Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Ethylene Oxide Emissions From Sterilization Facilities (40 CFR Part 63, Subpart O) (Renewal), EPA ICR Number 1666.06, OMB Control Number 2060-0283

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

In compliance with the Paperwork Reduction Act, this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. This ICR is scheduled to expire on February 29, 2004. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. This ICR describes the nature of the information collection and its estimated burden and cost.

DATES:

Additional comments may be submitted on or before April 2, 2004.

ADDRESSES:

Submit your comments, referencing docket ID number OECA-2003-0033, to (1) EPA online using EDOCKET (our preferred method), by e-mail to docket.oeca@epa.gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Enforcement and Compliance Docket and Information Center, Mail Code 2201T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2) OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Gregory Fried, Compliance Assessment and Media Programs Division, Office of Compliance, Mail Code 2223A, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202) 564-7016; fax number: (202) 564-0050; e-mail address: fried.gregory@epa.gov.

SUPPLEMENTARY INFORMATION:

EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On May 19, 2003 (68 FR 27059), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments, or has addressed the comments received.

EPA has established a public docket for this ICR under Docket ID Number OECA-2003-0033, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Avenue, NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Enforcement and Compliance Docket and Information Center is (202) 566-1752. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at http://www.epa.gov/edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select “search,” then key in the docket ID number identified above.

Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, Confidential Business Information (CBI), or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 (May 31, 2002), or go to http://www.epa.gov/edocket.

Title: NESHAP for Ethylene Oxide Emissions from Sterilization Facilities (40 CFR Part 63, Subpart O) (Renewal)

Abstract: The Administrator has judged that ethylene oxide (EO) emissions from sterilization facilities cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. 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 or new commercial EO sterilization facilities will submit one-time reports of actual or 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 an EO sterilization facility 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.

The emissions test reports and other records must be kept at the facility for a minimum of five years and be made available to the Administrator upon request. All reports and records must comply with the General Provisions to 40 CFR part 63. Owners or operators of a source subject to these standards will provide a semiannual report of excess emissions that includes the monitored operating parameter value readings required by the standards. The respondent's state or local agency can be delegated enforcement authority by EPA and also request these reports.

In order to ensure compliance with the standards promulgated to protect public health, adequate reporting and recordkeeping is necessary. In the absence of such information enforcement personnel would be unable to determine whether the standards are being met on a continuous basis, as required by the Clean Air Act.

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, and are identified on the form and/or instrument, if applicable.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 37 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; to 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; to adjust the existing ways to comply with any previously applicable instructions and requirements; to train personnel to be able to respond to a collection of information; search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information.

Respondents/Affected Entities: Ethylene Oxide Sterilization Facilities.

Estimated Number of Respondents: 119.

Frequency of Response: Initial and semiannual.

Estimated Total Annual Hour Burden: 8,662 hours.

Estimated Total Annual Costs: $1,196,000, which includes $65,000 annualized capital/startup costs, $583,000 annual O&M costs and $548,000 annual labor costs.

Changes in the Estimates: There is an increase of 1,334 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. The increase in burden from the most recently approved ICR is primarily due to an adjustment in the number of sources subject to the standard.