Agency Information Collection Activities; Submission for OMB Review and Approval; Comment Request; NESHAP for Pharmaceuticals Production, EPA ICR Number 1781.03, OMB Control Number 2060-0358

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 March 31, 2004.

ADDRESSES:

Submit your comments, referencing docket ID number OECA-2003-0035, 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 (ECDIC), Mail Code 2201T, 1200 Pennsylvania Ave., 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:

Learia Williams, Compliance Assessment and Media Programs Division, Office of Compliance, Mail Code 2223A, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 564-4113; fax number: (202) 564-0050; e-mail address: williams.learia@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.

EPA has established a public docket for this ICR under Docket ID Number OECA-2003-0035, 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 Ave., 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 Pharmaceuticals Production (40 CFR part 63, subpart GGG), OMB Control Number 2060-0358, EPA ICR Number 1781.03.

Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP), were proposed on April 2, 1997 and promulgated on September 21, 1998. These standards apply to the facilities in Pharmaceuticals Production that are major sources of hazardous air pollutants (HAP). The affected facility includes all pharmaceutical manufacturing operations, which includes process vents, storage tanks, equipment components, and wastewater systems commencing construction or reconstruction after the date of the proposal. In general, all NESHAP requires initial notifications, performance tests, and periodic reports.

Owners or operators are required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and in general, are required of all sources subject to NESHAP. The required 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 that the standard is being met.

Any owner or operator subject to the provisions of this part will maintain a file of these measurements, and retain the file for at least five years following the date of such measurements, maintenance reports, and records. Performance tests reports are needed as they are the Agency's record of a source's initial capability to comply with the emission standard, and serve as a record of the operating conditions under which compliance was achieved.

Any 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 are estimated to average 250 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; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information.

Respondents/Affected Entities: Pharmaceuticals Production Plants.

Estimated Number of Respondents: 101.

Frequency of Response: Quarterly, semiannually and on occasion.

Estimated Total Annual Hour Burden: 158,179 hours.

Estimated Total Annual Costs: $10,015,020 which includes $4,400 annualized capital/startup costs, $4,158 annual O&M costs and $10,006,462 Labor costs for Respondents.

Changes in the Estimates: There is a decrease of 3,147 hours in the total estimated hour burden currently identified in the OMB Inventory of Approved ICR Burdens. The decrease in hour burden from the most recently approved ICR is due to a decrease in the number of sources. Our data indicates that there are approximately 101 sources, including one new source due to reconstruction.