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United States Environmental Protection Agency Ecological Risk Assessment for the Proposed New Chemical Registration of GS-U-ACTX-Hv1a-SEQ2 (Versutide™ peptide) on Vegetables and Cole Crops; Herbs, Spices, and Mints; Pasture and Hay Crops; Fruit, Nut, and Vine Crops; Field Crops; Commercial Flowers and Ornamental Plants; Forest, Shade Tree, and Nursery Stock; and Turf ASSOCIATED BARCODE: D411507 By Meghan Radtke, Ph.D., Biologist Peer Reviewers Faruque Khan, Ph.D., Senior Scientist Edward Odenkirchen, Ph.D., Senior Scientist Sujatha Sankula, Ph.D., Lead Biologist Acting Branch Chief Edward Odenkirchen, Ph.D. Date of Approval May 30, 2013 1 1. PROBLEM FORMULATION 1.1 Nature of the Registration Action This environmental risk assessment evaluates the potential ecological risks of the new broad spectrum insecticide, GS-U-ACTX-Hv1a-SEQ2 (Versutide™ peptide). The insecticide is proposed for use on a number of agricultural and home/garden uses; general categories include: vegetable and cole crops; herbs, spices, and mints; fruit, nut, and vine crops; field crops; commercial flowers and ornamental plants; forest, shade tree, and nursery stock; and turf. The insecticide is listed as being effective to control numerous insects including: alfalfa looper, army worm, Colorado potato beetle larvae, hornworms, spotted cucumber beetle, tobacco budworm, European corn borer, cankerworm, western tent caterpillar, cutworms, corn earworm, and gypsy moth. Two formulations (20% and 30% ai) are being registered. The proposed maximum single application rate is 0.8 lb ai/A with a maximum yearly application rate (assumed) of 0.8 lb ai/A. The products are foliar sprays that are applied via ground or aerial application equipment. 1.2 Nature of the Chemical Stressor GS-U-ACTX-Hv1a-SEQ2 is a peptide that is derived from the venom of a species of Australian funnel spider (Hadronyche versuta). Specifically, it is derived from the u-ACTX-HV1 peptide, which represents a small fraction of the funnel spider’s venom (< 0.5% by dry weight); there are only two amino acid differences between the u-ACTX-HV1 peptide and GS-U-ACTX-Hv1a- SEQ2. The protein structure consists of a solvent-accessible beta-hairpin protruding from a disulphide-bonded globular core comprising four beta-turns. The three intramolecular disulphide bonds form a cystine knot motif similar to that seen in several other neurotoxic peptides. The u- ACTX-HV1 peptide acts by inhibiting insect voltage-gated calcium channel currents (Fletcher et al. 1997) and by inhibiting the calcium activated potassium channels (Gunning et al., 2008). GS-U-ACTX-Hv1a-SEQ2 is mass produced via transgenic yeast. 1.3 Use Characterization GS-U-ACTX-Hv1a-SEQ2 is proposed for registration on a wide variety of uses. Vegetable and Cole Crops: artichoke, arugula, asparagus, beans, beets, bok choy, broccoli, broccoli raab, Brussels sprouts, cabbage, cardoni, carrots, cassava, cauliflower, cavalo, celeriac, celery, chayote root, chervil, chick peas, chicory, China greens, Chinese artichoke, Chinese broccoli, Chinese cabbage (napa), Chinese mustard cabbage, collards, corn salad, cress, cucumber, cucurbits, dandelion dock, dry bulb onions, edible burdock, edible chrysanthemum, edible gourds, eggplant, escarole, endive, garlic, ginger, ginseng, green onions, greens (beet, China, dandelion, mustard, turnip, rape), ground cherry, horseradish, Jerusalem artichoke, kale, kohlrabi, leeks, lentils, lettuce (head, leaf, romaine), lupine, malanga, melons, mizuna, mustard spinach, okra, olives, onions, parsley, parsnips, peas, pepino, peppers, potatoes, pumpkins, purslane, radicchio, radishes, rhubarb, rutabaga, salsify, shallots, skirret, soybean foliage, soybean, spinach, squash, sugar beets, sweet potatoes, swiss chard, tomatillo, tomatoes, turmeric, turnips, turnip-rooted chervil, turnip-rooted parsley, watercress, yams 2 Herbs, Spices, and Mints: angelica, balm, basil, borage, burnet, catnip, chamomile, chervil, chives, cilantro, clary, coriander, costmary, curry, dill, dill weed, fennel, horehound, hyssop, lavender, lemongrass, lovage, marjoram, mint, nasturtium, oregano, parsley, peppermint, rosemary, sage, savory, spearmint, sweet bay, tansy, tarragon, thyme, wintergreen, woodruff, wormwood Pasture and Hay Crops: alfalfa (hay and seed), hay and other forage crops, pasture (grasses and hay), silage Pome and Stone Fruit Trees: apples, apricots, crabapple, cherries, figs, loquat, mayhaw, nectarines, peaches, pears, plums, prunes, quince Nut Trees: almonds, cashew, chestnuts, filberts, macadamia nut, pecans, pistachios, walnuts Tree Fruits: acerola, atemoya, biriba, black sapote, canistel, cherimoya, custard apple, feijoa, guava, llama, jaboticaba, kiwi, longan, lychee, mamey sapote, mango, papaya, passion fruit, pulasan, rambutan, sapodilla, soursop, Spanish lime, star apple, starfruit, sugar apple, ti palm, wax jambu, white sapote Citrus: grapefruit, lemons, limes, organs, tangerines Small Fruit and Berries: blackberries, blueberries, boysenberries, cranberries, currants, elderberry, gooseberry, huckleberry, juneberry, ligonberry, loganberries, raspberries, salal, strawberries, grapes Tropical and Other Fruit: bananas, kiwi, persimmon, pomegranate, pineapple Tropical/Sub-Tropical Fruits: avocado, guava, lychee, sugar apple Field Crops: canola/rape seed, evening primrose, meadow foam, corn (field, sweet, popcorn, seed), cotton, hops, jojoba, peanuts, rice safflower Small Grains: barley, buckwheat, grain amaranth, millet, milo, oats, pearl, proso millet, rye, triticale, wheat, sorghum, soybeans, sunflower (oil and seed), tobacco, coffee Commercial Flowers and Ornamental Plants: bedding plants, flowers (greenhouse and field), greenhouse ornamentals, greenhouse vegetables, container stock Forest, Shade Tree, and Nursery Stock: deciduous, forest, shade trees, nursery trees, ornamental trees, conifers (including Christmas trees) Turf: turf and turf grown for seed According to the label, for all uses, a single application can range from 0.025 to 0.8 lb ai/A; the single maximum application rate is 0.8 lb ai/A. The target pests include: achema sphinx moth, alfalfa caterpillar, alfalfa looper, alfalfa webworm, amorbia, armyworm, artichoke plume moth, 3 asparagus beetle, avocado leaf roller, azalea caterpillar, azalea moth, bagworm, banana skipper, banana moth, banded sunflower moth, beet armyworm, bertha armyworm, blackheaded budworm, blackheaded fireworm, blueberry leaf roller, bollworm, browntail moth, cabbage budworm, cabbage looper, cabbage webworm, California oakworm, cankerworm, celery leaftier, cereal leaf beetle, cherry fruitworm, citrus cutworm, citrus peelminer, codling moth, Colorado potato beetle larvae, corn earworm, corn rootworm, cotton leaf perforator, cottonwood leaf beetle, cranberry fruitworm, cranberry girdler, cross-stripped cabbageworm, cutworms, diamondback moth, douglas fir tussock moth, eastern tent caterpillar, ello moth, elm spanworm, European corn borer, European grapevine moth, European skipper, fall webworm, filbert leaf roller, filbert webworm, fireworm, Florida fern caterpillar, fruit tree leaf roller, grape berry moth, grape leaffolder, grapeleaf skeletonizer, green cloverworm, green fruitworm, greenstriped mapleworm, gummosos-batrachedra commosae, gypsy moth, headworm, heliothis, hemlock looper, hickory shuckworm, hornworm, imported cabbageworm, jack pine budworm, leaf rollers, light brown apple moth, lo moth, looper, melonworm, mimosa webworm, navel orangeworm, oblique banded leaf roller, oleander moth, omniforous leaftier, omnivorous leaf roller, orange tortix, orangedog, oriental fruit moth, pandemic leaf roller, peach twig borer, pecan nut casebearer, pickleworm, pine butterfly, pine tip moths, plum curculio, podworm, red-neck peanut worm, redbanded leaf roller, redhumped caterpillar, rindworm complex, roughskinned cutworm, saddleback caterpillar, saddle prominent caterpillar, saltmarsh caterpillar, silverleaf whitefly nymphs, sod webworm, southwestern corn border, soybean looper, spanworm, sparganothis, spotted asparagus beetle, spotted cucumber beetle, spotted cutworm, spring and fall cankerworm, spruce budworm, striped cucumber beetle, sunflower moth, tent caterpillar, thecla- thecla basilides, tobacco budworm, tobacco hornworm, tomato fruitworm, tomato hornworm, tomato pinworm, tortix, tortix moth, tropical sod webworm, tufted apple budmoth, tussock moth, twig borer, variegated cutworm, variegated leaf roller, velvetbean caterpillar, viburnam beetle, walnut caterpillar, webworm, western bean cutworm, western corn cutworm, western raspberry fruitworm, western tent caterpillar, western tussock moth, yellow margined leaf beetle larvae, and yellowstriped armyworm. The label does not specify a yearly maximum application rate. Therefore, it is assumed that 0.8 lb ai/A is the maximum annual application rate for GS-U-ACTX-Hv1a-SEQ2. For single application rates below 0.8 lb ai/A, the application interval is 3 to 10 days. 1.5 Analysis Plan The screening-level risk assessment is used as the approach to determine risk to non-target organisms from the proposed new uses of GS-U-ACTX-Hv1a-SEQ2. Given that the toxicity data for this chemical are non-definitive and that limited fate data are provided, the assessment will qualitatively analyze the anticipated effects of GS-U-ACTX-Hv1a-SEQ2 on non-target organisms in the environment. The qualitative analysis is done by comparing the estimated environmental concentrations (EECs) with the toxicity value generated during testing. The environmental fate of proteins will also be explored. 2. ENVIRONMENTAL FATE CHARACTERIZATION
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