Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations 33195

Dated: June 4, 2001.

Joseph Merenda,

Acting Director, 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. Part 180 is amended by adding

§180.571 to read as follows:

§ 180.571 Mesotrione; tolerances for

residues.

(a) General. Tolerances are

established for residues of the herbicide

mesotrione, 2-[4-(methylsulfonyl)-2-

nitrobenzoyl]-1,3-cyclohexanedione, in

or on the following commodities:

Commodity Parts per

million

Corn, field, forage 0.01

Corn, field, grain 0.01

Corn, field, stover 0.01

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 01–15614 Filed 6–20–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301136; FRL–6785–6]

RIN 2070–AB78

L-Glutamic Acid and Gamma

Aminobutyric Acid; Exemptions from

the Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

exemptions from the requirement of a

tolerance for residues of L-glutamic acid

and gamma aminobutyric acid on all

food commodities when applied/used in

accordance with good agricultural

practices. Emerald BioAgriculture

Corporation submitted two petitions to

EPA under the Federal Food, Drug, and

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996,

requesting exemptions from the

requirement of a tolerance. This

regulation eliminates the need to

establish a maximum permissible level

for residues of L-glutamic acid and

gamma aminobutyric acid.

DATES: This regulation is effective June

21, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301136, must be received

by EPA on or before August 20, 2001.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301136 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Carol E. Frazer, c/o Product

Manager (PM) 90, Biopesticides and

Pollution Prevention Division (7511C),

Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–8810; and e-mail address:

frazer.carol@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:

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.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301136. 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 December 6,

2000 (65 FR 76241) (FRL–6748–9), EPA

issued a notice pursuant to section 408

of the Federal Food, Drug, and Cosmetic

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

amended by the Food Quality Protection

Act (FQPA) (Public Law 104–170)

announcing the filing of two pesticide

tolerance petitions by Emerald

BioAgriculture Corporation, 3125

Sovereign Drive, Suite B, Lansing, MI

48911–4240. This notice included a

summary of the petitions prepared by

the petitioner Emerald BioAgriculture

Corporation. There were no comments

33196 Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations

received in response to the notice of

filing.

The petition requested that 40 CFR

180.1187 and 180.1188 be amended by

establishing exemptions from the

requirement of a tolerance for residues

of L-glutamic acid and gamma

aminobutyric acid.

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.

Supporting data for these sections

were submitted with Pesticide Petitions

PP 7F4842 and 7F4843 (65 FR 76241).

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. No differences in exposure

are expected when compared to those

described in PPs 7F4842 and 7F4843.

2. Drinking water exposure. No

differences in exposure are expected

when compared to those described in

PPs 7F4842 and 7F4843.

B. Other Non-Occupational Exposure

No differences in exposure are

expected when compared to those

described in PPs 7F4842 and 7F4843.

VI. Cumulative Effects

No differences in exposure are

expected when compared to those

described in PPs 7F4842 and 7F4843.

VII. Determination of Safety for U.S.

Population, Infants and Children

1. U.S. population. Based on its

abundance in nature and long history of

use by humans without deleterious

effects, there is reasonable certainty that

no harm will result from aggregate

exposure to the U.S. population,

including infants and children, to

residues of L-glutamic and gamma

aminobutyric acids. This includes all

dietary exposure and all other exposures

for which there is reliable information.

This is a reasonable conclusion because

the preponderance of data from open

literature supporting the safe use of Lglutamic acid in foods, that GABA does

not cross the blood-brain barrier, both

chemicals are consumed daily by the

human population from naturally

occurring sources, and the supporting

acute toxicity data on AuxiGro and

inconsequential exposure resulting from

its application to crops.

2. Infants and children. No

differences in exposure are expected

compared to those in PPs 7F4842 and

7F4843.

VIII. 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–301136 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 20, 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

Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations 33197

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–301136, 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

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).

IX. 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.

X. 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

33198 Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations

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 31, 2001.

Kathleen Knox,

Acting 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. Sections 180.1187 and 180.1188 are

revised to read as follows:

§ 180.1187 L-glutamic acid; exemption

from the requirement of a tolerance.

L-glutamic acid is exempt from the

requirement of a tolerance on all food

commodities when used in accordance

with good agricultural practices.

§ 180.1188 Gamma aminobutyric acid;

exemption from the requirement of a

tolerance.

Gamma aminobutyric acid is exempt

from the requirement of a tolerance on

all food commodities when used in

accordance with good agricultural

practices.

[FR Doc. 01–15615 Filed 6–20–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301013A; FRL–6786–5]

Pyridaben; Pesticide Tolerance

Technical Correction

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule; technical correction.

SUMMARY: EPA published a final rule in

the Federal Register of July 14, 2000,

that amended and established tolerances

for pyridaben. The regulatory text of the

document incorrectly amended the table

in § 180.494(a) by adding an entry

‘‘citrus, crop group’’ at a tolerance level

of 0.05 parts per million (ppm). The

entry should have read ‘‘citrus’’ at a

tolerance level of 0.5 ppm. This

document corrects the error.

DATES: This technical correction is

effective June 21, 2001.

FOR FURTHER INFORMATION CONTACT:

Melody Banks, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

305–5413; e-mail address:

banks.melody@epa.gov.

SUPPLEMENTARY INFORMATION:

I. 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:

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.

II. 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 electronicversion of 40 CFR

part 180 is available at http://

www.access.gpo.gov/nara/cfr/cfr_00/

Title_40/40cfr180_00. a beta site

currently under development.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301013. 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

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.

III. What Does this Technical

Correction Do?

Tolerances for pyridaben on various

commodities were published in the

Federal Register of July 14, 2000 (65 FR

43704) (FRL–6593–1). In that document,

the regulatory text incorrectly amended

§ 180.494(a) by adding an entry ‘‘citrus,

crop group’’ at a tolerance level of 0.05

ppm. The entry should have read

‘‘citrus’’ at a tolerance level of 0.5 ppm.

This technical correction re-establishes

the tolerance for ‘‘citrus’’ at 0.5 ppm and

removes the entry for ‘‘citrus, crop

group’’ under the table in § 180.494(a).

The preamble of the final rule clearly

stated that the tolerance level for citrus

was to remain the same. (See Unit II. of

the final rule.)

IV. Why is this Technical Correction

Issued as a Final Rule?

Section 553 of the Administrative

Procedure Act (APA), 5 U.S.C.

553(b)(B), provides that, when an

agency for good cause finds that notice

and public procedure are impracticable,

unnecessary or contrary to the public

interest, the agency may issue a rule

without providing notice and an

opportunity for public comment. EPA

has determined that there is good cause

for making this rule final without prior

proposal and opportunity for comment,

because EPA is merely re-establishing

the tolerance level for pyridaben on