[Federal Register Volume 68, Number 146 (Wednesday, July 30, 2003)]
[Notices]
[Pages 44780-44784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19354]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0256; FRL-7319-7]


Indian Meal Moth Granulosis Virus; 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 ID number OPP-2003-0256, must be 
received on or before August 29, 2003.

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: Leonard Cole, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 305-5412; 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:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] 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.

[[Page 44781]]

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 identification (ID) number OPP-2003-0256. 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, 
1921 Jefferson Davis Hwy., 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.1. 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 in 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 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-2003-0256. 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-2003-0256. 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-2003-0256.

[[Page 44782]]

    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, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID Number OPP-2003-0256. 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: July 21, 2003.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner 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.

AgriVir, LLC

PP 3F6736

    EPA received a pesticide petition (PP 3F6736) from AgriVir, LLC, 
1901 L St., NW., Suite 250, Washington, DC 20036, 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 180.1218 to expand the tolerance 
exemption from the existing exemption for use on dried fruits and nuts 
to use on all agricultural commodities and relevant processed 
fractions. EPA has determined that the petition contains data or 
information regarding the elements set forth in section 408(d)(2); 
however, EPA has not completed a review of the sufficiency of the 
submitted data at this time. The summary represents the views of 
AgriVir, LLC. EPA is still in the process of evaluating the petition. 
EPA has made minor edits to the summary for the purpose of clarity.

A. Residue Chemistry

    Residue chemistry, per se, is not required in support of the 
proposed tolerance exemption. This is because EPA has waived this 
requirement for microbial pet control agents which do not trigger Tier 
II toxicology concerns. Indian Meal Moth Granulosis Virus (IMMGV) does 
not trigger Tier II toxicology concerns. A brief summary of the 
identity of the microbial pest control agent IMMGV follows for 
information purposes
    EPA has previously registered AgriVir's microbial pest control 
product FruitGuard-V/NutGuard-V (these are alternate names for the same 
product), EPA Reg. No. 73176-1. This is a biological insecticide 
intended to control Indian meal moth, a serious pest of various stored 
commodities.
    The Indian meal moth, is a serious cosmopolitan pest of many stored 
agricultural commodities and processed fractions. Infestation can occur 
at any time from harvest to eventual consumption of the commodity. 
Indian meal moth, is estimated to be responsible, for example, for 
approximately 90% of the damage done to dried fruits and nuts in 
storage. In facilities where susceptible commodities are handled, 
fragments and other debris from the commodities gets into cracks, 
crevices, and other places and Indian meal moth, propagates on this 
material. This establishes a general infestation and reservoir for the 
Indian meal moth in such facilities.
    Control of Indian meal moth by FruitGuard-V/NutGuard-V is by means 
of a naturally occurring microbial pest control agent (MPCA) which is 
contained in the product.
    The MPCA used in NutGuard-V/FruitGuard-V is a granulosis virus 
which infects the larvae of the Indian meal moth. This virus is 
designated IMMGV in the balance of this summary. The MPCA contained in 
NutGuard-V/FruitGuard-V is a naturally occurring isolate of the IMMGV. 
It has not been genetically modified.
    IMMGV has no hosts other than larvae of the Indian meal moth and 
acts by making the Indian meal moth larvae sick, rather than by a toxic 
mechanism (i.e., IMMGV does not produce any specific toxin which kills 
the larvae).

[[Page 44783]]

 Indian meal moth larvae succumb to granulosis disease due to serious 
damage to one of their major organs for storage of nutrients.
    The above-cited products are equivalent to a technical grade of 
IMMGV. They are prepared without isolation of IMMGV and, as such, the 
MPCA which is the subject of the present petition consists, therefore, 
of IMMGV occlusion bodies (viral particles) and Indian meal moth larval 
parts mixed into a production larval diet containing wheat bran, 
brewer's yeast, vitamins, methyl paraben, and sorbic acid.

B. Toxicological Profile

    The mode of action for IMMGV in its host, the larval stage of P. 
interpunctella, is pathogenic in nature. IMMGV produces granulosis 
disease in the larvae of P. interpunctella. ``Granulosis'' disease is 
so named because cells in infected tissue sections, when observed under 
light microscopy, are full of minute, refractile bodies termed 
``granules.'' The initial signs of granulosis disease occur several 
days after larval ingestion of the viral occlusion bodies and consist 
of sluggishness and loss of appetite. These initial signs are followed 
by a change in the appearance of the larvae. They are normally light 
brown and semilucent but when infected become opaque and white. This 
change is the result of the massive accumulation of viral occlusion 
bodies in the fat body of the infected larva. The fat body is the site 
of intermediary metabolism in these larvae and it is in the fat body 
that fat, protein, and glycogen are primarily stored. The pathogenicity 
of IMMGV to the larva results from the mode of viral release from cells 
of the fat body. As discussed above, this occurs by rupture of the 
cells of the fat body, thereby leading to degeneration and necrosis of 
the fat body and, ultimately, death of the infected larva.
    The above-cited mode of action is distinct from a toxicity based 
mode of action. That is, unlike some microbial pest control agents 
which produce endo- or exo-toxins which act to kill the target pest, 
IMMGV produces no toxins as part of its mode of action.
    1. Hazard potential to mammals. IMMGV poses no hazard potential to 
mammals via ingestion, dermal contact, or inhalation. There is no 
baculovirus (the type of virus which IMMGV is) known to infect or 
replicate in any vertebrate host. Among invertebrates, IMMGV itself has 
no known host other than larvae of P. interpunctella and has been shown 
not to cross-infect lepidopteran or other insects other than P. 
interpunctella.
    A number of studies on the toxicity of baculoviruses, inclusive of 
granulosis viruses, to animals have shown that these agents are non-
toxic by the oral, dermal, inhalation, and injection routes of exposure 
and that no effects on overall health, gross or micro pathology, 
hematology, clinical chemistry, and antibody stimulation occur in test 
animals. These studies have been published in the open literature and 
were submitted as part of AgriVir, LLC's petition.
    Cell culture studies (submitted by AgriVir as part of its 
submission) have shown that IMMGV which is actively infective and 
pathogenic to IMM larva does not produce cytotoxicity nor does it 
replicate in or produce pathogenicity in the following mammalian cell 
lines:
    WI-38 (ATTC CCL 75: human lung (embryonic))
    WS1 (ATTC CRL 1502: human endothelium (embryonic skin))
    CV-1 (ATTC CCL 70: African green monkey, renal)
These cell culture studies further support the already established fact 
that IMMGV poses no hazard to mammals.
    Due to the physical properties of the final product and of the bran 
carrier, the technical MPCA does have a mild to moderate, reversible 
eye irritation potential.
    2. Hazard potential to the environment. The only potential 
environmental effect of IMMGV is on the population of Indian meal 
moths. This is because, as discussed above, IMMGV has no hosts other 
than larvae of the Indian meal moth and acts by a pathogenicity 
mechanism rather than a toxicity mechanism (i.e., IMMGV does produce 
any specific toxin). Since IMMGV is a naturally occurring virus which 
has naturally infected Indian meal moth larvae for at least decades and 
probably longer, its use on Indian meal moth larvae which may infest 
dried fruits and nuts and other stored commodities cannot reasonably be 
expected to endanger the Indian meal moth population as a whole.
    Therefore, there are no reasonably anticipated or likely 
environmental effects of use of IMMGV for protection of agricultural 
commodities from Indian meal moth damage.
    3. Hazard potential to non-target species. There is no hazard 
potential to non-target species. As above-noted, there is no 
baculovirus known to infect or replicate in any vertebrate host. Among 
invertebrates, IMMGV itself has no known host other than larvae of P. 
interpunctella and has been shown not to cross-infect lepidopteran or 
other insects other than P. interpunctella.

C. Aggregate Exposure

    1. Dietary exposure-i. Food. The levels of residues in treated 
commodities will be very low. The application rates for IMMGV are from 
1 to 5 ounces of formulated (i.e., technical) MPCA per ton of commodity 
to be treated. Therefore, dietary exposure is insignificant.
    ii. Drinking water. The proposed use patterns for IMMGV are for 
indoor food and non-food uses. Therefore, there is no potential for 
drinking water exposure associated with the approval of this petition.
    2. Non-dietary exposure. IMMGV only has any pest control utility in 
the treatment of various commodities for control of Indian meal moth. 
Therefore, the only potential for non-dietary exposure is to 
applicators and to mixer/loaders who will use product containing IMMGV. 
These non-dietary exposures are not covered within FQPA and they are 
expected to be low. Information already in EPA's data bases which had 
been cited by AgriVir, LLC indicates that workers involved with 
baculovirus production and use do not experience adverse effects as a 
result of these exposures.

D. Cumulative Effects

    Due to its mechanism of action and extremely limited host 
specificity, it can be reliably stated that IMMGV does not share a 
common mechanism of action with any other conventional, biochemical, or 
microbial pesticide.

E. Endocrine Effects

    There is no reliable information to indicate that IMMGV has a 
potential to produce endocrine effects. The available studies suggest 
that IMMGV is essentially biologically inactive in any organism other 
than its natural host, the larva of the Indian meal moth.

F. Safety Determination

    1. U.S. population. Since the available information reliably 
supports that IMMGV will not produce adverse effects in humans of any 
age as a result of exposure by ingestion, dermal contact, or 
inhalation, AgriVir, LLC concludes that there is a reasonable certainty 
that no harm to the general adult population will result from dietary 
exposure to residues which could occur as a result of approval of this 
petition.
    2. Infants and children. Since the available information reliably 
supports that IMMGV will not produce adverse effects in humans of any 
age as a result of exposure by ingestion, dermal

[[Page 44784]]

contact, or inhalation, AgriVir, LLC concludes that there is a 
reasonable certainty that no harm to infants and children will result 
from dietary exposure to residues which could occur as a result of 
approval of this petition.
    3. Sensitive individuals. Since the available information reliably 
supports that IMMGV will not produce adverse effects in humans of any 
age as a result of exposure by ingestion, dermal contact, or 
inhalation, and indeed that IMMGV appears to be biologically inactive 
in other than its natural host, AgriVir, LLC concludes that there is a 
reasonable certainty that no harm to sensitive persons will result from 
dietary exposure to residues which could occur as a result of approval 
of this petition.

G. International Tolerances

    There are no Codex maximum residue levels established for residues 
of IMMGV. IMMGV containing products are presently not registered for 
pest control outside of the U.S.

[FR Doc. 03-19354 Filed 7-29-03; 8:45 am]
BILLING CODE 6560-50-S