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