

[Federal Register: December 28, 2007 (Volume 72, Number 248)]
[Rules and Regulations]               
[Page 73611-73625]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de07-11]                         

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
http://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 a-and-r-Docket@epa.gov.


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: markwordt.david@epa.gov.

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:

----------------------------------------------------------------------------------------------------------------
                   Category                      NAICS\1\ code      Example of potentially regulated entities
----------------------------------------------------------------------------------------------------------------
General Medical and Surgical Hospitals.......            622110  Hospital sterilizers.
Specialty (Except Psychiatric and Substance              622310  Hospital sterilizers.
 Abuse) Hospitals.
----------------------------------------------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \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 CCG-ONG@EPA.GOV or via 
U.S. mail or other mail delivery service to U.S. EPA, Sector Policies 
and Programs Division, Coatings and Chemicals Group (E143-01), Attn: 
Hospital Sterilizers Project

[[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.
----------------------------------------------------------------------------------------------------------------


[FR Doc. E7-25233 Filed 12-27-07; 8:45 am]

BILLING CODE 6560-50-P
