2010-12273. Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Pharmaceutical Production (Renewal), EPA ICR Number 1781.05, OMB Control Number 2060-0358

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), 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. The ICR which is abstracted below describes the nature of the collection and the estimated burden and cost.

DATES:

Additional comments may be submitted on or before June 21, 2010.

ADDRESSES:

Submit your comments, referencing docket ID number EPA-HQ-OECA-2009-0381 to (1) EPA online using http://www.regulations.gov (our preferred method), or by e-mail to [e-mail], or by mail to: EPA Docket Center (EPA/DC), Environmental Protection Agency, Enforcement and Compliance Docket and Information Center, mail code 28221T, 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:

Learia Williams, Compliance Assessment and Media Programs Division, Office of Compliance, Mail Code 2223A, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

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 July 8, 2009 (74 FR 32580), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional comments on this ICR should be submitted to EPA and OMB within 30 days of this notice.

EPA has established a public docket for this ICR under docket ID number EPA-HQ-OECA-2009-0381, which is available for public viewing online at http://www.regulations.gov,, in person viewing at the Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 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 [phone], and the telephone number for the Enforcement and Compliance Docket is [phone].

Use EPA's electronic docket and comment system at http://www.regulations.gov,, to submit or view public comments, to access the index listing of the contents of the docket, and to access those documents in the docket that are available electronically. Once in the system, select “docket search,” then key in the docket ID number identified above. Please note that EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing at http://www.regulations.gov,, 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. For further information about the electronic docket, go to http://www.regulations.gov.

Title: NESHAP for Pharmaceutical Production (Renewal).

ICR Numbers: EPA ICR Number 1781.05, OMB Control Number 2060-0358.

ICR Status: This ICR is scheduled to expire on July 31, 2010. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. 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 in title 40 of the CFR, after appearing in the Federal Register when approved, are listed in 40 CFR part 9, and displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR part 9.

Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Pharmaceutical Production (40 CFR part 63, subpart GGG) were proposed on April 2, 1997, and promulgated on September 21, 1998. These standards apply to the facilities in pharmaceutical production that are major sources of hazardous air pollutants (HAP). The affected facility is all pharmaceutical manufacturing operation, 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 require initial notifications, performance tests, and periodic reports.

Owners/operators of affected pharmaceutical production 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. Semiannual reports are also required.

Any owner or operator subject to the provisions of this part shall maintain a file of these measurements, and retain the records for at least five years following the date of such measurements, maintenance reports, and records. Performance tests reports are required as this is 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.

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. This information is being collected to assure compliance with 40 CFR part 63, subpart GGG, as authorized in sections 112 and 114(a) of the Clean Air Act. The required information consists of emissions data and other information that have been determined to be private.

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 Number for EPA regulations listed in 40 CFR part 9 and 48 CFR chapter 15, are identified on the form and/or instrument, if applicable.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information estimated to average 178 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose, and 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. All existing ways will have to adjust to comply with any previously applicable instructions and requirements that have subsequently changed; 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: Pharmaceutical production facilities.

Estimated Number of Respondents: 27.

Frequency of Response: Initially, quarterly, semiannually, and occasionally.

Estimated Total Annual Hour Burden: 44,246.

Estimated Total Annual Cost: $4,297,480 which includes $4,185,214 in labor costs, no capital/startup costs, and $112,266 in operation and maintenance (O&M) costs.

Changes in the Estimates: There is an adjustment in the labor hours in this ICR, compared to the previous ICR. The labor burden is decreased compared to the most recently approved ICR due to a reduction in the number of sources. The reduction was caused by a number of sources becoming synthetic area minor sources before the compliance date. All of the sources subject to the standard are major sources.

There is a decrease in the capital/startup and operations and maintenance (O&M) costs from the previous ICR due to the decrease in the number of sources.

Dated: May 17, 2010.

John Moses,

Director, Collection Strategies Division.