[Federal Register Volume 59, Number 44 (Monday, March 7, 1994)]
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[Page 0]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 94-5149]


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[Federal Register: March 7, 1994]


                                                    VOL. 59, NO. 44

                                              Monday, March 7, 1994
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[AD-FRL-4845-7]
RIN 2060-AC28

 

National Emission Standards for Hazardous Air Pollutants for 
Ethylene Oxide Commercial Sterilization and Fumigation Operations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule and notice of public hearing.

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SUMMARY: The proposed standards would limit emissions of ethylene oxide 
(EO) from existing and new commercial sterilization and fumigation 
operations. The proposed national emission standards for hazardous air 
pollutants (NESHAP) implement section 112(d) of the Clean Air Act 
(Act). The intent of the proposed standards is to protect public health 
by requiring existing and new major sources and existing area sources 
to control emissions to the level achievable by the maximum achievable 
control technology (MACT), and by requiring new area sources to control 
emissions using generally available control technology (GACT).

DATES: Comments. Comments must be received on or before May 6, 1994.
    Public Hearing. If anyone contacts the EPA requesting to speak at a 
public hearing by April 4, 1994, a public hearing will be held on April 
12, 1994, beginning at 10 a.m.
    Request to Speak at Hearing. Requests to present oral testimony 
must be received by April 4, 1994.

ADDRESSES: Comments. Comments should be submitted (in duplicate, if 
possible) to: Air and Radiation Docket and Information Center (LE-131), 
Attention, Docket No. A-88-03, U.S. Environmental Protection Agency, 
401 M Street SW., Washington, DC 20460. The Agency requests that a 
separate copy also be sent to the contact person listed below.
    Public Hearing. If anyone contacts the EPA requesting a public 
hearing, it will be held at the EPA Office of Administration Auditorium 
in Research Triangle Park, North Carolina. Persons interested in 
requesting a hearing, verifying that a hearing will be held, or wishing 
to present oral testimony should contact Ms. Lina Hanzely, Chemicals 
and Petroleum Branch (MD-13), U.S. Environmental Protection Agency, 
Research Triangle Park, North Carolina 27711, telephone number (919) 
541-5673 by the dates specified above.
    Background Information Document. The background information 
document (BID) for the proposed standards may be obtained from the U.S. 
Department of Commerce, National Technical Information Service (NTIS), 
Springfield, Virginia 22161, telephone number (703) 487-4650. Please 
refer to ``Ethylene Oxide Emissions from Commercial Sterilization/
Fumigation Operations--Background Information for Proposed Standards, 
NTIS number PB 93-226744, EPA-453/D-93-016.'' Electronic versions of 
the BID as well as this proposed rule are available for download from 
the EPA's Technology Transfer Network (TTN), a network of electronic 
bulletin boards developed and operated by the Office of Air Quality 
Planning and Standards. The TTN provides information and technology 
exchange in various areas of air pollution control. The service is 
free, except for the cost of a phone call. Dial (919) 541-5742 for up 
to a 14,400 bits per second (bps) modem. If more information on TTN is 
needed contact the systems operator at (919) 541-5384.
    Docket. Docket No. A-88-03, containing supporting information used 
in developing the proposed standards, is available for public 
inspection and copying from 8 a.m. to 4 p.m., Monday through Friday, at 
the EPA's Air and Radiation Docket and Information Center, Waterside 
Mall, room M-1500, Ground Floor, 401 M Street SW., Washington, DC 
20460. The proposed regulatory text and other materials related to this 
rulemaking are available for review in the docket. A reasonable fee may 
be charged for copying.

FOR FURTHER INFORMATION CONTACT: For information concerning the 
standards or technical aspects, contact Mr. David Markwordt at (919) 
541-0837, Chemicals and Petroleum Branch, Emission Standards Division 
(MD-13), U.S. Environmental Protection Agency, Research Triangle Park, 
North Carolina 27711. For information concerning the health effects of 
EO, contact Dr. Nancy Pate at (919) 541-5347, Pollutant Assessment 
Branch, Emission Standards Division (MD-13) at the above address.

SUPPLEMENTARY INFORMATION: The information presented in this preamble 
is organized as follows:

I. List of Categories and Subcategories.
II. Background.
III. NESHAP Decision Process.
    A. Source of Authority for NESHAP Development.
    B. Criteria for Development of NESHAP.
    C. Maximum Achievable Control Technology Floor Determination and 
Process of Developing Regulations for Major and Area Sources.
IV. Summary of Proposed Standards.
    A. Source Categories to be Regulated.
    B. Pollutant to be Regulated.
    C. Affected Emission Points.
    D. Format of the Standards.
    E. Proposed Standards.
    F. Impacts of the Standards.
    G. Certification of Compliance.
    H. Monitoring Requirements.
    I. Reporting and Recordkeeping Requirements.
V. Summary of Environmental, Energy, and Economic Impacts.
    A. Facilities Affected by these NESHAP.
    B. Air Impacts.
    C. Water, Solid Waste, and Noise Impacts.
    D. Energy Impacts.
    E. Cost Impacts.
    F. Economic Impacts.
VI. Rationale.
    A. Selection of Pollutants and Source Category for Control.
    B. Selection of Emission Points to be Covered by the Standards.
    C. Selection of the Basis and Level of Proposed Standards for 
Major Sources.
    D. Selection of the Basis and Level of Proposed Standards for 
Area Sources.
    E. Selection of the Format of the Proposed Standards.
    F. Selection of Compliance and Performance Testing Provisions 
and Monitoring Requirements.
    G. Selection of Recordkeeping and Reporting Requirements.
    H. Operating Permit Program.
    I. Selection of Emission Test Methods.
    J. Solicitation of Comments.
VII. Administrative Requirements.
    A. Public Hearing.
    B. Docket.
    C. Executive Order 12866.
    D. Paperwork Reduction Act.
    E. Regulatory Flexibility Act.
    F. Miscellaneous.

    The proposed regulatory text is not included in this Federal 
Register notice, but is available in Docket No. A-88-03 or by request 
from the EPA contact persons designated earlier in this notice free of 
charge. The proposed regulatory language is also available on the EPA's 
Technology Transfer Network (TTN). See the DOCKET section of this 
preamble for more information on accessing TTN.

I. List of Categories and Subcategories

    Section 112 of the Act requires that the EPA evaluate and control 
emissions of hazardous air pollutants (HAP). The control of HAP is 
achieved through promulgation of emission standards under sections 
112(d) and 112(f) for categories of sources that emit HAP. The initial 
list of major and area source categories to be regulated was published 
in the Federal Register on July 16, 1992 (57 FR 31576).
    The source categories for which standards are proposed today are 
commercial EO sterilization and fumigation operations. Standards for 
both major and area sources of EO from commercial sterilization and 
fumigation operations are presented in today's proposed regulation. The 
commercial EO sterilization and fumigation source category consists of 
commercial operations that use EO in the sterilization of medical 
equipment supplies and in miscellaneous operations as a sterilant for 
heat- or moisture-sensitive materials or as a fumigant to control 
microorganisms or insects. A variety of materials are sterilized or 
fumigated with EO including medical equipment, pharmaceuticals, 
cosmetics, spices, books, artifacts, and beehives.
    Approximately 188 commercial EO sterilization and fumigation 
facilities are in operation in the U. S., emitting an estimated 1,070 
megagrams per year (Mg/yr) [1,180 tons per year (ton/yr)] of EO. 
Because all of the EO used for sterilization and fumigation is emitted 
following the sterilization process, the uncontrolled EO emissions from 
a facility are equal to the amount of EO used by that facility. 
Approximately 25 commercial sterilization and fumigation facilities 
each use 9,070 kilograms per year (kg/yr) [10 ton/yr] or more of EO and 
would, considering actual emissions, be considered major sources under 
section 112. Approximately 21 facilities use 9,070 kg/yr (10 ton/yr) or 
more of EO, but control the majority of EO emissions, emissions from 
the sterilization chamber vent, and would not be required to install 
additional controls on this emissions point. Of the remaining 142 known 
facilities, approximately 68 would be regulated as area sources under 
this proposed regulation. Approximately 74 of the smallest area sources 
would not be regulated.

II. Background

    In 1985, the EPA published a Federal Register notice titled 
``Assessment of Ethylene Oxide as a Potentially Hazardous Air 
Pollutant'' (50 FR 40286). In this notice, the EPA stated that it 
intended to list EO as a HAP under section 112 of the Act. The EPA then 
initiated an extensive information-gathering effort resulting in the 
development of the 1986 commercial sterilization data base as well as 
cost, industry profile, and other background information. In May 1988, 
the EPA presented a status report of the project to the National Air 
Pollution Control Techniques Advisory Committee (NAPCTAC). Both NAPCTAC 
members and members of the public provided comments on the draft BID 
that was presented at that time.
    In December 1988, work on the draft rule was temporarily suspended 
(although technical work continued) until the Agency responded to an 
appellate court ruling (Natural Resources Defense Council, Inc. v. EPA, 
824 F 2d at 1148 (DC Cir. 1987)) that the EPA must revise its NESHAP 
risk management policy so as to base decisions totally on health risk 
and to consider cost and technological feasibility only after the safe 
level of exposure has been set. As an interim activity, in March 1989, 
the EPA issued an Alternative Control Technology document (EPA-450-3/
89-007) that presents technical information to be used by State and 
local agencies in developing strategies for reducing emissions of 
volatile organic compounds (VOC) (e.g., EO) from sterilization and 
fumigation operations.
    With the passage of the 1990 Amendments to the Act, regulatory 
development activities resumed. The 1990 Amendments significantly 
changed the NESHAP decision-making process under section 112. Section 
112 of the Act requires the EPA to develop technology-based standards 
for source categories that emit HAP. This process is explained in 
section III of this preamble. The EPA is proposing to regulate EO 
emissions from commercial sterilization and fumigation operations under 
authority of section 112 of the amended Act.

III. NESHAP Decision Process

A. Source of Authority for NESHAP Development

    Title III of the 1990 Amendments was enacted to reduce the amount 
of nationwide air toxics emissions. Under title III, section 112 was 
amended to give the EPA the authority to establish national standards 
to reduce air toxics from certain industries that generate these 
emissions. Section 112(b) contains a list of HAP, which are the 
specific air toxics used to identify the source categories to be 
regulated by NESHAP. Section 112(c) directs the EPA to use this 
pollutant list to develop and publish a list of source categories for 
which NESHAP will be developed. A list of source categories was 
published in the Federal Register on July 16, 1992 (57 FR 31576). This 
list included both major and area commercial EO sterilization and 
fumigation sources.

B. Criteria for Development of NESHAP

    The NESHAP are to be developed to control HAP emissions from both 
new and existing sources according to the statutory directives set out 
in section 112 of the Act. The statute requires the standards to 
reflect the maximum degree of reduction in emissions of HAP that is 
achievable for new or existing sources. The NESHAP must reflect 
consideration of the cost of achieving the emission reduction, any 
nonair quality health and environmental impacts, and energy 
requirements for control levels more stringent than the MACT floors. 
(As described in section III.C. of this preamble, the MACT floor is the 
minimum stringency level for MACT standards, and is determined 
according to section 112(d) of the Act.) The emission reduction may be 
accomplished through application of measures, processes, methods, 
systems or techniques including, but not limited to, measures that: 1. 
Reduce the volume of, or eliminate emissions of, such pollutants 
through process changes, substitution of materials or other 
modifications;
    2. Enclose systems or processes to eliminate emissions;
    3. Collect, capture or treat such pollutants when released from a 
process, stack, storage, or fugitive emissions point;
    4. Are design, equipment, work practice, or operational standards 
(including requirements for operator training or certification) as 
provided in section 112(h); or
    5. Are a combination of the above (section 112(d)(2)).
    To develop NESHAP, the EPA collects information concerning the 
industry, including information on emission source characteristics, 
control technologies, data from HAP emission tests at well-controlled 
facilities, and information on the costs and other energy and 
environmental impacts of emission control techniques. The EPA uses this 
information to analyze possible regulatory approaches.
    Although NESHAP are normally structured in terms of numerical 
emission limits, alternative approaches are sometimes necessary. In 
some cases, physically measuring emissions from a source may be 
impossible or at least impracticable due to technological and cost 
limitations. Section 112(h) authorizes the Administrator to promulgate 
a design, equipment, work practice, or operational standard, or 
combination thereof, in those cases where it is not feasible to 
prescribe or enforce an emissions standard.

C. Maximum Achievable Control Technology Floor Determination and 
Process of Developing Regulations for Major and Area Sources

    The EPA must set MACT standards for each of the source categories 
listed under section 112(c) of the Act that contain major sources. Such 
standards must be set at a level at least as stringent as the 
``floor.'' Congress provides certain very specific directives to guide 
the EPA in the process of determining this regulatory floor. As 
described below, area sources may be regulated with either a MACT 
standard or a GACT standard. A GACT standard is not required to be as 
stringent as the MACT floor.
    For MACT, Congress specified that the EPA shall establish standards 
that require ``the maximum degree of reduction in emissions of the HAP 
* * * that the Administrator, taking into consideration the cost of 
achieving such emission reduction, and any nonair quality health and 
environmental impacts and energy requirements, determines is achievable 
for new or existing sources in the category or subcategory to which 
such emission standard applies * * *'' (the Act, section 112(d)(2)). In 
addition, Congress limited the Agency's discretion by establishing a 
minimum baseline or ``floor'' for standards. For new sources, the 
standards for a source category or subcategory ``shall not be less 
stringent than the emission control that is achieved in practice by the 
best controlled similar source, as determined by the Administrator'' 
(the Act, section 112(d)(3)). Congress provided that existing source 
standards could be less stringent than new source standards but could 
be no less stringent than the average emission limitation achieved by 
the best performing 12 percent of the existing sources (excluding 
certain sources) for categories and subcategories with 30 or more 
sources or the best performing 5 sources for categories or 
subcategories with fewer than 30 sources (the Act, section 112(d)(3)).
    Once the floor has been determined for new or existing sources for 
a category or subcategory, the Administrator must set a MACT standard 
that is no less stringent than the floor. Such standards must then be 
met by all sources within the category or subcategory. However, in 
establishing standards, the Administrator may distinguish among 
classes, types, and sizes of sources within a category or subcategory 
(the Act, section 112(d)(1)).
    In addition, the Act provides the Administrator further flexibility 
to regulate area sources. Section 112(d)(5) provides that in lieu of 
establishing MACT standards under section 112(d), the Administrator may 
promulgate standards that provide for the use of ``generally available 
control technologies or management practices.'' Area source standards 
promulgated under this authority (GACT standards) would not be subject 
to the MACT ``floors'' described above. Moreover, for area source 
categories subject to standards promulgated under section 112(d)(5), 
the EPA is not required to conduct a residual risk analysis under 
section 112(f).
    At the end of the data gathering and analysis, the EPA must decide 
whether it is more appropriate to follow the MACT or the GACT approach 
for regulating an area source category. An area source is ``any 
stationary source of HAP that is not a major source.'' As stated 
previously, MACT is required for major sources. If all or some portion 
of the sources emit less than 9.1 Mg/yr (10 tons/yr) of any one HAP (or 
less than 22.7 Mg/yr [25 tons/yr] of total HAP), then it may be 
appropriate to define subcategories within the source category and 
apply a combination MACT/GACT approach, MACT for major sources and GACT 
for area sources. In other cases, it may be appropriate to regulate 
both major and area sources under MACT.
    The next step in establishing a MACT or GACT standard is the 
investigation of regulatory alternatives. With MACT standards, only 
alternatives at least as stringent as the floor may be considered. 
Information about the industry is analyzed to develop model plant 
populations for projecting national impacts, including HAP emission 
reduction levels, costs, energy, and secondary impacts. Several 
regulatory alternative levels (which may be different levels of 
emissions control or different levels of applicability or both) are 
then evaluated to determine the appropriate MACT or GACT level.
    The regulatory alternatives for new versus existing sources may be 
different, and separate regulatory decisions must be made for new and 
existing sources. For both source types, the selected alternative may 
be more stringent than the MACT floor. However, the control level 
selected must be technically achievable. In selecting a regulatory 
alternative to represent MACT or GACT, the Agency considers the 
achievable reduction in emissions of HAP (and possibly other pollutants 
that are co-controlled), the cost impacts, energy impacts, and other 
environmental impacts of the alternatives above the floor. The 
objective is to achieve the maximum degree of emission reduction 
without unreasonable impacts.
    The selected regulatory alternative is then translated into a 
proposed regulation. The regulation implementing the MACT or GACT 
decision typically includes sections of applicability, standards, test 
methods, and compliance demonstration, monitoring, reporting, and 
recordkeeping. The preamble to the proposed regulation provides an 
explanation of the rationale for the decision. The public is invited to 
comment on the proposed regulation during the public comment period. 
Based on an evaluation of these comments, the EPA reaches a final 
decision and promulgates the standard.

IV. Summary of Proposed Standards

A. Source Categories To Be Regulated

    These proposed standards would regulate emissions of EO from 
existing and new commercial sterilization and fumigation operations 
using 907 kg/yr (1 ton/yr) of EO or more. The commercial sterilization 
and fumigation source categories cover the use of EO as a sterilant and 
fumigant in the production of medical equipment and supplies and in 
miscellaneous sterilization and fumigation operations at both major and 
area sources. The facilities affected by these proposed standards 
include, but are not limited to, medical equipment suppliers (SIC 3841 
and 3842); pharmaceutical suppliers (SIC 2831, 2833, 2834, and 5122); 
other health-related industries (SIC 2211, 2821, 2879, 3069, 3079, 
3569, 3677, 3693, 3999, and 5086); spice manufacturers (SIC 2034, 2035, 
2046, 2099, and 5149); contract sterilizers (SIC 7218, 7399, and 8091); 
and laboratories (0279, 7391, 7397, 8071, and 8922). These commercial 
sterilization facilities use EO as a sterilant for heat- or moisture-
sensitive materials and as a fumigant to control microorganisms or 
insects. Materials may be sterilized at the facility that produces or 
uses the product or by contract sterilizers (i.e., firms under contract 
to sterilize products manufactured by other companies).

B. Pollutant To Be Regulated

    Section 112(b) of the amended Act lists EO as a HAP. Ethylene oxide 
is emitted from commercial EO sterilization and fumigation operations 
in significant quantities. The nationwide emissions from all commercial 
EO sterilization and fumigation facilities are approximately 1,070 Mg/
yr (1,180 ton/yr).

C. Affected Emission Points

    One of the affected emission points is the sterilization chamber 
vent(s) at existing and new commercial EO sterilization and fumigation 
operations. This vent is the emission point for EO evacuated from the 
sterilization chamber following sterilization. The EO is removed from 
the sterilization chamber via a series of air washes. As explained in 
section VI.B. of this preamble, a component of this emission point is 
the emissions from any vacuum pump drain used to evacuate the chamber 
during these air washes.
    The second emission point affected by this proposed regulation is 
the chamber exhaust vent(s). Prior to unloading the sterilization 
chamber, the chamber door is automatically cracked, and the chamber 
exhaust is activated. The chamber exhaust evacuates EO-laden air from 
the sterilization chamber prior to unloading and while the chamber is 
being unloaded (and reloaded). The chamber exhaust enables facilities 
to meet U.S. Occupational Safety and Health Administration (OSHA) 
workplace exposure standards; not all facilities have or need chamber 
exhaust vents.
    The third emission point affected by this proposed regulation is 
the aeration room vent(s) at existing and new major source commercial 
EO sterilization and fumigation operations. Aeration rooms or chambers 
are used to allow further diffusion of residual EO from the sterilized 
products prior to shipping in order to comply with U.S. Food and Drug 
Administration (FDA) residual EO guidelines. Exhaust from these 
aeration rooms or chambers is emitted through the aeration room vent.

D. Format of the Standards

    A percent reduction format in the form of a mass reduction 
determination was selected for the proposed standard for the 
sterilization chamber vents. This format provides flexibility to the 
owner or operator in the use of any technology or operational practice 
that achieves the same level of reduction.
    A concentration-based format was selected for the proposed standard 
for the chamber exhaust and aeration room vents: parts per million of 
EO emitted per unit volume of air. This format is desirable because it 
requires measurement at only one point in the process and continuous 
monitoring of compliance is possible. Additionally, because the inlet 
concentrations from the aeration room vents are relatively low, and the 
outlet concentrations of some of the controlled aeration room vents 
approach the levels of detection for EO, some facilities may not be 
able to demonstrate compliance with an ``equivalent'' percent reduction 
requirement.

E. Proposed Standards

    A summary of today's proposed standards is listed in Table 1.

        Table 1.--Proposed Standards, National Costs, and Emission Reductions for Major and Area Sources        
----------------------------------------------------------------------------------------------------------------
                    EO use                                                              Emission                
   Vent type     cutoff, kg/                         Standard                        reduction, Mg/     Annual  
                 yr (ton/yr)                                                           yr (ton/yr)    cost, $MM 
----------------------------------------------------------------------------------------------------------------
Sterilizer vent      907 (1)  99 percent reduction.................................     950 (1,050)          3.8
Chamber exhaust      907 (1)  5,300 ppmv maximum concentration.....................               0          0  
Aeration room..   9,070 (10)  1 ppmv maximum concentration.........................         48 (53)          2.6
----------------------------------------------------------------------------------------------------------------

Included in this table are applicability cutoffs based on annual EO 
use, descriptions of the standards, and the estimated impacts 
associated with these proposed standards for each type of vent.
    Owners or operators of existing commercial EO sterilization and 
fumigation operations would be required to install the control 
technology needed to comply with the proposed standards within 2 years 
after the effective date of the standard. Owners or operators of new 
commercial EO sterilization and fumigation operations that have 
commenced construction or reconstruction after the standards are 
proposed, and before the final standards are promulgated, would be 
required to have installed the control technology needed to comply with 
the proposed standards upon startup. Owners or operators of new 
commercial EO sterilization and fumigation operations that have 
commenced construction or reconstruction after the standards are 
promulgated would be required to comply with all requirements upon 
startup.

F. Impacts of the Standards

    The nationwide impacts presented below are the impacts the 
standards would have on existing operations. The growth rate in the 
source categories covered by these standards is projected to be 
approximately zero. A more detailed discussion on how these impacts 
were calculated can be found in Chapters 6 through 8 of the Background 
Information Document (see ADDRESSES section).
    The nationwide emission reduction beyond the baseline resulting 
from these standards would be 1,000 Mg/yr (1,100 tons/yr). The 
nationwide annual costs beyond baseline would be $6.4 million. Except 
for contract sterilizers, most facilities are not expected to face 
significant increases in the total costs of producing sterilized goods. 
Although contract sterilizers will face greater production cost 
increases, their business volume is expected to increase as other types 
of facilities opt to switch from in-house sterilization to contract 
sterilization to avoid the costs of regulation. No closures are 
anticipated as a result of compliance with these standards. The energy, 
solid waste, and water impacts attributable to the use of these control 
technologies are expected to be minimal (see sections V.C. and D. of 
this preamble for a more detailed discussion of these impacts).

G. Certification of Compliance

    The tests required under the proposed standards include initial 
performance testing of control equipment installed on the sterilization 
chamber vents, and aeration room vents at affected EO commercial 
sterilization and fumigation operations. The schedule for performance 
testing is provided in Sec. 63.7 of the proposed General Provisions. 
The initial performance test is required 120 days after the effective 
date of the standards or after startup for a new facility, or 120 days 
after the compliance date specified for an existing facility.

H. Monitoring Requirements

    The owner or operator of a commercial EO sterilization and 
fumigation operation controlling emissions from the sterilization 
chamber vent through the use of an acid-water scrubber would be 
required to monitor the ethylene glycol concentration in the scrubber 
liquor. Owners or operators controlling emissions from the 
sterilization chamber vent through the use of catalytic oxidation would 
be required to monitor the change in temperature across the catalyst 
bed.
    The owner or operator of a commercial EO sterilization and 
fumigation operation would be required to measure the concentration of 
EO in the sterilization chamber immediately before the chamber exhaust 
is activated. Owners or operators of commercial EO sterilization and 
fumigation operations would be required to continuously monitor the 
concentration of EO being emitted from the aeration room vent at the 
outlet to the environment.

I. Reporting and Recordkeeping Requirements

    Owners or operators of commercial EO sterilization and fumigation 
operations using 907 kg (1 ton) or more of EO in any consecutive 12-
months would be required by the proposed General Provisions of part 63 
of 40 CFR to submit an initial notification report. For new sources, 
the EO use information must be an estimate of expected use during the 
first consecutive 12 months of operation. Owners or operators of new 
sources would be required to submit the initial notification report 
within the timeframes specified in Sec. 63.9 of 40 CFR part 63, subpart 
A, according to the type of new source classification. For existing 
sources, the notification report must specify the amount of EO used in 
the previous consecutive 12 months as well as the information required 
under Sec. 63.9 of 40 CFR part 63, subpart A. Owners or operators of 
existing sources would be required to submit the initial notification 
report within 45 calendar days after the effective date of the 
standards or within 45 days of the month in which a facility exceeds 
the annual applicability cutoff.
    Owners or operators of any affected commercial EO sterilization and 
fumigation operation would be required to submit a report indicating 
their intention to conduct a performance test at least 75 days before 
the scheduled date of the test. This report must be accompanied by a 
site test plan. Once the performance test is approved and conducted 
properly, a report containing the test results must be submitted within 
30 days after completion of the test.
    Owners or operators of affected commercial EO sterilization and 
fumigation operations consistently using less than 9,070 kg (10 tons) 
of EO during 12 consecutive months would be required to maintain 
records of a 12-month rolling average of EO use. Owners or operators of 
commercial EO sterilization and fumigation operations who previously 
used less than 9,070 kg (10 tons) of EO but whose EO use within a 
consecutive 12 months equaled or exceeded 9,070 kg (10 tons) would be 
required to submit an initial notification and all related ``new 
source'' reports for the aeration room standard unless the facility was 
existing prior to the affected date of the standards.
    Owners or operators of commercial EO sterilization and fumigation 
operations subject to these standards would be required to report when 
their operations exceeded levels specified in the standards, and 
therefore violated the respective standard. The reports would be due by 
the 30th day following the end of each quarter in which excess 
emissions occurred. These reports would contain the date and time of 
the violation, the conditions and duration of the violation, and the 
steps taken to correct the violation and return the device to proper 
operation.
    Owners or operators of commercial EO sterilization and fumigation 
operations would be required to retain all information related to their 
initial performance test, compliance with the standards, and the test 
methods for a minimum of 5 years.

V. Summary of Environmental, Energy, and Economic Impacts

A. Facilities Affected by These NESHAP

    There are approximately 188 existing commercial EO sterilization 
and fumigation facilities throughout the country. Approximately 18 
percent of this total have already installed emission control equipment 
on sterilization chamber vents to comply with OSHA, State, or local 
requirements, and would not have to install additional control 
equipment to meet the proposed standards. Approximately 51 percent of 
the 47 commercial EO sterilization and fumigation major sources have 
installed emission control devices. About 83 existing commercial EO 
sterilization and fumigation facilities have uncontrolled sterilization 
chamber vents (or have sterilization chamber vents that are controlled 
at an efficiency insufficient to meet this proposed standard) and would 
be required to install control equipment on sterilization chamber vents 
under today's proposed standards. No commercial EO sterilization and 
fumigation operations contained in the EPA's commercial sterilization 
data base control emissions from the chamber exhaust vent. 
Approximately 114 facilities will be required to meet the 5,300 parts 
per million by volume (ppmv) concentration standard for emissions from 
the chamber exhaust vent. The 47 major sources would be required to 
control emissions from the aeration room vent. Sixteen of these 
facilities are known to have already installed control equipment to 
meet State or local permitting requirements and would not be required 
to install additional controls. About 31 existing commercial EO 
sterilization and fumigation facilities have uncontrolled aeration room 
vents (or have aeration room vents that are controlled at a 
concentration insufficient to meet this proposed standard) and would be 
required to install control equipment on aeration room vents. 
(Additional information on the status of control in this industry is 
found in the docket for this rulemaking effort.)
    Based on the projected zero growth rate of the commercial sector, 
it is estimated that the only newly constructed commercial EO 
sterilization and fumigation facilities covered by the proposed 
standards during the 5-year period from 1992 to 1997 would be 
facilities replacing those facilities that have retired.

B. Air Impacts

    The proposed standards would reduce nationwide emissions of EO from 
existing commercial EO sterilization and fumigation facilities by about 
93 percent in 1997 compared to the emissions that would result in the 
absence of the proposed standards. In the absence of a regulation, 
existing commercial EO sterilization and fumigation operations are 
projected to emit 1,070 Mg (1,180 tons) of EO in 1997. Under the 
proposed standards, these facilities are projected to emit 72 Mg (79 
tons) of EO, a reduction of approximately 1,000 Mg (1,100 tons). The 
standard for sterilization chamber vent emissions accounts for a 
nationwide reduction of 950 Mg (1,050 tons) of EO, and the standard for 
aeration room vent emissions accounts for a nationwide reduction of 48 
Mg (53 tons). There is no expected change in emissions from chamber 
exhaust vents because the intent of the standard for these vents is to 
prevent any emissions increases.

C. Water, Solid Waste, and Noise Impacts

    The water quality impact associated with these proposed standards 
is small. The impact of the proposed standards on water quality would 
result from ethylene glycol in the wastes generated by the acid-water 
scrubbers. Ethylene glycol is generated when the EO exhaust stream 
contacts and then reacts with the acid-water solution in this type of 
scrubber. When this solution is spent, the scrubber tank is emptied, 
and a fresh acid-water solution added. Each tank typically holds about 
833 liters (L) (220 gallons (gal)) of a 10 percent (by volume) aqueous 
sulfuric acid (H2SO4) solution, which is neutralized with 50 
percent (by weight) caustic (NaOH) before the tank is drained. The 
amount of ethylene glycol solution generated by existing sources as a 
result of this proposed regulation is expected to be 2,120 cubic meters 
per year (m3/yr) (561,000 gallons per year (gal/yr)). However, 
there are several operations offering no-credit, no-cost (except for 
shipping) ethylene glycol recovery; it is anticipated that the 
nationwide wastewater impacts will be lower than 2,120 m3/yr 
(561,000 gal/yr).
    The solid waste impact due to the proposed standards is small. 
Catalytic oxidation is used at some facilities as a control technology 
for both sterilization chamber vents and aeration room vents. The 
catalyst beds are typically returned to the control device manufacturer 
for regeneration where the spent catalyst is landfilled. The spent 
catalyst is not classified as a hazardous waste. However, control 
technologies utilizing acid-water scrubbers, which have no solid waste 
impacts, are used at the majority of facilities. Therefore, it is 
expected that the solid waste impacts will be minimal.
    There are no noise impacts associated with these proposed 
standards.

D. Energy Impacts

    The national energy impacts associated with these proposed 
standards are small. The total increase in annual electricity use 
resulting from the proposed standards in 1997 would be about 0.1 
gigawatt hours per year (GWh/yr). This increased electricity use 
attributed to existing sources results from the operation of control 
devices used in complying with the emissions standards for the 
sterilization vent and aeration room vent. The average electricity 
requirements for a typical operation affected by these standards are 
projected to increase 110 kilowatt hours/yr (KWh/yr) as a result of the 
proposed standards. Because a zero net growth rate is projected for 
these industries, no increase in energy use is expected to result from 
these proposed standards for new sources.

E. Cost Impacts

    Under the proposed NESHAP, the nationwide annualized costs for 
existing commercial EO sterilization facilities would increase by about 
$6.4 million beyond baseline based on an analysis of the application of 
controls to all existing facilities not currently controlled to the 
level of the standards. The levels of controls specified in the 
standards comprise the regulatory baseline. Because any new sources 
would be replacing existing sources, costs attributable solely to new 
sources are not anticipated.
    To comply with the proposed emission standards, the initial capital 
cost incurred by a typical uncontrolled existing source such as a large 
commercial EO sterilization and fumigation operation using 68,000 kg/yr 
(75 ton/yr) of EO would be about $310,000 for controlling the 
sterilization chamber vent emissions and about $270,000 for controlling 
the aeration room vent emissions. The annualized cost incurred by this 
typical source to operate the control devices would be about $100,000 
to control the sterilization chamber vent emissions and about $74,000 
to control the aeration room vent emissions.

F. Economic Impacts

    The analysis of economic impacts indicated that the commercial EO 
sterilization and fumigation facilities subject to these proposed 
standards would not experience significant economic impacts. Due to 
OSHA requirements limiting worker exposure and existing State 
regulations, the industry trend is toward increased control of EO 
emissions; thus, the level of control required by these standards is, 
in many cases, already in place.
    The proposed standards will have the potential to affect many 
contract sterilizers in two ways. First, because sterilization is 
nearly the entire ``product'' for contract sterilizers, the proposed 
standards will probably cause a more pronounced increase in contract 
sterilizers' production costs as compared to the cost increase for 
other facilities affected by the standards. However, the proposed 
standards will likely also result in an increased demand for contract 
sterilization services. Because contract sterilizers on average have 
larger chambers than the other industry groups and use more EO, the 
per-unit cost of the proposed standards is lower for contract 
sterilizers than for the other groups. The contract sterilizers' lower 
per-unit control costs are therefore, expected to result in additional 
business if firms in the other affected industries switch from in-house 
sterilization to contract sterilization.
    The controls required under the proposed standards will increase 
sterilization costs in the other affected industry groups. However, 
sterilization costs are generally very small relative to the total cost 
of producing sterilized products in these industries. Consequently, the 
proposed standards will not significantly increase production costs for 
most medical device suppliers, other health-related manufacturers, 
spice manufacturers, or pharmaceutical manufacturers. Some facilities 
may choose to switch from in-house to contract sterilization to avoid 
any direct regulatory impacts.

VI. Rationale

    This section describes the decisions made by the Administrator to 
select the proposed standards.

A. Selection of Pollutants and Source Category for Control

    Section 112(c)(1) as amended authorizes the Administrator to 
publish a list of all categories and subcategories of major sources and 
area sources of the HAP listed in section 112(b), ethylene oxide is one 
of these listed HAP. For the categories and subcategories the 
Administrator lists, emission standards are to be established pursuant 
to section 112(d).
    A list of source categories to be regulated was published on June 
16, 1992 (57 FR 31576). Both major and area commercial EO sterilization 
and fumigation sources were listed.

B. Selection of Emission Points To Be Covered by the Standards

    For EO commercial sterilization and fumigation operations, the 
source consists of three emission points. The standards address all 
three of these emissions points, which are: (1) The sterilization 
chamber vent (i.e., the vent of the vacuum pump gas/liquid separator), 
(2) the chamber exhaust vent, and (3) the aeration room vent.
    A component of the sterilization chamber vent at some EO commercial 
sterilization and fumigation operations is a once-through, water-ring 
vacuum pump that results in EO emissions from wastewater. The use of a 
closed-loop, recirculating vacuum pump drain, a technology used at many 
EO commercial sterilization and fumigation operations, would eliminate 
these EO drain emissions (i.e., the EO that would be emitted via the 
drain would instead be emitted via the sterilization chamber vent). 
Thus, to prevent these wastewater emissions, the Agency is including 
any emissions from a vacuum pump drain as emissions from the 
sterilization chamber vent.

C. Selection of the Basis and Level of Proposed Standards for Major 
Sources

1. New Source MACT Floor Determination
    The following discussion presents the Agency's determination of the 
MACT floor for each of the three source types at new major source 
commercial EO sterilization and fumigation operations. Additional 
information on this analysis is found in the docket for this 
rulemaking.
    a. Sterilization chamber vent. The greatest sterilization chamber 
vent emission reduction by similar existing sources is the reduction of 
99 percent of emissions. Therefore, this emissions reduction comprises 
the MACT floor for new commercial EO sterilization and fumigation 
operations.
    b. Chamber exhaust vent. It is possible that chamber exhaust vent 
emissions could be controlled with existing technology. However, 
despite the presence of regulations in some States (e.g., California) 
that require emission reductions from this emission source, the EPA's 
database does not contain any existing chamber exhaust vents that are 
routed to a control device. Therefore, the MACT floor for new source 
chamber exhaust vents requires no reduction in emissions from these 
vents. However, to ensure that the current amount of EO being evacuated 
via the sterilization pump continues to be routed to a control device 
rather than exhausted via an uncontrolled vent, the Agency is 
incorporating a concentration-based limit on emissions from chamber 
exhaust vents. The new source MACT floor for chamber exhaust vents is a 
concentration limit of 5,300 ppmv. Because this floor maintains the 
``status quo'' for emissions from the chamber exhaust vent, and does 
not require the use of any control technologies, the Administrator 
determined that the use of this limit does not constitute measures 
beyond the MACT floor for these sources. The EPA is soliciting comments 
and data regarding demonstrated control technologies for this source.
    c. Aeration room vent. The best controlled aeration room vent at a 
similar source utilizes control technologies that reduce emissions to 1 
ppmv at most. This level of control therefore comprises the MACT floor 
for aeration room vents at new commercial EO sterilization and 
fumigation operations.
2. Existing Source MACT Floor Determination
    The following discussion presents the Agency's analysis that led to 
the determination of MACT floors for each of the three source types at 
existing commercial EO sterilization and fumigation operations. 
Additional information on this analysis is found in the docket for this 
rulemaking.
    a. Sterilization chamber vent. In the EPA's commercial 
sterilization data base, 24 of 47 major source facilities (51 percent) 
have control devices (catalytic oxidizers and acid-water scrubbers) for 
their sterilization chamber vent emissions that achieve an emissions 
reduction of 99 percent. These control devices are used across a range 
of industry categories and for a wide range of facility sizes (from 3.7 
m3 to 280 m3 (130 ft3 to 10,000 ft3) cumulative 
chamber size). No control devices capable of achieving greater emission 
reductions were found. Therefore, a 99-percent reduction was selected 
as the MACT floor for these existing emissions sources.
    b. Chamber exhaust vent. As is the case for the new source MACT 
floor, there are no existing chamber exhaust vents routed to a control 
device. Therefore the MACT floor for existing source chamber exhaust 
vents requires no reduction in emissions from these vents. However, to 
ensure that the current amount of EO being evacuated via the 
sterilization pump continues to be routed to a control device rather 
than exhausted via an uncontrolled vent, the Agency is incorporating a 
concentration-based limit on emissions from chamber exhaust vents. The 
existing source MACT floor for chamber exhaust vents is therefore a 
concentration limit of 5,300 ppmv. Because this floor maintains the 
``status quo'' for emissions from the chamber exhaust vent, and does 
not require the use of any control technologies, the Administrator 
determined that the use of this limit does not constitute measures 
beyond the MACT floor for these sources.
    c. Aeration room vent. There are approximately 16 major sources (34 
percent) known to have controlled aeration room vent emissions. The 
MACT floor for aeration room vents at existing commercial EO 
sterilization and fumigation operations using 9,070 kg (10 ton) or more 
of EO in a consecutive 12-months is therefore a reduction of emissions 
to a maximum concentration of 1 ppmv.
3. Development of Regulatory Alternatives
    a. New sources. The regulatory alternatives developed for new major 
sources incorporate the regulatory approaches described in section V.C. 
of this preamble as well as the MACT floors discussed above. In 
addition, these alternatives incorporate technologies that achieve an 
emission reduction beyond that of the MACT floors. These regulatory 
alternatives are listed in Table 2.

                   Table 2.--Major Source Regulatory Alternatives for New and Existing Sources                  
----------------------------------------------------------------------------------------------------------------
                                   Control levels                         Emission                              
             ----------------------------------------------------------  reduction,     Annual         Cost     
 Reg. alt.                          Aeration room     Chamber exhaust   Mg/yr (ton/   cost, $MM   effectiveness,
               Sterilizer vent          vent               vent             yr)                    $/Mg ($/ton) 
----------------------------------------------------------------------------------------------------------------
A             99       <1 ppmv outlet     99             830           5.5         6,600  
               percent mass        concentration.     percent mass            (910)  ...........        (6,000) 
               reduction.                             reduction.                                                
Ba            99       <1 ppmv outlet     <5,300 ppmv               800           4.3         5,400  
               percent mass        concentration.     outlet                  (880)  ...........        (4,900) 
               reduction.                             concentration.                                            
----------------------------------------------------------------------------------------------------------------
aRegulatory Alternative B represents the MACT floor for existing sources as well as the best controlled similar 
  source (i.e., MACT) for new sources.                                                                          

The nationwide emission reduction and cost data in Table 2 are based on 
existing sources.
    (1) Regulatory alternative A. Regulatory alternative A represents 
the most stringent reduction in emissions of EO from new commercial EO 
sterilization and fumigation of major sources. This alternative would 
require the installation of control devices on all three emission 
sources--the sterilization chamber vent, chamber exhaust vent, and 
aeration room vent. The control devices would be required to achieve an 
emission reduction of 99 percent (1 ppmv maximum emissions limit for 
aeration room vents). As discussed in the MACT floor analysis, the 
Agency is unaware of any demonstrated controls in use on a chamber 
exhaust vent. However, for purpose of this analysis, a model control 
device was evaluated.
    (2) Regulatory alternative B. This regulatory alternative reflects 
the application of MACT floor controls on the three emissions sources. 
Regulatory alternative B represents a reduction in emissions of EO from 
new commercial EO sterilization and fumigation sources that is less 
stringent than regulatory alternative A. The difference is that instead 
of reducing emissions from the chamber exhaust vent, the owner or 
operator would be required to not exceed ``status quo'' emissions.
    (3) Selected regulatory alternative. In determining MACT, the EPA 
evaluated the emission reductions, costs, economic impacts, and other 
environmental and energy impacts of the MACT floor control level and 
the levels of control more stringent than the floor. Based on the 
provisions of section 112(d)(2) of the amended Act, the Administrator 
selected regulatory alternative B as the basis for today's proposed 
standards for new sources. In the case of the sterilization chamber and 
aeration room vents, the Agency is unaware of a technology that 
achieves a demonstrated emissions reduction beyond the MACT floor 
controls. For chamber exhaust vents, the high costs coupled with the 
relatively low emissions reduction associated with controlling the 
existing sources (more than $40,000 per Mg) indicates that requiring 
this level of control would also impose overly-burdensome costs on new 
sources and would be inconsistent with Sec. 112(d) of the Act where the 
Administrator is required to consider the costs of any controls beyond 
the MACT floor.
    b. Existing sources. Regulatory alternatives were also developed 
for existing commercial EO sterilization and fumigation operations. 
These regulatory alternatives are listed in Table 2 and are identical 
to the regulatory alternatives developed for new sources. As with new 
sources, these regulatory alternatives reflect the application of the 
MACT floor controls to these major sources as well as the application 
of control technologies more stringent than the MACT floor.
    (1) Regulatory alternative A. Regulatory alternative A represents 
the most stringent reduction in emissions of EO from commercial EO 
sterilization and fumigation major sources. This alternative would 
require the installation of control devices on all three emission 
points--the sterilization chamber vents, chamber exhaust vents, and 
aeration room vents--at all major source commercial EO sterilization 
and fumigation operations. The control devices would be required to 
achieve an emission reduction of 99 percent (1 ppmv emissions limit for 
aeration room vents).
    (2) Regulatory alternative B. Regulatory alternative B represents a 
reduction in emissions of EO from commercial EO sterilization and 
fumigation sources that is less stringent than regulatory alternative 
A. This alternative represents the MACT floor for existing major 
sources.
    (3) Selected regulatory alternative. As with the determination of 
MACT for new sources, the EPA evaluated the emission reductions, costs, 
economic impacts, and other environmental and energy impacts of the 
MACT floor control level and the levels of control more stringent than 
the floor. Based on the provisions of section 112(d)(2) of the amended 
Act, the Administrator selected regulatory alternative B as the basis 
for today's proposed standards for existing sources. The incremental 
cost effectiveness of moving from regulatory alternative B to 
regulatory alternative A is $40,000 per Mg. The Administrator 
determined that this additional burden was excessive given the 
relatively low additional emission reduction achieved by the more 
stringent alternative. Regulatory alternative B therefore provides 
MACT-level controls while not imposing overly burdensome costs on the 
regulated community.

D. Selection of the Basis and Level of Proposed Standards for Area 
Sources

    In developing standards for area sources, the Administrator first 
determined that area sources using less than 907 kg/yr (1 ton) would 
not be required to control emissions from any of the emissions points. 
The Administrator based this decision on a number of factors discussed 
herein including the low emissions of sources below this cutoff (1.5 
percent of nationwide emissions or approximately 14 Mg/yr (15 ton/yr) 
of EO) and the high cost effectiveness (more than $50,000 per Mg) that 
is anticipated if just the emissions from the sterilization chamber 
vent were controlled at a 99-percent reduction limit. The data 
represent an increasing cost effectiveness at facilities using smaller 
quantities of EO. Because of these analyses, the Administrator decided 
not to regulate facilities using less than 907 kg/yr (1 ton/yr) of EO.
    For area sources using 907 kg/yr (1 ton/yr) of EO or more, the 
Agency evaluated MACT as the bases for regulations of new and existing 
sources. For new area sources, GACT was also evaluated as a basis for 
the standards. The potential approaches and corresponding levels of 
control for new and existing sources are shown in Table 3.

Table 3.--Potential Regulatory Approaches and Control Limits Examined by
              the Agency for New and Existing Area Sources              
------------------------------------------------------------------------
                                      Control limits                    
                  ------------------------------------------------------
                            New area sources              Existing area 
 Emissions point  -------------------------------------     sources     
                                                       -----------------
                         GACT            MACT floor        MACT floor   
------------------------------------------------------------------------
Sterilization      99% emission       99% emission      99% emission    
 chamber vent.      reduction.         reduction.        reduction.     
Chamber exhaust    5,300 ppmv         5,300 ppmv        5,300 ppmv      
 vent.              emission limit.    emission limit.   emission limit.
Aeration room      No controls        1 ppmv emission   No controls     
 vent.              required.          limit.            required.      
------------------------------------------------------------------------

1. New Area Sources

    As shown in table 3, the best performing area source (i.e., new 
source MACT floor) reduces emissions from the sterilization chamber 
vent by 99 percent, does not control emissions from the chamber exhaust 
vent but would prevent increases in emissions from this vent by 
requiring an emissions limit of 5,300 ppmv, and reduces emissions from 
the aeration room vent to a maximum of 1 ppmv. Because impact data for 
existing area sources indicate an incremental cost effectiveness of 
over $110,000/Mg ($100,000/ton) associated with requiring controls on 
aeration room vents for area sources, the Administrator rejected MACT 
as a basis for the new area source standards. The Administrator 
employed her authority under section 112(f) of the Act to base the 
standards for new area sources on GACT.
    As shown in table 3, GACT for new area sources results in a 99 
percent reduction in emissions from the sterilization chamber vent, an 
emissions limit of 5,300 ppmv for emissions from the chamber exhaust 
vent, and no control for emissions from the aeration room vent. These 
requirements would result in a nationwide cost effectiveness of $10,900 
per Mg ($9,900 per ton) for existing area sources. Based on these data 
from existing sources, the Administrator determined that the projected 
costs of compliance of requiring these controls for new sources was 
justified given the anticipated reductions in emissions.

2. Existing Area Sources

    The following discussion presents the Agency's analysis that led to 
the determination of MACT floors for each of the three source types at 
existing area source commercial EO sterilization and fumigation 
operations.
    a. Sterilization chamber vent. In the EPA's commercial 
sterilization data base, 8 of 67 area source facilities (12 percent) 
using 907 kg/yr (1 ton/yr) or more of EO have control devices 
(catalytic oxidizers and acid-water scrubbers) for their sterilization 
chamber vent emissions that achieve an emissions reduction of 99 
percent. No devices were found which exceed this level of control. 
Therefore, a 99-percent reduction was selected as the MACT floor for 
these vents at existing area source commercial EO sterilization and 
fumigation operations.
    b. Chamber exhaust vent. As is the case for the major source MACT 
floor at existing sources, there are no existing chamber exhaust vents 
routed to a control device. Therefore the MACT floor for existing area 
source chamber exhaust vents requires no reduction in emissions from 
these vents. However, to ensure that the current amount of EO being 
evacuated via the sterilization pump continues to be routed to a 
control device rather than exhausted via an uncontrolled vent, the 
Agency is incorporating a concentration-based limit on emissions from 
chamber exhaust vents. The existing area source MACT floor for chamber 
exhaust vents is therefore a concentration limit of 5,300 ppmv. Because 
this floor maintains the ``status quo'' for emissions from the chamber 
exhaust vent, and does not require the use of any control technologies, 
the Administrator determined that the use of this limit does not 
constitute measures beyond the MACT floor for these sources.
    c. Aeration room vent. There are 2 of 68 area sources (3 percent) 
using 907 kg/yr (1 ton/yr) or more of EO known to have controlled 
aeration room vent emissions. When the emissions reduction of the best 
performing 12 percent of these existing area sources is averaged, a 25 
percent control efficiency would be required. Because this 25 percent 
emissions reduction does not correspond to any known control 
technology, the median (94th percentile) of the best performing 12 
percent control technology was used to determine the MACT floor. This 
median source is uncontrolled. Therefore, the MACT floor for aeration 
room vents at existing area source commercial EO sterilization and 
fumigation operations is no control.
    d. Selected basis. The Administrator determined that there was no 
justification to reject MACT as the basis for regulating existing area 
sources. In making this decision, the Administrator noted that if 
additional data were made available to the Agency showing a controlled 
MACT floor for aeration room vents, there could be sufficient 
justification to reject MACT. Such a decision would be based on the 
high cost effectiveness coupled with the relatively low emissions 
reduction associated with controlling aeration room vents.
    In making the decision to base the standards for existing area 
sources on MACT, the Administrator also noted that the Agency would be 
required to perform a residual risk analysis under section 112(f) of 
the Act. The Administrator requests comment on the weight that this 
requirement (to perform a residual risk analysis) should carry in 
determining the basis for area source standards. For example, where 
MACT and GACT would require the same level of control (as in this 
case), is it permissible to call the standard GACT for area sources in 
order to exempt those sources from the requirements of 112(f)?

3. Development of Regulatory Alternatives for Existing Area Sources

    The regulatory alternatives developed for existing area sources 
incorporate the regulatory approaches and MACT floors described in 
section V.D. of this preamble. In addition, these alternatives 
incorporate technologies that achieve an emission reduction beyond that 
of the MACT floors. These regulatory alternatives and their nationwide 
emission reduction and cost impacts are listed in table 4.

                       Table 4.--Area Source Regulatory Alternatives for Existing Sources                       
----------------------------------------------------------------------------------------------------------------
                                   Control levels                         Emission                              
             ----------------------------------------------------------  reduction,     Annual         Cost     
  Reg. Alt.                         Aeration room     Chamber exhaust   Mg/yr (ton/   cost, $MM   effectiveness,
                Sterilizer vent          vent               vent            yr)                    $/Mg ($/ton) 
----------------------------------------------------------------------------------------------------------------
A             99       <1 ppmv outlet     99             206           4.3        20,900  
               percent mass        concentration.     percent mass            (227)  ...........       (19,000) 
               reduction.                             reduction.                                                
B             99       <1 ppmv outlet     <5,300 ppmv              (222)          3.0        15,000  
               percent mass        concentration.     outlet                         ...........       (14,000) 
               reduction.                             concentration.                                            
C             99       No control.......  <5,300 ppmv               193           2.1        10,900  
               percent mass                           outlet                  (213)  ...........        (9,900) 
               reduction.                             concentration.                                            
----------------------------------------------------------------------------------------------------------------

    a. Regulatory alternative A. Regulatory alternative A represents 
the most stringent reduction in emissions of EO from existing 
commercial EO sterilization and fumigation area sources. This 
alternative would require the installation of control devices on all 
three emission sources--the sterilization chamber vent, chamber exhaust 
vent, and aeration room vent. The control devices would be required to 
achieve an emission reduction of 99 percent (1 ppmv maximum emissions 
limit for aeration room vents). As discussed in the MACT floor analysis 
for these area sources, the Agency is unaware of any demonstrated 
controls in use on a chamber exhaust vent. However, for purpose of this 
analysis, a model control device was evaluated.
    b. Regulatory alternative B. This regulatory alternative reflects 
the installation of control devices on two of the emission sources--the 
sterilization chamber vent and aeration room vent. The control devices 
would be required to achieve an emission reduction of 99 percent (1 
ppmv maximum emissions limit for aeration room vents). No controls 
would be required for the chamber exhaust vents, however increases in 
these emissions would be disallowed by the use of an emissions cap of 
5,300 ppmv.
    c. Regulatory alternative C. This regulatory alternative reflects 
the application of MACT floor controls on the three emissions sources. 
Control devices would only be required for the sterilization chamber 
vent. No controls would be required for the chamber exhaust vent or 
aeration room vent, however increases in emissions from the chamber 
exhaust vent would be disallowed by the use of an emissions cap of 
5,300 ppmv.
    d. Selected regulatory alternative. In determining MACT for 
existing area sources, the EPA evaluated the emission reductions, 
costs, economic impacts, and other environmental and energy impacts of 
the MACT floor control level and the levels of control more stringent 
than the floor. Based on the provisions of section 112(d)(2) of the 
amended Act, the Administrator selected regulatory alternative C as the 
basis for today's proposed standards for existing sources. Although the 
cost effectiveness for MACT is relatively high, in this case the MACT 
approach was not rejected in favor of GACT because of the high toxicity 
of EO; one pound of EO is roughly equivalent in cancer potency to 15 
pounds of benzene. In addition to being a probable carcinogen, EO is 
also associated with severe noncancer health effects.
    In the case of the sterilization chamber vents, the Agency is 
unaware of a technology that achieves a demonstrated emissions 
reduction beyond the MACT floor controls. For aeration room and chamber 
exhaust vents, the high costs of requiring controls for these vents are 
overly burdensome (more than $110,000 per Mg ($100,000 per ton) 
incremental cost effectiveness associated with the control of aeration 
room vents under the next most stringent Regulatory Alternative). These 
high costs, coupled with the relatively low emissions reduction 
associated with controlling these vents, are inconsistent with section 
112(d) of the Act where the Administrator is required to consider the 
costs of any controls beyond the MACT floor.

E. Selection of the Format of the Proposed Standards

1. Alternative Formats Considered

    Consistent with section 112(d)(2) of the amended Act, the EPA 
considered performance-based formats for the standards. The Agency also 
considered alternative formats for the three emissions sources 
addressed in today's proposed regulation.
    a. Sterilization chamber vent emissions. Two formats consisting of 
concentration limits and percent reduction (efficiency) were considered 
for regulating emissions from the sterilization chamber vent. These 
formats addressed the varying EO concentrations and air flow rate 
characteristics associated with these batch sterilization and 
fumigation operations.
    (1) Concentration limit format. Standards based on a specified EO 
concentration at the control device outlet (e.g., outlet concentration 
requirement) are desirable because they require measurement at only one 
point in the process. However, outlet concentration was deemed to be an 
inferior format for the sterilization vent standard because outlet 
concentration alone is not a direct measure of the performance of the 
control devices used by this industry for control of this vent. Outlet 
concentration depends on the inlet concentration and flow rate of air 
through the control device. Because these are batch operations, the 
inlet concentrations and the flow rates may vary significantly during 
the sterilization cycle.
    Another reason a concentration format was not chosen for 
sterilization vent emissions is that the EPA lacks sufficient test data 
to establish a credible concentration limit that could be met by the 
industry as a whole and that would represent equivalent levels of 
control by all sources. The EPA could calculate a nationwide (or even 
plant-specific) concentration limit based on standard sterilization 
parameters, but (as discussed below) such a limit would have to be 
based on an assumed control device efficiency. Because the purpose of 
the outlet concentration standard format is to be a reliable indicator 
of control device efficiency, this method is inferior to other methods.
    (2) Percent reduction format. The EPA also considered a percent 
reduction format for the sterilization chamber vent standard. Although 
other methods of assessing percent reduction were considered (notably 
the comparison of inlet and outlet concentrations), the Agency 
determined that a mass-based reduction measurement of efficiency was 
the most effective for sterilization chamber vent emissions. This 
format was the only alternative that was feasible given the variable 
operating conditions of these batch operations. This mass-based 
measurement involves a compliance test where the outlet EO 
concentration and gas flowrate are measured in order to calculate the 
mass of EO at the outlet.
    Additionally, the inlet mass is determined through the measurement 
of the flowrate and concentration or by knowing the amount of EO 
charged to the chamber and chamber operating conditions.
    b. Chamber exhaust vent emissions. Two formats consisting of 
concentration limits and emission calculation were considered for 
regulating emissions from chamber exhaust vents.
    (1) Concentration limit format. A format based on a specified EO 
concentration in the sterilization chamber immediately prior to 
activating the chamber exhaust would be desirable because it requires 
measurement at only one point in the process and continuous monitoring 
of compliance is possible. Owners or operators of commercial EO 
sterilization and fumigation facilities could easily monitor this 
concentration and reduce the EO concentration inside the sterilization 
chamber below this level by performing air wash cycles as needed (the 
exhaust from these air wash cycles would exit via the sterilization 
chamber vent and would be considered to be emissions from the 
sterilization chamber vent emission point).
    (2) Emissions calculation format. During the development of these 
NESHAP, the Agency developed calculations that could be used to 
estimate chamber exhaust vent emissions. The Agency used actual test 
data as well as hypothetical situations to calculate the concentrations 
of EO remaining in the sterilization chamber after a certain number of 
air washes. These calculations assumed that EO behaved as an ideal gas 
and that a reasonable number of air wash chamber evacuations were 
performed (reasonable being dependent upon the type of sterilant gas 
and the product being sterilized). The concentrations of EO emitted 
from the chamber exhaust vent were consistently found to be less than 2 
percent of the original concentration of EO charged to the chamber when 
this reasonable number of air evacuations was performed. The Agency 
used these data to develop a regulatory format whereby an owner or 
operator of a commercial EO sterilization and fumigation operation 
could meet the chamber exhaust standard by performing the calculated 
number of chamber evacuations before engaging the chamber exhaust. 
Additional information on the development of this format is found in 
the docket for this rulemaking.
    The Agency noted that this format would be sufficient for 
commercial EO sterilization and fumigation operations that sterilized 
similar materials on a routine basis. However, because the calculated 
number of air evacuations to be performed depends on the materials to 
be sterilized, the Agency believes that this format would not be 
realistic for operations that sterilize a variety of materials. The 
Agency therefore did not select this format. The Agency is, however, 
soliciting comment on the use of this format as an alternative to the 
selected concentration-based format for commercial EO sterilization and 
fumigation operations that sterilize similar materials on a routine 
basis.
    c. Aeration room vent emissions. Two formats, percent reduction and 
concentration limit, were considered for regulating EO emissions from 
the aeration room vent. The Administrator is requesting specific 
comment on the format selected for the aeration room vent and any test 
data regarding emissions from this vent.
    (1) Percent reduction format. As with the format for the 
sterilization chamber vent standard, the EPA considered a percent 
reduction format for the standard for aeration room vents. However, the 
Agency believes that this format is not appropriate because the EO 
concentrations at the outlet of the control device could theoretically 
be below the limits of detection for EO and might, therefore, 
inaccurately measure the efficiency of a control device. Aeration room 
EO concentrations are typically 20 to 30 ppmv. Because of these low 
inlet EO concentrations, the outlet EO concentrations from a control 
device required to perform at the same efficiency as a control device 
for the sterilization chamber vent emissions could not be measured 
given the level of detection for EO. The Agency therefore determined 
that this percent reduction format was inappropriate for the aeration 
room vent standard.
    (2) Concentration limit format. A concentration format based on the 
EO concentration at the control device outlet is desirable because it 
requires measurement at only one point in the process and continuous 
monitoring of compliance is possible. Even though outlet concentration 
was deemed to be an inferior alternative for the sterilization vent 
standard, it is appropriate for the aeration room vent standard because 
of the less variable operating conditions. Because the outlet 
concentration depends on the inlet concentration when scrubbers are 
used, and the inlet concentrations do not vary significantly in the 
data available, the Administrator believes that an outlet concentration 
limit is an appropriate format for this emission source. This format 
also has the advantage that the concentration limit selected, 1 ppmv, 
approaches the limit of detection for EO, and would comprise the 
default outlet emission concentration if used to determine the percent 
emission reduction.

2. Formats Selected

    The percent reduction format, in the form of a mass reduction, was 
selected as the format of the standard for the sterilization chamber 
vent emissions. The Administrator determined that this format was 
technically achievable and provided a sufficient indicator of 
performance while also not imposing prohibitive costs on the owners or 
operators subject to the standard.
    A concentration limit format was selected as the format of the 
standards for the chamber exhaust vent and aeration room vent 
emissions. The Administrator determined that the use of the 
concentration limit format for these vents would provide the most 
accurate measurement of the performance of the control devices. The EO 
concentrations typically encountered in the aeration room vents (i.e., 
relatively low inlet EO concentrations and outlet EO concentrations 
approaching the limits of detection) precluded the use of the percent 
reduction format. In the case of the chamber exhaust vents, the 
Administrator determined that the variability of materials sterilized 
or fumigated would preclude the use of the emissions calculation format 
for many commercial EO sterilization and fumigation operations. 
However, as mentioned previously, the Agency is soliciting comment on 
the use of this format for chamber exhaust vents.

F. Selection of Compliance and Performance Testing Provisions and 
Monitoring Requirements

    The proposed regulation contains compliance provisions that require 
owners or operators to conduct an initial performance test to 
demonstrate compliance with the proposed standards. As a means of 
demonstrating compliance with the sterilization chamber vent standards 
following this initial performance test, the owner or operator must 
also establish source-specific parameters based on the type of control 
device used at that operation to control emissions from the 
sterilization chamber vent. The Administrator determined that these 
provisions were necessary to meet the enhanced monitoring provisions 
established in section 114(a)(3) of the Act.
    The provisions for enhanced monitoring contained in the Act as 
amended in 1990 give the Administrator the authority to promulgate 
regulations requiring compliance certification and enhanced monitoring 
by the owners or operators of all stationary sources. Consistent with 
the legislative history of the 1990 Amendments, the Agency has 
interpreted this new statutory authority as linking the data obtained 
from enhanced monitoring and compliance so that enhanced monitoring 
would be used to determine whether compliance was continuous. The 
Agency has therefore defined enhanced monitoring as monitoring 
conducted for the purpose of determining continuous compliance with 
emission limitations and standards. By requiring the use of enhanced 
monitoring, it will be possible to determine compliance on a continuous 
basis. Although the term ``continuous'' generally means at all times, 
the Agency has determined that less frequent measurements or 
determinations of compliance can ensure continuous compliance. The 
potential variability of the emissions or parameters is a primary 
factor in establishing the frequency of measurements. If the potential 
variability is high, measurements must be done frequently or even 
continuously. If the potential variability is low, measurements may be 
done less frequently at prescribed intervals. In any event, the 
monitoring must be capable of detecting deviations with sufficient 
reliability and timeliness to determine whether compliance with 
applicable standards is continuous.

1. Sterilization Chamber Vent

    As part of the compliance provisions of the proposed regulation, 
all owners or operators of commercial EO sterilization and fumigation 
operations subject to the sterilization chamber vent standard would be 
required to demonstrate compliance with the 99-percent emission 
reduction standard through a direct calculation of the emissions 
reduction. During this demonstration of compliance with the 
sterilization chamber vent standard, owners or operators of commercial 
EO sterilization and fumigation operations would also be required to 
establish site-specific monitoring parameters. These site-specific 
parameters depend on the type of emission control systems installed at 
the source. Owners or operators complying with the sterilization 
chamber standard through the use of acid-water scrubbers would be 
required to establish a maximum concentration of ethylene glycol in the 
scrubber liquor when emissions from the vent are in compliance with the 
99-percent emissions reduction standard. Subsequent operation of the 
affected sterilization source with an ethylene glycol concentration in 
the scrubber liquor in excess of the baseline ethylene glycol 
concentration shall constitute a violation of the sterilization chamber 
vent standard.
    Owners or operators complying with the sterilization chamber 
standard through the use of catalytic oxidation would be required to 
establish a temperature baseline of the change in temperature across 
the catalyst bed when emissions from the vent are in compliance with 
the 99-percent emissions reduction standard. Operation of the affected 
sterilization source during any period when the temperature change 
across the catalyst bed varies from the baseline temperature change in 
excess of 5.6 deg.C (10 deg.F) shall constitute 
a violation of the sterilization vent standard. Owners or operators 
complying with the sterilization chamber standard through the use of 
another control technology would be required to obtain approval from 
the Administrator for their monitoring protocols.
    Once the parameters to be monitored were selected, the mechanism 
for determining the limits for these parameters was investigated. The 
Agency considered establishing a nationwide limit for these parameters 
but after consultation with control device vendors is proposing that 
each commercial EO sterilization and fumigation operation, during the 
initial compliance demonstration, establish site-specific limits for 
the appropriate control device. The Administrator determined that site-
specific determination of these compliance limits would address the 
variabilities in operating conditions and designs of individual control 
devices.

2. Aeration Room Vent

    Owners of operators of commercial EO sterilization and fumigation 
operations subject to the aeration room vent standard would be required 
to monitor the concentration of EO being emitted from the aeration room 
vent (after any control device). Operation of the sterilization source 
in excess of the 1 ppmv EO concentration limit shall constitute a 
violation of the aeration room standard. This requirement provides a 
direct measurement of compliance with the standard and is in keeping 
with the principles established for enhanced monitoring.

3. Chamber Exhaust Vent

    Under today's proposed regulation, owners or operators of 
commercial EO sterilization and fumigation operations subject to the 
chamber exhaust standard would be required to monitor the concentration 
of EO in the sterilization chamber immediately prior to the operation 
of the chamber exhaust (i.e., at the completion of the sterilization 
cycle and immediately prior to the opening of the chamber door for 
unloading and subsequent loading of the chamber). Operation of the 
affected sterilization source in excess of the 5,300 ppmv EO 
concentration shall constitute a violation of the chamber exhaust vent 
standard. This requirement provides a direct measurement of compliance 
with the standard and is in keeping with the principles established for 
enhanced monitoring. Because the chamber exhaust is an integral part of 
a batch operation, true continuous monitoring of the vent is not 
necessary. In addition, because of the nature of this emissions point, 
the maximum concentration of EO that could be emitted from this 
emission point would be measured during under this monitoring approach.

G. Selection of Recordkeeping and Reporting Requirements

    Section 114 of the amended Act authorizes the EPA to require 
sources to monitor, test, keep records, and make reports. The proposed 
standards would require an owner or operator to submit the following 
four types of reports: 1. Initial Notification; 2. Notification of 
Compliance Status; 3. Periodic Reports; and 4. Other reports.
    The purpose and contents of each of these reports are described in 
this section. The proposed rule requires all reports to be submitted to 
the ``Administrator.'' The term Administrator refers either to the 
Administrator of the Agency, an Agency regional office, a State agency, 
or other entity that has been delegated the authority to implement this 
rule. In most cases, reports will be sent to State agencies. Addresses 
are provided in the proposed General Provisions (subpart A) of 40 CFR 
part 63.
    Records of reported information and other information necessary to 
document compliance with the regulation are generally required to be 
kept for 5 years. Records pertaining to the design and operation of the 
control and monitoring equipment must be kept for the life of the 
equipment.

1. Initial Notification

    The proposed standards would require owners or operators who are 
subject to today's proposed standards to submit an Initial 
Notification. This report notifies the agency of applicability for 
existing facilities or of construction for new facilities as outlined 
in Sec. 63.5 of the proposed General Provisions. This report will 
establish an early dialogue between the source and the regulatory 
agency, allowing both to plan for compliance activities. The notice is 
due within 45 days after the date of promulgation for existing sources. 
For new sources, it is due 180 days before commencement of construction 
or reconstruction, or 45 days after promulgation of today's proposed 
rules, whichever is later.
    The Initial Notification must include a statement as to whether the 
source can achieve compliance by the specified compliance date. If an 
existing source anticipates a delay that is beyond its control, it is 
important for the owner or operator to discuss the problem with the 
regulatory authority as early as possible. Pursuant to section 112(i) 
of the Act, the General Provisions contain provisions for a 1-year 
compliance extension to be granted by the Administrator on a case-by-
case basis. This report will also include a description of the 
parameter monitoring system intended to be used. Finally, the owner or 
operator of commercial EO sterilization and fumigation operations would 
be required to include in this report the amount of EO used within the 
previous consecutive 12 months. For new sources, this report would 
include the amount of EO expected to be used during the first 
consecutive 12 months of operation.

2. Notification of Compliance Status

    The Notification of Compliance Status (NCS) would be submitted no 
later than 30 days after the facility's initial performance test. It 
contains the information necessary to demonstrate that compliance has 
been achieved, such as the results of the initial performance test and 
the establishment of the control device baseline monitoring parameters. 
The submission of the performance test report will allow the regulatory 
authority to verify that the source has followed the correct sampling 
and analytical procedures, and has performed all calculations 
correctly.
    Included in the performance test report submitted with the NCS 
would be the calculation of the operating parameter values for the 
selected operating parameters to be monitored. The notification must 
include the data and rationale to support these parameter values as 
ensuring continuous compliance with the emission limits.

3. Periodic Reports

    Periodic reports are required to ensure that the standards continue 
to be met. An exceedance of any of the regulatory standards during any 
quarter following the applicable compliance date would require that a 
report of noncompliance be submitted by the 30th day following the end 
of each quarter in which excess emissions occurred. These reports would 
include information on the violations such as when any of the monitored 
operating parameters were outside the required values (e.g., an 
ethylene glycol concentration in excess of the baseline ethylene glycol 
concentration, or a catalyst bed temperature below the baseline 
oxidation temperature).

4. Other Reports

    There are also a limited number of other reports required under the 
proposed standards. In a few cases it is necessary for the facility to 
provide information to the regulatory authority shortly before or after 
a specific event. For example, notification before a performance test 
is required to allow the regulatory authority the opportunity to have 
an observer present (as specified in the proposed General Provisions to 
part 63). This type of reporting must be done separately from the 
periodic reports because some situations require a shorter term 
response from the reviewing authority.
    Reports of start of construction, anticipated and actual startup 
dates, and modifications, as required under Secs. 63.5 and 63.9 of the 
General Provisions, are entered into the Agency's Aerometric 
Information Retrieval System (AIRS) and are used to determine whether 
emission limits are being met.
    Records required under the proposed standards are generally 
required to be kept for 5 years. General recordkeeping requirements are 
contained in the proposed General Provisions under Sec. 63.10(b). These 
requirements include records of malfunctions and maintenance performed 
on the air pollution control systems and the parameter monitoring 
systems. Monitoring data from parameter monitors will provide a record 
of compliance with the emissions standards. Owners or operators of 
affected facilities who use less than 9,070 kg/yr (10 tons/yr) would be 
required to maintain records of a 12-month rolling average of EO use. 
These records are required to document that the facility is below the 
EO use applicability threshold for the aeration room standard.

H. Operating Permit Program

    Under title V of the amended Act, all sources subject to standards 
promulgated under section 112 will be required to obtain an operating 
permit unless otherwise exempted. As discussed in the rule establishing 
the operating permit program published on July 21, 1992 (57 FR 32251), 
this new permit program would include in a single document all of the 
emission limits, monitoring, recordkeeping, and reporting requirements 
that pertain to a single source. All applicable requirements of these 
standards will ultimately be included in the source's title V operating 
permit. The permit will contain Federally enforceable conditions with 
which the source must comply. Once a State's permit program has been 
approved, each commercial EO sterilization and fumigation facilities 
within that State must apply for and obtain an operating permit. If the 
State where the facility is located does not have an approved 
permitting program, the owner or operator of a facility must submit the 
application to the Regional Office. The addresses for the Regional 
Offices and States will be included in the proposed General Provisions 
for 40 CFR part 63 standards.

I. Selection of Emission Test Methods

    The proposed test methods found in the regulation have been 
developed for use with the proposed standards. During the development 
of these test methods, input was received from the regulated community 
and trade associations (including the Health Industry Manufacturers 
Association (HIMA)). Other information for these test methods was 
developed from tests of existing commercial EO sterilization and 
fumigation operations. Additional input for these proposed test methods 
was obtained from test methods developed by States for their air 
pollution control programs. In developing these proposed methods, the 
Agency has attempted to provide owners or operators of commercial EO 
sterilization and fumigation facilities with as much flexibility as 
possible by offering several equivalent methodologies for determining 
the certification and compliance parameters.
    The proposed method for sterilization chamber vents would establish 
a procedure for determining the efficiency of the control device used 
to achieve the 99-percent emission reduction required by the proposed 
standard for these vents. This method includes instructions for 
determining the amount of EO charged to the sterilization chamber, 
remaining in the chamber after the first evacuation cycle, at the inlet 
to the control device, and emitted from the control device. These data 
are used to determine the efficiency of the control device during a 
compliance test.
    Specifications for replication of these methods are also provided.
    Methods are also provided for determining the site-specific 
monitoring parameters to be used in determining compliance with the 
sterilization chamber vent standard. These methods depend on the type 
of control device used to control emissions of the sterilization 
chamber vent (i.e., acid-water scrubber or catalytic oxidation).
    The proposed methods for chamber exhaust and aeration room vents 
are based on a measurement of EO concentrations. The methods for 
measuring these concentrations are contained in Sec. 7.2 of Test Method 
18, 40 CFR part 60, appendix A.

J. Solicitation of Comments

    The Administrator welcomes comments from interested persons on any 
aspect of the proposed standards, and on any statement in the preamble 
or the referenced supporting documents. The proposed standards were 
developed on the basis of information available. The Administrator 
specifically requests factual information that may support either the 
approach taken in the proposed standards or an alternate approach. To 
receive proper consideration, documentation or data should be provided. 
In addition, the Administrator is specifically requesting factual 
information and comments in the following areas:

1. Selection of MACT as the Basis for the Area Source Standards

a. Selection of Regulatory Approach for Area Sources
    The Agency is requesting comment on whether the application of 
section 112(f) should be a factor in deciding whether to apply MACT of 
GACT to an area source category. In addition, the Agency is requesting 
data on the existence of controls on aeration room vents at area 
sources.
b. MACT Floor Determination
    The EPA does not believe that the interpretation of the MACT floor 
would change the proposed standards in this package. However, the EPA 
is considering more than one interpretation of the statutory language 
concerning the MACT floor for existing sources and is soliciting 
comment on them in another rulemaking. This solicitation is being made 
in a reopening of the comment period for the national emission 
standards for hazardous air pollutants from the synthetic organic 
chemical manufacturing industry. Please refer to that rulemaking 
(Docket No. A-90-19) for further information or to comment on the 
issue.

2. Chamber Exhaust Vent MACT Floor

    It is possible that chamber exhaust vent emissions can be 
controlled using existing technologies such as acid-water scrubbers or 
catalytic oxidizers, because EO concentrations in this vent stream are 
higher and exhaust rates are potentially lower than in aeration room 
vent streams, which are controlled at many facilities. However, despite 
the presence of State regulations (e.g., California's) that require 
emission reductions from chamber exhaust vents, the EPA's database does 
not contain any existing chamber exhaust vents that are routed to a 
control device and for which emission reductions are demonstrated. On 
this basis, the Administrator determined that the MACT floor for new 
and existing sources is a zero level of control because no single best 
controlled ``similar'' source could be found. The Administrator 
solicits comments and data regarding demonstrated control technologies 
for this source.

3. Format of Chamber Exhaust Vent Standard

    The Agency considered an alternative format to the proposed 
concentration limit format for the chamber exhaust vent standard. The 
Agency used actual test data as well as hypothetical situations to 
calculate the concentration of EO remaining in the sterilization 
chamber after a certain number of air washes. These calculations 
assumed that EO behaved as an ideal gas and that a reasonable number of 
air wash chamber evacuations were performed given the type of sterilant 
gas and the product being sterilized. Under these scenarios, the 
concentration of EO in the chamber exhaust gas was consistently less 
than 2 percent of the original concentration of EO charged to the 
chamber. These data were then used to develop a regulatory format 
whereby an owner or operator could meet a standard of maintaining the 
concentration of EO in the chamber exhaust at less than 2 percent of 
the original EO charge by performing a calculated number of air washes 
before engaging the chamber exhaust.
    The advantage of this format is that it would not require the owner 
or operator to monitor the actual concentration of EO in the chamber 
exhaust. However, because the calculated number of air evacuations to 
be performed depends on the materials to be sterilized, this format 
could be onerous for those facilities that sterilize numerous materials 
using differing sterilization protocols. The Agency is soliciting 
comment on the use of this format as an alternative to the proposed 
concentration-based format.

4. Monitoring Parameters

    During the selection of the sterilization chamber vent monitoring 
parameters, the Agency investigated several possible parameters for the 
two types of control devices typically used to control EO emissions. In 
consultation with control device vendors, the regulated community, and 
State regulators, the Agency determined that the parameters selected 
(ethylene glycol concentration for acid-water scrubbers and temperature 
across the catalyst bed for catalytic oxidizers) would provide suitable 
indicators of performance. However, the Agency is soliciting comment 
and data on the correlation between these parameters and the 
performance of the control devices.
    The Agency is also soliciting comment on the monitoring 
requirements for the chamber exhaust vent and aeration room vent 
standards that specify direct measurement of the EO concentration. 
Specifically, the Agency is requesting comment on the practicality of 
requiring these direct measurements, and solicits alternative 
monitoring requirements that would also provide the required indication 
of compliance for these standards.

5. Emissions Averaging

    During the development of today's proposal, the EPA considered 
including an emissions averaging approach but did not identify any 
viable alternatives. The EPA would be interested in pursuing the 
development of an averaging alternative if such an alternative would be 
protective of the environment and, as expected, lower the cost of 
achieving any particular emission reduction. A possible benefit of an 
averaging approach is that it may provide sources greater flexibility 
in achieving emission reductions that may also translate into cost 
savings for the source. The Agency is interested and requests data and 
comments that could be used to develop an emission averaging 
alternative in the final rule.

VII. Administrative Requirements

A. Public Hearing

    A public hearing will be held, if requested, to discuss the 
proposed standards in accordance with section 307(d)(5) of the amended 
Act. Persons wishing to make oral presentation on the proposed 
standards for EO emissions from commercial EO sterilization and 
fumigation operations should contact the EPA at the address given in 
the ADDRESSES section of this preamble. Oral presentations will be 
limited to 15 minutes each. Any member of the public may file a written 
statement before, during, or within 30 days after the hearing. Written 
statements should be addressed to the Air and Radiation Docket and 
Information Center address given in the ADDRESSES section of this 
preamble and should refer to Docket No. A-88-03.
    A verbatim transcript of the hearing and written statements will be 
available for public inspection and copying during normal working hours 
at the EPA's Air and Radiation Docket and Information Center in 
Washington, DC (see ADDRESSES section of this preamble).

B. Docket

    The docket is an organized and complete file of all the information 
submitted to or otherwise considered by the EPA in developing this 
proposed rulemaking. The principal purposes of the docket are: (1) To 
allow interested parties to identify and locate documents readily so 
that they can effectively participate in the rulemaking process and (2) 
to serve as the official record in case of judicial review (except for 
interagency review materials (the Act, section 307(d)(7)(A))).

C. Executive Order 12866

    Under Executive Order 12866, (58 FR 51735 (October 4, 1993)) the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to Office of Management and Budget (OMB) review 
and the requirements of this Executive Order. The Order defines 
``significant regulatory action'' as one that is likely to result in a 
rule that may:
    (1) Have an annual effect of the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities;
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
this Executive Order.
    Pursuant to the terms of Executive Order 12866, the OMB has 
notified the EPA that this action is a ``significant regulatory 
action'' within the meaning of the Executive Order. For this reason, 
this action was submitted to the OMB for review. Changes made in 
response to the OMB suggestions or recommendations will be documented 
in the public record.

D. Paperwork Reduction Act

    The information-collection requirements in this proposed rule have 
been submitted for approval to the OMB under the Paperwork Reduction 
Act, 44 U.S.C. 3501 et seq. An Information Collection Request document 
has been prepared by the EPA (ICR No. 1666.01), and a copy may be 
obtained from Ms. Sandy Farmer, Information Policy Branch, U. S. 
Environmental Protection Agency, 401 M Street, SW. (2136), Washington, 
DC 20460, or by calling (202) 260-2740. The public reporting burden for 
this collection of information is estimated to average 338 hours per 
response, including time for reviewing instructions, searching existing 
data sources, gathering and maintaining the data needed, and completing 
and reviewing the collection of information.
    Send comments regarding the burden estimate or any other aspect of 
this collection of information, including suggestions for reducing this 
burden, to Chief, Information Policy Branch, (2136), U. S. 
Environmental Protection Agency, 401 M Street, SW., Washington, DC 
20460, and to the Office of Information and Regulatory Affairs, Office 
of Management and Budget, Washington, DC 20503, marked, ``Attention: 
Desk Officer for the EPA.'' The final rule will respond to any OMB or 
public comments on the information collection requirements contained in 
this proposal.

E. Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires the 
EPA to consider potential impacts of proposed regulations on small 
business ``entities.'' If a preliminary analysis indicates that a 
proposed regulation would have a significant economic impact on 20 
percent or more of small entities, then a regulatory flexibility 
analysis must be prepared.
    Present Regulatory Flexibility Act guidelines indicate that an 
economic impact should be considered significant if it meets one of the 
following criteria: (1) Compliance increases annual production costs by 
more than 5 percent, assuming costs are passed on to consumers; (2) 
compliance costs as a percentage of sales for small entities are at 
least 10 percent more than compliance costs as a percentage of sales 
for large entities; (3) capital costs of compliance represent a 
``significant'' portion of capital available to small entities, 
considering internal cash flow plus external financial capabilities; or 
(4) regulatory requirements are likely to result in closures of small 
entities.
    Pursuant to the provisions of 5 U.S.C. 605(b), I hereby certify 
that this proposed rule, if promulgated, will not have a significant 
economic impact on a substantial number of small business entities 
because: (1) In all industry categories except the contract 
sterilization industry, there is not a substantial number of small 
entities, and (2) contract sterilizers should experience an increase in 
demand for their services as other facilities switch from in-house to 
contract sterilization. As a result, contract sterilizers will not be 
adversely impacted by the proposed rule.

F. Miscellaneous

    In accordance with section 117 of the Act, publication of this 
proposal was preceded by consultation with appropriate advisory 
committees, independent experts, and Federal departments and agencies. 
The Administrator will welcome comments on all aspects of the proposed 
regulation, including health, economic and technological issues, and on 
the proposed test methods.
    This regulation will be reviewed 8 years from the date of 
promulgation. This review will include an assessment of such factors as 
evaluation of the residual health risks, any overlap with other 
programs, the existence of alternative methods, enforceability, 
improvements in emission control technology and health data, and the 
recordkeeping and reporting requirements.

    Statutory Authority: The statutory authority for this proposal 
is provided by sections 101, 112, 114, 116 and 301 of the Clean Air 
Act, as amended; 42 U.S.C. 7401, 7412, 7414, 7416, and 7601.

List of Subjects in 40 CFR Part 63

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

    Dated: February 28, 1994.
Carol M. Browner,
Administrator.
[FR Doc. 94-5149 Filed 3-4-94; 8:45 am]
BILLING CODE 6560-50-P