PMEP Home Page --> Pesticide Active Ingredient Information --> Herbicides, Growth Regulators and Desiccant --> sesone to vernolate (Vernam) --> triasulfuron (Amber) --> triasulfuron (Amber) Pesticide Tolerance 7/95

triasulfuron (Amber) Pesticide Tolerance 7/95

Date: Tue, 18 Jul 1995 15:31:56 -0400
Reply-To: epa-pest@unixmail.rtpnc.epa.gov Originator: epa-pest@unixmail.rtpnc.epa.gov Sender: epa-pest@unixmail.rtpnc.epa.gov
Precedence: bulk
From: S001627@swais.access.gpo.gov
To: Multiple recipients of list <epa-pest@unixmail.rtpnc.epa.gov> Subject: Triasulfuron; Pesticide Tolerances X-Comment: U.S. EPA FEDERAL REGISTER PESTICIDE documents Status: O
X-Status:
[Federal Register: July 18, 1995 (Volume 60, Number 137)] [Rules and Regulations]
[Page 36729-36731]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov] 
----------------------------------------------------------------------- 
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 3F4225/R2150; FRL-4964-7]
RIN 2070-AB78
Triasulfuron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA). 
ACTION: Final rule.
----------------------------------------------------------------------- 
SUMMARY: This document establishes tolerances for residues of the herbicide triasulfuron [3-(6-methoxy-4-methyl-1,3,5-triazin-2-yl)-1-2- (2-chloroethoxy) phenylsulfonyl)urea] in or on the raw agricultural commodities (RACs) grass forage at 7.0 parts per million (ppm) and grass hay at 2.0 ppm. This document also increases the tolerance for kidney of cattle, goats, hogs, horses, and sheep to 0.5 ppm. Ciba-Geigy Corp. requested these tolerances in a petition submitted to EPA pursuant to the Federal Food, Drug and Cosmetic Act (FFDCA). 
EFFECTIVE DATE: This regulation becomes effective July 18, 1995. 
ADDRESSES: Written objections and hearing requests, identified by the document control number, [PP 3F4225/R2150], 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 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 hearing requests filed with the Hearing Clerk may also be submitted electronically by sending electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and hearing requests must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Copies of objections and hearing requests will also be accepted on disks in WordPerfect in 5.1 file format or ASCII file format. All copies of objections and hearing requests in electronic form must be identified by the docket number [PP 3F4225/R2150]. No Confidential Business Information (CBI) should be submitted through e-mail. Electronic copies of objections and hearing requests 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 (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 241, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6027; e-mail: taylor.robert@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of October 21, 1993 (58 FR 54354), EPA issued a notice announcing that Ciba-Geigy Corp., Agricultural Division, P.O. Box 18300, Greensboro, NC 27419, had submitted a pesticide petition (PP 3F4225) proposing to amend 40 CFR part 180 by establishing a regulation under section 408(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(d)) to permit residues of the herbicide triasulfuron, 3-(6-methoxy-4-methyl-1,3,5- triazin-2-yl)-1-(2-(2-chloroethoxy) phenylsulfonyl)urea, in or on the raw agricultural commodities (RACs) grass forage at 7.0 ppm and grass hay at 2.0 ppm. There were no comments or requests for referral to an advisory committee received in response to the notice of filing. 
The petitioner subsequently amended the petition by submitting a revised Section F proposing to establish tolerances for residues of the herbicide triasulfuron in or on the RACs grass forage at 7.0 ppm, grass hay at 2.0 ppm, and to increase the established tolerances on kidney of cattle, goats, hogs, horses, and sheep to 0.5 ppm. In the Federal Register of May 24, 1995 (60 FR 27506), EPA issued an amended filing notice proposing these tolerances. There were no comments or requests for referral to an advisory committee recieved in response to the notice.
In the Federal Register of May 3, 1995 (60 FR 21734), EPA issued a document in the Federal Register which changed the current time-limited tolerances for residues of the herbicide triasulfuron to permanent tolerances.
The data submitted in the petition and other relevant material have been evaluated. The toxicology data listed below were considered in support of these tolerances.
1. Several acute studies placing technical-grade triasulfuron in Toxicity Categories III and IV. It is not a dermal sensitizer. 
2. A subchronic (90-day) feeding study in which male and female rats were fed diets containing triasulfuron yielding dose levels of 0, 9.8/12.5, 517/668, and 1,082/1,430 (male/female) milligrams/kilogram body weight/day (mg/kg/day) demonstrated a no-observable-effect level (NOEL) of 9.8/12.5 (males/ females) mg/kg/day based on decreased body weight and food intake in males and females and increased kidney atrophy and epithelial hyperplasia in females 517/668 (males/females) mg/kg/day.
3. A 1-year feeding study with male and females dogs fed diets containing triasulfuron yielding dose levels of 0, 2.5, 25, and 125/250 mg/kg/day demonstrated a NOEL of 2.5 mg/kg/day based on increased relative (organ to body weight ratio) liver weight and prostate cystic hyperplasia at 25 mg/kg/day. After 10 weeks, dogs receiving 250 mg/kg/ day exhibited reduced weight
[[Page 36730]]
and food intake as well as hematological changes; therefore, the dose level was reduced to 125 mg/kg/day.
4. A 2-year chronic feeding/carcinogenicity study inmale and female rats fed triasulfuron in the diet yielding dose levels of 0, 0.3/0.4, 32.1/42.9, and 220.8/274.4 (males and females) mg/kg/day demonstrated that no carcinogenic effects were observed under the conditions of the study at dose levels up to and including 220.8/274.4 (males/females) mg/kg/day (highest dose tested [HDT]) and a systemic NOEL of 32.1/42.9 (males/females) mg/kg/day based upon a decrease in mean body weight gain for both sexes and in males a decrease in absolute heart and testes weight at 220.8/ 274.4 mg/kg/day (HDT). 
5. A 2-year feeding/carcinogenic study in male and female mice fed diets containing triasulfuron yielding dose levels 0, 1.2/1.5, 129/158, 620/793, and 1,301/1,474 (males/females) mg/kg/day demonstrated that no carcinogenic effects observed under the conditions of the study at dose levels up to and including 1,301/1,474 (males/females) mg/kg/day (HDT) and a systemic NOEL of 1.2 mg/kg/day based on a centrilobular hepatocytomegaly in males at 129 mg/kg/day. 
6. A developmental toxicity study in pregnant rats dosed orally (by gavage) with triasulfuron during days 6 through 15 at dose levels of 0, 100, 300, and 900 mg/kg/day demonstrated a developmental NOEL of 300 mg/kg/day (mid-dose tested [MDT]), based on increased incidence of dumbbell-shapped thoracic vertebrae at 900 mg/kg/day (HDT) and a maternal NOEL of 100 mg/kg/day, based on decreased body weight and body weight gain during gestation at 300 mg/kg/day (MDT). 
7. A developmental toxicity study in pregnant female rabbits dosed orally (by gavage) with triasulfuron at dose levels of 0, 40, 120, and 240 mg/kg/day during days 6 through 18 of gestation demonstrated a developmental NOEL greater than 240 mg/kg/day (HDT), based on the absence of any developmental toxicity, and a maternal NOEL of 120 mg/ kg/day (HDT) based on depressed body weight during the gestation period at 240 mg/kg/day (HDT).
8. A two-generation reproduction study in male and female rats fed diets of triasulfuron yielding dose levels of 0, 0.5, 50, and 250 mg/ kg/day demonstrated a reproductive (F1<INF>a, F1<INF>b, and F2<INF>b) NOEL of 50 mg/kg/day, based on reduced pup weight at birth and during lactation at 250 mg/kg/day (HDT), and a paternal (F<INF>0 + F<INF>1) NOEL of 50 mg/kg/day based on decreased body weight gain at 250 mg/kg/ day (HDT).
9. Mutagenicity studies included an Ames test, a mouse lymphoma mutagenicity test, a DNA damage/repair in vitro (HPC/UDS) test, and a micronucleus test in Chinese hamsters (all negative). 
The reference dose (RfD), based on a 2-year feeding study with mice (NOEL of 1.2 mg/kg/day) and using a hundred-fold safety factor, is calculated to be 0.01 mg/kg/day. The theoretical maximum residue contribution (TMRC) for the existing tolerances for the overall U.S. population is 0.000463 mg/kg/body weight/day and utilizes 4.63 percent of the RfD. The current action will increase the TMRC by 0.001225 mg/kg bwt/day. These tolerances and previously established tolerances will utilize a total of 11.4 percent of the RfD for the overall U.S. population. For U.S. subgroup populations, nonnursing infants and children aged 1 to 6, the current action and previously established tolerances utilize, respectively, a total of 3.23 percent and 23.2 percent of the RfD, assuming that residue levels are at the established tolerances and 100 percent of the crop is treated. 
There are no desirable data lacking for this chemical. The pesticide is useful for the purposes for which these tolerances are sought. The nature of the residue is adequately understood for the purpose of establishing tolerances. Adequate analytical methodology-- high performance liquidchromatography (HPLC) using column switching and ultraviolet detection--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 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, (703)-305-5937. 
There are currently no actions pending against the registration of this chemical. Any secondary residue occurring in meat, fat, and meat byproducts of cattle, goats, hogs, horses, and sheep, and milk will be covered by previously established tolerances on livestock commodities except for kidney of cattle, goats, hogs, horses, and sheep which are being increased by this action. There is no reasonable expectation that finite residues of triasulfuron will occur in poultry tissues and eggs as a result of the proposed use on grasses. 
Based on the information cited above, the Agency has determined that the establishment of the tolerances 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 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 in 40 CFR 180.33 (i). If a hearing is requested, the objections must include a statement of factual issue(s) on which a hearing is requested, the requestor`s contentions on each such issue, and a summary of any evidence relied upon by the objector, 40 CFR 178.27. A request for a hearing will be granted is the Administrator determines that the material submitted shows the following: There is a genuine as 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 3F4225/R2150] (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 3F4225/R2150], may be submitted to the Hearing Clerk (1900), Environmental Protection
[[Page 36731]]
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 review by the Office Of Management and Budget (OMB) and the requirements of the Executive Order. Under section 3(f), the order defines a ``significant 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 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 the rights and obligation 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, 21 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 28, 1995.
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. By revising Sec. 180.459, to read as follows: 
Sec. 180.459 Triasulfuron; tolerances for residues. 
(a) Tolerances are established for residues of the herbicide triasulfuron [3-(6-methoxy-4-methyl-1,3,5-triazin-2-yl)-1-(2-(2- chloroethoxy)phenylsulfonyl)urea] in or on the following raw agricultural commodities:
------------------------------------------------------------------------ 
Parts per
Commodity	million
------------------------------------------------------------------------ 
Barley, forage.............................................	5.0
Barley, grain..............................................	0.02
Barley, straw..............................................	2.0
Cattle, fat................................................	0.1
Cattle, mbyp except kidney.................................	0.1
Cattle, meat...............................................	0.1
Goats, fat.................................................	0.1
Goats, mbyp except kidney..................................	0.1
Goats, meat................................................	0.1
Hogs, fat..................................................	0.1
Hogs, mbyp.................................................	0.1
Hogs, meat.................................................	0.1
Horses, fat................................................	0.1
Horses, mbyp except kidney.................................	0.1
Horses, meat...............................................	0.1
Milk.......................................................	0.02
Sheep, fat.................................................	0.1
Sheep, mbyp except kidney..................................	0.1
Sheep, meat................................................	0.1
Wheat, forage..............................................	5.0
Wheat, grain...............................................	0.02
Wheat, straw...............................................	2.0
------------------------------------------------------------------------ 
(b) Time-limited tolerances are are established for residues of the herbicide triasulfuron [3-(6-methoxy-4-methyl-1,3,5-triazin-2-yl)-1-(2- (2-chloroethoxy)phenylsulfonyl)urea] in or on the following raw agricultural commodities:
------------------------------------------------------------------------ 
Parts per
Commodity	million	Expiration date
------------------------------------------------------------------------ 
Cattle, kidney........................	0.5 July 20, 1998.
Goats, kidney.........................	0.5 Do.
Grass, forage.........................	7.0 Do.
Grass, hay............................	2.0 Do.
Horses, kidney........................	0.5 Do.
Sheep, kidney.........................	0.5 Do.
------------------------------------------------------------------------ 
[FR Doc. 95-17128 Filed 7-17-95; 8:45 am] BILLING CODE 6560-50-F