Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 / Notices 31771

based on the completeness and

reliability of the toxicity data and the

conservative exposure assessment, there

is a reasonable certainty that no harm

will result from aggregate exposure to

residues of carfentrazone-ethyl,

including all anticipated dietary

exposure and all other non-occupational

exposures. 2. Infants and children. In assessing

the potential for additional sensitivity of

infants and children to residues of

carfentrazone-ethyl, EPA considers data

from developmental toxicity studies in

the rat and rabbit and the 2-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development. Reproduction studies

provide information relating to effects

on the reproductive capacity of males

and females exposed to the pesticide.

Developmental toxicity was not

observed in developmental toxicity

studies using rats and rabbits. In these

studies, the rat and rabbit maternal

NOELs were 100 mg/kg/day and 150

mg/kg/day, respectively. The

developmental NOEL for the rabbit was

greater than 300 mg/kg/day which was

the HDT and for the rat was 600 mg/kg/

day based on increased litter incidences

of thickened and wavy ribs. These two

findings are not considered adverse

effects of treatment but related delays in

rib development which are generally

believed to be reversible.

In a 2-generation reproduction study

in rats, no reproductive toxicity was

observed under the conditions of the

study at 4,000 ppm which was the HDT. Section 408 of the FFDCA provides

that EPA may apply an additional safety

factor for infants and children in the

case of threshold effects to account for

pre- and post-natal toxicity and the

completeness of the database. Based on

the current toxicological data

requirements, the database relative to

pre- and post-natal effects for children

is complete and an additional

uncertainty factor is not warranted.

Therefore at this time, the provisional

RfD of 0.06 mg/kg/day is appropriate for

assessing aggregate risk to infants and

children.

F. Reference Dose

Using the conservative exposure

assumptions described above, the

percent of the RfD that will be utilized

by aggregate exposure to residues of

carfentrazone-ethyl for non-nursing

infants (<1-year old) would be 0.28%

and for children 1-6 years of age would

be 1.37% (the most highly exposed

group). Based on the completeness and

reliability of the toxicity data and the

conservative exposure assessment, there

is a reasonable certainty that no harm

will result to infants and children from

aggregate exposure to the residues of

carfentrazone-ethyl including all

anticipated dietary exposure.

G. International Tolerances

There are no Codex Alimentarius

Commission (Codex) Maximum Residue

Levels (MRLs) for carfentrazone-ethyl

on any crops at this time. However,

MRLs for small grains in Europe have

been proposed which consist of

carfentrazone-ethyl and carfentrazoneethyl-chloropropionic acid.

[FR Doc. 98–15177 Filed 6–9–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–812; FRL–5793–4]

Notice of Filing of a Pesticide Petition

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

amendment of pesticide petition (PP

5F4483), proposing the establishment of

regulations for residues of certain

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by the

docket control number PF–812, must be

received on or before July 10, 1998.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch (7502C),

Information Resources and Services

Division, Office of Pesticides Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460. In

person bring comments to: Rm. 119, CM

#2, 1921 Jefferson Davis Highway,

Arlington, VA.

Comments and data may also be

submitted electronically to: oppdocket@epamail.epa.gov. Follow the

instructions under ‘‘SUPPLEMENTARY

INFORMATION.’’ No confidential

business information should be

submitted through e-mail.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

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. All written

comments will be available for public

inspection in Rm. 119 at the address

given above, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Shanaz Bacchus, Biopesticides

and Pollution Prevention Division

(7511W), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location and telephone number:

Rm. CS51B6, Westfield Building North

Tower, 2800 Crystal Drive, Arlington,

VA 22202, (703) 308–8097; e-mail:

bacchus.shanaz@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition as follows

proposing the establishment and/or

amendment of regulations for residues

of certain pesticide chemicals 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.

The official record for this notice of

filing, as well as the public version, has

been established for this notice of filing

under docket control number [PF–812]

(including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The official

record is located at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Comment and data will

also be accepted on disks in

Wordperfect 5.1/6.1 or ASCII file

format. All comments and data in

electronic form must be identified by

the docket control number [PF–812] and

appropriate petition number. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries.
31772 Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 / Notices

List of Subjects

Environmental protection,

Agricultural commodities, Food

additives, Feed additives, Pesticides and

pests, Reporting and recordkeeping

requirements.

Dated: May 29, 1998.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

Summary of the Petition

Petitioner summary of the pesticide

petition is printed below as required by

section 408(d)(3) of the FFDCA. The

summary of the petition was prepared

by the petitioners and represent the

views of the petitioners. EPA is

publishing the petition summary

verbatim without editing it in any way.

The petition summary announces the

availability of a description of the

analytical methods available to EPA for

the detection and measurement of the

pesticide chemical residues or an

explanation of why no such method is

needed.

Troy Biosciences, Inc.

PP 5F4483

EPA has received an amended

pesticide petition (PP 5F4483) from

Troy Biosciences, Inc., 2620 North 37th

Dr., Phoenix, Arizona 85009, proposing

pursuant to section 408(d) of the Federal

Food, Drug, and Cosmetic Act, 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 Beauvaria bassiana

ATCC 74040 in or on all raw

agricultural commodities. The initial

notice of filing was published in the

Federal Register of June 15, 1995 (60 FR

31465) (FRL–4955–4). This amended

petition was submitted to comply with

the provisions of the 1996 Food Quality

Protection Act (FQPA).

Pursuant to section 408(d)(2)(A)(i) of

the FFDCA, as amended, Troy

Biosciences, Inc. has submitted the

following summary of information, data

and arguments in support of their

pesticide petition. This summary was

prepared by Troy Biosciences, Inc. and

EPA has not fully evaluated the merits

of the petition. The summary may have

been edited by EPA if the terminology

used was unclear, the summary

contained extraneous material, or the

summary was not clear that it reflected

the conclusion of the petitioner and not

necessarily EPA.

A. Product Name and Proposed Use

Practices

Beauvaria bassiana ATCC 74040 is

the active ingredient in the technical

product Naturalis. End-use products are

to be used to treat all food commodities

using standard ground and aerial

application equipment.

B. Product Identity/Chemistry

1. Identity of the pesticide and

corresponding residues. The active

ingredient, Beauveria bassiana ATCC #

74040 (TBI#1), is a naturally occurring,

soil-borne fungal entomopathogen that

is found in soil environments

worldwide. This particular strain was

isolated for TBI from an infected boll

weevil collected from the Rio Grande

Valley in Texas. Beauveria bassiana

organisms, and particularly the spores,

do not display good viability outside

soil environments. They are extremely

sensitive to high ambient temperatures,

low humidity and intense light.

Following foliar application to RACs, it

is unlikely spores will survive beyond 3

to 5 days. Data generated under

experimental use permits and data

obtained from use of Beauveria bassiana

ATCC # 74040 (TBI#1) on ornamentals

and turf demonstrate that there are no

detectable organisms.

2. Magnitude of residue at the time of

harvest and method used to determine

the residue— Plant metabolism.

Beauveria bassiana is a well-known,

soil-inhabiting fungal organism. It is not

pathogenic to plants, and will not

invade plant tissue. Results of research

conducted under the Experimental Use

Permit (EUP) also document that the

conidia of Beauveria bassiana are not

viable 96 hours following foliar

applications.

3. A statement of why an analytical

method for detecting and measuring the

levels of the pesticide residue are not

needed. An acceptable analytical

method exists to determine the viability

of spores on the foliar surface. Troy

Biosciences also has developed a

method to enumerate viable spores per

unit volume. Additionally, Troy

Biosciences has developed methods and

provided data required by EPA on

screens for bacterial contaminants,

including human pathogens, and on

beauvericin and aflatoxins, potential

metabolites of concern for the active

ingredient. Further, the inert ingredients

used in the formulated product are food

grade or meet all other applicable FDA

standards. Finally, all lots of the active

ingredient and the formulated product

are monitored as part of Troy

Biosciences’ rigorous quality control

program.

C. Mammalian Toxicological Profile

Acute toxicity. The acute oral toxicity/

pathogenicity of the technical grade

active ingredient (TGAI) in the rat was

determined following a single exposure

to 108 colony forming units (CFU). The

organism was not infectious to the rat

and total clearance from the animal was

projected to occur in 23 days. In a single

24 hour dermal exposure of two grams

of the technical powder, erythema and

edema were observed in 30% of the

animals. These symptoms cleared in 1-

7 days and indicated that the material

was a moderate dermal irritant. These

results were classified as Toxicity

Category IV. A bovine corneal opacity

and permeability assay was conducted

to project the potential irritancy of the

technical powder. The results indicated

that the technical powder might be a

slight irritant. The results of a primary

eye irritation study confirmed that the

technical powder was a slight irritant to

the eye (Toxicity Category III). A study

was conducted in the rat in which the

animals were exposed by intraperitoneal

injection to 107 CFU of the material

(MRID 43294201). The animals were

unaffected by the test material during

the 29 day observation period. In a rat

intratracheal toxicity study, rats were

exposed to 107 CFU per animal. There

were small tan nodules in the lungs of

the test animals following exposure.

These lesions reversed as the study

progressed and the author opined that

they would be totally reversible if more

time were allowed. Total clearance of

Beauveria bassiana occurred within 15

days. There were no effects on survival

and the test material was not found in

any tissue outside the lungs. The

organism was not considered toxic or

pathogenic in this test animal.

D. Aggregate Exposure

1. Dietary exposure— Food. Troy

Biosciences has requested an exemption

from the requirement for a tolerance,

based on the well-documented

instability of the conidia of Beauveria

bassiana outside its natural

environment, the soil. Residues should

not be present because Troy Biosciences

has requested a waiver of the

requirement for a tolerance, based on

the well-documented instability of the

conidia of Beauveria bassiana outside

its natural environment, the soil.

Residues should not be present because

spores are not viable 96 hours following

application.

2. Drinking water. Use of Naturalis L

in agriculture could result in the entry

of the active ingredient into surface

waters via drift from the agricultural

application or run-off from treated
Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 / Notices 31773

foliage during rainfall events. It is

unlikely that the organism, because of

its short half-life, would survive more

than 1-2 days in this environment and

would be unlikely to contaminate

drinking water. Further, the organism is

not a known human pathogen.

3. Non-dietary exposure. The only

non-dietary exposures are expected to

be to applicators and other pesticide

handlers working with the product,

including those workers involved at the

manufacturing facility. Use of the

product according to the directions for

use on the label is not expected to result

in any risk of adverse health effects.

Exposure to the active ingredient in the

manufacturing process is minimized by

engineering controls. There may also be

limited dermal exposure as a result of

the turf use of the product (homes,

schools, other public areas). Adults and

children could contact treated foliage;

however, these residues are not

pathogenic in humans and the residues

degrade rapidly over time after

application.

E. Cumulative Exposure

Beauveria bassiana is a naturally

occuring, soil-borne microorganism

which is found throughout the World.

Over 400 different strains have been

identified, with concentrations varying

from region to region depending on soil

type and climatic conditions. Factors

such as sunlight, temperature and

humidity affect the persistence of this

organism in the environment. Data from

the past experimental use program

indicate residues of this organism are

not present on treated crops 96 hours

after application.

Optimum growth for Beauveria

bassiana occurs between 28-32°C, with

no growth occurring at temperatures

above 35°C. From a biological viewpoint

the human body does not have the

specific surface factors nor proper

temperature to stimulate spore

germination and infection hindering the

organism’s ability to cause systemic

disease. This is corroborated by

additional biological data from animal

testing via oral, intraperitoneal,

intratracheal, and dermal exposure.

These studies indicate both a lack of

systemic toxicity and nonpathogenicity. In addition, clearance of

the test animals occurs within a

relatively short time (<21 days).

Beauveria bassiana is effective by

infecting target insects. In this respect,

it shares a common mode of action with

many other registered biological

pesticides, including another strain of

Beauveria bassiana. The lack of

infectivity in humans and other noninsect species, combined with low

toxicity indicates that there is likely to

be no appreciable cumulative effect

from application of several pesticides

with this mode of action. Moreover,

because both products have similar

target pests (whiteflies, aphids and

thrips) and the product labels state that

7 to 9 days at a minimum are needed to

observe control, it is unlikely that both

products would be used within the 96-

hour effective period on the foliage.

Consequently, there would be no

accumulation of residues.

F. Safety Determination

1. U.S. population. Beauveria

bassiana is a ubiquitous soil

microorganism which is susceptible to

sunlight, temperature and humidity.

Data generated during the experimental

use program (1992-1994) indicate that,

once applied to raw agricultural

commodities, Beauveria bassiana does

not persist. Exposure to the general

public from treated foods will be

negligible. Biological data previously

cited indicate the organism does not

persist in the mammalian body, is not

pathogenic and clearance from the body

occurs within 21 days.

Troy Biosciences’ Beauveria bassiana

and its formulated product, Naturalis L,

are carefully monitored under a rigorous

quality control program. The active

ingredient is screened for bacterial

contaminants, including human

pathogens, and for the presence of

beauvericin and aflatoxins, metabolites

of potential concern. Raw materials

used for the formulated product also are

subject to quality control screens and

meet all applicable EPA and FDA

quality standards. To further assure the

safety of the formulated product, each

batch is monitored and must meet

rigorous quality control standards.

2. Infants and children. Based upon

the lack of persistence, favorable

biological data and quality control

procedures no adverse effects would be

expected for infants and children.

Residues of Beauveria bassiana would

not be present on commodities used for

the production of foods or formulae for

infants and children.

G. Effects on the Immune and Endocrine

Systems

Beauveria bassiana ATCC # 74040

(TBI#1) is a naturally-occurring, living,

fungal organism that is not pathogenic

to humans. It is unlikely that exposure

to this organism would result in an

effect on the human endocrine or

immune systems. There are no reports

of any estrogenic or other adverse effects

to human population as a result of the

use of Beauveria bassiana in the field.

Based on this information, combined

with its low mammalian toxicity, it is

concluded that there is a reasonable

certainty that no adverse endocrine

effects nor immune system effects will

result from the use of Beauveria

bassiana as an insecticide.

H. Existing Tolerances

No maximum residue level has been

established for this organism by the

Codex Alimentarius Commission.

[FR Doc. 98–15325 Filed 6–9–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–6109–8]

Public Notice of Draft NPDES General

Permits for Wastewater Lagoon

Systems Located On Indian

Reservations in Montana, North

Dakota, South Dakota, Utah, and

Wyoming

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of intent to issue NPDES

general permits.

SUMMARY: Region VIII of EPA is hereby

giving notice of its tentative

determination to issue National

Pollutant Discharge Elimination System

(NPDES) general permits for wastewater

lagoon systems located on Indian

Reservations in the States of MT, ND,

SD, UT, and WY and treating primarily

domestic wastewater. The use of

wastewater lagoon systems is the most

common method of treating municipal

wastewater and domestic wastewater

from isolated housing developments,

schools, etc., on the Indian Reservations

in those states. Region VIII is proposing

to use general permits instead of

individual permits for permitting the

discharges from such facilities in order

to reduce the Region’s administrative

burden of issuing separate individual

permits. The administrative burden for

the regulated sources is expected to be

about the same under the general

permits as with individual permits, but

it will be much quicker to obtain permit

coverage with general permits than with

individual permits. The discharge

requirements would be essentially the

same with an individual permit or

under the general permit. A separate

general permit is proposed to cover the

aforementioned facilities within the

exterior boundaries of a single

reservation.

DATES: Public comments on this

proposal must be received, in writing,

on or before August 10, 1998.