ELAP - Regulations

Overview

As stated in Health and Safety Code section 100825, the California Environmental Laboratory Accreditation Program (ELAP) is responsible for accrediting environmental testing laboratories that produce analytical data for California regulatory agencies that protect public health. The Act allows ELAP to adopt regulations pertaining to Laboratory Personnel, Quality Assurance Procedures, Laboratory Equipment, Facilities, Standard Operating Procedures, Proficiency Testing, Onsite Assessments, Recordkeeping, Fields of Accreditation, etc. in order to ensure that laboratories are capable of producing analytical data of known and documented quality.

ELAP’s current regulations have not been updated since 1994; they are vague and outdated. Most importantly, ELAP’s current regulations do not include quality systems, a program for continuous improvement that provides feedback to identify problems and correct them systematically, so that they don’t occur again, which is a critical component in ensuring laboratories produce defensible data of known and documented quality.

The proposed ELAP regulations facilitate implementation of a sustainable accreditation program, ensuring that laboratories are capable of generating environmental and public health data of known, consistent, and documented quality to meet stakeholder needs. Most importantly, they foster the environmental laboratory community to obtain a quality management system and produce reliable quality data, which is essential for protecting public and environmental health.

Announcements

Public Workshops

In January 2019, ELAP's Draft Regulations Team held two public workshops in Sacramento and Los Angeles. A presentation was given by ELAP on the Third Preliminary Draft Regulations text, and the public presented oral comments. The Sacramento workshop was webcasted and recorded. The presentation given by ELAP, and the recording of the Sacramento workshop can be found below.

ELAP's Draft Regulations Team held public workshops throughout California from July 25th, 2017 - August 3rd, 2017 to solicit comments, answer questions, and review the First Preliminary Draft Regulations text for clarity and completeness. Please see below for more information regarding the First Preliminary Draft Regulations Public Workshops.

View our map of public workshop locations relevant to ELAP-accredited laboratories.

Assistance with the 2016 TNI Standard

The State Water Board is proposing to assist laboratories in making the transition to the 2016 TNI Standard by providing tools, training, and a three-year implementation period for many requirements.

  • TNI Documentation Workshops
    We envision a one-day workshop focused on document development that is open to all laboratories. It will be held throughout the state and will include in-class work with a consultant to develop documentation required by the TNI Standard. Laboratories will receive templates and tools as part of this workshop.
  • Support for TNI Mentor Groups
    In 2016, ELAP conceptualized a TNI Mentorship Initiative to assist laboratories in the implementation of the TNI Standard. In December 2018, the American Council of Independent Laboratories (ACIL) formed a TNI Mentor Group to assist laboratories in California to implement Quality Management System requirements in the 2016 TNI Standard. The participating laboratories ranged from small, remotely located municipal laboratories to small commercial or public health laboratories. There are currently seven early adopter laboratories who volunteered to participate as a Mentee to advance their laboratory operations and management practices and provide data of known, documented and defensible quality. The information from these early adopter laboratories will help inform ELAP on what specific tools, templates, and trainings California laboratories need to successfully implement the 2016 TNI Standard.

    ELAP is offering support to any laboratory mentor groups that have formed to assist each other with implementation of the TNI Standard. Contact us at elapca@waterboards.ca.gov to see how we can assist you.

  • TNI Membership
    ELAP has negotiated a free 6-month membership to TNI, for its laboratories, which includes member rates on documents and trainings. This membership can be requested until the time the Regulations package is adopted by the State Water Board. Email TNI's Executive Administrator, Suzanne Rachmaninoff, at suzanne.rachmaninoff@nelac-institute.org to request membership. In addition to receiving discounted rates on TNI implementation resources, members also have the benefit of participating in the formal consensus process. ELAP encourages laboratories to take an active role in this process and represent California at the national level.

ELAP Administrative Approval Process

Reference Documents

Other Information

Draft Regulations Readiness Level is currently an 8.  Here are the levels: 
12. Regulations Become Effective, 
11. Submit to OAL for Final Review,
10. Submit for Water Board Consideration,
9. Notice of Publication,
8. Approve Regulations Package for Submittal to OAL,
7. Prepare Draft Regulations Package,
6. Hold Stakeholder Workshops,
5. Develop Preliminary Draft Regulations Text,
4. Select Accreditation Standard,
3. Evaluate Recommendations from Advisory Committees,
2. Assess Feasibility Through Stakeholder Outreach,
1. Research Accreditation Standard Options

Contact Information