[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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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: [email protected]. 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: [email protected].

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 Q1* 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 

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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.


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    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