30822 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations

B. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of the rule in

the Federal Register. This rule is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

C. Petitions for Judicial Review

Under section 307(b)(1) of the Clean

Air Act, petitions for judicial review of

this action must be filed in the United

States Court of Appeals for the

appropriate circuit by August 7, 2001.

Filing a petition for reconsideration by

the Administrator of this final rule does

not affect the finality of this rule for the

purposes of judicial review nor does it

extend the time within which a petition

for judicial review may be filed, and

shall not postpone the effectiveness of

such rule or action. This action,

pertaining to the approval of Delaware’s

accidental release prevention program

(Clean Air Act Section 112(r)), may not

be challenged later in proceedings to

enforce its requirements. (See section

307(b)(2).)

List of Subjects 40 CFR Part 63

Environmental protection,

Administrative practice and procedure,

Air pollution control, Hazardous

substances, Incorporation by reference,

Intergovernmental relations.

Dated: May 16, 2001.

Thomas C. Voltaggio,

Acting Regional Administrator, Region III.

40 CFR part 63 is amended as follows:

PART 63—[AMENDED]

1. The authority citation for part 63

continues to read as follows:

Authority: 42 U.S.C. 7401, et seq.

2. Section 63.14 is amended by

adding paragraph (d)(3) to read as

follows:

§ 63.14 Incorporation by Reference.

* * * * *

(d) * * *

(3)(i) Letter of June 7, 1999 to the U.S.

Environmental Protection Agency

Region 3 from the Delaware Department

of Natural Resources and Environmental

Control requesting formal full

delegation to take over primary

responsibility for implementation and

enforcement of the Chemical Accident

Prevention Program under Section

112(r) of the Clean Air Act Amendments

of 1990.

(ii) Delaware Department of Natural

Resources and Environmental Control,

Division of Air and Waste Management,

Accidental Release Prevention

Regulation, sections 1 through 5 and

sections 7 through 14, effective January

11, 1999, IBR approved for

§ 63.99(a)(8)(i) of subpart E of this part.

Subpart E—Approval of State

Programs and Delegation of Federal

Authorities

3. Section 63.99 is amended by

adding paragraph (a)(8) to read as

follows:

§ 63.99 Delegated Federal Authorities

(a) * * *

(8) Delaware

(i) Affected sources must comply with

the Delaware Department of Natural

Resources and Environmental Control,

Division of Air and Waste Management,

Accidental Release Prevention

Regulation, sections 1–5 and sections 7–

14, January 11, 1999 (incorporated by

reference as specified in § 63.14). The

material incorporated in the Delaware

Department of Natural Resources and

Environmental Control, Division of Air

and Waste Management, Accidental

Release Prevention Regulation, sections

1–5 and sections 7–14 pertains to

owners and operators of stationary

sources in the State of Delaware that

have more than a threshold quantity of

a regulated substance in a process, as

described in section 5.10 of Delaware’s

regulation, and has been approved

under the procedures in §§ 63.93 and

63.95 to be implemented and enforced

in place of 40 CFR part 68–Chemical

Accident Prevention Provisions.

(ii) [Reserved]

[FR Doc. 01–14079 Filed 6–7–01; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301127; FRL–6780–9]

RIN 2070–AB78

Methyl Anthranilate; Exemption from

the Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an

exemption from the requirement of a

tolerance for residues of the methyl

anthranilate on corn and sunflower

when applied/used as a bird repellent.

Bird Shield Repellent Corporation

submitted a petition to EPA under the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996, requesting an

exemption from the requirement of a

tolerance. This regulation eliminates the

need to establish a maximum

permissible level for residues of methyl

anthranilate on corn and sunflower and

reasses the existing tolerance exemption

for methyl anthranilate.

DATES: This regulation is effective June

8, 2001. Objections and requests for

hearings, identified by docket control

number [OPP–301127], must be

received by EPA, on or before August 7,

2001.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, electronically, or in person. Please

follow the detailed instructions for each

method as provided in Unit IX. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301127 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Jim Downing, c/o Product

Manager (PM) 91, Biopesticides and

Pollution Prevention Division (7511C),

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: 703–308–

9071; and e-mail address:

downing.jim@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:

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations 30823

Categories NAICS

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,’’ ‘‘Regulations

and Proposed Rules,’’ 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/. A frequently

updated electronic version of 40 CFR

part 180 is available at http://

www.access.gpo.gov/nara/cfr/

cfrhtml_00/Title_40/40cfr180_00.html, a

beta site currently under development.

To access the OPPTS Harmonized

Guidelines referenced in this document,

go directly to the guidelines at http://

www.epa.gov/opptsfrs/home/

guidelin.htm.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301127. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

Davis Hwy., 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.

II. Background and Statutory Findings

In the Federal Register of January 24,

2000 (65 FR 3693) (FRL–6485–5), EPA

issued a notice pursuant to section 408

of the Federal Food, Drug, and Cosmetic

Act (FFDCA), 21 U.S.C. 346a(d), as

amended by the Food Quality Protection

Act (FQPA) (Public Law 104–170)

announcing the filing of pesticide

tolerance petitions (PP 9F5056 and

9F5055) by Bird Shield Repellent

Corporation, P.O. Box 785, Pullman,

WA 99163. This notice included a

summary of the petitions prepared by

the petitioner Bird Shield Repellent

Corporation. There were no comments

received in response to the notice of

filing.

The petition requested that 40 CFR

180.1143 be amended by establishing an

exemption from the requirement of a

tolerance for residues of methyl

anthranilate on corn and sunflower.

III. Risk Assessment

New section 408(c)(2)(A)(i) of the

FFDCA allows EPA to establish an

exemption from the requirement for a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

‘‘safe.’’ Section 408(c)(2)(A)(ii) defines

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Additionally, section 408(b)(2)(D)

requires that the Agency consider

‘‘available information’’ concerning the

cumulative effects of a particular

pesticide’s residues and ‘‘other

substances that have a common

mechanism of toxicity.’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides. Second, EPA examines

exposure to the pesticide through food,

drinking water, and through other

exposures that occur as a result of

pesticide use in residential settings.

IV. Toxicological Profile

Consistent with section 408(b)(2)(D)

of FFDCA, EPA has reviewed the

available scientific data and other

relevant information in support of this

action and considered its validity,

completeness, and reliability and the

relationship of this information to

human risk. EPA has also considered

available information concerning the

variability of the sensitivities of major

identifiable subgroups of consumers,

including infants and children.

Methyl anthranilate is naturally

occurring in certain foods, such as

concord grapes. It is also synthetically

produced and used as a flavoring agent

(21 CFR 182.60) in beverages, ice cream,

candy, baked goods, gelatins, puddings,

and chewing gum. It is also exempt from

the requirement of a tolerance in or on

blueberries, cherries, and grapes (40

CFR 180.1143). A discussion of the

rationale supporting that exemption

may be found in the proposed rule, as

well as in the April 26, 1995 final rule.

In addition, methyl anthranilate is

classified as generally recognized as safe

(GRAS) by FDA (21 CFR 182.60).

Methyl anthranilate, because of

volatility, rapidly decomposes into nontoxic components leaving no significant

residue relative to levels found in food

on corn and sunflower to which it is

applied. The residue studies showed

that the residues of methyl anthranilate

found on corn and sunflower were less

than those found naturally in grapes.

Moreover, it has been determined that

even if ingested, the chemical rapidly

metabolizes in the intestines and

byproducts are excreted. In addition to

this information, the Agency has

determined that all toxicology data

requirements have been satisfied and it

has conducted a review of these studies.

Summaries of these studies are

presented below. For a more detailed

discussion of these studies, see the Data

Review Records located in the

information docket referred to above.

Mammalian toxicity. Methyl

anthranilate exhibits little or no

mammalian toxicity. As mentioned

before, it metabolizes in the intestine

when consumed. The LD50 values for

methyl anthranilate were estimated to

30824 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations

be greater than 5,000 milligram/

kilogram (mg/kg) in an acute oral

toxicity study in rats (Toxicity Category

IV). Methyl anthranilate was found to

cause moderate irritation in a rabbit skin

irritation assay after continuous

exposure of the compound for 4 hours

(Toxicity Category III) and corneal

effects that cleared in 8 to 21 days in a

rabbit eye irritation assay (Toxicity

Category II). Since the mammalian

toxicity is low and considering the

diluted formulation that is used, no

hypersensitivity studies were necessary.

Guideline Study MRID No. Toxicity Category

870.1100 Acute Oral Toxicity -rat 447403-01 IV

870.1200 Acute Dermal Toxicity 447403-02 III

870.1300 Acute Inhalation Toxicity - rat 447403-03 III

870.2400 Acute (Primary) Eye Irritation - rabbits 440703-02 II

870.2500 Acute (Primary Dermal) Skin Irritation 440703-01 III

870.2600 Hypersensitivity (skin sensitization) NA Waived

Appropriate labeling (protective

eyewear) was used to mitigate these

moderately acute toxicological risks.

Due to the low toxicity, metabolism,

rapid degradation and long history of

dietary exposure to this naturally

occurring biochemical, chronic and

subchronic data were waived. No other

toxic endpoints were identified and

therefore no reference dose and no

observable effect level were established.

V. Aggregate Exposures

In examining aggregate exposure,

FFDCA section 408 directs EPA to

consider available information

concerning exposures from the pesticide

residue in food and all other nonoccupational exposures, including

drinking water from ground water or

surface water and exposure through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses).

A. Dietary Exposure

1. Food. Methyl anthranilate residues,

when used as a bird repellent, are

already exempt from the requirement of

a tolerance on blueberries, cherries and

grapes, based upon a ‘‘worst case’’

maximum concentration on cherries of

35 ppm (60 FR 9816, February 22, 1995)

and the fact that natural levels of 33

ppm occur in commonly consumed

foods, such as grapes, and that use of

methyl anthranilate as a flavoring agent

results in residues of approximately 30

ppm in baked goods and up to 400 ppm

in gum. For corn and sunflowers,

methyl anthranilate, applied at a rate of

only 0.2862 pounds per acre, results in

residues of less than 33 ppm on these

crops, even when taking into account

the 4.5-fold and 14-fold maximum

theoretical concentration factors for

processed commodities. Because methyl

anthranilate is a volatile compound,

which rapidly degrades when exposed

to ultraviolet light (sunlight), and warm

temperatures in the environment,

further reduction in residues is

expected. The dietary exposure is not

anticipated to be increased significantly

in a typical human diet by the use of

this biochemical pesticide on

sunflowers and corn. Further, since

methyl anthranilate has shown no

mammalian toxicity and is rapidly

metabolized in human intestines and

liver, no dietary risk from these

additional uses of this biochemical

pesticide are anticipated.

2. Drinking water exposure. Methyl

anthranilate is very unlikely to be found

in drinking water, given the extremely

low application rate and rapid

environmental and microbial

degradation (MRID 431194–01).

B. Other Non-Dietary, NonOccupational Exposure

The primary non-dietary, nonoccupational sources of exposure the

Agency considered include exposure

through use in lawns (turf), and on

cherries, blueberries and grapes grown

around the home or structures. Methyl

anthranilate products are registered for

use on residential turf (lawns) but not

for any indoor uses. Limited exposure

would result from use on home lawns,

because of the rapid degradation of

methyl anthranilate under sunlight.

Even though methyl anthranilate

products can be used on household

(gardens) grown cherries, blueberries

and grapes, the use is expected to be

infrequent and very low, because of the

limited quantities needed to control the

targeted species during any growing

season. In addition, methyl anthranilate

rapidly degrades, thus limited exposure

is anticipated. Use of methyl

anthranilate around structures would

not significantly increase the exposure,

because of the limited use anticipated

around the home. Home applicators

could be exposed to methyl

anthranilate, but this would be in a

limited manner due to the infrequent

use around the home. The Agency

expects little risk from this exposure

due to the low toxicity (LD50 of >5,000

mg/kg oral toxicity in rats; dermal LD50

of >2,000 thru 5,000 mg/kg; inhalation

LD50 of >0.5 thru 2.0 mg/liter) of this

natural constituent of certain plants

(i.e., grapes).

VI. Cumulative Effects

Methyl anthranilate does not exhibit a

toxic mode of action to the target

species (birds) or any mammals to

which limit dose were tested. Thus,

because there is no indication of

mammalian toxicity to this substance,

no cumulative effects with other related

compounds is expected.

VII. Determination of Safety for U.S.

Population, Infants and Children

Methyl anthranilate has been

demonstrated by the results of acute

toxicity testing in mammals to cause no

adverse effects when dosed orally and

via inhalation at the limit dose of each

study. Further, significant methyl

anthranilate residues relative to levels

found in foods have not been detected

on treated corn and sunflower.

Considering the low toxicity and the

lack of significant residues of this

naturally occurring biochemical,

combined with its metabolism in the

intestines if ingested, EPA has

concluded that there is reasonable

certainty that no harm will result from

aggregate exposure to the U.S.

population, or any significant

subpopulation, including infants and

children, to residues of methyl

anthranilate. This includes all

anticipated dietary exposures and all

other exposures for which there is

reliable information. EPA did not use a

10x safety factor for children in its

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations 30825

analysis because of the low toxicity of

methyl anthranilate and the lack of

significant residue relative to levels

found in food when applied to corn and

sunflower.

VIII. Other Considerations

A. Endocrine Disruptors

EPA is required under the FFDCA, as

amended by FQPA, to develop a

screening program to determine whether

certain substances (including all

pesticide active and other ingredients)

‘‘may have an effect in humans that is

similar to an effect produced by a

naturally-occurring estrogen, to other

such endocrine effects as the

Administrator may designate.’’

Following the recommendations of its

Endocrine Disruptor Screening and

Testing Advisory Committee (EDSTAC),

EPA determined that there was

scientific basis for including, as part of

the program, the androgen and thyroid

hormone systems, in addition to the

estrogen hormone system. EPA also

adopted EDSTAC’s recommendation

that the Program include evaluations of

potential effects in wildlife. For

pesticide chemicals, EPA will use

FIFRA and, to the extent that effects in

wildlife may help determine whether a

substance may have an effect in

humans, FFDCA authority to require the

wildlife evaluations. As the science

develops and resources allow, screening

of additional hormone systems may be

added to the Endocrine Disruptor

Screening Programs (EDSP).

When the appropriate screening and/

or testing protocols being considered

under the Agency’s Endocrine Disruptor

Screening Program have been

developed, methyl anthranilate may be

subjected to additional screening and/or

testing to better characterize effects

related to endocrine disruption. Based

on the weight of the evidence of

available data, no endocrine systemrelated effects have been identified.

B. Analytical Method(s)

This action is establishing an

exemption from the requirement of a

tolerance for the reasons described

above. As previously noted, methyl

anthranilate exhibits rather low toxicity.

For this reason and because no

significant residues have been detected

on treated corn and sunflower (in other

words, residues beyond that of methyl

anthranilate found naturally in grapes

are unlikely), no analytical method for

enforcement purposes is required.

C. Codex Maximum Residue Level

The Agency is not aware of any

international tolerances, exemptions

from tolerance or Maximum Residue

Levels (MRLs) issued for methyl

anthranilate. Furthermore, the Agency is

not aware of any issues regarding Codex

Maximum Residue Levels.

IX. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations which govern the

submission of objections and requests

for hearings appear in 40 CFR part 178.

Although the procedures in those

regulations require some modification to

reflect the amendments made to the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) provides

essentially the same process for persons

to ‘‘object’’ to a regulation for an

exemption from the requirement of a

tolerance issued by EPA under new

section 408(d), as was provided in the

old FFDCA sections 408 and 409.

However, the period for filing objections

is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an

Objection or Request a Hearing?

You must file your objection or

request a hearing on this regulation in

accordance with the instructions

provided in this unit and in 40 CFR part

178. To ensure proper receipt by EPA,

you must identify docket control

number OPP–301127 in the subject line

on the first page of your submission. All

requests must be in writing, and must be

mailed or delivered to the Hearing Clerk

on or before August 7, 2001.

1. Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(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). Information submitted in

connection with an objection or hearing

request may be claimed confidential 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. A copy of the

information 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.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. You

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. The Office of

the Hearing Clerk is open from 8 a.m.

to 4 p.m., Monday through Friday,

excluding legal holidays. The telephone

number for the Office of the Hearing

Clerk is (202) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

tompkins.jim@epa.gov, or by mailing a

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

Unit IX.A., you should also send a copy

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by docket number

OPP–301127, to: Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460. In person or by courier, bring

a copy to the location of the PIRIB

described in Unit I.B.2. You may also

send an electronic copy of your request

via e-mail to: opp-docket@epa.gov.

Please use an ASCII file format and

avoid the use of special characters and

any form of encryption. Copies of

30826 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations

electronic objections and hearing

requests will also be accepted on disks

in WordPerfect 6.1/8.0 or ASCII file

format. Do not include any CBI in your

electronic copy. You may also submit an

electronic copy of your request at many

Federal Depository Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

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

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

X. Regulatory Assessment

Requirements

This final rule establishes an

exemption from the tolerance

requirement under FFDCA section

408(d) in response to a petition

submitted to the Agency. The Office of

Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993).

This final rule does not contain any

information collections subject to OMB

approval under the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq., or impose any enforceable duty or

contain any unfunded mandate as

described under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Public Law 104–4). Nor does it require

any special considerations under

Executive Order 12898, entitled Federal

Actions to Address Environmental

Justice in Minority Populations and

Low-Income Populations (59 FR 7629,

February 16, 1994); or OMB review or

any Agency action under Executive

Order 13045, entitled Protection of

Children from Environmental Health

Risks and Safety Risks (62 FR 19885,

April 23, 1997). This action does not

involve any technical standards that

would require Agency consideration of

voluntary consensus standards pursuant

to section 12(d) of the National

Technology Transfer and Advancement

Act of 1995 (NTTAA), Public Law 104–

113, section 12(d) (15 U.S.C. 272 note).

Since tolerances and exemptions that

are established on the basis of a petition

under FFDCA section 408(d), such as

the exemption in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.) do not apply. In addition, the

Agency has determined that this action

will not have a substantial direct effect

on States, on the relationship between

the national government and the States,

or on the distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism(64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that

have‘‘substantial direct effects on the

States, on the relationship between the

national government and the States, or

on the distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

For these same reasons, the Agency has

determined that this rule does not have

any ‘‘tribal implications’’ as described

in Executive Order 13175, entitled

Consultation and Coordination with

Indian Tribal Governments (65 FR

67249, November 6, 2000). Executive

Order 13175, requires EPA to develop

an accountable process to ensure

‘‘meaningful and timely input by tribal

officials in the development of

regulatory policies that have tribal

implications.’’ ‘‘Policies that have tribal

implications’’ is defined in the

Executive Order to include regulations

that have ‘‘substantial direct effects on

one or more Indian tribes, on the

relationship between the Federal

government and the Indian tribes, or on

the distribution of power and

responsibilities between the Federal

government and Indian tribes.’’ This

rule will not have substantial direct

effects on tribal governments, on the

relationship between the Federal

government and Indian tribes, or on the

distribution of power and

responsibilities between the Federal

government and Indian tribes, as

specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.

XI. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of this final

rule in the Federal Register. This final

rule is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 25, 2001.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 321(q), 346(a) and

371.

2. Section 180.1143 is revised to read

as follows:

§ 180.1143 Methyl anthranilate; exemption

from the requirement of a tolerance.

Methyl anthranilate, a biochemical

pesticide, is exempt from the

requirement of a tolerance when used in

accordance with good agricultural

practices on the following raw

agricultural commodities: Blueberry,

cherry, corn, grape, and sunflower.

[FR Doc. 01–14487 Filed 6–7–01; 8:45 am]

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47 CFR Part 73

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