National Emission Standards for Hospital Ethylene Oxide Sterilizers
[Federal Register: November 6, 2006 (Volume 71, Number 214)]
[Proposed Rules]
[Page 64907-64917]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no06-11]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[EPA-HQ-OAR-2005-0171; FRL-8239-8]
RIN 2060-AM14
National Emission Standards for Hospital Ethylene Oxide Sterilizers
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing two primary regulatory alternatives for new
and existing hospital sterilizers that emit hazardous air pollutants
and are area sources within the meaning of Clean Air Act section
112(a)(2). The first alternative proposes a generally available
management practice requirement for new and existing hospital
sterilizers that are area sources. The second alternative proposes that
there are no generally available control technologies or management
practices within the meaning of Clean Air Act section 112(d)(5) for
this source category. We are proposing these two different alternatives
because we currently have imperfect information concerning the ability
of the proposed management practice to reduce hazardous air pollutant
emissions and the cost-effectiveness of such management practice.
This action is being proposed as part of EPA's obligation to
regulate area sources listed for regulation pursuant to Clean Air Act
section 112(c)(3).
DATES: Comments. Written comments must be received on or before January
5, 2007.
Public Hearing. If anyone contacts EPA by November 27, 2006
requesting to speak at a public hearing, a public hearing will be held
on December 6, 2006.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2005-0171, by one of the following methods:
? http://www.regulations.gov. Follow the on-line
instructions for submitting comments.
? E-mail: a-and-r-docket@epa.gov.
? Fax: (202) 566-1741.
? Mail: U.S. Postal Service, send comments to: Air and
Radiation Docket (6102T), Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460. Please include a total
of two copies. We request that a separate copy also be sent to the
contact person identified below (see FOR FURTHER INFORMATION CONTACT).
Hand Delivery: In person or by courier, deliver comments to: Air
and Radiation Docket (6102T), Environmental Protection Agency, EPA West
Building, 1301 Constitution Avenue, NW., Room B-102, Washington, DC
20014. Please include a total of two copies. Such deliveries are
accepted only during the Docket's normal hours of operation and special
arrangements should be made for deliveries of boxed information. We
request that a separate copy also be sent to the contact person
identified below (see FOR FURTHER INFORMATION CONTACT).
Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2005-0171. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://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 http://www.regulations.gov
or e-mail. The http://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
http://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 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. For additional information about EPA's public docket, visit
the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air and Radiation
Docket, Docket ID No. EPA-HQ-OAR-2005-0171, EPA West Building, Room B-
102, 1301 Constitution Ave., NW., Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is (202) 566-1744, and the telephone number for the EPA Docket
Center is (202) 566-1742.
Note: The EPA Docket Center suffered damage due to flooding
during the last week of June 2006. The Docket Center is continuing
to operate. However, during the cleanup, there will be temporary
changes to Docket Center telephone numbers, addresses, and hours of
operation for people who wish to make hand deliveries or visit the
Public Reading Room to view documents. Consult EPA's Federal
Register notice at 71 FR 38147 (July 5, 2006) or the EPA Web site at
http://www.epa.gov/epahome/dockets.htm for current information on
docket operations, locations, and telephone numbers. The Docket
Center's mailing address for U.S. mail and the procedure for
submitting comments to http://www.regulations.gov are not affected by the
flooding and will remain the same.
Public Hearing: If a public hearing is held, it will be held at 10
a.m. at the EPA's Environmental Research Center Auditorium, Research
Triangle Park, NC, or at an alternate site nearby.
FOR FURTHER INFORMATION CONTACT: For questions about the proposal,
contact Mr. David Markwordt, EPA, Office of Air Quality Planning and
Standards, Sector Policies and Programs Division, Coatings and
Chemicals Group (E143-01), Research Triangle Park, NC 27711;
[[Page 64908]]
telephone number (919) 541-0837; fax number (919) 541-0246; e-mail
address: markwordt.david@epa.gov.
SUPPLEMENTARY INFORMATION: Regulated Entities. Categories and entities
potentially regulated by the proposed action are hospitals which
sterilize with ethylene oxide. The proposed action would affect the
following categories of sources:
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NAICS Example of potentially
Category \1\ code regulated entities
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General Medical and Surgical 622110 Hospital sterilizers.
Hospitals.
Specialty (Except Psychiatric and 622310 Hospital sterilizers.
Substance Abuse) Hospitals.
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\1\ North American Industrial Classification Code.
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by the
proposed rule. If you have any questions regarding the applicability of
the proposed action to a particular entity, contact the person listed
in the preceding FOR FURTHER INFORMATION CONTACT section. Submitting
CBI. Do not submit information which you claim to be CBI to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information on a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. Information so marked will
not be disclosed except in accordance with procedures set forth in 40
CFR part 2. In addition to one complete version of the comment that
includes information claimed as CBI, a copy of the comment that does
not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part 2.
Public Hearing. Persons interested in presenting oral testimony or
inquiring as to whether a hearing is to be held should contact Mr.
David Markwordt, EPA, Office of Air Quality Planning and Standards,
Sector Policies and Programs Division, Coatings and Chemicals Group
(E143-01), Research Triangle Park, NC 27711, telephone number (919)
541-0837, e-mail address: markwordt.david@epa.gov, at least 2 days in
advance of the potential date of the public hearing. Persons interested
in attending the public hearing must also call Mr. David Markwordt to
verify the time, date, and location of the hearing. A public hearing
will provide interested parties the opportunity to present data, views,
or arguments concerning the proposed action.
World Wide Web (WWW). In addition to being available in the docket,
an electronic copy of the proposed rule is also available on the WWW.
Following the Administrator's signature, a copy of the proposed rule
will be posted on EPA's Technology Transfer Network (TTN) policy and
guidance page for newly proposed or promulgated rules at http://
www.epa.gov/ttn/oarpg. The TTN at EPA's Web site provides information
and technology exchange in various areas of air pollution control.
Organization of this Document. The information presented in this
preamble is organized as follows:
I. Background
II. Summary of the Proposed Standards
A. What Source Category Would Be Affected By This Proposal?
B. Proposed Regulatory Alternative 1
C. Proposed Regulatory Alternative 2
III. Rationale for the Proposed Standards
IV. Summary of Environmental, Energy, Cost, and Economic Impacts of
the Proposed Standards
V. Solicitation of Public Comments
A. Introduction and General Solicitation
B. Specific Comment and Data Solicitations
VI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination with
Indian Tribal Governments
G. Executive Order 13045: Protection of Children from
Environmental Health Risks and Safety Risks
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
I. National Technology Transfer and Advancement Act
I. Background
Section 112(k)(3)(B) of the Clean Air Act (CAA) requires us to
identify not less than 30 hazardous air pollutants (HAP) which, as the
result of emissions from area sources, present the greatest threat to
public health in the largest number of urban areas, and section 112(c)
requires us to list sufficient area source categories or subcategories
to ensure that emissions representing 90 percent of the 30 listed HAP
(area source HAP) are subject to regulation under section 112(d) of the
CAA. The Urban Air Toxics Strategy (Strategy), issued on July 19, 1999
(64 FR 38706) included a list of 30 area source HAP and a list of area
source categories emitting the listed HAP. CAA Section 112(d) includes
authority to issue new and existing source maximum achievable control
technology (MACT) standards, health threshold standards, and generally
available control technology (GACT) or management practice standards
for area sources. We are issuing today's proposal pursuant to CAA
section 112(d)(5) to address our obligation under CAA section 112(c)(3)
to subject to regulation the listed area source category of hospital
sterilizers.
II. Summary of the Proposed Standards
The source category at issue in this proposal is hospital
sterilizers that emit HAP and that are area sources. EPA is proposing
two primary regulatory alternatives for this source category. The first
alternative (Regulatory Alternative 1) proposes a management practice
to reduce HAP emissions from hospital sterilizers that do not use
control devices to reduce ethylene oxide emissions.
The second alternative (Regulatory Alternative 2) proposes that
there are no generally available control technologies or management
practices within the meaning of section 112(d)(5) for this particular
source category. We are proposing these two alternatives because we
currently have limited information concerning the ability of the
proposed management practice to reduce HAP emissions and the cost-
effectiveness of such management practice. As explained below, we
believe this proposal meets the requirements of CAA sections 112(c)(3)
and 112(d)(5).
A. What Source Category Would Be Affected by This Proposal?
The source category that is affected by this proposed action is the
hospital sterilizer area source category. This source category includes
area source facilities that perform the operations necessary to
sterilize medical items with ethylene oxide at hospitals.
B. Proposed Regulatory Alternative 1
1. What Would Be the Affected Sources and Emission Points?
The affected source to which the proposed management practice
applies is the group of ethylene oxide sterilizers at a hospital and
that are located at hospitals that emit less than major source
quantities of HAP. If EPA finalizes Regulatory Alternative 1, you would
be subject to the requirements in
[[Page 64909]]
the proposed subpart if you own or operate one or more of the affected
sources identified above. These requirements would apply nationwide. We
are also considering applying proposed Regulatory Alternative 1 to
urban areas only and are taking comment on this approach. In a separate
action, we are proposing various definitions related to the urban only
approach (e.g., definitions for ``Metropolitan Statistical Area,''
``Urban,'' ``Urban 1 areas,'' and ``Urban 2 areas''). These proposed
definitions are included in the proposed National Emission Standards
for Hazardous Air Pollutants for Source Categories: Gasoline
Distribution Bulk Terminals, Bulk Plants, Pipeline Facilities, and
Gasoline Dispensing Facilities; this proposal is in Docket EPA-HQ-OAR-
2006-0406. If we decide to finalize the urban-only approach, we would
include in this final rule definitions related to that approach.
The emission source subject to the management practice is the
sterilization unit.
2. What Would Be the Emission Limits, Equipment Standards, and/or
Management Practice Standards?
Under Regulatory Alternative 1, we are proposing two different
alternatives with regard to uncontrolled hospital sterilizers. First,
we propose to require that hospitals with uncontrolled sterilizers
follow the management practice of sterilizing full loads of items
having a common aeration time, except where emergency circumstances
dictate the use of less than full loads to protect human health. As
discussed below, we are soliciting comment on particular circumstances
where an exemption to the full load requirement would be necessary for
medical or other reasons. Alternatively, we propose that hospitals with
uncontrolled sterilizers follow the management practice of sterilizing
full loads of items having a common aeration to the extent practical.
Unlike the first proposed approach, this alternative would eliminate
the need for a specific list of exemptions.
As for hospitals with controlled sterilizers, we propose that these
hospitals be required to certify that the control devices are operating
and will continue to operate in accordance with applicable State and/or
local laws or, if controls are voluntary, in accordance with
manufacturers' specifications. If controls are subsequently removed,
the management practice would take effect.
3. What Would Be the Testing and Initial Compliance Demonstration
Requirements?
There are no performance test requirements for the proposed
management practice standard.
4. What Would Be the Notification, Recordkeeping, and Reporting
Requirements?
We are proposing an initial compliance notification/certification
status that would require affected sources to notify EPA that they
operate a sterilizer covered by the rule and certify that they will
operate the sterilizer in accordance with the requirements of the rule.
We are taking comment on the costs and benefits of this initial
compliance notification/certification status and whether or not there
should be annual compliance certifications.
For Regulatory Alternative 1, we are also proposing two options for
recordkeeping. The first option does not require recordkeeping. The
second option requires that affected sources maintain records on-site
of the date and time of each sterilization operation. If less than a
full load is sterilized at any time, the operator must, in addition to
noting the date and time of the sterilization operation, identify the
reason why a less-than-full load was sterilized.
We are soliciting comment on the particular circumstances where a
hospital may need to run the sterilizer with less than a full load, and
whether to require records of such loads and the reason they were run.
C. Proposed Regulatory Alternative 2
As explained further below, we alternatively propose today that
there are no generally available control technologies or management
practices within the meaning of section 112(d)(5) for this category of
sources. We are proposing this alternative in addition to Regulatory
Alternative 1 because of the possibility that the proposed management
standard will not result in meaningful or cost-effective reductions in
ethylene oxide. That is, given the incentives that operators have to
minimize ethylene oxide emissions to reduce operating costs as well as
their own exposures, it is uncertain whether the issuance of additional
work practice standards would result in meaningful HAP emission
reductions. Even if such reductions occurred, they could be expensive.
For example, as noted above, we assume that work practice standards
would reduce emissions by 2 to 9 tons per year (tpy), and that
recordkeeping costs can be as high as $1.3 million per year, resulting
in reductions that cost $150,000 to $650,000 per ton. Costs would be
reduced significantly without recordkeeping requirements, but emission
reductions would be expected to be lower in this instance. For these
reasons, the Agency is alternatively proposing today to find that there
are no GACT or management practices within the meaning of CAA section
112(d)(5) for this category of sources. We believe that this would be a
reasonable approach given the high costs of controlling emissions of
ethylene oxide from hospital sterilizers using the identified control
technology and the uncertainties as to whether the proposed work
practice standard will result in HAP emission reductions and whether
such reductions are cost-effective. We request comment on this alternative.
III. Rationale for the Proposed Standards
Ethylene oxide is used in hospitals to sterilize medical items,
particularly heat-sensitive items that cannot be steam sterilized.
Ethylene oxide can be used directly in pure gaseous form or in gaseous
mixtures. The ethylene oxide sterilization process includes preparation
of the sterilization chamber (temperature, evacuation, humidification,
and ethylene oxide gas concentration), the sterilization cycle when the
medical item is exposed to ethylene oxide, evacuation and air washes,
and the aeration (or off-gas) cycle. Emissions points from hospital
ethylene oxide sterilization processes include: (1) Emissions from
evacuating the chamber following sterilization, (2) emissions from the
chamber during aeration, and (3) emissions that occur when the
sterilizer door is opened. Most hospitals have eliminated another
potential source of emissions, the once-through water-sealed vacuum
pump used to evacuate the ethylene oxide from the chamber, in order to
meet Occupational Safety and Health Administration (OSHA) guidelines
for worker exposure. Hospitals now use recirculating vacuum-sealed pumps.
There were an estimated 5,800 hospitals nationwide in the United
States in 2002. Based on a nationwide and State search for permits and
inventory data, we specifically compared the number of hospitals
identified and the number confirmed to conduct ethylene oxide
sterilization, and extrapolated to nationwide numbers. The percentage
of hospitals with ethylene oxide sterilization ranges from 28 to 33
percent. Based on this range, there are approximately 1,600 to
[[Page 64910]]
1,900 hospitals nationwide that conduct ethylene oxide sterilization.
The predominant type of air pollution control devices are the EtO-
AbatorTM and the Safe-Cell technology. Both technologies
reduce emissions by approximately 99 percent. The EtO-
AbatorTM oxidizes the ethylene oxide with a catalyst to form
carbon dioxide and water vapor. The latest version of the EtO-
AbatorTM (sold by 3M) is sold only for use with pure
ethylene oxide systems; however, earlier versions were used with gas
blends. The Safe-Cell technology, which can be used with either pure
ethylene oxide or ethylene oxide gas blends, is a two-stage process. In
the first stage, an acid hydrolysis scrubber removes ethylene oxide
from the gas stream and converts it to ethylene glycol; in the second
stage, the remaining ethylene oxide is captured and destroyed on a dry
bed filter impregnated with a chemical reactant.
We estimated that ethylene oxide emissions were 1,060 megagrams per
year (Mg/yr) (1,170 tpy) from hospital sterilization processes
nationwide in 1990. As discussed below, there have been declines in
ethylene oxide usage and emissions for sterilization processes.
Nationwide ethylene oxide usage was estimated to be 192 Mg/yr (212 tpy)
in 2000 and 122 Mg/yr (135 tpy) in 2005. We estimate that at least half
of the ethylene oxide being used by hospitals with controlled
sterilizers, which would emit negligible amounts of ethylene oxide, and
the other half is used in uncontrolled sterilizers. This resulted in
about 40 Mg/yr (44 tpy) of ethylene oxide emissions in 2005. We
estimate approximately 0.05 cases of cancer per year resulting from the
release of the 40 Mg/yr of ethylene oxide to the atmosphere. Ethylene
oxide emissions for hospital sterilizers therefore have decreased over
90 percent from 1990 to 2005 (from 1,060 to 40 Mg/yr reduction).
The decline in ethylene oxide usage for hospital sterilization is
due mainly to: (1) New regulations and excise taxes on
chlorofluorocarbons, (2) development of new sterilization processes,
such as liquid peracetic acid and hydrogen peroxide plasma processes,
for certain medical items, (3) increased concern over the toxicity of
ethylene oxide residuals, and (4) new restrictions on reprocessing
single use devices (SUD). As a corollary to the decline in EO usage and
emissions, the number of hospitals that conduct ethylene oxide
sterilization has been declining. Regulation of ethylene oxide
sterilization at hospitals has contributed to the decline in the number
of hospitals that conduct sterilization processes. In California, there
were approximately 600 hospitals that operated ethylene oxide
sterilizers in 1991. Since implementation of the California Air
Resources Board regulation for hospital sterilizers in 1991, at least
60 percent of these hospitals are no longer conducting sterilization
operations.
In 2000, the Food and Drug Administration (FDA) regulated the
reprocessing of SUD, and these regulations have made it more difficult
for hospitals to continue the reprocessing. Many hospitals have reacted
to the 2000 FDA regulations by discontinuing the reuse of SUD or by
outsourcing the sterilization processing of SUD. With the trends
mentioned, hospitals in urban areas have begun to consolidate ethylene
oxide sterilization processes, and one hospital with a large sterilizer
may conduct sterilization processes for its neighbor or affiliated
hospitals or those in close proximity. As a result of the many SUD
reuse issues, when hospitals are outsourcing and using reprocessed
devices, ethylene oxide usage by contract sterilizers is increasing,
and when hospitals are not reprocessing SUD, ethylene oxide usage by
medical device manufacturers has increased as they manufacture more
SUD. (Sterilization processes by commercial sterilizers, which include
commercial contract sterilizers and medical device manufacturers, are
subject to MACT controls under 40 CFR part 63, subpart O.)
Emissions from controlled hospital sterilizers are negligible, and
we are not aware of any practical emission reduction strategies to
further reduce emissions after control. The ethylene oxide emissions
from hospitals average less than 300 pounds per year. The capital costs
of add-on controls for these facilities range from $23,000 to $130,000
per hospital and the annualized costs of add-on controls range from
$10,000 to $46,000 per year. These costs do not include any potential
monitoring, recordkeeping, and reporting (MRR) costs that would be
necessary to ensure continuous compliance if controls were required.
Total nationwide annualized cost to control all uncontrolled facilities
would be approximately $8.5 million. The cost to reduce a ton of
ethylene oxide emissions is over $200,000 per year.
As a first step in our analysis, we considered the option of
applying a MACT standard to hospital sterilizers under CAA section
112(d)(2). Hospitals that are currently controlling their ethylene
oxide sterilizers generally are doing so to comply with existing State
or local requirements. More than half of the hospital sterilizers have
add-on controls. Due to this widespread use of controls on hospital
sterilizers, the MACT floor level of control would be add-on controls
if we were to develop this area source rule based on CAA section
112(d)(2). We propose to reject the application of MACT and the
requirement to control all presently uncontrolled hospital sterilizers
based on the small amount of ethylene oxide emissions from uncontrolled
hospital sterilizers and the poor cost-effectiveness associated with
requiring add-on controls on the currently uncontrolled sources. The
average hospital emits less than 300 pounds per year of ethylene oxide.
The cost-effectiveness of applying MACT is over $200,000 per ton of
ethylene oxide reduced, excluding any potential MRR costs, which we
think is excessive for control of these emissions.
Consequently, the Administrator is exercising his discretion to
promulgate standards or requirements under CAA section 112(d)(5) which
provide for the use of management practices to reduce emissions of HAP
from uncontrolled sterilizers.
The FDA regulates the hospital sterilizer as a medical device;
these requirements help ensure sterility of the sterilized product. The
FDA requires the manufacturer follow the Association for the
Advancement of Medical Instrumentation (AAMI) standards for
sterilizers. The FDA does not directly regulate the hospital use of the
sterilizer unit. However, the amount of ethylene oxide used per
sterilizer cycle is factory set by the manufacturers to comply with the
AAMI standards, i.e., for a given sterilizer cycle, one uses the same
amount of ethylene oxide whether the sterilizer is full or not. Because
of this, hospital sterilizer operators have little discretion in the
operation of the sterilizer other than to minimize the use of the
sterilizer by only running full loads. Under Regulatory Alternative 1,
we are therefore proposing the management practice that requires the
sterilization of full loads to minimize the number of times the sterilizer
is operated. As explained above, we are considering two different
approaches for framing the standard under Regulatory Alternative 1.
This management practice is consistent with the American National
Standards Institute, Inc. (ANSI) and the AAMI jointly developed
American National Standard ANSI/AAMI ST41:1999. The ANSI/AAMI ST41:1999
standard is recognized by the FDA as a consensus standard. The ANSI/
AAMI standard requires the operator sterilize full loads of items
having a common aeration time, to the extent practical.
[[Page 64911]]
The rationale provided in the standard states the following:
As compared to sterilizing the same volume in partial loads,
sterilizing full loads of items having a common aeration time is cost-
effective and reduces the potential for occupational exposure and for
environmental release of ethylene oxide. This practice also reduces the
temptation for workers to attempt to retrieve items with short aeration
times from cabinets in which other items might not be fully aerated and
thus helps avoid unnecessary exposure to ethylene oxide.''
It is possible that not all hospitals sterilize every load
consistent with this standard. We believe that the management practice
should increase the awareness of pollution prevention and that it has
the potential to reduce emissions from uncontrolled hospital
sterilizers. For purposes of Regulatory Alternative 1, we assume that
the cost of implementing the management practice is low. We believe the
cost of performing the management practice may be off-set by the
reduced purchasing costs of ethylene oxide and other operating costs
resulting from fewer loads. We also believe the implementation of the
management practice can be done relatively quickly due to the expected
low effort to set up the recordkeeping necessary for the practice. For
these reasons, we are proposing Regulatory Alternative 1, which would
require compliance with the management practice requirements within 1
year after the effective date of the final rule.
Under Regulatory Alternative 1, we are proposing that the
management practice apply to uncontrolled hospital sterilizers.
Hospitals controlling their sterilizers with add-on emission control
devices would be required to certify either compliance with all State
or local requirements applicable to the controls or, if controls are
voluntary, certify that they are operating the controls in accordance
with the manufacturer's specifications. If controls are subsequently
removed, the management practice would take effect. Facilities
complying with the management practice will be required to maintain
records on-site of the date and time of sterilization and whether a
full load was sterilized, and the reason for not running a full load.
We estimated the costs to keep records at $1.3 million per year for the
uncontrolled facilities. We are assuming the controlled facilities will
certify compliance with either State or local requirements, or they are
operating the controls consistent with the manufacturer's
specifications. The cost estimates noted above are only estimates,
however. We are taking comment on the costs and benefits of this
recordkeeping requirement and on whether this rule should apply
nationally or only to hospitals in urban areas. We are considering
applying today's proposal only to urban areas as defined in the
proposed National Emission Standards for Hazardous Air Pollutants for
Source Categories: Gasoline Distribution Bulk Terminals, Bulk Plants,
Pipeline Facilities, and Gasoline Dispensing Facilities in Docket EPA-
HQ-OAR-2006-0406.
Based on the information and assumptions noted above, we are
proposing two options for Regulatory Alternative 1. First, we propose
that full loads of items having a common aeration time be sterilized,
except where emergency circumstances dictate the use of less than full
loads to protect human health. With regard to this proposed option, we
specifically solicit comment on whether there are other exemptions to
the full load requirement that are appropriate. Alternatively, we
propose that operators be required to sterilize full loads of items
having a common aeration time to the extent practical. Under this
alternative approach, there is no need for a specified list of
exemptions for specific circumstances, as is the case with the first
proposed approach. Rather, the operator must fully load the sterilizer
to the extent practical.
Both options recognize that hospital sterilizers have strong
economic incentives to operate sterilizers with a full load because
doing so reduces the quantity of ethylene oxide needed to run their
operation and, accordingly, reduces costs. This alternative approach is
consistent with the ANSI/AAMI standard described above. Indeed, as
noted by the AAMI and FDA, operation at full loads reduces operating
costs by reducing the consumption of ethylene oxide, minimizing wear
and tear on machines, and reducing associated labor costs. We solicit
comment on these two alternative approaches.
Under Regulatory Alternative 2, we are proposing that there are no
GACT or management practices within the meaning of section 112(d)(5) of
the CAA for this source category. We are currently not aware of any
control technology or management practice other than those discussed in
this proposal that would reduce ethylene oxide emissions from hospital
sterilizers. We have already identified that there is a high cost of
controlling emissions of ethylene oxide from hospital sterilizers using
the identified control technology, such that we currently do not
believe that there is any GACT. We also have limited information to
conclude either that the proposed management practice reduces emissions
of ethylene oxide or that the proposed practice is cost-effective. We
are therefore co-proposing Regulatory Alternative 2.
We are soliciting comment on whether, for this source category, it
is reasonable to conclude that no such generally available means of
reducing emissions is available. In this regard, we specifically
solicit comment on whether there is any other control technology or
management practice that is not described in this proposal, but that
may provide a cost-effective means of reducing ethylene oxide emissions
from hospital sterilizers. To the extent a commenter identifies such an
alternative means of emission reduction, we request information
relating to the nature of the emission reduction and the cost of
obtaining such reduction.
Section 502(a) of the CAA provides that EPA may exempt one or more
area sources from the requirements of title V if EPA finds that
compliance with such requirements is ``impracticable, infeasible, or
unnecessarily burdensome'' on such area sources. EPA must determine
whether to exempt an area source from title V at the time we issue the
relevant CAA section 112 standard (40 CFR 70.3(b)(2)). If we pursue
Regulatory Alternative 1 in the final rule, we are proposing today to
exempt hospital sterilizer area sources from the requirements of title
V. Hospital sterilizer area sources would not be required to obtain
title V permits solely as a function of being the subject of today's
proposed national emission standards for hazardous air pollutants
(NESHAP); however, if they were otherwise required to obtain title V
permits, such requirement(s) would not be affected by today's proposed
exemption.
Consistent with the statute, EPA has found that compliance with
title V permitting is ``unnecessarily burdensome'' for hospital
sterilizer area sources. EPA's inquiry into whether this criterion was
satisfied was based primarily upon consideration of the following four
factors: (1) Whether title V would result in significant improvements
to the compliance requirements that we are proposing for this area
source category; (2) whether title V permitting would impose a
significant burden on hospital sterilizer area sources; (3) whether the
costs of title V permitting for hospital sterilizer area sources would
be justified, taking into consideration any potential gains in
compliance likely to occur for such sources; and (4) whether there are
[[Page 64912]]
implementation and enforcement programs in place that are sufficient for
assuring compliance with this NESHAP without relying on title V permits.
Additionally, EPA also considered whether exempting hospital
sterilizer area sources would adversely affect public health, welfare,
or the environment. We first determined the extent to which these
factors were present for this area source category. We then determined
whether those factors collectively demonstrated that compliance with
title V requirements would be unnecessarily burdensome for hospital
sterilizer area sources.
In our consideration of these factors, we believe the addition of
title V permitting would not result in significant improvements to the
compliance requirements that we are proposing for this area source
category. Under Regulatory Alternative 1, we are unaware of any
additional compliance procedures, in or outside the title V program,
which would improve the assurance of significantly more gains in
compliance and emission reductions. We have not identified any adverse
effect on public health, welfare, or the environment by the proposed
title V exemption.
We also believe that title V permitting may impose a significant
burden on facilities within this source category, some of which are
small businesses. For many facilities, the cost of obtaining a title V
permit may far exceed the cost of complying with this proposed rule
without significant gains in compliance. Based on the above analysis,
we conclude that title V permitting would be ``unnecessarily
burdensome'' for hospital sterilizer area sources. We are therefore
proposing that this area source category be exempt from title V
permitting requirements if we pursue Regulatory Alternative 1.
We have prepared regulatory text for proposed Regulatory
Alternative 1. The proposed regulatory text implements the first option
described above for Regulatory Alternative 1 and includes proposed
recordkeeping requirements. We have included regulatory text for this
proposed approach because it is the approach that would involve the
most extensive regulatory text. If we finalize the second option
described above for Regulatory Alternative 1 (i.e., following the ANSI/
AAMI standard), we will modify the regulatory text appropriately.
IV. Summary of Environmental, Energy, Cost, and Economic Impacts of the
Proposed Standards
We estimate that in 2002 there were, at most, 1,900 hospital area
sources, of which approximately 630 do not presently have add-on
controls. The management practice that we are proposing today as
Regulatory Alternative 1 is estimated to reduce the 40 Mg/yr emitted
from uncontrolled sterilizers from 2 to 9 Mg/yr per year based on a
range of assumptions for the extent to which hospital sterilizers are
presently not being run with full loads. We estimate cancer incidence
would be reduced from approximately 0.05 to 0.044 cases of cancer per
year. We further believe that if we pursue Regulatory Alternative 1 in
the final rule, there will be minimal effect on other air quality or
non-air quality environmental impacts and will be negligible energy or
economic impacts. Annualized costs to comply with the proposed
standards are estimated to be less than $2 million per year. There will
be no environmental, energy, cost, or economic impacts associated with
Regulatory Alternative 2.
V. Solicitation of Public Comments
A. Introduction and General Solicitation
We request comments on all aspects of the proposed action. All
significant comments received during the public comment period will be
considered in the development and selection of the final rulemaking.
B. Specific Comment and Data Solicitations
1. Management practice costs and benefits--We are requesting
comment on our estimate of the costs to comply with the management
practice and the associated MRR requirements. As stated earlier, we are
proposing one time initial compliance notification/certification. We
are requesting comment on the costs and benefits of the proposed
initial compliance notification/certification status and recordkeeping
and on the costs and benefits of hospitals also annually certifying
their compliance with the proposed rule. We are requesting comment on
the two proposed options for recordkeeping. The first option does not
require records to minimize the burden compared to the emission
reduction benefit. The second option requires recordkeeping to ensure
compliance. We solicit comments on approaches other than recordkeeping
which may ensure compliance at a smaller cost. Finally, we are
requesting comment on whether this rule should apply nationally or only
to hospitals in urban areas.
2. Full loads--The ANSI/AAMI ST41:1999 standards rationale for load
configuration states the following:
``Overloading impedes proper air removal, humidification of the
load, and sterilant penetration and evacuation. Proper loading ensures
that the sterilized items will not touch the operator's hands during
transfer from the sterilizer to the aerator.''
We do not want the proposed requirements to impede the
sterilization cycle or in any way compromise the process of
sterilization. We are requesting comment on our definition of full load
and for specific cases where it would not be practical or appropriate
to require full loads. We are also soliciting comment on our
alternative proposal of requiring hospitals with uncontrolled
sterilizers to follow the management practice of sterilizing full loads
of items having a common aeration, to the extent practical.
3. Emission estimate for the management practice--We currently have
insufficient information concerning the ability of the proposed
management practice to reduce HAP emissions. Our emissions reduction
estimates attributed to the management practice are based on
assumptions concerning the current practice at hospitals. The basis of
our emissions estimate is the assumption that 10 to 50 percent of the
sterilization is performed on half loads and that the amount of
ethylene oxide used is fixed per cycle. The emission estimate also
makes the assumption that all loads could be full. We are requesting
comments on the extent to which hospitals presently sterilize less than
full loads, to what extent these less than full loads could be
eliminated, and any additional information that may assist in
estimating emissions. We are requesting comment on whether this
management practice is an effective means of reducing emissions from
these sources and, if not, whether it would be appropriate to set no
standard on the grounds that no technology or management practice are
generally available to reduce emissions from these sources.
VI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is a ``significant regulatory action'' because it may raise
novel legal and policy issues. Accordingly, EPA submitted this action
to the Office of Management and Budget (OMB) for review under Executive
Order 12866 and any changes made in response to OMB recommendations
have been
[[Page 64913]]
documented in the docket for this action.
B. Paperwork Reduction Act
The information requirements in the proposed NESHAP for Hospital
Ethylene Oxide Sterilization Area Sources have been submitted for
approval to OMB under the Paperwork Reduction Act, 44 U.S.C. 3501, et
seq. The Information Collection Request (ICR) document prepared by EPA
has been assigned EPA ICR number 2245.01.
The proposed information collection requirements are based on the
information collection requirements in the part 63 General Provisions
(40 CFR part 63, subpart A), some of which are incorporated into the
proposed NESHAP. The ICR document includes the burden estimates for all
applicable General Provisions. These recordkeeping and reporting
requirements are mandatory pursuant to section 114 of the CAA (42
U.S.C. 7414). All information submitted to EPA pursuant to the
information collection requirements for which a claim of
confidentiality is made is safeguarded according to CAA section 114(c)
and the Agency's implementing regulations at 40 CFR part 2, subpart B.
Proposed Regulatory Alternative 2 does not impose any new
information collection burden. Proposed Regulatory Alternative 1 does
propose information collection requirements. Specifically, the annual
burden for the information collection averaged over the first 3 years
of this ICR is estimated to total 23,694 labor hours per year at a cost
of $1.6 million for the 1,900 existing hospital sterilizer area
sources. No capital/startup costs or operation and maintenance costs
are associated with the proposed requirements. No costs or burden hours
are estimated for new area sources because no new sources are estimated
during the 3-year period of the ICR. We have no indication there will
be any new sources in the next 3 years.
Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, disclose, or provide
information to or for a Federal agency. This includes the time needed
to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR part 63 are listed in 40 CFR part 9.
To comment on the Agency's need for this information, the accuracy
of the provided burden estimates, and any suggested methods for
minimizing respondent burden, including the use of automated collection
techniques, EPA has established a public docket for this action, which
includes this ICR, under Docket ID number EPA-HQ-OAR-2005-0171. Submit
any comments related to the ICR for the proposed rules to EPA and OMB.
See ``Addresses'' section at the beginning of this notice for where to
submit comments to EPA. Send comments to OMB at the Office of
Information and Regulatory Affairs, Office of Management and Budget,
725 17th Street, NW., Washington, DC 20503, Attention: Desk Officer for
EPA. Since OMB is required to make a decision concerning the ICR
between 30 and 60 days after November 6, 2006, a comment to OMB is best
assured of having its full effect if OMB receives it by December 6,
2006. The final rule will respond to any OMB or public comments on the
information collection requirements contained in this proposal.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small not-for-profit enterprises, and small governmental jurisdictions.
For the purposes of assessing the impacts of today's proposed area
source NESHAP on small entities, a small entity is defined as: (1) A
small business that is a hospital as defined by NAICS codes 622110 and
622310 whose parent company has less than $31.5 million in gross
revenue (based on Small Business Administration (SBA) size standards);
(2) a small governmental jurisdiction that is a government of a city,
county, town, school district, or special district with a population of
less than 50,000; and (3) a small organization that is any not-for-
profit enterprise which is independently owned and operated and is not
dominant in its field.
After considering the economic impacts of today's proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. Proposed
Regulatory Alternative 1 proposes to require the use of a work practice
to minimize the operation of the ethylene oxide sterilization unit and
will, therefore, have minimal nationwide costs, i.e., less than $2
million per year. We have determined that less than 3 percent of the
hospitals are small businesses as defined by the SBA. We have also
determined that none of these small businesses are significantly
impacted by this proposal for none of them will incur annualized
compliance costs of 0.1 percent of sales or greater. There are no costs
associated with proposed Regulatory Alternative 2.
We continue to be interested in the potential impacts of the
proposed rule on small entities and welcome comments on issues related
to such impacts.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures by State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
1 year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective, or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective, or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted.
Before EPA establishes any regulatory requirements that may
significantly or uniquely affect small governments, including Tribal
governments, it must have developed under section 203 of the
[[Page 64914]]
UMRA, a small government agency plan. The plan must provide for
notifying potentially affected small governments, enabling officials of
affected small governments to have meaningful and timely input in the
development of EPA regulatory proposals with significant Federal
intergovernmental mandates, and informing, educating, and advising
small governments on compliance with the regulatory requirements.
EPA has determined that the proposed rule does not contain a
Federal mandate that may result in expenditures of $100 million or more
for State, local, and tribal governments, in the aggregate, or the
private sector in any 1 year. As discussed previously in this preamble,
if we finalize Regulatory Alternative 1, the estimated expenditures for
the private sector in any 1 year are less than $2 million. There are no
costs associated with proposed Regulatory Alternative 2. Thus, the
proposed rule is not subject to the requirements of sections 202 and
205 of the UMRA. In addition, the proposed rule does not significantly
or uniquely affect small governments. The proposed rule would not
result in expenditures by them of $100 million or more in any 1 year or
any disproportionate impacts on them. Therefore, the proposed rule is
not subject to section 203 of the UMRA.
E. Executive Order 13132: Federalism
Executive Order 13132 (64 FR 43255, August 10, 1999), requires EPA
to develop an accountable process to ensure ``meaningful and timely
input by State and local officials in the development of regulatory
policies that have federalism implications.'' ``Policies that have
federalism implications'' are defined in the Executive Order to include
regulations that 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.''
The proposed rule does not have federalism implications. It will
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. To the extent the proposed rule
proposes requirements, it does so only with respect to owners and
operators of specified area sources and not State and local
governments. Thus, Executive Order 13132 does not apply to the proposed
rule. In the spirit of Executive Order 13132, and consistent with EPA
policy to promote communications between EPA and State and local
governments, EPA specifically solicits comment on this proposed rule
from State and local officials.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
Executive Order 13175 (59 FR 22951, November 9, 2000) requires EPA
to develop an accountable process to ensure ``meaningful and timely
input by Tribal officials in the development of regulatory policies
that have Tribal implications.'' ``Policies that have tribal
implications'' are defined in the Executive Order to include
regulations that have ``substantial direct effects 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.''
The proposed rule does not have tribal implications, as specified
in Executive Order 13175. It will not have substantial direct effects
on Tribal governments, 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 in Executive Order 13175. To the extent the proposed rule
proposes requirements, it does so only with respect to owners and
operators of specified area sources and not Tribal governments. Thus,
Executive Order 13175 does not apply to the proposed rule.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any
rule that: (1) Is determined to be ``economically significant'' as
defined under Executive Order 12866, and (2) concerns an environmental
health or safety risk that EPA has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, the EPA must evaluate the environmental health or safety
effects of the planned rule on children, and explain why the planned
regulation is preferable to other potentially effective and reasonably
feasible alternatives considered by the EPA.
EPA interprets Executive Order 13045 as applying only to those
regulatory actions that are based on health or safety risks, such that
the analysis required under section 5-501 of the Executive Order has
the potential to influence the regulation. The proposed rule is not
subject to the Executive Order. It is based on control technology and
not on health or safety risks.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
The proposed rule is not a ``significant energy action'' as defined
in Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy. Further, we have concluded that the
proposed rule is not likely to have any adverse energy effects because
energy requirements would likely be less than existing levels. No
additional pollution controls or other equipment that would consume
energy are required by the proposed rules.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) of 1995, Public Law 104-113, 12(d), (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards (VCS) in its
regulatory activities, unless to do so would be inconsistent with
applicable law or otherwise impractical. The VCS are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
VCS bodies. The NTTAA directs EPA to provide Congress, through OMB,
explanations when the Agency decides not to use available and
applicable VCS.
The proposed rule does not include technical standards.
List of Subjects in 40 CFR Part 63
Environmental protection, Air pollution control, Hazardous
substances, Reporting and recordkeeping requirements.
Dated: October 31, 2006.
Stephen L. Johnson,
Administrator.
For the reasons stated in the preamble, title 40, chapter I, part
63 of the Code of Federal Regulations is proposed to be amended as follows:
PART 63--[AMENDED]
1. The authority citation for part 63 continues to read as follows:
Authority: 42 U.S.C. 7401 et seq.
Subpart A--[Amended]
2. Part 63 is amended by adding subpart WWWWW to read as follows:
[[Page 64915]]
Subpart WWWWW--National Emission Standards for Hospital Ethylene Oxide
Sterilization
Applicability and Compliance Dates
Sec.
63.10382 Am I subject to this subpart?
63.10384 What are my compliance dates?
Standards
63.10390 What management practice standards must I meet?
Initial Compliance Requirements
63.10400 How do I demonstrate initial compliance?
63.10402 By what date must I demonstrate initial compliance?
Monitoring--Continuous Compliance Requirements
63.10420 How do I demonstrate continuous compliance with the
management practice requirements?
Notifications, Reports, and Records
63.10430 What notifications must I submit and when?
63.10432 What records must I keep?
63.10434 In what form and for how long must I keep my records?
Other Requirements and Information
63.10440 What parts of the General Provisions apply to me?
63.10442 Who implements and enforces this subpart?
63.10446 Do title V permitting requirements apply to area sources
subject to this subpart?
63.10448 What definitions apply to this subpart?
Tables to Subpart WWWWW of Part 63
Table 1 to Subpart WWWWW of Part 63--Applicability of General
Provisions to Subpart WWWWW
Subpart WWWWW--National Emission Standards for Hospital Ethylene
Oxide Sterilization
Applicability and Compliance Dates
Sec. 63.10382 Am I subject to this subpart?
(a) You are subject to this subpart if you own or operate an
ethylene oxide sterilization facility at a hospital that is an area
source of hazardous air pollutant (HAP) emissions. Your hospital
facility is an area source of HAP if it is a stationary source or group
of stationary sources within a contiguous area under common control
that emits or has the potential to emit any single HAP at a rate of
less than 9.07 megagrams (10 tons) per year and any combination of HAP
at a rate of less than 22.68 megagrams (25 tons) per year.
(b) The affected source subject to this subpart is each new or
existing sterilization facility.
(1) An affected source is existing if you commenced construction or
reconstruction of the affected source before November 6, 2006.
(2) An affected source is new if you commenced construction or
reconstruction of the affected source on or after November 6, 2006.
Sec. 63.10384 What are my compliance dates?
(a) Existing source. If you have an existing affected source, you
must comply with applicable requirements in this subpart no later than
[1 YEAR AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE Federal
Register].
(b) New source. If you have a new or reconstructed affected source
for which the initial startup date is on or before [DATE OF PUBLICATION
OF THE FINAL RULE IN THE Federal Register], you must comply with
applicable requirements in this subpart by [DATE OF PUBLICATION OF THE
FINAL RULE IN THE Federal Register].
(c) New source. If you have a new or reconstructed affected source
for which the initial startup date is after [DATE OF PUBLICATION OF THE
FINAL RULE IN THE Federal Register], you must comply with applicable
requirements in this subpart upon initial startup.
Standards
Sec. 63.10390 What management practice standards must I meet?
(a) You must sterilize full loads of items having a common aeration
time, except under the following conditions: emergency circumstances
dictate the use of less than full loads to protect human health.
(b) You are exempt from the management practice standards in
paragraph (a) of this section if your sterilization unit is equipped
with an add-on air pollution control device and you submit a
certification in accordance with Sec. 63.10400.
Initial Compliance Requirements
Sec. 63.10400 How do I demonstrate initial compliance?
(a) Uncontrolled sources. You must demonstrate initial compliance
with the management practice standards in Sec. 63.10390(a) by
submitting an initial Notification of Compliance Status certifying that
you are sterilizing with full loads of items having a common aeration time.
(b) Controlled sources subject to State and local regulation. You
must demonstrate initial compliance with Sec. 63.10390(b) by
submitting an initial Notification of Compliance Status certifying that
you are operating the sterilization unit in accordance with your State
or local regulation and following control device manufacturer's
recommended procedures.
(c) Controlled sources not subject to State and local regulation.
You must demonstrate initial compliance with Sec. 63.10390(b) by
submitting an initial Notification of Compliance Status certifying that
you are venting the ethylene oxide emissions from each sterilization
unit to an add-on air pollution control device. You must certify that
you are operating the control device during all sterilization processes
and in accordance with manufacturer's recommended procedures.
Sec. 63.10402 By what date must I demonstrate initial compliance?
You must demonstrate initial compliance with Sec. 63.10390 upon
startup or no later than 180 calendar days after your compliance date,
whichever is later.
Monitoring--Continuous Compliance Requirements
Sec. 63.10420 How do I demonstrate continuous compliance with the
management practice requirements?
For each sterilization unit not equipped with an add-on air
pollution control device, you must demonstrate continuous compliance
with the management practice standards in Sec. 63.10390(a) by checking
and recording the date and time of each sterilization cycle, whether
each sterilization cycle contains a full load of items, and if not,
which allowable reason.
Notifications, Reports, and Records
Sec. 63.10430 What notifications must I submit and when?
(a) You must submit the initial Notification of Compliance Status
to the authority provided for in Sec. 63.9(a)(4). In addition to
submitting your initial Notification of Compliance Status to the State
or Region Office, you must also submit a copy of the initial
Notification of Compliance Status to EPA's Office of Air Quality
Planning and Standards. Send your notification via e-mail to
CCG-ONG@EPA.GOV or via U.S. mail or other mail delivery service to U.S.
EPA, Sector Policies and Programs Division, Coatings and Chemicals
Group (E143-01), Attn: Hospital Sterilizers Project Leader, Research
Triangle Park, NC 27711.
(b) You must submit an initial Notification of Compliance Status
for the initial compliance demonstration in Sec. 63.10400(a), (b), or
(c) before 5 p.m. on the 60th calendar day following the compliance
demonstration, consistent with Sec. 63.10402. Your Notification of
Compliance Status must include the information required in paragraphs
[[Page 64916]]
(b)(1) through (5) of this section and the applicable certification in
Sec. 63.10400.
(1) The name and address of the owner or operator.
(2) The address (i.e., physical location) of the affected source.
(3) An identification of the relevant standard, or other
requirement, that is the basis of the notification and the source's
compliance date.
(4) A brief description of the nature, size, design, and method of
operation of the source and an identification of the types of emission
points within the affected source subject to the relevant standard and
types of hazardous air pollutants emitted.
(5) A statement that the affected source is an area source.
Sec. 63.10432 What records must I keep?
You must keep the records specified in paragraphs (a) and (b) of
this section.
(a) All sources. A copy of the initial Notification of Compliance
Status that you submitted to comply with this subpart.
(b) Uncontolled sources. Records of checks needed to document
continuous compliance with the management practice standards required
by Sec. 63.10420.
Sec. 63.10434 In what form and for how long must I keep my records?
(a) Your records must be in a form suitable and readily available
for expeditious review, according to Sec. 63.10(b)(1).
(b) As specified in Sec. 63.10(b)(1), you must keep each record
for 5 years following the date of each occurrence, report, or record.
(c) You must keep each record onsite for at least 2 years after the
date of each occurrence, measurement, maintenance, corrective action,
report, or record, according to Sec. 63.10(b)(1). You may keep the
records offsite for the remaining 3 years.
Other Requirements and Information
Sec. 63.10440 What parts of the General Provisions apply to me?
Table 1 to this subpart shows which parts of the General Provisions
in 40 CFR 63.1 through 63.16 apply to you.
Sec. 63.10442 Who implements and enforces this subpart?
(a) This subpart can be implemented and enforced by us, the U.S.
EPA, or a delegated authority such as your State, local, or tribal
agency. If the U.S. EPA Administrator has delegated authority to your
State, local, or tribal agency, then that Agency has the authority to
implement and enforce this subpart. You should contact your U.S. EPA
Regional Office to find out if this subpart is delegated to your State,
local, or tribal agency.
(b) In delegating implementation and enforcement authority of this
subpart to a State, local, or tribal agency under 40 CFR part 63,
subpart E, the authorities contained in paragraph (c) of this section
are retained by the Administrator of the U.S. EPA and are not
transferred to the State, local, or tribal agency.
(c) The authorities that will not be delegated to State, local, or
tribal agencies include approval of alternatives to the applicability
requirements under 40 CFR 63.10382, the compliance date requirements in
40 CFR 63.10384, and the management practice standards as defined in 40
CFR 63.10390.
Sec. 63.10446 Do title V permitting requirements apply to area
sources subject to this subpart?
You are exempt from the obligation to obtain a permit under 40 CFR
part 70 or 40 CFR part 71, provided you are not otherwise required by
law to obtain a permit under 40 CFR 70.3(a) or 40 CFR 71.3(a).
Notwithstanding the previous sentence, you must continue to comply with
the provisions of this subpart.
Sec. 63.10448 What definitions apply to this subpart?
Terms used in this subpart are defined in the Clean Air Act (CAA),
in 40 CFR 63.2, and in this section as follows:
Aeration process means any time when ethylene oxide is removed from
the aeration unit through the aeration unit vent or from the
combination sterilization unit through the sterilization unit vent,
while aeration or off-gassing is occurring.
Aeration unit means any vessel that is used to facilitate off-
gassing of ethylene oxide.
Air pollution control device means a catalytic oxidizer, acid-water
scrubber, or any other air pollution control equipment that reduces the
quantity of ethylene oxide from the effluent gas stream from
sterilization and aeration processes.
Combination sterilization unit means any enclosed vessel in which
both the sterilization process and the aeration process occur within
the same vessel, i.e., the vessel is filled with ethylene oxide gas or
an ethylene oxide/inert gas mixture for the purpose of sterilizing and
is followed by off-gassing of ethylene oxide.
Common aeration time means that items require the same length of
time to off-gas ethylene oxide.
Controlled source means a sterilization facility using ethylene
oxide in sterilization units with an add-on air pollution control
device used to reduce the quantity of ethylene oxide emissions.
Full load means the maximum number of items that does not impede
proper air removal, humidification of the load, or sterilant
penetration and evacuation in the sterilization unit.
Hospital means a facility that provides medical care and treatment,
including diagnostic and major surgery facilities, for patients who are
acutely ill or chronically ill on an inpatient basis under supervision
of licensed physicians and under nursing care offered 24 hours per day.
Doctor's offices, clinics, or other facilities whose primary purpose is
to provide medical services to humans or animals on an outpatient basis
are excluded.
State or local regulation means a regulation at the State or local
level that requires a hospital to reduce the quantity of ethylene oxide
emissions from ethylene oxide sterilization units.
Sterilization facility means the group of ethylene oxide
sterilization units at a hospital using ethylene oxide gas or an
ethylene oxide/inert gas mixture for the purpose of sterilizing.
Sterilization process means any time when ethylene oxide is removed
from the sterilization unit or combination sterilization unit through
the sterilization unit vent.
Sterilization unit means any enclosed vessel that is filled with
ethylene oxide gas or an ethylene oxide/inert gas mixture for the
purpose of sterilizing.
Uncontrolled source means a sterilization facility using ethylene
oxide in sterilization units with no add-on air pollution control
device used to reduce the quantity of ethylene oxide emissions.
Tables to Subpart WWWWW of Part 63
As required in Sec. 63.10440, you must comply with the
requirements of the General Provisions (40 CFR part 63, subpart A)
shown in the following table.
[[Page 64917]]
Table 1.--To Subpart WWWWW of Part 63--Applicability of General Provisions to Subpart WWWWW
----------------------------------------------------------------------------------------------------------------
Applies to
Citation Subject subpart Explanation
WWWWW
----------------------------------------------------------------------------------------------------------------
Sec. 63.1(a)(1)-(4), (a)(6), Applicability................... Yes ................................
(a)(10)-(12), (b)(1).
Sec. 63.1(a)(5), (7)-(9).... [Reserved]...................... ............ ................................
Sec. 63.1(b)(2)............. [Reserved]...................... ............ ................................
Sec. 63.1(c)(1)-(2)......... Applicability of this part after Yes States have the option to
a relevant standard has been exclude area sources affected
set. by this rule--Area Source
Permitting.
Sec. 63.1(c)(3)-(4)......... [Reserved]...................... ............ ................................
Sec. 63.1(c)(5)............. Subject to notification No ................................
requirements.
Sec. 63.1(d)................ [Reserved]...................... ............ ................................
Sec. 63.1(e)................ Emission limitation by permit... Yes ................................
Sec. 63.2................... Definitions..................... Yes ................................
Sec. 63.3................... Units and abbreviations......... Yes ................................
Sec. 63.4................... Prohibited activities........... Yes ................................
Sec. 63.5................... Construction/Reconstruction..... No ................................
Sec. 63.6(a), (b)(1)-(5), Compliance with standards and Yes ................................
b(7). maintenance requirements.
Sec. 63.6(b)(6)............. [Reserved]...................... ............ ................................
Sec. 63.6(c)(1)............. Compliance dates for existing No Subpart WWWWW requires
sources. compliance 1 year after the
effective date.
Sec. 63.6(c)(2)-(c)(5)...... Compliance dates for CAA section No ................................
112(f) standards and for area
sources that become major.
Sec. 63.6(d)................ [Reserved]...................... ............ ................................
Sec. 63.6(e)-(h)............ Alternative nonopacity emission No ................................
standard.
Sec. 63.6(i)-(j)............ Compliance extension............ Yes ................................
Sec. 63.7................... Performance testing requirements No ................................
Sec. 63.8................... Monitoring requirements......... No ................................
Sec. 63.9(a)................ Applicability and initial Yes ................................
notifications addressees.
Sec. 63.9(b)................ Initial notifications........... No ................................
Sec. 63.9(c)................ Request for extension of Yes ................................
compliance.
Sec. 63.9(d)-(j)............ Other notifications............. No ................................
Sec. 63.10(a)(1)-(2)........ Recordkeeping and reporting No ................................
requirements, applicability.
Sec. 63.10(a)(3)-(4)........ General information............. Yes ................................
Sec. 63.10(a)(5)-(7)........ Recordkeeping and reporting No ................................
requirements, reporting
schedules.
Sec. 63.10(b)(1)............ Retention time.................. Yes ................................
Sec. 63.10(b)(2)-(f)........ Recordkeeping and reporting No ................................
requirements.
Sec. 63.11.................. Control device requirements..... No ................................
Sec. 63.12.................. State authority and delegations. Yes ................................
Sec. Sec. 63.13-63.16...... Addresses, Incorporations by Yes ................................
Reference, availability of
information, performance track
provisions.
----------------------------------------------------------------------------------------------------------------
[FR Doc. E6-18644 Filed 11-3-06; 8:45 am]
BILLING CODE 6560-50-P
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