[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]



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 

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


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].


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 
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 

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.

40 CFR part 52 is amended as follows:


1. The authority citation for part 52 continues to read as follows:

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

Subpart V--Maryland

2. In Sec.  52.1070, the table in paragraph (c) is amended by adding an 
entry for COMAR to read as follows:

Sec.  52.1070  Identification of plan.

* * * * *
    (c) * * *

                                                      EPA--Approved Regulations in the Maryland SIP
Code of Maryland administrative                                  State                                              Additional explanation/ citation at
  regulations (COMAR) citation         Title/subject        effective date            EPA approval date                        40 CFR 52.1100
                                                                      * * * * * * *
                                               26.11.19 Volatile Organic Compounds from Specific Processes
                                                                      * * * * * * *  Control of Volatile                6/5/06  1/11/07 [Insert page number where the
                                  Organic Compounds from                     document begins]
                                  Medical Device
                                                                       * * * * * *

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* * * * *
 [FR Doc. E7-250 Filed 1-10-07; 8:45 am]