[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:

------------------------------------------------------------------------
                                                              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