2 I NTRODUCTION

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

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

- metolachlor registration review docket (EPA

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. Metolachlor (PC Code 108801) is a racemic broad spectrum herbicide that consists of 50% each of the R enantiomer and the S

- enantiomer, which is the herbicidally active isomer. S

- Metolachlor (PC Code 108800) is an isomer enriched form of metolachlor, comprised of 88% S

- isomer and 12% R

- isomer. Metol achlor and S

- metolachlor are selective, chloroacetanilide herbicides used primarily for grassy weed control in many agricultural food and feed crops; residential lawns; commercial turf (including golf courses, sports fields, recreation areas, and sod farms ); ornamental plants, trees, shrubs, and vines; hedge rows; and horticultural nurseries.

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will revie w 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 s ure 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. Informa tio n on this program is provided on the Agency’s website

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The FWP begins with any updates 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

, expect ed 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 metolachlor and S

- metolachlor

. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

The Agency has reviewed the rationale submitted by Syngenta as part of the public comment period regarding the need for chronic sediment toxicity testing for the metolachlor/S

- metolachlor registration review. Upon further review of the previously submitted Grade (1998) study, EPA does not plan on requiring the non

- guideline chronic sediment toxicity study as part of registration review.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comment period on the metolachlor and S

- metolachlor Preliminary Work Plan , which opened on December 19, 2014 and closed on February 20, 2015 , the Agen cy received four public comments. Comments were submitted by the FIFRA Endangered Species Task Force, the Center for Biological Diversity, the Metolachlor Task Force, and Syngenta Crop

1 http://www.epa.gov/oppsrrd1/registration_review/3 Protection, LLC. The comments do not address the timeline described i n 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 , and trade irritants, and one comment was received by Syngenta regarding water quality. The comment discussed submitted data from the USGS National Water

- Quality Assessment Program on S

- metolachlor in surface and ground water, along with other state and federal water monitoring pr ograms. Syngenta encouraged EPA to continue to rely on these data in future drinking water assessments. The Agency will continue to use a combination of modeling and monitoring data as appropriate. Although the U.S. Geological Survey’s National Water Quali ty Assessment (NAWQA) program has conducted some monitoring for metolachlor/S

- metolachlor and its degradates, the NAWQA monitoring data are not targeted specifically to metolachlor/S

- metolachlor use areas or during times of known metolachlor/S

metolachlor use; thus, the dataset does not likely reflect peak concentrations that may occur in surface waters when runoff events occur shortly after metolachlor/S

- metolachlor is applied.

Summarized below are public comments that resulted in changes to the anticipat ed 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 docket, EPA

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- Metolachlor while those relevant to the anticipated human health risk asses sment or data needs are in the Metolachlor and S

Metolachlor. Response to Comments on the HED Human Health Scoping Document and pertaining the BEAD Chemical Profile and usage information in the BEAD Response to Public Comments in Support of Registration Re view (EPA Docket ID No.: EPA

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– Metolachlor Case [S

- metolachlor (108800) and Metolachlor (108801)]

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

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1. 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 metolachlor and S

- metolachlor in accordance with the Endangered Spe cies Act (ESA). CBD mentions 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 critic al habitat. CBD also expressed concern regarding the rigor of the Agency’s preliminary determinations regarding the effects of metolachlor and S

- metolachlor on endangered and threatened (listed) species and their designated critical habitat for the metola chlor and S

- metolachlor registration review.

Response: EPA has reviewed the comments from CBD on the registration review docket opening for metolachlor and S

- metolachlor 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 Sciences4 (NAS) report. EPA will address concerns specific to metolachlor and S

- metolachlor in connection with the development of its final registration review decision for this pesticide.

In November 2013, EPA, along with the Services and USDA, rel eased a summary of their joint i nterim a pproac hes for assessing risks to endangered and threatened (listed) species from pesticides. The i nterim a pproaches were developed jointly by the agencies in response to the NAS recommendations and reflect a common approach to risk assessment shared by the
agen cies 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 a pproaches were released prior to a stakeholder workshop held on Novemb er 15, 2013. In addition, the EPA presented the joint interim a pproaches at the December 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, allowing additional opportunities for stakeholders to comment on the interim a pproaches. Additional workshops are planned to enhance stakeholder involvement. As part of a phased, iterat ive process for developing the i nterim

a pp roaches, the agencies will also consider public comments on the interim a pproaches in connection with the development of upcoming r egistration r eview decisi ons. The details of the joint interim a pproaches are contained in the white paper

, I nterim Approach es for National

- Level Pesticide Endangered Species Act Assessments 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 wor k toward implementa tion of the i nterim a pproaches to assess the potential risks of pesticides to listed species and their designated critical habitat, the ecological problem formulation supporting this FWP for metolachlor and S

- metolachlor 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 formulation document for metolachlor and S

metolachlor

, EPA described the screening

- level risk assessment to determine the potential effects of metolachlor and S

- metolachlor 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 o f the application of metolachlor and S

- metolachlor . 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 ha ve been fully vetted. While the agencies continue to develop a common method for ESA analysis, the planned screening

- level risk assessment for the registration review of metolachlor and S

metolachlor will describe the level of ESA analysis completed for th is 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

2 http://www.nap.edu/catalog.php?record_id=18344

3 http://www.epa.gov/espp/2013/nas.html5 their designated critical habitats, these method s will be applied to subsequent analyses for metolachlor and S

- metolachlor as part of completing this registration review.

Comments submitted by FIFRA Endangered Species Task Force (FESTF), in EPA

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1. Comment: The technical regist rant for metolachlor and S

- metolachlor, as identified on the fact sheet included in the PWP, is Syngenta Crop Protection, LLC, which is a FESTF member and is entitled to rely on FESTF data.

Response: EPA appreciates FESTF’s comments and will consider thi s information during the

registration review of metolachlor and S

- metolachlor

. Comments submitted by Metolachlor Task Force in EPA

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1. Comment: The Metolachlor Task Force provided input and comments stating that EPA has not been consistent when evaluating metolachlor and S

- metolachlor’s relative equivalency when evaluating risk. The Metolachlor Task Force believes that the efficacy of both metolachlor’s is equal.

Response: The Agency appreciates the Metolachlor Task Force ’ s comm ents and will consider this information during the registration review of metolachlor and S

- metolachor. BEAD will review the information provided and conside r it for future analyses of metolachlor and S

- metolachlor efficacy

. Comments submitted by Syngenta Crop Protection, LLC in EPA

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. Comment: Syngenta provided several comments on the registration review Problem Formulation (PF) published in the docket . These comments included a discussion on end points from submitted studies that were referenced in the PF. Additionally, comments were made regarding a submitted chronic sediment toxicity study and whether that would fulfill the requirement for the non

- gu ideline chronic sediment toxicity study

. Lastly, Syngenta commented on EFED’s planned endangered species assessment for registration review.

Response: The Agency thanks Syngenta for their input and concurs with the majority of Syngenta’s discussed end po ints. U pon further review of the previously submitted Grade (1998) study, EPA does not plan on requiring the non

- guideline chronic sediment toxicity study as part of registration review. Concerning the Endangered Species assessment the Agency is still in t he process of finalizing our approach to assess the potential risks of pesticides to listed species and their designated critical habitat. Once this approach is finalized these methods will be applied to subsequent analyses of metolachlor/S

- metolachlor

as part of completing Registration Review. For a more detailed look into the Agency’s response on these comments please refer to Response to Public Comments on the EFED Registration Review Problem Formulation for Metolachlor and S

- Metolachlor now in the metol achlor and S

- metolachlor docket.6 2

. Comment: Syngenta provided comments regarding the registration review Scoping Document. This included rational to support the fulfillment of residue data to support labeled directions for use for registered bulb veget able, cotton, soybean, and tomato.

Response: The Agency and HED acknowledges receipt of this information and thanks Syngenta for their comment. For a more detailed look into the Agency’s response on these comments please refer to Metolachlor and S

- Metola chlor. Response to Comments on the HED Human Health Scoping Document now in the metolachlor and S

- metolachlor docket.

3. Comment: Syngenta provided comments regarding the BEAD Chemical Profile (BCP) . This included a detailed use characterization for both metolachlor and S

- metolachlor based on information in the BCP. Syngenta also provided a clearer picture of the history of the metolachlor registrations and it’s cancellation by Syngenta in 2001 and 2002 leading to an increase in S

- metolachlor usage.

Response: EPA and the Biological and Economic Analysis Division appreciates the information provided by Syngenta and will take it into consideration as appropriate during the registration review process. The Agency particularly ap preciates the usage clarifications which will help refine our view of current uses. For a more detailed look into the Agency’s response on these comments please refer to BEAD Response to Public Comments in Support of Registration Review (EPA Docket ID No. : EPA

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– Metolachlor Case [S

- metolachlor (108800) and Metolachlor (108801)] now in the metolachlor and S

metolachlor docket.7 PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for metolachlor and S

- metolachlor based o n the Registration Review Problem Formulation for Metolachlor and S

- Metolachlor

, the Human Health Scoping Document in Support of Registration Review

, the Response to Public Comments on the EFED Registration Review Problem Formulation for Metolachlor a nd S

- Metolachlor

, and Response to Public Comments on the EFED Registration Review Problem Formulation for Metolachlor and S

- Metolachlor

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

.

Table 1: Planned Data Needs for the Metolachlor and S

- Metolachlor Registration Review

Guideline Number 4 Study Title 1 Test Material Estimated Timeframe (Months from receipt of DCI)

Planned D ata Needs for the Parent (either metolachlor or S

- metolachlor) 835.4100 Aerobic soil metabolism (2 additional soils) TGAI 24 835.4200 Anaerobic s oil m etabolism (3 additional soils) TGAI 24

835.4300 Aerobic aquatic metabolism (1 additional sediment system) TGAI 24

835.4400 Anaerobic aquatic metabolism (1 additional sediment system) TGAI 24

850.2100 Avian acute oral toxicity test, passerine species TGAI 12

850.6 100 ECM/ILV: method and independent validation in soil and independent validation in water TGAI 12

Non

Guideline Honey bee adult chronic oral toxicity TGAI 12

Non

Guideline

(OECD

237) Honey bee larval acute oral toxicity TGAI 12

Non

Guideline Honey bee larval chronic oral toxicity TGAI 12

Non

Guideline Residues in pollen and nectar TEP 24

Non

Guideline Semi

- field testing for pollinators TEP 24

850.3040 Field testing for pollinators TGAI/TEP 24

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 G uidelines; OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

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- 00288 Table 1: Planned Data Needs for the Metolachlor and S

- Metolachlor Registration Review

Guideline Number 4 Study Title 1 Test Material Estimated Timeframe (Months from receipt of DCI)

Planned Data Needs for S

- m etolachlor

850.4100 Seedling emergence and seedling growth (four species of dicots , one of which is soybean ) TEP 12

850.4150 Vegetative vigor (four species of dicots , one of which is soybean ) TEP 12

875.2100 Turf Transferable Residue TGAI 12 Planned Data Needs for Metolachlor 870.3465 28

- day inhalation toxicity study TGAI 24
Planned Data Needs for the Metolachlor Ethanesulfonic Acid (ESA) Degradate

850.4100 Seedling emergence and seedling growth (ryegrass, tomato, and carrot) TGAI 12

Planned Data Needs for the Metolachlor Oxanilic Acid (OA) Degradate
850.4100 Seedling emergence and seedling growth (onion) TGAI 12 TGAI = technical grade active ingredient; TEP = typical end

- use product

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 metolachlor and S

- metolachlor

. For human health

, EPA will conduct revised dietary, residential , aggregate , and occupational risk
assessment s during registration review

. If toxicological endpoints 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

.

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

.9 Table 2: Planned Risk Assessments for the Metolachlor and S

- M etolachlor 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 Y Although degradates Ethanesulfonic Acid (ESA) and Oxanilic Acid (OA) are less toxic than parent metolachlor/S

- metolachlor, they are more persistent and are formed to a significant extent. Consequently, data are needed for the metolachlor degradates ESA and OA; these data have been listed in table 1. Incidents Will check for updates For a discussion of reported ecological incidents for metolachlor and S

- metolachlor, see page 28 of the Problem Formulation. Human Health Dietary Food Y The most current risk assessments do not indicate risk estimates of concern, however, if there are changes to the toxicological points of departure (PODs) or Uncertainty Factors (UFs) or significant changes to the Estimated Drinking Water Concentrations (EDWCs) an updated assessment will be needed. Drinking water Y

Occupational Handlers (mixers, loaders, applicators) Y Though previous occupational handler and post

application exposure assessments did not identify risks of concern, registration review may include updated estimates based on current policies and PODs/UFs may change based on the planned data

r equirements. Post

- application Y

Residential Handlers Y S

- metolachlor is not intended for homeowner purchase or use (only registered for use by professional/commercial applicators), therefore a residential handler assessment is not anticipated. However, registration review may include updated estimates based on current policies and PODs/UFs may change based on the planned data requirements. An updated post

- application exposure assessment may be needed during registration review dependent upon the information received in the planned Turf Transferable Residue stud y. The need for a bystander assessment may also be needed and will be revisited at the time of the risk assessment. Post

- application Y10 Other Aggregate Y E valuates the combined risk from dietary and residential exposures. Though no aggregate risks of concern were identified in the most recent assessment, an updated assessment may be needed to include any significant change that might occur for toxicological PODs, FQPA and uncertainty factors, dietary exposure estimates or EDWCs. Cumulative N Metolachlor and S

- metolachlor are not members of a cumulative group. Tolerances Y No changes to tolerances are anticipated at this time, since the tolerance expression is in accord with
current guidance and is compatible with the Canadian expression. However, U.S. tolerance levels are higher for certain crops and should be examined during registration review to determine if numerical harmonization is possible. Incidents Will check for updates Du e to the low frequency of reported incidents there does not appear to be a concern at this time that would warrant further investigation. For a discussion of reported human incidents for metolachlor and S

metolachlor, see page 11 of the Scoping Document

an d the Metolachlor: Tier I Review of Human Incidents

.

TIMELINE

EPA has created the following estimated timeline for the completion of the metolachlor and S

metolachlor registration review in Table 3 below

. The projected timeline has not changed since
t he PWP.

Table 3: Registration Review for Metolachlor and S

- M etolachlor

– Projected Registration Review Timeline Activities Estimated Date Opening the D ocket Open Docket and 60

- day Public Comment Period December 2014

– Completed Close Public Comment February 2015

– Completed Case Development Final Work Plan June 2015

– Completed Issue DCI 2015 July

– Sept. Data Submission 2017 July

– Sept. 60

- day Public Comment Period for Draft Risk Assessments 5 2019 Jan.

- March

5 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.11 Table 3: Registration Review for Metolachlor and S

- M etolachlor

– Projected Registration Review Timeline Activities Estimated Date Registration Review Decision 60

- day Public Comment Period for Proposed Registration Review D ecision 2019 Oct.

– Dec.

Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 2020

Total ( years ) 6

NEXT STEPS

As noted previously, the Agency plans to require several environmental fate, ecological effects, and human health studies for metolachlor and S

- metolachlor through a D ata C all

- I n Notice

, expected to be issued in 2015

.