Updates to ELAP’s Wastewater Fields of Accreditation Due to the Clean Water Act Methods Update Rule (MUR) - 2021
In July of 2021, the US EPA promulgated changes to the Code of Federal Regulations, title 40, part 136. At the request of the State Water Resources Control Board Quality Assurance Officer, the Environmental Laboratory Accreditation Program (ELAP) updated non-potable water Field of Accreditation (FOA) Tables to reflect these changes, including adding newly approved methods and removal of old methods no longer approved by the US EPA.
ELAP does not expect all laboratories to be ready to update their accreditations immediately and is offering laboratories the ability to submit amendment applications when they are ready. Laboratory Certificates will not change until action is taken by the laboratory. The laboratory’s current FOAs will remain unchanged until:
- The laboratory amends its accreditation to add the newly offered methods, or
- The laboratory’s current certificate expires, and the laboratory is unable to renew the older edition of the method which ELAP no longer offers.
Some methods have a newer edition promulgated in 40 CFR 136, and ELAP will remove the older edition on February 1, 2024. Laboratories are encouraged to review the 2021 MUR FOA Changelog which identifies FOAs that have an older edition that will be replaced. To obtain accreditation for any of the FOAs added or replaced due to the 2021 MUR, laboratories must file an amendment application. Laboratories may file an amendment application at any time, and amendment applications will not remove old FOAs from the laboratory’s certificate. Before submitting an amendment application, laboratories must create or update any affected Standard Operating Procedures, Quality Manual, and perform proficiency test studies using the new/updated procedures. This will ensure that the method the laboratory uses and will report to clients matches the method the laboratory is seeking for accreditation.
ELAP is maintaining FOA Tables containing the old methods until February 1, 2024, to allow for additional time for laboratories to submit an amendment application. ELAP is also offering a one-time on-site assessment waiver and reduced fee for some methods if certain requirements are met. It is the laboratory’s responsibility to identify which methods ELAP will no longer be offering for accreditation.
Important Documents
This document identifies all FOAs that are being replaced, and identifies the FOAs for newly added alternative test procedures (ATPs). It does not include reference to FOAs which remain unchanged:
This document may be used in leu of an on-site assessment for FOAs identified with a replacement in the 2021 MUR FOA Changelog. Laboratories must complete the waiver in its entirety to be eligible for the waiver:
Special On-Site Assessment Waiver for FOAs changed by the 2021 MUR
This document identifies the naming convention used by ELAP and future Water Board databases. While ELAP makes efforts to update all FOAs to match this convention, some may be dictated by state agency requirements:
2021 MUR Application Information
To add or update the laboratory’s scope of accreditation to reflect the new methods approved by the US EPA in the 2021 MUR, laboratories are required to submit an amendment application. Amendment applications may be filed at any time, regardless of the renewal cycle, provided that all requirements are met. ELAP is offering on-site assessment waivers to laboratories who hold accreditation for a method that is being replaced/updated because of the 2021 MUR, and also provides eligibility for an amendment application discount. All items must be complete in the on-site assessment waiver for a laboratory to be considered, and the waiver form should be submitted with the laboratory’s application.
ELAP expects a larger influx of amendment applications with the waiver form. While ELAP will review these applications in the order submitted, our priority is to process applications vital to a laboratory’s ability to do work first, those being renewal applications and amendments to reinstate denied applications. If you have not received a notice from ELAP accepting your amendment application within 3 weeks, contact elapca@waterboards.ca.gov to follow up on the status of your application.
Relevant Application Forms
On-Site Assessment Waiver for “Replaced” FOAs - MUST be included with application.
Select the “Amendment” Application on the Application Webpage.
Updated Non-potable Water FOA Tables
Select FOA Tables on the Application Webpage.
Guidance and Specifics of Changes
Changes to Method Versions
The US EPA’s changes to 40 CFR 136 require laboratories to use specific method versions highlighted in the examples below. Several method versions are replaced by newer method versions, the scope of which can be found in 2021 MUR FOA Changelog . The replaced method versions identified in the 2021 MUR FOA Changelog are eligible for the on-site assessment waiver. Below are examples of methods promulgated by the US EPA.
| Old Method Offered | New Method Offered | Analyte Tested |
|---|---|---|
| SM 9223 B-2004 Colilert | SM 9223 B-2016 Colilert | E. coli (Enumeration) |
| SM 2540 C-2011 | SM 2540 C-2015 | Residue, Filterable (TDS) |
| ASTM D6919-09 | ASTM D6919-17 | Ammonia (as N) |
| ASTM D7511-12 | ASTM D7511-12(17) | Cyanide, Total |
NOTE: This is not a comprehensive list, and laboratories are encouraged to compare their current certificate against changes made. The 2021 MUR FOA Changelog highlights all changes, both replaced method versions and newly added methods.
NOTE: The 2021 MUR also specifies the versions of the Standard Methods Quality Assurance and Quality Control sections that laboratories must use. While the specific method version may not change, laboratories must review their documents to ensure that Standard Operating Procedures or their Quality Manual reference and reflect the appropriate section.
New Methods Offered and Removed Methods
As part of the 2021 MUR, the US EPA also approved several new methods through their Alternative Test Procedure (ATP). The State Water Resources Control Board Quality Assurance Officer reviewed and requested ELAP to offer several ATP methods now posted on ELAP’s Fields of Accreditation Tables. Newly added methods require the laboratory to submit a complete amendment application, including an on-site assessment with approved corrective action plan. The special on-site assessment waiver does not extend to any of the newly added methods.
One method was removed from 40 CFR 136 and is no longer approved for use. The method SM 9222 G-2006 is no longer approved to test for E. Coli, and laboratories will be unable to renew this Field of Accreditation. Laboratories who currently hold accreditation will keep it on their certificate until the certificate expires.
Proficiency Testing Reporting Requirements
To obtain or maintain accreditation for any FOA, laboratories are required to have a corresponding PT result which matches the method(s) the laboratory used to generate the result. The PT must:
- be completed for the appropriate matrix (i.e., a Water Pollution PT for wastewater)
- identify which method(s) the laboratory is using to conduct analysis.
- be reported in such a way that matches the FOAs ELAP offers.
To obtain accreditation, PTs must be completed for all FOAs for which the laboratory intends to apply, as identified on the FOAs on ELAP’s MUR FOA table.
To retain accreditation, PTs must be completed for all FOAs for which the laboratory currently holds accreditation, as listed on the laboratory’s certificate.
The method the laboratory reports must match the FOA the laboratory is seeking to include on its certificate, or the PT results will not be accepted. Laboratories wishing to obtain new method versions and maintain old method versions must have a PT result which matches each FOA the laboratory intends to have listed on its certificate. ELAP recommends that laboratories write in the method description, so it matches the FOA(s) on our FOA tables if the PT provider does not have the method available in their drop-down menu.
Timeline for Compliance
The regulatory agencies receiving the data may have alternative timelines for their regulated entities. ELAP suggests contacting clients to verify when your laboratory needs to add the new methods to your certificate.
Laboratories must submit an amendment application to add MUR or New FOAs to their certificate, including for the methods that are being “replaced” by a newer method version. Amendment applications will not remove FOAs from a laboratory’s certificate; If a laboratory wishes to remove any of the older FOAs, they may request ELAP to do so by email or in the cover letter of an amendment applications, however, ELAP recommends requesting removal once the laboratory has completed the amendment application. Amendment applications may be filed whenever the laboratory is ready to update its certificate, regardless of when the renewal application is due. Because of the changes to US EPA approved method versions, the challenges with scheduling an on-site assessment and ordering Proficiency Tests, ELAP will keep the old FOA Tables on the website until February 1, 2024.
ELAP encourages laboratories to amend their certificate with the new 2021 MUR methods as soon as they are ready and is offering one-time on-site assessment waivers for some methods if certain requirements are met. These waiver forms should be submitted with the laboratory’s amendment application. For more information, review the 2021 MUR OSA Waiver.
If Your Renewal Application is Due Before February 1, 2024
- You may file an amendment application at any time to add the new FOAs to your certificate.
- Amendment application PTs should identify the methods the laboratory is seeking to add to your certificate.
- Laboratories must submit an amendment application to add any FOAs to their Scope of Accreditation
Example: Laboratory A’s current certificate expires on December 31, 2023. Laboratory A submits an amendment application with the on-site assessment waiver using the 2021MUR FOA Tables.
- ELAP will only accept renewal applications using the OLD FOA Tables
- Renewal application PTs should identify the methods the laboratory currently has on your certificate.
Example: Laboratory B’s current certificate expires on October 31, 2023, but is not ready to amend their accreditation. Laboratory B submits a renewal application using the OLD FOA Tables, following the guidance provided in the ELAP Timeline Guidance Tool, and files an amendment application in March 2024.
If Your Renewal Application is Due Before February 1, 2024, AND You Have Already Completed Your Amendment Application to add the 2021 MUR Methods to your Accreditation
- ELAP will accept renewal applications using either the OLD or NEW FOA Tables
- You may need to submit both if you wish to maintain both the old and new FOAs on your certificate.
- Renewal application PTs should identify the method(s) the laboratory wishes to keep on your certificate.
Example: Laboratory A already submitted its amendment application before its renewal deadline in the ELAP Timeline Guidance Tool, and has a certificate that lists both old and replaced method versions on their amended certificate. Laboratory A submits their renewal application using the 2021MUR FOA Tables because they match the FOAs listed on their certificate. The replaced FOAs on Laboratory A’s certificate are removed because the laboratory chooses to not select the old FOAs.
If Your Renewal Application is Due After February 1, 2024
- ELAP suggests filing an amendment application before your renewal application is due.
- You may file both the renewal and amendment applications at the same time, however, both application forms must be filled out and emailed separately to elapCA@waterboards.ca.gov
- Your laboratory may only renew methods that are both listed on your expiring certificate and ELAP’s new FOA tables.
- Laboratories will be unable to renew methods ELAP no longer lists on our FOA Tables
- Your renewal application will be denied if you select FOAs not on your certificate, even if you held an older version of that method.
- Laboratories must submit an amendment application to add any FOAs to their Scope of Accreditation
Example: Laboratory C did not submit an amendment application to add the replaced FOAs to their certificate. Laboratory C may not use the renewal application to attempt to add the replaced FOAs to their certificate, and the laboratory’s application will be denied for the FOAs which do not match the FOAs on their prior certificate. To avoid this situation, ELAP recommends filing an amendment application before your renewal application is due.
For all situations identified above, Annual PT requirements remain unaffected. PTs must be completed by your laboratory’s annual fee deadline (before the end of year 1 of the certificate) and must be completed for all FOAs on your certificate. The method the laboratory reports must match the FOA the laboratory has or is seeking to include on its certificate, or the PT results will not be accepted. Laboratories wishing to maintain both new method versions and old method versions must have a PT result which matches each FOA the laboratory intends to have listed on their certificate.
