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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)]
  [Page 55247-55248]
  >From the Federal Register Online via GPO Access [wais.access.gpo.gov]
  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.
      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
      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
      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
  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)
  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
  tony tweedale