[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]


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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.

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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 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
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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.
    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