2 

### Propanil Preliminary Work Plan

– Table of Contents

OVERVIEW

................................ ................................ ................................ ................................ ... 3

ANTICIPATED DATA NEEDS

................................ ................................ ................................ .... 4

STATUT ORY AND REGULATORY AUTHORITY

................................ ................................ ... 5

CHEMICAL FACTS

................................ ................................ ................................ ...................... 6

USE AND USAGE INFORMATION

................................ ................................ ............................ 6

RECENT ACTIONS

................................ ................................ ................................ ....................... 7

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

................................ 7

TIMELINE

................................ ................................ ................................ ................................ .... 10

NEXT STEPS

................................ ................................ ................................ ............................... 11 Appendix

– Additional Areas Considered in the Propanil Registration Review

...................... 12

References:

This Preliminary Work Plan summarize s the Environmental Protection Agency's current position based on the following documents:

1. Registration Review: Preliminary Problem F ormulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Propanil . Ryan Mroz, He Zhong, and Edom Seifu. April 28, 2015.

2. Propanil: Registration Review Human Health Scoping Document

. Mohsen Sahafeyan, Evisabel Craig, and Shalu Shelat. April 23, 2015

.

3. Propanil: Tier I Review of Human Incidents. Shanna Recore and Elizabeth Evans. January 8, 2015.

4. BEAD Chemical Profile (BCP) for Registration Review: Propanil (028201) . Sunil Ratnayake, Sepehr Haddad, and Stephen Smearman. December 2, 2014.

5. Propanil (028201) Screening Level Usage Analysis (SLUA). July 18, 2014.

6. EFED Table 1 Report, Propanil (028201) . November 24, 2014.

7. HED Master Label Report, Propanil (028201). November 24, 2014.

These and other supporting documents for the propanil registration review case may be found in

the docket EPA

- HQ

- OPP

- 2015

- 0052 at http://www.regulations.gov

.3 OVERVIEW

The docket for propanil is now open , initiating the first public comment period for this registration review (docket number EPA

- HQ

- OPP

- 2015

- 0052 ) . This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about propanil

, highlighting anticipated data and assessment nee ds, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing the registration review for propanil

.

The registration review process was designed to in clude a public participation component to solicit input from interested stakeholders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows about propanil and what types of new data or other

information would be helpful for the Agency to receive as it moves toward a decision on propanil . The Agency encourages all interested stakeholders to review the PWP and Appendix and to provide comments and additional information that will help the Agency’s decision

making process for this chemical. In addition to general areas on which persons may wish to comment, there are some areas identified in the PWP and Appendix about which the Agency specifically seeks comments and information. Interested stakeholders could include : environmental non

- profit or interest groups; pesticide manufacturers; agricultural labor or commodity groups; commercial, institutional, residential, and other users of pesticides; or the public at large.

The Preliminary Work Plan begins by listing the anticipated data needs for propanil

. Next, it discusses the statutory and regulatory authority for R egistration R eview. Then the document provides chemical facts, use and usage information, recent actions, the anticipated risk assessments, and a projected registration review timeline for propanil

. Finally, the Appendix to this document includes identification and discussion of some areas that are considered generally

in R egistration R eview along with some additional chemical case

- specific information.4 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for propanil . For additional discussion of the anticipated data needs, see the Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Propanil and Propanil: Registration Review Human Health Scoping Document

.

Table 1: Anticipated D ata Needs for the Propanil Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated D ata Needs for the Parent Propanil

835.4100 Aerobic soil metabolism TGAI 24

850.6100 Environmental chemistry methods and associated independent laboratory validation for

water T GAI 24

850.2100 Avian 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 2 TEP 8

Non

Guideline (OECD 213) Acute oral toxicity to adult honey bees

TGAI 12

Non

Guideline Chronic oral toxicity to adult honey bees TGAI 1 2

Non

Guideline Chronic oral toxicity to larval honey bees including acute endpoints TGAI 12

Non

Guideline Residues in pollen and nectar TEP 24

Non

Guideline (OECD 75) Semi

- Field Testing for Honeybees TEP 24

Anticipated Data Needs for the 3,4

- DCA Degradate

835.4100 Aerobic soil metabolism DEGR 24

835.4300 Aerobic aquatic metabo l ism DEGR 24

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 A vailability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0154

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

the DCI.5 Table 1: Anticipated D ata Needs for the Propanil Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.4400 Anaerobic aquatic metabolism DEGR 24

850.6100 Environmental chemistry methods and associated independent laboratory validation for

water DEGR 24

Outstanding Data Requirements from GDCI

- 028201

- 17893 3

850.2200 Avian s ubacute d ietary t oxicity

- b obwhite

q uai l DEGR Overdue

850.4100 Terrestrial plant toxicity, seedling emergence (Tier 1) DEGR Overdue

850.4150 Terrestrial plant toxicity, vegetative vigor (Tier 1) DEGR Overdue

870.3465 90

- day inhalation toxicity TGAI Overdue
TGAI = technical grade active ingredient; TEP = typical end

- use product ; DEGR = degradate

STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program

. All pesticides distributed or sold in the United States (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Agency), based on scientific data showing that they will not cause unreasonable risks to human health or the envi ronment when used as directed on product labeling. 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 of no unreasonable adverse effects to human health or the

environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically reevaluates pesticides to make

s ure that as change occurs, products in the marketplace can be used safely. Informatio n on this program is provided on EPA’s website

. 4

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicid e, 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. The regulations governing registration review begin at 40 CFR 155.40

. T he Agency will consider benefits information and data as required 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 what it knows about the pesticide and what additi onal risk analyses and data or information it believes are needed to make a registration review decision. After

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 anticipated Regis tration Review DCI because they are already required through the earlier DCI.

4 http://www.epa.gov/oppsrrd1/registration_review/6 reviewing and responding to comments and data received in the docket during this initial comment period, the Agency will develop a F inal W ork P lan (FWP) and anticipated schedule for the registration review of propanil

.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for propanil

.

Table 2: Chemical Facts for Propanil

PC code 028201

Case Number 0226

CAS Number 709

- 98

- 8

Year first registered 1973 Pesticide Type Herbicide

Chemical class Amide

R eregistration Eligibility Decision (R E D) 2003, amended in 2006

Tolerance Reassessment Eligibility Decision (TRED) Not applicable, tolerance reassessment was included in the RED

Cumulative group Not applicable

40 CFR Citation Tolerances for propanil and its degradate are established in 40 CFR §180.274

. Dual

- use Propanil is registered for conventional pesticidal uses only and has no registered antimicrobial or biopesticidal uses.

Non

- pesticidal uses There are no identified non

- pesticidal uses of propanil

Pesticide Re

- evaluation Division, Chemical Review Manager Joel Wolf, wolf.joel@epa.gov , 703

- 347

- 0228

Registration Division

, Product Manager Reuben Baris, baris.reuben@epa.gov , 703

- 305

- 7356

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for propanil

. Please see the BEAD Chemical Profile (BCP) for Registration Review: Propanil (028201) in the registration review docket for

more details

.

Table 3 : Propanil Use and Usage Information

Summary of Use Post

- emergence herbicide to control certain grasses and broadleaf weeds in rice production. This herbicide has no residual activity.

Use Sites Agricultural Use Sites Rice is the only registered agricultural use site for propanil.

Non

- Agricultural Use Sites7 Table 3 : Propanil Use and Usage Information

There are no registered non

- agricultural use sites for propanil. Summary of Usage Based on pr ivate market usage data from 1998

- 2012, usage averaged approximately 6 million pounds active ingredient (a.i.) applied annually on 1.8 million acres treated. The average a.i. rate over this time period was 3.34 lbs a.i./acre. From 2004

- 2012 on average 45 percent of the rice crop wa s treated with propanil. Formulation Type(s) E mulsifiable concentrate liquid, water dispersible granule (dry flowable), soluble concentrate liquid, and flowable concentrate liquid Application Method(s) Typically applied as a broadcast treatment with ground boom sprayers and aerial equipment. Technical Registrant (s) RiceCo, LLC ; Willowood Propanil, LLC; ProNil, LLC No. of Registrations 41 Section 3 products 5

Restricted Use No

Guidance for Commente rs: Additi onal areas of use and usage related information requested for this registration r eview , and of particular interest to EPA, are described below.

• Certain propanil labels are unclear with respect to application parameters such as

retreatment intervals

. Without further inf ormation, EPA expects to use conservative assumptions to approximate th is parameter in order to conduct a quantitative risk

assessment. However, t he Agency will work with registrants to clarify information on propanil product labels

.

• C onfirmation of the f ollowing label information : frequency of application, application intervals, and maximum number of applications per season

.

• Typical a pplication timing (date of first application and application intervals)

– national, state, and county

.

• F oreign technical re gistrants not listed above who supply technical propanil to the US

market

.

RECENT ACTIONS

Recently, EPA has required registrants to utilize a closed

- system for their dry flowable

formulations

.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for propanil was completed i n March 2003 in preparation for the Reregistration Eligibility Decision . An addendum t o the risk assessment was completed i n June 2011

. T he most recent ecological and enviro nmental fate risk assessment was completed in March 2003 in preparation for the Reregistration Eligibility

Decision

. Additionally, a California red

- legged frog endangered species assessment was

5 Section 3 product labels can be obtained from the Pesticide Produ ct Label System (PPLS) website

( http://oaspub.epa.gov/pestlabl/ppls.home ).8 completed in 2009

. Findings and conclusions from these risk a ssessments are summarized in the Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Propanil and Propanil: Registration Review Human Health Scoping D ocument

.

During registration review, t he Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of propanil

. For human health, EPA anticipates the need to conduct revised dietary and occupational risk

assessment s during registration review

. If toxicological endpoints or points of departure are

revised based on the data that are anticipated to be required for registration review

, they will be

considered in the new a ssessment s
, as well as any changes to the standard operating p rocedures or default exposure assumptions

.

T able 4 below summarizes the anticipated registration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document

.9 Table 4: Anticipated Risk Assessments for the Propanil Registration Review

Type of Risk Assessment Conduct ? Notes

Eco logical and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms ), including endangered species Y E PA anticipates conducting an updated comprehensive ecological risk assessment during registration review. The new assessment will incorporate the most up

- to

- date modeling methodologies, updated toxicological endpoints, and data submitted under the anticipa ted registration

review Data Call

- In Notice.

Incidents Will check for updates For a discussion of reported ecological incidents for propanil , see page 1 7 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 estimates, as well as updated percent crop treated information may need to be completed to support registration review. Drinking water Y

Occupational Handlers (mixers, loaders, applicators) Y The occupational exposure/risk assessments for propanil may need to be reassessed to address updates to exposure policies, including updates to exposure data used for handler scenarios, post

application transfer coefficients, transferable residue assumptio ns, and assumptions for body weights. A

reassessment may also need to be done if changes to the toxicity endpoints or uncer tainty factors are made during registration r eview. Post

- application Y

Residential

Handlers N The re are no residential uses for propanil ; therefore, a residential exposure assessment will not be required. However, r esidential bystander exposures resulting from off

- site transport (e.g., spray drift or 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. Post

- application N

Other10 Aggregate N T here 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 reques ts to establish a

new propanil tolerance.

Incidents Will check for updates For a discussion of reported human incidents for propanil , see page 8 of the Scoping Document and

the Propanil: Tier I Review of Human Incidents

. A formal review is not planned, bu t the agency will continue to monitor incident data throughout registration review.

TIMELINE

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

review in Table 5 below

.

Table 5: Projected Propanil Registration Review Timeline

Activities Estimated Dat e Opening the Docket Open Docket and 60

- day Public Comment Period 2015

- June

Close Public Comment 2015

- August Case Development

Final Work Plan 2015

– November

Issue DCI 2016 Jan.

- March

Data Submission 2018 Jan.

- March

6 0

- day Public Comment Period for Draft Risk

Assessments 6 2019 July

– Sept.

Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review Decision 2020 Oct.

– Dec.

Registration Review Decision and Begin Post

- Decision

Follow

- up 2021

Total (years) 6

6 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, t he Agency plans to provide a 60 calendar day public comment period generally for draft risk assessment s

.11 NEXT STEPS

After the 6 0

- day public comment period closes, the Agency will review and respond to any comments received in a timely manner and then issue a Final Work Plan for the registration

review of propanil

.12 

### Appendix

– Additional Areas Considered in the Propanil Registration Review

PUBLIC COMMENTS AND FEEDBACK :

Guidance for C ommenters: The areas below highlight topics of special interest to the Agency where your comments, data submissions, or reference to sou rces of additional information c ould be of particular use.

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The Agency

will work to harmonize tolerances and international maximum residue limits (MRL s ) and may modify tolerance levels to do so, when possible

. Growers and other stakeholders are asked to

comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding

the nature of the concern.

Water Quality:

Propanil is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act

. 7 In addition, n o Total Maximum Daily Load s (TMDL) have been developed for propanil

. 8 More information on impaired water bodies and TMDLs can

be foun d at the Agency’s website

. 9 The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix

A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Bod y and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process 10
in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environment al justice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to propanil compared to the general population. Please comment if you are aware of any sub

- populations that may have atypical, unusually high exposure compared to the general population.

ENDANGERED SPECIES :

7 http://iaspub.epa.gov/tmd l_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

8 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_

group_name=PESTICIDES

9 http://www.epa.gov/owow/tmdl/

10 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm13 A risk assessment that supports a complete endangered species determination has n ot been

conducted for propanil

. The ecological risk assessment planned during registration review will allow the Agency to determine whether use of propanil has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service

and/or National Marine Fisheries Service (the Services), as appropriate.

On June 5, 2013 , the Center for Biological Diversity and the Pesticide Action Network North

America filed an amended complaint in its lawsuit in the United States District Court for the

Northern District of Californ ia, against the EPA for allegedly failing to undergo consultation

with the United States Fish and Wildlife Service and the National Marine Fisheries Service regarding the effects o f over 50 pesticides, including propanil , on over 1 00 endangered and threatened species throughout the United States (Center for Biological Diversity, et al. v. EPA, et al., No. C 11

- 00293 (N.D.Cal.)

.

A previous endangered species assessment was conducted for propanil in October 2009 . The

assessment was conducted for Calif ornia red

- legged frog.

ENDOCRINE DISRUPTOR SCREENING PROGRAM :

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmen tal and reproductive effects in different taxonomic groups. As part of its reregistration decision for propanil

, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing

hazard database. H owever, as required by FFDCA section 408(p), propanil is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide

active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening an d are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to i dentify any adverse endocrine

- related effects caused by the substance, and

establish a dose

- response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between14 October 200 9 and February 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 11 and includes some pesticides scheduled for registration review and chemicals found in water

. Neither of these lists should be construed as a list of known or likely endocrine disruptors.

For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our

website. 12

HUMAN STUDIES :

Occupational

Past propanil risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine their dermal and inhalation exposure. Many such studies, involving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide Ha ndlers Exposure Database (PHED) and the Agricultural Reentry Task Force (ARTF) Database

. EPA has reviewed all the studies supporting

these multi

- pesticide generic exposure databases, and has found no clear and convincing evidence that the conduct of any of them was eith er fundamentally unethical or significantly deficient relative to the ethical standards prevailing at the time the research was conducted. A ll applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have bee n satisfied , and t here is no regulatory barrier to continued reliance on

these studies

.

11 See http://www.regulations.gov/#!documentDetail; D=EPA

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of

chemicals.

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