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Fenoxaprop-p-ethyl Focus Meeting Summary 

 November 8, 2012 

9:30 – 11:00 am 

Attendees

Bayer CropSicence (Bayer): George Sabbagh, Mike Gorrell, Tharacad Ramanarayaman, 

Tilghman Hall 

 

Syngenta Crop, LLC (Syngenta): Tamara Murphy 

Environmental Protection Agency (EPA or Agency): Tracy Perry (PRD), Molly Clayton (PRD), 

Michael Goodis (PRD), Scott Glaberman (EFED), Charles Peck (EFED), Don Wilbur (HED), 

Christine Olinger (HED), Deborah Smegal (HED), Kathryn Montague (RD), Andy Ertman (RD), 

Sepehr Haddad (BEAD), Bill Phillips (BEAD) 

Objective

The purpose of the meeting was for members of the EPA’s Pesticide Re-evaluation Division 

(PRD), Environmental Fate and Effects Division (EFED), Health Effects Division (HED), 

Biological and Economic Analysis Division (BEAD) and Registration Division (RD) to meet with 

Bayer, a technical registrant for fenoxaprop p-ethyl (FPE), and Syngenta, an end use registrant for 

FPE, for the following reasons: 1) discuss potential label changes and use pattern clarification 

necessary for the upcoming registration review ecological and human health risk assessments, and 

2) discuss data that has been submitted since the publication of the August 2007 Summary 

Document and data that might still be submitted to help inform the upcoming risk assessments. 

Presentation

Bayer’s presentation covered: 

 

 the use pattern (e.g., application timing and rates) of current end use products; 

 proposals for label changes to specify use parameters and remove ambiguities on the 

products’ intended use 

 description of data submitted since the FPE registration review docket opening (docket 

number EPA-HQ-OPP-2007-0437) 

 

Discussion

Label/Use Clarification 

EPA commented on the use information presented by Bayer, noting that parameters describing 

the use patterns are not clearly defined for all FPE end use product labels. These patterns are 

critical to conducting the exposure and risk assessments. Without label specifications for these 

use parameters, EPA may make conservative assumptions in the planned registration review risk 

assessments. 
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To address the concerns raised by the Agency, Bayer and Syngenta agreed to revise the labels to 

clarify the use patterns. The revisions will limit the total annual rate of fenoxaprop-p-ethyl to 

0.188 lb a.i/A from all sources for uses in/on crops, will limit the total annual rate of FPE to 

0.531 lb a.i/A from all sources for non-crop uses, will specify the maximum use rate per 

application, and will specify the retreatment interval (number of days between applications). 

Details on planned label changes are described in the letters from Bayer (November 30, 2012) 

and Syngenta (November 30, 2012), available in the FPE docket. 

Data 

Prior to conducting the human health cancer risk assessment for registration review, EPA will 

hold a Cancer Assessment Review Committee meeting to determine the cancer classification for 

FPE. EPA requested that Bayer re-submit its 2007 position paper on carcinogenicity in the 

International Programme on Chemical Safety (IPCS) Mode of Action Framework in order to 

facilitate the Agency’s review of these data. In addition, the Agency indicated that it will inform 

Bayer how to submit this document and any other existing supporting data. Bayer agreed to 

review the existing data and their ability to develop such a framework document. 

HED explained that EPA does not have a dislodgeable foliar residue (DFR) study for FPE. The 

label review has shown that some of the uses are post-emergent, and there is potential for 

workers to be exposed to residues while performing post-application activities. Bayer replied 

that there are no DFR data available. HED responded that in the absence of these data, standard 

default assumptions will be made in the upcoming registration review risk assessment. 

EPA inquired about the existence of additional toxicity data for sediment-dwelling organisms. 

Bayer replied that it is unlikely that there are additional sediment toxicity data other than those 

that have been submitted, but Bayer will conduct a search and submit any additional available 

data . Bayer will also check with the European Union for data, as FPE is currently undergoing 

the Annex 1 renewal process. In the absence of additional data, EFED stated that they would use 

invertebrate water column data in the ecological risk assessment for registration review. 

Bayer pointed out that 32 studies, relevant to ecological risk assessment, were submitted as part 

of the registration review process, and these studies should help address the uncertainty in the 

ecological risk assessment. Also, Bayer indicated that the results from these studies pointed to 

the parent and the P-acid (the active moiety of the product) as the only residues of toxicological 

relevance for the aquatic assessment. Bayer feels that EPA’s plan to use the total toxic residue 

approach is too conservative, as the degradation rate for all residues is significantly longer than 

the rate for parent and the P-acid alone. Furthermore, Bayer mentioned that a short-grass study 

report, also submitted as part of the registration review process, showed a half-life of 5-6 days 

rather than 30 days. EPA agreed to review the new data. 

Next Steps

EPA plans to complete the preliminary human health and ecological risk assessments for 

registration review in September 2013, and post them for public comment in the docket.