[Federal Register Volume 59, Number 233 (Tuesday, December 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29823]
[[Page Unknown]]
[Federal Register: December 6, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 63
[AD-FRL-5115-8]
RIN 2060-AC28
National Emission Standards for Hazardous Air Pollutants for
Ethylene Oxide Commercial Sterilization and Fumigation Operations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: National emission standards for hazardous air pollutants
(NESHAP) for ethylene oxide commercial sterilization and fumigation
operations were proposed in the Federal Register on March 7, 1994. This
Federal Register action announces the EPA's final decisions on the
rule. This action promulgates NESHAP for ethylene oxide commercial
sterilization and fumigation operations. These standards implement
section 112 of the Clean Air Act (Act) and are based on the
Administrator's determination that commercial sterilization and
fumigation operations emit ethylene oxide, a pollutant identified in
the Act list of 189 hazardous air pollutants (HAP). The intent of the
standards is to protect public health by requiring existing and new
major sources to control emissions to the level achievable by the
maximum achievable control technology (MACT) and by requiring existing
and new area sources to control emissions using generally available
control technology (GACT). These standards are consistent with section
112(d) of the Act.
EFFECTIVE DATE: This regulation is effective December 6, 1994.The
incorporation by reference of certain publications listed in the
regulations is approved by the Director of the Federal Register as of
December 6, 1994. See SUPPLEMENTARY INFORMATION section concerning
judicial review.
ADDRESSES: Background Information Document. The background information
document (BID) for the promulgated 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 Final
Standards,'' NTIS number EPA-453/R-94-084b. The BID contains: (1) A
summary of all the public comments made on the proposed standards and
the Administrator's response to the comments, and (2) a summary of the
changes made to the standards since proposal.
Electronic versions of the promulgation BID as well as this final
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 data transfer of up to a 14,400 bits per
second (bps). 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 promulgated 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 (formerly
known as the Air Docket), Waterside Mall, room M-1500, Ground Floor,
401 M Street SW., Washington DC 20460. 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, 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, Information Transfer and Program Integration
Division (MD-13), U.S. Environmental Protection Agency, Research
Triangle Park, North Carolina 27711.
SUPPLEMENTARY INFORMATION: Under section 307(b)(1) of the Act, judicial
review of NESHAP is available only by the filing of a petition for
review in the U.S. Court of Appeals for the District of Columbia
Circuit within 60 days of today's publication of this rule. Under
section 307(b)(2) of the Act, the requirements that are the subject of
today's notice may not be challenged later in civil or criminal
proceedings brought by the EPA to enforce these requirements.
The information presented in this preamble is organized as follows:
I. The Standards
II. Summary of Impacts
III. Significant Changes to the Proposed Standards.
A. Public Participation
B. Comments on the Proposed Standards
C. Significant Changes
IV. Administrative Requirements
A. Docket
B. Paperwork Reduction Act
C. Executive Order 12866
D. Regulatory Flexibility Act
I. The Standards
National emission standards for hazardous air pollutants
established under section 112(d) of the Act reflect:
* * * the maximum degree of reduction in emissions of the
hazardous air pollutants subject to this section (including a
prohibition on such emissions, where achievable) 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))
The promulgated standards include multiple alternatives to allow
owners or operators maximum compliance flexibility. A summary of
today's final standards is listed in Table 1. Included in this table
are applicability cutoffs based on annual EO use, general descriptions
of the standards, and the estimated impacts associated with these
standards for each vent type.
Section 114(a)(3) of the Act requires enhanced monitoring and
compliance certifications of all major stationary sources. The annual
compliance certifications certify whether compliance has been
continuous or intermittent. Enhanced monitoring shall be capable of
detecting deviations from each applicable emission limitation or
standard with sufficient representativeness, accuracy, precision,
reliability, frequency, and timeliness to determine if compliance is
continuous during a reporting period. The monitoring in this regulation
satisfies the requirements of enhanced monitoring.
Owners or operators of all commercial EO sterilization and
fumigation operations with an initial startup date before December 8,
1997 that are subject to the emissions standards are required to
install the control technology needed to comply with the standards
within 3 years from December 6, 1994. Owners or operators of new
commercial EO sterilization and fumigation operations with initial
startup after December 8, 1997 would be required to comply with all
requirements upon startup.
Table 1.--Proposed Standards, National Costs, and Emission Reductions for Major and Area Sources
----------------------------------------------------------------------------------------------------------------
Ethylene oxide use, kg/ Emission reduction, Mg/ Annual cost,
Vent type yr (ton/yr) Standard yr (ton/yr) $MM
----------------------------------------------------------------------------------------------------------------
Sterilizer vent..... 907 (1)
Chamber exhaust..... 9,070 (10) device controlling
emissions from another
vent type or 99 percent
emission reduction.
907-9,070 (1-10) Maximum chamber 0 0.05
concentration limit of
5,300 ppmv prior to
activation of the
chamber exhaust.
Aeration room....... 9,070 (10) concentration or 99
percent reduction.
----------------------------------------------------------------------------------------------------------------
II. Summary of Impacts
These standards will reduce nationwide emissions of hazardous air
pollutants (HAP) from ethylene oxide commercial sterilization and
fumigation operations by 1,030 Mg (1,140 tons), or 96 percent, in 1997
compared to the emissions that would result in the absence of the
standards. No significant adverse secondary air impacts, water, solid
waste or energy impacts are anticipated from the promulgation of these
standards.
The implementation of this regulation is expected to result in
nationwide annualized costs for existing commercial EO sterilization
facilities of about $6.6 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. Capital costs 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 $290,000 for controlling the aeration room
vent and chamber exhaust 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
$80,000 to control the aeration room vent and chamber exhaust vent
emissions.
The economic impact analysis done prior to proposal showed that the
economic impacts from the proposed standard would not be significant.
No changes have been made to the proposed rule that would increase the
economic impacts to a significant level.
III. Significant Changes to the Proposed Standards
A. Public Participation
Prior to proposal of the standards, interested parties were advised
by public notice in the Federal Register (56 FR 1186), of a meeting of
the National Air Pollution Control Techniques Advisory Committee to
discuss the ethylene oxide commercial sterilization and fumigation
source category recommended for proposal. This meeting was held on
January 29-31, 1991. The meeting was open to the public and each
attendee was given an opportunity to comment on the standards
recommended for proposal.
The standards were proposed and the preamble was published in the
Federal Register on March 7, 1994 (59 FR 10591). The preamble to the
proposed standards discussed the availability of the regulatory text
and proposal BID, which described the regulatory alternatives
considered and the impacts of those alternatives. Public comments were
solicited at the time of proposal, and copies of the regulatory text
and BID were distributed to interested parties. Electronic versions of
the preamble, regulation, and BID were made available to interested
parties via the TTN (see ADDRESSES section of this preamble).
To provide interested persons the opportunity for oral presentation
of data, views, or arguments concerning the proposed standards, a
public hearing was offered at proposal; however, one was not requested.
The public comment period was from March 7 to May 6, 1994. Twenty
comment letters were received (two letters were received from one
commenter; nineteen commenters submitted comments). The comments have
been carefully considered, and changes have been made to the proposed
standards when determined by the Administrator to be appropriate.
B. Comments on the Proposed Standards
Comments on the proposed standards were received from nineteen
commenters composed mainly of States, environmental groups, control
device vendors, industry, and trade associations. A detailed discussion
of these comments and responses can be found in the promulgation BID,
which is referred to in the ADDRESSES section of this preamble. The
summary of comments and responses in the BID serve as the basis for the
revisions that have been made to the standards between proposal and
promulgation. Most of the comment letters contained multiple comments.
The comments have been divided into the following areas:
(1) Determination of MACT floor for major source chamber exhaust
vents.
(2) Selection of MACT/GACT regulatory approach for area sources.
(3) Request for flexibility in meeting the aeration room vent
standard.
(4) Stringency of MACT for sterilization chamber vents.
(5) Compliance schedule.
(6) Alternative monitoring and compliance demonstration
requirements.
(7) Revisions to monitoring requirements for acid-water scrubbers,
catalytic oxidizers, and aeration room vents.
(8) Addition of compliance provisions and monitoring requirements
for thermal oxidizers.
(9) Revision of requirements to calibrate the temperature monitors
used for catalytic oxidizers and thermal oxidizers.
(10) Applicability of the rule to research and laboratory
facilities, hospital facilities, and sources emitting less than 907 kg/
yr (1 ton/yr) of ethylene oxide.
(11) Incorporation of the final General Provisions to part 63 into
these standards.
(12) Revisions to reporting requirements.
(13) Importance of residual risk to the selection of a regulatory
approach.
(14) Revisions to definitions and wording of the regulation.
C. Significant Changes
Several changes have been made since the proposal of these
standards. The majority of the changes have been made to clarify
portions of the rule that were unclear to the commenters. Other changes
include adding additional flexibility to sources by allowing
alternative monitoring approaches to meet the standards. A summary of
the major changes is presented below.
(1) A controlled MACT floor for chamber exhaust vents at operations
using 9,070 kg/yr (10 tons/yr) or more of EO was determined based on
data submitted by commenters (see Docket Entry IV-B-02). Existing and
new sources using 9,070 kg/yr (10 tons/yr) or more of EO are now
required to control the emissions from the chamber exhaust vent. Owners
or operators of new and existing chamber exhaust vents at sources using
9,070 kg/yr (10 tons/yr) or more of EO must parametrically monitor the
control device used in achieving the emissions reduction requirements
of the standards.
As noted above, the Agency has required control of emissions from
the chamber exhaust vent at major sources because data were received
from commenters indicating that the emissions from this vent are routed
to a control device used to control emissions from other vent types
(i.e., manifolded to either the aeration room vent or sterilization
chamber vent). The Agency also received data showing minimal nationwide
annualized cost impacts of approximately $240,000 associated with
manifolding these emissions (see Docket Entry IV-B-03). The Agency
therefore believes that the requirements to control this vent at the
MACT floor are not burdensome for major sources and do not represent a
significant change in the Agency's regulatory approach.
(2) The format of the standard for aeration room vents at sources
using 9,070 kg/yr (10 tons/yr) or more of EO was revised to provide
owners or operators flexibility to either meet a maximum emission limit
of 1 ppmv ethylene oxide or achieve a 99 percent reduction in ethylene
oxide emissions, whichever is less stringent.
(3) The compliance date for all sources has been changed from 2 to
3 years. This extension has been provided to allow sources additional
time to achieve compliance with these standards. New sources with
startup after the 3 year compliance date will be required to comply
upon startup of the source.
(4) Owners or operators of all chamber exhaust vents at sources
using 907 kg/yr (1 ton/yr) or more but less than 9,070 kg/yr (10 tons/
yr) of EO were provided additional flexibility to show compliance by
either measuring the ethylene oxide concentration in the chamber prior
to activation of the chamber exhaust vent (as proposed) or
parametrically monitoring the performance of a control device used to
reduce emissions from this vent.
(5) The monitoring requirements for aeration room vents at sources
using 9,070 kg/yr (10 tons/yr) or more of EO were revised to provide
sources additional flexibility to monitor either the ethylene oxide
outlet concentration or parameters of control device performance. For
sources choosing to measure the EO outlet concentration, measurements
of ethylene oxide concentration that are below the detection limit of
0.5 ppmv for ethylene oxide are accepted as a demonstration of
compliance with the aeration room vent standards.
(6) The Agency reduced the frequency of monitoring of the ethylene
glycol concentration in the scrubber liquor for sources complying with
emission reduction standards using an acid-water scrubber. Owners or
operators are now only required to monitor the ethylene glycol
concentration weekly. The Agency also provided sources using this
control technology flexibility to alternatively monitor the level of
the scrubber liquor in the liquor tank on a weekly basis.
(7) Several commenters suggested that maintenance of catalytic
oxidizers within a temperature range was not appropriate. In the final
rule, a baseline temperature is established as a minimum oxidation
temperature.
(8) Based on information from commenters, compliance provisions and
monitoring requirements have been included in the final rule for
thermal oxidizers. These requirements include the establishment of a
baseline temperature and continuous monitoring of this temperature.
(9) The frequency for calibrating the temperature monitor used for
catalytic oxidizers and thermal oxidizers has been reduced from once
per month to twice per year.
(10) Several commenters requested clarification of the general
provisions to part 63 as they relate to this rule. A table identifying
the relationship of the final General Provisions requirements has been
added to the final regulation. Language similar to that in the General
Provisions has been added to subpart O in cases where a direct
reference to the General Provisions was not appropriate.
(11) Based on comments received, an excess emissions report is
required semi-annually, whether the source has experienced excess
emissions or not; the Administrator may determine on a case basis that
more frequent reporting is necessary.
(12) Revisions to definitions and phrasing have been made to
clarify the regulation.
One topic for which comments were received that did not result in a
change in the regulation concerned hospital sterilization. Several
comments were received that recommended the inclusion of hospital
ethylene oxide sterilization operations under the standards promulgated
in today's action. While the EPA listed ``commercial sterilization
facilities'' and ``hospital sterilization facilities'' as two separate
categories on the proposed source category list, hospital sterilizers
were removed from the final source category list and only commercial
sterilization facilities were included on the list. Section 112(c)
specifies that the source category list will periodically be revised,
and hospitals (with EO emissions greater than 1 ton/yr) may be added to
the source category list at a future date. Hospital sterilization
sources (under 1 ton/yr ethylene oxide emissions) will likely be
assessed as part of section 112(k) of the Act.
IV. Administrative Requirements
A. Docket
The Docket is an organized and complete file of all the information
considered by the EPA in the development of this rulemaking. The Docket
is a dynamic file, since material is added throughout the rulemaking
development. The docketing system is intended to allow members of the
public and industries involved to readily identify and locate documents
so that they can effectively participate in the rulemaking process.
Along with the statement of basis and purpose of the proposed and
promulgated standards and the EPA responses to significant comments,
the contents of the Docket will serve as the record in case of judicial
review (section 307(d)(7)(A)).
B. Paperwork Reduction Act
The information collection requirements in this rule have been
approved by the Office of Management and Budget (OMB) under the
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and
have been assigned OMB control number (2060-0283). An Information
Collection Request (ICR) document has been prepared by the EPA (ICR No.
1666.02) to reflect the changed information requirements of the final
rule.
This collection of information has an estimated burden per affected
facility of about 510 hours for the first year. In subsequent years,
the burden is approximately 60 hours per affected facility. These
burden estimates include 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; U.S. Environmental
Protection Agency (Mail Code 2136); 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 EPA.''
C. Administrative Designation and Regulatory Analysis
Under Executive Order 12866 (58 FR 51735 (October 4, 1993)), the
EPA is required to judge whether a regulation is ``significant'' and
therefore subject to Office of Management and Budget (OMB) review and
the requirements of this Executive Order to prepare a regulatory impact
analysis (RIA). The Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may: (1) Have an annual
effect on 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
obligation 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 the Executive Order.
Pursuant to the terms of Executive Order 12866, it has been
determined that this rule is not ``significant'' because none of the
listed criteria apply to this action. Consequently, this action was not
submitted to OMB for review under Executive Order 12866.
D. 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. The EPA's analysis of these impacts was
provided in the preamble to the proposed rule (59 FR 10591).
Pursuant to the provisions of 5 U.S.C. 605(b), the EPA certifies
that this rule 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 (see
Docket Entry II-A-22). As a result, contract sterilizers will not be
adversely impacted by this rule.
List of Subjects in 40 CFR Parts 9 and 63
Environmental protection, Air pollution control, Ethylene oxide
sterilization, Hazardous substances, Incorporation by reference,
Reporting and recordkeeping requirements.
Dated: November 22, 1994.
Carol M. Browner,
Administrator.
For reasons set out in the preamble, title 40, chapter I of the
Code of Federal Regulations is amended as follows:
PART 9--[AMENDED]
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 135-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1321, 1326, 1330, 1344,
1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975
Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1,
300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3,
300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-
9657, 11023, 11048.
2. Section 9.1 is amended by adding a new entry to the table under
the indicated heading in numerical order to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
----------------------------------------------------------------------------------------------------------------
40 CFR citation OMB Control No.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
National Emissions Standards for Hazardous Air Pollutants for Source Categories:
* * * * * * *
63.363-63.367.................................................... 2060-0283
* * * * * * *
----------------------------------------------------------------------------------------------------------------
PART 63--[AMENDED]
1. The authority citation for part 63 continues to read as follows:
Authority: 42 U.S.C. 7401, et seq.
2. Section 63.14 is amended by adding paragraph (b)(4) to read as
follows:
Sec. 63.14 Incorporation by reference.
* * * * *
(b) * * *
(4) ASTM D 3695-88, Standard Test Method for Volatile Alcohols in
Water by Direct Aqueous-Injection Gas Chromatography, IBR approved for
Sec. 63.365(e)(1) of subpart O of this part.
* * * * *
3. By adding a new subpart O to read as follows:
Subpart O--Ethylene Oxide Emissions Standards for Sterilization
Facilities
Sec.
63.360 Applicability.
63.361 Definitions.
63.362 Standards.
63.363 Compliance and performance testing.
63.364 Monitoring requirements.
63.365 Test methods and procedures.
63.366 Reporting requirements.
63.367 Recordkeeping requirements.
Subpart O--Ethylene Oxide Emissions Standards for Sterilization
Facilities
Sec. 63.360 Applicability.
(a) All sterilization sources using 1 ton (see definition) in
sterilization or fumigation operations are subject to the emissions
standards in Sec. 63.362, except as specified in paragraphs (b) through
(e) of this section. Owners or operators of sources using 1 ton (see
definition) subject to the provisions of this subpart must comply with
the requirements of subpart A, of this part according to the
applicability of subpart A of this part to such sources in Table 1 of
this section.
Table 1 of Section 63.360. General Provisions Applicability to Subpart Q
----------------------------------------------------------------------------------------------------------------
Applies to sources Applies to sources
Reference using 10 tons in using 1 to 10 tons in Comment
subpart Oa subpart Oa
----------------------------------------------------------------------------------------------------------------
63.1(a)(1).......................
(1) Yes Additional terms
defined in Sec.
63.361; when overlap
between subparts A and
O occurs, subpart O
takes precedence..
63.1(a)(2).......................
(1)Yes .......................
63.1(a)(3).......................
(1)Yes .......................
63.1(a)(4).......................
(1)Yes Subpart O clarifies the
applicability of each
paragraph in subpart A
to sources subject to
subpart O..
63.1(a)(5).......................
(1)No Reserved...............
63.1(a)(6).......................
(1)Yes .......................
63.1(a)(7).......................
(1)Yes .......................
63.1.1(a)(8).....................
(1)Yes .......................
63.1(a)(9).......................
(1)No Reserved...............
63.1(a)(10)......................
(1)Yes .......................
63.1(a)(11)......................
(1)Yes Sec. 63.366(a) of
subpart O also allows
report submissions via
fax and on electronic
media..
63.1(a)(12)-(14).................
(1)Yes .......................
63.1(b)(1)-(2)...................
(1)Yes .......................
63.1(b)(3).......................
(1)No Sec. 63.367 clarifies
the applicability of
recordkeeping
requirements for
sources that determine
they are not subject
to the emissions
standards..
63.1(c)(1).......................
(1)Yes Supart O clarifies the
applicability of each
paragraph in subpart A
to sources subject to
subpart O in this
table..
63.1(c)(2).......................
(1)Yes Subpart O also
specifies which
sources are required
to obtain a Title V
permit in Sec. 63.360..
63.1(c)(3).......................
(1)No Reserved...............
63.1(c)(4).......................
(1)Yes .......................
63.1(c)(5).......................
(1)No Sec. 63.360 specifies
applicability..
63.1(d)..........................
(1)No Reserved...............
63.1(e)..........................
(1)Yes .......................
63.2.............................
(1)Yes Additional terms
defined in Sec.
63.361; when overlap
between subparts A and
O occurs, subpart O
takes precedence..
63.3.............................
(1)Yes Other units used in
supart O are defined
in the text of subpart
O..
63.4(a)(1)-(3)...................
(1) Yes .......................
63.4(a)(4).......................
(1) No Reserved...............
63.4(a)(5).......................
(1) Yes .......................
63.4(b)..........................
(1) Yes .......................
63.4(c)..........................
(1) Yes .......................
63.5(a)..........................
(1) No Sec. 63.366(b)(1)
contains applicability
requirements for
constructed or
reconstructed sources..
63.5(b)(1)....................... Yes.................... No..................... ...........................
63.5(b)(2).......................
(1) No Reserved...............
63.5(b)(3).......................
(1) No See Sec. 63.366(b)(2)..
63.5(b)(4)....................... Yes.................... No..................... ...........................
63.5(b)(5)....................... Yes.................... No..................... ...........................
63.5(b)(6)....................... Yes.................... No..................... ...........................
63.5(c)..........................
(1) No Reserved...............
63.5(d)(1)-(2)...................
(1) No See Sec. 63.366(b)(3)..
63.5(d)(3)-(4)................... Yes.................... No..................... ...........................
63.5(e).......................... Yes.................... No..................... ...........................
63.5(f)(1) and (2)...............
(1) No See Sec. 63.366(b)(4)..
63.6(a)(1).......................
(1) Yes .......................
63.6(a)(2).......................
(1) No Sec. 63.360 specifies
applicability..
63.6(b) and (c)..................
(1) No Sec. 63.360(g)
specifies compliance
dates for sources..
63.6(d)..........................
(1) No Reserved...............
63.6(e)..........................
(1) No Subpart O does not
contain any operation
and maintenance plan
requirements..
63.6(f)(1).......................
(1) No Sec. 63.362(b)
specifies when the
standards apply..
63.6(f)(2)(i)....................
(1) Yes .......................
63.6(f)(2)(ii)...................
(1) No Sec. 63.363 specifies
parameters for
determining
compliance..
63.6(f)(2)(iii)-(iv).............
(1) Yes .......................
63.6(f)(2)(v)....................
(1) No .......................
63.6(f)(3).......................
(1) Yes
63.6(g)..........................
(1) Yes
63.6(h)..........................
(1) No Subpart O does not
contain any opacity or
visible emission
standards..
63.6(i)(1)-(14)..................
(1) Yes
63.6(i)(15)......................
(1) No Reserved...............
63.6(i)(16)......................
(1) Yes
63.6(j)..........................
(1) Yes
63.7(a)(1).......................
(1) Yes
63.7(a)(2).......................
(1) No Sec. 63.365(a)(2)
specifies performance
test dates..
63.7(a)(3).......................
(1) Yes
63.7(b)..........................
(1) Yes
63.7(c).......................... Yes.................... No.....................
63.7(d).......................... Yes.................... No.....................
63.7(e)..........................
(1) Yes Sec. 63.365 also
contains test methods
specific to sources
subject to the
emissions standards..
63.7(f)..........................
(1) Yes
63.7(g)(1).......................
(1) Yes
63.7(g)(2).......................
(1) No Reserved...............
63.7(g)(3).......................
(1) Yes
63.7(h)..........................
(1) Yes
63.8(a)(1).......................
(1) Yes
63.8(a)(2).......................
(1) Yes
63.8(a)(3).......................
(1) No Reserved...............
63.8(a)(4).......................
(1) Yes
63.8(b)(1).......................
(1) Yes
63.8(b)(2).......................
(1) Yes
63.8(b)(3).......................
(1) No
63.8(c)(1) (i) and (ii)..........
(1) No A startup, shutdown,
and malfunction plan
is not required for
these standards..
63.8(c)(1)(iii)..................
(1) Yes
63.8(c)(2)-(3)...................
(1) Yes
63.8(c)(4)-(5)...................
(1) No Frequency of monitoring
measurements is
provided in Sec.
63.364; opacity
monitors are not
required for these
standards..
63.8(c)(6).......................
(1) No Performance
specifications for gas
chromatographs and
temperature monitors
are contained in Sec.
63.365..
63.8(c)(7)(i)(A)-(B).............
(1) No Performance
specifications for gas
chromatographs and
temperature monitors
are contained in Sec.
63.365..
63.8(c)(7)(i)(C).................
(1) No Opacity monitors are
not required for these
standards..
63.8(c)(7)(ii)...................
(1) No Performance
specifications for gas
chromatographs and
temperature monitors
are contained in Sec.
63.365..
63.8(c)(8).......................
(1) No
63.8(d).......................... Yes.................... No.....................
63.8(e)(1).......................
(1) Yes
63.8(e)(2).......................
(1) Yes
63.8(e)(3)....................... Yes.................... No.....................
63.8(e)(4).......................
(1) Yes
63.8(e)(5)(i)....................
(1) Yes
63.8(e)(5)(ii)...................
(1) No Opacity monitors are
not required for these
standards..
63.8(f)(1)-(5)...................
(1) Yes
63.8(f)(6).......................
(1) No
63.8(g)(1).......................
(1) Yes
63.8(g)(2).......................
(1) No
63.8(g)(3)-(5)...................
(1) Yes
63.9(a)..........................
(1) Yes
63.9(b)(1)-(i)...................
(1) Yes
63.9(b)(1)(ii)-(iii).............
(1) No Sec. 63.366(c)(1)(i)
contains language for
sources that increase
usage such that the
source becomes subject
to the emissions
standards..
63.9(b)(2)-(3)...................
(1) Yes Sec. 63.366(c)(3)
contains additional
information to be
included in the
initial report for
existing and new
sources..
63.9(b)(4)-(5)...................
(1)No Sec. 63.366(c)(1)(ii)
and (iii) contains
requirements for new
or reconstructed
sources subject to the
emissions standards..
63.9(c)..........................
(1)Yes
63.9(d)..........................
(1)No
63.9(e)..........................
(1)Yes
63.9(f)..........................
(1)No Opacity monitors are
not required for these
standards..
63.9(g)(1).......................
(1)Yes
63.9(g)(2)-(3)...................
(1)No Opacity monitors and
relative accuracy
testing are not
required for these
standards..
63.9(h)(1)-(3)...................
(1)Yes
63.9(h)(4).......................
(1)No Reserved...............
63.9(h)(5).......................
(1)No Sec. 63.366(c)(2)
instructs sources to
submit actual data..
63.9(h)(6).......................
(1)Yes
63.9(i)..........................
(1)Yes
63.9(j)..........................
(1)Yes
63.10(a).........................
(1)Yes
63.10(b)(1)......................
(1)Yes
63.10(b)(2)(i)...................
(1)No Not applicable due to
batch nature of the
industry..
63.10(b)(2)(ii)..................
(1)Yes
63.10(b)(2)(iii).................
(1)No
63.10(b)(2)(iv)-(v)..............
(1)No A startup, shutdown,
and malfunction plan
is not required for
these standards..
63.10(b)(2)(vi)-(xii)............
(1)Yes
63.10(b)(2)(xiii)................
(1)No
63.10(b)(2)(xiv).................
(1)Yes
63.10(b)(3)......................
(1)No Sec. 63.367 (b) and (c)
contains applicability
determination
requirements..
63.10(c)(1)......................
(1)Yes
63.10(c)(2)-(4)..................
(1)No Reserved...............
63.10(c)(5)......................
(1)Yes .......................
63.10(c)(6)......................
(1)No .......................
63.10(c)(7)......................
(1)No Not applicable due to
batch nature of the
industry..
63.10(c)(8)......................
(1)Yes .......................
63.10(c)(9)......................
(1)No Reserved...............
63.10(c)(10)-(13)................
(1)Yes .......................
63.10(c)(14)..................... Yes.................... No.....................
63.10(c)(15).....................
(1)No A startup, shutdown,
and malfunction plan
is not required for
these standards..
63.10(d)(1)......................
(1)Yes .......................
63.10(d)(2)......................
(1)Yes .......................
63.10(d)(3)......................
(1)No Subpart O does not
contain opacity or
visible emissions
standards..
63.10(d)(4)......................
(1)Yes .......................
63.10(d)(5)......................
(1)No A startup, shutdown,
and malfunction plan
is not required for
these standards..
63.10(e)(1)......................
(1)Yes .......................
63.10(e)(2)(i)...................
(1)Yes .......................
63.10(e)(2)(ii)..................
(1)No Opacity monitors are
not required for these
standards..
63.10(e)(3)(i)-(iv)..............
(1)Yes .......................
63.10(e)(3)(v)...................
(1)No Sec. 63.366(a)(3)
specifies contents and
submittal dates for
excess emissions and
monitoring system
performance reports..
63.10(e)(3)(vi)-(viii)...........
(1)Yes .......................
63.10(e)(4)......................
(1)No Opacity monitors are
not required for these
standards..
63.10(f).........................
(1)Yes .......................
63.11............................
(1)Yes .......................
63.12-63.15......................
(1)Yes ......................
----------------------------------------------------------------------------------------------------------------
aSee definition.
(b) Sterilization sources using less than 1 ton (see definition)
are not subject to the emissions standards in Sec. 63.362. The
recordkeeping requirements of Sec. 63.367(c) apply.
(c) This subpart does not apply to beehive fumigators.
(d) This subpart does not apply to research or laboratory
facilities as defined in section 112(c)(7) of title III of the Clean
Air Act Amendment of 1990.
(e) This subpart does not apply to ethylene oxide sterilization
operations at stationary sources such as hospitals, doctors offices,
clinics, or other facilities whose primary purpose is to provide
medical services to humans or animals.
(f) The owner or operator of a source using 1 ton (see definition)
is required to obtain a title V permit from the permitting authority in
which the source is located.
(g) The owner or operator shall comply with the provisions of this
subpart as follows:
(1) All sources subject to the emissions standards in Sec. 63.362
with an initial startup date before December 8, 1997, no later than 3
years after the effective date.
(2) All sources subject to the emissions standards in Sec. 63.362
with an initial startup date after December 8, 1997, immediately upon
initial startup of the source.
(3) All sources using less than 10 tons that increase their
ethylene oxide usage after December 8, 1997 such that any vent becomes
subject to the emissions standards in Sec. 63.362, immediately upon
becoming subject to the emissions standards.
Sec. 63.361 Definitions.
Terms and nomenclature used in this subpart are defined in the
Clean Air Act (the Act) as amended in 1990, Secs. 63.2 and 63.3 of
subpart A of this part, or in this section. For the purposes of subpart
O, if the same term is defined in subpart A and in this section, it
shall have the meaning given in this section.
Aeration room means any vessel or room that is used to facilitate
off-gassing of ethylene oxide at a sterilization facility.
Aeration room vent means the point(s) through which the evacuation
of ethylene oxide-laden air from an aeration room occurs.
Baseline temperature means any temperature at the outlet point of a
catalytic oxidation unit control device or at the exhaust point from
the combustion chamber for a thermal oxidation unit control device
established during the performance test when the respective unit
achieves at least 99-percent control of ethylene oxide emissions.
Chamber exhaust vent means the point(s) through which ethylene
oxide-laden air is removed from the sterilization chamber during
chamber unloading following the completion of sterilization and
associated air washes.
Compliance date means the date by which a source subject to the
emissions standards in Sec. 63.362 is required to be in compliance with
the standard.
Effective date means the date of promulgation in the Federal
Register notice.
Initial startup date means the date when a source subject to the
emissions standards in Sec. 63.362 first begins operation of a
sterilization process.
Manifolding emissions means combining ethylene oxide emissions from
two or more different vent types for the purpose of controlling these
emissions with a single control device.
Maximum ethylene glycol concentration means any concentration of
ethylene glycol in the scrubber liquor of an acid-water scrubber
control device established during a performance test when the scrubber
achieves at least 99-percent control of ethylene oxide emissions.
Maximum liquor tank level means any level of scrubber liquor in the
acid-water scrubber liquor recirculation tank established during a
performance test when the scrubber achieves at least 99-percent control
of ethylene oxide emissions.
Oxidation temperature means the temperature at the outlet point of
a catalytic oxidation unit control device or at the exhaust point from
the combustion chamber for a thermal oxidation unit control device.
Parametric monitoring means monitoring of a specific operating
parameter of the control device that demonstrates that the control
device is operating under conditions that meet the standard.
Source(s) using less than 1 ton means source(s) using less than 907
kg (1 ton) of ethylene oxide within all consecutive 12-month periods
after December 6, 1996.
Source(s) using 1 ton means source(s) using 907 kg (1 ton) or more
of ethylene oxide within any consecutive 12-month period after December
6, 1996.
Source(s) using 1 to 10 tons means source(s) using 907 kg (1 ton)
or more of ethylene oxide in any consecutive 12-month period but less
than 9,070 kg (10 tons) of ethylene oxide in all consecutive 12-month
periods after December 6, 1996.
Source(s) using less than 10 tons means source(s) using less than
9,070 kg (10 tons) of ethylene oxide in all consecutive 12-month
periods after December 6, 1996.
Source(s) using 10 tons means source(s) using 9,070 kg (10 tons) or
more of ethylene oxide in any consecutive 12-month period after
December 6, 1996.
Sterilization chamber means any enclosed vessel or room that is
filled with ethylene oxide gas, or an ethylene oxide/inert gas mixture,
for the purpose of sterilizing and/or fumigating at a sterilization
facility.
Sterilization chamber vent means the point (prior to the vacuum
pump) through which the evacuation of ethylene oxide from the
sterilization chamber occurs following sterilization or fumigation,
including any subsequent air washes.
Sterilization facility means any stationary source where ethylene
oxide is used in the sterilization or fumigation of materials.
Sterilization operation means any time when ethylene oxide is
removed from the sterilization chamber through the sterilization
chamber vent or the chamber exhaust vent or when ethylene oxide is
removed from the aeration room through the aeration room vent.
Sec. 63.362 Standards.
(a) Each owner or operator of a source subject to the provisions of
this subpart shall comply with these requirements on and after the
compliance date specified in Sec. 63.360(g). The standards of this
section are summarized in Table 1 of this section.
Table 1 of Section 63.362.--Standards for Ethylene Oxide Commercial Sterilizers and Fumigators
----------------------------------------------------------------------------------------------------------------
Existing and new Sterilization chamber
sources Source type vent Aeration room vent Chamber exhaust vent
----------------------------------------------------------------------------------------------------------------
Source size...... <907 kg (<1 ton)......
(2)No controls
required;
minimal
recordkeeping
requirements
apply (see Sec.
63.367(c)).
907 kg and 99% emission reduction No control............ Maximum chamber
<9,070 kg (1 ton and <10 tons. of 5,300 ppm prior
to activation of the
chamber exhaust\1\
(see Sec.
63.362(e)(2)).
9,070 kg 99% emission reduction 1 ppm maximum outlet Manifold to a control
(10 tons). (see Sec. 63.362(c)). concentration or 99% device used to
emission reduction comply with Sec.
(see Sec. 63.362(d)). 63.362 (c) or (d) or
99 percent emission
reduction (see Sec.
63.362(e)(1)).
----------------------------------------------------------------------------------------------------------------
\1\Affected sources may show compliance by manifolding emissions to a control device used to comply with Sec.
63.362 (c) or (d) by reducing emissions by at least 99 percent.
(b) Applicability of emission limits. The emission limitations of
paragraphs (c), (d), and (e) of this section apply during sterilization
operation. The emission limitations do not apply during periods of
malfunction.
(c) Sterilization chamber vent at sources using 1 ton. Each owner
or operator of a sterilization source using 1 ton shall reduce ethylene
oxide emissions to the atmosphere by at least 99 percent from each
sterilization chamber vent.
(d) Aeration room vent at sources using 10 tons. Each owner or
operator of a sterilization source using 10 tons shall reduce ethylene
oxide emissions to the atmosphere from each aeration room vent to a
maximum concentration of 1 ppmv or by at least 99 percent, whichever is
less stringent, from each aeration room vent.
(e) (1) Chamber exhaust vent at sources using 10 tons. Each owner
or operator of a sterilization source using 10 tons shall either reduce
ethylene oxide emissions to the atmosphere by manifolding emissions
from each chamber exhaust vent to a control device used to comply with
paragraphs (c) or (d) of this section or shall reduce ethylene oxide
emissions by at least 99 percent from each chamber exhaust vent
(without manifolding).
(2) Chamber exhaust vent at sources using 1 to 10 tons. Each owner
or operator of a sterilization source using 1 to 10 tons shall limit
ethylene oxide emissions from the chamber exhaust vent to the
atmosphere to a maximum concentration of 5,300 ppmv from each chamber
exhaust vent. If the owner or operator chooses to limit emissions to
5,300 ppmv concentration through the use of a control device, the owner
or operator may choose either to manifold ethylene oxide emissions from
each chamber exhaust vent to a control device used to comply with
paragraph (c) of this section or to reduce ethylene oxide emissions by
at least 99 percent (without manifolding).
Sec. 63.363 Compliance and performance testing.
(a) (1) The owner or operator of a source subject to emissions
standards in Sec. 63.362 shall conduct an initial performance test
using the procedures listed in Sec. 63.7 of subpart A of this part
according to the applicability in Table 1 of Sec. 63.360, the
procedures listed in this section, and the test methods listed in
Sec. 63.365.
(2) The owner or operator of all sources subject to these emissions
standards shall complete the performance test within 180 days after the
compliance date for the specific source as determined in
Sec. 63.360(g).
(b) The following procedures shall be used to determine compliance
with the emission limits under Sec. 63.362(c), the sterilization
chamber vent standard:
(1) During the performance test required in paragraph (a) of this
section, the owner or operator shall determine the efficiency of
control devices used to comply with Sec. 63.362(c) using the test
methods and procedures in Sec. 63.365(b)(1). The owner or operator
shall also determine the following:
(i) For facilities with acid-water scrubbers, the owner or operator
shall establish as a site-specific operating parameter during the test
methods and procedures in Sec. 63.365(b)(1) either:
(A) The maximum ethylene glycol concentration using the procedures
described in Sec. 63.365(e)(1); or
(B) The maximum liquor tank level using the procedures described in
Sec. 63.365(e)(2).
(ii) For facilities with catalytic oxidizers or thermal oxidizers,
the owner or operator shall establish as a site-specific operating
parameter the baseline temperature during the performance test in
Sec. 63.365(b)(2) using the procedures described in Sec. 63.365(f)(1).
(2) Following the date on which the initial performance test is
completed, the owner or operator shall comply with one of the following
provisions:
(i) For facilities with acid-water scrubbers, operation of the
facility with an ethylene glycol concentration in the scrubber liquor
in excess of the maximum ethylene glycol concentration or the liquor
tank level in excess of the maximum liquor tank level shall constitute
a violation of the sterilization chamber vent standard.
(ii) For facilities with catalytic oxidizers or thermal oxidizers,
operation of the facility with the oxidation temperature, averaged over
three cycles, more than 5.6 deg.C (10 deg.F) below the baseline
temperature shall constitute a violation of the sterilization chamber
vent standard.
(c) The following procedures shall be used to determine compliance
with the emission limits under Sec. 63.362(d), the aeration room vent
standard:
(1) During the performance test required in paragraph (a) of this
section, the owner or operator shall determine either:
(i) The concentration of ethylene oxide emitted from the aeration
room into the atmosphere (after any control device used to comply with
Sec. 63.362(d)) using the methods in Sec. 63.365(c)(1); or
(ii) The efficiency of the control device used to comply with
Sec. 63.362(d) using the test methods and procedures in
Sec. 63.365(d)(1).
(2) For facilities seeking to comply with paragraph (c)(1)(ii) of
this section with catalytic oxidizers or thermal oxidizers, the owner
or operator must also establish as a site-specific operating parameter
the baseline temperature using the procedures described in
Sec. 63.365(f)(2).
(3) Following the date on which the initial performance test is
completed, the owner or operator of a facility shall comply with one of
the following provisions:
(i) For facilities continuously measuring the ethylene oxide
concentration emitted from the aeration room (after any control
device), operation of the facility with a 3-hour average ethylene oxide
concentration in excess of the 1 ppmv ethylene oxide concentration
limit shall constitute a violation of the aeration room vent standard.
(ii) For facilities with catalytic oxidizers or thermal oxidizers,
operation of the facility with the oxidation temperature, averaged over
three hours, more than 5.6 deg.C (10 deg.F) below the baseline
temperature shall constitute a violation of the aeration room vent
standard.
(d) The following procedures shall be used to determine compliance
with the emission limits under Sec. 63.362(e)(1), the chamber exhaust
vent standard for sources using 10 tons:
(1) For facilities manifolding emissions from the chamber exhaust
vent to a control device controlling emissions from the sterilization
chamber vent and/or the aeration room vent, the owner or operator shall
comply with the appropriate compliance provisions for that vent type
and control device (see paragraphs (b) and (c) of this section).
(2) For facilities not manifolding emissions from the chamber
exhaust vent (to a control device used to comply with Sec. 63.362(c) or
(d)), the owner or operator shall comply with the following:
(i) During the performance test required in paragraph (a) of this
section, the owner or operator shall determine the efficiency of
control devices used to comply with Sec. 63.362(e)(1) using the test
methods and procedures in Sec. 63.365(d)(2) as well as the following:
(A) For facilities with acid-water scrubbers, the owner or operator
shall establish as a site-specific operating parameter either:
(1) The maximum ethylene glycol concentration using the procedures
described in Sec. 63.365(e)(1); or
(2) The maximum liquor tank level using the procedures described in
Sec. 63.365(e)(2).
(B) For facilities with catalytic oxidizers or thermal oxidizers,
the owner or operator shall establish as a site-specific operating
parameter the baseline temperature using the procedures described in
Sec. 63.365(f)(3).
(ii) Following the date on which the initial performance test is
completed, the owner or operator of a facility shall comply with one of
the following provisions:
(A) For facilities with acid-water scrubbers, operation of the
facility with an ethylene glycol concentration in the scrubber liquor
in excess of the maximum ethylene glycol concentration or the liquor
tank level in excess of the maximum liquor tank level shall constitute
a violation of the chamber exhaust vent standard for sources using 10
tons.
(B) For facilities with catalytic oxidizers or thermal oxidizers,
operation of the facility with the oxidation temperature, averaged over
the cycle, more than 5.6 deg.C (10 deg.F) below the baseline
temperature shall constitute a violation of the chamber exhaust vent
standard for sources using 10 tons.
(e) The following procedures shall be used to determine compliance
with the emission limits under Sec. 63.362(e)(2), the chamber exhaust
vent standard for sources using 1 to 10 tons:
(1) For facilities manifolding emissions from the chamber exhaust
vent to a control device controlling emissions from the sterilization
chamber vent, the owner or operator shall comply with the appropriate
compliance provisions for the appropriate control technology (see
paragraph (b) of this section).
(2) For facilities not manifolding emissions from the chamber
exhaust vent (to a control device used to comply with Sec. 63.362(c)),
during the performance test required in paragraph (a) of this section,
the owner or operator shall either:
(i) Determine the concentration of ethylene oxide in the
sterilization chamber immediately prior to the operation of the chamber
exhaust using the test methods and procedures in Sec. 63.365(c)(2); or
(ii) Determine the efficiency of control devices used to comply
with Sec. 63.362(e)(2) using the test methods and procedures in
Sec. 63.365(d)(2) as well as the following:
(A) For facilities with acid-water scrubbers, the owner or operator
shall establish as a site-specific operating parameter either:
(1) The maximum ethylene glycol concentration using the procedures
described in Sec. 63.365(e)(1); or
(2) The maximum liquor tank level using the procedures described in
Sec. 63.365(e)(2).
(B) For facilities with catalytic oxidizers or thermal oxidizers,
the owner or operator shall establish as a site-specific operating
parameter the baseline temperature using the procedures described in
Sec. 63.365(f)(3).
(3) Following the date on which the initial performance test is
completed, the owner or operator of a facility shall comply with one of
the following provisions:
(i) For facilities determining the ethylene oxide concentration,
operation of the facility with the ethylene oxide concentration in the
sterilization chamber (immediately prior to activation of the chamber
exhaust) in excess of the 5,300 ppmv ethylene oxide concentration
standard shall constitute a violation of the chamber exhaust vent
standard for sources using 1 to 10 tons.
(ii) Following the date on which the initial performance test is
completed, the owner or operator of a facility shall comply with one of
the following provisions:
(A) For facilities with acid-water scrubbers, operation of the
facility with an ethylene glycol concentration in the scrubber liquor
in excess of the maximum ethylene glycol concentration or the liquor
tank level in excess of the maximum liquor tank level shall constitute
a violation of the chamber exhaust vent standard for sources using 1 to
10 tons.
(B) For facilities with catalytic oxidizers or thermal oxidizers,
operation of the facility with the oxidation temperature, averaged over
the cycle, more than 5.6 deg.C (10 deg.F) below the baseline
temperature shall constitute a violation of the chamber exhaust vent
standard for sources using 1 to 10 tons.
(f) For facilities complying with the emissions limits under
Sec. 63.362 with a control technology other than acid- water scrubbers
or catalytic or thermal oxidizers:
(1) The owner or operator of the facility shall provide to the
Administrator information describing the design and operation of the
air pollution control system including recommendations for the
operating parameters to be monitored to indicated proper operation and
maintenance of the air pollution control system. Based on this
information, the Administrator will determine the site-specific
operating parameter(s) to be established during the performance test.
During the performance test required in paragraph (a) of this section
using the methods approved in Sec. 63.365(g), the owner or operator
shall determine the site-specific operating parameter(s) approved by
the Administrator.
(2) Operation of the facility in a manner that exceeds a site-
specific parameter established as a maximum requirement or falls below
a site-specific parameter established as a minimum requirement
(depending on the parameters monitored) shall constitute a violation of
the applicable emissions standard under Sec. 63.362.
Sec. 63.364 Monitoring requirements.
(a)(1) The owner or operator of a source subject to emissions
standards in Sec. 63.362 shall comply with the monitoring requirements
in Sec. 63.8 of subpart A of this part, according to the applicability
in Table 1 of Sec. 63.360, and in this section.
(2) Each owner or operator of an ethylene oxide sterilization
facility subject to these emissions standards shall monitor the
parameters specified in this section. All monitoring equipment shall be
installed such that representative measurements of emissions or process
parameters from the source are obtained. For monitoring equipment
purchased from a vendor, verification of the operational status of the
monitoring equipment shall include completion of the manufacturer's
written specifications or recommendations for installation, operation,
and calibration of the system.
(b) For sterilization facilities complying with Sec. 63.363 (b),
(d), or (e) through the use of an acid-water scrubber, the owner or
operator shall either:
(1) Sample the scrubber liquor and analyze and record once per week
the ethylene glycol concentration of the scrubber liquor using the test
methods and procedures in Sec. 63.365(e)(1). Monitoring is required
during a week only if the scrubber unit has been operated; or
(2) Measure and record once per week the level of the scrubber
liquor in the recirculation tank. The owner or operator shall install,
maintain, and use a liquid level indicator to measure the scrubber
liquor tank level (i.e., a marker on the tank wall, a dipstick, a
magnetic indicator, etc.).
(c) For sterilization facilities complying with Sec. 63.363(b),
(c), (d), or (e) through the use of catalytic oxidation or thermal
oxidation, the owner or operator shall continuously monitor and record
the oxidation temperature at the outlet to the catalyst bed or at the
exhaust point from the thermal combustion chamber using the temperature
monitor described in paragraph (c)(4) of this section.
(1) For the sterilization chamber vent, a data acquisition system
for the temperature monitor shall compute and record an average
oxidation temperature over the length of the cycle (based on the length
of the cycle used during the performance test in Sec. 63.365(b)(2)) and
a three-cycle block average every third cycle.
(2) For the aeration room vent, a data acquisition system for the
temperature monitor shall compute and record an average oxidation
temperature each hour and a 3-hour block average every third hour.
(3) For the chamber exhaust vent, a data acquisition system for the
temperature monitor shall compute and record an average oxidation
temperature over the length of the cycle (based on the length of the
cycle used during the performance test in Sec. 63.365(d)(2)).
(4) The owner or operator shall install, calibrate, operate, and
maintain a temperature monitor accurate to within 5.6 deg.C
(10 deg.F) to measure the oxidation temperature. The owner
or operator shall verify the accuracy of the temperature monitor twice
each calendar year with a reference temperature monitor (traceable to
National Institute of Standards and Technology (NIST) standards or an
independent temperature measurement device dedicated for this purpose).
During accuracy checking, the probe of the reference device shall be at
the same location as that of the temperature monitor being tested.
(d) For sterilization facilities complying with Sec. 63.363(b),
(c), (d), or (e) through the use of a control device other than acid-
water scrubbers or catalytic or thermal oxidizers, the owner or
operator shall monitor the parameters as approved by the Administrator
using the methods and procedures in Sec. 63.365(g).
(e) For sterilization facilities complying with
Sec. 63.363(c)(3)(i) or (e)(2)(i) through the use of direct measurement
of ethylene oxide concentration, the owner or operator shall follow
either paragraph (e)(1) or (2) of this section:
(1) Measure and record once per hour the ethylene oxide
concentration at the outlet to the atmosphere from the aeration room
vent after any control device according to the procedures specified in
Sec. 63.365(c)(1). The owner or operator shall compute and record a 3-
hour average every third hour. The owner or operator will install,
calibrate, operate, and maintain a gas chromatograph consistent with
the requirements of performance specification (PS) 9 in 40 CFR part 60,
Appendix B, to measure ethylene oxide. The daily calibration
requirements of section 7.2 of PS 9 are required only on days when
ethylene oxide emissions are vented to the control device from the
aeration room vent.
(2) Measure and record the ethylene oxide concentration in the
sterilization chamber immediately before the chamber exhaust is
activated according to the procedures specified in Sec. 63.365(c)(2).
The owner or operator shall install, calibrate, operate, and maintain a
gas chromatograph consistent with the requirements of PS 9 to measure
ethylene oxide concentration. The daily calibration requirements of
section 7.2 of PS 9 are required only on days when the chamber exhaust
is activated.
(f) For sterilization facilities complying with Sec. 63.363(d)(1)
or (e)(1) by manifolding emissions from the chamber exhaust vent to a
control device controlling emissions from another vent type, the owner
or operator shall monitor the control device to which emissions from
the chamber exhaust vent are manifolded using the appropriate
monitoring requirements in paragraphs (a) through (e) of this section
and record the monitoring data.
Sec. 63.365 Test methods and procedures.
(a) Performance testing. The owner or operator of a source subject
to the emissions standards in Sec. 63.362 shall comply with the
performance testing requirements in Sec. 63.7 of subpart A of this
part, according to the applicability in Table 1 of Sec. 63.360, and in
this section.
(b) Efficiency at the sterilization chamber vent. The following
procedures shall be used to determine the efficiency of all types of
control devices used to comply with Sec. 63.362(c), sterilization
chamber vent standard.
(1) First evacuation of the sterilization chamber. This procedure
shall be performed on an empty sterilizer for the duration of the first
evacuation under normal operating conditions (i.e., sterilization cycle
pressure and temperature) and charging a typical amount of ethylene
oxide to the sterilization chamber.
(i) The amount of ethylene oxide loaded into the sterilizer
(Wc) shall be determined by either:
(A) Weighing the ethylene oxide gas cylinder(s) used to charge the
sterilizer before and after charging. Record these weights to the
nearest 45 g (0.1 lb). Multiply the total mass of gas charged by the
weight percent ethylene oxide present in the gas.
(B) Installing calibrated rotameters at the sterilizer inlet and
measuring flow rate and duration of sterilizer charge. Use the
following equation to convert flow rate to weight of ethylene oxide:
TR06DE94.024
where:
Wc=weight of ethylene oxide charged, g (lb)
Fv=volumetric flow rate, liters per minute (L/min) corrected to 20
deg.C and 101.325 kilopascals (kPa) (scf per minute (scfm) corrected
to 68 deg.F and 1 atmosphere of pressure (atm)); the flowrate must be
constant during time (t)
t=time, min
%EOV=volume fraction ethylene oxide
SV=standard volume, 24.05 liters per mole (L/mole)=22.414 L/mole ideal
gas law constant corrected to 20 deg.C and 101.325 kPa (385.32 scf per
mole (scf/mole)=359 scf/mole ideal gas law constant corrected to 68
deg.F and 1 atm).
MW=molecular weight of ethylene oxide, 44.05 grams per gram-mole (g/g-
mole) (44.05 pounds per pound-mole (lb/lb-mole)), or
(C) Calculating the mass based on the conditions of the chamber
immediately after it has been charged using the following equation:
TR06DE94.025
where:
P=chamber pressure, kPa (psia)
V=chamber volume, liters (L) (ft\3\)
R=gas constant, 8.313 LkPa/g-mole (10.73
psiaft\3\/mole deg.R)
T=temperature, K ( deg.R)
Note: If the ethylene oxide concentration is in weight percent,
use the following equation to calculate mole fraction:
TR06DE94.026
where:
WEO=weight percent of ethylene oxide
Wx=weight percent of compound in the balance of the mixture
MWx=molecular weight of compound in the balance gas mixture
(ii) The residual mass of ethylene oxide in the sterilizer shall be
determined by recording the chamber temperature, pressure, and volume
after the completion of the first evacuation and using the following
equation:
TR06DE94.027
where:
Wr=weight of ethylene oxide remaining in chamber (after the first
evacuation), in g (lb)
(iii) Calculate the total mass of ethylene oxide at the inlet to
the control device (Wi) by subtracting the residual mass (Wr)
calculated in paragraph (b)(1)(ii) of this section from the charged
weight (Wc) calculated in paragraph (b)(1)(i) of this section.
(iv) The mass of ethylene oxide emitted from the control device
outlet (Wo) shall be calculated by continuously monitoring the
flow rate and concentration using the following procedure.
(A) Measure the flow rate through the control device exhaust
continuously during the first evacuation using the procedure found in
40 CFR part 60, appendix A, Test Methods 2, 2A, 2C, or 2D, as
appropriate. (Method 2D (using orifice plates or Rootstype meters) is
recommended for measuring flow rates from sterilizer control devices.)
Record the flow rate at 1-minute intervals throughout the test cycle,
taking the first reading within 15 seconds after time zero. Time zero
is defined as the moment when the pressure in the sterilizer is
released. Correct the flow to standard conditions (20 deg.C and 101.325
kPa (68 deg.F and 1 atm)) and determine the flow rate for the run as
outlined in the test methods listed in paragraph (b) of this section.
(B) The Tedlar bag sampling procedure in section 7.1 of Test Method
18, 40 CFR part 60, appendix A (hereafter referred to as Method 18)
shall be used to collect samples of exhaust gas throughout the test
cycle. Follow the procedures in paragraph (b)(1)(iv)(B)(1) or (2) of
this section.
(1) Continuously sample a slipstream of the control device outlet
into a Tedlar bag by having a Tedlar bag attached to the slipstream for
the entire duration of the run for an integrated bag sample. Whenever a
Tedlar bag is full, a new bag must be reattached immediately. Note the
time the bag is changed so the sample time and corresponding flow rates
can be determined for each bag.
(i) Follow the procedures in section 6 of Method 18 and choose the
appropriate column, analytical apparatus, and calibration gases for the
analysis of the bag samples collected. The bag samples shall be
analyzed within 8 hours of collection.
(ii) Prepare a graph of volumetric flow rate versus time
corresponding to the period each bag was sampled. Integrate the area
under the curve to determine the volume.
(iii) Calculate the mass of ethylene oxide for each bag by using
the following equation:
TR06DE94.028
where:
Wb=Mass of ethylene oxide for each bag, g (lb)
C=concentration of ethylene oxide in ppmv
V=volume of gas exiting the control device corresponding to each bag
sample corrected to standard conditions, L (ft\3\)
1/10\6\=correction factor LEO/10\6\ LTOTAL GAS (ft\3\EO/
10\6\ ft\3\ TOTAL GAS)
Sum the mass corresponding to each bag (Wb) used during the
evacuation to calculate the total mass (Wo).
(iv) Calculate the efficiency by the equation in paragraph
(b)(1)(v) of this section.
(2) Collect a Tedlar bag (or equivalent collection device) sample
at 1-minute intervals throughout the test cycle. (The first bag must be
in place and sampling at t=15 seconds. A fresh bag shall be in place
and sampling exhaust gas at each 1-minute mark after time zero.)
Collect enough sample gas in each bag to complete the analysis. Each
bag sample shall be labeled with the sampling time and run number.
(i) Follow the procedures in section 6 of Method 18 and choose the
appropriate column, analytical apparatus, and calibration gases for the
analysis of the bag samples collected. The bag samples shall be
analyzed within 8 hours of collection. (Syringe samples should be
analyzed within 4 hours.)
(ii) Plot a concentration versus time curve using the average
concentration, in ppmv, determined in each bag sample. Prepare another
graph of volumetric flow rate versus time. Calculate the mass flow at
each 1-minute interval point by selecting the concentration (C) and
volumetric flow rate corrected to standard conditions (Fv) at each
1-min point.
(iii) Use the following equation to determine the mass flow rate of
ethylene oxide exiting the control device:
TR06DE94.029
where:
Wt = mass flow rate of ethylene oxide
(iv) Plot a curve of mass flow rate versus time and integrate for
total mass of ethylene oxide for the control device outlet (Wo).
(v) Calculate efficiency by the equations in paragraphs (b)(1) (v)
and (vi) of this section.
(C) As an alternative to paragraph (b)(1)(ii) of this section, the
direct interface sampling and analysis procedure described in Method
18, section 7.2, may be used to continuously monitor ethylene oxide
concentration at the inlet and outlet of the control device using a gas
chromatograph with flame ionization detector (GC/FID) or
photoionization detector (GC/PID). This procedure may be used only if a
vent sample may be sampled and analyzed by the GC/FID or GC/PID at
least once per minute.
(1) Follow the procedures in section 6 of Method 18 and choose the
appropriate column, analytical apparatus, and calibration gases for the
analysis of the sample.
(2) Follow the procedures in paragraphs (b)(1)(iv)(B)(2) (ii)
through (v) of this section.
(v) Determine control device efficiency (% Eff) using the following
equation:
TR06DE94.030
where:
% Eff = percent efficiency
Wi = mass flow rate into the control device
Wo = mass flow rate out of the control device
(vi) Repeat the procedures in paragraphs (b)(1) (i) through (v) of
this section three times. The arithmetic average percent efficiency of
the three runs shall determine the overall efficiency of the control
device.
(2) Last evacuation of the sterilization chamber. One of the
following procedures (paragraph (b)(2) (i) or (ii) of this section)
shall be performed during the last evacuation of the sterilization
chamber:
(i) The direct interface sampling and analysis procedure described
in Method 18, section 7.2, may be used to continuously monitor ethylene
oxide concentration at the inlet and outlet of the control device using
a GC/FID or GC/PID; this procedure may be used only if a vent may be
sampled and analyzed by the GC/FID or GC/PID once per minute for the
duration of the last cycle.
(A) Follow the procedures in section 6 of Method 18 and choose the
appropriate column, analytical apparatus, and calibration gases for the
analysis of the sample.
(B) Follow the procedures in paragraphs (b)(1)(iv)(B)(2)(ii)
through (iv) of this section.
(C) Determine control device efficiency (% Eff) using the following
equation:
TR06DE94.031
where:
% Eff = percent efficiency
Wi = mass flow rate into the control device
Wo = mass flow rate out of the control device
(D) Repeat the procedures in paragraphs (b)(2)(i) (A) through (C)
of this section three times. The arithmetic average percent efficiency
of the three runs shall determine the overall efficiency of the control
device.
(ii) The Tedlar bag sampling procedure in section 7.1 of Method 18,
may be used to collect samples of inlet and exhaust gas for the
duration of the last cycle.
(A) Continuously sample a slipstream of the control device inlet
and outlet into a Tedlar bag by having a Tedlar bag attached to the
slipstream for the entire duration of the run for an integrated bag
sample. Whenever a Tedlar bag is full, a new bag must be reattached
immediately. Note the time the bag is changed so the sample time and
corresponding flow rates can be determined for each bag.
(B) Follow the procedures in section 6 of Method 18 and choose the
appropriate column, analytical apparatus, and calibration gases for the
analysis of the bag samples collected. The bag samples shall be
analyzed within 8 hours of collection.
(C) Follow the procedures in paragraphs (b)(1)(iv)(B)(2)(ii)
through (iv) of this section.
(D) Determine control device efficiency (% Eff) using the equation
in paragraph (b)(2)(i)(C) of this section.
(E) Repeat the procedures in paragraphs (b)(2)(ii)(A) through (D)
of this section three times. The arithmetic average percent efficiency
of the three runs shall determine the overall efficiency of the control
device.
(iii) In the event that the outlet concentration from the control
device is below the detection limit for ethylene oxide for determining
the efficiency in paragraph (b)(2)(i)(C) or (ii)(D) of this section,
the owner or operator shall assume the control device is meeting the
standard in Sec. 63.362(e)(1) or (2) if the inlet ethylene oxide
concentration is at or below approximately 50 ppmv.
(c) Concentration determination. The following procedures shall be
used to determine the ethylene oxide concentration as the monitored
parameter established in Sec. 63.363(c) and (e) for aeration room
emissions and chamber exhaust vents, respectively, and to continuously
monitor the ethylene oxide concentration for aeration room vents as
established in Sec. 63.364(e)(1) and to monitor the ethylene oxide
concentration before activation of the chamber exhaust for chamber
exhaust vents as established in Sec. 63.364(e)(2).
(1) Aeration room vent. For determining the ethylene oxide
concentration for aeration room emissions, the procedures outlined in
section 7.2 of Method 18 shall be used. Repeat these procedures three
times. The arithmetic average of the ethylene oxide concentration of
the three test runs shall determine the overall outlet ethylene oxide
concentration from the control device. Compliance testing of gas
chromatographs shall be performed using PS 9 in 40 CFR part 60.
(2) Sterilization chamber prior to activation of the chamber
exhaust. For determining the ethylene oxide concentration in the
sterilization chamber before activation of the chamber exhaust, the
procedures outlined in sections 7.2 or 7.3 of Method 18 shall be used.
The ethylene oxide concentration from one test run shall determine the
outlet ethylene oxide concentration from the chamber exhaust vent.
Compliance testing of gas chromatographs shall be performed using PS 9
in 40 CFR part 60.
(d) Efficiency determination at the aeration room vent and at the
chamber exhaust vent (not manifolded). The following procedures shall
be used to determine the efficiency of a control device used to comply
with Sec. 63.362(d) or (e), the aeration room vent standard or the
chamber exhaust vent standards (without manifolding the chamber exhaust
vent emissions to another vent type):
(1) Aeration room vent. For determining the efficiency of aeration
room vent control devices, either of the following test methods
(paragraph (d)(1)(i) or (ii) of this section) may be used:
(i) the direct interface sampling and analysis procedure described
in Method 18, section 7.2, may be used to
continuouslymonitorethyleneoxideP
concentration at the inlet and outlet of the control device using a GC/
FID or GC/PID; this procedure may be used only if a vent may be sampled
and analyzed by the GC/FID or GC/PID once every 5 minutes throughout a
1-hour test run.
(A) Follow the procedures in section 6 of Method 18 and choose the
appropriate column, analytical apparatus, and calibration gases for the
analysis of the sample.
(B) Follow the procedures in paragraphs (b)(1)(iv)(B)(2)(ii)
through (iv) of this section.
C) Determine control device efficiency (% Eff) using the following
equation:
TR06DE94.032
where:
% Eff=percent efficiency
Wi=mass flow rate into the control device
Wo=mass flow rate out of the control device
(D) Repeat the procedures in paragraphs (d)(1)(i)(A) through (C) of
this section three times. The arithmetic average percent efficiency of
the three runs shall determine the overall efficiency of the control
device.
(ii) The Tedlar bag sampling procedure in section 7.1 of Method 18
may be used to collect samples of inlet and exhaust gas throughout a 1-
hour test run.
(A) Continuously sample a slipstream of the control device inlet
and outlet into a Tedlar bag by having a Tedlar bag attached to the
slipstream for the entire duration of the run for an integrated bag
sample. Whenever a Tedlar bag is full, a new bag must be reattached
immediately. Note the time the bag is changed so the sample time and
corresponding flow rates can be determined for each bag.
(B) Follow the procedures in section 6 of Method 18 and choose the
appropriate column, analytical apparatus, and calibration gases for the
analysis of the bag samples collected. The bag samples shall be
analyzed within 8 hours of collection.
(C) Follow the procedures in paragraphs (b)(1)(iv)(B)(2)(ii)
through (iv) of this section.
(D) Determine control device efficiency (% Eff) using the equation
in paragraph (d)(1)(i)(C) of this section.
(E) Repeat the procedures in paragraphs (d)(1)(ii)(A) through (D)
of this section three times. The arithmetic average percent efficiency
of the three runs shall determine the overall efficiency of the control
device.
(2) Chamber exhaust vent (not manifolded). For determining the
efficiency of non-manifolded chamber exhaust vent control devices,
either of the following test methods (paragraph (d)(2)(i) or (ii) of
this section) may be used:
(i) The direct interface sampling and analysis procedures described
in Method 18, section 7.2 or 7.3, may be used to continuously monitor
ethylene oxide concentration at the inlet and outlet of the control
device using a GC/FID or GC/PID; these procedures may be used only if a
vent may be sampled and analyzed by the GC/FID or GC/PID once per
minute for the duration of each cycle when the chamber exhaust vent is
operated.
(A) Follow the procedures in section 6 of Method 18 and choose the
appropriate column, analytical apparatus, and calibration gases for the
analysis of the sample.
(B) Follow the procedures in paragraphs (b)(1)(iv)(B)(2)(ii)
through (iv) of this section.
(C) Determine control device efficiency (% Eff) using the following
equation: where:
TR06DE94.033
where:
% Eff = percent efficiency
Wi = mass flow rate into the control device
Wo = mass flow rate out of the control device
(D) Repeat the procedures in paragraphs (d)(2)(i)(A) through (C) of
this section three times. The arithmetic average percent efficiency of
the three runs shall determine the overall efficiency of the control
device.
(ii) The Tedlar bag sampling procedure in section 7.1 of Method 18
may be used to collect samples of inlet and exhaust gas for the
duration of each cycle when the chamber exhaust vent is operated.
(A) Continuously sample a slipstream of the control device inlet
and outlet into a Tedlar bag by having a Tedlar bag attached to the
slipstream for the entire duration of the run for an integrated bag
sample. Whenever a Tedlar bag is full, a new bag must be reattached
immediately. Note the time the bag is changed so the sample time and
corresponding flow rates can be determined for each bag.
(B) Follow the procedures in section 6 of Method 18 and choose the
appropriate column, analytical apparatus, and calibration gases for the
analysis of the bag samples collected. The bag samples shall be
analyzed within 8 hours of collection.
(C) Follow the procedures in paragraphs (b)(1)(iv)(B)(2)(ii)
through (iv) of this section.
(D) Determine control device efficiency (% Eff) using the equation
in paragraph (d)(2)(i)(C) of this section.
(E) Repeat the procedures in paragraphs (d)(2)(ii)(A) through (D)
of this section three times. The arithmetic average percent efficiency
of the three runs shall determine the overall efficiency of the control
device.
(iii) In the event that the outlet concentration from the control
device is below the detection limit for ethylene oxide for determining
the efficiency in paragraph (d)(2)(i)(C) or (ii)(D) of this section,
the owner or operator shall assume the control device is meeting the
standard in Sec. 63.362(e)(1) or (2) if the inlet ethylene oxide
concentration is at or below approximately 50 ppmv.
(e) Determination of baseline parameters for acid-water scrubbers.
The procedures in this paragraph shall be used to determine the
monitored parameters established in Sec. 63.363(b), (d), or (e) for
acid-water scrubbers and to monitor the parameters as established in
Sec. 63.364(b).
(1) Ethylene glycol concentration. For determining the ethylene
glycol concentration, the facility owner or operator shall establish
the maximum ethylene glycol concentration as the ethylene glycol
concentration averaged over three test runs; the sampling and analysis
procedures in ASTM D 3695-88, Standard Test Method for Volatile
Alcohols in Water By Direct Aqueous-Injection Gas Chromatography,
(incorporated by reference--see Sec. 63.14) shall be used to determine
the ethylene glycol concentration.
(2) Scrubber liquor tank level. For determining the scrubber liquor
tank level, the sterilization facility owner or operator shall
establish the maximum liquor tank level based on a single measurement
of the liquor tank level during one test run.
(f) Determination of baseline temperature for oxidation units. The
procedures in this paragraph shall be used to demonstrate the baseline
temperature required in Sec. 63.363(b), (c), (d), or (e) for catalytic
oxidation units or thermal oxidation units and to continuously monitor
the oxidation temperature as established in Sec. 63.364(c).
(1) Sterilization chamber vent. The sterilization facility owner or
operator shall establish the baseline temperature for the sterilization
chamber vent as the temperature for the catalytic oxidation unit or the
oxidation temperature at the exhaust point from the thermal oxidation
unit averaged over three test runs using the procedures in paragraph
(b)(2) of this section.
(2) Aeration room vent. The sterilization facility owner or
operator shall establish the baseline temperature for the aeration room
vent as the temperature for the catalytic oxidation unit or the
oxidation temperature at the exhaust point from the thermal oxidation
unit averaged over three test runs using the procedures in paragraph
(d)(1) of this section.
(3) Chamber exhaust vent. The sterilization facility owner or
operator shall establish the baseline temperature for the chamber
exhaust vent as the temperature for the catalytic oxidation unit or the
oxidation temperature at the exhaust point from the thermal oxidation
unit averaged over three test runs using the procedures in paragraph
(d)(2) of this section.
(g) An owner or operator of a sterilization facility seeking to
demonstrate compliance with the standards found at Sec. 63.362(c), (d),
or (e) with a control device other than an acid-water scrubber or
catalytic or thermal oxidation unit shall provide to the Administrator
the information requested under Sec. 63.363(f). The owner or operator
shall submit: a description of the device; test results collected in
accordance with Sec. 63.363(f) verifying the performance of the device
for controlling ethylene oxide emissions to the atmosphere to the
levels required by the applicable standards; the appropriate operating
parameters that will be monitored; and the frequency of measuring and
recording to establish continuous compliance with the standards. The
monitoring plan submitted identifying the compliance monitoring is
subject to the Administrator's approval. The owner or operator of the
sterilization facility shall install, calibrate, operate, and maintain
the monitor(s) approved by the Administrator based on the information
submitted by the owner or operator. The owner or operator shall include
in the information submitted to the Administrator proposed performance
specifications and quality assurance procedures for their monitors. The
Administrator may request further information and shall approve
appropriate test methods and procedures.
(h) An owner or operator of a sterilization facility seeking to
demonstrate compliance with the standards found at Secs. 63.362(d) or
(e) with a monitoring device or procedure other than a gas
chromatograph shall provide to the Administrator information describing
the operation of the monitoring device or procedure and the
parameter(s) that would indicate proper operation and maintenance of
the device or procedure. The Administrator may request further
information and will specify appropriate test methods and procedures.
Sec. 63.366 Reporting requirements.
(a) The owner or operator of a source subject to the emissions
standards in Sec. 63.362 shall fulfill all reporting requirements in
Secs. 63.10(a), (d), (e), and (f) of subpart A, according to the
applicability in Table 1 of Sec. 63.360. These reports will be made to
the Administrator at the appropriate address identified in Sec. 63.13
of subpart A of this part.
(1) Reports required by subpart A and this section may be sent by
U.S. mail, fax, or by another courier.
(i) Submittals sent by U.S. mail shall be postmarked on or before
the specified date.
(ii) Submittals sent by other methods shall be received by the
Administrator on or before the specified date.
(2) If acceptable to both the Administrator and the owner or
operator of a source, reports may be submitted on electronic media.
(3) Content and submittal dates for excess emissions and monitoring
system performance reports. All excess emissions and monitoring system
performance reports and all summary reports, if required per
Sec. 63.10(e)(3) (vii) and (viii) of subpart A of this part, shall be
delivered or postmarked within 30 days following the end of each
calendar half or quarter as appropriate (see Sec. 63.10(e)(3) (i)
through (iv) for applicability). Written reports of excess emissions or
exceedances of process or control system parameters shall include all
information required in Sec. 63.10(c) (5) through (13) of subpart A of
this part as applicable in Table 1 of Sec. 63.360 and information from
any calibration tests in which the monitoring equipment is not in
compliance with PS-9 or the method used for temperature calibration.
The written report shall also include the name, title, and signature of
the responsible official who is certifying the accuracy of the report.
When no excess emissions or exceedances have occurred or monitoring
equipment has not been inoperative, repaired, or adjusted, such
information shall be stated in the report.
(b) Construction and Reconstruction. The owner or operator of each
source using 10 tons shall fulfill all requirements for construction or
reconstruction of a source in Sec. 63.5 of subpart A of this part,
according to the applicability in Table 1 of Sec. 63.360, and in this
paragraph.
(1) Applicability. (i) This paragraph and Sec. 63.5 of subpart A of
this part implement the preconstruction review requirements of section
112(i)(1) for sources subject to these emissions standards. In
addition, this paragraph and Sec. 63.5 of subpart A of this part
include other requirements for constructed and reconstructed sources
that are or become subject to these emissions standards.
(ii) After the effective date, the requirements in this section and
in Sec. 63.5 of subpart A of this part apply to owners or operators who
construct a new source or reconstruct a source subject to these
emissions standards after December 6, 1994. New or reconstructed
sources subject to these emissions standards with an initial startup
date before the effective date are not subject to the preconstruction
review requirements specified in paragraphs (b) (2) and (3) of this
section and Sec. 63.5(d) (3) and (4) and (e) of subpart A of this part.
(2) After the effective date, whether or not an approved permit
program is effective in the State in which a source is (or would be)
located, no person may construct a new source or reconstruct a source
subject to these emissions standards, or reconstruct a source such that
the source becomes a source subject to these emissions standards,
without obtaining advance written approval from the Administrator in
accordance with the procedures specified in paragraph (b)(3) of this
section and Sec. 63.5(d) (3) and (4) and (e) of subpart A of this part.
(3) Application for approval of construction or reconstruction. The
provisions of paragraph (b)(3) of this section and Sec. 63.5(d) (3) and
(4) of subpart A of this part implement section 112(i)(1) of the Act.
(i) General application requirements.
(A) An owner or operator who is subject to the requirements of
paragraph (b)(2) of this section shall submit to the Administrator an
application for approval of the construction of a new source subject to
these emissions standards, the reconstruction of a source subject to
these emissions standards, or the reconstruction of a source such that
the source becomes a source subject to these emissions standards. The
application shall be submitted as soon as practicable before the
construction or reconstruction is planned to commence (but not sooner
than the effective date) if the construction or reconstruction
commences after the effective date. The application shall be submitted
as soon as practicable before the initial startup date but no later
than 60 days after the effective date if the construction or
reconstruction had commenced and the initial startup date had not
occurred before the effective date. The application for approval of
construction or reconstruction may be used to fulfill the initial
notification requirements of paragraph (c)(1)(iii) of this section. The
owner or operator may submit the application for approval well in
advance of the date construction or reconstruction is planned to
commence in order to ensure a timely review by the Administrator and
that the planned commencement date will not be delayed.
(B) A separate application shall be submitted for each construction
or reconstruction. Each application for approval of construction or
reconstruction shall include at a minimum:
(1) The applicant's name and address.
(2) A notification of intention to construct a new source subject
to these emissions standards or make any physical or operational change
to a source subject to these emissions standards that may meet or has
been determined to meet the criteria for a reconstruction, as defined
in Sec. 63.2 of subpart A of this part.
(3) The address (i.e., physical location) or proposed address of
the source.
(4) An identification of the relevant standard that is the basis of
the application.
(5) The expected commencement date of the construction or
reconstruction.
(6) The expected completion date of the construction or
reconstruction.
(7) The anticipated date of (initial) startup of the source.
(8) The type and quantity of hazardous air pollutants emitted by
the source, reported in units and averaging times and in accordance
with the test methods specified in the standard, or if actual emissions
data are not yet available, an estimate of the type and quantity of
hazardous air pollutants expected to be emitted by the source reported
in units and averaging times specified. The owner or operator may
submit percent reduction information, if the standard is established in
terms of percent reduction. However, operating parameters, such as flow
rate, shall be included in the submission to the extent that they
demonstrate performance and compliance.
(9) Other information as specified in paragraph (b)(3)(ii) of this
section and Sec. 63.5(d)(3) of subpart A of this part.
(C) An owner or operator who submits estimates or preliminary
information in place of the actual emissions data and analysis required
in paragraphs (b)(3)(i)(B)(8) and (ii) of this section shall submit the
actual, measured emissions data and other correct information as soon
as available but no later than with the notification of compliance
status required in paragraph (c)(2) of this section.
(ii) Application for approval of construction. Each application for
approval of construction shall include, in addition to the information
required in paragraph (b)(3)(i)(B) of this section, technical
information describing the proposed nature, size, design, operating
design capacity, and method of operation of the source subject to these
emissions standards, including an identification of each point of
emission for each hazardous air pollutant that is emitted (or could be
emitted) and a description of the planned air pollution control system
(equipment or method) for each emission point. The description of the
equipment to be used for the control of emissions shall include each
control device for each hazardous air pollutant and the estimated
control efficiency (percent) for each control device. The description
of the method to be used for the control of emissions shall include an
estimated control efficiency (percent) for that method. Such technical
information shall include calculations of emission estimates in
sufficient detail to permit assessment of the validity of the
calculations. An owner or operator who submits approximations of
control efficiencies under paragraph (b)(3) of this section shall
submit the actual control efficiencies as specified in paragraph
(b)(3)(i)(C) of this section.
(4) Approval of construction or reconstruction based on prior State
preconstruction review.
(i) The Administrator may approve an application for construction
or reconstruction specified in paragraphs (b)(2) and (3) of this
section and Sec. 63.5(d)(3) and (4) of subpart A of this part if the
owner or operator of a new or reconstructed source who is subject to
such requirement demonstrates to the Administrator's satisfaction that
the following conditions have been (or will be) met:
(A) The owner or operator of the new or reconstructed source
subject to these emissions standards has undergone a preconstruction
review and approval process in the State in which the source is (or
would be) located before the effective date and has received a
federally enforceable construction permit that contains a finding that
the source will meet these emissions standards as proposed, if the
source is properly built and operated;
(B) In making its finding, the State has considered factors
substantially equivalent to those specified in Sec. 63.5(e)(1) of
subpart A of this part.
(ii) The owner or operator shall submit to the Administrator the
request for approval of construction or reconstruction no later than
the application deadline specified in paragraph (b)(3)(i) of this
section. The owner or operator shall include in the request information
sufficient for the Administrator's determination. The Administrator
will evaluate the owner or operator's request in accordance with the
procedures specified in Sec. 63.5 of subpart A of this part. The
Administrator may request additional relevant information after the
submittal of a request for approval of construction or reconstruction.
(c) Notification requirements. The owner or operator of each source
subject to the emissions standards in Sec. 63.362 shall fulfill all
notification requirements in Sec. 63.9 of subpart A of this part,
according to the applicability in Table 1 of Sec. 63.360, and in this
paragraph.
(1) Initial Notifications
(i)(A) If a source that otherwise would be subject to these
emissions standards subsequently increases its use of ethylene oxide
within any consecutive 12-month period after December 6, 1996, such
that the source becomes subject to these emissions standards or other
requirements, such source shall be subject to the notification
requirements of Sec. 63.9 of subpart A of this part.
(B) Sources subject to these emissions standards may use the
application for approval of construction or reconstruction under
paragraph (b)(3)(ii) of this section and Sec. 63.5(d) (3) of subpart A
of this part, respectively, if relevant to fulfill the initial
notification requirements.
(ii) The owner or operator of a new or reconstructed source subject
to these emissions standards that has an initial startup date after the
effective date and for which an application for approval of
construction or reconstruction is required under paragraph (b)(3) of
this section and Sec. 63.5(d) (3) and (4) of subpart A of this part
shall provide the following information in writing to the
Administrator:
(A) A notification of intention to construct a new source subject
to these emissions standards, reconstruct a source subject to these
emissions standards, or reconstruct a source such that the source
becomes a source subject to these emissions standards with the
application for approval of construction or reconstruction as specified
in paragraph (b)(3)(i)(A) of this section;
(B) A notification of the date when construction or reconstruction
was commenced, submitted simultaneously with the application for
approval of construction or reconstruction, if construction or
reconstruction was commenced before the effective date of these
standards;
(C) A notification of the date when construction or reconstruction
was commenced, delivered or postmarked not later than 30 days after
such date, if construction or reconstruction was commenced after the
effective date of these standards;
(D) A notification of the anticipated date of startup of the
source, delivered or postmarked not more than 60 days nor less than 30
days before such date; and
(E) A notification of the actual date of initial startup of the
source, delivered or postmarked within 15 calendar days after that
date.
(iii) After the effective date, whether or not an approved permit
program is effective in the State in which a source subject to these
emissions standards is (or would be) located, an owner or operator who
intends to construct a new source subject to these emissions standards
or reconstruct a source subject to these emissions standards, or
reconstruct a source such that it becomes a source subject to these
emissions standards, shall notify the Administrator in writing of the
intended construction or reconstruction. The notification shall be
submitted as soon as practicable before the construction or
reconstruction is planned to commence (but no sooner than the effective
date of these standards) if the construction or reconstruction
commences after the effective date of the standard. The notification
shall be submitted as soon as practicable before the initial startup
date but no later than 60 days after the effective date of this
standard if the construction or reconstruction had commenced and the
initial startup date has not occurred before the standard's effective
date. The notification shall include all the information required for
an application for approval of construction or reconstruction as
specified in paragraph (b)(3) of this section and Sec. 63.5(d)(3) and
(4) of subpart A of this part. For sources subject to these emissions
standards, the application for approval of construction or
reconstruction may be used to fulfill the initial notification
requirements of Sec. 63.9 of subpart A of this part.
(2) If an owner or operator of a source subject to these emissions
standards submits estimates or preliminary information in the
application for approval of construction or reconstruction required in
paragraph (b)(3)(ii) of this section and Sec. 63.5(d)(3) of subpart A
of this part, respectively, in place of the actual emissions data or
control efficiencies required in paragraphs (b)(3)(i)(B)(8) and (ii) of
this section, the owner or operator shall submit the actual emissions
data and other correct information as soon as available but no later
than with the initial notification of compliance status.
(3) The owner or operator of any existing sterilization facility
subject to this subpart shall also include the amount of ethylene oxide
used during the previous consecutive 12-month period in the initial
notification report required by Sec. 63.9(b)(2) and (3) of subpart A of
this part. For new sterilization facilities subject to this subpart,
the amount of ethylene oxide used shall be an estimate of expected use
during the first consecutive 12-month period of operation.
Sec. 63.367 Recordkeeping requirements.
(a) The owner or operator of a source subject to the emissions
standards in Sec. 63.362 shall comply with the recordkeeping
requirements in Secs. 63.10(b) and (c) of subpart A of this part,
according to the applicability in Table 1 of Sec. 63.360, and in this
section.
(b) The owners or operators of a source using 1 to 10 tons not
subject to an emissions standard in Sec. 63.362 shall maintain records
of ethylene oxide use on a 12-month rolling average basis (until the
source changes its operations to become a source subject to an
emissions standard in Sec. 63.362). These records shall be kept onsite
at the source for a period of 5 years.
(c) The owners or operators of a source using less than 1 ton shall
maintain records of ethylene oxide use on a 12-month rolling average
basis (until the source changes its operations to become a source
subject to the emissions standards in Sec. 63.362). These records shall
be kept onsite at the source for a period of 5 years.
[FR Doc. 94-29823 Filed 12-5-94; 8:45 am]
BILLING CODE 6560-50-P