Docket Number E PA-HQ

- OPP-2014-0779 www.regulations

. gov



## Fluazifop-p

- butyl Preliminary Work Plan

Registration Review: Initial Docket

Case Number 2285

Approved by:

Da t e: 

## December 2014**p -u.-t.** **~** Richard P. Keigwin, Jr.

. Director

Pesticide Re-evaluat i on Division2 

### Fluazifop-p-butyl Preliminary Work Plan – Table of Contents

OVERVIEW ...................................................................................................................... ............. 3

ANTICIPATED DATA NEEDS .................................................................................................... 4

STATUTORY AND REGULATORY AUTHORITY ................................................................... 5

CHEMICAL FACTS ................................................................................................................ ...... 6
USE AND USAGE INFORMATION ............................................................................................ 6

RECENT ACTIONS ................................................................................................................ ....... 8

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW ................................ 8

TIMELINE ...................................................................................................................... .............. 10

NEXT STEPS .................................................................................................................... ........... 10 Appendix – Additional Areas Considered in th e Fluazifop-p-butyl Re gistration Review ....... 11

References:

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

1. EFED Registration Review Problem Formulation for Fluazifop-p-butyl. Federoff, N.E.; Wong, Edmund. December 3, 2014

2. Fluazifop-P-butyl. Human Health Risk Assessment Scoping Document in Support of Registration Review . Dapson, Steve; Donovan, William; LaMay, Alexandra. December,

2014

3. BEAD Chemical Profile (BCP) for Registra tion Review: Fluazifop-P-butyl (122809). Haddad, Sepehr; Phillips, Bill; Smearman, Stephen. August 18, 2014.

4. Fluazifop-p-butyl (122809) Screening Level Usage Analysis (SLUA). May 27, 2010.

5. Fluazifop-p-butyl EFED Table 1 Report. April 16, 2014.

6. Fluazifop-p-butyl HED Master Label Report. April 16, 2014.

These and other supporting documents for the fluazi fop-p-butyl registration review case may be found in the docket EPA-HQ-OPP-2014-0779 at http://www.regulations.gov

.3 OVERVIEW

The docket for fluazifop-p-butyl is now open, ini tiating the first public comment period for this registration review (docket num ber EPA-HQ-OPP-2014-0779). Fluazif op-p-butyl is a selective, post-emergent herbicide registered for the co ntrol of perennial a nd annual grass weeds. Fluazifop-p-butyl's registered uses include food/feed use on as paragus, carrot, coffee, cotton, endive (escarole), garlic, macadamia nut, onion, pecan, pepper, rhubarb, soybeans, stone fruits, sweet potato, bananas, citrus, gr apes, sugar beets, and yams. It is also registered for use on lawns/turf in residential settings. This Prelim inary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about fl uazifop-p-butyl, highligh ting anticipated data and assessment needs, identifying th e 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 fo r fluazifop-p-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 fluazifop-p-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 fluazifop-p-butyl. The Agency en courages all interested stake holders 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 Preliminary Work Plan begins by listing the anticipated data needs for fluazifop-p-butyl. Next, it discusses the statutory and regulatory authority for Registration Review. Then the document provides chemical facts, use and usage information, recent actions , the anticipated risk assessments, and a projected registration review timeline for fluazifop-p-butyl. Finally, the Appendix to this document includes identifica tion and discussion of some areas that are considered generally in Registra tion Review along with some a dditional chemical case-specific

information.4 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for fluazifop-p-butyl. For additional discussion of the anticipat ed data needs, see the EFED Registration Review Problem Formulation for Fluazifop-p-butyl and Fluazifop-p-butyl: Human Health Risk Assessment Scoping Document in Support of Registration Review

.

Table 1: Anticipated Data Needs for the Fluazifop-p-butyl Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.1230

835.1240 Adsorption/Desorption TGAI and Degradate: fluazifop-p-acid 12

835.4400 Anaerobic aquatic metabolism TGAI 24

850.1350 Aquatic invertebrate life cycle (saltwater) Degradate: fluazifop-p acid 12

850.1400 Fish early-life stage toxicity (saltwater) Degradate: fluazifop-p acid 12

850.2300 Avian Reproduction Degradate: fluazifop-p acid 24

850.4100 Seedling emergence and seedling growth (Tier I) TGAI 12 850.4150 Vegetative vigor (Tier I) TGAI 12

850.4400 Aquatic plant growth (aquatic vascular plant toxicity) (Tier II) Degradate: fluazifop-p acid 12

850.4500 Algal Toxicity (Tier II) Degradate: fluazifop-p acid 12

850.4550 Cyanobacteria Toxicity (Tier II) Degradate: fluazifop-p acid 12

NonGuideline Honeybee adult acute oral toxicity TGAI 12

NonGuideline Honeybee adult chronic oral toxicity TGAI 12

NonGuideline Honeybee larval acute toxicity TGAI 12

NonGuideline Honeybee larval chronic toxicity TGAI 12

850.6100 Environmental chemistry methods and associated independent laboratory validation

for water and soil TGAI and Degradate:fluazifop-pacid 12

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 Av ailability” 77 FR 38282 , June 27, 2012. http://www.regulations.gov/#!documen tDetail;D=EPA-HQ-OPPT-2009-0154-00285 Table 1: Anticipated Data Needs for the Fluazifop-p-butyl Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

860.1900 Field Accumulation in Rotational Crops TEP 24 870.3250 90-Day Dermal Toxicity TEP 24 870.3465 90-Day/28-Day Inhalation Toxicity TEP 24

875.2100 Turf Transferable Residue Data TEP 12
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 comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for the registration review of fluazifop-p-butyl.

2 http://www.epa.gov/oppsrrd1/registration_review/6 CHEMICAL FACTS

Table 2 provides a summary of the ch emical facts for fluazifop-p-butyl.

Table 2: Chemical Facts for fluazifop-p-butyl

PC code 122809

Case Number 2285

CAS Number 79241-46-6 Year first registered 1992 Pesticide Type Herbicide Chemical class Aryloxphenoxypropionic Reregistration Eligibility Decision (RED) Fluazifop-p-butyl was registered after November 1984; therefore, it was not subject to reregistration.

Tolerance Reassessment Eligibility Decision (TRED) The TRED for fluazifop-p-butyl was completed in 2005.

Cumulative group Not applicable. Fluazif op-p-butyl has not b een identified as a member of a cumulative group that shares a common mechanism of toxicity.

40 CFR Citation Tolerances for fluazif op-p-butyl are established in 40 CFR §180.411. Dual-use Fluazifop-p-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 fluazifop-p-butyl.

Pesticide Re-evaluation Division, Chemical Review Manager Matthew Manupella, manupella.matthew@epa.gov , (703) 347-

0411

Registration Division, Product Manager Kathryn Montague, montague.kathryn@epa.gov , (703) 305-1243

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage informa tion for fluazifop-p-but yl. Please see the BEAD Chemical Profile (BCP) for Registra tion Review: Fluazifo p-P-butyl (122809) in the registration

review docket for more details.

Table 3: Fluazifop-p-butyl Use and Usage Information

Summary of Use Fluazifop-p- butyl is registered for use to control annual and perennial grass weeds in numer ous crops. Between the years of 2008 and 2012 this herbicide was applied primarily postemergence in soybean to control volunteer corn. Grass herbicides like fluazifop-p-butyl can be a tool in the control of

herbicide resistant volunteer corn in broadleaf crops such as soybeans. However, the use of this herbicide in soybeans has7 Table 3: Fluazifop-p-butyl Use and Usage Information

declined since 1998 and as such its use in soybeans has fallen to approximately one percent of the crop.

Fluazifop-p-butyl is applied in a large percentage of the carrot crop. Approximately 25 percent of the carrot crop reportedly

receives treatments with this herbicide. Use Sites Agricultural use sites: almonds, apples, asparagus, carrots, cherries, com, cotton, Christmas tree plantings, dry beans/peas, garlic, grapes, non-bearing orchards, onions, oranges, peaches, peanuts, pecans, peppers, pi stachios, prunes, soybeans, strawberries, and walnuts.

Non-agricultural use sites: non-agricultura l outdoor buildings, building foundations, curbs, driveways, fencerows, nonagricultural areas (wild life refuge), non-crop areas, ornamentals, lawns, flowering shrubs, flow ering plants, gardens, ground covers, plants, trees, turf, a nd woody shrubs, patios, pathways, rights-of-way, sidewalk s, and storage yards Summary of Usage Based on private ma rket usage data from 1998-2012, usage averaged approximately 223,000 pounds active ingredient (a.i.) applied annually on approximately 1.73 million acres treated. The average a.i. rate over this tim e period was 0.13 pounds a.i./acre. In terms of pounds applied and ac res treated there has been a sharp decline in its use from 1998 through 2005 with use remaining fairly steady from 2005 through 2012.

Most available non-agricu ltural usage data for fluazifop-p-butyl is

limited and dated. There are two data sources for fluazifop-pbutyl non-agricultural usage. Thes e are the publically available USDA's National Agricultural Statistics Service (NASS) 2006 and 2009 Nursery and Floriculture reports, and the proprietary Kline & Company data. In addition to NASS 2006 and 2009 Floriculture data which reporte d 1,000 lbs a.i. used in 2006 and 200 lbs a.i. used in 2009 for nursery, other reported data are

available from Kline for a number of years. Total non-agricultural usage between 2004 and 2006 appears to have increased for golf courses, and institutional turf, but decreased for nursery/greenhouse; however, more recent data (post-2006) are

not available to determine if this trend has continued since only one category of non-agricultural usage (institutio nal turf) was

available for 2011. Formulation Type(s) Fluazifop-p-butyl is form ulated as an emulsifiable concentrate. Application Method(s) Fluazif op-p-butyl is applied using gr ound or aerial equipment. It may be applied preplant, at-plant ing and/or postemergence to the plant.8 Table 3: Fluazifop-p-butyl Use and Usage Information

Technical Registrant(s) S yngenta Crop Protection, LLC No. of Registrations 24 Section 3 products 3 14 Special Local Need products

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.

 Except for recent usage data on consumer lawns in 2011, BEAD does not have recent (post-2006) data on non-agricu ltural usage for golf course s, nursery/greenhouse and turf farms. Usage data such as pounds a. i. applied and applic ation rates would be

useful if available.

 It would be helpful to have more informati on about the benefits of this herbicide to carrot and garlic production.

RECENT ACTIONS

A Special Local Need product was registered for us e on alfalfa crops in Washington State in July

2014.

ANTICIPATED RISK ASSESSMENT S FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for fluazifop-p-butyl was completed in 2011 for a new use request bananas, plantains, citrus, grapes and sugarbeets. The most recent ecological and environmental fate risk assessment was completed for a new use request in 2008 for use on peanuts and dry beans, and in 2010 for use on bananas, plantains, citrus, grapes and sugarbeets. Findings and conclusions from these risk assessments are

summarized in the EFED Registration Review Problem Formulation for Fluazifop-p-butyl and Fluazifop-P-butyl. Human Health Risk Assessment Scoping Document in Support of Registration Review.

During registration review, the Agency antici pates the need to conduct a comprehensive ecological risk assessment for all uses of fluazi fop-p-butyl. For human health, EPA anticipates the need to conduct revised dietary, residentia l, and occupational risk assessments during registration review. If toxico logical endpoints or points of de parture are revised based on the data that are anticipated to be required for regist ration review, they will be considered in the new assessments, as well as any changes to the sta ndard operating procedures or default exposure assumptions.

Table 4 below summarizes the anticipated regi stration review risk assessments based on the

EFED Problem Formulation and HED 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).9 Table 4: Anticipated Risk Asse ssments for the fluazifop-p-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 endangered species Yes EPA anticipates conducting an updated comprehensive ecological risk assessment during registration review. The new assessment will incorporate the most up-to-date modeling methodologies, updated toxico logical endpoints, and

data submitted under the anticipated registration

review Data Call-In Notice.

Incidents Will check for updates For a discussion of reporte d ecological incidents for fluazifop-p-butyl, see page 32 of the Problem

Formulation.

Human Health Dietary Food No A new dietary assessment may be required if 1) there are any significant changes to toxicological Points of Departure (PODs) or uncertainty factors, or 2) EFED recommends higher estimated drinking water concentrations (EDWCs) than the current values. Drinking water

Occupational Handlers (mixers, loaders, applicators) Yes An updated occupational handler assessment is likely required under registration review to include any significant changes in exposure assessment methodology, toxicological PODs or uncertainty

factors. Post-application No There is sufficien t information available to assess post-application exposures. Updated post-application exposure assessments may be needed during Registration Review.

Residential Handlers Yes Updated resident ial handler and conventional residential post application exposure assessments are expected to be needed during Registration Review. Post-application Yes

Other Aggregate No Evaluates the combined risk from dietary and residential exposures. Cumulative No Fluazifop-p-butyl has not been identified as a member of a cumulative group that shares a common mechanism of toxicity. Tolerances No update

needed. Tolerances are currently established under 40 CFR §180.411 for residues of fluazi fop-P-butyl in/on many

commodities.10 Incidents Will check for updates For a discussion of reported human incidents for fluazifop-p-butyl, see Fluazifop-Butyl & Fluazifop-Pbutyl: Tier I Review of Human Incidents.

TIMELINE

EPA has created the following estimated timeline for the completion of the fluazifop-p-butyl registration review in Table 5 below.

Table 5: Projected Fluazifop-p-but yl Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period December 2014 Close Public Comment February 2015 Case Development Final Work Plan May 2015 Issue DCI July-September 2015 Data Submission July-September 2017 60-day Public Comment Period for Draft Risk

Assessments 4 January-March 2019

Registration Review Decision 60-day Public Comment Period for Proposed Registration Review Decision October - December 2019

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

Total (years) 6 years

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 fluazifop-p-butyl.

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.11 

### Appendix – Additional Areas Co nsidered in the Fluazifop-p-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:

Fluazifop-p-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. 5 In addition, no Total Maximum Daily Loads (TMDL) have been deve loped for fluazifop-p-butyl. 6 More information on impaired

water bodies and TMDLs can be found at the Agency’s website. 7 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 Body and Other Water Quality Data in O PP’s Registration Review Risk Assessment and Management Process 8 in order to ensure they can be used 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 fluazif op-p-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.

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

6 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl _pollutant_detail?p_pollutant_group_id=885&p_pollutant_

group_name=PESTICIDES

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

8 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 fluazifop-p-butyl. The ecological risk assessment plan ned during registration review will allow the Agency to determine whet her use of fluazifop-p-bu tyl has “no effect” or “may affect” federally listed threatened or endang ered species (listed species) or their designated

critical habitats. When an assessment conclude s that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Ag ency will consult with the U.S. Fish and Wildlife

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

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 decision for fluazifop-p-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), fluazifop-p-butyl is subject to the endocrine screening part of the Endocrine 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 9 and includes some

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

chemicals.13 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.

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. 10

AGRICULTURAL HEALTH STUDY:

Fluazifop-p-butyl is among seve ral agricultural chemicals included in the Agricultural Health Study (AHS). The AHS began in 1993 and is a collaboration of the National Institute of Environmental Health Sciences (NIEHS), the Nati onal Cancer Institute (NCI), the EPA, and the National Institute for Occupational Safety and H ealth (NIOSH). Designe d as a large long-term epidemiological study, the AHS collects and analyzes data on the health and work practices of nearly 90,000 farmers and their families in Iowa and North Carolina who enrolled in the study before any disease developed. The study focu ses particularly on fa rmers' exposure to 50 chemicals including many of the most widely used pesticides. As data are collected over a period of years, scientists can compare overall he alth outcomes for people who differ in whether they have had exposure to various chemicals. While these comparisons cannot conclusively demonstrate how exposure affects health, they ca n show some statistical associations. More information on the AHS can be found at: http:/ /aghealth.nci.nih.gov. EPA is monitoring the results of the AHS and will consider this study in the registration review of fluazifop-p-butyl as appropriate.

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