[Federal Register Volume 66, Number 213 (Friday, November 2, 2001)]
[Rules and Regulations]
[Pages 55577-55585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27594]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[AD-FRL-7096-1]
RIN 2060-AC28


Ethylene Oxide Emissions Standards for Sterilization Facilities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; amendments.

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SUMMARY: This action finalizes amendments to the emissions standards 
for sterilization facilities by eliminating maximum achievable control 
technology (MACT) requirements for chamber exhaust vents. This action 
reduces safety problems associated with the existing requirements. This 
action also amends testing and monitoring requirements for 
sterilization chamber, aeration, and chamber exhaust vents to correct 
technical problems associated with the existing requirements.

EFFECTIVE DATE: November 2, 2001.

ADDRESSES: Docket No. A-88-03 contains supporting information used in 
developing the standards for the ethylene oxide commercial 
sterilization source category. 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.

FOR FURTHER INFORMATION CONTACT: Mr. David W. 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, facsimile (919) 541-0942, electronic mail 
address: [email protected].

SUPPLEMENTARY INFORMATION: Docket. The docket is an organized and 
complete file of all the information considered by EPA 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) 260-7548. 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 today's final rule amendments will also be 
available on the WWW through the EPA's Technology Transfer Network 
(TTN). Following signature, a copy of the rule amendments will be 
posted on the TTN's 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 the TTN 
HELP line at (919) 541-5384.
    Regulated Entities. Categories and entities regulated by this 
action include:

------------------------------------------------------------------------
                                                          Examples of
            Category                 SIC a/NAICS b    regulated entities
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Industry........................  3841, 3842........  Medical suppliers.
                                  2834, 5122, 2831,   Pharmaceuticals.
                                   2833
                                  2099, 5149, 2034,   Spice
                                   2035, 2046          manufacturers.
                                  7399, 7218, 8091    Contract
                                                       sterilizers.
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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 likely to be regulated by this 
action. To determine whether your facility is regulated by this action, 
you should examine the applicability criteria in Sec. 63.2131 of the 
final rule.
    Judicial Review. Under section 307(b) of the CAA, judicial review 
of this final rule is available only by filing a petition for review in 
the U.S. Court of Appeals for the District of Columbia Circuit by 
January 2, 2002. Under section 307(d)(7)(B) of the CAA, only an 
objection to these rule amendments which was raised with reasonable 
specificity during the period for public comment can be raised during 
judicial review. Moreover, under section

[[Page 55578]]

307(b)(2) of the CAA, the requirements established by today's final 
action may not be challenged separately in any civil or criminal 
proceeding we bring to enforce these requirements.

I. Background

    On July 11, 1997, we learned of reports of explosions at several 
ethylene oxide sterilization facilities. Some of the explosions 
occurred at facilities affected by the ethylene oxide emissions 
standards. As a result, we took immediate steps to suspend the rule 
until December 1998 pending an investigation of the explosions and to 
notify facility owners.
    We completed our investigation in 1998 to determine if the emission 
control equipment mandated by the emissions standards was in any way 
associated with the problems at these facilities. 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). In June 1998, the Ethylene Oxide Sterilization 
Association (EOSA) recommended ``additional time to consider safe and 
economical control, installation, operation, and maintenance 
alternatives applicable to aeration and chamber exhaust (backvent) 
emissions.'' The EOSA provided a time line of approximately 12 months 
beyond December 1998 to enable implementation of the appropriate 
changes to ensure safe operation. We agreed with EOSA's recommendation 
and further extended the compliance date for chamber exhaust and 
aeration room vents for all sources affected by the ethylene oxide 
emissions standards by 1 year, until December 8, 1999. The two affected 
emission points, the chamber exhaust and aeration room vent, represent 
approximately 1 and 3 percent of the uncontrolled emissions, 
respectively.
    In June 1999, the EOSA requested elimination of the requirement for 
chamber exhaust vent controls. In December 1999, we again suspended the 
compliance dates for chamber exhaust and aeration room vents. A 1-year 
suspension of control requirements for aeration room vents was based on 
the fact that many facilities are routing chamber exhaust emissions to 
the emission control device for aeration room vents. Since control of 
the aeration room vent by itself does not pose any known safety 
problems, we did not anticipate any further suspensions of requirements 
for aeration room vents beyond December 6, 2000. We provided a 2-year 
suspension of control requirements for chamber exhaust vent emissions 
based on the anticipated time required to propose and promulgate 
changes in the Federal Register. We committed to reconsidering the 
original MACT determination for chamber exhaust vents and proposing a 
course of action in the near future.
    The use of existing technology by some sources in the relevant 
industry category presumes the ability to operate that technology in a 
proven safe manner. Nonetheless, at the time of promulgation (December 
1994), state-of-the-art control technology for chamber exhaust vent 
emissions apparently involved safety hazards not known at that time. To 
date, solutions to the safety problems have not been developed, and 
there is no indication that resolution of the safety issues is 
forthcoming. Consequently, on March 6, 2001, we proposed eliminating 
the MACT requirements for chamber exhaust vents (66 FR 13464). We also 
proposed amendments to testing and monitoring requirements for 
sterilization chamber, aeration, and chamber exhaust vents.

II. What Are the Final Rule Amendments?

A. Chamber Exhaust Vents

    We have removed the requirement to control the ethylene oxide 
emissions from the chamber exhaust vents. See the March 6, 2001 
proposal preamble for the detailed reasons for this change. For all 
facilities (i.e., both major and area sources), we have removed the 
5,300 parts per million per volume (ppmv) concentration limit 
requirement for chamber exhaust vents.

B. Catalytic Oxidizer Monitoring

    We have removed the requirement to operate at the average 
temperature to demonstrate continuous compliance. We are now requiring 
facilities to maintain a minimum temperature for catalytic oxidizers 
based on manufacturer design and perform a work practice. Facilities 
can do either of the following work practices: periodically replace 
catalyst, or annually test control device performance and if necessary 
restore the catalyst.
    We have made changes to the monitoring requirements to provide 
facilities an alternative to continuous catalyst temperature 
monitoring. Facilities can monitor either temperature or ethylene oxide 
concentration for catalytic oxidizers. In the final rule, we have added 
several additional test method to measure ethylene oxide concentration.

III. What Major Changes Have We Made to the Rule Since Proposal?

    In response to comments received on the proposed amendments, we 
made several changes for the final rule. While some of the changes we 
made were clarifications designed to make our intentions more clear, 
some of the changes do alter the requirements as proposed. The 
substantive comments and/or changes and responses made since the 
proposal are summarized in the following sections. Our complete 
responses to public comments are contained in a memorandum that can be 
obtained from docket A-88-03.

A. Elimination of 5,300 ppmv Concentration Requirement

    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 proposed a 
concentration-based limit on emissions from major source chamber 
exhaust vents. In the original, existing rule, this requirement 
currently applies to area sources but not to major sources.
    Comments: Commentors questioned ``the Agency's reliance on the 
5,300 ppmv empty chamber concentration as a suitable limitation when 
such test conditions have zero connection to the reality of operations 
in a commercial sterilization facility.'' The commentor also stated 
that their research showed ``no reliable justification for the 5,300 
ppmv MACT and we are convinced from our own experience that this level, 
however determined, was unfounded at the time the regulation was 
originally drafted.''
    One commentor stated that industry does not have knowledge of any 
proven instrumentation it could employ to comply with the proposed 
requirement to determine the concentration of ethylene oxide in the 
sterilization chamber immediately prior to the operation of the chamber 
exhaust. The commentor stated it is universally known and understood 
that a safe, reliable and accurate technology capable of providing a 
determination of the exhaust vent concentration is not available. The 
commentor also stated that a separate system (suitable for small 
exhaust, high concentration, for a short time period of 5 minutes or 
less ) would be needed, probably for each chamber. If gas 
chromatography (GC)-based systems are used, costs are $60,000-$100,000 
per chamber, provided some existing system could somehow be made safe, 
reliable, and accurate. Also,

[[Page 55579]]

units for area and process control are not satisfactory because they 
are set up differently and measure different concentration levels.
    Response: As stated previously, the Agency is removing the control 
requirement for the major source chamber exhaust vent as proposed. The 
Agency had also proposed a 5,300 ppmv concentration limit on the 
chamber exhaust vent for larger facilities (i.e., major sources). The 
5,300 ppmv concentration limit was required in the original rule for 
smaller facilities (i.e., area sources with 1 to 10 tons of ethylene 
oxide use) which were not required to control chamber exhaust vent 
emissions.
    We agree with the commentor that the 5,300 ppmv concentration limit 
was based on ``Agency modeling, not actual operating conditions.'' We 
also agree with the commentor that there is no proven instrumentation 
which could be employed to comply with the proposed requirement to 
determine the concentration of ethylene oxide in the sterilization 
chamber immediately prior to the operation of the chamber exhaust. For 
these reasons, we have reconsidered the proposed and existing 
concentration limit requirement.
    The sterilization chamber vent emissions are currently controlled 
with add-on control devices; these devices are required to reduce inlet 
emissions by 99 percent. For small facilities, under the existing rule 
the MACT floor for new and existing source chamber exhaust vents 
requires no reduction in emissions from these vents. The purpose of the 
existing rule's 5,300 ppmv limitation on the small chamber exhaust 
vents is 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. The 
5,300 ppmv requirement maintained the status quo for emissions from the 
chamber exhaust vent, and did not require the use of any control 
technologies. In promulgating the existing rule, the Administrator 
determined that the use of this limit did not constitute measures 
beyond the MACT floor for these sources (59 FR 10591). The chamber 
exhaust concentration limit was added to the rule as a precautionary 
measure; the Agency did not know of any plant operators by-passing main 
sterilization vent control devices.
    Comment: One commentor recommended a 7,500 ppmv limit (25 percent 
of the lower explosive limit); the limit would be determined based on 
empty chamber cycle calculations for all cycles. This approach does not 
require test equipment. The commentor stated that it is common industry 
practice to analyze the safety of a sterilization cycle by calculating 
the residual sterilant in an empty sterilizer at the completion of the 
process. Most sterilization facilities require that the safety analysis 
be performed on every new sterilization cycle. The intent of the safety 
analysis is to demonstrate that the concentration of ethylene oxide gas 
in the sterilizer at the end of processing is below 1 percent (10,000 
ppmv). This ensures that during routine processing the sterilizer 
environment is non-flammable when the door is opened and the exhaust 
vent is activated. The determination of this empty chamber 
concentration relies on simple dilution formulas and the ideal gas 
laws. Using partial pressure data of ethylene oxide in the sterilizer 
following the initial charge, one can determine concentration through 
the subsequent evacuation and purging sequences. The commentor stated 
that sterilization cycles in question are generally validated to meet 
the requirements of the Food and Drug Administration (FDA).
    Another commentor believes the present regulations provide adequate 
assurance to ensure that ethylene oxide from the sterilization chamber 
vent continues to be routed through a control device. The EPA 
specifically defines sterilization chamber vent as ``* * * 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.'' The rule also 
specifically requires that sources using greater than 1 ton per year of 
ethylene oxide ``* * * shall reduce ethylene oxide emissions to the 
atmosphere by at least 99 percent from each sterilization chamber 
vent.''
    Rerouting sterilization chamber vents to exhaust out the 
uncontrolled chamber exhaust vent would be in direct violation of the 
present regulation.
    Response: After considering the comments and additional 
information, we decided that the concentration limit approach is not 
feasible because there is no known way to safely measure concentration. 
A gas chromatograph is a logical testing approach but it includes a 
flame source which introduces a safety issue.
    Today, we have less concern regarding by-passing the main 
sterilization control equipment by routing ethylene oxide to the 
chamber exhaust vent. As stated previously, there were no data 
suggesting plant operators were by-passing the main control device. 
Since initial work on the rule in the 1980's, significant regulatory 
changes have occurred which have affected the sterilization industry. 
In response to the phase-out of chlorofluorocarbon production, industry 
switched from a mixture of chlorofluorocarbons and ethylene oxide to 
pure ethylene oxide for processing. The Occupational Safety and Health 
Administration (OSHA) tightened workplace ethylene oxide concentration 
exposure limits, and on October 7, 1996, the FDA revised the Current 
Good Manufacturing Practice (CGMP) requirements for medical devices and 
incorporated them into a quality system regulation.
    Now that the use of pure ethylene oxide dominates industry 
practice, there are serious safety issues associated with by-passing 
the main control device. Venting pure ethylene oxide to the atmosphere 
could cause an explosion. Additionally, it is probable that venting 
would result in workplace exposure concentrations which would violate 
the OSHA limits. Industry is very aware of these safety concerns.
    The FDA quality system regulation includes requirements related to 
the methods used in, and the facilities and controls used for, 
designing, manufacturing, packaging, labeling, storing, installing, and 
servicing of medical devices intended for human use. The action was 
necessary to add preproduction design controls and to achieve 
consistency with quality system requirements worldwide. The regulation 
sets forth the framework for device manufacturers to follow and gives 
them greater flexibility in achieving quality requirements (61 FR 
52601).
    These requirements apply to contract sterilization and specify 
quality system requirements including management controls, design 
controls, material controls, equipment controls, production and process 
controls, corrective and preventive action, and documentation. For 
sterilization operations, the objectives of the quality system 
regulation apply only to the safety and effectiveness of medical 
devices following sterilization. However, compliance with its 
requirements may also provide an assurance that processing will be 
performed in a way which meets concerns regarding vent emissions. For 
example, in meeting the requirement in the quality system regulation 
for a definition of specifications for all steps of the process, a 
sterilizing facility must specify the number of air washes in the 
ethylene oxide sterilization process. By meeting the requirements for 
documentation to demonstrate that each process step has been performed 
as specified, the facility will establish

[[Page 55580]]

procedures to document performance of the air washes. The requirements 
of the quality system are already in place; compliance with the quality 
system regulation will ensure that specifications for process steps are 
defined and met.
    The Agency believes there are sufficient practical reasons (i.e., 
safety considerations as well as existing OSHA and FDA regulatory 
requirements) for eliminating our original presumptive need for the 
chamber exhaust emission limit. The Agency sees no practical benefit to 
adding additional requirements to accomplish the same thing. Therefore, 
because the concentration cannot be measured and there is now little or 
no value to the requirement, we are not promulgating the chamber 
exhaust concentration limit for large facilities and are withdrawing 
the requirement for small facilities.

B. Alternative to Catalyst Replacement Requirement

    We proposed a requirement to replace catalytic oxidizer catalyst 
every 2 years to ensure that the catalyst remains active and in 
continuous compliance with the control device performance requirement. 
The proposed replacement of catalyst every 2 years was opposed by 
commentors because the practice was believed to be wasteful and costly. 
Some commentors stated that the compliance test should suffice to 
indicate compliance.
    We agreed with the commentors that performance testing is a viable 
alternative to routine replacement of catalyst in ensuring continuous 
compliance. Therefore, we have added a test alternative to the rule. If 
test results show the control efficiency is below the performance 
standard, the facility will have to restore the catalyst as soon as 
practicable but no later than 180 days after the performance test.

IV. Summary of Environmental, Energy and Economic Impacts

    There are negligible environmental, energy, and economic impacts 
associated with these amendments. Ethylene oxide emissions from the 
chamber exhaust vent comprise less than 1 percent of the uncontrolled 
emissions from the sterilization process.

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 the regulatory action is ``significant'' and 
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 
this Executive Order.
    Pursuant to the terms of Executive Order 12866, it has been 
determined that these rule amendments are not a ``significant 
regulatory action'' under the terms of Executive Order 12866. 
Consequently, this action was not submitted to OMB for review under 
Executive Order 12866.

B. Paperwork Reduction Act

    The information collection requirements of the ethylene oxide 
national emission standards for hazardous air pollutants (NESHAP) were 
submitted to and approved by OMB. A copy of the Information Collection 
Request (ICR) document (OMB control number 2060-0283) may be obtained 
from Ms. Sandy Farmer by mail at the U.S. EPA, Office of Environmental 
Information, Collection Strategies Division (2822), 1200 Pennsylvania 
Avenue, Washington, DC 20460, by e-mail 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 final rule amendments 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. The final rule is mandated by statute and 
does not impose requirements on States; however, States will be 
required to implement the rule by incorporating the rule into permits 
and enforcing the rule upon delegation. States will collect permit fees 
that will be used to offset the resource burden of implementing the 
rule. Thus, the requirements of section 6 of the Executive Order do not 
apply to this rule. Although section 6 of Executive Order 13132 does 
not apply to this rule, the EPA did consult with State and local 
officials in developing these rule amendments.

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

    Executive Order 13175, entitled ``Consultation and Coordination 
with Indian Tribal Governments'' (65 FR 67249, November 6, 2000), 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal government and Indian tribes.''
    These final rule amendments do not have tribal implications. They 
will not have substantial direct effects on tribal governments, on the 
relationship between the Federal government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
This is because no tribal governments own or operate an ethylene oxide 
sterilization facility. Thus, Executive

[[Page 55581]]

Order 13175 does not apply to these rule 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, the 
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 by 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 objectives of the rule. The provisions of 
section 205 do not apply when they are inconsistent with applicable 
law. Moreover, section 205 allows the 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 as to 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 final rule amendments contain no Federal mandate that may 
result in expenditures of $100 million or more for State, local, and 
tribal governments, in the aggregate, or the private sector in any 1 
year. These amendments eliminate existing requirements. Thus, today's 
final rule amendments are not subject to the requirements of sections 
202 and 205 of the UMRA. In addition, the EPA has determined that these 
amendments contain no regulatory requirements that might significantly 
or uniquely affect small governments because it contains no regulatory 
requirements that apply to such governments or impose obligations upon 
them. Therefore, today's final rule amendments are not subject to the 
requirements of section 203 of the UMRA.
    Because these final rule amendments do not include a Federal 
mandate and are estimated to result in expenditures less than $100 
million in any 1 year by State, local, and tribal governments, the EPA 
has not prepared a budgetary impact statement or specifically addressed 
the selection of the least costly, most cost-effective, or least 
burdensome alternative. In addition, because small governments will not 
be significantly or uniquely affected by these rule amendments, the EPA 
is not required to develop a plan with regard to small governments. 
Therefore, the requirements of the UMRA do not apply to this action.

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 purposes of assessing the impacts of today's final rule 
amendments on small entities, small entity is defined as: (1) A small 
business according to the Small Business Administration (SBA) size 
standards by NAICS code ranging from 500 to 1,000 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; and (3) a small organization that is any not-for-profit 
enterprise which is independently owned and operated and is not 
dominant in its field.
    After considering the economic impacts of today's final rule 
amendments on small entities, EPA has concluded that this action will 
not have a significant impact on a substantial number of small 
entities. We believe there will be little or no impact on any small 
entities because these amendments do not impose additional requirements 
but instead either eliminate or streamline some existing requirements 
of the ethylene oxide NESHAP. Based on the foregoing, the EPA concludes 
that these rule amendments will not have a significant impact on a 
substantial number of small businesses.
    Although these final rule amendments will not have a significant 
impact on a substantial number of small entities, EPA nonetheless has 
tried to reduce the impact on small entities by providing alternatives 
to compliance and monitoring requirements.

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 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 final rule amendments provide technical corrections and minor 
technical amendments to the Ethylene Oxide Emissions Standards for 
Sterilization Facilities (40 CFR part 63, subpart O). These amendments 
include two technical standards: EPA Method 25A and PS-8. Consistent 
with the NTTAA, the EPA conducted searches to identify voluntary 
consensus standards in addition to these EPA methods and performance 
specifications. No voluntary consensus standards were identified for 
PS-8. The search and review results have been documented and are placed 
in the Docket No. A-88-03 (see ADDRESSES section) for these rule 
amendments.
    The search for emissions monitoring procedures identified two 
voluntary consensus standards, both for EPA Method 25A. The EPA 
determined that these two standards identified for measuring emissions 
of hazardous air pollutants or surrogates subject to emission standards 
in the final rule would not be practical due to lack of equivalency, 
detail, and/or quality assurance and/or quality control requirements. 
Therefore, we did not use this voluntary consensus standard in this 
rulemaking.
    The two voluntary consensus standards, EN 12619:1999 ``Stationary 
Source Emissions--Determination of the Mass Concentration of Total 
Gaseous

[[Page 55582]]

Organic Carbon at Low Concentrations in Flue Gases--Continuous Flame 
Ionization Detector Method'' and ISO 14965:2000(E) ``Air Quality--
Determination of Total Nonmethane Organic Compounds--Cryogenic 
Preconcentration and Direct Flame Ionization Method,'' are impractical 
alternatives to EPA Method 25A for the purposes of this rulemaking 
because the standards do not apply to solvent process vapors in 
concentrations greater than 40 ppm (EN 12619) and 10 ppm carbon (ISO 
14965). Methods whose upper limits are this low are too limited to be 
useful in measuring source emissions, which are expected to be much 
higher.
    Section 63.365 of the NESHAP lists the EPA test methods and 
performance standards included in this rulemaking. Under 40 CFR 63.7(f) 
of the General Provisions, a source may apply to EPA for permission to 
use alternative test methods in place of any of the EPA testing 
methods.

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 rule is preferable to other potentially effective and 
reasonable alternatives considered by the Agency.
    The EPA interprets Executive Order 13045 as applying only to those 
regulatory actions that are based on health or safety risks, such that 
the analysis required under section 5-501 of the Executive Order has 
the potential to influence the regulation. These final rule amendments 
are not subject to Executive Order 13045 because they are based on 
technology performance and not on health or safety risks. No children's 
risk analysis was performed because no alternative technologies exist 
that would provide greater stringency at a reasonable cost. 
Furthermore, these rule amendments have been determined not to be 
``economically significant'' as defined under Executive Order 12866.

I. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801, et seq., as added by 
the Small Business Regulatory Enforcement Fairness Act of 1996, 
generally provides that before a rule may take effect, the agency 
promulgating the rule must submit a rule report, which includes a copy 
of the rule, to each House of the Congress and to the Comptroller 
General of the United States. The EPA will submit a report containing 
these rule amendments and other required information to the U.S. 
Senate, the U.S. House of Representatives, and the Comptroller General 
of the United States prior to publication of the rule in the Federal 
Register. A major rule cannot take effect until 60 days after it is 
published in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2). These amendments will be effective 
November 2, 2001.

J. Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution or Use

    This rule is not subject to Executive Order 13211 (66 FR 28355 May 
22, 2001) because it is not a significant regulatory action under 
Executive Order 12866.

List of Subjects in 40 CFR Part 63

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

    Dated: October 24, 2001.
Christine Todd Whitman,
Administrator.

    For reasons set out in the preamble, title 40, chapter I, part 63 
of the Code of Federal Regulations is 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. Section 63.360 is amended:
    a. In Table 1 by revising the entry for ``63.7(a)(2)'';
    b. Removing and reserving paragraphs (g)(7) through (10).
    The revision reads as follows:


Sec. 63.360  Applicability.

    (a) * * *

[[Page 55583]]



                    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
----------------------------------------------------------------------------------------------------------------
 
*                  *                  *                  *    Yes           *                  *
                                                        *
 
63.7(a)(2)............................
 
*                  *                  *                  *                  *                  *
                                                        *
----------------------------------------------------------------------------------------------------------------
a See definition.

* * * * *

    3. Section 63.361 is amended by removing the definition for 
``Parametric monitoring,'' revising the definition for ``Baseline 
temperature,'' and adding a definition for ``Thermal oxidizer'' and 
``Deviation'' in alphabetical order to read as follows:


Sec. 63.361  Definitions.

* * * * *
    Baseline temperature means a minimum temperature at the outlet from 
the catalyst bed of a catalytic oxidation control device or at the 
exhaust point from the combustion chamber of a thermal oxidation 
control device.
* * * * *
    Deviation means any instance in which an affected source, subject 
to this subpart, or an owner or operator of such a source:
    (1) Fails to meet any requirement or obligation established by this 
subpart including, but not limited to, any emission limitation 
(including any operating limit) or work practice standard;
    (2) Fails to meet any term or condition that is adopted to 
implement an applicable requirement in this subpart and that is 
included in the operating permit for any affected source required to 
obtain such a permit; or
    (3) Fails to meet any emission limitation (including any operating 
limit) or work practice standard in this subpart during startup, 
shutdown, or malfunction, regardless of whether or not such failure is 
permitted by this subpart.
* * * * *
    Thermal oxidizer means all combustion devices except flares.

    4. Section 63.362 is amended by:
    a. Revising Table 1 of paragraph (a);
    b. Removing and reserving paragraph (e).
    The revision reads as follows:


Sec. 63.362  Standards.

    (a) * * *

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

* * * * *
    (e) [Reserved]

    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 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 and to 
establish operating limits for the control devices:
    (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).
    (2) For facilities with acid-water scrubbers, the owner or operator 
shall establish as an operating limit 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 operating limit consists of the recommended minimum oxidation 
temperature provided by the oxidation unit manufacturer for an 
operating limit.
    (4) Facilities with catalytic oxidizers shall comply with one of 
the following work practices:
    (i) Once per year after the initial compliance test, conduct a 
performance test during routine operations, i.e., with product in the 
chamber using the procedures described in Sec. 63.365(b) or (d) as 
appropriate. If the percent efficiency is less than 99 percent, restore 
the catalyst as soon as practicable but no later than 180 days after 
conducting the performance test; or
    (ii) Once per year after the initial compliance test, analyze 
ethylene oxide

[[Page 55584]]

concentration data from Sec. 63.364(e) or a continuous emission 
monitoring system (CEMS) and restore the catalyst as soon as 
practicable but no later than 180 days after data analysis; or,
    (iii) Every 5 years, beginning 5 years after the initial compliance 
test (or by December 6, 2002, whichever is later), replace the catalyst 
bed with new catalyst material.
    (c) The procedures in paragraphs (c)(1) through (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)(2).
    (d) [Reserved]
    (e) 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, 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 demonstrate continuous compliance. Based on this 
information, the Administrator will determine the operating 
parameter(s) to be measured 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 limit(s)for the operating 
parameters approved by the Administrator.
    (f) A facility must demonstrate continuous compliance with each 
operating limit and work practice standard required under this section, 
except during periods of startup, shutdown, and malfunction, 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. Removing and reserving 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) or 
(c) through the use of catalytic oxidation or thermal oxidation, the 
owner or operator shall either comply with Sec. 63.364(e) or 
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. Strip chart data shall be 
converted to record a daily average oxidation temperature each day any 
instantaneous temperature recording falls below the minimum 
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) or 
(c) 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) 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 24-hour average daily. The owner 
or operator will install, calibrate, operate, and maintain a monitor 
consistent with the requirements of performance specification (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.
    (f) [Reserved]

    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. Removing and reserving 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) * * *
    (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] TR02NO01.002

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 (ft3)
1/106 = correction factor LEO/106 
LTOTAL GAS (ft3EO/106 
ft3TOTAL GAS)

    (3) Calculate the efficiency by the equation in paragraph (b)(1)(v) 
of this section.
    (C) [Reserved]
* * * * *
    (2) [Reserved]
* * * * *
    (c) Concentration determination. The following procedures shall be 
used to determine the ethylene oxide concentration.

[[Page 55585]]

    (1) Parameter monitoring. For determining the ethylene oxide 
concentration required in Sec. 63.364(e), 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) Initial compliance. For determining the ethylene oxide 
concentration required in Sec. 63.363(c)(2), the procedures outlined in 
Method 18 or Method 25 A (40 CFR part 60, appendix A) shall be used. A 
Method 18 or Method 25A test consists of three 1-hour runs. If using 
Method 25A to determine concentration, calibrate and report Method 25A 
instrument results using ethylene oxide as the calibration gas. 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.
    (d) Efficiency determination at the aeration room 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), the 
aeration room vent standard.
    (1) Determine the concentration of ethylene oxide at the inlet and 
outlet of the control device using the procedures in 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] TR02NO01.001

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) [Reserved]
* * * * *
    (h) An owner or operator of a sterilization facility seeking to 
demonstrate compliance with the requirements of Sec. 63.363 or 
Sec. 63.364, 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 demonstrate 
continuous compliance with each operating limit. 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) to read 
as follows:


Sec. 63.366  Reporting requirements.

    (a) * * *
    (3) Content and submittal dates for deviations and monitoring 
system performance reports. All deviations and monitoring system 
performance reports and all summary reports, if required per 
Sec. 63.10(e)(3)(vii) and (viii), 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 deviations from an operating limit shall include all 
information required in Sec. 63.10(c)(5) through (13), 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 deviations 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 Sec. 63.362 shall 
comply with the recordkeeping requirements in Sec. 63.10(b) and (c), 
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 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 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 Sec. 63.362).
    (d) The owners or operators complying with Sec. 63.363(b) (4) shall 
maintain records of the compliance test, data analysis, and if catalyst 
is replaced, proof of replacement.

[FR Doc. 01-27594 Filed 11-1-01; 8:45 am]
BILLING CODE 6560-50-P