[Federal Register Volume 65, Number 250 (Thursday, December 28, 2000)]
[Notices]
[Pages 82349-82352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-33174]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-990; FRL-6761-6
Notice of Filing a Pesticide Petition to Establish a Tolerance
for a Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket control number PF-990, must be
received on or before January 29. 2001.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure
proper receipt by EPA, it is imperative that you identify docket
control number PF-990 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers,
Registration Division (7505C, Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 308-3194; e-mail address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
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Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number PF-990. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as confidential business information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. The public version of the official record, which
includes printed, paper versions of any electronic comments submitted
during an applicable comment period, is available for inspection in the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number PF-990 in the subject line on the
first page of your response.
1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
3. Electronically. You may submit your comments electronically by
e-mail to: [email protected], or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket control number PF-990. Electronic comments may
also be filed online at many Federal Depository Libraries.
D. How Should I Handle CBI That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version
[[Page 82350]]
of the official record without prior notice. If you have any questions
about CBI or the procedures for claiming CBI, please consult the person
identified under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
control number assigned to this action in the subject line on the first
page of your response. You may also provide the name, date, and Federal
Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in section 408(d)(2); however, EPA has
not fully evaluated the sufficiency of the submitted data at this time
or whether the data support granting of the petition. Additional data
may be needed before EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: December 22, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide petition is printed below
as required by section 408(d)(3) of the FFDCA. The summary of the
petition was prepared by the petitioner and represents the view of the
petitioners. EPA is publishing the petition summary verbatim without
editing it in any way. The petition summary announces the availability
of a description of the analytical methods available to EPA for the
detection and measurement of the pesticide chemical residues or an
explanation of why no such method is needed.
Research Project Number 4 and Gowan Company
0E6198 and 0E6215
EPA has received pesticide petitions (0E6198 and 0E6215) from the
Interregional Research Project Number 4 (IR-4), Technology Centre of
New Jersey, 681 U.S. Highway #1 South, North Brunswick, New Jersey
08902-3390 proposing, pursuant to section 408(d) of the FFDCA, 21
U.S.C. 346a(d), to amend 40 CFR part 180 by establishing tolerances for
residues of the miticide, 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 (ppm) of the parent
compound in or on the following raw agricultural commodities (RAC) at
the tolerance levels listed:
PP 0E6198 proposes the establishment of a tolerance for
mint at 2.0 ppm.
PP 0E6215 proposes the establishment of a tolerance for
the caneberry subgroup at 1.0 ppm.
EPA has determined that the petitions contain data or information
regarding the elements set forth in section 408(d)(2) of the FFDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data support granting of the
petitions. Additional data may be needed before EPA rules on these
petitions. This notice includes a summary of the petitions prepared by
Gowan Company, POB 5569, Yuma AZ 85366-5569.
A. Residue Chemistry
1. Plant metabolism. The metabolism of hexythiazox as well as the
nature of the residues in plants is adequately understood for purposes
of these tolerances. Metabolism studies were conducted in four crops,
viz.; pears, grapes, citrus, and apples. The major residue component is
unmetabolized parent. The metabolites are hydroxylcyclohexyl, and
ketocyclohexyl analogs of hexythiazox, and the amide formed by loss of
the cyclohexyl ring. Parent hexythiazox and its metabolites are
converted to a common moiety for residue analysis.
2. Analytical method. A practical analytical method, high pressure
liquid chromatography with a ultraviolet ray (UV) detector which
detects and measures residues of hexythiazox and its metabolites as a
common moiety, is available for enforcement purposes with a limit of
detection that allows monitoring of food with residues at or above the
levels set in these tolerances.
3. Magnitude of residues. Hexythiazox was applied to mint in
eastern Washington to support the proposed use. Two trials were
conducted on spearmint and 1 on peppermint. There was no concentration
of hexythiazox in the processed commodity, mint oil. This data support
the proposed tolerance of 2.0 ppm on mint. Hexythiazox was applied to
caneberries in Pennsylvania, Michigan, Washington, and Oregon to
support the proposed use. Four trials were conducted on red raspberries
and one on blackberries. The data support the proposed tolerance of 1.0
ppm in or on caneberries.
B. Toxicological Profile
1. Acute toxicity. A battery of acute toxicity studies places
technical grade hexythiazox in toxicity category IV for acute oral
lethal dose LD50 (LD50 >5,000 milligrams/kilogram
(mg/kg)), category III for dermal LD50 (LD50
>5,000 mg/kg), category III for inhalation lethal concentration
(LC)50 (LC50>2.0 mg/L), category III for primary
eye irritation (showed mild irritation (reddened conjunctiva)), and
category IV for dermal irritation (non irritant). Hexythiazox is a non-
sensitizer. Acute toxicological studies place technical grade
hexythiazox in toxicology category III.
2. Genotoxicity. The following genotoxicity studies were all
negative: Ames gene mutation, chinese hamster ovary (CHO) gene
mutation, chromosome aberration, mouse micronucleus, and rat hepatocyte
unscheduled DNA synthesis.
3. Reproductive and developmental toxicity. In a developmental
toxicity study in rats, the maternal no observed adverse effect level
(NOAEL) was 240 mg/kg/day and the maternal lowest observed adverse
effect level (LOAEL) was 720 mg/kg/day based on increased ovarian
weights and decreased bone ossification.
In a developmental toxicity study in rabbits, the maternal NOAEL
was 1,080 mg/kg/day highest dose tested (HDT); the maternal LOAEL was
not determined. In a 2-generation reproduction study in rats, the
parental
[[Page 82351]]
NOAEL was 35 mg/kg/day and the parental LOAEL was 200 mg/kg/day based
on decreased body weight (bwt) gain, decreased food consumption and
efficiency, and increased liver, kidney and ovarian weights. The
reproductive NOAEL was 35 mg/kg/day and the reproductive LOAEL was 200
mg/kg/day based on decreased pup bwt during lactation, delayed hair
growth and eye opening.
4. Subchronic toxicity. In a 1-month feeding study in dogs, the
NOAEL was 1.75 mg/kg/day and the LOAEL was 12.5 mg/kg/day, based on
increased liver, and adrenal weights.
5. Chronic toxicity. In a 1-year feeding study in dogs, the NOAEL
was 2.5 mg/kg/day and the LOAEL was 12.5 mg/kg/day, based on increased
alkaline phosphatase, increased adrenal, and liver weights, liver, and
adrenal lesions. In a carcinogenicity study in mice, the NOAEL was 36
mg/kg/day and the LOAEL was 215 mg/kg/day. Effects were decreased bwt
in males and increased hepatocellular carcinomas and combined adenoma/
carcinomas.
In a chronic feeding/carcinogenicity study in rats, the NOAEL
(systemic) was 26 mg/kg/day and the LOAEL (systemic) was 180 mg/kg/day
based on decreased bwt gain, and increased liver weights in both sexes.
The chronic reference dose (RfD) for hexythiazox is based on the 1-
year dog feeding study with a NOAEL of 2.5 mg/kg/day and an uncertainty
factor of 100. The Agency has classified hexythiazox as a category C
(possible human) carcinogen based on an increased incidence of
hepatocellular carcinomas (p = 0.028) and combined adenomas/carcinomas
(p = 0.024) in female mice at the HDT (1,500 ppm) when compared to the
controls as well as a significantly increased (p <0.001) incidence of
pre-neoplastic hepatic nodules in both males and females at the HDT.
The decision supporting a category C classification was based primarily
on the fact that only one species was affected and mutagenicity studies
were negative. 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 liver tumors in the female mouse. A Q1* of
0.022 (mg/kg/day)-1 in human equivalents was published in
the Federal Register, October 16, 1998, 63FR 55540 (FRL-6035-2).
6. Animal metabolism. The metabolism of hexythiazox has been
studied in goats, hens, and rats. Metabolic pathways in the animal are
similar to those in plants.
7. Metabolite toxicology. There are no metabolites of toxicological
concern based on a differential metabolism between plants and animals.
8. Endocrine disruption. No specific tests have been conducted with
hexythiazox to determine whether the chemical may have an effect in
humans that is similar to an effect produced by a naturally occurring
estrogen or other endocrine effects. However, there were no significant
findings in other relevant toxicity tests, i.e., developmental and
multi-generation reproduction studies, which would suggest that
hexythiazox produces effects characteristic of the disruption of the
estrogenic hormone.
C. Aggregate Exposure
1. Dietary exposure--i. Food. Tolerances have been established (40
CFR 180.479) for residues of 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 in or on apples at 0.02 ppm, pears at 0.3 ppm, and
hops (imported) at 2 ppm. Additional tolerances are pending for a
variety of plant and animal RACs and process fractions including apple
pomace at 0.7 ppm, apples at 0.4 ppm, almond hulls at 10 ppm, cattle
fat at 0.05, cattle meat at 0.05 ppm, cattle MBTP at 0.01 ppm, cotton
gin by-products at 3 ppm (California), cottonseed at 0.2 ppm
(California), milk at 0.05 ppm, prunes at 5 ppm, raisins at 10 ppm,
stone fruit at 1 ppm, strawberries at 3 ppm, and tree nuts (crop group
14) at 0.2 ppm. Additional tolerances are being requested in this
petition by IR-4 for mint at 2.0 ppm, and caneberries at 1.0 ppm.
Chronic exposure. A chronic dietary exposure analysis for existing
and pending proposed uses was conducted for the general U.S. population
and 26 population subgroups. Mint and caneberry did not contribute to
dietary exposure. In this analysis it was assumed that 100% of crops
were treated for both crops. Chronic exposures of 0.000172 mg/kg/day
and 0.000203 mg/kg/day were calculated for mint and caneberry
respectively for the average U.S. population. Non-nursing infants, the
most heavily exposed subgroup, had a calculated exposure of 0.000972
mg/kg/day and 0.001080 mg/kg/day respectively for mint and caneberry.
Actual exposures would be much lower, however, because far less than
100% of crops would be treated.
The Agency has not conducted a detailed analysis of potential
exposure to hexythiazox via drinking water or outdoor ornamental plants
from existing or pending proposed new uses. However, it is believed
that chronic exposure from these sources is very small.
Acute exposure. No developmental, reproductive or mutagenic
effects have been observed with hexythiazox. Therefore, an analysis of
acute exposure has not been conducted.
ii. Drinking water. The environmental fate of hexythiazox has been
evaluated, and Gowan Company believes that the compound is not expected
to contaminate groundwater or surface water to any measurable extent.
2. Non-dietary exposure. Hexythiazox is also registered for use on
outdoor ornamental plants by commercial applicators only. It is
believed that non-occupational exposure from this use is very low.
Hexythiazox is not registered for greenhouse, lawn, garden, or
residential use.
D. Cumulative Effects
Gowan Company does not have, at this time, available data to
determine whether hexythiazox has a common mechanism of toxicity with
other substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
hexythiazox does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this action, therefore, Gowan
Company has not assumed that hexythiazox has a common mechanism of
toxicity with other substances. For purposes of these petitions only,
the potential risks of hexythiazox in its aggregate exposure will be
considered.
E. Safety Determination
1. U.S. population--i. Chronic risk. Chronic risk was calculated
using anticipated residue concentrations from all current and proposed
uses of hexythiazox and assuming that 100% of each crop is treated.
Dietary exposure of the general U.S. population was equivalent to 0.7%
of the RfD. Exposure of the most heavily exposed subgroup, non-nursing
infants, was equivalent to 3.9% of the RfD.
ii. Carcinogenic risk. Carcinogenic risk was evaluated using
anticipated residue concentrations and taking into account the percent
of crop known or expected to be treated. Lifetime carcinogenic risk for
the U.S. population was calculated, to be 4.5 X 10-7.
iii. Acute risk. An estimate of acute risk with this compound has
not been conducted since no acute reproductive
[[Page 82352]]
or developmental effects have been observed.
2. Infants and children. In assessing the potential for additional
sensitivity of infants and children to residues of hexythiazox, EPA
considered data from developmental toxicity studies in the rat and
rabbit, and a 2-generation study in the rat. The developmental toxicity
studies are designed to evaluate adverse effects on the developing
organism resulting from pesticide exposure during prenatal development
to 1 or both parents. Reproduction studies provide information relating
to effects from exposure to the pesticide on the reproductive
capability of mating animals and data on systemic toxicity.
No developmental or reproductive effects have been observed in any
study with hexythiazox. The lowest acute NOAEL was 2,400 ppm in the
diet (200 mg/kg/day), HDT, in the 2-generation rat reproduction study.
In the rat developmental study, the maternal and fetotoxic NOAEL was
240 mg/kg/day and the developmental NOAEL was 2,160 mg/kg/day, HDT. In
the rabbit developmental study, the maternal and developmental NOAEL
was 1,080 mg/kg/day, HDT.
Taking into account current toxicological data requirements, the
data base for hexythiazox relative to prenatal and postnatal effects is
complete. In the rat developmental study, the NOAELs for maternal
toxicity and fetotoxicity were the same, which suggests that there is
no special prenatal sensitivity in the absence of maternal toxicity.
Furthermore, the lowest developmental or reproductive NOAEL is 2 orders
of magnitude higher than the chronic NOAEL on which the RfD is based.
It is concluded that there is a reasonable certainty of no harm to
infants and children from aggregate exposure to hexythiazox residues.
F. International Tolerances
Codex MRLs for 12 commodities, not including mint, have been
established. A MRL for blackberries at 0.2 ppm has been established in
the Netherlands. There are no Canadian or Mexican MRLs for hexythiazox.
[FR Doc. 00-33174 Filed 12-27-00; 8:45 am]
BILLING CODE 6560-50-S