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

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.

* * * * *

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40 CFR citation OMB Control No.

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* * * * * * *

National Emissions Standards for Hazardous Air Pollutants for Source Categories:

* * * * * * *

63.363-63.367.................................................... 2060-0283

* * * * * * *

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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 and 99% emission reduction No control............ Maximum chamber

1 ton and 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]

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