Document ID: EPA-HQ-OPP-2010-1018-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-04-20T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460
                                                                      OFFICE OF
                                                            CHEMICAL SAFETY AND
\* MERGEFORMAT
                                                           POLLUTION PREVENTION

MEMORANDUM

Date: February 23, 2012

SUBJECT:	Quizalofop-P-ethyl:  Amendment to the Human Health Risk Assessment and Summary of Analytical Chemistry and Residue Data for New Uses on Sorghum, Rapeseed Crop Group 20 A, and Field Corn
 
PC Code:  128709
DP Barcode:   D398731
Decision No.: 441518 and 443799
Registration No.: 352-541 and 352-542
Petition No.: 0E7802 and 1F7822
Regulatory Action: Tolerance Petition
Risk Assessment Type: NA 
Case No.: NA
TXR No.: NA
CAS No.: 100646-51-3
MRID No.: NA
40 CFR: § 180.441

FROM:		Ideliz Negrón-Encarnación, Ph.D., Risk Assessor
		Risk Assessment Branch V
		Health Effects Division (7509P)
		Office of Pesticide Programs

THROUGH:	William Donovan, Ph.D., Chemist
		Michael Metzger, Branch Chief
		Risk Assessment Branch V
		Health Effects Division (7509P)
		Office of Pesticide Programs

TO:		Laura Nollen, Risk Manager
		Risk Management Division (RM 5; 7508 P)

			and

		Mindy Ondish, Risk Manager 
		Risk Management Division (RM 25; 7508P)

An amendment to the Human Health Risk Assessment (D384660 and D386678) and the Summary of Analytical and Residue Data (D395630) for new uses of quizalofop-P-ethyl was required to address changes in the commodity definition of feedstuff commodities, grazing restrictions and adjuvant specifications.  In addition, clarification on the decision for the storage stability studies of field corn was needed.  The registrant is undergoing a storage stability study with field corn which will be further evaluated; however, storage stability was proven for wheat which is tentatively used to cover that of the field corn samples.  Based on this, HED understands that a conditional registration is not necessary for this case.
   1. Tolerances for meal commodities 
   RAB V recommended the creation of the rapeseed, subgroup 20A, meal, except flax, meal to propose tolerances for the meal commodities under the rapeseed, subgroup 20A, seed, except flaxseed.  OPP further evaluated the proposal and considered that the registrant proposal was adequate for this case.  In addition, the preferred commodity term for canola is rapeseed.  Therefore, recommended commodity definitions and tolerances for the meal commodities are:  
         gold of pleasure, meal		2.0 ppm
         crambe, meal			2.0 ppm
	rapeseed, meal			2.0 ppm

   2. Grazing restrictions
   The Section (3) label of Assure II (EPA Reg. No. 352-541) indicates that grazing of livestock is prohibited in treated areas.  This restriction is not considered practical and should be removed.  However, the grazing interval established in the supplemental labels for use in field corn containing DAS-40278-9 and sorghum containing the INZEN AII herbicide tolerant trait are considered appropriate because they match the PHIs established in the label.  Therefore, the following directions should be kept in the supplemental labels.  
      * Field corn containing DAS-40278-9:  "Do not allow grazing on treated corn within 30 days of application." 
      * Sorghum containing the INZEN AII herbicide tolerant trait:  "Do not graze livestock in treated areas or feed treated grain, forage, fodder, straw, or hay to livestock within 45 days of Assure II application."
   
   3. Adjuvant specifications
   It was noted that the use of adjuvants established in the supplemental label for sorghum need to be modified to reflect the conditions of the field trials.  The adjuvant concentration was 1% (v/v) of the COC in all trials except one in which they used 0.25 % (v/v) of the NIS.  The residue data only supports 1% of the COC or 0.25% of the NIS.  Therefore, the label should be modified accordingly since in the draft label up to 2% COC and 0.5% NIS is recommended.