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Prosulfuron. May 10, 1995. Pesticide Tolerances. Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/1995/May/Day-10/pr-258DIR/pr-258.html
[Federal Register: May 10, 1995 (Volume 60, Number 90)] [Rules and Regulations] [Page 24788-24790] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr10my95-9] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [PP 4F4336/R2133; FRL-4953-8] RIN 2070-AB78 Pesticide Tolerances for Prosulfuron AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This rule establishes time-limited tolerances, to expire on December 31, 1995, for residues of the herbicide prosulfuron, 1-(4- methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)- phenylsulfonyl]-urea, in or on the raw agricultural commodities corn (fodder, forage, grain and fresh [including sweet kernels plus cobs with husks removed]) at 0.01 part per million (ppm), milk at 0.01 part per million (ppm), and fat, kidney, liver, meat, and meat byproducts of cattle, goats, hogs, horses, and sheep at 0.05 part per million (ppm). Ciba-Geigy Corp. requested this regulation pursuant to the Federal Food, Drug and Cosmetic Act (FFDCA). The regulation establishes maximum permissible levels for residues of the herbicide in or on the commodities. EFFECTIVE DATE: This regulation becomes effective May 10, 1995. ADDRESSES:Written objections and hearing requests, identified by the document control number, [PP 4F4336/R2133] maybe submitted to the 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 36277M, Pittsburgh, PA 15251. A copy of objections and hearing request 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. A copy of objections and requests for hearings filed with the Hearing Clerk may also be submitted electronically by sending electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Copies and requests for hearings must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Copies of objections and requests for hearings will also be accepted on disks in WordPerfect in 5.1 file format or ASCII file format. All copies of objections and requests for hearings in electronic form must be identified by the docket number [PP 4F4336/R2133]. No Confidential Business Information (CBI) should be submitted through e-mail. Electronic copies of objections and requests for hearings on this 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 J. Taylor, Product Manager (PM) 25, Registration Division (H7505C), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 245, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6800; e-mail: taylor.robert@epamail.epa.gov. SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the Federal Register of November 2, 1994 (59 FR 54907), which announced that the Ciba-Geigy Corp., P.O. Box 18300, Greensboro, NC 27419-8300, had submitted a pesticide petition, PP 4F4336, to EPA proposing to amend 40 CFR part 180 by establishing a tolerance under section 408 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 346a, for the residues the herbicide prosulfuron, 1-(4-methoxy-6-methyl-triazin-2- yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea, in or on corn, forage at 0.02 ppm; corn, fodder at 0.02 ppm; corn, grain at 0.02 ppm; corn, fresh (including sweet kernels plus cobs with husks removed) at 0.02 ppm; milk at 0.02 ppm; meat byproducts, kidney and liver of cattle, goats, hogs, horses, and sheep at 0.10 ppm; poultry, fat, kidney, liver, meat and meat byproducts at 0.10 ppm; and eggs at 0.10 ppm. The petitioner subsequently amended the petition by lowering the tolerances and withdrawing poultry from the list of proposed tolerances. A notice was not filed since there is less risk to man and the environment. There were no comments or requests for referral to an advisory committee received in response to the notice of filing. The data submitted in the petition and other relevant material have been evaluated. The toxicology data listed [[Page 24789]] below were considered in support of this tolerance. 1. Several acute toxicology studies placing technical-grade prosulfuron in Toxicity Category III, and an acute neurotoxicity study in rats at dose levels of 0, 10, 250, 500, or 1,000 mg/kg with an NOEL of 10 mg/kg based on reduced motor activity and body temperature in males and impaired righting reflex in females. A 90-day neurotoxicity study in rats demonstrated NOELs of greater than 5,000 ppm in females and 10,000 ppm in males. 2. A 1-year feeding study with dogs fed dosages of 0, 0.33, 1.95, 18.6, or 41.0 mg/kg/day (males) and 0, 0.31, 1.84, 20.2, or 48.8 mg/kg/ day (females). The NOEL was 1.84 mg/kg/day based on hematologic and clinical chemistry effects and incidence of lipofuscin accumulation in the liver at 18.6 mg/kg/day. 3. An 18-month carcinogenicity study in mice fed dosages of 0, 1.71, 81.4, 410 or 832 mg/kg/day (males), and 0, 2.11, 100, 508 or 1,062 mg/kg/day (females). There was no evidence of carcinogenic effects up to 1,062 mg/kg/day, the highest dose tested (HDT). 4. A 2-year chronic feeding/carcinogenicity study in rats fed dosages of 0, 0.4, 7.9, 79.9 or 160.9 (males), and 0, 0.5, 9.2, 95.7 or 205.8 mg/kg/day (females). There was uncertain evidence of carcinogenicity with slight increases in the incidence of mammary gland adenocarcinomas in females at 95.7 and 205.8 mg/kg/day, slight increase in incidence of benign testicular interstital cell tumors at 79.9 and 160.9 mg/kg/day (significant trend only). A systemic NOEL of 7.9 mg/kg/ day was based on decreased body weight and body weight gain, hematopoietic effects (males), and possibly increased serum GGT and decreased liver, kidney and adrenal weights (females) at 79.9 mg/kg/ day. 5. A three-generation reproduction study with rats fed dosages of 0, 0.67, 13.3, 136, or 278 (males), and 0, 0.76, 15.3, 152 or 311 mg/ kg/day (females) with a reproductive and a systemic NOEL of 13.3 mg/kg/ day based on decreased mean body weights and body weight gain observed at 136 mg/kg/day for both pups and parental animals. 6. A developmental toxicity study in rats at dose levels of 0, 5, 50, 200 and 400 mg/kg/day by gavage. The developmental NOEL was 200 mg/ kg/day based on a statistically significant elevation of combined skeletal findings at 400 mg/kg/day, and maternal toxicity NOEL of 200 mg/kg/day, based on marginal effects on body weight gain at 400 mg/kg/ day. 7. A developmental toxicity study in rabbits at dose levels of 0, 1.0, 10 and 100 mg/kg/day by gavage with no indications of developmental toxixicy at dose levels up to 100 mg/kg/day. The registrant was required to submit another study at higher doses to establish the NOEL and LEL for maternal and developmental toxicity. A new study is being conducted, and this deficiency is not considered sufficient to affect registration. 8. Three acceptable mutagenicity studies were reviewed for prosulfuron. These include assays with Salmonella typhimurium strains TA1535, TA1537, TA98, and TA100 or E. coli WP2 uvrA exposed in either the presence or absence of mammalian metabolic activation; unscheduled DNA synthesis (UDS) in primary rat hepatocytes; and a structural chromosomal aberration micronucleus test in mice. All these tests were negative for mutagenicity. The prosulfuron Reference Dose (RfD) was established at 0.02 mg/kg/ day based on the 1-year dog chronic feeding study with an uncertainty factor of 100. The theoretical maximum residue contribution (TMRC) for tolerances on corn grain, straw and forage, and milk, meat and meat byproducts utilizes 1.4% of the RfD for the total U.S. population. The most highly exposed subgroups, children (ages 1 to 6) and nonnursing infants (less than 1-year old), utilize 4.3% of the RfD. The HED RfD/Peer Review Committee classified this chemical as a Class D oncogen based on the conclusion that there was uncertain evidence of carcinogenicity with slight increases in the incidence of mammary gland adenocarcinomas in female rats at 95.7 and 205.8 mg/kg/ day, but significant only at 95.7 mg/ kg/day, a slight increase in incidence of benign testicular interstital cell tumors in rats at 79.9 and 160.9 mg/kg/day, and no evidence in carcinogenicity in mice. The committee also decided that prosulfuron was not associated with any significant reproductive or develpmental toxicity under the conditions of testing. This pesticide is useful for the purposes for which the tolerances are sought. The nature of the residues is adequately understood for the purposes of establishing these tolerances. An analytical method, HPLC with column switching, is available for determination of residues of prosulfuron in corn and has been validated by an independent laboratory. The field residue and radio-labeled field metabolism studies submitted to the Agency indicate that there are no residues in corn grain, forage or fodder following application of prosulfuron. In addition, as noted above, the TMRC for the most highly exposed subgroups utilizes only 4.3% of the RFD. Therefore, this time limited tolerance is being issued prior to the completion of the method validation process by the EPA laboratory. Because of this, the Agency has set an expiration date of December 31, 1995 for the tolerance. Adequate analytical methodology, HPLC with UV detection, for animal tissues is available for enforcement purposes. Because of the long lead time from establishing these tolerances to publication the enforcement methodology is being made available in the interim to anyone interested in pesticide enforcement when requested by mail from: Calvin Furlow, Public Response 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. 1130A, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Required data include a repeat of the developmental study in rabbits, the submission of stability data (storage and chemical), information on accuracy of the method used to verify the certified limits, experimental details of all solubility determinations, additional corn and ruminant metabolism data, and completion of method trial. There are currently no actions pending against the registration of this chemical. Any secondary residues occurring in meat, milk, and meat byproducts will be covered by the proposed tolerances in these commodities. Based on the data and information submitted above, the Agency has determined that the establishment of tolerances by amending 40 CFR part 180 will protect the public health. Therefore, EPA is establishing the tolerances as described below. Any person adversely affected by this regulation may, within 30 days after the date of publication in the Federal Register, file written objections with the Hearing Clerk, Environmental Protection Agency, 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 [[Page 24790]] requestor's contentions on each issue, 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. A record has been established for this rulemaking under docket number [PP 4F4336/R2133] (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 Rm. 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 requests for hearings, identified by the document control number [PP 4F4336/R2133], 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 requests for hearings filed with the Hearing Clerk can be sent directly to EPA at: opp-Docket@epamail.epa.gov A copy of electronic objections and requests for hearings 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, Oct. 4, 1993) the Agency must determine whether the regulatory action is ``significant'' and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Order. Under section 3(f), the order defies a ``signficant regulatory action'' as an action that is likely to result in 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 referred to as ``economically significant''); (2) creating serious inconsistancy 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 the rights and obligations of recipients thereof; 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 the 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 3, 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. 180.481, to read as follows: Sec. 180.481 Prosulfuron; tolerances for residues. Time-limited tolerances, to expire on December 31, 1995, are established for residues of the herbicide prosulfuron, 1-(4-methoxy-6- methyl-triazin-2-yl)-3-[2-(3,3,3-trifluoropyl)-phenyl-sulfonyl]-urea, in or on the following raw agricultural commodities: ------------------------------------------------------------------------ Parts per Commodity million Expiration date ------------------------------------------------------------------------ Cattle, fat............... 0.05............ Dec. 31, 1995. Cattle, kidney............ 0.05............ Do. Cattle, liver............. 0.05............ Do. Cattle, meat.............. 0.05............ Do. Cattle, mbyp.............. 0.05............ Do. Corn, fodder.............. 0.01............ Do. Corn, forage.............. 0.01............ Do. Corn, grain and fresh (including sweet kernels plus cobs with husks removed)................. 0.01............ Do. Goats, fat................ 0.05............ Do. Goats, kidney............. 0.05............ Do. Goats, liver.............. 0.05............ Do. Goats, meat............... 0.05............ Do. Goats, mbyp............... 0.05............ Do. Hogs, fat................. 0.05............ Do. Hogs, kidney.............. 0.05............ Do. Hogs, liver............... 0.05............ Do. Hogs, meat................ 0.05............ Do. Hogs, mbyp................ 0.05............ Do. Horses, fat............... 0.05............ Do. Horses, kidney............ 0.05............ Do. Horses, liver............. 0.05............ Do. Horses, meat.............. 0.05............ Do. Horses, mbyp.............. 0.05............ Do. Milk...................... 0.01............ Do. Sheep, fat................ 0.05............ Do. Sheep, kidney............. 0.05............ Do. Sheep, liver.............. 0.05............ Do. Sheep, meat............... 0.05............ Do. Sheep, mbyp............... 0.05............ Do. ------------------------------------------------------------------------ [FR Doc. 95-11667 Filed 5-8-95; 1:34 pm] BILLING CODE 6560-50-F