### Page 1 of 4 **UNITED STA**

**TES ENVIRONMENTA L PROTECTION A** **GENCY WA** **SHINGTON, D.C. 20460**
**OFFICE OF CHEMICAL**  **S AFETY**  **AND POLLUTION PREVENTION** 



### MEMORANDUM

**Date:** December 9 , 201 3 **SUBJECT: Methoxyfenozide**  **: Registration Review**

**– HED Review of Comments Received in** 

**Response to the Preliminary Work**  **P lan (PWP).**  **PC Code:** 121027 **DP Barcode:** D 415832 **Decision No.:** 4 84448 **Registration No. :**  N A **Petition No.:** NA **Regulatory Action:** Registration Review **Risk Assessment Type:** NA **Case No.:** 7 431 **T XR No.:**  NA **CAS No.:** 161050

- 58

- 4 **MRID No. :**  NA **40 CFR:** §180.544 **FROM:** Christina Swartz , Chemist

Risk Assessment Branch I I Health Effects Division (7509P) Office of Pesticide Programs **THR OUGH**  **:** 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 methoxy fenozide. **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 m ethox yfenozide ( C. Swartz, et al.; D408668, 5/10/13 ). The scoping document conclusions were incorporated into a PWP issued by the Pesticide Re

- evalu ation Division (PRD)

### Page 2 of 4

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 onl y to the endangered species aspects of the Agency’s review of m ethox yfenozide, whereas the WIPM response included usage information to be addressed by the Biological and Economic Analy sis 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 Effec ts 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 h ave 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 si ngle 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 originall y 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 (SL N) labeling, specificall y 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**  **Me thoxyfenozide**  **Insecticide .**  **Registered products &**  **Form ul. Types**  **% AI**  **Use Sites and Applicable ORE Reviews**  **Application equipment**  **Comments** 62719

- 437 Technical 9 8

. 2 NA NA 62719

- 438 Intrepid WSP MUP 80 A pples, Crabapples, Loquat. M ay h a w, 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 Bushberri es (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 aerial, chemigation and ground equipment (airblast), ground boom, hand held 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

### Page 3 of 4

**Table 3.**  **1 .**  **Methoxyfenozide Sec. 3**  **Product Formulations of**  **Me thoxyfenozide**  **Insecticide .**  **Registered products &**  **Form ul. Types**  **% AI**  **Use Sites and Applicable ORE Reviews**  **Application equipment**  **Comments** 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), Straw

berry , Tree Nuts (Crop Group 14) and Pistachios, Tropical Tree Fruits, and Tuberous and Corm Vegetables (Except Potato) (Subgroup 1D) equipment (backpack sprayer, manually

pressurized handwand and hand gun), and hose

- end sprayer ai/A/seasonal

max imum Various Pre

harvest intervals (PHIs) are allowed, ranging from 1 to 30 days. There are no rotational r estrictions for crops on the label; all others have a 7

- day plant

back restriction. Abbre viations used: AI = active ingredient, WSP = water soluble package , MUP = Manufacturing Use Product, F = Flowable Concentrate

.

**Table 3.**  **2 .**  **Special Local Need ( SLN**  **) Registrations**  **for Me**  **thoxyfenozide 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 Lo w volume spray concentrate

### Page 4 of 4

**Table 3.**  **2 .**  **Special Local Need ( SLN**  **) Registrations**  **for Me**  **thoxyfenozide Insecticide**  **.** CO120002, 62719

- 442 22.6.F Beans, dried type; sugar beet 0.25 lb ai/A ; aerial Lo w volume spray concentrate



### Northwest Horticultural Council The Northwest Horticultural Council (NHC) comments addressed several registration review cases, including methox yfenozide. The NH C represents the growers and shippers of deciduous tree fruit (apples, pears and cherries) from 3 states, Washington, Oregon and I daho. The comments included details regarding the use of methox yf enozide on the 3 critical crops, and cited the need f

or 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 (MRL s) 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. Specificall y, 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. Finall y, the NHC notes that the MRLof 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 MRL s 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 MRL s 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 currentl y 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 activel y to address harmonizati on 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 MRLof 2 ppm. In som e 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 methox yf enozide.