United States
              Environmental Protection
              'Agency
       Office of Water
       4601
EPA/814-F-96-002
May 1996
4>EPA   ICR  Implementation
             EPA ICR Fact Sheet Series
            #2 -Laboratory Approval
                              This fact sheet summarizes the laboratory approval requirements
                              for the Information Collection Requirements (ICR) Rule as
                              promulgated in May 1996.
      ICR needs data of known
      accuracy and precision
     Approval vs. certification
     Approved labs list
     QC data entry software
Lab Approval

The Reg-Neg Advisory Committee determined that in order to
meet the ICR objectives, data must meet specific accuracy and
precision requirements. The committee also determined that to
ensure useable data, EPA must identify qualified laboratories to
perform the required analyses for public water systems.

Laboratories are normally certified to perform drinking water
analyses by the Primacy Agency responsible for enforcing the
regulations. Since the ICR is a direct implementation rule, EPA
cannot require states to certify laboratories for ICR compliance
monitoring. Therefore, EPA has established a national laboratory
approval process as part of the ICR which is distinct from the
drinking water laboratory certification program.

List of Approved Labs - Laboratory approval decisions will be
made based on EPA's review of the completed application
packages and the performance evaluation (PE) study data. An
initial list containing the names of the "approved" laboratories will
be mailed to applicable ICR water systems. The list will be
updated periodically (contact the Safe Drinking Water Hotline for
the most current list).

Lab Data System - EPA is developing laboratory quality control
(QC) data entry software (similar to that developed for the utilities)
to be used by the approved laboratories to report QC data to EPA.
EPA will provide the software to all approved laboratories.

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 Two separate lab approval
 processes
 ICR Lab Coordinator
 Customized laboratory
application package
Third PE Study in July
1996
 There axe two separate and distinct laboratory approval processes,
 one for the chemistry laboratories and one for the microbiological
 laboratories. They are described below:

 ICR Laboratory Approval for Chemistry

 Laboratories that intend to perform chemical analyses during the
 18-month monitoring period or to perform the TOC monitoring to
 determine applicability for the bench- and pilot-scale treatment
 studies must initiate the approval process by writing to:

       ICR Laboratory Coordinator (Chemistry)
       Technical Support Division/USEPA
       26 W. Martin Luther King Jr. Drive
       Cincinnati, OH 45268

 EPA will then send a registration form to the laboratory on which
 the lab will indicate the analyses for which they are seeking
 approval. Upon receipt of the registration form, EPA will send a
 customized application package to the laboratory requesting
 information regarding the lab's qualifications and capability. This
 information will be used by EPA to review and evaluate the lab's
 qualifications. On-site inspections may also be conducted on a
 sample of the applying laboratories.

 Laboratories that have state certification or approval to perform
 specific ICR analyses (e.g., pH, chlorine residuals,
 trihalomethanes, etc.) will be approved after they provide
 documentation to verify their certification/approval. Approval to
 perform ICR analyses not covered by state evaluation processes
 (e.g., HAAs, TOC, etc.) will be contingent upon successful
 demonstration of capabilities through submission of an application
 and participation in PE studies.

 After Promulgation - EPA will mail registration and application
packages to laboratories requesting approval after promulgation.
 Initial requests will be honored for up to six (6) months after
promulgation and the laboratories will be given approximately
three (3) months to submit completed applications.

PE Samples - two ICR Chemistry PE Studies have been
completed and a third will be conducted in July 1996.  These
studies include the following parameters: THMs, HANs, CH,

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Micro lab approval
Lab requirements
QC samples
HAAs, TOX,; TOC, UV, Br, CIO,', C1O3-, and BrO3-. Laboratories
that receive approval to perform these analyses for the ICR will
also be required to successfully participate in quarterly PE studies
beginning shortly before and continuing throughout the 18-month
monitoring period.

Maintaining Lab Approval - Laboratories approved to perform
general water quality analyses (e.g., pH, chlorine residuals, etc.)
based on state certification/approval are required to maintain state
approval during the course of the 18-month monitoring period.
Laboratories approved to perform DBF, Br, TOC and UV analyses
must meet specific QC and PE study requirements during the 18-
month monitoring period in order to maintain lab approval.

ICR Laboratory Approval for Microbiology

The current drinking water laboratory certification program does
not address analyses for Giardia, Cryptosporidium and total cultur-
able viruses. Therefore, EPA has developed a separate program for
the ICR, using the term "laboratory approval" rather than
"laboratory certification."  Laboratory approval will require: (1)
submission and acceptance of an application for approval,  (2)
satisfactory analysis of unknown Performance Evaluation (PE)
samples; and (3) passing an on-site laboratory  evaluation. The
laboratory approval process for pathogen testing will begin when
the laboratory director makes a formal request for approval to the:

       ICR Laboratory Coordinator (Microbiology)
       USEPA, Office of Ground Water & Drinking Water
       Technical Support Division
       26 West Martin Luther King Drive
       Cincinnati, OH  45268

Requests may be made up to three (3) months  after promulgation.
Following receipt of requests  for approval, EPA will send an
application package to the laboratory.
•     Only laboratories that meet the minimal facility, equipment
       and personnel requirements described in the application
       package will be considered for approval.
•      Quality Control (QC)  samples containing known Giardia
       cyst,: Cryptosporidium oocyst or virus concentrations will
       be provided to analysts requesting approval who have
       successfully completed the application. QC samples will
       be used as part of an on-going approval process.

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 PE samples
 On-site lab evaluation
 Coliform and E. Coli
Maintaining lab approval
for protozoa and viruses
For more information
 •      Qualified laboratory personnel must satisfactorily analyze
        PE sample sets to become approved and then subsequent
        PE sets for on-going approval.
 •      Laboratory on-site evaluation will be conducted to evaluate
        the facilities and equipment of the laboratory and the
        analyst's ability to adhere to the monitoring protocols. The
        use of uniform methodology makes it possible to compare
        data generated by the different laboratories.
 Laboratories that desire to perform quantitative analyses for total
 coliforms and fecal coliforms or E. coli in source water and
 drinking water must provide validation of certification under the
 drinking water laboratory certification program. A Verification of
 State Certification form will be included in the application package
 for these laboratories to complete and forward to EPA.

 Maintaining Lab Approval - Laboratories approved to perform
 general microbial analyses (e.g., coliforms, E. coli, etc.) based on
 state certification/approval are required to maintain state approval
 during the course of the 18-month monitoring period.  Laboratories
 approved to perform protozoa and virus analyses must meet
 specific QC and PE study requirements during the 18-month
monitoring period in order to maintain lab approval.

Contact the Safe Drinking Water Hotline, 1-800-426-4791.

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