77900 Federal Register / Vol. 69, No. 249 / Wednesday, December 29, 2004 / Rules and Regulations 

included in this classification, see 

§ 882.5950 of this chapter.

(b) Classification. Class II (special 

controls.) The special control for this 

device is the FDA guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Vascular and 

Neurovascular Embolization Devices.’’

For availability of this guidance 

document, see § 870.1(e).

PART 882—NEUROLOGICAL DEVICES

■ 3. The authority citation for 21 CFR 

part 882 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371.

■ 4. Section 882.5950 is revised to read 

as follows:

§ 882.5950 Neurovascular embolization 

device.

(a) Identification. A neurovascular 

embolization device is an intravascular 

implant intended to permanently 

occlude blood flow to cerebral 

aneurysms and cerebral ateriovenous 

malformations. This does not include 

cyanoacrylates and other embolic 

agents, which act by polymerization or 

precipitation. Embolization devices 

used in other vascular applications are 

also not included in this classification, 

see § 870.3300.

(b) Classification. Class II (special 

controls.) The special control for this 

device is the FDA guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Vascular and 

Neurovascular Embolization Devices.’’

For availability of this guidance 

document, see § 882.1(e).

Dated: December 15, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–28437 Filed 12–28–04; 8:45 am]

BILLING CODE 4160–01–S

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52

[R03–OAR–2004–VA–0005; FRL–7853–7] 

Approval and Promulgation of Air 

Quality Implementation Plans; Virginia; 

Approval of the Control of VOC 

Emissions From Municipal Solid Waste 

Landfills in Northern Virginia

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: EPA is taking direct final 

action to approve a revision to the 

Commonwealth of Virginia (the 

Commonwealth) State Implementation 

Plan (SIP). The revision establishes 

regulations for the control of volatile 

organic compound (VOC) emissions 

from municipal solid waste landfills 

(MSWLs) located in the Northern 

Virginia Portion of the Metropolitan 

Washington, D.C. Ozone Nonattainment 

Area. (Northern Virginia). EPA is 

approving this revision to the SIP in 

accordance with the requirements of the 

Clean Air Act (CAA or the Act).

DATES: This rule is effective on February 

28, 2005, without further notice, unless 

EPA receives adverse written comment 

by January 28, 2005. If EPA receives 

such comments, it will publish a timely 

withdrawal of the direct final rule in the 

Federal Register and inform the public 

that the rule will not take effect.

ADDRESSES: Submit your comments, 

identified by Regional Material in 

Edocket (RME) ID Number R03–OAR–

2004–VA–0005 by one of the following 

methods: 

A. Federal eRulemaking Portal:

http://www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

B. Agency Web site: http://

www.docket.epa.gov/rmepub/ RME, 

EPA’s electronic public docket and 

comment system, is EPA’s preferred 

method for receiving comments. Follow 

the on-line instructions for submitting 

comments. 

C. E-mail: Morris.Makeba@epa.gov.

D. Mail: R03–OAR–2003–VA–0005, 

Makeba Morris, Chief, Air Quality 

Planning Branch, Mailcode 3AP21, U.S. 

Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

E. Hand Delivery: At the previouslylisted EPA Region III address. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

RME ID No. R03–OAR–2004–VA–0005. 

EPA’s policy is that all comments 

received will be included in the public 

docket without change, and may be 

made available online at http://

www.docket.epa.gov/rmepub/, 

including any personal information 

provided, unless the comment includes 

information claimed to be Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Do not submit 

information that you consider to be CBI 

or otherwise protected through RME, 

regulations.gov or e-mail. The EPA RME 

and the Federal regulations.gov Web 

sites are an ‘‘anonymous access’’

system, which means EPA will not 

know your identity or contact 

information unless you provide it in the 

body of your comment. If you send an 

e-mail comment directly to EPA without 

going through RME or regulations.gov, 

your e-mail address will be 

automatically captured and included as 

part of the comment that is placed in the 

public docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the 

electronic docket are listed in the RME 

index at http://www.docket.epa.gov/

rmepub/. Although listed in the index, 

some information is not publicly 

available, i.e., CBI or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically in RME or 

in hard copy during normal business 

hours at the Air Protection Division, 

U.S. Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

Copies of the State submittal are 

available at the Virginia Department of 

Environmental Quality, 629 East Main 

Street, Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT:

Janice Lewis, (215) 814–2185, or by email at lewis.janice@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

On February 12, 2004, the 

Commonwealth submitted a revision to 

its State Implementation Plan (SIP). The 

SIP revision consists of regulations to 

control VOC emissions from Municipal 

Solid Waste Landfills (MSWLs) in the 

Northern Virginia portion of the 

Metropolitan Washington, D.C. Ozone 

Nonattainment Area. The regulation 

establishes emission standards for 

MSWLs, as well as operational, 

monitoring and reporting requirements. 

This revision applies to the Northern 

Virginia portion of the Metropolitan 

Washington, D.C. Ozone Nonattainment 

Area, and is not intended to apply to 

Federal Register / Vol. 69, No. 249 / Wednesday, December 29, 2004 / Rules and Regulations 77901

any other portion of the 

Commonwealth. 

II. Summary of SIP Revision 

The Commonwealth’s February 12, 

2004 submittal includes regulations that 

apply to MSWLs which commenced 

construction, reconstruction, or 

modification before May 30, 1991 in the 

Northern Virginia VOC Control Area 

(Arlington County, Alexandria City, 

Fairfax County, Fairfax City, Falls 

Church City, Loudon County, Manassas 

City, Manassas Park City, Prince 

William County, and Stafford County) 

as designated in 9 VAC 5–20–206. The 

landfill design capacity applicability 

criteria is 1.0 million megagrams (Mg) or 

more and 1.0 million cubic meters. The 

emission rate applicability criteria is 

emissions of nonmethane organic 

compound (NMOCs) greater than or 

equal to 23 Mg per year. The primary 

components of MSWL emissions are 

methane and NMOCs. VOCs are a 

component of NMOCs. 

Landfills that have a design capacity 

greater than or equal to 1.0 million Mg 

and 1.0 million cubic meters are 

required to test and report their 

emission rate annually. If the NMOC 

emission rate exceeds 23 Mg per year, 

the MSWL is required to submit plans 

for and to install a collection system and 

control system for the subject emissions. 

The regulation establishes specifications 

for the collection and control systems 

and provide test methods and 

calculation procedures for estimating 

NMOC emission rates. In addition, the 

regulation provides compliance 

schedules and reporting requirements, 

and incorporates control and equipment 

maintenance and malfunction 

provisions. 

III. General Information Pertaining to 

SIP Submittals From the 

Commonwealth of Virginia 

In 1995 Virginia adopted legislation 

that provides, subject to certain 

conditions, for an environmental 

assessment (audit) ‘‘privilege’’ for 

voluntary compliance evaluations 

performed by a regulated entity. The 

legislation further addresses the relative 

burden of proof for parties either 

asserting the privilege or seeking 

disclosure of documents for which the 

privilege is claimed. Virginia’s 

legislation also provides, subject to 

certain conditions, for a penalty waiver 

for violations of environmental laws 

when a regulated entity discovers such 

violations pursuant to a voluntary 

compliance evaluation and voluntarily 

discloses such violations to the 

Commonwealth and takes prompt and 

appropriate measures to remedy the 

violations. Virginia’s Voluntary 

Environmental Assessment Privilege 

Law, Va. Code Sec. 10.1–1198, provides 

a privilege that protects from disclosure 

documents and information about the 

content of those documents that are the 

product of a voluntary environmental 

assessment. The Privilege Law does not 

extend to documents or information (1) 

that are generated or developed before 

the commencement of a voluntary 

environmental assessment; (2) that are 

prepared independently of the 

assessment process; (3) that demonstrate 

a clear, imminent and substantial 

danger to the public health or 

environment; or (4) that are required by 

law. 

On January 12, 1998, the 

Commonwealth of Virginia Office of the 

Attorney General provided a legal 

opinion that states that the Privilege 

law,Va. Code Sec. 10.1–1198, precludes 

granting a privilege to documents and 

information ‘‘required by law,’’

including documents and information 

‘‘required by Federal law to maintain 

program delegation, authorization or 

approval,’’ since Virginia must ‘‘enforce 

Federally authorized environmental 

programs in a manner that is no less 

stringent than their Federal 

counterparts....’’ The opinion 

concludes that ‘‘[r]egarding § 10.1–1198, 

therefore, documents or other 

information needed for civil or criminal 

enforcement under one of these 

programs could not be privileged 

because such documents and 

information are essential to pursuing 

enforcement in a manner required by 

Federal law to maintain program 

delegation, authorization or approval.’’

Virginia’s Immunity law, Va. Code 

Sec. 10.1–1199, provides that ‘‘[t]o the 

extent consistent with requirements 

imposed by Federal law,’’ any person 

making a voluntary disclosure of 

information to a state agency regarding 

a violation of an environmental statute, 

regulation, permit, or administrative 

order is granted immunity from 

administrative or civil penalty. The 

Attorney General’s January 12, 1998 

opinion states that the quoted language 

renders this statute inapplicable to 

enforcement of any Federally authorized 

programs, since ‘‘no immunity could be 

afforded from administrative, civil, or 

criminal penalties because granting 

such immunity would not be consistent 

with Federal law, which is one of the 

criteria for immunity.’’

Therefore, EPA has determined that 

Virginia’s Privilege and Immunity 

statutes will not preclude the 

Commonwealth from enforcing its 

program consistent with the Federal 

requirements. In any event, because 

EPA has also determined that a state 

audit privilege and immunity law can 

affect only state enforcement and cannot 

have any impact on Federal 

enforcement authorities, EPA may at 

any time invoke its authority under the 

Clean Air Act, including, for example, 

sections 113, 167, 205, 211 or 213, to 

enforce the requirements or prohibitions 

of the state plan, independently of any 

state enforcement effort. In addition, 

citizen enforcement under section 304 

of the Clean Air Act is likewise 

unaffected by this, or any, state audit 

privilege or immunity law. 

IV. Final Action 

EPA is approving the revision to the 

Commonwealth’s SIP which establish 

regulations for the control of emission of 

volatile organic compound (VOC) 

emissions from municipal solid waste 

landfills (MSWLs) located in Northern 

Virginia portion of the Metropolitan 

Washington, D.C. Ozone Nonattainment 

Area (Northern Virginia). This revision 

applies only to the Northern Virginia 

Ozone Nonattainment Area, and is not 

intended to apply to any other part of 

the Commonwealth. 

EPA is publishing this rule without 

prior proposal because the Agency 

views this as a noncontroversial 

amendment and anticipates no adverse 

comment. However, in the ‘‘Proposed 

Rules’’ section of today’s Federal 

Register, EPA is publishing a separate 

document that will serve as the proposal 

to approve the SIP revision if adverse 

comments are filed. This rule will be 

effective on February 28, 2005 without 

further notice unless EPA receives 

adverse comment by January 28, 2005. 

If EPA receives adverse comment, EPA 

will publish a timely withdrawal in the 

Federal Register informing the public 

that the rule will not take effect. EPA 

will address all public comments in a 

subsequent final rule based on the 

proposed rule. EPA will not institute a 

second comment period on this action. 

Any parties interested in commenting 

must do so at this time. Please note that 

if EPA receives adverse comment on an 

amendment, paragraph, or section of 

this rule and if that provision may be 

severed from the remainder of the rule, 

EPA may adopt as final those provisions 

of the rule that are not the subject of an 

adverse comment. 

V. Statutory and Executive Order 

Reviews 

A. General Requirements 

Under Executive Order 12866 (58 FR 

51735, October 4, 1993), this action is 

not a ‘‘significant regulatory action’’ and 

therefore is not subject to review by the 

77902 Federal Register / Vol. 69, No. 249 / Wednesday, December 29, 2004 / Rules and Regulations 

Office of Management and Budget. For 

this reason, this action is also not 

subject to Executive Order 13211, 

‘‘Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001). This action merely approves 

state law as meeting Federal 

requirements and imposes no additional 

requirements beyond those imposed by 

state law. Accordingly, the 

Administrator certifies that this rule 

will not have a significant economic 

impact on a substantial number of small 

entities under the Regulatory Flexibility 

Act (5 U.S.C. 601 et seq.). Because this 

rule approves pre-existing requirements 

under state law and does not impose 

any additional enforceable duty beyond 

that required by state law, it does not 

contain any unfunded mandate or 

significantly or uniquely affect small 

governments, as described in the 

Unfunded Mandates Reform Act of 1995 

(Public Law 104–4). This rule also does 

not have tribal implications because it 

will not have a substantial direct effect 

on one or more Indian tribes, 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 by Executive Order 13175 (65 

FR 67249, November 9, 2000). This 

action also does not have Federalism 

implications because it does 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). This action 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. This rule also is not 

subject to Executive Order 13045 

‘‘Protection of Children from 

Environmental Health Risks and Safety 

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

because it is not economically 

significant. 

In reviewing SIP submissions, EPA’s 

role is to approve state choices, 

provided that they meet the criteria of 

the Clean Air Act. In this context, in the 

absence of a prior existing requirement 

for the State to use voluntary consensus 

standards (VCS), EPA has no authority 

to disapprove a SIP submission for 

failure to use VCS. It would thus be 

inconsistent with applicable law for 

EPA, when it reviews a SIP submission, 

to use VCS in place of a SIP submission 

that otherwise satisfies the provisions of 

the Clean Air Act. Thus, the 

requirements of section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272 note) do not apply. This rule does 

not impose an information collection 

burden under the provisions of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

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 February 28, 

2005. 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, approving the 

Commonwealth of Virginia’s regulation 

to require municipal solid waste 

landfills in Northern Virginia to control 

emissions of volatile organic 

compounds 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, Ozone, Reporting and 

recordkeeping requirements, Volatile 

organic compounds.

Dated: December 14, 2004. 

Donald S. Welsh, 

Regional Administrator, Region III.

■ 40 CFR part 52 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 VV—Virginia

■ 2. Section 52.2420, the table in 

paragraph (c) is amended by adding 

entries under chapter 40, part II to read 

as follows:

§ 52.2420 Identification of plan.

* * * * *

(c) EPA approved regulations and 

statutes.

EPA—APPROVED REGULATIONS AND STATUTES IN THE VIRGINIA SIP 

State citation

(9 VAC 5) Title/subject State effective date EPA approval date 

Explanation

(former SIP 

section) 

* * * * * * * 

Chapter 40 Existing Stationary Sources

Federal Register / Vol. 69, No. 249 / Wednesday, December 29, 2004 / Rules and Regulations 77903

EPA—APPROVED REGULATIONS AND STATUTES IN THE VIRGINIA SIP—Continued

State citation

(9 VAC 5) Title/subject State effective date EPA approval date 

Explanation

(former SIP 

section) 

* * * * * * * 

Part II Emission Standards

* * * * * * * 

Article 43 Municipal Solid Waste Landfills (Rule 4–43)

5–40–5800 Applicability and Designation of Affected Facility.1/29/04 12/29/04 [Insert page number where the 

document begins].

5–40–5810 Definitions ...................................................... 1/29/04 12/29/04 [Insert page number where the 

document begins].

5–40–5820 Standards for Air Emissions .......................... 1/29/04 12/29/04 [Insert page number where the 

document begins].

5–40–5822 Operational standards for collection and control systems.1/29/04 12/29/04 [Insert page number where the 

document begins].

5–40–5824 Specifications for active collection systems .. 1/29/04 12/29/04 [Insert page number where the 

document begins].

5–40–5850 Compliance .................................................... 1/29/04 12/29/04 [Insert page number where the 

document begins].

5–40–5855 Compliance schedule ..................................... 1/29/04 12/29/04 [Insert page number where the 

document begins].

5–40–5860 Test methods and procedures ....................... 1/29/04 12/29/04 [Insert page number where the 

document begins].

5–40–5870 Monitoring ...................................................... 1/29/04 12/29/04 [Insert page number where the 

document begins].

5–40–5880 Reporting ........................................................ 1/29/04 12/29/04 [Insert page number where the 

document begins].

5–40–5890 Recordkeeping ............................................... 1/29/04 12/29/04 [Insert page number where the 

document begins].

5–40–5900 Registration .................................................... 1/29/04 12/29/04 [Insert page number where the 

document begins].

5–40–5910 Facility and control equipment maintenance 

or malfunction.

1/29/04 12/29/04 [Insert page number where the 

document begins].

5–40–5920 Permits ........................................................... 1/29/04 12/29/04 [Insert page number where the 

document begins].

[FR Doc. 04–28351 Filed 12–28–04; 8:45 am] 

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[R03–OAR–2004–DC–0004; FRL–7853–5] 

Approval and Promulgation of Air 

Quality Implementation Plans; District 

of Columbia; VOC Emission Standards 

for Portable Fuel Containers and 

Spouts

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: EPA is taking direct final 

action to approve revisions to the 

District of Columbia State 

Implementation Plan (SIP). Specifically, 

EPA is approving new emission 

standards for portable fuel containers 

and spouts sold, supplied, offered for 

sale, or manufactured for sale in the 

District of Columbia (the District). EPA 

is approving the new portable fuel 

container and spouts standards to 

reduce emissions of volatile organic 

compounds (VOC) in accordance with 

the requirements of the Clean Air Act 

(CAA or the Act).

DATES: This rule is effective on February 

28, 2005 without further notice, unless 

EPA receives adverse written comment 

by January 28, 2005. If EPA receives 

such comments, it will publish a timely 

withdrawal of the direct final rule in the 

Federal Register and inform the public 

that the rule will not take effect.

ADDRESSES: Submit your comments, 

identified by Regional Material in 

EDocket (RME) ID Number R03–OAR–

2004–DC–0004 by one of the following 

methods: 

A. Federal eRulemaking Portal: 

http://www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

B. Agency Web site: http://

www.docket.epa.gov/rmepub/ RME, 

EPA’s electronic public docket and 

comment system, is EPA’s preferred 

method for receiving comments. Follow 

the on-line instructions for submitting 

comments. 

C. E-mail: morris.makeba@epa.gov.

D. Mail: R03–OAR–2004–DC–0004, 

Makeba Morris, Chief, Air Quality 

Planning Branch, Mailcode 3AP21, U.S. 

Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

E. Hand Delivery: At the previouslylisted EPA Region III address. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

RME ID No. R03–OAR–2004–DC–0004. 

EPA’s policy is that all comments 

received will be included in the public 

docket without change, and may be 

made available online at http://

www.docket.epa.gov/rmepub/, 

including any personal information 

provided, unless the comment includes 

information claimed to be Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Do not submit