Federal Register / Vol. 62, No. 196 / Thursday, October 9, 1997 / Rules and Regulations 52659

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Rotorcraft Standards Staff.

(g) Special flight permits will not be

issued.

(h) The inspections and repair shall be

done in accordance with Eurocopter

Deutschland GmbH (ECD) Alert Service

Bulletin ASB–MBB–BK117–30–106, Revision

3, dated May 5, 1997, including Appendix.

This incorporation by reference was

approved by the Director of the Federal

Register in accordance with 5 U.S.C. 552(a)

and 1 CFR part 51. Copies may be obtained

from American Eurocopter Corporation, 2701

Forum Drive, Grand Prairie, Texas 75053–

4005, telephone (972) 641–3460, fax (972)

641–3527. Copies may be inspected at the

FAA, Office of Regional Counsel, Southwest

Region, 2601 Meacham Blvd., Room 663, Fort

Worth, Texas; or at the Office of the Federal

Register, 800 North Capitol Street, NW., suite

700, Washington, DC.

Note 3: The subject of this AD is addressed

in Luftfahrt-Bundesamt (Germany) AD 97–

144/2, dated June 5, 1997.

(i) This amendment becomes effective on

October 24, 1997.

Issued in Fort Worth, Texas, on September

26, 1997.

Eric Bries,

Acting Manager, Rotorcraft Directorate,

Aircraft Certification Service.

[FR Doc. 97–26792 Filed 10–8–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 331

RIN 0905–AA06

Antacid Drug Products for Over-theCounter Human Use; Amendment of

Antacid Monograph

CFR Correction

In Title 21 of the Code of Federal

Regulations, parts 300 to 499, revised as

of April 1, 1997, on page 227, in

§ 331.10, the revision of paragraph (a)

and the source note were inadvertently

omitted. The correct text of paragraph

(a) and the source note read as follows:

§ 331.10 Antacid active ingredients.

(a) The active antacid ingredients of

the product consist of one or more of the

ingredients permitted in § 331.11 within

any maximum daily dosage limit

established, each ingredient is included

at a level that contributes at least 25

percent of the total acid neutralizing

capacity of the product, and the finished

product contains at least 5 meq of acid

neutralizing capacity as measured by

the procedure provided in the United

States Pharmacopeia 23/National

Formulary 18. The method established

in § 331.20 shall be used to determine

the percent contribution of each antacid

active ingredient.

* * * * *

[39 FR 19874, June 4, 1974, as amended at

61 FR 4822, Feb. 8, 1996]

BILLING CODE 1505–01–D

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 436

Antibiotic Drugs; Loracarbef,

Loracarbef Capsules, and Loracarbef

for Oral Suspension and Rifabutin and

Rifabutin Capsules

CFR Correction

In Title 21 of the Code of Federal

Regulations, parts 300 to 499, revised as

of April 1, 1997, on page 399, in

§ 436.215(c)(16)(iv), make the following

changes:

1. Immediately following the

equation, insert the word ‘‘where:’’ as a

separate line.

2. In the second column, delete the

hyphen between the words

‘‘milligrams’’ and ‘‘per’’ in line 2.

3. In paragraph (c)(18)(iv) of

§ 436.215, immediately following the

equation, insert the word ‘‘where:’’ as a

separate line.

BILLING CODE 1505–01–D

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

New Animal Drugs

CFR Correction

In Title 21 of the Code of Federal

Regulations, parts 500 to 599, revised as

of April 1, 1997, on page 48, in

§ 510.515, paragraph (c), entry 5 is

amended by adding ‘‘Arsanilic acid’’

below ‘‘Chlortetracyline’’ in the first

column.

BILLING CODE 1505–01–D

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[MO 027–1027; FRL–5891–2]

Approval and Promulgation of

Implementation Plans; State of

Missouri

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final conditional rule.

SUMMARY: The EPA is taking final action

to conditionally approve the State

Implementation Plan (SIP) revision

concerning Missouri Rule 10 CSR 10–

2.330, Control of Gasoline Reid Vapor

Pressure, submitted by the Missouri

Department of Natural Resources

(MDNR). This revision sets a

summertime gasoline Reid vapor

pressure (RVP) limit of 7.2 pounds per

square inch (psi), and 8.2 psi for

gasoline containing at least 9.0 percent

by volume but not more than 10.0

percent by volume ethanol, for gasoline

distributed in Clay, Platte, and Jackson

Counties in Missouri. This revision is

necessary to ensure that the area

continues to maintain the National

Ambient Air Quality Standard (NAAQS)

for ozone.

DATES: This rule is effective on

November 10, 1997.

ADDRESSES: Copies of the documents

relevant to this action are available for

public inspection during normal

business hours at the: Environmental

Protection Agency, Air Planning and

Development Branch, 726 Minnesota

Avenue, Kansas City, Kansas 66101.

FOR FURTHER INFORMATION CONTACT: Stan

Walker at (913) 551–7494.

SUPPLEMENTARY INFORMATION: On March

24, 1997 (62 FR 13846) the EPA

proposed approval of the SIP revision

concerning Missouri Rule 10 CSR 10–

2.330, Control of Gasoline Reid Vapor

Pressure, submitted by MDNR. This

revision, which limits the RVP of

gasoline sold in the Missouri portion of

the Kansas City metropolitan area, is

necessary to help the Kansas City area

maintain the NAAQS for ozone. In

accord with section 211(c)(4)(C), the

EPA is able to approve this fuel control

measure because the state of Missouri

demonstrated that the measure is

necessary to achieve the national

primary and secondary ambient air

quality standard. The EPA also approves

the state fuel requirement as necessary

because no other measures would bring

about timely attainment, or if other

measures exist, they are unreasonable or

impracticable.
52660 Federal Register / Vol. 62, No. 196 / Thursday, October 9, 1997 / Rules and Regulations

The state emergency rule was adopted

and approved by the Missouri Air

Conservation Commission (MACC) after

proper public notice and hearing

procedures. The emergency rule became

effective on May 1, 1997, and expires on

October 27, 1997. The state’s permanent

rule has undergone proper public notice

and hearing and was adopted at the June

26, 1997, public hearing by the MACC,

and will become effective in October

1997.

The EPA proposed approval of the

state’s permanent rule using parallel

processing procedures. Under this

procedure, the EPA proposed to approve

the Missouri rule based on adoption of

a final rule. The EPA received no

comments on its proposed approval.

The state has completed its rule

adoption procedures for the permanent

rule; however, the emergency rule will

remain in effect until October 27, 1997.

Full approval is contingent upon

Missouri submitting the permanent rule

by November 30, 1997.

For additional background on this

action and the EPA’s detailed rationale

for approval, please refer to the

technical support document of the

aforementioned notice of proposed

rulemaking (62 FR 13846).

I. Final Action

The EPA is taking final action to

conditionally approve the SIP revision

concerning Missouri Rule 10 CSR 10–

2.330, Control of Gasoline Reid Vapor

Pressure, submitted by MDNR.

Nothing in this action should be

construed as permitting or allowing or

establishing a precedent for any future

request for revision to any SIP. Each

request for revision to the SIP shall be

considered separately in light of specific

technical, economic, and environmental

factors, and in relation to relevant

statutory and regulatory requirements.

Full approval is contingent upon

Missouri completing its rule adoption

procedures prior to expiration of the

emergency rule, and submitting the

permanent rule by November 30, 1997.

If the conditional approval is

converted to a disapproval under

section 110(k), based on the state’s

failure to meet the commitment, it will

not affect any existing state

requirements applicable to small

entities. The EPA’s disapproval of the

submittal does not impose a new

Federal requirement. Therefore, the EPA

certifies that this disapproval action

does not have a significant impact on a

substantial number of small entities,

because it does not substitute a new

Federal requirement.

II. Administrative Requirements

A. Executive Order 12866

The Office of Management and Budget

has exempted this regulatory action

from Executive Order 12866 review.

B. Regulatory Flexibility Act

SIP approvals under section 110 and

subchapter I, part D of the CAA do not

create any new requirements but simply

approve requirements that the state is

already imposing.

This Federal action authorizes and

approves into the Missouri SIP

requirement previously adopted by the

state, and imposes no new

requirements. Therefore, the

Administrator certifies that it does not

have a significant impact on any small

entities affected. Moreover, due to the

nature of the Federal-state relationship

under the CAA, preparation of a

regulatory flexibility analysis would

constitute Federal inquiry into the

economic reasonableness of state action.

The CAA forbids the EPA to base its

actions concerning SIPs on such

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

E.P.A., 427 U.S. 246, 256–66 (S.Ct.

1976); 42 U.S.C. 7410(a)(2)).

C. Unfunded Mandates

Under section 202 of the Unfunded

Mandates Reform Act of 1995, signed

into law on March 22, 1995, the EPA

must prepare a budgetary impact

statement to accompany any proposed

or final rule that includes a Federal

mandate that may result in estimated

costs to state, local, or tribal

governments in the aggregate; or to

private sector, of $100 million or more

in any one year. Under section 205, the

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 the

EPA to establish a plan for informing

and advising any small governments

that may be significantly or uniquely

impacted by the rule.

The EPA has determined that the

approval action does not include a

Federal mandate that may result in

estimated costs of $100 million or more

to either state, local, or tribal

governments in the aggregate, or to the

private sector. This Federal action

authorizes and approves into the

Missouri SIP requirements previously

adopted by the state, and imposes no

new requirements. Accordingly, no

additional costs to state, local, or tribal

governments, or to the private sector,

result from this action.

D. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A) as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

EPA submitted 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 General Accounting

Office prior to publication of this rule in

today’s Federal Register. This rule is

not a ‘‘major rule’’ as defined by 5

U.S.C. 804(2).

E. Petitions for Judicial Review

Under section 307(b)(1) of the CAA,

petitions for judicial review of this

action must be filed in the United States

Court of Appeals for the appropriate

circuit by December 8, 1997. 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, Carbon monoxide,

Hydrocarbons, Incorporation by

reference, Intergovernmental relations,

Lead, Nitrogen dioxide, Ozone,

Particulate matter, Reporting and

recordkeeping requirements, Sulfur

oxides, Volatile organic compounds.

Dated: August 25, 1997.

William Rice,

Acting Regional Administrator.

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. 7401–7671q.

Subpart AA—Missouri

2. Section 52.1320 is amended by

adding paragraph (c)(98) to read as

follows:

§ 52.1320 Identification of plan.

* * * * *

(c) * * *

(98) Revision to the Missouri SIP

submitted by the Missouri Department

of Natural Resources on July 14, 1997.

(i) Incorporation by reference.
Federal Register / Vol. 62, No. 196 / Thursday, October 9, 1997 / Rules and Regulations 52661

(A) Missouri Emergency Rule, 10 CSR

10–2.330, Control of Gasoline Reid

Vapor Pressure, effective May 1, 1997,

and expires October 27, 1997.

* * * * *

3. Section 52.1323 is amended by

adding paragraph (l) to read as follows:

§ 52.1323 Approval status.

* * * * *

(l) The Administrator conditionally

approves Missouri emergency rule 10

CSR 10–2.330 under § 52.1320(c)(98).

Full approval is contingent on the state

submitting the permanent rule, to the

EPA, by November 30, 1997.

[FR Doc. 97–26529 Filed 10–8–97; 8:45 am]

BILLING CODE 6560–50–U

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[MD 053–3020; FRL–5905–8]

Approval and Promulgation of Air

Quality Implementation Plans;

Maryland; 15% Rate of Progress Plan

for the Baltimore Ozone Nonattainment

Area

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is granting conditional

approval of the State Implementation

Plan (SIP) revision submitted by the

State of Maryland, for the Baltimore

severe ozone nonattainment area, to

meet the 15 percent reasonable further

progress (RFP, or 15% plan)

requirements of the Clean Air Act (the

Act). EPA is granting conditional

approval of the 15% plan, submitted by

the State of Maryland, because, on its

face, the plan achieves the required 15%

emission reduction, but additional

documentation to verify the emission

calculations is necessary for full

approval. Additionally, the plan relies

upon Maryland’s inspection and

maintenance (I/M) program that

received final conditional approval on

July 31, 1997. This action is being taken

under section 110 of the Clean Air Act.

EFFECTIVE DATE: This final rule is

effective on November 10, 1997.

ADDRESSES: Copies of the documents

relevant to this action are available for

public inspection during normal

business hours at the Air, Radiation,

and Toxics Division, U.S.

Environmental Protection Agency,

Region III, 841 Chestnut Building,

Philadelphia, Pennsylvania 19107; and

the Maryland Department of the

Environment, 2500 Broening Highway,

Baltimore, Maryland 21224.

FOR FURTHER INFORMATION CONTACT:

Carolyn M. Donahue, Ozone/Carbon

Monoxide and Mobile Sources Section

(3AT21), USEPA—Region III, 841

Chestnut Building, Philadelphia,

Pennsylvania 19107, or by telephone at

(215) 566–2095 or via e-mail, at the

following address:

donahue.carolyn@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Section 182(b)(1) of the Act requires

ozone nonattainment areas classified as

moderate or above to develop plans to

reduce volatile organic compounds

(VOC) emissions by 15% from 1990

baseline levels. The Baltimore area is

classified as a severe ozone

nonattainment area and is subject to the

15% plan requirement. The Baltimore

ozone nonattainment area consists of

the City of Baltimore, and Anne

Arundel, Baltimore, Carroll, Howard,

and Harford Counties.

The State of Maryland submitted the

15% plan SIP revision for the Baltimore

nonattainment area on July 12, 1995. On

August 5, 1997, EPA published a notice

of proposed rulemaking (NPR) in the

Federal Register proposing conditional

approval of the 15% plan (62 FR 42079).

EPA’s rationale for granting conditional

approval to the Maryland 15% plan for

the Baltimore area and the details of the

July 12, 1995 submittal are contained in

the August 5, 1997 NPR and the

accompanying technical support

document and will not be restated here.

II. Public Comments and EPA

Responses

EPA received a letter in response to

the August 5, 1997 NPR from the

Earthjustice Legal Defense Fund (ELDF).

The following discussion summarizes

and responds to the comments received.

Comment 1: ELDF commented that

the Baltimore 15% plan must be

disapproved because it failed to produce

the 15% emission reduction of 73.3

tons/day identified in the plan as

prescribed by section 182(b)(1)(A)(I) of

the Act.

Response 1: Under section 110(k)(4)

of the Act, EPA may conditionally

approve a plan based on a commitment

from the state to adopt specific

enforceable measures within one year

from the date of approval. EPA believes

that the 15% required reduction in the

Baltimore nonattainment area will be

63.9 tons/day based on new information

supplied by the State. Although this

information has not been established

through an official SIP submittal, this

information is contained in Maryland’s

rate-of-progress SIP revision for the

1996–1999 time period (known at the

Post-1996 plan). Maryland has held a

public hearing on this SIP revision,

which EPA provided comments on for

the public record, and expects to submit

it to EPA shortly. Under these

circumstances—including the fact that

the amount of emissions at issue is a

relatively small percentage of the 15%

requirement—EPA has the authority to

conditionally approve Maryland’s 15%

SIP, on the condition that Maryland

submit the requisite documentation.

The State of Maryland has agreed to

document the amount of reductions

needed to meet the 15% requirement,

and submitted such commitment in

writing on September 4, 1997.

Comment 2: EPA concluded that

‘‘EPA cannot credit this claim’’ of 6.3

tons/day from enhanced rule

compliance for the Baltimore area. EPA

nevertheless included this measure in

the list of creditable measures, acting

unlawfully and inconsistently.

Response 2: The commenter is

correct. This inconsistency is the result

of a typographical error. The credit

claim of 6.3 tons/day (TPD) from

enhanced rule compliance is not

creditable toward the 15% rate-ofprogress requirement for the Baltimore

nonattainment area. Therefore, the total

credits achieved by Maryland toward

the 15% requirement in the plan is 64.2

TPD.

Comment 3: ELDF commented that

the Maryland 15% plan, which takes

credit for federal control measures such

as architectural and industrial

maintenance coating, consumer/

commercial products and autobody

refinishing, should not be approved

because those federal control measures

have not yet been promulgated. ELDF

states that allowing such credit violates

section 182(b)(1)(C) of the Act. ELDF

further commented that EPA cannot

lawfully base SIP decisions on

unpromulgated rules because it does not

know what these final rules will say.

ELDF contends that allowing credit on

as yet unpromulgated rules, even with

the caveat that the states must revisit the

rule later if the federal rules turn out

differently than predicted, amounts to

an unlawful extension of a SIP

submission deadline. ELDF stated that

EPA must base its decision on the

record before it at the time of its

decision; not on some record that the

agency hopes will exist in the future.

Response 3: Section 182(b)(1)(A) of

the Act requires states to submit their

15% SIP revisions by November, 1993.

Section 182(b)(1)(C) of the Act provides

the following general rule for