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EtO sterilization NESHAP info gathering
any hospital waste incinerator activists out there? the ICR period of
rulemaking is imo often far away the best time to influence epa thinking on
rules, if you have good data that may refute what industry is providing to
epa. (tho in this case it's to consider the efficacy of an existing rule).
last i checked EtO formulations were still mixed w/ cfc's (allowable use
for sterilisation units). obviously, sterilization is an alternative to
single use -> incinerate products, too many of which are made of pvc; but
there are beaucoup working alternatives to EtO sterilization, which is an
incredibly potent mutagen and a human (pretty sure) carcinogen.
---
[Federal Register: October 23, 1997 (Volume 62, Number 205)]
[Notices]
[Page 55247-55248]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc97-95]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-5913-1]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request; National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Commercial Ethylene Oxide Sterilization and
Fumigation Operations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this notice announces that the following Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval: Reporting and Recordkeeping
Requirements for the National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Commercial Ethylene Oxide Sterilization and
Fumigation Operations, OMB Control Number 2060-0283, expiration date
December 31, 1997. The ICR describes the nature of the information
collection and its expected burden and cost; where appropriate, it
includes the actual data collection instrument.
DATES: Comments must be submitted on or before November 24, 1997.
FOR FURTHER INFORMATION CONTACT: Call Sandy Farmer at EPA, (202) 260-
2740, or download off the Internet from http://www.epa.gov/icr/icr.htm
and refer to EPA ICR No. 1666.03.
SUPPLEMENTARY INFORMATION:
Title: NESHAP Subpart O: National Emission Standards for Hazardous
Air Pollutants (NESHAP) for Commercial Ethylene Oxide Sterilization and
Fumigation Operations (OMB Control No. 2060-0283; EPA ICR No. 1666.03)
expiring 12/31/97. This is a request for extension of a currently
approved collection.
Abstract: The Agency is required under section 112(d) of the Clean
Air Act, as amended, to regulate emissions of hazardous air pollutants
listed in section 112(b).
In the Administrator's judgement, ethylene oxide (EO) emitted from
commercial EO sterilization and fumigation operations causes, or
contributes significantly to air pollution that may reasonably be
anticipated to endanger public health or welfare. Consequently, the
NESHAP for EO emissions have been developed for this source category.
[[Page 55248]]
Certain records and reports are necessary to enable the
Administrator to: (1) identify new, modified, reconstructed, and
existing sources subject to the standards and (2) ensure that the
standards, which are based on maximum achievable control technology
(MACT) and generally available control technology (GACT), are being
achieved.
The NESHAP for Commercial Ethylene Oxide Sterilization and
Fumigation Operations were promulgated on December 6, 1994. These
standards apply to new and existing commercial EO sterilization and
fumigation facilities that use air pollution control devices that are
in operation after promulgation of the NESHAP.
Owners or operators of the affected facilities described must
submit one-time reports of start of construction, anticipated or actual
startup dates, and physical or operation changes to existing
facilities. In addition, owners or operators of existing commercial EO
sterilization and fumigation operations will submit one-time reports of
actual annual EO use. Owners or operators of new commercial EO
sterilization and fumigation operations will submit one-time reports of
estimated annual EO use.
Reports of initial emissions testing are necessary to determine
that the applicable emission limit is being met. The owner or operator
of a commercial EO sterilization and fumigation operation that uses an
air pollution control device to meet the emission limit is required to
maintain records of the site-specific monitoring parameters as well as
daily and monthly inspections of the control device.
All reports are sent to the delegated State or local authority. In
the event that there is no such delegated authority, the reports are
sent directly to the EPA Regional Office. Notifications are used to
inform the Agency or delegated authority when a source becomes subject
to the standard. The reviewing authority may then inspect the source to
check if the pollution control devices are properly installed and
operated and the standard is being met. Performance test reports are
needed as these are the Agency's record of a source's initial
capability to comply with the emission standard. An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number. The OMB control numbers for EPA's regulations are
listed in 40 CFR part 9 and 48 CFR Chapter 15. The Federal Register
Notice required under 5 CFR 1320.8(d), soliciting comments on this
collection of information was published on 6/18/97 (62 FR 33068); no
comments were received.
Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 75
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
Respondents/Affected Entities: Commercial Ethylene Oxide
Sterilization and Fumigation Operations.
Estimated Number of Respondents: 98.
Frequency of Response: Daily, Monthly, and Semi-annually.
Estimated Total Annual Hour Burden: 7,328 hours.
Estimated Total Annualized Cost Burden: $228,000.
Send comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden, including through the use of
automated collection techniques to the following addresses. Please
refer to EPA ICR No. 1666.03 and OMB Control No. 2060-0283 in any
correspondence.
Ms. Sandy Farmer, U.S. Environmental Protection Agency, OPPE Regulatory
Information Division (2137), 401 M Street, SW, Washington, DC 20460.
(or E-Mail Farmer.Sandy@epamail.epa.gov)
and
Office of Information and Regulatory Affairs, Office of Management and
Budget, Attention: Desk Officer for EPA, 725 17th Street, NW,
Washington, DC 20503.
Dated: October 17, 1997.
Richard Westlund,
Acting Director, Regulatory Information Division.
[FR Doc. 97-28139 Filed 10-22-97; 8:45 am]
BILLING CODE 6560-50-P
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tony tweedale