[Federal Register Volume 64, Number 232 (Friday, December 3, 1999)]
[Rules and Regulations]
[Pages 67789-67793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31354]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[AD-FRL-6500-2]
RIN 2060-A137
National Emission Standards for Hazardous Air Pollutants for
Ethylene Oxide Commercial Sterilization and Fumigation Operations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Interim final rule.
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SUMMARY: Today's action suspends the National Emission Standards for
Hazardous Air Pollutants for Ethylene Oxide Commercial Sterilization
and Fumigation Operations (EO NESHAP) requirements for chamber exhaust
and aeration room vents. The suspension allows affected sources subject
to the EO NESHAP to defer compliance with the NESHAP requirements for
chamber exhaust until December 6, 2001 and aeration room vents until
December 6, 2000. This suspension does not affect the requirement for
sources subject to the EO NESHAP to comply with provisions for
sterilizer vents. This action does not change the level of the
standards or the intent of the NESHAP promulgated in 1994.
DATES: This action is effective December 3, 1999. Comments may be
submitted until January 3, 2000.
ADDRESSES: Docket No. A-88-03, category VIII Amendments, contains
supporting information used in developing the standards. The docket is
located at the U.S. Environmental Protection Agency, 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. This docket also contains information
considered by the EPA in proposing and promulgating the original EO
NESHAP.
FOR FURTHER INFORMATION CONTACT: For information concerning the
analysis performed in developing this interim rule, contact David W.
Markwordt at the Emission Standards Division (MD-13), U.S.
Environmental Protection Agency, Research Triangle Park, North Carolina
27711; telephone number (919) 541-0837, facsimile (919) 541-0942, e-
mail address markwordt.david@epa.gov.
SUPPLEMENTARY INFORMATION:
Docket
The docket is an organized file of information considered by the
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 (Act).) 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.
Judicial Review
Under section 307(b)(1) of the Clean Air Act (Act), judicial review
of this final action is available only by filing a petition for review
in the U.S. Court of Appeals for the District of Columbia Circuit
within 60 days of today's publication of this interim final rule. Under
section 307(b)(2) of the Act, the actions taken in today's notice may
not be challenged later in civil or criminal proceedings brought by the
EPA to enforce these requirements.
Technology Transfer Network
In addition to being available in the docket, an electronic copy of
today's interim final rule is also available through the Technology
Transfer Network (TTN). Following signature, a copy of the rule 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
Regulated categories and entities include:
Table 1.--Regulated Categories and Entities
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Entity category Description/SIC code
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Industrial................................ Medical suppliers/3841,
3842, Pharmaceuticals/2834,
5122, 2831, 2833.
Spice manufactures/2099,
5149, 2034, 2035, 2046.
Contract Sterilizers/7399,
7218, 8091.
Federal Government........................ Not Affected.
State/Local/Tribal Gov.................... Not Affected.
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This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities regulated by the NESHAP addressed
in this interim final rule. If you have questions regarding the
applicability of the NESHAP addressed in this interim final rule to a
particular entity, consult the person listed in the preceding FOR
FURTHER INFORMATION section.
I. What Is the Background for This Suspension?
On December 6, 1994, we promulgated the EO NESHAP which regulates
emissions of ethylene oxide from new and existing commercial
sterilization and fumigation operations using 1 ton or more of EO per
year (59 FR 62585). The regulated category and entities affected by
today's action are the sources described in 40 CFR 63.360. That
provision includes commercial operations using ethylene oxide as a
[[Page 67790]]
sterilant and fumigant in the production of medical equipment and
supplies, and in miscellaneous sterilization and fumigation operations
at both major and area sources. Note that this description is not
intended to be exhaustive but, rather, to provide a guide for readers
interested in this suspension. To determine whether your facility is
affected by today's action, you should carefully examine the
applicability criteria in 40 CFR 63.360 and the explanation provided in
this interim final rule. If you have questions about the applicability
of today's action to a particular entity, consult the appropriate
person listed in the preceding FOR FURTHER INFORMATION CONTACT section.
In July 1997, we learned of reports of explosions at ethylene oxide
sterilization and fumigation facilities. We subsequently suspended the
EO NESHAP for 1 year until December 6, 1998 to provide time to
determine the appropriate action necessary to mitigate the cause of the
explosions (62 FR 64736).
After becoming aware of the explosions, the industry worked through
the Ethylene Oxide Sterilization Association (EOSA) to begin
investigations. The EOSA established a Safety Committee in September
1997 which has been meeting on a bimonthly basis since then.
Sterilization industry leaders, abatement device vendors, and Federal,
State and local agencies have been participating in the Safety
Committee meetings.
In a June 2, 1998 letter to EPA, the EOSA recommended, ``additional
time to consider safe and economical control, installation, operation
and maintenance alternatives applicable to aeration and chamber exhaust
(backvent) emissions * * *'' (see Docket No. A-88-03). The Health
Industries Manufacturers Association (HIMA) reviewed the
recommendation. The EOSA and HIMA membership represent most of the
ethylene oxide sterilization and fumigation industry. The EOSA
``concluded that the oxidizer systems had not been properly integrated
with traditional ethylene oxide sterilization process operations, that
is, installation, operation and maintenance issues had not been
sufficiently addressed by sterilizer operators.'' The EOSA also
concluded that ``improperly overfeeding the oxidizer system from the
chamber backvent was the primary safety concern.''
We also conducted an independent investigation of the accidents and
reviewed reports prepared by EPA Regional Offices and by EOSA member
sterilization companies and, based on that investigation and review,
concurred with the industry conclusion and recommendation (see Docket
No. A-88-03). We further suspended the EO NESHAP for both aeration room
vents and chamber backvents for 1 year until December 6, 1999 to
provide time to determine the appropriate action necessary to mitigate
the cause of the explosions (63 FR 66990). Aeration room vents were
included in the suspension because control systems typically integrate
both vents to the same control device.
II. What Is the Rationale for Today's Suspension of Chamber Exhaust
and Aeration Room Vent Requirements?
As noted above, in July 1997, the Agency learned of reports of
explosions at ethylene oxide facilities. Several of these explosions
occurred at facilities subject to the EO NESHAP. The Agency immediately
began conducting a preliminary investigation to determine if the
emission control equipment mandated by 40 CFR part 63, subpart O, was
in any way associated with the cause of the problems at these
facilities. The Agency, on December 9, 1997, wishing to adopt a
cautious approach in order to assure public and worker safety,
published in the Federal Register an interim final rule suspending 40
CFR part 63, subpart O (62 FR 64736). Since publication of the December
9, 1997 rule, both EPA and industry have continued to investigate the
cause of the accidents.
In 1998, the Agency 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). The Agency
concluded that main vent emissions routed through the vacuum pump
played no role in the explosions. The Agency also concluded that any
emissions control technology necessary to comply with the EO NESHAP
needs to be properly integrated into the sterilization system and
operations and must reflect the full range of normal and abnormal
conditions that may occur.
The suspension, in December 1998, for chamber exhaust vents was
based on the assumption that sterilization chamber operators would be
able to evaluate and integrate the emission control technology with
sterilizer operation to ensure prevention of future explosions by
December 6, 1999. To date, solutions to the safety problems have not
been developed. Consequently, the EOSA and individual plant operators
have requested EPA to eliminate the requirement for backdraft vents
(see Docket No. A-88-03).
It is beyond the Agency's legal mandate and technical expertise to
certify equipment for safe use. The Clean Air Act generally requires
the Agency to assess existing emission control technology for
application to non-controlled emission sources. The use of existing
technology by some sources in the relevant category presumes the
ability to operate that technology in a proven safe manner. At the time
of promulgation (December 1994), state-of-the-art control technology
for chamber exhaust emissions apparently involved safety hazards not
known at that time. Therefore, the Agency will reconsider its original
MACT determination for chamber exhaust vents and propose a course of
action in the near future.
Today's 2-year suspension of control requirements for chamber
exhaust emissions is based on the anticipated time required to propose
and promulgate changes in the Federal Register. It's our intent to
resolve this matter as quickly as possible, and we hope to finalize a
revised rule in less than 2 years.
Today's 1-year suspension of control requirements for aeration room
vents is based on the fact that many facilities are routing chamber
exhaust emissions to the emission control device for aeration room
vents. Facilities that control both aeration and chamber exhaust
emissions via one abatement device will need to disconnect the chamber
exhaust vent from the aeration room control device. Therefore, the
Agency is providing time to separate chamber exhaust emissions from
integrated control systems, if needed.
In this matter, we wish to err, if at all, on the side of safety.
Accordingly, we are, today, further suspending the EO NESHAP emission
limitation requirements in 40 CFR part 63, subpart O, for chamber
exhaust and aeration room vents, as those emission points are defined
at 40 CFR 63.361, until December 6, 2001 and December 6, 2000,
respectively, pursuant to our general rulemaking authority under
section 301(a) of the Act, 42 U.S.C. 7601(a). Sources must continue to
comply with the EO NESHAP emission limitation requirements in 40 CFR
part 63, subpart O, for sterilization chamber vents, as those emission
points are defined at 40 CFR 63.361, because we have determined that
their controls do not pose a safety concern.
Section 301(a) of the Act grants the Administrator of the EPA the
authority ``to prescribe such regulations as are necessary to carry out
his functions
[[Page 67791]]
under this Act.'' Given the unique circumstances and uncertainty
surrounding the EO NESHAP, as described in this interim final rule, EPA
believes that it is necessary to further suspend this rule's
requirements for chamber exhaust and aeration room vents for the safety
of the public and workers in and around EO facilities. The control
requirements of the EO NESHAP for chamber exhaust and aeration room
vents continue to pose potential safety problems for which viable
solutions are not currently available. This action is consistent with
the objectives of the Act as stated in section 101(b), 42 U.S.C.
7401(b), ``(T)he purposes of this subchapter are * * * to promote the
public health and welfare and the productive capacity of its population
* * *.''
The original EO NESHAP and today's interim final rule are
promulgated pursuant to section 307(d) of the Act, 42 U.S.C. 7607(d),
which requires that any rule subject to that section be issued only
after the public has received notice of, and an opportunity to comment
on, the rule. However, section 307(d)(1) exempts from those
requirements any rule for which the Agency finds under the
Administrative Procedure Act, 5 U.S.C. 553(b), that providing prior
notice-and-comment would be impracticable, unnecessary or contrary to
the public interest.
We believe the circumstances presented here provide good cause to
take this action without prior notice-and-comment. We find providing
prior notice-and-comment would be impracticable and contrary to the
public interest based on the potential ongoing danger to public and
worker safety posed by the recent incidents at ethylene oxide
facilities. There is simply not enough time to provide notice-and-
comment procedures before the current compliance date of December 6,
1999 arrives, and until the compliance date is extended, sources are
faced with having to install control equipment in time to meet the
current compliance date. Only by omitting notice-and-comment from this
action can we provide sources affected by the EO NESHAP with timely
legal relief from the current compliance date while we further
investigate the situation. Consequently, this action is being
promulgated without prior notice-and-comment as provided for in section
307(b)(1) of the Act and is immediately effective as provided for in
section 112(d)(10) of the Act.
Nonetheless, we are providing 30 days for submission of public
comments. We will consider all written comments submitted in the
allotted time period to determine if any change to this action is
necessary.
In suspending the EO NESHAP requirements for chamber exhaust and
aeration room vents, the Administrator wishes to remind the public and
the regulated community that the role of the EPA has been and continues
to be protection of public health and the environment in a way that is
consistent with safety concerns.
III. Administrative Requirements
A. Paperwork Reduction Act
The information collection requirements of the EO NESHAP were
submitted to and approved by the Office of Management and Budget (OMB).
A copy of this Information Collection Request (ICR) document (OMB
control number 2060-0283) may be obtained from Ms. Sandy Farmer,
Information Policy Branch (2136), U.S. EPA, 401 M Street, SW,
Washington, DC 20460, or by calling (202) 260-2740.
Today's action has no impact on the information collection burden
estimates made previously. Today's action merely suspends the EO NESHAP
requirements for chamber exhaust and aeration room vents for 1 year.
This change does not impose new requirements. Consequently, the ICR has
not been revised.
B. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA
must determine whether the regulatory action is ``significant'' and
therefore subject to review by OMB on the basis of the requirements of
the Executive Order in addition to its normal review requirements. The
Executive Order defines ``significant regulatory action'' as one that
is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or Tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs, or the rights and obligations of
recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Today's action does not fall within any of the four categories
described above. Instead, it reduces the burden on certain sources by
temporarily suspending the EO NESHAP requirements for chamber exhaust
and aeration vents. Consequently, under Executive Order 12866, this
action is not a ``significant regulatory action'' and is therefore not
subject to review by OMB.
C. Executive Order 13132
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.'' Under
Executive Order 13132, EPA may not issue a regulation that has
federalism implications, that imposes substantial direct compliance
costs, and that is not required by statute, unless the federal
government provides the funds necessary to pay the direct compliance
costs incurred by State and local governments, or EPA consults with
State and local officials early in the process of developing the
proposed regulation. The EPA also may not issue a regulation that has
federalism implications and that preempts State law unless the Agency
consults with State and local officials early in the process of
developing the proposed regulation.
If EPA complies by consulting, Executive Order 13132 requires EPA
to provide to OMB, in a separately identified section of the preamble
to the rule, a federalism summary impact statement (FSIS). The FSIS
must include a description of the extent of EPA's prior consultation
with State and local officials, a summary of the nature of their
concerns and the Agency's position supporting the need to issue the
regulation, and a statement of the extent to which the concerns of
State and local officials have been met. Also, when EPA transmits a
draft final rule with federalism implications to OMB for review
pursuant to Executive Order 12866, EPA must include a certification
from the agency's Federalism Official stating that EPA has met the
requirements of Executive Order 13132 in a meaningful and timely
manner.
This final rule will not have substantial direct effects on the
States,
[[Page 67792]]
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132. Today's
action suspends existing requirements which were promulgated in
December 1994. There are minimal, if any, impacts associated with this
action, thus, the requirements of section 6 of the Executive Order do
not apply to this rule.
D. Regulatory Flexibility/Small Business Regulatory Enforcement
Fairness Act of 1996
Under the Regulatory Flexibility Act, Pub. L. 96-354, whenever an
Agency publishes any proposed or final rule in the Federal Register, it
must, except under certain circumstances, prepare a Regulatory
Flexibility Analysis (RFA) that describes the impact of the rule on
small entities (i.e., small businesses, organizations, and governmental
jurisdictions). That analysis is not necessary if the Agency determines
that the rule will not have a significant economic impact on a
substantial number of small entities.
The EPA believes that there will be little or no adverse impact on
any small entities as a result of the promulgation of this rule
because, rather than imposing additional requirements, this rule
provides additional time to comply with parts of the EO NESHAP. Because
the impacts are anticipated to be insignificant or beneficial, EPA has
concluded that this rule will not have a significant economic impact on
a substantial number of small entities. Consequently, an RFA is not
required.
E. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to 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 objects of the rule. The provisions of section 205 do
not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation of why that
alternative was not adopted. Before 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 rule contains no Federal mandates (under the regulatory
provisions of Title II of the UMRA) for State, local, or tribal
governments or the private sector. Instead, this rule provides
additional time to comply with some requirements of the EO NESHAP.
Because the rule is not expected to result in the expenditure by State,
local, and tribal governments or the private sector of $100 million or
more in any 1 year, the Agency has not prepared a budgetary impact
statement or specifically addressed the selection of the least costly,
most effective, or least burdensome alternative. Because small
governments will not be significantly or uniquely affected by this
rule, the Agency is not required to develop a plan with regard to small
governments. For the reasons stated above, the requirements of the UMRA
do not apply to this section.
F. National Technology Transfer and Advancement Act
Section 12 of the National Technology Transfer and Advancement Act
of 1995 (NTTAA) requires Federal agencies to evaluate existing
technical standards when developing new regulations. To comply with the
NTTAA, EPA must consider and use ``voluntary consensus standards''
(VCS) if available and applicable when developing programs and policies
unless doing so would be inconsistent with applicable law or otherwise
impractical.
The EPA believes that the use of VCS in this interim final rule is
impractical. The suspension of the EO NESHAP requirements for chamber
exhaust and aeration room vents is merely a procedural action that does
not require sources to take substantive steps that lend themselves to
VCS.
G. Executive Order 13045
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997), applies to any rule that (1) OMB determines is ``economically
significant'' as defined under Executive Order 12866, and (2) EPA
determines the environmental health or safety risk addressed by the
rule has a disproportionate effect on children. If the regulatory
action meets both criteria, the Agency must evaluate the environmental
health or safety aspects of the planned rule on children, and explain
why the planned regulation is preferable to other potentially effective
and reasonably feasible alternatives considered by the Agency.
This interim final rule is not subject to the Executive Order
because it is not economically significant as defined in E.O. 12866,
and because the Agency does not have reason to believe the
environmental health or safety risks addressed by this action present a
disproportionate risk to children.
H. Executive Order 13084
Under Executive Order 13084, EPA may not issue a regulation that is
not required by statute, that significantly or uniquely affects the
communities of Indian tribal governments, and that imposes substantial
direct compliance costs on those communities, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by the tribal governments, or EPA consults with those
governments. If EPA complies by consulting, Executive Order 13084
requires EPA to provide to the Office of Management and Budget, in a
separately identified section of the preamble to the rule, a
description of the extent of EPA's prior consultation with
representatives of affected tribal governments, a summary of the nature
of their concerns, and a statement supporting the need to issue the
regulation. In addition, Executive Order 13084 requires EPA to develop
an effective process permitting elected officials and other
representatives of Indian tribal governments ``to provide meaningful
and timely input in the development of regulatory policies on matters
that significantly or uniquely affect their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This interim final rule
imposes no enforceable duties on these entities. Rather, the interim
[[Page 67793]]
final rule temporarily suspends certain regulatory requirements.
Accordingly, the requirements of section 3(b) of Executive Order 13084
do not apply to this rule.
I. Congressional Review Act
Under the Small Business Regulatory Enforcement Fairness Act of
1996, we submitted a report containing these final amendments and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the General Accounting
Office prior to publication of these final amendments in the Federal
Register. This is not a ``major rule'' as defined by the Small Business
Regulatory Enforcement Fairness Act.
List of Subjects in 40 CFR Part 63
Environmental protection, Air pollution control, Ethylene oxide
sterilization, Hazardous substances, Reporting and recordkeeping
requirements.
Dated: November 29, 1999.
Carol M. Browner,
Administrator.
For the reasons set out in the preamble, title 40, chapter I, 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 by revising paragraphs (g)(4), (g)(5),
and (g)(6) and adding paragraphs (g)(7), (g)(8), (g)(9), and (g)(10) to
read as follows:
Sec. 63.360 Applicability.
* * * * *
(g) * * *
(4) All aeration room vents subject to the emissions standards in
Sec. 63.362 with an initial startup date before December 6, 2000, no
later than December 6, 2000.
(5) All aeration room vents subject to the emissions standards in
Sec. 63.362 with an initial startup date on or after December 6, 2000,
immediately upon initial startup of the source.
(6) All aeration room vents at sources using less than 10 tons that
increase their ethylene oxide usage after December 6, 2000, such that
the aeration room vents become subject to the emissions standards in
Sec. 63.362, immediately upon becoming subject to the emission
standards.
(7) All chamber exhaust vents subject to the emissions standards in
Sec. 63.362 with an initial startup date before December 6, 2001, no
later than December 6, 2001.
(8) All chamber exhaust vents subject to the emissions standards in
Sec. 63.362 with an initial startup date on or after December 6, 2001,
immediately upon initial startup of the source.
(9) All chamber exhaust vents at sources using less than 1 ton that
increase their ethylene oxide usage after December 6, 2001, such that
the chamber exhaust vents become subject to the emissions standards in
Sec. 63.362, immediately upon becoming subject to the emission
standards.
(10) All chamber exhaust vents at sources using less than 10 tons
that increase their ethylene oxide usage after December 6, 2001, such
that the chamber exhaust vents become subject to the emissions
standards in Sec. 63.362(e)(1), immediately upon becoming subject to
the emission standards.
* * * * *
[FR Doc. 99-31354 Filed 12-2-99; 8:45 am]
BILLING CODE 6560-50-P
