[Federal Register Volume 72, Number 7 (Thursday, January 11, 2007)]
[Rules and Regulations]
[Pages 1289-1291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-250]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[EPA-R03-OAR-2006-0638; FRL-8267-7]
Approval and Promulgation of Air Quality Implementation Plans;
Maryland; Control of Volatile Organic Compounds From Medical Device
Manufacturing
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is approving a State Implementation Plan (SIP) revision
submitted by the Maryland Department of the Environment. This revision
pertains to the control of volatile organic compounds from medical
device manufacturing. EPA is approving this revision in accordance with
the requirements of the Clean Air Act (CAA).
EFFECTIVE DATE: This final rule is effective on February 12, 2007.
ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2006-0638. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (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 through www.regulations.gov or in hard
copy for public inspection 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 Maryland Department of the Environment,
1800 Washington Boulevard, Suite 705, Baltimore, Maryland 21230.
FOR FURTHER INFORMATION CONTACT: Linda Miller, (215) 814-2068, or by e-
mail at [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On May 31, 2006 and July 5, 2006, the State of Maryland submitted a
revision to the State Implementation Plan (SIP). The revision
(06-04) establishes the Reasonably Available Control
Technology (RACT) requirement for Volatile Organic Compounds (VOC) for
medical device manufacturing. Medical Device manufacturing includes the
manufacturing of hypodermic products, syringes, catheters, blood
handling and other medical devices. EPA proposed approval of the SIP
revision on October 10, 2006 (71 FR 59413).
II. Summary of SIP Revision
The revision establishes the Reasonably Available Control
Technology (RACT) requirement for Volatile Organic Compounds (VOC) for
medical device manufacturing installations that emit or have the
potential to emit, 100 pounds or more per day of VOC emissions.
Other specific requirements of the provisions of COMAR 26.11.19.31
and the rationale for EPA's proposed action are explained in the NPR
and will not be restated here. No public comments were received on the
NPR.
III. Final Action
EPA is approving the VOC RACT requirements for medical device
manufacturing including the manufacture of hypodermic products,
syringes, catheters, blood handling and other medical devices as a
revision to the Maryland SIP.
IV. 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 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
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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
requirement, 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 March 12, 2007. 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 to approve VOC RACT requirements for
medical device manufacturing 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: January 4, 2007.
Donald S. Welsh,
Regional Administrator, Region III.
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40 CFR part 52 is amended as follows:
PART 52--[AMENDED]
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1. The authority citation for part 52 continues to read as follows:
Authority: 42 U.S.C. 7401 et seq.
Subpart V--Maryland
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2. In Sec. 52.1070, the table in paragraph (c) is amended by adding an
entry for COMAR 26.11.19.31 to read as follows:
Sec. 52.1070 Identification of plan.
* * * * *
(c) * * *
EPA--Approved Regulations in the Maryland SIP
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Code of Maryland administrative State Additional explanation/ citation at
regulations (COMAR) citation Title/subject effective date EPA approval date 40 CFR 52.1100
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26.11.19 Volatile Organic Compounds from Specific Processes
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* * * * * * *
26.11.19.31.................... Control of Volatile 6/5/06 1/11/07 [Insert page number where the
Organic Compounds from document begins]
Medical Device
Manufacturing.
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[FR Doc. E7-250 Filed 1-10-07; 8:45 am]
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