### Docket Number EPA-HQ-OPP-2014-0778 www.regulations.gov



# Oxyfluorfen Final Work Plan Registration Review

Case Number 2490

June 2015

Approved by:



# @.0 **c~-P ~~**  **~~ ~**  Richard P. Keigwit;,f. Director Pesticide Re-evaluation Division

Date:

### INTRODUCTION This is the Environmental Protection Agency's (EPA or the Agency) Final Work Plan (FWP) for the registration review of Oxyfluorfen. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the oxyfluorfen registration review docket (EPA-HQ-OPP-20 14-0778). Oxyfluorfen is a light-dependent peroxidizing herbicide (LDPH) in the diphenyl ether chemical class. It is used for pre- and post-emergence control of monocotyledonous and broad leaf weeds in agricultural crops (including fallow fields prior to planting) , ornamental nurseries , and residential areas. 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. 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. Information on this program is provided on the Agency's website.'
The FWP begins with any updates that may have occured since the Preliminary Work Plan (PWP) was issued. Next is a summary of substantive comments received during the public comment period for the PWP that concern anticipated data needs , expected risk assessments, or the estimated timeline identified in the PWP , and a summary of the Agency's responses to those comments. This section is followed by registration review planned data needs , risk assessments expected to be conducted, and the projected registration review timeline for oxyfluorfen. Lastly, there is a discussion of next steps. 

### UPDATES SINCE THE PWP WAS ISSUED

• The Agency inadvertently left off the data requirement for 

### semi-field test for pollinators, and has added it to the Planned Data Needs table of this work plan. 

### SUMMARY OF COMMENTS AN D AGENCY RES PO NSES During the 60-day public comment period for the Oxyfluorfen PWP , which opened on 12119114 and closed on 02117115 , the Agency received five comments
. Comments were submitted by Dow AgroSciences, the FIFRA Endangered Species Task Force, the City of Sacramento Department of Utilities, the Almond Board of California, and the Center for Biodiversity (CBD). The comments from Dow AgroSciences and others did not result in changes to the anticipated data requirements or timelines outlined in the PWP. In the PWP , EPA also solicited comments on the specific topics of environmental justice, water quality concerns , and trade irritants

. Of those topics, the comments from the City of Sacramento Department of Utilities were with regards to water quality concerns.

1 http: //www .epa .gov/oppsrrd I /registration

_review/ 2

### This section does not capture every comment made in response to the PWP nor all of the Agency ' s responses, but summarizes public comments regarding data needs, risk assessments , timelines , or that are of a broader regulatory nature. For more information on public comments and EPA responses, please see the following Agency documents: (i) Response to Public Comments on the EFED Registration Review Problem Formulationfor Oxyjluorfen, (ii) Resp onse to Commentsfrom Dow Agro Science (DAS) , LLC on Oxyjluorfen (111601) BEAD Chemical Profile (BCP); and, (iii) the Oxyjluorfen : Response to Comments on the HED Human Health Scoping Document , 

### available in the public docket , EPA-HQ-OPP-2014-0778, which can be accessed at www.regulations .gov.

Co mm ent submitted by Center for Biological diversity in EPA-HQ-OPP -2014 -0 778-0010 

### Comments: The Center for Biological Diversity (CBD) comments focus on EPA's independent duty under the Endangered Species Act (ESA) to consult with the US. Fish and Wildlife Service and the National Marine and Fisheries Service (Services) on the registration review of oxyjluorfen. Specifically, CBD opposes the propo sed decisionfor oxyjluorfen prior to completion of consultation with the Services. 

### EPA Response: EPA has reviewed the comments from CBD on the registration review docket opening for oxyfluorfen and plans to address many of the concerns raised by CBD as part ofthe implementation plan for assessing the risks of pesticides to listed species based on the recommendations ofthe April2013 National Academy of Sciences (NAS) report. EPA will address concerns specific to oxyfluorfen in connection with the development of its final registration review decision for oxyfluorfen

. Consistent with EPA's responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to federally listed threatened and endangered (listed) species from registered uses of pesticides in accordance with the Joint Interim Approaches developed to implement the recommendations of the April 2013 National Academy of Sciences (NAS) report , Assessing Risks to Endangered and Threatened Speciesfrom Pesticides. 

### 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 ESA and FIFRA. EPA will address concerns specific to oxyfluorfen in connection with the development of its final registration review decision for oxyfluorfen. In November 2013, EPA , the U.S. Fish and Wildlife Service , National Marine Fisheries (the Services) , and USDA released a white paper containing a summary of their joint Interim Approaches for assessing risks to listed species from pesticides. These Interim Approaches were developed jointly by the agencies in response to the 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. Details of the joint Interim Approaches are contained in the November 1, 2013 white paper, Interim Approaches.for National-Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy ofSciences April 2013 Report.

3Given that the agencies are continuing to deve lop and work toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, this Final Work Plan for oxyfluorfen does not describe the specific ESA analysis, including effects determinations for specific listed species or designated critical habitat, to be conducted during registration review. While the agencies continue to develop a common method for ESA analysis, the planned risk assessment for the registration review of oxyfluorfen will describe the level of ESA analysis completed for this particular registration review case. This assessment will allow EPA to focus its future evaluations on the types of species where the potential for effects exists, once the scientific methods being developed by the agencies have been fully vetted. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments for listed species and their designated critical habitats, these methods will be applied to subsequent analyses of oxyfluorfen as part of completing this registration review.

Co mm ent submitted by City of S acramento Department of Utilities in EPA -HQ-OPP-2014 - 0778-0011 Comment: 

### The City 

### a_[Sacramento Department ofUtilities expressed their concern that oxyfluorfen has been detected in surface water and thatpresence in surface water indicates a pathway for the pesticide to reach water treatment plant intakes

. Among other concerns raised by the City of Sacramento Department ofUtilities was: the potential for adverse taste and odor from pesticides; presence of pesticide breakdown products in drinking water , transformation products and metabolites in drinking water; effects from pesticide concentrations that may occur in downstream surface water; and, cumulative and potential synergistic effects of exposure to multiple pesticides

. EPA Response: The Agency thanks the City of Sacramento Department of Utilities for its comment and will consider appropriate information as it conducts registration review and makes its registration review decisions.

Co mm ent submitted by FI FRA Endangered S pecies Task Force (FESTF) in EPA -HQ OPP-2014-0778-001 2 Comment: 

### FESTF identifies that Dow AgroSciences and Albaugh, Inc. , the technical registrants for oxyfluorjim, as members ofFESTF and are entitled to rely on species proximity data developed by FESTF in response to the Agency ' s endangered species requirements.
EPA Response: The Agency thanks FESTF for its comment.

Co mm ents submitted by Dow A gro Sci ences LLC in EPA -HQ-OPP-2014-0778-0013 Comment: 

### Dow AgroSciences provided a number of comments, among the topics included with Dow AgroSciences ' comments are: the .fate properties of oxyfluorfen;pre-existing data (fate ,

4

### ecological , and human health effects data) it 

### intends to submit; comment on the use, formulation , and application methods for oxyjluorfen; and, a comments on the pollinator data requirements

. EPA Respon se: EPA apprec iates the comments by Dow AgroSciences. Based upon the comments submitted by Dow AgroSciences , the Age ncy anticipates the submission of certain data and will evaluate these data with respect to existing data requirements , anticipated risk assessments and safety factors for oxyfluorfen.

Co mm ents s ubmitted by the A lmond Board of California in E PA -HQ-OPP-2014-0778-0014 

### Comment: 

### The Almond Board of California provided information on the importance of oxyjluorfen for weed control in almondproduction. EPA Response: The Agency thanks the Almond Board of California for its comment and will consider such information as it conducts registration review and makes its registration review decisions.

PLANNE D D ATA NEE D S 

### Table 1 below summarizes the planned data needs for oxyfluorfen based on the 

### Registration Review Problem Formulationfor Oxyjluorfen, Oxyjluorfen: Human Health Assessment Scoping Document in Support of Registration Review, and the 

### BEAD Chemical Profile (BCP)for Reg istration Review: Ox yjluorfen (I I 160I). Agency inadvertently left off the data requirement for 

### semi-field test for pollinators, and as added it to the oxyfluorfen registration review data needs identified in the table below.
Ta ble 1 : P lann ed Data N eed s fo r th e O xy fluorf en R egistrati o n R ev iew Estimated Guideline Timeframe Number Study Title Test Material (Months from receipt of DCI) 835.2240 Aqueous Ph otol ysis TGA! 12 835

. 4300 Aerob ic Aquatic Metabolism TGAI 24 83 5.4400 A naerob ic aquatic metabolism T GA I 24 850.10 75 Fish acute toxicity tes t , estuarine / marin e fish or TGA!, TEP 12 fathead minn ow 850. /400 Saltwater fish earl y lif e stage TG A ! 12 850.2 100 Av ian o ral toxicity , Pass erin e Species TGAI 12 850.3040 Fie ld toxic ity test with hon eyb ee 3 T EP 24

2 On June 27,2012, EPA announced certain revi s ion s in harmonized guideline series 850

- Eco lo g ical Effects Tests

- including renumberin g and other designations or changes for s ome guideline studies. See " Final Test Guidelines; OCSPP 850 Series ; Notice of Availability " 77 FR 38282 , June 27,2012

. http: / /www.regulations.gov/# !documentDetail; D= EPA-HQ-OPPT-2009

-0 154-0028 5Table 1: Planned Data Need s for the Oxyfluorfen Regi stration Rev iew Estimated Guideline Timeframe Number Study Title Test Material (Months from receipt of DCI) 850.6/00 E nvironm ental C h emistry Method/Independent TGAI 12 Laboratory Val idation (ECM\ !L V) for soil and water 870.3200 2 1 1 28-Day dermal toxicity TG A I 24 875. 2 100 Dislodgeable foliar residue (b ulb vegetable) TEP 12 Non- Pollinator Chronic Toxicity

- honeybee larva e TGAI 1 2 Guideline No n- Pollinator Chronic Oral T oxic it y - hon eybee adult TGA! 12 Guideline Non- Pollinator Acute Oral Toxicity

- hon eybee adult TGAI 12 Gu id elin e Non- Pollinator Acu te Oral Toxicity

- honeybee larva e TGAI 12 Gu id eline No n- Se mi-field tes t for pollinators3 TEP 24 Guideline Non- Res idu e ana l ys i s of nectar andpollen inflowering TEP 24 Gu id elin e crops 3 TGA! 

### = techm cal gra de active ingredient; TEP = typical end-us e prod uct;

RISK ASSESSMENTS FOR REGISTRATION REVIEW Table 2 below summarizes the p lanned registration review risk assessments based on the EFE D Problem Formu lation and HED Scoping Document and has not changed from the PWP.

3 The need for this test is contingent upon results of lower tier pollinator tests. Protocol is required for this test.



### 6

### Table 2: Planned Risk Assessments for the Oxyfluorfen Registration Review Type of Risk Assessment Conduct? Notes 

### E colo2ical and Environmental Fate Comprehensive ecological 

### y (species to be assessed include terrestrial and aquatic organisms) , including endangered species Incidents 

### y Review of the Agency's ecological incident databases identified a total of 25 discreet ecological incidents associated with oxyfluorfen (involving plants and animals)

. In addition , the Agency also has 42 aggregate counts of incidents associated with oxyfluorfen (involving plants). 

### Human Health Dietary Food 

### y The Agency ' s most recent dietary assessment was in Drinking water 

### y 2002. An acute dietary risk assessment was not conducted due to a lack of an acute end point, chronic dietary risk estimates were not of concern. A revised drinking water assessment is anticipated for registration review to reflect updated drinking water models and any changes based on anticipated fate data requirements. Therefore a revised dietary analysis is anticipated, including cancer and noncancer endpoints , for the oxyfluorfen registration review. Occupational Handlers (mixers , loaders, 

### y The previous occupational exposure assessment applicators) covered all scenarios relevant to oxyfluorfen and no

7Post-application y occupational handler or post-application risk estimates of concern were identified with use of appropriate personal protective equipment (PPE) (i.e. , label required chemical-resistant gloves). However, the oxyfluorfen registration review will include updated handler analysis to reflect current policies and anticipated toxicology data (a subchronic dermal toxicity study is required). The oxyfluorfen registration review will also include a revised post-application (worker) analysis to reflect anticipated exposure data (dislodgeable foliar residue (DFR) data)

. Residential Handlers y The most current residential risk assessment did not identify risks of concern 4

. However, updates to HED 's Residential SOPs 5 (2012) have been made along with policy changes for body weight assumptions that need to be incorporated into the Agency ' s analysis of oxyfluorfen. Therefore, the residential exposure risk assessment will be updated during registration review Post-application y The need for spray drift and volatilization risk assessments for oxyfluorfen will be examined during the registration review process. Other Aggregate y There are no current aggregate risks estimates of concern. Updated aggregate assessments may be conducted based on updates to either the dietary or residential analysis. Cumulative 

### N The Agency has not made a common mechanism of toxicity finding as to oxyfluorfen and any other substances , and oxyfluorfen does not appear to produce a toxic metabolite produced by other substances. The Agency has not assumed that oxyfluorfen has a common mechanism of toxicity with other substances. Tolerances y The current tolerance expression for oxyfluorfen may be updated during registration review. However, since there are no oxyfluorfen MRLs established under CODEX or Mexico and current tolerance values are harmonized with Canadian MRLs (excluding Canadian MRLs with no U.S. equivalents), no further harmonization is anticipated.
8Incidents y The Agency reviewed its human health incident databases and found a low frequency of human health incidents associated with oxyfluorfen as the sole active ingredient. However a number of human health incidents were reported that were associated with Ortho Fence & Grass Edger Formula IITM , which contains oxyfluorfen , but also contains glyphosate.
Due to the proportion of reported incidents associated with Ortho Fence & Grass Edger Formula IITM , the Agency may further evaluate this particular product during registration review. 

### TIMELINE
EPA has created the following estimated timeline for the completion of the oxyfluorfen registration review in Table 3 below. The projected timeline has not changed since the PWP

. Table 3: Registration Review for Oxyfluorfen- Projected Registration Review Timeline Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period December 2014- Completed Close Public Comment February 20 15

- Completed Case Development Final Work Plan June2015 Iss ue DCI September 2015 Data Submission September 2017 60-day Public Comment Period for Draft Risk Assessments 6 January

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

- September 2019 Registration Review Decision and Begin Post-Decision Follow-up 2020 Total (years) 6 

### NEXT STEPS As noted previously , the Agency plans to require several environmental fate and ecological effects studies for oxyfluorfen through a Data Call-In (DCI) Notice , expected to be issued in September 2015.

4 Oxyfluorfen: Second Revi se d Occupational and Res idential Non-Cancer and Cancer Ex po s ure and Ri s k Assessments for the Rereg istration E li g ibility Deci s ion ( RE D) Document. T. Dole

. 05 /01 /20 02

. D281831 5 Avai lab le : http: //www .epa. gov/pesticides/science/residentia 1-exposure-sop.htm I 6 The re g ulation s governing Regi stration Review generally require the Agenc y to provide a public comment period

o f at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pe sticide s, the Age ncy plans to provide a 60 calendar day public comment period generally for draft ri sk assessments
. 9