Cal. Code Regs. tit. 3 § 4943

Current through Register 2024 Notice Reg. No. 50, December 13, 2024
Section 4943 - Approved Laboratory for Testing Industrial Hemp for THC Concentration
(a) Testing of industrial hemp for THC concentration shall be conducted by a laboratory with International Organization for Standardization (ISO) / International Electrotechnical Commission (IEC) 17025 accreditation using a validated method in accordance with Sections 4942, 4944, and 4945 for THC analysis on plant material from an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement.
(1) Laboratories testing industrial hemp for THC concentration shall register with the United States Drug Enforcement Administration no later than December 31, 2022.
(2) Laboratories shall meet the AOAC International Standard Method Performance Requirements (SMPR) for Quantitation of Cannabinoids in Plant Materials of Hemp (Low THC Varieties Cannabis sp.) (SMPR 2019.003, October 9, 2019), which is hereby incorporated by reference, for each testing method used.
(b) A laboratory shall obtain written approval from the Department before testing industrial hemp for THC concentration. A laboratory shall submit a signed laboratory approval application with the following information to the Department for review and approval:
(1) name and contact information of the applicant,
(2) name and physical address of the testing laboratory,
(3) starting December 31, 2022, a copy of the testing laboratory's DEA registration certificate, if applicable,
(4) a copy of the testing laboratory's ISO/IEC 17025 certificate of accreditation,
(5) a copy of the testing laboratory's ISO/IEC 17025 scope of accreditation,
(6) a copy of the testing laboratory's standard operating procedures for THC testing, and
(7) a copy of the laboratory sample test report in accordance with Section 4944(b).
(c) Once the Department receives the application in accordance with the application procedures outlined in Section 4944(b) for approval or renewal and determines that the requirements outlined in this section are met and the laboratory's standard operating procedures for THC testing and sample test report comply with the requirements outlined in Sections 4942, 4944, and 4945, the Department shall approve the laboratory to conduct THC testing on industrial hemp using the approved standard operating procedures in 4943(b)(6) for THC testing and laboratory test report by issuing a proof of approval, and adding the testing laboratory to the list of approved testing laboratories.
(d) If the Department determines that the application for approval or renewal does not meet the testing laboratory requirements outlined Division 24 of the Food and Agricultural Code and this chapter, the Department shall provide written notification to the laboratory applicant of the deficiencies in the application. If the deficiency is a lack of requested information required in 4943(b), the laboratory shall have 30 calendar days from the receipt of the notification to provide the requested information to the Department. If the requested information is not provided within the timeframe, the Department will deny approval.
(1) If laboratory approval is denied due to deficiencies in the application for approval or renewal, the applicant must submit a new application to the Department in order to obtain approval to test industrial hemp for THC concentration.
(e) lf the Department determines that the approved testing laboratory no longer meets the testing laboratory requirements outlined in Division 24 of the Food and Agricultural Code and this chapter, the Department shall revoke the approval and provide written notification to the laboratory applicant regarding the revocation. The revocation is effective as of the date on the notification.
(f) Laboratory approval shall be valid for one year from date of approval by the Department, after which the laboratory shall renew the approval.
(g) Laboratories shall request renewal of Department approval in accordance with the procedures outlined in Section 4943(b). Renewed approval shall be valid for one year from date of renewal by the Department.
(h) Any changes to the approved laboratory's standard operating procedures shall be submitted to the Department for review and approval prior to implementation. Once the Department has determined that the requirements outlined in this section are met and the laboratory's standard operating procedures comply with testing requirements outlined in Sections 4942, 4944, and 4945, the Department shall notify the laboratory that testing may be completed under the revised standard operating procedures.
(i) The Department shall make a template of a laboratory application and the list of approved testing laboratories available on the Department's website.

Cal. Code Regs. Tit. 3, § 4943

1. New section filed 6-10-2019 as an emergency; operative 6-10-2019 (Register 2019, No. 24). A Certificate of Compliance must be transmitted to OAL by 12-9-2019 or emergency language will be repealed by operation of law on the following day.
2. New section refiled 12-10-2019 as an emergency; operative 12-10-2019 (Register 2019, No. 50). A Certificate of Compliance must be transmitted to OAL by 3-9-2020 or emergency language will be repealed by operation of law on the following day.
3. Repealed by operation of Government Code section 11346.1(g) (Register 2020, No. 13).
4. New section refiled 3-24-2020 as an emergency; operative 3-24-2020 (Register 2020, No. 13). A Certificate of Compliance must be transmitted to OAL by 6-22-2020 or emergency language will be repealed by operation of law on the following day.
5. New section refiled 3-24-2020 as an emergency; operative 3-24-2020. Expiration date of emergency extended 60 days (Executive Order N-40-20) plus an additional 60 days (Executive Order N-66-20) (Register 2020, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-20-2020 or emergency language will be repealed by operation of law on the following day.
6. Repealed by operation of Government Code section 11346.1(g) (Register 2021, No. 3).
7. New section filed 1-11-2021; operative 1-11-2021 pursuant to Government Code section 11343.4(b)(3) (Register 2021, No. 3).
8. Amendment filed 7-11-2022 as an emergency; operative 7-11-2022 (Register 2022, No. 28). A Certificate of Compliance must be transmitted to OAL by 1-9-2023 or emergency language will be repealed by operation of law on the following day.
9. Amendment refiled 1-3-2023 as an emergency; operative 1-3-2023 (Register 2023, No. 1). A Certificate of Compliance must be transmitted to OAL by 4-3-2023 or emergency language will be repealed by operation of law on the following day.
10. Certificate of Compliance as to 1-3-2023 order, including amendment of subsections (c) and (d), transmitted to OAL 3-29-2023 and filed 5-11-2023; amendments effective 5-11-2023 pursuant to Government Code section 11343.4(b)(3) (Register 2023, No. 19).

Note: Authority cited: Sections 407 and 81006, Food and Agricultural Code. Reference: Section 81006, Food and Agricultural Code.

1. New section filed 6-10-2019 as an emergency; operative 6/10/2019 (Register 2019, No. 24). A Certificate of Compliance must be transmitted to OAL by 12-9-2019 or emergency language will be repealed by operation of law on the following day.
2. New section refiled 12-10-2019 as an emergency; operative 12/10/2019 (Register 2019, No. 50). A Certificate of Compliance must be transmitted to OAL by 3-9-2020 or emergency language will be repealed by operation of law on the following day.
3. Repealed by operation of Government Code section 11346.1(g) (Register 2020, No. 13).
4. New section refiled 3-24-2020 as an emergency; operative 3/24/2020 (Register 2020, No. 13). A Certificate of Compliance must be transmitted to OAL by 6-22-2020 or emergency language will be repealed by operation of law on the following day.
5. New section refiled 3-24-2020 as an emergency; operative 3-24-2020. Expiration date of emergency extended 60 days (Executive Order N-40-20) plus an additional 60 days (Executive Order N-66-20) (Register 2020, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-20-2020 or emergency language will be repealed by operation of law on the following day.
6. Repealed by operation of Government Code section 11346.1(g) (Register 2021, No. 3).
7. New section filed 1-11-2021; operative 1/11/2021 pursuant to Government Code section 11343.4(b)(3) (Register 2021, No. 3).
8. Amendment filed 7-11-2022 as an emergency; operative 7/11/2022 (Register 2022, No. 28). A Certificate of Compliance must be transmitted to OAL by 1-9-2023 or emergency language will be repealed by operation of law on the following day.
9. Amendment refiled 1-3-2023 as an emergency; operative 1/3/2023 (Register 2023, No. 1). A Certificate of Compliance must be transmitted to OAL by 4-3-2023 or emergency language will be repealed by operation of law on the following day.
10. Certificate of Compliance as to 1-3-2023 order, including amendment of subsections (c) and (d), transmitted to OAL 3-29-2023 and filed 5-11-2023; amendments effective 5/11/2023 pursuant to Government Code section 11343.4(b)(3) (Register 2023, No. 19).