[Federal Register: July 5, 1995 (Volume 60, Number 128)] ----------------------------------------------------------------------- 40 CFR Part 180 [PP 1F4025/R2148; FRL-4963-3] RIN 2070-AB78 Pesticide Tolerance for O-[2-(1,1-Dimethylethyl)-5-Pyrimidinyl] O-Ethyl-O-(1-Methylethyl) Phosphorothioate AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This rule establishes a time-limited tolerance for residues of the insecticide O-[2-(1,1-dimethylethyl)-5-pyrimidinyl] O-ethyl-O-(1- methylethyl) phosphorothioate in or on the raw agricultural commodities, corn, sweet (K+CWHR); corn, grain, field, and pop; corn, forage and fodder, field, pop, and sweet at 0.01 part per million (ppm). The Agricultural Division of Miles, Inc., requested in a petition submitted pursuant to the Federal Food, Drug and Cosmetic Act (FFDCA) this regulation to establish a maximum permissible level for residues of the insecticide. EFFECTIVE DATE: This regulation becomes effective July 5, 1995. ADDRESSES: Written objections and hearing requests, identified by the document control number, [PP 1F4025/R2148], may be submitted to: Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. 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. A copy of any objections and hearing requests filed with the Hearing Clerk should be identified by the document control number and submitted to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental 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. Comments and data may also be submitted electronically by sending electronic mail (e-mail) to: firstname.lastname@example.org. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on disks in WordPerfect in 5.1 file format or ASCII file format. All comments and data in electronic form must be identified by the docket number [1F4025/R2148]. No Confidential Business Information (CBI) should be submitted through e-mail. Electronic comments on this proposed rule may be filed online at many Federal Depository Libraries. Additional information on electronic submissions can be found below in this document. FOR FURTHER INFORMATION CONTACT: By mail: Robert A. Forrest, Product Manager (PM) 14, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 219, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6600; e-mail: email@example.com. SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the Federal Register of April 5, 1995 (60 FR 17355), which announced that Miles, Inc., Agriculture Division, 8400 Hawthorn Road, P.O. Box 4913, Kansas City, MO 64120, had submitted a pesticide petition, PP 1F4025, 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 a tolerance for residues of the insecticide "phostebupirim" (O-[2-(1,1-dimethylethyl)-5-pyrimidinyl] O-ethyl-O-(1-methylethyl) phosphorothioate) in or on the raw agricultural commodities corn, fresh; corn, grain, field and pop; and corn, forage and fodder, field, pop, and sweet at 0.01 part per million (ppm). (Because the name "phostebupirim" was not accepted as the common name, no further reference to this name will be made.) For consistency, the raw agricultural commodity, corn, fresh is expressed as corn, sweet (K+CWHR). There were no comments received in response to the notice. The scientific data submitted in the petition and other relevant material have been evaluated. The toxicological data considered in support of the tolerance include: 1. Several acute toxicological studies placing the technical grade of the insecticide in toxicity category I. 2. A 3-week subacute rabbit dermal study with a no-observed-effect level (NOEL) of 0.3 milligram/kilogram/day (mg/kg/day) for cholinesterase inhibition effects. Levels tested were 0.3, 1.0, and 3.0 mg/kg/day. 3. A subchronic (86 days) rat-feeding study with a NOEL for cholinesterase effects of 4.0 ppm and a systemic NOEL of 12.0 ppm. Levels tested were 2.0, 4.0, 12.0, and 36.0 ppm. (0.1, 0.2, 0.6, and 1.8 mg/kg/day, respectively). 4. An acute delayed neurotoxicity study in hens in which a dosage of 10 mg/kg was administered by gavage with no delayed neurotoxicity effects observed under conditions of the study. 5. A 1-year dog-feeding study with a NOEL of 0.02 mg/kg/day. Plasma, red blood cell, and brain cholinesterase inhibition effects were observed at the 5.0 ppm (0.125 mg/kg) dose level. No systemic effects were observed under the conditions of the study. Levels tested were 0.2, 0.7, and 5.0 ppm. (0.005, 0.018, and 0.125 mg/kg/day, respectively). 6. The following three studies fulfill the rat chronic/oncogenicity study requirement. a. A 2-year rat-feeding carcinogenicity study with a NOEL of 1.0 ppm for cholinesterase inhibition and 5.0 ppm for systemic effects. The study was negative for carcinogenic effects under the conditions of the study. Systemic effects observed at the 25-ppm dose level consisted of a decrease in body weight gain for first 6 months (males); soft stools; and poor general conditions, salivation, and tremors (females). Levels tested were 1.0 ppm, 5.0 ppm, and 25.0 ppm. (0.05, 0.25, and 1.25 mg/ kg/day, respectively). b. A 6-month cholinesterase study in rats with a NOEL of 0.3 ppm (0.02 mg/kg) for erythrocyte cholinesterase inhibition. There were no apparent systemic effects observed under conditions of the study. The levels tested were 0.3, 1.0, and 3.0 ppm. (0.015, 0.05, and 0.15 mg/kg/ day, respectively). c. A 12-month sacrifice study in rats administered 0 or 25 ppm (1.25 mg/kg/day) in which a decrease in body weight gain, an increase in food consumption, and an inhibition of brain cholinesterase activity were observed. 7. The following two studies fulfill the mouse chronic/oncogenicity study. a. A 2-year mouse carcinogenicity study which was negative for carcinogenic effects under the conditions of the study. The cholinesterase NOEL was 1.0 ppm (0.52 mg/kg/day for males and 0.58 mg/ kg/day for females) for erythrocyte, plasma and brain. Levels tested were 1.0 ppm, 9.0 ppm, and 80.0 ppm. b. A 12-month mouse cholinesterase study with a NOEL for cholinesterase inhibition of 0.3 ppm in males (0.13 mg/kg/day) and less than 0.3 ppm in females (0.16 mg/kg/day). The lowest-observed-effect level (LOEL) in males was 1.0 ppm (0.43 mg/kg/day) and in females, 0.3 ppm (0.16 mg/kg/day). The NOEL for systemic effects was 3.0 ppm (1.23 and 1.63 mg/kg/day in males and females, respectively). Levels tested were 0.3, 1.0, and 3.0 ppm. 8. A two-generation reproduction study in rats with a developmental NOEL of 5.0 ppm (approximately 0.25 mg/kg). A decrease in fertility indices and an increase in number of dead pups were observed at the 25.0-ppm dose level. There were no teratogenic effects observed under conditions of the study. The maternal NOEL for cholinesterase and systemic effects was 5.0 ppm. Tremors, decreased body weight gain, and cholinesterase inhibition were observed at the 25.0-dose level. Levels tested were 1.0 ppm, 5.0 ppm, and 25.0 ppm. 9. A rat developmental study with no developmental effects observed under conditions of the study. The maternal NOEL was 0.50 mg/kg. At the 0.75-mg/kg dose level, mortality and a decrease in body weight gain as well as food consumption during days 11 to 16 of the gestation; and inhibition of plasma, erythrocyte, and brain cholinesterase was observed. Levels tested were 0.25, 0.50, and 0.75 mg/kg. 10. A rabbit developmental study with an NOEL of 0.1 mg/kg for developmental effects (fetotoxicity). At the 0.3 mg/kg-dose, there was a decreased number of live fetuses/litter, a higher number of resorptions per group, and a greater number of litters with at least one resorption. Erythrocyte cholinesterase inhibition was also observed at the 0.3-mg/kg dose level. The test material was administered by gavage at doses of 0.03, 0.1, and 0.3 mg/kg. 11. Several mutagenicity studies in which the insecticide showed no evidence of mutagenic effects. These studies included gene mutation in cultured Chinese Hamster ovary cells (CHO/HGPRT); salmonella plate assays; in vivo micronucleus assay in mice; sister chromatid exchange assay in Chinese hamster ovary cells; unscheduled DNA synthesis assay in primary rat hepatocytes; and mitotic recombination. 12. A rat metabolism study demonstrated that the insecticide was readily absorbed, distributed, metabolized, and excreted and that bioaccumulation and retention of the compound and/or its metabolites are low in rats. In vivo and in vitro metabolism studies indicate that the insecticide is metabolized by mixed function oxidases to O-[2-(1,1- dimethylethyl)-5-pyrimidinyl] O-ethyl-O-(1-methylethyl) phosphorothioate (OMAT), an oxygen analog, which is rapidly hydrolyzed to 2-(1,1-dimethylethyl)-5-hydroxypyrimidine (TPHP) and excreted as the glucuronide conjugate of TBHP, a major metabolite representing 60 to 74 percent of the administered radioactivity. The reference dose (RfD) is established at 0.0002 mg/kg/day based on a NOEL of 0.02 mg/kg/day from the 2-year dog feeding study and an uncertainty factor of 100. The Theoretical Maximum Residue Contribution (TMRC) from the current action is estimated at .000006 mg/kg of body weight/day and utilizes 2.887 percent of the RfD for the U.S. population. There are no other tolerances established for this chemical. The TMRC for children, aged 1 to 6 years old, and nonnursing infants (the subgroups most highly exposed) utilizes 7.0 percent of the RfD for each subgroup. An acute dietary exposure analysis utilizing the NOEL of 0.3 mg/kg/ day from the rabbit developmental study as the toxicological endpoint was conducted. The subpopulation of particular concern (females 13+ years) has a Margin of Exposure (MOE) of 1,667 and therefore has a negligible acute risk for developmental toxicity from the establishment of these tolerances. The acute dietary analysis estimates the distribution of single-day exposures for the overall population and certain subgroups, and the MOE, calculated as the ratio of the NOEL to the exposure, is a measure of how close the high-end exposure comes to the NOEL. The nature of the residue in plants and animals is adequately understood. An adequate analytical method, gas-liquid chromatography, is available for enforcement purposes. The enforcement methodology has been submitted to the Food and Drug Administration for publication in the Pesticide Analytical Manual, Vol. II (PAM). Because of the long lead time for publication of the method in PAM II, the analytical methodology is being made available in the interim to anyone interested in pesticide enforcement when requested from: Calvin Furlow, Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401, M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 1132, CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703)-305-5232. There is no reasonable expectation that secondary residues will occur in milk, eggs, or the meat, fat and meat byproducts (mbyp) of livestock or poultry as a result of this action. Desirable data lacking include acute and subchronic rat neurotoxicity studies which are recent data requirements for cholinesterase-inhibiting pesticides. The gross cholinesterase inhibitory properties of the insecticide have been characterized in the available studies; however, additional characterization of the neurotoxic/neuropathological potential of the insecticide in mammals (rodents) is necessary. These studies have since been received by the Agency and are currently in review. Because of the lack of the mammalian neurotoxicity studies and the need to be consistent with the conditional registration being issued in conjunction with this regulation, the Agency is limiting the period of time that the regulation is to be in effect. Because the conditional registration being issued is for a combination product consisting of two active ingredients with the insecticide, cyfluthrin, as the second active ingredient, a regulation establishing time-limited tolerances for the use of cyfluthrin on corn is also being issued concurrently with this regulation. Upon evaluation of the rat neurotoxicity studies and receipt and evaluation of the other data/information required as conditions of the registration, the Agency will reassess the tolerances and registration and, if appropriate, will issue permanent tolerances and an unconditional registration for the use of these insecticides on corn. There are currently no actions pending against the registration of this chemical. Elsewhere in this issue of the Federal Register, the Agency is concurrently issuing a notice of conditional registration for the use of this new chemical on corn and a rule establishing a time-limited tolerance for residues of the insecticide, cyfluthrin, in/on corn commodities. Based on the information and data considered, the Agency has determined that the tolerance established by amending 40 CFR part 180 will protect the public health. Therefore, the tolerance is 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 1F4025/R2148] (including objections and hearing requests 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. Written objections and hearing requests, identified by the document control number [PP 1F4025/R2148], may be submitted to the Hearing Clerk (1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW., Washington, DC 20460. A copy of electronic objections and hearing requests filed with the Hearing Clerk can be sent directly to EPA at: opp-Docket@epamail.epa.gov A copy of electronic objections and hearing requests filed with the Hearing Clerk 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 any objections and hearing requests 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 objections and hearing requests 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: June 23, 1995. Daniel M. Barolo, Director, 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. By adding new Sec. 180.483, to read as follows: Sec. 180.483 O-[2-(1,1-Dimethylethyl)-5-pyrimidinyl] O-ethyl-O-(1-methylethyl) phosphorothioate; tolerances for residues. Time-limited tolerances are established for residues of the insecticide O-[2-(1,1-dimethylethyl)-5-pyrimidinyl] O-ethyl-O-(1-methylethyl) phosphorothioate in or on the following raw agricultural commodities: ------------------------------------------------------------------------ Parts per Expiration Commodity million date ------------------------------------------------------------------------ Corn, forage and fodder, field, pop, and sweet 0.01 July 6, 1999 Corn, grain, field and pop.................... 0.01 Do. Corn, sweet (K+CWHR).......................... 0.01 Do. ------------------------------------------------------------------------
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