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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[AD-FRL-5933-6]

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, on an interim final basis, the

National Emission Standards for Hazardous Air Pollutants for Ethylene

Oxide Commercial Sterilization and Fumigation Operations (EO NESHAP).

The suspension allows affected sources subject to the EO NESHAP to

defer compliance with the NESHAP for one year until 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, 1997.

Under section 307(b)(1) of the Clean Air Act (Act), judicial review

of this final action is available only by filing a petition for review

in the U.S. Court of Appeals for the District of Columbia Circuit

within 60 days of today's publication of this interim final rule. Under

section 307(b)(2) of the Act, the requirements that are the subject of

today's document may not be challenged later in civil or criminal

proceedings brought by the EPA to enforce these requirements.

ADDRESSES: Docket. 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: Greg Roscoe, Air Programs Enforcement Office Chief, U.S.

EPA, Region I, JFK Federal Building (SEA), Boston, MA 02203, Telephone

number (617) 565-3221

Region II: Kenneth Eng, Air Compliance Branch Chief, U.S. EPA,

Region II, 290 Broadway, New York, NY 10007, Telephone number (212)

637-4080, Fax number (212) 637-3998

Region III: Walter K. Wilkie, U.S. EPA, Region III (3AT12), 841

Chestnut Building, Philadelphia, PA 19107, Telephone number (215) 566-

2150, Fax number (215) 566-2114

Region IV: Lee Page, U.S. EPA, Region IV (AR-4), 100 Alabama

Street, SW, Atlanta, GA 30303-3104, Telephone number (404) 562-9131,

Fax number (404) 562-9095

Region V: Howard Caine (AE-17J), U.S. EPA, Region V, 77 W. Jackson

Blvd., Chicago, IL 60604, Telephone number (312) 353-9685, Fax number

(312) 353-8289

Region VI: Sandra A. Cotter (6EN-AT), U.S. EPA, Region VI (6PD-R),

1445 Ross Avenue, Dallas, TX 75202-2733, Telephone number (214) 665-

7347, Fax number (214) 665-7446

Region VII: Bill Peterson, U.S. EPA, Region VII, 726 Minnesota

Avenue, Kansas City, KS 66101, Telephone number (913) 551-7881

Region VIII: Heather Rooney, U.S. EPA, Region VIII (8ART-AP), 999

18th Street, Suite 500, Denver, CO 80202-2405, Telephone number (303)

312-6971, Fax number (303) 312-6826

Region IX: Christine Vineyard, U.S. EPA, Region IX (Air-4), 75

Hawthorne Street, San Francisco, CA 94105, Telephone number (415) 744-

1197

Region X: Chris Hall, Office of Air Quality (OAQ-107), U.S. EPA,

Region X, 1200 Sixth Avenue, Seattle, WA 98101-9797, Telephone number

(206) 553-1949 or (800) 424-4372 x1949

OECA: Julie Tankersley, U.S. EPA, OECA (2223A), 401 M Street, SW,

Washington, DC 20460, Telephone number (202) 564-7002, Fax number (202)

564-0050.

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, telephone number (919) 541-0837 or fax number (919) 541-0942.

For information concerning the accident

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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,

telephone number (202) 260-9781.

SUPPLEMENTARY INFORMATION: An electronic version of this rule is

available for download from the EPA Technology Transfer Network (TTN),

a network of electronic bulletin boards developed and operated by the

Office of Air Quality Planning and Standards. The TTN provides

information and technology exchange in various areas of air pollution

control. The service is free, except for the cost of a phone call. Dial

(919) 541-5742 for data transfer of up to 14,400 bits per second. If

more information on the operation of the TTN is needed, contact the

systems operator at (919) 541-5384. The TTN is also available on the

Internet (access: http://ttnwww.rtpnc.epa.gov).

The information presented in this preamble is organized as follows:

I. Background and Summary of Action

II. Summary of and Rationale for Suspension of the Rule

III. Administrative Requirements

A. Paperwork Reduction Act

B. Executive Order 12866, Unfunded Mandates Reform Act, and

Regulatory Flexibility Act

C. Submission to Congress and the Comptroller General

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 1 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. 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 does not

want matters associated with the December 1997 compliance date to

possibly compromise safety. Therefore, the Agency is suspending the EO

NESHAP for one year until December 6, 1998.

II. Summary of and Rationale for Suspension of the Rule

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 precise cause of

the explosions is still uncertain at this time. The Agency, however,

wishes to adopt a cautious approach in order to assure public and

worker safety and, consequently, 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.

In a July 18, 1997 memorandum, the director of EPA's Office of Air

Quality Planning and Standards (OAQPS) asked all Regional Air Division

Directors and Regional Air Toxics Coordinators to inform all ethylene

oxide facilities of the recent incidents and the potential safety

problem. Because subpart O's December 1997 compliance date had not yet

been triggered, this memorandum also recommended that, if the owners or

operators of the facilities had any safety concern, they should

disconnect the control units until the matter could be examined

further.

EPA does not know the extent to which the explosions that have

occured to date were related to the installation of control equipment

to comply with the EO NESHAP. However, the Agency wishes to err, if at

all, on the side of safety. Accordingly, the Agency is today suspending

the EO NESHAP for one year, until December 6, 1998 pursuant to the

authority inherent to EPA's general rulemaking authority under CAA

section 301(a), 42 U.S.C. 7601(a).

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 notice, EPA

believes that it is necessary to suspend this rule for the safety of

the public and workers in and around EO facilities. This action is

consistent with the objectives of the Clean Air Act as stated in

section 101(b), 42 U.S.C. Sec. 7401(b), ``The purposes of this

subchapter are * * * to promote the public health and welfare and the

productive capacity of its population * * *''

The original EO NESHAP and today's action suspending that rule 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. Sec. 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,

1997 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 immediately effective 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 addition, the OAQPS Director has requested that the appropriate

Regional Offices, in cooperation with the Office of Solid Waste and

Emergency Response's Chemical Emergency Preparedness and Prevention

Office (CEPPO), and the Regional CEPPO program offices, visit the

facilities where the incidents have occurred to gather all relevant

information. In suspending the EO NESHAP and directing this

investigation effort, 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

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health and the environment in a way that is consistent with safety

concerns.

As mentioned above, EPA has been investigating and will continue to

investigate the cause of these incidents. During the one year

suspension period, the Agency will provide the public with the results

of the investigation. At the conclusion of the one year period, EPA

expects to have addressed any safety concerns with the EO NESHAP

requirements. If the Agency finds that changes to the EO NESHAP are

necessary to address safety concerns, EPA will conduct a rulemaking to

promulgate a revised standard and sources will be given adequate

opportunity to comply with the revised rule. If, however, EPA concludes

that no changes are necessary, EO facilities will be expected to be in

compliance with the EO NESHAP by December 6, 1998.

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

for one year. This change does not impose new requirements.

Consequently, the ICR has not been revised.

B. Executive Order 12866, Unfunded Mandates Reform Act, and Regulatory

Flexibility Act

Today's action serves to reduce the burden on certain sources by

temporarily suspending the EO NESHAP. 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. Since this action is not subject to notice-and-comment

rulemaking requirements under the APA or any other law, it is also not

subject to sections 202, 204 or 205 of the Unfunded Mandates Reform Act

(UMRA). In addition, since this action does not impose annual costs of

$100 million or more and will not significantly or uniquely affect

small governments, the Agency has no obligations under section 203 of

UMRA. Moreover, since this action is not subject to notice-and-comment

requirements under the APA or any other statute as discussed above, it

is not subject to section 603 or 604 of the Regulatory Flexibility Act.

C. Submission to Congress and the Comptroller General

EPA submitted a report containing this action and other information

to the U.S. Senate, the U.S. House of Representatives, and the

Comptroller General of the United States prior to publication in

today's Federal Register. This action is not a ``major rule'' as

defined by 5 U.S.C. 804(2). This rule is effective immediately pursuant

to 5 U.S.C. 808(2) because the EPA for good cause finds that notice and

comment is impracticable, unnecessary, or contrary to the public

interest, for the reasons stated previously.

List of Subjects in 40 CFR Part 63

Environmental protection, Air pollution control, Ethylene oxide

sterilization, Hazardous substances, Reporting and recordkeeping

requirements.

Dated: December 4, 1997.

Carol M. Browner,

Administrator.

For the reasons set out in the preamble, Title 40, Part 63, Subpart

O of the Code of Federal Regulations, is hereby suspended until

December 6, 1998.

[FR Doc. 97-32328 Filed 12-5-97; 1:16 pm]

BILLING CODE 6560-50-P