### Docket Number E PA-HQ-OPP

- 20 15-00 52 www.regulations.gov



# Propanil Final Work Plan Registration Review: Initial Docket Case Number 0226

Approved by:

Date: 

# November 2015

**~~p }~**  Richard P

. Keigwin , Jr. D irector Pe sticide R e - eval u ation Di v ision

### INTRODUCTION This i s the Environmental Protection Agency's (EPA or the Agency) Final Work Plan (FWP) for the registration re v iew of propanil. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the propanil registration review docket (EPA-HQ-OPP-2015-0052). Propanil is a post

- emergence herbicide used to cont rol certain grasses and broadleaf weeds in rice production

. It i s onl y regis tere d for use in agricultural rice production and is not used in any residential , commercial , institutional , or industr i a l areas. The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered pest icide every 15 years to determine whether it continues to meet the FIFRA standard for registration. Changes in science, public policy , and pesticide use practices occur over time

. The registration review program is intended to make sure that , as the ability to assess risk evo lves and as po li cies and practices change , all registered pesticides continue to meet the statutory stand ard. The public phase of registration review begins when the initial docket is opened for eac h case. In fo rm ation on this program is provided on the Agency's website

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### The FWP begins with any updates since the PWP was issued. Next is a summary of substantive comments received during the public comment period for the PWP concerning anticipated data needs , expected risk assessments, or th e estimated time line identified in the PWP , and a summary of the Agency ' s respons es to those comments. This section is followed by registration rev iew planned data n eeds, ri sk assessments expected to be co ndu cted , and t he projected registration rev iew time line for propani l. Lastly , there i s a discussion of n ext steps
. UPDATES SINCE THE PWP WAS ISS UE D There are no additional updates on propanil since the PWP. SUMMARY OF COMMENTS AND AGENCY RESPONSES During the 60-day public comment peri od on the propanil Preliminary Work Plan, which opened on June , 25th 2015 and closed on August 24th 2015 , the Agency received five public comments. Comments concerning future endangered species consultations were provided by the Center for Biological Div ersity. The City of Sacramento Department of U tilities reminded the EPA to thoroug hl y review the implications of propanil on ri ce w ith regards to its potential to affect drinking water. The Californi a Rice Commiss io n p r ovided useful information about propanil use in California, and the USA Rice Federati on provided usage data from all USA Rice member states. RiceCo , one of the technical registrants , provided usage information fo r all states in which propani l is currently registered. Several commenters did not think po lli nator studies were necessary because ri ce is se lf

- pollenated. However, the Agency d id not co ncur because pollinators could be exposed adjacent to rice fields

. The comments do not address the timeline described in the PWP, but they do address the planned ecological and human health risk assessments and data requirements. In the PWP , E PA a lso solicited comments on the spec ific

1 http: //www.epa.gov/opp s rrd I/registration

_ review/ 

### 2topics of env i ronmental justice , water quality concerns , and trade irritants , but no comments or information were received on those issues. Public comments in their entirety are located 

### in the docket, EPA

- HQ -OPP-20 15-0052. Summarized public comments and Agency responses related to the anticipated ecological risk assessment and data needs are in the 

### Respons e to Public Comments Regarding the Registration Review Problem Formulation. The Agency thanks commenters for submission of information which wi ll be used to advise the risk assessment.

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### PLANNED DATA NEEDS Table 1 below summarizes the planned data needs for propanil based on the Preliminmy Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Propanil and Response to Public Comments Regarding the Registration Review Problem Formulation. The planned data needs have not changed from what was included in the PWP.

Table 1: Planned Data Needs for the P r opan il Reg i stration Review Estimated Gu ideline St u dy Title 1 

### Timeframe Number Test Material (Months from receipt of DCI) Data Needs for the Parent P r opanil 835.4100 Aerobic soil metabo lism TGAI 24 850.6100 Environmental chemistry methods and associated TGAI 24 independent laboratory validation for water 850.2100 A vi an acute oral toxicity with a passerine species TGAI 12 850.3040 Full-Field testing for pollinators TEP 24 870.6200 Acu te neurotoxicity TGAI 12 875.2100 Dislodgeable foliar residue in rice TGAI 12 875.1100 ? Dermal exposure-outdoor TEP 8 Non- Acute oral toxicity to adult honey bees TGAI 12 Guideline

(OECD

213) Non- Chronic oral toxicity to adu l t ho ne y bees TGAI 12 Guideline Non- Chronic oral toxici ty to larval honey bee s TGAI 12 Guideline in c luding acute e ndpoints Non- Residues in pollen and nectar TEP 24 Guide line Non- Semi-Field Testing for Honeybees TEP 24 Guide line

(O ECD

75)

1 On June 27, 2012, EPA announced certain rev is ion s in harmonized guideline series 850

- Ecological Effects Tests

- including renumbering and other designations or changes for some guideline studies. See "F inal Test Guidelines; OCSPP 850 Series ; Notice of Availability " 77 FR 38282 , June 27 , 2012

. http: //www.regulations.gov /# !documentDe tail;D = EPA -HQ-OPPT -2009-0 154-0028 2 This study was requested as part of the RED DCI and while information was submitted, there are still uncertainties

associated with dermal exposu r e , so add iti onal st ud y data is still being requested. For those systems determined to be closed systems or closed system equivalent , th e registrant s hould su bmit a waiver request to EPA at the time of the DCI. 

### 4

### Tab le 1: P l anned Data Needs for the Propanil Reg istr ation Review Estimated G uideline Study Tit le 1 

### Timeframe Nu mber Test Material (Months fro m recei pt ofDCI)
·, 

# . Data Needs for the 3,4-DCA Degradate 835.4100 Aerobic soi l metaboli sm DEGR 24 835.4300 Aerobic aquatic metabol i sm DEGR 24 835.4400 Anaerobic aquatic metaboli s m D EG R 24 850 .6100 Environmental chemistry method s and associated DEGR 24 independent laboratory validation for water 

### Outstanding Data Requirements fro m GDCI

- 028201-07893 3 850.2200 Avian subacute dietary toxicity

- bobwhite DEGR Overdue quail 850.4100 Terrestrial plant toxicity, seedling e mergence DEGR Overdue (Tier I) 850.4150 Terrestrial plant toxici ty, vegetative vigor (Tier I) DEGR Overdue 870

. 3465 90-day inhalation toxicity TGAI Overdue TGAI = technica l grade active mgredient ; TEP = typical e nd-u se product ; DEGR = degradate

3 The stu di es li sted in this section were previously require d through a generic data call-in issued in April 2006 and are still outstanding. These st udi es wi ll not be included in the ant i c ipated Registration Review DC! because they are already requ ired through the earli er 

### ocr. 5

### RISK ASSESSMENTS FOR REGISTRATION REVIEW 

### During registration review , the Agency will conduct a comprehensive eco logical risk assessment , including an endangered species assessment , for all uses ofpropanil. For human health, EPA will conduct revised dietary and occupational risk assessments during registration review. If toxicological endpoints or points of departure are revised based on the data that are required for regis tration review , they will be cons idered in the new assessments, as well as any changes to the standard operating procedures or default exposure assumptions. Table 2 below summarizes the planned registration review risk assessments based on the Problem Formulation and Scoping Document. The planned assessments have not changed from what was included in the PWP.



### 6Tab l e 2: P l a nn ed Risk Assess m e n ts fo r t h e propa nil Regis t rat ion Review Type of Risk Assessment C on du c t? Notes 

### EcO I«»gi cal and Environmental F ate Comprehensive ecological y See the document R egistration Review : Preliminary (species to be assessed Problem Formulation for Environmental Fate, include terrestria l and aquatic Ecological Ri sk, Endangered Species, and Drinking organisms) , including Water Exposure Assessments for Propanif for additional endangered species details. The new assessment wi ll incorporate the most up-to-date modeling methodologies , updated toxico l ogical endpoints, and data submitted under the anticipated regis tration review Data Call-ln Not ice.

Incidents Will check for For a discussion of reported ecologica l incidents for updates propanil , see page 17 of the Problem Formulation

. A formal review is not planned , but the agency will cont inue to monitor incident data throughou t registration review

. 

### H

uman H ealth Dietary



### - Food y An updated dietary exposure and risk assessment, which incorp orates changes to points of departures and unc e rta inty factors, includes updated drinking water Drinking water y estimates, as well as updated percent crop treated information may need to be completed to support re g istration review

. Occupational 

## - Hand lers (mixers, loaders , y The occ upational exposure/risk assessments for propanil app licators) may need to be reassessed to address updates to exposure policies , including updates to exposure data used for handler scenarios , post-application transfer Post-application y coefficients , transferab l e residue assumptions , and assumptions for body weights. A reassessment may also need to be done if changes to the toxicity endpoints or uncertainty factors are mad e during registration r eview

. Residential/Occupational Handlers 

### N There are no residential uses for propanil ; therefore , a re s idential exposure assessment w ill not be required. However , non- oc cupational bystander exposures resulting from off

- site transport (e.g. , spray drift or Post-application N volat i li zat ion) may occur as a result of applicat i ons of propanil. EPA is currently evaluating these types of exposures and wi l l examine the need for spray dri ft and volatilization assessments for propanil during registration review

. Other
7Aggregate N Th ere are c urrent l y no res identi a l uses for propanil; therefore the prop anil aggregate ri sk assessment includes on ly dietar y exp osure (food and wate r ) which may need to be updated

. Cumula t ive N Propanil has not been identified as a member of a cumu l ative gr oup that shares a com m on mec hanism of toxicity. Toleranc es N T oler ances a r e establ ished under 40 C FR 

### § 180. 274 for the combined residues of the herbicide pro panil (3' , 4'

- dichloropropionanilide) and it s metabolites convert ibl e to 3 , 4-dic hl oroan iline (3 , 4 -D CA). At thi s time , there are no pending requests to estab lish a new propanil tolerance. Incidents Will check for For a discussion of reported human incid ents for updates propani l, see page 8 of the Scop in g Document and the Propanil: Tier I Review of Human Incidents. A forma l review is not p l anned, but the age ncy w ill continue to monitor incident data thro ughout reg istrat i on review. 

### TIMELINE
E P A has created the following estimated timeline for the completion of the propanil registratio n review in Tab l e 3 bel ow . The pro j ected tirneline has not changed since the PWP

. 

### Table 3 : Registration Review for Propanil- Projected Registration Review Timeline Activities Estimated Date Opening the Docket Open Docket and 60 -d ay Public Comment Period June 2015- Completed C lose Public Comment August 20 15

- Completed Case Development Final Work Plan November 20 15 - Completed Issue DCI January

- March 20 16 Data Submission January-March 20 18 60 -d ay Public Comment Period for Draft Risk Assessments4 Ju ly

- September 2019 Registration Review D ecis ion 60-day Public Comment Period for Proposed Registration R ev iew October- December Decision 2020 Registration Review D ecis i o n and Begin Post-Decision Fo ll ow-up 2021 T otal (years) 6

4 T he regulations governing Re gistration Review ge nerall y require the Agency to provide a public comment period

of at least 30 calendar days for draft ri sk assessments; see 40 CFR Part 155.53(c). For conventional pesticides , the Agency plans to provide a 60 calendar day pub li c comment period gene rally for draft r isk assessments. 

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# .

### Docket Number EPA-HQ-OPP-20 15-0052 www.regulations.go v
NEXT STEPS 

### As noted previously , the Agency plans to require se veral environmental fate , ecological effects , and human health studies for propanil through a Data Call

- In Notice , expected to be issued by March of2016.