                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON, D.C. 20460      

                                                                                                      OFFICE OF CHEMICAL SAFETY
                                                                                                       AND POLLUTION PREVENTION


	

MEMORANDUM


Date:		December 9, 2013

            SUBJECT:	Methoxyfenozide:  Registration Review  -  HED Review of Comments Received in Response to the Preliminary Work Plan (PWP).
            
PC Code:  121027
DP Barcode:  D415832
Decision No.:  484448 
Registration No.:  NA
Petition No.:  NA
Regulatory Action: Registration Review              
Risk Assessment Type:  NA
Case No.: 7431
TXR No.:  NA
CAS No.:  161050-58-4
MRID No.:  NA
40 CFR:    §180.544          

FROM:		Christina Swartz, Chemist                
		Risk Assessment Branch II
		Health Effects Division (7509P)
		Office of Pesticide Programs

THROUGH:	Linnea J. Hansen, Ph.D., Biologist
		Risk Assessment Branch II
		Health Effects Division (7509P)
		Office of Pesticide Programs

TO:		Bonnie Adler, Chemical Review Manager
		Pesticide Re-Evaluation Division (7508P)
		Office of Pesticide Programs

Attached is the Health Effects Division's (HED) response to comments received following publication of the Preliminary Work Plan (PWP) for registration review of the insecticide methoxyfenozide.

Background

The Health Effects Division (HED) completed a human health assessment scoping document to determine the data needed and level of effort required to support registration review for the insecticide methoxyfenozide (C. Swartz, et al.; D408668, 5/10/13).  The scoping document conclusions were incorporated into a PWP issued by the Pesticide Re-evaluation Division (PRD) June, 21, 2013 [Docket ID No. EPA-HQ-OPP-2012-0663].  The Agency received comments from the following:

FIFRA Endangered Species Task Force (FESTF), 8/8/13; the Western Integrated Pest Management Center (representing 7 western states, Alaska, California, Idaho, Montana, Oregon, Utah, and Washington), 8/26/13; Dow AgroSciences, LLC, 8/22/13; and the Northwest Horticultural Council, 8/26/13.

The FESTF response was related only to the endangered species aspects of the Agency's review of methoxyfenozide, whereas the WIPM response included usage information to be addressed by the Biological and Economic Analysis Division (BEAD).  However, the Dow AgroSciences and Northwest Horticultural Council responses are relevant to HED and are addressed below.

Dow AgroSciences LLC

Dow provided updated usage information for numerous crops; a comprehensive use pattern summary table, which includes application rate/frequency as well as pests controlled, comments related to the Environmental Fate and Effects Division (EFED) problem formulation, and changes/clarifications for the use pattern summary in HED's scoping document.

HED Response:
During registration review, HED will consult the use pattern summary provided by Dow to ensure all relevant scenarios have been assessed in accordance with current labels.  The 2 tables provided below were taken from the 5/10/13 human health assessment scoping document, and have been corrected with the information provided by Dow.  For Table 3.1, this includes a maximum single application rate of 0.38 lb ai/A for tree nuts on the Intrepid 2F label, and a maximum single application rate of 0.25 lb ai/A for the other crops listed, as originally indicated by HED.  Dow also noted that the use on peanut was omitted, and this has now been added.  For Table 3.2, Dow provided updated information for the Special Local Need (SLN) labeling, specifically the cancellation of the LA06001, and the addition of an SLN label in CO - CO120002.  These changes have been included in Table 3.2.


Table 3.1.  Methoxyfenozide Sec. 3 Product Formulations of Methoxyfenozide Insecticide.
                                  Registered
                         products & Formul. Types 
                                     % AI
                                Use Sites and 
                            Applicable ORE Reviews 
                            Application  equipment 
                                   Comments 
62719-437 
Technical
                                     98.2
NA
NA
                                       
62719-438 
Intrepid WSP
MUP
                                      80
Apples, Crabapples, Loquat. Mayhaw, Pears including Oriental, Quince, Cotton
0.05 to 0.4 lb ai/A
Ground, aerial
                      Allow 14 days between applications
62719-442
Intrepid 2F

                                     22.6
Bushberries (Subgroup 13 07B); Cilantro Leaves, Brassica (Cole) Leafy Vegetables (Crop Group 5), Leafy Vegetables (Crop Group 4), Leaves of Root and Tuber Vegetables (Crop Group
2),Turnip Greens, Citrus Fruits (Crop Group 10-10), Corn (Field, Sweet, Seed), Cotton, Cranberry, Cucurbit Vegetables (Crop Group 9), Fruiting Vegetables (Crop Group 8), Okra, Globe artichoke, Grape, Grass Forage Fodder, and Hay (Crop Group 17), Green Onion (Subgroup 3-07B), Legume Vegetables (Succulent or Dried) (Crop Group 6), Foliage of Legume
Vegetables (Except Soybean) (Subgroup 7A), Nongrass Forage, Fodder, Straw and Hay (Crop Group 18), Ornamentals, Peanut, Pome Fruits (Crop Group 11), Pomegranate, Popcorn, Root Vegetables (Subgroups 1A, 1B), Soybean, Spearmint, Peppermint, Stone Fruits (Crop Group 12), Strawberry, Tree Nuts (Crop Group 14) and Pistachios, Tropical Tree Fruits, and Tuberous and Corm Vegetables (Except Potato) (Subgroup 1D) 
aerial, chemigation and ground equipment (airblast), ground boom, hand held equipment (backpack sprayer, manually-pressurized handwand and hand gun), and hose-end sprayer
Up to 0.38 lb ai/A for single application to tree nuts, and 0.25 lb ai/A for all other crops; 1.0 lb ai/A/seasonal maximum
                                       
 Various Pre-harvest intervals (PHIs) are allowed, ranging from 1 to 30 days. 
                                       
There are no rotational restrictions for crops on the label; all others have a 7-day plant-back restriction.
Abbreviations used:  AI = active ingredient, WSP = water soluble package, MUP = Manufacturing Use Product, F = Flowable Concentrate.
 

Table 3. 2.  Special Local Need (SLN) Registrations for Methoxyfenozide Insecticide.
                                  SLN No. and
                                Parent Reg. No.
                                % AI of Parent
                                   Use Site
                               Single Appl. Rate
                                  and Method
                                   Comments
MS060014, 62719-442
                                    22.6 F
Sweet potatoes
0.16 lb ai/A; ground/aerial
                                       
NC060003, 62719-442
                                       


                                       
CA060026, 62719-442
                                       


                                       
CA060013, 62719-442
                                    22.6 F
Alfalfa for seed productions
0.25 lb ai/A; ground; aerial
              Maximum of 1lb ai/A/season; maximum of 60,000 Acres
CA070015, 62719-442
                                     22.6F
Citrus (non-bearing)
0.18 lb ai/A; ground/aerial
      Maximum of 4 applications per year to avoid resistance development
FL100001, 62719-442
                                     22.6F
Citrus crop group 10
0.25 lb ai/A; ground
                          Maximum of 1 lb ai/A/season
WY120005, 62719-442
                                     22.6F
Beans, dried type; sugar beet
0.25 lb ai/A; aerial
                         Low volume spray concentrate
CO120002, 62719-442
                                    22.6.F
Beans, dried type;
sugar beet
0.25 lb ai/A; aerial
                         Low volume spray concentrate


Northwest Horticultural Council

The Northwest Horticultural Council (NHC) comments addressed several registration review cases, including methoxyfenozide.  The NHC represents the growers and shippers of deciduous tree fruit (apples, pears and cherries) from 3 states, Washington, Oregon and Idaho.  The comments included details regarding the use of methoxyfenozide on the 3 critical crops, and cited the need for continued use of the chemical in pest management for these crops.  In addition to the region-specific usage information provided, the NHC noted that differences in established maximum residue limits (MRLs) in certain countries, when compared with the US tolerances, creates trade irritants, and can negatively affect the ability of US growers to export their produce.  Specifically, the NHC notes the absence of MRLs for residues in pear and cherry in countries such as Saudi Arabia, Indonesia, Russia, China, Canada and Brazil, and the absence of an MRL for residues in apples in Saudi Arabia, Russia and Indonesia.  These countries constitute important export markets for US growers.  Finally, the NHC notes that the MRL of 0.2 ppm for methoxyfenozide residues in apples in Brazil is significantly lower than the US tolerance of 1.5 ppm.  Likewise, trade irritants are created by the EU/UK MRLs of 0.3 in pear (US tolerance of 1.5 ppm) and 0.02 ppm in cherry (US tolerance of 3 ppm).

HED Response:
During registration review, HED will work to minimize trade irritants and harmonize US tolerances with MRLs from important export markets, to the extent feasible.  The Agency works with the Foreign Agricultural Service and the United States Trade Representative to minimize trade irritants.  EPA is currently working with some of the countries identified by Northwest Horticultural Council to assist with the development of science-based MRLs.

In the specific case of methoxyfenozide, HED is working actively to address harmonization issues, both in conjunction with new use actions as well as during registration review.  For example, HED has recently recommended an increase in the pome fruit tolerance from 1.5 ppm to 2.0 ppm in order to harmonize with the Codex MRL of 2 ppm.  In some cases HED may not be able to harmonize with Codex or other countries due to differences in the use pattern and associated residues.  The concerns of the NHC will be considered in HED's ongoing harmonization efforts for methoxyfenozide.





