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Notice

Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium

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AGENCY:

Environmental Protection Agency.

ACTION:

Notice; request for comment.

SUMMARY:

Today's notice invites comment on the U.S. Environmental Protection Agency's (EPA's) proposed Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium under the Safe Drinking Water Act (Lab QA Program) (Section I). EPA also plans to submit to the Office of Management and Budget (OMB) for review and approval an Information Collection Request (ICR) associated with information collections under the proposed Lab QA Program (Section II). EPA is requesting comments on specific aspects of the proposed Lab QA Program and the ICR. Finally, EPA solicits comments on its intention to seek an emergency clearance from OMB to begin collecting data from laboratories that are interested in participating in the Lab QA Program prior to OMB's final approval of the ICR.

DATES:

The Agency requests comments on today's notice. Comments must be received or post-marked by midnight May 3, 2002. If EPA does not receive adverse comments on or before April 3, 2002 regarding EPA's request for an emergency clearance, the Agency intends to seek a 90-day emergency clearance from OMB to begin collecting data from laboratories that are interested in participating in the Lab QA Program.

ADDRESSES:

Please send an original and three copies of your written comments and enclosures (including references) to the W-01-17 Comment Clerk, Water Docket (MC-4101), EPA, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. Due to the uncertainty of mail delivery in the Washington, DC area, in order to ensure that all comments are received please send a separate copy of your comments Start Printed Page 9732via electronic mail (e-mail) to Mary Ann Feige, EPA, Office of Ground Water and Drinking Water, feige.maryann@epa.gov, or mail to the attention of Mary Ann Feige, EPA, Technical Support Center, 26 West Martin Luther King Drive (MS-140), Cincinnati, Ohio 45268. Hand deliveries should be delivered to: EPA's Water Docket at 401 M Street, SW., Room EB57, Washington, DC 20460. Please make certain to reference EPA ICR No. 2052.02 and OMB Control No. 2040-0229.

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FOR FURTHER INFORMATION CONTACT:

For a copy of the ICR, contact Sharon Gonder at EPA by phone at (202) 564-5256 or by email at gonder.sharon@epa.gov or download off the Internet at http://www.epa.gov/​icr and refer to EPA ICR No. 2052.02. For technical inquiries, contact Mary Ann Feige, 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, feige.maryann@epa.gov.

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SUPPLEMENTARY INFORMATION:

Submission of Comments

Individuals who want EPA to acknowledge receipt of their comments should enclose a self-addressed, stamped envelope. No facsimiles (faxes) will be accepted. Comments may also be submitted electronically to ow-docket@epamail.epa.gov. Electronic comments must be submitted as an ASCII, WP5.1, WP6.1 or WP8 file avoiding the use of special characters and form of encryption. Electronic comments must be identified by docket number W-01-17. Comments and data will also be accepted on disks in WP5.1, 6.1, 8 or ASCII file format. Electronic comments on this notice may be filed online at many Federal Depository Libraries.

Availability of Docket

The record for this notice has been established under docket number W-01-17, and includes supporting documentation as well as printed, paper versions of electronic comments. The record is available for inspection from 9 a.m. to 4 p.m., Monday through Friday, excluding legal holidays at the Water Docket, EB 57, EPA Waterside Mall, 401 M Street, SW., Washington, DC 20460. For access to docket materials, please call (202) 260-3027 to schedule an appointment.

Section I: Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium Under the Safe Drinking Water Act

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 is to address risk from microbial pathogens, specifically Cryptosporidium, and the Stage 2 DBPR is to address risk from disinfection byproducts. 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 intends to take into account the Committee's advice and recommendations embodied in the Agreement when developing the regulations.

To support Cryptosporidium monitoring under the LT2ESWTR, the Committee Agreement recommended that “compliance schedules for the LT2ESWTR * * * be tied to the availability of sufficient analytical capacity at approved laboratories for all large and medium-size affected systems to initiate Cryptosporidium and E.coli monitoring * * * ” (65 FR 83015, Dec. 29, 2000) (EPA, 2000). Further, the Agreement recommended that Cryptosporidium monitoring by large and medium systems begin within six months following rule promulgation. Given the time necessary for EPA to approve a sufficient number of laboratories to assure adequate capacity for LT2ESWTR monitoring, EPA would need to begin laboratory evaluation prior to promulgation of the rule in order to accommodate such an implementation schedule.

Another factor that warrants initiation of the Lab QA Program prior to promulgation of the LT2ESWTR is grandfathering of monitoring data. The Agreement recommends that systems with “historical” Cryptosporidium data that are equivalent to data that would be collected under the LT2ESWTR be afforded the opportunity to use those “historical” (grandfathered) data in lieu of collecting new data under LT2ESWTR. EPA intends to propose such grandfathering provisions in the LT2ESWTR. If EPA indicates that laboratories meet the criteria in the Lab QA Program described today prior to finalizing the LT2ESWTR, systems could develop monitoring data prior to the LT2ESWTR in anticipation of using it as grandfathered data.

EPA's Office of Ground Water and Drinking Water plans to request from OMB an emergency clearance that would enable expeditious implementation of a voluntary Lab QA Program to support Cryptosporidium monitoring under the LT2ESWTR. As such, the Agency could begin to evaluate laboratories that can reliably measure for Cryptosporidium using EPA Method 1622 and Method 1623. During the effective period of the emergency clearance, EPA intends to submit to OMB for review and approval a final ICR in order to continue data collection for the Lab QA Program.

As part of today's notice, EPA is inviting comment on the Lab QA Program. Under the Lab QA Program, EPA would evaluate 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. The intent of this notice is not to propose establishing the Lab QA Program through a rulemaking. Rather, the criteria described in section I.C. are intended to provide guidance to laboratories that are interested in participating in the Lab QA Program.

EPA has not yet proposed rulemaking on use of such “historical” data nor on the methods themselves under the LT2ESWTR. As noted above, EPA intends to propose allowing systems to use equivalent “historical” data in lieu of collecting new data. EPA anticipates the data generated by labs 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, lab 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 is not establishing the Lab QA Program through rulemaking, but rather as a discretionary and voluntary program under the Safe Drinking Water Act, section 1442 (42 USC 300j-1(a)).

A. What Is the Purpose of the Laboratory Quality Assurance Evaluation Program?

The purpose of the Lab QA Program is to identify laboratories that can Start Printed Page 9733reliably measure for the occurrence of Cryptosporidium in surface water. Existing laboratory certification programs do not include Cryptosporidium analysis. This program is designed to assess and confirm the capability of laboratories to perform Cryptosporidium analyses. The program will assess whether laboratories meet the recommended personnel and laboratory criteria in today's notice. This evaluation program is voluntary for laboratories. In the LT2ESWTR, however, EPA intends to require systems to use approved (or certified) laboratories when conducting Cryptosporidium monitoring under the LT2ESWTR.

B. Why Has EPA Selected Methods 1622 and 1623 as the Basis for Determining the Data Quality of Laboratories That Measure for Cryptosporidium?

EPA Method 1622 and EPA Method 1623 were developed as improved alternatives to the ICR Protozoan Method (EPA, 1996). EPA validated Method 1622 for the determination of Cryptosporidium in ambient water in August 1998 and distributed an interlaboratory validated draft method in January 1999. In addition, EPA validated Method 1623 for the simultaneous determination of Cryptosporidium (and Giardia) in ambient water in February 1999 and distributed a validated draft method in April 1999.

In April 2001, EPA revised and updated Method 1622 (EPA-821-R-01-026) (EPA, 2001a) and Method 1623 (EPA-821-R-01-025) (EPA, 2001b) based on the following: laboratory feedback, the development of equivalent filters and antibodies for use with the methods, and method performance data generated during the ICR Supplemental Surveys (EPA, 2001e). The results of these studies are documented in the Method 1622 interlaboratory validation study report (EPA-821-R-01-027) (EPA, 2001c) and the Method 1623 interlaboratory validation study report (EPA-821-R-01-028) (EPA, 2001d).

C. What Criteria Should I Use To Determine if My Laboratory Should Apply?

A laboratory that is interested in participating in the Lab QA Program currently should be operating in accordance with its QA plan (developed by the laboratory) for Cryptosporidium analyses. In addition, an interested laboratory should demonstrate its capacity and competency to analyze Cryptosporidium using the following recommended criteria:

1. Recommended Personnel Criteria

Principal Analyst/Supervisor (one per laboratory) should have:

  • BS/BA in microbiology or closely related field.
  • A minimum of one year of continuous bench experience with Cryptosporidium and immunofluorescent assay (IFA) microscopy.
  • A minimum of six months experience using EPA Method 1622 and/or EPA Method 1623.
  • A minimum of 100 samples analyzed using EPA Method 1622 and/or EPA Method 1623 (minimum 50 samples if the person was an analyst approved to conduct analysis for the ICR Protozoan Method (EPA, 1996)) for the specific analytical procedure they will be using.
  • Submit to EPA, along with the application package, resumes detailing the qualifications of the laboratory's proposed principal analyst/supervisor.

Other Analysts (no minimum number of analysts per laboratory) should have:

  • Two years of college (or equivalent) in microbiology or closely related field.
  • A minimum of six months of continuous bench experience with Cryptosporidium and IFA microscopy.
  • A minimum of three months experience using EPA Method 1622 and/or EPA Method 1623.
  • A minimum of 50 samples analyzed using EPA Method 1622 and/or EPA Method 1623 (minimum 25 samples if the person was an analyst approved to conduct analysis for the ICR Protozoan Method) for the specific analytical procedures they will be using.
  • Submit to EPA, along with the application package, resumes detailing the qualifications of the laboratory's proposed other analysts.

Technician(s) (no minimum number of technicians per laboratory) should have:

  • Three months experience with the specific parts of the procedure they will be performing.
  • A minimum of 50 samples analyzed using EPA Method 1622 and/or EPA Method 1623 (minimum 25 samples if the person was an analyst approved to conduct analysis for the ICR Protozoan Method) for the specific analytical procedures they will be using.
  • Submit to EPA, along with the application package, resumes detailing the qualifications of the laboratory's proposed technician(s).

2. Recommended Laboratory Criteria

  • Appropriate instrumentation as described in EPA Methods 1622 and 1623 (EPA, 2001a,b).
  • Equipment and supplies as described in EPA Methods 1622 and 1623 (EPA 2001a, 2001b).
  • Detailed laboratory standard operating procedures for each version of the method that the laboratory will use to conduct the Cryptosporidium analyses.
  • Laboratory should provide a current copy of the table of contents of their laboratory's quality assurance plan for protozoa analyses.
  • EPA Method 1622 or EPA Method 1623 initial demonstration of capability (IDC) data, which include precision and recovery (IPR) test results and matrix spike/matrix spike duplicate (MS/MSD) test results for Cryptosporidium. EPA intends to evaluate the IPR and MS/MSD results against the performance acceptance criteria in the April 2001 version of EPA Method 1622 or EPA Method 1623 (EPA, 2001a, 2001b).

D. How Can I Obtain an Application Package?

After the OMB clearance described above, EPA plans to make applications available on EPA's website at www.epa.gov/​safewater/​cryptolabapproval.html. Completed applications should be sent to: EPA's Laboratory Quality Assurance Evaluation Program Coordinator, c/o Dyncorp I&ET, Inc., 6101 Stevenson Avenue, Alexandria, VA 22304-3540. If a laboratory does not have access to the Internet, the laboratory may contact Dyncorp I&ET, Inc. to request an application package.

E. If I Demonstrate My Laboratory's Capacity and Competency According to the Personnel and Laboratory Criteria, What Do I Do Next?

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

1. Upon receipt of a complete package, 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 Start Printed Page 9734times 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.

F. My Laboratory Has Already Submitted Initial Demonstration of Capability (IDC) and Initial Performance Testing (IPT) Data As Part of the EPA Protozoan Performance Evaluation (PE) Program. Do I Have To Perform This Demonstration Testing Again?

No. If a laboratory currently participates in the EPA Protozoan PE Program and acceptable IDC and IPT data have already been submitted (for the version of the method that the laboratory will use to conduct Cryptosporidium analyses), EPA would not expect the laboratory to repeat IDC and IPT analyses.

Section II: Paperwork Reduction Act

The information collection requirements in this notice have been submitted for approval to the OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. An ICR document has been prepared by EPA (ICR No. 2052.02) and a copy may be obtained from Susan Auby by mail at Collection Strategies Division; EPA (2822); 1200 Pennsylvania Ave., NW, Washington, DC 20460, by email at auby.susan@epamail.epa.gov, or by calling (202) 260-4901. A copy may also be downloaded off the internet at http://www.epa.gov/​icr.

Since the EPA would solicit information in application packages, including supporting documentation, analytical data, and other pertinent information from laboratories that are interested in participating in the voluntary Lab QA Program, the Agency is required to submit an ICR to OMB for review and approval. Entities potentially affected by this action include public and private laboratories that wish to be evaluated to determine if they can reliably measure for the occurrence of Cryptosporidium in surface waters that are used for drinking water sources using EPA Method 1622 or Method 1623.

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 recordkeeping burden for this collection of information is estimated for a total of 60 respondents and an average 78 hours per response for a total of 4,676 hours at a cost of $123,650. 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 $133,880.

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.

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 are listed in 40 CFR part 9 and 48 CFR chapter 15.

Comments are requested on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques. Send comments on the ICR to the Director, Collection Strategies Division; EPA (2822); 1200 Pennsylvania Ave., NW., Washington, DC 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th St., NW., Washington, DC 20503, marked “Attention: Desk Officer for EPA.” Include the ICR number in any correspondence. Because OMB is required to make a decision concerning the ICR between 30 and 60 days after March 4, 2002, a comment to OMB is best assured of having its full effect if OMB receives it by April 3, 2002. The final ICR approval notice will respond to any OMB or public comments on the information collection requirements contained in today's notice.

References

EPA. 1996. ICR Microbial Laboratory Manual. Office of Research and Development. EPA/600/R-95/178. April 1996.

EPA. 2000. Stage 2 Microbial and Disinfection Byproducts Federal Advisory Committee Agreement in Principle. Federal Register. Vol. 65, pp. 83015-83024. December 29, 2000.

EPA. 2001a. EPA Method 1622: Cryptosporidium in Water by Filtration/IMS/FA. Office of Water. Washington, DC 20460. EPA-821-R-01-026. April 2001.

EPA. 2001b. EPA Method 1623: Cryptosporidium and Giardia in Water by Filtration/IMS/FA. Office of Water. Washington, DC 20460. EPA-821-R-01-025. April 2001.

EPA. 2001c . Interlaboratory Validation Study Results for Cryptosporidium Precision and Recovery for EPA Method 1622. Office of Water. Washington, DC 20460. EPA-821-R-01-027. April 2001.

EPA. 2001d. Interlaboratory Validation Study Results for the Determination of Cryptosporidium and Giardia Using EPA Method 1623. Office of Water. Washington, DC 20460. EPA-821-R-01-028. April 2001.

EPA. 2001e. Implementation and Results of the Information Collection Rule Supplemental Surveys. Office of Water. Washington, DC 20460. EPA-815-R-01-003. February 2001.

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Dated: February 25, 2002.

Diane C. Regas,

Acting Assistant Administrator, Office of Water.

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[FR Doc. 02-5078 Filed 3-1-02; 8:45 am]

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