97-32328. National Emission Standards for Hazardous Air Pollutants for Ethylene Oxide Commercial Sterilization and Fumigation Operations

[Federal Register Volume 62, Number 236 (Tuesday, December 9, 1997)]
[Rules and Regulations]
[Pages 64736-64738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32328]


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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 [phone]. 
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 [phone]
    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 [phone]
    Region III: Walter K. Wilkie, U.S. EPA, Region III (3AT12), 841 
Chestnut Building, Philadelphia, PA 19107, Telephone number (215) 566-
2150, Fax number [phone]
    Region IV: Lee Page, U.S. EPA, Region IV (AR-4), 100 Alabama 
Street, SW, Atlanta, GA 30303-3104, Telephone number [phone], 
Fax number [phone]
    Region V: Howard Caine (AE-17J), U.S. EPA, Region V, 77 W. Jackson 
Blvd., Chicago, IL 60604, Telephone number [phone], Fax number 
[phone]
    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 [phone]
    Region VII: Bill Peterson, U.S. EPA, Region VII, 726 Minnesota 
Avenue, Kansas City, KS 66101, Telephone number [phone]
    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 [phone]
    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 
[phone] or [phone] x1949
    OECA: Julie Tankersley, U.S. EPA, OECA (2223A), 401 M Street, SW, 
Washington, DC 20460, Telephone number [phone], 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 [phone] or fax number [phone]. 
For information concerning the accident

[[Page 64737]]

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 [phone].

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 
[phone] 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 [phone]. 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

[[Page 64738]]

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 [phone].
    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