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Propiconazole (Tilt) - Proposed Pesticide Tolerances 10/95

[Federal Register: November 16, 1995 (Volume 60, Number 221)]
[Notices]
[Page 57570-57571]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 2E4037 and 5E4437/P635; FRL-4983-3]
RIN 2070-AC18
1-[[2-(2,4-Dichlorophenyl)-4- Propyl-1,3-Dioxolan-2-yl]Methyl]-1H-1,2,4-
   Triazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish tolerances for residues of the
fungicide 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2yl]methyl]-
1H-1,2,4-triazole (also called propiconazole) and its metabolites
determined as 2,4-dichlorobenzoic acid and expressed as parent compound
in or on the raw agricultural commodities mint tops (leaves and stems)
at 0.3 part per million (ppm) and mushrooms at 0.1 ppm. The
Interregional Research Project No. 4 (IR-4) submitted petitions under
the Federal Food, Drug and Cosmetic Act (FFDCA) requesting that EPA
establish maximum permissible levels for residues of propiconazole in
or on the commodities.

DATES: Comments, identified by the document control number [PP 2E4037
and 5E4437/P635], must be received on or before December 15, 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. Comments and data may
also be submitted to OPP by sending electronic mail (e-mail) to:
opp-docket@epamail.epa.gov
    Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comments and data
will also be accepted on disks in WordPerfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by docket numbers [PP 2E4037 and 5E4437/P635]. Electronic
comments on this proposed rule may be filed online at many Federal
Depository Libraries. Additional information on electronic submissions
can be found in the SUPPLEMENTARY INFORMATION section of this document.
    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 should not be submitted
through e-mail. Information marked as CBI 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 4:30 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 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; e-mail:
jamerson.hoyt@epamail.epa.gov.

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 to EPA
pesticide petitions, PP 2E4037 and PP 5E4437, on behalf of the named
Agricultural Experiment Stations. The petitions request 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 180.434 by
establishing tolerances for residues of 1-[[2-(2,4-dichlorophenyl)-4-
propyl-1,3-dioxolan-2yl]methyl]-1H-1,2,4-triazole and its metabolites
determined as 2,4-dichlorobenzoic acid and expressed as parent compound
in or on certain raw agricultural commodities as follows:
    1. PP 2E4037. Petition submitted on behalf of the Agricultural
Experiment Station of Oregon proposing a tolerance for mint tops
(leaves and stems) at 0.3 ppm. The petitioner proposed that use of
propiconazole on mint be limited to mint production areas west of the
Cascade Mountains based on the geographical representation of the
residue data submitted. Additional residue data will be required to
expand the area of usage. Persons seeking broader registration should
contact the Agency's Registration Division at the address provided
above.
    2. PP 5E4437. Petition submitted on behalf of the Agricultural
Experiment Station of Pennsylvania proposing a tolerance for mushrooms
at 0.1 ppm.
    The scientific data submitted in the petitions and other relevant
material have been evaluated. The toxicological data considered in
support of the proposed tolerances include:
    1. A 1-year feeding study with dogs, which were fed diets
containing 0, 5, 50, or 250 ppm, with a no-observed-effect level (NOEL)
of 50 ppm (equivalent to 1.25 mg/kg/day). Mild irritation of stomach
mucosa was observed at the 250- ppm dose level.
    2. A developmental toxicity study with rabbits, which were given
gavage doses of 0, 30, 90, or 180 mg/kg/day, with no evidence of
maternal or developmental toxicity observed under the conditions of the
study.
    3. A second developmental toxicity study in rabbits, which were
given gavage doses of 0, 100, 250, or 400 mg/kg/day on gestation days 7
through 19, with no developmental toxicity observed under the
conditions of the study. The NOEL for maternal toxicity for this study
is established at 100 mg/kg/day based on decreased food consumption,
weight gain, and an increase in the number of resorptions at the higher
dose levels.
    4. A developmental toxicity study with rats, which were given
gavage doses of 0, 30, 100, or 300 mg/kg/day, with no developmental
toxicity observed under the conditions of the study. The NOEL for maternal
toxicity for this study is established at 100 mg/kg/day based on decreased
body weight gain and food consumption in rats from the high-dose group. The
NOEL for fetotoxicity (ossification retardation) is established at 30
mg/kg/day.
    5. A second developmental toxicity study with rats, which were
given gavage doses of 0, 30, 90, or 360/300 mg/kg/day, with a NOEL for
developmental toxicity of 30 mg/kg/day. Evidence of developmental
toxicity observed at the 90 mg/kg/day level includes increased
incidence of unossified sternebrae, rudimentary ribs, and shortened or
absent renal papillae.
    6. A two-generation reproduction study with rats, which were fed
diets containing 0, 1, 100, 500, or 2,500 ppm, with no reproductive
effects observed under the conditions of the study. The NOEL for
developmental toxicity is established at 500 ppm (equivalent to 25 mg/
kg/day) based on decreased offspring survival, body weight depression,
and increased incidence of hepatic lesions in rats at the 2,500-ppm
level.
    7. A 2-year chronic feeding/carcinogenicity study with rats fed
diets containing 0, 100, 500, or 2,500 ppm with a systemic NOEL of 100
ppm (equivalent to 5 mg/kg/day) based on hepatocyte changes in males at
the 500-ppm level and in both sexes at the 2,500-ppm level. There were
no carcinogenic effects observed under the conditions of the study.
    8. A 2-year chronic feeding/carcinogenicity study with mice, which
were fed diets containing 0, 100, 500, or 2,500 ppm, with a systemic
NOEL of 100 ppm (equivalent to 15 mg/kg/day) based on decreased body
weight, and increased liver lesions and liver weight in males. There
was a statistically significant increase in combined adenomas and
carcinomas of the liver in male mice at the 2,500-ppm level (equivalent
to 375 mg/kg/day).
    9. A battery of mutagenicity studies to determine propiconazole's
potential for gene mutation, chromosomal aberrations, and other
genotoxic effects were all negative.
    Propiconazole is classified as a possible human carcinogen (Group
C) by the Office of Pesticide Programs' Health Effects Division's
Carcinogenicity Peer Review Committee. (See the Federal Register of May
25, 1994 (59 FR 26948) for additional information regarding EPA's
evaluation of the carcinogenicity potential of propiconazole.) Based on
the weight of evidence, EPA has, therefore, chosen to use the reference
dose (RfD) to estimate dietary risk from propiconazole residues.
    The reference dose is established at 0.013 mg/kg/day, based on a
NOEL of 1.25 mg/kg of body weight/day and an uncertainty factor of 100.
The NOEL is taken from a 1-year feeding study in dogs which
demonstrates irritation of the stomach in males as an endpoint effect.
The Agency has evaluated dietary exposure to the propiconazole residues
based the anticipated residue contribution (ARC) from certain existing
tolerances and the theoretical maximum residue contribution (TMRC) from
other existing tolerances and the proposed tolerances for mushrooms and
mint. The TMRC assumes that 100 percent of the crops are treated and
that the resulting residues are at tolerance levels. The ARC estimates
expected dietary exposure based on actual residue levels that are
anticipated on the treated commodities and/or the estimated percent of
the crop treated.
    Dietary exposure to residues of propiconazole from existing uses
and the proposed uses on mushrooms and mint is estimated at 0.000630
mg/kg/day (5 percent of the RfD) for the general population, or
0.002020 mg/kg/day (16 percent of the RfD) for nonnursing infants, less
than 1-year-old. The dietary risk assessment indicates that there is no
appreciable risk from established tolerances and the proposed
tolerances for mushrooms and mint.
    The nature of the residue in plants is adequately understood for
the purposes of the proposed tolerances. Adequate analytical methods
are available for enforcement purposes. Because of the long lead time
from establishing these tolerances to publication of the enforcement
methods in the Pesticide Analytical Manual, Vol. II, the analytical
methods are being made available to anyone with an interest 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.
    There is no reasonable expectation that secondary residues will
occur in meat, milk, poultry or eggs since there are no livestock feed
items associated with the proposed tolerances.
    There are presently 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 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 notice in the Federal Register that this rulemaking proposal be
referred to an Advisory Committee in accordance with section 408(e) of
the FFDCA.
    A record has been established for this rulemaking under docket
numbers [PP 2E4037 and 5E4437/P635] (including comments and data
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 Rm. 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.
    Electronic comments can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
    Electronic comments 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 described above will be kept in paper form. Accordingly,
EPA will transfer all comments 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 comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ADDRESSES at the beginning of
this document.
    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 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: October 24, 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. 180.434, paragraph (a) is amended in the table therein
by adding and alphabetically inserting an entry for mushrooms, and
paragraph (b) is amended in the table therein by adding and
alphabetically inserting an entry for mint, to read as follows:

Sec. 180.434   1 - [[2 - (2,4 - dichlorophenyl) - 4 - propyl - 1,3 -
dioxolan - 2 - yl]methyl] - 1H - 1,2,4 - triazole; tolerances for
residues.

    (a) *  *  *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
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Mushrooms..................................................     0.1
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    (b) *  *  *

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                                                              Parts per
                         Commodity                             million
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Mint, tops (leaves and stems)..............................     0.3
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* * * * *