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Agency Information Collection Activities: Proposed Collection; 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 EPA is planning to submit a continuing Information Collection Request (ICR) to the Office of Management and Budget (OMB). This is a request to renew an existing approved collection. This ICR is scheduled to expire on October 31, 2005. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection as described below.


Comments must be submitted on or before August 2, 2005.


Submit your comments, referencing docket ID number OW-2002-0011, to EPA online using EDOCKET (our preferred method), by e-mail to, or by mail to: EPA Docket Center, Environmental Protection Agency, W-01-17 Comment Clerk, Water Docket (MC-4101), EPA, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

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Sean Conley, Environmental Protection Agency, Mail Stop 4607M, 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 established a public docket for this ICR under Docket ID number OW-2002-0011, which is available for public viewing at the Water Docket 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., Start Printed Page 32608Monday 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​edocket. Use EDOCKET to obtain a copy of the draft collection of information, 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 within 60 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​edocket.

Affected entities: Entities potentially affected by this action are public and private water testing laboratories. EPA estimates that a total of 65 laboratories (approximately 22 laboratories per year) will seek EPA recognition under the Laboratory QA Program.

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

Abstract: In September 2000, the Stage 2 Microbial and Disinfection Byproducts Federal Advisory Committee (Committee) signed an Agreement in Principle (Agreement) (65 FR 83015, Dec. 29, 2000) (EPA, 2000) with consensus recommendations for two future drinking water regulations: the Long Term 2 Enhanced Surface Water Treatment Rule (LT2ESWTR) and the Stage 2 Disinfectants and Disinfection Byproducts Rule. The LT2ESWTR will address risk from microbial pathogens, specifically Cryptosporidium. The Committee recommended that the LT2ESWTR require public water systems (PWSs) to monitor their source water for Cryptosporidium using EPA Method 1622 or EPA Method 1623. Additional Cryptosporidium treatment requirements for public water systems (PWSs) would be based on the source water Cryptosporidium levels. EPA took into account the Committee's recommendations as it developed the proposed LT2ESWTR, which was published on August 11, 2003, (68 FR 47639), and is taking the recommendations into account as it develops the final regulation.

In the LT2ESWTR proposed rule, EPA indicated that PWSs would be required to use approved laboratories when conducting Cryptosporidium monitoring under the LT2ESWTR. EPA also indicated that laboratories approved to analyze Cryptosporidium samples under the rule must meet the criteria in the Laboratory Quality Assurance Evaluation Program (Lab QA Program) described in this notice. The purpose of the Lab QA Program is to identify laboratories that can reliably measure for the occurrence of Cryptosporidium in surface water. Other existing laboratory approval programs do not include Cryptosporidium analysis.

EPA initiated the Lab QA Program prior to promulgation of the final LT2ESWTR to provide the time necessary to approve a sufficient number of laboratories to assure adequate capacity for LT2ESWTR monitoring. Early initiation of the Lab QA Program was also necessary to conform with the Agreement recommendation that water systems with “historical” Cryptosporidium data that are equivalent to data that will be collected under the LT2ESWTR be afforded the opportunity to use those “historical” data in lieu of collecting new data under LT2ESWTR. In the LT2ESWTR proposed rule, EPA proposed such provisions to allow water systems to “grandfather” the historical data.

EPA anticipates the data generated by laboratories which meet the evaluation criteria would be very high quality, thus increasing the likelihood that such data would warrant consideration as acceptable “grandfathered” data. However, laboratory evaluation would not guarantee that data generated will be acceptable as “grandfathered” data, nor would failure to meet evaluation criteria necessarily preclude use of “grandfathered” data. For these reasons, EPA established the Lab QA Program as a discretionary and voluntary program under the Safe Drinking Water Act, section 1442 (42 U.S.C. 300j-1(a)).

Through today's notice, EPA is inviting comment on the continuation of the Lab QA Program. Under the Lab QA Program, EPA evaluates laboratories 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 (IDC) data for EPA Method 1622 or EPA Method 1623, which include precision and recovery (IPR) test results and matrix spike/matrix spike duplicate (MS/MSD) 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 (IPT) samples to the laboratory (unless the laboratory has already successfully analyzed such samples under EPA's Protozoan PE program). IPT samples packets consist of eight spiked samples shipped to the laboratory within a standard matrix.

3. The laboratory analyzes IPT samples and submits data to EPA.

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

5. The laboratory analyzes ongoing proficiency testing (OPT) samples three times per year and submits the data to EPA. OPT 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 Start Printed Page 32609demonstrating capacity and competency, and other guidance to laboratories that are interested in participating in the Lab QA 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 48 CFR Chapter 15.

The EPA is soliciting comments to:

(i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

(ii) Evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(iii) Enhance the quality, utility, and clarity of the information to be collected; and

(iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

Burden Statement: The burden estimate for the Lab QA Program information collection includes all the burden hours and costs required for gathering information, and developing and maintaining records associated with the Lab QA Program. The annual public reporting and record keeping burden for this collection of information is estimated for a total of 65 respondents. For each respondent, an average of 19 hours is estimated per response, with 3.3 responses per year, for a total of 3,980 hours at a cost of $166,393. The average cost per response is estimated at $776 per response. The proposed frequency of responses is three times a year for analysis and reporting of PT samples and once every three years for the on-site evaluation. This estimate assumes that laboratories participating in the Lab QA program have the necessary equipment needed to conduct the analyses. Therefore, there are no start-up costs. The estimated total annual capital costs is $0.00. The estimated Operation and Maintenance (O&M) costs is $108,504.

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.

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Dated: May 26, 2005.

Cynthia C. Dougherty,

Director, Office of Ground Water and Drinking Water.

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[FR Doc. 05-11103 Filed 6-2-05; 8:45 am]