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ENVIRONMENTAL PROTECTION AGENCY

Environmental Protection Agency

CFR Citation: 40 CFR Part 63

RIN ID: RIN 2060-AM14

EPA ID: [EPA-HQ-OAR-2005-0171; FRL-8512-1]

NOTICE: RULES

ACTION: Air pollutants, hazardous; national emission standards:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: National Emission Standards for Hospital Ethylene Oxide Sterilizers

DATES: The final rule is effective on December 28, 2007.

DOCUMENT 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).

SUMMARY: Hospital ethylene oxide sterilizers,

SUPPLEMENTAL 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. Addon 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 LowIncome 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
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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 38715716, 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 addon 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
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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 addon 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 fourfactor 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 casebycase 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 1525415255, 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 abovementioned 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 60day 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. EPAHQOAR20050171.
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
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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 costeffective, 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 addon 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 addon 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 addon 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 oxidesterilized 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 singleuse 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 fullload 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
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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 costeffectiveness 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., Urban1 and Urban2 areas) rule.\4\ We have received no comments recommending that we limit this rule's applicability only to hospitals in Urban1 and Urban2 areas. \4\ In the Integrated Urban Strategy, EPA defined ``urban areas'' to include Urban1 and Urban2 areas. (64 FR 38724). The Urban1 and Urban2 definitions are based on the United States Census Bureau's most current decennial census data. Urban1 areas are counties with metropolitan statistical areas with a population greater than 250,000. Urban2 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 1year 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
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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 nontitle 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
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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 costeffective. 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 costeffective. 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 costeffective. 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. Addon Controls

1. Cost Considerations

Comment: Four commenters recommended that EPA require addon 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., acidwater 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 addon controls, it suggests that these controls are practical and feasible.

One commenter expressed that, with nearly half of the hospitals using addon controls, it is hard to understand EPA's rationale in the proposed rule that addon 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
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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 costbenefit needed to justify new hospital investment in the control devices. The commenter noted that the cost of addon 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. 101228, 101st Cong. 1st session. 171172). 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 addon 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 addon 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 addon 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 addon 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 addon controls showed poor costeffectiveness. Specifically, EPA's costeffectiveness estimate for addon controls was $200,000 per ton of ethylene oxide reduced. This costeffectiveness 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 addon control is outweighed by the various costs associated with such control. Based on the foregoing, we determined that addon controls do not represent GACT for this area source category.

One commenter argued that EPA required addon control in the HMIWI standard that were not necessarily costeffective 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 costeffectiveness, 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 CeEmission Guidelines and
Compliance Times for Hospital/Medical/Infectious Waste Incinerators (constructed on or before June 20, 1996).

40 CFR part 60, subpart EcStandards 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 addon 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 addon 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
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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 beyondthefloor 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 addon 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 addon controls is outweighed by the costs associated with such control. We believe the consideration of costs is especially important for the wellcontrolled area sources at issue in this final action because, given current wellcontrolled 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 addon control appears to be based on costeffectiveness 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 addon 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 addon 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 twophase 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 technologybased, 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 riskbased analysis. Specifically, CAA section 112(f)(2) requires EPA to determine8 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
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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. 101228, 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 approache

FOR FURTHER INFORMATION CONTACT Mr. David Markwordt, Office of Air Planning and Standards, Sector Policies and Programs Division, Coatings and Chemicals Group (E14301), Environmental Protection Agency, Research Triangle Park, NC 27711, telephone number: (919) 5410837; fax number: (919) 5410246; email address: markwordt.david@epa.gov.