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Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Environmental Protection Agency.




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. This ICR is scheduled to expire on October 31, 2005. 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.


Additional comments may be submitted on or before November 25, 2005.


Submit your comments, referencing docket ID number OW-2002-0012, to (1) EPA online using EDOCKET (our preferred method), by e-mail to, or by mail to: EPA Docket Center, Environmental Protection Agency, Water Docket, Mail Code 4101T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

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Sean Conley, Office of Groundwater and Drinking Water, (Mail Code 4607M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202-564-1781; fax number: 202-564-3767; e-mail address: For technical inquiries, contact Carrie Moulton, EPA, Office of Ground Water and Drinking Water, Technical Support Center, 26 West Martin Luther King Drive (MS-140), Cincinnati, Ohio 45268; fax number: (513) 569-7191; e-mail address:

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EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On June 3, 2005 (70 FR 32607), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA has addressed the comments received.

EPA has established a public docket for this ICR under Docket ID No. OW-2002-0012, which is available for public viewing at the Water Docket 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 Water Docket is (202) 566-2426. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at Start Printed Page 61810​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. Once 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, 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​edocket.

Title: Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium under the Safe Drinking Water Act.

Abstract: Under the Laboratory Quality Assurance Evaluation Program, EPA evaluates labs on a case-by-case basis through evaluating their capacity and competency to reliably measure for the occurrence of Cryptosporidium in surface water using EPA Method 1622 or EPA Method 1623. To obtain approval under the program, the laboratory must submit an application package and provide: a demonstration of availability of qualified personnel and appropriate instrumentation, equipment and supplies; a detailed laboratory standard operating procedure for each version of the method that the laboratory will use to conduct the Cryptosporidium analyses; a current copy of the table of contents of their laboratory's quality assurance plan for protozoa analyses; and an initial demonstration of capability data for EPA Method 1622 or EPA Method 1623, which include precision and recovery test results and matrix spike/matrix spike duplicate test results for Cryptosporidium.

After the laboratory submits to EPA an application package including supporting documentation, EPA and the laboratory conduct the following steps to complete the process:

1. EPA contacts the laboratory for follow-up information and to schedule participation in the performance testing program.

2. EPA sends initial proficiency testing samples to the laboratory (unless the laboratory has already successfully analyzed such samples under EPA's Protozoan PE program). These sample packets consist of eight spiked samples shipped to the laboratory within a standard matrix.

3. The laboratory analyzes initial proficiency testing samples and submits data to EPA.

4. EPA conducts an on-site evaluation and data audit.

5. The laboratory analyzes ongoing proficiency testing samples three times per year and submits the data to EPA. These sample packets consist of three spiked samples shipped to the laboratory within a standard matrix.

6. EPA contacts laboratories by letter within 60 days of their laboratory on-site evaluation to confirm whether the laboratory has demonstrated its capacity and competency for participation in the program.

The procedure for obtaining an application package, the criteria for demonstrating capacity and competency, and other guidance to laboratories that are interested in participating in the program, are provided at​safewater/​lt2/​cla_​final.html.

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 40 CFR are listed in 40 CFR part 9 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 19 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: Public and private water testing laboratories.

Estimated Number of Respondents: 22.

Frequency of Response: Three times per year.

Estimated Total Annual Hour Burden: 3,980.

Estimated Total Annual Cost: $275,000, includes $109,000 annualized capital or O&M costs.

Changes in the Estimates: There is a decrease of 367 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This decrease is just an adjustment to the estimate.

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Dated: October 18, 2005.

Sara Hisel-McCoy,

Acting Director, Collection Strategies Division.

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[FR Doc. 05-21370 Filed 10-25-05; 8:45 am]