[Federal Register Volume 67, Number 42 (Monday, March 4, 2002)]
[Notices]
[Pages 9731-9734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-5078]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-7152-6]


Laboratory Quality Assurance Evaluation Program for Analysis of 
Cryptosporidium Under the Safe Drinking Water Act; Agency Information 
Collection: Proposed Collection; Comment Request

AGENCY: Environmental Protection Agency.

ACTION: Notice; request for comment.

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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

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via electronic mail (e-mail) to Mary Ann Feige, EPA, Office of Ground 
Water and Drinking Water, [email protected], 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.

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 
[email protected] 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, [email protected].

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 [email protected]. 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

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reliably 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

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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.
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 [email protected], 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.


    Dated: February 25, 2002.
Diane C. Regas,
Acting Assistant Administrator, Office of Water.
[FR Doc. 02-5078 Filed 3-1-02; 8:45 am]
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