Spirotetramat; Pesticide Tolerances

Jul 09, 2008 (Environmental Protection Agency Documents and Publications/ContentWorks via COMTEX) -- BYILF | Quote | Chart | News | PowerRating -- SUMMARY: This regulation establishes tolerances for combined residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI08330-enol-, and BYI 08330-mono-hydroxy, calculated as spirotetramat equivalents, in or on vegetable, tuberous and corm, subgroup 1C; potato, flakes; onion, bulb, subgroup 3A-07; vegetable, leafy, except brassica, group 4; brassica, head and stem, subgroup 5A; brassica, leafy greens, subgroup 5B; vegetable, fruiting, group 8; vegetable, cucurbit, group 9; fruit, citrus, group 10; citrus, oil; fruit, pome, group 11; fruit, stone, group 12; nut, tree, group 14; almond, hulls; small fruit vine climbing subgroup, except fuzzy kiwifruit, subgroup 13-07F; grape; raisin; strawberry; hop, dried cones; and for the combined residues of spirotetramat and its metabolite BYI 08330-enol, calculated as spirotetramat equivalents, in or on milk; and meat, fat, and meat byproducts of cattle, goat; sheep, and horse. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 9, 2008. Objections and requests for hearings must be received on or before September 8, 2008, 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-2007-0475. 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 Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. 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:

Rita Kumar, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8291; e-mail address: kumar.rita@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).

* Animal production (NAICS code 112).

* Food manufacturing (NAICS code 311).

* Pesticide manufacturing (NAICS code 32532).

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-2007-0475 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 September 8, 2008.

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-2007-0475, 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 Ave., NW., Washington, DC 20460-0001.

* Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. 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 July 15, 2007 (FR 40877) (FRL-8137-1), 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 6F7119) by Bayer CropScience LLC, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709 . The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide spirotetramat, (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-azaspiro [4.5] dec-3-en-4-yl-ethyl carbonate, and its metabolite cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro4.5dec-3-en-2-one, calculated as spirotetramat equivalents, in or on the raw agricultural commodities vegetable, tuberous and corm, subgroup 1C at 1.0 parts per million (ppm); potato, granules/flakes at 2.5 ppm; onions, dry bulb, subgroup 3A at 0.3 ppm; vegetables, leafy, except brassica, group 4 at 5.0 ppm brassica, head and stem, subgroup 5A at 3.0 ppm; brassica, leafy greens, subgroup 5B at 16.0 ppm; vegetables, fruiting, group 8 at 1.0 ppm; tomato, dried pomace at 2.5 ppm; vegetable, cucurbit, group 9 at 0.2 ppm; fruit, citrus, group 10 at 0.5 ppm; citrus, oil at 4.0 ppm; fruit, pome, group 11 at 0.5 ppm; fruit, stone, group 12 at 2.0 ppm; nut, tree, group 14 at 0.5 ppm; almond, hulls at 9.0 ppm; grape at 1.0 ppm; grape, raisin at 2.5 ppm; hop at 10.0 ppm; strawberry at 0.5 ppm; cattle, goat, hog, sheep and horse, meat at 0.01 ppm; cattle, goat, hog, sheep and horse, fat at 0.01 ppm; cattle, goat, hog, sheep and horse, liver at 0.01 ppm; cattle, goat, hog, sheep and horse, meat byproducts, except liver at 0.02 ppm. That notice referenced a summary of the petition prepared by Bayer CropScience, 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 review of the data supporting the petition, EPA has revised tolerance expression for vegetable, tuberous and corm, subgroup 1C; potato, granules/flakes; vegetables, leafy, except brassica, group 4; brassica, head and stem, subgroup 5A; brassica, leafy greens, subgroup 5B; vegetables, fruiting, group 8; tomato, dried pomace; vegetable, cucurbit, group 9; fruit, citrus, group 10; citrus, oil; fruit, pome, group 11; fruit, stone, group 12; nut, tree, group 14; small fruit vine climbing subgroup, except fuzzy kiwifruit, subgroup 13-07F; grape; raisin; strawberry; cattle, goat, hog, sheep and horse, meat; cattle, goat, hog, sheep and horse, fat; cattle, goat, hog, sheep and horse, liver; cattle, goat, hog, sheep and horse, meat byproducts, except liver. A tolerance for milk was also included. The reasons for these changes are explained in Unit IV.D.

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. . . ."

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, 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 combined residues of spirotetramat. EPA's assessment of exposures and risks associated with establishing tolerances follows.

--This is a summary of a Federal Register article originally published on the page number listed below--

Final rule.

CFR Part: "40 CFR Part 180"

Citation: "73 FR 39251"

Document Number: "EPA-HQ-OPP-2007-0475; FRL-8367-1"

Federal Register Page Number: "39251"

"Rules and Regulations"

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