Approval and Promulgation of Air Quality Implementation Plans; Maryland; Control of Volatile Organic Compounds From Medical Device Manufacturing, 59413-59414 [E6-16653]
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Federal Register / Vol. 71, No. 195 / Tuesday, October 10, 2006 / Proposed Rules
summoned an exempt member for jury
duty.
Dated: October 3, 2006.
C.R. Choate,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. E6–16643 Filed 10–6–06; 8:45 am]
BILLING CODE 5001–06–P
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
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
jlentini on PROD1PC65 with PROPOSAL
AGENCY:
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: 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 previouslylisted 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
VerDate Aug<31>2005
16:33 Oct 06, 2006
Jkt 211001
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 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
PO 00000
Frm 00004
Fmt 4702
Sfmt 4702
59413
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
E:\FR\FM\10OCP1.SGM
10OCP1
59414
Federal Register / Vol. 71, No. 195 / Tuesday, October 10, 2006 / Proposed Rules
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 °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.
jlentini on PROD1PC65 with PROPOSAL
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
VerDate Aug<31>2005
16:33 Oct 06, 2006
Jkt 211001
(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.).
PO 00000
Frm 00005
Fmt 4702
Sfmt 4702
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]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 52 and 81
[EPA–R03–OAR–2006–0353; FRL–8229–5]
Approval and Promulgation of Air
Quality Implementation Plans;
Maryland; Redesignation of the Kent
and Queen Anne’s 8-Hour Ozone
Nonattainment Area to Attainment and
Approval of the Maintenance Plan
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
SUMMARY: EPA is proposing to approve
a redesignation request and a State
Implementation Plan (SIP) revision for
the Kent and Queen Anne’s, MD (herein
referred to as the ‘‘Kent and Queen
Anne’s area’’) area from nonattainment
to attainment of the 8-hour ozone
National Ambient Air Quality Standard
(NAAQS). The Maryland Department of
the Environment (MDE) is requesting
that Kent and Queen Anne’s County,
Maryland (herein known as ‘‘Kent and
Queen Anne’s area’’) be redesignated as
attainment for the 8-hour ozone
NAAQS. The Kent and Queen Anne’s8-hour ozone nonattainment area is
comprised of two counties (Kent and
Queen Anne’s Counties, Maryland).
EPA is proposing to approve the ozone
redesignation request for the Kent and
Queen Anne’s area. In conjunction with
its redesignation request, the MDE
submitted a SIP revision consisting of a
maintenance plan for Kent and Queen
Anne’s that provides for continued
attainment of the 8-hour ozone NAAQS
for the next 12 years. EPA is proposing
to make a determination that Kent and
Queen Anne’s has attained the 8-hour
ozone NAAQS based upon three years
of complete, quality-assured ambient air
quality ozone monitoring data for 2003–
2005. EPA’s proposed approval of the 8hour ozone redesignation request is
based on its determination that Kent
and Queen Anne’s has met the criteria
for redesignation to attainment specified
in the Clean Air Act (CAA). EPA is
E:\FR\FM\10OCP1.SGM
10OCP1
Agencies
[Federal Register Volume 71, Number 195 (Tuesday, October 10, 2006)]
[Proposed Rules]
[Pages 59413-59414]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-16653]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: 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 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 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,
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]
BILLING CODE 6560-50-P