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73602 Federal Register / Vol. 72, No.

248 / Friday, December 28, 2007 / Rules and Regulations

adversely affect the safety, effectiveness, (4) § 809.10(d)(1)(i) through (d)(1)(v), ENVIRONMENTAL PROTECTION
or availability of the specified lots, (d)(1)(viii), and (d)(2); and AGENCY
batches, or other units of the in vitro (5) § 809.10(e)(1)(i) through (e)(1)(vi)
diagnostic product for human use that and (e)(1)(ix) through (e)(1)(xi). 40 CFR Part 52
are or will be held in the Strategic [EPA–R03–OAR–2007–0381; FRL–8510–3]
National Stockpile; PART 812—INVESTIGATIONAL
(iv) Describe any proposed safeguards DEVICE EXEMPTIONS Approval and Promulgation of Air
or conditions that will be implemented Quality Implementation Plans; Virginia;
so that the labeling of the product ■ 17. The authority citation for 21 CFR Clean Air Interstate Rule Budget
includes appropriate information part 812 continues to read as follows: Trading Programs
necessary for the safe and effective use Authority: 21 U.S.C. 331, 351, 352, 353,
of the product, given the anticipated AGENCY: Environmental Protection
355, 360, 360c–360f, 360h–360j, 371, 372,
circumstances of use of the product; Agency (EPA).
374, 379e, 381, 382, 383; 42 U.S.C. 216, 241,
(v) Provide a draft of the proposed 262, 263b–263n. ACTION: Final rule.
labeling of the specified lots, batches, or
other units of the in vitro diagnostic ■ 18. Section 812.5 is amended by SUMMARY: EPA is approving a State
products for human use subject to the adding paragraph (d) to read as follows: Implementation Plan (SIP) revision
exception or alternative; and submitted by the Commonwealth of
§ 812.5 Labeling of investigational
(vi) Provide any other information Virginia. This revision establishes
devices.
requested by the Center Director in budget trading programs for nitrogen
* * * * * oxides (NOX) annual, NOX ozone
support of the request.
(c) The Center Director must respond (d) The appropriate FDA Center season, and sulfur dioxides (SO2)
in writing to all requests under this Director, according to the procedures set annual emissions to address the
section. The Center Director may forth in § 801.128 or § 809.11 of this requirements of EPA’s Clean Air
impose appropriate conditions or chapter, may grant an exception or Interstate Rule (CAIR). Virginia will
safeguards when granting such an alternative to the provisions in meet its CAIR requirements by
exception or alternative under this paragraphs (a) and (c) of this section, to participating in the EPA-administered
section. the extent that these provisions are not regional cap-and-trade program for NOX
(d) A grant of an exception or explicitly required by statute, for annual, NOX ozone season, and SO2
alternative under this section will specified lots, batches, or other units of annual emissions. EPA is determining
include any safeguards or conditions a device that are or will be included in that the SIP revision fully implements
deemed appropriate by the Center the Strategic National Stockpile. the CAIR requirements for Virginia.
Director to ensure that the labeling of Therefore, as a consequence of the SIP
PART 814—PREMARKET APPROVAL approval, EPA will also withdraw the
the product subject to the exception or
OF MEDICAL DEVICES CAIR Federal Implementation Plan (FIP)
alternative includes the information
necessary for the safe and effective use that addresses NOX annual, NOX ozone
of the product, given the anticipated ■ 19. The authority citation for 21 CFR season, and SO2 annual emissions in
circumstances of use. part 814 continues to read as follows: Virginia.
(e) If the Center Director grants a Authority: 21 U.S.C. 351, 352, 353, 360, EFFECTIVE DATE: The final rule is
request for an exception or alternative to 360c–360j, 371, 372, 373, 374, 375, 379, 379e,
effective on December 28, 2007.
the labeling requirements under this 381.
ADDRESSES: EPA has established a
section: ■ 20. Section 814.39 is amended by docket for this action under Docket ID
(1) The Center Director may adding paragraph (g) to read as follows: Number EPA–R03–OAR–2007–0381. All
determine that the submission and grant
§ 814.39 PMA Supplements. documents in the electronic docket are
of a written request under this section
listed in the www.regulations.gov index.
satisfies the provisions relating to * * * * *
Although listed in the index, some
premarket notification submissions (g) The submission and grant of a information is not publicly available,
under § 807.81(a)(3) of this chapter. written request for an exception or i.e., confidential business information
(2)(i) For a Premarket Approval alternative under § 801.128 or § 809.11 (CBI) or other information whose
Application (PMA)-approved in vitro of this chapter satisfies the requirement disclosure is restricted by statute.
diagnostic product for human use, the in paragraph (a) of this section. Certain other material, such as
submission and grant of a written
■ 21. Section 814.84 is amended by copyrighted material, is not placed on
request under this section satisfies the
adding paragraph (b)(3) to read as the Internet and will be publicly
provisions relating to submission of
follows: available only in hard copy form.
PMA supplements under § 814.39 of
Publicly available docket materials are
this chapter; however, § 814.84 Reports.
(ii) The grant of the request must be available either electronically at
identified in a periodic report under * * * * * www.regulations.gov or in hard copy
§ 814.84 of this chapter. (b) * * * during normal business hours at the Air
(f) The Center Director may grant an Protection Division, U.S. Environmental
(3) Identify changes made pursuant to
exception or alternative under this Protection Agency, Region III, 1650
an exception or alternative granted
section to the following provisions of Arch Street, Philadelphia, Pennsylvania
under § 801.128 or § 809.11 of this
this part, to the extent that the 19103. Copies of the State submittal are
chapter.
requirements in these provisions are not available at the Virginia Department of
Dated: December 20, 2007.
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explicitly required by statute: Environmental Quality, 629 East Main


Jeffrey Shuren, Street, Richmond, Virginia, 23219.
(1) § 809.10(a)(1) through (a)(6) and
(a)(9); Assistant Commissioner for Policy. FOR FURTHER INFORMATION CONTACT:
(2) § 809.10(b); [FR Doc. E7–25165 Filed 12–27–07; 8:45 am] Marilyn Powers, (215) 814–2308 or by e-
(3) § 809.10(c)(2); BILLING CODE 4160–01–S mail at powers.marilyn@epa.gov.

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Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations 73603

SUPPLEMENTARY INFORMATION: CAIR implementation are large enough additional analysis on whether Virginia
that, even with local controls, it may be or any other state satisfies the
I. Background
difficult for Connecticut to attain the 8- requirements of 110(a)(2)(D)(i) before
On March 30, 2007, and hour ozone NAAQS by 2010. Finally, approving Virginia’s CAIR SIP
supplemented on April 30, 2007 and CTDEP questions EPA’s determination submission.
June 11, 2007, the Virginia Department that highly cost effective controls are
of Environmental Quality (VADEQ) III. Information Pertaining to SIP
adequate to address States’ section Submittals From the Commonwealth of
submitted a CAIR SIP revision to meet 110(a)(2)(D)(i) obligations as compared
the requirements of CAIR, which was Virginia
to ‘‘reasonable cost’’ controls that could
promulgated on May 12, 2005 (70 FR be achieved to effect more stringent In 1995, Virginia adopted legislation
25162), and subsequently revised on NOX reductions. that provides, subject to certain
April 28, 2006, and December 13, 2006. conditions, for an environmental
Response: EPA does not agree that it
The SIP revision is comprised of new assessment (audit) ‘‘privilege’’ for
is appropriate or necessary for EPA to
regulations under 9 VAC 5 Chapter 140 voluntary compliance evaluations
conduct additional analysis before
of the Virginia Code as follows: Part II— performed by a regulated entity. The
approving Virginia’s CAIR SIP revision.
NOX Annual Trading Program; Part III— legislation further addresses the relative
In the CAIR rulemaking promulgated on
NOX Ozone Season Trading Program; burden of proof for parties either
May 12, 2005 (70 FR 25162), EPA
and Part IV—SO2 Annual Trading asserting the privilege or seeking
established model rules for multi-State
Program. The regulations address all the disclosure of documents for which the
requirements of the part 96 model rules cap and trade programs for annual NOX, privilege is claimed. Virginia’s
set forth in the May 12, 2005 CAIR ozone season NOX, and annual SO2 that legislation also provides, subject to
rulemaking. States may choose to adopt to meet the certain conditions, for a penalty waiver
On September 25, 2007 (72 FR 54385), required emissions reductions in a for violations of environmental laws
EPA published a notice of proposed flexible and cost-effective manner. EPA when a regulated entity discovers such
rulemaking (NPR) to approve Virginia’s requires States that wish to participate violations pursuant to a voluntary
CAIR SIP revision. A detailed in the EPA-administered cap and trade compliance evaluation and voluntarily
discussion of the CAIR requirements, program to use the model rule (with discloses such violations to the
Virginia’s CAIR submittal, and EPA’s only limited flexibility to modify Commonwealth and takes prompt and
rationale for approval of Virginia’s CAIR specific provisions) to ensure that all appropriate measures to remedy the
SIP revision may be found in the NPR participating sources, regardless of violations. Virginia’s Voluntary
and will not be repeated here. On which State in the CAIR region they are Environmental Assessment Privilege
October 24, 2007, EPA received adverse located, are subject to the same trading Law, Va. Code Sec. 10.1–1198, provides
comments from the State of Connecticut and allowance holding requirements. a privilege that protects from disclosure
Department of Environmental Virginia has chosen to participate in the documents and information about the
Protection. cap and trade program administered by content of those documents that are the
EPA and has chosen to adopt the model product of a voluntary environmental
II. Public Comments and EPA rules with modifications allowed by
Responses assessment. The Privilege Law does not
flexibilities in the model rule. EPA has extend to documents or information (1)
Comment: On October 24, 2007, the evaluated Virginia’s SIP revision and that are generated or developed before
Connecticut Department of determined that Virginia is meeting its the commencement of a voluntary
Environmental Protection (CTDEP) CAIR requirements. CTDEP does not environmental assessment; (2) that are
submitted adverse comments on EPA’s challenge this determination. Thus, prepared independently of the
proposed approval of Virginia’s CAIR CTDEP’s comments do not specifically assessment process; (3) that demonstrate
SIP revision. CTDEP encourages EPA to pertain to any aspect of EPA’s proposed a clear, imminent and substantial
approve state programs adopted to meet action to approve the Virginia CAIR SIP danger to the public health or
the emission reduction requirements of revision. Rather, the comments appear environment; or (4) that are required by
CAIR. However, it argues that before to be directed broadly at EPA’s law.
approving state CAIR plans, EPA should decisions with regard to States’ section On January 12, 1998, the
evaluate individually and in the 110(a)(2)(D)(i) obligations. These Commonwealth of Virginia Office of the
aggregate each state’s clean air decisions were made by EPA in the Attorney General provided a legal
programs. They argue such evaluation is context of the CAIR rulemaking, not in opinion that states that the Privilege
necessary to ensure that each state’s the proposed action to approve law, Va. Code Sec. 10.1–1198, precludes
emissions do not significantly Virginia’s CAIR SIP revision. Therefore, granting a privilege to documents and
contribute to downwind nonattainment. CTDEP’s comments are not relevant to information ‘‘required by law,’’
CTDEP asserts its belief that the CAIR the proposed action. CTDEP had ample including documents and information
program does not ensure that the CAA opportunity to submit comments both ‘‘required by Federal law to maintain
section 110(a)(2)(D)(i) requirements to during the comment period for the program delegation, authorization or
prohibit transported emissions that proposed CAIR rulemaking of January approval,’’ since Virginia must ‘‘enforce
significantly contribute to 30, 2004 (70 FR 49708) and during the Federally authorized environmental
nonattainment in Connecticut and other comment period for the proposed CAIR programs in a manner that is no less
states will be met. CTDEP expresses FIP of August 24, 2005 (70 FR 49708). stringent than their Federal counterparts
concern that EPA is determining EPA’s proposal to approve Virginia’s * * *.’’ The opinion concludes that
through this and other similar CAIR SIP did not reopen either the ‘‘[r]egarding § 10.1–1198, therefore,
rulemakings that CAIR programs are CAIR or CAIR FIP rulemakings. documents or other information needed
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sufficient to meet States’ section Consequently, CTDEP’s comments are for civil or criminal enforcement under
110(a)(2)(D)(i) obligations. CTDEP not relevant to this rulemaking, or one of these programs could not be
asserts, based on EPA and State timely with respect to the CAIR and privileged because such documents and
modeling for CAIR, that the levels of CAIR FIP rulemakings. Thus, EPA does information are essential to pursuing
transported pollution remaining after not believe it is necessary to conduct enforcement in a manner required by

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73604 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations

Federal law to maintain program V. Effective Date Government and Indian tribes, or on the
delegation, authorization or approval.’’ EPA finds that there is good cause for distribution of power and
Virginia’s Immunity law, Va. Code this approval to become effective on the responsibilities between the Federal
Sec. 10.1–1199, provides that ‘‘[t]o the date of publication because a delayed Government and Indian tribes, as
extent consistent with requirements effective date is unnecessary due to the specified by Executive Order 13175 (65
imposed by Federal law,’’ any person nature of the approval, which allows the FR 67249, November 9, 2000). This
making a voluntary disclosure of Commonwealth to make allocations action also does not have Federalism
information to a state agency regarding under its CAIR rules. The expedited implications because it does not have
a violation of an environmental statute, effective date for this action is substantial direct effects on the States,
regulation, permit, or administrative authorized under both 5 U.S.C. on the relationship between the national
order is granted immunity from 553(d)(1), which provides that rule government and the States, or on the
administrative or civil penalty. The actions may become effective less than distribution of power and
Attorney General’s January 12, 1998 30 days after publication if the rule responsibilities among the various
opinion states that the quoted language ‘‘grants or recognizes an exemption or levels of government, as specified in
relieves a restriction’’ and section 5 Executive Order 13132 (64 FR 43255,
renders this statute inapplicable to
U.S.C. 553(d)(3), which allows an August 10, 1999). This action merely
enforcement of any Federally authorized
effective date less than 30 days after approves a state rule implementing a
programs, since ‘‘no immunity could be
publication ‘‘as otherwise provided by Federal requirement, and does not alter
afforded from administrative, civil, or
the agency for good cause found and the relationship or the distribution of
criminal penalties because granting
published with the rule.’’ power and responsibilities established
such immunity would not be consistent
CAIR SIP approvals relieve states and in the Clean Air Act. This rule also is
with Federal law, which is one of the
CAIR sources within states from being not subject to Executive Order 13045
criteria for immunity.’’
subject to allowance allocation ‘‘Protection of Children from
Therefore, EPA has determined that provisions in the CAIR FIPs that Environmental Health Risks and Safety
Virginia’s Privilege and Immunity otherwise would apply to them, Risks’’ (62 FR 19885, April 23, 1997),
statutes will not preclude the allowing States to make their own because it approves a state rule
Commonwealth from enforcing its allowance allocations based on their implementing a Federal standard. In
program consistent with the Federal SIP-approved State rule. The relief from reviewing SIP submissions, EPA’s role
requirements. In any event, because these obligations is sufficient reason to is to approve state choices, provided
EPA has also determined that a state allow an expedited effective date of this that they meet the criteria of the Clean
audit privilege and immunity law can rule under 5 U.S.C. 553(d)(1). Air Act. In this context, in the absence
affect only state enforcement and cannot of a prior existing requirement for the
VI. Statutory and Executive Order
have any impact on Federal State to use voluntary consensus
Reviews
enforcement authorities, EPA may at standards (VCS), EPA has no authority
any time invoke its authority under the A. General Requirements to disapprove a SIP submission for
CAA, including, for example, sections Under Executive Order 12866 (58 FR failure to use VCS. It would thus be
113, 167, 205, 211 or 213, to enforce the 51735, October 4, 1993), this action is inconsistent with applicable law for
requirements or prohibitions of the state not a ‘‘significant regulatory action’’ and EPA, when it reviews a SIP submission,
plan, independently of any state therefore is not subject to review by the to use VCS in place of a SIP submission
enforcement effort. In addition, citizen Office of Management and Budget. For that otherwise satisfies the provisions of
enforcement under section 304 of the this reason, this action is also not the Clean Air Act. Thus, the
CAA is likewise unaffected by this, or subject to Executive Order 13211, requirements of section 12(d) of the
any, state audit privilege or immunity ‘‘Actions Concerning Regulations That National Technology Transfer and
law. Significantly Affect Energy Supply, Advancement Act of 1995 (15 U.S.C.
Distribution, or Use’’ (66 FR 28355, May 272 note) do not apply. This rule does
IV. Final Action
22, 2001). This action merely approves not impose an information collection
EPA is approving Virginia’s CAIR SIP state law as meeting Federal burden under the provisions of the
revision submitted on March 30, 2007, requirements and imposes no additional Paperwork Reduction Act of 1995 (44
and supplemented on April 30, 2007 requirements beyond those imposed by U.S.C. 3501 et seq.).
and June 11, 2007. Under the SIP state law. Accordingly, the B. Submission to Congress and the
revision, Virginia will participate in the Administrator certifies that this rule Comptroller General
EPA-administered cap-and-trade will not have a significant economic
programs for NOX annual, NOX ozone impact on a substantial number of small The Congressional Review Act, 5
season, and SO2 annual emissions. The entities under the Regulatory Flexibility U.S.C. 801 et seq., as added by the Small
SIP revision meets the applicable Act (5 U.S.C. 601 et seq.). Because this Business Regulatory Enforcement
requirements in 40 CFR 51.123(o) and rule approves pre-existing requirements Fairness Act of 1996, generally provides
(aa), with regard to NOX annual and under state law and does not impose that before a rule may take effect, the
NOX ozone season emissions, and 40 any additional enforceable duty beyond agency promulgating the rule must
CFR 51.124(o), with regard to SO2 that required by state law, it does not submit a rule report, which includes a
emissions. As a consequence of the SIP contain any unfunded mandate or copy of the rule, to each House of the
approval, the Administrator of EPA will significantly or uniquely affect small Congress and to the Comptroller General
issue, without providing an opportunity governments, as described in the of the United States. EPA will submit a
for a public hearing or an additional Unfunded Mandates Reform Act of 1995 report containing this rule and other
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opportunity for written public (Public Law 104–4). This rule also does required information to the U.S. Senate,
comment, a final rule to withdraw the not have tribal implications because it the U.S. House of Representatives, and
CAIR FIPs for SO2, NOX annual, and will not have a substantial direct effect the Comptroller General of the United
NOX ozone season emissions for on one or more Indian tribes, on the States prior to publication of the rule in
Virginia. relationship between the Federal the Federal Register. This rule is not a

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Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations 73605

‘‘major rule’’ as defined by 5 U.S.C. This action to approve Virginia’s PART 52—[AMENDED]
804(2). CAIR SIP revision may not be
challenged later in proceedings to ■ 1. The authority citation for 40 CFR
C. Petitions for Judicial Review
enforce its requirements. (See section part 52 continues to read as follows:
Under section 307(b)(1) of the Clean 307(b)(2).)
Air Act, petitions for judicial review of Authority: 42 U.S.C. 7401 et seq.
this action must be filed in the United List of Subjects in 40 CFR Part 52
States Court of Appeals for the Subpart VV—Virginia
Environmental protection, Air
appropriate circuit by February 26, pollution control, Incorporation by
2008. Filing a petition for ■ 2. In § 52.2420, the table in paragraph
reference, Nitrogen dioxide, Ozone,
reconsideration by the Administrator of Particulate matter, Reporting and (c) is amended by adding the entries for
this final rule does not affect the finality recordkeeping requirements, Sulfur Chapter 140, Sections 1010 through
of this rule for the purposes of judicial oxides. 3880 to read as follows:
review nor does it extend the time
Dated: December 13, 2007. § 52.2420 Identification of plan.
within which a petition for judicial
review may be filed, and shall not Donald S. Welsh, * * * * *
postpone the effectiveness of such rule Regional Administrator, Region III.
(c) * * *
or action. ■ 40 CFR part 52 is amended as follows:

EPA-APPROVED VIRGINIA REGULATIONS AND STATUTES


State ef-
State citation (9 Explanation [former SIP
Title/subject fective EPA approval date
VAC 5) citation]
date

* * * * * * *
Chapter 140 Regulation for Emissions Trading

* * * * * * *
Part II NOX Annual Trading Program

Article 1 CAIR-NOX Annual Trading Program General Provisions

5–140–1010 .......... Purpose .................................................... 4/18/07 12/28/07 ................................................... [Insert page number
where the document
begins]
5–140–1020 .......... Definitions ................................................ 4/18/07 12/28/07 [Insert page number where the Except for definition of
document begins]. ‘‘Nonattainment condi-
tion’’
5–140–1030 .......... Measurements, abbreviations, and acro- 4/18/07 12/28/07 [Insert page number where the
nyms. document begins].
5–140–1040 .......... Applicability .............................................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1050 .......... Retired Unit Exemption ............................ 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1060 .......... Standard requirements ............................ 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1070 .......... Computation of time ................................ 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1080 .......... Appeal procedures ................................... 4/18/07 12/28/07 [Insert page number where the
document begins].

Article 2 CAIR-designated Representative for CAIR NOX Sources

5–140–1100 .......... Authorization and responsibilities of 4/18/07 12/28/07 [Insert page number where the
CAIR-designated representative. document begins].
5–140–1110 .......... Alternate CAIR-designated representa- 4/18/07 12/28/07 [Insert page number where the
tive. document begins].
5–140–1120 .......... Changing CAIR-designated representa- 4/18/07 12/28/07 [Insert page number where the
tive and alternate CAIR-designated document begins].
representative; changes in owners and
operators.
5–140–1130 .......... Certificate of representation .................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1140 .......... Objections concerning CAIR-designated 4/18/07 12/28/07 [Insert page number where the
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representative. document begins].


5–140–1150 .......... Delegation by CAIR-designated rep- 4/18/07 12/28/07 [Insert page number where the
resentative and alternate CAIR-des- document begins].
ignated representative.

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73606 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations

EPA-APPROVED VIRGINIA REGULATIONS AND STATUTES—Continued


State ef-
State citation (9 Explanation [former SIP
Title/subject fective EPA approval date
VAC 5) citation]
date

Article 3 Permits

5–140–1200 .......... General CAIR NOX Annual Trading Pro- 4/18/07 12/28/07 [Insert page number where the
gram permit requirements. document begins].
5–140–1210 .......... Submission of CAIR permit applications 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1220 .......... Information requirements for CAIR permit 4/18/07 12/28/07 [Insert page number where the
applications. document begins].
5–140–1230 .......... CAIR permit contents and term ............... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1240 .......... CAIR permit revisions .............................. 4/18/07 12/28/07 [Insert page number where the
document begins].

Article 5 CAIR NOX Allowance Allocations

5–140–1400 .......... CAIR NOX Annual trading budgets ......... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1410 .......... Timing requirements for CAIR NOX al- 4/18/07 12/28/07 [Insert page number where the
lowance allocations. document begins].
5–140–1420 .......... CAIR NOX allowance allocations ............ 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1430 .......... Compliance supplement pool .................. 4/18/07 12/28/07 [Insert page number where the
document begins].

Article 6 CAIR NOX Allowance Tracking System

5–140–1510 .......... Establishment of accounts ....................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1520 .......... Responsibilities of CAIR-authorized ac- 4/18/07 12/28/07 [Insert page number where the
count representative. document begins].
5–140–1530 .......... Recordation of CAIR NOX allowance al- 4/18/07 12/28/07 [Insert page number where the
locations. document begins].
5–140–1540 .......... Compliance with CAIR NOX emissions 4/18/07 12/28/07 [Insert page number where the
limitation. document begins].
5–140–1550 .......... Banking .................................................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1560 .......... Account error ........................................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1570 .......... Closing of general accounts .................... 4/18/07 12/28/07 [Insert page number where the
document begins].

Article 7 CAIR, NOX Allowance Transfers

5–140–1600 .......... Submission of CAIR NOX allowance 4/18/07 12/28/07 [Insert page number where the
transfers. document begins].
5–140–1610 .......... EPA recordation ....................................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1620 .......... Notification ............................................... 4/18/07 12/28/07 [Insert page number where the
document begins].

Article 8 Monitoring and Reporting

5–140–1700 .......... General requirements .............................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1710 .......... Initial certification and recertification pro- 4/18/07 12/28/07 [Insert page number where the
cedures. document begins].
5–140–1720 .......... Out of control periods .............................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1730 .......... Notifications ............................................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1740 .......... Recordkeeping and reporting .................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1750 .......... Petitions ................................................... 4/18/07 12/28/07 [Insert page number where the
document begins].

Article 9 CAIR NOX Opt-in Units


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5–140–1800 .......... Applicability .............................................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1810 .......... General .................................................... 4/18/07 12/28/07 [Insert page number where the
document begins].

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EPA-APPROVED VIRGINIA REGULATIONS AND STATUTES—Continued


State ef-
State citation (9 Explanation [former SIP
Title/subject fective EPA approval date
VAC 5) citation]
date

5–140–1820 .......... CAIR-designated representative .............. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1830 .......... Applying for CAIR opt-in permit ............... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1840 .......... Opt-in process ......................................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1850 .......... CAIR opt-in permit content ...................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1860 .......... Withdrawal from CAIR NOX Annual 4/18/07 12/28/07 [Insert page number where the
Trading Program. document begins].
5–140–1870 .......... Change in regulatory status .................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–1880 .......... CAIR NOX allowance allocations to CAIR 4/18/07 12/28/07 [Insert page number where the
NOX opt-in units. document begins].

Part III NOX Ozone Season Trading Program

Article 1 CAIR NOX Ozone Season Trading Program General Provisions

5–140–2010 .......... Purpose .................................................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2020 .......... Definitions ................................................ 4/18/07 12/28/07 [Insert page number where the Except for definition of
document begins]. ‘‘Nonattainment condi-
tion’’
5–140–2030 .......... Measurements, abbreviations, and acro- 4/18/07 12/28/07 [Insert page number where the
nyms. document begins].
5–140–2040 .......... Applicability .............................................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2050 .......... Retired unit exemption ............................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2060 .......... Standard requirements ............................ 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2070 .......... Computation of time ................................ 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2080 .......... Appeal procedures ................................... 4/18/07 12/28/07 [Insert page number where the
document begins].

Article 2 CAIR- Designated Representative for CAIR NOX Ozone Season Sources

5–140–2100 .......... Authorization and responsibilities of 4/18/07 12/28/07 [Insert page number where the
CAIR-designated representative. document begins].
5–140–2110 .......... Alternate CAIR-designated representa- 4/18/07 12/28/07 [Insert page number where the
tive. document begins].
5–140–2120 .......... Changing CAIR-designated representa- 4/18/07 12/28/07 [Insert page number where the
tive and alternate CAIR-designated document begins].
representative; changes in owners and
operators.
5–140–2130 .......... Certificate of representation .................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2140 .......... Objections concerning CAIR-designated 4/18/07 12/28/07 [Insert page number where the
representative. document begins].
5–140–2150 .......... Delegation by CAIR-designated rep- 4/18/07 12/28/07 [Insert page number where the
resentative and alternate CAIR-des- document begins].
ignated representative.

Article 3 Permits

5–140–2200 .......... General CAIR NOX Ozone Season Trad- 4/18/07 12/28/07 [Insert page number where the
ing Program permit requirements. document begins].
5–140–2210 .......... Submission of CAIR permit applications 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2220 .......... Information requirements for CAIR permit 4/18/07 12/28/07 [Insert page number where the
applications. document begins].
pwalker on PROD1PC71 with RULES

5–140–2230 .......... CAIR permit contents and term ............... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2240 .......... CAIR permit revisions .............................. 4/18/07 12/28/07 [Insert page number where the
document begins].

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73608 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations

EPA-APPROVED VIRGINIA REGULATIONS AND STATUTES—Continued


State ef-
State citation (9 Explanation [former SIP
Title/subject fective EPA approval date
VAC 5) citation]
date

Article 5 CAIR NOX Ozone Season Allowance Allocations

5–140–2400 .......... CAIR NOX Ozone Season trading budg- 4/18/07 12/28/07 [Insert page number where the
ets. document begins].
5–140–2405 .......... State trading budgets for nonelectric 4/18/07 12/28/07 [Insert page number where the
generating units. document begins].
5–140–2410 .......... Timing requirements for CAIR NOX 4/18/07 12/28/07 [Insert page number where the
Ozone Season allowance allocations. document begins].
5–140–2420 .......... CAIR NOX Ozone Season allowance al- 4/18/07 12/28/07 [Insert page number where the
locations. document begins].
5–140–2430 .......... CAIR NOX Ozone Season allowance al- 4/18/07 12/28/07 [Insert page number where the
locations for individual existing non- document begins].
electric generating units.

Article 6 CAIR NOX Ozone Season Allowance Tracking System

5–140–2510 .......... Establishment of accounts ....................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2520 .......... Responsibilities of CAIR-authorized ac- 4/18/07 12/28/07 [Insert page number where the
count representative. document begins].
5–140–2530 .......... Recordation of CAIR NOX Ozone Sea- 4/18/07 12/28/07 [Insert page number where the
son allowance allocations. document begins].
5–140–2540 .......... Compliance with CAIR NOX emissions 4/18/07 12/28/07 [Insert page number where the
limitation. document begins].
5–140–2550 .......... Banking .................................................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2560 .......... Account error ........................................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2570 .......... Closing of general accounts .................... 4/18/07 12/28/07 [Insert page number where the
document begins].

Article 7 CAIR NOX Ozone Season Allowance Transfers

5–140–2600 .......... Submission of CAIR NOX Ozone Season 4/18/07 12/28/07 [Insert page number where the
allowance transfers. document begins].
5–140–2610 .......... EPA recordation ....................................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2620 .......... Notification ............................................... 4/18/07 12/28/07 [Insert page number where the
document begins].

Article 8 Monitoring and Reporting

5–140–2700 .......... General requirements .............................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2710 .......... Initial certification and recertification pro- 4/18/07 12/28/07 [Insert page number where the
cedures. document begins].
5–140–2720 .......... Out of control periods .............................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2730 .......... Notifications ............................................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2740 .......... Recordkeeping and reporting .................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2750 .......... Petitions ................................................... 4/18/07 12/28/07 [Insert page number where the
document begins].

Article 9 CAIR NOX Ozone Season Opt-in Units

5–140–2800 .......... Applicability .............................................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2810 .......... General .................................................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2820 .......... CAIR-designated representative .............. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2830 .......... Applying for CAIR opt-in permit ............... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2840 .......... Opt-in process ......................................... 4/18/07 12/28/07 [Insert page number where the
pwalker on PROD1PC71 with RULES

document begins].
5–140–2850 .......... CAIR opt-in permit contents .................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2860 .......... Withdrawal from CAIR NOX Ozone Sea- 4/18/07 12/28/07 [Insert page number where the
son Trading Program. document begins].

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Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations 73609

EPA-APPROVED VIRGINIA REGULATIONS AND STATUTES—Continued


State ef-
State citation (9 Explanation [former SIP
Title/subject fective EPA approval date
VAC 5) citation]
date

5–140–2870 .......... Change in regulatory status .................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–2880 .......... CAIR NOX Ozone Season allowance al- 4/18/07 12/28/07 [Insert page number where the
locations to CAIR NOX Ozone Season document begins].
opt-in units.

Part IV SO2 Annual Trading Program

Article 1 CAIR SO2 Trading Program General Provisions

5–140–3010 .......... Purpose .................................................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3020 .......... Definitions ................................................ 4/18/07 12/28/07 [Insert page number where the Except for definition of
document begins]. ‘‘Nonattainment condi-
tion’’
5–140–3030 .......... Measurements, abbreviations, and acro- 4/18/07 12/28/07 [Insert page number where the
nyms. document begins].
5–140–3040 .......... Applicability .............................................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3050 .......... Retired Unit Exemption ............................ 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3060 .......... Standard requirements ............................ 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3070 .......... Computation of time ................................ 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3080 .......... Appeal procedures ................................... 4/18/07 12/28/07 [Insert page number where the
document begins].

Article 2 CAIR-designated Representative for CAIR SO2 Sources

5–140–3100 .......... Authorization and responsibilities of 4/18/07 12/28/07 [Insert page number where the
CAIR-designated representative. document begins].
5–140–3110 .......... Alternate CAIR-designated representa- 4/18/07 12/28/07 [Insert page number where the
tive. document begins].
5–140–3120 .......... Changing CAIR-designated representa- 4/18/07 12/28/07 [Insert page number where the
tive and alternate CAIR-designated document begins].
representative; changes in owners and
operators.
5–140–3130 .......... Certificate of representation .................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3140 .......... Objections concerning CAIR-designated 4/18/07 12/28/07 [Insert page number where the
representative. document begins].
5–140–3150 .......... Delegation by CAIR-designated rep- 4/18/07 12/28/07 [Insert page number where the
resentative and alternate CAIR-des- document begins].
ignated representative.

Article 3 Permits

5–140–3200 .......... General CAIR SO2 Trading Program per- 4/18/07 12/28/07 [Insert page number where the
mit requirements. document begins].
5–140–3210 .......... Submission of CAIR permit applications 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3220 .......... Information requirements for CAIR permit 4/18/07 12/28/07 [Insert page number where the
applications. document begins].
5–140–3230 .......... CAIR permit contents and term ............... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3240 .......... CAIR permit revisions .............................. 4/18/07 12/28/07 [Insert page number where the
document begins].

Article 5 CAIR SO2 Allowance Allocations

5–140–3400 .......... State trading budgets .............................. 4/18/07 12/28/07 [Insert page number where the
document begins].
pwalker on PROD1PC71 with RULES

5–140–3410 .......... Timing requirements for CAIR SO2 allow- 4/18/07 12/28/07 [Insert page number where the
ance allocations. document begins].
5–140–3420 .......... CAIR SO2 allowance allocations ............. 4/18/07 12/28/07 [Insert page number where the
document begins].

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73610 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations

EPA-APPROVED VIRGINIA REGULATIONS AND STATUTES—Continued


State ef-
State citation (9 Explanation [former SIP
Title/subject fective EPA approval date
VAC 5) citation]
date

Article 6 CAIR SO2 Allowance Tracking System

5–140–3510 .......... Establishment of accounts ....................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3520 .......... Responsibilities of CAIR-authorized ac- 4/18/07 12/28/07 [Insert page number where the
count representative. document begins].
5–140–3530 .......... Recordation of CAIR SO2 allowances ..... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3540 .......... Compliance with CAIR SO2 emissions 4/18/07 12/28/07 [Insert page number where the
limitation. document begins].
5–140–3550 .......... Banking .................................................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3560 .......... Account error ........................................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3570 .......... Closing of general accounts .................... 4/18/07 12/28/07 [Insert page number where the
document begins].

Article 7 CAIR SO2 Allowance Transfers

5–140–3600 .......... Submission of CAIR SO2 allowance 4/18/07 12/28/07 [Insert page number where the
transfers. document begins].
5–140–3610 .......... EPA recordation ....................................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3620 .......... Notification ............................................... 4/18/07 12/28/07 [Insert page number where the
document begins].

Article 8 Monitoring and Reporting

5–140–3700 .......... General requirements .............................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3710 .......... Initial certification and recertification pro- 4/18/07 12/28/07 [Insert page number where the
cedures. document begins].
5–140–3720 .......... Out of control periods .............................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3730 .......... Notifications ............................................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3740 .......... Recordkeeping and reporting .................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3750 .......... Petitions ................................................... 4/18/07 12/28/07 [Insert page number where the
document begins].

Article 9 CAIR SO2 Opt-in Units

5–140–3800 .......... Applicability .............................................. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3810 .......... General .................................................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3820 .......... CAIR-designated representative .............. 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3830 .......... Applying for CAIR opt-in permit ............... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3840 .......... Opt-in process ......................................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3850 .......... CAIR opt-in permit contents .................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3860 .......... Withdrawal from CAIR SO2 Trading Pro- 4/18/07 12/28/07 [Insert page number where the
gram. document begins].
5–140–3870 .......... Change in regulatory status .................... 4/18/07 12/28/07 [Insert page number where the
document begins].
5–140–3880 .......... CAIR SO2 allowance allocations to CAIR 4/18/07 12/28/07 [Insert page number where the
SO2 opt-in units. document begins].
pwalker on PROD1PC71 with RULES

* * * * * * *

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Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations 73611

* * * * * material, such as copyrighted material, A. What is the affected source and the
[FR Doc. E7–24950 Filed 12–27–07; 8:45 am] is not placed on the Internet and will be compliance date?
publicly available only in hard copy B. What is required by the management
BILLING CODE 6560–50–P
form. Publicly available docket practice?
materials are available either C. What are the testing and initial
compliance requirements?
ENVIRONMENTAL PROTECTION electronically through
D. What are the notification,
AGENCY www.regulations.gov or in hard copy at
recordkeeping, and reporting
the EPA Docket Center in the EPA requirements?
40 CFR Part 63 Headquarters Library, Room Number IV. Exemption of Certain Area Source
[EPA–HQ–OAR–2005–0171; FRL–8512–1] 3334 in the EPA West Building, located Categories From Title V Permitting
at 1301 Constitution Ave., NW., Requirements
RIN 2060–AM14 Washington, DC. The EPA/DC Public V. Summary of Comments and Responses
National Emission Standards for Reading Room hours of operation are A. Proposed Alternative 1: Management
Hospital Ethylene Oxide Sterilizers 8:30 a.m. to 4:30 p.m. Eastern Standard Practice
Time (EST), Monday through Friday, B. Proposed Alternative 2: No Control
AGENCY: Environmental Protection excluding legal holidays. The telephone C. Add-on Controls
Agency (EPA). number for the Public Reading Room is VI. Summary of Environmental, Energy, Cost,
ACTION: Final rule. (202) 566–1744. For the Air and and Economic Impacts
Radiation Docket and Information VII. Statutory and Executive Order Reviews
SUMMARY: EPA is issuing national A. Executive Order 12866: Regulatory
Center, the telephone number is (202)
emissions standards for new and Planning and Review
566–1742, the fax number is (202) 566– B. Paperwork Reduction Act
existing hospital sterilizers that emit 9744, the Web site is http://
hazardous air pollutants and are area C. Regulatory Flexibility Act
www.epa.gov/oar/docket.html, and the D. Unfunded Mandates Reform Act
sources within the meaning of Clean Air e-mail address is a-and-r- E. Executive Order 13132: Federalism
Act section 112(a)(2). The final rule is Docket@epa.gov. F. Executive Order 13175: Consultation
based on EPA’s determination as to and Coordination with Indian Tribal
what constitutes the generally available FOR FURTHER INFORMATION CONTACT: Mr.
David Markwordt, Office of Air Governments
control technology or management G. Executive Order 13045: Protection of
practices for the hospital sterilizer area Planning and Standards, Sector Policies
Children From Environmental Health
source category. and Programs Division, Coatings and
Risks and Safety Risks
This action is being finalized as part Chemicals Group (E143–01), H. Executive Order 13211: Actions
of EPA’s obligation to regulate area Environmental Protection Agency, Concerning Regulations That
sources listed for regulation pursuant to Research Triangle Park, NC 27711, Significantly Affect Energy Supply,
Clean Air Act section 112(c)(3). telephone number: (919) 541–0837; fax Distribution, or Use
DATES: The final rule is effective on number: (919) 541–0246; e-mail address: I. National Technology Transfer and
December 28, 2007. markwordt.david@epa.gov. Advancement Act
SUPPLEMENTARY INFORMATION: Outline. J. Executive Order 12898: Federal Actions
ADDRESSES: EPA has established a
The information presented in this to Address Environmental Justice in
docket for this action under Docket ID Minority Populations and Low-Income
No. EPA–HQ–OAR–2005–0171. All preamble is organized as follows:
Populations
documents in the docket are listed in I. General Information K. Congressional Review Act
the Federal Docket Management System A. Does this action apply to me?
index at http://www.regulations.gov. B. Where can I get a copy of this I. General Information
document?
Although listed in the index, some A. Does this action apply to me?
C. Judicial Review
information is not publicly available, II. Background Information for Final Area
e.g., confidential business information Source Standard The regulated categories and entities
or other information whose disclosure is III. Summary of the Final Rule and potentially affected by these final
restricted by statute. Certain other Significant Changes Since Proposal standards include:

Example of potentially
Category NAICS1 code regulated entities

General Medical and Surgical Hospitals ............................................................................................. 622110 Hospital sterilizers.


Specialty (Except Psychiatric and Substance Abuse) Hospitals ........................................................ 622310 Hospital sterilizers.
1 North American Industrial Classification System.

This table is not intended to be permit authority for the entity or your action will be posted on the TTN’s
exhaustive, but rather provides a guide EPA regional representative as listed in policy and guidance page for newly
for readers regarding entities likely to be 40 CFR 63.13 of subpart A (General proposed or promulgated rules at the
affected by this action. To determine Provisions). following address: http://www.epa.gov/
whether your facility is regulated by this ttn/oarpg/. The TTN provides
B. Where can I get a copy of this
action, you should examine the information and technology exchange in
applicability criteria in 40 CFR 63.10382 document?
various areas of air pollution control.
of subpart WWWWW (National In addition to being available in the
C. Judicial Review
pwalker on PROD1PC71 with RULES

Emissions Standards for Hospital docket, an electronic copy of this final


Ethylene Oxide Sterilizers). If you have action is also available on the Under section 307(b)(1) of the Clean
any questions regarding the Worldwide Web through the Air Act (CAA), judicial review of this
applicability of this action to a Technology Transfer Network (TTN). final rule is available only by filing a
particular entity, consult either the air Following signature, a copy of this final petition for review in the United States

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