Document ID: EPA-HQ-OPP-2017-0333-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2017-10-24T04:00Z

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

Docket ID Number: EPA-HQ-OPP-2017-0333  

EPA Registration Division contact: Shaja Joyner/ PM 20 (703) 308-3194

Interregional Research Project Number 4

Pesticide Petition Number: 7E8565
            
EPA has received a pesticide petition Number (7E8565) from IR-4, IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201W, Princeton, NJ 08540 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180, by establishing regional tolerances for residues of the herbicide flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, including its metabolites and degradates, in or on the raw agricultural commodities:  Grass, forage at 0.4 parts per million; Grass, hay at 0.05 parts per million.

EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry 
      
	1. Plant metabolism.  The metabolism of flumioxazin is adequately understood for the purpose of granting the proposed tolerances.
	2.  Analytical method.  Practical analytical methods for detecting and measuring levels of flumioxazin have been developed and validated in/on all appropriate agricultural commodities and respective processing fractions. The LOQ of flumioxazin in the methods is 0.02 ppm which will allow monitoring of food with residues at the levels proposed for the tolerances.
      3. Magnitude of residues.  Residue data has been submitted which adequately support the requested tolerances. 

B. Toxicological Profile

      The toxicological profile for flumioxazin, which supports this petition for tolerances was published in the Federal Register on April 5, 2013 (78 FR 20461) (FRL-9381-7).
      Immunotoxicity and neurotoxicity studies have been submitted to the Agency to fulfill revised FIFRA 40 CFR part 158.340 data requirements. The results of these studies show no indication of immunotoxicity or neurotoxicity and do not result in any changes to the toxicology endpoints used for risk assessment purposes.  

C. Aggregate Exposure

      1. Dietary exposure.  
      
      The newly petitioned crops and the proposed tolerances will have negligible impact on dietary exposure.

       Food.  Dietary exposures are reviewed in 78 FR 20461 (FRL-9381-7).   
       Drinking water.  Drinking water exposures are reviewed in 78 FR 20461 (FRL-9381-7)

      2. Non-dietary exposure.  Non-dietary (residential and recreational) aggregate exposures to Flumioxazin may occur because people may swim in flumioxazin-treated water bodies or come into contact with treated turf in residential or recreational (golf) areas.  Aggregate exposure scenarios were conducted and reported previously and are not being revisited herein because the proposed tolerances will have no impact on non-dietary exposures.  

D. Cumulative Effects  

Section 408(b)(2)(D)(v) requires that the Agency must consider "available information" concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity." Available information in this context includes not only toxicity, chemistry, and exposure data, but also scientific policies and methodologies for understanding common mechanisms of toxicity and conducting cumulative risk assessments. EPA does not have, at this time, available data to determine whether flumioxazin has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment.  For the purposes of this tolerance action, EPA has not assumed that flumioxazin has a common mechanism of toxicity with other substances.

E. Safety Determination  

1.  U.S. population. 
       Acute Risk.  See 78 FR 20461 (FRL-9381-7)  
       Chronic Risk.  See 78 FR 20461 (FRL-9381-7).  

2. Infants and children.  See 78 FR 20461 (FRL-9381-7)
      i. 	Acute Risk. See 78 FR 20461 (FRL-9381-7)
      ii 	Chronic Risk.  See 78 FR 20461 (FRL-9381-7)

F. International Tolerances   N/A for grass grown for seed