	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2006-0638; FRL-         ]

	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.

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 [insert date 30 days
from date of publication].

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 website.   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 miller.linda@epa.gov.  

SUPPLEMENTARY INFORMATION:  

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 COMAR26.11.19.31 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 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 [insert date 60 days from date of
publication of this document in the Federal Register].  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.

                        ___________/s/________________    

Dated:   January 4, 2007        				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 V( Maryland

2. In ( 52.1070, the table in paragraph (c) is amended by adding an
entry for COMAR 26.11.19.31 to read as follows:

( 52.1070  	Identification of plan.

*		*		*		*		*

(c)* * *

       EPA-APPROVED REGULATIONS IN THE MARYLAND SIP



Code of Maryland administrative regulations (COMAR) citation	

Title/subject	

State effective date	

EPA approval date	

Additional explanation/

citation at 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 Organic Compounds from Medical Device Manufacturing

	

6/5/06	

[Insert Federal Register publication date]

[Insert page number where the document begins]

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