2 I NTRODUCTION

This is the Environm ental Protection Agency’s (EPA or the Agency ) Final Work Plan (FWP) for the registration review of pinoxaden. This work plan addresses public commen ts received concerning the Preliminary Work Plan (PWP) , which was posted in the pinoxaden registration review docket (EPA

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- 0603 ). Pinoxaden is a selective and systemic herbicide registered for use to control annual grass weeds and certain broad leaf weeds in barley, winter wheat, and spring wheat. Pinoxaden is not registered for residential, public recreational, or other

non

- agricultural use.

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

. 1

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 pinoxaden. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

There are no additional updates on pinoxaden since the PWP.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comment period on the pinoxaden Preliminary Work Plan , which opened on Octobe r 2, 2015 and closed on December 1, 2015 , the Agency received three public comments. Comments were submitted by the FIFRA Endangered Species Task Force (FESTF),

the Center for Biological Diversity, and Syngenta Crop Protection, LLC. The comments do not

ad dress 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 solicited comments on the specific topics of environmental justice, water quality concerns , a nd 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 addressed the anticipated registration review data needs, risk assessments, or timeline, or are of a broader regulatory nature. Public comments and EPA responses in their entirety are located in the d ocket, EPA

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1 http://www2.epa.gov/pesticide

- reevaluation3 0603 . Summarized public comments and Agency responses rel ated to the anticipated ecological

risk assessment or data needs are in the EFED Response to Registrant Comments Regarding the Registration Review Problem Formulation for Pinoxaden , located in the pinoxaden registration

review docket.

Comments submitted b y Syngenta Crop Protection, LLC Syngenta) In EPA

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Comment : Syngenta presented alternative analyses of ecological effects endpoints and noted discrepancies in reported test materials. Syngenta also noted that they intend to submit several

studies for EPA review.

Response : The Agency agrees with the identified errors regarding test formulations and further explains the endpoints chosen in the EFED Response to Registrant Comments Regarding the Registration Review Problem Formulatio n for Pinoxaden. In addition, EPA has received the referenced studies and will review them in preparation for the draft risk assessment.

Comment : Syngenta believes that they have submitted adequate information to demonstrate that technical pinoxaden is practically non

- toxic to adult honey bees on an acute oral toxicity basis and that no further information is needed for the registration review of pinoxaden.

Response : The Agency is requesting additional information on the solubility issues encountered

w ith the adult bee acute oral toxicity study (MRID 47293203). If additional information demonstrates that testing was conducted with a stable and homogeneous suspension, further testing would likely not be required.

Comment: Syngenta comments that a more recent Local Lymph Node Assay (LLNA) has been conducted since the Guinea pig maximization assay referenced in the HED Scoping Document and should be used to update the skin sensitization safety assessment profile

.

Response : The above referenced LLNA study (MRID 48346201) was overlooked in the scoping process and will be cited in the pinoxaden risk assessment.

Comment : Syngenta notes that all end

- use products are emulsifiable concentrates (EC).

Response: The EPA a grees that all end

- use products are emulsifiable concentrates, and that

information will be reflected in the risk assessment

.

Comment: Syngenta notes that pinoxaden produc ts are not registered for use on durum wheat.

Response: EPA agrees that current labels prohibit use on durum wheat.4 Comments submitted by the FIFRA Endangered Species Task Force (FESTF) in EPA

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Comment : Syngenta is a FESTF member and is entitled to rely on the FESTF data to suppor t
the analysis of pinoxaden use and potential exposure to end angered and threatened (listed) species.

Response: The Agency will consider the FESTF data during t he pinoxaden registration review.

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

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Comment: CBD’s 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 pinoxaden in accordance with the Enda ngered Species Act (ESA). CBD’s 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 listed species and their designated criti cal habitat. CBD also expresses concern regarding the rigor of the Agency’s preliminary determinations regarding the effects of pinoxaden on listed species and their designated critical habitat.

Response: EPA has reviewed the comments from CBD on the r egistration re view docket opening for pinoxaden and plans to address many of the concerns raised by CBD as part 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

add re ss concerns specific to pinoxaden in connection with the development of its final registration review decision for pinoxaden

.

In November 2013, the EPA, along with the Services and the USDA, released a summ ary of their joint Interim Approaches for assessing risks to listed species from pesticides. The Interim Approaches were developed jointly by the agencies in response to the NAS report
recommendations

, and reflect a common approach to risk assessment share d by the agencies as a way of addressing scientific differences between the EPA and the Services. The NAS report 2
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.

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 D ecember 2013 Pesticide Program Dialogue Committee (PPDC) and State

- FIFRA Issues Research and Evaluation Group ( SFIREG) meetings

. The agencies also held stakeholder workshop s in April

and October 2014, and in April 2015, allowing additional opportunities fo r stakeholders to comment on the Interim Approaches. Additional 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

2 http://www.nap.edu/catalog.php?record_id=183445 development of upcoming 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 Assessment s Based on the Recommendations of the National Academy of Sciences April 2013 Report” 3 , 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 pes ticides to listed species and their designated critical habitat, the ecological problem formulation supporting this FWP for pinoxaden does not describe the specific ESA analysis

, includ ing effects determinations for specific listed species or designated critical habitat , to be conducted during registration review

. In the ecological problem f ormulation document for pinoxaden

, EPA described the screening

level risk assessment to determine the potential effects of pinoxaden 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 vicinit y of the application of pinoxaden . This screening

- level 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. While the agencies continue to develop a common method for ESA ana lysis, the planned screening

- level risk assessment for the registration review of pinoxaden will describe the level of ESA analysis completed for this particular registration review case. Once the agencies have fully developed and implemented the scientifi c methods necessary to complete risk assessments for listed species and their designated critical habitats, these methods will be app lied to subsequent analyses for pinoxaden as part of compl eting this registration review.

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for pinoxaden based on the EFED Registration Review Problem Formulation for Pinoxaden, Pinoxaden Human Health Assessment Scoping Document in Support of Registration Review and Response to Comments document

. The planned data needs have not changed from what was included in the PWP

.

3 http://www.epa.gov/espp/2013/nas.html6 Table 1: Data Needs for the Pinoxaden Registration Review

Guideline

Number 4 Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

Data Needs for the Parent Pinoxaden

850.6100 Environmental Chemistry Method and Independent Laboratory Validation for Water TGAI 12

Non

- Guideline (Tier 1) Honey bee larvae acute toxicity TGAI 12

Non

- Guideline (Tier 1) Honey bee adult chronic oral toxicity TGAI 12

Non

- Guideline (Tier 1) Honey bee larvae chronic toxicity TGAI 12

Non

- Guideline (Tier 2) 5 Semi

- field testing for pollinators (tunnel or colony feeding studies TEP or TGAI 24

Non

- Guideline (Tier 2) 5 Field trials of residues in pollen and nectar TEP 24

OCSPP 850.3040 (Tier 3) 5 Field testing for pollinators TEP 24

Data Needs for the Pinoxaden Degradate

850.6100 Environmental Chemistry Method and Independent Laboratory Validation for Water NOA

- 407854 12

850.6100 Environmental Chemistry Method and Independent Laboratory Validation for Water NOA

- 447204 12

Outstanding Data Requirements from Conditional Registration(s) 6

Non

- Guideline (Tier 1) Honey bee adult acute oral toxicity TGAI Due

9/2/2016

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 pinoxaden. For human health, EPA

will conduct revised dietary, residential

, and occupational risk assessment s during registration

review

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

4 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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5 Tier 2 and 3 (Semi

- field and full field colo ny

- level studies). The need for a higher

- tiered 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.

6 The study listed in this section was previousl y requir ed as a condition of registration in 2005 and is due on

9/2/2016 per the Agency’s 9/2/2015 letter to Syngenta . Th is study will not be included in the anticipated Registration Review DCI because it is already required as a condition of registration.7 required for registration review

, they will be considered in the new asses sment s
, as well as any changes to the standard operating p rocedures or default exposure assumptions

.

Table 2 below summarizes the planned registration review risk assessments based on the EFED

Problem Formulation and HED Scoping Docum ent. T he planned asse ssments have not changed

from what was included in the PWP.8 Table 2: Planned Risk Assessments for the Pinoxaden 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 Y The Total Toxic Residue approach will be used for modeling exposure to all three pinoxaden residues (pinoxaden parent, NOA

- 407854, and

NOA

- 447204).

Incidents Will check for updates For a discussion of reported ecological incidents for pinoxaden see page 26 of the Problem Formulation.

Human Health Dietary

Food Y Revised dietary risk assessments may be required to reflect the most recent dietary exposure models, newly estimated drinking water concentrations and/or changes to the toxicological endpoints. Drinking water

Occupational Handlers (mixers, loaders, applicators) Y Updated occupational exposure assessments may be required during Registration Review to reflect all currently registered uses and consider new exposure estimates based on current SOPs and science policies or if there are changes in toxicolog ical endpoints. Post

- application

Residential

Handlers N Pinoxaden is not registered for use in residential or public settings.

Post

- application Spray drift/volatilization Y The need for a spray drift and volatilization risk assessment for pinoxaden will be examined during Registration Review.

Other Aggregate Y Evaluates the combined risk from dietary and residential exposures. As there are no residential uses, a revised aggregate assessment would be equivalent to the revised dietary assessment.

Cumulative N Not applicable; pinoxaden has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.

Tolerances Y The need for livestock commodity tolerances will be re

- evaluated. In addition, the tolerance expression in 40 CFR§180.611 will need to be updated so that it appropriately covers the metabolites and degradates of pinoxaden and specifies the residues to be measured for each

commo dity. Potential harmonization of the residues of concern for U.S. tolerances and Canadian maximum residue limits (MRLs) will be

evaluated.

Incidents Will check for updates For a discussion of reported human incidents for pinoxaden, see page 8 of the Scopi ng Document and the Tier I (Scoping) Review of Human

Incidents

.9 TIMELINE

EPA has created the following estimated timeline for the completion of the pinoxaden registration review in Table 3 below

. The projected timeline has not changed since the PWP.

Table 3: Registration Review for Pinoxaden

– Projected Registration Review Timeline

Activities Estimated Date Opening the D ocket Open Docket and 60

- day Public Comment Period September 2015

– Completed

Close Public Comment November 2015

– Completed Case Development

Final Work Plan March 2016

– Completed

Issue DCI 2016

– April

– June

Data Submission 2018

– April

– June

6 0

- day Public Comment Period for Draft Risk Assessments 7 2019

– October

– December Registration Review Decision

60

- day Public Comment Period for Proposed Registration

Review D ecision 2020

– July

– September

Registration Review D ecision and Begin P ost

- D ecision F ollow

up 2021

Total ( years ) 6

NEXT STEPS

As noted previously, the Agency plans to require several environmental fate, ecological effects,

and human health studies for pinoxaden through a D ata C all

- I n Notice , expected to be issued in

June 2016

.

7 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 cal endar day public comment period generally for draft risk assessments.