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Water: Information Collection

Fact Sheet 2: Laboratory Approval

United States Environmental Protection Agency
Office of Water
May 1996

ICR Implementation
EPA ICR Fact Sheet Series

The final Information Collection Rule (ICR) was published in the Federal Register on May 14, 1996. This FR notice finalizes requirements for monitoring microbial contaminants and disinfection byproducts by large public water systems (PWSs). It also requires large PWSs to provide operating data and a description of their treatment plant design. Finally, it requires large PWSs to conduct either bench- or pilot-scale testing of advanced treatment techniques.
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
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.

Approval vs. certification
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.
Approved labs list
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).
QC data entry software
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.
Two separate lab approval processes
There are two separate and distinct laboratory approval processes, one for the chemistry laboratories and one for the microbiological laboratories. They are described below:

ICR Lab Coordinator

1. 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

Customized laboratory application package
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.

Third PE Study in July 1996

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, HAAs, TOX, TOC, UV, Br-, ClO2-, ClO3-, 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 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

2. ICR Laboratory Approval for Microbiology

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:

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.

Lab requirements
  • Only laboratories that meet the minimal facility, equipment and personnel requirements described in the application package will be considered for approval.

QC samples
  • 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.

PE samples
  • Qualified laboratory personnel must satisfactorily analyze PE sample sets to become approved and then subsequent PE sets for on-going approval.

On-site lab evaluation
  • 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.

Coliform and E. Coli
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 for protozoa and viruses
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.
For more information
Contact the Safe Drinking Water Hotline, 1-800-426-4791.

Federal Register Notice on May 14, 1996


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