[Federal Register Volume 63, Number 233 (Friday, December 4, 1998)]
[Rules and Regulations]
[Pages 66990-66994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31396]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[AD-FRL-6192-8]
RIN 2060-AC28
National Emission Standards for Hazardous Air Pollutants for
Ethylene Oxide Commercial Sterilization and Fumigation Operations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Interim final rule.
-----------------------------------------------------------------------
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 and aeration room vents for one year until December 6,
1999. This suspension does not affect the requirement for sources
subject to the EO NESHAP to comply with provisions for sterilizer vents
by December 6, 1998. 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 4, 1998.
Comments may be submitted until January 4, 1999.
ADDRESSES: Comments may be submitted to the Docket address which
follows. Docket No. A-88-03, category VIII Amendments, containing
information considered by the EPA in developing this rule, is available
for public inspection and copying between 8:00 a.m. and 5:30 p.m.,
Monday through Friday, except for Federal holidays, at the EPA's Air
and Radiation Docket and Information Center, room M1500, U.S. EPA, 401
M Street, SW, Washington, DC 20460; telephone (202) 260-7548. A
reasonable fee may be charged for copying. This docket also contains
information considered by the EPA in proposing and promulgating the
original EO NESHAP.
FOR FURTHER INFORMATION CONTACT: For information concerning
applicability and rule determinations, contact the appropriate EPA
regional or Office of Enforcement and Compliance Assurance (OECA)
representative:
Region I: Susan Lancey, Air Programs Enforcement Office Chief, U.S.
EPA, Region I, JFK Federal Building (SEA), Boston, MA 02203-2211, PH:
(617) 565-3587 Fax: (617) 565-4940
Region II: Umesh Dholakia, Air Compliance Branch Chief, U.S. EPA,
Region II, 290 Broadway, New York, NY 10007-1866, PH: (212) 637-4023,
Fax: (212) 637-3901
Region III: Dianne Walker, U.S. EPA, Region III (3AT12), 841 Chestnut
Building, Philadelphia, PA 19107, PH: (215) 566-3297, Fax number (215)
566-2114
Region IV: Lee Page, U.S. EPA, Region IV (AR-4), 100 Alabama Street,
SW, Atlanta, GA 30303-3104, PH: (404) 562-9131, Fax: (404) 562-9095
Region V: Bruce Vainer (AE-17J), U.S. EPA, Region V, 77 W. Jackson
Blvd., Chicago, IL 60604, PH: (312) 886-6793, Fax: (312) 353-8289
Region VI: Robert Todd (6PD-R), U.S. EPA, Region VI (6PD-R), 1445 Ross
Avenue, Suite 700, Dallas, TX 75202-2733, PH: (214) 665-2156, Fax:
(214) 665-7263
Region VII: Richard Tripp, U.S. EPA, Region VII, 726 Minnesota Avenue,
Kansas City, KS 66101, PH: (913) 551-7566 Fax: (913) 551-7065
Region VIII: Victoria Parker-Christensen, U.S. EPA, Region VIII (8P2-
A), 999 18th Street, Suite 500, Denver, CO 80202-2405, PH: (303) 312-
6441, Fax: (303) 312-6064
Region IX: Mae Wang, U.S. EPA, Region IX (Air-4), 75 Hawthorne Street,
San Francisco, CA 94105, PH: (415) 744-1200 Fax: (415) 744-1076
Region X: Andrea Wullenweber, Office of Air Quality (OAQ-107), U.S.
EPA, Region X, 1200 Sixth Avenue, Seattle, WA 98101-9797, PH: (206)
553-8760 Fax: (206) 553-0110
OECA: Charlie Garlow, U.S. EPA, OECA (2242A), 401 M Street, SW,
Washington, DC 20460, PH: (202) 564-1088, Fax: (202) 564-0068.
For information concerning the analyses performed in developing
this interim final rule, contact Mr. David Markwordt, Policy, Planning
and Standards Group, Emission Standards Division (MD-13), Office of Air
Quality Planning and Standards, U.S. EPA, Research Triangle Park, NC
27711, PH: (919) 541-0837 Fax: (919) 541-0942. For information
concerning the accident investigations, contact Mr. Craig Matthiessen,
Chemical Emergency Preparedness and Prevention Office (5101), Office of
Solid Waste and Emergency Response, U.S. EPA, 401 M Street, SW,
Washington, DC 20460, PH: (202) 260-9781 Fax: (202) 260 0927.
SUPPLEMENTARY INFORMATION:
Electronic Access
An electronic version of this rule is available for downloading
from the EPA Technology Transfer Network (TTN) at ``http://www.epa.gov/
ttn/oarpg/ramain.html.'' For assistance in downloading files, call the
TTN Help line at (919) 541-5384.
Regulated Entities
Regulated categories and entities include:
Table 1.--Regulated Categories and Entities
------------------------------------------------------------------------
Entity category Description/SIC code
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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.
The information presented in this preamble is organized as follows:
I. Background and Summary of Action
II. Summary of and Rationale for Suspension of Chamber Exhaust and
Aeration Room Vent Requirements
III. Administrative Requirements
A. Paperwork Reduction Act
B. Executive Order 12866--Regulatory Planning and Review
C. Unfunded Mandates Reform Act
D. Regulatory Flexibility Act
E. Executive Order 13045--Protection of Children From
Environmental Health Risks and Safety Risks
F. National Technology Transfer and Advancement Act
G. Executive Order 12875--Enhancing the Intergovernmental
Partnerships
H. Executive Order 13084--Consultation and Coordination With
Indian Tribal Governments
I. Submission to Congress and the Comptroller General
J. Petitions for Judicial Review
[[Page 66991]]
I. Background and Summary of Action
On December 6, 1994 (59 FR 62585), the EPA promulgated the EO
NESHAP which regulates emissions of ethylene oxide from new and
existing commercial sterilization and fumigation operations using one
ton or more of EO per year. 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
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 compliance extension. 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 document. 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, the Agency learned of reports of explosions at
ethylene oxide sterilization and fumigation facilities. EPA
subsequently suspended the EO NESHAP for one year until December 6,
1998 to provide time to determine the appropriate action necessary to
mitigate the cause of the explosions. 62 FR 64736
II. Summary of and Rationale for 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 a June 2, 1998 letter to the Agency, 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 . . . ``(see Docket No. A-88-03, Item No. VIII-D-
2). The Health Industries Manufacturers Association (HIMA) reviewed the
recommendation. EOSA and HIMA membership represent most of the ethylene
oxide sterilization and fumigation industry. EOSA ``concluded that the
oxidizer systems had not been properly integrated with traditional EtO
sterilization process operations, that is, installation, operation and
maintenance issues had not been sufficiently addressed by sterilizer
operators.'' EOSA also concluded that ``improperly overfeeding the
oxidizer system from the chamber backvent was the primary safety
concern.''
The Agency 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
quoted above (see Docket No. A-88-03, Item No. VIII-B-1). The Agency
agrees 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). Normally, EO rich effluent drawn (vented) from the
sterilizer chamber at low flow is metered or mechanically restricted
and diluted with air to prevent high concentrations of EO from entering
the emissions control unit. The much greater backvent or chamber
exhaust flow, often in combination with aeration room exhaust,
generally is not restricted or diluted before entering the emissions
control unit. Aeration room concentrations typically are well below the
lower flammability limit for EO and the backvent is supposed to be
activated only when an extremely low concentration of EO is present in
the chamber during loading/unloading of products. Although all units
functioned as intended, the abnormal activation of the backvent at high
EO concentrations in the sterilization chamber led to the explosions.
The Agency also concludes main vent emissions routed through the vacuum
pump played no role in the explosions.
The Agency also concludes that any emissions control technology
necessary to comply with this rule 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. Investigations
and safety reviews, conducted independently by EPA and EOSA members,
confirmed that, as currently designed and operated, there still is a
possibility that backvents could be activated while high EO
concentrations are present in the sterilization chamber. Consequently,
sterilization chamber operators will need to further evaluate the
integration of the emission control technology with sterilizer
operation to ensure prevention of future explosions. Total system
safety issues can be addressed by conducting a comprehensive process
hazard analysis (PHA) for each sterilizer process and developing and
instituting safeguards that address these hazards. Additional time is
required to complete these analyses and install safeguards.
In this matter, the Agency wishes to err, if at all, on the side of
safety. Accordingly, the Agency is today 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, for one year, until December 6, 1999,
pursuant to EPA's general rulemaking authority under CAA Section
301(a), 42 U.S.C. 7601(a). Sources must 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 by December 6, 1998 because EPA has determined that they do
not pose a safety concern.
CAA Section 301(a) grants the Administrator of the EPA the
authority ``to prescribe such regulations as are necessary to carry out
his functions under this Act.'' Given the unique circumstances and
uncertainty surrounding the EO NESHAP, as described in this document,
EPA believes that it is necessary to further suspend this rule's
requirements for chamber exhaust and aeration room vent for the safety
of the public and workers in and around EO facilities. As EOSA's and
EPA's investigations have shown, the control requirements of the EO
NESHAP for chamber exhaust and aeration room vents continue to pose
potential problems for which solutions are being developed. These
solutions include the redesign of control systems to prevent the
overfeeding of EO in concentrations above safe operating limits. The
EOSA is also exploring an alternative control strategy for back draft
vent emissions. This control approach does not require an abatement
device thus completely eliminating the possibility of overfeeding (see
Docket No. A-88-03, Items No.VIII-D-2 & 6).
[[Page 66992]]
The further extension provided in this document allows time for those
solutions to be perfected and finalized. This action is consistent with
the objectives of the Clean Air Act as stated in Section 101(b), 42
U.S.C. 7401(b). ``The purposes of this sub chapter are . . . to promote
the public health and welfare and the productive capacity of its
population. . . .''
The original EO NESHAP and today's action are promulgated pursuant
to CAA Section 307(d), 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.
EPA believes the circumstances presented here provide good cause to
take this action without prior notice-and-comment. EPA finds that
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,
1998 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 EPA provide sources affected by the EO NESHAP with timely
legal relief from the current compliance date, while EPA investigates
the situation. Consequently, this action is being promulgated without
prior notice-and-comment as provided for in CAA Section 307(b)(1) and
is effective December 4, 1998 as provided for in CAA Section
112(d)(10).
Nonetheless, EPA is providing 30 days for submission of public
comments. EPA 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 one year.
This change does not impose new requirements. Consequently, the ICR has
not been revised.
B. Executive Order 12866--Regulatory Planning and Review
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 the Office of Management and Budget.
C. 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
one 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 one 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
[[Page 66993]]
with regard to small governments. For the reasons stated above, the
requirements of the UMRA do not apply to this section.
D. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (or RFA), Public Law 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 certifies that the rule will not have a significant economic
impact on a substantial number of small entities.
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, pursuant to
the provisions of 5 U.S.C. 605(b), I hereby certify that this rule will
not have a significant economic impact on a substantial number of small
entities. Consequently, an RFA is not required.
E. Executive Order 13045--Protection of Children From Environmental
Health Risks and Safety Risks
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.
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 12875--Enhancing the Intergovernmental Partnership
Under Executive Order 12875, EPA may not issue a regulation that is
not required by statute and that creates a mandate upon a State, local
or tribal government, unless the Federal government provides the funds
necessary to pay the direct compliance costs incurred by those
governments, or EPA consults with those governments. If EPA complies by
consulting, Executive Order 12875 requires EPA to provide to the Office
of Management and Budget a description of the extent of EPA's prior
consultation with representatives of affected State, local and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create a mandate on State, local or tribal
governments. The rule does not impose any enforceable duties on these
entities. Rather, the rule temporarily suspends certain regulatory
requirements. Accordingly, the requirements of section 1(a) of
Executive Order 12875 do not apply to this rule.
H. Executive Order 13084--Consultation and Coordination With Indian
Tribal Governments
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 rule imposes no
enforceable duties on these entities. Rather, the rule temporarily
suspends certain regulatory requirements. Accordingly, the requirements
of section 3(b) of Executive Order 13084 do not apply to this rule.
I. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as amended 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. EPA will submit a report containing this
rule 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). This rule will be effective December 4, 1998.
J. Petitions for 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
[[Page 66994]]
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 document may not be challenged later
in civil or criminal proceedings brought by the EPA to enforce these
requirements.
List of Subjects in 40 CFR Part 63
Environmental protection, Air pollution control, Ethylene oxide
sterilization, Hazardous substances, Reporting and recordkeeping
requirements.
Dated: November 18, 1998.
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)(1), (g)(2),
and (g)(3) and adding paragraphs (g)(4), (g)(5), and (g)(6) to read as
follows:
Sec. 63.360 Applicability.
* * * * *
(g) * * *
(1) All sterilization chamber vents subject to the emissions
standards in Sec. 63.362 with an initial startup date before December
6, 1998, no later than December 6, 1998.
(2) All sterilization chamber vents subject to the emissions
standards in Sec. 63.362 with an initial startup date on or after
December 6, 1998, immediately upon initial startup of the source.
(3) All sterilization chamber vents at sources using less than 1
ton of ethylene oxide that increase their ethylene oxide usage after
December 6, 1998 such that the sterilization chamber vent becomes
subject to the emissions standards in Sec. 63.362(c), immediately upon
becoming subject to the emission standards.
(4) All aeration room and chamber exhaust vents subject to the
emissions standards in Sec. 63.362 with an initial startup date before
December 6, 1999, no later than December 6, 1999.
(5) All aeration room and chamber exhaust vents subject to the
emissions standards in Sec. 63.362 with an initial startup on or after
December 6, 1999, immediately upon initial startup of the source.
(6) All aeration room and chamber exhaust vents at sources using
less than 10 tons of ethylene oxide that increase their ethylene oxide
usage after December 6, 1999 such that the aeration room and chamber
exhaust vents become subject to the emissions standards in
Sec. 63.362(d) and Sec. 63.362(e), immediately upon becoming subject to
the emission standards.
[FR Doc. 98-31396 Filed 12-3-98; 8:45 am]
BILLING CODE 6560-50-P