Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Notices 44689

The low toxicity of the subject active

ingredient is demonstrated by the data

summarized above. Based on this

information, it can be concluded that

aggregate exposure to Bacillus

sphaericus over a lifetime will not pose

appreciable risks to human health.

There is reasonable certainty that no

harm will result from aggregate

exposure to residues of Bacillus

sphaericus and, consequently,

exempting Bacillus sphaericus from the

requirement of a tolerance is considered

safe.

2. Infants and children. It is the

opinion of Abbott Laboratories that the

toxicity and exposure data are

sufficiently complete to adequately

address the potential for additional

sensitivity of infants and children to

residues of Bacillus sphaericus. A

determination of safety for infants and

children can be made due to the

insignificant exposure expected beyond

naturally occurring background levels

and the low acute toxicity of this

microbial insecticide. It can be

concluded with reasonable certainty

that no harm will result to infants and

children from aggregate exposure to

Bacillus sphaericus residues.

G. Existing Tolerances

Abbott Laboratories is not aware of

any existing tolerances or tolerance

exemption for Bacillus sphaericus.

[FR Doc. 97–22374 Filed 8–21–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–756; FRL–5737–2]

Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of pesticide petitions

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–756, must be

received on or before September 22,

1997.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch (7506C),

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. 1132,

CM #2, 1921 Jefferson Davis Highway,

Arlington, VA.

Comments and data may also be

submitted electronically by following

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. 1132 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 (PM) 90,

Biopesticides and Pollution Prevention

Division, (7501W), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location and telephone

number: Rm. 5th floor, CS1, 2800

Crystal Drive, Arlington, VA. 22202,

(703) 308–8097; e-mail:

bacchus.shanaz@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received pesticide petitions 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 these petitions

contain 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–756]

(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 file format or ASCII file

format. All comments and data in

electronic form must be identified by

the docket number [PF–756] and

appropriate petition number. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries.

List of Subjects

Environmental protection,

Agricultural commodities, Food

additives, Feed additives, Pesticides and

pests, Reporting and recordkeeping

requirements.

Dated: August 17, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

Summaries of Petitions

Petitioner summaries of the pesticide

petitions are printed below as required

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

summaries of the petitions were

prepared by the petitioners and

represent the views of the petitioners.

EPA is publishing the petition

summaries verbatim without editing

them 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.

1. BioWorks, Inc.

PP 6F4650

EPA has received a pesticide petition

from Bioworks, Inc., 122 North Genesee

Street, Geneva, New York 14456,

proposing pursuant to section 408(d) of

the Federal Food, Drug and Cosmetic

Act, 21 U.S.C. section 346a(d), to amend

40 CFR Part 180 to establish an

exemption from the requirement of a

tolerance for Trichoderma harzianum

Rifai strain KRL-AG2 in or on all raw

agricultural commodities, except

mushrooms.
44690 Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Notices

A. Residue Chemistry

1. Plant metabolism. The active

ingredient is Trichoderma harzianum

Rifai strain KRL-AG2 (a.k.a. T–22), a

strain of a naturally occurring soil

microorganism. This organism controls

plant diseases mechanically and is not

absorbed or otherwise incorporated into

the plant. It has no affect on plant

metabolism. This organism controls

plant disease by competing with plant

pathogens for root and foliar surfaces for

the establishment of fungal colonies.

Trichoderma harzianum Rifai strain

KRL-AG2 also controls plant pathogens

by the mechanism of mycoparasitism.

2. Analytical method. BioWorks has

not proposed an analytical method for

assessing residues because this

organism is naturally occuring, nontoxic and present in a wide variety of

habitats, including water. Because there

is a natural background population of

this organism it would be impossible to

distinguish between natural and

introduced microbial populations and to

establish and enforce any tolerance for

this organism. Trichoderma harzianum

(T-22) does not have adverse affects on

the environment, animals or humans.

This organism does not persist when

applied to foliage or fruit. Ordinary

environmental conditions cause rapidly

declining population levels of the

microbe soon after application to aboveground plant parts.

3. Magnitude of residues. The only

residue expected at harvest is the

background level of Trichoderma

harzianum (T-22) currently present on

agricultural commodities. Any

Trichoderma harzianum (T-22), either

naturally occurring or applied,

remaining at harvest will be removed or

rendered nonviable by the usual

processing of the food or feed.

B. Toxicological profile

1. Acute toxicity. Strain T–22 was

determined to be non-toxic during the

initial Tier I toxicological tests. This

pesticide is currently registered for seed

treatments for which an exemption from

tolerance exists for certain raw

agricultural commodities (40 CFR

180.1102). In PR Notice 95–3, June 7,

1995 the Agency included this fungus in

a list of low risk pesticides qualifying

for reduced restricted entry intervals.

a. Acute oral toxicity/pathogenicity.

Ingestion of this product produced no

apparent signs of toxicity,

pathogenicity, or infection following a

21–day test period in both female and

male rats. The active ingredient is

classified as toxicity category IV for oral

toxicity.

b. Acute pulmonary toxicity/

pathogenicity. A high concentration test

article given by intratracheal injection to

male and female rats produced no

apparent signs of toxicity or

pathogenicity. The active ingredient is

classified as toxicity category IV for

pulmonary toxicity.

c. Primary dermal and eye irritation.

EPA granted a waiver for the acute

dermal toxicity studies in a letter dated

June 28, 1990. The active ingredient is

classified as toxicity category III for

dermal exposure.

d. Acute intravenous toxicity. A high

concentration test article was given by

intravenous injection to male and

female rats. Not apparent signs of

toxicity or pathogenicity were observed.

e. Hypersensitivity incidents reported.

No incidents of hypersensitivity in

humans have been reported during the

production and handling of this active

ingredient.

f. Immune response. This organism is

non-toxic and naturally occurring.

There is no evidence of any negative

impact on the immune systems of

humans.

g. Tissue culture. All available

literature indicates that the use of this

organism as a pesticide is safe for

humans.

Based on the results of the Tier I tests

there was no indication that subchronic

or chronic studies were required.

2. Metabolite toxicology. Strain T–22

produces no known metabolites of any

environmental or health concern. This

organism controls plant disease by

competing with plant pathogens for root

and foliar surfaces for the establishment

of fungal colonies and by

mycoparasitism.

C. Aggregate Exposure

1. Dietary exposure. Trichoderma

harzianum (T-22) is a non-toxic,

naturally occurring fungi. There is no

evidence that it presents any risk to

animals or humans. It is present in

many different types of environments

worldwide. Because of its ubiquitous

nature all humans and animals have

some natural exposure to the organism.

Proposed application methods, uses,

and application rates will not result in

a sustained increase in the population

levels of this organism beyond the

naturally occurring background levels of

Trichoderma harzianum (T-22).

2. Food. Use of strain T–22 as a

pesticide will result in little or no

residue on food and feed and is highly

unlikely to increase exposure of humans

to Trichoderma harzianum (T-22) fungi

by dietary means.

3. Drinking water. Trichoderma

harzianum strains are commonly found

in water worldwide. Their presence in

drinking water does not present a risk

to animals or humans because the

fungus is non-toxic and consumed in

low concentrations. It is highly unlikely

that use of strain T–22 as a pesticide

will increase the concentration of this

organism in the water supply beyond

the already existing background levels

of naturally occurring populations.

4. Non-dietary exposure. The only

non-dietary exposure expected is to

applicators. However, exposure to this

organism resulting from its application

according to label directions is not

expected to present any risk of adverse

health effects.

D. Cumulative Effects

Because this organism controls

disease by mechanical, not chemical

means, and the organism itself is nontoxic there will be no cumulative

exposure created by other pesticides

acting with the same mode of toxicity.

In addition, no cumulative adverse

health effects are expected from longterm exposure to this organism.

E. Safty Determination

1. U.S. population. Strain T–22 is a

strain of naturally occurring non-toxic

organism. Use of this organism as a

pesticide product will result in little or

no residues on food or feed. Since

people are already exposed to this

organism in nature, the incremental

exposure from its use as a pesticide

product is expected to be negligible.

2. Infants and children. Any

differences in infants and children’s

dietary habits or exposure patterns to

this organism do not correlate with an

increased risk of harm to children.

There is no information suggesting

differential sensitivity of infants and

children to this natural organism.

Infants and children are currently

exposed to this organism in the natural

environment and no data suggest that

the use of this organism as a pesticide

will harm children.

F. Internal Tolerances

There are no international tolerances

or tolerance exemptions for this

biocontrol fungus.

2. Makhteshim-Agan of North America

Inc.

PP 7F4812

EPA received a pesticide petition (PP

7F4812) from Makhteshim-Agan of

North America Inc., 551 Fifth Avenue,

Suite 1100, New York, NY 10176,

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 by establishing an exemption

from the requirement of a tolerance for

residues of the biofungicide Trichodex
Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Notices 44691

(Trichoderma harzianum T-39) in or on

all raw agricultural commodities.

A. Proposed Use Practices

Recommended application method

and rate(s), frequency of application,

and timing of application. Trichodex

may be applied with conventional spray

equipment for control of Botrytis (gray

mold) on fruit and vegetable crops. The

rate of application is two to four pounds

of Trichodex per acre in sufficient

gallonage to insure adequate coverage.

The frequency and timing of application

vary with the crop being treated. For

example, one to four applications are

made to wine grapes in a rotational

program with conventional chemical

fungicides, while four to six

applications may be applied to wine

grapes when the product is used alone.

Table grapes are treated with one to

three applications during pre-bloom to

fruit set. Treatments on strawberry may

include up to eight applications (once

per week) throughout the growing

season from pre-bloom to harvest.

B. Product Identity/ Chemistry

1. Identity of the pesticide and

corresponding residues. The active

ingredient is Trichoderma harzianum

T–39, a fungus which occurs naturally

in the environment worldwide,

including in the U.S. The strain of T.

harzianum used in Trichodex has been

designated as ‘‘T-39.’’ This strain has

been characterized by colony and

structural morphology, RFLP mapping

and classified by intraspecific DNA

primers. The strain is typical of T.

harzianum and does not express

characteristics of plant pathogenic

strains. The organism does not persist in

the environment and relies on repeated

application to achieve plant protection.

The organism degrades in the

environment to natural organic

constituents.

2. Magnitude of residue anticipated at

the time of harvest and method used to

determine the residue. MakhteshimAgan of North America has requested

waivers for these data requirements. The

waiver requests were based on the

known low toxicity of Trichodex, the

natural occurrence of T. harzianum T–

39 in the environment, the non-toxic

mode of action, the submitted data and

information available in the open

literature.

3. Statement of why an analytical

method for detecting and measuring the

levels of the pesticide residue are not

needed. Makhteshim-Agan of North

America has not proposed an analytical

method, because residues of T.

harzianum T–39 resulting from

Trichodex applications do not pose a

hazard to humans, plants and animals.

T. harzianum T–39 from naturally

occurring strains is commonly found in

the environment and can be reasonably

expected to exist whether or not

Trichodex has been applied to the

growing crop.

C. Mammalian Toxicological Profile

Provide the following or rationale for

waiver request.

1. Acute toxicity. The health effects

data submitted in the Makhteshim-Agan

of North America Inc. petition and all

other relevant material have been fully

evaluated by the EPA in their approval

of an Experimental Use Permit for large

scale field evaluation of Trichodex. The

mammalian toxicological data

considered in support of the exemption

from the requirement of a tolerance for

Trichodex include: an acute oral

toxicity study in rats, a primary eye

irritation study in rabbits and an acute

inhalation study in rats. All three

studies were assigned Toxicity Category

III. The submitted acute dermal toxicity

study in rabbits, primary dermal

irritation study in rabbits, and a dermal

sensitization study in guinea pigs were

assigned Toxicity Category IV.

The results of these studies indicated

that Trichodex has an acute oral LD50

greater than 500 mg/kg body weight in

rats, an acute dermal LD50 greater than

1,150-1,570 mg/kg body weight in

rabbits. Trichodex caused reversible eye

irritation with complete clearance after

7 days. No dermal irritation in rabbits

was observed, however, the product was

found to be a delayed contact dermal

sensitizer in guinea pigs (based on the

modified Beuhler Assay). The acute

pulmonary toxicity/ pathogenicity study

in the rat showed no evidence of

pathogenicity or Trichodex

reproduction in the tissues examined.

Although the study was of insufficient

duration to achieve complete clearance

in the lung, the study demonstrated

clearance in brain, blood, lymph nodes,

kidney, liver, spleen, and caecum.

Toxicity Category III was assigned to

pulmonary exposure mitigated by label

instructions indicating personal

protective equipment for applicators.

2. Genotoxicity, reproductive and

developmental toxicity, subchronic

toxicity, and chronic toxicity. The T-39

strain of T. harzianum, the active

ingredient in Trichodex, does not

produce fungal metabolites as its

primary mode of action against target

plant pathogens. Submitted studies

using the Ames Test and Mouse

Micronucleus test show no indication of

genotoxic or reproductive effects.

D. Aggregate Exposure

1. Dietary exposure— a. Food.

Trichodex is based on a naturally

occurring organism normally found in

the environment. For the purposes of

assessing the potential dietary exposure

under this exemption, it should be

considered that T. harzianum may be

present on all RACs. Submitted studies

indicate that residues of Trichodex do

not pose a hazard to humans by route

of ingestion.

b. Drinking water. Based on the

available studies presented for use in

the assessment of environmental risk, it

is not anticipated that drinking water

will provide a route of exposure to

residues of Trichodex. The anticipated

use pattern for Trichodex does not

include use in or on waterways. Even

though Trichodex can be washed off

treated plants by rain and during

processing of crops by water, it degrades

in an aqueous environment into organic

constituents by normal biological,

physical, and chemical processes.

c. Non-dietary exposure. Based on

label directions for use as a foliar

applied biofungicide. The only nondietary exposure is to applicators of the

product. However, exposure to

Trichodex resulting from its proper

application according to label directions

for the use of personal protective

equipment is not expected to present

any risk of adverse health effects.

E. Cumulative Exposure

Other than a possible allergic reaction

to spores present in the product

following repeated exposure, no

cumulative adverse health effects are

expected from long-term exposure to

Trichodex. Risk of dermal sensitization

is addressed on the label which

specifies proper personal protective

equipment to minimize exposure.

Exposure through other pesticides

and substances with a common mode of

toxicity with this pesticide.

Consideration of a common mechanism

of toxicity is not appropriate for several

reasons:

(1) Trichodex has a non-toxic mode of

action.

(2) Only a small number of pesticidal

products containing T. harzianum as an

active ingredient are currently

registered.

(3) The species is ubiquitous in

nature.

(4) The active ingredient has been

demonstrated to be non-toxic in

submitted acute studies.

F. Safety Determination

1. U.S. population in general.

Trichodex is based on a naturally
44692 Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Notices

occurring organism normally found in

the environment and on crop plants.

The low toxicity of the subject active

ingredients is demonstrated by the data

summarized above. Based on this

information, it has been determined that

aggregate exposure to Trichodex over a

lifetime will not pose appreciable risks

to human health and there is a

reasonable certainty that no harm will

result from Trichodex residues. Since

people are exposed to T. harzianum

from natural sources, the incremental

exposure from its use in pesticide

products is expected to be negligible.

2. Infants and children. It has been

determined that the toxicity and

exposure data are sufficiently complete

to adequately address the potential for

additional sensitivity of infants and

children to residues of Trichodex. It is

concluded that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to Trichodex residues.

G. Existing Tolerances

1. Existing tolerances or tolerance

exemptions. A temporary tolerance

exemption in conjunction with an

Experimental Use Permit for Trichodex

is currently in effect. EPA has also

promulgated permanent exemptions

from the requirement for a tolerance for

strains of T. harzianum other than T-39.

2. International tolerances or

tolerance exemptions. No maximum

residue level has been established for

Trichodex by the Codex Alimentarius

Commission. Exemptions from the

requirement of a tolerance have been

granted for Trichodex in all

international registrations.

[FR Doc. 97–22375 Filed 8–21–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[OPPTS–00215; FRL–5724–5]

Printed Wiring Board Cleaner

Technologies Substitutes Assessment,

Making Holes Conductive; Notice of

Availability

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of Availability for

Comment.

SUMMARY: The Environmental Protection

Agency (EPA) is announcing the

availability of the draft document

entitled ‘‘Printed Wiring Board Cleaner

Technologies Substitutes Assessment:

Making Holes Conductive.’’ This

document details the findings of EPA’s

Design for the Environment (DfE)

Printed Wiring Board (PWB) Project

regarding alternative technologies for

performing the ‘‘making holes

conductive’’ function during the

manufacture of PWBs.

DATES: Comments are due no later than

October 6, 1997.

ADDRESSES: Comments should be

mailed in triplicate to: TSCA Public

Docket, Rm. NEG 99, U.S.

Environmental Protection Agency, 401

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

Comments and data may also be

submitted electronically by following

the instructions under Unit II. No CBI

should be submitted through e-mail.

Comments are available for public

inspection and copying in the TSCA

Nonconfidential Information Center,

Rm. NEB 607, 401 M St., SW.,

Washington, DC. Free copies of the

complete 2-volume report (EPA 744–R–

97–002 a and b) can be obtained by

contacting the EPA’s Pollution

Prevention Information Clearinghouse

(PPIC), at 401 M St., SW., (7407),

Washington DC, 20460; 202–260–1023;

fax 202–260–4659, or the report can be

reviewed on the DfE home page at http:/

/www.epa.gov/dfe.

FOR FURTHER INFORMATION CONTACT:

Dipti Singh, Design for the Environment

Program, Office of Pollution Prevention

and Toxics (7406), U.S. EPA, 401 M St.,

SW., Washington, DC, 20460; 202–260–

1678, e-mail: oppt.dfe@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

I. Project Background

EPA’s Design for the Environment

(DfE) Program began working with the

printed wiring board (PWB) industry in

1994, to identify and evaluate

environmentally beneficial and cost

effective alternatives to PWB

manufacturing technologies. The DfE

PWB Project is a voluntary, cooperative

partnership between EPA, the PWB

industry, public-interest groups, and

other stakeholders. The goal of this

Project is to provide information that

will assist the PWB industry in making

informed decisions when evaluating

and implementing beneficial

alternatives to PWB manufacturing

technologies.

For purposes of this study, the project

evaluated seven alternative technologies

for performing the ‘‘making holes

conductive’’ (MHC) function during the

manufacture of PWBs. The nonconveyorized electroless copper process

was considered the baseline process

against which alternative technologies

and equipment configurations were

compared. With this notice, EPA is

announcing the availability of the draft

document entitled ‘‘Printed Wiring

Board Cleaner Technologies Substitutes

Assessment: Making Holes Conductive.’’

This document marks the culmination

of over 2–years of research by the DfE

PWB Project and the University of

Tennessee Center for Clean Products

and Clean Technologies. The data

gathered on the comparative risk,

performance, cost, and natural resource

requirements of the alternatives and

baseline technologies are presented in

this document.

II. Public Record

The official record for this notice, as

well as the public version, has been

established for this notice under docket

number [OPPTS–00215], and will

include any comments and data

submitted electronically. A public

version of this record, including

printed/paper versions of electronic

comments, which does not include any

information claimed as confidential

business information CBI, is available

for inspection from 12 noon to 4 p.m.,

Monday through Friday, excluding

Federal 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:

oppt.ncic@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Comments and data will

also be accepted on disks in

WordPerfect in 5.1 file format or ASCII

file format. All comments and data in

electronic form must be identified by

the docket number [OPPTS–00215].

Electronic comments on this proposed

rule may be filed online at many Federal

Depository Libraries.

Dated: August 12, 1997.

Mary Ellen Weber,

Director, Economics, Exposure, and

Technology Division, Office of Pollution

Prevention and Toxics.

[FR Doc. 97–22376 Filed 8–21–97; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL COMMUNICATIONS

COMMISSION

[Report No. 2217]

Petitions for Reconsideration and

Clarification of Action in Rulemaking

Proceedings

August 19, 1997.

Petitions for reconsideration have

been filed in the Commission’s

rulemaking proceeding listed in this