Docket Number EPA-HQ-OPP-2015-0052 

www.regulations.gov 

Propanil Final Work Plan 

Registration Review: Initial Docket 

Case Number 0226 

Approved by: 

Date: 

November 2015 

~~p }~ Richard P. Keigwin, Jr. 

Director 

Pesticide Re-evaluation Division 
INTRODUCTION 

This is the Environmental Protection Agency's (EPA or the Agency) Final Work Plan (FWP) for 

the registration review 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 

control certain grasses and broadleaf weeds in rice production. It is only registered for use in 

agricultural rice production and is not used in any residential, commercial, institutional, or 

industrial 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 

pesticide 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 evolves and 

as policies and practices change, all registered pesticides continue to meet the statutory standard. 

The public phase of registration review begins when the initial docket is opened for each case. 

Information 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 the estimated timeline identified in the PWP, and a 

summary of the Agency's responses to those comments. This section is followed by registration 

review planned data needs, risk assessments expected to be conducted, and the projected 

registration review timeline for propanil. Lastly, there is a discussion of next steps. 

UPDATES SINCE THE PWP WAS ISSUED 

There are no additional updates on propanil since the PWP. 

SUMMARY OF COMMENTS AND AGENCY RESPONSES 

During the 60-day public comment period 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 Diversity. The City of Sacramento Department of Utilities reminded the EPA to 

thoroughly review the implications of propanil on rice with regards to its potential to affect 

drinking water. The California Rice Commission provided useful information about propanil use 

in California, and the USA Rice Federation provided usage data from all USA Rice member 

states. RiceCo, one of the technical registrants, provided usage information for all states in which 

propanil is currently registered. Several commenters did not think pollinator studies were 

necessary because rice is self-pollenated. However, the Agency did not concur 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, EPA also solicited comments on the specific 

1 http://www.epa.gov/oppsrrd I /registration _review/ 

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topics of environmental 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 Response to Public Comments Regarding the Registration 

Review Problem Formulation. The Agency thanks commenters for submission of information 

which will 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 Propanil Registration Review 

Estimated 

Guideline Study Title1 Timeframe 

Number Test Material (Months from 

receipt of DCI) 

Data Needs for the Parent Propanil 

835.4100 Aerobic soil metabolism 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 Acute 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 lt honey bees TGAI 12 

Guideline 

Non- Chronic oral toxicity to larval honey bees TGAI 12 

Guideline including acute endpoints 

Non- Residues in pollen and nectar TEP 24 

Guideline 

Non- Semi-Field Testing for Honeybees TEP 24 

Guideline 

(OECD 

75) 

1 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850 - Ecological Effects Tests 

- including renumbering and other designations or changes for some guideline studies. See "Final Test 

Guidelines; OCSPP 850 Series; Notice of Availability" 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;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 exposure, so additional study data is still being requested. For those systems determined to 

be closed systems or closed system equivalent, the registrant should submit a waiver request to EPA at the time of 

the DCI. 

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Table 1: Planned Data Needs for the Propanil Registr ation Review 

Estimated 

Guideline Study Title1 Timeframe 

Number Test Material (Months from 

receipt ofDCI) ·, . Data Needs for the 3,4-DCA Degradate 

835.4100 Aerobic soil metabolism DEGR 24 

835.4300 Aerobic aquatic metabolism DEGR 24 

835.4400 Anaerobic aquatic metabolism DEGR 24 

850.6100 Environmental chemistry methods and associated DEGR 24 

independent laboratory validation for water 

Outstanding Data Requirements from GDCI-028201-078933 

850.2200 Avian subacute dietary toxicity - bobwhite DEGR Overdue 

quail 

850.4100 Terrestrial plant toxicity, seedling emergence DEGR Overdue 

(Tier I) 

850.4150 Terrestrial plant toxicity, vegetative vigor (Tier I) DEGR Overdue 

870.3465 90-day inhalation toxicity TGAI Overdue 

TGAI = technical grade active mgredient; TEP = typical end-use product; DEGR = degradate 

3 The studies listed in this section were previously required through a generic data call-in issued in April 2006 and 

are still outstanding. These studies will not be included in the antic ipated Registration Review DC! because they are 

already required through the earlier ocr. 

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RISK ASSESSMENTS FOR REGISTRATION REVIEW 

During registration review, the Agency will conduct a comprehensive ecological risk assessment, 

including an endangered species assessment, for all uses of propanil. 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 

registration review, they will be considered 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. 

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Table 2: Planned Risk Assessments for the propanil Registration Review 

Type of Risk Assessment Conduct? Notes 

EcOI«»gical and Environmental Fate 

Comprehensive ecological y See the document Registration Review: Preliminary 

(species to be assessed Problem Formulation for Environmental Fate, 

include terrestrial and aquatic Ecological Risk, Endangered Species, and Drinking 

organisms), including Water Exposure Assessments for Propanif for additional 

endangered species details. The new assessment will incorporate the most 

up-to-date modeling methodologies, updated 

toxicological endpoints, and data submitted under the 

anticipated registration review Data Call-ln Notice. 

Incidents Will check for For a discussion of reported ecological incidents for 

updates propanil, see page 17 of the Problem Formulation. A 

formal review is not planned, but the agency will 

continue to monitor incident data throughout 

registration review. 

Human Health 

Dietary - Food y An updated dietary exposure and risk assessment, which 

incorporates changes to points of departures and 

uncertainty factors, includes updated drinking water 

Drinking water y estimates, as well as updated percent crop treated 

information may need to be completed to support 

registration review. 

Occupational -

Handlers (mixers, loaders, y The occupational exposure/risk assessments for propanil 

applicators) 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, transferable 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 made during registration review. 

Residential/Occupational 

Handlers N There are no residential uses for propanil; therefore, a 

residential exposure assessment will not be required. 

However, non-occupational bystander exposures 

resulting from off-site transport (e.g., spray drift or 

Post-application N volatilization) may occur as a result of applications of 

propanil. EPA is currently evaluating these types of 

exposures and will examine the need for spray drift and 

volatilization assessments for propanil during 

registration review. 

Other 

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Aggregate N There are currently no residential uses for propanil; 

therefore the propanil aggregate risk assessment 

includes only dietary exposure (food and water) which 

may need to be updated. 

Cumulative N Propanil has not been identified as a member of a 

cumulative group that shares a common mechanism of 

toxicity. 

Tolerances N Tolerances are established under 40 CFR § 180.274 for 

the combined residues of the herbicide propanil (3', 4'-

dichloropropionanilide) and its metabolites convertible 

to 3, 4-dichloroaniline (3, 4-DCA). At this time, there 

are no pending requests to establish a new propanil 

tolerance. 

Incidents Will check for For a discussion of reported human incidents for 

updates propanil, see page 8 of the Scoping Document and the 

Propanil: Tier I Review of Human Incidents. A formal 

review is not planned, but the agency will continue to 

monitor incident data throughout registration review. 

TIME LINE 

EPA has created the following estimated timeline for the completion of the propanil registration 

review in Table 3 below. The projected 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-day Public Comment Period June 2015- Completed 

Close Public Comment August 20 15 -

Completed 

Case Development 

Final Work Plan November 20 15 -

Completed 

Issue DCI January-March 2016 

Data Submission January-March 20 18 

60-day Public Comment Period for Draft Risk Assessments4 July-September 

2019 

Registration Review Decision 

60-day Public Comment Period for Proposed Registration Review October-December 

Decision 2020 

Registration Review Decision and Begin Post-Decision Follow-up 2021 

Total (years) 6 

4 The regulations governing Registration Review generally require the Agency to provide a public comment period 

of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pesticides, the 

Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments. 

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' ' . 
Docket Number EPA-HQ-OPP-20 15-0052 

www.regulations.gov 

NEXT STEPS 

As noted previously, the Agency plans to require several environmental fate, ecological effects, 

and human health studies for propanil through a Data Call-In Notice, expected to be issued by 

March of2016.