Docket Number EPA-HQ-OPP-2007-0437 

www.regulations.gov 

Fenoxaprop-p-ethyl 

Interim Registration Review Decision 

Case Number 7209 

December 2015 

Approved by: ~(.U...d.. fJ ±Y-:-2LL~ ,:O 

Richard P. Keigwin, Jr. 

Director 

Pesticide Re-evaluation Division 

Date: __ /J Lf/. 1 J,_... ___ _ 

Contents 

Fenoxaprop-p-ethyl Interim Decision 

Table of Contents 

I. INTRODUCTION ................................................................................... 3 

II. USE AND USAGE ..................... .. .... .. ... ... ... .. ... ... ... .... ......... ...... ... ............ ? 

III. SCIENTIFIC ASSESSMENTS .. ... ................... ... ... ........... ... .................. ...... 8 

A. Human Health ......... ..... ...................................................................... 8 

I. Risk Conclusions ..................... .... ... ... ... .. ... ... ..... ... ...... ......... ...... ... . 8 

2. Human Incidents ..... ... ..... .. ............................................................. 8 

3. Tolerances .. ...... ..................... ....................................................... 9 

B. Ecological .... .. .... .. ........................ ............ .......... ................ ............... 9 

1. Risk Conclusions ..... ..... ... .... ... .. ..................................................... . 9 

2. Ecological Incidents .... .. .................................................................. 12 

3. Characterization ofEcological Risk ... ....... ... ... ... ... .... ..... ...... .................. l2 

C. Benefits Assessment ............................. ... ... ... ... .... .... .......... ............ ..... 13 

D. Endangered Species Assessment ............ ... ..... ... ... .... ........ .... .......... ... ...... 13 

E. Endocrine Disrupter Screening Program .................................................... 14 

IV. INTERIM REGISTRATION REVIEW DECISION ........... ........ ......................... 15 

V. NEXT STEPS AND TIME LINE .............. ... .................. ....... .... ...... .... ... ....... 17 

Appendix A: Summary of Actions Taken for Fenoxaprop-p-ethyl. ......... ................ ...... .... 18 

Appendix B: Fenoxaprop-p-ethyl Label Table ... ........................................................ 18 

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I. INTRODUCTION 

This document is the Environmental Protection Agency's (EPA or the Agency) Interim 

Registration Review Decision for Fenoxaprop-p-ethyl (FPE) (case 7209. PC code 129092) 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 (FlFRA). 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 additional data or other 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 progran1 is 

provided at 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. 

EPA is issuing an inlerim registration review decision for FPE so that it can (1) move forward 

with aspects of the registration review that are complete and (2) implement interim risk 

mitigation. The Agency is currently working with the U.S. Fish and Wildlife Service and the 

National Marine Fisheries Service (the Services) to develop methodologies for conducting 

national endangered species assessments for pesticides. Therefore, although EPA has not yet 

fully evaluated risks to threatened and endangered species, the Agency will complete its 

endangered species assessment and any necessary consultation with the Services for FPE prior to 

completing the FPE registration review. Likewise, the Agency will complete endocrine 

screening for FPE, pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA) section 

408(p ), before completing this registration review. Last, EPA will determine whether additional 

pollinator exposure and effects data are necessary to make a final registration review decision for 

FPE and issue a data call-in (OCI) to obtain any such data prior to completing the FPE 

registration review. 

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, 

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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. 

This document is organized in five sections: the Introduction, which includes this summary and a 

summary of public comments and EPA's response; Use and Usage, which describes how and 

why FPE is used and summarizes data on its use; Scientific Assessments, which summarizes 

EPA's risk assessment, any revisions, and risk conclusions; the Interim Registration Review 

Decision, which describes the mitigation measures needed to address risks of concern and the 

regulatory rationale for EPA's registration review decision; and, last, the Next Steps and 

Timeline for completion of this registration review. 

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 of FPE Summary Document for a 90-day public comment 

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

accompanied by the scoping document and problem formulation. 

• February 29, 2008- Final Work Plan (FWP) for FPE was issued. The Agency received 

comments from two sources during the 90-day public comment period on the PWP. The 

FIFRA Endangered Species Task Force (FESTF) commented on data compensation 

issues. Bayer, a technical registrant, submitted comments on FPE study results, revisions 

to FPE registrations, and details of the human health and ecological risk assessments. 

Bayer's comments and accompanying data submissions resulted in an adjustment to the 

timeline indicated in the PWP to accommodate the review of these data prior to issuance 

of a data call-in notice 

• February 2, 2010 - Generic Data Call-In Notice (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 

Prelimin01y /Drafi 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 CBD commented about the 

Agency's obligations under the Endangered Species Act (ESA). 

4 
• August 2015 - The Agency published the Fenoxaprop-p-ethyl Proposed interim 

Registration Review Decision for a 60-day public comment period. In addition to that 

document, the Agency published 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 

Grol-vnfor Seed. ShaJu Shelat, Christopher Schlosser, Donald Wilbur. December 

3, 2014 

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

Scott Olaberman. June 4, 2015 

o Fenoxaprop and Fenoxaprop-ethyl Usage Information/or Risk Assessment. Bill 

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

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

Michelle Ran ville. June 11 , 2015 

During the 60-day comment period on the FPE Proposed Interim Registration Review 

Decision, which opened on August 8, 2015 and closed on October 9, 2015, the Agency 

received comments from Bayer and the CBD, which are summarized below. 

• December 2015 - The Agency is now publishing the Fenoxaprop-p-ethyllnterim 

Registration Review Decision in the registration review docket (EPA-HQ-OPP-2007-

0437). 

Comments Received from Bayer CropScience (EPA-HQ-OPP-2007-0437-0028) 

Comment: Bayer expressed appreciation for the Agency 's consideration of/heir comments on 

the draft ecological assessment for FPE and provided additional comments on technical aspects 

ofthe Addendum to the Ecological Risk Assessment, which wasposted along with the FPE 

Proposed fnlerim Registration Review Decision. 

Response: The Agency appreciates Bayer's comments, agrees with the typographical errors 

noted, and disagrees with other points such as the No Observed Adverse Effect Level for tomato 

in a seedling emergence study. Bayer's comments do not affect the overall risk assessment 

conclusions for effects to nontarget plants nor the mitigation measures specified for FPE. For 

additional details on Bayer's comments and the Agency's response, please see Review of 

Comments on Addendum lo the Ecological Risk Assessment for Fenoxaprop-p-ethyl, dated 

November 13, 2015, in the FPE registration review docket. 

Comments Received from the Center for Biological Diversitv (EPA-HQ-OPP-2007-0437-

0033) 

Comment: CBD opposes I he proposed reregistration of FPE at this time as premature because 

they assert that the Agency has determined that FPE has the potential to cause adverse effects to 

species. In CBD 's comments on the Proposed Interim Registration Review Decision for 

Fenoxaprop-p-ethyl, they focus on EPA ·s duty to initiate consultation with the U.S. Fish and 

5 
Wildlife Service and the National Marine Fisheries Service (the Services) prior to completion of 

the registration review process for FP E. CBD states that the reregistration of FP E cannot be 

completed in compliance with EPA 's obligations under both FIFRA and the ESA until the EPA 

concludes that the continued use of FP E will have "no effect " on listed species or critical habitat 

or completes consultation. CBD also contends that there are readily available data and 

information sources that would allow EPA to complete Step 1 of the Interim Approaches/or 

National Level Endangered Species Assessments Based on the Recommendations of the National 

Academy ofScience. CBD refers to their previous comments1 on EPA 's draft ecological risk 

assessment, which provided specific label language to implement the Bulletins Live! System, 

stating that this label language would enable EPA to comply with current and continuing ESA 

duties. (CBD incorporated these and all other previous comments on the draft ecological risk 

assessment by reference.) Last, they state that EPA must take a precautionGiy approach and 

enter into consultations with the Services on FP E as outlined in the Interim Approaches 

document. 

Response: As an initial matter, CBD's comments suggest that it may not fully appreciate the 

distinction between EPA's interim and final registration review decision. Additionally, CBD 

seems to use "reregistration" interchangeably with "registration review." Both are separate 

programs mandated by FIFRA; FPE is currently undergoing Registration Review. As provided in 

EPA's registration review regulations at 40 CFR section 155.56, EPA may, in its discretion, 

issue an interim decision before the completion of registration review when, among other things, 

it determines that it cannot complete registration review because additional information is 

necessary to complete the Agency's assessment. In addition, section 155.56 also provides that 

EPA may require risk mitigation measures in an interim decision. Consistent with this 

provision, EPA is issuing this interim registration review decision for FPE in part so that it can 

move forward with aspects of the registration review decision that are complete while EPA 

continues to work with the Services on developing the interim approaches that will be used to 

complete its registration review endangered species assessment for FPE. Under section 3(g) of 

FIFRA, EPA must complete the registration review of FPE by October I, 2022. While EPA 

~ould, therefore, choose not to complete any aspect of the FPE registration review for several 

more years until it completes its endangered species assessment and any necessary consultation, 

EPA believes the public and the environment benefit from EPA's early action on the matters 

covered by this interim decision -- including risk mitigation, such as use of spray nozzles 

limiting FPE droplet size and other drift reduction measures -- as described in Section IV of this 

document. EPA does not believe the Endangered Species Act compels a contrary result. Taking 

early action to address some risks now serves to benefit the environment and does not preclude 

EPA from taking any additional necessary actions to address effects to listed species that EPA 

concludes are necessary as it works to complete registration review. 

Accordingly, EPA's previous response to CBD's comments on the draft ecological risk 

assessment (in the Proposed Interim Decision) stated that EPA plans to address CBD's concerns 

with the development of its Final Registration Review Decision. This is still EPA's plan. EPA 

anticipates initiating consultation with the Services after issuing the Interim Registration Review 

Decision, but prior to issuing the Final Registration Review Decision. This Interim Registration 

Review Decision, like the Proposed Interim Decision, states that EPA is not making a complete 

1 Full CBD comments located on docket EPA-HQ-OPP-2007-0437-0033 

6 
endangered species fmding, and that the Agency's Final Registration Review Decision for FPE 

will depend upon the result of an ESA Section 7 consultation with the Services, an assessment of 

non-target exposure to bees, as well as the FFDCA Section 408(P) endocrine screening 

requirements. 

EPA is still in the process of developing the interim approaches based on the 2013 NAS Report 

recommendations, including Steps 1 and 2 ofthe Biological Evaluation for listed species. 

CBD's previous comments provide reference to the available critical habitat; however, as CBD 

noted, not all species have critical habitat. Furthermore, critical habitat is just one piece of the 

species' range. EPA is working with the Services to obtain the best available species range 

information for all listed species. We are also working together to determine the appropriate 

pesticide use footprint. EPA will be taking public comment on our interim approaches as 

developed and implemented for the three pilot chemicals: chlorpyrifos, diazinon and malathion. 

As a result, EPA may develop a revised approach for Steps I and 2 through work on the three 

pilot chemicals before completing Step l for FPE. 

CBD's previous comments also provided label language referring pesticide applicators to EPA's 

Bulletins Live! System, and a statement that all product labels for FPE must contain this 

language. However, since there are no Bulletins for FPE in Bulletins Live! Two, it is 

unnecessary, at this point in time, to include this language on the label for FPE. Inclusion of a 

reference to Bulletins on the product label when no Bulletins exist is likely to result in confusion 

for pesticide applicators and growers. However, EPA is in agreement with CBD that Bulletins 

are the appropriate mechanism to implement any necessary geographically-specific pesticide use 

limitations intended to protect listed species. EPA plans to use Bulletins Live! Two to implement 

any Bulletins that would be generated as we complete the evaluation of potential risks ofFPE to 

listed species and designated critical habitat. 

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. N'on-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 of this 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). Percent crop treated is approximately 10 percent for 

barley, 5 percent for rice, 2.5 percent for soybeans, and 10 percent for wheat. 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 of FPE 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 the 10 percent of FPE-treated acres for barley are applied 

aerially, and more than fifty percent of the five percent of FPE-treated acres for rice are applied 

aerially. The aerial applications for rice were apparently made to accommodate the large number 

7 
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 Fenoxapropethyl 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 of FPE. 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 

Grass Grown for Seed dated December 3, 2014. Both of these documents are available in the 

public docket EPA-HQ-OPP-2007-0437, which can be accessed at http://www.regulations.gov/. 

1. Risk Conclusions 

EPA has no dietary risks of concern for FPE from exposure to residues in either food or 

drinking water. The Agency has no risk concerns for residential use of FPE on turf or 

ornamentals. Furthermore, EPA has no risk concern from aggregate exposure to FPE 

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

common mechanism of toxicity fmding 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 post application exposures and risks were not of 

concern on the day of application. 

2. Human Incidents 

The Agency completed a review of FPE incidents in the OPP Incident Data Systems 

(IDS), for the period covering January 1, 2008 to July 31, 2013, 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) database for the period covering 1998-2009. 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 

8 
triggered, additional analysis will be conducted. For additional detail, see Tier I Updated 

Review of Human Incidents for Preliminary Risk Assessment (0416023, November 13, 

2013) available in the public docket EPA-HQ-OPP-2007-0437 

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 this raw 

agricultural commodity is no longer considered to be a significant livestock feed item.2• 

The Agency is not aware of any international harmonization issues related to the existing 

FPE tolerances. Further details on necessary revisions to FPE tolerance can be found on 

page 10 of Fenoxaprop-p-ethyl: Registration Review PrefiminaTy Risk Assessment and 

Proposed New Grass Grown for Seed, which can be accessed on the public docket EPAHQ-OPP-2007-0437. 

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 of FPE. 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 Ecol_ogical Assessment for Fenoxaprop-p-ethyl dated June 4, 2015, and the EFED 

Response to Comments on the Environmental Fate and Ecological Risk Assessment for the 

Registration Review of Fenoxaprop-p-ethyl, dated November 3, 20 I 4. These documents are 

available in the public docket EPA-HQ-OPP-2007-0437, which can be accessed at 

http://www.regulations.gov/. 

The Agency also completed a screening-level listed species assessment for FPE and identified 

potential risks to several taxa (terrestrial and semi-aquatic monocot plants and mammals). The 

Agency is currently working with its federal partners and other stakeholders to implement an 

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. 

I. 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 commented 

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

2 hllp://www.regulations.gov/# !documcntDetai I:D=EPA-110-0PPT -2009-0155-0003 

9 
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 0.0 I 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 of the June 2014 Guidance for Assessing Pesticide Risks to Bees3, 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 

that additional pollinator exposure and effects data are necessary to help make a final 

registration review decision, EPA intends to issue a DCI to obtain these data. In the near 

future, EPA will provide further information and guidance on this effort. The pollinator 

studies that could be required are included in Table I below. The Agency will require 

data it believes are necessary to help inform the pollinator risk assessment. 

T a bl e 1 P o t en f ta l P o 11" ma or DtR a a eqmremen t s 

Guideline# Study J 

, L 

850.3020* 1 Acute contact toxicity study with adult honey bees 

850.3030* 1 Honey bee toxicity of residues on fo liage 

850.3040** Field testing for pollinators 

Non- Honey bee adult acute oral toxicity 

Guide! ine* 1 

(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 

NonResidues in pollen and nectar/field residue analysis Guideline** 

3 http //www2.~:na gov/s it slproduction/liles/20 14-06/documents/pollinator risk assessment guidance 06 19 14.pdf 

10 
NonGuideline** 

(OECD 75) 

Semi-field testing for pollinators (tunnel or colony feeding studies) 

*Tier I (Laboratory-based studies) 

••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. 

1. Acceptable data have already been sulrnitted for FPE or arc 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 

registrants4

, 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. 

The terrestrial plant assessment presents estimates of how far off the treated field (i.e., the 

effects distance) one might expect adverse effects to occur to non-target plants from spray 

drift. The initial assessment indicated effects dis~ances of > I 000 feet for non-target 

monocotyledonous terrestrial plants (monocots) for some use patterns. The revised 

assessment indicates a 7 foot effects distance for ground applications (all use sites) and a 

7-43 foot effects distance for aerial applications (varies by site) using a medium-coarse 

droplet size. 

While the above revtswns 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 

ofFPE. There is some Lmcertainty 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 sediment4 See EPA, Bayer. Syngcnta. and Nufam1 Meeting on Fenoxaprop Registration Review. May 5. 2015. located in the docket. 

11 
dwelling organisms. Based on the available data, risks to aquatic plants are not expected 

from the currently registered uses of FPE. 

2. Ecological Incidents 

As of 2013, 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 Regis/ration Review of 

Fenoxaprop-p-ethyl dated April 21, 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 the LOC 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. 

Mammals - While the LOC is exceeded for chronic risk to mammals, EPA does not 

expect risk to mammals based on the following lines of evidence. Chronic risk estimates 

to mammals were calculated using data bridged from fenoxaprop-ethyl (FE), which 

appears to be more toxic to mammals than FPE (see human health risk assessment). In 

addition, the endpoint used in the mammalian assessment is from a rat two-generation 

study where the no adverse effect level was the highest concentration tested in the study, 

since no significant adverse effects were observed at any of the levels tested. Given the 

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. 

12 
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 , 20 15. 

D. Endangered Species Assessment 

ln 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 Approaches5 were developed jointly by the agencies in response to 

the National Academy of Sciences' (NAS) recommendations and refl ect 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 report6 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 stakeholder workshops- in April 

and October 2014, and in April 2015 - 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 (ESA) Assessments Based on the Recommendations of the National 

Academy of Sciences April 2013 Report7, dated November 1, 2013. 

5 Interim Approaches for National-Level Pesticide Endangered Species Act (ESA) Assessments Based on the 

Recommendations of the National Academy ofSciences April2013 Report. Available at 

hrro://v.rww2.epa.gov/endangered-species/interim-approaches-pesticide-endangered-species-act-assessments-basednas-report 

6 Assessing Risks to Endangered and Threatened Species from Pesticides. National Acadamy of Sciences. 1983. 

Available from http://www.nap.edu/catalog.php?record id=18344 7 Available at http://www.epa.gov/espp/20 13/nas.html 

13 
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 Decision for 

FPE 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 interim decision, EPA's evaluation 

assumed, for all taxa of non-target wildlife and plants, that listed species and designated critical 

habitats may be present in the vicinity of the application of FPE. This assessment allows 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 methodology for evaluating risks for listed 

species and their designated critical habitats, these methods will be applied to subsequent 

analyses for FPE as part of completing the final registration review decision. 

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 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 withE, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will detennine 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 fust group of67 

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 14,20138 

8 Sec hn:p://www.rcgulations.gov/#!documentDetaii;D=EPA-HO-OPPT-2009-0477-0074 for the final second list of chemicals. 

14 
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.9 

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

associated with the EDSP screening ofFPE. Before completing this Registration Review, the 

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

IV. 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 labeling language, described below, is to 

be incorporated on labels of products used in agricultural, wide area, or rights-of-way 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. 

• For aerial applications, the distance of the outer most nozzles on the boom should 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 

FPE belongs to a class of herbicides (ACCase inhibitors) that has the third highest number of 

resistant plant species (>40) out of the most commonly used classes ofherbicides. 10 In addition, 

the majority of usage occurs in wheat, which is the crop with the highest number of resistant 

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

barley, 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 

9 htto://www.cpa.gov/endo/ 10 International Survey of Herbicide Resistant Weeds ( http://weedscience.org/) 

15 
development/expansion of FPE-resistant weed species, FPE registrants have agreed to include 

herbicide-resistance management language uniformly across their labels. 

The Agency is requiring 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 label requirements follow the recommendations of the Weed 

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

Best Management Practices and Recommendations''· 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 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 

following year). Bayer and Syngenta have agreed to implement the use rate clarifications as 

specified in their commitment letters, along with Bayer's correction to the rice maximum annual 

application rate, after the Agency's issuance of its registration review decision for FPE. The 

November 30, 2012 commitment letters can be found in EPA's public docket for the FPE 

registration review (EPA-HQ-OPP-2007-0437). 

B. Tolerance Amendments 

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: 

11 Norsworthy et al. 20 12. Weed Science 2012. Special Issue: 3 1-62. 

16 
• 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 agricultw-al commodity. 

C. Interim Registration Review Decision 

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

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

case, the Agency has made the following Interim Registration Review Decision: (1) with the 

possible exception of pollinator studies listed in Section IIIB of this document, 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 interim registration review decision, EPA is making no human health or environmental 

safety fmdings 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. Registration Review Decision 

A final decision on the FPE registration review case will occur after an ESA determination and 

an EDSP FFDCA section 408(p) determination have been made, as well as completion of an 

assessment of the non-target exposure to bees. 

B. Implementation of Mitigation Measures 

EPA is requiring registrants to submit amended labels that include the agreed-upon risk 

mitigation, described in Appendices A and B below, to the Agency for approval within 60 days 

of the issuance of this Interim Registration Review Decision. 

17 
A-ppendix A: Summary of Actions Taken for Fenoxaprop-p-ethyl ~egistration Review Case#: 7209 . tc Code: 1 29092 

Chemical Type: herbicide 

Chemical Family: Aryloxy Phenoxy Propionic Acid 

Mechanism of Action: WSSA Group l 

Affected Source of Route of Duration of Risk(s) of Action(s) K:;omment 

r Population(s) Exposure Exposure Exposure Concern Taken ~ 

./ Terrestrial ./ Aerial ./ Foliar ./ Acute ./ Acute ./ Require 

Plants Application absorption toxicity spray drift 

(monocots) reduction 

language 

./ Clarify 

rice annual 

maximum 

application 

rate 

Appendix B: FPE Label Table 

Summary of Labeling Cha nges for FPE 

Description Labeling La nguage 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 I 0 mph. 

• For aerial applications, the maximum release height 

must be no higher than I 0 feet fTom 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-foUJ1hs 

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. 

H ERBIC IDE RESISTANCE MANAGEMENT- Products Labeled for Agricultural Use 

Herbicide Mechanism Front Panel, upper right 

of Action "Group I HERBIC IDE" 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 confinn product 

perfonnance; 

18 
Summary of Labeling C hanges for FPE 

Description Labelin2: LanS?:uaS?:e for FPE Products Placement on Label 

• Instructions to report herbicide fa ilure to local 

extension specialists, certified crop advisors, and/or 

FPE registrants. 

DIRECTIONS FOR USE 

Clarify use rates as • F. or rice, the maximum seasonal rate of 0.142 lbs Directions for Use for Specific 

specified in Bayer's a. i./A is equivalent to the maximum annual Crops 

20 12 commitment letter application rate for a given field 

(with the exception of 

use on rice, which is 

corrected in this table) 

and in Syngenta's 2012 

commitment letter 

19