Fenoxaprop-p-ethyl 

Proposed Interim Registration Review Decision 

Case Number 7209 

June 2015 

Approved by: ,Jl 

Richard P. Keigwin, Jr. 

Director Pesticide Re-evaluation Division 

Date: 
I. INTRODUCTION ................................................................................... 3 

II. USE AND USAGE ................................................................................... 5 

III. SCIENTIFIC ASSESSMENTS .................................................................... 6 

A. Human Health .................................................................................... 6 

1. Risk Conclusions ........................................................................... 6 

2. Human Incidents ............................................................................ 6 

3. Tolerances .................................................................................... 6 

B. Ecological ......................................................................................... 6 

1. Risk Conclusions ............................................................................ ? 

2. Ecological Incidents ......................................................................... 9 

3. Characterization of Ecological Risk ........................................................ 9 

C. Benefits Assessment ............................................................................ 1 0 

D: Endangered Species Assessment ............................................................. 1 0 

E. Endocrine Disruptor Screening Program .................................................... 11 

IV. PROPOSED INTERIM REGISTRATION REVIEW DECISION ........................... 12 

V. NEXT STEPS AND TIMELINE .................................................................. 14 

Appendix A: Summary of Actions Taken for Fenoxaprop-p-ethyl .................................... 16 Appendix B: Fenoxaprop-p-ethyl Label Table ........................................................... 16 

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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. For further information on FPE, additional documents can be found in EPA's public 

docket (EPA-HQ-OPP-2007-0437) 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 re-evaluates 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/oppsrrdllregistration 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. 

FPE is a selective aryloxy phenoxy-propionate herbicide registered for use to control grass 

weeds after emergence. It is currently registered for agricultural use on barley, cotton, rice, 

soybeans, and wheat. It is also registered for non-agricultural use on conservation reserves, 

ornamentals, rights-of-way, grass grown for seed (Washington, Oregon and Utah only), and turf. 

There are 16 FIFRA Section 3 registrations and several FIFRA 24 (c) Special Local Need 

registrations. A Reregistration Eligibility Decision (RED} was not conducted for FPE because 

the pesticide was registered after 1984 and, therefore, was not subject to reregistration. 

Pursuant to 40 CFR section 155.50, EPA formally initiated registration review for FPE (case 

7209). The following summary highlights significant events that have occurred during the 

registration review ofFPE and can be found in EPA's public docket, EPA-HQ-OPP-2007-0437, 

accessed at www.regulations.gov: 

• August 29, 2007- Publication ofFPE Summary Document for a 90-day public comment 

period. The Summary Document included the Preliminary Work Plan (PWP) and was 

accompanied by the scoping document and problem formulation. 

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• February 2, 2010- Generic Data Call-In (GDCI) for FPE was issued. 

• July 1, 2014 - The Agency published the Preliminary/Draft Ecological Risk Assessment 

for the Registration Review of Fenoxaprop-p-ethyl and the Registration Review 

Preliminary/Draft Human Health Risk Assessment for Fenoxaprop-p-ethyl for a 60-day 

public comment period. Comments were received from two sources, Bayer CropScience 

(Bayer) and the Center for Biological Diversity (CBD). Bayer clarified how FPE is 

typically used in agriculture, corrected typographical errors in the human health risk 

assessment, and provided justification for using alternative endpoints in the non-target 

plant and chronic mammalian assessments. The Agency largely concurred with Bayer's 

comments and modified its assessments accordingly. The Center for Biological Diversity 

(CBD) commented on the Agency's obligations under the Endangered Species Act 

(ESA). 

• June 2015- The Agency is now publishing the Fenoxaprop-p-ethyl Proposed Interim 

Registration Review Decision, in docket number EPA-HQ-OPP-2007-0437 for a 60-day 

public comment period. In addition to this document, the Agency is also publishing the 

following supporting documents: 

o EFED Response to Comments on the Environmental Fate and Ecological Risk 

Assessment for the Registration Review of Fenoxaprop-p-ethyl. Chuck Peck, Scott 

Glaberman. November 3, 2014 

o Fenoxaprop-p-ethyl: Response to Registrant Comments .from Bayer Crop Science 

on the Draft Preliminary Risk Assessment and Proposed New Use on Grass 

Grown for Seed. Shalu Shelat, Christopher Schlosser, Donald Wilbur. December 

3,2014 

o Addendum to the Ecological Assessment for Fenoxaprop-p-ethyl. Chuck Peck, 

Scott Glaberman. June 4, 2015 

o Fenoxaprop and Fenoxaprop-ethyl Usage lnformationfor Risk Assessment. Bill 

Chism, Jihad Alsadek, Michelle Ranville. May 8, 2015 

o Fenoxaprop and Fenoxaprop-ethyl Qualitative Benefits Assessment. Bill Chism, 

Michelle Ranville. June 11, 2015 · 

Comments Received from the Center for Biological Diversity 

Comment: The Center for Biological Diversity's (CBD) comments focus on the EPA's duty to 

consult with the US. Fish and Wildlife Service and the National Marine Fisheries Service (the 

Services) on the registration review of FPE in accordance with the ESA. The CBD comments 

mention various aspects of the risk assessment process, including use of the best available data 

to develop threatened and endangered {listed) species risk assessments, and evaluation of effects 

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its final registration review decision for this pesticide. See Endangered Species Assessment on 

page 10 of this document for more information. 

II. USE AND USAGE 

FPE is a post-emergence herbicide registered for use to selectively control annual and perennial 

grass weeds in barley, cotton, soybeans, rice, and wheat. Non-agricultural use sites include 

rights-of-way, ornamentals, grass grown for seed (Washington, Oregon and Utah only), and turf. 

FPE inhibits acetyl CoA carboxylase enzyme (ACCase) (WSSA Group 1) and interferes with 

meristematic tissue development. While most ofthis herbicide is used in wheat crops, it is also 

applied to a relatively large percentage of barley and rice crops in the United States. Between 

2004 and 2012, the average annual pounds active ingredient (a.i.) used are as follows: barley 

(20,000 lbs a.i /year), rice (1 0,000 lbs a.i /year), soybeans (20,000 lbs a.i /year), and 

spring/winter wheat (200,000 lbs a.i /year). EPA's analysis did not find any evidence of the use 

ofFPE applications on an in-season (same calendar year) rotational crop in the same state. 

The majority ofFPE usage over the years 2009-2013 was through ground application. Only two 

crops, barley and rice, had a significant percentage of treatment through aerial application. 

Approximately eight percent of total FPE-treated acres for barley are applied aerially, and more 

than fifty percent of total FPE-treated acres for rice are applied aerially. The aerial applications 

for rice were apparently made to accommodate the large number of acres involved and not 

specifically because of wet fields, since they were applied pre-flood and only a small number of 

acres were treated post-flood. The barley and wheat aerial applications were generally applied 

late post-emergence so that the large fields could be treated in a short amount of time when the 

weeds were most sensitive. See Fenoxaprop and Fenoxaprop-ethyl Usage Information for Risk 

Assessment, dated May 8, 2015, for additional detail on FPE use and usage information. 

III. SCIENTIFIC ASSESSMENTS 

A. Human Health 

A summary of the Agency's human health risk assessment is presented below. The Agency used 

the most recent Agency science policies and risk assessment methodologies to prepare a 

quantitative risk assessment in support of the registration review ofFPE. For a detailed 

discussion of the human health assessment for FPE, see Fenoxaprop-p-ethyl Human Health Risk 

Assessment dated March 20, 2014 and Fenoxaprop-p-ethyl: Response to Registrant Comments 

from Bayer Crop Science on the Draft Preliminary Risk Assessment and Proposed New Use on 

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from food, drinking water, and residential/bystander exposure. EPA has not made a 

common mechanism of toxicity finding as to FPE and any other substance and it does not 

appear to produce a toxic metabolite produced by other substances. Therefore, EPA has 

not assumed that FPE has a common mechanism of toxicity with other substances for this 

assessment. 

For pesticide handlers receiving occupational exposure to FPE, EPA has no risk concerns 

associated with dermal routes of exposure when handlers use chemical-resistant gloves, 

which are required personal protective equipment on all product labels. The Agency also 

evaluated exposure and risk to agricultural workers who enter areas treated with FPE after application. EPA determined that postapplication exposures and risks were not of 

concern on the day of application. 

2. Human Incidents 

The Agency completed a review ofFPE incidents in 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) databases. Based on the low frequency and severity of 

incident cases reported for FPE in both IDS and NIOSH 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. 

3. Tolerances 

Currently there are tolerances established for FPE based on previously-established 

tolerances for fenoxaprop. Certain tolerances need revision based on current Agency 

policy. The commodity definition for soybean will be changed from "soybean" to "soybean, seed" and the tolerance for "peanut hulls" will be revoked since that 

commodity is no longer a regulated raw agricultural commodity. The Agency is not 

aware of any international harmonization issues related to the existing FPE tolerances. 

B. Ecological 

A summary of the Agency's ecological risk assessment is presented below. The Agency used 

the most updated Agency science policies and risk assessment methodologies to prepare a 

quantitative risk assessment in support of the registration review ofFPE. For a detailed 

discussion of the ecological assessment for FPE, see Environmental Fate and Ecological Risk 

Assessment for Registration Review of Fenoxaprop-p-ethyl dated April 21, 2014, the Addendum 

to the Ecological Assessment for Fenoxaprop-p-ethyl dated June 4, 2015, and the EFED 

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interim approach for assessing potential risk to listed species and their designated critical 

habitats. Once the scientific methods necessary to complete risk assessments for listed species 

and their designated critical habitats are finalized, the Agency will complete its endangered 

species assessment for FPE. As such, potential risks to listed species will not be discussed 

further in this document. 

1. Risk Conclusions 

Terrestrial Assessment 

Mammals - In the preliminary risk assessment for FPE, the Agency identified chronic 

risks of concern for mammals for all labeled uses except for grass grown for seed. 

During the public comment period for the preliminary risk assessment, Bayer conimented 

that the assessment included some incorrect application rates for some uses. EPA 

verified the information provided by Bayer and then revised the risk assessment to reflect 

the correct use rates. As a result of Bayer's clarification of several application rates, 

chronic mammalian risks are no longer of concern for the conservation reserve and the 

soybean uses when three applications are assumed. However, as noted in the risk 

assessment addendum, the chronic risk level of concern (LOC) for mammals is still 

exceeded for several use sites (risk quotients range from 0.01 to 2.36). 

Birds - There are no acute or chronic risks of concern to non-target birds or to reptiles 

and terrestrial-phase amphibians for which birds serve as surrogates. 

Invertebrates - Based on available data for young adult bees, FPE is classified as 

practically non-toxic to non-target terrestrial invertebrates on an acute contact exposure 

basis. Since the acute contact toxicity study for honeybees was non-definitive (i.e., the 

LDso was greater than the highest dose tested), risks were not assessed for terrestrial 

invertebrates. There is some uncertainty regarding toxicity of FPE to honeybee larvae 

since no data on this developmental stage were available at the time of the assessment. 

When initially scoping the registration review for FPE, EPA did not identify the need for 

any additional studies to evaluate potential effects on pollinators. However, since the 

issuance ofthe June 2014 Guidance for Assessing Pesticide Risks to Beesf11, EPA has 

begun to require these data where applicable. EPA is currently determining whether 

additional pollinator data are needed for active ingredients in registration review whose 

dockets opened prior to June 2014. For those active ingredients where EPA determines 

[II http://www2.epa.gov/sites/production/files/20 14-

06/documents/pollinator risk assessment guidance 06 19 14.pdf 

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Guideline# Study 

850.3020* 1 Acute contact toxicity study with adult honey bees 

850.3030* 1 Honey bee toxicity of residues on foliage 

850.3040** Field testing for pollinators 

Non-Guideline* 1 Honey bee adult acute oral toxicity 

(OECD 213) 

Non-Guideline* Honey bee larvae acute oral toxicity 

(OECD 237) 

Non-Guideline* Honey bee adult chronic oral toxicity 

Non-Guideline* Honey bee larvae chronic oral toxicity Non- Residues in pollen and nectar/field residue analysis Guideline** 

Non- Semi-field testing for pollinators (tunnel or colony feeding Guideline** 

(OECD 75) studies) 

*Tier 1 (Laboratory-based stud1es) 

**Tier 2 and 3 (Semi-field and full field colony-level studies) The need for a higher tier test for pollinators will be determined 

based upon lower-tiered tests and/or other lines of data and the need for a refined pollinator risk assessment. 

I. Acceptable data have already been submitted for FPE or are waived based on available information. 

Plants - Based on Bayer's comments during the public comment period and the 

information gained about application practices in a subsequent meeting with FPE 

registrants 1, the Agency revised several aspects of the risk assessment, including terrestrial 

plant endpoints, risk estimates, and spray drift calculations. EPA agreed with Bayer that 

the initial endpoints used for the plant assessment (i.e., root/radicle measurements) are no 

longer specified in current terrestrial plant guidelines and are subject to high variability. 

When root/radical endpoints were omitted from the assessment, plant risk estimates were 

greatly reduced. In addition, for the initial modeling assessment, the Agency assumed 

smaller droplet sizes than are routinely used, as FPE labels are inconsistent when referring 

to droplet size (e.g., medium size, micron range, or no size at all). The Agency initially 

used the American Society of Agricultural and Biological Engineers (ASABE) very fineto-fine droplet sizes to model ground applications and fine-to-medium sizes to model aerial 

applications. Revised modeling included ASABE medium-to-coarse droplet sizes for aerial 

applications, based on the registrants' commitment to amend product labeling to include 

this droplet size range across labels. 

1 See EPA, Bayer, Syngenta, and Nufarm Meeting on Fenoxaprop Registration Review, May 5, 2015, located in the docket. 

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While the above revisions to the terrestrial plant assessment resulted in a significant 

decrease in risk estimates, the overall risk conclusion that all labeled uses of FPE pose 

potential risks of concern to non-target monocots has not changed. 

Aquatic Assessment 

Risks of concern to fish and aquatic invertebrates are not expected from the labeled uses 

of FPE. There is some uncertainty associated with this finding since there are no chronic 

estuarine/marine fish data available nor benthic invertebrate sediment toxicity data. 

However, extrapolating from chronic freshwater fish data, risks to estuarine/marine fish 

are not expected. In addition, exposure to benthic invertebrates is expected to be orders 

of magnitude below available aquatic toxicity endpoints and, thus, risks of concern are 

not expected. FPE degrades rapidly in the aquatic environment and benthic invertebrates 

would likely be exposed to FPE degradates, which appear to be less toxic to sedimentdwelling organism. Based on the available data, risks to aquatic plants are not expected 

from the currently registered uses of FPE. 

2. Ecological Incidents 

The Agency has received 113 reports of adverse field effects to non-target plants that 

have been linked to the use of FPE. All of these incidents involved damage to grain crops 

(barley, com, lentil, rice, or wheat). The Agency considered the cause and attribution to 

FPE to be uncertain in 75 cases because more than one herbicide was applied to the crop. 

In the remaining 38 cases, the Agency considers FPE to be the probable cause. Most of 

the incidents were reports of crop damage that occurred following application of the 

herbicide directly to the crop, although four incidents occurred from carryover effects of 

applications made to another crop in a previous growing season. None of the incidents 

involved damage to crops or other plants outside the treatment site. For a detailed 

discussion of the ecological incidents for FPE, see Environmental Fate and Ecological 

Risk Assessment for Registration Review ofFenoxaprop-p-ethyl dated April21, 2014. 

3. Characterization of Ecological Risk 

The preliminary risk assessment and risk assessment addendum for FPE identified some 

risks that exceeded EPA's LOC for non-listed species. The Agency uses theLOC as an 

indicator of potential adverse effects to non-target organisms. LOC exceedances are only 

one line of evidence used by EPA to describe the risks posed by a pesticide to non-target 

organisms. This risk characterization section is an attempt to describe other lines of 

evidence for FPE, and put the LOC exceedances into a broader context 

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conservative nature of the assessment described herein, the Agency does not expect 

chronic risks to mammals from the use of FPE. · 

Terrestrial Plants - This assessment indicates that all labeled uses of FPE pose potential 

risks of concern to non-target terrestrial plants (monocots), which is supported by a series 

of incidents reported for grain crops treated with FPE. The Agency's principal concern is 

off-target spray drift resulting from aerial applications. To address this concern, EPA and 

the FPE registrants have agreed to various label changes designed to reduce off-target 

spray drift. 

C. Benefits Assessment 

FPE is registered for use for selective post-emergence control of difficult to control annual and 

perennial grass species in barley, rice, soybeans, and winter and spring wheat. Approximately 

ten percent of the barley and wheat crop is treated with this herbicide, on average, indicating that 

FPE is important in controlling grass weeds in these crops. In California, on barley and wheat, 

FPE is part of an Integrated Pest Management program for the control of several difficult to 

control grasses. As a post-emergence treatment, the grower can avoid making prophylactic 

preemergence applications. In these crops, FPE is less expensive than several of the other 

available alternative herbicides. FPE is generally applied early to late postemergence to the crop 

and weeds using ground equipment, with low booms. Aerial applications primarily occur in only 

two crops with 8% of total acres treated for barley and 53% percent of total acres treated for rice. 

For additional detail on the qualitative benefits ofFPE, see Fenoxaprop and Fenoxaprop-ethyl 

Qualitative Benefits Assessment dated June 11,2015. 

D. Endangered Species Assessment 

Consistent with EPA's responsibility under the Endangered Species Act (ESA), the Agency will 

evaluate risks to federally listed species from registered uses of pesticides in accordance with the 

Joint Interim Approaches developed to implement the recommendations ofthe April2013 

National Academy ofSciences·(NAS) report, Assessing Risks to Endangered and Threatened 

Speciesfrom Pesticides. The NAS report[IJ 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 FPE in connection with the development of its final registration 

review decision for FPE. 

[IJ http://www.nap.edu/catalog.php?record id=l8344 

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Recommendations of the National Academy of Sciences April 2013 Report. 121 

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 FPE 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 ofFPE describes the level ofESA 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 FPE as part of completing this registration review. 

E. 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 FPE, 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), FPE is subject to the 

endocrine screening part of the Endocrine Disrupter 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 

121 http://www.epa.gov/espp/20 13/nas.html 

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chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of 

chemicals identified for EDSP screening, which included FPE, was published on June 14, 20132 

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 disrupters. 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.3 

In this proposed interim decision, EPA is making no human health or environmental safety 

findings associated with the EDSP screening of FPE. Before completing this Registration 

Review, the Agency will make an EDSP FFDCA section 408(p) determination. 

IV. PROPOSED INTERIM REGISTRATION REVIEW DECISION 

A. Risk Mitigation and Regulatory Rationale 

Spray Drift Reduction 

As discussed in the ecological risk assessment section of this document, FPE poses a potential 

risk concern for non-target terrestrial (monocot) plants exposed to off-site spray drift from aerial 

applications primarily. FPE labels are inconsistent with regard to droplet size (one of the main 

factors affecting spray drift), with some referencing medium droplet size, micron size, or no 

specific reference to size. In addition, some labels reference wind speed restrictions or 

maximum release height while others do not. To address spray drift concerns, the Agency and 

the FPE registrants have agreed to various label changes for FPE registrations. These label. 

changes are intended to establish a baseline level of protection that is consistent across FPE 

labels. EPA believes this revised labeling, once in place, will reduce risks associated with drift 

without a significant reduction in product efficacy. The proposed labeling language, described 

below, would be incorporated on labels of products used in agricultural, wide area, or rights-ofway settings. · 

• Select nozzles and pressure that deliver medium or coarser spray droplets as indicated in 

nozzle manufacturer's catalogs and in accordance with ASABE Standard S-572. 

• Applicators may spray only when wind speed is between 3 and 10 mph. 

• For aerial applications, the release height must be no higher than 10 feet from the top of 

the crop canopy, unless a greater application height is required for pilot safety. 

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

3 htto://www.epa.gov/endo/ 

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weed species ( 71 ). The other crops on which FPE is most commonly used (rice, winter wheat, 

soybeans, and cotton) are also among the top ten crops with the greatest number of 

herbicide-resistant species. In order to extend the useful life of FPE and slow the 

development/expansion of FPE-resistant weed species, FPE registrants have agreed to include 

herbicide-resistance management language uniformly across their labels. 

The Agency is proposing that all herbicide products containing FPE (except for those registered 

solely for homeowner use) contain the following minimum herbicide-resistance management 

elements on their labels. These specifications follow the recommendations of the Weed Science 

Society of America (WSSA) publication, Reducing the Risks of Herbicide Resistance, Best 

Management Practices and Recommendations5. The Agency first provided guidance on 

resistance management labeling in Pesticide Registration (PR) Notice 2001-5, Guidance for 

Pesticide Registrants on Resistance Management Labeling. 

• Listing of herbicide mechanism of action, and/or WSSA herbicide group number, at the 

top of the first page of each product label; 

• Instructions to alternate use of products containing FPE with other herbicides with 

different mechanisms of action; 

• Recommendations to scout for weeds before and after FPE application, to ensure proper 

identification of weeds and growth stage and to confirm product performance; and 

• Instructions to report herbicide failure to local extension specialists, certified crop 

advisors, and/or FPE registrants. 

EPA believes that the inclusion of herbicide-resistance management language on FPE labels is 

important to slow the development of resistance to this herbicide while maintaining flexibility 

for growers. Weed resistance is a complex issue and registrants play an important role in 

ensuring effective resistance management. Educating all stakeholders on best practices for 

managing herbicide resistance is important and the product label is a critical piece of this effort. 

Use Rate Clarifications 

In response to the November 8, 2012 EPA-Registrant FPE Focus Meeting, Bayer and Syngenta 

submitted separate letters on November 30, 2012 committing to clarify use patterns on product 

labels (e.g., maximum annual rates, retreatment intervals). Bayer recently noted one correction 

to the information contained in its letter for applications to rice: the maximum seasonal rate of 

0.142 lbs a.i./ A is equivalent to the maximum annual application rate (i.e., for a given year, prior 

to growing rice and after the rice has been harvested, no FPE can be applied to that field until the 

4 International Survey of Herbicide Resistant Weeds ( http://weedscience.org/) 

5 Norsworthy et al. 2012. Weed Science 2012. Special Issue: 31-62. 

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Although EPA has determined that there are no adverse human health effects from all uses of 

FPE, the Agency will pursue the following changes to the tolerances for FPE, to reflect current 

policies. EPA will revise the following established tolerances in 40 CFR § 180.430 (b) as 

follows: 

• The commodity definition for "soybean" to be changed to "soybean, seed". • The tolerances for "peanut, hull" will be revoked since that commodity is no longer a 

regulated raw agricultural commodity. 

C. Proposed Interim Registration Review Decision 

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this Proposed 

Interim Registration Review Decision. Except for the EDSP and ESA components of this case, 

the Agency has made the following Proposed Interim Registration Review Decision: (1) no 

additional data are required at this time; and (2) changes to the affected registrations and their 

labeling are needed at this time. 

In this proposed interim registration review decision, EPA is making no human health or 

environmental safety findings associated with the EDSP screening of FPE, nor is it making a 

complete endangered species finding or a complete assessment of effects to pollinators. The 

Agency's final registration review decision for FPE will depend upon the results of an ESA 

Section 7 consultation with the Services, an EDSP FFDCA section 408(p) determination, and an 

assessment of the non-target exposure to bees. 

V. NEXT STEPS AND TIMELINE 

A. Interim Registration Review Decision 

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this Proposed 

Interim Registration Review Decision, and placing it in the FPE registration review docket 

(EPA-HQ-OPP-2007-0437) for public comment for 60 days. A Federal Register Notice will 

announce the availability of this Proposed Interim Registration Review Decision for FPE and 

initiate a 60-day comment period. If there are no significant comments or additional information 

submitted to the docket during the comment period that leads the Agency to change its proposed 

decision, EPA will issue an Interim Registration Review Decision for FPE (case 7209). 

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language 

./ Clarify 

rice annual 

maximum 

application 

rate 

Appendix B: FPE Label Table 

Summary of Labeling Changes for FPE 

Description Proposed Labeling Language for FPE Products Placement on Label 

SPRAY DRIFT 

Spray Drift Language • Select nozzles and pressure that deliver medium or Directions for Use 

coarser spray droplets as indicated in nozzle 

manufacturer's catalogs and in accordance with 

ASABE Standard S-572. 

• Applicators may spray only when wind speed is 

between 3 and 10 mph. 

• For aerial applications, the maximum release height 

must be no higher than I 0 feet from the top of the 

crop canopy, unless a greater application height is 

required for pilot safety. 

• For aerial applications, the distance of the outer most 

nozzles on the boom must not exceed three-fourths 

of the length of the wingspan or rotor diameter. To 

further reduce drift, use one-half of the length of the 

wingspan or rotor diameter at the edge of a field. 

HERBICIDE RESISTANCE MANAGEMENT- Products Labeled for Agricultural Use 

Herbicide Mechanism Front Panel, upper right 

of Action "Group 1 HERBICIDE" quadrant, surrounded by a black (or suitable color) 

rectangle 

Weed Resistance • Instructions to alternate use of products containing Directions for Use, prior to 

Management FPE with other herbicides with different directions for specific crops 

mechanisms of action; under the heading "WEED 

• Recommendations to scout for weeds before and RESISTANCE 

after FPE application, to ensure proper identification MANAGEMENT" 

of weeds and growth stage and to confirm product 

performance; 

• Instructions to report herbicide failure to local 

extension specialists, certified crop advisors, and/or 

FPE registrants. 

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corrected in this table) and in Syngenta's 2012 

commitment letter 

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