63950 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations

proposed rule. Based on the data and

information considered, the Agency

concludes that the tolerance will protect

the public health. Therefore, the

tolerance is established as set forth

below.

Any person adversely affected by this

regulation may, within 30 days after

publication of this document in the

Federal Register, file written objections

and/or request a hearing with the

Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issue(s) on

which a hearing is requested, the

requestor’s contentions on such issues,

and a summary of any evidence relied

upon by the objector (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issue(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

A record has been established for this

rulemaking under docket number [PP

5E4464/R2185] (including any

objections and hearing requests

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 a.m. to

4:30 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in Room 1132 of the

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Written objections and hearing

requests, identified by the document

control number [PP 5E4464/R2185],

may be submitted to the Hearing Clerk

(1900), Environmental Protection

Agency, Rm. 3708, 401 M St., SW.,

Washington, DC 20460.

A copy of electronic objections and

hearing requests filed with the Hearing

Clerk can be sent directly to EPA at:

opp-Docket@epamail.epa.gov

A copy of electronic objections and

hearing requests filed with the Hearing

Clerk must be submitted as an ASCII file

avoiding the use of special characters

and any form of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any objections and hearing

requests received electronically into

printed, paper form as they are received

and will place the paper copies in the

official rulemaking record which will

also include all objections and hearing

requests submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ‘‘ADDRESSES’’ at the beginning of

this document.

Under Executive Order 12866 (58 FR

51735, Oct. 4, 1993), the Agency must

determine whether the regulatory action

is ‘‘significant’’ and therefore subject to

review by the Office of Management and

Budget (OMB) and the requirements of

the Executive Order. Under section 3(f),

the order defines a ‘‘significant

regulatory action’’ as an action that is

likely to result in a rule (1) having an

annual effect on the economy of $100

million or more, or adversely and

materially affecting a sector of the

economy, productivity, competition,

jobs, the environment, public health or

safety, or State, local, or tribal

governments or communities (also

referred to as ‘‘economically

significant’’); (2) creating serious

inconsistency or otherwise interfering

with an action taken or planned by

another agency; (3) materially altering

the budgetary impacts of entitlement,

grants, user fees, or loan programs or the

rights and obligations of recipients

thereof; or (4) raising novel legal or

policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in this Executive

Order.

Pursuant to the terms of the Executive

Order, EPA has determined that this

rule is not ‘‘significant’’ and is therefore

not subject to OMB review.

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96-

354, 94 Stat. 1164, 5 U.S.C. 601-612),

the Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemptions from tolerance

requirements do not have a significant

economic impact on a substantial

number of small entities. A certification

statement to this effect was published in

the Federal Register of May 4, 1981 (46

FR 24950).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: November 21, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR part 180 is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

2. In § 180.184, paragraph (a) is

amended in the table therein by revising

the entry for asparagus, to read as

follows:

§ 180.184 Linuron; tolerances for residues.

* * * * *

(a) * * *

Commodity Parts per

million

Asparagus ................................. 7.0

* * * * *

* * * * *

[FR Doc. 95–29989 Filed 12–12–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 5F4467/R2193; FRL–4990–8]

RIN 2070–AB78

Neem Oil; Tolerance Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes an

exemption from the requirement of a

tolerance for residues of clarified

hydrophobic extract of neem oil when

used according to good agricultural

practice as a broad-spectrum fungicide/

insecticide/miticide on all greenhouse

and terrestrial food crops. A request for

an exemption from the requirement of a

tolerance was submitted by W.R. Grace

Co.-Conn. This regulation eliminates the

need to establish a maximum
Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations 63951

permissible level for residues of this

broad-spectrum fungicide/insecticide/

miticide on all greenhouse and

terrestrial food crops when used

according to good agricultural practice.

EFFECTIVE DATE: This rule becomes

effective on December 13, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 5F4467/

R2193], may be submitted to: Hearing

Clerk (1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. A copy of any

objections and hearing requests filed

with the Hearing Clerk should be

identified by the document control

number and submitted to: Public

Response and Program Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

copy of objections and hearing requests

to: Rm. 1132, CM #2, 1921 Jefferson

Davis Highway, Arlington, VA 22202.

Fees accompanying objections shall be

labeled ‘‘Tolerance Petition Fees’’ and

forwarded to: EPA Headquarters

Accounting Operations Branch, OPP

(Tolerance Fees), P.O. Box 360277M,

Pittsburgh, PA 15251.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect in 5.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket number [PP 5F4467/R2193].

No Confidential Business Information

(CBI) should be submitted through email. Electronic copies of objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

below in this document.

FOR FURTHER INFORMATION CONTACT: By

mail: Paul Zubkoff, 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:

5th Floor, CS #1, 2800 Crystal Drive,

Arlington, VA 22202, (703)-308-8694; email: zubkoff.paul@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register of September 29, 1995

(60 FR 50582), which announced that

W.R. Grace Co.-Conn., 7379 Route 32,

Columbia, MD 21044, had submitted a

pesticide petition (PP) 5F4467 to EPA

requesting that the Administrator,

pursuant to section 408(d) of the Federal

Food, Drug, and Cosmetic Act (FFDCA),

21 U.S.C. 346a(d), establish an

exemption from the requirement of a

tolerance for the use of clarified

hydrophobic extract of neem oil on all

greenhouse and terrestrial food crops

when used according to good

agricultural practice. There were no

adverse comments or requests for

referral to an advisory committee

received in response to the notice of

filing of PP 5F4467.

Existing Food Clearances

The clarified hydrophobic extract is

prepared from the crude botanical

extract of the seed kernels of the neem

tree, Azadiracta indica. The

constituents of clarified hydrophobic

extract of neem oil are long-chain fatty

acids and glycerides. Long-chain fatty

acids and glycerides are Generally

Recognized As Safe (GRAS) for use in

foods by the U.S. Food and Drug

Administration (FDA). Under title 21 of

the Code of Federal Regulations (CFR)

(21 CFR 172.860), oleic acid derived

from tall oil fatty acids (21 CFR

172.862), and linoleic acid (21 CFR

184.1065), glyceryl monooleate (21 CFR

184.1323), glyceryl monostearate (21

CFR 184.1324), and mono- and

diglycerides (21 CFR 184.1505) are

considered as GRAS.

Natural Occurrence

Long-chain fatty acids and glycerides

are readily synthesized by most forms of

life and are common constituents of

human, avian, and other mammalian

diets. In most soil and aquatic

environments, these constituents of

clarified hydrophobic extract of neem

oil would be readily metabolized by

endemic microbial populations and

should not accumulate. Because

clarified hydrophobic extract of neem

oil is a naturally occurring compound

which displays a nontoxic mode of

action to the target pest, the Agency

classified the active ingredient as a

biochemical pesticide.

Toxicology Assessment

All studies submitted for acute

mammalian toxicology support the

registration of the technical

manufacturing product (Reg. No. 11688-

8) and the end-use product for use on

all terrestrial and greenhouse food

crops. Summarized below are data and

information for the registration of

clarified hydrophobic extract of neem

oil. EPA has examined the acute

mammalian toxicology data related to

human health submitted for clarified

hydrophobic extract of neem oil. The

mammalian toxicology data for clarified

hydrophobic extract of neem oil

indicate low acute toxicity following all

routes of exposure. With the exceptions

of the primary eye irritation study

(toxicity category III) and the acute

dermal study (toxicity category III), all

other acute studies (oral, dermal

irritation, and inhalation toxicity) were

classified toxicity category IV. Based on

the results from the sensitization test

(Buehler), the clarified hydrophobic

extract of neem oil is considered to be

a mild (minimal) contact sensitizer. In

addition, clarified hydrophobic extract

of neem oil was shown not to be

cytotoxic or mutagenic via the Ames test

(Salmonella/reverse mutation assay).

Further genotoxicity tests to address

structural chromosomal aberrations and

forward mutations have been waived

based on the known composition (fatty

acids and glycerides) and GRAS status

of the technical manufacturing product

(clarified hydrophobic extract of neem

oil, the lack of mammalian and avian

toxicity, and the negative results

observed in the Ames tests).

Consequently, at levels used on plants,

human exposure is expected to be

negligible and acute toxicity from such

exposure is not expected.

Tolerance exemptions are usually, in

part, based on the results of subchronic

(90-day) feeding and developmental

toxicity studies submitted to support

registration. However, these studies

were waived for clarified hydrophobic

extract of neem oil because of the low

demonstrated acute toxicity, the GRAS

nature of the naturally occurring

components (saturated fatty acids and

glycerides) of the active pesticidal

ingredient, and the negligible exposure

to humans and the environment owing

to the low use rates. Such use rates

would not significantly increase dietary

intake over routine exposure from

general consumption of fatty acids in

foods. Moreover, the Agency knows of

no reported cases of adverse effects from

exposure to low amounts of fatty acids.

Residue Chemistry Data

Residue chemistry data are usually

required for biochemical pesticides only

if the submitted mammalian toxicology

studies indicate that additional Tier II or

Tier III toxicology data would be

required as specified in 40 CFR

158.165(e). The submitted toxicology

data for this use indicate that the

product is of low mammalian toxicity;

it has naturally occurring components

in many food plants and, therefore, it is
63952 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations

a component of the normal human diet.

Therefore, Tier II or Tier III data are not

required. Based on the information

considered, the Agency concludes that

the establishment of a tolerance for the

active ingredient, clarified hydrophobic

extract of neem oil, is not necessary to

protect the public health from food

residues expected from the use of

clarified hydrophobic extract of neem

oil. Since this rule establishes an

exemption from the requirement of a

tolerance, the Agency has concluded

that an analytical method is not

required for enforcement purposes for

clarified hydrophobic extract of neem

oil.

Metabolism

Clarified hydrophobic extract of neem

oil consists of naturally occurring fatty

acids and glycerides that are considered

GRAS by the FDA. The oxidative

degradation of fatty acids is a central

metabolic pathway in animals, plants,

and microbes. Glycerides are degraded

into glycerol and fatty acids of varying

chain lengths. Glycerol is readily

metabolized or used as an energy source

or as a precursor to other carbohydrates,

lipids, or amino acids. Fatty acids are

metabolized into two-carbon fragments

through a sequence of enzyme-catalyzed

reactions. The metabolic products are

then incorporated into fats,

carbohydrates, and amino acids.

Conclusion

Based on the information considered,

the Agency concludes that

establishment of a tolerance for clarified

hydrophobic extract of neem oil (Reg.

No. 11688-8) is not necessary to protect

the public health. Therefore, the

exemption from tolerance is established

as set forth below.

Any person adversely affected by this

regulation may, within 30 days after

publication of this document in the

Federal Register, file written objections

to the regulation and may also request

a hearing on those objections.

Objections and hearing requests must be

filed with the Hearing Clerk, at the

address given above (40 CFR 178.20). A

copy of the objections and/or hearing

requests filed with the Hearing Clerk

should be submitted to the OPP docket

for this rule-making. The objections

submitted must specify the provisions

of the regulation deemed objectionable

and the grounds for the objections (40

CFR 178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issue(s) on

which a hearing is requested, the

requestor’s contentions on such issues,

a summary of any evidence relied upon

by the objector as well as the other

materials required by 40 CFR 178.27. A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issue(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

A record has been established for this

rulemaking under docket number [PP

5F4467/R2193] (including objections

and hearing requests 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 a.m. to 4:30 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Rm. 1132 of the Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, Crystal Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA.

Written objections and hearing

requests, identified by the document

control number [PP 5F4467/R2193],

may be submitted to the Hearing Clerk

(1900), Environmental Protection

Agency, Rm. 3708, 401 M St., SW.,

Washington, DC 20460.

A copy of electronic objections and

hearing requests filed with the Hearing

Clerk can be sent directly to EPA at:

opp-Docket@epamail.epa.gov

A copy of electronic objections and

hearing requests filed with the Hearing

Clerk must be submitted as an ASCII file

avoiding the use of special characters

and any form of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any objections and hearing

requests received electronically into

printed, paper form as they are received

and will place the paper copies in the

official rulemaking record which will

also include all objections and hearing

requests submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ADDRESSES at the beginning of this

document.

Under Executive Order 12866 (58 FR

51735, October 4, 1993), the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to all the requirements of the

Executive Order (i.e., Regulatory Impact

Analysis, review by the Office of

Management and Budget (OMB)). Under

section 3(f), the order defines

‘‘significant’’ as those actions likely to

lead to a rule (1) having an annual effect

on the economy of $100 million or

more, or adversely and materially

affecting a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local or tribal governments or

communities (also known as

‘‘economically significant’’); (2) creating

serious inconsistency or otherwise

interfering with an action taken or

planned by another agency; (3)

materially altering the budgetary

impacts of entitlement, grants, user fees,

or loan programs; or (4) raising novel

legal or policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in this Executive

Order. Pursuant to the terms of this

Executive Order, EPA has determined

that this rule is not ‘‘significant’’ and is

therefore not subject to OMB review.

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96-

354, 94 Stat. 1164, 5 U.S.C. 601-612),

the Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemptions from tolerance

requirements do not have a significant

economic impact on a substantial

number of small entities. A certification

statement to this effect was published in

the Federal Register of May 4, 1981 (46

FR 24950).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: November 30, 1995.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

Therefore, 40 CFR part 180 is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

2. In subpart D, by adding new

§ 180.1161, to read as follows:
Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations 63953

§ 180.1161 Clarified hydrophobic extract of

neem oil; exemption from the requirement

of a tolerance.

Clarified hydrophobic extract of neem

oil (Reg. No. 11688-8) is exempt from

the requirement of a tolerance on all raw

agricultural commodities when used as

a botanical fungicide/insecticide/

miticide.

[FR Doc. 95–29991 Filed 12–12–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 8E3574/R2165; FRL–4973–5]

RIN 2070–AB78

Terbufos; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document extends the

time-limited tolerance for combined

residues of the insecticide/nematicide

terbufos and its cholinesteraseinhibiting metabolites in or on the raw

agricultural commodity (RAC) green

coffee beans for an additional 2 years.

American Cyanamid Co. submitted a

petition under the Federal Food, Drug

and Cosmetic Act (FFDCA) requesting

the regulation to establish a maximum

permissible level for combined residues

of the insecticide/nematicide in or on

the commodity.

EFFECTIVE DATE: This regulation

becomes effective December 13, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 8E3574/

R2165], may be submitted to: Hearing

Clerk (1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk should be

identified by the document control

number and submitted to: Public

Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

person, bring copy of objections and

hearing requests to: Rm. 1132, CM #2,

1921 Jefferson Davis Hwy., Arlington,

VA 22202.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect in 5.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket number [PP 8E3574/R 2165].

No Confidential Business Information

(CBI) should be submitted through email. Electronic copies of objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

below in this document.

FOR FURTHER INFORMATION CONTACT: By

mail: Robert A. Forrest, Product

Manager (PM) 14, Registration Division

(7505C), Environmental Protection

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

DC 20460. Office location and telephone

number: Rm. 219, CM #2, 1921 Jefferson

Davis Hwy., Arlington, VA 22202, (703)-

305-6600; e-mail:

forrest.robert@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 2, 1995 (60

FR 39299), EPA issued a proposed rule

(FRL-4963-5) that gave notice that the

American Cyanamid Co. had submitted

data and a request under the FFDCA

that a time-limited tolerance for

residues of the insecticide/nematicide

terbufos on coffee beans be changed to

permanent status. The Agency proposed

an extension of the time-limited

tolerance to allow it to complete its indepth reassessment of the current

established tolerances for terbufos.

The following comments were

received from the petitioner, American

Cyanamid.

1. American Cyanamid believes that

since the acceptance of the new rat

metabolism study fulfills the condition

of the time-limited coffee bean

tolerance, it is sufficient to establish the

regulation as permanent, regardless of

any on-going analysis of tolerances for

reregistration purposes.

2. Additionally, American Cyanamid

believes that ‘‘the toxicological endpoint of a no-observable-effect level

(NOEL) based upon plasma

cholinesterase (ChE) inhibition, as

mentioned in the proposed rule, is of

equivocal value when used in risk

assesments’’ and that ‘‘A NOEL based

upon alternative tox endpoints such as

red blood cell ChE inhibition, brain ChE

inhibition, or clinical signs would be

more appropriately used to establish

reference dose for regulatory purposes.’’

American Cyanamid has requested a

reevaluation of plasma cholinesterase as

a suitable endpoint.

The Agency acknowledges that the

condition upon which the initial timelimited tolerance was based, i.e., the

lack of an acceptable guideline rat

metabolism study, has now been

fulfilled.

However, as described in the

proposed rule referenced above, the

Agency currently has concern over the

potential acute dietary risk posed by the

current established tolerances based on

the estimated margins of exposure

(MOE). In light of this concern, the

Agency believes that it is prudent to

limit the period of time in which the

coffee bean tolerance is in effect

pending the Agency reassessment of the

tolerances.

The Agency will take American

Cyanamid’s comments relative to the

toxicological endpoint into

consideration in its reassessment of the

established tolerances.

There were no requests for referral to

an advisory committee received in

response to the proposed rule.

The data submitted with the proposal

and other relevant material have been

evaluated and discussed in the

proposed rule. Based on the data and

information considered, the Agency

concludes that the time-limited

tolerance will protect the public health.

Therefore, the time-limited tolerance is

established as set forth below.

Any person adversely affected by this

regulation may, within 30 days after

publication of this document in the

Federal Register, file written objections

and/or request a hearing with the

Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issue(s) on

which a hearing is requested, the

requestor’s contentions on such issues,

and a summary of any evidence relied

upon by the objector (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the