[Federal Register Volume 71, Number 195 (Tuesday, October 10, 2006)]
[Proposed Rules]
[Pages 59413-59414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16653]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2006-0638; FRL-8229-6]


Approval and Promulgation of Air Quality Implementation Plans; 
Maryland; Control of Volatile Organic Compounds From Medical Device 
Manufacturing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve a State Implementation Plan 
revision submitted by the Maryland Department of the Environment. This 
revision pertains to the control of volatile organic compounds from 
medical device manufacturing. This action is being taken under the 
Clean Air Act (CAA or the Act).

DATES: Written comments must be received on or before November 9, 2006.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2006-0638 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for 
submitting comments.
    B. E-mail: [email protected].
    C. Mail: EPA-R03-OAR-2006-0638, Makeba Morris, Chief, Air Quality 
Planning Branch, Mailcode 3AP21, U.S. Environmental Protection Agency, 
Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed 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 Docket ID No. EPA-R03-OAR-
2006-0638. EPA's policy is that all comments received will be included 
in the public docket without change, and may be made available online 
at www.regulations.gov, 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 www.regulations.gov or e-mail. 
The www.regulations.gov Web site is 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 www.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 
www.regulations.gov index. 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 www.regulations.gov 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 Maryland Department of the Environment, 1800 
Washington Boulevard, Suite 705, Baltimore, Maryland 21230.

FOR FURTHER INFORMATION CONTACT: Helene Drago, (215) 814-5796, or by e-
mail at [email protected].

SUPPLEMENTARY INFORMATION: On May 31, 2006 and July 5, 2006, the 
Maryland Department of the Environment (MDE) submitted a revision 
(06-04) to its State Implementation Plan (SIP) to establish 
Reasonably Available Control Technology (RACT) requirements for the 
manufacturing of hypodermic products, syringes, catheters, blood 
handling and other medical devices. The revision applies to any medical 
device manufacturing installation that emits, or has the potential to 
emit, 100 pounds or more per day of volatile organic carbon (VOC). The 
revisions add Regulation .31 under the Code of Maryland Regulations 
(COMAR) 26.11.19, Volatile Organic Compounds from Specific Processes.

I. Background

    Medical device manufacturing includes production of hypodermic 
products, catheters, syringes, blood collection, processing, storage 
and transfusion products. Although the products are small in size, the 
large volume of pieces manufactured generates significant VOC 
emissions. The majority of VOC emissions from manufacturing of medical 
devices comes from bonding of components, coating and cleaning 
operations. First and foremost, medical device manufacturers are 
required to comply with the requirements of Food, Drug and Cosmetics 
Act and the regulations promulgated by Food and Drug Administration 
(FDA). Medical device manufacturing operations are not covered under 
any specific Federal environmental regulations.
    Under Maryland's regulations found at COMAR 26.11.19, Control of 
Volatile Organic Compounds from Specific Processes, a facility that has 
the potential to emit more than 25 tons a year of VOC emissions is 
subject to the RACT requirements under COMAR 26.11.19.02. The purpose 
of this regulation is to establish a RACT requirement specific to the 
medical device manufacturers engaged in the production of hypodermic 
products, syringes, catheters, blood handling and other medical 
devices.

II. Summary of SIP Revision

    The regulation applies to a person who owns or operates a medical 
device manufacturing installation that emits or has the potential to 
emit, 100 pounds or more per day of VOC emissions. Medical device 
manufacturing operations are also subject to the compliance, 
recordkeeping and general requirements under COMAR 26.11.19.02 and 
equipment leak requirements under COMAR 26.11.19.16. The regulations 
establish control requirements for three main VOC emitting operations: 
(1) Solvent bonding, (2) biopassive coating, and (3) steel cannula 
coating. For solvent bonding operations, appropriately designed VOC 
impermeable covers on dip pots are required. Due to the evolving nature 
of the process, the State may, if necessary, require participation in 
an evaluation of new or innovative designs or VOC material 
substitutions. Biopassive coating operation is required

[[Page 59414]]

to be carried out using an enclosed system for fully assembled medical 
devices. Individual components can only be coated if an approval is 
granted based on technical and economic justification. Solvents used in 
steel cannula coating must be chilled to 50 [deg]F or less using a 
solvent chiller system to minimize VOC emissions. The regulations 
provide flexibility for companies to achieve an equivalent level of 
control through an alternative method.
    At this time, there is only one affected source located in Cecil 
County, Maryland. The company manufactures syringes and a range of 
cardiovascular products and devices such as catheters, filters, pumps 
and heat exchangers. It is estimated that as a result of this 
regulation, approximately 1.2 to 1.7 tons of VOC emissions per year 
will be reduced.

III. Proposed Action

    EPA has reviewed the material submitted by Maryland on May 31, 2006 
and July 5, 2006. EPA is proposing to approve the Maryland SIP revision 
for RACT requirements for the manufacturing of hypodermic products, 
syringes, catheters, blood handling and other medical devices. EPA is 
soliciting public comments on the issues discussed in this document. 
These comments will be considered before taking final action.

IV. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
proposed 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 proposes to approve state law as meeting Federal 
requirements and imposes no additional requirements beyond those 
imposed by state law. Accordingly, the Administrator certifies that 
this proposed 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 proposes to approve 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 (Pub. L. 104-4). This proposed rule also does 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), nor will it 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), because it 
merely proposes to approve 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 
proposed rule also is not subject to Executive Order 13045 (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. As required by section 3 
of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing 
this proposed rule, EPA has taken the necessary steps to eliminate 
drafting errors and ambiguity, minimize potential litigation, and 
provide a clear legal standard for affected conduct. EPA has complied 
with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining 
the takings implications of the rule in accordance with the ``Attorney 
General's Supplemental Guidelines for the Evaluation of Risk and 
Avoidance of Unanticipated Takings'' issued under the executive order. 
This proposed rule for RACT requirements for the manufacturing of 
hypodermic products, syringes, catheters, blood handling and other 
medical devices does not impose an information collection burden under 
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Ozone, Reporting 
and recordkeeping requirements, Volatile organic compounds.

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

    Dated: September 28, 2006.
William T. Wisniewski,
Acting Regional Administrator, Region III.
[FR Doc. E6-16653 Filed 10-6-06; 8:45 am]
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