[Federal Register Volume 65, Number 131 (Friday, July 7, 2000)]
[Notices]
[Pages 41984-41988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17072]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-940; FRL-6556-8]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for Certain Pesticide Chemicals 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-940, must be 
received on or before August 7, 2000.

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-940 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Linda Hollis, Biopesticides 
and Pollution Prevention Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 
308-8733; e-mail address: <a href="/cdn-cgi/l/email-protection#d0b8bfbcbcb9a3febcb9beb4b190b5a0b1feb7bfa6"><span class="__cf_email__" data-cfemail="375f585b5b5e44195b5e5953567752475619505841">[email protected]</span></a>.

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:

 
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                                                          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'' 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-940. 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-940 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, Ariel Rios Bldg., 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

[[Page 41985]]

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: ``<a href="/cdn-cgi/l/email-protection#bbd4cbcb96dfd4d8d0decffbdecbda95dcd4cd"><span class="__cf_email__" data-cfemail="600f10104d040f030b0514200510014e070f16">[email protected]</span></a>,'' 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-940. 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 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 supports 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: June 23, 2000.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

Summary of Petition

    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
AgriVir, LLC has submitted the following summary of information, data, 
and arguments in support of their pesticide petition. This summary was 
prepared by AgriVir, LLC and EPA has not fully evaluated the merits of 
the pesticide petition. The summary may have been edited by EPA if the 
terminology used was unclear, the summary contained extraneous 
material, or the summary unintentionally made the reader conclude that 
the findings reflected EPA's position and not the position of the 
petitioner.

AgriVir, LLC

OF6113

    EPA has received a pesticide petition 0F6113 from AgriVir, LLC, 
1625 K Street, NW., Washington DC 20006, 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 to establish an exemption from the 
requirement of a tolerance for the microbial pesticide in or on Indian 
Meal Moth Granulosis Virus commodity.

A. Product Name and Proposed Use Practices

    The product which contains the microbial pest control agent which 
is the subject of the present petition for a tolerance exemption is 
``FruitGuard-V'' or ``NutGuard-V'' (these are alternate names for the 
same product). This product is a biological insecticide intended to 
control Indian meal moth, a serious pest of various stored commodities. 
The product will be used as a protectant for stored, dry commodities 
such as dried fruits, and nuts, and for crack treatment of facilities 
where such commodities are handled.
    The Indian meal moth (IMM), is a serious cosmopolitan pest of dried 
commodities. Infestation can occur at any time from harvest to eventual 
consumption of the commodity. IMM is estimated to be responsible for 
approximately 90% of the damage done to dried fruits and nuts in 
storage. In facilities where these types of commodities are handled, 
fragments and other debris from the commodities get into cracks, 
crevices, and other places and IMM propagates on this material. This 
establishes a general infestation and reservoir for the Indian meal 
moth in such facilities.
    Control of IMM by FruitGuard-V/NutGuard-V is by means of a 
naturally occurring microbial pest control agent (MPCA) which is 
contained in the product. This MPCA is a granulosis virus (GV) which 
infects the larvae of the IMM. This virus is, thus, designated as 
Indian Meal Moth Granulosis Virus (IMMGV). The IMMGV contained in 
NutGuard-V/FruitGuard-V is a naturally occurring isolate of the IMMGV 
and has not been genetically modified.
    In FruitGuard-V/NutGuard-V, the amount of IMMGV (the MPCA ion in 
the product) is very small in terms of weight percent. The bulk of the 
product is, in fact, milled wheat bran (96%<SUP>+</SUP>) and brewers 
yeast (ca. 3%) to which have been added some vitamins (0.1%) and 
antioxidants (0.4%). All of these carrier ingredients are either OPP 
List 4A inerts\1\, are tolerance exempted under 40 CFR 180.1001, and/or 
are generally recognized as safe (GRAS) or otherwise approved for 
direct food use under 21

[[Page 41986]]

CFR part 184 section 184.1 subpart B pp.446-543.
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    \1\ Per U.S. EPA/OPP: ``List 4A inert ingredients are considered 
to be minimal risk inert ingredients. List 4A is generally reserved 
for those substances that are common foods or substances that are 
ubiquitous in nature and are not expected to present a hazard to 
human health or the environment.''
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    The product is produced as a milled powder and has the physical 
appearance of a coarse, off-white to tan powder. Due to the physical 
characteristics of the powder and of the milled wheat bran which 
constitutes the bulk of the product, this product does have a potential 
for producing mild, temporary eye irritation. This has been tested in 
an eye irritation study which has been submitted by AgriVir in support 
of this application. The product's labeling, therefore, carries a 
warning in regard to eye irritation potential.
    1. The product can be applied dry or in water suspension. For the 
latter, it is suspended in water at a concentration of from 2 oz to 4 
oz per 10 gallons of water. This provides for a sprayable suspension.
    2. The proposed application rate for dried fruits and for nuts is 
from 30 grams (1 oz) to 140 grams (5 oz) product/ton of commodity to be 
protected.
    3. The proposed application rate for crack, crevice, and surface 
spot treatments is from 60 grams (2 oz) to 300 grams (10 oz) product/
100 square feet.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. This is a 
microbial pesticide in which the MPCA is IMMGV. This is a naturally 
occurring insect virus which produced a pathogenic condition termed 
``granulosis'' in larvae of the IMM. Since IMMGV cannot be propagated 
other than in insect larvae, the pesticide product itself consists of 
IMMGV viral particles contained in body parts from infected larvae, all 
of which is mixed in with the wheat bran diet mixture upon which the 
infected larvae were grown. The residues which would result are:
    i. The infected larval parts containing virus.
    ii. The wheat bran larval diet mixture.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. The rate of application for this pesticide 
product is from 1 oz to 5 oz product per ton of treated commodity. The 
product contains <SUP><ls-thn-eq></SUP> 0.01% MPCA by weight (expressed 
for this purpose as viral particles). The MPCA is not metabolized in or 
on the commodity after application. Therefore, at the maximum 
application rate, maximum MPCA residues will be <SUP><ls-thn-eq></SUP> 
0.00013% or (<SUP><ls-thn-eq></SUP> 1.3 parts per billion (ppb)). At 
the lower rate of application residues will be less than 0.26 ppb.
    3. Analytical method. A statement of why an analytical method for 
detecting and measuring the levels of the pesticide residue are not 
needed. No analytical method is required because:
    i. This application is for a tolerance exemption.
    ii. Any method which could be developed to detect IMMGV at the very 
low maximum levels noted above would be a molecular biology method 
requiring specialized equipment and procedures not readily available in 
enforcement laboratories.
    It is noted that microbial pet control agents which do not trigger 
Tier II toxicology concerns do not trigger specific residue chemistry 
requirements. A brief summary of the identity of the microbial pest 
control agent IMMGV follows:
    AgriVir, LLC has applied to EPA for registration of its microbial 
pest control product ``FruitGuard-V/NutGuard-V'' (these are alternate 
names for the same product). This is a biological insecticide intended 
to control IMM, a serious pest of various stored commodities. The IMM, 
is a serious cosmopolitan pest of dried commodities. Infestation can 
occur at any time from harvest to eventual consumption of the 
commodity. IMM is estimated to be responsible for approximately 90% of 
the damage done to dried fruits and nuts in storage. In facilities 
where these types of commodities are handled, fragments and other 
debris from the commodities gets into cracks, crevices, and other 
places and IMM propagates on this material. This established a general 
infestation and reservoir for the IMM in such facilities.
    Control of IMM by FruitGuard-V/NutGuard-V is by means of a 
naturally occurring microbial pest control agent (or 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 IMM. 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 IMM and acts by making 
the IMM larvae sick, rather than by a toxic mechanism (i.e., IMMGV does 
not produce any specific toxin which kills the larvae). IMM 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.

C. Mammalian 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. This release 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 mode of action is distinct 
from a toxicity based mode of action. That is, unlike some microbial 
pest control agents which produce endo-toxins or exo-toxins which act 
to kill the target pest, IMMGV produces no toxins as part of its mode 
of action.
    IMMGV is a member of the class of insect viruses known as 
baculoviruses. There are two known types of baculoviruses: polyhedrosis 
viruses and granulosis viruses. There is currently 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.
    A number of studies on the toxicity of baculoviruses, inclusive of 
granulosis viruses, to animals have shown that these agents produced no 
effects on overall health, gross or micro pathology, hematology, 
clinical chemistry, and antibody stimulation occur in test animals when 
exposure is by the oral, dermal, inhalation, and injection routes

[[Page 41987]]

of exposure and either single exposure or repeated exposure. 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 in nor does it 
replicate in or produce pathogenicity in human embryonic lung cells, 
human embryonic skin cells, and monkey kidney cells. These cell lines 
are relevant to the safety assessment of IMMGV with regard to hazard 
potential to humans and domestic animals because the first two (lung 
and skin) represent tissues which would be the first points of contact 
with/attack by IMMGV and the renal line is a representative of an organ 
which can receive parenteral exposure and which can easily harbor 
infections.
    Due to the physical properties of the final product and of the bran 
carrier, the technical MPCA does have a mild, rapidly reversible eye 
irritation potential. An eye irritation study has been conducted to 
further characterize this potential. It is summarized below.
    Primary eye irritation. Due to the physical properties of the final 
product and of the bran carrier, the technical MPCA is expected to have 
a mild to moderate, reversible eye irritation potential. This has been 
confirmed in a rabbit eye irritation study sponsored by AgriVir, LLC. 
Six healthy New Zealand white rabbits (4 males and 2 females) each 
received 0.1 mL of the IMMGV product placed into the conjunctival sac 
of their right eye. The upper and lower lids were held together for 
approximately 1 second. In each test animal, the left eye served as an 
untreated control. Ocular irritation was evaluated by the Draize et al. 
A 1 hour post-instillation six to six treated eyes showed conjunctival 
irritation and one to six showed irritation of the iris. No treated 
eyes showed corneal effects at 1 hour post-instillation. The mean 
irritation score for treated eyes was 11.5 out of 110 maximum possible. 
At 24 hrs, the incidence of treated eyes which exhibited conjunctival 
irritation was five to six with one to six showing irritation of the 
iris. Also, at 24 hrs three to six treated eyes showed some signs of 
corneal opacity. This was grade 1 (scattered or diffuse, details of 
iris clearly visible) with respect to intensity and grade 1 with 
respect to area (or = to 1/4 of the cornea involved) in each case. The 
corneal score in each eye which exhibited corneal opacity was 5 out of 
a maximum possible 80 for corneal effects alone. The mean irritation 
score at 24 hrs was 8.3 out of a maximum possible 110. At 48 hrs post-
instillation, the incidence of treated eyes which exhibited 
conjunctival irritation was one to six with one to six also showing 
irritation of the iris. Also, at 48 hrs three to six treated eyes still 
showed some signs of corneal opacity (same animals as at 24 hrs). This 
was still grade 1 with respect to intensity and grade 1 with respect to 
area in each case. The corneal score in each eye which exhibited 
corneal opacity was 5 out of a maximum possible 80 for corneal effects 
alone. The mean irritation score at 48 hrs was 4.3 out of a maximum 
possible 110. By 72 hours post-instillation, no treated eyes exhibited 
conjunctival or irineal irritation, but two to six treated eyes still 
showed a minimal corneal effect (two of the animals which had exhibited 
the same effects at 24 hrs and 48 hrs, still scored 1 for intensity and 
1 for area; therefore, 5 out of a possible 80 for each animal). The 
mean irritation score at 72 hrs was 1.7 out of a maximum possible 110. 
By day 4 (96 hrs) post-instillation, all treated eyes were free of 
conjuctival irritation, irineal irritation, and corneal effects. The 
mean irritation score at day 4 was 0 out of a maximum possible 110. The 
highest mean irritation score reported (11.5 at 1 hour post-
instillation) would be classified as ``mildly'' irritating per the 
Draize evaluation method. This score itself would normally be 
classified as ``minimally'' irritating, but the absence of complete 
resolution by 72 hrs requires a one-level increase in the descriptor. 
The fact that the corneal effects seen were minimal in both intensity 
and area, were seen in only half of the treated eyes, and resolved 
fairly rapidly (by 96 hours) suggests that these were probably due to 
simple mechanical abrasion by the solid test article after instillation 
into the treated eyes.

D. 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 
1/5 ounces of formulated (i.e., technical) MPCA per ton of commodity to 
be treated. Maximum theoretical residue concentrations will not, 
therefore, exceed 1.3 ppb for the MPCA. The types of commodities which 
are potentially to be treated with IMMGV represent less than 1% of the 
average total daily diet. With a 2 kilograms (kg) total daily diet the 
maximum theoretical average dietary exposure to the MPCA is 0.026 
(<greek-m>g)/day. Since IMMGV is a naturally occurring insect virus, 
there is some, not readily quantifiable, baseline exposure in the daily 
diet.
    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 pest control utility in the 
treatment of commodities for control of IMM. 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 the Food Quality Protection Act (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.

E. Cumulative Exposure

    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.

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, including sensitive 
individuals, 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 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.

G. Effects on the Immune and Endocrine Systems

    There is no reliable information to indicate that IMMGV has a 
potential to produce adverse effects on the immune or endocrine 
systems. In fact, the available studies establish that IMMGV is 
essentially biologically inactive in any organism other than its 
natural host, the larva of the Indian meal moth. Due to the natural 
occurrence and endemic

[[Page 41988]]

infestation of dry commodities by the IMM, IMM larval parts and the 
IMMGV are historically a part of the human diet (although one of which 
most persons are unaware). Animal safety studies on a closely related 
granulosis virus (which have been submitted by AgriVir, LLC as part of 
the support for its registration application and the present tolerance 
exemption petition) showed, that after inhalation exposure of guinea 
pigs to an atomized mist containing 2 x 10<SUP>11</SUP> granulosis 
virus (GV) particles (``granula'')/L of air, no antibodies to the 
granula were observed to form and no changes in blood proteins were 
found. Also, there were no signs of toxicity or other adverse effects 
noted during the 21-day post-exposure observation period. On pathology, 
no irritation of lungs or airways was found. This study further 
supports lack of an IMMGV hazard potential with regard to the immune 
system. In a different study with the same closely related GV, multiple 
dose feeding of a total of 5 x 10<SUP>11</SUP> granula/mouse, divided 
into 34 equal doses given every third day over 99 days produced:
    1. No signs of toxicity or other adverse effects.
    2. No effect on hematology parameters when checked at 45 days and 
at 99 days.
    3. No remarkable pathology findings on terminal sacrifice.
    4. No evidence for increased chromosome aberrations were found. 
This study further supports the lack of an IMMGV hazard potential with 
regard to the endocrine system.

H. Existing Tolerances

    There are no existing tolerances for IMMGV (the MPCA). The present 
petition is for the establishment of an exemption from a tolerance.
    All of the intentionally added inerts in NutGuard-V/FruitGuard-V 
are either OPP List 4A inerts, are tolerances exempted under 40 CFR 
180.1001, and/or are GRAS or are otherwise approved for direct food use 
under 21 CFR part 184 section 184.1 subpart B pp. 446-543. Therefore, 
all of the inert ingredients in FruitGuard-V/NutGuard-V are already 
tolerance exempted and/or are cleared for indirect food contact as a 
result of their incidental entry into commodities.

I. 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 United States.
[FR Doc. 00-17072 Filed 7-6-00; 8:45 am]
BILLING CODE 6560-50-F


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