1 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 Divi sion (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 Synge nta, 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 ecol ogical and human health risk assessments, and 2) discuss data that has been submitted si nce 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 a nd rates) of current end use products;

 proposals for label changes to specify use parameters a nd 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 cons ervative assumptions in the pl anned registration review risk

assessments.2 To address the concerns raised by the Agency, Baye r and Syngenta agreed to revise the labels to clarify the use patterns. The revisions will lim it the total annual rate of fenoxaprop-p-ethyl to 0.188 lb a.i/A from all sources for uses in/on crop s, 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 re treatment interval (number of days between applications). Details on planned label changes are describe d in the letters from Bayer (November 30, 2012) and Syngenta (November 30, 2012), av ailable in the FPE docket.

Data Prior to conducting the human health cancer ri sk assessment for registration review, EPA will

hold a Cancer Assessment Review Committee meeti ng 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 (IP CS) Mode of Action Framework in order to facilitate the Agency’s review of these data. In addition, the Agen cy 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 dislodg eable 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 perfor ming post-application activ ities. Bayer replied

that there are no DFR data availa ble. HED responded that in the absence of these data, standard default assumptions will be made in the upc oming registration review risk assessment.

EPA inquired about the existence of additional to xicity 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 ecol ogical risk assessment for registration review.

Bayer pointed out that 32 studies, relevant to eco logical risk assessment, were submitted as part of the registration review process, and these st udies 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 resi dues is significantly longer than the rate for parent and the P-aci d alone. Furthermore, Bayer me ntioned 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 agr eed 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 pos t them for public comment in the docket.