[Federal Register Volume 61, Number 116 (Friday, June 14, 1996)]
[Rules and Regulations]
[Pages 30167-30170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15194]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
RIN 2070-AB78
[PP 4F4278/R2239; FRL-5377-7]
Triflusulfuron Methyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Rule.
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SUMMARY: This document establishes time-limited tolerances for residues
of the herbicide triflusulfuron methyl, methyl 2-[[[[[4-
(dimethylamino)-6-(2,2,2-trifluroroethoxy)-1,3,5-triazin-2-
yl]amino]carbonyl]amino]sulfonyl]-3-methylbenzoate, in or on the raw
agricultural commodities sugar beet tops and sugar beet roots. Because
additional time is needed for the petitioner to submit additional
product chemistry data for an updated manufacturing process, the Agency
is granting the tolerances for sugar beet root and top with a 3-year
expiration date. E.I. duPont de Nemours Company requested these
tolerances in a petition submitted to EPA pursuant to the Federal Food,
Drug, and Cosmetic Act (FFDCA).
EFFECTIVE DATE: June 14, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
docket number, [PP PP 4F4278/R2239], 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 Office 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 docket 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 request 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: oppdocket@epamil.gov. Copies of objections and hearing
must submitted as an ACSII file avoiding the use of special characters
and any firm of encryption. Copies of objections and hearing requests
will also be accepted on disks in Word Perfect in 5.1 file format or
ASCII file format. All copies of objections and hearing requests in
electronic hearing requests in electronic form must be identified by
the docket number [PP 4F4278/R2239]. 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: EPA issued a notice, published in the
Federal Register of August 17, 1995 (60 FR 42884) (FRL-4963-7) which
announced that E.I. DuPont de Nemours Co., Barley Mill Plaza, Walkers
Mill Building 37, Post Office Box 80038, Wilmington, DE 19880-0038, had
submitted a pesticide petition (PP 4F4278) which proposed to amend 40
CFR part 180 by establishing a regulation to permit residues of the
herbicide triflusulfuron methyl (methyl 2-[[[[[4-(dimethylamino)-6-
(trifluoroethoxy)-1,3.5-(triazin-2-yl]amino]carbonyl]amino] sulfonyl]-
3-methylbenzoate) in or on the raw agricultural commodities sugar beet
root and sugar beet top at 0.05 ppm. No comments or request for
referral to an advisory committee were received in response to this
notice of filing.
The scientific data submitted in the petitions and other relevant
material have been evaluated. The toxicological data considered in
support of the proposed tolerances are listed below.
1. Several acute toxicology studies placing technical grade
triflusulfuron methyl in toxicity Category III for acute dermal
toxicity and primary eye irritation and toxicity Category IV for acute
oral toxicity, acute inhalation toxicity and primary dermal irritation.
Technical triflusulfuron methyl was not a skin sensitizer.
2. An acute neurotoxicity screening battery with rats fed dosages
of 500, 1,000 or 2,000 milligrams/kilograms/day (mg/kg/day) with a no-
observed-effect level (NOEL) of 2,000 mg/kg/day (limit dose).
3. A 21-day dermal toxicity study with rabbits fed dosages of 50,
300, or 1,000 mg/kg/day with a systemic toxicity NOEL equal to or
greater than 1,000 mg/kg for males and females and a dermal toxicity
NOEL equal to or greater than 1,000 mg/kg/day for males and females.
4. A subchronic neurotoxicity study with rats fed dosages of 0,
6.1, 46.1, 92.7, or 186.2 mg/kg/day (males) or 7.1, 51.6, 104.1 or
205.2 mg/kg/day (females) with a NOEL of 92.7 mg/kg/day (males) and 7.1
mg/kg/day (females) based on decreased body weight/body weight gain at
the lowest observed effect level (LOEL) of 186.2 mg/kg/day (males) and
51.6 mg/kg/day (females).
5. A 1 year oral toxicity study with dogs fed dosages of 1.0, 26.9,
111.6 mg/kg/day (males) and 1.2, 27.7, and 95.5 mg/kg/day (females)
with a NOEL of 26.9 mg/kg/day (males) based on increases in alkaline
phosphatase; liver weight, and incidence of minimal centrilobular
hepatocellular hypertrophy at the LOEL of 111.6 (males) and a NOEL of
27.7 mg/kg/day (females) based on increased liver weight and increased
incidence of minimal centrilobular hepatocellular hypertrophy at the
LOEL of 95.5 mg/kg/day (females).
6. In an 18-month carcinogenicity study mice were fed dosages of
1.37, 20.9, 349 and 1,024 mg/kg/day (males) and 1.86, 27.7, 488 and
1,360 mg/kg/day (females). Male mice had statistically significant
positive trends for hepatocellular adenomas and for combined adenoma/
carcinoma (driven entirely by adenomas) at 349 and 1,024
[[Page 30168]]
mg/kg/day. These increases were not significant in pair-wise
comparisons with control groups and were determined not to be
carcinogenic effects by the Carcinogenicity Peer Review Committee
(CPRC).
7. In the combined chronic toxicity/carcinogenicity study rats were
fed dosages of 0, 0.406, 4.06, 30.6 and 64.5 mg/kg/day (males) and 0,
0.546, 5.47, 41.5, and 87.7 mg/kg/day (females). Male rats had a
significant increasing trend and significant differences in pair-wise
comparisons of the 30.6 and 64.5 mg/kg/day dose groups with controls
for interstitial cell ademonas. This effect was determined to be a
carcinogenic effect by the CPRC. No carcinogenic effects were noted in
females up to and including 87.7 mg/kg/day (highest dose tested (HDT)).
The LOEL for chronic toxicity is 30.6 mg/kg/day (males) and 41.5 mg/kg/
day (females) based on decreased body weight and body weight gain,
alterations in the hematology parameters (males predominately) and an
increased incidence of interstitial cell hyperplasia in males. The NOEL
for chronic toxicity is 4,06 mg/kg/day (males) and 5.47 mg/kg/day
(females). This value is adjusted to the lowest concentration level of
the chemical at this dosage (60%) resulting in NOELs 2.44 mg/kg/day
(males) and 3.28 mg/kg/day (females).
8. In a developmental study rats were fed dosages of 0, 30, 120,
350, and 1,000 mg/kg/day with a developmental NOEL equal to or greater
than 1,000 mg/kg/day (HDT) and a maternal toxicity NOEL of 120 mg/kg/
day with a LOEL of 350 mg/kg/day based on reduced body weight gain in
the 350 and 1,000 mg/kg/day animals, reduced food consumption in the
1,000 mg/kg/day animals and lower food efficiency in the 350 and 1,000
mg/kg/day groups.
9. In a developmental study rabbits were fed dosages of 0, 15, 90,
270, and 800 mg/kg/day with a NOEL for developmental toxicity of 90 mg/
kg/day with a LOEL of 270 mg/kg/day based on the increase in abortions
and a decrease in mean fetal body weight. The NOEL for maternal
toxicity is 90 mg/kg/day with a LOEL of 270 mg/kg/day based on maternal
death and abortions, an increase in clinical signs noted in the mid-
high and high dose groups, decreased food efficiency and increased post
mortem finding describing gastrointestinal effects.
10. In a two-generation rat reproduction study rats were fed
dosages of 0, 0.588, 5.81, 44.0 and 89.5 mg/kg/day (males) and 0,
0.764, 7.75, 58 and 115 mg/kg/day (females) with a reproductive
toxicity NOEL equal to or greater than 89.5 and 115 mg/kg/day for males
and females, respectively, based on the absence of reproductive effects
in rats at the highest dose level. The NOEL for systemic toxicity was
5.81 and 7.75 for males and females, respectively, based on decreased
body weight/body weight gain and food efficiency in males and females,
and decreased weights of offspring from the Fo generation on days 14
and 21 post-partum at 44.0 and 58.0 mg/kg/day in males and females
respectively.
11. Mutagenicity data submitted for the parent compound,
triflusulfuron methyl included a reverse mutation assay (Ames Test)
which was negative at concentrations up to 1,000 g/plate, the
highest level tested; a Salmonella typhimurium plate incorporation
assay which was negative at concentration up to 3,000 g/plate,
the highest level tested; and a CHO/HPRT assay which was negative at
concentrations up to 2,000 mg/kg/day, the highest level tested. A
chromosomal aberration/human lymphocyte assay was positive in the
presence of metabolic activation at concentrations greater than or
equal to 1,500 g/ml. A second chromosomal aberration/human
lymphocyte assay was positive in the presence of metabolitic activation
at concentrations of 2,000 g/ml. Results in the absence of
metabolic activation were inconclusive for both chromosomal aberration
studies. The mouse bone marrow micronucleus test was negative at doses
up to 5,000 mg/kg, the highest dose level tested. In three Salmonella
typhimurium plate incorporation assays metabolites of triflusulfuron
methyl were negative up to 5,000 g/plate, the highest level
tested.
12. A series of in vivo and in vitro studies were conducted in male
rats to investigate the mechanism by which triflusulfuron methyl
induces Leydig cell tumors in the testes. The studies demonstrated that
triflusulfuron methyl produces a dose dependent decrease in the
aromatase activity in vitro. However, the effects of the chemical on
the enzyme in vivo are not conclusive since no inhibition of activity
at extremely high dose levels after a 2-week exposure period were
observed. Further, the hypothesis that this effect is mediated by a
chronic depression in estradiol altering the negative feedback
mechanism for LH upon the Leydig cells of the testes has been suggested
but not clearly demonstrated. A trend but not pairwise statistical
significance has been shown for either the 750 or 1,500 ppm serum
levels of testosterone or estradiol after 1 year of exposure. In
addition, no elevation in serum levels of LH were noted at either dose
level.
The Carcinogenicity Peer Review Committee (CPRC) of Health Effects
Division (HED) has evaluated the rat and mouse cancer studies on
triflusulfuron methyl along with other short term toxicity studies,
mutagenicity studies and structure activity relationships. The CPRC
agreed that triflusulfuron methyl should be classified as a Group C-
possible human carcinogen and that for the purpose of risk
characterization the Reference Dose (RfD) approach should be used for
quantification of human risk.
This decision was based on evidence of highly significant, dose-
related increase in the incidence of interstitial cell adenomas in the
rat at two doses. Evidence of a hormonal basis for these tumors was
suggestive, but not conclusive. There was some evidence of clastogenic
activity for triflusulfuron methyl which needs further study. A DNA
damage/repair test in germ cells (e.g. alkaline elution assay) is being
requested to clarify this. The evidence from structurally related
analogs was mixed, of 12 chemicals in this class (sulfonylureas),
primisulfuron methyl, prosulfuron, and tribenuron methyl have been
associated with carcinogenic activity in rodents. The RfD approach for
risk quantification was chosen because the tumors (testicular
interstitial cell) were benign.
Based on an NOEL of 2.44 mg/kg bwt/day in the 2 year rat feeding
study, and using a 100-fold safety factor, the reference dose RfD for
triflusulfuron methyl is calculated to be 0.024 mg/kg bwt/day. The
theoretical maximum residue contribution (TMRC) for these tolerances is
0.000017 mg/kg/day which represents 0.069% of the RfD for the overall
U. S. population. For U. S. subgroup population, children aged 1 to 6,
the TMRC for these tolerances is 0.000041 which represents 0.17% of the
RfD assuming residue levels are at established tolerances and that 100
percent of the crop is treated. No other tolerances are published for
triflusulfuron methyl.
Data desirable but lacking for this chemical include additional
product chemistry data on an updated manufacturing process and a DNA
damage/repair test on germ cells. The Agency is granting the tolerances
for sugar beet top and sugar beet root with a 3-year expiration date to
allow the petitioner E.I. DuPont de Nemours Company to provide the
additional product chemistry data.
There are currently no regulations against the registration of this
chemical for use on sugar beets. Even though triflusulfuron methyl is
classified as a C-carcinogen, EPA believes that the
[[Page 30169]]
establishment of these tolerances will not pose an unreasonable risk to
humans as a result of dietary exposure. The establishment of these
tolerances utilize less than 1% (0.069%) of the RfD.
The pesticide is useful for the purpose for which the tolerances
are sought. The nature of the residue in plants and animals is
adequately understood for the purposes of establishing these
tolerances. Adequate analytical methodology (high pressure liquid
chromatography (HPLC) using a C-8 or C-18 reverse phase analytical
column) is available for enforcement purposes. Because of the long
lead-time from establishing tolerances to publication, the enforcement
methodology is being made available in the interim to anyone interested
in pesticide enforcement. Request by mail from Calvin Furlow, Public
Response Program Resources Branch, Field Operations Division (H7506C),
Office of Pesticide Programs, Environmental Protection Agency, 401 M
Street, SW., Washington DC 20460. Office location and telephone number:
Rm. 1130A, CM #2, 1921 Jefferson Davis Hwy, Arlington, VA 22202. No
detectable secondary residues are expected in milk; eggs; meat, fat,
and meat byproducts of cattle, goats, hogs, horses, sheep, or poultry
from this use.
Based on the information and data considered, the Agency has
determined that the tolerances established by amending 40 CFR part 180
would protect the public health. Therefore, EPA is establishing the
tolerances 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 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 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 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 4F4278/R2239] (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 docket
number [PP 4F4278/R2239], 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 describes 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 a paper record maintained at
the Virginia 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
``economicallysignificant''); (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.
This action does not impose any enforceable duty, or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership; or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
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, Food additive, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: June 3, 1996.
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.
[[Page 30170]]
2. By adding Sec. 180.492 to subpart C to read as follows;
Sec. 180.492 Triflusulfuron Methyl; Tolerances for Residues
Tolerances to expire as shown in the table below are established
for residues of the herbicide, triflusulfuron methyl, methyl 2-[[[[[4-
(dimethylamino)-6-(2,2,2-trifluorothoxy)-1,3,5-triazin-2-
yl]amino]carbonyl]amino]sulfonyl]-3-methylbenzoate, in or on the raw
agricultural commodities:
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Parts per
Commodity million Expiration date
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Sugar beet, root................... 0.05 June 14, 1999.
Sugar beet, top.................... 0.05 June 14, 1999.
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[FR Doc. 96-15194 Filed 6-13-96; 8:45 am]
BILLING CODE 6560-50-F
