2



### Diclofop

- methyl Preliminary Work Plan

– Table of Contents

OVERVIEW

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

ANTICIPATED DATA NEEDS

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

ST ATUTORY AND REGULATORY AUTHORITY

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

CHEMICAL FACTS

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

USE AND USAGE INFORMATION

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

RECENT ACTIONS

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

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

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

TIMELINE

................................ ................................ ................................ ................................ ...... 9

NEXT STEPS

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

References:

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

1. EFED Registration R eview Problem Formulation for Diclofop

- methyl

. N.E. Federoff and Greg Orrick

. August 28 , 2014

.

2. Diclofop

- methyl: Human Health Assessment Scoping Document in support of Registration Review

. Shiela Piper, Yung Yang, and Monica Hawkins

. August 5 , 2014

.

3. Diclofop

- methyl: Tier 1 Review of Human Incidents

. Shanna Recore

. May 29, 2014

.

4. BEAD Chemical Profile (BCP) for Registration Review: Diclofop

- methyl (110902)

. Bill Phillips, Jihad Alsadek, and Michelle Ranville

. April 29, 2014

.

5. Diclofop

- methyl (110902) Screening Level Usage Analysis (SLUA). March 1 4, 2014

.

These and other supporting documents for the diclofop

- methyl registration review case may be found in the docket EPA

- HQ

- OPP

- 2014

- 0577 at http://www.regulations.gov

.3

OVERVIEW

The docket for diclofop

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

- HQ

- OPP

- 2014

- 0577 )

. Diclofop

- methyl is a restricted

use, selective systemic herbicide with contact action registered for the control of wild oats and grassy weeds

. The agricultural uses of diclofop

- methyl include wheat and barley, and non

agricultural uses include golf course turf and roadsides. There are no registered residentia l uses

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

- methyl

, highlighting anticipated data and assessment needs, 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 diclofop

- methyl

.
The registration review process was designed to include a public participation component to solicit input from interested s takeholders. The Agency intends, b y sharing this information in the docket, to inform the public of what it knows about diclofop

- methyl and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decisio n on diclofop

- methyl . The Agency encourages all interested stakeh olders 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; pesticid e 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 diclofop

- methyl

. Next, it d iscusses 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 diclofop

- methyl

. Fi nally, 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

Tab le 1 below summarizes anticipated data needs for diclofop

- methyl . For additional discussion of the anticipated data needs, see the EFED Registration R eview Problem Formulation for Diclofop

- methy and Diclofop

- methyl: Human Health Assessment Scoping Documen t in support of Registration Review

.

Table 1: Anticipated Data Needs for the Diclofop

- methyl Registration Review

Guideline Number 1 Study Title 1 Test Material Estimated Timeframe (Months from receipt of DCI)

Anticipated D ata Needs for the Parent Diclofop

- methyl ( ester)
835. 4300 Aerobic aquatic metabolism: two systems T GAI 24
8 35

. 44 00 Anaerobic aquatic metabolism: one system TGAI 24
850. 1025 Oyster acute toxicity test (shell deposition) TGAI 12
850. 1035 Mysid acute toxicity test TGAI 12
850.1075 Fish acute toxicity test, marine TGAI 12
850.3020 Honeybee acute contact toxicity TGAI 12
Non GLN Pollinator acute oral toxicity (honeybee adult) TG AI 12
Non GLN Pollinator acute oral toxicity (honeybee larvae) TG AI 12
850. 4500 Algal Toxicity TGAI 12
850. 4550 Cyanobact er ia Toxicity (Anabaena flos

- aquae) TGAI 12

850. 6100 Environmental chemistry method and associated

independent laboratory validation , water TGAI 12

875.2100 Foliar dislodgeable residue dissipation

– t urf

t ransferrable r esidue TGAI 24

875.2100 Foliar dislodgeable residue dissipation

–

d islodgeable f

oliar r esidue (wheat, barley) TGAI 24

Anticipated Data Needs for the diclofop acid

850. 6100 Environmental chemistry method and associated

independent laboratory validation

, water TGAI 12

TGAI = technical grade active ingredient; TEP = typical end

- use product ;

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 Guideline s; OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0154

- 00285

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

. 2

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. The regulations governing registration review begin at 40 CFR 155.40

. T he Agency will consider benefits information and data as required b y 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 additional risk analyses and data or information it believ es are needed to make a registration review decision. After 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 registrat ion review of diclofop

- methyl

.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for diclofop

- methyl

.

Table 2: Chemical Facts for Diclofop

- methyl
PC code 110902 Case Number 2160 CAS Number 51338

- 27

- 3 Year first registered 1982 Pesticide Type Herbicide Chemical class Aryloxphenoxypropionate R eregistration Eligibility Decision (R E D) 9/1/2000

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

Cumulative group Not applicable; diclofop

- methyl has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.

2 http://www.e pa.gov/oppsrrd1/registration_review/6 Table 2: Chemical Facts for Diclofop

- methyl
40 CFR Citation Tolerances for diclofop

- methyl are established in §180.385

. Dual

- use Diclofop

- methyl is registered for conve ntional pesticidal uses only and has no registered antimicrobial or biopesticidal uses

. Non

- pesticidal uses There are no identified non

- pesticidal uses of diclofop

- methyl. Pesticide Re

- evaluation Division, Chemical Review Manager Marianne Mannix, mannix.marianne@epa.gov , (703) 347

- 0275

Registration Division

, Product Manager Kathryn Montague, montague.kathryn@epa.gov , ( 703 ) 305

- 1243

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for diclofop

- methyl

. Please see the BEAD Chemical Profile (BCP) for Registration Review: Diclofop

- methyl (110902) in the registration review docket for more details

.

Table 3: Diclofop

- methyl Use and Usage Information Summary of Use Diclofop

- methyl is an acetyl CoA carboxylase inhibitor that can be applied both preemergence and postemergence to control wild oats and grassy weeds. Use Sites Agricultural use sites of diclofop

- methyl include barley and wheat. Diclofop

- methyl is registe red for non

- agricultural use sites

, including golf courses and roadsides. There are no registered residential uses of diclofop

- methyl. Summary of Usage Between 1998 and 2012, an average of approximately 144,000 lbs/ai of diclofop

- methyl was used on approx imately 236,000 acres treated. I n 2014, barley and wheat commodities had less than one percent crop treated (PCT) with diclofop

- methyl. This indicates that diclofop

- methyl is not heavily relied on to control weeds for these crops. U sage data related to the non

- agricultural uses (golf course turf and roadways) for diclofop

- methyl is limited and dated. Formulation Type(s) Diclofop

- methyl formulations include emulsifiable concentrate and liquid. Application Method(s) Diclofop

- methyl p roducts can be applied by aerial, groundboom, or handheld equipment. Technical Registrant (s) Bayer CropScience No. of Registrations 3 active Section 3 registrations; 1 Special Local Need registration Restricted Use Diclofop

- methyl is a restricted use pesticide due to carcinogenicity in mice.

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.7

 Certain diclofop

- methyl labels are unclear with respect to reapplication interval for use of diclofop

- methyl on golf course turf. Without further information, EPA expects to use conservative assumptions to approximate these parameters in order to conduct a quantitative risk asse ssment. However, the Agency will work with registrants to clarify information on diclofop

- methyl product labels

.

 C onfirmation of the following label information : sites of application ; formulations ; application methods and equipment ; maximum application ra tes ; frequency of application, application intervals, and maximum number of applications per season ; and geographic limitations on use

.

 U se distribution ( e.g. , acreage and geographical distribution of relevant use sites )

.

 M edian and 90 th percentile reported use rates (lbs ai/ A ) from usage data

– national, state, and county

.

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

– national, state, and county

.

 Usage/use information for non

- agricultural uses

.

 Typica l application interval (days)

.

 S tate or local use restrictions

.

 F oreign technical registrants not listed above who supply technical diclofop

- methyl to the US market

.

RECENT ACTIONS

There are no recent actions for diclofop

- methyl.

ANTICIPATED RISK ASSESS MENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for diclofop

- methyl was completed on August 10, 2000 in preparation for the Reregistration Eligibility Decision

. T he most recent ecological and environmental fate ri sk assessment was completed on March 22, 2000 and updated on July 26, 2000 for the same purpose . Findings and conclusions from these risk assessments are summarized in the EFED Registration R eview Problem Formulation for Diclofop

- methy l and Diclofop

- methyl: Human Health Assessment Scoping Document in support of Registration Review

.
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 diclofop

methyl

. For human health, EPA anticipates the need to conduct a revised dietary (drinking water only), residential, and occupational risk assessments 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 assessment 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

.8

T able 4: Anticipated Risk Assessments for the Diclofop

- methyl 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 EPA anticipates updating the ecological risk assessment including a complete endangered species determination.

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

diclofop

- methyl , see page 15 of the Problem Formulation. Human Health Dietary Food N If the drinking water concentrations increase significantly, a revised dietary risk assessment may be needed

. Drinking water Y EPA anticipates u pdat ing the drinking water
assessment

. Occupational Handlers (m ixer s, loader s, applicators ) N An updated occupational handler assessment may be needed based on significant changes to exposure assessment methodology and any new data that are submitted. Post

- application N An updated occupational post

- application assessment may be needed based on si gnificant changes to exposure assessment methodology and any new data that are submitted. Residential Handlers N EPA does not anticipate conducting a residential handler assessment as there are no residential uses. Post

- application Y EPA anticipates u pdat ing residential post

- application assessment to incorporate the anticipated d ata using the 2012 residential standard operating procedures

. Other Aggregate Y E valuates the combined risk from dietary and residential exposures. EPA anticipates that updating the aggregate risk assessment will be required to i ncorporate updated drinking water estimates and revised residential post

- application exposure estimates. Cumulative N Diclofop

- methyl has not been identified as a member of a cumulative group tha t shares a common mechanism of toxicity.9

Table 4: Anticipated Risk Assessments for the Diclofop

- methyl Registration Review (cont.)
Type of Risk Assessment Conduct? Notes
Tolerances Y EPA anticipates updating diclofop

- methyl tolerances, established in 40 CFR §180. 385 , to align with new crop groups and, where possible, to harmonize with international MRLs. Incidents Will check for updates For a discussion of reported human incidents for

diclofop

- methyl, see page 10 of the Scoping Document and the Diclofop

- methyl: Tier 1 Review of Human Incidents

.

Guidance for Commente rs: Additional ecological i nformation r equested for this registration r eview , and of particular interest to EPA, is described below.

 Ec ological incidents (non

- target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency

.

 Water quality m onitoring data (see Appendix for further details)

.

TIMELINE

EPA has created the following estimated timeline for the completion of the diclofop

- methyl registration review in Table 5 below

.

Table 5: Projected Diclofop

- methyl Registration Review Timeline

Activities Estimated Dat e Opening the Docket Open Docket and 60

- day Public Comment Period September 2014 Close Public Comment November 2014 Case Development Final Work Plan February 2015 Issue DCI April

– June 2015 Data Submission April

– June 2017 6 0

- day Public Comment Period for Draft Risk Assessments 3 October

– December 2018

Registration Review Decision 60

- day Public Comment Period for Proposed Registration Review Decision July

– September 2019

Registration Review Decision and Begin Post

- Decision Follow

- up 2020

Total (years) 6

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

.10

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 diclofop

- methyl

.11



### Appendix

– Additional Areas Considered in the Diclofop

- methyl 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:

Diclofop

- methyl is not ident ified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act

. 4 In addition, no Total Maximum Daily Loads (TMDL) have been developed for diclofop

- methyl

. 5 More information on impaired water bodies and TMDLs can be found at the Agency’s website

. 6 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 I mpaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process 7 in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmental 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 poli cies. 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 diclofop

- methyl 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.

4 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

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

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

7 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm12

ENDANGERED SPECIES :

A risk assessment that supports a complete endangered species determination has not been conducted for diclofop

- methyl

. The ecological risk assessment planned during registration review will allow the Agency to determine whether use of diclofop

- methyl 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. Fis h and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

ENDOCRINE DISRUPTOR SCREENING PROGRAM :

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chem icals. 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 suscept ible 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, developmental and reproductive effects in different taxonomic groups. As part of its reregistration decision for diclofop

- methyl

, EPA reviewed these data and selected the most sensitive endpoi nts for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p ), diclofop

- methyl 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 Administr ator 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, o r thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and 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 identify 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 FFD CA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 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 8 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 end ocrine disruptors.

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

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of chemicals.13

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. 9

HUMAN STUDIES :

Occupationa l and Residentia l

Past diclofop

- methyl 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 d ifferent pesticides, comprise generic pesticide exposure databases such as the Pesticide Ha ndlers Exposure Database (PHED), the Agricultural Reentry Task Force (ARTF) Database

. EPA has reviewed all the studies supporting these multi

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

.

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