[Federal Register Volume 61, Number 35 (Wednesday, February 21, 1996)]
[Rules and Regulations]
[Pages 6551-6554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-3721]
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[[Page 6552]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5F4476/R2203; FRL-5350-6]
RIN 2070-AB78
Hexythiazox; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Rule.
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SUMMARY: This document establishes a tolerance for the combined
residues of the acaricide hexythiazox, trans-5-(4-chlorophenyl)-N-
cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide and its metabolites
containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety
(expressed as parts per million of the parent compound), in or on the
raw agricultural commodity apples. Gowan Company requested this
regulation to establish a maximum permissible level for residues of the
acaricide pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA).
EFFECTIVE DATE: This regulation becomes effective February 21, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [PP 5F4476/R2203], may be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. A copy of any objections and hearing
requests filed with the Hearing Clerk should be identified by the
docket 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
requests to: Rm. 1132, CM #2, 1921 Jefferson Davis Highway, Arlington,
VA. 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.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number [PP
5F4476/R2203]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of objections and hearing
requests on this rule may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions can be
found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: George LaRocca, Product
Manager (PM) 13, Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location, telephone number, and e-mail address: Rm.
204, CM #2, 1921 Jefferson Davis Highway, Arlington, VA, (703) 305-
6100; e-mail: larocca.george@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of May 3 1995 (60 FR 21815), which announced that
Gowan Company, P.O. Box 5569, Yuma, AZ 85366-5569, had submitted a
pesticide petition (PP 5F4476) to EPA requesting the Administrator,
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(d), to establish a tolerance for the combined
residues of the acaricide hexythiazox, trans-5-(4-chlorophenyl)-N-
cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide and its metabolites
containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety
(expressed as parts per million of the parent compound), in or on the
raw agricultural commodity apples at 0.05 parts per million (ppm). In a
letter dated October 10, 1995, Gowan requested that the pesticide
petition be amended by proposing a lower tolerance on apples at 0.02
ppm. No comments were received in response to the notice of filing.
The data submitted in support of this tolerance and other relevant
material have been reviewed. The toxicological and metabolism data
considered in support of this tolerance are discussed in detail in a
related document published in the Federal Register of April 26, 1989
(54 FR 17947).
The Agency has classified hexythiazox as a class C (possible human)
carcinogen based on a significantly increased incidence of
hepatocellular carcinomas (p=0.028), and adenomas/carcinomas combined
(p=0.024) in female mice at the highest dose tested (1,500 ppm) when
compared to the controls as well as a significantly increased (p<0.001) incidence="" of="" preneo-plastic="" hepatic="" nodules="" in="" both="" males="" and="" females="" at="" the="" highest="" dose="" tested="" (1,500="" ppm).="" the="" decision="" supporting="" a="" category="" c="" classification="" (rather="" than="" a="" category="" b)="" was="" based="" primarily="" on="" the="" fact="" that="" only="" one="" species="" was="" affected="" (mouse),="" mutagenicity="" assays="" did="" not="" support="" upgrading="" to="" a="" b="" classification,="" and="" structure-activity="" relationship="" of="" hexythiazox="" to="" other="" compounds="" supported="" a="" c="" classification.="" in="" classifying="" hexythiazox="" as="" a="" category="" c="" carcinogen,="" the="" agency="" concluded="" that="" a="" quantitative="" estimate="" of="" the="" carcinogenic="" potential="" for="" humans="" should="" be="" calculated="" because="" of="" the="" increased="" incidence="" of="" malignant="" liver="" tumors="" in="" the="" female="" mouse.="" thus,="" a="">1* of 3.9 x 10-2 (mg/kg/day)-1 in human
equivalents has been calculated.
A full review of the data indicates that although hexythiazox is a
carcinogen in mice, the risks would be extremely small from the
proposed use on apples. Estimated dietary carcinogenic risk to the
general population based on the highly conservative assumption that all
apples are treated with hexythiazox and would bear residues at the
proposed tolerance level is estimated to be 2 x 10-6. This is
slightly higher than 1 x 10-6 a level which is generally
considered of negligible risk concern by the Agency. The Agency
believes that actual exposure and risk would be lower. The basis for
this is that the risk estimate reflects a worst-case dietary exposure
because it assumes that 100 percent of all apples consumed in the
United States are treated with hexythiazox and that all quantities of
the food consumed would bear residues levels as high as the proposed
tolerance. In reality, the Agency knows that all apples would not be
treated with this pesticide and expect that even apples receiving
maximum treatment will have residues far below tolerance level. For
example, in field trials conducted using application rates 10 times the
label amount, residues in apples still did not exceed the tolerance
level. Further, the maximum residue level in apple juice would be
expected to be less than 50 percent of the residue level in whole
fruit.
Based on an assessment of the cancer risks of the proposed use of
hexythiazox, the Agency believes that the proposed use of hexythiazox
on apples will pose an extremely small risk to humans.
A chronic dietary exposure/risk assessment has been performed for
hexythiazox using a Reference Dose (RfD) of 0.025 mg/kg-bwt/day. The
RfD was based on a NOEL of 2.5 mg/kg/day from a 1-year dog feeding
study and a safety factor of 100. The endpoint effect of concern was
hypertrophy of the adrenal cortex in both sexes, decreased red blood
cell counts, hemoglobin content and hematocrit in males. The
[[Page 6553]]
analysis was performed using tolerance level residues and 100% crop
treated information. The exposure for established tolerances and the
current action is estimated at 0.000051 mg/kg-bwt/day and utilizes 0.2%
of the RfD for the U.S. population. For non-nursing infants less than 1
year old (the sub-group population with the highest exposure level),
the exposure for established tolerances and the current action is
estimated at 0.000600 mg/kg-bwt/day and utilizes 2.4% of the RfD.
Generally speaking, the Agency has no concern if dietary exposure is
less than the RfD for all published and proposed tolerances.
The nature and metabolism of the chemical in plants and animals for
the use is adequately understood. Since the petitioner has included the
label restriction ``Do not graze or feed livestock on cover crops
growing in treated areas'' and hexythiazox animal feeding studies
indicate that there is no reasonable expectation of finite residue
transfer to meat, milk, poultry and eggs, no secondary residues in meat
or milk are expected. Adequate analytical methodology (gas liquid
chromatography with an electron capture detector) 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 Resource Branch, Field Operations Division (7506C), Office of
Pesticide Programs, U.S. 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, (703) 305-5232.
The tolerances established by amending 40 CFR part 180 will be
adequate to cover residues in or on apples. 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 tolerance established by amending 40 CFR 180 would protect the
public health. Therefore, it is proposed that the tolerance be
established as set forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections and/or request a hearing 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 such issues, 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 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 or 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).
A record has been established for this rulemaking under docket
number [PP 5F4476/R2203] (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper version 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,
Crystall 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, 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.
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: February 8, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 continues to read as follows:
PART 180--[AMENDED]
1. The authority citation of part 180 continues to read as follows:
Authority: 21 U.S.C. 346a.
[[Page 6554]]
2. By amending Sec. 180.448 in the table therein and alphabetically
inserting an entry for apples, to read as follows:
Sec. 180.448 Hexythiazox; tolerances for residues.
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Commodity Parts per million
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Apples.................................... 0.02
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[FR Doc. 96-3721 Filed 2-20-96; 8:45 am]
BILLING CODE 6560-50-F
