[Federal Register Volume 70, Number 45 (Wednesday, March 9, 2005)]
[Notices]
[Pages 11648-11651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4273]


-----------------------------------------------------------------------

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).

ACTION: Notice.

-----------------------------------------------------------------------

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 identification (ID)number OPP-
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 as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:  Mary L. Waller, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9354; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

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 this 
action. Other types of entities not listed in this unit could also be 
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 any 
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 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 docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although, a part of the official docket, the public docket does not 
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 at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
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-
5805.
    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. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. 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 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 in 
EPA's electronic public docket. EPA's policy is that copyrighted 
material will not be placed in EPA's electronic public docket but will 
be available only in printed, paper form in the official public docket. 
To the extent feasible, publicly available docket materials will be 
made available in EPA's electronic public docket. When a document is 
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 I.B. 
EPA intends to work towards providing electronic access to all of the 
publicly available docket materials through EPA's electronic public 
docket.
     For public commenters, it is important to note that EPA's policy 
is that public comments, whether submitted electronically or on paper, 
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 that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
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 public 
docket. Public comments that are mailed or delivered to the docket will 
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 of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to

[[Page 11649]]

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 in 
the body of your comment. Also, include this contact information on the 
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 or 
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 you 
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 for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2005-0035. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
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 as 
part of the comment that is placed in the official public docket, and 
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 file 
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 Mall 
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. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
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 not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
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 
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 
ID 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 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 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: 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 the 
view of the petitioner. 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.

 K-I Chemical U.S.A., Inc.

 PP 3E6545

     EPA has received a pesticide petition PP 3E6545 from K-I Chemical 
U.S.A., Inc., 11 Martine Avenue, Suite 970,

[[Page 11650]]

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), to 
amend 40 CFR part 180, by establishing a tolerance for residues of 
[[isopropyl[(S)-1-[(R)-1-(6-fluoro-1,3-benzothiazol-2-
yl)ethyl]carbamoyl-2-methylpropyl]carbamate] 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 well 
as in or on the raw agricultural commodity imported tomato at 0.5 ppm, 
and tomato processed commodities at 0.5 ppm. For tomato paste the 
proposed tolerance is 1.5 ppm. EPA has determined that the petition 
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 data 
support granting of the petition. Additional data may be needed before 
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 is 
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 tubers 
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 occurs 
via. conjugation of sugar to the hydroxyl group. The residue of concern 
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. The 
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 at 
the proposed label rates was significantly below this level. The 
maximum residues observed in raisins and wine were 0.16 ppm and 0.08 
ppm, respectively.
     The maximum average residue observed in tomatoes was 0.22 ppm from 
trials conducted in the greenhouse. The residues observed in the field 
trials were significantly lower, with the residues in two of the three 
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 ppm, 
and puree at 0.21 ppm.

B. Toxicological Profile

    1. Acute toxicity. The acute oral LD50 in Wistar rats is 
>5,000 milligrams/kilogram (mg/kg).
    2. Genotoxicity. Benthiavalicarb-isopropyl is negative in all tests 
conducted:
    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 NOAEL was 
10,000 ppm.
    ii. In a developmental toxicity study in New Zealand White rabbits 
receiving 0, 10, 20 or 40 mg/kg/day benthiavalicarb-isopropyl from day 
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 of 
small fetus and delayed ossification of the hindlimb talus at 40 mg/kg/
day.
    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. The 
NOAEL was 200 ppm, equivalent to 14.1 mg/kg/day and 15.3 mg/kg/day in 
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 to 
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 and 
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 18.6 
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 on 
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

[[Page 11651]]

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 mouse 
liver, was a slight enzyme inducer, and did not cause hepatocyte 
proliferation.
    6. Animal metabolism. Benthiavalicarb-isopropyl is rapidly absorbed 
at the dose levels tested in both sexes. The distribution of 
radioactivity was generally throughout the body, with the liver having 
the highest levels at all time points. Excretion was predominantly via 
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 and 
mouse. Under the conditions of these studies, no endocrine disrupting 
activity was displayed.

C. Aggregate Exposure

    1. Dietary exposure. There are no registered uses of 
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 in/on 
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 at 
the proposed tolerance levels. This is a ``worst case'' scenario in two 
ways-the product is not and will not be registered for use in many of 
the countries exporting these commodities to the U.S., and it is 
unlikely that all residues will be at the tolerance levels. Based on 
the expected reference dose (RfD) of 0.1 mg/kg/day, the exposure to the 
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 risk 
is acceptable.
    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 as 
this is an import tolerance and no U.S. registrations are expected.
    2. Non-dietary exposure. There are no non-occupational sources of 
exposure to benthiavalicarb-isopropyl for the general population due to 
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 the 
potential risks of benthiavalicarb-isopropyl in the exposure 
assessments.

E. Safety Determination

    1. U.S. population. Using the exposure assumptions described above, 
based on the completeness and the reliability of the toxicity data, K-I 
Chemical U.S.A. has estimated that aggregate exposure to 
benthiavalicarb-isopropyl will utilize less than 1% of the RfD for the 
U.S. population. EPA generally has no concern for exposure below 100% 
of the RfD. Therefore, based on the completeness and the reliability of 
the toxicity data, and the exposure assessment discussed above, K-I 
Chemical U.S.A. concludes that there is a reasonable certainty that no 
harm will result from aggregate exposure to residues of 
benthiavalicarb-isopropyl, including all anticipated dietary and all 
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. The compound 
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, no 
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, the 
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, K-
I Chemical U.S.A. concludes that there is a reasonable certainty that 
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