[Federal Register Volume 66, Number 44 (Tuesday, March 6, 2001)]
[Proposed Rules]
[Pages 13464-13473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5414]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[AD-FRL-6950-9]
RIN 2060-AC28


Ethylene Oxide Emissions Standards for Sterilization Facilities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed amendments.

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SUMMARY: This proposal amends the emission standards for sterilization 
facilities by eliminating maximum achievable control technology (MACT) 
requirements for chamber exhaust vents. This action is being proposed 
to eliminate safety problems associated with the existing requirements. 
This proposal also amends testing and monitoring requirements for 
sterilization chamber, aeration, and chamber exhaust vents. Specific 
testing and monitoring requirements are being removed or simplified to 
correct technical problems associated with the existing requirements.

DATES: Submit comments on or before May 7, 2001.
    Public hearing. If anyone contacts the EPA requesting to speak at a 
public hearing by March 26, 2001, a public hearing will be held on 
April 5, 2001.

ADDRESSES: Comments. Written comments should be submitted (in duplicate 
if possible) to: Air and Radiation Docket and Information Center 
(6102), Attention Docket Number A-88-03, U.S. EPA, 401 M Street, SW, 
Washington, DC 20460. The EPA requests a separate copy also be sent to 
the contact person listed below (see FOR FURTHER INFORMATION CONTACT).
    Docket. Docket No. A-88-03 contains supporting information used in 
developing the standards. The docket is located at the U.S. EPA, 401 M 
Street, SW., Washington, DC 20460, in room M-1500, Waterside Mall 
(ground floor), and may be inspected from 8:30 a.m. to 5:30 p.m., 
Monday through Friday, excluding legal holidays.
    Public Hearing. If a public hearing is held, it will be held at 10 
a.m. in the EPA's Office of Administration Auditorium, Research 
Triangle Park, North Carolina, or at an alternate site nearby.

FOR FURTHER INFORMATION CONTACT: David Markwordt, Policy, Planning, and 
Standards Group, Emission Standards Division, (MD-13), U.S. EPA, 
Research Triangle Park, North Carolina 27711, telephone number (919) 
541-0837, electronic mail address [email protected].

SUPPLEMENTARY INFORMATION: Comments. Comments and data may be submitted 
by electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file to avoid the use of special 
characters and encryption problems and will also be accepted on disks 
in WordPerfect version 5.1, 6.1 or Corel 8 file format. All 
comments and data submitted in electronic form must note the Docket No. 
A-88-03. No confidential business information (CBI) should be submitted 
by e-mail. Electronic comments may be filed online at many Federal 
Depository Libraries.
    Commenters wishing to submit proprietary information for 
consideration must clearly distinguish such information from other 
comments and clearly label it as CBI. Send submissions containing such 
proprietary information directly to the following address, and not to 
the public docket, to ensure that proprietary information is not 
inadvertently placed in the docket: Attention: David Markwordt, C/O 
OAQPS Document Control Officer, U.S. Environmental Protection Agency, 
411 W. Chapel Hill Street, (Room 740B), Durham NC 27701. The EPA will 
disclose information identified as CBI only to the extent allowed by 
the procedures set forth in 40 CFR part 2. If no claim of 
confidentiality accompanies a submission when it is received by the 
EPA, the information may be made available to the public without 
further notice to the commenters.
    Public Hearing. Persons interested in presenting oral testimony or 
inquiring as to whether a hearing is to be held should contact Dorothy 
Apple, Policy, Planning, and Standards Group, Emission Standards 
Division (MD-13), U.S. EPA, Research Triangle Park, North Carolina 
27711, telephone number: (919) 541-4487 at least 2 days in advance of 
the public hearing. Persons interested in attending the public hearing 
must also call Dorothy Apple to verify the time, date, and location of 
the hearing. The public hearing will provide interested parties the 
opportunity to present data, views, or arguments concerning these 
proposed emission standards amendments.
    Docket. The docket is an organized and complete file of all the 
information we considered in the development of this rulemaking. The 
docket is a dynamic file because material is added throughout the 
rulemaking process. 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 proposed and promulgated standards and their 
preambles, the contents of the docket will serve as the record in the 
case of judicial review. (See section 307(d)(7)(A) of the Clean Air Act 
(CAA)). The regulatory text and other materials related to this 
rulemaking are available for review in the docket or copies may be 
mailed on request from the Air Docket by calling (202) 260-

[[Page 13465]]

7548. A reasonable fee may be charged for copying docket materials. 
World Wide Web (WWW). In addition to being available in the docket, an 
electronic copy of these proposed amendments will also be available on 
the Technology Transfer Network (TTN). Following signature, a copy of 
the rule will be posted on the policy and guidance page for newly 
proposed or promulgated rules http://www.epa.gov/ttn/oarpg. The TTN 
provides information and technology exchange in various areas of air 
pollution control. If more information regarding the TTN is needed, 
call our HELP line at (919) 541-5384.
    Regulated Entities. Categories and entities regulated by this 
action include:

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             Category                     SICa/NAICSb                   Examples of regulated entities
----------------------------------------------------------------------------------------------------------------
Industry.........................  3841, 3842...............  Medical suppliers.
                                   2834, 5122, 2831, 2833...  Pharmaceuticals.
                                   2099, 5149, 2034, 2035,    Spice Manufactures Contract.
                                    2046.
                                   7399, 7218, 8091.........  Sterilizers.
Federal Government...............  Not Affected.............  ..................................................
State/Local/Tribal Gov...........  Not affected.............  ..................................................
----------------------------------------------------------------------------------------------------------------
a Standard Industrial Classification Code.
b North American Information Classification System.

    This table is not intended to be exhaustive, but rather provides a 
guide for readers regarding entities regulated by the NESHAP addressed 
in these proposed amendments. To determine whether your facility is 
regulated by this action, you should examine the applicability criteria 
in Sec. 63.360 of the proposed rule. If you have questions regarding 
the applicability of the NESHAP addressed in this proposed rule to a 
particular entity, consult the person listed in the preceding FOR 
FURTHER INFORMATION CONTACT section.
    Outline. The information presented in this preamble is organized as 
follows:

I. Chamber Exhaust Vents
    A. Why are we reconsidering MACT for chamber exhaust vents?
    B. What is MACT for chamber exhaust vents?
II. Monitoring
    A. Why are we reconsidering the monitoring requirements?
    B. How are we proposing to amend the monitoring requirements?
III. Testing
    A. Why are we proposing to change the testing requirements?
    B. How are we proposing to amend the testing requirements?
IV. Summary of Environmental, Energy, and Economic Impacts
V. Administrative Requirements
    A. Executive Order 12866, Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Executive Order 13132, Federalism
    D. Executive Order 13084, Consultation and Coordination with 
Indian Tribal Governments
    E. Unfunded Mandates Reform Act of 1995
    F. Regulatory Flexibility Act (RFA), as Amended by the Small 
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 
U.S.C. 601 et seq.
    G. National Technology Transfer and Advancement Act of 1995
    H. Executive Order 13045, Protection of Children from 
Environmental Health Risks and Safety Risks

I. Chamber Exhaust Vents

A. Why Are We Reconsidering MACT for Chamber Exhaust Vents?

    On December 6, 1994, we promulgated the ethylene oxide (EO) 
national emission standards for hazardous air pollutants (NESHAP) which 
regulate emissions of ethylene oxide from commercial sterilization and 
fumigation operations (59 FR 62585). In July 1997, we learned of 
explosions at ethylene oxide sterilization and fumigation facilities. 
We suspended the EO NESHAP for 1 year until December 6, 1998 to provide 
time to determine the appropriate action necessary to mitigate the 
cause of the explosions (62 FR 64736).
    After becoming aware of the explosions, the industry worked through 
the Ethylene Oxide Sterilization Association (EOSA) to begin 
investigations. The EOSA established a Safety Committee in September 
1997 which continues to meet bimonthly. Sterilization industry leaders, 
abatement device vendors, and Federal, State and local agencies have 
been participating in the Safety Committee meetings.
    In a June 2, 1998 letter to EPA, the EOSA recommended, ``additional 
time to consider safe and economical control, installation, operation 
and maintenance alternatives applicable to aeration and chamber exhaust 
(backvent) emissions * * *.'' The Health Industries Manufacturers 
Association (HIMA) reviewed the recommendation. Together, the EOSA and 
HIMA memberships represent most of the ethylene oxide sterilization and 
fumigation industry. The EOSA concluded that ``The oxidizer systems had 
not been properly integrated with traditional ethylene oxide 
sterilization process operations, that is, installation, operation and 
maintenance issues had not been sufficiently addressed by sterilizer 
operators.'' The EOSA also concluded that ``improperly overfeeding the 
oxidizer system from the chamber backvent was the primary safety 
concern.''
    The EPA conducted an independent investigation of the accidents and 
reviewed reports prepared by EPA Regional Offices and by EOSA member 
sterilization companies and, based on that investigation and review, 
concurred with the industry conclusion and recommendation. In 1998, we 
agreed with industry that, in the cases where explosions occurred, the 
catalytic oxidizer units were overfed with ethylene oxide in 
concentrations above the safe operations limit due to abnormal 
activation of the chamber exhaust (backvent). We concluded that the 
main sterilizer vent emissions routed through the vacuum pump played no 
role in the explosions. Therefore, the December 6, 1998 compliance date 
for the main sterilizer vent was allowed to take effect. However, we 
further suspended the EO NESHAP for both aeration room vents and 
chamber exhaust vents for 1 year (until December 6, 1999) to provide 
time to determine the appropriate action necessary to mitigate the 
cause of the explosions (63 FR 66990). Aeration room vents were 
included in the suspension because control systems typically integrate 
both vents to the same control device.
    We also concluded that any emissions control technology necessary 
to comply with the EO NESHAP needs to be properly integrated into the 
sterilization system and operations; it must reflect the full range of 
normal and abnormal conditions that may occur. The December 1998 
suspension was based on the assumption that sterilization chamber 
operators would be able to evaluate and integrate the emission control 
technology with sterilizer

[[Page 13466]]

operations to ensure prevention of future explosions by December 6, 
1999. In June 1999, the EOSA and individual plant operators requested 
that EPA eliminate the control requirement for chamber exhaust vents. 
In response to the June 1999 request, we further suspended the control 
requirements for aeration and chamber exhaust vents on December 3, 1999 
(64 FR 67789).
    We suspended the control requirements for aeration room vents 
because they are typically combined with chamber exhaust vents and 
ducted to a single control device. The December 3, 1999 notice (64 FR 
67789) explained that there is no safety issue associated with 
controlling only the aeration room vent; no revisions to control 
requirements were anticipated. The 1999 notice also suspended the 
compliance date for aeration room vents by 1 year to provide time to 
decouple them from any chamber exhaust vents. Aeration room vents were 
required to comply with the emission control requirements by December 
6, 2000.
    However, the compliance date for the chamber exhaust vent control 
requirements was suspended until December 6, 2001 in the 1999 notice 
(64 FR 67789). At the time we said, ``The suspension, in December 1998, 
for chamber exhaust vents was based on the assumption that 
sterilization chamber operators would be able to evaluate and integrate 
the emission control technology with sterilizer operations to ensure 
prevention of future explosions by December 6, 1999. To date, solutions 
to the safety problems have not been developed.'' We further stated 
that the Agency would reconsider its original MACT determination for 
chamber exhaust vents and propose a course of action in the near 
future.
    In April 2000, a report jointly published by the National Institute 
for Occupational Safety and Health (NIOSH), EPA, and the EOSA concluded 
the following:
    1. Fires and explosions result when sterilizer oxidizing emission 
control devices (OECD) are overfed with high concentrations of ethylene 
oxide;
    2. Current procedures for aborting the ethylene oxide sterilizer 
cycle are deficient when OECD are used;
    3. Current safety systems for ethylene oxide sterilization 
processes are deficient when OECD are used; and
    4. When OECD are used as the only emission control device (that is, 
when acidified wet scrubbers are not used or are bypassed), the risk of 
fire and explosion is greatly increased.
    The conclusions in this report are supportive of our conclusions in 
the December 3, 1999 notice.
    We are still in the position today of being unable to make a 
finding that solutions to the safety problems have been developed. It 
is beyond the Agency's legal mandate and technical expertise to certify 
equipment for safe use. The CAA generally requires the Agency to assess 
existing emission control technology for application to non-controlled 
emission sources. The use of existing technology by some sources in the 
relevant category presumes the ability to operate that technology in a 
proven safe manner. At the time of rule promulgation (December 1994), 
state-of-the-art control technology for chamber exhaust emissions 
involved safety hazards not known at the time.
    We are aware that some companies have removed their catalytic 
oxidizers and replaced them with alternative control devices. Some of 
these alternative control devices operate without a flame source and 
would presumably be safer than systems which rely on combustion. 
However, even non-combustion control devices must be designed to avert 
potential safety problems due to exothermic reaction resulting from the 
control of ethylene oxide. We are not aware of any authoritative 
institution which has evaluated these alternative systems for safe 
operation.

B. What Is MACT for Chamber Exhaust Vents?

    In the preamble to the proposed NESHAP (59 FR 10598), we explained 
the basis of the MACT floor for chamber exhaust vents. The available 
data indicated that there were no chamber exhaust vents routed to a 
control device; we concluded that the MACT floor for chamber exhaust 
vents at new and existing major and area sources required no reduction 
in emissions from these vents. However, to ensure that the current 
amount of ethylene oxide being evacuated via the sterilization pump 
continued to be routed to a control device rather than exhausted via an 
uncontrolled vent, the proposed NESHAP incorporated a concentration-
based limit on emissions from chamber exhaust.
    In public comments received on the proposed rule, an abatement 
device vendor provided sufficient data to establish a MACT floor 
consisting of control requirements for chamber exhaust vents at both 
existing and new major sources. The vendor data listed ethylene oxide 
sterilizer operations using catalytic oxidizers for control of chamber 
exhaust vents. No data indicating the use of technology other than 
catalytic oxidizers were supplied to us. As described in the preamble 
to the promulgated NESHAP (59 FR 62585), based on vendor data, we 
required control of chamber exhaust vent emissions at new and existing 
major sources. However, at the time, neither we nor the commercial 
sterilizer industry were aware of the potential safety issues 
associated with controlling chamber exhaust vents.
    Experience over the last 5 years clearly demonstrates the over-
simplification of controlling chamber exhaust by simply ducting the 
vent stream to a control device designed to control aeration room vent 
emissions. Based on what we have learned since the explosions, it is 
clear that no one was aware of the potential to overfeed the aeration 
control with ethylene oxide inadvertently routed from the chamber 
exhaust. Control systems designed for aeration room emissions had not 
been designed to handle potentially large quantities of ethylene oxide 
from chamber exhaust malfunctions. Obviously, appropriate safety design 
features are necessary to make this control approach acceptable as a 
viable means of emissions reductions. The same safety issue exists for 
control devices dedicated exclusively to chamber exhaust vent 
emissions.
    The CAA requires that emission standards for HAP established under 
section 112(d) be based on ``* * * the maximum degree of reduction in 
emissions of the hazardous air pollutants subject to this section * * * 
that the Administrator, taking into consideration the cost of achieving 
such emission reduction, and any non-air 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 standards applies * * *.'' These emission standards are 
commonly referred to as MACT.
    The requirement to consider ``any non-air quality health and 
environmental impacts and energy requirements'' would necessarily 
require control devices to be intrinsically safe. Had we known of the 
potential safety issue and known this control approach was blind to the 
safety issue, we would have refuted the commenters' assertion and made 
a finding of MACT floor as no control of chamber exhaust emissions. As 
stated above, it is beyond the Agency's legal mandate and technical 
expertise to certify equipment for safe use. Since no one has 
demonstrated to the Agency's satisfaction that the equipment is safe 
for this purpose, we are reconsidering

[[Page 13467]]

our original MACT determination for chamber exhaust vents.
    Today, we are proposing that MACT for chamber exhaust vents at 
major sources should be no control. To ensure that the current amount 
of ethylene oxide being evacuated via the sterilization pump continues 
to be routed to a control device rather than exhausted via an 
uncontrolled vent, we are proposing a concentration-based limit on 
emissions from major source chamber exhaust vents. This is the same 
requirement that was originally proposed for the major sources and 
currently applies to area sources.

II. Monitoring

A. Why Are We Reconsidering the Monitoring Requirements?

    Commercial sterilization facilities subject to the rule were 
originally required to demonstrate compliance by June 8, 1998. Before 
that date, the Agency received requests to clarify specific testing and 
monitoring requirements. Companies conducting tests questioned how to 
determine the level of the monitored temperature which would be used to 
determine compliance on a continuous basis.
    There are three emission vents associated with the sterilization 
process: the sterilization chamber vent, the aeration room vent, and 
the chamber exhaust vent. The sterilization process results in short-
term episodic releases of various concentrations of ethylene oxide. The 
majority of facilities use either scrubbers or catalytic oxidizers or a 
combination of both to reduce emissions.
    Catalytic oxidizers combust ethylene oxide, an exothermic reaction, 
which increases the catalyst bed temperature. The higher the 
concentration of ethylene oxide fed to the catalytic oxidizer, the 
higher the bed temperature. The bed temperature spikes during periods 
when higher concentrations of ethylene oxide are fed to the catalyst 
bed. Generally, a catalytic oxidizer bed is designed to be at or above 
a minimum temperature to be hot enough to combust ethylene oxide when 
it contacts the bed.
    Sterilization chambers are filled with the product to be sterilized 
and then infused with ethylene oxide gas. The ethylene oxide is pumped 
from the chamber after completion of the sterilization cycle. After the 
chamber is evacuated, the chamber is flooded with air to facilitate 
off-gassing of ethylene oxide residing in the product. Then, the 
chamber pump is turned on and the chamber is evacuated again. This air 
wash/evacuation cycle is repeated multiple times. The amount of 
ethylene oxide decreases with each subsequent evacuation. For main 
sterilization vents controlled with a catalytic oxidizer, chamber 
evacuations cause temporary spikes in catalyst bed temperature.
    The existing rule requires a 99 percent reduction in emissions for 
the main sterilizer vent, and either a 99 percent reduction in 
emissions or a 1 parts per million per volume (ppmv) maximum outlet 
concentration for aeration room vents. For the main sterilizer vent, 
the existing rule requires the operator to demonstrate compliance with 
the 99 percent reduction requirement only during the first evacuation.
    The existing rule also requires facilities to meet appropriate 
operating limits to ensure continuous compliance with the emission 
reduction requirements. We did not establish the relationship between 
any of the operating limits and the emissions reductions associated 
with the technologies used in the industry.
    Nearly all operators who had installed controls prior to 
promulgation of the final rule used either catalytic oxidizers or acid 
scrubbers to reduce emissions. Acid scrubbers are used primarily to 
control the main sterilizer vent. The existing rule requires monitoring 
of either the ethylene oxide glycol concentration of the scrubbing 
liquor or the level of liquor in the scrubber tank. Facilities could 
perform the initial compliance test when the ethylene glycol 
concentration or liquor level was at the highest level at which the 
emission reduction requirement could be met. Both the ethylene glycol 
concentration and liquor level increase with each sterilization batch 
that is run. Over a period of time, which could be weeks or months, the 
concentration of ethylene glycol gradually increases and will result in 
less emissions reductions; the liquor level is an indirect method of 
measuring ethylene glycol concentration. The rule states that to exceed 
these parameters would violate the emission reduction requirement. As 
stated previously, we have not established a precise relationship 
between ethylene glycol concentrations or levels and the 99 percent/1 
ppmv emission reduction requirements. On the other hand, we have not 
received data showing problems using the ethylene glycol concentration 
or scrubber level, determined during the initial performance test, on a 
continuous basis to indicate good operation (as opposed to compliance 
with the specific 99 percent/1 ppmv emission reduction requirements).
    Catalytic oxidizers are used primarily to control emissions from 
aeration room vents. To ensure continuous compliance with the emission 
reduction requirements for the main sterilizer, aeration, or chamber 
exhaust vent, the promulgated rule (59 FR 62585, December 6, 1994) 
requires the oxidizer to operate at a temperature, averaged over the 
sterilization cycle, above the baseline temperature established during 
the initial compliance test. This requirement is based on the premise 
that the temperature at which the equipment operated during the initial 
performance test directly correlates with the 99 percent emission 
reductions requirement under all operating conditions. The existing 
requirement also states that if the operating temperature falls below 
the baseline temperature, then the facility has violated the 99 percent 
emission reduction requirement. Again, we did not establish the 
relationship between temperature and emission reduction. Given the 
fluctuations in temperature of this batch process, it is unlikely that 
a single temperature could be selected to correlate with emissions 
reductions.
    The basic difference between using operating limits determined 
during the initial performance test for scrubbers and catalytic 
oxidizers is that catalytic oxidizer operating limits are sensitive to 
changing operating conditions during each batch operation. Scrubber 
operating limits change gradually over many batch operations.
    In the response to comments published with the promulgated rule, we 
added a specific additional test during the final evacuation in an 
attempt to establish an operating limit valid for the full range of 
operating conditions. We stated that, ``Demonstration of the baseline 
temperature during the last evacuation addresses concerns that a 
baseline temperature established during the first evacuation would not 
be sustainable for subsequent evacuations where the ethylene oxide 
concentration is lower.''
    However, in practice we have found that this additional test did 
not solve the problem because operating temperatures during the last 
evacuation, although lower than temperatures during the first 
evacuation, are typically higher than temperatures during periods when 
ethylene oxide is not being fed to the control devices. Therefore, 
facilities cannot meet either temperature requirement on a continuous 
basis.
    The catalytic oxidizer operates at a design temperature of 
approximately 280 deg.F when little or no ethylene oxide is being fed 
to the oxidizer. During the short periods when ethylene oxide is 
introduced to the oxidizer (approximately 10 minutes), the

[[Page 13468]]

temperature spikes to about 400 deg.F. Therefore, the average 
temperature over the sterilization cycle is between the design 
temperature (280 deg.F) and the highest temperature (400 deg.F). In 
fact, the only temperature that can actually be met consistently is the 
temperature when little or no ethylene oxide is being fed to the 
oxidizer (i.e., approximately 280 deg.F).
    The requirement to operate at the average temperature is 
inconsistent with normal operation of the equipment. Properly operated 
equipment will maintain the design temperature, approximately 
280 deg.F, to ensure proper combustion when ethylene oxide is 
introduced to the catalyst. Short term temperature spikes do not 
directly correlate to the 99 percent emission reduction requirement for 
the control system.

B. How Are We Proposing To Amend the Monitoring Requirements?

    To correct the problems discussed in the previous section, we are 
proposing a new rule structure. There will be no change to the emission 
limits. We are proposing a different workable approach for ensuring 
continuous compliance. We will maintain the 99 percent emission 
reduction requirement and measure compliance only through performance 
testing during the first evacuation. An initial performance test is 
still required; facilities that have performed this test need not 
repeat the test. (Note that enforcement agencies can always request 
another test at a later date if they choose.)
    We have decided the only practical way to ensure continuous 
compliance of catalytic control devices is to establish two 
requirements. One concerns catalyst replacement to ensure that the 
catalyst remains active. The other concerns maintaining a minimum 
temperature to ensure that ethylene oxide is combusted when it passes 
through the catalytic oxidizer.
    First, to ensure that the catalyst remains active we are proposing 
a work practice standard. The work practice standard would require that 
facilities periodically replace the catalyst. Failure to perform the 
work practice would be a violation of the work practice standard.
    Efficient emission destruction depends on the catalyst being 
active. Vendors advertise a 3 to 5 year catalyst life after which 
performance may decline. Therefore, to ensure proper combustion, we are 
proposing that facilities replace the catalyst every 2 years.
    We are proposing an operating limit that requires facilities to 
maintain a minimum design temperature sufficiently high to ensure 
combustion when ethylene oxide contacts the catalyst. We are proposing 
that the combustion device be operated at or above the vendor-
recommended minimum design temperature. Operating at or above the 
vendor minimum design temperature would ensure that combustion takes 
place but does not require direct correlation to the 99 percent 
requirement.
    Because we are proposing a minimum temperature based on the vendor 
minimum design temperature, we can eliminate the existing requirement 
to test the last evacuation. We originally required a test on the last 
evacuation of the main sterilizer vent because we believed this would 
be a lower ``average'' temperature than that during the first 
evacuation. Since we are proposing a new approach, there is no longer a 
need for this test.
    We are proposing the reporting of ``deviations.'' A deviation 
occurs when control equipment fails to achieve the 99 percent emission 
reduction during a performance test, when one doesn't perform a 
required work practice, or when the operating limits for maintaining a 
minimum temperature are not met.
    Although we are not changing the monitoring requirements for 
scrubbers, we are proposing the removal of rule language which states 
that the failure to maintain an operating limit ``shall constitute a 
violation of the * * * standard.'' However, failure to meet either the 
minimum liquor level or ethylene glycol concentration requirement will 
constitute a deviation from the operating limit. We are replacing the 
current reporting requirements with the requirement to report all 
deviations.
    The current rule has two alternative standards for aeration room 
vents; facilities can demonstrate initial compliance with either the 99 
percent emission reduction or the 1 ppmv concentration limit. 
Facilities demonstrating compliance with the 99 percent emission 
reduction are required to use temperature as an operating limit. 
Facilities demonstrating compliance with the 1 ppmv concentration limit 
are required to use ethylene oxide concentration as an operating limit.
    The 1 ppmv concentration limit was based on phone conversations 
with facilities operating catalytic oxidizers. These facilities stated 
that their test results showed no measurable ethylene oxide after 
controls; 1 ppmv was the lower detectable limit at the time. We allowed 
an alternative 99 percent emission reduction limit to provide a 
demonstrable emission limit for facilities which have high inlet 
concentrations; in this situation, it would not be possible to 
demonstrate compliance with the 1 ppmv limit even though the control 
unit was operating efficiently. We had very limited data to support 
these limits and no knowledge that the limits are achievable under all 
operating conditions.
    Although ethylene oxide concentration measurements would indicate 
whether outlet concentrations are above or below 1 ppmv, it would not 
indicate proper operation under all operating conditions. For this 
reason, we are proposing, for facilities which demonstrate initial 
compliance with the 1 ppmv concentration limit, an operating limit that 
requires facilities to maintain the vendor minimum design temperature.

III. Testing

A. Why Are We Proposing To Change the Testing Requirements?

    Prior to promulgation of the rule in 1994, many facilities used 
chlorofluorocarbons with ethylene oxide. The current rule requires the 
use of the EPA Method 18 because chlorofluorocarbons will distort test 
results. If a source is using an organic compound along with ethylene 
oxide in the sterilizer, the current Method 25A or Performance 
Specification (PS) 8 test method requirement would count the organic 
constituent as ethylene oxide. Since the industry has shifted almost 
exclusively to using only ethylene oxide, we are proposing a test 
method change to a less expensive test method.

B. How are we proposing to amend the testing requirements?

    We are proposing the use of Method 25A and PS 8 as an option to 
avoid the higher cost of the current test method requirement. The 
affected sources would have the option of using a flame ionization 
analyzer (Method 25A or PS 8) or a gas chromatograph (Method 18 or PS 
9) to measure ethylene oxide concentration.

IV. Summary of Environmental, Energy and Economic Impacts

    There are negligible environmental, energy, and economic impacts 
associated with these amendments.

V. Administrative Requirements

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), we must 
determine whether a proposed regulatory action is ``significant'' and,

[[Page 13469]]

therefore, subject to review by the Office of Management and Budget 
(OMB) and the requirements of the Executive Order. The Executive 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 obligations of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    Pursuant to the terms of Executive Order 12866, it has been 
determined that this rule is not a ``significant regulatory action'' 
because none of the listed criteria apply to this action. Consequently, 
this action was not submitted to OMB for review under Executive Order 
12866.

B. Paperwork Reduction Act

    The information collection requirements of the EO NESHAP were 
submitted to and approved by Management and OMB. A copy of this 
Information Collection Request (ICR) document (OMB control number 2060-
0283) may be obtained from Ms. Sandy Farmer by mail at the U.S. 
Environmental Protection Agency, Office of Environmental Information, 
Collection Strategies Division (2822), 1200 Pennsylvania Avenue, 
Washington, DC 20460, by email at [email protected], or by calling 
(202) 260-2740. A copy may also be downloaded off the internet at 
http://www.epa.gov/icr.
    Today's action has little or no impact on the information 
collection burden estimates made previously. Today's action eliminates 
requirements for chamber exhaust vents and clarifies testing and 
monitoring requirements for sterilization and aeration room vents. 
These changes revise existing requirements and do not impose new 
additional burdens; consequently, the ICR has not been revised.

C. Executive Order 13132, Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 
10, 1999), requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
Policies that have federalism implications is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
the States, on the relationship between the national Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.''
    These proposed amendments do not have federalism implications and 
will not have substantial direct effects on the States, on the 
relationship between the national Government and the States, or on the 
distribution of power and responsibilities among the various levels of 
Government, as specified in Executive Order 13132. Today's action 
eliminates requirements for chamber exhaust vents and streamlines 
requirements for monitoring and testing which were promulgated in 
December 1994. There are minimal, if any, impacts associated with this 
action. Thus, Executive Order 13132 does not apply to these proposed 
amendments.

D. Executive Order 13175, Consultation and Coordination With Indian 
Tribal Governments

    On January 1, 2001, Executive Order 13084 was superseded by 
Executive Order 13175. However, this proposed rule was developed during 
the period when Executive Order 13084 was still in force, and so tribal 
considerations were addressed under Executive Order 13084. Development 
of the final rule will address tribal considerations under Executive 
Order 13175.
    Under Executive Order 13084, EPA may not issue a regulation that is 
not required by statute, that significantly or uniquely affects the 
communities of Indian tribal governments, and that imposes substantial 
direct compliance costs on those communities unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by the tribal governments, or we consult with those 
governments. If EPA complies by consulting, EPA is required by 
Executive Order 13084 to provide to the OMB in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPAs prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's proposed amendments do not significantly or uniquely affect 
the communities of Indian tribal governments because the affected 
facilities are not located on tribal lands. Accordingly, the 
requirements of Executive Order 13084 do not apply to these proposed 
amendments.

E. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and tribal 
governments and the private sector. Under section 202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with ``Federal mandates'' that 
may result in expenditures to State, local, and tribal governments, in 
aggregate, or by the private sector, of $100 million or more in any 1 
year. Before promulgating an EPA rule for which a written statement is 
needed, section 205 of the UMRA generally requires EPA to identify and 
consider a reasonable number of regulatory alternatives and adopt the 
least-costly, most cost-effective, or least-burdensome alternative that 
achieves the objective of the rule. The provisions of section 205 do 
not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least-
costly, most cost-effective, or least-burdensome alternative if the 
Administrator publishes with the final rule an explanation why that 
alternative was not adopted. Before the EPA establishes any regulatory 
requirements that may significantly or uniquely affect small 
governments, including tribal governments, it must have developed under 
section 203 of the UMRA a small government agency plan. The plan must 
provide for notifying potentially affected small governments, enabling 
officials of affected small governments to have meaningful and timely 
input in the development of EPA regulatory proposals with significant 
Federal intergovernmental mandates, and informing, educating, and 
advising small governments on compliance with the regulatory 
requirements.
    Today's proposed amendments contain no Federal mandates for State, 
local, and tribal governments or the private sector. Instead, these 
proposed amendments either eliminate or

[[Page 13470]]

streamline requirements of the existing rule. Thus, today's proposed 
amendments are not subject to the requirements of sections 202 and 205 
of the UMRA. In addition, we have determined that these proposed 
amendments contain no regulatory requirements that might significantly 
or uniquely affect small governments because they contain no 
requirements that apply to such governments or impose obligations upon 
them.

F. Regulatory Flexibility Act (RFA), as Amended by the Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et 
seq.

    The RFA generally requires an agency to prepare a regulatory 
flexibility analysis of any rule subject to notice and comment 
rulemaking requirements under the Administrative Procedure Act or any 
other statute unless the Agency certifies that the rule will not have a 
significant economic impact on a substantial number of small entities. 
Small entities include small businesses, small organizations, and small 
governmental jurisdictions.
    For the purposes of assessing the impacts of today's proposed 
amendments on small entities, a small entity is defined as: (1) A small 
business whose parent company has fewer than 1000 employees; (2) a 
small governmental jurisdiction that is a government of a city, county, 
town, school district or special district with a population of less 
than 50,000; or (3) a small organization that is any not-for-profit 
enterprise which is independently owned and operated and is not 
dominant in its field.
    We believe there will be little or no impact on any small entities 
because these proposed amendments do not impose additional requirements 
but instead either eliminate or streamline some existing requirements 
of the EO NESHAP. The Administrator certifies that this action will not 
have a significant economic impact on a substantial number of small 
entities.

G. National Technology Transfer and Advancement Act of 1995

    Section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) of 1995, (Public Law No. 104-113) (15 U.S.C. 272 note), 
directs EPA to use voluntary consensus standards in their regulatory 
and procurement activities unless to do so would be inconsistent with 
applicable law or otherwise impractical. Voluntary consensus standards 
are technical standards (e.g., materials specifications, test methods, 
sampling procedures, business practices) developed or adopted by one or 
more voluntary consensus bodies. The NTTAA directs EPA to provide 
Congress, through annual reports to OMB, with explanations when an 
agency does not use available and applicable voluntary consensus 
standards.
    These proposed amendments do not establish or modify technical 
standards in the existing rule. The EPA believes that the use of 
voluntary consensus standards for these proposed amendments is not 
necessary. These proposed amendments do not require sources to take 
substantive steps that lend themselves to voluntary consensus 
standards.

H. Executive Order 13045, Protection of Children from Environmental 
Health Risks and Safety Risks

    Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any 
rule that (1) is determined to be ``economically significant'' as 
defined under Executive Order 12866, and (2) concerns an environmental 
health or safety risk that EPA has reason to believe may have a 
disproportionate effect on children. If the regulatory action meets 
both criteria, the Agency must evaluate the environmental health or 
safety effects of the planned rule on children and explain why the 
planned regulation is preferable to other potentially effective and 
reasonable alternatives considered by the Agency.
    These proposed amendments are not subject to Executive Order 13045 
because they are not an economically significant regulatory action as 
defined by Executive Order 12866. In addition, the EPA interprets 
Executive Order 13045 as applying only to those regulatory actions that 
are based on health or safety risks. These proposed amendments are not 
subject to Executive Order 13045 because they are based on technology 
performance and not on health or safety risks.

List of Subjects in 40 CFR Part 63

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

    Dated: February 28, 2001.
Christine Todd Whitman,
Administrator.
    For reasons set out in the preamble, part 63 of title 40, chapter I 
of the Code of Federal Regulations is proposed to be amended as 
follows:

PART 63--[AMENDED]

    1. The authority citation for part 63 continues to read as follows:

    Authority: 42 U.S.C. 7401, et seq.

Subpart O--[Amended]

    2. Table 1 of Sec. 63.360 is amended by revising the entry for 
``63.7(a)(2)'' to read as follows:


Sec. 63.360  Applicability.

    (a) * * *

                     Table 1 of Section 63.360-General Provisions Applicability to Subpart O
----------------------------------------------------------------------------------------------------------------
                                          Applies to sources       Applies to sources
              Reference                    using 10 tons in      using 1 to 10 tons in           Comment
                                            subpart O \a\            subpart O \a\
----------------------------------------------------------------------------------------------------------------
 
*                  *                  *                  *                  *                  *
                                                        *
63.7(a)(2)...........................                        (Yes)                       .......................
 
*                  *                  *                  *                  *                  *
                                                        *
----------------------------------------------------------------------------------------------------------------
\a\-See definition.

* * * * *
    3. Section 63.361 is amended by removing the definition for 
``Parametric monitoring'' and revising the definition for ``Baseline 
temperature'' to read as follows:


Sec. 63.361  Definitions.

* * * * *
    Baseline temperature means an average minimum temperature at the 
catalyst bed of a catalytic oxidation control device or at the exhaust 
point from the combustion chamber for a thermal oxidation control 
device.
* * * * *
    4. Section 63.362 is amended by:
    a. Revising Table 1 of paragraph (a);

[[Page 13471]]

    b. Removing and reserving paragraph (e)(1);
    c. Revising paragraph (e)(2).
    The revisions read as follows:


Sec. 63.362  Standards.

    (a) * * *

          Table 1 of Section 63.362--Standards for Ethylene Oxide Commercial Sterilizers and Fumigators
----------------------------------------------------------------------------------------------------------------
                                                         Sterilization                          Chamber exhaust
    Existing and new sources          Source type        chamber vent     Aeration room vent         vent
----------------------------------------------------------------------------------------------------------------
Source size.....................  907 kg (1 ton)....    No control required; minimal recordkeeping requirements
                                                                         (see Sec.  63.367(c))
                                  907 kg   99% emission        No control........  Maximum chamber
                                   and 9,070 kg (1 ton and    Sec.  63.362(c)).                       limit of 5,300
                                   10 tons).                                                   ppm prior to
                                                                                               activation of the
                                                                                               chamber
                                                                                               exhaust\1\ (see
                                                                                               Sec.  63.362(e)).
                                  9,070    99% emission        1 ppm maximum       Maximum chamber
                                   kg (10   reduction (see      outlet              concentration
                                   tons).              Sec.  63.362(c)).   concentration or    limit of 5,300
                                                                           99% emission        ppm prior to
                                                                           reduction (see      activation of the
                                                                           Sec.  63.362(d)).   chamber
                                                                                               exhaust\1\ (see
                                                                                               Sec.  63.362(e)).
 
----------------------------------------------------------------------------------------------------------------
\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%.
*                  *                  *                  *                  *

    (e)(1) [Reserved]
    (2) Chamber exhaust vent at sources using 1 to 10 tons or sources 
using 10 tons. Each owner or operator of a sterilization source using 1 
to 10 tons or a sterilization source using 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) or (d) of this section or to reduce ethylene oxide 
emissions to the atmosphere (without manifolding) to a maximum 
concentration of 1 ppmv or by at least 99 percent, whichever is less 
stringent.
    5. Section 63.363 is revised (including the section heading) to 
read as follows:


Sec. 63.363  Compliance and performance provisions.

    (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 procedures in paragraphs (b)(1) through (3) Of this section 
shall be used to determine initial compliance with the emission limits 
under Sec. 63.362(c), the sterilization chamber vent standard;
    (1) 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). The owner or operator shall also 
determine:
    (2) For facilities with acid-water scrubbers, the owner or operator 
shall establish as an operating parameter either:
    (i) The maximum ethylene glycol concentration using the procedures 
described in Sec. 63.365(e)(1); or
    (ii) The maximum liquor tank level using the procedures described 
in Sec. 63.365(e)(2).
    (3) For facilities with catalytic oxidizers or thermal oxidizers, 
the owner or operator shall establish a baseline temperature for an 
operating parameter using the procedures described in Sec. 63.365(f) 
and shall, after the initial compliance test, comply with the following 
work practice by, every 2 years, replacing the catalyst bed with new 
catalyst material and conducting a performance test using the 
procedures described in Sec. 63.365(b) or (d) as appropriate.
    (c) The procedures in paragraphs (c)(1) through (c)(3) of this 
section shall be used to determine initial compliance with the emission 
limits under Sec. 63.362(d), the aeration room vent standard:
    (1) The owner or operator shall comply with either paragraph (b)(2) 
or (3) of this section.
    (2) Determine 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
    (3) Determine 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).
    (d) The procedures in paragraphs Sec. 63.363(d)(1) through (3) 
shall be used to determine initial compliance with the emission limits 
under Sec. 63.362(e)(2), the chamber exhaust vent standard for sources 
using 1 to 10 tons or 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, the owner or operator shall comply with the applicable 
compliance provisions for the appropriate control technology (see 
paragraphs (b)(2) and (3) of this section).
    (2) For facilities controlling only emissions from the chamber 
exhaust vent with a control device, the owner or operator shall 
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:
    (i) For facilities with acid-water scrubbers, the owner or operator 
shall comply with paragraph (b)(2) of this section.
    (ii) For facilities with catalytic oxidizers or thermal oxidizers, 
the owner or operator shall comply with paragraph (b)(3) of this 
section.
    (3) For facilities exhausting emissions to the atmosphere, the 
owner or operator shall 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).
    (e) For facilities complying with the emissions limits under 
section Sec. 63.362 with a control technology other than

[[Page 13472]]

acid-water scrubbers or catalytic or thermal oxidizers, the owner or 
operator of the facility shall provide to the Administrator or 
delegated authority information describing the design and operation of 
the air pollution control system including recommendations for the 
operating parameters to be monitored to indicate proper operation and 
maintenance of the air pollution control system. Based on this 
information, the Administrator will determine the 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.
    (f) A facility must demonstrate continuous compliance with each 
operating limit and work practice standard required under Sec. 63.363, 
except during periods of startup and shutdowns, according to the 
methods specified in Sec. 63.364.
    6. Section 63.364 is amended by:
    a. Revising paragraph (b) introductory text;
    b. Adding a sentence to the end of paragraph (b)(2);
    c. Revising paragraph (c) introductory text;
    d. Removing and reserving paragraphs (c)(1), (2) and (3);
    e. Adding a sentence to the end of paragraph (c)(4);
    f. Revising paragraph (d);
    g. Revising paragraph (e); and
    h. Revising paragraph (f).
    The additions and revisions read as follows:


Sec. 63.364  Monitoring requirements.

* * * * *
    (b) For sterilization facilities complying with Sec. 63.363 (b) or 
(d) through the use of an acid-water scrubber, the owner or operator 
shall either:
* * * * *
    (2) * * * Monitoring is required during a week only if the scrubber 
unit has been operated.
    (c) For sterilization facilities complying with Sec. 63.363(b), 
(c), or (d) 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. Monitoring is 
required only when the oxidation unit is operated. From 15-minute or 
shorter period temperature values, a data acquisition system for the 
temperature monitor shall compute and record a daily average oxidation 
temperature.
    (1) [Reserved]
    (2) [Reserved]
    (3) [Reserved]
    (4) * * * As an alternative, the accuracy temperature monitor may 
be verified in a calibrated oven (traceable to NIST standards).
    (d) For sterilization facilities complying with Sec. 63.363(b), 
(c), or (d) 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)(2), or through the use of direct measurement of ethylene oxide 
concentration, the owner or operator shall follow paragraph (e)(1) of 
this section. For sterilization facilities complying with 
Sec. 63.363(d)(3) through the use of direct measurement of ethylene 
oxide concentration, the owner or operator shall follow paragraph 
(e)(2) of this section.
    (1) Measure and record once per hour the ethylene oxide 
concentration at the outlet to the atmosphere 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 
monitor consistent with the requirements of performance specifications 
(PS) 8 or 9 in 40 CFR part 60, appendix B, to measure ethylene oxide. 
The daily calibration requirements of section 7.2 of PS 9 or section 
2.3 of PS 8 are required only on days when ethylene oxide emissions are 
vented to the control device.
    (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 
monitor consistent with the requirements of PS 8 or 9 to measure 
ethylene oxide concentration. The daily calibration requirements of 
section 7.2 of PS 9 or section 2.3 of PS 8 are required only on days 
when the chamber exhaust is activated. Sources complying with PS 8 are 
exempt from the relative accuracy procedures in sections 2.4 and 3 of 
PS 8.
    (f) For sterilization facilities complying with Sec. 63.363(d)(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 determine which emissions 
from the chamber exhaust vent are manifolded using the applicable 
monitoring requirements in paragraphs (a) through (e) of this section 
and record the monitoring data.
    7. Section 63.365 is amended by:
    a. Revising paragraph (b)(1) introductory text;
    b. Revising paragraph (b)(1)(iv)(B);
    c. Removing and reserving paragraph (b)(1)((iv)(C);
    d. Removing and reserving paragraph (b)(2);
    e. Revising paragraph (c);
    f. Revising paragraph (d);
    g. Revising paragraph (f);
    h. Revising paragraph (h).
    The revisions read as follows:


Sec. 63.365  Test methods and procedures.

* * * * *
    (b) * * *
    (1) First evacuation of the sterilization chamber. These procedures 
shall be performed on an empty sterilization chamber, charged with a 
typical amount of ethylene oxide, for the duration of the first 
evacuation under normal operating conditions (i.e., sterilization 
pressure and temperature).
* * * * *
    (iv) * * *
    (A) * * *
    (B) Test Method 18 or 25A, 40 CFR part 60, appendix A (hereafter 
referred to as Method 18 or 25A respectively), shall be used to measure 
the concentration of ethylene oxide.
    (1) Prepare a graph of volumetric flow rate versus time 
corresponding to the period of the run cycle. Integrate the area under 
the curve to determine the volume.
    (2) Calculate the mass of ethylene oxide by using the following 
equation:
[GRAPHIC] [TIFF OMITTED] TP06MR01.032

Where:

Wo = Mass of ethylene oxide, g (lb)
C = concentration of ethylene oxide in ppmv
V = volume of gas exiting the control device 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)

    (3) Calculate the efficiency by the equation in paragraph (B)(1)(v) 
of this section.
    (C) [Reserved]
* * * * *

[[Page 13473]]

    (2) [Reserved]
* * * * *
    (c) Concentration determination. The following procedures shall be 
used to determine the ethylene oxide concentration as the monitored 
parameter 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 vents as established in Sec. 63.364(e)(2).
    (1) Parameter Monitoring. For determining the ethylene oxide 
concentration established in Sec. 63.363(b)(2)(i), (c)(2), and (d)(2), 
follow the procedures in PS 8 or PS 9 in 40 CFR part 60, appendix B. 
Sources complying with PS 8 are exempt from the relative accuracy 
procedures in sections 2.4 and 3 of PS 8.
    (2) Sterilization chamber prior to activation of the chamber 
exhaust. For determining the ethylene oxide concentration established 
in Sec. 63.363(d)(2) for the sterilization chamber before activation of 
the chamber exhaust, follow the procedures in PS 8 or PS 9 in 40 CFR 
part 60, appendix B. Sources complying with PS 8 are exempt from the 
relative accuracy procedures in sections 2.4 and 3 of PS 8.
    (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.
    (1) Determine the concentration of ethylene oxide at the inlet and 
outlet of the control device using the procedures in Test Method 18 or 
25A in 40 CFR part 60, appendix A. A test is comprised of three 1-hour 
runs.
    (2) Determine control device efficiency (% Eff) using the following 
equation:
[GRAPHIC] [TIFF OMITTED] TP06MR01.033


Where:

% Eff = percent efficiency
Wi = mass flow rate into the control device
Wo = mass flow rate out of the control device

    (3) Repeat the procedures in paragraphs (d)(1) and (2) of this 
section three times. The arithmetic average percent efficiency of the 
three runs shall determine the overall efficiency of the control 
device.
* * * * *
    (f) Determination of baseline temperature for oxidation units. The 
procedure in paragraph (f)(1) of this section shall be used to 
establish the baseline temperature required in Sec. 63.363(b), (c), or 
(d) for catalytic oxidation units or thermal oxidation units.
    (1) The owner or operator shall maintain the recommended minimum 
oxidation temperature provided by the oxidation unit manufacturer.
    (2)-(3) [Reserved]
* * * * *
    (h) An owner or operator of a sterilization facility seeking to 
demonstrate compliance with the standards found at Sec. 63.362(d) or 
(e) with a monitoring device or procedure other than a gas 
chromatograph or a flame ionization analyzer 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.
    8. Section 63.366 is amended by revising paragraph (a)(3) as 
follows:
* * * * *


Sec. 63.366  Reporting requirements.

    (a) * * *
    (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 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 
exceedances, excursions, or violations of process or control system 
parameters, or operating limits, 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 exceedances, excursions, or violations have occurred or 
monitoring equipment has not been inoperative, repaired, or adjusted, 
such information shall be stated in the report.
* * * * *
    9. Section 63.367 is revised to read as follows:


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 Sec. 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. All records required to be maintained by this subpart or a 
subpart referenced by this subpart shall be maintained in such a manner 
that they can be readily accessed and are suitable for inspection. The 
most recent 2 years of records shall be retained onsite or shall be 
accessible to an inspector while onsite. The records of the preceding 3 
years, where required, may be retained offsite. Records may be 
maintained in hard copy or computer-readable form including, but not 
limited to, on paper, microfilm, computer, computer disk, magnetic 
tape, or microfiche.
    (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).
    (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 standard in Sec. 63.362).
[FR Doc. 01-5414 Filed 3-5-01; 8:45 am]
BILLING CODE 6560-50-P