National Emission Standards for Hospital Ethylene Oxide Sterilizers, 64907-64917 [E6-18644]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 214 (Monday, November 6, 2006)]
[Proposed Rules]
[Pages 64907-64917]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18644]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2005-0171; FRL-8239-8]
RIN 2060-AM14


National Emission Standards for Hospital Ethylene Oxide 
Sterilizers

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing two primary regulatory alternatives for new 
and existing hospital sterilizers that emit hazardous air pollutants 
and are area sources within the meaning of Clean Air Act section 
112(a)(2). The first alternative proposes a generally available 
management practice requirement for new and existing hospital 
sterilizers that are area sources. The second alternative proposes that 
there are no generally available control technologies or management 
practices within the meaning of Clean Air Act section 112(d)(5) for 
this source category. We are proposing these two different alternatives 
because we currently have imperfect information concerning the ability 
of the proposed management practice to reduce hazardous air pollutant 
emissions and the cost-effectiveness of such management practice.
    This action is being proposed as part of EPA's obligation to 
regulate area sources listed for regulation pursuant to Clean Air Act 
section 112(c)(3).

DATES: Comments. Written comments must be received on or before January 
5, 2007.
    Public Hearing. If anyone contacts EPA by November 27, 2006 
requesting to speak at a public hearing, a public hearing will be held 
on December 6, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2005-0171, by one of the following methods:
     https://www.regulations.gov. Follow the on-line 
instructions for submitting comments.
     E-mail: a-and-r-docket@epa.gov.
     Fax: (202) 566-1741.
     Mail: U.S. Postal Service, send comments to: Air and 
Radiation Docket (6102T), Environmental Protection Agency, 1200 
Pennsylvania Avenue, NW., Washington, DC 20460. Please include a total 
of two copies. We request that a separate copy also be sent to the 
contact person identified below (see FOR FURTHER INFORMATION CONTACT).
    Hand Delivery: In person or by courier, deliver comments to: Air 
and Radiation Docket (6102T), Environmental Protection Agency, EPA West 
Building, 1301 Constitution Avenue, NW., Room B-102, Washington, DC 
20014. Please include a total of two copies. Such deliveries are 
accepted only during the Docket's normal hours of operation and special 
arrangements should be made for deliveries of boxed information. We 
request that a separate copy also be sent to the contact person 
identified below (see FOR FURTHER INFORMATION CONTACT).
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2005-0171. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available online at 
https://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through www.regulations.gov 
or e-mail. The www.regulations.gov Web site is an ``anonymous access'' 
system, which means EPA will not know your identity or contact 
information unless you provide it in the body of your comment. If you 
send an e-mail comment directly to EPA without going through 
www.regulations.gov, your e-mail address will be automatically captured 
and included as part of the comment that is placed in the public docket 
and made available on the Internet. If you submit an electronic 
comment, EPA recommends that you include your name and other contact 
information in the body of your comment with any disk or CD-ROM you 
submit. If EPA cannot read your comment due to technical difficulties 
and cannot contact you for clarification, EPA may not be able to 
consider your comment. Electronic files should avoid the use of special 
characters, any form of encryption, and be free of any defects or 
viruses. For additional information about EPA's public docket, visit 
the EPA Docket Center homepage at https://www.epa.gov/epahome/
dockets.htm.
    Docket: All documents in the docket are listed in the 
www.regulations.gov index. Although listed in the index, some 
information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in https://www.regulations.gov or in hard copy at the Air and Radiation 
Docket, Docket ID No. EPA-HQ-OAR-2005-0171, EPA West Building, Room B-
102, 1301 Constitution Ave., NW., Washington, DC. The Public Reading 
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Public Reading 
Room is (202) 566-1744, and the telephone number for the EPA Docket 
Center is (202) 566-1742.

    Note: The EPA Docket Center suffered damage due to flooding 
during the last week of June 2006. The Docket Center is continuing 
to operate. However, during the cleanup, there will be temporary 
changes to Docket Center telephone numbers, addresses, and hours of 
operation for people who wish to make hand deliveries or visit the 
Public Reading Room to view documents. Consult EPA's Federal 
Register notice at 71 FR 38147 (July 5, 2006) or the EPA Web site at 
https://www.epa.gov/epahome/dockets.htm for current information on 
docket operations, locations, and telephone numbers. The Docket 
Center's mailing address for U.S. mail and the procedure for 
submitting comments to www.regulations.gov are not affected by the 
flooding and will remain the same.

    Public Hearing: If a public hearing is held, it will be held at 10 
a.m. at the EPA's Environmental Research Center Auditorium, Research 
Triangle Park, NC, or at an alternate site nearby.

FOR FURTHER INFORMATION CONTACT: For questions about the proposal, 
contact Mr. David Markwordt, EPA, Office of Air Quality Planning and 
Standards, Sector Policies and Programs Division, Coatings and 
Chemicals Group (E143-01), Research Triangle Park, NC 27711;

[[Page 64908]]

telephone number (919) 541-0837; fax number (919) 541-0246; e-mail 
address: markwordt.david@epa.gov.

SUPPLEMENTARY INFORMATION: Regulated Entities. Categories and entities 
potentially regulated by the proposed action are hospitals which 
sterilize with ethylene oxide. The proposed action would affect the 
following categories of sources:

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

    This table is not intended to be exhaustive, but rather provides a 
guide for readers regarding entities likely to be regulated by the 
proposed rule. If you have any questions regarding the applicability of 
the proposed action to a particular entity, contact the person listed 
in the preceding FOR FURTHER INFORMATION CONTACT section. Submitting 
CBI. Do not submit information which you claim to be CBI to EPA through 
www.regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information on a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. Information so marked will 
not be disclosed except in accordance with procedures set forth in 40 
CFR part 2. In addition to one complete version of the comment that 
includes information claimed as CBI, a copy of the comment that does 
not contain the information claimed as CBI must be submitted for 
inclusion in the public docket. Information so marked will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2.
    Public Hearing. Persons interested in presenting oral testimony or 
inquiring as to whether a hearing is to be held should contact Mr. 
David Markwordt, EPA, Office of Air Quality Planning and Standards, 
Sector Policies and Programs Division, Coatings and Chemicals Group 
(E143-01), Research Triangle Park, NC 27711, telephone number (919) 
541-0837, e-mail address: markwordt.david@epa.gov, at least 2 days in 
advance of the potential date of the public hearing. Persons interested 
in attending the public hearing must also call Mr. David Markwordt to 
verify the time, date, and location of the hearing. A public hearing 
will provide interested parties the opportunity to present data, views, 
or arguments concerning the proposed action.
    World Wide Web (WWW). In addition to being available in the docket, 
an electronic copy of the proposed rule is also available on the WWW. 
Following the Administrator's signature, a copy of the proposed rule 
will be posted on EPA's Technology Transfer Network (TTN) policy and 
guidance page for newly proposed or promulgated rules at https://
www.epa.gov/ttn/oarpg. The TTN at EPA's Web site provides information 
and technology exchange in various areas of air pollution control.
    Organization of this Document. The information presented in this 
preamble is organized as follows:

I. Background
II. Summary of the Proposed Standards
    A. What Source Category Would Be Affected By This Proposal?
    B. Proposed Regulatory Alternative 1
    C. Proposed Regulatory Alternative 2
III. Rationale for the Proposed Standards
IV. Summary of Environmental, Energy, Cost, and Economic Impacts of 
the Proposed Standards
V. Solicitation of Public Comments
    A. Introduction and General Solicitation
    B. Specific Comment and Data Solicitations
VI. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination with 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children from 
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act

I. Background

    Section 112(k)(3)(B) of the Clean Air Act (CAA) requires us to 
identify not less than 30 hazardous air pollutants (HAP) which, as the 
result of emissions from area sources, present the greatest threat to 
public health in the largest number of urban areas, and section 112(c) 
requires us to list sufficient area source categories or subcategories 
to ensure that emissions representing 90 percent of the 30 listed HAP 
(area source HAP) are subject to regulation under section 112(d) of the 
CAA. The Urban Air Toxics Strategy (Strategy), issued on July 19, 1999 
(64 FR 38706) included a list of 30 area source HAP and a list of area 
source categories emitting the listed HAP. CAA Section 112(d) includes 
authority to issue new and existing source maximum achievable control 
technology (MACT) standards, health threshold standards, and generally 
available control technology (GACT) or management practice standards 
for area sources. We are issuing today's proposal pursuant to CAA 
section 112(d)(5) to address our obligation under CAA section 112(c)(3) 
to subject to regulation the listed area source category of hospital 
sterilizers.

II. Summary of the Proposed Standards

    The source category at issue in this proposal is hospital 
sterilizers that emit HAP and that are area sources. EPA is proposing 
two primary regulatory alternatives for this source category. The first 
alternative (Regulatory Alternative 1) proposes a management practice 
to reduce HAP emissions from hospital sterilizers that do not use 
control devices to reduce ethylene oxide emissions.
    The second alternative (Regulatory Alternative 2) proposes that 
there are no generally available control technologies or management 
practices within the meaning of section 112(d)(5) for this particular 
source category. We are proposing these two alternatives because we 
currently have limited information concerning the ability of the 
proposed management practice to reduce HAP emissions and the cost-
effectiveness of such management practice. As explained below, we 
believe this proposal meets the requirements of CAA sections 112(c)(3) 
and 112(d)(5).

A. What Source Category Would Be Affected by This Proposal?

    The source category that is affected by this proposed action is the 
hospital sterilizer area source category. This source category includes 
area source facilities that perform the operations necessary to 
sterilize medical items with ethylene oxide at hospitals.

B. Proposed Regulatory Alternative 1

1. What Would Be the Affected Sources and Emission Points?
    The affected source to which the proposed management practice 
applies is the group of ethylene oxide sterilizers at a hospital and 
that are located at hospitals that emit less than major source 
quantities of HAP. If EPA finalizes Regulatory Alternative 1, you would 
be subject to the requirements in

[[Page 64909]]

the proposed subpart if you own or operate one or more of the affected 
sources identified above. These requirements would apply nationwide. We 
are also considering applying proposed Regulatory Alternative 1 to 
urban areas only and are taking comment on this approach. In a separate 
action, we are proposing various definitions related to the urban only 
approach (e.g., definitions for ``Metropolitan Statistical Area,'' 
``Urban,'' ``Urban 1 areas,'' and ``Urban 2 areas''). These proposed 
definitions are included in the proposed National Emission Standards 
for Hazardous Air Pollutants for Source Categories: Gasoline 
Distribution Bulk Terminals, Bulk Plants, Pipeline Facilities, and 
Gasoline Dispensing Facilities; this proposal is in Docket EPA-HQ-OAR-
2006-0406. If we decide to finalize the urban-only approach, we would 
include in this final rule definitions related to that approach.
    The emission source subject to the management practice is the 
sterilization unit.
2. What Would Be the Emission Limits, Equipment Standards, and/or 
Management Practice Standards?
    Under Regulatory Alternative 1, we are proposing two different 
alternatives with regard to uncontrolled hospital sterilizers. First, 
we propose to require that hospitals with uncontrolled sterilizers 
follow the management practice of sterilizing full loads of items 
having a common aeration time, except where emergency circumstances 
dictate the use of less than full loads to protect human health. As 
discussed below, we are soliciting comment on particular circumstances 
where an exemption to the full load requirement would be necessary for 
medical or other reasons. Alternatively, we propose that hospitals with 
uncontrolled sterilizers follow the management practice of sterilizing 
full loads of items having a common aeration to the extent practical. 
Unlike the first proposed approach, this alternative would eliminate 
the need for a specific list of exemptions.
    As for hospitals with controlled sterilizers, we propose that these 
hospitals be required to certify that the control devices are operating 
and will continue to operate in accordance with applicable State and/or 
local laws or, if controls are voluntary, in accordance with 
manufacturers' specifications. If controls are subsequently removed, 
the management practice would take effect.
3. What Would Be the Testing and Initial Compliance Demonstration 
Requirements?
    There are no performance test requirements for the proposed 
management practice standard.
4. What Would Be the Notification, Recordkeeping, and Reporting 
Requirements?
    We are proposing an initial compliance notification/certification 
status that would require affected sources to notify EPA that they 
operate a sterilizer covered by the rule and certify that they will 
operate the sterilizer in accordance with the requirements of the rule. 
We are taking comment on the costs and benefits of this initial 
compliance notification/certification status and whether or not there 
should be annual compliance certifications.
    For Regulatory Alternative 1, we are also proposing two options for 
recordkeeping. The first option does not require recordkeeping. The 
second option requires that affected sources maintain records on-site 
of the date and time of each sterilization operation. If less than a 
full load is sterilized at any time, the operator must, in addition to 
noting the date and time of the sterilization operation, identify the 
reason why a less-than-full load was sterilized.
    We are soliciting comment on the particular circumstances where a 
hospital may need to run the sterilizer with less than a full load, and 
whether to require records of such loads and the reason they were run.

C. Proposed Regulatory Alternative 2

    As explained further below, we alternatively propose today that 
there are no generally available control technologies or management 
practices within the meaning of section 112(d)(5) for this category of 
sources. We are proposing this alternative in addition to Regulatory 
Alternative 1 because of the possibility that the proposed management 
standard will not result in meaningful or cost-effective reductions in 
ethylene oxide. That is, given the incentives that operators have to 
minimize ethylene oxide emissions to reduce operating costs as well as 
their own exposures, it is uncertain whether the issuance of additional 
work practice standards would result in meaningful HAP emission 
reductions. Even if such reductions occurred, they could be expensive. 
For example, as noted above, we assume that work practice standards 
would reduce emissions by 2 to 9 tons per year (tpy), and that 
recordkeeping costs can be as high as $1.3 million per year, resulting 
in reductions that cost $150,000 to $650,000 per ton. Costs would be 
reduced significantly without recordkeeping requirements, but emission 
reductions would be expected to be lower in this instance. For these 
reasons, the Agency is alternatively proposing today to find that there 
are no GACT or management practices within the meaning of CAA section 
112(d)(5) for this category of sources. We believe that this would be a 
reasonable approach given the high costs of controlling emissions of 
ethylene oxide from hospital sterilizers using the identified control 
technology and the uncertainties as to whether the proposed work 
practice standard will result in HAP emission reductions and whether 
such reductions are cost-effective. We request comment on this 
alternative.

III. Rationale for the Proposed Standards

    Ethylene oxide is used in hospitals to sterilize medical items, 
particularly heat-sensitive items that cannot be steam sterilized. 
Ethylene oxide can be used directly in pure gaseous form or in gaseous 
mixtures. The ethylene oxide sterilization process includes preparation 
of the sterilization chamber (temperature, evacuation, humidification, 
and ethylene oxide gas concentration), the sterilization cycle when the 
medical item is exposed to ethylene oxide, evacuation and air washes, 
and the aeration (or off-gas) cycle. Emissions points from hospital 
ethylene oxide sterilization processes include: (1) Emissions from 
evacuating the chamber following sterilization, (2) emissions from the 
chamber during aeration, and (3) emissions that occur when the 
sterilizer door is opened. Most hospitals have eliminated another 
potential source of emissions, the once-through water-sealed vacuum 
pump used to evacuate the ethylene oxide from the chamber, in order to 
meet Occupational Safety and Health Administration (OSHA) guidelines 
for worker exposure. Hospitals now use recirculating vacuum-sealed 
pumps.
    There were an estimated 5,800 hospitals nationwide in the United 
States in 2002. Based on a nationwide and State search for permits and 
inventory data, we specifically compared the number of hospitals 
identified and the number confirmed to conduct ethylene oxide 
sterilization, and extrapolated to nationwide numbers. The percentage 
of hospitals with ethylene oxide sterilization ranges from 28 to 33 
percent. Based on this range, there are approximately 1,600 to

[[Page 64910]]

1,900 hospitals nationwide that conduct ethylene oxide sterilization.
    The predominant type of air pollution control devices are the EtO-
AbatorTM and the Safe-Cell technology. Both technologies 
reduce emissions by approximately 99 percent. The EtO-
AbatorTM oxidizes the ethylene oxide with a catalyst to form 
carbon dioxide and water vapor. The latest version of the EtO-
AbatorTM (sold by 3M) is sold only for use with pure 
ethylene oxide systems; however, earlier versions were used with gas 
blends. The Safe-Cell technology, which can be used with either pure 
ethylene oxide or ethylene oxide gas blends, is a two-stage process. In 
the first stage, an acid hydrolysis scrubber removes ethylene oxide 
from the gas stream and converts it to ethylene glycol; in the second 
stage, the remaining ethylene oxide is captured and destroyed on a dry 
bed filter impregnated with a chemical reactant.
    We estimated that ethylene oxide emissions were 1,060 megagrams per 
year (Mg/yr) (1,170 tpy) from hospital sterilization processes 
nationwide in 1990. As discussed below, there have been declines in 
ethylene oxide usage and emissions for sterilization processes. 
Nationwide ethylene oxide usage was estimated to be 192 Mg/yr (212 tpy) 
in 2000 and 122 Mg/yr (135 tpy) in 2005. We estimate that at least half 
of the ethylene oxide being used by hospitals with controlled 
sterilizers, which would emit negligible amounts of ethylene oxide, and 
the other half is used in uncontrolled sterilizers. This resulted in 
about 40 Mg/yr (44 tpy) of ethylene oxide emissions in 2005. We 
estimate approximately 0.05 cases of cancer per year resulting from the 
release of the 40 Mg/yr of ethylene oxide to the atmosphere. Ethylene 
oxide emissions for hospital sterilizers therefore have decreased over 
90 percent from 1990 to 2005 (from 1,060 to 40 Mg/yr reduction).
    The decline in ethylene oxide usage for hospital sterilization is 
due mainly to: (1) New regulations and excise taxes on 
chlorofluorocarbons, (2) development of new sterilization processes, 
such as liquid peracetic acid and hydrogen peroxide plasma processes, 
for certain medical items, (3) increased concern over the toxicity of 
ethylene oxide residuals, and (4) new restrictions on reprocessing 
single use devices (SUD). As a corollary to the decline in EO usage and 
emissions, the number of hospitals that conduct ethylene oxide 
sterilization has been declining. Regulation of ethylene oxide 
sterilization at hospitals has contributed to the decline in the number 
of hospitals that conduct sterilization processes. In California, there 
were approximately 600 hospitals that operated ethylene oxide 
sterilizers in 1991. Since implementation of the California Air 
Resources Board regulation for hospital sterilizers in 1991, at least 
60 percent of these hospitals are no longer conducting sterilization 
operations.
    In 2000, the Food and Drug Administration (FDA) regulated the 
reprocessing of SUD, and these regulations have made it more difficult 
for hospitals to continue the reprocessing. Many hospitals have reacted 
to the 2000 FDA regulations by discontinuing the reuse of SUD or by 
outsourcing the sterilization processing of SUD. With the trends 
mentioned, hospitals in urban areas have begun to consolidate ethylene 
oxide sterilization processes, and one hospital with a large sterilizer 
may conduct sterilization processes for its neighbor or affiliated 
hospitals or those in close proximity. As a result of the many SUD 
reuse issues, when hospitals are outsourcing and using reprocessed 
devices, ethylene oxide usage by contract sterilizers is increasing, 
and when hospitals are not reprocessing SUD, ethylene oxide usage by 
medical device manufacturers has increased as they manufacture more 
SUD. (Sterilization processes by commercial sterilizers, which include 
commercial contract sterilizers and medical device manufacturers, are 
subject to MACT controls under 40 CFR part 63, subpart O.)
    Emissions from controlled hospital sterilizers are negligible, and 
we are not aware of any practical emission reduction strategies to 
further reduce emissions after control. The ethylene oxide emissions 
from hospitals average less than 300 pounds per year. The capital costs 
of add-on controls for these facilities range from $23,000 to $130,000 
per hospital and the annualized costs of add-on controls range from 
$10,000 to $46,000 per year. These costs do not include any potential 
monitoring, recordkeeping, and reporting (MRR) costs that would be 
necessary to ensure continuous compliance if controls were required. 
Total nationwide annualized cost to control all uncontrolled facilities 
would be approximately $8.5 million. The cost to reduce a ton of 
ethylene oxide emissions is over $200,000 per year.
    As a first step in our analysis, we considered the option of 
applying a MACT standard to hospital sterilizers under CAA section 
112(d)(2). Hospitals that are currently controlling their ethylene 
oxide sterilizers generally are doing so to comply with existing State 
or local requirements. More than half of the hospital sterilizers have 
add-on controls. Due to this widespread use of controls on hospital 
sterilizers, the MACT floor level of control would be add-on controls 
if we were to develop this area source rule based on CAA section 
112(d)(2). We propose to reject the application of MACT and the 
requirement to control all presently uncontrolled hospital sterilizers 
based on the small amount of ethylene oxide emissions from uncontrolled 
hospital sterilizers and the poor cost-effectiveness associated with 
requiring add-on controls on the currently uncontrolled sources. The 
average hospital emits less than 300 pounds per year of ethylene oxide. 
The cost-effectiveness of applying MACT is over $200,000 per ton of 
ethylene oxide reduced, excluding any potential MRR costs, which we 
think is excessive for control of these emissions.
    Consequently, the Administrator is exercising his discretion to 
promulgate standards or requirements under CAA section 112(d)(5) which 
provide for the use of management practices to reduce emissions of HAP 
from uncontrolled sterilizers.
    The FDA regulates the hospital sterilizer as a medical device; 
these requirements help ensure sterility of the sterilized product. The 
FDA requires the manufacturer follow the Association for the 
Advancement of Medical Instrumentation (AAMI) standards for 
sterilizers. The FDA does not directly regulate the hospital use of the 
sterilizer unit. However, the amount of ethylene oxide used per 
sterilizer cycle is factory set by the manufacturers to comply with the 
AAMI standards, i.e., for a given sterilizer cycle, one uses the same 
amount of ethylene oxide whether the sterilizer is full or not. Because 
of this, hospital sterilizer operators have little discretion in the 
operation of the sterilizer other than to minimize the use of the 
sterilizer by only running full loads. Under Regulatory Alternative 1, 
we are therefore proposing the management practice that requires the 
sterilization of full loads to minimize the number of times the 
sterilizer is operated. As explained above, we are considering two 
different approaches for framing the standard under Regulatory 
Alternative 1.
    This management practice is consistent with the American National 
Standards Institute, Inc. (ANSI) and the AAMI jointly developed 
American National Standard ANSI/AAMI ST41:1999. The ANSI/AAMI ST41:1999 
standard is recognized by the FDA as a consensus standard. The ANSI/
AAMI standard requires the operator sterilize full loads of items 
having a common aeration time, to the extent practical.

[[Page 64911]]

The rationale provided in the standard states the following:
    As compared to sterilizing the same volume in partial loads, 
sterilizing full loads of items having a common aeration time is cost-
effective and reduces the potential for occupational exposure and for 
environmental release of ethylene oxide. This practice also reduces the 
temptation for workers to attempt to retrieve items with short aeration 
times from cabinets in which other items might not be fully aerated and 
thus helps avoid unnecessary exposure to ethylene oxide.''
    It is possible that not all hospitals sterilize every load 
consistent with this standard. We believe that the management practice 
should increase the awareness of pollution prevention and that it has 
the potential to reduce emissions from uncontrolled hospital 
sterilizers. For purposes of Regulatory Alternative 1, we assume that 
the cost of implementing the management practice is low. We believe the 
cost of performing the management practice may be off-set by the 
reduced purchasing costs of ethylene oxide and other operating costs 
resulting from fewer loads. We also believe the implementation of the 
management practice can be done relatively quickly due to the expected 
low effort to set up the recordkeeping necessary for the practice. For 
these reasons, we are proposing Regulatory Alternative 1, which would 
require compliance with the management practice requirements within 1 
year after the effective date of the final rule.
    Under Regulatory Alternative 1, we are proposing that the 
management practice apply to uncontrolled hospital sterilizers. 
Hospitals controlling their sterilizers with add-on emission control 
devices would be required to certify either compliance with all State 
or local requirements applicable to the controls or, if controls are 
voluntary, certify that they are operating the controls in accordance 
with the manufacturer's specifications. If controls are subsequently 
removed, the management practice would take effect. Facilities 
complying with the management practice will be required to maintain 
records on-site of the date and time of sterilization and whether a 
full load was sterilized, and the reason for not running a full load. 
We estimated the costs to keep records at $1.3 million per year for the 
uncontrolled facilities. We are assuming the controlled facilities will 
certify compliance with either State or local requirements, or they are 
operating the controls consistent with the manufacturer's 
specifications. The cost estimates noted above are only estimates, 
however. We are taking comment on the costs and benefits of this 
recordkeeping requirement and on whether this rule should apply 
nationally or only to hospitals in urban areas. We are considering 
applying today's proposal only to urban areas as defined in the 
proposed National Emission Standards for Hazardous Air Pollutants for 
Source Categories: Gasoline Distribution Bulk Terminals, Bulk Plants, 
Pipeline Facilities, and Gasoline Dispensing Facilities in Docket EPA-
HQ-OAR-2006-0406.
    Based on the information and assumptions noted above, we are 
proposing two options for Regulatory Alternative 1. First, we propose 
that full loads of items having a common aeration time be sterilized, 
except where emergency circumstances dictate the use of less than full 
loads to protect human health. With regard to this proposed option, we 
specifically solicit comment on whether there are other exemptions to 
the full load requirement that are appropriate. Alternatively, we 
propose that operators be required to sterilize full loads of items 
having a common aeration time to the extent practical. Under this 
alternative approach, there is no need for a specified list of 
exemptions for specific circumstances, as is the case with the first 
proposed approach. Rather, the operator must fully load the sterilizer 
to the extent practical.
    Both options recognize that hospital sterilizers have strong 
economic incentives to operate sterilizers with a full load because 
doing so reduces the quantity of ethylene oxide needed to run their 
operation and, accordingly, reduces costs. This alternative approach is 
consistent with the ANSI/AAMI standard described above. Indeed, as 
noted by the AAMI and FDA, operation at full loads reduces operating 
costs by reducing the consumption of ethylene oxide, minimizing wear 
and tear on machines, and reducing associated labor costs. We solicit 
comment on these two alternative approaches.
    Under Regulatory Alternative 2, we are proposing that there are no 
GACT or management practices within the meaning of section 112(d)(5) of 
the CAA for this source category. We are currently not aware of any 
control technology or management practice other than those discussed in 
this proposal that would reduce ethylene oxide emissions from hospital 
sterilizers. We have already identified that there is a high cost of 
controlling emissions of ethylene oxide from hospital sterilizers using 
the identified control technology, such that we currently do not 
believe that there is any GACT. We also have limited information to 
conclude either that the proposed management practice reduces emissions 
of ethylene oxide or that the proposed practice is cost-effective. We 
are therefore co-proposing Regulatory Alternative 2.
    We are soliciting comment on whether, for this source category, it 
is reasonable to conclude that no such generally available means of 
reducing emissions is available. In this regard, we specifically 
solicit comment on whether there is any other control technology or 
management practice that is not described in this proposal, but that 
may provide a cost-effective means of reducing ethylene oxide emissions 
from hospital sterilizers. To the extent a commenter identifies such an 
alternative means of emission reduction, we request information 
relating to the nature of the emission reduction and the cost of 
obtaining such reduction.
    Section 502(a) of the CAA provides that EPA may exempt one or more 
area sources from the requirements of title V if EPA finds that 
compliance with such requirements is ``impracticable, infeasible, or 
unnecessarily burdensome'' on such area sources. EPA must determine 
whether to exempt an area source from title V at the time we issue the 
relevant CAA section 112 standard (40 CFR 70.3(b)(2)). If we pursue 
Regulatory Alternative 1 in the final rule, we are proposing today to 
exempt hospital sterilizer area sources from the requirements of title 
V. Hospital sterilizer area sources would not be required to obtain 
title V permits solely as a function of being the subject of today's 
proposed national emission standards for hazardous air pollutants 
(NESHAP); however, if they were otherwise required to obtain title V 
permits, such requirement(s) would not be affected by today's proposed 
exemption.
    Consistent with the statute, EPA has found that compliance with 
title V permitting is ``unnecessarily burdensome'' for hospital 
sterilizer area sources. EPA's inquiry into whether this criterion was 
satisfied was based primarily upon consideration of the following four 
factors: (1) Whether title V would result in significant improvements 
to the compliance requirements that we are proposing for this area 
source category; (2) whether title V permitting would impose a 
significant burden on hospital sterilizer area sources; (3) whether the 
costs of title V permitting for hospital sterilizer area sources would 
be justified, taking into consideration any potential gains in 
compliance likely to occur for such sources; and (4) whether there are

[[Page 64912]]

implementation and enforcement programs in place that are sufficient 
for assuring compliance with this NESHAP without relying on title V 
permits.
    Additionally, EPA also considered whether exempting hospital 
sterilizer area sources would adversely affect public health, welfare, 
or the environment. We first determined the extent to which these 
factors were present for this area source category. We then determined 
whether those factors collectively demonstrated that compliance with 
title V requirements would be unnecessarily burdensome for hospital 
sterilizer area sources.
    In our consideration of these factors, we believe the addition of 
title V permitting would not result in significant improvements to the 
compliance requirements that we are proposing for this area source 
category. Under Regulatory Alternative 1, we are unaware of any 
additional compliance procedures, in or outside the title V program, 
which would improve the assurance of significantly more gains in 
compliance and emission reductions. We have not identified any adverse 
effect on public health, welfare, or the environment by the proposed 
title V exemption.
    We also believe that title V permitting may impose a significant 
burden on facilities within this source category, some of which are 
small businesses. For many facilities, the cost of obtaining a title V 
permit may far exceed the cost of complying with this proposed rule 
without significant gains in compliance. Based on the above analysis, 
we conclude that title V permitting would be ``unnecessarily 
burdensome'' for hospital sterilizer area sources. We are therefore 
proposing that this area source category be exempt from title V 
permitting requirements if we pursue Regulatory Alternative 1.
    We have prepared regulatory text for proposed Regulatory 
Alternative 1. The proposed regulatory text implements the first option 
described above for Regulatory Alternative 1 and includes proposed 
recordkeeping requirements. We have included regulatory text for this 
proposed approach because it is the approach that would involve the 
most extensive regulatory text. If we finalize the second option 
described above for Regulatory Alternative 1 (i.e., following the ANSI/
AAMI standard), we will modify the regulatory text appropriately.

IV. Summary of Environmental, Energy, Cost, and Economic Impacts of the 
Proposed Standards

    We estimate that in 2002 there were, at most, 1,900 hospital area 
sources, of which approximately 630 do not presently have add-on 
controls. The management practice that we are proposing today as 
Regulatory Alternative 1 is estimated to reduce the 40 Mg/yr emitted 
from uncontrolled sterilizers from 2 to 9 Mg/yr per year based on a 
range of assumptions for the extent to which hospital sterilizers are 
presently not being run with full loads. We estimate cancer incidence 
would be reduced from approximately 0.05 to 0.044 cases of cancer per 
year. We further believe that if we pursue Regulatory Alternative 1 in 
the final rule, there will be minimal effect on other air quality or 
non-air quality environmental impacts and will be negligible energy or 
economic impacts. Annualized costs to comply with the proposed 
standards are estimated to be less than $2 million per year. There will 
be no environmental, energy, cost, or economic impacts associated with 
Regulatory Alternative 2.

V. Solicitation of Public Comments

A. Introduction and General Solicitation

    We request comments on all aspects of the proposed action. All 
significant comments received during the public comment period will be 
considered in the development and selection of the final rulemaking.

B. Specific Comment and Data Solicitations

    1. Management practice costs and benefits--We are requesting 
comment on our estimate of the costs to comply with the management 
practice and the associated MRR requirements. As stated earlier, we are 
proposing one time initial compliance notification/certification. We 
are requesting comment on the costs and benefits of the proposed 
initial compliance notification/certification status and recordkeeping 
and on the costs and benefits of hospitals also annually certifying 
their compliance with the proposed rule. We are requesting comment on 
the two proposed options for recordkeeping. The first option does not 
require records to minimize the burden compared to the emission 
reduction benefit. The second option requires recordkeeping to ensure 
compliance. We solicit comments on approaches other than recordkeeping 
which may ensure compliance at a smaller cost. Finally, we are 
requesting comment on whether this rule should apply nationally or only 
to hospitals in urban areas.
    2. Full loads--The ANSI/AAMI ST41:1999 standards rationale for load 
configuration states the following:
    ``Overloading impedes proper air removal, humidification of the 
load, and sterilant penetration and evacuation. Proper loading ensures 
that the sterilized items will not touch the operator's hands during 
transfer from the sterilizer to the aerator.''
    We do not want the proposed requirements to impede the 
sterilization cycle or in any way compromise the process of 
sterilization. We are requesting comment on our definition of full load 
and for specific cases where it would not be practical or appropriate 
to require full loads. We are also soliciting comment on our 
alternative proposal of requiring hospitals with uncontrolled 
sterilizers to follow the management practice of sterilizing full loads 
of items having a common aeration, to the extent practical.
    3. Emission estimate for the management practice--We currently have 
insufficient information concerning the ability of the proposed 
management practice to reduce HAP emissions. Our emissions reduction 
estimates attributed to the management practice are based on 
assumptions concerning the current practice at hospitals. The basis of 
our emissions estimate is the assumption that 10 to 50 percent of the 
sterilization is performed on half loads and that the amount of 
ethylene oxide used is fixed per cycle. The emission estimate also 
makes the assumption that all loads could be full. We are requesting 
comments on the extent to which hospitals presently sterilize less than 
full loads, to what extent these less than full loads could be 
eliminated, and any additional information that may assist in 
estimating emissions. We are requesting comment on whether this 
management practice is an effective means of reducing emissions from 
these sources and, if not, whether it would be appropriate to set no 
standard on the grounds that no technology or management practice are 
generally available to reduce emissions from these sources.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is a ``significant regulatory action'' because it may raise 
novel legal and policy issues. Accordingly, EPA submitted this action 
to the Office of Management and Budget (OMB) for review under Executive 
Order 12866 and any changes made in response to OMB recommendations 
have been

[[Page 64913]]

documented in the docket for this action.

B. Paperwork Reduction Act

    The information requirements in the proposed NESHAP for Hospital 
Ethylene Oxide Sterilization Area Sources have been submitted for 
approval to OMB under the Paperwork Reduction Act, 44 U.S.C. 3501, et 
seq. The Information Collection Request (ICR) document prepared by EPA 
has been assigned EPA ICR number 2245.01.
    The proposed information collection requirements are based on the 
information collection requirements in the part 63 General Provisions 
(40 CFR part 63, subpart A), some of which are incorporated into the 
proposed NESHAP. The ICR document includes the burden estimates for all 
applicable General Provisions. These recordkeeping and reporting 
requirements are mandatory pursuant to section 114 of the CAA (42 
U.S.C. 7414). All information submitted to EPA pursuant to the 
information collection requirements for which a claim of 
confidentiality is made is safeguarded according to CAA section 114(c) 
and the Agency's implementing regulations at 40 CFR part 2, subpart B.
    Proposed Regulatory Alternative 2 does not impose any new 
information collection burden. Proposed Regulatory Alternative 1 does 
propose information collection requirements. Specifically, the annual 
burden for the information collection averaged over the first 3 years 
of this ICR is estimated to total 23,694 labor hours per year at a cost 
of $1.6 million for the 1,900 existing hospital sterilizer area 
sources. No capital/startup costs or operation and maintenance costs 
are associated with the proposed requirements. No costs or burden hours 
are estimated for new area sources because no new sources are estimated 
during the 3-year period of the ICR. We have no indication there will 
be any new sources in the next 3 years.
    Burden means the total time, effort, or financial resources 
expended by persons to generate, maintain, retain, disclose, or provide 
information to or for a Federal agency. This includes the time needed 
to review instructions; develop, acquire, install, and utilize 
technology and systems for the purposes of collecting, validating, and 
verifying information, processing and maintaining information, and 
disclosing and providing information; adjust the existing ways to 
comply with any previously applicable instructions and requirements; 
train personnel to be able to respond to a collection of information; 
search data sources; complete and review the collection of information; 
and transmit or otherwise disclose the information.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in 40 CFR part 63 are listed in 40 CFR part 9.
    To comment on the Agency's need for this information, the accuracy 
of the provided burden estimates, and any suggested methods for 
minimizing respondent burden, including the use of automated collection 
techniques, EPA has established a public docket for this action, which 
includes this ICR, under Docket ID number EPA-HQ-OAR-2005-0171. Submit 
any comments related to the ICR for the proposed rules to EPA and OMB. 
See ``Addresses'' section at the beginning of this notice for where to 
submit comments to EPA. Send comments to OMB at the Office of 
Information and Regulatory Affairs, Office of Management and Budget, 
725 17th Street, NW., Washington, DC 20503, Attention: Desk Officer for 
EPA. Since OMB is required to make a decision concerning the ICR 
between 30 and 60 days after November 6, 2006, a comment to OMB is best 
assured of having its full effect if OMB receives it by December 6, 
2006. The final rule will respond to any OMB or public comments on the 
information collection requirements contained in this proposal.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency 
to prepare a regulatory flexibility analysis of any rule subject to 
notice and comment rulemaking requirements under the Administrative 
Procedure Act or any other statute unless the agency certifies that the 
rule will not have a significant economic impact on a substantial 
number of small entities. Small entities include small businesses, 
small not-for-profit enterprises, and small governmental jurisdictions.
    For the purposes of assessing the impacts of today's proposed area 
source NESHAP on small entities, a small entity is defined as: (1) A 
small business that is a hospital as defined by NAICS codes 622110 and 
622310 whose parent company has less than $31.5 million in gross 
revenue (based on Small Business Administration (SBA) size standards); 
(2) a small governmental jurisdiction that is a government of a city, 
county, town, school district, or special district with a population of 
less than 50,000; and (3) a small organization that is any not-for-
profit enterprise which is independently owned and operated and is not 
dominant in its field.
    After considering the economic impacts of today's proposed rule on 
small entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. Proposed 
Regulatory Alternative 1 proposes to require the use of a work practice 
to minimize the operation of the ethylene oxide sterilization unit and 
will, therefore, have minimal nationwide costs, i.e., less than $2 
million per year. We have determined that less than 3 percent of the 
hospitals are small businesses as defined by the SBA. We have also 
determined that none of these small businesses are significantly 
impacted by this proposal for none of them will incur annualized 
compliance costs of 0.1 percent of sales or greater. There are no costs 
associated with proposed Regulatory Alternative 2.
    We continue to be interested in the potential impacts of the 
proposed rule on small entities and welcome comments on issues related 
to such impacts.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and tribal 
governments and the private sector. Under section 202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with ``Federal mandates'' that 
may result in expenditures by State, local, and tribal governments, in 
the aggregate, or to the private sector, of $100 million or more in any 
1 year. Before promulgating an EPA rule for which a written statement 
is needed, section 205 of the UMRA generally requires EPA to identify 
and consider a reasonable number of regulatory alternatives and adopt 
the least costly, most cost-effective, or least burdensome alternative 
that achieves the objectives of the rule. The provisions of section 205 
do not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least 
costly, most cost-effective, or least burdensome alternative if the 
Administrator publishes with the final rule an explanation why that 
alternative was not adopted.
    Before EPA establishes any regulatory requirements that may 
significantly or uniquely affect small governments, including Tribal 
governments, it must have developed under section 203 of the

[[Page 64914]]

UMRA, a small government agency plan. The plan must provide for 
notifying potentially affected small governments, enabling officials of 
affected small governments to have meaningful and timely input in the 
development of EPA regulatory proposals with significant Federal 
intergovernmental mandates, and informing, educating, and advising 
small governments on compliance with the regulatory requirements.
    EPA has determined that the proposed rule does not contain a 
Federal mandate that may result in expenditures of $100 million or more 
for State, local, and tribal governments, in the aggregate, or the 
private sector in any 1 year. As discussed previously in this preamble, 
if we finalize Regulatory Alternative 1, the estimated expenditures for 
the private sector in any 1 year are less than $2 million. There are no 
costs associated with proposed Regulatory Alternative 2. Thus, the 
proposed rule is not subject to the requirements of sections 202 and 
205 of the UMRA. In addition, the proposed rule does not significantly 
or uniquely affect small governments. The proposed rule would not 
result in expenditures by them of $100 million or more in any 1 year or 
any disproportionate impacts on them. Therefore, the proposed rule is 
not subject to section 203 of the UMRA.

E. Executive Order 13132: Federalism

    Executive Order 13132 (64 FR 43255, August 10, 1999), requires EPA 
to develop an accountable process to ensure ``meaningful and timely 
input by State and local officials in the development of regulatory 
policies that have federalism implications.'' ``Policies that have 
federalism implications'' are defined in the Executive Order to include 
regulations that have ``substantial direct effects on the States, on 
the relationship between the national government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government.''
    The proposed rule does not have federalism implications. It will 
not have substantial direct effects on the States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government, 
as specified in Executive Order 13132. To the extent the proposed rule 
proposes requirements, it does so only with respect to owners and 
operators of specified area sources and not State and local 
governments. Thus, Executive Order 13132 does not apply to the proposed 
rule. In the spirit of Executive Order 13132, and consistent with EPA 
policy to promote communications between EPA and State and local 
governments, EPA specifically solicits comment on this proposed rule 
from State and local officials.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    Executive Order 13175 (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.'' ``Policies that have tribal 
implications'' are defined in the Executive Order to include 
regulations that have ``substantial direct effects on one or more 
Indian tribes, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes.''
    The proposed rule does not have tribal implications, as specified 
in Executive Order 13175. It will not have substantial direct effects 
on Tribal governments, on the relationship between the Federal 
Government and Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes, as 
specified in Executive Order 13175. To the extent the proposed rule 
proposes requirements, it does so only with respect to owners and 
operators of specified area sources and not Tribal governments. Thus, 
Executive Order 13175 does not apply to the proposed rule.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any 
rule that: (1) Is determined to be ``economically significant'' as 
defined under Executive Order 12866, and (2) concerns an environmental 
health or safety risk that EPA has reason to believe may have a 
disproportionate effect on children. If the regulatory action meets 
both criteria, the EPA must evaluate the environmental health or safety 
effects of the planned rule on children, and explain why the planned 
regulation is preferable to other potentially effective and reasonably 
feasible alternatives considered by the EPA.
    EPA interprets Executive Order 13045 as applying only to those 
regulatory actions that are based on health or safety risks, such that 
the analysis required under section 5-501 of the Executive Order has 
the potential to influence the regulation. The proposed rule is not 
subject to the Executive Order. It is based on control technology and 
not on health or safety risks.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    The proposed rule is not a ``significant energy action'' as defined 
in Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not 
likely to have a significant adverse effect on the supply, 
distribution, or use of energy. Further, we have concluded that the 
proposed rule is not likely to have any adverse energy effects because 
energy requirements would likely be less than existing levels. No 
additional pollution controls or other equipment that would consume 
energy are required by the proposed rules.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) of 1995, Public Law 104-113, 12(d), (15 U.S.C. 272 note) 
directs EPA to use voluntary consensus standards (VCS) in its 
regulatory activities, unless to do so would be inconsistent with 
applicable law or otherwise impractical. The VCS are technical 
standards (e.g., materials specifications, test methods, sampling 
procedures, and business practices) that are developed or adopted by 
VCS bodies. The NTTAA directs EPA to provide Congress, through OMB, 
explanations when the Agency decides not to use available and 
applicable VCS.
    The proposed rule does not include technical standards.

List of Subjects in 40 CFR Part 63

    Environmental protection, Air pollution control, Hazardous 
substances, Reporting and recordkeeping requirements.

    Dated: October 31, 2006.
Stephen L. Johnson,
Administrator.
    For the reasons stated in the preamble, title 40, chapter I, part 
63 of the Code of Federal Regulations is proposed to be amended as 
follows:

PART 63--[AMENDED]

    1. The authority citation for part 63 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart A--[Amended]

    2. Part 63 is amended by adding subpart WWWWW to read as follows:

[[Page 64915]]

Subpart WWWWW--National Emission Standards for Hospital Ethylene Oxide 
Sterilization

Applicability and Compliance Dates

Sec.
63.10382 Am I subject to this subpart?
63.10384 What are my compliance dates?

Standards

63.10390 What management practice standards must I meet?

Initial Compliance Requirements

63.10400 How do I demonstrate initial compliance?
63.10402 By what date must I demonstrate initial compliance?

Monitoring--Continuous Compliance Requirements

63.10420 How do I demonstrate continuous compliance with the 
management practice requirements?

Notifications, Reports, and Records

63.10430 What notifications must I submit and when?
63.10432 What records must I keep?
63.10434 In what form and for how long must I keep my records?

Other Requirements and Information

63.10440 What parts of the General Provisions apply to me?
63.10442 Who implements and enforces this subpart?
63.10446 Do title V permitting requirements apply to area sources 
subject to this subpart?
63.10448 What definitions apply to this subpart?

Tables to Subpart WWWWW of Part 63

Table 1 to Subpart WWWWW of Part 63--Applicability of General 
Provisions to Subpart WWWWW

Subpart WWWWW--National Emission Standards for Hospital Ethylene 
Oxide Sterilization

Applicability and Compliance Dates


Sec.  63.10382  Am I subject to this subpart?

    (a) You are subject to this subpart if you own or operate an 
ethylene oxide sterilization facility at a hospital that is an area 
source of hazardous air pollutant (HAP) emissions. Your hospital 
facility is an area source of HAP if it is a stationary source or group 
of stationary sources within a contiguous area under common control 
that emits or has the potential to emit any single HAP at a rate of 
less than 9.07 megagrams (10 tons) per year and any combination of HAP 
at a rate of less than 22.68 megagrams (25 tons) per year.
    (b) The affected source subject to this subpart is each new or 
existing sterilization facility.
    (1) An affected source is existing if you commenced construction or 
reconstruction of the affected source before November 6, 2006.
    (2) An affected source is new if you commenced construction or 
reconstruction of the affected source on or after November 6, 2006.


Sec.  63.10384  What are my compliance dates?

    (a) Existing source. If you have an existing affected source, you 
must comply with applicable requirements in this subpart no later than 
[1 YEAR AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE Federal 
Register].
    (b) New source. If you have a new or reconstructed affected source 
for which the initial startup date is on or before [DATE OF PUBLICATION 
OF THE FINAL RULE IN THE Federal Register], you must comply with 
applicable requirements in this subpart by [DATE OF PUBLICATION OF THE 
FINAL RULE IN THE Federal Register].
    (c) New source. If you have a new or reconstructed affected source 
for which the initial startup date is after [DATE OF PUBLICATION OF THE 
FINAL RULE IN THE Federal Register], you must comply with applicable 
requirements in this subpart upon initial startup.

Standards


Sec.  63.10390  What management practice standards must I meet?

    (a) You must sterilize full loads of items having a common aeration 
time, except under the following conditions: emergency circumstances 
dictate the use of less than full loads to protect human health.
    (b) You are exempt from the management practice standards in 
paragraph (a) of this section if your sterilization unit is equipped 
with an add-on air pollution control device and you submit a 
certification in accordance with Sec.  63.10400.

Initial Compliance Requirements


Sec.  63.10400  How do I demonstrate initial compliance?

    (a) Uncontrolled sources. You must demonstrate initial compliance 
with the management practice standards in Sec.  63.10390(a) by 
submitting an initial Notification of Compliance Status certifying that 
you are sterilizing with full loads of items having a common aeration 
time.
    (b) Controlled sources subject to State and local regulation. You 
must demonstrate initial compliance with Sec.  63.10390(b) by 
submitting an initial Notification of Compliance Status certifying that 
you are operating the sterilization unit in accordance with your State 
or local regulation and following control device manufacturer's 
recommended procedures.
    (c) Controlled sources not subject to State and local regulation. 
You must demonstrate initial compliance with Sec.  63.10390(b) by 
submitting an initial Notification of Compliance Status certifying that 
you are venting the ethylene oxide emissions from each sterilization 
unit to an add-on air pollution control device. You must certify that 
you are operating the control device during all sterilization processes 
and in accordance with manufacturer's recommended procedures.


Sec.  63.10402  By what date must I demonstrate initial compliance?

    You must demonstrate initial compliance with Sec.  63.10390 upon 
startup or no later than 180 calendar days after your compliance date, 
whichever is later.

Monitoring--Continuous Compliance Requirements


Sec.  63.10420  How do I demonstrate continuous compliance with the 
management practice requirements?

    For each sterilization unit not equipped with an add-on air 
pollution control device, you must demonstrate continuous compliance 
with the management practice standards in Sec.  63.10390(a) by checking 
and recording the date and time of each sterilization cycle, whether 
each sterilization cycle contains a full load of items, and if not, 
which allowable reason.

Notifications, Reports, and Records


Sec.  63.10430  What notifications must I submit and when?

    (a) You must submit the initial Notification of Compliance Status 
to the authority provided for in Sec.  63.9(a)(4). In addition to 
submitting your initial