[Federal Register Volume 67, Number 6 (Wednesday, January 9, 2002)]
[Rules and Regulations]
[Pages 1102-1107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-223]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301193; FRL-6812-5]
RIN 2070-AB78


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the Indian Meal Moth Granulosis Virus on 
dried fruits and nuts when applied/used as a microbial pesticide to 
control the Indian Meal Moth (Plodia interpunctella). AriVir, LLC. 
submitted a petition to EPA

[[Page 1103]]

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 Indian 
Meal Moth Granulosis Virus (IMMGV).

DATES: This regulation is effective January 9, 2002. Objections and 
requests for hearings, identified by docket control number [OPP-
301193], must be received by EPA, on or before March 11, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, electronically, or in person. Please follow the detailed 
instructions for each method as provided in Unit IX. of the 
SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your 
objections and hearing requests must identify docket control number 
[OPP-301193] in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Linda Hollis, c/o Product 
Manager (PM) 90, Biopesticides and Pollution Prevention Division 
(7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-8733; and e-mail 
address: [email protected].

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:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS Codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
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,'' ``Regulations and Proposed Rules,'' 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 ttp://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_180/Title_40/40cfr180_00.html, a beta site currently under 
development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301193. The official record 
consists of the documents specifically referenced in this action, 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 Hwy., 
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.

II. Background and Statutory Findings

    In the Federal Register of July 7, 2000 (65 FR 41984) (FRL-6556-8), 
EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a(e), as amended by the FQPA (Public Law 104-170) announcing the 
filing of a pesticide tolerance petition by AgriVir, LLC., 1625 K St., 
NW., Washington, DC 20006. 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 part 180 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 ``safe.'' Section 408(c)(2)(A)(ii) 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(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) 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 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

[[Page 1104]]

control the Indian Meal Moth on stored nuts and dried fruits. 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 (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, 
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, 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). Consigili, R.A., D.L, Russell and M.E. Wilson. 1986. 
The biochemistry and molecular biology of the granulosis virus that 
infects Plodia interpunctella. Cur. Top. Microbiol. and Immunol. 131: 
69-101. Hunter, D.K. 1970. Pathogenicity of a granulosis virus of the 
Indian meal moth. J. Invertebr. Pahtol. 16: 339-341.
    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 #'s 453070-01, 450662-07 & 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 
(254-321g) 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 
108 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 108 viral capsules. 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 106 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 106 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 nor 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 (~7.14 x 109 
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. Toxicity 
Category IV.
    Data waivers were requested for the following studies:
    1. 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 & 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, 
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.
    2. 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 viral pest control agent (450662-07 & 
450662-08). Cell culture infectivity and cytoxicity assays demonstrated 
that there were no toxic

[[Page 1105]]

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 inhalation toxicity study. In addition, 
the product labeling includes precautionary language for the pesticide 
handler to a dust mask as a further measure of safety.
    3. 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 & 
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.
    4. 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 to include 
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, FFDCA section 408 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 (Consigili, 
R.A., and Wilson, M.E., 1986. The Biochemical and Molecular Biology of 
the Granulosis Virus that Infects Plodia Interpunctella. Current topics 
in Microbiology and Immunology 131:69-101. 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 likely there will not be an 
increase of IMMGV in drinking water. In addition, because the virus 
host range is limited to the Indian meal moth, even if the virus is 
found in drinking water, 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 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 (Consigili, 
R.A., and Wilson, M.E., 1986. The Biochemical and Molecular Biology of 
the Granulosis Virus that Infects Plodia Interpunctella. Current topics 
in Microbiology and Immunology 131:69-101. 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.

[[Page 1106]]

VII. Determination of Safety

    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 (safety) (MOE) for 
infants and children in the case of threshold effects to account for 
prenatal and postnatal toxicity and the completeness of the database 
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 which 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 numberical 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 of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
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 control number OPP-301193 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 March 11, 
2002.
    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 (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. 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 (202) 260-4865.
    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 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    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.
    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.2. Mail your 
copies, identified by docket number OPP-301193, 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. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request

[[Page 1107]]

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. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) 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 FFDCA section 408(d), such as the tolerance 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 FFDCA section 408(n)(4). 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. Thus, Executive Order 13175 does not apply to 
this rule.

XI. Submission to Congress and the Comptroller General

    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: December 21, 2001.
James Jones,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. Section 180.1218 is added to subpart D 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 
in or on dried fruits and nuts.
[FR Doc. 02-223 Filed 1-8-02; 8:45 am]
BILLING CODE 6560-50-S