Laboratory Approval Program for the Unregulated Contaminant Monitoring Rule (UCMR 5)
- Basic information about the UCMR 5 laboratory approval program
- Step-by-step laboratory approval process
- Maintaining laboratory approval
Basic information about the UCMR 5 laboratory approval program
NOTICE: The UCMR 5 laboratory approval program is officially closed, as of December 9, 2022, the completion date of the final Proficiency Testing (PT) study.
The “UCMR 5 laboratory approval program” applies to all laboratories that analyze samples for the fifth Unregulated Contaminant Monitoring Rule (UCMR 5). Laboratories were encouraged to apply for method-specific UCMR 5 approval as early as possible, as public water systems that collected samples in the first year of monitoring made arrangements for sample analysis in 2022. Laboratories that successfully completed a registration and application process received approval from EPA. See the discussion of step-by-step process for deadlines.
UCMR 5 approved laboratories that were interested in analyzing samples for small public water systems (those serving 10,000 or fewer people) competed via EPA's contract procurement process and contracts have been awarded.
EPA approved laboratories for UCMR 5.
The laboratory approval program was designed to assess whether laboratories met the requirements described under UCMR 5 for:
- Equipment
- Laboratory performance
- Data reporting
Step-by-step laboratory approval process
Applicants already certified for UCMR 5 methods by their state or EPA Region to conduct drinking water analyses still needed to complete EPA's UCMR 5 approval steps. Laboratories that participated in the UCMR 5 laboratory approval program, registered and completed the necessary application materials by August 1, 2022. The steps for the laboratory approval process were:
1. Request to participate
Laboratories emailed [email protected] and requested registration materials.
2. Registration
Laboratory applicants provided the following registration information: laboratory name, mailing address, shipping address, contact name, phone number, email address and a list of the UCMR 5 methods, for which the laboratory sought approval. This registration step provided EPA with the necessary contact information and ensured that each laboratory received a customized application package. The final opportunity for a laboratory to complete and submit the necessary registration and application information was August 1, 2022.
3. Application package
Laboratory applicants then completed and returned a customized application package that included the following: initial demonstration of capability (IDC) data, including precision, accuracy and results of MRL studies; information regarding analytical equipment and other materials; proof of current drinking water laboratory certification (for select compliance monitoring methods); method specific SOPs; and example chromatograms for each method under review.
As a condition of maintaining approval, the laboratory must promptly post UCMR 5 monitoring results and quality control data that meet method criteria (on behalf of its PWS clients) to EPA's UCMR electronic data reporting system, the Safe Drinking Water Accession and Review System (SDWARS).
4. EPA’s review of application package
EPA reviewed the application packages and, if necessary, requested follow-up information. Laboratories that successfully completed the application process became eligible to participate in the UCMR 5 PT program.
5. Proficiency testing
A PT sample is a synthetic sample containing a concentration of an analyte or mixture of analytes that is known to EPA, but unknown to the laboratory. All approved laboratories met specific acceptance criteria for the analysis of a UCMR 5 PT sample(s) for each analyte in each method, for which the laboratory sought approval. EPA held eight studies prior to the start of sampling.
Laboratories participated in and reported data for at least two PT studies. This allowed EPA to collect a robust data set for PT results, and provided laboratories with extra analytical experience using UCMR 5 methods. Laboratories passed a PT for every analyte in the method to be approved for that method. EPA does not expect to conduct additional PT studies after the start of PWS monitoring; however, laboratory audits will likely be ongoing throughout the implementation of UCMR 5. Initial laboratory approval was contingent on successful completion of PT studies, which included properly uploading the PT results to SDWARS. Continued laboratory approval is contingent on successful completion of the audit process and satisfactorily meeting all the other stated conditions.
6. Written EPA approval
After a laboratory successfully completed steps 1 through 5, EPA then sent a letter listing the methods, for which the laboratory was approved.
Maintaining laboratory approval
Approved laboratories must adhere to the quality assurance and quality control procedures and criteria outlined in the method(s) and rule language to maintain their approval status.
Under UCMR 5, laboratories are required to post sample data and required quality control data electronically via the Safe Drinking Water Accession and Review System (SDWARS) within 90 days of sample collection date.
Once a laboratory is disapproved, EPA does not anticipate any opportunity for reinstatement during the UCMR 5 monitoring period. Approved laboratories are subject to on-site laboratory and/or off-site (paper) audits.