### D oc ke t N um be r E PA -HQ-OPP- 2 0 1 5- 0 4 00 www. reg ul a t io n s.gov



# Amicarbazone F inal Work Plan Registration Review

Case N umber 7269
Februa ry 2016

A ppro ve d b y :



### D a te:

### INTRODUCTION This is the E n v iromnental Protection Age n cy's (EPA or the Age nc y) F inal Work Plan (FWP) for the registratio n review of amicarbazone. This wo r k plan add resses pub li c com m e nt s received co n cerni n g th e Pre limin ary Work Plan (PWP), which was posted in th e amicarbazone registration r ev iew docket (EPA-HQ- OP P-20 1 5 -0 400)
. Amica rbazone , 4-amino-N-( 1 , 1

- dimethylethyl)-4,5-dihydro-3-(1-methylethyl)-5-oxo-1 H -1 ,2,4 -tri azo le -1- carboxam id e , is a select ive herbicide that acts through the inhib it io n of photosynthesis
. 

### It is r eg i stered for use as a preplant , preemergence , o r postemergence application to field com for selective control of broad leaf weeds. It i s also u sed fo r co n trol of broad leaf weeds on turf , C hri stmas tree farms , conifers in nurseries , and n on - crop areas . To lerances are estab li shed in 40CFR § 18 0.615 fo r res idu es in or on fie ld com , li vestock commod iti es , and rotational crops. The Age n cy i s implementing the registration review program pursuant to Sect ion 3(g) of the Federal Insectic id e, Fungicide, and Rodenticide Act (FIFRA), an d will rev iew eac h re g i stered pesticide eve r y 15 years to determine w h ether it continues to meet the FIFRA standard for registrati on. Changes in science , public policy , and pesticide u se practices occ ur ove r t im e . T h e r eg i st rat io n review program i s intended to m ake sure th at, as th e ability to assess r i sk evo lves a nd as po li cies and practices change , a ll registered pesticides continue t o meet the s tatu tory s t a nd a rd
. T h e public p h ase of reg i stration review begins when th e initial docket i s ope n ed fo r eac h case. Infor m atio n on this p rogra m i s provided on the Agency ' s websi te.' The FW P begins with any up dates s ince the PWP was issued. Nex t is a su mm ary of substa n t ive comments received during th e public comment period fo r the PWP concerning anticipated data n eeds , expected ri s k assessme nt s, o r the est im ated time lin e id entified in the PWP , and a summary of the Agency ' s responses to th ose comments . This sec ti on i s followed by reg i strat i on r ev iew planned data needs , risk assessments expected to b e cond u cted, a n d the projected reg i strat io n review t im e lin e fo r a mi carbazone. Lastl y, th ere is a discussion of next steps. 

### UPDATES SINCE THE PWP WAS ISSUED There are no add it io n al u pdates on amicarbazone since the PWP (Sep tember 2015). 

### SUMMARY OF COMMENTS AND AGENCY R ES PONSES During the 60

- day public co mm ent period on the am icarbazo n e PWP, wh ich opened on October 2, 20 15 and closed on D ecembe r 2 , 2015 , the Agency received a public co mm ent fro m one stakeholde r . The comment was submi tt ed by the Cente r for Biologica l Di ve r sity. T h e comment does not add ress the t im e lin e described in the PWP or th e planned human health risk assessmen ts and data r equ ireme n ts . It does add r ess the planned eco log ica l r i sk assessment. Co n s id e r at io n of thi s commen t did not resu lt in any c h anges to the data the Agency ant ic ip a tes requiring fo r the amicarbazo n e registration rev iew or the planned ri sk assessments. In the PWP, E PA also so li c ited comments on the spec ifi c top i cs of e n v ironm e nt al justice, wate r q u ality concerns, and trade irr itants, but no commen t s or infonnation were received on th ose issues.

1 http ://www 2
.cpa. gov/ pc s li c idc-rc ev aluali o n 

### 2Su mm arized below is the sole publ ic comment received on the amicarbazone PWP. The comment in its entirety is located in the docket. 

### Comment submitted by the Center for Biological Diversity (CBD) in EPA -HQ-O PP -201 5 - 0400-0007 . Comment: 

### The CBD focuses on the EPA ' s duty under the Endangered Species Act (ESA ) to consult w ith the U.S. 

### Fish and Wildlife Serv i ce and the National Marine Fisher ies Service (the Services) on the registration review of amicarbazone. Response: EPA plans to address many of the concerns raised by CBD as part of the implementation plan for assessing the risks of pesticides to listed species based on the recommendations ofthe April 20 1 3 National Academy of Sciences (NAS) report, ava il ab le at http: // vvww.nap.edu/ catalog.php ? record_id = 18344. EPA will address concerns specific to amicarbazone in connec ti on with the development of its registration review dec i sion for am i carbazone
. The NAS r eport outlines recommendations on specific scienti fic and technical issues re lated to the development of pest ic id e ri sk assessments that EPA and the Services must conduct in connecti on with their ob li gations under the ESA and FIFRA. At this t im e , EPA has not fu ll y developed its risk assessment process for listed species. In November 2013, the EPA , a long wit h the Serv ices and the U.S
. Department of Agricu lture , re leased a summary of their joi nt In terim Approac h es for assessing ri sks to listed spec i es from pest ic id es (see the wh ite paper " Interim Approaches for Nationa l- Leve l Pesticide Endangered Species Act Assessments Based o n the Recommendations of the National Academy of Sciences Apri l 20 1 3 Report," availab l e at http: // www.epa.gov / espp/ 2013 / nas.html). T h e Interim Approaches were developed by the Agenc ies in response to the NAS recommendations , a nd reflect a common approach t o risk assessment shared by the Agencies as a way of address in g sc i ent i fic differences between the EPA and the Services. The j oint Interim Approaches we r e released prior to a stake h older workshop held on November 1 5 , 2013 . I n addition, the EPA presented the joint Interim Approac h es at the December 2013 Pesticide Program Di alogue Committee and State

- F I FRA I ssues Research and Evaluation Group meetings , allow in g additiona l opportunities for stakeho lders to commen t. As part of a p h ased , iterative process for furt her deve lopment of the Interim Approaches, the Age n cies w ill a l so cons id er public comme n ts on the Interim Approaches in the con text of upcoming registration review decisions.

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### PLANNED DATA NEE DS Tab le l below summa ri zes th e planned data needs [or amicarbazone based on th e Amicarbazone Problem Formulation for R eg istration Review 

### and Amicarbazone Scoping Document and Draft Human Health Risk Assessment for Registration Rev iew. 

### The planned data needs have not changed from what was included in the PWP. Table 1 : Planned Data Nee d s for th e A micarb azo n c Re g is trat io n R ev i ew
Guideline Study Title Te st Number Mate rial 1


### P l anned Dat a Needs for Amicarbazone 835.4200 A na erobic soil metaboli sm 835.4300 Aerobic aquatic metaboli sm 835.4400 Anaerobic aquatic metabolism 850.2100 A vi an ora l toxicity (passerine spec ies) Special Study 2 

### Honey bee larvae acute oral toxicity (Tier I) Special Study Ho ne y bee adult chro n ic ora l toxicity (Tie r 1) Special Study Honey bee larvae c lu·onic ora l (Tier I) toxicity Special Study Field trial of residues in pollen and (Tier 2) necta r Special Study 3 

### Semi-field testing for pollinators (Tier 2) (tunne l or colony feeding s tudies) 850.3040 Field testing fo r po llin ators (T ier 3) 860.1900 4 

### Field rotationa l crops 1 TGAI = tc chn1cal grade acuve 1n g rcd1cnt; TE P = typ1cal e nd-u sc product 2 I Ioney bee acute l arva l toxicit y test protocol available thr oug h OECD TG 237 3 Sem i-field tunnel study protocol avai lable throu gh OECD Guidance 75 

### TGAI TGAI TGAI TGAI TGA I TGAI TGAI T EP TEP TEP T EP Esti m a ted Timeframe

(Months from receipt ofDCI) 24 24 24 12 12 12 12 12 24 24 36

4 lfth e re g is trant wishes to retain root and tuber vegetab l es a s rota ti onal crops, additional tlc l d rotationa l crop data are needcd
.



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### R I SK ASSESSMENTS FO R REG I STRATION REV I EW The most recent dietary (food and drinking water) exposure and risk assessment for amicarbazone was completed in June 2015
. The most recent eco logical and environmental fate risk assessment was conducted in Apri l 2005. Findings and conclusions from these risk assessments are summarized in 

### Amicarbazone. Scoping Document and Draji Human Health Risk Assessment for Registration Review and 

### Amicarbazone Problem Formulation for Registration Revie'vv
. During registration review, the Agency will conduct a comprehens ive ecological r i sk assessment, including an endangered species assessment , for all uses of amicarbazone. The Agency intends to consider the need for bystander drift and volatilization human health risk assessments . In addition, if toxicological endpoints or points of departure are revised based on the data that are required for registration rev iew, they will be considered in the new assessments , as will any changes to the standard operating procedures o r default exposure assumptions
. Table 2 below summarizes the planned registration review risk assessments . The planned assessments have not changed from what was included in the PWP.



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### T a b l e 2: Pl a nned Ri s k A ss e ss ment s for th e A mi ca rb az on e Re gi s tration Review T y pe o f Ri s k Assess ment C onduct ? N otes E colo2ica l and E nvironmental Fate Comprehensive ecological 

### y The Agency will conduct a comp reh ensive eco logica l (species to be assessed risk assessment for the parent amicarbazone , include terrestrial and aquatic including an endangered species assessment. organisms), including endangered species I nc iden ts Will c heck for Fo r a d isc ussion of rep011ed eco logica l incide nts for updates am icarbazone, see page 19 

### of th e Prob lem Formu la ti on . Human Health ' ... -· 

### Dietary Food N 

### A new d ietary (food) risk assessment is not ant ic ipated to be needed during reg istration review
. Dri nking water N 

### A new drinking water risk assessment is not anticipated to be needed dur ing regist ration rev iew unless there are significant i ncreases to the drinking water exposu re es timates. Occupatio nal Handlers ( mixers , loaders, N 

### A new occupationa l handler risk assessment is not applicators) anticipated to be needed during registration review. Post-appl ication N 

### A new occupational post-application exposure is not anticipated to be needed during regis tration review. Residen t ial Handlers N 

### A new res i dent i a l handler exposu r e assessment is not an ticipated to be needed d uri ng registrati o n review. Post-app li ca ti on 

### y Du r i ng reg istrat io n r ev iew, t h e Age ncy w ill determ i ne if data (e.g., 

### .flux stud ies) or fUJ1h er a nalys i s i s req ui red fo r a bys tande r ri sk assess men t. O th e r Aggregate N 

### A new agg r egate assessment is not anticipated to be needed un less there are changes in endpo ints, PO D s , or other components of aggregate risk. Cumulative N 

### EPA has not made a common mechanism oftoxicity finding for amicarbazone and any other substances; and amica rbazone does not appear to produce a tox ic metabolite produced by other substances
. Tole rances 

### y If the regis trant chooses to 

### support the root and tube r vegetab le plant-back timeframes through data submission , the Agency will review those data and propose any n ecessary changes to the tolerances for such crops.



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### Incident s Will check for There h ave been no reported human incidents for updates am icarbazone; see page 35 of the Scoping D oc um ent/ Draft Ri s k Assessme nt and Amicarbazone: Tier 1 (Scoping) Review of Human In c id e nt s . T IM E LI NE 

### EPA ha s created the following estimated timel ine f o r th e co mpletion of the amicarbazone reg is tra tion rev iew in Table 3 be l ow. The projected timeline ha s not changed since the PWP
. T a bl e 3: Re g is tration Review for A micarb azonc - Projecte d Re g i s tration Revi ew Timelinc Activitie s E stimated Date 

### Open ing the Docke t Op e n Dock et and 60-day Pub li c Commen t Period Septembe r 20 15

- Comp leted C lose Public Co mment November 20 I 5

- Completed Case Deve lopme nt Fin a l Work Plan F e brua ry 2016 Issue D C I Apri l

- June 2016 Data S ubm i ss io n April- June 20 19 60 -d ay Publi c Comment Perio d for Draft Risk Assessme nts 2 

### October

- December 2020 Re g is tration Rev iew Decision 60-day Pub li c Co mment Period for Proposed Regi s trati o n Rev iew July- September Deci s ion 2021 R

eg istra tion Review Dec ision a nd Beg in Post
- Dec is ion Fo ll ow-up 2021 Tota l (years) 6 NEXT S T E PS 

### As noted prev iou s ly , the Agency p la n s to require seve ra l environmental fate, ecological effects , and re s idu e s tudie s for am icarbazone through a Data Call- I n Notice, expected to be issued in April

- Jun e 20 16
.

1 T h e re g ulm ions gove rn ing Rcgi s trnti on Review ge nerall y requ ire th e Agency to prov ide a publ ic com m e nt period of at l eas t 30 calendar d ays l o r dmli ri sk ass ess ments ; sec 40 CFR Pan 1 55
. 53(c)
. For co nventi o nal pes ti cides, th e Age n cy plnn s 1 0 provide a 60 ca l e ndar day pub l ic co rnn1 c 1 H peri o d gc n crn ll y for draft ri s k assessmen t s . 

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