E9-4009. Agency Information Collection Activities; Proposed Collection; Comment Request; Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium Under the Safe Drinking Water Act (Renewal); EPA ICR No. 2067.04, OMB Control No....

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a request to renew an existing approved Information Collection Request (ICR) to the Office of Management and Budget (OMB). This ICR is scheduled to expire on May 31, 2009. This notice describes the current “Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium under the Safe Drinking Water Act,” hereafter referred to as the “Lab QA Program,” and requests comment on both the program and the renewed paperwork requirements.

DATES:

Comments must be submitted on or before April 27, 2009.

ADDRESSES:

Submit your comments, identified by Docket ID No. EPA-HQ-OW-2002-0011, by one of the following methods:

• http://www.regulations.gov: Follow the on-line instructions for submitting comments.
• Mail: Water Docket, Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
• Hand Delivery: Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is [phone], and the telephone number for the Water Docket is [phone]. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2002-0011. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected using http://www.regulations.gov or e-mail. Please contact EPA prior to submitting CBI. The http://www.regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through http://www.regulations.gov your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/​epahome/​dockets.htm.

FOR FURTHER INFORMATION CONTACT:

Carrie Miller, EPA, Office of Ground Water and Drinking Water, Technical Support Center, 26 West Martin Luther King Drive (MS-140), Cincinnati, Ohio 45268; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OW-2002-0011, which is available for online viewing at http://www.regulations.gov, or in person viewing at the Water Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA/DC 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.

Use http://www.regulations.gov to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the contents of the 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 in this document.

What Information Is EPA Particularly Interested in?

Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically solicits comments and information to enable it 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. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

EPA is also interested in any other comments regarding the improvements to the Lab QA Program described in this notice.

What Should I Consider When I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible and provide specific examples.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Offer alternative ways to improve the collection activity.

6. Make sure to submit your comments by the deadline identified under DATES.

7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

What Information Collection Activity or ICR Does This Apply to?

Affected entities: Entities potentially affected by this action are public and private water testing laboratories. EPA estimates that a total of 65 laboratories will seek to attain or maintain EPA recognition under the Lab QA Program. This estimate includes 63 laboratories seeking continued recognition under the Lab QA Program and 2 laboratories seeking initial recognition.

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

ICR numbers: EPA ICR No. 2067.04, OMB Control No. 2040-0246.

ICR status: This ICR is currently scheduled to expire on May 31, 2009. 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. Approved OMB control numbers for EPA's regulations in title 40 of the CFR are listed in 40 CFR part 9 of the Federal Register and displayed either by publication of the Federal Register or by other appropriate means, such as on the applicable collection instrument or form.

Abstract: In September 2000, the Stage 2 Microbial and Disinfection Byproducts Federal Advisory Committee (Committee) signed an Agreement in Principle (Agreement) (65 FR 83015, December 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 was to 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 PWSs would be based on the source water Cryptosporidium levels. EPA took into account the Committee's advice and recommendations as it developed the LT2ESWTR, which was published on January 5, 2006.

Under the LT2ESWTR, EPA requires public water systems to use approved laboratories when conducting Cryptosporidium monitoring. In the preamble to the LT2ESWTR as well as several other notices, EPA has described the criteria for approval of laboratories to analyze Cryptosporidium samples under the LT2ESWTR. See 71 FR 727 (January 5, 2006) and 67 FR 9731 (March 4, 2002). The Lab QA Program, as revised, is 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 and to ensure that approved laboratories maintain that capability. Other, State-based laboratory oversight programs do not currently address approval of laboratories for the Cryptosporidium analysis required by the LT2ESWTR.

Through today's notice, EPA is inviting comment on refinements to the information collected to support EPA's Lab QA Program. As of May 2007, EPA concluded that sufficient laboratory capacity exists for the LT2ESWTR. As a result, EPA has generally postponed evaluation of additional laboratories, including commercial, county, municipal and utility laboratories, until further notice. Subject to the availability of resources, EPA will consider evaluation of State and EPA Regional laboratories on a case-by-case basis, based on the role that States and EPA Regions play in the certification and approval programs for laboratories. The Lab QA Program is continuously being refined and updated as new information and technologies become available. The program will continue to evolve and EPA will continue to revise and update burden estimates, as needed, with any subsequent ICR.

Approved laboratories will have demonstrated, and are to continue to demonstrate, proficient and reliable detection and enumeration of Cryptosporidium in surface water sources for public water systems. They will have passed all elements in the Lab QA Program and continue to successfully participate in all program activities. Approved laboratories are responsible for notifying EPA of losses of key personnel or essential equipment and changes in policies or procedures that directly affect the validity of data or any other change affecting the capability of the laboratory including change in location. Participating laboratories are to also demonstrate ongoing capability and method performance by following all applicable method quality control (QC) procedures, analyzing ongoing proficiency testing (PT) samples (generally three times per year), submitting requested data to EPA, and participating in periodic re-evaluations.

The Lab QA Program procedures have been updated to reflect that the minimum recovery for Cryptosporidium in ongoing precision and recovery (OPR) samples is now 22 percent, updated from the original 11 percent. This updated minimum recovery is based on an updated data set and should provide a better assessment of laboratory performance than the original value for the following reasons: (1) The data set is more current and is based on more samples (a total of 333); (2) 52 more laboratories are included in the data set; (3) data were generated using the 2005 version of Method 1623, which is the required version for LT2ESWTR analyses; (4) data were generated using filters currently used to analyze LT2ESWTR samples rather than those filters used originally; and (5) the number of oocysts spiked into the samples was unknown to the laboratories. Calculations for the updated criteria are available in Docket ID No. EPA-HQ-OW-2002-0011. Laboratories are to now document a minimum of 22 percent recovery for OPR samples in an updated QC chart prior to analysis of LT2ESWTR samples at the frequency required in section 9.7 of the method.

The ongoing PT sample packets generally consist of three spiked samples shipped to the laboratory within a standard matrix. If a laboratory submits poor PT results, EPA may recommend additional follow-up action to demonstrate that the laboratory's performance remains acceptable. Additional actions may include submission of PT slides to EPA, repeat analyses, providing additional QC data, and investigation of problems with reagents and equipment. Repeated failure to demonstrate laboratory capability and acceptable method performance may result in suspension or downgrading of approval status as outlined later in this section.

EPA may re-evaluate laboratories participating in the program to verify Cryptosporidium laboratory quality assurance (QA) on both an “as-needed” and periodic basis (generally not exceeding once every three years). In the case of a periodic assessment, EPA will generally notify the laboratory that they are due for re-evaluation and request a package with documentation of personnel status, equipment maintenance, standard operating procedures, training records, and QC charts. After the package has been received, it will be evaluated for completeness. EPA generally contacts the laboratory within 15 days of package submission if information is missing. When a complete package has been received, the following steps will complete the process:

1. The laboratory will send positive staining control and OPR slides for evaluation by EPA.

2. The laboratory will order blind slides spiked with Cryptosporidium from a qualified vendor for each analyst. Each analyst will perform an independent count of one slide. The results and slides will be submitted to a technical auditor.

3. EPA will schedule an on-line Internet analyst verification of performance for microscopists to demonstrate their ability to identify Cryptosporidium oocysts.

4. EPA conducts a one-day on-site evaluation that will primarily focus on method performance and data recording. Laboratory personnel will be asked to order blind oocyst suspensions for use in sample and IMS control spiking in the presence of an auditor, and then complete the analyses within applicable method holding times and send results to EPA.

5. EPA will send the laboratory a report detailing all findings, generally within 60 days after the evaluation is complete. The laboratory is then asked to provide written responses to any deficiencies identified in the report within 60 days. Provided all responses to the deficiencies cited in the report are acceptable, the Lab QA Program will then base its decision for continued laboratory approval on PT results, quality of the positive control and OPR slide, slide counts, Internet analyst verification, on-site evaluation and recovery values for blind analyses initiated during the on-site evaluation.

State and EPA Regional Laboratories may contact the laboratory approval manager regarding new application submissions. Subject to available resources, EPA estimates that up to two State or EPA Regional Laboratories will seek first-time approval each year. Laboratories seeking approval under the program must submit an application package and provide: a demonstration of availability of qualified personnel and appropriate instrumentation, equipment and supplies; detailed laboratory standard operating procedures; a current copy of the table of contents of their laboratory's QA plan for protozoa analyses; and an initial demonstration of capability data for EPA Method 1623, which includes initial precision and recovery IPR test results and matrix spike/matrix spike duplicate (MS/MSD) test results for Cryptosporidium. After EPA completes its review of the application, the Agency will contact the laboratory for follow-up information and to schedule shipment of initial PT samples consisting of eight spiked samples within a standard matrix. EPA then generally conducts an on-site evaluation and data audit. Further information is provided at http://www.epa.gov/​safewater/​disinfection/​lt2/​lab_​home.html. The Agency notes that completion of an application by a laboratory does not ensure that the Agency will act on the laboratory's request; interested laboratories are encouraged to contact the laboratory approval manager prior to investing substantial effort towards their application. Further, a decision by the Agency to review an application, to send initial PT samples, and/or to schedule or conduct an on-site evaluation and data evaluation, does not ensure that the review process will be completed or that the laboratory will ultimately be approved. Decisions will be made based on the facts associated with a particular application and actions will be taken as Agency resources permit.

Approved laboratories that do not continue to meet the criteria for the Lab QA Program may have their status downgraded to provisional or have their approval suspended. Details of the basis for downgrading or suspending a laboratory's approval are provided in the section entitled “Clarification of Basis and Procedures for Downgrading/Suspending Approval for Laboratories for the Analysis of Cryptosporidium in Water Under the Long Term 2 Enhanced Surface Water Treatment Rule” (see the following section). Provided EPA has sufficient resources to review requests for upgrade or reinstatement, laboratories may have to undertake additional activities such as analyzing additional PT samples, undergoing an on-site evaluation, and/or counting blind spiked slides in order to have their status upgraded or their approval reinstated. Details regarding additional activities that may be required are provided in the next section.

Clarification of Basis and Procedures for Downgrading/Suspending Approval of Laboratories for the Analysis of Cryptosporidium in Water Under the Long Term 2 Enhanced Surface Water Treatment Rule

EPA's Office of Ground Water and Drinking Water, in the Office of Water, has developed a detailed description of the procedures and criteria used in actions concerning approving, downgrading and suspending laboratories for analysis of drinking water contaminants.

In order to assume primary enforcement responsibility for the drinking water regulations, a State must either have available laboratory facilities, approved by the Administrator, capable of conducting analytical measurements of drinking water contaminants, or establish and maintain its own program for approval of laboratories. States wishing to adapt these procedures and criteria for their own approval program should revise it to accurately reflect their State approval program.

This section is intended to clarify EPA's intended practices and procedures for laboratory approval, downgrading or suspension for analysis of Cryptosporidium under the Long Term 2 Enhanced Surface Water Treatment Rule (LT2ESWTR) and to reflect good laboratory practice and standard proficiency evaluation in the industry; it is not a regulation. While EPA intends to generally follow the procedures laid out in this section, not every situation is reflected in these procedures and EPA may need to address case-specific situations in ways that differ from the procedures spelled out here. EPA welcomes comment on these procedures and may decide to revise them at any time in the future to reflect changes to its approach or to clarify and update the text.

• “Approved Laboratories” have demonstrated, and continue to demonstrate, proficient and reliable detection and enumeration of Cryptosporidium in surface water sources for public water systems. They have passed all elements in the Lab QA Program and continue to successfully participate in all program activities. Approved Laboratories notify the Approval Authority (EPA individual(s) administering the program or State individual(s) administering an equivalent laboratory certification program) of loss of key personnel or essential equipment, change in policies or procedures that directly affect the validity of data, and any other change affecting the capability of the laboratory including change in location.
• “Provisionally Approved Laboratories” have deficiencies but demonstrate their ability to consistently produce data of known quality. They continue to successfully participate in all Lab QA Program activities. A Provisionally Approved Laboratory may analyze drinking water samples for LT2ESWTR compliance purposes if the laboratory has identified themselves as provisionally approved to their clients and any reports clearly state that the laboratory's status is “provisionally approved.”
• “Not Approved” designates a laboratory that has either not participated in the Lab QA Program, or has applied to the program but possesses deficiencies and, in the opinion of the Approval Authority, does not consistently produce data that has met all applicable method QC requirements or has falsified data.

Basis for Downgrading to “Provisionally Approved” Status

An Approved Laboratory (referred to as “laboratory”) may be downgraded to “Provisionally Approved” status for Cryptosporidium for any of the following reasons:

• Failure to analyze samples for the LT2ESWTR according to the December 2005 version of EPA Method 1623 or EPA Method 1622, including all QA/QC criteria;
• Failure to document a minimum of 22 percent for on-going precision and recovery values in an updated QC chart prior to analysis of LT2ESWTR samples at the frequency required in section 9.7 of the method;
• Failure to demonstrate proficiency based upon acceptable matrix spike recoveries for all modifications of the method procedures per Section 9.1.2 of the method;
• Failure to submit valid Proficiency Test (PT) results or meet PT acceptance limits described by the Approval Authority for the first two initial testing events or two out of three regular testing events administered by a vendor authorized by the Approval Authority. The acceptance limits are laboratory mean recovery between ±2 standard deviations (SD) of the mean recovery for all approved laboratories in a given test event. Recoveries below the mean recovery minus 2 SD will fail the PT test event. Recoveries higher than the mean recovery plus 2 SD trigger additional evaluation, which may include one or more of the following: (1) On-site evaluation; (2) presence of a proctor when processing PT samples during the next test event; and/or (3) submission of PT microscope slides to the Approval Authority before the expiration of holding time during the next test event;
• Failure to submit PT slides within three weeks of PT test event when requested by the Approval Authority;
• Failure to maintain records of method modifications per section 9.1.2.2 of the method;
• Failure to notify the Approval Authority of loss of key personnel or essential equipment, change in policies or procedures that directly affect the validity of data, or other changes affecting the capability of the laboratory including change in location. Laboratory Approval does not automatically survive such changes; the Approval Authority may request an on-site or off-site evaluation and/or further proof of compliance with all applicable method requirements;
• Failure to submit on-site evaluation materials and any other requested information within the time period requested by the Approval Authority; or
• Failure to participate satisfactorily in the Approval Authority Lab QA Program and demonstrate proficiency based upon: Sample and method holding time records; analyst verification skills; relative quality of positive staining control and on-going precision recovery (OPR) slides; acceptable performance of QC checks, including but not limited to blind slide counts; and acceptable precision and recovery values for all method variations.

Procedures for Downgrading to “Provisionally Approved” Status

• The Approval Authority will notify the laboratory director or owner of its intent to downgrade after becoming aware of the situation warranting downgrading;
• The laboratory director should review the problems cited, and within 30 days of receipt of the letter, send a letter to the Approval Authority specifying immediate corrective actions that are being taken;
• The Approval Authority will consider the adequacy of the response and notify the laboratory in writing of its approval status, generally within 14 days of receipt of the laboratory's response;
• After the Approval Authority notifies a laboratory, the Approval Authority will post status on the Web site list of laboratories and may schedule an on-site evaluation of the laboratory;
• The laboratory should identify and correct its problem(s) to the Approval Authority's satisfaction within 30 days of being notified of the downgrade or have approval status suspended;
• A Provisionally Approved laboratory may continue to analyze samples for compliance purposes, but must identify its status as Provisionally Approved on any report;
• A laboratory may request that the Approval Authority or State provide technical assistance to help identify and resolve any problem; however, adequate performance is the laboratory's responsibility and Approval Authority assistance should not delay the downgrading procedure.

Basis for Suspending Approval Status

A laboratory may be downgraded from Approved or Provisionally Approved status to “Not Approved” for any of the following reasons:

• Repeated verification that all applicable method QC requirements have been followed, when in fact they have not all been met;
• Repeated failure to document acceptable OPR values prior to analysis of LT2ESWTR samples;
• Reporting PT data from another laboratory as its own;
• Falsification of data or other deceptive practices including false verification that data submitted to the Data Collection and Tracking System (DCTS) was generated using approved methods and met all method QA/QC criteria;
• Refusal to participate in on-site or off-site evaluations conducted by the Approval Authority.

Basis for Suspending Provisionally Approved Status

• Failure to provide a letter to the Approval Authority within 30 days that adequately explains what immediate corrective actions were taken;
• Failure to identify and correct problems in response to downgrade within 30 days;
• Failure to provide accurate OPR control charts to the Approval Authority;
• Failure to submit valid PT results for the next two consecutive authorized PT test events within the acceptance limits specified;
• Continued failure to use the analytical methodology specified in the regulations;
• Failure to correct deviations identified during an on-site evaluation within 30 days; or
• Failure to provide requested demonstration, materials and documentation within 30 days, including: acceptable matrix spike recoveries for all method variations per section 9.1.2 of the method; bench sheets, examination forms or OPR charts for any samples requested; remote analyst verification; recent positive staining control and OPR microscope slides, one of each; and blind slide counts for each analyst.

Procedures for Suspension

The Approval Authority will notify the laboratory, in writing, of its intent to suspend approval. If the laboratory wishes to request reconsideration of this decision, it should submit such a request in writing to the Approval Authority within 30 days of receipt of the notice of intent to suspend approval. The laboratory will generally be downgraded immediately to “provisional approval” in the interim while the suspension is being considered. If no request for reconsideration is filed, approval will be suspended.

The request for reconsideration should be supported with an explanation of the reasons for the challenge and should be signed by a responsible official from the laboratory such as the president/owner for a commercial laboratory, the laboratory supervisor of a municipal laboratory, or the laboratory director for a State or Regional laboratory.

The Approval Authority will make a decision and notify the laboratory in writing, generally within 30 days of receipt of the request for reconsideration. If the request is determined to be valid, the Approval Authority will take appropriate measures to reevaluate the facility and notify the laboratory, in writing, of its decision, generally within 60 days of the reevaluation.

Denial of the request will generally result in suspension of the laboratory's approval. Once approval is suspended, a public water system may not use the laboratory to analyze source water samples for compliance with LT2ESWTR source water monitoring requirements. The laboratory should notify its clients that it is no longer approved and will not accept any more LT2ESWTR samples for analysis.

Upgrading or Reinstatement of Approval

Subject to the availability of resources, the Approval Authority will consider written requests from the laboratory to seek upgrading or reinstatement of approval. Requests should state the reasons why the laboratory should regain its approval status. The laboratory should demonstrate that all deficiencies have been corrected and successfully complete two consecutive authorized PT test events within acceptance limits for Provisionally Approved laboratories or three consecutive authorized PT test events within acceptance limits for suspended laboratories. The authorized PT test events being described here are those submitted to all laboratories in the Lab QA Program, not special issue blind samples purchased independently from the vendor. The laboratory should provide evidence why the reasons for downgrading or suspension are no longer applicable and explain its technical competence. Acceptable demonstration of technical competence may include an on-site evaluation and/or any other measure the Approval Authority deems appropriate. The Approval Authority will consider compliance history, corrective actions implemented by the laboratory, effectiveness of corrective actions, and professional judgment of the Approval Authority.

Grievances

Laboratories with grievances during the authorized PT events or regarding participation in the Lab QA Program should immediately contact the Program Manager at the Approving Authority and try to remedy the problem. When the laboratory feels they have not gotten immediate or satisfactory results, they should contact the supervisor at the Approving Authority. The management at the Approving Authority will work with the Program Manager to quickly address grievances. A final decision for all grievances will be made generally within 30 days of contacting the Approving Authority.

Request for Comment

The EPA is soliciting comments on this notice to:

1. 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;

2. 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;

3. Enhance the quality, utility, and clarity of the information to be collected;

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

5. Consider any necessary changes to the Lab QA Program. As an example, EPA is particularly interested in comments from States regarding the potential for their laboratory programs to assume any/all responsibility for the approval and oversight of LT2ESWTR laboratories, including comments on the appropriate timeframes for such. The Agency also welcomes comments regarding the appropriateness of turning to commercial PT providers as the source of PT samples for laboratories, in lieu of the PT program currently administered by the Agency.

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. An estimated 65 respondents will participate in an average of 4.4 responses per year to include: analysis and reporting of PT samples three times per year, application for initial or re-audit once every three years, off-site re-evaluation activities once every three years, and on-site evaluation once every three years. A small subset of laboratories will perform follow-up activities based on inadequate QA/QC, failed OPRs, incomplete records, delayed communication to EPA or poor PT results. A few laboratories perform more than one method version and will analyze an additional set of PT samples three times per year. The total annual public reporting and recordkeeping burden for this collection of information is estimated to be 4843 hours at a cost of $269,800.40. The average hours and cost per response for the average of 4.4 responses per year are 16.9 hours and $943.36, respectively. These estimates assume 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 cost is $0.00. The total estimated Operation and Maintenance (O&M) costs is $141,929.00.

The ICR provides a detailed explanation of the Agency's estimate, which is only briefly summarized here:

Estimated Total Number of Potential Respondents: 65.

Frequency of Response: Annual.

Estimated Total Average Number of Responses for Each Respondent: 4.4.

Estimated Total Annual Burden Hours: 4843 hours.

Estimated Total Annual Costs: $411,729.40. This includes an estimated burden cost of $269,800.40 and an estimated cost of $141,929.00 for capital investment or maintenance and operational costs.

Are There Changes in the Estimates From the Last Approval?

Changes in burden have occurred due to inflation, re-evaluation of hours for tasks, and improved demonstration of capability. Inflation has increased all operation and maintenance and labor costs accordingly. The increase in the respondent universe has increased the overall burden costs for the respondents. EPA's original estimates for hours to participate and maintain the Lab QA Program were made before the program began. Because the program has matured and several years of QC data have been collected, the burden has changed for performing improved and refined procedures. The burden for some tasks has been estimated and will be re-evaluated as the program progresses. EPA has added the preceding section entitled “Clarification of Basis and Procedures for Downgrading/Suspending Approval for Laboratories for the Analysis of Cryptosporidium in Water Under the Long Term 2 Enhanced Surface Water Treatment Rule.” Some approved laboratories may have to undertake additional activities to demonstrate continued acceptable performance to EPA, which may increase the burden of participation in the Lab QA Program for those laboratories. EPA estimates that nine laboratories per year may have to undertake additional activities to demonstrate acceptable performance to EPA. These estimates will be corrected as the program continues.

What is the Next Step in the Process for This ICR?

EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. At that time, EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the technical person listed under FOR FURTHER INFORMATION CONTACT.

Dated: February 19, 2009.

Cynthia C. Dougherty,

Director, Office of Ground Water and Drinking Water.