[Federal Register Volume 59, Number 95 (Wednesday, May 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11991]
[[Page Unknown]]
[Federal Register: May 18, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 0F3872/R2060; FRL-4778-9]
RIN 2070-AB78
Pesticide Tolerances for Thifensulfuron Methyl
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes a tolerance for residues of the
herbicide thifensulfuron methyl (methyl-3-[[[[(4-methoxy-6-methyl-
1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-2-
thiophenecarboxylate) in or on the raw agricultural commodities (RACs)
corn grain, field at 0.05 part per million (ppm); corn forage, field at
0.1 ppm and corn fodder, field at 0.1 ppm. This regulation was
requested by E.I. Du Pont de Nemours & Co., Inc., and establishes the
maximum permissible level for residues of the herbicide in or on this
RAC.
EFFECTIVE DATE: May 18, 1994.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 0F3872/R2060], may be submitted to:
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M
St., SW., Washington, DC 20460. 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
request to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA
22202. 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.
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. 245, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6800.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 16, 1991
(56 FR 1631), EPA issued a notice that announced that Du Pont,
Agricultural Products, P.O. Box 80038, Walkers Mill, Barley Mill Plaza,
Wilmington, DE 19880-0038, proposed pursuant to section 408 of the
Federal Food, Drug and Cosmetic Act, 21 U.S.C. 346a, to amend 40 CFR
part 180 by establishing a regulation for a tolerance to permit
residues of the herbicide thifensulfuron methyl in or on corn grain,
field at 0.05 part per million (ppm) and corn forage, field and corn
fodder, field at 0.1 ppm.
No comments were received to this notice of filing.
The data submitted in the petition and other relevant material have
been evaluated. The toxicological data listed below were considered in
support of these tolerances.
1. Several acute toxicology studies placing technical-grade
thifensulfuron methyl in toxicity category III for acute dermal
toxicity and toxicity category IV for acute oral, acute inhalation, eye
irritation, and skin irritation.
2. A 90-day feeding study in rats fed dosages of 0, 5, 125, and 375
milligrams/kilograms/day (mg/kg/day) with a no-observed-effect level
(NOEL) of 5 mg/kg/day based on decreased body weight, and clinical
pathology at 125 mg/kg/day, the lowest effect level (LOEL).
3. A 13-week feeding study in dogs fed dosages of 0, 1.875, 37.5,
and 187.5 mg/kg/day with a no-observed-effect level (NOEL) of 37.5 mg/
kg/day and a LOEL of 187.5 mg/kg/day [highest dosage tested (HDT)]
based on decreased body and adrenal gland weights in males.
4. A 1-year feeding study in dogs fed dosages of 0, 1.25, 18.75,
and 187.5 mg/kg/day with a NOEL of 18.75 mg/kg/day based on decreased
body weight/body weight gain in males and increased liver weight at
187.5 mg/kg/day (HDT).
5. A 2-year chronic feeding/carcinogenicity study in mice fed
dosages of 0, 3.75, 112.5, and 1,125 mg/kg/day with no carcinogenic
effects observed under the conditions of the study at dose levels up to
and including 1,125 mg/kg/day (HDT) and a systematic NOEL of 3.75 based
on decreased body weight gains at 112.5 mg/kg/day.
6. A 2-year chronic feeding/carcinogenicity study in rats fed
dosages of 0, 1.25, 25 and 125 mg/kg/day with no carcinogenic effects
under the conditions of the study at dosage levels up to including 125
mg/kg/day (HDT) and a systemic NOEL of 1.25 based on decreased sodium
levels, body weight/gains at 25 mg/kg/day.
7. A developmental toxicity study in rats fed dosages of 0, 30,
159, and 725 mg/kg/day with a developmental toxicity NOEL of 159 mg/kg
based on increased incidence of small or absentice of renal papilla at
725 mg/kg/day (HDT). The maternal NOEL was 725 mg/kg (HDT).
8. A developmental toxicity study in rabbits fed dosage of 0, 30,
158, and 511 mg/kg/day with a developmental toxicity NOEL of 511 mg/kg/
day (HDT) and a maternal NOEL of 158 mg/kg/day based on reduced body
weight gain at 511 mg/kg/day (HDT).
9. A two-generation reproduction study in rats fed dosages of 0,
1.25, 25, and 125 mg/kg/day with no reproductive effects observed up to
and including 125 mg/kg/day (HDT). The systemic NOEL was 125 mg/kg/day
(HDT).
10. Mutagenicity studies included a reverse mutagenic assay (not
mutagenic in Salmonella typhimurium strains with and without
activation), gene mutation (no increase in mutation frequency seen at
HDT of 7 mM, the limit of solubility); chromosomal aberration (negative
for clastogenic response at 5,000 mg/kg) and DNA synthesis/rat
hepatocytes in vitro (material did not induce significant increase in
unscheduled DNA synthesis (UDS).
The RfD based on a NOEL of 1.25 mg/kg/day established in the 2-year
feeding study in rats, and an uncertainty factor of 100 is calculated
to 0.013 mg/kg bwt/day. The theoretical maximum residue contribution
(TMRC) for published tolerances is 0.000108 mg/kg bwt/day for the
overall U.S. population. The current action will increase the TMRC
0.000017 mg/kg bwt/day (0.13% of the RfD) for the overall U.S.
population. For the U.S. subgroup populations, nonnursing infants and
children aged 1 to 6 years old, the current actions will increase the
TMRC 0.000049 mg/kg body weight/day (0.376% of the RfD) and 0.000044
mg/kg bwt/day (0.3% of the RfD) respectively. This tolerance and
previously established tolerances utilize 0.9% of the RfD for the
overall U.S. population. For U.S. subgroup populations, nonursing
infants and children aged 1 to 6, the current action and previously
established tolerances utilize 2 percent of the RfD, assuming that
residue levels are at established tolerances and that 100 percent of
the crop is treated.
There are no desirable data lacking.
This pesticide is useful for the purposes for which the tolerances
are sought. The nature of the residues is adequately understood for the
purposes of establishing these tolerances. Adequate analytical
methodology, high- pressure liquid chromotography, is available for
enforcement purposes. Because of the long lead time from establishing
this tolerance 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
Program Resources 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.
There are currently no actions pending against the registration of
this chemical. There is no expectation of residue occurring in meat,
milk, poultry, or eggs from this tolerance. Based on the data and
information submitted above, the Agency has determined that the
establishment of tolerances by amending 40 CFR part 180 will protect
the public health. Therefore, EPA is establishing the tolerance as
described below.
Any person adversely affected 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 accounted 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.
Under Executive Order 12866 (58 FR 51735, Oct. 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 adveresly and materially affecting
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
govenments 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 obligations 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, 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).
Lists of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Recording and
recordkeeping requirements.
Dated: April 26, 1994.
Douglas D. Campt,
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.
2. In Sec. 180.439 by adding and alphabetically inserting entries
for the raw agricultural commodities field corn, fodder and forage, to
read as follows:
Sec. 180.439 Methyl-3-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-
yl)amino]carbonyl]amino]sulfonyl]-2-thiophenecarboxylate; tolerances
for residues.
* * * * *
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Parts per
Commodity million
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Corn fodder, field......................................... 0.1
Corn forage, field......................................... 0.1
Corn grain, field.......................................... 0.05
*****
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[FR Doc. 94-11991 Filed 5-17-94; 8:45 am]
BILLING CODE 6560-50-F