Spinetoram; Pesticide Tolerance

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes a tolerance for the combined residues of the insecticide spinetoram, in or on acerola; almond, hulls; amaranth grain, grain; apple, wet pomace; artichoke, globe; asparagus; atemoya; avocado; banana; beet, sugar, molasses; biriba; brassica, head and stem, subgroup 5A; brassica, leafy greens, subgroup 5B; bushberry, subgroup 13B; caneberry, subgroup 13A; canistel; cattle, fat; cattle, liver; cattle, meat; cattle, meat byproducts (except liver); cherimoya; citrus, dried pulp; citrus, oil; corn, sweet, kernel plus cob with husks removed; cotton, gin byproducts; cotton, undelinted seed; cranberry; custard apple; egg; feijoa; fig; fruit, citrus, group 10; fruit, pome, group 11; fruit, stone, group 12; goat, fat; goat, liver; goat, meat; goat, meat byproducts (except liver); grain, aspirated fractions; grain, cereal, group 15, except rice, sorghum, pearl millet and proso millet; grain, cereal, group 16, forage; grain, cereal, group 16, hay; grain, cereal, group 16, stover; grain, cereal, straw, group 16, except rice; grape; grape, raisin; guava; herb, dried, subgroup 19A; herb, fresh, subgroup 19A; hog, fat; hog, meat; hog, meat byproducts; horse, fat; horse, liver; horse, meat; horse, meat byproducts (except liver); llama; jaboticaba; juneberry; lingonberry; longan; lychee; mango; milk; milk, fat; millet, pearl, grain; millet, proso, grain; nut, tree, group 14; okra; onion, green; papaya; passionfruit; pea and bean, dried shelled, except soybean, subgroup 6C; pea and bean, succulent shelled, subgroup 6B; peanut; peanut, hay; peppermint, tops; pistachio; poultry, fat; poultry, meat; poultry, meat byproducts; pulasan; rambutan; salal; sapodilla; sapote, black; sapote, mamey; sapote, white; sheep, fat; sheep, liver; sheep, meat; sheep, meat byproducts (except liver); sorghum, grain, grain; soursop; soybean, seed; spanish lime; spearmint, tops; star apple; star fruit; strawberry; sugar apple; ti, leaves; vegetable, bulb, group 3, except green onion; vegetable, cucurbit, group 9; vegetable, foliage of legume, group 7; vegetable, fruiting, group 8; vegetable, leafy, except brassica, group 4; vegetable, leaves of root and tuber, group 2; vegetable, legume, edible podded, subgroup 6A; vegetable, root and tuber, group 1; watercress; and wax jambu. Dow AgroSciences, LLC requested this tolerance under the Federal Food, Drug and Cosmetic Act (FFDCA).

DATES:

This regulation is effective October 10, 2007. Objections and requests for hearings must be received on or before December 10, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2007-0876. To access the electronic docket, go to http://www.regulations.gov , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov , or, if only available in hard copy, at the OPP Regulatory Public Docket in Room S-4400, One Potomac Yard (South Bldg.), 2777 South Crystal Dr., Arlington, VA 22202-3503. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT:

Bonaventure Akinlosotu, Registration Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001; telephone number: (703) 605-0653; e-mail address: akinlosotu.bonaventure@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery and floriculture workers; farmers.
• Animal production (NAICS code 112), e.g., cattle ranchers and farmers; dairy cattle farmers; livestock farmers.
• Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery and floriculture workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery and floriculture workers; residential users.

This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr . You may also access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at http://www.gpoaccess.gov/ecfr .

C. Can I File an Objection or Hearing Request?

Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-0876 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before December 10, 2007.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2007-0876, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov . Follow the on-line instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001.
• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Room S-4400, One Potomac Yard (South Bldg.), 2777 South Crystal Dr., Arlington, VA 22202-4503. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

In the Federal Register of August 22, 2007 (72 FR 47008) (FRL-8154-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5F7006) by Dow AgroSciences, LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1053. The petition requested the establishment of a tolerance for the combined residues of the insecticide XDE-175, expressed as a combination of XDE-175-J: 1-H-as-Indaceno[3,2-d] oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro1 14-methyl-, (2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR) and XDE-175-L: 1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-, (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS), in or on acerola at 1.5 parts per million (ppm); almond, hulls at 2 ppm; amaranth grain, grain at 1 ppm; apple pomace at 0.5 ppm; artichoke, globe at 0.3 ppm; asparagus at 0.2 ppm; atemoya at 0.3 ppm; avocado at 0.3 ppm; banana at 0.25 ppm; barley, hay and straw at 5 ppm; beet, sugar, molasses at 0.75 ppm; biriba at 0.3 ppm; brassica, head and stem, subgroup 5A at 2 ppm; bushberry, subgroup 13B at 0.25 ppm; caneberry, subgroup 13A at 0.7 ppm; canistel at 0.3 ppm; cattle, fat at 2 ppm; cattle, meat byproducts at 1 ppm; cattle, meat at 0.1 ppm; cherimoya at 0.3 ppm; citrus, dried pulp at 0.5 ppm; citrus, oil at 3 ppm; coriander, leaves at 8 ppm; corn, forage at 1.5 ppm; corn, hay at 1 ppm; corn, stover at 5 ppm; corn, straw at 1 ppm; corn, sweet, forage at 1.5 ppm; corn, sweet, kernel plus cob with husks removed at 0.02 ppm; corn, sweet, stover at 5 ppm; cotton, gin byproducts at 1.5 ppm; cotton, undelinted seed at 0.02 ppm; cranberry at 0.01 ppm; custard apple at 0.3 ppm; egg at 0.02 ppm; feijoa at 0.05 ppm; fig at 0.1 ppm; fruit, citrus, group 10 at 0.3 ppm; fruit, pome, group 11 at 0.3 ppm; fruit, stone, group 12 at 0.2 ppm; goat, fat at 2 ppm; goat, meat byproducts at 1 ppm; goat, meat at 0.1 ppm; grain, aspirated fractions at 5 ppm; grain, cereal, group 15 (except rice) at 0.02 ppm; grape at 0.5 ppm; grape, raisin at 0.7 ppm; guava at 0.3 ppm; herb, dried, subgroup at 22 ppm; herb, fresh, subgroup at 3 ppm; hog, fat at 1 ppm; hog, meat byproducts at 0.5 ppm; hog, meat at 0.1 ppm; horse, fat at 2 ppm; horse, meat byproducts at 1 ppm; horse, meat at 0.1 ppm; ilama at 0.3 ppm; jaboticaba at 0.3 ppm; juneberry at 0.25 ppm; leafy vegetables (except brassica vegetables group) at 8 ppm; legume vegetables, dried shelled pea and bean (crop subgroup 6C) at 0.02 ppm; legume vegetables, edible podded (crop subgroup 6A) at 0.3 ppm; legume vegetables, succulent shelled pea and bean (crop subgroup 6B) at 0.02 ppm; lingonberry at 0.25 ppm; longan at 0.3 ppm; lychee at 0.3 ppm; mango at 0.3 ppm; milk at 0.5 ppm; milk, fat at 1 ppm; millet, forage at 1.5 ppm; millet, hay and straw at 5 ppm; nut, tree, group 14 at 0.02 ppm; oat, forage at 1.5 ppm; oat, hay and straw at 5 ppm; okra at 0.4 ppm; onion, dry bulb at 0.1 ppm; onion, green at 2 ppm; papaya at 0.3 ppm; passionfruit at 0.3 ppm; peanut at 0.02 ppm; peanut, hay at 11 ppm; peppermint, tops at 3.5 ppm; pistachio at 0.02 ppm; plantain at 0.25 ppm; poultry, fat at 0.1 ppm; poultry, meat byproducts at 0.02 ppm; poultry, meat at 0.02 ppm; pulasan at 0.3 ppm; rambutan at 0.3 ppm; rye, forage at 1.5 ppm; rye, straw at 5 ppm; salal at 0.25 ppm; sapodilla at 0.3 ppm; sapote, black at 0.3 ppm; sapote, mamey at 0.3 ppm; sapote, white at 0.3 ppm; sheep, fat at 2 ppm; sheep, meat byproducts at 1 ppm; sheep, meat at 0.1 ppm; sorghum, forage at 1.5 ppm; sorghum, hay at 5 ppm; sorghum, stover at 5 ppm; soursop at 0.3 ppm; soybean at 0.02 ppm; spanish lime at 0.3 ppm; spearmint, tops at 3.5 ppm; star apple at 0.3 ppm; star fruit at 0.3 ppm; strawberry at 1 ppm; sugar apple at 0.3 ppm; teosinte, forage at 1.5 ppm; ti, leaves at 10 ppm; triticale, forage at 1.5 ppm; triticale, hay at 5 ppm; vegetable, brassica, leafy, group 5 at 10 ppm; vegetable, bulb, group 3 (except green onion) at 0.1 ppm; vegetable, cucurbit (cucumber, melon, squashes), group 9 at 0.3 ppm; vegetable, foliage of legume, group 7 at 8 ppm; vegetable, fruiting, group 8 at 0.4 ppm; vegetable, leaves of root and tuber, group 2 at 10 ppm; vegetable, root and tuber, group 1 at 0.1 ppm; watercress at 8 ppm; wax jambu at 0.3 ppm; wheat, forage at 1.5 ppm; and wheat, hay and straw at 5 ppm. That notice referenced a summary of the petition prepared by Dow AgroSciences, LLC, the registrant, which is available to the public in the docket, http://www.regulations.gov . There were no comments received in response to the notice of filing.

Based upon EPA’s review of the residue chemistry data submitted in support of the petition, the Agency has revised commodity definitions and/or some of the proposed tolerances and concludes that the establishment of the following tolerance is appropriate for the insecticide spinetoram as follows: Acerola at 0.30 ppm; almond, hulls at 2.0 ppm; amaranth grain, grain at 1.0 ppm; apple, wet pomace at 0.50 ppm; artichoke, globe at 0.30 ppm; asparagus at 0.04 ppm; atemoya at 0.30 ppm; avocado at 0.30 ppm; banana at 0.25 ppm; beet, sugar, molasses at 0.75 ppm; biriba at 0.30 ppm; brassica, head and stem, subgroup 5A at 2.0 ppm; brassica, leafy greens, subgroup 5B at 10 ppm; bushberry, subgroup 13B at 0.25 ppm; caneberry, subgroup 13A at 0.70 ppm; canistel at 0.30 ppm; cattle, fat at 5.5 ppm; cattle, liver at 0.85 ppm; cattle, meat at 0.20 ppm; cattle, meat byproducts (except liver) at 0.60 ppm; cherimoya at 0.30 ppm; citrus, dried pulp at 0.50 ppm; citrus, oil at 3.0 ppm; corn, sweet, kernel plus cob with husks removed at 0.04 ppm; cotton, gin byproducts at 1.5 ppm; cotton, undelinted seed at 0.04 ppm; cranberry at 0.04 ppm; custard apple at 0.30 ppm; egg at 0.04 ppm; feijoa at 0.30 ppm; fig at 0.10 ppm; fruit, citrus, group 10 at 0.30 ppm; fruit, pome, group 11 at 0.20 ppm; fruit, stone, group 12 at 0.20 ppm; goat, fat at 5.5 ppm; goat, liver at 0.85 ppm; goat, meat at 0.20 ppm; goat, meat byproducts (except liver) at 0.60 ppm; grain, aspirated fractions at 20 ppm; grain, cereal, group 15, except rice, sorghum, pearl millet and proso millet at 0.04 ppm; grain, cereal, group 16, forage at 3.5 ppm; grain, cereal, group 16, hay at 10 ppm; grain, cereal, group 16, stover at 10 ppm; grain, cereal, straw, group 16, except rice at 1.0 ppm; grape at 0.50 ppm; grape, raisin at 0.70 ppm; guava at 0.30 ppm; herb, dried, subgroup 19A at 22 ppm; herb, fresh, subgroup 19A at 3.0 ppm; hog, fat at 0.40 ppm; hog, meat at 0.04 ppm; hog, meat byproducts at 0.04 ppm; horse, fat at 5.5 ppm; horse, liver at 0.85 ppm; horse, meat at 0.20 ppm; horse, meat byproducts (except liver) at 0.60 ppm; llama at 0.30 ppm; jaboticaba at 0.30 ppm; juneberry at 0.25 ppm; lingonberry at 0.25 ppm; longan at 0.30 ppm; lychee at 0.30 ppm; mango at 0.30 ppm; milk at 0.30 ppm; milk, fat at 7.5 ppm; millet, pearl, grain at 1.0 ppm; millet, proso, grain at 1.0 ppm; nut, tree, group 14 at 0.04 ppm; okra at 0.40 ppm; onion, green at 2.0 ppm; papaya at 0.30 ppm; passionfruit at 0.30 ppm; pea and bean, dried shelled, except soybean, subgroup 6C at 0.04 ppm; pea and bean, succulent shelled, subgroup 6B at 0.04 ppm; peanut at 0.04 ppm; peanut, hay at 11 ppm; peppermint, tops at 3.5 ppm; pistachio at 0.04 ppm; poultry, fat at 0.10 ppm; poultry, meat at 0.04 ppm; poultry, meat byproducts at 0.04 ppm; pulasan at 0.30 ppm; rambutan at 0.30 ppm; salal at 0.25 ppm; sapodilla at 0.30 ppm; sapote, black at 0.30 ppm; sapote, mamey at 0.30 ppm; sapote, white at 0.30 ppm; sheep, fat at 5.5 ppm; sheep, liver at 0.85 ppm; sheep, meat at 0.20 ppm; sheep, meat byproducts (except liver) at 0.60 ppm; sorghum, grain, grain at 1.0 ppm; soursop at 0.30 ppm; soybean, seed at 0.04 ppm; spanish lime at 0.30 ppm; spearmint, tops at 3.5 ppm; star apple at 0.30 ppm; star fruit at 0.30 ppm; strawberry at 1.0 ppm; sugar apple at 0.30 ppm; ti, leaves at 10 ppm; vegetable, bulb, group 3, except green onion at 0.10 ppm; vegetable, cucurbit, group 9 at 0.30 ppm; vegetable, foliage of legume, group 7 at 8.0 ppm; vegetable, fruiting, group 8 at 0.40 ppm; vegetable, leafy, except brassica, group 4 at 8.0 ppm; vegetable, leaves of root and tuber, group 2 at 10 ppm; vegetable, legume, edible podded, subgroup 6A at 0.30 ppm; vegetable, root and tuber, group 1 at 0.10 ppm; watercress at 8.0 ppm; and wax jambu at 0.30 ppm.

III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” These provisions were added to FFDCA by the Food Quality Protection Act (FQPA) of 1996.

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for the combined residues of the insecticide spinetoram. EPA’s assessment of exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its validity, completeness and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The toxicity database is incomplete for spinetoram; however, the database for spinetoram taken together with a similar spinosyn insecticide, spinosad, is adequate for risk assessment evaluations and determination of FQPA. All studies evaluated on spinetoram were deemed acceptable and met guideline criteria.

More detailed information on the studies received and the nature of the adverse effects caused by spinetoram as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found in the document entitled, “Spinetoram: Human Health Risk Assessment for Numerous Proposed Application Scenarios,” dated September 20, 2007, by going to http://www.regulations.gov . The referenced document is available in the docket established by this action, which is described under ADDRESSES, and is identified as EPA-HQ-OPP-2007-0876-0003 in that docket. Locate and click on the hyperlink for docket ID number EPA-HQ-OPP-2007-0876. Double-click on the document to view the referenced information on pages 53-59 of 97.

B. Toxicological Endpoints

For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. Short-term, intermediate-term and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded.

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .

A summary of the toxicological endpoints for spinetoram used for human risk assessment can be found in the document entitled, “Spinetoram: Human Health Risk Assessment for Numerous Proposed Application Scenarios,” dated September 20, 2007, by going to http://www.regulations.gov . The referenced document is available in the docket established by this action, which is described under ADDRESSES, and is identified as EPA-HQ-OPP-2007-0876-0003 in that docket. Locate and click on the hyperlink for docket ID number EPA-HQ-OPP-2007-0876. Double-click on the document to view the referenced information on pages 29-30 of 97.

Briefly, EPA has concluded that spinetoram is toxicologically identical to another pesticide, spinosad. As a result, EPA picked the lowest of the spinosad and spinetoram endpoints for each exposure scenario.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to spinetoram, EPA considered exposure under the petitioned-for tolerances for spinetoram. Spinosad and spinetoram are toxicologically equivalent and this fact was taken into account in assessing aggregate exposure.

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for spinosad and spinetoram; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. As previously stated, spinosad and spinetoram are toxicologically equivalent; however, EPA has concluded it would overstate exposure to assume that residues of both spinosad and spinetoram would appear on the same food because both products control the same pest species, and thus it is unlikely that spinosad and spinetoram will be applied to the same crop. Rather, EPA aggregated exposure by either assuming that all commodities contain spinosad (because side-by-side spinosad and spinetoram residue data indicated that spinetoram residues were less than or equal to spinosad residues) or summing the percentage of a crop that would be treated with spinosad and the percentage that would be treated with spinetoram. The approach of assuming 100 percent crop treated (PCT) was used for all food commodities and the approach of summing the percent of commodities projected to be treated with spinosad and spinetoram for feed commodities.

The chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model - Food Consumption Intake Database, Version 2.03 (DEEM^TM-FCID) which incorporates the United States Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). In addition to the PCT assumptions described above, EPA, in estimating chronic exposure, relied upon average field-trial residues for apple, leafy vegetables (except Brassica), citrus and fruiting vegetables; tolerance-level residues for the remaining food crop commodities; average feed crop residues for feed commodities from the following crops - sweet corn forage, leaves of root and tuber vegetables and aspirated grain fractions; average residues from animal feeding and dermal magnitude of residue studies; DEEM^TM (Version 7.81) default processing factors for all commodities excluding field corn (meal, starch, flour and oil), grape juice and wheat (flour and germ), where the results from the processing studies were assumed and modeled drinking water estimates.

iii. Cancer. Spinetoram is considered to be “Not likely to be Carcinogenic to Humans” based on its similarity to another spynosin pesticide, spinosad. Preliminary results of a carcinogenicity study in mice indicate that spinetoram is not carcinogenic to mice at doses up to 37.5 milligram/kilogram/day (mg/kg/day). As a result, cancer exposure assessment is not required for spinetoram.

iv. Anticipated residue and PCT information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must pursuant to FFDCA section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of this tolerance.

For the chronic dietary exposure assessment, EPA assumed: 100 PCT for all food crop commodities along with summing the percent of commodities projected to be treated with spinosad and spinetoram for feed commodities; average field-trial residues for apple, leafy vegetables (except Brassica), citrus and fruiting vegetables; tolerance-level residues for the remaining food crop commodities; average feed crop residues for feed commodities from the following crops: Sweet corn forage, leaves of root and tuber vegetables and aspirated grain fractions; average residues from animal feeding and dermal magnitude of residue studies; DEEM^TM (Version 7.81) default processing factors for all commodities excluding field corn (meal, starch, flour and oil), grape juice and wheat (flour and germ), where the results from the processing studies were assumed and modeled drinking water estimates.

EPA estimates an upper bound of projected percent crop treated (PPCT) for a new pesticide use by assuming that its actual PCT during the initial 5 years of use on a specific use site will not exceed the recent PCT of the market leader (i.e., the one with the greatest PCT) on that site. EPA calls this the market leader PPCT estimate. In this specific case, the new use to be estimated is the combined use of spinosad together with that of spinetoram since most new use of spinetoram will likely replace previous use of spinosad. An average market leader PCT, based on 3 recent surveys of pesticide usage, if available, is used for chronic risk assessment. The average market leader PCT may be based on 1 or 2 survey years if 3 are not available. Also, with limited availability of data, the average market leader PCT may be based on a cross-section of state PCTs. Comparisons are only made among pesticides of the same pesticide type (i.e., the leading insecticide on the use site is selected for comparison with the new insecticide), or, refined estimates, among pesticides targeting the same pests. The market leader PCTs used to determine the average may be each for the same pesticide or for different pesticides for any year since the same or different pesticides may dominate for each year. Typically, EPA uses USDA/National Agricultural Statistics Service (NASS) as the source for raw PCT data because it is publicly available. When a specific use site is not surveyed by USDA/NASS, EPA uses other sources including proprietary data.

An estimated PPCT, based on the average PCT of the market leaders, is appropriate for use in chronic dietary risk assessment. This method of estimating PPCT for a new use of a registered pesticide or a new pesticide produces a high-end estimate that is unlikely, in most cases, to be exceeded during the initial 5 years of actual use. Predominant factors that bear on whether the PPCT could be exceeded may include PCTs of similar chemistries, pests controlled by alternatives, pest prevalence in the market and other factors. All relevant information currently available for predominant factors has been considered for the combined use of spinetoram and spinosad on each of these several crops. It is the Agency’s opinion that it is unlikely that actual combined PCTs for spinetoram and spinosad will exceed the corresponding estimated PPCTs during the next five years.

The PPCTs for the combined use of spinosad and spinetoram for chronic risk assessment were determined using the market leader approach for the feed commodities of sweet corn, grain sorghum, soybeans and turnip greens. For turnip greens, the PCTs of market leaders were averaged over states rather than years because only 1-year of data was available.

The Agency believes that the 3 conditions listed in this Unit have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA’s computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA’s risk assessment process ensures that EPA’s exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which spinetoram may be applied in a particular area.

2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for spinetoram in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of spinetoram. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm .

Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated environmental concentrations (EECs) of spinetoram for acute exposures are estimated to be 14.419 parts per billion (ppb) for surface water and 0.072 ppb for ground water. The EECs for chronic exposures are estimated to be 6.171 ppb for surface water and 0.072 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 14.419 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 6.171 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides and flea and tick control on pets).

The Agency has concluded that spinosad and spinetoram are toxicologically equivalent; therefore, residential exposure to both spinosad and spinetoram was evaluated. Spinosad is currently registered for the following residential non-dietary sites: Homeowner application to turf grass and ornamentals to control a variety of worms, moths, flies, beetles, midges, thrips, leafminers and fire ants (granular formulation). Spinetoram is proposed for homeowner applications to gardens, lawns/ornamentals and turf grass for control of lepidopterous larvae (worms or caterpillars), dipterous leafminers, thrips, sawfly larvae, certain psyllids and leaf-feeding beetles and red imported fire ants.

There is potential for residential handler and post-application exposures to both spinosad and spinetoram. Since spinosad and spinetoram control the same pests, EPA concludes that these products will not be used in combination with each other and combining the residential exposures is unnecessary. Short-term residential inhalation risks were estimated for adult residential handlers, as well as short-term post-application incidental oral risks for toddlers, based on applications to home lawns, home gardens and ornamentals.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide’s residues and “other substances that have a common mechanism of toxicity.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to spinetoram and any other substances and spinetoram does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action; therefore, EPA has not assumed that spinetoram has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at http://www.epa.gov/pesticides/cumulative .

D. Safety Factor for Infants and Children

1. In general. Section 408 of FFDCA provides that EPA shall apply an additional (“10x”) ten-fold margin of safety for infants and children in the case of threshold effects to account for pre- and/or post-natal toxicity and the completeness of the database on toxicity and exposure unless EPA determines, based on reliable data, that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10x when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate.

2. Pre-natal and post-natal sensitivity. There is no evidence of increased susceptibility of rat and rabbit fetuses to in utero exposure to spinetoram. In the developmental toxicity study in rats, no developmental effects were observed at dose levels that induced maternal toxicity. In the developmental study in rabbits, no developmental toxicity was seen at dose levels that induced maternal toxicity. In the 2-generation reproduction study, no offspring toxicity occurred. Parental/systemic toxicity was observed at a lower dose than the dose at which offspring showed no effects.

3. Conclusion. EPA has determined that reliable data show that it would be safe for infants and children to reduce the 10x FQPA safety factor to 1x. That decision is based on the following findings:

i. The toxicity database for spinetoram is adequate for this risk assessment despite the lack of a chronic toxicity study in rats. The preliminary review of a mouse carcinogenicity study provides evidence that the chronic toxicity of spinosad and spinetoram is comparable since spinetoram chronic toxicity produced similar toxicity at the similar doses as seen previously with spinosad. Therefore, it is expected that the ongoing spinetoram chronic carcinogenicity study in rats would produce similar chronic toxicity at a similar dose as was seen in the chronic toxicity study in rats with spinosad.

ii. There is no indication that spinetoram is a neurotoxic chemical and there is no need for a DNT study or additional UFs to account for neurotoxicity.

iii. There is no evidence that spinetoram results in increased susceptibility in in utero rats or rabbits in the pre-natal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases.

E. Aggregate Risks and Determination of Safety

Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate-term and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, no acute risks were identified in the toxicological studies for spinosad and spinetoram; therefore, a quantitative acute dietary exposure assessment is not required for spinetoram.

2. Chronic risk. Since there are no registered/proposed uses which result in chronic residential exposures, the chronic aggregate exposure assessment is concerned only with exposure from food and water. Using the exposure assumptions described in this unit for chronic dietary exposure, EPA has concluded that exposure to spinosad and spinetoram from food and water will utilize ≤72% of the cPAD for the population group children 1-2 years old, the most highly exposed population.

3. Short-term risk. Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Spinetoram is currently registered for uses that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for spinetoram.

Short-term incidental oral exposures to toddlers are anticipated from the registered turf and ornamental application scenarios for spinosad and spinetoram and short-term inhalation exposure to handler/applicators is anticipated for the proposed home garden, turf and ornamental application scenarios for spinetoram; however, no handler/applicator exposure to spinosad is anticipated. Since spinosad and spinetoram control the same pests, EPA concludes that these products will not be used in combination with each other and incidental oral exposure from spinosad and spinetoram do not need to be added together. For aggregate short-term assessment, EPA selected the incidental oral exposure resulting from application of spinosad as this was higher than the incidental exposure resulting from application of spinetoram.

The incidental oral or inhalation exposures were combined with chronic dietary (food and water) exposure for determination of aggregate short-term exposure. EPA uses chronic dietary exposure when conducting short-term aggregate assessments as it has been determined that this will more accurately reflect exposure from food over the Agency’s defined short-term interval (1-30 days) than will acute exposure. Since the short-term inhalation and incidental oral endpoints are based on the same study and since the level of concern for incidental oral and inhalation assessments are both 100, chronic dietary exposure may be added to short-term inhalation or short-term incidental oral exposure and this total exposure can then be compared to the selected endpoints for aggregate risk assessment. The aggregate MOEs are ≥190; therefore, short-term aggregate exposure to spinosad and spinetoram are not of concern to EPA.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Though residential exposure could occur, no toxicological effects have been identified for intermediate-term toxicity. Therefore, the aggregate risk is the sum of the risk from food and water.

5. Aggregate cancer risk for U.S. population. The Agency considers spinetoram to be “Not likely to be Carcinogenic to Humans.” See Unit III.C.iii. for more detailed information.

6. Determination of safety. Based on the risk assessment, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to spinetoram residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

EPA review of the proposed enforcement method, without laboratory trial, indicates that the registrant’s methods for plant and animal commodities appear to meet the Agency’s residue chemical guidelines for acceptable tolerance enforcement methods. EPA recommends that a laboratory validation is not necessary for spinetoram based on the following reasons:

• The methods appear well-written and include detailed instructions.
• The methods appear quick and efficient.
• The recovery data are acceptable for all tested commodities; and
• The independent laboratory validation (ILV) data submitted are acceptable and indicate that method performance is acceptable. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Road, Fort Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

B. International Residue Limits

There are currently no established CODEX, Canadian or Mexican maximum residue limits (MRLs) for residues of spinetoram in/on various plant and livestock commodities. The Agency notes that spinetoram is being evaluated as part of a joint review with Health Canada’s Pest Management Regulatory Agency (PMRA) and the plant tolerances recommended in Unit V. are based on translation of spinosad residue data (i.e., translation of the spinosad tolerances). The majority of the spinosad plant tolerances were established prior to the use of the tolerance spreadsheet calculator and the procedure used by EPA and PMRA to establish these tolerances were different; therefore, many of the plant tolerances are not harmonized with the Canadian MRLs although they are based on the same residue data. Since the EPA and PMRA spinetoram tolerances are based on the same residue data, trade issues are not expected to be an issue. EPA harmonized the livestock tolerances with the Canadian MRLs when possible (i.e., when the PMRA-recommended tolerance was greater than the EPA-recommended tolerance).

V. Conclusion

Therefore, the tolerance is established for the combined residues of the insecticide spinetoram, expressed as a combination of XDE-175-J: 1-H-as-Indaceno[3,2-d] oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro1 14-methyl-, (2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR) and XDE-175-L: 1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-, (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS).

VI. Statutory and Executive Order Reviews

This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.

This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, this rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

VII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Pesticides and pests
• Reporting and recordkeeping requirements

Therefore, 40 CFR chapter I is amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

2. Section 180.635 is added to read as follows:

(a) General. Tolerances are established for the combined residues of the insecticide spinetoram, expressed as a combination of XDE-175-J: 1-H-as-Indaceno[3,2-d] oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro1 14-methyl-, (2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR) and XDE-175-L: 1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-, (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS), in or on the following raw agricultural commodities:

(b) Section 18 emergency exemptions. [Reserved]

(c) Tolerances with regional registration. [Reserved]

(d) Indirect and invertent residues. [Reserved]