[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:
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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