[Federal Register Volume 61, Number 21 (Wednesday, January 31, 1996)]
[Proposed Rules]
[Pages 3363-3365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1917]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 0E3853/P640; FRL-4993-6]
RIN 2070-AC18
Pesticide Tolerance for Hexaconazole
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish a time-limited tolerance, to expire
on (3) years after the signature date of the final rule), for residues
of the fungicide hexaconazole, [alpha-butyl-alpha-(2,4-dichloro-
phenyl)-1H-1,2,4-triazole-1-ethanol)], in or on the imported raw
agricultural commodity bananas at 0.1 part per million (ppm). Zeneca
Agrochemicals Products (Zeneca) petitioned for this regulation to
establish a maximum permissible level for residues of the fungicide.
DATES: Comments, identified by the document control number [PP 0E3853/
P488], must be received on or before March 1, 1996.
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 a copy of the comments to Rm.
1132, CM #2, 1921 Jefferson Davis Highway., Arlington, VA 22202.
Information submitted as a comment concerning this notice 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.
Comments and data may also be submitted electronically 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 the
docket number, ``[PP 0E3853/P640].'' No Confidential Business
Information (CBI) should be submitted through e-mail. Electronic
comments on this proposed rule may be filed online at many Federal
Depository Libraries. Additional information on electronic submissions
can be found below.
FOR FURTHER INFORMATION CONTACT: By mail: Connie B. Welch, Product
Manager (PM) 21, Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 227, CM #2, 1921
Jefferson Davis Highway., Arlington, VA 22202, (703) 305-6900, e-mail:
welch.connie@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA is proposing to establish a time-limited
tolerance for residues of the fungicide hexaconazole, [(alpha-butyl-
alpha-(2,4-dichlorophenyl)-1H-1,2,4-triazole-1-ethanol)], in or on the
raw agricultural commodity bananas at 0.1 part per million (ppm). The
proposed regulation to establish a maximum permissible level of the
fungicide pursuant to section 408(e) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a, by amending 40 CFR part 180 to
include this commodity was requested in a petition (0E3853) submitted
by Zeneca, New Murphy Road, Concord Pike, Wilmington, DE 19897. The
scientific data submitted in the petition and other relevant material
have been evaluated. The toxicological data
[[Page 3364]]
considered in support of the proposed tolerance include the following:
1. In a 2-year feeding study in rats, hexaconazole was tested at
10, 100 and 1,000 ppm (equivalent to 0.47, 4.7 and 47 mg/kg/day in
females and 0.61, 6.1 and 61 mg/kg/day in males). The no-observed-
effect level (NOEL) was established at 100 ppm (equivalent to 0.61 and
0.47 mg/kg/day in males and females, respectively) for body weight gain
reduction and liver pathology (centrilobular fatty changes and
hypertrophy).
2. A 1-year dog feeding study using doses of 2, 10 and 50 mg/kg/
day, tested hexaconazole in male and female Beagle dogs. The chemical
was administered in gelatin capsules. The NOEL was established at 2 mg/
kg/day based upon fatty infiltration of the liver and increased liver
weight.
3. In a developmental toxicity study, hexaconazole was tested at
2.5, 25 and 250 mg/kg/day in Wistar rats. The NOEL/LOEL for maternal
toxicity were considered to be 25 and 250 mg/kg/day based upon reduced
body weight gain. The LOEL for developmental toxicity was established
at 25 mg/kg/day based upon delayed skeletal ossification and increased
incidence of the 14th rib (bilateral). The NOEL for developmental
toxicity was found to be 2.5 mg/kg/day.
In two developmental toxicity studies involving New Zealand White
rabbits, hexaconazole was tested at 25, 50 and 100 mg/kg/day. The NOEL/
LOEL for maternal toxicity were established at 50 and 100 mg/kg/day
based upon reduced maternal body weight gain. The NOEL/LOEL for
developmental toxicity were considered to be 25 and 50 mg/kg/day based
upon decreased mean fetal body weight.
The Agency is requiring an occupational exposure risk assessment
based on the NOEL of 2.5 mg/kg/day demonstrated in the developmental
toxicity study in rats, as well as, an acute dietary exposure study in
rats.
4. In a 2-generation reproduction study in Wistar rats, the
chemical was tested at 20, 100 and 1,000 ppm (equivalent to 1, 5 and 50
mg/kg/day). On the basis of abnormal liver pathology, a systemic NOEL
was set at 20 ppm. The NOEL/LOEL for reproductive toxicity were
established at 100 and 1,000 ppm based upon decreased weight gain and
survival in pups. Reproductive toxicity of hexaconazole was considered
minimal.
5. From a 2-year carcinogenicity study in Wistar rats, hexaconazole
was classified as a Group C (possible Human) carcinogen with a Q1*
of 0.023 mg/kg/day based on testicular Leydig cell tumors. This
classification was recommended based upon a statistically significant
increase in benign Leydig cell tumors, with a positive dose-related
trend in rats. Moreover, the Leydig cell tumor is an uncommon tumor in
this strain of rats, and occurred at an accelerated rate and at a dose
level below what would be considered an adequate level to determine the
carcinogenic potential of hexaconazole. There was also some indication
of marginal increases in liver cell tumors in mice. The classification
was further supported by structural similarity of hexaconazole to other
triazole pesticides known for their potential as liver carcinogens in
mice.
6. The Reference Dose (RfD) value for use in dietary exposure
analysis was 0.02 mg/kg body weight(bwt)/day, basis of a NOEL of 2 mg/
kg bwt/day and an uncertainty factor of 100. This NOEL was derived from
a 1-year feeding study in dogs that showed increased liver weight
accompanied by fatty infiltration of the liver observed at 10 mg/kg/
day.
7. A chronic dietary exposure analysis for use of hexaconazole in/
on imported bananas was performed to estimate the Theoretical Maximum
Residue Contribution (TMRC) for the general population and 22
population subgroups. Results show the TMRC and %RfD for the U.S.
population is 0.023 g/kg/day and 0.11% for the RfD,
respectively. The highest exposed subgroup is non-nursing infants (<1 year="" old)="" for="" which="" tmrc="" and="" %rfd="" are="" 0.108="">g/kg/day and
0.45%, respectively.
The Agency concluded from this analysis that chronic dietary risk
is not a concern.
8. From cancer risk assessment, the upper-bound carcinogenic risk
from food uses of hexaconazole for the general U.S. population as
calculated using the following equation:
Upper Bound Cancer Risk = Dietary Exposure (TMRC) x Q1*
Based on a Q1* of 0.023 (mg/kg/day)-1 the upper bound cancer
risk was calculated to be 5.3 x 10-7, contributed by the upper
bound excess lifetime carcinogenic risk appears to be below the range
that the Agency generally considers to be negligible.
9. Mutagenicity assays including an Ames test, an invitro
cytogenetics assay in human lymphocytes, an assay for unscheduled DNA
synthesis in rat hepatocytes, and a micronucleus assay in mice were
conducted on this chemical. The results of these tests produced no
evidence of mutagenicity due to hexaconazole.
Acute toxicity testing is not required for import tolerances and
those data are not presented here.
The nature of the residue in bananas is adequately understood. The
residue to be regulated is parent hexaconazole. Based on the residue
data submitted which reflected application to bagged bananas (the
typical agricultural practice in the countries of origin), residue
levels in bananas treated with hexaconazole are not likely to exceed
the requested 0.1 ppm tolerance. However, the Agency's current practice
is to review data on unbagged bananas as well as bagged bananas to
insure that a worst case scenario is examined. Therefore, the
petitioner is required to conduct at least four residue trials on
unbagged bananas. Ample time is provided for completion of these trials
over the duration of this proposed time-limited tolerance.
Adequate analytical methodology is available for enforcement. Prior
to their publication in the Pesticide Analytical Manual, Vol. II, the
enforcement methodology is being made available in the interim to
anyone who is interested in pesticide enforcement when requested from:
Calvin Furlow, Public Information Branch, Field Operations Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location and telephone
number: Rm 1128C, CM #2, 1921 Jefferson Davis Highway, Arlington, VA
22202, (703) 305-5232.
The pesticide is considered useful for the purpose for which the
tolerance is sought. Based on the information and data considered, the
Agency has determined that the tolerance established by amending 40 CFR
part 180 will protect the public health. Therefore, the tolerances are
established as set forth below. By way of public reminder, this notice
also reiterates the registrant's responsibility under section 6(a)(2)
of FIFRA, to submit additional factual information regarding adverse
effects on the environment and to human health by these pesticides.
Public Docket
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.
[[Page 3365]]
Interested persons are invited to submit written comments on the
proposed regulation. A record has been established for this rulemaking
under docket number [PP 0E3853/P640] (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 Room 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.
Administrative Assessment Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 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.
B. Regulatory Flexibility Act
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: January 17, 1996.
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. By adding new Sec. 180.488, to read as follows:
Sec. 180.488 Hexaconazole; tolerance for residues.
A tolerance is established for residues of the fungicide
hexaconazole, [alpha-butyl-alpha-(2,4-dichloro-phenyl)-1H-1,2,4-
triazole-1-ethanol)], in or on the imported raw agricultural commodity
bananas at 0.1 part per million. This tolerance will expire on [ 3
years after the signature date of the final rule]. There are no U.S.
registrations as of January 31, 1996 for use on bananas.
[FR Doc. 96-1917 Filed 1-30-96; 8:45 am]
BILLING CODE 6560-50-F
