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.
At this time, 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 4.1.7.2 (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.
Principal Analyst
The term Principal Analyst has been carried over from the previous ELAP regulations and will remain in effect until January 1, 2024.
At this time, 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).
Quality Manager
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 4.1.7.1.