[Federal Register Volume 59, Number 248 (Wednesday, December 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-31928]
[Federal Register: December 28, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 1F4005/R2096; FRL-4925-6]
RIN 2070-AB78
Pesticide Tolerances for Rimsulfuron
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes tolerances for residues of the herbicide
rimsulfuron (N-((4,6-dimethoxypyridin-2-yl)aminocarbonyl)-3-
(ethylsulfonyl)-2-pyridinesulfonamide) in or on various raw
agricultural commodities (RACs). E. I. duPonte de Nemours & Co., Inc.,
requested this regulation to establish the maximum permissible level
for residues of the herbicide on the RACs.
EFFECTIVE DATE: December 28, 1994.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [1F4005/R2096], may be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington DC 20460. A copy of objections and hearing requests
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 November 8, 1994
(59 FR 55478), EPA issued a notice that announced that Dupont
Agricultural Products, P.O. Box 80038, Walkers Mill, Barley Mill Plaza,
Wilmington, DE 19880-0038, had 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 tolerances to permit residues
of the herbicide rimsulfuron in or on corn, field, fodder at 0.1 part
per million (ppm); corn, field, forage at 0.1 ppm; corn, field, grain
at 0.1 ppm; and potatoes, tubers at 0.1 ppm.
There were no comments received in response to the notice of
filing.
The data submitted in the petition and other relevant material have
been evaluated. The toxicology data listed below were considered in
support of the tolerances.
1. Several acute toxicology studies placing technical rimsulfuron
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.
2. A subchronic feeding study with rats fed dosages of 0, 3.35,
102, 495, or 1,311 mg/kg/day (males) and 0, 4.11, 120, 615, or 1,622
mg/kg/day (females) with no-observable-effect levels (NOELs) of 102 mg/
kg/day (males) and 120 mg/kg/day (females) based on reduced body weight
gains at 495 mg/kg/day (males) and 615 mg/kg/day (females).
3. A subchronic feeding study with dogs fed dosages of 0, 9.63,
193, or 793 mg/kg/day (males) and 0, 10.6, 189, or 677 mg/kg/day
(females) with NOELs of 9.63 mg/kg/day (males) and 10.6 mg/kg/day
(females) based on urinary volume and osmolarity at 193 mg/kg/day
(males) and 189 mg/kg/day.
4. A 1-year feeding study with dogs fed dosages of 0, 1.6, 81.8,
and 342.4, mg/kg/day for males and 0, 1.6, 86.5, and 358.5 mg/kg/day
for females. The NOEL for males was 1.6 mg/kg/day based on increased
absolute liver and kidney weights and increased incidence of
seminiferous tubule degeneration and increased numbers of spermatid
giant cells present in epididymides at 81.8 mg/kg/day. The NOEL for
females was 86.5 mg/kg/day based on decreased mean body weight and body
weight gain, increased serum cholesterol levels and alkaline
phosphatase activity, increased absolute liver weight, and increased
relative liver and kidney weights at 358.5 mg/kg/day (highest dose
tested (HDT)).
5. An 18-month feeding/carcinogenicity study in mice fed dosages of
0, 3.47, 35.5, 351, or 1,127 mg/kg/day for males and 0, 4.99, 50.5,
488, or 1,505 mg/kg/day for females with no carcinogenic effects
observed under the conditions of the study at dose levels up to and
including 1,127 mg/kg/day for males (HDT) and 1,505 mg/kg/day for
females (HDT). The systemic NOEL for females was 488 mg/kg/day and 351
mg/kg/day for males based on decreased mean body weights in females at
1,505 mg/kg/day (HDT) and decreased mean body weights, increased
incidence of dilation and cysts in the grandular stomach, and
degeneration of the testicular artery and tunica albuginea in males at
1,127 mg/kg/day (HDT).
6. A 2-year chronic feeding/carcinogenicity study with rats fed
dosages of 1.00, 11.8, 121, or 414 mg/kg/day for males and 0, 1.38,
17.1, 163, or 569 mg/kg/day for females with no carcinogenic effects
observed under the conditions of the study at dose levels up to and
including 414 mg/kg/day (males) (HDT) and 569 mg/kg/day (females)
(HDT). The systemic NOELs are 11.8 and 163 mg/kg/day, for males and
females, respectively, based on decreased body weight gain and
increased relative liver weights at 121 and 569 mg/kg/day (HDT) for
males and females, respectively.
7. A two-generation reproduction study with rats fed dosages of 0,
2.76, 165, or 830 (F0 males); 0, 3.38, 204, or 1,021 (F0
females); 0, 3.66, 217, or 1,316 (F1 males) and 0, 4.29, 264, or
1,316 (F1 females) mg/kg/day with a reproductive NOEL of 165 to
264 mg/kg/day based on a significant increase in the incidence of small
body size and a decrease in the mean body weight of F1 pups at 830
to 1,316 mg/kg/day (HDT) and a systemic NOEL of 165 to 264 mg/kg/day
based on a decreased mean body weight of F1 males, decreased body
weight gain by F0 males, and F0 and F1 females, and
decreased mean daily food consumption by F1 males at 830 to 1,316
mg/kg/day (HDT).
8. A developmental study in rats fed dosages of 0, 200, 700, 2,000
and 6,000 mg/kg/day with no developmental effects or systemic toxicity
under the conditions of the study up to and including 6,000 mg/kg/day
(HDT).
9. A developmental study in rabbits fed dosages of 0, 25, 170, 500,
or 1,500 mg/kg/day with a developmental NOEL of 500 mg/kg/day based on
production of only two viable fetuses at 1,500 mg/kg/day (HDT). The
maternal NOEL was 170 mg/kg/day based on death and reduced body weight
gain at 500 mg/kg/day.
10. Mutagenicity studies included an in vitro gene mutation assay
(CHO/HGPRT) (no evidence of mutagenicity with and without activation at
10 to 1,300 ug/plate); an in vitro unscheduled DNA synthesis in primary
rat hepatocytes (no DNA damage or induced repair evident from 0.0008 to
1.1 mg/ml); a mammalian cell cytogenetics (Human Lymphocytes) assay
(not clastogenic in human lymphocytes at 100-1,300 ug/ml with or
without activation); an in vivo micronucleus assay in mice (did not
induce micronucleated polychromatic erythrocytes at doses from 500 to
5,000 mg/kg; and an in vivo micronucleus test in mice (no significant
differences in the frequency of micronucleated cells were noted in bone
marrow cells).
The RfD based on a NOEL of 1.6 mg/kg/day established in the 1-year
feeding study with dogs and an uncertainy factor of 100 is calculated
to be 0.016 mg/kg/day. The theoretical maximum residue contribution
(TMRC) for these tolerances for the overall U.S. population is 1.47 X
10-4 mg/kg/day or 0.92% of the RfD. The TMRC for the most exposed
subgroups, children (1 to 6 years old) and nonnursing infants (less
than one-year old) were 3.12 X 10-4 and 2.37 X 10-4 mg/kg/
day, respectively, or 1.95% and 1.48% of the RfD, respectively,
assuming the residues are at established tolerance level and that 100
percent of the crop is treated. There are no published tolerances for
rimsulfuron.
The 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. The residue of concern is
rimsulfuron per se. Adequate analytical methodology, high-pressure
liquid chromatography with UV detection, is available for enforcement
purposes. Because of the long lead time between establishing these
tolerances and publication of the enforcement method in the Pesticide
Analytical Manual (PAM), the enforcement methodolgy is being made
available to anyone interested in pesticide enforcement when requested
by mail from: Calvin Furlow, Public Response and 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 reasonable expectation of residues occurring
in meat, milk, poultry, or eggs from these tolerances. 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
tolerances as described below.
Any person adversely affected by this regulation may, within 30
days of 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 of 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 (Oct. 4, 1993; 58 FR 51735), 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
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 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 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, Reporting and
recordkeeping requirements.
Dated: December 14, 1994.
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.
2. By adding new Sec. 180.478, to read as follows:
Sec. 180.478 Rimsulfuron; tolerances for residues.
Tolerances are established for residues of the herbicide
rimsulfuron, N-((4,6-dimethoxypyridin-2-yl)aminocarbonyl)-3-
(ethylsulfonyl)-2-pyridinesulfonamide, in or on the following raw
agricultural commodities:
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Parts per
Commodity million
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Corn, field, fodder........................................ 0.1
Corn, field, forage........................................ 0.1
Corn, field, grain......................................... 0.1
Potatoes, tubers........................................... 0.1
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[FR Doc. 94-31928 Filed 12-27-94; 8:45 am]
BILLING CODE 6560-50-F
