Docke t

Numbe r EPA-HQ-OPP-2008-062 5
www.regulations.go v



## Flumetsula m

Propose d Interi m Registratio n Revie w Decisio n

Cas e Numbe r 722

9

Septembe r 201 4

Approve d by : 'zJ^cJicccci P H ^<^^UTi..c<^ ^

Richar d P

. Keigwin

, Jr

. Directo r

Pesticid e Re-evaluatio n Divisio n

Date : Q -H ^^C,^Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-06 25 Proposed Interim Regi stration Review Decision www.regulations.gov Pesticide Re-evaluation Division

2 

### Table of Contents

I. Introduction .............................................................................................................. ................ 3

II. Scientific Assessments ................................................................................................... ......... 5

A. Environmental Assessment ................................................................................................ 5

B

. Endangered Species Assessment....................................................................6

C. Human Health Assessment ................................................................................................. 7 D. Endocrine Disruptor Screening Program ......................................................................... 8 E. Incident Reports .......................................................................................................... ........ 9

F. Public Comments ........................................................................................................... .... 10

G. Environmental Justice ..................................................................................................... . 11 III. Proposed Interim Registra tion Review Decision ............................................................... 11 A. Ecological Risk ........................................................................................................... ....... 12 B. Risk Mitigation Measures ................................................................................................. 13 IV. Next Steps and Timeline ................................................................................................... ... 14 A. Proposed Interim Regist ration Review Decision ............................................................ 14 B. Implementation of Mitigation Measures ......................................................................... 14 Appendix A: Flumetsu lam Label Table................................................................15Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-06 25 Proposed Interim Regi stration Review Decision www.regulations.gov Pesticide Re-evaluation Division

3 I. INTRODUCTION

This document is the Environmental Prot ection Agency’s (EPA or the Agency) Proposed Interim Registrati on Review Decision for Flumetsulam and is being issued pursuant to 40 CFR sections 155.56 and 155.58. A registration review d ecision is the Agency's determination whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (F IFRA). The Agency may issue, when it determines it to be appropriate, an interim registra tion review decision before co mpleting a registration review. Among other things, the interim registration review decision may (1) require new risk mitigation measures; (2) impose interim risk mitigation measures; (3) identify data or information required to complete the review; and (4) include schedules for submitting the required data, conducting the new risk assessment and completing the registration review.

FIFRA, as amended by the Food Quality Pr otection Act (FQPA) of 1996, mandated the continuous review of existing pes ticides. All pesticides distributed or sold in the United States generally must be registered by the EPA based on sc ientific data showing that they will not cause

unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review pr ogram is intended to make sure th at, as the abilit y to assess and reduce risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreas onable adverse effects. Change s in science, public policy, and pesticide use practices will occur over time. Thr ough the registration review program, the Agency periodically reevaluates pesticides to make sure that as these changes occur, products in the marketplace can continue to be used safel y. Information on this program is provided as www.epa.gov/oppsrrd1/registration_review /.

In 2006, the Agency implemented the registration review program pursuant to FIFRA section 3(g) and will review each registered pesticide every 15 years to determine whether it

continues to meet the FIFRA st andard for registration.

Pursuant to 40 CFR §155.50, the Agency forma lly initiated registration review for flumetsulam (Case 7229). The Agency’s registrati on review of flumetsulam (Case 7229) includes all registered pesticidal uses of flumetsulam which include agricultu ral uses; there are no registered residential or public recreatio nal uses of flumetsulam.

Flumetsulam has been registered as a pesticid e in the United States since 1985. A Tolerance Reassessment Eligibility Decision (TRED) was completed in 2004. The EPA has determined that

flumetsulam does not have a common mechanism of toxicity with the other pesticides and does not appear to produce a toxic metabolite produced by other substances. Flumetsulam is currently registered for use as an herbicide for control of broadleaf weeds in fi eld corn and soybeans. Formulations include water dispersible granules (WDG), emulsifiable concentrate (EC) and water soluble packets (WSP); flumetsula m is often applied in formulati on with other activ e ingredients. Formulations may be applied as a pre-plant su rface, pre-emergence treatment with either soil incorporated treatment, or fo liar application via aerial or ground spray. Products containing

flumetsulam include label restrictions for the to tal amount of flumetsulam applied per application and per year to 0.07 lbs a.i./A.Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-06 25 Proposed Interim Regi stration Review Decision www.regulations.gov Pesticide Re-evaluation Division

4 The following timeline highlights significant events that have occurred during the registration review of flumetsulam and the documen ts that can be found in the public docket (EPAHQ-OPP-2008-0625):

 September 10, 2008 – The Agency completed the Flumetsulam Registration Review Summary Document in the docket as EPA-HQ-O PP-2008-0625-0004 for a 90-day public comment period beginning on September 17, 2008 (comment period closed December 17, 2008). The Summary Document included the Agency’s Preliminary Work Plan for

Flumetsulam and a Flumetsulam Fact Sheet, which were based on the following:

o June 3, 2008 – Flumetsulam Registration Review: Ecological Risk Assessment

Problem Formulation (in the docket as EPA-HQ-OPP-2008-0625-0006)

o August 12, 2008 – Amended Human Health Assessment Scoping Document in Support of Registration Review (in the docket as EPA-HQ-OPP-2008-0625-0005)

o November 19, 2007 – Screening Level Use Analysis (SLUA) (in the docket as EPAHQ-OPP-2008-0625-0007)

o The Agency received three comments concerning the Flumetsulam Registration Review Summary Document. However, these comments di d not change the data and risk assessment needs or the work plan fo r the registration review of flumetsulam.

The comments were addressed in the Flumetsulam Final Work Plan.

 February 13, 2009 – The Agency completed the Flumetsulam Final Work Plan (in the docket as EPA-HQ-OPP-2008-0625-0011), which st ated that the Agency would conduct a comprehensive ecological risk assessment that included an endangered species risk

assessment and a human health risk assessm ent if pending submission/evaluation of immunotoxicity and acute and s ubchronic neurotoxicity data l ead to revision of endpoints and safety factors.

 August 2, 2013 – The Ag ency completed the Flumetsulam Generic Data Call-In (in the docket as EPA-HQ-OPP-2008-0625-0012), which listed three studies: UV/Visible absorption (830.7050), neurotoxicity screenin g battery (870.6200) and immunotoxicity (870.7800).

 August 16, 2013 – The Agency completed Registration Review Drinking Water Assessment for Flumetsulam (in the docket as EPA-HQ-OPP-2008-0625-0016).

 July 10, 2013 – The Agency completed Flumetsulam: Review of Human Incidents for Preliminary Risk Assessment (to be posted to docket with the Flumetsulam Proposed Interim Registration Review Decision , see last bullet below)

 September 19, 2013 – The Agency completed Flumetsulam: Preliminary Human Health Risk Assessment for Registration Review (in the docket as EPA-HQ-OPP-2008-0625- 0014).

 September 19, 2013 – The Agency completed Flumetsulam: Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Ri sk Assessment for Registration Review (in the docket as EPA-HQ-OPP-2008-0625-0017).Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-06 25 Proposed Interim Regi stration Review Decision www.regulations.gov Pesticide Re-evaluation Division

5  September 19, 2013 – The Agency completed Preliminary Ecological Risk Assessment for the Registration Revi ew of Flumetsulam (in the docket as EP A-HQ-OPP-2008-0625-0015).

 May 16, 2014 – The Agency completed the EFED Response to Comments on the Registration Review Preliminary Risk Assessment for Flumetsulam (to be posted to docket

with the Flumetsulam Proposed Interim Registration Review Decision , see last bullet below).

 September 24. 2014 – The Agency is now publishing the Flumetsulam Proposed Interim Registration Review Decision in docket number EPA-HQ-OPP-2008-0625 for a 60-day public comment period.

The Agency has not completed an endangered species risk assessment of flumetsulam. Furthermore, flumetsulam has not been eval uated under the Endocrine Disruptor Screening Program (EDSP). Therefore, the Agency’s issuan ce of a final registration review decision for

flumetsulam will not occur until there has been Section 7 Endangered Species consultation with

the U.S. Fish and Wildlife Service and work has been completed under the EDSP. Pending the outcome of these actions, EPA intends to issu e an Interim Registrati on Review Decision for

flumetsulam.

For further information on Flumetsulam , additional documents can be found in EPA’s public docket (EPA-HQ-OPP-2008-0625) at www.regulations.gov

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II. SCIENTIFIC ASSESSMENTS

A. Environmental Assessment

A summary of the Agency’s environmental risk assessment is presented below. A quantitative risk assessment was conducted for te rrestrial and aquatic or ganisms. For detailed discussions of all aspects of the environmental risk assessment see Preliminary Ecological Risk Assessment for the Registration Review of Flumetsulam dated September 19, 2013 (in the docket as EPA-HQ-OPP-2008-0625-0015) which can be accessed on http://www.regulations.gov

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Risk Characterization

Aquatic and Terrestrial Animals

The mode of action of flumetsulam (ALS in hibition) is highly specific to plants and microorganisms. As with other AL S-inhibiting herbicides (such as those in the su lfonylurea class), flumetsulam has low acute and chronic toxicity to te rrestrial vertebrates, te rrestrial arthropods, fish and aquatic invertebrates. When combined with the low use rate (maximum seasonal rate is 0.07 lb a.i./A), the risk of direct toxicity to these an imals is very low. The lack of ecological incidentsFlumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-06 25 Proposed Interim Regi stration Review Decision www.regulations.gov Pesticide Re-evaluation Division

6 for these taxa and results of the current uses of flumetsulam on corn and soybean suggest that exposures to flumetsulam pose low risk to all aquatic and te rrestrial animals. Though flumetsulam exposures are not expected to cause signifi cant direct effects to listed species of animals, indirect eff ects to aquatic and terrestrial anim als are possible as the result of the potential damage to vege tation and aquatic plants.

Aquatic and Terrestrial Plants

Despite the relatively low flumetsulam us e rates, the very high phytotoxicity of

flumetsulam results in the conclu sion that all uses may pose risk to aquatic plan t and non-target terrestrial plants. The risk assessment indicates th at corn and soybean uses of flumetsulam exceed

the EPAs level of concern for both listed and non-listed aquatic and terrestrial plants. Flumetsulam is moderately persistent in the terrestrial environment but persistent in the aquatic environment. Thus, while flumetsulam is typically applied only on ce per year, residues in soil and water may remain at phytotoxic levels fo r a long period of time. This is confirmed by numerous reported incidents of crop damage wh ich have been attributed to carryover of flumetsulam, that is, damage from exposure to re sidues which remain in the soil from application during a previous growing season. In addition, flumetsulam has little binding potential to organic ma terial in the soil, and thus is prone to movement in runoff. Both of these factors increase the potential for residues to be transported from the use site into terrestrial an d aquatic habitats where non-target plants can be exposed.

Water Quality

Flumetsulam is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 1 In addition, no Total Maximum Daily Loads (TMDL) have been developed for flumetsulam. 2 More information on impaired water bodies and TMDLs can be found at the Agency’s website. 3

B. Endangered Species Assessment

In November 2013, the EPA, al ong with the U.S. Fish & W ildlife Service (USFWS), the National Marine Fisheries Service (NMFS) (collec tively, the Services), a nd the U.S. Department of Agriculture (USDA) released a summary of th eir joint Interim Approaches for assessing risks to listed species from pesticides. The Interim Ap proaches were developed jointly by the agencies in response to the National Academy of Scien ces’ (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. The NAS report outlines recommendations on specific

scientific and technical issues related to the de velopment of pesticide risk assessments that EPA

and the Services must conduct in connection with their obligations under the Endangered Species Act (ESA) and FIFRA.

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

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

3 http://www.epa.gov/owow/tmdl/Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-06 25 Proposed Interim Regi stration Review Decision www.regulations.gov Pesticide Re-evaluation Division

7 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 Committee (PPDC) and State-FI FRA Issues Research and Evaluation Group (SFIREG) meetings , and held a stakeholder workshop in April 2014, allowing additional opportunities for stakeholders to comme nt on the Interim Approaches. As part of a phased, iterative process for devel oping the Interim Approaches, the agencies will also consider public comments on the Interim Approaches in connection with the development of upcoming Registration Review decisi ons. The details of the joint Interi m Approaches are contained in the white paper “Interim Approaches for National-Le vel Pesticide Endangered Species Act

Assessments Based on the Recommendations of the National Academy of Sciences 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 habitat, the ecological risk assessment supporting this Proposed Interim Registration

Review Decision for flumetsulam does not contain a complete ESA analysis that includes effects determinations for specific listed species or desi gnated critical habitat. Although EPA has not yet completed effects determinations for specific species or habitats, for this preliminary assessment EPA conducted a screening-level assessment for all taxa of non-target wildlife and plants that

assumes for the sake of the assessment that listed species and designated cri tical habitats may be present in the vicinity of the a pplication of flumetsulam This screening level assessment will

allow EPA to focus its future evaluations on th e types of species where the potential for effects exists once the scientific methods being develope d by the agencies have been fully vetted. While the agencies continue to develop a common method for ESA analysis, the regulatory section of the Proposed Interim Registration Review Decision docum ent will describe the level of ESA analysis completed for this particular re gistration review case. Once the ag encies 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 flumetsulam as part of completing this re gistration review.

C. Human Health Assessment

The Agency considered the flumetsulam hu man health scoping docum ent, its supporting documents, and the most updated Agency science policies and risk asse ssment methodologies to prepare a quantitative risk assess ment in support of the registration review of flumetsulam. Based

on the human health risk assessm ent, HED has determined that there are no potential risks of concern for the currently registered uses of fl umetsulam. In this Proposed Interim Registration Review Decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of flumetsulam. Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.

For detailed discussions of all aspects of the human health risk assessment, see the Flumetsulam: Preliminary Human Health Risk Assessment for Registration Review (in the docketFlumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-06 25 Proposed Interim Regi stration Review Decision www.regulations.gov Pesticide Re-evaluation Division

8 as EPA-HQ-OPP-2008-0625-0014), dated Septembe r 19, 2013. A summary of the Agency’s human health risk assessment is presented below.

Flumetsulam has low acute toxicity by oral, derm al or inhalation routes of exposure. It is not a skin or eye irritant and is not a skin sens itizer. The available toxicity database shows that

flumetsulam is not a neurotoxic or immunotoxic chemical and it does not induce developmental or reproductive toxicity. Flumetsu lam is classified as ‘Group E’ (evidence of non-carcinogenicity for humans); mutagenicity studies conduc ted with flumetsulam were negative.

An acute dietary exposure assessment was not performed as no appr opriate endpoints were

identified from the available flumetsulam toxici ty studies. A chronic dietary exposure assessment incorporated food and water. Estimated exposure for the general U.S. popul ation and all population subgroups did not exceed HED’s level of concern; estimates resulted in exposures less than 1% of the chronic population adjusted dose (cPAD). A cancer dietary exposur e assessment was not performed given the ‘Gr oup E’ classification.

A residential/non-occupational e xposure assessment is not re quired given that there are no registered residential uses associated with fl umetsulam. Occupational exposure for handlers was assessed using the inhalation route. The short- and intermediate-term inhalation risk estimates for all occupational handler scenarios do not exceed HED’ s level of concern; th e margin of exposures are greater than 100 (MOEs > 100) at baseline pe rsonal protective equipmen t. Worker protective gear is still advised as well as appropriate rest ricted entry intervals (R EIs) currently on end use product labels. Spray drift analys is was conducted for hand-to-mout h (HtM) scenario for children ages 1 to less than 2 years using Tier 1 scr eening parameters. The aerial and ground applications of flumetsulam and the current maximum applicat ion rates resulted in MOEs that are not of concern for field corn and soybeans.

Tolerances are established for the herbicide flumetsulam under 40 CFR: §180.468 for bean, dry, seed; corn, field, forage; cor n, field, grain; corn, field, stover; soybean, seed, each at 0.05 ppm.

D. Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA review s numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these st udies include acute,

subchronic and chronic toxicit y, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, a nd general or systemic toxicit y. These studies include endpoints which may be susceptible to e ndocrine influence, including e ffects on endocrine target organ histopathology, organ weights, es trus cyclicity, sexual maturati on, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. Fo r ecological hazard assess ments, EPA evaluates

acute tests and chronic studies that assess growth, developmen tal and reproductive effects in different taxonomic groups. As part of its most recent registration decision for flumetsulam, EPA

reviewed these data and selected the most se nsitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p),Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-06 25 Proposed Interim Regi stration Review Decision www.regulations.gov Pesticide Re-evaluation Division

9 flumetsulam is subject to the endocrine screen ing 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 ha ve an effect in humans or wildlif e similar to an effect produced by a “naturally occurring estrogen, or other su ch endocrine effects as the Administrator may designate.” The EDSP employs a two-tiered approach to making the 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 thr ough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are ne cessary based on the available data. Tier 2 testing is designed to identify any adve rse endocrine-related effects caused by the substance, and establish a dose-response relationship between th e 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 pes ticide active ingredients and 9 inert ingredients. A second list of chemicals, including flumetsulam, identified for EDSP screening was published on June 14, 2013 4
and includes some pesticides scheduled for Regist ration Review and chemicals found in water.

Neither of these lists should be co nstrued as a list of known or li kely endocrine di sruptors. For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website. 5

In this interim decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of flumetsula m. Before completing th is Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.

E. Incident Reports

Human Incidents

The U.S.EPA 2013 Review of Human Incidents for Preliminary Risk Assessment ( see EPAHQ-OPP-2008-0625 in flumetsulam docket) conc ludes that based on the low frequency and severity of incident cases repo rted for flumetsulam in both the OPP Incident Data System (IDS)

and the Centers for Disease Control and Prevention /National Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR-Pesticides), there does not appear to be a concern at this time that would warrant further investigation. The Agency will continue to mon itor the incident informa tion and if a concern is triggered, additional analysis will be conducted.

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

chemicals.

5 http://www.epa.gov/endo/Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-06 25 Proposed Interim Regi stration Review Decision www.regulations.gov Pesticide Re-evaluation Division

10 For the Main IDS, from January 1, 2008 to May 8, 2013, there were no incidents reported for single chemical only in the database involving flumetsulam. There were 5 additional incidents reported involving more than one chemical. However, they were all foreign incidents, one incident

occurred in Australia and four in cidents occurred in China. Forei gn incidents are no t reviewed in detail because of the potential differences in the exposure patterns, use practices, and product

formulation. All of these incidents were classified as moderate severity.

In Aggregate IDS, from Janua ry 1, 2008 to May 8, 2013, there were nine reported incidents involving flumetsulam. These incidents were classifi ed as minor severity. Overall, there are few incidents involving flumetsulam reported to IDS.

A query of SENSOR-Pesticides, which is a database that cove rs eleven states from 1998 to 2009, identifies no cases involving flumetsulam.

In addition, findings from the Agricultural Health Study (AHS) were reviewed. The AHS is a high quality, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer. Flumet sulam is included in the AHS, but it is only in phase III and there are no studies available yet to consider.

Ecological Incidents

A review of the Ecological Incident Informa tion System (EIIS, version 2.1), queried July 8, 2012 and which is maintained by the Agency’s Office of Pesticide Programs, indicates that a total of 368 ecological incidents are linked to exposure to flumetsulam. All incidents involved mortality or damage to plants. Sp ecies affected include corn, soyb ean, alfalfa, cotton and clover. A review of the Aggregate Incide nt Reports (v. 1.0) database c ontained in the Incident Data System (IDS), and the Avian Monitoring Informa tion System (AIMS) for ecological incidents involving flumetsulam was completed on July 8, 2012. AIMS did not repor t any incidents in relation to avian species. IDS identified 224 incidents linking exposure to flumetsulam from January 1998 through December 2012; all except two of the incidents were minor plant incidents.

For detailed discussions of al l aspects of the environmental risk assessment including a description of the ecologi cal incident data see Preliminary Ecological Ri sk Assessment for the Registration Review of Flumetsulam dated September 19, 2013 (in the docket as EPA-HQ-OPP2008-0625-0015) which can be accessed on http://www.regulations.gov

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F. Public Comments

On September 19, 2013, the Ag ency formally issued the Flumetsulam: Preliminary Human Health Risk Assessment for Registration Review, the Flumetsulam: Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for Registration Review and the Preliminary Ecological Risk Assessment fo r the Registration Review of Flumetsulam . The Notice of Availability was published in the Federal Re gister, initiating a 60-da y public comment period (which ended Nov 26, 2013). During that time, comments from three commenters were received

which are available in the docket.Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-06 25 Proposed Interim Regi stration Review Decision www.regulations.gov Pesticide Re-evaluation Division

11 Brief comments were submitted at two differ ent times by Crop Life America commending

the EPA on its work to refine ecological risk assessment work consistent with the National Academy of Sciences (NAS) recommendations as well as efforts to maintain and improve transparency and communication throughout the registration review process.

A set of specific comments about the HED a nd EFED risk assessments were received from Dow AgroSciences that span the following topi cs: spray-drift reduction technology, registration updates, qualitative use of monitoring data, updates to aquatic and terrestrial plant toxicological endpoints and TerrPlant model assu mptions. In addition, the Minnesota Department of Agriculture (MDA) submitted monitoring data for flumetsulam. Data sets were provided which give results of analysis for flumetsulam residues in samples of surface water and ground water collected in

Minnesota from 2011 to 2013. The detailed EFED response to DAS and MDA comments will be posted to the flumetsulam docket (EPA -HQ-OPP-2008-0625) along with this Proposed Interim Registration Review Decision

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G. Environmental Justice

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, nati onal origin, or income, in the development, implementation, and enforcement of environmenta l laws, regulations, and policies. To help address potential enviro nmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their loca tion, cultural practices, or other factors, may have atypical, unusually high exposure to flum etsulam, compared to the general population. The Agency did not receive any comments concerni ng any environmental justice issues. At this time, EPA does not believe that use of the regi stered pesticide products containing flumetsulam will cause harm to or a disproportionate impact on at-risk communities.

For additional information regarding enviro nmental justice issues, please visit EPA’s

website at: www.epa.gov/compliance/environmentaljustice/index.html

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III. PROPOSED INTERIM REGI STRATION REVIEW DECISION

Per the Flumetsulam Preliminary Work Pl an, EPA has completed human health and ecological risk assessments, including a listed species risk assessment, for flumetsulam as part of registration review. The Agency is, therefore, issuing a Proposed Interim Registration Review Decision pursuant to 40 CFR sections 155.56 and 155.58. The registration review timeline in the Flumetsulam Final Work Plan projected that the Agency would issue the preliminary risk assessments between May and July, 2013 and issu e the Proposed Interim Registration Review Decision between December, 2013 and January, 2014. However, the Agency is issuing the Proposed Interim Registration Re view Decision in September 2014 and expects to issue the Interim Registration Review Decision in late 2014.Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-06 25 Proposed Interim Regi stration Review Decision www.regulations.gov Pesticide Re-evaluation Division

12 Based on the screening-level risk assessments, the Agency’s level of concern is exceeded

for risks to listed and non-liste d aquatic and terrestria l plants (monocots and dicots) from the use of flumetsulam on corn and soybean s. Listed aquatic and terrestrial animals may also be affected through indirect effects because of the potenti al effects on listed a nd non-listed aquatic and terrestrial plant species. As discussed earlie r (refer to the Endangered Species Assessment discussion), the scientific methods necessary to complete risk assessments for endangered and threatened (listed) species and their designated cr itical habitats will be applied to subsequent analyses for flumetsulam as part of completing this registration review.

In this Proposed Interim Re gistration Review Decision, EP A is making no human health or environmental safety findings associated with the EDSP screening of flumetsulam. Before completing this Registration Review, the Agen cy will make an EDSP FFDCA section 408(p) determination as well as complete the ESA work. Therefore, issuance of the Agency’s final registration review decision is dependent upon (1) the completion of Section 7 Endangered Species

consultation with the U.S. Fish and Wildlife Service and (2) a conclu sion under the EDSP FFDCA section 408(p).

A. Ecological Risk Characterization

EPA has determined that there is potential for ri sk to non-target aquatic and terrestrial plant species from all uses considered for corn and soybeans. Currently, most labels include language that would reduce the potential effect from drift (see Appendix A ). All labels include restrictions that include limits for use on target plant spec ies and language intended to reduce the potential

effect from runoff and wind erosi on. Furthermore, most labels incl ude aerial spray restrictions as well as droplet size and applications within a gi ven wind speed range. Howe ver, these restrictions

are not consistent across the labels and, though the current labe l language reduces the potential effect from drift, it does not elim inate risk to non-target plants.

Aerial Spray Restrictions

Application rate being equal, RQ s for aquatic and terrestrial plan ts are greater for aerial spray applications than for ground spray applications. Th e ecological risk assessment estimated that RQs from aerial exposure (more so th an for ground spray application – i.e., high boom height) could

exceed LOCs more than 1000 ft from the treated field. However, seven out of ten labels do not allow aerial application of flumetsulam, and those that do have some restrictions. Two do not allow aerial application in NY State, a nd one only allows aerial applicati on in nine states (Colorado, Iowa, Kansas, Minnesota, Nebraska, Oklahoma, North Dakota, South Dakota, and Texas).
However, the registrant of these products, Dow Agricu ltural Sciences, has agreed to prohibit aerial application on one of these three labels (62719-253) adding “Do not apply this product using aerial application equipment,” and by removi ng language that allows aerial application “with EPA approved supplemental labeling.”

The registrant of the labels which allow aerial a pplication indicated that this application method was important to corn and soybean growers. They indicated that flumetsulam is important for the

control of teaweed and that aeria l application was necessary for successful control. The labelsFlumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-06 25 Proposed Interim Regi stration Review Decision www.regulations.gov Pesticide Re-evaluation Division

13 which allow aerial application in nine states were written this way because at times wet conditions do not allow ground application e quipment into the field. The Agency welcomes submission of information during the comment period on these claims, and the frequency with which aerial application of flumetsulam is necessary.

Droplet size Restrictions

The ecological risk assessment also estimated the distances from the field to which exposure from ground spray of flumetsulam might ex ceed levels of concern for terrestrial plants. In each case, the

distance from the field was reduced from the us e of medium-coarse sprays instead of fine-tomedium sprays. Currently, all but two flumetsula m labels contain language prohibiting the use of nozzles which produce a fine droplet size spectrum; the registrant of these products, Dow Agricultural Sciences, has agreed to add th is language to the two remaining labels. Therefore,

the shorter distances in the risk assessment may be a better estimat e overall of potential risk. In addition, because the screenin g assessment considers the 90 th percentile exposure, the distance to which exposures of concern would routin ely occur would be shorter, as well.

Dow Agricultural Sciences commented that the spra y drift analysis conduct ed by the Agency does not reflect the coarser spray produ ced by currently available nozzle types with spray-drift reduction technology (DRT). They showed resu lts of their analysis showing that the distance from the field that exposures would exceed LOCs is dramatical ly reduced when using these newer nozzles. The Agency is currently nearing completion of its preliminary evaluation of DRT. Thereafter, the Agency anticipates discussing these advances w ith DAS and other registrants to establish how including the use of DRT nozzles on pesticide labels could reduce potential exposure to non-target organisms such as plants.

Although the risk assessment did not explicitly take into account the droplet size effect for aquatic plants –instead a 5% drift assumption for aeria l spray applications, 1% for ground spray, and 0% for impregnated fertilizer was us ed in the exposure modeling – th e potential for risk to aquatic plants is also reduced by spray drift language on the labels. The risk to aquatic plants does not appear to be as severe as that for terrestrial plants, given the magnitude of the RQs, and the assumptions of the modeling. For instance, the RQs were calculated for a small pond directly adjacent to a treated field. The amount of flum etsulam reaching a water body via drift will be less

for water bodies some distance from a treated field, and the amount ente ring via runoff may be reduced, as well.

Wind speed Restrictions

Evaluation of the footprint away from the field assumes a 10 mph wind in the direction of nontarget plants. However, the registrant indicated th at flumetsulam needs to be applied at wind speeds below 3 mph and up to 15 mph, and all labels but one state that wind veloc ity of approximately 3 to 10 mph favors on-target product deposition Another three labels, also state that wind speeds in excess of 15 mph will lead to uneven spray coverage resulting in drift (see Appendix A )Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-06 25 Proposed Interim Regi stration Review Decision www.regulations.gov Pesticide Re-evaluation Division

14 B. Risk Mitigation Measures

In developing this Proposed Interim Registra tion Review Decision, th e Agency considered a number of mitigation measures that would furt her reduce risk from flumetsulam uses. Possible measures included the following:

 Eliminating the use of the produc t with aerial spray equipment

 Increasing droplet size spectra

 Applying the compound within a given wind-speed range

Specific language addressing the three miti gation options were searched across the

flumetsulam end-use labels. The use restriction language as well as the labels that do not incorporate it are listed in Appendix A . As described above, regist rant DAS has agreed to add label restrictions which will give all labels restriction against nozzl es that produce fine droplet size spectra, and which will reduce the number of labe ls allowing aerial application to two. The EPA will continue to work with the registrants to expl ore other potential measures to reduce off-site transport of flumetsulam, such as the incor poration of DRT measures onto product labels.

IV. NEXT STEPS AND TIMELINE

A. Interim Registration Review Decision

In accordance with 40 CFR 155.56 and 155.58, the Agency is issuing this Flumetsulam Proposed Interim Registration Re view Decision and placing it in the flumetsulam registration review docket (EPA-HQ-O PP-2008-0625). A Federal Regist er Notice will announce its availability and allow a 60-day public comment period. If there are no significant comments or

additional information submitted to the docket du ring that comment period that would lead the Agency to change its decision, EPA will issue an Interim Registration Review Decision for flumetsulam (Case 7229). The Agency anticipates the Flumetsulam Interim Registration Review Decision will be issued in late 2014. The Agency expects to issue a Pr oposed Final Decision and Final Decision on the flumetsulam registration review case after both (1) conclusion of ESA Section 7 consultation with the FWS and (2) an EDSP FFDCA section 408(p) determination has

been made.

B. Implementation of Mitigation Measures

Registrants will be required to submit propos ed amendments and registered and amended labels that include the agreed-upon risk mitigat ion to the Agency for approval within 60 days following issuance of the Interim Regist ration Review Decision is final.Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-06 25 Proposed Interim Regi stration Review Decision www.regulations.gov Pesticide Re-evaluation Division

15 

### Appendix A: Flumetsulam Label Table

The following labels were searched for language specifically restricting use that would reduce potential off-site transport of flumetsulam: 62719-679, -224, -253, -277, -278, -279, -315, -570; 524-614; and, 89167-34.

Summary of Labeling Changes for Flumetsulam Uses

Section. Description Amended Labeling Language for Flumetsulam Use Products Labels Without this Language

End Use Products

A. Language to restrict aerial application “Do not apply this product using aerial spray equipment” ( The registrant has ag reed to apply this language to 62719-253 ) 62719-253 ♠ ,-277 ♠

62719-315 ◊

B. Language to restrict droplet size “Do not use nozzles that prod uce a fine-droplet spray” ( The registrant has agreed to apply this la nguage to all of its flumetsulam product

labels ) 62719-277 ▲ , -315 □

C. Language to restrict wind speed “Make application when the wind velocity favors on-target product deposition (approximately 3 to 10 mph)” 62719-253 ◘

D. Language to restrict wind speed “Do not apply when wind is gusting or wind speed exceeds 15 mph as uneven spray coverage and drift may result.” (Alternatively, EPA proposed: “Do not apply when wind speed is lower than 3 mph or higher than 10 mph”) 62719-224 ♣ , -278 ♣

, -279 ♣

E. Language to restrict use to target species only “Do not apply near desirable vegetation” ---

F. Language to minimize

drift “Do not apply when weather conditions favor drift to non-target sites.” 62719-277

G. Language to minimize

runoff and wind erosion “Do not apply under conditions that favor runoff or wind erosion of soil containing this product to non-target areas. To prevent off-site movement due to runoff or wind erosion: Do not apply to impervious substrates such as paved or highly compacted surfaces or frozen

or snow covered soils.

Do not use tailwater from the first flood or furrow irrigation of treated field to treat non-target crops unless at least 1/2 inch of rainfall ha s occurred between application and the first irrigation ---

♠ Supplemental labeling enables aerial application everywhere except NY

◊ Supplemental labeling enables aerial application in nine U.S. st ates including Colorado, Iowa, Kansas, Minnesota, Nebraska, Okl ahoma, North Dakota, South Dakota, and Texas.

▲ The droplet size language is not available on the master or the supplemental labels.

□ The droplet size language is available on the master label but not on the supplemental label.

◘ This label does not have wind speed restrictive language as written above. Other labels including 62719-277 and -315 provide t he following language: “Drift potential is lowest between wind speeds of 2 to 10mph.” Labels 62719-278, -224 and -279 state: “Do not spray w hen wind is gusting or steady wind speed is greater than 10 mph.”

♣ These labels do not have wind speed restrictive language as written above. Other labels including 62719-277 and -315 provide t he following language: “Avoid applications below 2 mph due to variable wind direction and high inversion potential.”