Fact Sheet 2: Laboratory 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.

ICR Lab Coordinator

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:

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.

Third PE Study in July 1996

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 DBP, 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.

Micro lab approval

The current drinking water laboratory certification program does not address analyses for Giardia, Cryptosporidium and total culturable 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:

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.

• 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.