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Triflusulfuron Methyl (DuPont). June 14, 1996. Pesticide Tolerance for beets. Final Rule. Federal Register.
http://www.epa.gov/docs/fedrgstr/EPA-PEST/1996/June/Day-14/pr-742DIR/pr-742.html
[Federal Register: June 14, 1996 (Volume 61, Number 116)] [Rules and Regulations] 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.
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.
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 midhigh 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 <greek-m>g/plate, the highest level
tested; a Salmonella typhimurium plate incorporation assay which was negative
at concentration up to 3,000 <greek-m>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 <greek-m>g/ml. A second chromosomal aberration/human
lymphocyte assay was positive in the presence of metabolitic activation
at concentrations of 2,000 <greek-m>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 <greek-m>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 Cpossible 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, doserelated 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 0.06912f 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 0.1712f 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:oppDocket @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]
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:
Parts per
Commodity million Expiration date
[FR Doc. 96-15194 Filed 6-13-96; 8:45 am] BILLING CODE 6560-50-F