ELAP - Regulations
On October 11, 2019, the State Water Board officially entered the Administrative Procedure Act (APA) rulemaking process. This date also initiated the start of the public comment period, which will conclude on December 20, 2019. A public hearing to receive written and oral comments will be held on December 18, 2019 and the State Water Board will consider adoption of the proposed ELAP regulations at the Board’s March 17, 2020 State Water Board meeting. See Rulemaking Information below for full details on scheduling and location information.
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ELAP’s current regulations have not been updated since 1994; they are vague and outdated.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.
- New! State Board meeting to consider adoption of proposed regulations cancelled (3/16/20)
- State Board to consider adoption of proposed regulations on March 17th (3/9/20)
- View ELAP’s Proposed Revised Regulations text (2/13/20)
- How to Submit Comments for the Proposed Revised Regulations text (2/13/20)
- Notice of Public Availability of Changes to Proposed Regulations, Initiating Public Comment Period for Proposed Regulatory Action (2/13/20)
- Notice of Proposed Rulemaking Published, Initiating Public Comment Period for Proposed Regulatory Action (10/11/19)
- Scheduling and Location Information for ELAP Draft Regulations Public Hearing and State Water Board Meeting (10/11/19)
- How to Submit Comments for ELAP Draft Regulations (10/11/19)
- 2016 TNI Standard Available for Viewing at Division of Drinking Water District Offices, Regional Water Quality Control Board Offices, and CalEPA Headquarters in Sacramento (8/26/19)
Rulemaking Information: SBDDW-19-ELAP Accreditation of Environmental Laboratories
Information and Documentation Pertaining to This Regulatory Proposal
California Code of Regulations: Title 22 Sections: 64802, 64802.05, 64802.10, 64802.15, 64802.20, 64802.25, 64803, 64805, 64806, 64807, 64808, 64808.05, 64808.10, 64808.15, 64809, 64810, 64810.05, 64810.10, 64811, 64812, 64812.05, 64813, 64814, 64814.05, 64814.10, 64815, 64816, 64816.05, 64816.10, 64817, 64819, 64821, 64823, 64825, 64827, 64860.
Status of Rulemaking Proceedings
- Notice of Proposed Rulemaking Published: 10/11/2019
- Close of the 45-Day Public Comment Period: 12/20/2019
- Date of Scheduled Public Hearings: 12/18/2019
- Start of the 15-Day Public Comment Period: 02/13/2020
- Close of the 15-Day Public Comment Period: 02/28/2020
- State Water Board Meeting to Consider Adoption: 03/17/2020
Status of Proposal
This Rulemaking is in Progress.
The State Water Board will consider adoption of the proposed ELAP regulations at the Board’s March 17, 2020 State Water Board meeting as detailed below:
Tuesday, March 17, 2020 – 9:30 a.m.
Joe Serna Jr. CalEPA Headquarters Building
1001 I Street, Second Floor
Sacramento, CA 95814
How to Submit Comments
Any person, or his or her representative, may submit written comments on the new changes to the proposed regulations. For this comment period, only comments that pertain to the new changes to the proposed regulations will be considered and included in the rulemaking record. Pursuant to Government Code section 11346.8(c), the written comment period closes in 15 days, at 5:00 p.m. on February 28, 2020. The State Board will only consider comments received at the State Board offices by that time. Submit written comments via at least one of the following:
You may submit written comments via any of the following:
- Electronic mail (email): email@example.com
- FAX: (916) 341-5620
- U.S. Postal Service:
Ms. Jeanine Townsend, Clerk to the Board
State Water Resources Control Board
P.O. Box 100. Sacramento, CA 95812-2000
- Hand Delivery:
Ms. Jeanine Townsend, Clerk to the Board
State Water Resources Control Board
1001 I Street, 24th Floor, Sacramento, CA 95814
Persons delivering comments must check in with lobby security and have them contact Ms. Jeanine Townsend at (916) 341-5600
Also, please indicate in the subject line and/or on the cover page of submittals: “Comments – Proposed Revised ELAP Regulations.”
All comments, including email or fax transmissions, should include the author’s name and contact information, including either email or U.S. Postal Service mailing address in order for the State Board to provide any notices that may be required in future.
Due to the limitations of the email system, emails larger than 15 megabytes (MB) may be rejected and will not be received by the State Board. Therefore, emails larger than 15 MB should be submitted under separate emails that are each less than 15 MB, or another form of delivery should be used.
The State Board requests, but does not require, that written comments sent by mail or hand- delivered be submitted in triplicate.
The State Board requests, but does not require, that if reports or articles in excess of 25 pages are submitted in conjunction with the comments, that the commenter provide a summary of the report or article and describe the reason for which the report or article is being submitted or is relevant to the proposed regulation.
Please note that under the California Public Records Act (Gov. Code, § 6250 et seq.), your written comments, attachments, and associated contact information (e.g., your address, phone, email, etc.) become part of the public record and can be released to the public upon request.
In the Final Statement of Reasons, staff will respond to all comments received on the record during the comment periods. The Administrative Procedures Act requires that staff respond to comments received regarding all noticed changes. Therefore, staff will only address comments received during this 15-day comment period that are related to the changes detailed in the proposed revised regulatory text.
How to View the 2016 TNI Standard
TNI has provided access to a read-only, unlicensed version of the 2016 TNI Standard for all interested parties at the following link:
To access the documents, enter the password: T6E79WS. The link to this document will remain active until public access to the document is no longer needed for the rulemaking process. To obtain a copy of the 2016 TNI Standard, interested parties may contact TNI's Executive Administrator, Suzanne Rachmaninoff, at firstname.lastname@example.org. Discounted rates for the 2016 TNI Standard are available for a limited time.
In addition, copies of the 2016 TNI Standard are available for viewing at every Division of Drinking Water District Office and Regional Water Quality Control Board Office throughout the State of California, as well as at the CalEPA Headquarters Office in Sacramento.
Division of Drinking Water District Offices
364 Knollcrest Drive, Suite 101
Redding, CA 96002
1001 I St, 13th Floor
Sacramento, CA 95814
Santa Rosa Office
50 D Street, Suite 200
Santa Rosa, CA 95404
850 Marina Bay Parkway, Bldg. P, 2nd Floor
Richmond, CA 94804-6403
31 E. Channel Street, Room 270
Stockton, CA 95202
265 West Bullard Ave, Suite 101
Fresno, CA 93704
1 Lower Ragsdale Dr, Bldg.1, Suite 120
Monterey, CA 93940
4925 Commerce Dr, Suite 120
Bakersfield, CA 93309
San Bernardino Office
464 W. 4th Street, Room 437
San Bernardino, CA 92401
1180 Eugenia Place, Suite 200
Carpinteria, CA 93013
500 North Central Avenue, Suite 500
Glendale, CA 91203
Santa Ana Office
2 MacArthur Pl, Suite 150
Santa Ana, CA 92707
San Diego Office
1350 Front Street, Room 2050
San Diego, CA 92101
Regional Water Quality Control Board Offices
North Coast Regional Water Quality Control Board
5550 Skylane Blvd, Suite A
Santa Rosa CA 95403-1072
Phone: (707) 576-2220
San Francisco Bay Regional Water Quality Control Board
1515 Clay Street, Suite 1400
Oakland, CA 94612
Phone: (510) 622-2300
Central Coast Regional Water Quality Control Board
895 Aerovista Place, Suite 101
San Luis Obispo, CA 93401-7906
Phone: (805) 549 3147
Los Angeles Regional Water Quality Control Board
320 West Fourth Street, Suite 200
Los Angeles, CA 90013
Phone: (213) 576-6600
Central Valley Regional Water Quality Control Board – Sacramento
11020 Sun Center Drive, #200
Rancho Cordova, CA 95670-6114
Phone: (916) 464-3291
Central Valley Regional Water Quality Control Board – Fresno
1685 "E" Street
Fresno, CA 93706-2007
Phone: (559) 445-5116
Central Valley Regional Water Quality Control Board – Redding
364 Knollcrest Drive, #205
Redding, CA 96002
Phone: (530) 224-4845
Lahontan Regional Water Quality Control Board
South Lake Tahoe Branch
2501 Lake Tahoe Blvd
South Lake Tahoe, CA 96150
Phone: (530) 542-5400
15095 Amargosa Road, Bldg 2 - Suite 210
Victorville, CA 92394
Phone: (760) 241-6583
Colorado River Basin Regional Water Quality Control Board
73-720 Fred Waring Drive, Suite 100
Palm Desert, CA 92260
Phone: (760) 346-7491
Santa Ana Regional Water Quality Control Board
3737 Main Street, Suite 500
Riverside, CA 92501-3348
Phone: (951) 782-4130
San Diego Regional Water Quality Control Board
2375 Northside Drive, Suite 100
San Diego, CA 92108-2700
Phone: (619) 516-1990
CalEPA Headquarters – Sacramento
1001 I Street
Sacramento, CA 95814
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 email@example.com to see how we can assist you.
- TNI Implementation Tools for Laboratories
The following tools are available to TNI members at a discounted rate, but can be purchased by non-members as well.
- Getting Ready for the NEW California Accreditation Program, (FREE) presented by Marlene Moore at the 2016 TNI Standard Workshops in San Diego, Oakland, Sacramento, and Los Angeles
- TNI Quality Systems Checklist
- TNI Small Laboratory Handbook
- TNI Quality Manual Template
- Laboratory Method SOPs
- TNI Training Courses
- 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 firstname.lastname@example.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.
- The Rulemaking Process and ELAP's Regulations (coming soon)
- Health and Safety Code
Health and Safety Code, Environmental Laboratories in Section 100825-100920
- California Code of Regulations
Title 22, Division 4, Chapter 19, Certification of Environmental Laboratories
- Jacob Oaxaca
Senior Environmental Scientist, Unit Chief
- Katlin Bloom
- Andrew Hamilton
- Comments: email@example.com