[Federal Register Volume 68, Number 188 (Monday, September 29, 2003)]
[Rules and Regulations]
[Pages 55870-55875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24563]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0256; FRL-7328-8]


Indian Meal Moth Granulosis Virus; Exemption from the Requirement 
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the Indian Meal Moth Granulosis Virus 
(IMMGV) in or on all food commodities when applied/used in accordance 
with approved label rates and good agricultural practices. AgriVir, LLC 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(FQPA), requesting an exemption from the requirement of a tolerance. 
This regulation eliminates the need to establish a maximum permissible 
level for residues of IMMGV.

DATES: This regulation is effective September 29, 2003. Objections and 
requests for hearings, identified by docket identification number OPP-
2003-0256, must be received on or before November 28, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit IX. 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 code 111)
    [sbull] Animal production (NAICS code 112)
    [sbull] Food manufacturing (NAICS code 311)
    [sbull] Pesticide manufacturing (NAICS code 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 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/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml --00/Title --40/40cfr180 --00.html, 
a beta site currently under development.
    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. Once in the system, select ``search,'' 
then key in the appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of July 30, 2003 (68 FR 447804) (FRL-7319-
7), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a(e), as amended by FQPA (Public Law 104-170), announcing the filing 
of a pesticide tolerance petition (PP 3F6736) by AgriVir, LLC, 1901 L 
Street, NW., Suite 250, Washington, DC 20036. This notice included a 
summary of the petition prepared by the petitioner AgriVir, LLC. There 
were no comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.1218 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of IMMGV.

III. Risk Assessment

    New section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is

[[Page 55871]]

 ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA defines ``safe '' to 
mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408 of the FFDCA (b)(2)(C) requires EPA 
to give special consideration to exposure of infants and children to 
the pesticide chemical residue in establishing a tolerance and to 
``ensure that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to the pesticide 
chemical residue. . . . '' Additionally, section 408(b)(2)(D) of the 
FFDCA requires that the Agency consider ``available information'' 
concerning the cumulative effects of a particular pesticide's residues 
and ``other substances that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

IV. Toxicological Profile

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action and considered its validity, completeness, and 
reliability and the relationship of this information to human risk. EPA 
has also considered available information concerning the variability of 
the sensitivities of major identifiable subgroups of consumers, 
including infants and children.
    Based on the toxicology data cited and the limited exposure to 
humans and domestic animals, there is a reasonable certainty that no 
harm will result from aggregate exposure to IMMGV to the U.S. 
population including infants and children to residues of IMMGV when 
used as viral pest control agent to control the Indian Meal Moth on all 
food commodities. This includes all anticipated dietary exposures and 
all other exposures for which there is reliable information. The Agency 
has arrived at this conclusion based on the long history of research, 
use and safety of testing baculoviruses which is documented in the 
public scientific literature (Refs. 1-5). IMMGV is a naturally 
occurring organism to which some environmental and dietary exposure is 
likely to be common for most individuals. The conclusion of safety is 
further supported by the lack of toxic or pathogenic effects on test 
animals at high doses (data submitted by the registrant, MRID numbers 
453070-01, 450662-07, and 450662-08). Baculoviruses have been described 
in the scientific literature for approximately 40 years. In addition to 
their natural occurrence, these viruses have a long history of safe use 
as bioinsecticides. Baculoviruses have been studied extensively in both 
laboratory and field experiments, which have shown that the virus host 
range is limited to arthropods. IMMGV has been shown to be very 
restricted in its insect host range. No toxicological or pathogenic 
effects produced by the baculovirus itself, have been observed in 
mammals, birds, fish or plants. The lack of mammalian toxicity at high 
levels of exposure to IMMGV demonstrates the safety of the product at 
levels well above maximum possible exposure levels anticipated in the 
crops. There has been a significant amount of research performed on 
baculoviruses and numerous scientific references are available which 
describe the biology of these viruses, their host range, and their mode 
of action. Toxicity studies submitted in support of this tolerance 
exemption include the following:
    1. Acute oral toxicity/pathogenicity (453070-01). Thirteen male 
(254-321 grams (g)) and 13 female (160-208g) albino rats were divided 
into three groups and treated with 0.1 milliliter (mL) of the test 
substance. Treatment was administered by oral gavage with at least 1 x 
10\8\ viral particles per animal. No deaths occurred in any of the test 
animals. Other than diarrhea during the first few hours following 
dosing, there were no other apparent clinical symptoms. Based upon the 
data there were no significant adverse effects reported upon doses of 
at least 1 x 10\8\ viral capsules. The toxicity category was deemed 
Toxicity Category IV.
    2. In vitro mammalian cell viral infectivity in mammalian cells 
(450662-08). Human WI-38 and WS1 cell cultures and African green monkey 
CV-1 cell cultures were exposed to 1 x 10\6\ units of the test 
substance. The cell cultures were observed daily for 21 days following 
inoculation for virus induced cytopathic effects. The test preparation 
was shown to be highly infectious and cytopathic to the target Plodia 
interpunctella larva. No differences were seen between the virus 
treated nor the solvent treated control cell cultures with respect to 
any cytopathic endpoint at any time post-inoculation. Based on the 
data, there was no evidence that the virus could infect any of the 
three mammalian cell lines.
    3. In vitro mammalian cell viral induced cytotoxicity (450662-07). 
Human WI-38 and WS1 cell cultures and African green monkey CV-1 cell 
cultures were exposed to 1 x 10\6\ units of IMMGV technical (IMMGV) for 
1 hour. The cell cultures were then washed, refed with virus-free 
medium, incubated for 8 days, fixed, stained and the number of colonies 
counted. The test preparation was shown to be highly infectious and 
cytopathic to the target Plodia interpunctella larva although analysis 
determined that the actual number of viral capsules used was only 42% 
of the target value. No differences were seen between the virus treated 
and the solvent treated control cell cultures with respect to cloning 
efficiency in any of the three cell lines. Based on the data, there was 
no evidence that the test substance was cytotoxic to any of the three 
mammalian cell lines.
    4. Acute eye irritation (450662-09). The test substance was 
instilled in the eyes of four males and two female adult New Zealand 
albino rabbits at approximately 0.04 g/eye ([tilde]7.14 x 10\9\ viral 
capsules). Animals were acclimated for 11 days and before treatment 
their eyes were checked for normalcy using ophthalmic fluorescein and 
an ultraviolet (UV) lamp. The right eye of each animal was treated and 
the other eye served as a control. No deaths occurred. Clinical signs 
noted included conjunctivitis, corneal opacity and iritis, all of which 
cleared within 4 days of treatment. The toxicity from this study was 
deemed Toxicity Category IV.
    5. Data waivers. Data waivers were requested for the following 
studies:
    i. Acute dermal toxicity. This study was waived based upon the lack 
of toxicity in animals dosed orally (453070-01) and more importantly 
cells inoculated with viral pest control agent (450662-07 and 450662-
08). Cell culture infectivity and cytoxicity assays demonstrated that 
there were no toxic effects to mammalian cell lines (human lung, human 
endothelial and primate renal cell lines) when innoculated with doses 
of IMMGV. Cell culture assays provide valuable information on the 
ability of the viral pest control agent to infect, replicate in, 
transform or cause toxicity in mammalian cell lines. Thus, this assay 
is the most likely indicator of evaluating the toxicity of a viral pest 
control agent. Unlike the oral, dermal and inhalation routes of 
exposure, these barriers (exposure conditions) do not exist in cell 
culture assays as the host cell is completely exposed, thus,

[[Page 55872]]

providing a higher exposure scenario (for exposure of body tissues, 
organs and systems). Cell culture studies which demonstrate no toxicity 
to mammalian cell lines upon inoculation with the viral pest control 
agent can therefore be used as an indicator in determining the 
probability of toxicity to the viral pest control agent via other 
routes of exposure (oral, dermal, inhalation). Therefore, this 
evaluation criteria along with the data submitted (referenced above) 
and the long history of safe use of baculoviruses provided the Agency 
with a scientific rationale to waive the requirement for an acute 
dermal toxicity study. In addition, the IMMGV is a characteristically 
large molecular entity and is therefore unable to penetrate intact 
skin. However, in the unlikely event that viral penetration does occur 
through contact with broken skin, the studies submitted by the 
registrant have demonstrated a lack of toxicity/pathogenicity and 
infectivity associated with IMMGV.
    ii. Acute inhalation toxicity. This study was waived based upon the 
lack of toxicity in animals dosed orally (453070-01) and, more 
importantly cells inoculated with the viral pest control agent (450662-
07 and 450662-08). Cell culture infectivity and cytoxicity assays 
demonstrated that there were no toxic effects to mammalian cell lines 
(human lung, human endothelial and primate renal cell lines) when 
infected with doses of IMMGV. Cell culture assays provide valuable 
information on the ability of the viral pest control agent to infect, 
replicate in, transform or cause toxicity in mammalian cell lines. 
Thus, this assay is the most likely indicator of evaluating the 
toxicity of a viral pest control agent. Unlike the oral, dermal and 
inhalation routes of exposure, these barriers (exposure conditions) do 
not exist in cell culture assays as the host cell is completely exposed 
thus providing a higher exposure scenario (for exposure of body 
tissues, organs and systems). Cell culture studies which demonstrate no 
toxicity to mammalian cell lines upon infection with the viral pest 
control agent can therefore be used as an indicator in determining the 
probability of toxicity to the viral pest control agent via other 
routes of exposure (oral, dermal and inhalation). Therefore, this 
evaluation criteria along with the data submitted (referenced above) 
and the long history of safe use of baculoviruses provided the Agency 
with a scientific rationale to waive the requirement for an acute 
inhalation toxicity study. In addition, the product labeling includes 
precautionary language for the pesticide handler to use a dust mask as 
a further measure of safety.
    iii. Primary dermal irritation. This study was waived based upon 
the lack of toxicity in animals dosed orally (453070-01) and, more 
importantly cells inoculated with viral pest control agent (450662-07 
and 450662-08). Cell culture infectivity and cytoxicity assays 
demonstrated that there were no toxic effects to mammalian cell lines 
(human lung, human endothelial and primate renal cell lines) when 
infected with doses of IMMGV. Cell culture assays provide valuable 
information on the ability of the viral pest control agent to infect, 
replicate in, transform or cause toxicity in mammalian cell lines. 
Thus, this assay is the most likely indicator of evaluating the 
toxicity of a viral pest control agent. Unlike the oral, dermal and 
inhalation routes of exposure, these barriers (exposure conditions) do 
not exist in cell culture assays as the host cell is completely exposed 
thus providing a higher exposure potential (for exposure of body 
tissues, organs and systems). Cell culture studies which demonstrate no 
toxicity to mammalian cell lines upon infection with the viral pest 
control agent can therefore be used as an indicator in determining the 
probability of toxicity to the viral pest control agent via other 
routes of exposure (oral, dermal and inhalation). Therefore, this 
evaluation criteria along with the data submitted (referenced above) 
and the long history of safe use of baculoviruses provided the Agency 
with a scientific rationale to waive the requirement for an acute 
dermal toxicity study. In addition, the product labeling includes 
precautionary language for the pesticide handler to wear gloves as a 
further measure of safety.
    iv. Literature citations (450662-06). Information from the open 
scientific literature has been cited in support of the relative safety 
and lack of mammalian toxicity associated with baculoviruses, including 
the IMMGV. The IMMGV is very host-specific, it does not infect any host 
other than the Indian meal moth larvae and does not cross-infect any 
Lepidopteran or other insect. The range for the insect host is 
worldwide. Studies listed in the literature review provide information 
on the life cycle and mode of action of IMMGV such that it acts by 
pathogenicity, not a toxic mechanism. It presents no hazard potential 
to mammals and non-target species.

V. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA directs 
EPA to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).

A. Dietary Exposure

    1. Food. Because baculoviruses are naturally occurring organisms, 
there is a great likelihood for previous exposure for most, if not all 
individuals. To date, there have been no reports of any 
hypersensitivity incidents or reports of any known adverse reactions 
resulting from exposure to IMMGV. The amount of product used will 
result in a negligible increase, if any, of virus exposure. In 
addition, even if there is a significant increase in exposure to the 
virus, the toxicity studies submitted by the registrant along with the 
extensive reports in the scientific literature indicating the safety of 
the viruses, suggest that there should not be any additional risk of 
adverse effects due to exposure to IMMGV.
    2. Drinking water exposure. Because of the use site and amount of 
product that will be applied, potential non-occupational exposures in 
drinking water is negligible. Currently, there are no reports which 
show that IMMGV has been found in any drinking water. Baculoviruses 
occur naturally in soil and there is a low likelihood that they would 
survive passage through the soil to reach underground water (Ref. 1, 
MRID 450662-06). Even if the virus is able to reach ground water, it is 
highly unlikely that the viruses would survive municipal water 
treatment due to its inability to survive outside its host. Therefore, 
it is not likely there will be an increase of IMMGV in drinking water. 
In addition, because the virus host range is limited to the Indian meal 
moth, the results of the acute oral toxicity studies using a high dose 
of the virus, suggest that there will not be any adverse effects upon 
human consumption in the unlikely event any virus found its way into 
drinking water, therefore; the Agency has no drinking water exposure 
concerns.

B. Other Non-Occupational Exposure

    Baculoviruses are naturally occurring viruses that have been 
described in the scientific literature for approximately 40 years. In 
addition to scientific research, there has been a long history of safe 
use of baculoviruses to control arthropods. Because the amount of virus 
which will be applied is small, it is not likely that there will be a 
significant increase in potential exposure. Any increase in virus titer 
is likely to be negligible at

[[Page 55873]]

most. Baculoviruses have been shown to have a host range limited to 
arthropods and the host range of this virus is even more restrictive 
than most baculoviruses (Ref. 1, MRID 450662-06). Therefore, even if 
there was an increase in exposure, there should not be any increase in 
potential human health effects.

VI. Cumulative Effects

    The Agency has considered available information on the cumulative 
effects of such residues and other substances that have a common 
mechanism of toxicity. These considerations included the cumulative 
effects on infants and children of such residues and other substances 
with a common mechanism of toxicity. Because there is no indication of 
mammalian toxicity to this or other baculovirus-containing products, 
the Agency is confident that there will not be cumulative effects from 
the registration of this product.

VII. Determination of Safety for U.S. Population, Infants and Children

    1. U.S. population. There is a reasonable certainty that no harm 
will result from aggregate exposure to the U.S. population from 
exposure to residues of IMMGV. This includes all anticipated dietary 
exposures and all other exposures for which there is reliable 
information. The Agency has arrived at this conclusion based on the 
long history of safe use of baculoviruses as bioinsecticides, the lack 
of mammalian toxicity associated with IMMGV, the limited host range of 
the virus and the inability of IMMGV to infect mammalian cell lines.
    2. Infants and children. FFDCA section 408 provides that EPA shall 
apply an additional tenfold margin of exposure (MOE) (safety) for 
infants and children in the case of threshold effects to account for 
prenatal and postnatal toxicity and the completeness of the data base 
unless EPA determines that a different MOE will be safe for infants and 
children. MOEs are often referred to as uncertainty (safety) factors. 
In this instance, based on all the available information, the Agency 
concludes that IMMGV is practically non-toxic to mammals, including 
infants and children and that they will consume only minimal, if any, 
residues of the microbial pesticide. Thus, there are no threshold 
effects of concern and, as a result, the provision requiring an 
additional margin of safety does not apply. Further, the provisions of 
consumption patterns, special susceptibility, and cumulative effects do 
not apply.
    As a result, EPA has not used a MOE approach to assess the safety 
of the IMMGV.

VIII. Other Considerations

A. Endocrine Disruptors

    There are no reports or indications in the available scientific 
literature that suggests that Indian meal moth granulosis virus has 
caused or has the potential to cause adverse effects on the endocrine 
and/or immune systems of humans or animals. The virus host range is 
limited to the Indian meal moth, where it would be expected to affect 
the defense systems of the target insect pest. The target insect's 
response is not different from any animal's response to a disease 
agent. These suppositions are confirmed by the results of the 
mammailian toxicity tests cited above.

B. Analytical Method(s)

    The Agency proposes to establish an exemption from the requirement 
of a tolerance without any numerical limitation for the reasons stated 
above. For the same reasons, the Agency has concluded that an 
analytical method is not required for enforcement purposes for the 
IMMGV.

C. Codex Maximum Residue Level

    There are no Codex Maximum Residue Levels established for residues 
of the IMMGV.

IX. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object '' to a regulation for an exemption 
from the requirement of a tolerance issued by EPA under new section 
408(d) of the FFDCA, as was provided in the old sections 408 and 409 of 
the FFDCA. However, the period for filing objections is now 60 days, 
rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0256 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
28, 2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential 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. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental

[[Page 55874]]

Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit IX.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2003-0256, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

X. References

    1. Consigili, R.A., D.L., Russell and M.E. Wilson. 1986. The 
biochemistry and molecular biology of the granulosis virus that infects 
plodia interpunctella. Current Topics in Microbiology and Immunology 
131:69-101.
    2. Doller, G. 1985. The safety of insect virus as biological 
control agents. In ``Viral Insecticides for Biolocial Control'' (Eds. 
Maramorosch, K. and Sherman, H.G.), Academic Press, New York: 399.
    3. Groner, A. 1986. Specificity and safety of baculoviruses. In 
``The Biology of Baculoviruses Vol. I: Biological Properties and 
Molecular Biology'' (Eds. Granados, R.D. and Federici, B.A.), CRC 
Press, Boca Raton, Florida: 177-202).
    4. Heimpel, A.M. 1971. Safety of insect pathogens for man and 
vertebrates. In ``Microbial Control of Insects and Mites'' (Eds. 
Burges, H.D. and Hussey, N.W.), Academic Press, New York: 469-489.
    5. Hunter, D.K. 1970. Pathogenicity of a granulosis virus of the 
Indian meal moth. J. Invertebr. Pathol. 16:339-341.

XI. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under section 408(d) of the FFDCA in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the exemption in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175.

[[Page 55875]]

 Thus, Executive Order 13175 does not apply to this rule.

XII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: September 22, 2003.
Janet L. Andersen
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

     Authority: 21 U.S.C. 321(q), 346(a) and 371.

0
2. Section 180.1218 is revised to read as follows:


Sec.  180.1218  Indian Meal Moth Granulosis Virus; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Indian Meal Moth Granulosis Virus 
when used in or on all food commodities.

[FR Doc. 03-24563 Filed 9-26-03; 8:45 am]
BILLING CODE 6560-50-S