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[Federal Register: March 9, 2005 (Volume 70, Number 45)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0035; FRL-7699-4]Benthiavalicarb-Isopropyl; Notice of
Filing Petition for the
Establishment of Tolerances on Imported Grapes and Tomatoes
AGENCY: Environmental Protection Agency (EPA).
SUMMARY: This notice announces the initial
filing of a pesticide
petition proposing the establishment of regulations for residues
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket identification
2005-0035, must be received on or before April 8, 2005.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Mary L. Waller, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9354; e-mail address: email@example.com .
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111)
Animal production (NAICS 112)
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by
action. Other types of entities not listed in this unit could also
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether 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
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2005-0035. The official public
consists of the documents specifically referenced in this action,
public comments received, and other information related to this
Although, a part of the official docket, the public docket does
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing
the Public Information and Records Integrity Branch (PIRIB), Rm.
Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/ .
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets.
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket
are available electronically. Although, not all docket materials
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
Certain types of information will not be placed in the EPA
Dockets. Information claimed as CBI and other information whose
disclosure is restricted by statute, which is not included in the
official public docket, will not be available for public viewing
EPA's electronic public docket. EPA's policy is that copyrighted
material will not be placed in EPA's electronic public docket but
be available only in printed, paper form in the official public
To the extent feasible, publicly available docket materials will
made available in EPA's electronic public docket. When a document
selected from the index list in EPA Dockets, the system will identify
whether the document is available for viewing in EPA's electronic
public docket. Although not all docket materials may be available
electronically, you may still access any of the publicly available
docket materials through the docket facility identified in Unit
EPA intends to work towards providing electronic access to all of
publicly available docket materials through EPA's electronic public
For public commenters, it is important to note that EPA's policy
is that public comments, whether submitted electronically or on
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic
docket. Public comments that are mailed or delivered to the docket
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page
your comment. Please ensure that your comments are submitted within
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to
consider these late comments. If you wish to submit CBI or information
that is otherwise protected by statute, please follow the instructions
in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or
information protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information
the body of your comment. Also, include this contact information
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method
receiving comments. Go directly to EPA Dockets at
and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID
OPP-2005-0035. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to
Attention: Docket ID number OPP-2005-0035. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included
part of the comment that is placed in the official public docket,
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID number OPP-2005-0035.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal
#2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID
number OPP-2005-0035. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail.
may claim information that you submit to EPA as CBI by marking any
or all of that information as CBI (if you submit CBI on disk or
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information
is 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
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed 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
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
7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first
of your response. You may also provide the name, date, and Federal
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
pesticide chemical in or on various food commodities under section
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data
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
Dated: February 18, 2005.
Betty Shackleford, Acting
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner's summary of the pesticide petition is printed
below as required by FFDCA section 408(d)(3). The summary of the
petition was prepared by K-I Chemical U.S.A., Inc., and represents
view of the petitioner. The petition summary announces the availability
of a description of the analytical methods available to EPA for
detection and measurement of the pesticide chemical residues or
explanation of why no such method is needed.
K-I Chemical U.S.A., Inc.
EPA has received a pesticide petition PP 3E6545 from K-I
U.S.A., Inc., 11 Martine Avenue, Suite 970,
White Plains, New York 10606 proposing,
pursuant to section 408(d) of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d),
amend 40 CFR part 180, by establishing a tolerance for residues
in or on the raw
agricultural commodity imported grapes at
0.5 parts per million (ppm)
and on grape processed commodities juice and wine at 0.5 ppm, as
as in or on the raw agricultural commodity imported tomato at 0.5
and tomato processed commodities at 0.5 ppm. For tomato paste the
proposed tolerance is 1.5 ppm. EPA has determined that the
contains 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
support granting of the petition. Additional data may be needed
EPA rules on the petition.
A. Residue Chemistry
1. Plant metabolism. The metabolism of benthiavalicarb-isopropyl
was investigated in grapes, tomatoes, and potatoes. The rate of
degradation in grapes and tomatoes is low and the unchanged parent
the major component, accounting for 90% or more of the total
radioactive residue (TRR). The metabolites were below quantifiable
levels in both grapes and tomatoes. Residues in foliar treated potato
tubers showed more extensive metabolism with the unchanged parent
accounting for only 4.7%, unidentified metabolites 76.5%, and
unextracted radioactivity, 17.5%. About 21.9% of the unidentified
metabolites are present as sugar conjugates. Analysis of the potato
foliage from foliage treated plants indicated that 90% of the residue
is unchanged parent and that no conversion to other isomers had
occurred. Metabolites in the foliage were different than in the
and were identified as sugar conjugates of phenyl ring hydroxylated
parent. The metabolism in potatoes occurs primarily via ring
hydroxylation of the parent molecule. Secondary metabolism then
via. conjugation of sugar to the hydroxyl group. The residue of
can be quantified as the unchanged parent.
2. Analytical method. The proposed residue method involves analysis
by gas chromatography with a nitrogen-phosphorous detector (GC/NPD).
The limit of quantification (LOQ) for all matrices, raw agricultural
and relevant processed fractions, was determined to be 0.01 ppm.
method is capable of measuring the unchanged parent as well a minor
isomer present in the technical. However, the minor isomer is generally
present at extremely low levels, often below the LOQ. Mean recoveries
ranged from a low of 77% to a high of 112%, with standard deviations
ranging from 2.0 to 18.7%.
3. Magnitude of residues. The maximum average field trial residue
measured in grapes was 0.22 ppm, although, the majority of the data
the proposed label rates was significantly below this level. The
maximum residues observed in raisins and wine were 0.16 ppm and
The maximum average residue observed in tomatoes was 0.22 ppm from
trials conducted in the greenhouse. The residues observed in the
trials were significantly lower, with the residues in two of the
trials below the LOQ. The maximum residues observed in the processed
commodities (all from greenhouse treated tomatoes) were as follows:
Juice at 0.06 ppm, ketchup at 0.183 ppm, canned tomatoes at 0.035
and puree at 0.21 ppm.
B. Toxicological Profile
1. Acute toxicity. The acute oral
LD 50 in Wistar rats is
>5,000 milligrams/kilogram (mg/kg).
2. Genotoxicity. Benthiavalicarb-isopropyl
is negative in all tests
i. Reverse mutation (S. typhimurium and e. coli).
ii. In vitro chromosomal aberration (CHL cells),
iii. In vitro mouse lymphoma (L5178Y cells),
iv. In vitro unscheduled DNA synthesis (UDS) (rat hepatocytes),
v. In vivo mouse miconucleus (mouse bone marrow),
vi. In vivo gene mutation assay in transgenic mice (transgenic
mouse liver), and
vii. In vivo/in vitro UDS (rat hepatocytes).
3. Reproductive and developmental toxicity--
i. In a 2-generation reproduction study in Sprague Dawley rats
receiving 0, 100, 1,000 or
10,000 ppm benthiavalicarb-isopropyl in the diet, the parental no
observed adverse effect level (NOAEL) was 100 ppm based on hepatocyte
hypertrophy at the next higher dose level. The reproductive
ii. In a developmental toxicity study in
New Zealand White rabbits
receiving 0, 10, 20 or 40 mg/kg/day benthiavalicarb-isopropyl from
6 to 28 of gestation, the maternal NOAEL was
20 mg/kg/day based on
abortion and increased liver weights at the 40 mg/kg/day dose. The
developmental NOAEL was 20 mg/kg/day based on increased incidence
small fetus and delayed ossification of the hindlimb talus at 40
iii. In a developmental toxicity study in
Sprague Dawley rats
receiving 0, 10, 100 or 1,000 mg/kg/day from day 7 to day 19 of
gestation, the maternal NOAEL was 10 mg/kg/day
based on elevated liver
and adrenal weights at 100 mg/kg/day. The NOAEL for developmental
toxicity was 1,000 mg/kg/day.
4. Subchronic toxicity. i. In the
13-week feeding study with rats
the dose levels were 0, 50, 200, 5,000, or 20,000 ppm in the diet.
NOAEL was 200 ppm, equivalent to 14.1 mg/kg/day and 15.3 mg/kg/day
males and females, respectively), based on
blood chemistry and organ
weight changes at 5,000 ppm.
ii. In the 13-week feeding study with mice,
the dose levels were 0,
50, 200, 7,000, or 20,000 ppm. The NOAEL was 200 ppm (equivalent
33.0 mg/kg/day and 45.2 mg/kg/day in males and females, respectively,
based on systemic toxicity of decreased body
weights, anemias, and
generalized liver toxicity at 7,000 ppm.
iii. In the 3 month dog feeding study
the dose levels were 0, 40,
200, or 1,000 mg/kg/day. The NOAEL was 40 mg/kg/day based on
hematological and clinical chemistry changes,
organ weight changes and
the findings of hepatocyte hypertrophy and pigmentation in the spleen
at 200 mg/kg/day.
5. Chronic toxicity.
i. In a chronic/oncogenicity study Fisher
rats received 0, 50, 200, 5,000, or 10,000 ppm of benthiavalicarb-
isopropyl for up to 104 weeks. The NOAEL was 200 ppm (9.9 mg/kg/day
12.5 mg/kg/day in males and females respectively), based
on a variety
of toxic effects, primarily in the liver and kidney, and
adenocarcinomas of the uterus at 5,000 ppm.
ii. In an oncogenicity study in mice,
the dietary doses were 0, 20,
100, 2,500 or 5,000 ppm. The NOAEL was 100 ppm (13.7 mg/kg/day and
mg/kg/day in males and females, respectively) based on
a variety of
toxic effects, primarily in the liver and kidney, and hepatocellular
blastoma and carcinoma at 2,500 ppm.
iii. In a 52-week study with Beagle dogs,
the dietary dose levels
were 0, 4, 40, or 400 mg/kg/day. The NOAEL was 40 mg/kg/day based
increased liver weights in males and females
at 400 mg/kg/day.
iv. Numerous supplemental mechanistic studies in the rodent were
carried out to further elucidate the mechanisms involved in tumor
formation in the lifetime rodent studies.
These studies indicated that
benthiavalicarb-isopropyl behaves like a
promotor following initiation
with diethylnitrosamine (DEN), and does not have initiating activity.
The compound did not cause oxidative damage in studies on rat or
liver, was a slight enzyme inducer,
and did not cause hepatocyte
6. Animal metabolism. Benthiavalicarb-isopropyl
is rapidly absorbed
at the dose levels tested in both sexes. The
radioactivity was generally throughout the body, with the liver
the highest levels at all time points. Excretion was predominantly
the bile. The metabolism was complex. The predominant routes of
metabolism were gluthione conjugation or hydroxylation on the benzene
or valyl moieties. This resulted in a large
number of metabolites, many
present only in small quantities.
7. Metabolite toxicology. It was concluded
that no specific
metabolite toxicity studies were needed.
8. Endocrine disruption. Benthiavalicarb-isopropyl
was tested for
its potential to induce hormomimetic effects in ovariectimized rats,
potential effects on estradiol, progesterone, LH and aromatase activity
in the rat, and potential effects on thyroid hormones in the rat
mouse. Under the conditions of these studies, no endocrine disrupting
activity was displayed.
C. Aggregate Exposure
1. Dietary exposure. There are no registered
benthiavalicarb-isopropyl in the United States, (U.S.) and no other
tolerance petitions have been submitted to EPA for this active
ingredient. Dietary exposure is limited in the U.S. to residues
imported grapes and tomatoes and their processed components.
A Tier I
exposure analysis was conducted which assumed that 100% of the imported
grape and tomato products consumed in the U.S. contained residues
the proposed tolerance levels. This is a ``worst case'' scenario
ways-the product is not and will not be registered for use in many
the countries exporting these commodities to the U.S., and it is
unlikely that all residues will be at the tolerance levels. Based
the expected reference dose (RfD) of 0.1 mg/kg/day, the exposure
general population in this worst case scenario is 0.17% of the RfD.
Based on an aRfD of 0.1 mg/kg/day, the exposure to the general
population in this worst case scenario is 1.18 % of the aRfD. Cancer
dietary exposure estimates were also conducted, which indicate that
with a very conservative Q* and linear extrapolation, the cancer
i. Food. This is a new chemical and there are no other food uses
except for the proposed uses on grapes and tomatoes.
ii. Drinking water. No exposure is expected from drinking water
this is an import tolerance and no U.S. registrations are expected.
2. Non-dietary exposure. There are no non-occupational sources
exposure to benthiavalicarb-isopropyl for the general population
the fact that the requested action is to establish tolerances for
import purposes only.
D. Cumulative Effects
There is no evidence available to suggest that benthiavalicarb-
isopropyl has a mode of action that is common with other registered
pesticides. Therefore K-I Chemical U.S.A. Inc. has considered only
potential risks of benthiavalicarb-isopropyl in the exposure
E. Safety Determination
1. U.S. population. Using the exposure assumptions described above,
based on the completeness and the reliability of the toxicity data,
Chemical U.S.A. has estimated that aggregate exposure to
benthiavalicarb-isopropyl will utilize less than 1% of the RfD for
U.S. population. EPA generally has no concern for exposure below
of the RfD. Therefore, based on the completeness and the reliability
the toxicity data, and the exposure assessment discussed above,
Chemical U.S.A. concludes that there is a reasonable certainty that
harm will result from aggregate exposure to residues of
benthiavalicarb-isopropyl, including all anticipated dietary and
other non-occupational exposures.
2. Infants and children. Benthiavalicarb-isopropyl did not display
reproductive toxicity in rats and the data
show that pups are not more
sensitive to the effects of the compound than adults are.
was not a developmental toxicant in the tests conducted, with only
delayed growth due to maternal toxicity observed.
The rat and rabbit
developmental studies indicate that the fetuses were not more sensitive
than the adults to the effects of the test compound. Therefore,
additional safety factor is needed for children.
Using the same worst case assumptions as for the general
population, K-I Chemical concludes that the most sensitive population
group for chronic assessment is children 1-6. The exposure to this
group is 0.56% of the chronic RfD. For acute exposure assessment,
most sensitive population is non-nursing infants, with an exposure
estimate utilizing about 5% of the acute reference dose. Therefore,
based on the toxicity data and the worst case estimates of exposure,
I Chemical U.S.A. concludes that there is a reasonable certainty
no harm will result to infants and to children from aggregate exposure
to residues of benthiavalicarb-isopropyl, including all anticipated
dietary exposure and all other non-occupational exposures.
F. International Tolerances
Currently there are no international tolerances.
[FR Doc. 05-4273 Filed 3-8-05; 8:45 am]
BILLING CODE 6560-50-S