### Docket Number EPA-HQ-OPP-2015-0693 www.regulations.gov



## p-Menthane-3,8-diol (PMD) PC Code: 011550 Registration Review Final Work Plan


## June 2016
Case #6017

Approved by: 

### Robert McNall , Directo I 

### Biopesticides and Pollution Prevention Division
Date:

### INTRODUCTION This is the E nvironmental Protection Age ncy ' s (E PA or the Agency) Final Work Plan (FWP) for the registration review of p - methane-3 , 8

- diol (PMD). This work plan addresses public comments received concerning the Pre lim in ary Work Plan (PWP) , wh ich was posted in the PMD registration rev iew docket (EPA -HQ-OPP-20 1 5 -0 693)
. PMD is currently registered in four endu se product s (EPs) for outdoor , re s id e ntial no n-fo od u se as an insect repellent to be applied to exposed human skin and clothing. T he Agenc y i s implementing the registration review program pursuant to Section 3(g) of the Federal In sec ticide , Fung ic ide, and Rodenticide Act (FI FRA), and will re view each regi stered pesticide every 1 5 years to determine whet h er it continues to meet th e FIFRA standard for registration. C han ges in sc ience, pub li c p o li cy, and pesticide u se practices occur over time. The reg i s trati o n rev i ew pro gram i s intended to mak e s ure th at , as th e abili ty to assess ri s k evo lves and as polici es and practices change , a ll registered pesticides co ntinu e to meet the statutory stan dard. T he pu b li c phase of registration review begins whe n the initial docket is o pened for each case . Inf ormation on thi s program i s provided on the Agency's website. 1 T he FWP begins w ith any updates since the PWP was issued
. Next i s a summary of s ub s t antive comments rece ived durin g th e public co mment period for th e PWP concerning anticipated data needs , expected ri sk assess ments, or the estimated timeline id ent ified in the PWP, and a summary of the Agency ' s respo n ses to those com m ents . This section is followed by r eg i stration rev iew planned data needs , risk assessments expected to be conducted , and the projected registration review timeline for PMD. Lastly , there i s a discussion of next steps . 

### UP D ATES SINCE THE PWP WAS ISSUED The re are no additional updates on PMD s ince th e i ss uance of the PWP
. 

### SUMMARY OF COMMENTS AND AGENCY RESPONSES During t h e 60-day public comment period on the PMD PWP , which opened on January 11 , 20 16 , and closed on March 11 , 20 1 6 , th e Age nc y did not r ece ive any comme n ts concerning this case. 

### PLANNED DATA NEEDS The planned data needs h ave not c h anged from what was inclu ded in the PMD PWP.


### RISK ASSESSMENTS FOR REGISTRATION REVIEW As stated in t h e PWP , no data gaps (an ticipated data needs) for PMD have been identified. The most recent comprehensive risk assessment for PMD was completed on February 26 , 199 9 , in s upp o rt of the first biochemical registration ofPMD , which occurred in May , 2000. Because

1http s: // www.e p a.gov/p es ti c id e -r eeva lu a ti o n/r e gi s trat io n-rev i ew- p rocess 2there are no data gaps for PMD , and no ad ditional inf ormation ha s b ee n re ce ived o n thi s bioche m i ca l s ince it was fir st regi s tered , the Agenc y doe s not anticipate the ne ed to conduct a ne w ri s k assessment duri n g re g is trati on re v ie w. 

### T I MEL I NE E PA ha s cre a ted the fo ll ow i ng e s timated tim e line for the completion o f the PMD regi s t rat ion rev iew in Table 1, below. Thi s projected time line has not changed since the PWP. 

### Ta bl e 1 : Reg i s t rat i on Rev iew f or p- Me th a n e-3 ,8-d i o l (PMD)

- Proj ec t e d Reg istra t io n R eview T im e lin e Ac ti v iti es Est i mated Mo n t h lY ea r Op e nin g th e D oc k et Op e n Docket and 60-Day Publ ic Co mme nt Peri o d D ece mb e r 2015 C lose Public Co mment Period Feb ruary 2 01 6 

### Case D eve lopm e nt I ss ue Fina l Work P lan June 20 1 6 I ss ue Data Ca ll -in N/ A Data Submission N /A Open 30

- Day Public Comment Pe riod f o r Dra ft Ri s k Assessments N /A C lo se Public Co mment Period N / A 

### R eg i stratio n R ev i ew D ec i s io n Open 60-Day Pub l ic Co mment Period for Pro po sed R eg i stra tio n Review December 20 1 6 D ec i sio n C lo se Pub li c Co mme n t P e riod Fe bru ary 20 1 7 F inal Decision Jun e 20 1 7 Estimated Total (years) 1 year and 6 months*

. . 

### * T h1 s s chedule IS s ubj ec t to rev 1 s 1

o n s hou l d un fo re seen 1 ss u es an se durm g th e reg 1 s trat1on rev 1 ew proce ss. I n th e eve nt a n iss u e ari ses , s uch as the fa ilure to ac qu i re an EDS P exe mption , an am e nd ed Fin al Work Plan will be iss u ed at th at tim e. T hat Fin a l W ork Plan wi ll i de nti f y any n ewly a nti c ipated data n ee ds and set forth a new t i me lin e. 

### NEXT STEPS The Agency plan s to iss ue a Prop ose d Reg is tr ati o n R ev iew D ecision for thi s case in D e cember , 20 16
. At that tim e , a 60

- day publi c co mm ent period w ill be opened to accept co mm e nt s on the Prop ose d D ecis io n.

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