### Docket Number EPA
- HQ
- OPP
- 2013
- 0749

www .regulations.gov



# Aminopyralid **Preliminary Work**  **Plan Registration**  **Review :**  **Initial Docket**  **Case Number**  **7267 March**  **2014**

Approved by: 

### Director

Pesticide Re
- evaluation Division
Date:2



## Aminopyralid **Preliminary Work**  **Plan -**  **Table of**  **Contents**

OVERVIEW
............................................................................................................................. ...... . 4 AN'flCIPATED DATA NEED S
........ . . ...................... . ........ . ............ . ......... ........... ...... . ....... . .......... . 5 STATUTORY AND REGULATORY AUTHORITY
.................................................................. . 5 CHEMICAL FA C TS
. . . . . .. . . ........... . . . . . . . . . ................................ . . .................... . . ................................. . 6 USE AND USAGE INFORMATION
.......... . .......... . ......... . ......... ............ . .......... . ................... . . ...... . ? RECENT ACTIONS
............................................................................ . .. . .. ................. . ..... . ............ . 9 ANTICIPATED RISK ASSESSMENTS FOR RE G ISTRA T ION REVIEW......................
. . ........ . 9 T IM ELINE
..... . . . .. . ......... . ........... . ..... . ........ . .. . . ........... . . ............. . . ... . .. . . .. . ................ . . . . .......... . ... . . .. . . . 11 NEXT STEPS
......... . .. . . . .. .......... . . . . . . .................. . . ........................................................................... 12 Appe n dix
- A d ditional Areas Considered in the Am inopy ralid Registration Review ..............13

Reference s : This Pre l imi n ary Wo

rk Pl an su mmari z es the E nvironmenta l Protection Agency's current position based on the f

o l l owing documents: 1. Registration Review: Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinkin g Water Exposu r e Assessments for Aminopyralid, Potassium Salt of Aminopyralid, and Triisopropanolamine Salt of Aminopyralid. EFE D

!Edwar d Scollon, Ph.D. and Kat r ina White, Ph.D. February 1 2 , 2 0 1 4. 2. Aminopyralid

. Human Health Assessment Scoping Document in Support of Registration Review. HED/Douglas Dotson, Ph.D., Jaime D ' Agostino, Ph.D. and Za ida Figueroa, February 12, 2014. 3. Aminopyralid: Tier l Review of Human Incidents. Shanna Reco re. November 12, 2013. 4. BEAD Chem i

cal Profile (B CP )for Registration Review: Aminopyralid Case Level Composed of Aminopyralid (005100), Aminopyralid, Potassium Salt (005219) and3

Triisopropcmolamine Salt ofAminopyralid (005209). BEAD/Sunil Ratnayake, Rafael A. Pri eto and Stephen Smearman, March 31,2014. 5. Aminopyralid (005100 , 00520 9 , 005219). Screening Level Usage Analysis (S LU A ), March 18, 2014. 

### 6. Environmental Fate and Effects Division Label Data R e port S p readsheet: PC Co des : 005100, 00520 9

, 005219. August 23, 2013. 7. Health Effects Division Master Label Report Spreadsheet: PC Codes: 005100, 00520 9 ,005 2 19. August 23, 2013.
These and other s upporting documents for the aminopy ralid registration review case m a y be found in the docke t EPA
- HQ
- OP P
- 201 3
-0749 at http://www.re! !u lali o n s.gov .4



### OVERVIEW The docket for aminopy

ralid i s now open, initiating th e first public comment period for th i s reg i s tration re v iew (docket number EPA
- H Q
- OPP
- 201 3
- 0 749). This case inclu d es the aminopy ralid a c id a l o ng with its pota ss i um and triisopropanolamine s a l t s . Aminop y

rali d , 4
- amino
- 3,6
- dichloro
- 2
- pyridinecarboxylic acid, i s a sys t e mic herbicide which i s re g i st e red for use to control a number of noxious and in va s ive annu a l , b i enn ial and perenni a l weed speci e s . This p e s ti cide belongs to th e p yri d i n e carboxylic acid fam i l y and i s registered f or u se as a pree mergence and pos t- e mergen ce herb i cide to control broadleaf weed species in many agri c ultur a l and no n - a gricultural u se sites. A minopyralid acts lik

e a plant gro w th regu l ator b y mimicking natur al plan t gro w th hormo n

es (auxin s) and di s rupting the pl ant's norma l growth proc e ss, cau s ing abnormal growth patte rns in the plant s. Aminopyralid may b e ap p l ied via aircraf t , ground sprayer, han d
- h e

ld sprayer, and boom sp rayer. Am ino p y ra l id may also be applied to for es t planti n gs v ia broadcast, high v o lume sp ray , s pot treatment , st ump treatment , gi rdle treatment , frill treat

m e nt, tree wound tr

e atment, and tree injection. T h i s Preliminary Work Plan (PWP) docum e n t explains what EPA 's Off i c e of P e s t i c i d e Pro gra ms knows about ami nopyrli d , h i g hlighti n g anti c

ip ate d dat a an d ass es sment needs, identifying the ty p es of information that would be espe c ially u s e

ful to the Agency in conducting the revi ew, and providi n g an ant i c ipated tim eline for c o mp leti n g the re gi s tratio n review for ami n op y ralid. The registration r eview pro c ess was d e s igned to inclu d e a public participation component to solicit input from int e rested s t akeh o l ders. T he Agency intends, by shari n g th i s information in th e d ocket, to inform the public of what it knows abo ut aminopy ra l id and what typ e s of new d a ta or oth e r inform a

tion would be h elpf

u l for the Agency to receive as it mov es toward a decis i on on aminopy ralid. The Ag ency e n c o ura g es a ll int ere sted stak e

hol d ers to r eview the PWP and Appendix and to p r

o v ide comm e

nt s and additional information th at will help the Agenc y 's d e ci s ion
- making pro ce s s for this chemical. In a d dition to gener a l areas o n which perso n s may wish to comment, t

h ere are some are a s identif i e d in th e PWP and Ap p en d ix a b o ut w hi ch the Agency speci f

ically se eks comments and i n f o rmation. In t e

re s ted stake holde rs co uld include: environmental no n - prof

it or in tere s t gro u p s ; p e s ticide manufacturers; agricultural labor or commodity gro u

p s ; comm e

r ci a l , i ns titutional , r e s identia l , and other u sers o f p estic i de s; or the publ i c at large . T h e P relimi n a ry

- Work Plan begins by l i st i ng th e ant i cip a ted dat a nee d s f o r aminopy

ralid. Next , i t di s c usses the st a t utory and re g ulato r y authority for Registration Review. Then the document provides chemical fact s , use and usa g e informatio n , re c e nt ac t ions, the an ticipat ed risk a sses s ment

s, and a p r

ojected regi s tration r e

view timelin e for aminopy ralid. Fi n a l l y , the Appendix to th i s docum e nt includes identification and discussion of some are as that are co n side red ge nerally in Reg i s t ration Re v iew a l ong with s o m e addi t iona l chem i c a l case - specific information.5

Table 1: Anticipated Data N e eds for the Aminopyralid Registration Re view
Guideline Number Study Titl e 1 Te s t M ateri al Estimated Timeframe (Months from receipt of DCI ) Anticipated Data Need s for the Aminopyralid 835.4300 Aerobic aquatic metabolism TGAI 24 835.7100 Prospective Groundwater monitoring s tu d y TEP 1 2 850.1010 Freshw a t

e r invertebrate acute toxicit/ TEP 12 850.4100 Se e

dl ing emergence (soybe a n, lettu c e, onion ) 2 TEP 24 850.4150 Vegetativ e vigor (soybe a n , lettuc e , oni o n / · 3 TEP 24 850.4500 Aquatic plant growth (fres h diatom, Naviculla pelliculosa) 3 TEP 1 2 850.4550 Cya nob a cte

ria Toxicity TGAI 1 2 850.6100 Env ironm

e ntal Ch e mist

r y M e thod s and Indepen de n t Laboratory V a l idati o n for compost TGAI 1 2 Non
gui d e line C o mp o s t Dissipation Stu d y TEP 1 2 N o n guid e li n e Honey b e

e larval toxicity te s t (

O E CD 237) TGAI 1 2 ANTICIPATED DATA NEEDS Table 1 below summarizes anticipated data needs for aminopy ralid. For additional discu ss ion of the anticipated data: needs, see the Registration Review Problem Form u lation for Environmental Fate, Ecologic a l R isk, Endang e red S p ecies, and Human Health Drinking Water Exposure Assessments for Aminopyralid, Potassium Salt ofAminopyralid, and Tri iso p ropanolamin e Salt of Aminopyralid and the Human Health Assessment Scopin g Donrment in Support of Regi s t ra tion Review.

TGAI = = techm

ca l grade acttve m gredtent; T EP 

## = typ1cal e nd
- use p r

o duct STATUTORY AND REGULATORY AUTHORITY The F ood Qua lity Prote c

t ion Act (FQPA) of 1996 mandated a r egi s tration review program. All p e s ticides di s tributed or sold in the United States (U.S.) generally must b e r e g i s tered b y the Environmental Protection Agency (EPA or the Agency), based on s cie n ti fic data showing that they will not cause unreasonable ris ks to human health or the environment when used as directed

1 On June 2 7 , 2 0 1 2, EPA announ ced c e rtain revisions in h a r

m on i ze d guideline s e ries 850
- Ecological Ef f e c ts Tests

- in c l uding r e numberi n g and other designatio n s or c h anges for some guideli n e studies. See "Final Test Guidelines; OCSPP 850 Series; Notice of Availability" 77 FR 38282, Jun e 27,2 0 1 2
. 2 Fo r these Guideline Numbers, data a nd/or waiver requ e s t s are c urrently under review. 3 Data are anti c ipated to be needed for repre sentative Ty pical End
- Use Products (TEPs) that cont a in i) amin o pyralid and 2,4
- D; ii) a minopyralid and tri c l opy r; iii) am i n opy

ralid and c l o pyralid ; iv) a mino p y r a lid and m e

tsulfur o n ; and v

) ami no p yra lid and flur

oxyp y r - l
- m ethylheptyl e s t e r6

on product labeling. The reg i strat ion review program is intended to make sure that, as the ability to assess risk ev o lv es and as policies and practices change, all registered pesticides continue to meet the statutory stand ard of no unreasonable adverse effects to human health or the e .nvironment
. Changes in science, public policy , and pesticide u se practices will occur over time. Through the registration review program, the Ag e ncy periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely. Information on this p rogram is provided on EPA's website
. 4 The Agency is imp l em e

nti n g the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fun gici d e, and Rodenticide Act(FIFRA), and will review ea c h regi s ter e d pesticide every 15 ye ars to determine whether it continues to meet the FIFRA stand ard for registration. The regulations governing registration review begin at 40 CPR 155.40. The Agency will consider benefits information and data as r e quired by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency's opportunity to state w hat it knows about the pesticide and what additional risk analyses and data or information it believes ar e needed to make a registr at ion re v iew dec i s ion. Af ter reviewing and responding to comments and data received in th e docket during this initial comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for the regi s tration review of aminopyralid. 

### CHEMICAL **FACTS** Table 2 provides a sum

mary of the chemical facts for aminopyr a lid. **Table 2:**  **Chemical** 

### Facts **for Aminopyralid**  PC codes 005100 (aminopy ralid acid), 005219 (am i nopyralid potassium salt), 005209 (aminopy

ralid triisopropanolamine [TIPA] s a lt) Case Number 7267 CAS Numbers 150114
- 71
- 9 ( aminopy ralid acid) , 566192
- 87 (aminopyralid potassium salt), 566191
- 89
- 7 (aminopy ralid TIPA sal t ) Year first registered 2005 Pesticide Type Herbicide Chemical cl a ss Py ridine carboxyl i c acid Reregistration Eligibil i ty Decision ( RED ) Aminopy ralid was registered after November 1984; therefore, it was not subject to rer e gistration. To l e r ance Reassessment Eligibility Decision ( TRED ) Aminopy ralid was registered after November 1984; therefore , it was not subject to tolerance reassessment. Cumulative group No cumulative risk assessment is required a t this time since the Agency has not made a determin at ion regarding a common mo d e of action. 40 CFR Citation Tolerances f or aminopy

ra lid are established in 40 CPR § 180.610. Dua l
- use Aminopy ralid is registered for conv entional pesticidal uses o n l y and has no registered antimicrobial or bio N on - pesticidal uses There are no identified non - pesticidal uses of aminopyralid.

4 http://www.epa.gov/oppsrrd 1/reg i s tration_review/7 

### Table 2: Chemical Facts for Aminopyralid Pesticide Re
- evaluation Division, Chemical Review Manager Veronica Dutch, dutch.veronica@epa.go v , (703) 3 0 8
- 8585 Registration Division, Product Manager Kathry n Montague, montague . kathry n @ega.go v , (703) 30 5
- 1243 

### USE AND USAGE INFORMATION Table 3 sum

mariz es the use and usage information for aminopy ralid. Please see the BEAD Chemical Profile (BCP) for Registration R eview: Aminopyralid Case L evel Composed of Aminopyralid (005100), Aminopyralid, Potassium Salt (005219) and Triisopropanolamine Salt ofAminopy

ralid (005209) in the registration revi ew docket for more deta i l s. 

### Table 3: Aminopyralid Use and Usage Information Summary of Use Aminopy ralid. i s a sy stemic herbicide reg i ste red for broadleaf weed management in agricultural and non - agricultural lands. Arninopy ralid can be applied as pre - emergence or post - emergence treatment s using aerial a nd ground application methods. Aminopy ralid ac t s like a plant growth regulator by mimicking natural plant growth hormon e s ( auxins ). Use Sites Use sites for amlnopy ralid are wheat, hay , and p asture cro p s. Use sites for aminopy

ralid pot a s sium salt are f o r e stry plant i ngs, wheat, hay , and pasture crops. It is also registered for use on Conservation Reserve Program (CRP) l ands, right s - of
- way , and fallow and no n- agricultural uncultivated areas, including seasonally flooded wetland areas when dr y. Use sites for aminopy

ralid TIPA s a lt include forest plantings, wheat, corn (s i lage, f

i eld) , and hay and pasture cro p s. It is also registered for use on CRP areas, airports/landing fi elds, indu stri a l and construction areas, fallow and non - agricultural uncultivated agricultural uncultivated areas, including seas onally flooded wetland areas when dry. The predominant u se for these active ingredients i s on pasture (98+% of usage ). Summary of Usage Based on proprietary data from 2006
- 2012, average u s a ge was approximately 92,000 pounds of active ingredient ( a .i
. ) applied annually on 1.3 million acres. The av er age a. i
. rate over this time period was 0.07 pounds a.i./acre. There are limite d u sage data av a i lable for non - agricultural u se sites. Formu l at ion Type (s ) Ami Ami nopy ral i d i s formulated as an emulsi f i ab l e concentrate. nopy ralid potassium salt is formulated as a dr y flowable and8 **Table 3:**  **Aminopyralid** Use **and** Usage **Information** e m ulsifiab l e concentrate. Aminopy ralid triisopropan o lainine s alt is formulated as an emulsifiable c oncentrat e, liquid s o luble conc e ntrate, and flowable concentrate. Ap pl icat i on Method (s) Prod u c ts c a n be appl i e d as a broadcast tr e a tment by aircraf t , g round spraye r , or hand
- h e ld s prayer. A dditional treatments are spot treatment, stump treatment, gird l e treatment, frill t r eat ment , tree wound treatment, and tree in j e c tion. Tec hn i c a l Registrant Dow Agro $ciences LLC No. of Registrations 15 Section 3 produ cts:> and 36 S pecial Loc a l Needs (SLN; Section 24c) re gistrat io ns . Restric t e d Use No **Guidan c**  **e for**  **C o**  **mmenters:** Additional areas of use and usage related information requested for th i s registration revi ew, and of partic u l ar interest to E P A, are de s c ribed below.

• Certain current l a

b e l s w i th i nstructions for ap pl i cat io ns to trees (e.g., cut s ur f ace, cut - stump treatm e n t , tr ee in j e c tio n , hack and squirt treatment, and frill and gi r dle metho d ) do not specif y the maximum amo u nt of aminopy ralid that may be applied per tree ( e . g ., as a function of trunk diam eter), or th e maximum n umber of trees that may be treat e d per a c r e . Maximum application rates (both s i ngle and seas ona l ) in lbs a.i or a.e./A f or modeli n g exposures r

es u lting from th e

se ty p e s o f us e s may also be l acking as i s the maximum number of applicatio n s p e

r ye ar and minimum retreatment int erv a l.
• So me labels l i st non sp ecific use s i tes. With out sp ecif i c use s ite informati on, the Agency mu st emp l oy the ass um ption that amin o p yralid c an be used at any of the s p eci f i c use s i tes that f a ll within the broad range of agr i c ultur al, c o mme r

c i a l, re sident ial, and fore s t si t es name d on t

h e label, and that applications may be made to both aquatic and terres trial environments. T he following are ex a mp l es of no n specific u se sites: o Non
- irrigation di t c h banks, sea s onally dry wetlands (su c h as flood plai n s , d e lt a s, mars h es, swamps, o r bogs ) , t ran s itio n a l a reas between up l a nd and lowland sites when dry , ditch bank weeds, sho reline weed s , non - cropland areas, and n atural area s . • Som e l abel res tri c

t i ons ar e s p ec i f

ied on a product b asi s

. r a ther than on an a. i
. ba s i s . • So m e lab e l s Jack maximum an nu a l or season a l ap p licati on rate s, maximum number of appl i c a tion s , and minimum retre a t m en t intervals.

• Some l a be l s w i th mul t iple a .i
. s provide appl i cat i on rate i nformat i on on an acid e qu i v a l ent b a s i s but do not specify to which a. i
. the rat es a p p l y . • Confirmation of additional label in f ormation: ap plicati on method s and equipment, and geographic l imitations on u se.
• Use distr ibut i on (e.g., acreage and geo graph i c a l distribution of relev ant u se s it es )
. 5 Section 3 prod

u ct l a b e l s can be obtai ned from the Pesticide Product Lab e l S ystem ( P PL S) website ( http://oa\ pub.epa.gln,foestlabllppls.home ).9

o Median and 90th percentile reported use rate s (l bs ai/A) from usage data
- national, state, and county. f) Ty pical application timing (d a t e of first application and application intervals )
- national, state, and co un ty. o Usage/use information for non - agricultural site s . o State or local use restrictions. o For e i gn tec h n i c a l re g i s tr antthat supply technical aminopy ralid to th e US market. 

### RECENT **ACTIONS** In 2013, an amendment to registration for a Section 3 new use of aminopy ralid for control of broadleaf and woody plants and annual weeds in aquatic sites was submitted. The proposed l abel s defined aquatic s i tes as "non

- irrigation ditch banks; seasonally dry wetlands such as flood plains, deltas, marshes, swamps, or bogs; transitional areas between upland and lowland sites as well as along shorelines; and shallow areas of still and moving water." The sub mi s sion is curre ntly under review.
. 

### ANTICIPATED **RISK ASSESSMENTS**  **FOR REGISTRATION**  **REVIEW** The most recent comprehensive hum an health risk assessment for aminopy ralid was completed in 2009. The most recent ecological and environmental fate risk assessment was c o mple te d in 2010. Findings and conclusions from these ri sk as s ·essment s are s ummarized in Aminopyralid. Human Health Assessment Scoping Document in Support of Registration Review and Registration Review Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure Assessments for Aminopyralid, Potassium Salt ofAminopyralid, and Triisopropanolamine Salt of Aminopyra l id. During r egistrat ion r e view, t h e Agency an ti c ipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all u ses of aminopyr a l id. For human health, EPA anticipates the need to co n duct r evised dietary and aggregate ri s k assessm e

nt s during registration review. If toxicological endpoints or points of departure are revised based on the data that are anticipated to be required for r e gistration re v ie w , they will be c o

nsidered, as will any changes to the standard operating procedures or default expos u re assump t i o ns.10

Table 4 below summarizes the a nticipate d registrat i on review ri sk as s es s m e nts b as e d on the EFED Prob l em Formul a tion and HED Sc o pi n g Do c um e nt. Table 4: Anticipated Risk Assessments for the Aminopyralid Registration Review Ty pe of Risk Asse s

sm e nt Conduct? Notes Ecolofdcal and Enviro n me n tal Fate C o mp r e hen s i v e ec o log i cal (speci e s to be assess ed inclu d e terre strial and aquatic org an i sms), including e n dan g e red species 

### y The Agency w i ll con d u ct a comprehensi v e ec o l og ic a l asses s m e nt , including an e ndange r e d spe ci es asses sm e n

t. Effects of r e

s i dues in comp o st will b e a d dresse d
. I ncident s Will check for updates F o r di s c u ss ion of reported ecologic a l inci d e nts for

a mino p y r a l id, see page 1 7 of th

e Problem Formu l ation. Human He a

lth Dietary Food 

### y If new policies are put into place, or new toxicity and cro p treat ed data b e c ome av a i l able, the Ag ency will re v i sit. Drinki n g water 

### y Drink i n g water will be exam in ed as par t of r egistrat ion r eview. Occupation a l Handl ers (mixers, loa ders, applicators ) 

### y T he Agency will c o nsi d e r the need for a new hand l e r assessment to a c c o

unt for any p o l i cy ch an ges that take pl ace duri n g registrat i o n review. Post
- application N A n occupational quantitati v e p o st - a pplication asses s me n t will not be necessary during registration review because a dermal e n d poi n t h as not been s elected for aminopyral id. Residential Handl e rs N Aminopy ralid i s not appl i e

d by homeowners; therefore, a residential handler assessment w i ll not b e c o nduc t e d for registration r e v iew . Post
- application


### y During registr a tion review, a r e v i s e d r esident i a l e x posure assessm e

nt that inc l u d es post - appl i c at ion incidental oral exposure t o children (1 <2 ye ars ol d ) playing o n treated recreational s i tes may be nee d ed. The Agency may determine that a bystander spra y dr i f t risk as s e s sme n

t i s n e e d e d for am i

n opyralid during registration review. Other Aggregate 

### y If foo d , drinking water, or res iden tial port - a ppl i cati o n reasse ss ments are c o nd

u cted, a new aggr eg ate risk assessment may be nee d ed.11

Cumulative N Aminopy ralid h a s not been ide ntif i ed as belonging to a cumulative group, so the Agency does not anticipate that a cumu l ative ri sk assessment w i ll be pe rform e d
. Tolerances 

### y T he Agency w i ll revisit the t o leran ces during registration review. I n ci d e nts Will check for updates For a discussion of reported human inci d e nts for

aminopy ralid, s e e page 10 of the Seeping Document and Aminopyralid: Tier I Review of Human Incidents. **Guidance for**  **Commenters:** Additional ec ologic a l in f ormation requested for th is reg i stration review, and of particular interest to EPA, is described below.

o Eco l o g ical incidents (non
- target plant damage and avian, fish, rep_tilian, amphibian and mammalian mortaliti es) not already reported to the Agency. o The application of aminopy ralid to vegetative matter that is subsequently u sed as compost or animal fe e

d h as been fo u

nd to retain aminopy

ralid residues and affect no n - t arget p l a

n ts. Re s i du es in food item s that end up i n compost may also be found in compost. The Agency is interested in additional information about this i s s u e, which may inclu de incident reports and e nvironmental fate data. o Water quality monitoring data (see Appendix for further detai l s). **TIMELINE** EPA h a s created the following estimated timeline for the completion of the aminop yralid registrat i on review in Tab l e 5 b e l ow.

**Table 5:**  **Projected Aminopyralid**  **Registration Re**  **v iew**  **Timeline**

**Activities Es**  **t imated**  **Date** Opening the Docket Open Docket and 60
- day Public Comment Period March
- 2014 Close Public C o mment May
- 2014 C ase Dev el opme n t F i nal Work Plan August
- 2014 Issue DCI Oct ob er - Decemb er - 2014 Data Submission Oct ob e r - December
- 2 0 16 60
- day Public Comment Period for Draft Ri sk Assessment s 0 Apri l
- June
- 2018 Registrat i o n Re v i ew De c i sion 60
- day Public Comment Period for Proposed Registration Review Decision Januar y- March
- 2 0 19 Registrat i on Review Decision and Begin P o s t - Dec i sion Follow
- up 2020 Total ( ye a rs) 6 6 The re gu latio n s go v

erni n g Registration Re v iew generall y require the Agency to provi d e a publ i c comment period of at least 30 c a l e nd a

r days for draft risk assessments; see 40 CF R P a rt 15 5 .53(c). Fo r c o nventi o nal pesticides, the Agency plans to p r

ovide a 60 calendar d ay public comm e nt period generally for draft risk assessments.12



### NEXT **S T**  **EPS** After the 6 0
- day public comment period clos e s, the Agency will review and respond to any comments received in a timely manner and th e n issue a Final Work Plan for the registration review of aminopyrali d
.13

Appendix
- A

dditional Areas C onsi d ered in the Aminopyralid Registration Review



### . PUBLIC COMMENTS AND FEEDBA C K: Guidance for Commenters: The areas be l ow hi ghligh t topics of special interest to the Agency where your c o mment s , data submissions, or reference to s ources of additional informat io n could be of particular u s e . Trad e Irritants: Through th e registration review proc e ss, the Agency i n tends to s o l i cit information on trade irritants an d , to th e extent feasible, take st ep s toward facilitating irri t ant r es o lution. Th e Ag e n cy will work to harmonize tolerances and international maximum residue limit s (MRLs) and may modify to l e r an c e l ev e l s to do so, wh en possible. 

### Growers and other stakeholders are asked to comment on any trade irritant issues resulting from lack of MRLs or disparities b e tween U.S. toleranc e s and MRLs in key export markets, providing as much specificity as p o ss i ble regarding the n ature of the c o

ncern . Wa ter Q u ality: Aminopy r a l id i s not i d e ntified as a cause of impairment for an y wate bodi es l i st e d as impai red un d e r s ection 303(d) of the Clean Water Act
. 7 In ad d it i on, no Total Maximum Daily Loads (TMDLs) have b e e n de ve l oped for am inopyralid
. 8 Mo re information on i mpaired water bodies and TMDLs can be found at the Agency's websi te . 9 

### The Agency invites submission of water quality data f

or this pestic i de. To the extent p o ss ibl e , data s hould c onform to th e quali t y s tandards in Appendix A of the OPP Standard O p erating Pro c edu r

e: Inclu sio

n of Impaired Wa te r Bo d

y and Other Water Quality Data in OPP's R e g istration R

eview Risk Assessment and Management Pr

oces/ 0 in order to ensure they can be u s e d quantitatively or qualitatively in pesticide ri s k ass es s ments. Environ m e ntal J

us tice: EPA seeks to ach i eve environmental just i ce, the fair treatment and meaningful involvement of all peopl e , r egar

dl e ss of race, colo r , national origin, or incom e , in the d ev elopment , implem e ntat i o n , and e nfo r c e ment of environmental law s , r e g ulation s, and policie s . To help address potential environmental j u s tice i s s ue s , V!e A ge ncy see ks information on any groups or segments o f the population wh o , as a result of their locatio n , cultura l pr ac t ice s , or o ther fac t o rs, may h a

ve atypical , unusually high exposure to aminopyralid compared to the g e neral population. 

### P lea s e comment if yo u are aware of any sub
- populations that may have atypical, unusually high exposure compared to the general population.

7 http://ias.pub.epa.gov/tmdl water s I 0/attamnatio n cyxause detail 303d'? p cause group id
- !Hl5 8 http://iaspub.cpa.gov/tmdl \'>ater s I 0/attain s nation.tmdl pollutant detail?p pollutant l!fOUQ id
- 885&p pollutant group name=PESTICIDES 9 http://www.epa.gov/owow/tmdl/ 1 0 http://www.epa.gov/oppsnd !/registration re\ ie\\ / water quality '>Op.htm

### ENDANGE **R ED**  **SPECIES:**

A risk a s ses s ment that support s a comp le te endangered species determination h a s not been co nduc te d for aminopy

ralid. The eco l o gi c a l ri sk assessm e nt plaiUled during re gi s tration review will allow the Agency to determine whether u se of aminopy ralid h as " no effec t " or " may affect" · fed e rally l i sted thr e a tened or endangered species ( l i sted species) or th e ir design a t ed critical habitat s. When an assessment concludes that a p e s ticid e's use "may affect" a l isted species or its d e s ign at e d critical habitat , the Agency w ill consult with the U.S. Fish and Wi ldlife Serv i ce and/or National Marine F i s heri e s Servi ce (the Services), as a ppropriat e . 

### END **OCRINE DISRUPTOR**  **SCREENING PROGRAM:**  As requi re d by F

I FRA and FFDCA, EPA revie w s numero u s stu di e s to assess potential adverse o utco m es from exposure to chemic a l s. C oll ectively , these s tudies include acut e, s ubchroni c and chron i c to x icity, including assessments of c a rcin o ge n icity, n eur otox i city , d ev e

lopmenta l , reprod u c ti v e , and genera l or sy s temic toxicity. These studies include endp o int s which may be , susceptible to endocrine influ ence, including eff e c t s on endoc r ine target organ hi s topathology, organ weights, estrus cyclicity , se x ual maturatio n , fertility , pregnancy rates, rep roducti v e l o ss, and sex ratios in offspring. F o r ecological hazard asses sm ents, EPA ev a l uates acute tests and c h roni c s tudies that assess growth, de v e l opmental and reproductive e f fects in different taxonomic groups. As part of its m o s t recent reg i s t ration d e ci s ion for am inop yralid, EPA revie w ed these dat a and s e l e c t e d the m o st sensitive e

ndpoint s for rel ev a nt ri sk asses s ment scenar i o s from th e e x isting h az a rd database. However, as required by F F DCA sec t

ion 408(p ) , aminopy ralid is subje c

t to the en d ocrin e screening part of th e E n d ocrine Disrupter Screening

· Program ( EDS P). EPA h a s developed the EDSP to determine whet h er certain s ub stances (including pestici d e ac t i v e and other ingredient s) may have an effect in human s or wildli f e s imilar to an effect prod u c e d by a "n a tural l y occurring estrogen, or o t her such e n docrin e e f f e c t s as th e Admin i strator may d es i gnate . " The EDSP emplo y s a tw o - ti ered approach to making the s tatutorily requi re d determinations. Tier 1 cons i s ts of a battery of 11 sc reening assay s to identif y the potential of a chemical s ubstance to intera ct with the e s troge n , androgen, or thy roid (E, A, or T) hormonal sys t e m s. Chemicals that go through T i er 1 screening and ar e found to have the potential to intera ct with E, A, or T hormonal sy stems will proceed to t h e next stage of the EDSP whe r e EPA will de te rmine whi ch , if any , of the T i e r 2 tests are necessary based on t he available data. Tier 2 testi n g i s d esi g ned to identify any adverse endocrine
- related effects c a u s e d by the s u b stance, and establish a dose
- r e sponse relationship between t h e dose and the E, A, or T eff e c t. Under FF D CA se c tion 408(p), the Agency must sc reen all p e sticide c hemica ls. Between October 2009 and February 2 0 10, E P A i ss ued test orders/data call
- ins for the first group of 67 chemicals, which c o

ntain s 58 pesticide active ingredients and 9 in ert ingredient s. A second list of chemicals identi f

i ed for EDSP scr e e ning was p u blis h ed on June 1 4 , 2 0 1 3 1 1 and inclu d es s ome pestici d es s chedu l e

d for r e gi s tration re view and c h emical s found in w a te r. Neither of th ese l i s ts should be c o

nstr u e d as a l i st of known or like l y e ndocrine disrupters.

11 See http://w\vw.regulation
- ,.gov/#!documcntDetaii:D
- EPA
- HO
- OPP T
- 2009
- 0477
- 0074 f or the final second l i st of chemicals.

. 14For further information on the status of the EDSP, the policies and procedures, th e lists of

chemic a l s, future lists, the test gu i d elines and the Tier 1 screening battery , plea s e vi sit our website. 12 

### HUMAN STUDIES: Past aminopy

ralid risk assessments r el y in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine their d ermal and inhalation exposure. Many such studi e s, involving exposure to many different pesticides, compri se generic pesticide exposure databases su c h as the Pesticide Han d l er s Exposure Database (PHED), the Agric u l tural Reentry Task Force (ARTF) Datab a se, and the Outdoor Residential Exposure Task Force ( O RETF) Database. EPA has reviewed all the studies supporting these multi
- pesticide generic exposure databases, and has found no clear and c o nv incing evi d ence that the conduct of any o f them was either fundam e n tally unethical or significantly deficient relative to the eth i c a l s tandard s prevailing at the time the research was conducte d
. All applicable requirements of EPA's Rule for the P rotection of Human Subjects of Research (40 CFR Part 26) have b e e n satisfied, and there is no regulatory barrier to continued reliance on these stu d i e s.

12 http://www.epa.gov/endo/ 15