[Federal Register Volume 72, Number 248 (Friday, December 28, 2007)]
[Rules and Regulations]
[Pages 73611-73625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-25233]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[EPA-HQ-OAR-2005-0171; FRL-8512-1]
RIN 2060-AM14
National Emission Standards for Hospital Ethylene Oxide
Sterilizers
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is issuing national emissions standards 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 final rule is based on EPA's determination as to what constitutes
the generally available control technology or management practices for
the hospital sterilizer area source category.
This action is being finalized as part of EPA's obligation to
regulate area sources listed for regulation pursuant to Clean Air Act
section 112(c)(3).
DATES: The final rule is effective on December 28, 2007.
ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2005-0171. All documents in the docket are listed in the
Federal Docket Management System index at http://www.regulations.gov.
Although listed in the index, some information is not publicly
available, e.g., confidential business information or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically through
www.regulations.gov or in hard copy at the EPA Docket Center in the EPA
Headquarters Library, Room Number 3334 in the EPA West Building,
located at 1301 Constitution Ave., NW., Washington, DC. The EPA/DC
Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m.
Eastern Standard Time (EST), Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744. For the Air and Radiation Docket and Information Center, the
telephone number is (202) 566-1742, the fax number is (202) 566-9744,
the Web site is http://www.epa.gov/oar/docket.html, and the e-mail
address is [email protected].
FOR FURTHER INFORMATION CONTACT: Mr. David Markwordt, Office of Air
Planning and Standards, Sector Policies and Programs Division, Coatings
and Chemicals Group (E143-01), Environmental Protection Agency,
Research Triangle Park, NC 27711, telephone number: (919) 541-0837; fax
number: (919) 541-0246; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION: Outline. The information presented in this
preamble is organized as follows:
I. General Information
A. Does this action apply to me?
B. Where can I get a copy of this document?
C. Judicial Review
II. Background Information for Final Area Source Standard
III. Summary of the Final Rule and Significant Changes Since
Proposal
A. What is the affected source and the compliance date?
B. What is required by the management practice?
C. What are the testing and initial compliance requirements?
D. What are the notification, recordkeeping, and reporting
requirements?
IV. Exemption of Certain Area Source Categories From Title V
Permitting Requirements
V. Summary of Comments and Responses
A. Proposed Alternative 1: Management Practice
B. Proposed Alternative 2: No Control
C. Add-on Controls
VI. Summary of Environmental, Energy, Cost, and Economic Impacts
VII. 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
J. Executive Order 12898: Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations
K. Congressional Review Act
I. General Information
A. Does this action apply to me?
The regulated categories and entities potentially affected by these
final standards include:
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Category NAICS\1\ code Example of potentially regulated entities
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General Medical and Surgical Hospitals....... 622110 Hospital sterilizers.
Specialty (Except Psychiatric and Substance 622310 Hospital sterilizers.
Abuse) Hospitals.
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\1\ North American Industrial Classification System.
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
action. To determine whether your facility is regulated by this action,
you should examine the applicability criteria in 40 CFR 63.10382 of
subpart WWWWW (National Emissions Standards for Hospital Ethylene Oxide
Sterilizers). If you have any questions regarding the applicability of
this action to a particular entity, consult either the air permit
authority for the entity or your EPA regional representative as listed
in 40 CFR 63.13 of subpart A (General Provisions).
B. Where can I get a copy of this document?
In addition to being available in the docket, an electronic copy of
this final action is also available on the Worldwide Web through the
Technology Transfer Network (TTN). Following signature, a copy of this
final action will be posted on the TTN's policy and guidance page for
newly proposed or promulgated rules at the following address: http://www.epa.gov/ttn/oarpg/. The TTN provides information and technology
exchange in various areas of air pollution control.
C. Judicial Review
Under section 307(b)(1) of the Clean Air Act (CAA), judicial review
of this final rule is available only by filing a petition for review in
the United States
[[Page 73612]]
Court of Appeals for the District of Columbia Circuit by February 26,
2008. Under section 307(d)(7)(B) of the CAA, only an objection to this
final rule that was raised with reasonable specificity during the
period for public comment can be raised during judicial review. This
section also provides a mechanism for EPA to convene a proceeding for
reconsideration, ``[i]f the person raising an objection can demonstrate
to the EPA that it was impracticable to raise such objection within
[the period for public comment] or if the grounds for such objection
arose after the period for public comment (but within the time
specified for judicial review) and if such objection is of central
relevance to the outcome of the rule.'' Any person seeking to make such
a demonstration to us should submit a Petition for Reconsideration to
the Office of the Administrator, U.S. EPA, Room 3000, Ariel Rios
Building, 1200 Pennsylvania Ave., NW., Washington, DC 20460, with a
copy to both the person(s) listed in the preceding FOR FURTHER
INFORMATION CONTACT section, and the Associate General Counsel for the
Air and Radiation Law Office, Office of General Counsel (Mail Code
2344A), U.S. EPA, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Moreover, under section 307(b)(2) of the CAA, the requirements
established by this final rule may not be challenged separately in any
civil or criminal proceedings brought by EPA to enforce these
requirements.
II. Background Information for Final Area Source Standard
Sections 112(c)(3) and 112(k)(3)(B) of the CAA instruct EPA to
identify not less than 30 hazardous air pollutants (HAP) which, as a
result of emissions from area sources,\1\ present the greatest threat
to public health in the largest number of urban areas, and to list
sufficient area source categories to ensure that sources representing
90 percent of the 30 listed HAP (the ``urban HAP'') are subject to
regulation. Consistent with these provisions, in 1999, in the
Integrated Urban Air Toxics Strategy (64 FR 38706, 64 FR 38715-716,
July 19, 1999), EPA identified the 30 urban HAP and listed the source
categories that account for 90 percent of the urban HAP emissions.\2\
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\1\ An area source is a stationary source of HAP emissions that
is not a major source. A major source is a stationary source that
emits or has the potential to emit 10 tons per year (tpy) or more of
any HAP or 25 tpy or more of any combination of HAP.
\2\ Since its publication in the Integrated Urban Air Toxics
Strategy in 1999, the area source category list has undergone
several amendments.
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Under CAA section 112(d)(5), the Administrator may, in lieu of
standards requiring maximum achievable control technology (MACT) under
section 112(d)(2), elect to promulgate standards or requirements for
area sources ``which provide for the use of generally available control
technologies or management practices by such sources to reduce
emissions of hazardous air pollutants.'' As explained in the proposed
national emission standards for hazardous air pollutants (NESHAP), we
are setting standards for the Hospital Sterilizers Area Source category
pursuant to section 112(d)(5) of the CAA. See 71 FR 64907, November 6,
2006.
III. Summary of the Final Rule and Significant Changes Since Proposal
This section summarizes the final rule and identifies and discusses
the significant changes since proposal. For changes that were made as a
result of public comments, we have provided detailed explanations of
the changes and the rationale in the responses to comments in section V
of this preamble.
A. What is the affected source and the compliance date?
This final rule applies to any existing or new hospital ethylene
oxide sterilization facility that is an area source of HAP. The owner
or operator of an existing area source must comply with this area
source NESHAP by December 29, 2008. The owner or operator of a new area
source must comply with this area source NESHAP by December 28, 2007 or
upon initial startup, whichever is later.
B. What is required by the management practice?
In our November 6, 2006 proposal, we proposed two alternative
emission standards for this area source category. As Alternative 1, we
proposed to require that the affected source, as defined above,
sterilize full loads of medical items having common aeration times
except during emergency circumstances that dictate the use of less than
full loads to protect human health. As Alternative 2, we proposed a
finding that there are no generally available control technologies or
management practices (GACT) within the meaning of CAA section 112(d)(5)
for the Hospital Sterilizers Area Source category. As explained in more
detail in section V of this preamble, based on the comments and
information we received during the public comment period, we conclude
that the management practice described in Alternative 1 reflects GACT
for this area source category, and we, therefore, adopt Alternative 1
as the standard for area source hospital ethylene oxide sterilization
facilities.
Specifically, the final rule requires that a hospital ethylene
oxide sterilization facility sterilize full loads of items having a
common aeration time except where medical necessity dictates the use of
less than a full load to protect human health. As explained in more
detail in section V.A.3 of this preamble, the determination that a
medical necessity exists must be made by a hospital central services
staff,\3\ a hospital administrator, or a physician on duty. This
management practice applies to all affected sources. As explained in
more detail in section V.A.2 of this preamble, sources may demonstrate
compliance with this requirement by operating their sterilizers with an
air pollution control device and providing the certification required
in this final rule.
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\3\ Hospital central services staffs are healthcare
professionals, including managers and technicians, who are either
directly involved in or responsible for sterile processing at a
hospital.
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C. What are the testing and initial compliance requirements?
There are no performance test requirements for the management
practice standard. Affected sources are required to submit an Initial
Notification of Compliance Status that notifies EPA that they operate a
sterilizer covered by the rule and certify that they are operating
their sterilizers in accordance with the requirement of the rule.
In the preamble to the proposed rule, we acknowledged that some
hospitals operate their sterilizers with add-on controls and that such
controls achieve reductions in ethylene oxide emissions that are at
least equivalent to the ethylene oxide reductions resulting from the
management practice. Therefore, the final rule includes the use of a
control device as an alternative compliance option for the management
practice requirement. Specifically, a source may demonstrate compliance
by certifying that it is operating its sterilizer(s) with an air
pollution control device. The source must certify that it is running
the sterilizer(s) in accordance with any applicable State and/or local
regulations, or, if there are no such regulations, with manufacturers'
specifications.
D. What are the notification, recordkeeping, and reporting
requirements?
As mentioned above, affected sources must submit an Initial
Notification of Compliance Status that includes the
[[Page 73613]]
required compliance certification described above. The final rule does
not require ongoing reporting.
Except for hospital ethylene oxide sterilization facilities that
demonstrate compliance by using add-on controls, affected sources must
maintain on site records of the date and time of each sterilization
operation. If less than a full load is sterilized due to medical
necessity, the operator must record this as well. These sterilization
records must be kept in a form suitable and readily available for
expeditious review. They must be kept for 5 years and at least the most
recent 2 years on site.
IV. Exemption of Certain Area Source Categories From Title V Permitting
Requirements
Section 502(a) of the CAA provides that the Administrator may
exempt an area source category from title V if he determines that
compliance with title V requirements is ``impracticable, infeasible, or
unnecessarily burdensome'' on an area source category. See CAA section
502(a). In December 2005, in a national rulemaking, EPA interpreted the
term ``unnecessarily burdensome'' in CAA section 502 and developed a
four-factor balancing test for determining whether title V is
unnecessarily burdensome for a particular area source category, such
that an exemption from title V is appropriate. See 70 FR 75320,
December 19, 2005 (Exemption Rule).
The four factors that EPA identified in the Exemption Rule for
determining whether title V is ``unnecessarily burdensome'' on a
particular area source category include: (1) whether title V would
result in significant improvements to the compliance requirements,
including monitoring, recordkeeping, and reporting, that are proposed
for an area source category (70 FR 75323); (2) whether title V
permitting would impose significant burdens on the area source category
and whether the burdens would be aggravated by any difficulty the
sources may have in obtaining assistance from permitting agencies (70
FR 75324); (3) whether the costs of title V permitting for the area
source category would be justified, taking into consideration any
potential gains in compliance likely to occur for such sources (70 FR
75325); and (4) whether there are implementation and enforcement
programs in place that are sufficient to assure compliance with the
NESHAP for the area source category, without relying on title V permits
(70 FR 75326).
In discussing the above factors in the Exemption Rule, we explained
that we considered on ``a case-by-case basis the extent to which one or
more of the four factors supported title V exemptions for a given
source category, and then we assessed whether considered together those
factors demonstrated that compliance with title V requirements would be
`unnecessarily burdensome' on the category, consistent with section
502(a) of the Act.'' See 70 FR 75323. Thus, in the Exemption Rule, we
explained that not all of the four factors must weigh in favor of
exemption for EPA to determine that title V is unnecessarily burdensome
for a particular area source category. Instead, the factors are to be
considered in combination, and EPA determines whether the factors,
taken together, support an exemption from title V for a particular
source category.
In the Exemption Rule, in addition to determining whether
compliance with title V requirements would be unnecessarily burdensome
on the hospital sterilizer area source category, we considered,
consistent with the guidance provided by the legislative history of CAA
section 502(a), whether exempting the Hospital Sterilizer Area Source
category would adversely affect public health, welfare, or the
environment. See 70 FR 15254-15255, March 25, 2005.
In the proposed rule, we evaluated the four factors described above
in relation to the Hospital Sterilizer Area Source category and
explained our proposed conclusion that the factors collectively
demonstrated that compliance with title V requirements would be
unnecessarily burdensome for the source category. Among other things,
we explained in the preamble to the proposed rule, that title V
permitting would not result in significant improvements to the
compliance requirements for the Hospital Sterilizer Area Source
category. In the proposal, we further explained that title V permitting
may impose a significant burden on facilities within this source
category, some of which are small businesses. We explained that, for
many facilities, the cost of obtaining a title V permit may far exceed
the cost of complying with the final rule without significant gains in
compliance. Based on the above analysis, we proposed that title V
permitting would be ``unnecessarily burdensome'' for hospital
sterilizer area sources. We also proposed that the exemptions from
title V would not adversely affect public health, welfare, and the
environment.
In response to the proposed rule, we received two comments
concerning the proposed title V exemption. However, as discussed in
more detail in section V.A.7 of this preamble, neither comment
addressed the above-mentioned factors that we considered in proposing
the title V exemption. Accordingly, our assessment of these factors
remains unchanged in light of these comments. We, therefore, finalize
the proposed exemption for the Hospital Sterilizer Area Source category
in this rule. Hospital sterilizer area sources are not required to
obtain title V permits solely for purposes of being the subject of this
final NESHAP; however, if they are otherwise required to obtain title V
permits, such requirements are not affected by this exemption.
V. Summary of Comments and Responses
The hospital sterilizer area source rule was proposed on November
6, 2006 (71 FR 64907). The 60-day comment period ended on January 5,
2007, and we received a total of 10 comment letters on the proposed
NESHAP. Comments were received from one industry trade association, a
representative of one affected facility, representatives from two
affected Federal agencies, one sterilant manufacturer, three State and
local air pollution control agencies, one State agency association, and
one private citizen. This final rule reflects our consideration of all
of the comments received on the proposed action. This section
summarizes the significant comments received on the proposed NESHAP and
our response thereto. A summary of all of the minor comments and EPA's
response thereto are presented here in this preamble and in the
Response to Comments Document (RTC Document), which is available in
Docket No. EPA-HQ-OAR-2005-0171.
A. Proposed Alternative 1: Management Practice
1. Management Practice Approach
Comment: Two commenters supported promulgation of the management
practice approach, i.e., Regulatory Alternative 1. One of the
commenters noted that EPA recognizes that, by minimizing ethylene oxide
use with the management practice, hospital ethylene oxide sterilization
facilities also minimize ethylene oxide emissions. Both commenters
expressed that the proposed management practice alternative ensures
that hospitals sterilize the most number of medical devices per pounds
of ethylene oxide emitted, and it is consistent with hospital
practices.
Two commenters stated that the management practice is common sense.
One commenter argued that EPA's proposed GACT were neither acceptable
nor consistent with legal requirements. Another commenter stated that
EPA's
[[Page 73614]]
alternatives do not reflect what many sterilizers have achieved (using
control technology) and are capable of achieving cost effectively.
Response: As previously mentioned, we are setting standards for
hospital sterilizer area sources based on GACT (i.e., generally
available control technologies or management practices) pursuant to
section 112(d)(5) of the CAA. As several commenters noted, the
management practice for running sterilizers with full loads will ensure
that hospitals sterilize the most number of medical devices per pounds
of ethylene oxide emitted. We believe that the comments indicating that
the management practice is common sense, consistent with current
operating practices at many hospitals, and cost-effective, all support
our determination that this management practice represents a generally
available management practice that is used to control ethylene oxide
emissions from area source hospital sterilizers. We, therefore,
disagree with the comment that the management practice requirement in
this final rule is not consistent with legal requirements. In addition,
for a detailed discussion on EPA's consideration of the existing
control technologies, please see section V.C of this preamble.
2. Exemption of Certain Sources From the Rule
Comment: One commenter recommended that EPA exclude controlled
sources (i.e., sources with add-on control) and sources that use an
ethylene oxide concentration of less than 10 percent from all
requirements associated with Alternative 1 should EPA adopt that
alternative. The commenter expressed that Alternative 1 imposes no
additional substantive requirements on controlled sterilizers and would
only add administrative burdens with no additional environmental
benefits. The commenter also asserted that sources that use an ethylene
oxide concentration of less than 10 percent can be excluded with no
detrimental effect.
Response: EPA disagrees that this rule contains no substantive
requirements on controlled sterilizers. As we clarify in the final rule
and in section III.B of this preamble, all area source hospital
sterilizers, including sources with add-on controls, are subject to the
requirements in this final rule. However, the final rule provides
certain compliance options. Specifically, the final rule provides
sources with add-on controls the option of demonstrating compliance
with the management practice requirement by certifying that they will
continue to operate their sterilizers with such control.
EPA also rejects the recommendation of excluding from this rule
sources that use an ethylene oxide concentration of less than 10
percent. We recognize that there are hospital sterilization facilities
that use sterilant gas blends with low ethylene oxide concentrations.
However, we have no information suggesting that facilities using low
ethylene oxide sterilant gas blends emit negligible amounts of ethylene
oxide. On the contrary, it is our understanding that there is little
difference in the amount of ethylene oxide usage (and, therefore,
ethylene oxide emissions) between operating a sterilization cycle with
pure ethylene oxide as opposed to using sterilant gas blend with less
than 10 percent ethylene oxide. When we listed the Hospital Sterilizer
Area Source category, we included hospital ethylene oxide sterilization
facilities using sterilant gas blends and the commenter did not provide
any information that suggests these facilities should not be part of
the source category. Further, we have analyzed the costs and impacts
associated with the management practice that we are finalizing and we
believe the costs are reasonable. See section V.C.1 of this preamble.
For the reasons stated above, we reject the commenter's recommendation
to exclude from this regulation sources using sterilant gas blends with
less than 10 percent ethylene oxide concentration.
3. Exception to the Management Practice Requirement
Comment: One commenter stated that EPA would need to establish,
based on comments received and then propose again for comment, examples
of definitions of circumstances that would be acceptable for an
exemption to the full load requirement. Another commenter observed that
hospitals try to minimize their use of ethylene oxide and avoid
exceptions to full load runs. Although the commenter stated that
generating and managing an inclusive list of all the exceptions to
running a full load may be difficult, it provided examples for such
exceptions. Specifically, the commenter stated that, on some days, a
hospital may receive back from surgery just a few devices that must be
ethylene oxide-sterilized and returned as soon as possible to surgery
for cases scheduled for the next morning. The commenter stated that, in
these instances, the hospital can be forced to run a sterilizer with
less than a full load. The commenter also stressed that hospital
surgical needs can be unpredictable.
The commenter stated that hospitals have reduced their use of
ethylene oxide to sterilize medical devices (and its ethylene oxide
emissions) by switching to single-use devices or alternative
sterilizing and disinfection technologies, or by consolidating ethylene
oxide sterilization. The commenter noted that, ironically, a hospital
may increase the frequency with which it needs to run a partially
loaded ethylene oxide sterilizer as a result. The commenter, however,
emphasized that even with occasional running of less than full loads,
there has been a continuing decline in hospital ethylene oxide use and
emissions.
Another commenter similarly noted that hospitals currently strive
to run full loads unless it is medically necessary to run less than a
full load. According to the commenter, often the medical devices
processed by the hospital ethylene oxide sterilizer are expensive and
hospitals can only afford to retain a minimal number of such devices.
The commenter further noted that some of the devices are older devices
and cannot be replaced. The commenter stated that these devices are
typically utilized in surgical areas and, at times, these devices may
need to be used on consecutive days. The commenter stated that the
ethylene oxide sterilizer load is processed at the end of the day so
the devices will be ready for surgery the following day. According to
the commenter, by waiting to run a sterilization cycle until the end of
the day, the sterilizer load has a chance to fill up. The commenter
noted, however, that if a medical device is needed the following day,
the load will be processed even though the load is not full. The
commenter stated that the determination to process a load is based on
the needs of the patient.
Response: According to the comments, hospitals deviate from the
full-load management practice only when patient safety may be at risk.
EPA agrees that medical necessity warrants operating a partially loaded
ethylene oxide sterilizer. To accommodate patient needs, we have
incorporated in the final rule an exception based on medical necessity.
EPA also agrees with the comment that developing a comprehensive
list of medically necessary circumstances warranting sterilization of a
partial load is difficult. EPA is concerned that such a list may
inadvertently exclude some justified circumstances. Further, as
reflected in our final rule, we believe that the decision to run a
partially loaded sterilizer due to medical necessity should be made by
authorized hospital personnel who have knowledge
[[Page 73615]]
of patients' medical needs instead of by EPA. However, to assure that
hospitals run sterilizers in full loads except during medically
necessary circumstances, the final rule requires that facilities
document and maintain records of every sterilization cycle, including
each partially loaded sterilization, and confirm that it was medically
necessary.
Comment: One commenter noted that many university hospitals develop
new and unique surgical procedures and devices that may need to be
sterilized in partial loads to comply with the more stringent
requirements for sterilizing a new instrument.
Response: We believe that it is medically necessary to allow
hospitals to sterilize medical devices that are under research and
development without a full load. The novelty or uniqueness of the
design in some instances require different sterilizing parameters than
those used for regular medical devices. In addition, unlike medical
devices that are regularly used for patient care, new and experimental
medical devices that are under research and development do not have
established or known sterilization cycles. Therefore, they may
compromise the effectiveness of sterilizing other devices in the same
loads. However, hospitals generally do not possess enough medical
devices that are under research and development to fully load a
sterilizer. To avoid compromising the sterilization process of medical
devices regularly used for patient care, we believe that it is
medically necessary to allow hospitals to sterilize medical devices
that are under research and development in separate and partial loads.
Hospitals may invoke the medical necessity exception in the final rule
when sterilizing devices that are under research and development.
4. National or Urban
Comment: Three commenters recommended that EPA apply this rule
nationwide. Two of the commenters noted that hospital parking areas are
typically close to the hospital and that visitors and employees are,
therefore, exposed to emissions from hospital ethylene oxide
sterilizers regardless of the hospital's location (i.e., urban or
rural). One commenter stated that the impacts of ethylene oxide
emissions are localized and would be similar for most urban and rural
areas. According to the commenter, hospitals are typically located in
residential areas, whether or not they are in urban areas, and that
populations residing nearby would likely be exposed to the ethylene
oxide emissions from a hospital ethylene oxide sterilization facility.
Another commenter further stated that hospitals clearly serve more
sensitive populations who could be more susceptible to impacts from
exposure to ethylene oxide. The commenter similarly noted that the
impacts of ethylene oxide emissions are very local and would be roughly
the same for both urban and rural areas, except perhaps for hospitals
located in areas with a high population density.
Two commenters noted that the cost (of controlling a sterilizer) to
a facility is the same for a rural hospital and an urban hospital. The
commenters stated that, because the cost and impact are the same, there
does not appear to be any rationale for treating rural hospitals
differently from urban hospitals.
Response: We agree that a nationwide approach is appropriate given
the facts and circumstances of this particular area source category. A
rule of nationwide applicability is particularly appropriate here
because requiring controls nationwide provides for equitable emission
reductions. Control costs are not expected to differ in rural versus
urban settings, therefore, the control's cost-effectiveness is the
same, and economic impacts are equally distributed. Furthermore,
because hospitals are generally located in densely populated areas, we
expect negligible difference in the scope of this rule's coverage
between a national and an urban (i.e., Urban-1 and Urban-2 areas)
rule.\4\ We have received no comments recommending that we limit this
rule's applicability only to hospitals in Urban-1 and Urban-2 areas.
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\4\ In the Integrated Urban Strategy, EPA defined ``urban
areas'' to include Urban-1 and Urban-2 areas. (64 FR 38724). The
Urban-1 and Urban-2 definitions are based on the United States
Census Bureau's most current decennial census data. Urban-1 areas
are counties with metropolitan statistical areas with a population
greater than 250,000. Urban-2 counties are all other counties where
more than 50 percent of the population is designated urban by the
United States Census Bureau.
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5. Compliance Date
Comment: One commenter stated that EPA's proposal that a source
comply with the management practices within 1 year after the effective
date of the final rule may not be a sufficient period of time. The
commenter stated that two scenarios could result for medical facilities
under the management practice alternative. According to the commenter,
one scenario could be that medical facilities may need to purchase
smaller ethylene oxide sterilizers to turn around medical
instrumentation and equipment without having to purchase more of these
medical items, and this could involve construction projects/costs to
make ready additional space to accommodate the new sterilizers. The
commenter stated that the other scenario could be that medical
facilities may need to purchase additional medical instrumentation and
equipment to allow for sufficient availability while waiting for enough
items to accumulate to run a full load in an ethylene oxide sterilizer.
The commenter suggested that EPA consider the costs of additional
ethylene oxide sterilizer equipment and related construction, as well
as the additional medical instrumentation and equipment costs in any
proposed rule by EPA.
Response: EPA does not believe that the management practice
requirement in Alternative 1 will result in either of the scenarios
described above. The management practice requires sterilizing full
loads except during medically necessary circumstances, i.e., necessary
to protect human health. As discussed above, this exception to running
sterilizers in full loads is based on patient needs. Under the final
rule, whether a medically necessary circumstance exists must be
determined by an authorized hospital personnel. The final rule,
however, requires only that the hospital personnel consider whether
sterilizing a partial load is necessary to protect human health; the
personnel are not required to consider whether there are viable
alternatives to running a partial load, such as purchasing additional
sterilizer equipment or medical devices, before invoking the exception
to the management practice requirement. Therefore, we do not expect any
need for construction and/or capital expenditures associated with such
new purchases, as the commenter suggested. We have received no other
comments suggesting that hospitals may have difficulty achieving
compliance with the management practice alternative within 1 year, as
we proposed. We, therefore, retain the 1-year compliance deadline in
the final rule.
6. Recordkeeping
Comment: In the proposed rule, EPA solicited comments on whether to
require recordkeeping under Alternative 1. We received six comments on
recordkeeping. One commenter asked that EPA specify what recordkeeping
would entail if less than full loads were run and what EPA would
propose to be done with these records. Another commenter stated that,
regardless of the size of the load, all items sterilized are recorded
following the Association for the Advancement of Medical
Instrumentation standard, Ethylene
[[Page 73616]]
Oxide Sterilization in Health Care Facilities: Safety and
Effectiveness, ANSI/AAMI ST 41:1999. According to the commenter, the
sterilizer records under this standard include the following: Load or
lot number; item description and quantity; the department; the name of
the sterilizer operator; aeration time and temperature; results of the
biological monitoring (which is processed with each load to ensure that
sterilization has occurred); chemical indicator results; and reports of
nonresponsive chemical indicators.
Two commenters stated that hospitals keep a record of each load
they run for traceability. Two commenters stated that hospitals could
probably add a few more items of information to their records to comply
with EPA's requirements. These commenters recommended that EPA's
recordkeeping requirements be consistent with hospitals' current
practice in maintaining records of sterilized loads.
Two commenters indicated that some State programs require keeping
sterilization records, and one commenter stated that some States have
required such recordkeeping for many years. The commenters indicated
that some hospitals keep such records through computerized
recordkeeping systems while others use handwritten records. The
commenters believed that these requirements are not likely to be overly
burdensome or costly to the facilities.
Response: In light of the comments indicating that hospitals are
already keeping records of each sterilization cycle and that such
recordkeeping provisions are not overly costly or burdensome, we are
requiring affected facilities to keep sterilization records in the
final rule. Specifically, the final rule requires that a facility
record the date and time of each sterilization cycle, whether each
sterilization cycle contains a full load of items, and, for each
partial load, state that it was medically necessary. Based on
information provided during the comment period, we believe that this
recordkeeping requirement is consistent with hospitals' current
practice. We also believe the time required to keep these records would
be offset by the time saved by the reduced cycles run.
7. Title V Permitting
Comment: One commenter favored title V permitting. The commenter
stated that, by requiring title V permits, title V funds could be used
to assure compliance. The commenter noted that, according to an EPA
Regional office, title V funds cannot be used for non-title V programs.
The commenter stated that if, from a national perspective, EPA prefers
to exempt area sources such as these from title V permitting, EPA
should explain the level of effort they expect from State and local
agencies, and develop a funding mechanism for that effort. The
commenter further noted that, in this case, the commenter's State
already has operating permits for affected facilities and that there
would be little cost involved in updating these permits to reflect the
Federal rule during the normal permit renewal process.
Response: As discussed in the preamble to the proposed rule, EPA
considered four factors in determining whether title V is
``unnecessarily burdensome'' for a particular area source category.
Based on its consideration of these factors, EPA concluded that the
requirements of title V would be unnecessarily burdensome for area
source hospital ethylene oxide sterilization facilities. Among other
things, EPA concluded that title V permitting would not result in
significant improvements to the compliance requirements for the
hospital ethylene oxide sterilization area source category and that
title V permitting would likely impose a significant burden on
facilities within the source category, some of which are small
businesses. The Agency also found that, for many facilities, the cost
of obtaining a title V permit may far exceed the cost of complying with
the final rule without significant gains in compliance. EPA further
determined that the proposed exemptions from title V would not
adversely affect public health, welfare, and the environment.
Although the commenter advocates title V permitting, the commenter
failed to address EPA's application of the four factors described
above, and its conclusion that the proposed exemptions would not
adversely affect public health, welfare, and the environment. Indeed,
none of the commenters disagreed with any of EPA's proposed findings
described above and in the proposed rule that served as the basis for
the proposed title V exemption.
Instead of challenging EPA's application of the four factors
relevant to determining whether title V requirements would be
unnecessarily burdensome on a particular area source category, the
commenter focuses on the fact that, in its State, area source hospital
sterilizers have State operating permits and that adding the
requirements of this rule to those permits would involve little costs.
The fact that title V permitting may not be burdensome or costly in one
State does not reflect the burden or costs associated with title V
permitting nationwide. Once again, the commenter has not identified any
flaws in EPA's application of the four factor test described above,
which involve an assessment of the costs of title V reporting for the
entire source category. Therefore, for the reasons discussed above and
in the proposed rule, we are exempting area source hospital ethylene
oxide sterilization facilities from the requirements of title V in this
final rule.
The commenter apparently favored title V permitting based on its
belief that ``by requiring title V permits, EPA would allow title V
funds to be used to assure compliance.'' The commenter requested that
EPA explain the level of State and local efforts that may be involved
in implementing and enforcing the requirements of the final rule and
develop a funding mechanism for that effort. We expect such effort to
be minimal. We believe that the management practice and the associated
recordkeeping requirements in this final rule are straightforward and
can, therefore, be easily implemented and enforced. Further, according
to the comments received, the management practice requirement is
consistent with hospital practices and hospitals are already keeping
records of sterilization cycles. In light of the above, we do not
anticipate that State and local agencies would need to spend a
significant level of effort to implement and enforce this rule. EPA,
however, remains committed to working with State and local agencies to
implement this rule. State and local agencies that receive grants for
continuing air programs under CAA section 105 should work with their
project officers to determine what resources are necessary to implement
and enforce this area source standard. EPA will continue to provide the
resources appropriated for CAA section 105 grants consistent with the
statute and the allotment formula developed pursuant to the statute.
Comment: One commenter agreed with EPA's proposal that title V
permits are not necessary for area sources. The commenter noted that
some hospitals, however, already have or are covered by title V
permits, and that any rulemaking has the potential to impose additional
permit modification costs. The commenter asserted that EPA should
minimize title V permitting cost impacts by adding a provision in this
rule stating that an existing title V permit does not have to be
reopened or revised to address the requirements of this rule until the
next time the permit is renewed, reopened, or revised for another
reason. The commenter
[[Page 73617]]
alternatively proposed that EPA consider an exemption similar to that
which was included in 40 CFR 63.7881(c)(3) of the recently finalized
amendments to the Site Remediation NESHAP.
Response: The commenter requested that EPA prescribe in this rule
the time for reopening and revising existing title V permits for area
source hospital sterilizers. CAA section 502(a) authorizes EPA to
exempt an area source category from title V permitting if the
Administrator finds that compliance with title V is impracticable,
infeasible, or unnecessarily burdensome on such category; however, to
the extent that some sources within this area source category are
already otherwise required to obtain title V permits, CAA section
502(a) does not authorize EPA to affect in any way these sources'
existing obligations under title V, including when the permits must be
renewed. As discussed above, pursuant to CAA section 502(a), EPA has
determined that the requirements of title V would be unnecessarily
burdensome for area source hospital ethylene oxide sterilization
facilities. Accordingly, this final rule exempts area source
sterilization facilities from the obligation to obtain title V permits
for purposes of being subject to the requirements of this rule. The
commenter, however, is requesting that EPA prescribe in this rule the
time for reopening and revising existing title V permits for area
source hospital sterilizers. The commenter's request is unrelated to
and beyond the scope of EPA's authority to issue this area source rule
pursuant to CAA sections 112(c)(3) and 112(d)(5). The request is also
beyond the scope of EPA's authority under CAA section 502(a) to exempt
area sources from title V permitting. We, therefore, reject the
commenter's request to include its recommended language in this final
rule.
B. Proposed Alternative 2: No Control
Comment: One commenter recommended that EPA select Regulatory
Alternative 2 (the no additional control alternative). The commenter
stated that hospitals have strong economic incentives to operate
sterilizers with a full load because doing so reduces both material and
labor costs. According to the commenter, because economics already
drive hospital ethylene oxide sterilization facilities to implement the
management practice, Alternative 1 is unlikely to result in significant
emission reduction. The commenter states that it has encouraged its
facilities to switch to alternative sterilization methods and,
therefore, there are not many ethylene oxide sterilizers at its
facility.
Response: As previously mentioned, we included two regulatory
alternatives in the proposed rule. As Alternative 1, we proposed to
require that hospitals sterilize full loads of medical items having
common aeration times except during emergency circumstances that
dictate the use of less than full loads to protect human health.
However, at the time of the proposal, we had limited information to
conclude that the proposed management practice in Alternative 1 reduced
ethylene oxide emissions or was cost-effective. Therefore, we included
an alternative proposal (Alternative 2) that there are no GACT within
the meaning of CAA section 112(d)(5) for the Hospital Sterilizers Area
Source category. We also solicited comments on the costs and emission
reduction estimates for the management practice.
As explained in more detail in section V.A.1 of this preamble, we
have since received comments indicating that the management practice
minimizes ethylene oxide emissions by minimizing ethylene oxide use and
that the practice is cost-effective. We, therefore, conclude that the
management practice requirement we proposed as Alternative 1 reflects a
generally available management practice within the meaning of CAA
section 112(d)(5) for this area source category.
The commenter apparently agreed that the management practice is
cost-effective. It stated that hospitals have economic incentives to
run the sterilizers full because it reduces both labor and material
costs. The commenter, nevertheless, recommended Alternative 2, claiming
that Alternative 1 may not achieve significant reduction since it is
already being implemented. However, the CAA does not require a GACT
standard to achieve any specific level of emission reduction.
As explained above, we have determined that the management practice
that we proposed as Alternative 1 represents GACT for this area source
category. The commenter offered no information suggesting otherwise.
Having determined that our proposed Alternative 1 represents GACT, we
can no longer conclude that there are no GACT within the meaning of CAA
section 112(d)(5). We, therefore, reject the commenter's recommendation
that we adopt the no control option (Alternative 2) in this final rule.
C. Add-on Controls
1. Cost Considerations
Comment: Four commenters recommended that EPA require add-on
controls for the area source hospital ethylene oxide sterilizers. Two
commenters noted that, in the preamble to the proposed rule, EPA stated
that the two predominant types of control devices (i.e., acid-water
scrubbers and catalytic oxidation units) reduce emissions by
approximately 99 percent. One of these two commenters also noted that,
according to the National Toxicology Program, researchers have
demonstrated that the application of these control technologies to
hospital sterilizers effectively reduce ethylene oxide concentrations.
This commenter, therefore, concluded that proven control technology is
readily available to control ethylene oxide emissions from hospital
sterilizers and that application of this technology is practicable,
feasible, prudent, and not unnecessarily burdensome. Two commenters
drew the same conclusion, noting that the control technologies have
been required by some State programs for many years. One commenter
similarly stated that if more than half of the sources already have
add-on controls, it suggests that these controls are practical and
feasible.
One commenter expressed that, with nearly half of the hospitals
using add-on controls, it is hard to understand EPA's rationale in the
proposed rule that add-on controls are too costly. One commenter
suggested that, if cost is to be considered, EPA should consider a full
array of alternatives, including the cost of alternatives to
sterilization and alternative means of sterilization, and compare them
to the cost of controlling ethylene oxide sterilization. The commenter
stated that the proposed rule presumes ethylene oxide sterilization
must be preserved. The commenter noted that in the Hospital, Medical,
Infectious Waste Incinerator (HMIWI) standard, however, EPA recognized
that there were alternatives to incineration of the wastes and,
therefore, required emission controls that were not necessarily cost-
effective. The commenter recommended that the same approach should be
applied here.
One commenter stated that installing control would be an
unnecessary cost to hospitals providing no benefits. The commenter
observed that hospital ethylene oxide sterilization has declined due to
Occupational Safety and Health Administration regulations, new
sterilization methods, and new designs and materials used in medical
devices. The commenter, however, emphasized that ethylene oxide
sterilization is a
[[Page 73618]]
necessity in hospitals. The commenter explained that the medical
devices processed by ethylene oxide are expensive and that hospitals
can only afford minimal amounts on hand. The commenter further
explained that some of the medical devices are old and cannot be
replaced. The commenter noted that these devices are typically utilized
in surgical areas. The commenter stated that EPA's rationale makes
clear that existing ethylene oxide emission control technology will not
provide the type of cost-benefit needed to justify new hospital
investment in the control devices. The commenter noted that the cost of
add-on control would include not just the cost of the device, but also
the cost of installation, facility modification, annual testing of
control devices, and utility and maintenance.
Response: CAA section 112(d)(5) provides that, with respect to area
source categories listed pursuant to CAA section 112(c), the
Administrator may, in lieu of MACT, promulgate standards or
requirements which provide for the use of GACT. As explained in the
preamble to the proposed rule, EPA is issuing the standards for the
hospital sterilizers area source category under CAA section 112(d)(5).
In determining what constitutes GACT for a particular area source
category, EPA evaluates the control technologies and management
practices that reduce HAP emissions and are generally available for the
area source category. The legislative history supporting CAA section
112(d)(5) provides that EPA may consider costs in determining what
constitutes GACT for the area source category.\5\
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\5\ Additional information on the definition of ``generally
available control technologies or management practices'' (GACT) is
found in the Senate report on the 1990 amendments to the CAA (S.
Rep. No. 101-228, 101st Cong. 1st session. 171-172). That report
states that GACT is to encompass: * * * methods, practices and
techniques which are commercially available and appropriate for
application by the sources in the category considering economic
impacts and the technical capabilities of the firms to operate and
maintain the emissions control systems.
---------------------------------------------------------------------------
In considering costs, the commenters who recommended add-on control
focused mainly on the actual costs to hospitals and asserted that such
control is likely not too costly if many hospitals are using it under
existing State or local requirements. As we stated in the preamble to
the proposed rule, EPA recognizes that over half of the hospitals use
add-on controls. However, the actual cost to individual hospitals is
but one cost factor that we considered in this rulemaking. We also
noted that the total annualized cost for add-on controls, which we
estimated to be $8.5 million, exceeds the total annualized cost for the
management practice, which we estimated to range from $32,000 to
$61,000, by more than 100 fold. In addition, we considered the cost-
effectiveness of the add-on controls. See, e.g., Husquavarna AB v. EPA,
439 U.S. App. DC 118, 254 F.3d 195, 201 (DC Cir. 2001) (finding EPA's
decision to consider costs on a per ton of emissions removed basis
reasonable because CAA section 213 did not mandate a specific method of
cost analysis). EPA's cost analysis for the add-on controls showed poor
cost-effectiveness. Specifically, EPA's cost-effectiveness estimate for
add-on controls was $200,000 per ton of ethylene oxide reduced. This
cost-effectiveness excludes monitoring, recordkeeping, and reporting
costs.
We also considered alternatives to ethylene oxide sterilization, as
one commenter suggested. We learned from several commenters that,
although ethylene oxide sterilization in hospitals has declined, it
remains a necessity for certain medical devices that cannot be easily
replaced or sterilized by other means. We agree with these commenters
that, in light of the declined level of ethylene oxide sterilization
and the lack of alternatives for sterilizing certain unique and
expensive medical devices, the benefit of requiring add-on control is
outweighed by the various costs associated with such control. Based on
the foregoing, we determined that add-on controls do not represent GACT
for this area source category.
One commenter argued that EPA required add-on control in the HMIWI
standard that were not necessarily cost-effective and that EPA should
take the same approach in this final rule.\6\ The HMIWI standard,
however, was promulgated pursuant to section 129 of the CAA, which
requires that EPA establish standards that reflect the MACT. Consistent
with the requirements of CAA section 129, EPA issued the original HMIWI
standards based on MACT. CAA section 129(a)(2) does not allow EPA to
consider costs in setting the floor for control. By contrast, EPA is
issuing this final rule pursuant to CAA section 112(d)(5), which allows
EPA to consider costs, including cost-effectiveness, in establishing
GACT. Thus, the HMIWI rule is not relevant, because in that rule, EPA,
by statute, could not consider costs.
---------------------------------------------------------------------------
\6\ 40 CFR part 60, subpart Ce--Emission Guidelines and
Compliance Times for Hospital/Medical/Infectious Waste Incinerators
(constructed on or before June 20, 1996).
40 CFR part 60, subpart Ec--Standards of Performance for
Hospital/Medical/Infectious Waste Incinerators for Which
Construction is Commenced After June 20, 1996.
---------------------------------------------------------------------------
2. Best Available Control Technology (BACT) or MACT
Comment: One commenter stated that, because ethylene oxide is a
known human carcinogen, its emissions should be controlled using the
BACT. The commenter stated alternatively that, due to the widespread
use of control on hospital sterilizers, the MACT floor level of control
would be add-on controls under CAA section 112(d)(2). The commenter
stated that, based on the experience in its State, the MACT floor and
associated recordkeeping are feasible and prudent and, therefore, none
of EPA's proposals are in accordance with legal requirements. The
commenter claimed that the proposed NESHAP must be revised to represent
MACT floor of add-on emission control and recordkeeping as required by
law.
Response: CAA section 112(c)(2) requires that EPA establish
emission standards under CAA section 112(d) for the categories listed
under CAA section 112(c), including area source categories listed
pursuant to CAA section 112(c)(3). As mentioned above, EPA may issue
standards for listed area source categories based on MACT (CAA section
112(d)(2)) or GACT (CAA section 112(d)(5)). CAA Section 112(d) does not
contain a standard based on BACT. Therefore, EPA rejects the
commenter's request to require the use of BACT because such standard is
not authorized by the CAA.
The commenter also argued alternatively that neither of EPA's
proposed alternatives was in accordance with legal requirements and
that EPA must issue a MACT standard as required by law. The commenter,
however, did not identify any legal requirement that allegedly is not
satisfied by EPA's proposed alternatives or requires EPA to issue a
MACT standard for the Hospital Sterilizer Area Source category. On the
contrary, the commenter noted that ``EPA is 'exercising discretion' in
promulgating standards or requirements under section 112(d)(5) of the
CAA.'' Although the commenter acknowledged that EPA has discretion
under CAA section 112(d)(5) to issue a GACT standard in lieu of a MACT
standard for listed area source categories, it claimed that, based on
its State's experience with regulating and controlling ethylene oxide
emissions from hospital sterilizers, the MACT floor and associated
recordkeeping are feasible and prudent. The commenter argued that,
therefore, neither of EPA's proposals is acceptable in accordance with
legal requirements and that EPA
[[Page 73619]]
must issue a MACT standard as required by law.
The commenter's argument seems to imply that EPA must first find
that a MACT standard is infeasible, imprudent, or otherwise
inappropriate before the Agency can legally issue a GACT standard for
an area source category pursuant to section 112(d)(5) of the CAA.
However, there is no such requirement under the CAA. In fact, the CAA
does not contain any condition precedent for issuing a GACT standard
under CAA section 112(d)(5). CAA section 112(d)(5), which is entitled
``Alternative standard for area sources,'' provides:
With respect only to categories and subcategories of area
sources listed pursuant to subsection (c) of this section, the
Administrator may, in lieu of the authorities provided in paragraph
(2) and subsection (f) of this section, elect to promulgate
standards or requirements applicable to sources in such categories
or subcategories which provide for the use of generally available
control technologies or management practices by such sources to
reduce emissions of hazardous air pollutants. (Emphasis added).
There are two critical aspects to CAA section 112(d)(5). First, CAA
section 112(d)(5) applies only to those categories and subcategories of
area sources listed pursuant to CAA section 112(c). The commenter does
not dispute that EPA listed the Hospital Sterilizer Area Source
category pursuant to CAA section 112(c)(3). Second, CAA section
112(d)(5) provides that, for area sources listed pursuant to CAA
section 112(c), EPA ``may, in lieu of '' the authorities provided in
CAA section 112(d)(2) and 112(f), elect to promulgate standards that
provide for the use of generally available control technologies or
management practices (GACT). Section 112(d)(2) provides that emission
standards established under that provision ``require the maximum degree
of reduction in emissions'' of HAP (also known as MACT).\7\ Webster's
dictionary defines the phrase ``in lieu of'' to mean ``in the place
of'' or ``instead of.'' See Webster's II New Riverside University
(1994). Thus, CAA section 112(d)(5) authorizes EPA to promulgate
standards that provide for the use of GACT instead of issuing MACT
standards. The statute does not set any condition precedent for issuing
standards under CAA section 112(d)(5) other than that the area source
category or subcategory at issue must be one that EPA listed pursuant
to CAA section 112(c), which is the case here. Had Congress intended
that EPA first conduct a MACT analysis for each area source category
and only if cost or some other reason made applying the MACT standard
inappropriate for the category would EPA be able to issue a standard
under CAA section 112(d)(5), Congress would have stated so expressly in
CAA section 112(d)(5). Congress did not require EPA to conduct any MACT
analysis, floor analysis, or beyond-the-floor analysis before the
Agency could issue a CAA section 112(d)(5) standard. Rather, Congress
authorized EPA to issue GACT standards for area source categories
listed under CAA section 112(c)(3), and that is precisely what EPA has
done in this rulemaking.
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\7\ CAA section 112(d)(5) also references CAA section 112(f).
See CAA section 112(f)(5) (entitled ``Area Sources'' and providing
that EPA is not required to conduct a review or promulgate standards
under CAA section 112(f) for any area source category or subcategory
listed pursuant to CAA section 112(c)(3) and for which an emission
standard is issued pursuant to CAA section 112(d)(5)).
---------------------------------------------------------------------------
Although EPA has no obligation to justify why it is issuing a GACT
standard for an area source category as opposed to a MACT standard, we
did so in the proposed rule. See 71 FR 64910, November 6, 2006. As
explained in the proposed rule, we determined that 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). As explained in more detail
in section V.C.1 of this preamble, we took costs into consideration and
determined that the benefit of requiring add-on controls is outweighed
by the costs associated with such control. We believe the consideration
of costs is especially important for the well-controlled area sources
at issue in this final action because, given current well-controlled
levels, a MACT floor determination, where costs cannot be considered,
could result in only marginal reductions in emission at very high
costs.
3. Consideration of Health Impacts or Risks
Comment: According to one commenter, EPA's decision not to require
add-on control appears to be based on cost-effectiveness without much
regard for heath impact or risk. The commenter argued that an
appropriate analysis would consider the health impacts where people are
exposed. Four commenters identified health risks from ethylene oxide
exposure as a basis for requiring add-on control. The commenters noted
that ethylene oxide is a carcinogen and described in detail health
effects from ethylene oxide exposure. In addition, one commenter stated
that, since these sterilization units are located in hospitals which
are densely populated with staff and patients, extra care should be
taken to assure their health and safety. One commenter expressed
concern that people living, working, and visiting the vicinity of the
uncontrolled sources (i.e., those that do not have add-on controls) are
not afforded the same level of protection as those near controlled
sterilizers.
Two commenters stated that hospital ethylene oxide emissions are
minimal and declining and that the potential risks of ethylene oxide
emissions, based on the EPA analysis, are also minimal. Accordingly,
both commenters stated that there is no benefit for installing ethylene
oxide emission control equipment, and one commenter stated that any
benefits would be insignificant and far outweighed by the real costs
associated with the control.
Response: As previously explained, pursuant to sections 112(c)(3)
and 112(k)(3)(B) of the CAA, EPA identified ethylene oxide as one of 30
HAP that present the greatest threat to public health in the largest
number of urban areas and listed Hospital Sterilizers Area Source as a
category needed to ensure that sources representing 90 percent of area
source ethylene oxide emissions are subject to regulation.
In the 1990 CAA Amendments, Congress established a two-phase
approach for setting HAP emission standards. Sierra Club v. EPA, 353
F.3d 976, 980 (D.C. Cir. 2004). The first phase is the initial standard
setting phase, which is the phase at issue in this rulemaking.\8\ In
this phase, the standards are technology-based, and this is true
regardless of whether we issue MACT standards under CAA section
112(d)(2) and (d)(3), or GACT standards under CAA section 112(d)(5).\9\
See Senate Report at 148 (1989); Sierra Club v. EPA, 353 F.3d at 980.
---------------------------------------------------------------------------
\8\ The second phase of standard setting involves a risk-based
analysis. Specifically, CAA section 112(f)(2) requires EPA to
determine--8 years after issuance of the initial MACT standard--
whether residual risks remain that warrant more stringent standards
than achieved through MACT. CAA Section 112(f)(5) provides that the
Agency shall not be required to conduct a residual risk for area
sources for which EPA has issued a GACT standard.
\9\ CAA Section 112(d)(4) does provide, however, that with
respect to pollutants for which the EPA Administrator has
established a health threshold, EPA can consider such threshold in
setting standards under CAA section 112(d). Ethylene oxide is a
carcinogen and is, thus, not a pollutant for which the Administrator
has established a health threshold, and, therefore, CAA section
112(d)(4) is not relevant to this category.
---------------------------------------------------------------------------
In this final rule, EPA is establishing emissions standards for
this area source category under CAA section 112(d)(5), which authorizes
EPA to set emissions standards based on GACT for a listed area source
category. The legislative history describes GACT as ``methods,
practices, and techniques which are
[[Page 73620]]
commercially available and appropriate for application by sources in
the category considering economic impacts and the technical
capabilities of the firms to operate and maintain the emissions control
systems.'' S. Rep. No. 101-228, at 171 (1989) (Senate Report).
Consistent with the statute and the legislative history, in
determining GACT, we evaluated the control technologies and management
practices that reduce HAP emissions from the ethylene oxide Hospital
Sterilizer Area Source category, and we assessed the costs of
implementing such approaches. We did not consider health impacts or
risks in establishing the emission standards for the Hospital
Sterilizer Area Source category, as the commenters recommended, nor
were we required by statute to do so. However, we note that health risk
did play a role in this process in that the determination of which
pollutants to regulate and from which categories was governed by the
statutory requirement to regulate sources accounting for 90 percent or
more of the 30 HAP that present the greatest health threat in urban
areas.
4. Potential Backsliding
Comment: One commenter noted that many hospital ethylene oxide
sterilizers are controlled (i.e., with add-on controls) as the result
of State and local programs. The commenter stated that in the preamble
to the proposed rule, EPA recognizes the contributions of the State and
local programs and is apparently relying upon them to ensure adequate
control of hospital sterilizers. The commenter stated that EPA's
proposal to rely on these programs, in lieu of Federal requirements, is
unwise and inappropriate. The commenter stated that the existence of
State and local regulations does not relieve the agency of its duty to
set emissions control requirements under CAA section 112. The commenter
further noted that many State and local agencies are not able to be
more stringent than Federal requirement and that it is conceivable that
some agencies could be required to change their regulations to be
consistent with those of the Federal government, resulting in relaxing
of existing non-Federal rules. The commenter also claims that State and
local regulations can change in the future for other reasons. The
commenter stated that, in the absence of Federal requirements, there
would be nothing to prevent backsliding by the sources if a State or
local rule is realized or eliminated.
Another commenter stated that for sources in its State, EPA's
issuance of this rule means that existing sources would continue to be
subject to the State air toxics rule that requires 99 percent control,
but new sources would only be subject to EPA's requirement. The
commenter stated that this amounts to backsliding on emission control
requirements and an increase in emissions.
Response: EPA has not shed its responsibility to set emission
standards under CAA section 112 because of existing State and local
regulations. On the contrary, EPA is issuing this final rule today to
regulate ethylene oxide emissions from hospital sterilizers. As
described above, pursuant to CAA section 112(d)(5), EPA has established
in this final rule a management practice requirement that represents
GACT for this area source category. EPA did not reject the add-on
control option in this rulemaking because it was relying on existing
State and local programs to require add-on controls, as one commenter
contended. Rather, as previously explained in section V.C.1 of this
preamble, EPA concludes that add-on controls do not represent GACT for
this area source category.
Two commenters expressed concern that certain States may require
that their existing regulations be relaxed as not to be more stringent
than EPA's standards. However, CAA section 112(l) only prohibits States
from setting standards that are less stringent than EPA's standards;
the CAA does not affect State and local emission standards that are
more stringent than the requirements of this final rule. The issue of
potential backsliding that the commenters raised is based on State law,
which EPA has no authority to change. We, however, encourage States to
revisit their State laws to address this concern.
5. Emissions From Aeration
Comment: One commenter noted that some sterilizers only operate
their catalytic control devices during the initial purge of ethylene
oxide (following sterilization) and not during the entire aeration
cycle. The commenter stated that the control device should be used for
all discharges, not just the initial purge.
Response: The commenter appears to be arguing that a control device
should be used to control both sterilization and aeration ethylene
oxide emissions instead of just sterilization emissions. The final rule
does not, however, require the use of a control device. EPA has
determined that the management practice in the final rule represents
GACT and requires that hospitals run sterilizers in full loads except
during medically necessary circumstances. This requirement will reduce
both sterilization and aeration ethylene oxide emissions by reducing
the amount of ethylene oxide usage.
Although the final rule does not require the use of a control
device, it allows the use of a control device as an alternative
compliance option for the management practice requirement because the
use of a control device achieves reduction in ethylene oxide emissions
that are at least equivalent to the ethylene oxide reduction resulting
from the management practice. This is true even if the control device
is used to control ethylene oxide emissions from sterilization only.
Therefore, controlling aeration emissions with a control device is not
necessary under the alternative compliance option.
VI. Summary of Environmental, Energy, Cost, and Economic Impacts
We estimate that in 2002 there were, at most, 1,900 hospital area
sources that conduct ethylene oxide sterilization, of which
approximately 630 do not presently have add-on controls. The final
management practice was estimated at proposal to reduce the 44 tpy
emitted from ethylene oxide sterilizers by 2 to 9 tpy. We did not
receive any comments that would allow us to improve this estimate.
Several commenters, however, stated that they are already employing the
management practice. With the management practice, we believe there is
minimal effect on either air quality or non-air quality environmental
impacts and there are negligible energy or economic impacts. Annualized
costs to comply with the final standards are estimated to range from
$32,000 to $61,000 per year.
VII. 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 or 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 documented in the docket for this action.
B. Paperwork Reduction Act
The information requirements in this rule have been submitted for
approval to OMB under the Paperwork Reduction Act, 44 U.S.C. 3501, et
seq. The information collection requirements are not enforceable until
OMB approves them.
The recordkeeping and reporting requirements in the final rule are
based
[[Page 73621]]
on the information collection requirements in the 40 CFR part 63
General Provisions (subpart A), some of which are incorporated into the
final NESHAP. The ICR document includes the burden estimates for all
applicable General Provisions. The recordkeeping and reporting
requirements in the General Provisions 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.
The final NESHAP for area sources requires a one-time initial
notification by hospital ethylene oxide sterilization facilities
certifying that the facility is in compliance with rule requirements
and requires recordkeeping for each sterilization cycle for sterilizers
not equipped with an air pollution control device.
The annual burden for the information collection averaged over the
first 3 years of this ICR is estimated to total 3,576 labor hours per
year at a cost of $245,000 for the 1,900 existing hospital sterilizer
area sources. Small annualized capital/startup costs and small
operation and maintenance costs are associated with the requirements.
No costs or burden hours are estimated for new area sources because no
new sources are estimated during the next 3 years. Burden means the
total time, effort, or financial resources expended by persons to
generate, maintain, retain, or 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 are listed in 40 CFR part 9. When this ICR is
approved by OMB, the Agency will publish a technical amendment to 40
CFR part 9 in the Federal Register to display the OMB control number
for the approved information collection requirements contained in this
final rule.
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 would not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
For the purposes of assessing the impacts of the area source NESHAP
on small entities, 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 this final rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. The final
rule requires the use of a management practice to minimize the
operation of the ethylene oxide sterilization unit and will, therefore,
have minimal nationwide costs, i.e., range from $32,000 to $61,000 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.
Although this final rule will not have a significant economic
impact on a substantial number of small entities, EPA nonetheless has
tried to reduce the impact of this rule on small entities. The final
rule is designed to harmonize with existing State or local
requirements.
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 to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one 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 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 final 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 one year. Thus, the final rule is not subject to the
requirements of sections 202 and 205 of the UMRA. In addition, the
final rule does not significantly or uniquely affect small governments.
The final rule contains no requirements that apply to such governments,
impose no obligations upon them, and will not result in expenditures by
them of $100 million or more in any one year or any disproportionate
impacts on them. Therefore, the final rule is not subject to section
203 of the UMRA.
E. Executive Order 13132: Federalism
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999) requires EPA to develop an accountable process to ensure
``meaningful and timely input by State
[[Page 73622]]
and local officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is 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.''
This final 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. The final rule imposes
requirements on owners and operators of specified area sources and not
State and local governments. Thus, Executive Order 13132 does not apply
to this final rule.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, 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.'' This final 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.
This final rule imposes requirements on owners and operators of
specified area sources and not tribal governments. Thus, Executive
Order 13175 does not apply to this final rule.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045, ``Protection of Children from Environmental
Health Risks and Safety Risks'' (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 Agency 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 Agency.
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. This final rule is not
subject to Executive Order 13045 because it is based on technology
performance and not on health or safety risks.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This final rule is not a ``significant energy action'' as defined
in Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, and Use'' (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 final 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 this final rule.
I. National Technology Transfer and Advancement Act
As noted in the proposed rule, Section 12(d) of the National
Technology Transfer and Advancement Act (NTTAA) of 1995 (Pub. L. 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. 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.
This action does not involve technical standards. Therefore, EPA
did not consider the use of any VCS.
J. Executive Order 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it increases the
level of environmental protection for all affected populations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population. This final rule establishes national standards for
the area source category.
K. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801, et seq., as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
final rule and other required information to the United States Senate,
the United States House of Representatives, and the Comptroller General
of the United States prior to publication of the final rule in the
Federal Register. A major rule cannot take effect until 60 days after
it is published in the Federal Register. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2). This final rule will be effective
on December 28, 2007.
List of Subjects in 40 CFR Part 63
Environmental protection, Air pollution control, Hazardous
substances, Reporting and recordkeeping requirements.
Dated: December 20, 2007.
Stephen L. Johnson,
Administrator.
0
For the reasons stated in the preamble, title 40, chapter I, part 63 of
the Code of Federal Regulations is amended as follows:
PART 63--[AMENDED]
0
1. The authority citation for part 63 continues to read as follows:
Authority: 42 U.S.C. 7401, et seq.
0
2. Part 63 is amended by adding subpart WWWWW to read as follows:
[[Page 73623]]
Subpart WWWWW--National Emission Standards for Hospital Ethylene
Oxide Sterilizers
Sec.
Applicability and Compliance Dates
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?
Table 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 Sterilizers
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.
(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
December 29, 2008.
(b) New source. If you start up a new affected source on or before
December 28, 2007, you must comply with applicable requirements in this
subpart by December 28, 2007.
(c) New source. If you start up a new affected source after
December 28, 2007, you must comply with applicable requirements in this
subpart upon startup of your affected source.
Standards
Sec. 63.10390 What management practice standard must I meet?
You must sterilize full loads of items having a common aeration
time, except under medically necessary circumstances, as that term is
defined in Sec. 63.10448.
Initial Compliance Requirements
Sec. 63.10400 How do I demonstrate initial compliance?
(a) Except as provided in paragraphs (b) and (c) of this section,
you must demonstrate initial compliance with the management practice
standard in Sec. 63.10390 by submitting an Initial Notification of
Compliance Status certifying that you are sterilizing full loads of
items having a common aeration time except under medically necessary
circumstances.
(b) If you operate your sterilization unit(s) with an air pollution
control device pursuant to a State or local regulation, you may
demonstrate initial compliance with Sec. 63.10390 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) If you operate your sterilization unit(s) with an air pollution
control device but are not subject to any State or local regulation,
you may demonstrate initial compliance with Sec. 63.10390 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 air pollution
control device, you must demonstrate continuous compliance with the
management practice standard in Sec. 63.10390 by recording the date
and time of each sterilization cycle, whether each sterilization cycle
contains a full load of items, and if not, a statement from a hospital
central services staff, a hospital administrator, or a physician that
it was medically necessary.
Notifications, Reports, and Records
Sec. 63.10430 What notifications must I submit and by when?
(a) You must submit an Initial Notification of Compliance Status
that includes the information required in paragraphs (a)(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 standard and other applicable
requirements in this subpart that serve as the basis of the
notification and the source's compliance date.
(4) A brief description of the sterilization facility, including
the number of ethylene oxide sterilizers, the size (volume) of each,
the number of aeration units, if any, the amount of annual ethylene
oxide usage at the facility, the control technique used for each
sterilizer, and typical number of sterilization cycles per year.
(5) A statement that the affected source is an area source.
(b) You must submit the Initial Notification of Compliance Status
to the appropriate authority(ies) specified in Sec. 63.9(a)(4). In
addition, you must 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 [email protected] 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
[[Page 73624]]
Leader, Research Triangle Park, NC 27711.
(c) You must submit the Initial Notification of Compliance Status
no later than 180 calendar days after your compliance date, consistent
with Sec. 63.10402.
Sec. 63.10432 What records must I keep?
You must keep the records specified in paragraphs (a) and (b) of
this section.
(a) A copy of the Initial Notification of Compliance Status that
you submitted to comply with this subpart.
(b) Records required by Sec. 63.10420 for each sterilization unit
not equipped with an air pollution control device.
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.
(b) You must keep each record for 5 years following the date of
each record.
(c) You must keep each record onsite for at least 2 years after the
date of each record. 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 in 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.
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
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. Hospitals include diagnostic and major
surgery facilities but exclude doctor's offices, clinics, or other
facilities whose primary purpose is to provide medical services to
humans or animals on an outpatient basis.
Hospital central services staff means a healthcare professional,
including manager and technician, who is either directly involved in or
responsible for sterile processing at a hospital.
Medically necessary means circumstances that a hospital central
services staff, a hospital administrator, or a physician concludes,
based on generally accepted medical practices, necessitate sterilizing
without a full load in order to protect human health.
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. As used in this subpart, the term includes
combination sterilization units.
Table 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:
Table 1 to Subpart WWWWW of Part 63.--Applicability of General Provisions to Subpart WWWWW
----------------------------------------------------------------------------------------------------------------
Citation Subject Applies to subpart WWWWW Explanation
----------------------------------------------------------------------------------------------------------------
Sec. 63.1(a)(1)-(4), (6), (10)- Applicability......... Yes........................
(12), (b)(1), (3).
Sec. 63.1(a)(5), (7)-(9)......... [Reserved]............
Sec. 63.1(b)(2).................. [Reserved]............
[[Page 73625]]
Sec. 63.1(c)(1)-(2).............. Applicability of this Yes........................ Sec. 63.10446 of
part after a relevant this subpart exempts
standard has been set. affected sources from
the obligation to
obtain title V
operating permits for
purposes of being
subject to this
subpart.
Sec. 63.1(c)(3)-(4).............. [Reserved]............
Sec. 63.1(c)(5).................. Subject to No.........................
notification
requirements.
Sec. 63.1(d)..................... [Reserved]............
Sec. 63.1(e)..................... Emission limitation by Yes........................
permit.
Sec. 63.2........................ Definitions........... Yes........................
Sec. 63.3........................ Units and Yes........................
abbreviations.
Sec. 63.4........................ Prohibited activities. Yes........................
Sec. 63.5........................ Construction/ No.........................
reconstruction.
Sec. 63.6(a), (b)(1)-(5), (7).... Compliance with Yes........................
standards and
maintenance
requirements.
Sec. 63.6(b)(6).................. [Reserved]............
Sec. 63.6(c)(1).................. Compliance dates for Yes........................ Subpart WWWWW requires
existing sources. compliance 1 year
after the effective
date.
Sec. 63.6(c)(2), (5)............. Compliance dates for No.........................
CAA section 112(f)
standards and for
area sources that
become major.
Sec. 63.6(c)(3)-(4).............. [Reserved]............
Sec. 63.6(d)..................... [Reserved]............
Sec. 63.6(e)-(h)................. Alternative nonopacity No.........................
emission standard.
Sec. 63.6(i)-(j)................. Compliance extension.. Yes........................
Sec. 63.7........................ Performance testing No.........................
requirements.
Sec. 63.8........................ Monitoring No.........................
requirements.
Sec. 63.9(a)..................... Applicability and Yes........................
initial notifications
addressees.
Sec. 63.9(b)..................... Initial notifications. No.........................
Sec. 63.9(c)..................... Request for extension Yes........................
of compliance.
Sec. 63.9(d)-(j)................. Other notifications... No.........................
Sec. 63.10(a)(1)-(2)............. Recordkeeping and Yes........................
reporting
requirements,
applicability.
Sec. 63.10(a)(3)-(4)............. General information... Yes........................
Sec. 63.10(a)(5)-(7)............. Recordkeeping and No.........................
reporting
requirements,
reporting schedules.
Sec. 63.10(b)(1)................. Retention time........ Yes........................
Sec. 63.10(b)(2)-(f)............. Recordkeeping and No.........................
reporting
requirements.
Sec. 63.11....................... Control device No.........................
requirements.
Sec. 63.12....................... State authority and Yes........................
delegations.
Sec. Sec. 63.13-63.16........... Addresses, Yes........................
Incorporations by
Reference,
availability of
information,
performance track
provisions.
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[FR Doc. E7-25233 Filed 12-27-07; 8:45 am]
BILLING CODE 6560-50-P