Document ID: EPA-R03-OAR-2006-0638-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-10-10T04:00Z

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:  Proposed rule.

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 [insert date 30
days from date of publication].  

ADDRESSES:  Submit your comments, identified by Docket ID Number
EPA-R03-OAR-2006-0638 by one of the following methods:

 www.regulations.gov.  Follow the on-line instructions for submitting
comments.

     B.    E-mail:  morris.makeba@epa.gov

     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 website 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 drago.helene@epa.gov.

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, record keeping 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 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 ºF 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 Fed. Reg. 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 (Public Law 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.

                                                                        
                           /s/

___________________________                      
____________________________

Dated:  September 28, 2006                               William T.
Wisniewski, Acting

                                                                        
   Regional Administrator,

                                                                        
   Region III.

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