Flumetsulam Case 7229 Docket Number EPA-HQ-OPP- 2008-0625 Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

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### Table of Contents

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

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

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

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. 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 ..................................................................................................... . 13 III. Interim Registration Review Decision ................................................................................ 13 A. Ecological Risk ........................................................................................................... ....... 14 B. Risk Mitigation Measures ................................................................................................. 16 IV. Next Steps and Timeline ................................................................................................... ... 17 A. Registration Review Decision ........................................................................................... 17 B. Implementation of Mitigation Measures ......................................................................... 17Flumetsulam Case 7229 Docket Number EPA-HQ-OPP- 2008-0625 Interim Regist ration 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) Interim Registration Review Decision for flumetsulam and is being issued pursuant to 40 CFR sections 155.56 and 155.58. A registration review decision 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 (FIFRA). The Agen cy may issue, when it determines it to be appropriate, an interim registration review deci sion before completing a registration review. Among other things, the interim registration revi ew decision may require new risk mitigation measures or impose interim risk mitigation m easures. Additional supporting documents can be found in EPA’s public docket for the registrati on review of flumetsulam (docket number EPAHQ-OPP-2008-0625) at www.regulations.gov

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FIFRA, as amended by the Food Quality Pr otection Act (FQPA) of 1996, mandated the continuous review of existing pest icides. 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 program is intended to make sure that, as the ability to assess and reduce risk evolves and as polic ies and practices change, all regi stered pesticides continue to meet the statutory standard of no unreasonable a dverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically reevaluates pes ticides to make sure that as these changes occur, products in the marketplace can continue to be used safely. Information on this program is provided as www.epa.gov/oppsrrd1/registration_review/

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In 2006, the Agency implemented the registratio n review program pursuant to FIFRA section 3(g) and will review each regist ered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration.

Flumetsulam has been registered as a pestic ide 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 field corn and soybeans. Formulations include water dispersible granules (WDG), emulsifiable concentrate (EC) and water soluble packets (WSP); flumetsulam is of ten applied in formula tion with other active ingredients. Formulations may be applied as a pre-plant surface, pre-emergence treatment with either soil incorporated treatme nt, or foliar application via ae rial or ground spray. Products containing flumetsulam include label restrictions for the total amount of flumetsulam applied per application and per year to 0.07 lbs a.i./A.

Pursuant to 40 CFR §155.50, the Agency formally initiated registration review for flumetsulam (Case 7229) in 2008. The Agency’s registration revi ew of flumetsulam in cludes all registered pesticidal uses of flumetsulam. Flumetsulam is registered only for agricultural uses; there are no registered residential or public r ecreational uses of flumetsulam.Flumetsulam Case 7229 Docket Number EPA-HQ-OPP- 2008-0625 Interim Regist ration 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:

 September 10, 2008 – The Agency completed the Flumetsulam Registration Review Summary Document (in the docket as EPA-HQ- OPP-2008-0625-0004) and opened the flumetsulam docket for a 90-day public co mment period beginning on September 17, 2008 and closing on December 17, 2008. The Summary Document included the Agency’s Preliminary Work Plan (PWP) for Flumetsulam and a Flumetsulam Fact Sheet, which were based on the following:

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

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) The Agency received three comments concerning the Flumetsulam Registration Review Summary Document. However, these comments did not change the data and risk assessment needs or the work plan for the registration review of flumetsulam. The

comments were addressed in the Flumetsulam Final Work Plan (FWP).

 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 assessmen t, including an endangered species risk assessment; it also stated that the Agency would conduct a human health risk assessment if pending submission/evaluation of i mmunotoxicity and acute and subchronic neurotoxicity data led to revision of endpoints and sa fety factors.

 March 30, 2010 – The Agency issued the Flumetsulam Generic Data Call-In (Generic Data Call-In number: RR-129016-28845, posted to the docket with the Flumetsulam Interim Registration Review Decision ), which listed the following three studies: UV/Visible absorption (830.7050), neurotoxic ity screening batte ry (870.6200) and immunotoxicity (870.7800).

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

 July 10, 2013 – The Agency completed the Flumetsulam: Review of Human Incidents for Preliminary Risk Assessment (in the docket as EP A-HQ-OPP-2008-0625-0023).

 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 Risk Assessment for Registration Review (in the docket as EPA-HQ-OPP-2008-0625-0017).Flumetsulam Case 7229 Docket Number EPA-HQ-OPP- 2008-0625 Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

5  September 19, 2013 – The Agency completed Preliminary Ecologica l Risk Assessment for the Registration Review of Flumetsulam (in the docket as EPA-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 (in the docket as EPA-HQ-OPP-2008-0625-0024).

 August 8, 2014 – The Agency completed the Response to Comments on EDSP Related to the Flumetsulam Registration Review Docket (posted to the docket with the Flumetsulam Interim Registration Review Decision ).

 September 24, 2014 – The Agency published the Flumetsulam Proposed Interim Registration Review Decision in docket number EPA-HQ-OPP-2008-0625 for a 60-day public comment period. During the comment period, the Agency received comments from the following three stakeholders: the Cent er for Biological Dive rsity (CBD), Silent Shade Planting Company, and an individual na med J. Trenton Irby, Ph.D. The comments did not result in changes to the Agency’s proposed interim decision for flumetsulam (see

section F. of this document for further in formation on the comments received and the Agency’s response to comments). Thus, the Interim Registration review Decision is consistent with the Proposed Inte rim Registration Review Decision.

 March 2015 – The Agency is now publishing the Flumetsulam Interim Registration

Review Decision in docket number EPA-HQ-OPP-2008-0625.

Additional information and supporting documents, including this Interim Registration

Review Decision , can be found in EPA’s public docket for the registration review of flumetsulam (docket number EPA-HQ-O PP-2008-0625), which can be accessed 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 terrestrial and aquatic organisms. 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-HQOPP-2008-0625-0015) which can be accessed on http://www.regulations.gov

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Risk Characterization

Aquatic and Terrestrial AnimalsFlumetsulam Case 7229 Docket Number EPA-HQ-OPP- 2008-0625 Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

6 The mode of action of flumetsulam (ALS inhi bition) is highly sp ecific to plants and microorganisms. As with other ALS-inhibiting herbicides (such as those in the sulfonylurea class), flumetsulam has low acute and chronic toxi city to terrestrial vertebrates, terrestrial arthropods, fish and aquatic invertebrates. Wh en combined with the low use rate (maximum seasonal rate is 0.07 lb a.i./A), the risk of direct toxicity to these animals is very low. The lack of ecological incidents 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 terrestrial

animals.

Though flumetsulam exposures are not expected to cause significant direct effects to listed species of animals, indirect effects to aquatic a nd terrestrial animals are po ssible as the result of the potential damage to vege tation and aquatic plants.

Aquatic and Terrestrial Plants

Despite the relatively low flumetsulam use rate s, the very high phytotoxicity of flumetsulam results in the conclusion that all uses may pose ri sk to aquatic plant and non-target terrestrial plants. The risk assessment indicates that corn and soybean uses of flumetsulam exceed the

EPAs level of concern for both listed and non-listed aquatic and te rrestrial plants.

Flumetsulam is moderately persistent in the terr estrial environment but persistent in the aquatic environment. Thus, while flumetsulam is typicall y applied only once per year, residues in soil and water may remain at phytotoxic levels for a long period of time. This is confirmed by numerous reported incidents of crop damage which 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 mate rial in the soil, and thus is prone to movement in runoff. Both of these f actors increase the potential for residues to be transported from the use site into terrestrial and aquatic habitats where non-target plants can be exposed.

Water Quality

Flumetsulam is not identified as a cause of impair ment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 1 In addition, no Tota l 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

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- 2008-0625 Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

7 Consistent with EPA’s responsib ility 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 In terim Approaches developed to implement the recommendations of the April 2013 Nationa l Academy of Sciences (NAS) report, Assessing Risks to Endangered and Threat ened Species from Pesticides . The NAS report 4 outlines recommendations on specific scientific and tech nical issues related to the development of pesticide risk assessments that EPA and the Se rvices must conduct in connection with their obligations under the ESA and FIFRA. EPA will a ddress concerns specific to flumetsulam in connection with the developmen t of its final registration re view decision for flumetsulam

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In November 2013, EPA, the U.S. Fish and Wild life Service, National Ma rine Fisheries (the Services), and the U.S. Department of Agricultu re released a white pa per containing a summary of their joint Interim Approaches for assessing ri sks to listed species from pesticides. These Interim Approaches were developed jointl y 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 cont ained in the November 1, 2013 white paper

, Interim Approaches for National-Level Pesticide Endangered Species Ac t Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report. 5

Given that the agencies are continuing to de velop and work toward implementation of the Interim Approaches to assess the potential risk s of pesticides to listed species and their designated critical habitat, th e ecological risk assessment s upporting this Interim Registration

Review Decision for flumetsulam does not cont ain a complete ESA analysis, including effects determinations for specific listed species or desi gnated critical habitat. While the agencies continue to develop a common me thod for ESA analysis, the prelim inary risk assessment for the registration review of flumetsulam describes th e level of ESA analysis completed for this particular registration review case. This a ssessment will allow EPA to focus its future evaluations on the types of speci es where the potential for effect s exists, once the scientific methods being developed by the agencies have b een 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 flumetsulam as part of completing this re gistration review.

C. Human Health Assessment

The Agency considered the flumetsulam huma n health scoping docum ent, its supporting documents, and the most updated Agency science po licies and risk assessment methodologies to prepare a quantitative risk assessment in support of the registration review of flumetsulam. Based on the human health risk assessment, HED ha s determined that there are no potential risks of concern for the currently registered uses of flumetsulam. In this Interim Registration Review Decision, EPA is making no human health or envir onmental safety findings associated with the EDSP screening of flumetsulam. Before comple ting this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.

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

5 http://www.epa.gov/espp/2013/nas.htmlFlumetsulam Case 7229 Docket Number EPA-HQ-OPP- 2008-0625 Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

8 For detailed discussions of a ll aspects of the human health risk assessment, see the Flumetsulam: Preliminary Human Health Risk A ssessment for Registration Review (in the docket as EPA-HQOPP-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, dermal or inhalation routes of exposure. It is not a skin or eye irritant and is not a skin sensitizer. The availabl e 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 appropriate endpoints were

identified from the available flumetsulam toxici ty studies. A chronic dietary exposure assessment incorporated food and water. Estimated expos ure for the general U.S. population 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 (cP AD). A cancer dietary exposure assessment was not performed give n the ‘Group E’ classification.

A residential/non-occupational e xposure assessment is not re quired given that there are no registered residential uses asso ciated with flumetsulam. Occupa tional 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; the margin of exposures are greater than 100 (MOEs > 100) at ba seline personal protective equipment. Worker protective gear is still advised as well as appropri ate restricted entry intervals (REIs) currently on end use product labels. Spray drift analysis wa s conducted for hand-to-mout h (HtM) scenario for children ages 1 to less than 2 years using Ti er 1 screening parameters. The aerial and ground applications of flumetsulam and the current max imum application 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; corn, fi eld, grain; corn, fiel d, stover; soybean, see d, each at 0.05 ppm.

D. Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include e ndpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of its most recent registration decision fo r flumetsulam, EPA

reviewed these data and select ed the most sensitive 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- 2008-0625 Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

9 flumetsulam is subject to the endocrine screening part of th e Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whet her certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e 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 th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must scre en all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/dat a call-ins for the firs t group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredient s. A second list of chemicals, including flumetsulam, identified for EDSP screening was published on June 14, 2013 6 and includes some pesticides scheduled for Regist ration Review and chemicals found in water.

Neither of these lists should be construed as a list of known or likely e ndocrine disruptors. For further information on the status of the EDSP, the policies and procedures, th e lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website. 7

In this interim decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of flumet sulam. Before completing this 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 EPA-HQOPP-2008-0625 in flumetsulam docket) concludes th at based on the low frequency and severity of incident cases reported for flumetsulam in both the OPP Incident Data System (IDS) and the

Centers for Disease Control and Prevention/Na tional Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR-Pesticides), there does no t appear to be a concern at this time that would warrant further investigation. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be conducted.

For the Main IDS, from January 1, 2008 to Ma y 8, 2013, there were no in cidents reported for single chemical only in the data base involving flumetsulam. Ther e were 5 additional incidents

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

chemicals.

7 http://www.epa.gov/endo/Flumetsulam Case 7229 Docket Number EPA-HQ-OPP- 2008-0625 Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

10 reported involving more than one chemical. Howe ver, they were all foreign incidents, one

incident occurred in Australia and four incident s occurred in China. Foreign incidents are not

reviewed in detail because of the potential differences in the e xposure patterns, use practices, and product formulation. All of these incidents we re classified as m oderate severity.

In Aggregate IDS, from January 1, 2008 to May 8, 2013, there were nine reported incidents involving flumetsulam. These incidents were classi fied as minor severity. Overall, there are few incidents involving flumetsulam reported to IDS.

A query of SENSOR-Pesticides, which is a databa se that covers eleven states from 1998 to 2009, identifies no cases involving flumetsulam.

In addition, findings from the Agricultural Hea lth Study (AHS) were reviewed. The AHS is a high quality, prospective epidemiology study ev aluating 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 Informati on 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. Species affected include corn, soybean, 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 report any incidents in relation to avian species. ID S 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 a ll aspects of the environmenta l risk assessment including a description of the ecologi cal incident data see Preliminary Ecological Risk 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

Comments on the Flumetsulam Regi stration Review Risk Assessments

On September 19, 2013, the Agency 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 for the Registra tion Review of Flumetsulam . The Notice of Availability was published in the Federal Re gister, initiating a 60-day public comment periodFlumetsulam Case 7229 Docket Number EPA-HQ-OPP- 2008-0625 Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

11 (which ended Nov 26, 2013). During that time, comments from three commenters were received

which are available in the docket.

Brief comments were submitted at two differe nt 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 regi stration review process.

A set of specific comments about the HED and EFED risk assessments was received from Dow AgroSciences (DAS); these DAS comments span the following topics: spray-drift reduction technology, registration updates, qua litative use of mon itoring data, update s to aquatic and terrestrial plant toxicological endpoints and TerrPlant model assumptions. 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 was posted to th e flumetsulam docket (EPA-HQ-OPP-2008-0625) along with the Proposed Interim Regist ration Review Decision . A memo responding to DAS comments pertaining to EDSP issues is also being added to the flumetsulam docket along with

the Interim Registration Review Decision.

Comments on the Flumetsulam Proposed In terim Registration Review Decision

During the 60-day public comment period on th e flumetsulam Proposed Interim Registration Review Decision, which opened on September 24, 2014 and closed on November 24, 2014, the Agency received comments from the following three stakeholders: the Center for Biological Diversity (CBD), Silent Shade Planting Compan y, and an individual named J. Trenton Irby. The

section below summarizes the comments receive d and provides EPA’s response to comments. Public comments in their entirety are located in the flumetsulam registration review docket (docket number EPA-HQ-OPP-2008-0625) , which can be accessed at www.regulations.gov

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Comments submitted by CBD (in th e docket as EPA-HQ-OPP-2008-0625-0028)

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 th e National Marine Fisheries Service (the Services) on the registration review of flumets ulam in accordance with the Endangered Species Act (ESA). The CBD commen ts mention various aspects of the risk assessment process, including use of the best available data to develop endangered species risk assessments, and evaluation of effects on endangered and threatened species and their designated critical habitat. CBD also expresses concern regarding the rigor of the Agency’s preliminary determinations regarding the effects of flumetsulam on endangered and threatened (listed) species and their designated criti cal habitat for the flumetsulam registration review.

Response : EPA has reviewed the comments fr om CBD on the Proposed Registration Review Decision for flumetsulam 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 basedFlumetsulam Case 7229 Docket Number EPA-HQ-OPP- 2008-0625 Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

12 on the recommendations of the April 2013 Natio nal Academy of Sciences (NAS) report. EPA will address concerns specific to flumetsula m in connection with the development of its final registration review decision for flumetsulam.

In November 2013, the EPA, along with the Serv ices and the USDA, released a summary of their joint Interim Approaches for assessing ri sks to endangered and threatened (listed) species from pesticides. The Interim Approaches 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 th e 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 rela ted 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 presente d the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Co mmittee (PPDC) and State-FIFRA Issues Research and Evaluation Group (SFIREG) meetings. The agencies also held a stakeholder workshops in April 2014 and October 2014, allowing additional opportunities for stakeholders to comment on the Interim Appr oaches. Additional workshops are planned to enhance stakeholder involvement. As part of a phased, iterative process for developing the Interim Approaches, the agencies will al so consider public co mments on the Interim Approaches in connection with the deve lopment of upcoming Registration Review decisions. The details of the joint Inte rim Approaches are contained in the white paper “Interim Approaches for National-Level Pe sticide Endangered Species Act Assessments

Based on the Recommendations of the Nationa l Academy of Sciences April 2013 Report,” dated November 1, 2013.

Given that the agencies are continuing to de velop and work toward implementation of the Interim Approaches to assess the potential risk s of pesticides to listed species and their designated critical habitat, the ecological problem formulation supporting this Interim Registration Review Decision for flumetsulam doe s not describe the specific ESA analysis, including effects determinations for specific listed species or desi gnated critical habitat, to be conducted during registration review. In the ecological problem formulation document for flumetsulam, EPA described the screening-le vel risk assessment to determine the potential effects of flumetsulam on all taxa of non-target wildlife and plants, which will assume that listed species and their designated critical habi tats may be present in the vicinity of the application of flumetsulam. This screening-level assessment will allow EPA to focus its future evaluations on the types of species wh ere the potential for effects exists once the scientific methods being developed by the ag encies have been fully vetted. While the agencies continue to develop a common met hod for ESA analysis, the planned screeninglevel risk assessment for the registration review of flumetsulam will describe the level of ESA analysis completed for this particular re gistration review case. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments for endangered and threatened (listed) species and their designated criticalFlumetsulam Case 7229 Docket Number EPA-HQ-OPP- 2008-0625 Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

13 habitats, these methods will be applied to subsequent analyses for flumetsulam as part of completing this registration review.

Comments submitted by Silent Shade Planti ng Company (in the docket as EPA-HQ-OPP2008-0625-0026) and J. Trenton Irby, Ph.D. (i n the docket as EPA-HQ-OPP-2008-0625- 0027)

2. Comment: Silent Shade Planting Company and J. Trenton Irby, Ph.D. both submitted comments supporting the claims t hat aerial application of flu metsulam is important for successful control of teaweed and both request ed that EPA allow aerial application to remain on the labels for two particular flu metsulam products with registration numbers 62719-277 and 62719-315. They also both state that aerial application of flumetsulam products, if needed, occurs only once a season

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Response: The Agency thanks Silent Shade Planting Company and J. Trenton Irby, Ph.D. for their comments on the flumetsulam Proposed Interim Registration Review Decision. The Agency has considered the information submitted and has not made changes to the proposed mitigation; therefore, the Interim Registration Review Decision continues to allow aerial application on the labels fo r the following two flumetsula m product registrations: 72719-277

and 62719-315.

G. Environmental Justice

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to flumetsu lam, compared to the general population. The Agency did not receive any comments concerning a ny environmental justice issues. At this time, EPA does not believe that use of the registered pesticide products containing flumetsulam will cause harm to or a disproportiona te impact on at-risk communities.

For additional information regarding environmenta l justice issues, please visit EPA’s website at: www.epa.gov/compliance/environmentaljustice/index.html

.

III. INTERIM REGISTRATION REVIEW DECISION

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this Interim Registration Review Decision. EPA’s Interim Regi stration Review Decision for flumetsulam is that (1) no additional data are required at this time; and (2) registrants are required to submit amended labels that include the agreed-upon risk mitigation (listed on page 16-17) to the Agency for approval within 60 days following issuance of this Interim Registration Review Decision. This Interim Registration Review Decision does not cover the ESA or EDSP components of the flumetsulam registration review ca se. It also does not include a pollinator risk assessment. TheFlumetsulam Case 7229 Docket Number EPA-HQ-OPP- 2008-0625 Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

14 Agency is issuing an Interim Registration Revi ew Decision pending the completion of pollinator, ESA, and EDSP work for this case.

Based on the screening-level risk assessments, the Agency’s leve l of concern is exceeded for risks to listed and non-listed aqua tic and terrestrial plants (monocot s and dicots) from the use of flumetsulam on corn and soybeans. 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 earlier (refer to the Endangered Species Assessment discussion), the scientific met hods 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 Interim Registration Re view Decision, EPA is making no hu man 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 as well as complete the ESA work. Therefore, issuan ce of the Agency’s final registration review decision is dependent upon (1) the completion of a pollinator risk assessment, (2) the completion of Section 7 Endangered Species consultation with the U.S. Fish and Wildlife Service, and (3) a conclusion under the EDSP FFDCA section 408(p).

A. Ecological Risk Characterization

EPA has determined that there is potential for risk 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 eff ect from drift. All labels include restrictions that limit use to target plant species and language intended to reduce th e potential effect from runoff and wind erosion. Furthermore, most labels include aeria l spray restrictions as well as droplet size

restrictions and statements re garding making applications of flumetsulam within a given wind speed range. However, these restrictions are not consistent across the labels and, though the current label language reduces the potential effectfrom drift, it does not eliminate risk to nontarget 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 sp ray applications. The ecological risk assessment estimated that RQs from aerial exposure (more so than for ground spray application – i.e., high boom height)

could exceed LOCs more than 1000 ft from the tr eated 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 St ate, and one only allows aerial application in nine states (Colorado, Iowa, Kansas, Minnesota, Nebraska, Oklahoma, North Dakota, South Dakota, and Texas). However, the registrant of these products, DAS, has agreed to prohibit aerial application on one of these three labels (62719-253) adding “Do not a pply this product using aerial application equipment,” and by removing la nguage that allows aer ial application “with EPA approved supplemental labeling.”Flumetsulam Case 7229 Docket Number EPA-HQ-OPP- 2008-0625 Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

15 The registrant of the labels which allow aerial ap plication 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 aeri al application was necessary for successful control. The labels which allow aerial application in nine states were written this way because at times wet conditions do not allow ground application equi pment into the field. The Agency welcomed submission of information on these claims, as well as the frequency with which aerial application of flumetsulam is necessary, during the comm ent period on the flumetsulam Proposed Interim Registration Review Decision. During the commen t period, comments pertaining to these topics were received from Silent Shade Planting Co mpany and J. Trenton Irby, Ph.D. The comments supported the claims that aerial ap plication of flumetsulam is impor tant for successful control of teaweed and requested that EPA allow aerial app lication to remain on the labels for only two particular flumetsulam products with registration numbers 62719-277 and 62719-315. The

comments also stated that aerial application of flumetsulam products, if needed, occurs only once

a season.

Droplet size Restrictions

The ecological risk assessment also estimated th e distances from the field to which exposure from ground spray of flumetsulam might exceed leve ls of concern for terrestrial plants. In each case, the distance from the field was reduced from the use of medium-coarse sprays instead of fine-to-medium sprays. Currently, all but two flumetsulam labels cont ain language prohibiting the use of nozzles which produce a fine droplet size spectrum; the registrant of these products, DAS, has agreed to add this language to the two remaining labels. Therefore, the shorter distances in the risk assessment may be a better estimate overall of potential risk. In addition, because the screening assessment considers the 90 th percentile exposure, the distance to which exposures of concern would routinely occur would be shorter, as well.

During the comment period on the flumetsulam pr oposed risk assessments, DAS commented that the spray drift analysis conducted by the Agency does not reflect the co arser spray produced by currently available nozzle types with spray-dr ift reduction technology (DRT). Their analysis

showed that the distance from the field that exposures would exceed LOCs is dramatically reduced when using these newer nozzles. The Ag ency is currently nearing completion of its preliminary evaluation of DRT. Thereafter, the Agency anticipates discussing these advances with 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 acco unt the droplet size effect for aquatic plants –instead a 5% dr ift assumption for aerial spray a pplications, 1% for ground spray, and 0% for impregnated fertilizer was used in th e exposure modeling – the potential for risk to aquatic plants is also reduced by spray drift la nguage 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, th e 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 entering via runoff may be reduced, as well.Flumetsulam Case 7229 Docket Number EPA-HQ-OPP- 2008-0625 Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

16 Wind speed Restrictions

Evaluation of the footprint away from the fiel d assumes a 10 mph wind in the direction of nontarget plants. However, the registrant DAS indicat ed that flumetsulam may need to be applied at wind speeds below 3 mph and up to 15 mph. All la bels but one state th at wind velocity of approximately 3 to 10 mph favors on-target prod uct deposition. Another thr ee labels also state that wind speeds in excess of 15 mph will lead to uneven spray coverage resulting in drift.

B. Risk Mitigation Measures

As described above, in devel oping this Interim Registration Review Decision, the Agency considered a number of mitigation measures th at would further reduce risk from flumetsulam uses by reducing potential off-site transport of flumetsulam. These mitigation measures included restricting the use of th e product with aerial spray equipment, increasing droplet size spectra, and applying the compound within a given wind-speed range.

To mitigate ecological risks by reducing potential o ff-site transport of flumetsulam, the specific label language listed below must be included on flumetsulam end-use product and supplemental

labels.

Registrants are required to am end flumetsulam end-use produc t and supplemental labels to include all of the following use restrictions :

 Language to prohibit aerial applications on all labels (except the following two flumetsulam products only: 62719-277 and 62719-315)

o Add the statement “Do not apply this product using aerial spray equipment.”

o Remove language that allows aerial app lication “with EPA approved supplemental labeling.”

 Language to increase droplet size spectra

o Add the statement “Do not use nozzles that produce a fine -droplet spray.”

 Language to restrict wind speed (both statements below)

o Add the statement “Make application when the wind velocity favors on-target product deposition (approximately 3 to 10 mph).”

o Add the statement “Do not apply when wind is gusting or wind speed exceeds 15 mph as uneven spray coverage and drift may result.”

 Language to minimize drift

o Add the statement “Do not apply when weather conditions fa vor drift to nontarget sites.”

Some flumetsulam labels currently have one or mo re (but not all) of th e above restrictions, and

therefore need to be amended to include all of the restriction language ab ove. Only the labels for registration numbers 524-614 and 8 9167-34 currently have all of the above restrictions, and

therefore do not need to be amended at this time.

All flumetsulam end-use product labels curre ntly have the following language, which will continue to be required on all en d-use product and supplemental labels :

 Language to restrict use to target species onlyFlumetsulam Case 7229 Docket Number EPA-HQ-OPP- 2008-0625 Interim Regist ration Review Decision www.regulations.gov Pesticide Re-evaluation Division

17 o “Do not apply near desirable vegetation.”

 Language to minimize runoff and wind eros ion (all of the statements below)

o “Do not apply under conditions that fa vor 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 su ch 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 rain fall has occurred between application and the first irrigation.”

IV. NEXT STEPS AND TIMELINE

A. Registration Review Decision

A Federal Register Notice will announce the availa bility of this Interim Registration Review Decision for flumetsulam. The Agency expects to issue a Proposed Final Decision and Final Decision on the flumetsulam registration review ca se after (1) completion of a pollinator risk assessment, (2) conclusion of ESA Section 7 consultation with the FWS, and (3) an EDSP FFDCA section 408(p) determination has been made.

B. Implementation of Mitigation Measures

Registrants are required to submit label amendmen ts and registered and amended labels that include the agreed-upon risk mitigation to the Agency for approval within 60 days following

issuance of this Interim Re gistration Review Decision.