National Emission Standards for Hazardous Air Pollutants for Ethylene Oxide Commercial Sterilization and Fumigation Operations
Federal RegisterMar 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
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EO use Emission
Vent type cutoff, kg/ Standard reduction, Mg/ Annual
yr (ton/yr) yr (ton/yr) cost, $MM
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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
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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 99 830 5.5 6,600
percent mass concentration. percent mass (910) ........... (6,000)
reduction. reduction.
Ba 99 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 99 206 4.3 20,900
percent mass concentration. percent mass (227) ........... (19,000)
reduction. reduction.
B 99 99 No control....... 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
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.