Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-0625 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 ...................................................................................................... 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 ......................................................................... 17 

 
Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-0625 Interim Registration Review Decision 

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I. INTRODUCTION 

 

This document is the Environmental Protection 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 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 require new risk mitigation 

measures or impose interim risk mitigation measures. Additional supporting documents can be 

found in EPA’s public docket for the registration review of flumetsulam (docket number EPAHQ-OPP-2008-0625) at www.regulations.gov. 

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. 

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.

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

(Case 7229) in 2008. The Agency’s registration review of flumetsulam includes all registered 

pesticidal uses of flumetsulam. Flumetsulam is registered only for agricultural uses; there are no 

registered residential or public recreational uses of flumetsulam. 
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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 comment 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 stated that the Agency would conduct 

a comprehensive ecological risk assessment, including an endangered species risk 

assessment; it also stated that the Agency would conduct a human health risk assessment 

if pending submission/evaluation of immunotoxicity and acute and subchronic 

neurotoxicity data led to revision of endpoints and safety 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), neurotoxicity screening battery (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 EPA-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). 
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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 (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 Center for Biological Diversity (CBD), Silent 

Shade Planting Company, and an individual named 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 information on the comments received and the 

Agency’s response to comments). Thus, the Interim Registration review Decision is 

consistent with the Proposed Interim 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-OPP-2008-0625), which can be accessed 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-HQOPP-2008-0625-0015) which can be accessed on http://www.regulations.gov. 

Risk Characterization 

Aquatic and Terrestrial Animals 

 
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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 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 

 

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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Consistent with EPA’s responsibility 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 Interim Approaches developed to implement the 

recommendations of the April 2013 National Academy of Sciences (NAS) report, Assessing 

Risks to Endangered and Threatened Species from Pesticides. The NAS report4 outlines 

recommendations on specific scientific and technical issues related to the development of 

pesticide risk assessments that EPA and the Services must conduct in connection with their 

obligations under the ESA and FIFRA. EPA will address concerns specific to flumetsulam in 

connection with the development of its final registration review decision for flumetsulam. 

In November 2013, EPA, the U.S. Fish and Wildlife Service, National Marine Fisheries (the 

Services), and the U.S. Department of Agriculture released a white paper containing a summary 

of their joint Interim Approaches for assessing risks to listed species from pesticides. These 

Interim Approaches were developed jointly 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 contained in the November 1, 2013 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. 5

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 Interim Registration 

Review Decision for flumetsulam does not contain a complete ESA analysis, including effects 

determinations for specific listed species or designated critical habitat. While the agencies 

continue to develop a common method for ESA analysis, the preliminary risk assessment for the 

registration review of flumetsulam describes the level of ESA analysis completed for this 

particular registration review case. This 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. 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 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 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. 

 

4 http://www.nap.edu/catalog.php?record_id=18344 5 http://www.epa.gov/espp/2013/nas.html 
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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 as EPA-HQOPP-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, 20136

 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.7

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 EPA-HQOPP-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. 

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 

 

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/
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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 

Comments on the Flumetsulam Registration 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 Registration Review of Flumetsulam. The Notice 

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

AgroSciences (DAS); these DAS comments 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 was posted to the flumetsulam docket (EPA-HQ-OPP-2008-0625) 

along with the Proposed Interim Registration 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 Interim Registration Review Decision 

During the 60-day public comment period on the 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 Company, and an individual named J. Trenton Irby. The 

section below summarizes the comments received 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. 

Comments submitted by CBD (in the 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 the National Marine Fisheries 

Service (the Services) on the registration review of flumetsulam in accordance with the 

Endangered Species Act (ESA). The CBD comments mention various aspects of the risk 

assessment process, including use of the best available data to develop endangered 

species risk assessments, and evaluation of effects on 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 critical habitat for the 

flumetsulam registration review.

 

 Response: EPA has reviewed the comments from 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 based 
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on the recommendations of the April 2013 National Academy of Sciences (NAS) report. 

EPA will address concerns specific to flumetsulam in connection with the development of its 

final registration review decision for flumetsulam. 

 

 In November 2013, the EPA, along with the Services and the USDA, released a summary of 

their joint Interim Approaches for assessing risks to endangered and threatened (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 ESA and FIFRA. 

 The joint Interim Approaches were released prior to a stakeholder workshop held on 

November 15, 2013. In addition, the EPA presented the joint Interim Approaches at the 

December 2013 Pesticide Program Dialogue Committee (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 Approaches. Additional workshops are planned to 

enhance stakeholder involvement. As part of a phased, iterative process for developing the 

Interim Approaches, the agencies will also consider public comments on the Interim 

Approaches in connection with the 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 problem formulation supporting this Interim 

Registration Review Decision for flumetsulam does not describe the specific ESA analysis, 

including effects determinations for specific listed species or designated critical habitat, to be 

conducted during registration review. In the ecological problem formulation document for 

flumetsulam, EPA described the screening-level 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 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 planned screeninglevel risk assessment for the registration review of flumetsulam 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 
Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-0625 Interim Registration Review Decision 

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habitats, these methods will be applied to subsequent analyses for flumetsulam as part of 

completing this registration review. 

Comments submitted by Silent Shade Planting Company (in the docket as EPA-HQ-OPP2008-0625-0026) and J. Trenton Irby, Ph.D. (in 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 that aerial application of flumetsulam is important for 

successful control of teaweed and both requested that EPA allow aerial application to 

remain on the labels for two particular flumetsulam 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. 

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 for the following two flumetsulam product registrations: 72719-277 

and 62719-315. 

 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. 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 Registration 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 case. It also does not include a pollinator risk assessment. The 
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14 

Agency is issuing an Interim Registration Review Decision pending the completion of pollinator, 

ESA, and EDSP work for this case. 

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 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 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 effect from drift. All labels include restrictions that limit use to 

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 

restrictions and statements regarding 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 effect from drift, it does not eliminate risk to nontarget 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, DAS, 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.” 
Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-0625 Interim Registration Review Decision 

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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 

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 welcomed 

submission of information on these claims, as well as the frequency with which aerial application 

of flumetsulam is necessary, during the comment period on the flumetsulam Proposed Interim 

Registration Review Decision. During the comment period, comments pertaining to these topics 

were received from Silent Shade Planting Company and J. Trenton Irby, Ph.D. The comments 

supported the claims that aerial application of flumetsulam is important for successful control of 

teaweed and requested that EPA allow aerial application 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 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-to-medium 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, 

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 90th percentile exposure, the distance to which 

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

During the comment period on the flumetsulam proposed risk assessments, DAS 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). Their analysis 

showed 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. 
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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 DAS indicated that flumetsulam may need to be applied at 

wind speeds below 3 mph and up to 15 mph. 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. 

B. Risk Mitigation Measures 

As described above, in developing this Interim Registration Review Decision, the Agency 

considered a number of mitigation measures that would further reduce risk from flumetsulam 

uses by reducing potential off-site transport of flumetsulam. These mitigation measures included 

restricting the use of the 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 off-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 amend flumetsulam end-use product 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 application “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 favor drift to nontarget sites.” 

Some flumetsulam labels currently have one or more (but not all) of the above restrictions, and 

therefore need to be amended to include all of the restriction language above. Only the labels for 

registration numbers 524-614 and 89167-34 currently have all of the above restrictions, and 

therefore do not need to be amended at this time. 

All flumetsulam end-use product labels currently have the following language, which will 

continue to be required on all end-use product and supplemental labels: 

 Language to restrict use to target species only 
Flumetsulam Case 7229 Docket Number EPA-HQ-OPP-2008-0625 Interim Registration Review Decision 

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o “Do not apply near desirable vegetation.” 

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

o “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.”

IV. NEXT STEPS AND TIMELINE 

A. Registration Review Decision 

A Federal Register Notice will announce the availability 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 case 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 amendments 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 Registration Review Decision.