Bill Text: CA AB2548 | 2019-2020 | Regular Session | Amended
Bill Title: Cannabis: good manufacturing practice certification.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2020-03-09 - Re-referred to Com. on B. & P. [AB2548 Detail]
Download: California-2019-AB2548-Amended.html
|
Amended
IN
Assembly
March 05, 2020 |
CALIFORNIA LEGISLATURE—
2019–2020 REGULAR SESSION
Assembly Bill
No. 2548
| Introduced by Assembly Member Lackey |
February 19, 2020 |
An act to amend Section 26100 of, and to add Section 26130.5 to, the Business and Professions Code, relating to cannabis.
LEGISLATIVE COUNSEL'S DIGEST
AB 2548, as amended, Lackey.
Cannabis: good manufacturing practice certification.
Existing law, the Control, Regulate and Tax Adult Use of Marijuana Act (AUMA), approved by the voters at the November 8, 2016, statewide general election, regulates the cultivation, distribution, transport, storage, manufacturing, testing, processing, sale, and use of cannabis for nonmedical purposes by people 21 years of age and older. The existing Medicinal and Adult-Use Cannabis Regulation and Safety Act (MAUCRSA), among other things, consolidates the licensure and regulation of commercial medicinal and adult-use cannabis activities. AUMA authorizes the Legislature to amend its provisions with a 2/3 vote of both houses to further its purposes and intent.
Existing law establishes the State Department of Public Health as the licensing authority for cannabis manufacturers and requires the department, among other things, to promulgate regulations governing the licensing of cannabis manufacturers and standards for manufacturing, packaging, and labeling of all manufactured cannabis products. Existing law also establishes testing requirements for batches of cannabis to be sold at retail.
This bill, on or before January 1, 2022, would amend AUMA to require the department to establish a Good Cannabis Manufacturing Practice Certification, as specified, which could be obtained by specified manufacturers to test representative samples of batches of cannabis products instead of requiring testing of each batch. The bill would provide for doubled fines for a certificate holder who distributes contaminated cannabis products and would require the department to inspect certificate holders at least
twice each year to verify compliance with the certificate program terms.
This bill would make specified findings and declare that its provisions further the purposes and intent of AUMA.
Existing law, the Control, Regulate and Tax Adult Use of Marijuana Act, approved by the voters at the November 8, 2016, statewide general election, regulates the cultivation, distribution, transport, storage, manufacturing, testing, processing, sale, and use of cannabis for nonmedical purposes by people 21 years of age and older. The Medicinal and Adult-Use Cannabis Regulation and Safety Act, among other things, consolidates the licensure and regulation of commercial medicinal and adult-use cannabis activities.
Existing law establishes the State Department of Public Health as the licensing authority for cannabis manufacturers and requires the department, among other things, to promulgate regulations governing the licensing of cannabis manufacturers and standards for the manufacturing, packaging, and labeling of all manufactured cannabis
products.
This bill would state the intent of the Legislature to enact legislation that would create a good manufacturing practice certification for cannabis manufacturers.
Digest Key
Vote:Bill Text
The people of the State of California do enact as follows:
SECTION 1.
Section 26100 of the Business and Professions Code is amended to read:26100.
(a) Except as otherwise provided by law, cannabis or cannabis products shall not be sold pursuant to a license provided for under this division unless a representative sample of the cannabis or cannabis products has been tested by a licensed testing laboratory.(b) The bureau shall develop criteria to determine which batches shall be tested. tested, including the frequency of testing for licensed manufacturers with the Good Cannabis Manufacturing Practice Certification established pursuant to Section 26130.5. All testing of the samples shall be performed on the final form
in which the cannabis or cannabis product will be consumed or used.
(c) Testing of batches to meet the requirements of this division shall only be conducted by a licensed testing laboratory.
(d) For each batch tested, the testing laboratory shall issue a certificate of analysis for selected lots at a frequency determined by the bureau with supporting data, to report both of the following:
(1) Whether the chemical profile of the sample conforms to the labeled content of compounds, including, but not limited to, all of the following, unless limited through regulation by the bureau:
(A) Tetrahydrocannabinol (THC).
(B) Tetrahydrocannabinolic Acid (THCA).
(C) Cannabidiol (CBD).
(D) Cannabidiolic Acid (CBDA).
(E) The terpenes required by the bureau in regulation.
(F) Cannabigerol (CBG).
(G) Cannabinol (CBN).
(H) Any other compounds or contaminants required by the bureau.
(2) That the presence of contaminants does not exceed the levels established by the bureau. In establishing the levels, the bureau shall consider the American Herbal Pharmacopoeia monograph, guidelines set by the Department of Pesticide Regulation pursuant to subdivision (d) of Section 26060, and any other relevant sources. For purposes of this
paragraph, “contaminants” includes, but is not limited to, all of the following:
(A) Residual solvent or processing chemicals.
(B) Foreign material, including, but not limited to, hair, insects, or similar or related adulterant.
(C) Microbiological impurities as identified by the bureau in regulation.
(e)A testing laboratory may amend a certificate of analysis to correct minor errors, as defined by the bureau.
(f)
(e) Standards for residual levels of volatile organic compounds shall be established by the bureau.
(g)
(f) The testing laboratory shall conduct all testing required by this section in a manner consistent with general requirements for the competence of testing and calibrations activities, including sampling and using verified methods.
(h)
(g) All testing laboratories performing tests pursuant to this section shall obtain and maintain ISO/IEC 17025 accreditation as required by the bureau in regulation.
(i)(1) If
(h) If a test result falls outside the specifications authorized by law or regulation, the testing laboratory shall follow a standard operating procedure to confirm or refute
the original result.
(2)If a test result falls outside the specifications authorized
by law or regulation, the testing laboratory may retest the sample if both of the following occur:
(A)The testing laboratory notifies the bureau, in writing, that the test was compromised due to equipment malfunction, staff error, or other circumstances allowed by the bureau.
(B)The bureau authorizes the testing laboratory to retest the sample.
(j)
(i) A testing laboratory shall destroy the remains of
the sample of medical cannabis or medical cannabis product upon completion of the analysis, as determined by the bureau through regulations.
(k)
(j) Any presale inspection, testing transfer, or transportation of cannabis products pursuant to this section shall conform to a specified chain of custody protocol and any other requirements imposed under this division.
(l)
(k) This division does not prohibit a licensee from performing testing on the licensee’s premises for the purposes of quality assurance of the product in conjunction with reasonable business operations. This division also does not prohibit a licensee from performing testing on the licensee’s premises of cannabis or cannabis products obtained from another licensee. Onsite testing by the licensee shall not be certified by the bureau and does not exempt the licensee from the requirements of quality assurance testing at a testing laboratory pursuant to this section.
SEC. 2.
Section 26130.5 is added to the Business and Professions Code, to read:26130.5.
(a) On or before January 1, 2022, the State Department of Public Health shall establish through regulation a Good Cannabis Manufacturing Practice Certification for cannabis manufacturers.(b) The certification shall not be a requirement of licensure, but may be obtained by a licensee with a Manufacturing Level 1 or Manufacturing Level 2 license.
(c) Notwithstanding any other provision of this division and in place of the testing schedule required pursuant to Section 26100, a licensee with the certification shall have representative samples of the batches of cannabis products that are produced in the certified facility tested as required by the licensing authority. The
frequency of testing for representative sample batches shall be determined by the bureau and the State Department of Public Health.
(d) The State Department of Public Health shall approve each of the licensee’s manufacturing processes in order for the licensee to receive certification.
(e) The requirements for certification shall include standards for all of the following:
(1) Recordkeeping.
(2) Personnel qualifications.
(3) Sanitation.
(4) Cleanliness.
(5) Equipment verification.
(6) Process
validation.
(7) Complaint handling.
(8) Internal quality testing, including testing of cannabis or cannabis flower used in production of the product, and materials within the product, that will be consumed by a customer or be used in consumption.
(9) Internal quality assurance and quality control.
(10) Standard operating procedures for the processing of each cannabis product.
(f) (1) A licensee with the certification who distributes contaminated cannabis products shall be subject to double the standard monetary fines.
(2) Willful violation of this division by a licensee with the certification, or an attempt to conceal a
violation, are an aggravating factor in the licensing authority’s determination of whether to suspend or revoke the license, or to impose other penalties determined by the licensing authority.
(g) The State Department of Public Health shall inspect a licensee with the certification at least twice per calendar year to ensure compliance with the standards of certification.
SEC. 3.
The Legislature finds and declares that this act furthers the purposes and intent of the Control, Regulate and Tax Adult Use of Marijuana Act.It is the intent of the Legislature to enact legislation that would create a good manufacturing practice certification for cannabis manufacturers.
