders from ri s k s res ulting from expos ure to th e so il fumigant pe s ticide s . The m e a s ures were d es i g n e d to work togethe r to addre ss the fu ll range o f ri s k s, but were focu s ed on th e risks of vo l at ili zation to p e ople (worker s and by s tanders ), and includ ed res tricted-use status ,

90 http://w\\: w

**~pa.gov/!>c poly**  **"ap/meel JH!~**  **00-t/082404** m tg. h tm and http.//WW\ \
. exponent c om/pa fu m/
. 'l t Di s tr ibutio n based o n t h

e s tandard bell- s ha ped cu rve. 92 See 40 CFR § 15 8.500. 93 Chlorpy ri fos: httn://www

. regulation.,

. go v /# !docu m e nt Deta ii ;D=EPA

- HQ

- OPP

- 2008-0850-01 3 0 31

### use site limitations , application rate redu ctions, and buffer zones with chemical-specif i c widths. 94 

### Other risk management measures implemented for the fumigants are not re levant to conventional pe s ticides, such as the use of tarps over treated fields, which is employed i n conjunction with fumigant applications to red u ce the off-gassing from soil applications. Risk mitigation measure s differ among p esticides because the individual ri s k assessments were based o n chemical- s pecific information.

IX. 

### Res ponst.-s tu

**Rc(.tu~sts** Made

**b~** Petitioners


### EPA reads the p e tition to make three specific requests for programmatic changes: I ) 

### that EPA eval u ate the rish to c hildr en exposed to pe s ticide drift and volatilization for all pesticides, 2) that EPA modify 

### its pesticide re-evalua tio n process to expedite assessme nt of these ri s ks, and 3) 

### that, for certain type s of pesticides, the Agency require the adoption of ge neric buffer zones between treated areas a nd places where children cou ld congregate. 95 

### The Agency's response s to each of these elements follow

. Although this petition ad dresses how EPA assesses risk under the FFDCA , it does not specifica ll y request to cancel registrations or modify or revoke speci fic tolerances. The Pe t itioners also are requesting that E PA require interim buffers for all "drift-prone" pesticid es du r ing the time EPA makes the programma t i c c hang es they have reque sted. Because the Pe titioners are s ugg es tin g s pecific changes to u s e practices but not requesting cance llation of registrations, we al s o hav e interpreted the petition to request that EPA attempt to procure vo l untary label amendment s from the r egistrants. However 

### if the registrants did not agree , Age ncy-initiated cance llation actions would like l y be needed to achieve the requested relief. EPA Wi ll 

### E\.alu·ntt' the Risk' u1 

### Chilun.:n Ao.,,o u nte d 

### wi th Sp1a ) 

### Drift

**~lml Vuhllili~<•tion**  

### Expo--me,
. While it is true th at EPA has not always asses se d the risks to children from s pray drift and vola tilization , the n eed for cons i stent and refined method s have Jed to the development of appropriate methodol og ies for doing so. The development of these method s is described in detail in Sections 

### VII and 

### V III of this respon se . The Pc ;ri tioner s are requesting th at pe stici de drift and vo latilization ri sk a ssess ment s be con ducted for all pe stici de s. W e agree. The first ste p in E PA 's new sp ray drift assessment m

e thodology i s a screening proces s to 

### facilitate th e identification of conventional pesticides that cou ld pose ri sks of concern to bystanders through s pray drift. As previou s ly noted, the Agency rel e ased th1e draft sp ra y drift. assessment methodology earlier this year. Elements of the ''need s

94 ht tp:/lwwv.

. e pa .

### g o v/pe:,IJC ide:,/rerel-! istrat ion/so iI fum1gant s/i mplement1 PI! -new-safetymeusure s . htm 

### l#ri ' k 95 As noted ear l ier, the Agency co n s id ers resid e ntial exposures to include expos ures associated wit h hom es, home lawn s, yards, gardens, apartments and grou nds around apart me nt bu ildin gs. schools, sc hoolyards, daycare faci liti es. playgrounds, athleti c fields, and parks and other public s paces.
32sc reening" process arc detailed in mate r ials posted to the docket o n ''Consi d eration of Spray Dr i ft in Pe sticide Ri sk Assessment." 96 The n ew volatili zatio n meth o dol ogy i s designed to se rve as a sta nd-al one screen in g methodology for any a nd 

### all conve nti onal p es ti cides. A s noted above, the Age ncy has a l ready u sed the vol atilization m e lhodology to scree n a ll c urr e ntl y -r eg i s tered pe s ticide s . The sc r ee ning proce sses in c lud e co n s id eration of factor s s uch as m e thod s of app l ication and u se pa tte rns of the s ubje c t pe s ticide. Us ing the sc ree nin g procedures for both spray drift .and volatilizatio n , EPA cons id ers the po t e ntial for exposure in a qua l itative way. In the case of spray drift. p es ti cides for which the scree n indicates there are pot e n tial ri sk co nc ems will undergo a q u antitativ e assess m e nt. Thu s, we grant the Petitioners ' reque st to conduct spray drif t and vola tilizati on assessments for all pe s ti c ide s, while noting that some of these assessments w i ll not provide quant i tati ve results

. In th e l :ast seve ra l years, EPA ha s condu c te d a number of s pray d ri ft and vo la tili z at i on ri s k assess m e nt s, even w hil e the propose d asses l'; m e nt methodologie s were b e in g deve lo p e d and refined. EPA condu cte d vo latili zation as sess m e nt s for the fumigant pe s ticid es during reregistrati on. 97 ChloqJyr if os also re ce ntl y u nderwent a



### s~ **ray** drif t eva lu ation, 9 R while the rece ntly relea se d p roposed drift assessment methodology 9 wa s st ill in developme nt (see Section V II B ). The preliminary human health 1isk a ssess ment for c hl o r pyrifo s wa co mpl ete d in Ju ly 20 11 100 and attendant ris k reduction mea s ures for s pra y drift expo sures were imple m ented in July 2012

. 1 0 1 EPA also rece ntl y pub li s hed a draft vo latilization ri s k assessment for c hlorp yri fos 102 a nd i s wor king to finali ze the assess m e nt eve n a s work continue s on the vo l atilization methodo logy. T h e meth odo lo gie s set o ut

**tand~u**

**di ze**  **d** pro ce dure s so that th e way s pray drift and vo l atil i z ation are assessed w ill be co ns i s te nt b etween p es ti c id es in ge nera l , but they are no t sub s ta n ti ve ly diff e r

ent from the approac hes that were u sed to assess s pray dri ft and vo l ati lizatkm for pesti ci de s in rhe recent pa s t. Fmthc r evidence of EP A's co mmitm e n t to reduc in g the ri sks to c h ildre n exposed to pe s ticides is demonstrate d by actions taken du r ing pestici de reregistration proce ss to te rm inate residential uses, as wa · done with many organopho s phate in sec ti ci d es. E PA now 

### has b etterde ve l o ped t oo l s f o r de te rmining when s pray drift po ses ri s k s to by st and e r s, and i s co mmitt ed to t ak in g action on ri sks tO b ysta nd e r s, includi ng childr e n, during reg is tration rev i ew . The Pe1titioners al so are requesting that EPA in c lud e the drift a nd vo lati l ization exposw·es of c h i ldren 

### in it s aggregate assessments. Including s pray drift and vola tili zatio n in EPA's aggre gate ris k assessments wo uld in vo l ve the follo w in g s tep s. Firs t , EPA would look at ex p osures fro m drift and volat il izatio n und er the ne w pol ic i es to d e termine whether any n o n-neglig ible expo s ure

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**-2 00**  **8-0S5 -0**  11 4 33due to drift or volatil i z ation could occur. If non - negligib le exposur e cou ld occur, EPA would quantitatively asse ss that exposure under the new policies and th en aggregate that exposure with other sources of exposure cons i stent with existing policies on aggregate expo s ure. However, aggregation of drift and vo lati li zation expo s ure with other sources of exposure is not spec ifically addressed in existing aggregate exposure polici es, and thus EPA's approach may need to be modified to account for the factors involved in drift and volatilization exposure. Finally, if initi a l agg regate exposure es tim ates using conservative methodologies indicate there cou ld be a risk of co ncern, EPA would need to develop efficient approaches to refining tho se as sess ment s. EPA fully agrees w ith the Petitioners that exposures to spray drift and vo latilized pesticide s s hou ld be considered in our risk assessment s, and that the risks to chi ldren, with their uniqu e bi o logy and behavior s . must be considered se p arate ly from risks to adults. The Agency ha s de velo ped r the methodologie s for assessing drift and volatilization and i s comm itted to considering the comments of the public on them so that we may employ the best possible science in assess ing these ri s k s and taking action to mitig ate risks as needed. 

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**------~---------------------------------------------** Petitioners s tate th a t EPA s hould accelerate its schedu le for completing drift and vo l atilization risk asse ss ment s and prioritize pesticide reviews based on the s uspected degree of ris ks posed

. to chi ldren. Petitioners suggest that thi s acceleration shou ld be accomp li shed through m o difications to the registration review proce ss or by utilizing other authorities. Petitioners believe thart registration review i s too slow to be protective of drift and volatilization risk s to children. 103 EPA 's re s ponse to this request covers aspects of public health policy and the Agency 's obligation s under FIFRA and the FFDCA , and issues of efficiency. The Ag ; ency is denying the Petitioners ' reque . t to the extent that th ey ask EPA to perform bystander ri sk a ssessme nts of the chemical s hi g hlighted in the Petition b efore co nsidering other ex po sures and ri s k s . The re gis tration review program is an appropriate and ri s k

- protective approach for evaluating and managing the r isks associated with spray drift and vo la tilization (and other rtypes of risk as well). Utilizing a proce ss outside of registration rev iew to assess these ri sks to ch ildren separately from other types of ri s k would bypass and defer the comprehe n sive evaluations that allow the Agency to rely on the be s t and newe s t d evelo pm e nt s in sc ience and to address the full complement of potential risks. Th e c ons ideration of all potential ri s k s at one time for a s. ingle active ingredient can lead to th e adoption of a package of ri sk mitigation measmes that work s fo r a ll the risks of concem, or at the very least. that do not work in opposition to each other.

103 The lPetition ers also assert that because th e r eg is trati on r ev

j ew pr ocess i s des igned to updat e th e reregistrat ion ri sk assess m e nts, and since the Age ncy did not address the ri s ks to bys tand ers from drift and volati l ization durin g r ere g i s tratio n , regi s tration r ev i ew w ill not includ e s uc h assess m ents. In reality. th e Agency update s ri s k assess ments on the ba s i s o f avai lable data and sc ie nt ifi c deve lopments 1 so drift an d vo la tilization will be included in regis trati on r ev i ew, even if they were not conside r ed during rer egistration. 34To set the schedule for registration review, EPA relied primarily on the base lin e date for each pesticide case (usually its 

### RED date or the date the first product containing the ac tive ingredient was registered). Additionally, some registration review cases were grouped for program efficiency. The OPs and NMCs were among those cases. 104 For the most part, food- use pesticides subject to r er eg i s tration were given priority sc heduling in reregistration, and thu s, th ey have the eadiest baseline dates. The OPs and NMCs, o n which the Petitioners focus, have been scheduled at the front-end of registration review and many individual pesticides from those fami lie s are currently undergoi n g risk assessment. EPA believes that, insofar as the P eti tion requests EPA to give high priority to ce rt ain chemicals 

### in its registration review program, the pet i tion asks for an acllo n that has already occurred. The OPs and NMCs accou nt for more than 40 individual active ingredients. Alt of these pe stici des hav e entered registration revi ew ( o r were cance led prior to entering r eg i s tration rev iew).T he preliminary ri sk assessments for I 2 of th e pe s ticides in these two families are schedu led to be comp leted before October 2014.The schedule for OP and NMC registration reviews 105 is summarize d in the Appendix to this response. 106 The Appendix also identifies the pesticides in these group s that were cancelled subsequent to tolerance rea s sessment or durin g the beg inning stages of reg istration review. With respect to conducting separate bystander exposure assessments of individual pesticides. if the Agen1cy g ranted Pet iti one r s' proposal. it would s ign ificantl y redu ce the effic iency of th e ove rall registration review program. Separating tJ1e by s tander drift ri sk assessment fm children f rom the ongoing compre hens iv e eva luati ons for th ese same chemicals would require Agency res ources to be redirec ted to the evaluatio n of one type of potential ri s k. and ma na gement of the ful l complement of potential risks associated with a pesticide would be deferred. ln add iti on. the o v e rall demand for re so urces and the time ne eded to a ss ess firM spray drift and then al l other potential ri s k s for a gi ven pe s ticide wou ld be greater in total than the time and resources needed to conduct a comprehensive a s ses s ment of that pe s ticide, and thus would slow Agency action on risk management. Reg i su·ation review, as current ly planned, is the mo s t efficient way to achieve the Petitioners' and EPA' s co mmon goal of p r otecting human health, including the health of c hildren, and the env iro nm e nt. Adopting the approach proposed by th e Petitioners also would sign ificantly reduce EPA's ability to me e t it s s tatutory obligation to comple t e regis tration re view by 2022 or the date tlult i s I 5 years after th e date on which the first pesticide con tain ing a new active ingredient is regi s tered. See FIFRA 

### § 3(g)( I )(A)(iii). The same logic applie s to the idea of a s se ss ing chemical-specific volatili7.ation ri s ks s eparate l y from the comprehensive registrat i on review a s sessment. Significamly. preliminary application of the vola t ilization s cTeening methodology currentl y under dev e lopment Led the Agency to conclude thlt only 20% or so of all pe s ticide active ingredi e nt s h ave characteristics that suggest that they potentially could pose any meaningful level of volatilization risk. Thus, including the vo latili za tion risk assessment in the registration review process as a matter of

l iM Desc!fibed in a Fe deral Register Not i ce: http://www.gpo.gov/fdsyvpl..g!FR-2006

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### course w ill not appreciab l y affect the resources needed or ti ming fo r t h e vas t ma j o rity o f reg is trati o n review decis io n s. P e titioners s ugges t th at EP A c ould a cce l er a t e th e revi ews of drift ri s k s fo r c hildr en by utili z in g othe r autho rit ies , s uch a s rul e making 1 07 

### or th e s p e cial r ev i ew pr ocess. 1 08 

### R ulemakin g i s a lo ng, r eso urce -i n ten s ive pr ocess th at c an take m any years to c ompl ete, and EP A be li eves its l imited resources are be tt er spe nt assessing and develo p ing ri s k m itigation meas u res for pes t icides ind iv i dually th a n d eve lo pi ng a regu lation that coul d take m any years to f inal i ze . As a n exa mpl e, the P e tit io ne r s suggest th at th e WPS Ru le is an appropriate mode l f or i mp le menting broad changes for a large nu mb er of pestic id es at o nce. Al th o ugh the WPS is a n i mp o rtant and effecti ve to ol for red uc ing worke r ris k , it too k appr oximate l y ei g ht years t o deve lop and p

r o mul gate th e initi a l 

### J 992 ntl e a nd a s many yea rs to de v elop a se t o f pro p ose d amendm e nts to th e 1 99 2 rule. 109 · 

### An d wh il e Specia l Rev i ew se rv e d its pu rpose in t he p ast, i ndiv idu al Specia l R ev iews typ ica ll y too k m a n y years to co ncl ud e an d used Agency resou rces to address a n arrow s e t of ri s k co nce rn s a t a time wh en the re was no systemati c re-evaluatio n pr ocess for pestici de registrations. In deed, in 2009, the Age ncy ann ounced that " [t] h e p es ti c ide p r o gram i s mov ing toward cl os in g ou t bo th th e Spec ia l Review and t he r ereg istrat ion progra m s" in fa vor of new re-eva lu ati ons of prev io u s ly r egistered pes t ici des to be co nd ucted under reg is trati o n r eview. 1 1 0 

### T h at is no t t o say th at p o te nti al ri s k co nce rn s that ri se to th e h ighest leve ls, includin g ·'emergency" o r " immine nt hazard ' ' s tat u s, mu s t w ait t o b e addre sse d in reg is trati o n review

- th e processes for s u c h s itu ation s includ e th ose d escrib ed in Secti on 

### IV of thi s res pon se. B ase d o n th ese considerati ons, fo r ex i sti ng reg istr ation s, EP A h as concluded that r egistration review, as curren tl y planned, is the most appropriate , t ime]y, and effic i ent way to achieve the Petitioners' and E P A's common goal of protecting human health. including t he 

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# -------------------- - Petition ers re ques t th at E P A imp ose int erim no-spray bu f f e r s aro und locati o n s w h ere chi l d r e n con g regate an d that t h ese meas u res s hou ld app ly to OPs, NMCs, a nd a ll o th e r pesticides that a r e: "( 1 ) 

### r egistered fo r applicatio n by ground spraye r s, broa dcast equ ipmen t , and/o r aerial e qu ipment; a n d (2) 

### suspected of causing acu te poiso n ings, c ancer , endocri ne d is ru ptio n ,

107 Al thou g h P et iti o n e rs m e nti o n EPA 's ge nera l ru l e m aking authorit y und e r FIFRA, EP A i s not trea tin g thi s p e titi on as a spec i fi

c r e qu es t f o r rul e makin g. Ins t e ad E PA unde rstan ds Pe ti ti o ne rs' s tat e m e nts be i ng made .as ac ti o ns that cou ld be take n by EPA. T he Agency's gene r a l rul emak in g a utho rity is provi de d at 7 U.S.C. § 136w(a)( 1 ). 1 08 40 C.F. R. § 154.7 109 The revisio ns to the WPS we r e j u st released fo r publ i c com m e nt o n Feb ruary 20 , 20 1 4--

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### pag e/up datec-./2 00 9/namec han e.e- prd.h unl 3 6developmental effects, and/or reproductive effects." 111 Petitioners further state that. the interim buffers sho1d ld be at least 60 feet in width for grou nd applications and 300 feet in width for aerial applications regardless of the pesticide being applied, and that these buffer requirements should remain in p l ace at least until case-specific drift risk asse ss ment s can be undertaken. To accomplish this reque st, Petitioner s further s u gges t that the Age ncy could use administrative procedures rather than chemical-specific risk assessment and management to effect the generic buff ers i.e., rulemakin g or a Pesticide Registration (PR) Notice. The Agency' s response to this requ est covers the u sefulness o f the alternate approaches, the scientific ba sis for pesticide decision-making, and i ss ue s of eff iciency. The Agency denies the Petitioners ' request to impose a requirement for interim buffers of either 60 or 300 feet on the se pesticides before EPA complete s the registration reviews for the se pesticides. EPA contends that drift and volatilization are not posing risk s of conce rn for all pesticides , and that int erim buffers, as suggested by the Petitioners, are not the most efficient o r sc ientificallt appropriate way to mitigate such risks for any particular pesticid e or group of pesticide s. 1 2 I t is the Agency 's practice to assess pesticide risks based on chemical

- specific data. The Agency acknowledge s that the OPs and NMCs are generally among the more acutely toxic pe s ticides , but risk i s a function of both toxicity and exposure, so toxicity alone is not s ufficient to c haracteri ze th e risks these pesticides may cause to bystanders via drift or vo latili zation, or to determine if risk mitigation is needed. Additiona lly , th e OPs and the NMC s we re reevaluated both i n reregistration and in the tolerance rea ssess ment proce ss and, at that time found to meet the appl icable s tatutory s afety sta ndards

. The se pe st icides w i ll be rea ssessed again i n the next 'few years under regi s tration r eview. Because pesticides vary in environmental fate characteristics, and use sites and parameters, potentia l expo s ures also d iffer, not just between different active ingredient s, but also between different u ses of the same active in gredien t. The pest icides other than the OPs and NMCs that the Petitioners believe warrant the use of 60 and 300 foot buffers are a very large and diverse group. Without considering pe s ticidespecific data, it is impos s ibl e to know the ri s k s posed by each

. Again , the manner in whic h th e Petition prQiposes to manage the drift and volatilization risks associated with these pesticides ignores t h e interaction of expos ure and hazard. When the se pesticides und e rw en t reregistration , the Agency found that (with certain conditions) they met th e s tatutory sta ndards of FIFRA and FFDCA. ln order to make the same type of determination s when spray drift and volatilization exposures arc appropri a tely considered for each individual case, the Agency mu s t satisfy the same s tandmd s.

111 Whil e an exact cou nt of pesticides that fit in this seco nd category ca nnot be made, the effects li s t e d are a large su bse t of t he comp l e t

e set of adverse effects the Agen cy takes into consideration. Furthermor e, EPA note s that the Petition describes the refer e n ced pesticides and gro ups of pesticides as " drift pron e." The Agency rejects this notion. Because drift i s influenced by fac t o r s othe r tha n the c haracteristics of the pes ticide active ingredient , primarily the phy s i ca l fo rm of the product as applied , t h e app li catio n method , climat e, and wind, no o n e active in gredie nt or pe s ticide family can be considered to be drift-prone. There are particular formulations and application method s that ma y make certai n applications of a pes ticid e product prone to drift. Volatilization , on the other hand , i s a direc t function of th e phy s ica l and chemical properti es of an active ingredient, and the Agency i s able to identif y pe s ticides that tend to vo latilize. 112 EPA does not be li eve the Petitioners ha ve pr ese nted adequate ju stification for int e rim , ac ross-theboard buffers for all the pesticides they have identified as being of s pecial co n cern . 37Even if buffer r es tr ic tions may be appropriate to mitigate the ri s k s to c hildren from spray drift and volatilization for s ome pe sticid es, th e EPA con te nds that the sam e buffer width will not be a ppropriate for eac h of them. Despite the Petitioners ' request for acro ss- the

- board, interim buffers, the Petition itse lf mak es the point that case-s p ec ific asses s m e nts have s hown that buffer s of va r ying width s ar e nee ded to mitigate risks associated with differe nt pe s ticides. They cite exa mples of the diff e re nt buffer w idths th at EPA d e termined were ne cessary for products contain diff e re nt acti ve ingre di en ts - e.g., for the fumi gants, widths ranging from 25 ft to one-half mi l e. EPA beli eves that th e m o re sci entifically d e f e n sib l e approach invol ves determining whether nos p ray buffers are nece ssar y to protect children on a pesticide-by- p esticide ba s i s. Thi s i s the approach the Agency has taken and intend s to include in cons id eration of b ysta nder exposure in future risk asses s ment s. Finally , th e Agen cy believe s that th e reques t s mad e by the Pe t itioners with reg ard to interim buffers would divert limited Agency resour ces from important risk assess ment and risk management acti vities and wou ld dimini s h the overall l eve l of protection EPA i s able to achieve in its pe s ticid e re-evaluations. The alterna te means that th e Petitioners s ug ges t to imp lement the buffer req u irement are a l so r es ource-int e n s ive, time-co n s uming , and n ot lik ely to result in th e broad protections the Petitio ners de sir e. The reso urce and time requirements of rulemaking are di sc ussed above. The Petitioner s s u gges t that EPA could u se a P est icide Registration (PR) Notice 113 to inform registrants that lab e l amendments are n ecessar y to address drift and volatili za tion, a nd , that fai lure to make the se c h a n ges co uld re s ult in cancellation or th e findin g that their products are mi s branded. Although EPA agr ees tha t a PR Noti ce i s a us eful tool to com municate new p olicies to pe s ti ci de registrants , c ompliance with a PR Notice i s vol unta r y, and th e Agency b e li eves that reg i s trants are not lik e ly to im p l e m e nt c han ges that Jack a risk-based rationale. If EPA took action to require the amendment o f p es ti c ide regi st ration s to miti gate s pray drift v ia buffers of uniform width , p es ticide applicant s and registrants cou ld chall enge the validity and applicabil i 1 ty of the scie nce behind the Agency

- pre sc ribed regulatory action s . Add ition ally , the reso urce s need e d to purs ue a cancellation p roceed in g are extensive, and in the absence pesticid es pe cific a ss essment s, wo uld not be an effec t iv e u se o f E PA 's limited re so urces . 

### X. CH ndusion The Agency appreciates the concern th e petitioners express for b yst and e r s, particularl y c hildren, who may be h arm ed by exposure to sp ra y drift and the off-si te movement of vo la tilized pe s ticides. We s har e thi s c once rn. The Agen cy ha s assesse d spray drift and vo latilization for particular pesticide s in the past and i s now taking s tep s to formalize t h e assessmen t m e thodolog ies for future assessments. The se m e thodologies includ e scree nin g- leve l assessm ent proce ss es far u se in d e te rmining if there i s a n ee d to t ake a more in-depth loo k at any given pesticide. Thu s, all p est i c ide s will be a ssesse d ei ther qualitatively or quantitatively

. The Agency al s o believes that we are a ddressing pe s ticid e ri sks on a schedule that gives th e most potentiall y 113 PR No ti ces a r e Ls u e d by EPA's Office o f Pestici d e Prog rams to inf o rm pes ti c id e reg i s trants an d orh e r interested perso ns abo ut importa nt pol i cies, proced ures and regulatory d ecisio ns. The Age n cy's PR No ti ce webjpage i s at !.!Jtp://www.epa.gov/PR

**Notic~~**

**.** 38

### risky pesticides precedence. We w ill continue to u se approved approaches to account for the difference s between c hildren and adults in 

### th e ir exposures and se n sitivity to pe s ti cides. The Agency believe s that its cmTent program of reg istra tion review is the mo st comprehens ive and ef f ective way to assess and mitigate pesticide ri sks and to take advantage of new and emerg ing sc i e nc e. The Agency believes that looking at a particular pesticide and all the po tential ri sks associa ted with its use in a comprehensive fashion provides the best opportunity to effectuate necessary p r otecti ons for human hea lth and the environment. Other means of managing the ri sks po · e d by spray drift and vo latili za tion a s suggested by the Petitioners, such a s cond u cting drift and vo latilization-only as sessme nt s or re-ordering the p e s ticides in registration review, are either not nee ded , not likely to be successfu l , require more resources than are ava ilabl e, and/or tak e more time than registration rev iew. While we und erstand the thinking behind the proposal to mandate generic, uniform buff er requirements on pesticides of particu l ar concern, we do not agree that a "o n e s ize fit s all " so l ution is appropriate or scient ifically defen s ibl e. W ith out case-specific assessments and risk mitigation, we believe it is unlikely that registrants will voluntarily adopt generic buff ers. Pesticide registrants are by law afforded s p ec ifi c rights and opportunities to oppose deci s ion s by the Agency that affect their registrations. Because the evidence needed to suppo rt the cancellation or amendment of registration s within thi s context mu s t b e scientifi cally defensib le and specific to the s ubje ct pesticide, we believe that Agency resources are better spent in 

### registration review

.

39

### APPE:\D l'\ Regi stration Rev iew Timeline s for P estic id e Families Specifically C ited in the Petiti o n 

### T bl 1 A f

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### r anop osp ate e a stra aon e vte w estone s 11 4 

### Draft Human Active Ingredient Docket Opening Health Risk Assess ment Final Decision Acephate 3/18/09 2014 2015 Azinpllos-melhyl All registration s cancelled 20 12 B e n s ulide 6/25/08 2015 2015 Chlo relhox yfos 12/17/ 08 2014 2015 Chlorpyr i fos 3/1 8/09 July 6 , 2011 2016 Ch lorpyrifo s- me th yl 3/13/10 2015 2016 Couma phos 6/25/08 2014 2015 Diazinon 6/25/08 2014 2016 Dichlo : rvo s 6/24/09 20 1 5 2016 Di c rotopho s 6/25/08 2014 2015 Dim e thoate 3/ 18 /09 2014 2015 Di s ulfoton 3 / 18/09 All regi str atio ns su bsequent ly cancelled Ethoprop 12/17 /08 2014 2015 F enamipho s All registrations c anc e ll ed 200 7 Fenitmthion 3/18/09 20 15 2015 Fe n t hion All reg i su·a tion s cancell e d 2004 Fo s thiazate 6/24/09 20 13 2014 Malathion 6/24/09 2014 2016 Methamid ophos 1 2117/08 All regi s trations s ub sequen tl y c anc elle d M ethi dath ion 3/18/09 All regi s tration s s ub sequen tl y can celle d Methyl parathion 6/24/09 All regis trati ons subseq uently canc elle d Naled 3/18/09 2015 2016 Ox ydemeton

- m eth yl 6/25/08 All registration s su b seq ue ntly cancelled Phorate 3/18/09 2015 2015 Phosmet 6/24/09 2015 2015 Phostelbupirim 6/24/09 2016 2017 Pirimiphos-methy l 3/18/09 2015 2016 Profeno fo s 6/25/08 2015 2016 Propetamphos 6/25 /0 8 All regi strations su b seq uent! y c ance lled Pho salco n e 2/19/08 A ll regi s trat ions cance ll e d effective 12 /30/ 15 Temephos 6/25/08 All registration s s ub se que ntly cancelied Terbu£o s 6/25/08 2014 2015 Tetrach.lorvinpho s 6/25/08 2014 2015 Tribufos 3/18/09 2015 2016 Trichlorfon 3/18/09 2015 2016

114 Dat es in th e future s h o uld b e co n s jdered tentative. 40

### T bl 2 A t'

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### t d N M th I C b t 

### R

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### R
. Mil 115 

### a e . n acapa e 

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### ar ama es egastrabon evaew estones Draft Human Acti ve Ingredient Docket Openin g Health Risk Assessment Final Decision Aldicarb 6/20/12 2015 2017 Carbaryl 9/22/10 20 16 2018 Carbofuran All regi s tration s cance ll ed 2009 Fo rm etanate HCI 12/22/10 2016 2017 Methi oc arb 6/22/10 2015 2016 Methomyl 9/22/10 2 015 2016 Oxamyl 9/22/10 Earl y 20 15 2016 P irimicarb All re gistratio n s cancelled 20 10 Prop ox.ur 12/16/09 2014 2016 Thiodicarb 12/16/09 20 15 2016

115 Dates in the future sh ou l d b e co n s id e r ed t e nt ative.
41