2 I NTRODUCTION

This is the Environm ental Protection Agency’s (EPA or the Agency ) Final Work Plan (FWP) for the registration review of fluazifop

- p

- butyl

. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the fluazifop

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- butyl registration review docket (EPA

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- 0779 ). Fluazifop

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- butyl is a selective, post

emergent herbicide registered for the contro l of perennial and annual grass weeds. Fluazifop

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butyl's registered uses include food/feed use on asparagus, carrot, coffee, cotton, endive (escarole), garlic, macadamia nut, onion, pecan, pepper, rhubarb, soybeans, stone fruits, sweet potato, bananas, citrus, grapes, sugar beets, and yams. I t is also registered for use on lawns/turf in residential settings.
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 F IFRA standard for registration. Changes in science, public policy, and pesticide use practices occur over time. The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard. The public phase of registration review begins when the initial docket is opened for each case. Informatio n on this program is provided on the Agency’s website

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The FWP begins with any update s since the PWP was issued. Next is a summary of substantive comments received during the public comment period for the PWP concerning anticipated data needs
, expected risk assessments, or the estimated timeline identified in the PWP
, and a summary of the Agency’s response s to th o se comments

. This section is followed by registration review planned data needs, risk assessments expected to be conducted , and the projected registration review timeline for fluazifop

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- butyl

. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED
Field trial of residues in pollen and nectar, semi

- field testing for pollinators, and field testing for pollinators studies were added following the PWP due to implementation of pollinator risk assessment g uidance.
There are no additional updates on fluazifop

- p

- butyl since the PWP.

SUMMARY OF COMMENTS AND AGENCY RESPONSES
During the 60

- day public comment period on the Fluazifop

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- butyl Preliminary Work Plan, which opened on December 19, 2014 and closed on February 19, 2015, the Agency received three public comments. Comments were submitted by the FIFRA Endangere d Species Task Force (FESTF), the Center for Biological Diversity (CBD) , and Syngenta Crop Protection , LLC

. The comments do not address the timeline described in the PWP, but they do address the planned ecological and human health risk assessments and data requirements. In the PWP, EPA also

1 http://www.epa.gov/oppsrrd1/registration_review/3 solicited comments on the specific topics of environmental justice, water quality concerns, and trade irritants, but no comments or information were received on those issues.
This section does not capture every comment made about the PWP nor all of the Agency’s responses. Summarized below are public comments that resulted in changes to the anticipated registration review data needs, risk assessments, or are of a broader regulatory nature. Public comments in their entirety are located in the docket, EPA

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. Summarized public comments and Agency responses relat ed to the anticipated ecological data needs are in the EFED memo titled EFED Response to Registrant Comments Regarding the Registration Review Problem Formulation for Fluazifop

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- butyl

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Comments submitted by the FIFRA Endangered Species Task Force (FES TF) in EPA

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Comment: FESTF submitted a comment informing the Agency that the technical registrant of fluazifop

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- butyl, Syngenta Crop Protection, LLC , is a member of the FESTF (or a company having met its data compensation obligations) and is entitled to rely on FESTF data.
Response: The Agency thanks FESTF for its comment and will consider this information during registration review

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Comments submitted by the Center for Biological Diversity (CBD) in EPA

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Comment: The Center for Biological Diversity’s (CBD) comments focus on the EPA’s duty to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) on the registration review of fluazifop

- p

- butyl in accordance with the Endangered Species Act (ESA). The CBD comments mention various aspects of the risk assessment process, including use of the best available data to develop endangered species risk assessments, and evaluation of effects on endangered and threatened species and their designated critical habitat. CBD also expresses concern regarding the rigor of the Agency’s preliminary determinations regarding the effects of fluazifop

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butyl on endangered and threatened (listed) species and their desi gnated critical habitat for the fluazifop

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- butyl registration review

. Response: EPA has reviewed the comments from CBD on the registration review docket opening for fluazifop

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- butyl and plans to address many of the concerns raised by CBD as par t of the implementation plan for assessing the risks of pesticides to listed species based on the recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will address concerns specific to fluazifop

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- butyl in connection with the d evelopment of its final registration review decision for fluazifop

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- butyl

. In November 2013, the EPA, along with the Services and the USDA, released a summary of their joint Interim Approaches for assessing risks to endangered and threatened (listed) spe cies from pesticides. The Interim 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 scien tific differences between the EPA and the Services. The NAS report outlines recommendations on specific scientific and technical issues4 related to the development of pesticide risk assessments that EPA and the Services must conduct in connection with thei r obligations under the ESA and FIFRA.
The joint Interim Approaches were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presented the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Comm ittee (PPDC) and State

- FIFRA Issues Research and Evaluation Group (SFIREG) meetings. The agencies also held a stakeholder workshop in April and October 2014, allowing additional opportunities for stakeholders to comment on the Interim Approaches. Addition al workshops are planned to enhance stakeholder involvement. As part of a phased, iterative process for developing the Interim Approaches, the agencies will also consider public comments on the Interim Approaches in connection with the development of upco ming Registration Review decisions. The details of the joint Interim Approaches are contained in the white paper “Interim Approaches for National

- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of S ciences April 2013 Report,” dated November 1, 2013.
Given that the agencies are continuing to develop and work toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical h abitat, the ecological problem formulation supporting this Final Work Plan for fluazifop

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- butyl does not describe the specific ESA analysis, including effects determinations for specific listed species or designated critical habitat, to be conducted durin g registration review. In the ecological problem formulation document for fluazifop

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- butyl , EPA described the screening

- level risk assessment to determine the potential effects of fluazifop

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- butyl on all taxa of non

- target wildlife and plants, which will assume that listed species and their designated critical habitats may be present in the vicinity of the application of fluazifop

- p

- butyl . This screening

- level assessment will allow EPA to focus its future evaluations on the types of species where t he potential for effects exists once the scientific methods being developed by the agencies have been fully vetted. While the agencies continue to develop a common method for ESA analysis, the planned screening

- level risk assessment for the registration r eview of fluazifop

- p

- butyl will describe the level of ESA analysis completed for this particular registration review case. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments for endangered and threatened (listed) species and their designated critical habitats, these methods will be applied to subsequent analyses for fluazifop

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- butyl as part of completing this registration review.
Comments submitted by Syngenta Crop Protection in EPA

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. Comment: Syngenta notes that MRID 00162453 provided adult honeybee acute oral data
, and proposes that MRID00162453 will satisfy the honey bee adult acute oral data requirement.
Response: EPA a cknowledges this data has been submitted , and has been found adequate for a limit test

. N o new adult oral bee data are required.5 PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for fluazifop

- p

- butyl based on EFED Registration Review Problem Formulation for Fluazifop

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- butyl and Fluazifop

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- butyl: Human Health Risk Assessment Scoping Document in Support of Registration Review, and Response to Comments document

. The table has been updated since the PWP to reflect public comments which resulted in changes to t he data needs

. Field trial of residues in pollen and nectar, semi

field testing for pollinators, field testing for pollinators studies were added following the PWP due to implementation of pollinator risk assessment guidance.

Table 1: Anticipated Data N eeds for the F luazifop

- p - butyl Registration Review

Guideline Number 2 Study Title 1 Test Material Estimated Timeframe (Months from receipt of DCI)

835.1230 835.1240 Adsorption/Desorption TGAI and D egradate : fluazifop

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- 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) T EP 12 850.4150 Vegetative vigor (Tier I) T EP 12
850.4400 Aquatic plant growth (aquatic vascular plant toxicity) (Tier I I ) Degradate: fluazifop

- p acid 12

850.54 00 Algal Toxicity (Tier II) Degradate: fluazifop

- p acid 12

850.4550 Cyanobacteria Toxicity (Tier II) Degradate: fluazifop

- p acid 12

Non

Guideline * Honeybee adult chronic oral toxicity TGAI 12

Non

Guideline * Honeybee larval acute toxicity TGAI 12

Non

Guideline * Honeybee larval chronic toxicity TGAI 12

Non

guideline ** Field trial of residues in pollen and nectar TGAI 24

2 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

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- 00286 Table 1: Anticipated Data N eeds for the F luazifop

- p - butyl Registration Review

Guideline Number 2 Study Title 1 Test Material Estimated Timeframe (Months from receipt of DCI)
Non

guideline ** Semi

- field testing for pollinator s TGAI 24
850.3040 ** Field testing for pollinators TGAI 24 850.6100 Environmental chemistry methods and associated independent laboratory validation for water and soil TGAI and Degradate: fluazifop

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- acid 12

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 ingredient; TEP = typical end

- use product

. *Tier 1 (Laboratory

- based studies) **Tier 2 and 3 (Semi

- field and full field colony

- level studies) The need for a higher tier test for pollinators will be determined based upon lower

- tiered tests and/or other lines of data and the need for a refined pollinator risk assessment.

RISK ASSESSMENTS FOR REGISTRATION REVIEW
During registration review, t he Agency will conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of fluazifop

- p

- butyl

. For human health, EPA will conduct revised dietary, residential
, and occupational risk assessment s during registration review

. If toxicological en dpoints or points of departure are revised based on the data that are 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

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Table 2 below summarizes the planned registration review risk assessments based on the EFED Problem Formulation and HED Scoping Document and the planned assessments have not changed from what was included in the PWP

.7 Table 2: Planned Risk Assessments for the F lua zifop

- p - butyl 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 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 toxicological endpoints, and data submitted under the antici pated registration review Data Call

- In Notice. Incidents Will check for updates For a discussion of reported ecological incidents for fluazifop

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- 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. Dr inking 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 sufficient information available to assess post

- application exposures. Updated post

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

- application Yes Other Aggregate No E valuates the combined risk from dietary and residential exposures. Cumulative No Fluazifop

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- 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 fluazifop

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- but yl in/on many commodities.8 Incidents Will check for updates For a discussion of reported human incidents for fluazifop

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- butyl, see Fluazifop

- Butyl & Fluazifop

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butyl: Tier I Review of Human Incidents

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TIMELINE

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

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- butyl registration review in Table 3 below

. The projected timeline has not changed since the PWP.

Table 3: Registration Review for F luazifop

- p - butyl

– Projected 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 201 7 60

- day Public Comment Period for Draft Risk Assessments 3 January

- March 20 19 Registration Review Decision 60

- day Public Comment Period for Proposed Registration Review Decision October

- December 2019
Registration Review Decision and Begin Post

- Decision Follow

- up 202 0
Total (years) 6 years

NEXT STEPS
As noted previously, the Agency plans to require several environmental fate, ecological effects, and human health studies for fluazifop

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- butyl through a D ata C all

- I n Notice , expected to be issued in early 2016

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3 The regulations governing Registration Revie w 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 generall y for draft risk assessment s

.