About the Environmental Laboratory Accreditation Program (ELAP)
- ELAP Fee Notices will now be sent electronically! – August 30, 2021
- What email address will it be sent to?
- When will I receive my notice?
- Renewal and Annual Notices will be sent approximately three months before the due date.
- Amendment and Late Fee Notices will be sent at the beginning of the month following acceptance of the applicable application.
- Assessment Invoices will be sent when an assessment is scheduled. We are catching up on these notices, so if you haven’t received one yet for an assessment that was already scheduled or performed, don’t worry. You will receive one in the next month or two.
- A Friendly Reminder about Planning Ahead
- Information about Proficiency Testing (PT) Requirements – May 19, 2021
- Laboratories must pass one (1) PT each year for each Field of Accreditation (FOA) for which the laboratory holds accreditation. The requirements for the number of PT’s a laboratory must perform have not changed from the previous regulations.
- Laboratories must pass one PT for each FOA during the first year of its accreditation.
- This is called the “Annual” PT.
- The laboratory must report the method exactly as it is listed on the laboratory’s FOA List.
- The PT results must be submitted to ELAP by the PT Provider. The laboratory does not need to submit the results to ELAP.
- Laboratories must pass one PT during the first 9 months of the second year of its accreditation.
- This is called the “Renewal” PT.
- The laboratory must report the method exactly as it is listed in ELAP’s FOA Table.
- The PT results must be submitted to ELAP by the laboratory with the renewal application90 days before expiration of the certificate. The PT results must also be submitted to ELAP by the PT Provider.
All ELAP Fee Notices will now be sent to the laboratory by email. This includes Renewal Application Notices, Annual Fee Notices, Amendment Application Fee Notices, Late Fee Notices, and Assessment Fee Notices. The Water Board Division of Administration Services (DAS) Fee Branch will send notices electronically at the beginning of each month from the email address: DAS Drinking Water Fees email@example.com.
Notices will be sent to the email address the laboratory listed on its most recent application, unless you have sent in a request to update your contact information. If you need the contact information for your laboratory updated, send a note to firstname.lastname@example.org.
All ELAP notices sent by the Water Board are a courtesy and should not be the only mechanism a laboratory has in place to prompt the submission of an application or fee. It is the responsibility of the laboratory to know and understand the regulations related to its certification, including those related to application and fee submission requirements.
California Code of Regulations (CCR) section 64802.15 is the section of the new ELAP regulations related to the requirements for Proficiency Testing (PT). ELAP has provided some explanatory points below; however, laboratories are expected to read and understand the regulation text!
Reporting Requirements for Proficiency Testing
New Requirements for Failed Proficiency Tests
- If on the first attempt, a laboratory receives a “Not Acceptable” score on a PT, then within forty-five (45) days of receiving notification of the result, the laboratory must:
- Notify ELAP of the “Not Acceptable” score by emailing at ELAPCA_PT@waterboards.ca.gov;
- Investigate and document the root cause of the failure;
- Take corrective action;
- Achieve an acceptable score in a subsequent PT study for that FOA; and
- Notify ELAP at ELAPCA_PT@waterboards.ca.gov of the “Acceptable” score.
- If on the second attempt, a laboratory receives a “Not Acceptable” score for the same PT, the laboratory shall:
- Be automatically suspended for the FOA upon receiving the result from the provider per CCR Section 64802.15 (j). This suspension occurs automatically. The laboratory will not receive a suspension notice from ELAP;
- Immediately cease reporting of results for regulatory purposes for that FOA;
- Notify ELAP at ELAPCA_PT@waterboards.ca.gov of the “Not Acceptable” result within three days;
- Notify affected clients of second “Not Acceptable” result by registered mail, email with return receipt, or electronic signature document; and
- Investigate and document the root cause of the failure and take corrective action within 30 days.
- To be reinstated after suspension of an FOA, the laboratory must achieve an acceptable score and submit an amendment application.
- Note that you do not need to submit your root cause analysis or corrective action to ELAP. You do need to do them, document it, and keep the records. These will be reviewed during your next assessment.
Changes to the Proficiency Testing Evaluation Process
- Effective January 1, 2021, the due dates for PTs in the regulations are being enforced.
- Laboratories no longer receive a courtesy thirty-day extension beyond the due date to correct deficiencies in Annual or Renewal PT’s.
- ELAP was previously sending a courtesy “Failure to Comply with Proficiency Testing Requirements” notice to laboratories and allowing additional time for completion of PT’s.
- This practice was adopted as a measure to help laboratories when ELAP moved to the Water Boards in 2014 because there had been no previous enforcement of PT requirements.
- Instead, laboratories will now be notified of any deficiencies in PT requirements through a “Noncompliance Summary” document that will be sent with the final accreditation documents at the time an application is completed.
- To help laboratories avoid mistakes a list of common PT errors are included on ELAP’s Proficiency Testing webpage.
- Information about Laboratory Personnel Requirements in the New Regulation – May 5, 2021
California Code of Regulations (CCR) section 64812.00 is the section of the new ELAP regulations related to the requirements for Laboratory Personnel. ELAP has provided some explanatory points below; however, laboratories are expected to read and understand the regulation text!
Laboratory Director is now Technical Manager
- Effective January 1, 2021, the term Laboratory Director was changed to Technical Manager.
- The qualifications and responsibilities of the Technical Manager are the same as in the previous ELAP regulations.
- After January 1, 2024, the responsibilities of the Technical Manager will align with the responsibilities identified in the 2016 TNI Standard – Revision 2.1, Volume 1, Module 2, Section 22.214.171.124 (excluding part [f]).
- Note: The qualifications for Technical Manager will not change after January 1, 2024 because they are defined by the regulation, not the TNI Standard.
- The term Principal Analyst has been carried over from the previous ELAP regulations and will remain in effect until January 1, 2024.
- The qualifications and responsibilities of a Principal Analyst are the same as in the previous ELAP regulations.
- After January 1, 2024, the sections in the regulations that reference the term Principal Analyst will expire and the role of Principal Analyst will no longer exist.
- Laboratories will instead be required to meet the minimum personnel requirements identified in the 2016 TNI Standard – Revision 2.1, Volume 1, Module 2, Section 5.2 (excluding 5.2.6).
- Effective January 1, 2024, laboratories will be required to appoint a Quality Manager.
- A list of Quality Manager responsibilities can be found in the 2016 TNI Standard – Revision 2.1, Volume 1, Module 2, Section 126.96.36.199.
- Information and Reminders about Renewal Applications – April 20, 2021
The California Environmental Laboratory Accreditation Program would like to provide important information and reminders about renewal applications.
No Changes to FOAs in Renewal Applications
As part of ELAP’s new regulatory requirements that went into effect on January 1, 2021, changes to a laboratory’s Fields of Accreditation (FOAs) are not accepted in renewal applications pursuant to § 64808.15(d). The laboratory must submit an amendment application to add a FOA(s) to a laboratory’s current accreditation. Amendment applications may be submitted at any time.
Applying to Renew Hazardous Waste FOAs
Due to recent structural changes to the Hazardous Waste FOA Tables, some laboratories may find the FOA on their current accreditation is no longer available to select for renewal. Affected laboratories should follow the guidance below. If you have specific questions about what your laboratory may apply for, contact ELAP’s general inbox at email@example.com.
- Laboratories who were accredited for a group analysis may now apply for the individual compounds for the method.
- Laboratories may not apply for a newer version of a currently accredited method in a renewal application. To request accreditation for a newer method, an amendment application is required.
- For newly created FOA tables (tables 130-134), a laboratory may apply for a subgroup in one of the new tables if it is currently accredited for the method and version.
EXAMPLE: If a laboratory had accreditation using method EPA 6010B, previously listed only in Table 114, the laboratory may apply for accreditation using method EPA 6010B in FOA Table 114 and/or FOA Table 130. The laboratory would need to submit an amendment application for method EPA 6010D in either FOA Table, as it would be a new method for the laboratory.
Removing FOAs from a Certificate
A laboratory can request removal of FOAs from its accreditation by emailing firstname.lastname@example.org and including the specific subgroup number and effective date of the removal. An amendment application is not required.
- Information on the new CA ELAP Fees – April 15, 2021
New Fee Structure
A new fee structure became effective on January 1, 2021 as part of the new California Environmental Laboratory Accreditation Program Regulations.
Renewal Application Fee and Annual Accreditation Fee
Each laboratory is required to pay a nonrefundable renewal application fee at the time of submittal of the application, and an Annual Accreditation Fee one year from the date of issuance of accreditation. The fee is composed of the following components.
- Base fee – paid by all laboratories. $2,500
- Per Field of Accreditation (FOA) fee – paid by all laboratories. Count the number of individual subgroups in the Field(s) of Accreditation Tables for which you are seeking accreditation to determine which Tier applies. You do not have to pay the fees for any Tiers falling outside of the one that applies to your laboratory (i.e. only select one Tier price in the table below).
- Reciprocity fee – paid by all out-of-state laboratories. $5,000
Base Fee (all laboratories)
Reciprocity Fee (Out-of-State Laboratories only)
Field of Accreditation (FOA) Fee (select only one tier)
Tier 1 – 1-10 FOAs
Tier 2 – 11-49 FOAs
Tier 3 – 50-99 FOAs
Tier 4 – 100-149 FOAs
Tier 5 – 150-249 FOAs
Tier 6 – 250-349 FOAs
Tier 7 – 350+ FOAs
Application Late Fees
Late applications will be subject to a 15% late fee if received after the application deadline but before the expiration date of your certificate. Any application received after the expiration date of a certificate will be subject to a 30% late fee.
IMPORTANT: An on-time application may still be assessed a late fee if it is incomplete and requires ELAP to follow up for additional documentation beyond your application deadline. Be sure to submit all the required components of a complete application package as defined in California Code of Regulations § 64802.00 to avoid being charged a late fee.
Laboratories using ELAP to perform an assessment will be charged the following assessment fees. The Water Boards will send a notice that the assessment fee is due once it has been scheduled. Do not combine your assessment fee with a renewal or annual fee.
Initial and Renewal Assessments
- Main laboratory - $5000
- Satellite or mobile laboratory - $2500 each
- Addition or reinstatement of Field(s) of Accreditation - $1000
- Addition of a satellite or mobile Laboratory - $2500 each
- Change in laboratory location - $5000
While we aim to provide a laboratory a courtesy notice approximately 90 days before a renewal application or annual accreditation fee is due, any notice sent by ELAP is a courtesy on behalf of the program and should not be the only mechanism a laboratory has in place to prompt the submission of an application
- Sign up for the TNI Documentation Workshop!
California Environmental Laboratory Accreditation Program (ELAP) has opened registration for fourteen sessions of the 2016 TNI Quality System Documentation Workshop in partnership with A2LA Workplace Training. Register here today!
The workshop runs from 10:00 am – 3:00 pm (PT) with a break from noon to 1:00 pm on both days. This is a standalone training and you only need to register for one session. Only one person from each accredited laboratory may sign up. But don’t worry – we are recording the training and will post it on our website in the future so that everyone can watch.
“The TNI Documentation Training session was truly helpful, especially since our laboratory is at the start of our TNI transition. It opened our eyes on how to “read and understand” the TNI Standard, making it easier to set up the fundamental cornerstones aiding us with a smoother transition into TNI.”~Susie Arredondo
San Elijo Joint Powers Authority
What will you learn?
This virtual workshop is an 8-hour overview of the 2016 TNI Standard Quality System requirements that provides all the materials you need to create a quality system for your laboratory. Class sizes are capped at 30 students per session to allow for interaction and discussion with the expert instructor and your classmates.
You will receive the following learner materials when you register. Attendees should perform at least a brief review of the materials and note any questions you have before coming to the training.
- Templates: Fillable templates for 14 policies and procedure (Volume 1, Module 2) that can be directly implemented in your laboratory.
- Requirements & Explanations: An extensive document describing the requirements, explanations, and context for key areas of the Standard with which accredited laboratories have historically struggled. They also include potential solutions your laboratory can customize for itself.
- Examples of Policies & Procedures: Compliant and non-compliant policies and procedures are provided with explanations for why they do or do not comply with the 2016 TNI Standard. At least 3 compliant examples are provided for each clause covered in the course to help your laboratory implement a solution that best suits your processes.
- Job Aid: A “quick-look” tool that can be used immediately in your laboratory to identify where the TNI Standard requires policies, procedures, and records. It can function as a quick checklist to ensure your laboratory complies.
Is there anything else I need to know?
Take advantage of two Zoom breakout rooms during lunch each day! “Ask the Instructor” will be hosted by the trainer to answer TNI Questions, and “Ask ELAP” will be hosted by an ELAP staff member to answer ELAP-related questions.
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|31||2nd California Environmental Laboratory Accreditation Program Conference|
What does ELAP do?
ELAP provides evaluation and accreditation of environmental testing laboratories to ensure the quality of analytical data used for regulatory purposes to meet the requirements of the State's drinking water, wastewater, shellfish, food, and hazardous waste programs. The State agencies that monitor the environment use the analytical data from these accredited laboratories. The ELAP-accredited laboratories have demonstrated capability to analyze environmental samples using approved methods.
The California Environmental Laboratory Improvement Act (Assembly Bill 3739, Chapter 894, Statutes of 1988) took effect on January 1, 1989. It established a consolidated fee-supported accreditation program for environmental health laboratories, and a special fund, the Environmental Laboratory Improvement Fund, to support the program. Under the Act, accreditation is required of an environmental laboratory for producing analytical data for California regulatory agencies. The data is used to demonstrate compliance with requirements of drinking water, wastewater, food for pesticide residues, shellfish testing, and hazardous waste sections of the California Health and Safety and Water Codes. The Environmental Laboratory Accreditation Program (ELAP) is responsible for implementing the Act.
ELAP is part of the Division of Drinking Water at the State Water Resources Control Board and is overseen by Chief Christine Sotelo. ELAP’s staff and functions are divided between three locations - Sacramento, Glendale, and Richmond. The Sacramento location is ELAP’s headquarters and is home to the Program Development, Research, and Enforcement Unit (PDREU). The PDREU is responsible for all program transformation initiatives, technical research, and enforcement cases. The Glendale Field Office is ELAP’s Assessment Unit with a group of specialized auditors. The Richmond Field Office houses the Monitoring Unit responsible for the evaluation of annual proficiency testing results. ELAP staff in all offices work together across geographic boundaries to fulfill the duties prescribed by the Laboratory Improvement Act: Inspect, Accredit, Monitor, and Enforce.