Imidacloprid; Pesticide Tolerances

EPA issued a notice in the Federal Register of November 2, 1994 (59 FR 54907), which announced that Gustafson, Inc., P.O. Box 660065, Dallas, TX 75266-0065, had submitted a pesticide petition (PP 4F4337) to amend 40 CFR part 180 by establishing a regulation to permit residues of the insecticide 1-[6-chloro-3- pyridinyl) methyl]-N-nitro-2-imidazolidinimine in or on the raw agricultural commodities wheat, forage at 7.0 ppm, wheat, straw at 0.3 ppm, wheat, grain at 0.1 ppm; barley, forage at 1.2 ppm, barley, straw at 0.2 ppm, and barley, grain at 0.1 ppm; sorghum, forage at 0.2 ppm, sorghum, straw at 0.1 ppm, and sorghum, grain at 0.1 ppm; and beet, sugar (roots) at 0.1 pm and beets, sugar (tops) at 0.1 ppm. Gustafson, Inc., later withdrew the proposed sorghum tolerances and resubmitted them in a separate petition. On June 15, 1995, Gustafson amended this petition to request a feed additive tolerance of 0.5 ppm on sugarbeets and molasses. (See the Federal Register of June 15, 1995 (60 FR 31467)). On August 14, 1995, Gustafson submitted a revised Section F deleting barley from this petition and stating it would be resubmitted in a separate petition. EPA issued a notice in the Federal Register of October 25, 1995 (60 FR 54691), which announced that Gustasfson, Inc., P.O. Box 660065, Dallas, TX 75266-0065, had submitted a tolerance petition for premitting residues of insecticide imidacloprid in or the raw agriculture commodites barley, forage at 1.5 ppm, barley, straw at 0.2 ppm, and barley, grain at 0.05 ppm. These tolerances are being established as 3-year time-limited tolerances to enable Gustafson to complete additional residue trials and present a final report. On June 2, 1994, the Agency issued a guidance document on crop residue trials. Among other things, this document provided guidance on the number and location of domestic crop field trials for establishment of pesticide residue trials. Based on this guidance document, the Agency determined that additional field trials are needed for barley. However, the Agency does not believe that this data will significantly change its risk assessment. All relevant materials have been evaluated. The toxicology data considered in support of the tolerance include: 1. A three-generation rat reproduction study with a no-observed- effect level (NOEL) of 100 ppm (8 mg/kg/bwt); rat and rabbit teratology studies were negative at doses up to 30 mg/kg/ bwt and 24 mg/kg/bwt, respectively. 2. A 2-year rat feeding/carcinogenicity study that was negative for carcinogenic effects under the conditions of the study and had a NOEL of 100 ppm (5.7 mg/kg/bwt in males and 7.6 mg/kg/bwt in females) for noncarcinogenic effects that included decreased body weight gain in females at 300 ppm and increased thyroid lesions in males at 300 ppm and females at 900 ppm. 3. A 1-year dog-feeding study with a NOEL of 1,250 ppm (41/mg/kg/ bwt). 4. A 2-year mouse carcinogenicity study that was negative for carcinogenic effects under conditions of the study and that had a NOEL of 1,000 ppm (208/mg/kg/day). There is no cancer risk associated with exposure to this chemical. Imidacloprid has been classified under ``Group E'' (no evidence of carcinogenicity) by EPA's OPP/HED's Reference Dose (RFD) Committee. The reference dose (RfD) based on the 2-year rat feeding/ carcinogenic study with a NOEL of 5.7 mg/kg/bwt and 100-fold uncertainity factor is calculated to be 0.057 mg/kg/bwt. The theoretical maximum residue contribution (TMRC) from published uses is .000817 mg/kg/bwt/day utilizing 14.377% of the RFD. The proposed tolerance will not significantly increase the TMRC. For exposure of the most highly exposured subgroups in the population, children (ages 1 to 6 years), the TMRC for the published and proposed tolerances is 0.016934 mg/kg/day. This is equal to 29.709% of the RfD. Dietary exposure from the existing uses and proposed use will not exceed the reference dose for any subpopulation (including infants and children) based on the information available from EPA's Dietary Risk Evaluation System. The nature of the imidacloprid residue in plants and livestock is adequately understood. The residues of concern are combined residues of imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, all calculated as imidacloprid. The analytical method is a common moiety method for imidacloprid and its metabolites containing the 6-chloropyridiyl moiety using a permanganate oxidation, silyl derivatization, and capillary GC-MS selective ion monitoring. Imidacloprid and its metabolites are stable in the commodities when frozen for at least 24 months. There are adequate amounts of geographically representative crop field trial data to show that combined residues of imidacloprid and its metabolites, all calculated as imidacloprid, will not exceed the proposed tolerance when use as directed. There are currently no actions pending against the continued registration of this chemical. The pesticide is considered useful for the purposes for which the tolerance is sought and capable of achieving the intended physical or technical effect. Based on the information and data considered, the Agency has determined that the tolerances established by amending 40 CFR part 180 will protect the public health. Therefore, the tolerances are established as set forth below. Any person adversely affected by this regulation may, within 30 days after publication of this document in the Federal Register, file written objections to the regulation and may also request a hearing on those objections. Objections and hearing requests must be filed with the Hearing Clerk, at the address given above (40 CFR 178.20). A copy of the objections and/or hearing requests filed with the Hearing Clerk should be submitted to the OPP docket for this rulemaking. The objections submitted must specify the provisions of the regulation deemed objectionable and the grounds for the objections (40 CFR 178.25). Each objection must be accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is requested, the objections must include a statement of the factual issue(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). A

request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issue(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). A record has been established for this rulemaking under docket number [PP 5F4584/R2190] (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The public record is located in Room 1132 of the Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. Electronic comments can be sent directly to EPA at: opp-Docket@epamail.epa.gov

Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. The official record for this rulemaking, as well as the public version, as described above will be kept in paper form. Accordingly, EPA will transfer all comments received electronically into printed, paper form as they are received and will place the paper copies in the official rulemaking record which will also include all comments submitted directly in writing. The official rulemaking record is the paper record maintained at the address in ``ADDRESSES'' at the beginning of this document. Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether the regulatory action is ``significant'' and therefore subject to all the requirements of the Executive Order (i.e., Regulatory Impact Analysis, review by the Office of Management and Budget (OMB)). Under section 3(f), the order defines ``significant'' as those actions likely to lead to a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities (also known as ``economically significant''); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement, grants, user fees, or loan programs; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. Pursuant to the terms of this Executive Order, EPA has determined that this rule is not ``significant'' and is therefore not subject to OMB review. Pursuant to the requirements of the Regulatory Flexibility Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has determined that regulations establishing new tolerances or raising tolerance levels or establishing exemptions from tolerance requirements do not have a significant economic impact on a substantial number of small entities. A certification statement to this effect was published in the Federal Register of May 4, 1981 (46 FR 24950).

List of Subjects in 40 CFR Part 180

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

Dated: November 28, 1995.

Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR part 180 is amended as follows:

PART 180--[AMENDED]

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

Authority: 21 U.S.C. 346a and 371.

2. In Sec. 180.472, paragraph (e) is amended by redesignating the existing text as paragraph (e)(1), by revising the table therein, and by adding paragraph (e)(2) to read as follows:

Sec. 180.472 1-[(6-Chloro-3-pyridinyl) methyl]-N-2-imidazolidinimine; tolerances for residues.

* * * * * (e) * * *

------------------------------------------------------------------------ Parts per Expiration Commodity million date ------------------------------------------------------------------------ Barley, forage................................ 1.5 Nov. 28, 1998 Barley, grain................................. 0.05 Do. Barley, straw................................. 0.2 Do. Beets, sugar (roots).......................... 0.05 August 24, 1998 Beets, sugar (tops)........................... 0.1 Do. Wheat, forage................................. 7.0 Do. Wheat, grain.................................. 0.05 Do. Wheat, straw.................................. 0.3 Do. ------------------------------------------------------------------------

(2) Residues in the commodities listed in paragraph (e)(1) of this section not in excess of the established tolerances resulting from the uses described in this paragraph (e) remaining after expiration of the time-limited tolerances will not be considered to be actionable if the insecticide is applied during the term of and in accordance with the provisions of the above regulation in this paragraph (e).

[FR Doc. 95-29987 Filed 12-12-95; 8:45 am] BILLING CODE 6560-50-F