ELAP - Regulations

Overview

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ELAP’s current regulations have not been updated since 1994; they are vague and outdated.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.

Rulemaking Information: SBDDW-19-ELAP Accreditation of Environmental Laboratories

Information and Documentation Pertaining to This Regulatory Proposal

Sections Affected

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
  • State Water Board Meeting to Consider Adoption: 03/17/2020

Status of Proposal

This Rulemaking is in Progress.

Complete Rulemaking Documentation Files

The public hearing to receive written and oral comments will be held as detailed below:
Wednesday, December 18, 2019 – 9:30 a.m.
Joe Serna Jr. CalEPA Headquarters Building
1001 I Street, Second Floor
Sacramento, CA 95814

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

You may submit written comments via any of the following:

  • Electronic mail (email): commentletters@waterboards.ca.gov

  • 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 Environmental Laboratory Accreditation Program Regulations.

All comments should include the author’s name and U.S. Postal Service mailing address or email in order for the State Water Board to provide any notices that may be required in the future.

Due to limitations of the email system, emails larger than 15 megabytes (MB) may be rejected and will not be delivered and received by the State Water Board.  Therefore, emails larger than 15 MB should be submitted in several separate emails or another form of delivery should be used.

The State Water Board requests but does not require that written comments sent by mail or hand-delivered be submitted in triplicate.

The State Water Board requests but does not require that reports or articles in excess of 25 pages be submitted in conjunction with the comments, that the commentator 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 and oral 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.

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:
https://nelac-institute.org/docs/standards/2016/CA.

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 suzanne.rachmaninoff@nelac-institute.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


Redding Office

364 Knollcrest Drive, Suite 101
Redding, CA 96002
(530) 224-4800

Sacramento Office
1001 I St, 13th Floor
Sacramento, CA 95814
(916) 449-5681

Santa Rosa Office
50 D Street, Suite 200
Santa Rosa, CA 95404
(707) 576-2145

Richmond Office
850 Marina Bay Parkway, Bldg. P, 2nd Floor
Richmond, CA 94804-6403
(510) 620-3474

Stockton Office
31 E. Channel Street, Room 270
Stockton, CA 95202
(209) 948-7696

Fresno Office
265 West Bullard Ave, Suite 101
Fresno, CA 93704
(559) 447-3300

Monterey Office
1 Lower Ragsdale Dr, Bldg.1, Suite 120
Monterey, CA 93940
(831) 655-6939

Bakersfield Office
4925 Commerce Dr, Suite 120
Bakersfield, CA 93309
(661) 335-7315

San Bernardino Office
464 W. 4th Street, Room 437
San Bernardino, CA 92401
(909) 383-4328

Carpinteria Office
1180 Eugenia Place, Suite 200
Carpinteria, CA 93013
(805) 566-1326

Glendale Office
500 North Central Avenue, Suite 500
Glendale, CA 91203
(818) 551-2004

Santa Ana Office
2 MacArthur Pl, Suite 150
Santa Ana, CA 92707
(714) 558-4410

San Diego Office
1350 Front Street, Room 2050
San Diego, CA 92101
(619) 525-4159

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

Victorville Branch
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
(916) 449-5681

 

Implementation Assistance

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

  • The Rulemaking Process and ELAP's Regulations (coming soon)

Reference Documents

Other Information

Contact Information