Biopesticide Decision Document
1. DESCRIPTION OF THE CHEMICAL(S) (BIOCHEMICALS)
2. FOOD CLEARANCES/TOLERANCES
40 CFR 180.1194 was amended to read as follows:
3. USE PROFILE
Citrus, corn (field, and sweet), fruit trees (apples, apricots, cherries, nectarines, peaches, plums, and prunes), nut trees (pecans, almonds), sugar beets, soybeans, vegetables (asparagus, beans, beets, cabbage, cauliflower, celery, collards, cucurbits, eggplant, lettuce, lima beans, kale, mustard greens, peas, potatoes, peppers, radishes, spinach, squash, and tomatoes), figs, melon, olives, and small fruits (grapes, strawberry, blueberry, raspberry, and cranberry).
Bedding plants, ornamental and shade trees, houseplants.
Adelgids, aphids, apple red bugs, asparagus beetles, beetle larvae, blister beetles, cabbage loopers, cabbage worms, cankerworms, caterpillars, Colorado potato beetles, diamondback moth larvae, earwigs, flea beetles, fruittree leafrollers, fungus gnats, grape phylloxera, gypsy moths, harlequin bugs, Japanese beetles, lace bugs, leaf beetle larvae, leafhoppers, leafminers, leafrollers, Lygus bugs, mealybugs, Mexican bean beetles, mites, pear psylla, plant bugs (mature and immature), psyllids, sawfly larvae, scales, spittlebugs, springtails, sowbugs, spotted cucumber beetle, stinkbugs, tent caterpillars, thrips, webworms, and whiteflies.
4. SCIENCE ASSESSMENT
The Agency has waived the generic data requirements for canola oil, except for certain technical chemistry information. Available literature indicated that this substance has low chronic toxicities. In addition, FDA has granted GRAS status to low erucic acid rapeseed oil for use as an edible fat or oil in human food. Canola oil is an edible substance that is readily metabolized by humans. There is adequate information available from literature sources to characterize the toxicity of canola oil. These studies indicate that canola oil's nutritional and toxicological profile is similar to those of other vegetable oils (50FR 3745, 3752) (Kramer et. al., 1983). Moreover, the available literature indicates that the use of this substance as a component of food is safe. Data available on soybean oil, discussed in Reregistration Eligibility Decision (RED): Flower and Vegetable Oils EPA 738-R-93-031 December, 1993 also support the low toxicity of canola oil. There are no incident reports on file for low erucic acid canola oil. Canola oil has a non-toxic mode of action for the target pests.
Acute toxicity data were submitted for NEU1161 which contains active ingredients: 89.5% Canola oil and 0.5% Pyrethrins. NEU1161 is classified as toxicity category IV for acute inhalation and primary eye toxicity. These data are adequate to support all three canola formulations: NEU1160 Vegetable Oil Spray, NEU1161, and NEU1161 RTU. It should be noted, however, that the NEU1160 and NEU1161 RTU products contain either no or substantially less pyrethrin, respectively, and are thus likely to have a lower acute toxicity than the NEU1161 product.
Although the Agency does not have toxicity test results for nontarget insects, fish, and other wildlife directly exposed to canola oil, numerous metabolic studies on the dietary effects and metabolism of canola in birds, mammals, and fish are reported in the literature. Ecological effects data for terrestrial and aquatic animals, and nontarget plants for canola were waived for the same reasons given above; principally, the low toxicity of the product, and its rapid degradation in the environment. In addition, these canola products are not to be directly applied to bodies of water; thus the exposure to aquatic animals should be limited to residues from drift.
5. SUMMARY OF DATA GAPS :
There are no major data gaps.
6. REGULATORY POSITION:
DISCLAIMER: The information in this Pesticide Fact Sheet is a summary only and is not to be used to satisfy data requirements for pesticide registration and reregistration. Contact the Regulatory Action Leader listed above for further information.
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updated December 2, 1999