Federal Register / Vol. 65, No. 92 / Thursday, May 11, 2000 / Rules and Regulations 30355

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

VII. Comments

Interested persons may, on or before

July 25, 2000, submit to the Dockets

Management Branch (address above)

written comments regarding this direct

final rule. This comment period runs

concurrently with the comment period

for the companion proposed rule. Two

copies of any comment are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. Received comments may be

seen in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday. All comments received

will be considered comments regarding

the proposed rule and this direct final

rule. In the event the direct final rule is

withdrawn, all comments received

regarding the companion proposed rule

and the direct final rule will be

considered comments on the proposed

rule.

VIII. Report to Congress

For purposes of congressional review

requirements under 5 U.S.C. 801–808,

the report to Congress for this direct

final rule will be issued when FDA

confirms the effective date of this rule.

Thus, no report is due at this time. If,

however, a significant adverse comment

is received, the agency will withdraw

this direct final rule and no report will

be issued to Congress.

List of Subjects in 21 CFR Part 25

Environmental impact statements,

Foreign relations, Reporting and

recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 25 is

amended as follows:

PART 25—ENVIRONMENTAL IMPACT

CONSIDERATIONS

1. The authority citation for 21 CFR

part 25 continues to read as follows:

Authority: 21 U.S.C. 321–393; 42 U.S.C.

262, 263b–264; 42 U.S.C. 4321, 4332; 40 CFR

parts 1500–1508; E.O. 11514, 35 FR 4247, 3

CFR, 1971 Comp., p. 531–533 as amended by

E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp.,

p. 123–124 and E.O. 12114, 44 FR 1957, 3

CFR, 1980 Comp., p. 356–360.

2. Section 25.20 is amended by

revising paragraph (i) to read as follows:

§ 25.20 Actions requiring preparation of an

environmental assessment.

* * * * *

(i) Approval of food additive petitions

and color additive petitions, approval of

requests for exemptions for

investigational use of food additives, the

granting of requests for exemption from

regulation as a food additive under

§ 170.39 of this chapter, and allowing

notifications submitted under 21 U.S.C.

348(h) to become effective, unless

categorically excluded in § 25.32(b), (c),

(i), (j), (k), (l), (o), (q), or (r).

* * * * *

3. Section 25.32 is amended by

revising paragraphs (i), (j), (k), (q), and

(r) to read as follows:

§ 25.32 Foods, food additives, and color

additives.

* * * * *

(i) Approval of a food additive

petition or GRAS affirmation petition,

the granting of a request for exemption

from regulation as a food additive under

§ 170.39 of this chapter, or allowing a

notification submitted under 21 U.S.C.

348(h) to become effective, when the

substance is present in finished foodpackaging material at not greater than 5

percent-by-weight and is expected to

remain with finished food-packaging

material through use by consumers or

when the substance is a component of

a coating of a finished food-packaging

material.

(j) Approval of a food additive

petition or GRAS affirmation petition,

the granting of a request for exemption

from regulation as a food additive under

§ 170.39 of this chapter, or allowing a

notification submitted under 21 U.S.C.

348(h) to become effective, when the

substance is to be used as a component

of a food-contact surface of permanent

or semipermanent equipment or of

another food-contact article intended for

repeated use.

(k) Approval of a food additive

petition, color additive petition, or

GRAS affirmation petition, or allowing

a notification submitted under 21 U.S.C.

348(h) to become effective, for

substances added directly to food that

are intended to remain in food through

ingestion by consumers and that are not

intended to replace macronutrients in

food.

* * * * *

(q) Approval of a food additive

petition, the granting of a request for

exemption from regulation as a food

additive under § 170.39 of this chapter,

or allowing a notification submitted

under 21 U.S.C. 348(h) to become

effective for a substance registered by

the Environmental Protection Agency

under FIFRA for the same use requested

in the petition, request for exemption, or

notification.

(r) Approval of a food additive

petition, color additive, GRAS

affirmation petition, or allowing a

notification submitted under 21 U.S.C.

348(h) to become effective for a

substance that occurs naturally in the

environment, when the action does not

alter significantly the concentration or

distribution of the substance, its

metabolites, or degradation products in

the environment.

Dated: January 24, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–11749 Filed 5–10–00; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[CA 154–0236; FRL–6587–1]

Revisions to the California State

Implementation Plan, Mojave Desert

Air Quality Management District

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is finalizing a limited

approval and limited disapproval of

revisions to the Mojave Desert Air

Quality Management District portion of

the California State Implementation

Plan (SIP). This action was proposed in

the Federal Register on March 2, 2000

and concerns oxide of nitrogen (NOx)

emissions from cement kilns. Under

authority of the Clean Air Act as

amended in 1990 (CAA or the Act), this

action simultaneously approves local

rules that regulate these emission

sources and directs California to correct

rule deficiencies.

EFFECTIVE DATE: This rule is effective on

June 12, 2000.

ADDRESSES: You can inspect copies of

the administrative record for this action

at EPA’s Region IX office during normal

business hours. You can inspect copies

of the submitted rule revisions at the

following locations:

Environmental Protection Agency,

Region IX, 75 Hawthorne Street, San

Francisco, CA 94105–3901.

Environmental Protection Agency, Air

Docket (6102), Ariel Rios Building,

1200 Pennsylvania Avenue, N.W.,

Washington D.C. 20460.

California Air Resources Board,

Stationary Source Division, Rule

30356 Federal Register / Vol. 65, No. 92 / Thursday, May 11, 2000 / Rules and Regulations

Evaluation Section, 2020 ‘‘L’’ Street,

Sacramento, CA 95812.

Mojave Desert Air Quality Management

District, 15428 Civic Drive, Suite 200,

Victorville, CA 92392–2383

FOR FURTHER INFORMATION CONTACT: Max

Fantillo, Rulemaking Office (AIR–4),

U.S. Environmental Protection Agency,

Region IX, (415) 744–1183.

SUPPLEMENTARY INFORMATION:

Throughout this document, ‘‘we,’’ ‘‘us’’

and ‘‘our’’ refer to EPA.

I. Proposed Action

On March 2, 2000 (42 FR 11275), EPA

proposed a limited approval and limited

disapproval of the following rule that

was submitted for incorporation into the

California SIP.

Local agency Rule # Rule title Adopted Submitted

MDAQMD .............................................................. 1161 Portland Cement Kilns ......................................... 06/28/95 06/29/95

We proposed a limited approval

because we determined that this rule

improves the SIP and is largely

consistent with the relevant CAA

requirements. We simultaneously

proposed a limited disapproval because

some rule provisions conflict with

section 110 and part D of the Act. These

provisions include the following:

1. Alternative Compliance Strategy in

Section (D).

2. Exemption during start-up and

shutdown in Section (G)(1)(a).

3. Referencing a rule not approved in

State Implementation Plan in Section

(G)(1)(c).

Our proposed action contains more

information on the rule and our

evaluation.

II. Public Comments and EPA

Responses

EPA’s proposed action provided a 30-

day public comment period. During this

period, we received no comments.

III. EPA Action

No comments were submitted that

change our assessment of the rule as

described in our proposed action.

Therefore, as authorized in sections

110(k)(3) and 301(a) of the Act, EPA is

finalizing a limited approval of the

submitted rule. This action incorporates

the submitted rule into the California

SIP, including those provisions

identified as deficient. As authorized

under section 110(k)(3), EPA is

simultaneously finalizing a limited

disapproval of the rule. As a result,

sanctions will be imposed unless EPA

approves subsequent SIP revisions that

correct the rule deficiencies within 18

months of the effective date of this

action. These sanctions will be imposed

under section 179 of the Act as

described in 59 FR 39832 (August 4,

1994). In addition, EPA must

promulgate a federal implementation

plan (FIP) under section 110(c) unless

we approve subsequent SIP revisions

that correct the rule deficiencies within

24 months. Note that the submitted rule

has been adopted by the MDAQMD, and

EPA’s final limited disapproval does not

prevent the local agency from enforcing

it.

IV. Administrative Requirements

A. Executive Order 12866

The Office of Management and Budget

(OMB) has exempted this regulatory

action from Executive Order 12866,

entitled ‘‘Regulatory Planning and

Review.’’

B. Executive Order 13045

Executive Order 13045, entitled

Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997),

applies to any rule that: (1) Is

determined to be ‘‘economically

significant’’ as defined under Executive

Order 12866, and (2) concerns an

environmental health or safety risk that

EPA has reason to believe may have a

disproportionate effect on children. If

the regulatory action meets both criteria,

the Agency must evaluate the

environmental health or safety effects of

the planned rule on children, and

explain why the planned regulation is

preferable to other potentially effective

and reasonably feasible alternatives

considered by the Agency.

This rule is not subject to Executive

Order 13045 because it does not involve

decisions intended to mitigate

environmental health or safety risks.

C. Executive Order 13084

Under Executive Order 13084,

Consultation and Coordination with

Indian Tribal Governments, EPA may

not issue a regulation that is not

required by statute, that significantly

affects or uniquely affects the

communities of Indian tribal

governments, and that imposes

substantial direct compliance costs on

those communities, unless the Federal

government provides the funds

necessary to pay the direct compliance

costs incurred by the tribal

governments. If the mandate is

unfunded, EPA must provide to the

Office of Management and Budget, in a

separately identified section of the

preamble to the rule, a description of

the extent of EPA’s prior consultation

with representatives of affected tribal

governments, a summary of the nature

of their concerns, and a statement

supporting the need to issue the

regulation.

In addition, Executive Order 13084

requires EPA to develop an effective

process permitting elected and other

representatives of Indian tribal

governments ‘‘to provide meaningful

and timely input in the development of

regulatory policies on matters that

significantly or uniquely affect their

communities.’’ Today’s rule does not

significantly or uniquely affect the

communities of Indian tribal

governments. Accordingly, the

requirements of section 3(b) of

Executive Order 13084 do not apply to

this rule.

D. Executive Order 13132

Executive Order 13121, entitled

Federalism (64 FR 43255, August 10,

1999) revokes and replaces Executive

Orders 12612, Federalism and 12875,

Enhancing the Intergovernmental

Partnership. 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.’’ Under

Executive Order 13132, EPA may not

issue a regulation that has federalism

implications, that imposes substantial

direct compliance costs, and that is not

required by statute, unless the Federal

government provides the funds

necessary to pay the direct compliance

costs incurred by State and local

governments, or EPA consults with

State and local officials early in the

process of developing the proposed

regulation. EPA also may not issue a

regulation that has federalism

Federal Register / Vol. 65, No. 92 / Thursday, May 11, 2000 / Rules and Regulations 30357

implications and that preempts State

law unless the Agency consults with

State and local officials early in the

process of developing the proposed

regulation.

This rule will not 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, as specified in

Executive Order 13132 (64 FR 43255,

August 10, 1999), because it merely

approves a state rule implementing a

federal standard, and does not alter the

relationship or the distribution of power

and responsibilities established in the

Clean Air Act. Thus, the requirements of

section 6 of the Executive Order do not

apply to this rule.

E. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA)

generally requires an agency to conduct

a regulatory flexibility analysis of any

rule subject to notice and comment

rulemaking requirements unless the

agency certifies that the rule will not

have a significant economic impact on

a substantial number of small entities.

Small entities include small businesses,

small not-for-profit enterprises, and

small governmental jurisdictions.

This final rule will not have a

significant impact on a substantial

number of small entities because SIP

approvals under section 110 and

subchapter I, part D of the Clean Air Act

do not create any new requirements but

simply approve requirements that the

State is already imposing. Therefore,

because the Federal SIP approval does

not create any new requirements, I

certify that this action will not have a

significant economic impact on a

substantial number of small entities.

Moreover, due to the nature of the

Federal-State relationship under the

Clean Air Act, preparation of flexibility

analysis would constitute Federal

inquiry into the economic

reasonableness of state action. The

Clean Air Act forbids EPA to base its

actions concerning SIPs on such

grounds. Union Electric Co., v. U.S.

EPA, 427 U.S. 246, 255–66 (1976); 42

U.S.C. 7410(a)(2).

F. Unfunded Mandates

Under Section 202 of the Unfunded

Mandates Reform Act of 1995

(‘‘Unfunded Mandates Act’’), signed

into law on March 22, 1995, EPA must

prepare a budgetary impact statement to

accompany any proposed or final rule

that includes a Federal mandate that

may result in estimated annual costs to

State, local, or tribal governments in the

aggregate; or to private sector, of $100

million or more. Under Section 205,

EPA must select the most cost-effective

and least burdensome alternative that

achieves the objectives of the rule and

is consistent with statutory

requirements. Section 203 requires EPA

to establish a plan for informing and

advising any small governments that

may be significantly or uniquely

impacted by the rule.

EPA has determined that the approval

action promulgated does not include a

Federal mandate that may result in

estimated annual costs of $100 million

or more to either State, local, or tribal

governments in the aggregate, or to the

private sector. This Federal action

approves pre-existing requirements

under State or local law, and imposes

no new requirements. Accordingly, no

additional costs to State, local, or tribal

governments, or to the private sector,

result from this action.

G. 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. A major rule

cannot take effect until 60 days after it

is published in the Federal Register.

This rule is not a ‘‘major’’ rule as

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

H. National Technology Transfer and

Advancement Act

Section 12 of the National Technology

Transfer and Advancement Act

(NTTAA) of 1995 requires Federal

agencies to evaluate existing technical

standards when developing a new

regulation. To comply with NTTAA,

EPA must consider and use ‘‘voluntary

consensus standards’’ (VCS) if available

and applicable when developing

programs and policies unless doing so

would be inconsistent with applicable

law or otherwise impractical.

The EPA believes that VCS are

inapplicable to this action. Today’s

action does not require the public to

perform activities conducive to the use

of VCS.

I. 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 July 10, 2000.

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 may not

be challenged later in proceedings to

enforce its requirements. (See section

307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Hydrocarbons,

Incorporation by reference,

Intergovernmental relations, Nitrogen

dioxide, Ozone, Reporting and

recordkeeping requirements, volatile

organic compounds.

Dated: April 16, 2000.

Felicia Marcus,

Regional Administrator, Region IX.

Part 52, Chapter I, Title 40 of the Code

of Federal Regulations is amended as

follows:

PART 52— [AMENDED]

1. The authority citation for Part 52

continues to read as follows:

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

Subpart F—California

2. Section 52.220 is amended by

adding paragraphs (c)(274) to read as

follows:

§ 52.220 Identification of plan.

* * * * *

(c) * * *

(274) New and amended regulations

for the following APCD were submitted

on June 29, 1995, by the Governor’s

designee.

(i) Incorporation by reference.

(A) Mojave Desert Air Quality

Management District.

(1) Rule 1161, adopted on June 28,

1995.

* * * * *

[FR Doc. 00–11674 Filed 5–10–00; 8:45 am]

BILLING CODE 6560–50–P

30358 Federal Register / Vol. 65, No. 92 / Thursday, May 11, 2000 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[AL–53–200019(a); FRL–6605–8]

Approval and Promulgation of

Implementation Plans—Alabama:

Approval of Revisions to the Alabama

State Implementation Plan:

Transportation Conformity Interagency

Memorandum of Agreement

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: EPA is approving a revision to

the Alabama State Implementation Plan

(SIP) that contains the transportation

conformity rule pursuant to sections

110(k) and 176 of the Clean Air Act as

amended in 1990 (Act). The

transportation conformity rule assures

that projected emissions from

transportation plans and projects in air

quality nonattainment or maintenance

areas stay within the motor vehicle

emissions ceiling contained in the SIP.

The transportation conformity SIP

revision enables the State to implement

and enforce the Federal transportation

conformity requirements at the State

level per regulations on Conformity to

State or Federal Implementation Plans

of Transportation Plans, Programs, and

Projects Developed, Funded or

Approved Under Title 23 U.S.C. of the

Federal Transit Laws. This EPA

approval action streamlines the

conformity process and allows direct

consultation among agencies at the local

level. This final approval action is

limited to certain regulations on

Transportation Conformity. Rationale

for approving this SIP revision is

provided in the SUPPLEMENTARY

INFORMATION Section of this action.

DATES: This direct final rule is effective

on July 10, 2000, without further notice,

unless EPA receives adverse comment

by June 12, 2000. If adverse comment is

received, EPA will publish a timely

withdrawal of the direct final rule in the

Federal Register informing the public

that this rule will not take effect.

ADDRESSES: All comments should be

addressed to Kelly Sheckler at the EPA,

Region 4 Air Planning Branch, 61

Forsyth Street, SW, Atlanta, Georgia

30303.

Copies of the state submittal are

available at the following addresses for

inspection during normal business

hours:

Air and Radiation Docket and

Information Center (Air Docket 6102),

U.S. Environmental Protection

Agency, Ariel Rios Building, N.W.,

Washington, DC 20460.

Environmental Protection Agency,

Atlanta Federal Center, Region 4 Air

Planning Branch, 61 Forsyth Street

S.W., Atlanta, Georgia 30303–3104.

Attn: Kelly Sheckler, (404) 562–9042.

Alabama Department of Environmental

Management, Post Office Box 301463,

1400 Coliseum Boulevard,

Montgomery, Alabama 36130–1463.

FOR FURTHER INFORMATION CONTACT:

Kelly Sheckler, at 404/562–9042, Email: Sheckler.Kelly@epa.gov.

SUPPLEMENTARY INFORMATION: Outlined

below are the contents of this document:

I. Background

A. What is a SIP?

B. What is the Federal approval process for

a SIP?

C. What is transportation conformity?

D. Why must the State submit a

transportation conformity SIP?

E. How does transportation conformity

work?

II. Approval of the State Transportation

Conformity Rule

A. What did the State submit?

B. What is EPA approving today and why?

C. How did the State satisfy the

interagency consultation process (40 CFR

93.105)?

D. How does the State’s submittal address

the United States Court of Appeals for

the District of Columbia Circuit ruling

overturning the grace period for new

nonattainment areas (40 CFR 93.102(d))

in the Sierra Club v. Environmental

Protection Agency lawsuit?

E. What other parts of the rule are

excluded?

III. Opportunity for Public Comments

IV. Administrative Requirements

I. Background

A. What Is a SIP?

The states, under section 110 of the

Act, must develop air pollution

regulations and control strategies to

ensure that state air quality meets the

National Ambient Air Quality Standards

(NAAQS) established by EPA. The Act,

under section 109, established these

NAAQS which currently address six

criteria pollutants. These pollutants are:

carbon monoxide, nitrogen dioxide,

ozone, lead, particulate matter, and

sulfur dioxide.

Each state must send these regulations

and control strategies to EPA for

approval and incorporation into the

Federally enforceable SIP, which

protects air quality and contains

emission control plans for NAAQS

nonattainment areas. These SIPs can be

extensive, containing state regulations

or other enforceable documents and

supporting information such as

emission inventories, monitoring

networks, and modeling

demonstrations.

B. What Is the Federal Approval Process

for a SIP?

The states must formally adopt the

regulations and control strategies

consistent with state and Federal laws

for incorporating the state regulations

into the Federally enforceable SIP. This

process generally includes a public

notice, public comment period, public

hearing, and a formal adoption by a

state-authorized rulemaking body.

Once a state rule, regulation, or

control strategy is adopted, the state will

send these provisions to EPA for

inclusion in the Federally enforceable

SIP. EPA must then determine the

appropriate Federal action, provide

public notice, and request additional

public comment on the action. The

possible Federal actions include:

approval, disapproval, conditional

approval and limited approval/

disapproval. If adverse comments are

received, EPA must consider and

address the comments before taking

final action.

EPA incorporates state regulations

and supporting information (sent under

section 110 of the Act) into the

Federally approved SIP through the

approval action. EPA maintains records

of all such SIP actions in the CFR at

Title 40, Part 52, entitled ‘‘Approval and

Promulgation of Implementation Plans.’’

The EPA does not reproduce the text of

the Federally approved state regulations

in the CFR. They are ‘‘incorporated by

reference,’’ which means that the

specific state regulation is cited in the

CFR and is considered a part of the CFR

the same as if the text were fully printed

in the CFR.

C. What Is Transportation Conformity?

Conformity first appeared as a

requirement in the Act’s 1977

amendments (Pub. L. 95–95). Although

the Act did not define conformity, it

stated that no Federal department could

engage in, support in any way or

provide financial assistance for, license

or permit, or approve any activity which

did not conform to a SIP which has been

approved or promulgated.

The 1990 Amendments to the Act

expanded the scope and content of the

conformity concept by defining

conformity to a SIP. Section 176(c) of

the Act defines conformity as

conformity to the SIP’s purpose of

eliminating or reducing the severity and

number of violations of the NAAQS and

achieving expeditious attainment of