[Federal Register Volume 60, Number 55 (Wednesday, March 22, 1995)]
[Proposed Rules]
[Pages 15109-15111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6932]



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



ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 3E4241/P607; FRL-4941-1]
RIN 2070-AC18


Imazethapyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA proposes to establish tolerances with regional 
registration for the sum of the residues of the herbicide imazethapyr, 
as its ammonium salt, and its metabolite in or on the raw agricultural 
commodities lettuce and endive. The Interregional Research Project No. 
4 (IR-4) requested this proposed regulation.

DATES: Comments, identified by the document control number, [PP 3E4241/
P607], must be received on or before April 21, 1995.

ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA 22202.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). Information so marked will 
not be disclosed except in accordance with procedures set forth in 40 
CFR part 2. A copy of the comment that does not contain CBI must be 
submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice. All 
written comments will be available for public inspection in Rm. 1132 at 
the address given above, from 8 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson, 
Registration Division (7505W), Office of Pesticide Programs, 
Environmental Protection [[Page 15110]] Agency, 401 M St., SW., 
Washington, DC 20460. Office location and telephone number: Sixth 
Floor, Crystal Station #1, 2800 Jefferson Davis Hwy., Arlington, VA 
22202, (703)-308-8783.

SUPPLEMENTARY INFORMATION: The Interregional Research Project No. 4 
(IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231, 
Rutgers University, New Brunswick, NJ 08903, has submitted pesticide 
petition (PP) 3E4241 to EPA on behalf of the vegetable growers of 
Florida. The petition requests that the Administrator, pursuant to 
section 408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a(e), amend 40 CFR 180.447 by establishing tolerances with 
regional registration for residues of the herbicide imazethapyr, 2-
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-
ethyl-3-pyridine carboxylic acid, as its ammonium salt, and its 
metabolite, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-(1-hydroxyethyl-3-pyridine carboxylic acid), free and 
conjugated, in or on the raw agricultural commodities lettuce (head and 
leaf) and endive (escarole) at 0.1 part per million (ppm). The 
petitioner proposed that use of imazethapyr on lettuce and endive be 
limited to Florida based on the geographical representation of the 
residue data submitted. Additional residue data will be required to 
expand the area of usage. Persons seeking geographically broader 
registration should contact the Agency's Registration Division at the 
address provided above.
    The scientific data submitted in the petition and other relevant 
material have been evaluated. The toxicological data considered in 
support of the proposed tolerances include:
    1. Several acute toxicology studies placing technical-grade 
imazethapyr in Toxicity Category III and Toxicity Category IV.
    2. A 1-year feeding study with dogs fed diets containing 0, 1,000, 
5,000, or 10,000 part per million (ppm) with a systemic no-observed-
effect level (NOEL) of 1,000 ppm (25 milligrams (mg)/kilogram (kg)/day) 
based on decreased packed cell volume, hemoglobin, and erythrocytes in 
the blood of female dogs at the 5,000-ppm (125 mg/kg/day) dose level.
    3. A 78-week carcinogenicity study in mice fed diets containing 0, 
1,000, 5,000 or 10,000 ppm (equivalent to 0, 150, 750, or 1,500 mg/kg/
day) with a systemic NOEL of 5,000 ppm based on decreased body weight 
gain in both sexes at the 10,000-ppm dose level. No carcinogenic 
effects were observed under the conditions of the study.
    4. A 2-year chronic feeding/carcinogenicity study in rats fed diets 
containing 0, 1,000, 5,000, or 10,000 ppm (equivalent to 0, 50, 250, or 
500 mg/kg/day) with no treatment-related systemic or carcinogenic 
effects observed under the conditions of the study.
    5. A multi-generation reproduction study in rats fed diets 
containing 0, 1,000, 5,000, or 10,000 ppm (equivalent to 0, 50, 250, or 
500 mg/kg/day) with no treatment-related systemic or reproductive 
effects observed under the conditions of the study.
    6. Developmental toxicity studies in rats and rabbits with no 
developmental toxicity observed under the conditions of the studies at 
dose levels up to and including the highest dose tested (1,125 mg/kg/
day in rats and 1,000 mg/kg/day in rabbits).
    7. Mutagenicity studies include gene mutation assays in bacteria 
cells (negative) and Chinese hamster ovary cells (no dose-response); 
structural chromosomal aberration assays in vivo in rat bone marrow 
cells (negative) and in vitro in Chinese hamster ovary cells (positive 
without activation at levels toxic to cells and negative with 
activation); and other genotoxic effects (did not induce unscheduled 
DNA synthesis in rat hepatocytes cultured in vitro).
    The reference dose (RfD) for imazethapyr is established at 0.25 mg/
kg body weight/day. The RfD is based on a NOEL of 25 mg/kg/day 
established in the 1-year feeding study in dogs and an uncertainty 
factor of 100. The theoretical maximum residue contribution (TMRC) from 
existing uses and the proposed uses on lettuce and endive utilizes less 
than 1 percent of the RfD for the general population and all 22 
subgroup populations for which EPA routinely conducts dietary risk 
assessments. This is a worst-case estimate of dietary exposure which 
assumes tolerance level residues and treatment of the total production 
acreage of the commodities. The dietary risk assessment indicates that 
there is minimal risk from the establishment of the proposed tolerances 
for lettuce and endive.
    The nature of residues in lettuce and endive is adequately 
understood for the purposes of establishing the proposed tolerances. An 
adequate analytical method is available for enforcement purposes. The 
enforcement methodology has been submitted to the Food and Drug 
Administration for publication in the Pesticide Analytical Manual, Vol. 
II (PAM II). Because of the long lead time for publication of the 
method in PAM II, the analytical methodology is being made available in 
the interim to anyone interested in pesticide enforcement when 
requested from: Calvin Furlow, Public Response and Program Resources 
Branch, Field Operations Divisions (7506C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: Rm. 1132, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-5937.
    No secondary residues are expected to occur in meat, milk, poultry, 
or eggs from this action since lettuce and endive are not considered 
livestock feed commodities.
    There are currently no actions pending against the continued 
registration of this chemical.
    Based on the information and data considered, the Agency has 
determined that the tolerances established by amending 40 CFR 180.447 
would protect the public health. Therefore, it is proposed that the 
tolerances be established as set forth below.
    Any person who has registered or submitted an application for 
registration of a pesticide, under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA) as amended, which contains any of the 
ingredients listed herein, may request within 30 days after publication 
of this document in the Federal Register that this rulemaking proposal 
be referred to an Advisory Committee in accordance with section 408(e) 
of the FFDCA.
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
document control number, [PP 3E4241/P607]. All written comments filed 
in response to this petition will be available in the Public Response 
and Program Resources Branch, at the address given above from 8 a.m. to 
4 p.m., Monday through Friday, except legal holidays.
    Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency 
must determine whether the regulatory action is ``significant'' and 
therefore subject to all the requirements of the Executive Order (i.e., 
Regulatory Impact Analysis, review by the Office of Management and 
Budget (OMB)). Under section 3(f), the order defines ``significant'' as 
those actions likely to lead to 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 known as ``economically 
significant''); (2) creating serious inconsistency or 
[[Page 15111]] 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 (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 this 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).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 8, 1995.

Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR part 180 be 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. 180.447, by adding new paragraph (d), to read as 
follows:


Sec. 180.447   Imazethapyr, ammonium salt; tolerance for residues.

*    *    *    *    *
    (d) Tolerances with regional registration, as defined in 
Sec. 180.1(n) of this chapter, are established for the sum of residues 
of the herbicide imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-
methylethyl)-5-oxo-1H-imidazol-2-yl]-5-ethyl-3-pyridine carboxylic 
acid, as its ammonium salt, and its metabolite, 2-[4,5-dihydro-4-
methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-(1-hydroxyethyl)-3-
pyridine carboxylic acid, both free and conjugated, in or on the 
following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
Endive (escarole)..........................................          0.1
Lettuce (head and leaf)....................................          0.1
------------------------------------------------------------------------


[FR Doc. 95-6932 Filed 3-21-95; 8:45 am]
BILLING CODE 6560-50-F