2 

### Cyhalofop-butyl Preliminary Work Plan – Table of Contents

OVERVIEW ...................................................................................................................... ............. 4

ANTICIPATED DATA NEEDS .................................................................................................... 5

STATUTORY 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 .................................................................................................................... ........... 10

Appendix – Additional Areas Considered in th e Cyhalofop-butyl Regi stration Review ......... 11

References:

This Preliminary Work Plan summarizes the En vironmental Protection Agency's current position based on the following documents:

1. Preliminary Ecological Risk Assessment for Registration Review of cyhalofop-butyl

. K. Garber and R. Shamblen. September 10, 2014

2. Cyhalofop-butyl. Human Health Assessment Sc oping Document in Support of Registration

Review . D. Dotson, M. Collantes, J. D’Agostino. September 5, 2014

3. Cyhalofop-butyl: Tier I R eview of Human Incidents. S. Recore and E. Evans. June 25,

2014

4. B E AD Chemical Profile (BCP) for Re gistration Review: Cyhalofop-butyl (082583)

. B. Phillips, R. Priet o, and D. Berwald. May 7, 2014

5. Cyhalofop-butyl (082583) Screening Level Usage Analysis (SLUA). February 5, 2014

6. EFED Table 1 Report- Ingredie nt Cyhalofop-butyl (082583). March 14, 20143 7. HED Master Label Report- Ingr edient Cyhalofop-butyl (082583). March 14, 2014

These and other supporting documents for the cyhalo fop-butyl registration review case may be found in the docket EPA-HQ-OPP-2014-0115 at http://www.regulations.gov

.4 OVERVIEW

The docket for cyhalofop-butyl is now open, ini tiating the first public comment period for this registration review (docket number EPA-HQ-O PP-2014-0115). Cyhalofop-butyl is an herbicide that is registered for use for grass weed contro l in rice only. This Preliminary Work Plan (PWP) document explains what EPA’s Office of Pe sticide Programs knows about cyhalofop-butyl, highlighting anticipated data and assessment need s, 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 cyhalofop-butyl.

The registration review process was designed to include a publi c participation component to solicit input from interested stake holders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows abou t cyhalofop-butyl and wh at types of new data or other information would be helpful for the Agen cy to receive as it moves toward a decision on cyhalofop-butyl. The Agency encourages all in terested stakeholders to review the PWP and Appendix and to provide comments and addition al 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 iden tified in the PWP and Appendix about which the Agency specifically seeks comments and informa tion. Interested stakeholders could include: environmental non-profit or interest groups; pe sticide manufacturers; agricultural labor or commodity groups; commercial, institutional, reside ntial, and other users of pesticides; or the public at large.

The Agency is releasing a Preliminary Risk A ssessment (PRA) for ecological risk concurrent with the PWP. Rather than providing a Problem Formulation for planning the ecological risk assessment for cyhalofop-butyl, as is usual fo r docket openings, the Agency has already completed its preliminary ecological risk assessm ent. The preliminary eco logical risk assessment is included in the cyhalofop-butyl registration review docket, and the Agency is requesting comments on the preliminary risk assessment as well as the PWP during the docket opening comment period. The Agency does not anticipate conducting another ecological risk assessment during the registration revi ew of cyhalofop-butyl.

The Preliminary Work Plan begins by listing th e anticipated data need s for cyhalofop-butyl. Next, it discusses the statutory and regulatory authority for Registration Review. Then the document provides chemical facts, use and usag e information, recent act ions, the anticipated human health risk assessments, and a projected registration review timeline for cyhalofop-butyl. Finally, the Appendix to this document includes id entification and discussion of some areas that are considered generally in registration review along with some additional chemical case-specific

information.5 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipate d data needs for cyhalofop-butyl. For additional discussion of the anticipated data needs, see the Cyhalofop-butyl. Human Health Asse ssment Scoping Document in Support of Registration Review

.

Table 1: Anticipated Data Needs for th e Cyhalofop-butyl Registration Review

Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated Data Needs fo r the Parent Cyhalofop-butyl

870.3465 90-day Inhalation Rat 1 TGAI 24

TGAI = technical grade active ingredie nt; TEP = typical end-use product.

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 Stat es (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Ag ency), based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The registration review program is intended to ma ke 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 unreasonabl e 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 prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided on EPA’s website. 2

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The regulations governing regi stration review begin at 40 CFR 155.40. The 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 additional risk analyses

and data or information it believes are needed to make a registration review decision. After reviewing and responding to comments and data received in the docke t during this initial

1 Although the guideline is for a 90-day study, a 28-day study is considered adequate to satisfy the anticipated data requirement. HED’s HASPOC recommended, based on weight-of-evidence considerations, that a subchronic inhalation toxicity study is needed; however, if the regi strant can provide particle size distribution data for the granular product such that HED can determine what fraction of the product is both respirable and inhalable, the Agency could re-consider the need for the inhalation study.

2 http://www.epa.gov/oppsrrd1/registration_review/6 comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for the registration review of cyhalofop-butyl.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for cyhalofop-butyl.

Table 2: Chemical Facts for Cyhalofop-butyl

PC code 082583

Case Number 7255

CAS Number 122008-85-9 Year first registered 2002 Pesticide Type Herbicide

Chemical class Aryloxy-phenoxy propionate Reregistration Eligibility Decision (RED) Because it was registered after November 1984, cyhalofop-butyl was not subject to reregistration.

Tolerance Reassessment Eligibility Decision (TRED) Because it was registered after November 1984, cyhalofop-butyl was not subject to to lerance reassessment.

Cumulative group Not applicable. Cyhalof op-butyl has not been identified as a member of a cumulative group that shares a common mechanism of toxicity. 40 CFR Citation Tolerances for cyhalofop- butyl are establishe d in 40 CFR part §180.576. Dual-use Cyhalofop-butyl is register ed for conventional pesticidal uses only and has no registered antimic robial or biopesticidal uses. Non-pesticidal uses There are no identified non-pesticidal uses of cyhalofop-butyl.

Pesticide Re-evaluation Division, Chemical Review Manager Jolene Trujillo trujillo.jolene@epa.gov

703-347-0103 Registration Division, Product Manager Kathryn Montague montague.kathryn@epa.gov

703-305-1243

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage inform ation for cyhalofop-butyl. Please see the B E AD Chemical Profile (BCP) for Registration Review: Cyhalofop-butyl (082583) in the registration

review docket for more details.

Table 3: Cyhalofop-butyl Use and Usage Information

Summary of Use Cyhalofop-butyl is an herbicide that is registered for use on grass

weed control in rice

. Use Sites Cyhalofop -bu ty l is only re giste red for use on rice. There are no other

use s (agricultural or non agricultural).7 Table 3: Cyhalofop-butyl Use and Usage Information

Summary of Usage For years 2003-2012, cyhalofop-buty l annual usage averaged 103,000 pounds of active ingredient (A.I.) treating an annual average of 406,000 thousand acres, for an overall average application rate of 0.25 pounds A

. I. per acre. Formulation Type(s) Cyhalofop-butyl is formulated as an emulsifiable concentrate,

soluble concentrate, granular, and ready-to-use solution. Application Method(s) Cyhalofop-butyl can be broadcast aerially or by foliar application with ground equipment. Technical Registrant Dow AgroSciences No. of Registrations 10 Section 3 products 3

Restricted Use No

Guidance for Commenters: Additional areas of use and usage related information requested for this registration review, and of part icular interest to EPA, are described below.

 Information on any additional niche weeds that cyhalofop-butyl is used specifically to control. Information on any weed species that display potential for resistance.

 Confirmation of the following label information: sites of application; formulations; application methods and equipment; maxi mum application rates; frequency of application, application intervals, and maxi mum number of applica tions per season; and geographic limitations on use.

 Use distribution ( e.g. , acreage and geographical distri bution of relevant use sites).

 Median and 90 th percentile reported use rates (lbs a i/A) from usage data – national, state, and county.

 Typical application timing (date of first applic ation and application in tervals) – national, state, and county.

 Typical application interval (days).

 State or local use restrictions.

 Foreign technical registrants not listed above who supply tech nical cyhalofop-butyl to the

US market.

RECENT ACTIONS

There are no recent or pending actions for cyhalofop-butyl.

ANTICIPATED RISK ASSESSMENT S FOR REGISTRATION REVIEW

The most recent human health risk assessment fo r cyhalofop-butyl was completed in 2012 when

HED evaluated a label amendment to increase the single application rate fo r use of the herbicide on rice. Findings and conclusions from that ri sk assessment are summarized in the cyhalofopbutyl Scoping Document

.

3 Section 3 product labels can be obtained from th e Pesticide Product Label System (PPLS) website

(http://oaspub.epa.gov/pestlabl/ppls.home).8 During registration review, the Agency anticipa tes the need to conduct a revised occupational handler risk assessment and will consider the pot ential for new bystander drift and volatilization assessments. If toxicological e ndpoints or points of departure are revised based on the data that are required for registration revi ew, they will be considered in the new assessments, along with any changes to the standard operating pro cedures or default exposure assumptions.

Table 4 below summarizes antici pated registration review risk assessments based on the HED Scoping Document. As noted in Table 4, EFED has already developed its preliminary risk assessment for cyhalofop-butyl.9 Table 4: Anticipated Risk A ssessments for the Cyhalofop-butyl Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including an

assessment of risks to threatened and endangered species No A preliminary risk asse ssment was conducted at the problem formulation stage because the database was sufficient to support an ecological risk assessment. Based on currently registered uses and labeled rates, the preliminary assessment identifies potential risks to some non-target organisms. An endangered species assessment has not been conducted at this

time. Incidents No Four (4) ecological incidents have been reported for cyhalofop-butyl; see page 29 of the risk assessment.

Human Health Dietary

Food No Unless needed due to any updates to points of departure or exposure esti mates from the diet. The dietary exposure database is adequate to support the existing registrations. Dietary exposure estimates previously were not of concern. Drinking water No Unless needed due to any updates to points of departure or exposure estima tes from drinking water. No drinking water risks of concern have been

identified as of this time. Occupational Handlers (mixers, loaders, applicators) Yes A handler inhalation assessment will be needed to

account for inhalation toxici ty or particle size

distribution data. Post-application No An inhalation occupational post-application risk assessment will not be required.

Residential

Handlers No There are no resi dential handler scenarios for cyhalofop-butyl. Post-application Yes During registration review, the Agency will consider the potential for inhalati on exposure to bystanders through spray drift a nd volatilization.

Other Aggregate No Unless needed due to any updates to points of departure or exposure estimates from food and drinking water.

Cumulative No EPA has not made a common mechanism of toxicity finding as to cyhalofop-butyl and any other substances, and cyhalofop-but yl does not appear to produce a toxic metabolite produced by other

substances.10 Tolerances No There are no Codex Alimentarius Commission (Codex) or Canadian maximum residue limits (MRLs) for cyhalofop-butyl. As a result, there are no harmonization issues at the present time.

Incidents Will check for updates For a discussion of reported human incidents for cyhalofop-butyl, see page 10 of the Scoping

Document and the Cyhalofop-butyl: Tier I Review of

Human Incidents

.

TIMELINE

EPA has created the following estimated timelin e for the completion of the cyhalofop-butyl registration review in Table 5 below.

Table 5: Projected Cyhalofop-but yl Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period 2014 – September

Close Public Comment 2014 – November

Case Development

Final Work Plan 2015 – February

Issue DCI 2015 April - June

Data Submission 2017 April - June

60-day Public Comment Period for Draft Human

Health Risk Assessment [1] 2018 Oct. – Dec.

Registration Review Decision

60-day Public Comment Period for Proposed
Registration Review Decision 2019 July - September

Registration Review Decisi on and Begin Post-Decision
Follow-up 2020

Total (years) 6

NEXT STEPS

After the 60-day public comment period closes , the Agency will review and respond to any comments received in a timely manner and then i ssue a Final Work Plan for the registration review of cyhalofop-butyl.

[1] The regulations governing Registration Review generally require the Agency to provide a public comment period

of at least 30 calendar days for preliminary risk a ssessments; see 40 CFR Part 155.53(c). For conventional pesticides, the Agency plans to provide a 60 calendar day public comment period generally for preliminary risk

assessments.11 

### Appendix – Additional Areas Considered in the Cyhalofop-butyl Registration

Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency where your comments, data submi ssions, or reference to sources of additional information could be of particular use.

Trade Irritants:

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. The Agency will work to harmonize tolerances and international maximum residue limits (MRLs) 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, provi ding as much specificity as possible regarding

the nature of the concern.

Water Quality:

Cyhalofop-butyl is not identified 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 cyhalofop-butyl. 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 Procedur e: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Regist ration Review Risk Assessment and Management Process 7 in order to ensure they can be us ed quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, 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 thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to cyhalof op-butyl 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:

In November 2013, the EPA, along with the U. S. Fish & Wildlife Service (USFWS), the

National Marine Fisheries Service (NMFS) (collectively, the Servi ces), and the U.S. Department of Agriculture (USDA) released a summary of th eir joint Interim Approaches for assessing risks to listed species from pesticides. The Inte rim Approaches were developed jointly by the agencies in response to the National Academy of Sciences’ (NAS) recommendations and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific

differences between the EPA and the Services . The NAS report outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments

that EPA and the Services must conduct in connection with their obligations under the Endangered Species Act (ESA) and FIFRA.

The joint Interim Approaches were released prio r to a stakeholder workshop held on November 15, 2013. In addition, the EPA presented the jo int Interim Approaches at the December 2013 Pesticide Program Dialogue Committee (PPDC) and State-FIFRA Issues Research and Evaluation Group (SFIREG) meetings , and held a stakeholder workshop in April 2014, allowing additional opportunities for stake holders to comment on the Interim Approaches. As part of a phased, iterative process for developing the Inter im Approaches, the agencies will also consider public comments on the Interim Approaches in connection with the development of upcoming Registration Review decisions. Th e details of the joint Interim A pproaches are contained in the white paper “Interim Approaches for Nati onal-Level Pesticide Endangered Species Act

Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report,” dated November 1, 2013.

Given that the agencies are continuing to de velop and work toward implementation of the Interim Approaches to assess the potential risk s of pesticides to listed species and their designated critical habitat, the preliminary risk assessment for cyhalofop-butyl does not contain a complete ESA analysis that includes effects de terminations for specific listed species or designated critical habitat. Although EPA has not yet complete d effects determinations for specific species or habitats, for the prelimin ary assessment EPA conducted a screening-level

assessment for all taxa of non-ta rget wildlife and plants that assumes for the sake of the assessment that listed species and designated criti cal habitats may be present in the vicinity of the application of cyhalofop-butyl. This screening level assessment will allow EPA to focus its future evaluations on the types of species where th e potential for effects exists once the scientific methods being developed by the agencies have b een fully vetted. This screening-level risk assessment for cyhalofop-butyl indicates potential risks of direct eff ects to listed mammals, birds, terrestrial invertebrates, fish, and aquatic invertebrates on the sole registered use site. Listed species of aquatic and te rrestrial plants may also be a ffected through indirect effects because of the potential for direct effect s on listed and non-listed species upon which such species may rely. Potential direct effects on listed mammals, birds, terrestrial invertebrates, fish, and aquatic invertebrates from the use of cyhalof op-butyl may be associated with modification of Primary Constituent Elements (PCEs) of designated critical habitats, where such designations have been made. Once the agencies have fu lly developed and implemented the scientific methods necessary to complete risk assessments for endangered and threatened (listed) species13 and their designated critical habitats, these met hods will be applied to subsequent analyses for cyhalofop-butyl as part of comple ting this registration review.

ENDOCRINE DISRUPTOR SCREENING PROGRAM:

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include e ndpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of its most recent registration de cision for cyhalofop-butyl, EPA

reviewed these data and select ed the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), cyhalofop-butyl is subject to the endocrine scr eening part of the Endocri ne Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whet her 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 ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e 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 estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects 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. Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pest icide active ingredient s and 9 inert ingredients. A second list

of chemicals identified for EDSP sc reening 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 know n or likely endocri ne disruptors.

Cyhalofop-butyl does not appe ar on either of the lists.

For further information on the status of the ED SP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening ba ttery, please visit our

website. 9

8 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of

chemicals.

9 http://www.epa.gov/endo/14 HUMAN STUDIES:

Occupational

Past cyhalofop-butyl risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pest icide to determine their dermal and inhalation exposure. Many such studies, i nvolving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pestic ide Handlers Exposure Database (PHED) and the Agricultural Reentry Task Force (ARTF) Databa se. EPA has reviewed all the studies supporting these multi-pesticide generic exposure databa ses, 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 prevai ling at the time the research was conducted. All applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on

these studies.