Docket Number EPA- HQ

- OPP-2012-0896 www .regu l ations.gov



## Bromoxynil Preliminary Work Plan

Registration Review: Initial Docket Case Number 2070

March 2013

Approved by :

# <:b Richard P. Keigwill)f: Director Pesticide Re-eva luation Division

Date:

### Bromoxynil Preliminary Work Plan

- Table of Contents

Overview 3 Anticipated Data Needs 4 Statutory and Regulatory Authority 5 Chemical Facts 6 Use and Usage Information 6 Recent Actions 7 Anticipated Risk Assessments for Registration Review 8 Timeline 9 Next Steps 10 Appendix- Additional Areas Considered in 

### Bromoxynil's Registration Review 11 References: This Preliminary Work Plan s ummarize s the Environmenta l Protection Agenc y' s c urrent position based on the following documents: 1. EFED Registration Review Problem Formulationfor Bromoxynil and Bromoxynil Esters. N.E

. Federoff and E l y ss a Gelmann. January 22, 2013. 2. Bromoxynil. Human Health Assessment Scoping Document in Support of R egistration Review. Cassi Walls , Ph.D, Myron Ottley , Ph.D., Meheret Negussie, and Kri stin Rur y. O c tober 31, 20 12. 3

. BEAD Chemical Profilefor Regi s tration Re view: Bromoxynil and Its Ester s . Bill Phillips, Ph.D., Jihad Alsadek, Derek B e rwald , Ph.D. October 3, 2012. 4. Bromoxynil and Esters: Review of Human Incidents (HED Incident Report ). Shanna R eco re and E liz abeth Eva ns. November 13 , 2012. 5. Bromoxynil and its esters (035301,035302,035303,128920) S cree ning L eve l Usage Analysis (SLUA). November 2, 2011. 6. Bromo xynil octa noat e PRD Lab el Data R e port. Sept e mber, 24 , 2012. These and other supporting documents for the bromoxynil registration review ca se may be found in the do c ket EPA

- HQ-OPP

- OPP- 2012-0896 at http://www.regulation s .go v .
2OVERVIEW The docket for bromoxynil i s now open, initiating the first public comment period for this registration revi ew (docket number EPA-HQ-OPP- OPP-2012-0896). Thi s case incl udes the active ingredients bromox yni l pheno l , bromoxyni l octanoate , and bromoxynil heptanoate. The octanoate and the heptanoate are esters of the phenol. Thes e three active ingredients (collectively, "b romoxynil " ) are postemergence broadleaf weed herbicides that are registered for use in gr ass cro ps and som e tolerant broadl eaf crops, as well as non-crop site s. A third ester of bromoxynil pheno l , bromoxynil butyrate (PC 035303), was previously regi stered with the Agency but curr ently has no active regi stratio n s and is therefore not addressed in this Registration Rev iew. Bromox ynil products are u sed in both agricultural and commercial/industrial s ettings. Thi s Preliminary Work P l an (PWP) document explains what EPA's Office of Pesticide Programs knows about bromoxynil , highlighting anticipated data and assessment needs, identifying the types of information that would be especially u se ful to the Agency in conducting regi s tration review , and providing an anticipated timeline f or completing bromox ynil' s review. The regi stration review process was designed to include a public participation com ponent to solicit input fr om interested s takeholders. The Agency intend s, by sharing this information in the docket, to inform th e public of what it knows about bromoxynil and what types of new data or other information wou ld be helpfu l for th e Agency to receive a s it moves toward a decision on bromoxynil. Th e Agency enco urage s all intere s ted stakeholders to review the PWP and Appendix and t o provide comments and additional information that will h e lp the Agency' s decision-making pro cess for this chemical. In addition to general areas on which persons may wish to comment, there are so me areas identified in the PWP and Appendix about which the Agency specific ally seeks comments and information. Interested stakeholders could include: environmental non-profit or intere s t groups; pestic ide manufacturers; agricultural labor or commodity gro ups; commercial , institutional , re si dential , and other users of pe s ticides; or the public at large

. The Preliminary Work Plan begins by li s ting the anticipated data needs for bromoxynil. Next, it discusses the sta tutory and regu l atory authority for Registration Review. Then the document provides chemic al facts for bromoxynil, u s e and u sage information , recent action s, the anticipated risk assessments , and a projected reg i s tration re v iew timeline. Finally , the Appendix to this document include s id en tification and di scu ss ion of some areas that are considered generaJly in Reg istration Review along with some additional chemical case-s pecific information.



### 3ANTICIPATED D A TA NE EDS Tab l e 1 b elow s ummari ze s anticipated da ta need s for bromoxynil. For add itional discu ss ion of the an ti c ipated dat a need s, s ee the EFED Reg istration Review Problem Fo r m ulationf or Br o m o xynil and Br o mox y nil Es ters 

### and Bromo xy nil

. Human Hea lth A ss essmen t Scoping D ocum e nt i n Su p

port o f R eg is tr a tio n R eview
. Table 1: Anticipated Data Needs for the Re1,ristration Review of Bromoxynil 1 Estimated Guideline Study Title Timeframe Number Test (Months from Material 2 receipt of DCI) Bro moxyn il (p he no l )

- P C C o de 03 53 01 835.2240 Ph o to de grada t io n i n water 1 2 835 .4 1 00 A e ro b ic soi l me tabo lis m TGAior 24 PA IRA 8 3 5.43 0 0 A e robic aq u ati c me tabo l ism 24 85 0

. 6100 E n v i r onme nt a l C he mi s t r y M e t ho d s an d A ssoc iate d In de p e nde nt L ab o ratory V a lidat io n 3 TGAI 12 85 0. 23 00 A v ian r e prod uc ti o n 4 TGAI 24 8 5 0.4400 Aq u ati c pl ant grow th (a qu a ti c vasc u l ar pl ant) 12 T GAI 85 0 .45 00 Aqu at i c plant g row th ( al g al p l ant ) 1 2 875.2 100 Di s l o dg e ab le foli ar r e s i d ue a nd turf tran sfe r ab l e TEP 24 Res i dues B r o moxyn il oc tanoate - P C Co de 0 35302 835.4 100 Aerob i c s o il metab o li s m TGAI or 24 PAIRA 8 5 0.6 100 E n v iron m e n ta l C he mistry M e t ho d s a n d A ssoc iat e d In de pe nde nt Laborator y Va lid ati o n 3 TG AI 1 2 85 0 .2 100 A v ian o r al toxici t y ) TG AI 1 2 875.2 100 D i s l o dge abl e f o l iar r es idu e; turf tran sfe rab le TEP 24 Re s i dues Bro moxy nil heptano ate 0

- PC Cod e 1 28920 8 3 5

. 123 0 Ad sorp ti on/Des o r p t ion (Bat c h E q u ilibri u m) 12 835.2 120 H y dro ly s i s 12 835.2240 P ho to de gradat io n i n w ate r 12 835

. 24 1 0 So il photo ly s i s TGAI or 1 2 8 35 .4 1 00 Aerobic s o il me tabo li s m PAIRA 24 8 35 .4300 Aerobic aquat i c metab o l i sm 24 835.44 00 Anaer o bic aqu atic m e tab o li s m 24 85 0.6 100 E n v iron m ent a l C he mi s try M e thod s and A ssoc ia ted Ind e pe nde nt Labora tory Va li da ti o n 3 TGAI 1 2 87 5

. 2 100 Di s l odgeab l e f o l iar r es idu e and turf t ran s f e rab l e TEP 24 R e s id u es

41 On June 27, 2012, EPA announced certain revisions in harmonized g uidelin e series 850

- Ecol og ical Effects Te s ts -including renumb ering and other de s ignations o r c hanges for so me guide line s tudies. See " Final Test Guidelin es; OCSPP 850 Series; No tice of Availability" 77 FR 38282, June 27, 2 012. http ://www

. regulat io n s . gov/#!documen tD eta i l ; D -EP A- HO -O PPT

- 2009-0 J54-0028 2 TGAI ==technical g rade active ingredie nt; TEP =typical end-use product; PAIRA =pure active ingredient , radi ola

beled 3 T his ECM!ll..V re quest is for methods in water. 4 An avian reproduc ti on s tudy with bromoxynil (phenol) is an ant ic ipated data requi rement. ln ab s ence of the se data if they are required, the available endpoints for bro moxynil octa n oate will be used fo r ri sk assessment. 5 For this anticipated data requirement, the study is requested for a passerine species. A proto col for the study should be s ubmitted to E FED for approval before the study begin s. 6 The Agency will rev iew where it i s appropriate to bridg e the results of environmental fate studies co nduct ed with bromoxynil octanoate to bromoxynil heptanoate. If bridging i s determined to be an acceptable s trategy, aque o u s photolysis, aerobic aquat ic metaboli s m , and anaero bic aquatic metabolism, and adsorption/desorption studies u s ing bromoxynil heptanoate wo uld not be required.
STATUTORY A N D REGULATORY AUTHORITY The Food Qu al ity Protection Act (FQP A) of 1996 mandated a regi stra tion review program. All pesticides distri buted or so ld in the United States (U.S.) generally must be registered by the Environmental Pro tection Agency (EPA or the Agency ), based on scie ntific data show ing that they will not cause u nreaso nabl e risks to human health or the env iro nm ent when used as directed on product labeling. The registration review program i s intended to make sure that, as the ability to assess ri sk ev olv es and as policies and practices change, all regi s tered pesticid es continue to meet the sta tutor y s tan dard of no unreasonable adverse effects to human health or the env ironment. C hanges in science, publi c policy, and pesticide use practices will occur over time. Through the registrat ion review program , the Agency pe riodically reeval uate s pesticides to make sure that as c h ange occurs, products in the marketplace can be used sa fely. Information on thi s program is pro v ided on EPA's website 1 • The Agency i s imple menting the registration review program pur suant to Section 3(g) of the Federal In secticide, Fungicide , and Rodenticide Act (FIFRA), and wi ll review each registered pe sticide every 15 years to determine whether it continues to meet the FIFRA s tandard for registration. Th e r eg ulation s governing registration review begin at 40 CFR 155.40. T h e Agency will cons ider benefits information and data as required by FIFRA. The pub l ic phase of registration revi ew begins when the initial docket i s opened for each case. The docket is the Agency's oppo rtunity to state what it know s about the pesticide and what additional risk analyses and data or information it believes are needed to make a registration review deci s ion. After reviewing and respo nding to comments and data received in the docket during this initial comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedul e for the registration rev iew of bromoxynil.

1 http://www.epa.gov/op psrrdl/registration _review/ 5"d Table 2 p rovt es a summary o fthe current re gu ato ry statu s o fb 

### "l romox y m . 

### Tabl e 2: BRO M O X Y NI L C HEMICAL FACTS PC cod e Bromoxynilphenol: 035301 Bromoxyni l oc t anoate: 035302 Bro moxyni l h eptanoate: 128920 Case Number 2070 CAS Numb e r Bromoxynil phenol: 1689

- 84-5 Bromoxynil octanoate : 86702-80-9 Bromoxynil heptanoate: 56634-95-8 Year first registered 1965 Pesticide Type Herbicide Chemical class Hydroxybenzonitrile or nitrile herbicid e Reregi s tration Eligibility D e ci s ion Dec ember 1998 (RED) Chtto ://www .eoa . !!o v/ooo s rrd**l/RED s/2** **07 d~clf)**  Tol erance Reasses s ment Not applicable Eligibility Decision (TRED) Cumulative group Bromoxyni l is not a member of a cumu l ati ve group and no cumulative risk asse ss ment is planned. 40 CFR Citation Tolerances for bromoxynil are e s tabli s hed in 40 CFR 

### § 180.324. Dua l

- u s e Conventional pesticidal uses onl_y. Non-pesticida l u ses There are no no n - pesticidal u ses of bro m oxy nil. Pesticide Re-eva lu ation Divisio n , Margaret Hathaway , hathaway.margar e t @e pa . gov Chemi c a l Review Manager (703) 305

- 5076 Regi s tration D ivi s ion , Product Kathryn Montague , montague.kathryn @e pa. go v Manage r (703) 305- 1 243 

### USE AND USAGE INFORMATION Tab le 3 summarizes the u s e and usage information for bromoxynil. Pleas e s ee BEAD Chemical Profile fo r R e gis tration R ev iew : Brom o).y nil and Its Este r s in the registration re vi ew do ck et f o r more detail s . 

### T abl e 3: USE AND U S AGE INFORMATIO N Summary of Use Reg i stered for use as a post-emergence broad leaf w e ed herbicid e that can be applied in gras s crop s and some tol e ra nt broadl eaf crops. A l so regi s tered for u se a g ainst actively gr ow ing wee d s in non-crop s ite s. U s e Site s Alfalfa ; f a ll ow land ; cotton ; f o rage gras s e s, f ora ge legumes, and other non -g ra ss forage crop s; hay ; com (field , sweet, and p op); flax gra in crops (e.g., bar l ey, oats, rye, tr i tica le, whe at, so rghum , proso millet); mints; garlic; onion s; f e ncerows ; com mercia l /in du stria l lawn s; con se r v ation reserv e; drain a ge ditch b an ks; omarnental herbaceou s plant s; orname nt a l nonres idential l awns; golf course turf; gra ss see d production and s od farm s ; railroa d and roadway


### 6rights of way ; vacant lot s; outdoor indu s trial areas Summary of Us age From 2006-2010 , the crops with the greatest u s ag e ofbromoxynil were spring wheat, winter wheat, barley , and com. An average of approximately two million pounds of active ingredient was applied to eight million acres in that same period. Formulation T ype(s) Wettable powder , and emul s ifiable and s olub le conc en trates Application Me th o d(s) Products can be applied by air, chemi g ation, and ground boom. Technical Registrant(s) Bayer, NuFarm, MANA, and Albaugh No. of Registrat ions Ap prox. 50 Sect ion 3 products 2

, 3 SLNs Restricted Use Yes G uid ance fo r Commenters: Additional areas of u s e and usa g e related inf or mation requested for th is registration review, and of particular interest to EPA, are described below.

• Certain bromoxynil labels are uncl e ar with re s pect to applicat ion param e ter s like the s ize of the treated area , the e xtent of a treated "spot ," retreatment interval s, or maximum annual applic ation rate s . 

### In the ab s ence of such information , EPA expects to approximate these parameters in order to conduct a quantitative assessment for bromoxynil. The Agency will work with registrants to make s ure bromoxynillabel s do not include an y mi ss ing or ambiguou s use parameters. • Confirmatio n of the following label information: sites of application; formu lation s; appl i cation m ethods and equipm ent; maximum app lication rates; frequen c y of app l ication, application intervals, and maximum number of application s per season ; and geographic l imitation s on use. • Use distribut ion (e. g., acreage and geographical distribution of relevant u s e sites) • Median and 90lh percentile reported use rates (lbs ail A) from usage data

- national, state, and coun ty. • Application timing (date of fir s t applicati on and application intervals)

- national, state , and coun ty. • Usage/ u s e information for non-agricultural u s e s . • Typ ical application interval (day s). • State or local use restrictions. • Foreign technical regi s trants not li s ted above who s upply te chnical bromoxynil to the US market. 

### RECENT ACTION S New uses on so rghum and grass grown for seed were approved in June and July 2011.



### ANTIC IPATE D RISK ASSESSMENTS FOR REGISTRATION REVIEW

2 Se c tion 3 product la bels can b e o bt a ined fr o m th e Pe s ticide Pro du c t Label S ys t e m (PPLS) w e b s ite ( http://oaspub.epa .go v/ pestlabllppl s. home)

. 7The most recen t risk assessment for bromoxynil was conducted in 2011 fo r a new use request. The most recent eco logical and env ironmental fate risk ass ess ment was co mpleted in 2010 for the s am e purpo s e . In 2 0 04 , ri s k s from b romoxynil to endangered or thre atened P aci fi c sa lmon and s teelhead were a sse ss ed. Findings and conclusion s from the s e risk a ss essme nts are summarized in the following documents: EFED Reg istration Review Problem Formulationf or Bromoxynil and Brom o xyni l Este r s and Bromoxynil. Human Health A sses sment S c oping Do cument in Support o f Regis tration Re vi e w . During reg i stration review, the Agency antic ip ate s the need to conduct a com prehensive ecologi c al ri s k a ss e ss ment , including an e ndangered s pecie s a ss essm e nt , for all uses of bromoxyni l. For human health, EPA anticipate s the need to conduct re vise d dietary and occupational risk assessments during registration review. 

### If toxicological e ndpoints or points of departure are revi sed based on the data that are anticipated to be require d fo r r eg i strat ion review, they will be con s idered in the new a ss e ss ment s, a s well a s any change s to the stan dard operating procedures or de fau lt exposure assumptions. Table 4 below s ummarizes the anticipate d regi s tration re v ie w ri s k ass e ss m ents based on the E

FED Problem Formulation and HED Scop ing Document. 

### Ta ble 4 : Anticipated Risk As s es sments for Bromox y nil 's Re gis tr a tion R evi ew Type of Risk Assessment Conduct? Notes Ecological 

### and E nvlroomental Fate Comprehen s ive ecological Ye s ( s pecies to be assess e d include terrestrial and aquati c organism s ) , including endangered s pecie s Incidents Ye s For a discus s ion of bromoxynil ' s reported eco logical incidents, s ee page 17 of the Problem Formulation. 

### HIIIII8DIIealtb**KiF~J'fi** Dietary Food No A new dietary risk asse s sment may not be needed sin c e change s in the Agency 's a ssessment methods sin c e the mo s t recentl y conducted r i sk assessment are not an ticipated to affect the ris k concl usion. Drinkin g water Yes Occupational Handlers (mixers , loaders, Ye s app licators ) Post -app lication Y es Resi d ential Handlers No There are no residential uses of bromoxynil. Post

- application No Other


### 8Aggregate Yes Evaluates the c ombined risk from food and drinking water exposure s. Cumulative No Bromoxynil is not a member of a c umulative group and no cumul ati ve ri s k a ssess me nt i s plann e d

. Tol er ances Y es Tol e rance s f or b ro mo x ynil are li s te d in 40 C FR§180.324

. Incidents No There is not a c oncern at thi s tim e that would warrant fmther inve stigation. The Ag e n c y will continue to monitor the in c id e nt information and , if a c once rn i s tri g g e re d , addi t ion al anal ys i s will b e includ e d in th e ri s k a ss e ss me nt. F or a di s cu ss ion o f bromox y nil 's r e ported human in c iden t s, s ee page 10 of the S c oping Document. Guidance fo r Commenters: Addition a l ecological inf o rma tion requ es t e d fo r thi s registration revie w , and of particular inte r es t to EPA , i s describ e d belo w. • Ecologic al incidents (n o n-targ e t pl a n t d a mage and avi an , fi s h , r e pt ili a n , amphibian and mammalian mortaliti es) no t already reported to the A g enc y. • Water q u ality monitoring data (see App e ndix for further details).



### TIME LINE EPA has created the following e s timated time line for the completion of bromoxynil 's regi s trati o n review in Table 5 be low. Tab le 5: Proj ec ted Re gistration R evi ew Ti meli ne Activities Estimated D ate Opening the D ocket Open Docket and 60-day Publi c Comment P e riod 20 13

- March Clo se Public C omment 20 13

- May Case Dev e lopm ent Final Work Plan 20 1 3

- Augu s t I ssue DCI 2 0 1 4

- April

- Jun e Data Submissio n 20 1 6

- April

- June 60-day Public C omment P e riod for Draft Ri s k Assessme nts 20 1 7

- Oct.

- D ec. Registration Review Deci s ion 60-da y Public C omment P e riod for Propo se d Registration R e view Deci s io n 2 0 1 8- April

- Jun e Regi stratio n Rev iew D ec i s ion and Begin P os t-Deci s ion Foll ow- up 2 0 1 9 Total {years) 6



### NEXT STEPS
9After the 60-day p ubl ic commen t period closes, the Agency will rev ie w an d respond to any comment s received in a timely manner and then issue a Final Work Plan f or the registration review of bromoxynil.



### 10

### Appendix- A dditional Areas Considered in Bromoxynil's Registration Review PUBLIC COMME NTS AND FEEDBACK: Guidance for C o mm enters: The areas below highlight topic s of special intere s t to the Agency where your comments, data s ubmissions, or reference to source s of additional information could be of particular u se. Trade Irritants: Through the reg i stra tion revie'!V process, the Agency intends to s olicit information on trade irritants and, to the extent feasible, take s teps toward facilitating irritant resolution. The Agency will work to harm onize tolerances and international maximum residue li mit s (MRLs) and may modify tolerance leve ls to do s o, when po ss ible. Growers and other stakeholders are asked to comment on any trade irritant i ss ues res ult ing from lack of MRLs or di s pariti es between U.S. tolerances and MR L s in key export markets, providing a s much s pecificity a s po ss ible regardin g the nature of the conce rn. Water Quality: Bromoxynil is n ot i dentified as a cause of irTlfairment for any water bodie s l i s te d a s impair e d under section 303 (d) of the Clean Water Act

. In addition , no Total Maximum Daily Load s (TMDL) have been developed for bromoxynil 4 • More information on impaired water bodies and TMDLs can be found at the Agency's website 5

. The Agency invites submission of water q u a lity data for this pesticide. To the extent possible, data s hould conform to the quality standards in Appen dix A of th e OPP Standard Operating Proc e dure: Inclusi o n of Impaired Water Body and Othe r Water Quali ty Dat a in OPP 's Reg i s tration Re v iew Ri sk A s s essment and Management Procesi in ord e r to ensure th e y c an be used quantitatively or qualitativel y in pesticide risk ass essments . Environmental Justice: EPA seeks to achiev e environmenta l ju s tice , the fair treatm e nt and meaningful in v ol vement of all people, regardless of rac e, color , national origin, or income , in the devel opme nt , i mp l ementation , and enforcement of environmental laws , re gulations, and po li cie s . To help addre s s potential env i ronmental j ust ice is s ue s , the Agency s eek s information on any groups or s e gments of the population who, as a result of their location , cultural practice s, or other factor s, may have atypical, unusua lly high expo s ure to bromoxynil compared to the general population. Please co mm e n t if you are aware of any sub-populations that may have atypical, unusually high ex p osure co mpared to the general population.

3 http://iaspub.epa.gov/tmdl waters I 0/anains nation cy.cause detail 303d?p cause group icl=885 4 http://iaspub.epa.gov/tmdl waters I 0/attains nation.tmdl pollutant detail?p pollutant group id=885&p pollutant group name-PESTICIDES 3 hnp ://www

. epa.gov/owow/tmdl/ 6 http ://www.epa.gov/oppsrrd 1/registration review/water quality sop.htm 11

### ENDANGERED SPECIES: A risk asse ss m ent t hat s uppmts a complet e endangered s pecies dete rmination ha s not been conduct ed for bromoxynil. The ecolog i ca l risk asses s ment plann ed during regi stration review will a ll ow the Agency to determ in e whether bromo xyn il ' s u se has " no effect " or "may affect" fe d e r all y li s te d threatened or e ndang e re d s pec ie s ( l isted s pecie s) or their designa ted critical habitats. Wh e n an as s e ss m e nt co nclud es that a pe stic id e's use " may affect" a li sted species or its d es ig nated critical habitat , th e Agency will co nsult with th e U.S. Fish and W ild l ife Service and/or Natio nal Marine Fisheries Serv ice (the Services ) , as a pprop riate

. On January 1 9, 20 11, the Ce nter for Biological Divers ity and the Pesticide A ction Network North A merica filed a law s uit in the United States Di s trict Court for the Nort hern District of Ca lifornia , against the E n v ironmental Protection Age ncy (EPA) for allegedly fail ing to unde rgo consu ltation with the United States Fi sh and Wi ld life Service and the Nationa l M arine Fisheries Service regardi ng the effects of over 350 p est icid es, including bromoxynil, on o ver 200 e ndangered and threatened spec ies throughout the United States (Center for Biol og i ca l Diversity, et a l. v. EPA, et al., No

. C 11

- 00293 (N.D.Cal.)

. 

### ENDOCRIN E DISRUPTOR SCREENING PROGRAM : As required by FIFR A and FFDCA, EPA review s numerous s tudi es to as sess po tential adverse o ut co mes from expos ur e to c h e mical s. Co ll ectively, these studie s include acute, subchronic and chro nic toxi ci ty, including as sess ment s of ca r c ino gen i c ity , ne urotox icity , d eve lo pmental, reproductive , an d general or s ystemic toxici ty. These s tudie s includ e endpoints w hich may be susceptibl e to endocrine influence, including effects on endocrine target organ h istop athology, or gan weights, estrus cycli c ity, sexua l mat uration , fertility, pr egnan cy rat es, r eprodu ctive loss, and sex ratio s in offs prin g. For ecological haz ard as s essments, EPA evalu ate s acute tests and chron ic studi e s that assess growth , deve lopmental and reproductive effect s in di ffer ent taxonomic groups. As part of its mo st recent regi s tration deci sion for bromoxyn il, EPA rev ie wed t h ese data and se lec te d the m ost sensitive e ndpoints for re levant ri sk a ssessment sce nario s from t h e existing h azard d at abas e. How eve r , as re quired b y FFDCA section 408(p), bro mo xynil i s s ubject to the e ndocrine s creening part of the Endocrine Di sru p ter Screening Program (EDSP). EPA has dev e loped the EDSP to determin e whether certain s ub stances (includ in g pesticide acti ve and o th er ingredients ) may have an effect in hum a n s or w il dlife similar to an effect produced by a " naturall y occu rring estrogen , or other s uch endocrine effects as the Administrator may designate. " The EDSP e mploy s a two-t iered approach to making the s tatutorily required de termination s. Tier 1 consists of a batt e ry of 11 sc reening a ssa y s to identify the poten t ial of a chemical s ub sta nce to int er ac t with th e e s trogen , androgen, or th yro id (E, A, or T) hormonal s y s te m s. C hem ica l s that go thro ugh Tier 1 scree nin g and are found to ha ve th e potentia l to interact with E , A, or T hormonal syste m s w ill proceed to the ne xt stage of the EDSP where EPA will determine which, if any , of the T ier 2 tests are necess ary ba se d on the availa ble d ata. Tier 2 testing is d es i gne d to id entify any ad ver se endocrine

- related effec t s caused by th e substance, and e s t a bli s h a dose - res pon se relationship between the do s e and the E , A, or T e ffect.

12Under FFDCA s ection 408(p), the Agency must screen all pesticide chemicals.**Betw~en** October 2009 a nd F e bruary 2010, EPA issued test orders/data ca ll

- in s for the first group of 67 chemicals, which co ntains 58 pesticide act ive ingredients and 9 inert ingredients. Bromoxynil is not among the group of 58 pe s tic ide active ingredients on the initial list to be s creened under the EDSP. Accordingly , as part of registration review, EPA will i s sue future EDSP orders/da t a callins, requir ing the sub mission of EDSP screenin g assays for bromoxynil. For further information on the status of the EDSP, the policies and procedures, the li st of 67 chemical s , future li sts, the test guide l ines and the Tier 1 screening battery, please visit our website 7 •
HUMAN STUDIES: Occupational Past bromoxyni l risk asse s sments rely in part on data from studies in which adult human subjects were intentiona lly exposed to a pesticide to determine their dermal and inhalation exposure. Many such s tud i es, involving exposure to many different pesticides, compri s e generic pesticide exposure databases such as the Pesticide Handlers Exposure Database (PHED) and the Agricultura l Ree ntry Task Force (ARTF) Database. EPA ha s reviewed all the stud ie s supporting these mult i-pesticide generic exposure databases, and has found no clear and conv incing ev i dence that th e conduct of any of them was either fundamentally unethical or s ignificantly deficient relativ e to the ethical standards prevailing at the time the research wa s c onducted. All applicable requirements of EPA's Rule for the Protection of Human Subj e cts of Research (40 CFR Part 26) ha ve been sati s fied, and there i s no regulatory barrier to continued re li ance on these studies.

7 http://www.epa.gov/e ndo/ 13