41984 Federal Register / Vol. 65, No. 131 / Friday, July 7, 2000 / Notices

consideration of impacts on children by

stating that ‘‘each Federal agency: shall

ensure that its policies, programs,

activities, and standards address

disproportionate risks to children that

result from environmental health risks

or safety risks.’’ Many of the comments

the EPA received on the Proposed

Guidelines for Carcinogen Risk

Assessment relate to the

implementation of Executive Order

13045. In response to these comments

and regulatory initiatives, EPA has been

investigating ways to improve Agency

risk assessments for children.

An Agency workgroup convened

under the auspices of the Risk

Assessment Forum has been exploring

children’s exposure assessment issues.

This workgroup has concluded that a

major issue facing Agency assessors is

how to consider age related changes in

behavior and physiology when

preparing exposure assessments for

children. Children’s behavior changes

over time in ways that can have an

important impact on exposure. Further,

children’s physiology changes over time

in ways that can impact both their

exposures and their susceptibility to

certain health effects. There are two

aspects to these physiological changes.

First, there are anatomical changes

resulting from physical growth. Second,

there are changes in pharmacokinetics

and pharmacodynamics which affect the

absorption, distribution, excretion and

effects of environmental contaminants.

The Agency is examining the

pharmacokinetic/pharmacodynamic

changes in children through other

efforts and future meetings on this topic

are anticipated. This ERG hosted

workshop will focus on incorporating

age related changes in behavior and

anatomy into Agency exposure

assessments.

Dated: June 29, 2000.

George W. Alapas,

Acting Director, National Center for

Environmental Assessment.

[FR Doc. 00–17189 Filed 7–6–00; 8:45 am]

BILLING CODE 6560–50–P

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.

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:

hollis.linda@epa.gov.

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:

CategoriesNAICS

codes

Examples of 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’’ 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

Federal Register / Vol. 65, No. 131 / Friday, July 7, 2000 / Notices 41985

1Per 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.’’

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: ‘‘opp-docket@epa.gov,’’ 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%∂) 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

inerts1, 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

41986 Federal Register / Vol. 65, No. 131 / Friday, July 7, 2000 / Notices

CFR part 184 section 184.1 subpart B

pp.446-543.

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 >

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 >

0.00013% or (> 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

Federal Register / Vol. 65, No. 131 / Friday, July 7, 2000 / Notices 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 postinstillation) 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

(μg)/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 nondietary 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

41988 Federal Register / Vol. 65, No. 131 / Friday, July 7, 2000 / Notices

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 1011

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

1011 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

FEDERAL COMMUNICATIONS

COMMISSION

Notice of Public Information

Collection(s) Being Reviewed by the

Federal Communications Commission

July 3, 2000.

SUMMARY: The Federal Communications

Commission, as part of its continuing

effort to reduce paperwork burden

invites the general public and other

Federal agencies to take this

opportunity to comment on the

following information collection(s), as

required by the Paperwork Reduction

Act of 1995, Public Law 104–13. An

agency may not conduct or sponsor a

collection of information unless it

displays a currently valid control

number. No person shall be subject to

any penalty for failing to comply with

a collection of information subject to the

Paperwork Reduction Act (PRA) that

does not display a valid control number.

Comments are requested concerning (a)

whether the proposed collection of

information is necessary for the proper

performance of the functions of the

Commission, including whether the

information shall have practical utility;

(b) the accuracy of the Commission’s

burden estimate; (c) ways to enhance

the quality, utility, and clarity of the

information collected; and (d) ways to

minimize the burden of the collection of

information on the respondents,

including the use of automated

collection techniques or other forms of

information technology.

DATES: Written comments should be

submitted on or before August 7, 2000.

If you anticipate that you will be

submitting comments, but find it

difficult to do so within the period of

time allowed by this notice, you should

advise the contact listed below as soon

as possible.

ADDRESSES: Direct all comments to Judy

Boley, Federal Communications

Commission, Room 1–C804, 445 12th

Street, SW, DC 20554 or via the Internet

to jboley@fcc.gov.

FOR FURTHER INFORMATION CONTACT: For

additional information or copies of the

information collection(s), contact Judy

Boley at 202–418–0214 or via the

Internet at jboley@fcc.gov.

SUPPLEMENTARY INFORMATION:

OMB Control No.: 3060–0025.

Title: Application for Restricted

Radiotelephone Operator Permit—

Limited Use.

Form No.: FCC Form 755.

Type of Review: Revision of a

currently approved collection.

Respondents: Individuals or

households.

Number of Respondents: 1,000.

Estimated Time Per Response: .33

hours or 20 minutes.

Frequency of Response: On occasion

reporting requirement.

Total Annual Burden: 330 hours.

Total Annual Cost: $45,000.

Needs and Uses: Applicants must

possess certain qualifications in order to

qualify for a radio operator license. The

data submitted on FCC Form 755 aids

the Commission in determining whether

the applicant possess these

qualifications. The data will be used to

identify the individuals to whom the

license is issued and to confirm that the

individuals possess the required

qualifications for the license. If the data

were not collected, it would be

impossible to identify the person to

whom the license was issued.

This form is being revised to include

the FCC Registration Number (FRN)

which is required from anyone doing

business with the Commission.

OMB Control No.: 3060–0481.

Title: Application for Renewal of

Private Radio Station License.

Form No.: FCC Form 452R.

Type of Review: Revision of a

currently approved collection.

Respondents: Individuals or

households, business or other for-profit,

not-for-profit institutions, state, local or

tribal governments.

Number of Respondents: 2,700.

Estimated Time Per Response: .166

hours or 10 minutes.

Frequency of Response: On occasion

reporting requirement.

Total Annual Burden: 448 hours.

Total Annual Cost: $338,000.

Needs and Uses: In accordance with

FCC Rules, Aviation Ground and Marine

Coast Radio Station licensees are

required to apply for renewal of their

radio station authorization every five

years. The FCC Form 452R will be used

for that purpose. FCC staff will use the

data to determine eligibility for a

renewed radio station authorization,

and to issue a radio station license. The

data is also used by Compliance

personnel in conjunction with Field

Engineers for enforcement and

interference resolution purposes.

The form is being revised to collect

the FCC Registration Number (FRN)

which is required from anyone doing

business with the Commission.

Federal Communications Commission.

Magalie Roman Salas,

Secretary.

[FR Doc. 00–17250 Filed 7–6–00; 8:45 am]

BILLING CODE 6712–01–P