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Laboratories
Related Links
- List of approved laboratories PDF (5 pp, 77 K) (About PDF)
- Laboratory registration begins August 22, 2005
- Schedule deadlines for registration from final rule
- Complete and submit registration material by April 4, 2007
- Complete and submit application by August 27, 2007
- See the reporting page for more information.
EPA requires water systems use EPA-approved laboratories for the analysis of the 25 contaminants. All laboratories conducting analyses for Unregulated Contaminant Monitoring Regulation 2 (UCMR 2) must be approved by EPA.
The Laboratory Approval Program is voluntary and applies only to laboratories intending to analyze UCMR 2 samples. Laboratories planning to conduct analyses must first successfully complete the registration and application process according to the specified schedule, and receive formal written approval from EPA. Laboratories are encouraged to apply for approvals as early as possible.
Step-by-Step Laboratory Approval Process
The laboratory approval process is designed to assess whether laboratories meet the required equipment, laboratory performance, and data reporting criteria described under UCMR 2. With the exception of EPA Method 525.2, the methods do not currently have an established certification program. Applicants already certified by their state, primacy entity, or accredited through the National Environmental Laboratory Accreditation Conference (NELAC) to conduct drinking water analyses using Method 525.2 must still perform the UCMR 2 approval steps, including the related Proficiency Testing (PT).
The steps for the laboratory approval process are:
- Step 1. Request to Participate/Registration: Laboratories interested in the Laboratory Approval Program must send a letter to EPA requesting to participate in the program. In response, EPA will send the registration material. Laboratories must complete and submit their registration materials no later than 90 days after publication in the Federal Register (i.e., April 4, 2007). The registration information allows EPA to provide each laboratory with a customized application package that includes materials and instructions for the methods.
- UCMR 2 Laboratory Approval Coordinator
USEPA, Technical Support Center
26 West Martin Luther King Drive (MS 140)
Cincinnati, OH 45268
- UCMR 2 Laboratory Approval Coordinator
- Step 2. Application Package: The customized package includes a separate application for each of the methods selected in the registration, and a copy of the UCMR 2 Laboratory Approval Manual. Please return the completed applications as soon as possible, but please note that the applications must be submitted to EPA no later than 210 days after publication in the Federal Register (i.e., August 27, 2007). EPA will send a postcard to the laboratory upon receipt of the completed application material. Required application information will include:
- Precision, accuracy and minimum reporting level (MRL) studies for the analyses in question, and supporting documentation/chromatograms
- Documentation of state/regional certification or NELAC accreditation for one or more drinking water compliance analyses, and certification or accreditation for selected methods when requested on the application
- Personnel and quality assurance information (including the Table of Contents from the laboratory Quality Management Plan)
- Description of analytical equipment and sample handling procedures
- Step 3. EPA Review of Application Package: EPA will review the application package and, if necessary, request follow-up information. When EPA determines that the laboratory's application for a specific method meets the UCMR 2 method criteria, we will notify the laboratory in writing of its acceptable application. Once acceptable, the laboratory can participate in the PT studies for that method.
- Step 4. Proficiency Testing:Laboratories must successfully analyze PT sample(s) for each method for which they seek approval. EPA intends to offer laboratories at least three opportunities to successfully analyze the PT samples. Laboratories need only demonstrate performance through successful analysis of one set of PT samples (per method). No PT studies are expected to be conducted after the start of monitoring.
- Step 5. Written EPA Approval: Laboratories that successfully complete the above steps will be notified in writing of their approval. Approval to perform analyses is made on a method-by-method basis.
Maintaining Laboratory Approval
Approved laboratories must adhere to the quality assurance/quality control (QA/QC) procedures and criteria outlined in the method(s) and rule language to maintain their approval status. Laboratories must also post occurrence data, and required QC data electronically via the Safe Drinking Water Accession and Review System (SDWARS) within 120 days of sample collection date. Failure to post data using SDWARS may result in EPA revoking the laboratory's approval status. Once a laboratory is disapproved, it cannot be re-approved during the UCMR 2 monitoring period. Laboratories applying for approval and laboratories conducting analyses may be subject to on-site laboratory audits.
Links
- Methods - List of contaminants and corresponding analytical methods
- Reporting - Information on reporting requirements, data elements, and the electronic reporting system, SDWARS
- Statistical Protocol for the Determination of the Single-Laboratory Lowest Concentration Minimum Reporting Level (LCMRL) and Validation of Laboratory Performance at or Below the Minimum Reporting Level (MRL) - Protocol for developing lowest concentration MRLs (LCMRLs) and deriving MRLs from the LCMRL; and a downloadable tool to calculate LCMRLs
- UCMR 2: Frequently Asked Questions PDF (9 pp, 31 K) (About PDF)