Docket Number EPA-HQ-OPP-2008-0625 

www.regulations.gov 

Flumetsulam 

Proposed Interim Registration Review Decision 

Case Number 7229 

September 2014 

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

Richard P. Keigwin, Jr. 

Director 

Pesticide Re-evaluation Division 

Date: Q-H^^C,^ 
Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-0625 Proposed Interim Registration Review Decision 

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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 Registration Review Decision ............................................................... 11 

A. Ecological Risk .................................................................................................................. 12 

B. Risk Mitigation Measures ................................................................................................. 13 

IV. Next Steps and Timeline ...................................................................................................... 14 

A. Proposed Interim Registration Review Decision ............................................................ 14 

B. Implementation of Mitigation Measures ......................................................................... 14 

Appendix A: Flumetsulam Label Table................................................................15 

 
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I. INTRODUCTION 

 

This document is the Environmental Protection Agency’s (EPA or the Agency) Proposed 

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 Agency may issue, when it determines it to be 

appropriate, an interim registration review decision before completing 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 Protection Act (FQPA) of 1996, mandated the 

continuous review of existing pesticides. All pesticides distributed or sold in the United States 

generally must be registered by the EPA based on scientific 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 policies and practices change, all registered pesticides continue to meet 

the statutory standard of no unreasonable adverse effects. Changes in science, public policy, and 

pesticide use practices will occur over time. Through 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 safely. 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 standard for registration. 

Pursuant to 40 CFR §155.50, the Agency formally initiated registration review for 

flumetsulam (Case 7229). The Agency’s registration review of flumetsulam (Case 7229) includes 

all registered pesticidal uses of flumetsulam which include agricultural uses; there are no registered 

residential or public recreational uses of flumetsulam. 

Flumetsulam has been registered as a pesticide 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 often applied in formulation with other active ingredients. 

Formulations may be applied as a pre-plant surface, pre-emergence treatment with either soil 

incorporated treatment, or foliar application via aerial 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. 
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The following timeline highlights significant events that have occurred during the 

registration review of flumetsulam and the documents 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-OPP-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 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.

 February 13, 2009 – The Agency completed the Flumetsulam Final Work Plan (in the 

docket as EPA-HQ-OPP-2008-0625-0011), which stated that the Agency would conduct a 

comprehensive ecological risk assessment that included an endangered species risk 

assessment and a human health risk assessment if pending submission/evaluation of 

immunotoxicity and acute and subchronic neurotoxicity data lead to revision of endpoints 

and safety factors. 

 August 2, 2013 – The Agency 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 screening 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 Risk Assessment for Registration Review (in the 

docket as EPA-HQ-OPP-2008-0625-0017). 
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 September 19, 2013 – The Agency completed Preliminary Ecological 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 (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 evaluated under the Endocrine Disruptor Screening 

Program (EDSP). Therefore, the Agency’s issuance 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 issue an Interim Registration 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. 

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-HQ-OPP-2008-0625-0015) which can be accessed on http://www.regulations.gov. 

Risk Characterization 

Aquatic and Terrestrial Animals 

 The mode of action of flumetsulam (ALS inhibition) is highly specific to plants and 

microorganisms. As with other ALS-inhibiting herbicides (such as those in the sulfonylurea class), 

flumetsulam has low acute and chronic toxicity to terrestrial vertebrates, terrestrial 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 animals is very low. The lack of ecological incidents 
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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 and terrestrial animals are possible as the result of 

the potential damage to vegetation and aquatic plants. 

Aquatic and Terrestrial Plants 

Despite the relatively low flumetsulam use rates, the very high phytotoxicity of 

flumetsulam results in the conclusion that all uses may pose risk 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 terrestrial plants. 

Flumetsulam is moderately persistent in the terrestrial environment but persistent in the 

aquatic environment. Thus, while flumetsulam is typically 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 residues which remain in the soil from application 

during a previous growing season. 

In addition, flumetsulam has little binding potential to organic material 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 and 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, along with the U.S. Fish & Wildlife Service (USFWS), the 

National Marine Fisheries Service (NMFS) (collectively, the Services), and the U.S. Department 

of Agriculture (USDA) released a summary of their joint Interim Approaches for assessing risks 

to listed species from pesticides. The Interim Approaches were developed jointly by the agencies 

in response to the National Academy of Sciences’ (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 development 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/
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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-FIFRA Issues Research and 

Evaluation Group (SFIREG) meetings, and held a stakeholder workshop in April 2014, allowing 

additional opportunities for stakeholders to comment on the Interim Approaches. As part of a 

phased, iterative process for developing the Interim Approaches, the agencies will also consider 

public comments on the Interim Approaches in connection with the development of upcoming 

Registration Review decisions. The details of the joint Interim Approaches are contained in the 

white paper “Interim Approaches for National-Level Pesticide Endangered Species Act 

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 designated 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 critical habitats 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 where the potential for effects 

exists once the scientific methods being developed by the agencies have been fully vetted. While 

the agencies continue to develop a common method for ESA analysis, the regulatory section of the 

Proposed Interim Registration Review Decision document will describe the level of ESA analysis 

completed for this particular registration review case. Once the agencies have fully developed and 

implemented the scientific methods necessary to complete risk assessments for endangered and 

threatened (listed) species and their designated critical habitats, these methods will be applied to 

subsequent analyses for flumetsulam as part of completing this registration review. 

C. Human Health Assessment 

The Agency considered the flumetsulam human health scoping document, its supporting 

documents, and the most updated Agency science policies 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 has determined that there are no potential risks of 

concern for the currently registered uses of flumetsulam. 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 docket 
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as EPA-HQ-OPP-2008-0625-0014), dated September 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 available toxicity database shows that 

flumetsulam is not a neurotoxic or immunotoxic chemical and it does not induce developmental 

or reproductive toxicity. Flumetsulam is classified as ‘Group E’ (evidence of non-carcinogenicity 

for humans); mutagenicity studies conducted with flumetsulam were negative. 

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

identified from the available flumetsulam toxicity studies. A chronic dietary exposure assessment 

incorporated food and water. Estimated exposure 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 (cPAD). A cancer dietary exposure assessment was not 

performed given the ‘Group E’ classification. 

 

 A residential/non-occupational exposure assessment is not required given that there are no 

registered residential uses associated with flumetsulam. 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; the margin of exposures 

are greater than 100 (MOEs > 100) at baseline personal protective equipment. Worker protective 

gear is still advised as well as appropriate restricted entry intervals (REIs) currently on end use 

product labels. Spray drift analysis was conducted for hand-to-mouth (HtM) scenario for children 

ages 1 to less than 2 years using Tier 1 screening parameters. The aerial and ground applications 

of flumetsulam and the current maximum 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, field, grain; corn, field, stover; soybean, seed, each at 0.05 ppm. 

D. Endocrine Disruptor Screening Program 

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential 

adverse outcomes from exposure to chemicals. Collectively, these studies include acute, 

subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, 

developmental, reproductive, and general or systemic toxicity. These studies include endpoints 

which may be susceptible to endocrine influence, including effects on endocrine target organ 

histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, 

reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates 

acute tests and chronic studies that assess growth, developmental 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 sensitive endpoints for relevant risk assessment 

scenarios from the existing hazard database. However, as required by FFDCA section 408(p), 
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flumetsulam is subject to the endocrine screening part of the Endocrine Disruptor Screening 

Program (EDSP). 

EPA has developed the EDSP to determine whether 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 other such 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 estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through 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 necessary based on the available data. Tier 2 testing 

is designed to identify any adverse endocrine-related effects 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 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 pesticide active ingredients and 9 inert ingredients. A second list of 

chemicals, including flumetsulam, identified for EDSP screening was published on June 14, 20134

 

and includes some pesticides scheduled for Registration Review and chemicals found in water. 

Neither of these lists should be construed as a list of known or likely endocrine disruptors. 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 flumetsulam. 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 EPAHQ-OPP-2008-0625 in flumetsulam docket) concludes that 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/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 monitor the incident information 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/
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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 incidents occurred in China. Foreign incidents are not 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 January 1, 2008 to May 8, 2013, there were nine reported incidents 

involving flumetsulam. These incidents were classified as minor severity. Overall, there are few 

incidents involving flumetsulam reported to IDS. 

A query of SENSOR-Pesticides, which is a database that covers 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. Flumetsulam 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 Information 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 Incident Reports (v. 1.0) database contained in the Incident Data 

System (IDS), and the Avian Monitoring Information System (AIMS) for ecological incidents 

involving flumetsulam was completed on July 8, 2012. AIMS did not report 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 all aspects of the environmental risk assessment including a 

description of the ecological 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. 

F. Public Comments 

 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 Registration Review of Flumetsulam. The Notice 

of Availability was published in the Federal Register, initiating a 60-day public comment period 

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

which are available in the docket. 
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Brief comments were submitted at two different 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 and EFED risk assessments were received from 

Dow AgroSciences that span the following topics: spray-drift reduction technology, registration 

updates, qualitative use of monitoring data, updates 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 will be 

posted to the flumetsulam docket (EPA-HQ-OPP-2008-0625) along with this Proposed Interim 

Registration Review Decision. 

 G. Environmental Justice 

 EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement 

of all people, regardless of race, color, national origin, or income, in the development, 

implementation, and enforcement of environmental laws, regulations, 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 their location, cultural practices, or other factors, 

may have atypical, unusually high exposure to flumetsulam, compared to the general population. 

The Agency did not receive any comments concerning any 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 disproportionate impact on at-risk communities. 

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

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

 

III. PROPOSED INTERIM REGISTRATION REVIEW DECISION 

 Per the Flumetsulam Preliminary Work Plan, 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 issue the Proposed Interim Registration Review 

Decision between December, 2013 and January, 2014. However, the Agency is issuing the 

Proposed Interim Registration Review Decision in September 2014 and expects to issue the 

Interim Registration Review Decision in late 2014. 

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

for risks to listed and non-listed aquatic and terrestrial plants (monocots 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 potential effects on listed and non-listed aquatic and 

terrestrial plant species. As discussed earlier (refer to the Endangered Species Assessment 

discussion), the scientific methods necessary to complete risk assessments for endangered and 

threatened (listed) species and their designated critical habitats will be applied to subsequent 

analyses for flumetsulam as part of completing this registration review. 

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 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 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 effect from drift (see Appendix A). All labels include restrictions 

that include limits for use on target plant species and language intended to reduce the potential 

effect from runoff and wind erosion. Furthermore, most labels include aerial spray restrictions as 

well as droplet size and applications within a given wind speed range. However, these restrictions 

are not consistent across the labels and, though the current label language reduces the potential 

effect from drift, it does not eliminate risk to non-target plants. 

Aerial Spray Restrictions 

Application rate being equal, RQs for aquatic and terrestrial plants are greater for aerial spray 

applications than for ground spray 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 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, 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, Dow Agricultural 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 removing language that allows aerial application “with 

EPA approved supplemental labeling.” 

The registrant of the labels which allow aerial application 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 aerial application was necessary for successful control. The labels 
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which allow aerial application in nine states were written this way because at times wet conditions 

do not allow ground application equipment 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 exceed levels 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-tomedium sprays. Currently, all but two flumetsulam 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 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 90th percentile exposure, the distance to 

which exposures of concern would routinely occur would be shorter, as well. 

Dow Agricultural Sciences commented that the spray drift analysis conducted by the Agency does 

not reflect the coarser spray produced by currently available nozzle types with spray-drift reduction 

technology (DRT). They showed results of their analysis showing that the distance from the field 

that exposures would exceed LOCs is dramatically 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 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 account the droplet size effect for aquatic 

plants –instead a 5% drift assumption for aerial spray applications, 1% for ground spray, and 0% 

for impregnated fertilizer was used in the exposure modeling – the 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 flumetsulam 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. 

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 that flumetsulam needs to be applied at wind speeds 

below 3 mph and up to 15 mph, and all labels but one state that wind velocity 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-2008-0625 Proposed Interim Registration Review Decision 

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B. Risk Mitigation Measures 

In developing this Proposed Interim Registration Review Decision, the Agency considered 

a number of mitigation measures that would further reduce risk from flumetsulam uses. Possible 

measures included the following: 

 Eliminating the use of the product with aerial spray equipment 

 Increasing droplet size spectra 

 Applying the compound within a given wind-speed range 

Specific language addressing the three mitigation 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, registrant DAS has agreed to add 

label restrictions which will give all labels restriction against nozzles that produce fine droplet size 

spectra, and which will reduce the number of labels allowing aerial application to two. The EPA 

will continue to work with the registrants to explore other potential measures to reduce off-site 

transport of flumetsulam, such as the incorporation 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 Review Decision and placing it in the flumetsulam registration 

review docket (EPA-HQ-OPP-2008-0625). A Federal Register 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 during 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 Proposed 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 proposed amendments and registered and amended 

labels that include the agreed-upon risk mitigation to the Agency for approval within 60 days 

following issuance of the Interim Registration Review Decision is final. 
Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-0625 Proposed Interim Registration Review Decision 

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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 agreed to apply this language to 62719-253) 

62719-253♠,-277♠ 

62719-315◊

 

B. Language to restrict 

droplet size 

“Do not use nozzles that produce a fine-droplet spray” 

(The registrant has agreed to apply this language 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 has occurred between application and the first 

irrigation

--- 

♠Supplemental labeling enables aerial application everywhere except NY 

◊ Supplemental labeling enables aerial application in nine U.S. states including Colorado, Iowa, Kansas, Minnesota, Nebraska, Oklahoma, 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 the following 

language: “Drift potential is lowest between wind speeds of 2 to 10mph.” Labels 62719-278, -224 and -279 state: “Do not spray when 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 the following 

language: “Avoid applications below 2 mph due to variable wind direction and high inversion potential.”