[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]


=======================================================================
-----------------------------------------------------------------------

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