[Federal Register Volume 60, Number 137 (Tuesday, July 18, 1995)]
[Rules and Regulations]
[Pages 36729-36731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17128]



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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.

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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: [email protected]. 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: 
[email protected].

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 (F1a, F1b, and F2b) 
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 (F0 + F1) 
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-D[email protected]


    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
                                                                        
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    (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.               
                                                                        
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[FR Doc. 95-17128 Filed 7-17-95; 8:45 am]
BILLING CODE 6560-50-F