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Imidacloprid; Pesticide Tolerance
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[Federal Register: June 12, 1996 (Volume 61, Number 114)] [Rules and Regulations] [Page 29674-29676] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr12jn96-24] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [PP 5F4522/R2237; FRL-5367-8] RIN 2070-AB78 Imidacloprid; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This rule establishes a tolerance for residues of the insecticide (1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2- imidazolidinimine) and its metabolites in or on leafy green vegetables. Bayer Corporation (formerly Miles, Inc.) requested this regulation to establish these maximum permissible levels for residues of the insecticide. EFFECTIVE DATE: This regulation became effective May 28, 1996. ADDRESSES: Written objections and hearing requests, identified by the docket control number, [PP 5F4522/R2237], may be submitted to: Hearing Clerk (A-110), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. A copy of any objections and hearing requests filed with the Hearing Clerk should be identified by the docket control number and submitted to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental [[Page 29675]] Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring copy of objections and hearing requests to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees accompanying objections shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. FOR FURTHER INFORMATION CONTACT: By mail: Dennis H. Edwards, Jr., Product Manager (PM) 19, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location, telephone number, and e-mail address: Rm. 207, CM #2, 1921 Jefferson Davis Highway, Arlington, VA, (703) 305-6386, e-mail: edwards.dennis@epamail.epa.gov. SUPPLEMENTARY INFORMATION: EPA issued a notice in the Federal Register of July 26, 1995 (60 FR 38333) (FRL-4958-2), which announced that Bayer Corporation, 8400 Hawthorn Road, P.O. Box 4913, Kansas City, MO 64120- 0013, had submitted pesticide petition 5F4522 to EPA requesting that the Administrator, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), establish tolerances for residues of the insecticide 1-[(6-chloro-3-pyridinyl)methyl]-N- nitro-2-imidazolidinimine in or on leafy green vegetables (including amaranth; arrugual; chervil; chrysanthemum, edible-leaved; chrysanthemum, garland; corn salad; cress, garden; cress upland; dandelion; dock; endive; orach; parsley; purslane, garden; purslane, winter; radicchio, (red chicory; spinach; spinach, New Zealand; and spinach vine). There were no comments or request for referral to an advisory committee received in response to this notice of filing. 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 developmental toxicity 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 male and 7.6 mg/kg/bwt female) 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 0.008187 mg/kg/bwt/day utilizing 14.4% of the RfD. The proposed tolerance will increase the TMRC by 0.000172 mg/kg/day representing an increase in the ADI of 0.3%. Thus, the TMRC will be 0.008358 mg/kg/day utilizing 14.7% of the RfD. For exposure of the most highly exposed subgroups in the population, non-nursing infants (< 1 year old), the TMRC for the published and proposed tolerances is 0.01547 mg/kg/day. This is equal to 27.1% 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 it 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-chloropyridinyl moiety using a permanganate oxidation, silyl derivatization, and capillary GC-MS selective ion monitoring. There is also a compound specific HPLC-UV method available. 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 no livestock feed stuffs associated with the commodation in the petition. There are presently no actions pending against the continued registration of this chemical. This pesticide is considered useful for the purposes for which the tolerance is sought. 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, these 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 a 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). 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 [[Page 29676]] ``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: May 28, 1996. Stephen L. Johnson, 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. Section 180.472(a) is amended by revising the table therein by adding and alphabetically inserting the following commodities to read as follows: Sec. 180.472 1-[(6-Chloro-3-pyridinyl)methyl]-N-2-imidazolidinimine; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Commodity Parts per million ------------------------------------------------------------------------ * * * * * Leafy greens subgroup 3.5 Leafy vegetables crop group 3.5 * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 96-14629 Filed 6-11-96; 8:45 am] BILLING CODE 6560-50-F