Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Notices 3693

turf by professional lawn care

applicators or on sod farms. The

product is rarely, if ever, used on

homeowner turf due to the fact that the

diseases it controls (Brown patch, Fairy

ring, and snow molds) occur in highfertility, high-maintenance turf (e.g., golf

courses), not in homeowner lawns.

Thus, non-dietary exposure to flutolanil

would be minimal. Furthermore, no

dermal toxicity endpoints of concern

have been identified for flutolanil. Thus,

an assessment of non-dietary exposure

and risk is not considered to be

necessary.

D. Cumulative Effects

Flutolanil has demonstrated only

minimal toxicity in animal studies. The

mechanism of this toxicity is unknown.

Furthermore, there are no available data

to indicate that flutolanil has a common

mechanism of toxicity with other

substances. Thus, only the potential

risks from flutolanil are being

considered in this document.

E. Safety Determination

1. U.S. population. Based on the

existing and proposed tolerances in

potatoes, rice, peanuts and, secondary

commodities, the Theoretical Maximum

Residue Contribution (TMRC) of the

current action is estimated to be

0.001353 mg/kg/day for the U.S.

population in general. This exposure

would utilize less than 1% of the RfD.

There is generally no concern for

exposures below 100% of the RfD since

the RfD represents the exposure level at

or below which daily exposure over a

lifetime will not pose any appreciable

risks to human health. Therefore, there

is a reasonable certainty that no harm

will result in the U.S. population in

general from aggregate exposure to

flutolanil.

2. Infants and children. Data from

reproductive and developmental

toxicity studies are generally used to

assess the potential for increased

sensitivity of infants and children. No

evidence of developmental toxicity was

noted in rats or rabbits, even at the limit

dose of 1,000 mg/kg/day. Reduced pup

weights in the absence of parental

toxicity were noted at the high-dose

level (10,000 ppm) in a 3–generation rat

reproduction study. However, no such

effects were noted in a subsequent

reproduction study, even at a higher

dose level (20,000 ppm). Furthermore,

the reduced weight gain in the first

study began late in the lactation period,

at a time when the pups were likely

ingesting significant quantities of diet.

Feed intake is much higher in young

animals than in adults and the apparent

increase in sensitivity may simply

reflect the higher test material intake in

these pups on a mg/kg basis compared

to the adults. Thus, AgrEvo believes that

the overall weight of evidence does not

indicate any special concern for infants

and children, and that no additional

safety factor is necessary.

Based on the existing and proposed

tolerances in rice, potatoes, peanuts,

and secondary commodities, the TMRC

from the current petition is estimated to

be 0.006498 mg/kg/day for the most

highly exposed subpopulation, nonnursing infants (less than 1 year old).

This exposure would utilize

approximately 1% of the RfD. Therefore,

there is a reasonable certainty that no

harm will result to infants or children

from aggregate exposure to flutolanil.

F. International Tolerances

No Codex Alimentarius Commission

(CODEX) tolerances have been

established for flutolanil.

[FR Doc. 00–1551 Filed 1–21–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–911; FRL–6485–5]

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 pesticide petitions

proposing the establishment of

regulations for residues of certain

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by docket

control number PF–911, must be

received on or before February 23, 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–911 in the subject

line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Judy Loranger, Biopesticides and

Pollution Prevention Division (7511C),

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

telephone number: (703) 308–8056; email address: loranger.judy@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–

911. 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

3694 Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Notices

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

(CM 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–911 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, 401 M St., SW., Washington,

DC 20460.

2. In person or by courier. Deliver

your comments to: Public Information

and Records Integrity Branch (PIRIB),

Information Resources and Services

Division (7502C), Office of Pesticide

Programs (OPP), Environmental

Protection Agency, Rm. 119, CM 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–911. 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 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: January 10, 2000.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

Summaries of Petitions

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

the FFDCA, as amended, Bird Shield

Repellent Corporation has submitted the

following summary of information, data,

and arguments in support of their

pesticide petitions. These summaries

were prepared by Bird Shield Repellent

Corporation and EPA has not fully

evaluated the merits of the pesticide

petition. The summaries may have been

edited by EPA if the terminology used

was unclear, the summaries contained

extraneous material, or the summaries

unintentionally made the reader

conclude that the findings reflected

EPA’s position and not the position of

the petitioner.

I. Bird Shield Repellent Corporation

9F5055

EPA has received a pesticide petition

9F5055 from Bird Shield Repellent

Corporation, P.O. Box 785, Pullman,

WA 99163, 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

biochemical pesticide methyl

anthranilate in or on sunflower.

A. Product Name and Proposed Use

Practices

The commercial name for the end use

product containing methyl anthranilate

(MA) is Bird Shield Repellent, EPA Reg.

No. 66550–1. The product was approved

for use as a bird repellent on cherries,

blueberries and grapes on October 3,

1995. The active ingredient, methyl

anthranilate, is a natural constituent of

concord and heavy red grapes. It is

listed by the U.S. Food and Drug

Administration (FDA) as a flavoring

compound under 21 CFR 182.60 and is

classified as a Generally Recognized as

Safe (GRAS) compound by the Expert

panel of the Flavoring and Extract

Manufacturer’s Association (FEMA No.

2682). An exemption from the

requirement of a tolerance for the active

ingredient, methyl anthranilate for

cherries, blueberries and grapes under

40 CFR 180.1143 became effective on

April 26, 1995, as published in the

Federal Register (60 FR 20432) (FRL–

4941–8).

The mode of action is physical

whereby the repellent irritates the bird’s

taste buds, olfactory sensors and skin.

For this petition, methyl anthranilate is

Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Notices 3695

sprayed in a water solution at a rate of

0.2862 pounds (lbs) per acre to

sunflowers twice at 7-day intervals until

harvest. Applications to the crop can be

applied up to 2 days before harvest.

B. Product Identity/Chemistry

1. Identity of the pesticide and

corresponding residues. Methyl

anthranilate is a common component of

concord and other red grapes as well as

neroli, ylang-ylang, bergamot, jasmine

and other essential oils. It is

synthetically obtained by esterifying

anthranilic acid with methanol in the

presence of hydrochloric acid. In its

crystalline form it is slightly soluble in

water and freely soluble in alcohol or

ether. Methyl anthranilate is commonly

used as a perfume for ointments and

cosmetics, and a flavoring agent in

confectionary products, drugs and

beverages. Methyl anthranilate readily

volatilizes under ultraviolet (uv) light

and elevated temperatures.

2. Magnitude of residue at the time of

harvest and method used to determine

the residue. Residue studies, using gas

chromatography and mass spectrometry,

show no residues at the time of harvest.

No residues of methyl anthranilate are

expected to occur at the time of harvest

and thus the purpose for proposing an

exemption from the requirement of a

tolerance.

3. A statement of why an analytical

method for detecting and measuring the

levels of the pesticide residue are not

needed. The analytical method for

detecting and measuring the levels of

the residue is described above.

C. Mammalian Toxicological Profile

Methyl anthranilate is approved by

the FDA for food use as an artificial

flavoring and fragrance agent. Bird

Shield Repellent Corporation has

reviewed the acute toxicological studies

associated with these approvals and

conducted additional studies for

verification. Summaries of these studies

are presented below:

1. Mammalian. Methyl anthranilate

exhibits little or no mammalian toxicity.

Methyl anthranilate metabolizes in the

intestine when consumed. The lethal

dose50 (LD50) values for methyl

anthranilate were estimated to be greater

than 5,000 milligrams/kilograms (mg/

kg) in an acute oral toxicity study in rats

(Toxicity category IV) and greater than

2,000 mg/kg in an acute dermal toxicity

study in rats (Toxicity category III). The

LC50 value in an acute inhalation study

in rats was determined to be greater 2.24

mg/liters (L) (Toxicity category IV).

Methyl anthranilate was found to cause

moderate irritation in a rabbit skin

irritation assay and corneal effects that

cleared in 8 to 21 days in a rabbit eye

irritation assay.

2. Avian. Methyl anthranilate exhibits

little or no avian toxicity. Methyl

anthranilate’s irritating properties to

avian species preclude ingestion. In an

acute oral avian toxicity study, methyl

anthranilate was found to be practically

non-toxic to bobwhite quail. In a dietary

study, methyl anthranilate was

determined to be practically non-toxic

to mallard ducks. Based on these

studies, Bird Shield Repellent

Corporation concludes that methyl

anthranilate poses no unique or

additional risk to avian species.

D. Aggregate Exposure

1. Dietary exposure —i. Food. The

active ingredient in Bird Shield

Repellent Concentrate, methyl

anthranilate, is applied at a rate of

0.2862 lbs per acre. Because of the low

use rates, no active ingredient residues

are detectable using available methods

on treated crops even immediately after

application. Because of it’s volatility,

and degradation when exposed to

ultraviolet light and elevated

temperatures, no residues are expected

at harvest. Dietary exposure to methyl

anthranilate, via consumption of the

treated food or feed, is expected to be

low to negligible.

ii. Drinking water. The active

ingredient is unlikely to be found in

drinking water given the very low

application rate and rapid degradation

in soil.

2. Non-dietary exposure. Bird Shield

Repellent Corporation believes that the

potential for non-dietary exposure to the

general population, including infants

and children, is unlikely as the

proposed use is primarily to the

external, non-edible portions of the

crop. This mode of application would

not be expected to pose any quantifiable

risks due to lack of residues of

toxicological concern. Increased nondietary exposure of methyl anthranilate

is not considered likely because of the

low use rates and the lack of persistence

of the active ingredient.

E. Cumulative Exposure

Consideration of a common mode of

toxicity is not appropriate given there is

no indication of mammalian toxicity of

methyl anthranilate and no information

that indicates that the toxic effects

would be cumulative with any other

compounds. Moreover, methyl

anthranilate does not exhibit a toxic

mode of action in its target species.

F. Safety Determination

1. U.S. population. Methyl

anthranilate’s lack of toxicity has been

demonstrated by the results of acute

toxicity testing in mammals in which

the chemical caused no adverse effects

when dosed orally and via inhalation at

the limit dose for each study. Thus the

aggregate exposure to methyl

anthranilate over a lifetime should pose

negligible risks to human health.

2. Infants and children. Based on the

lack of toxicity and low exposure there

is reasonable certainty of no harm to

infants, children or adults from

aggregate exposure to the chemical’s

residues. Exempting methyl anthranilate

from the requirement of a tolerance

should pose no significant risk to

human health or the environment.

G. Effects on the Immune and Endocrine

Systems

Bird Shield Repellent Corporation has

no information to suggest that methyl

anthranilate will adversely affect the

immune or endocrine systems.

H. Existing Tolerances

An exemption from the requirement

of a tolerance for the active ingredient,

methyl anthranilate for cherries,

blueberries and grapes under 40 CFR

180.1143 became effective in the

Federal Register of April 26, 1995 (60

FR 20432).

I. International Tolerances

Bird Shield Repellent Corporation is

not aware of any tolerance, exemption

from tolerance or maximum residue

levels (MRLs) issued for methyl

anthranilate outside the United States.

II. Bird Shield Repellent Corporation

9F5056

EPA has received a pesticide petition

9F5056 from Bird Shield Repellent

Corporation, P.O. Box 785, Pullman,

WA 99163, proposing pursuant to

section 408(d) of the 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

biochemical pesticide methyl

anthranilate in or on corn.

A. Product Name and Proposed Use

Practices

The commercial name for the end use

product containing methyl anthranilate

is Bird Shield Repellent, EPA Reg. No.

66550–1. The product was approved for

use as a bird repellent on cherries,

blueberries and grapes on October 3,

1995. The active ingredient, methyl

anthranilate, is a natural constituent of

concord and heavy red grapes. It is

listed by the FDA as a flavoring

compound under 21 CFR 182.60 and is

classified as a GRAS compound by the

Expert panel of FEMA No. 2682. An

3696 Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Notices

exemption from the requirement of a

tolerance for the active ingredient,

methyl anthranilate for cherries,

blueberries and grapes under 40 CFR

180.1143 became effective on April 26,

1995 as published in the Federal

Register (60 FR 20432) (FRL–4941–8).

The mode of action is physical

whereby the repellent irritates the bird’s

taste buds, olfactory sensors and skin.

For this petition, methyl anthranilate is

sprayed in a water solution at a rate of

0.2862 pounds (lbs.) per acre to corn

twice and may be reapplied at 5 to 10

day intervals until harvest. Applications

to the crop can be applied up to 2 days

before harvest.

B. Product Identity/Chemistry

1. Identity of the pesticide and

corresponding residues. Methyl

anthranilate is a common component of

concord and other red grapes as well as

neroli, ylang-ylang, bergamot, jasmine

and other essential oils. It is

synthetically obtained by esterifying

anthranilic acid with methanol in the

presence of hydrochloric acid. In its

crystalline form it is slightly soluble in

water and freely soluble in alcohol or

ether. Methyl anthranilate is commonly

used as a perfume for ointments and

cosmetics, and a flavoring agent in

confectionary products, drugs and

beverages. Methyl anthranilate readily

volatilizes under ultraviolet (uv) light

and elevated temperatures.

2. Magnitude of residue at the time of

harvest and method used to determine

the residue. Residue studies, using gas

chromatograph and mass spectrometry,

show no residues at the time of harvest.

No residues of methyl anthranilate are

expected to occur at the time of harvest

and thus the purpose for proposing an

exemption from the requirement of a

tolerance.

3. A statement of why an analytical

method for detecting and measuring the

levels of the pesticide residue are not

needed. The analytical method for

detecting and measuring the levels of

the residue is described above.

C. Mammalian Toxicological Profile

Methyl anthranilate is approved by

the FDA for food use as an artificial

flavoring and fragrance agent. Bird

Shield Repellent Corporation has

reviewed the acute toxicological studies

associated with these approvals and

conducted additional studies for

verification. Summaries of these studies

are presented below:

1. Mammalian. Methyl anthranilate

exhibits little or no mammalian toxicity.

Methyl anthranilate metabolizes in the

intestine when consumed. The LD50

values for methyl anthranilate were

estimated to be greater than 5,000 mg/

kg in an acute oral toxicity study in rats

(Toxicity category IV) and greater than

2,000 mg/kg in an acute dermal toxicity

study in rats (Toxicity category III). The

LC50 value in an acute inhalation study

in rats was determined to be greater 2.24

mg/L (Toxicity category IV). Methyl

anthranilate was found to cause

moderate irritation in a rabbit skin

irritation assay and corneal effects that

cleared in 8 to 21 days in a rabbit eye

irritation assay.

2. Avian. Methyl anthranilate exhibits

little or no avian toxicity. Methyl

anthranilate’s irritating properties to

avian species preclude ingestion. In an

acute oral avian toxicity study, methyl

anthranilate was found to be practically

non-toxic to bobwhite quail. In a dietary

study, methyl anthranilate was

determined to be practically non-toxic

to mallard ducks. Based on these

studies, Bird Shield Repellent

Corporation concludes that methyl

anthranilate poses no unique or

additional risk to avian species.

D. Aggregate Exposure

1. Dietary exposure —i. Food. The

active ingredient in Bird Shield

Repellent Concentrate, methyl

anthranilate, is applied at a rate of

0.2862 lbs per acre. Because of the low

use rates, no active ingredient residues

are detectable using available methods

on treated crops even immediately after

application. Because of its volatility,

and degradation when exposed to

ultraviolet light and elevated

temperatures, no residues are expected

at harvest. Dietary exposure to methyl

anthranilate, via consumption of the

treated food or feed, is expected to be

low to negligible.

ii. Drinking water. The active

ingredient is unlikely to be found in

drinking water given the very low

application rate and rapid degradation

in soil.

2. Non-dietary exposure. Bird Shield

Repellent Corporation believes that the

potential for non-dietary exposure to the

general population, including infants

and children, is unlikely as the

proposed use is primarily to the

external, non-edible portions of the

crop. This mode of application would

not be expected to pose any quantifiable

risks due to lack of residues of

toxicological concern. Increased nondietary exposure of methyl anthranilate

is not considered likely because of the

low use rates and the lack of persistence

of the active ingredient.

E. Cumulative Exposure

Consideration of a common mode of

toxicity is not appropriate given there is

no indication of mammalian toxicity of

methyl anthranilate and no information

that indicates that the toxic effects

would be cumulative with any other

compounds. Moreover, methyl

anthranilate does not exhibit a toxic

mode of action in its target species.

F. Safety Determination

1. U.S. population. Methyl

anthranilate’s lack of toxicity has been

demonstrated by the results of acute

toxicity testing in mammals in which

the chemical caused no adverse effects

when dosed orally and via inhalation at

the limit dose for each study. Thus the

aggregate exposure to methyl

anthranilate over a lifetime should pose

negligible risks to human health.

2. Infants and children. Based on the

lack of toxicity and low exposure there

is reasonable certainty of no harm to

infants, children or adults from

aggregate exposure to the chemical’s

residues. Exempting methyl anthranilate

from the requirement of a tolerance

should pose no significant risk to

human health or the environment.

G. Effects on the Immune and Endocrine

Systems

Bird Shield Repellent Corporation has

no information to suggest that methyl

anthranilate will adversely affect the

immune or endocrine systems.

H. Existing Tolerances

An exemption from the requirement

of a tolerance for the active ingredient,

methyl anthranilate for cherries,

blueberries and grapes under 40 CFR

180.1143 became effective on April 26,

1995 (60 FR 20432).

I. International Tolerances

Bird Shield Repellent Corporation is

not aware of any tolerance, exemption

from tolerance or MRL’s issued for

methyl anthranilate outside the United

States.

[FR Doc. 00–1550 Filed 1–21–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–910; FRL–6484–9]

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