National Emission Standards for Hazardous Air Pollutants for Ethylene Oxide Commercial Sterilization and Fumigation Operations

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]

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