Amendment ID: S2090-93-R1
Redraft Amendment 93
Independent Testing Laboratories
Mr. deMacedo, Ms. O'Connor Ives, Messrs. O'Connor and Moore, Ms. Forry and Mr. Ross move to amend the bill by striking lines 270 through 274 in their entirety, and further amends the bill by inserting after Section 37, the following new section:
SECTION 38. The General Laws are hereby amended by inserting after chapter 94G the following chapter:
CHAPTER 94H
REGULATION OF MEDICAL AND ADULT USE MARIJUANA AND MARIJUANA PRODUCTS BY INDEPENDENT TESTING LABORATORIES.
Section 1. Definitions
“Cannabinoid” means any of several compounds produced by marijuana plants that have medical and psychotropic effects.
“Cannabinoid profile” means amounts, expressed as the dry-weight percentages, of delta-nine-tetrahydrocannabinol (∆9-THC), cannabidiol (CBD), tetrehydrocannabinolic acid (THCa) and cannabidiolic acid (CBDa) in a marijuana product. Amounts of other cannabinoids may be required by the commission.
“Cultivation batch” means a collection of marijuana plants from the same seed or plant stock and that are cultivated and harvested together. Because they are cultivated in the same location and time, plants in a cultivation batch receive an identical propagation and cultivation treatment (e.g., growing media, ambient conditions, watering and light regimes, agricultural or hydroponic inputs). The licensee must assign and record a unique, sequential alphanumeric identifier to each cultivation batch for the purposes of production tracking, product labeling and product recalls.
“Finished marijuana” means usable marijuana, cannabis resin or cannabis concentrate.
“Independent testing laboratory” means a laboratory that is licensed by the commission and is i) accredited to the most current International Organization for Standardization (ISO) 17025 by a third party accrediting body that is a signatory to the International Laboratory Accrediting Cooperation (ILAC) Mutual Recognition Arrangement or that is otherwise approved by the commission; ii) independent financially and otherwise from any registered medical or adult use marijuana dispensary for which it conducts a test; and, iii) qualified to test marijuana in compliance with this chapter.
“Laboratory agent” means an employee or qualified subcontractor of an independent testing laboratory who transports, possesses, or tests marijuana.
“Marijuana products” means products that have been manufactured and contain marijuana or an extract from marijuana, including concentrated forms of marijuana and products composed of marijuana and other ingredients that are intended for use or consumption, including edible products, beverages, topical products, ointments, oils and tinctures.
“Mycotoxin” means a secondary metabolite of a microfungus that is capable of causing death or illness in humans and other animals. For the purposes of this regulation, mycotoxins include alfatoxin B1, alfatoxin B2, alfatoxin G1, alfatoxin G2, and Ochratoxin A.
“Production batch” means a batch of finished plant material, cannabis resin, cannabis concentrate or edible made at the same time, using the same methods, equipment and ingredients. The licensee must assign and record a unique, sequential alphanumeric identifier to each production batch for the purposes of production tracking, product labeling and product recalls. All production batches must be traceable to one or more marijuana cultivation batch(es).
“Residual solvent” means a volatile organic chemical used in the manufacture of a marijuana product and that is not completely removed by practical manufacturing techniques.
“Terpenoid” means an isoprene that are the aromatic compounds found in cannabis, including but not limited to limonene, myrcene, pinene, linalool, eucalyptol, δ-terpinene, ß-caryophyllene, caryophyllene oxide, nerolidol and phytol.
Section 2. (a) Notwithstanding any general or special law to the contrary, the Massachusetts cannabis control commission shall promulgate regulations in accordance with chapter 30A of the General Laws for the licensure and oversight of independent testing laboratories, and shall establish testing protocols for the sampling, testing and analysis of finished marijuana and marijuana products in consultation with the department of public health and the department of agricultural resources. Such regulations shall address sampling and analysis to characterize the cannabinoid profile and biological and chemical contaminants, including but not limited to terpenoids, pesticides, plant growth regulators, metals, microbiological contaminants, mycotoxins, and residual solvents introduced through cultivation of marijuana plants and post-harvest processing and handling of marijuana, marijuana products and ingredients.
(b) At a minimum, the following elements shall be included on the labeling of all marijuana and marijuana products sold or otherwise marketed within the Commonwealth pursuant to sections 4 and 5, inclusive, of chapter 10A of the General Laws: i) a symbol or easily recognizable mark issued by the commission that indicates the package contains marijuana or a marijuana product; ii) the name and contact information of the marijuana cultivator or the marijuana product manufacturer who produced the marijuana or marijuana product; iii) the results of sampling, testing and analysis conducted by a licensed independent testing laboratory; iv) a seal certifying the marijuana product meets such testing standards; v) a unique batch number identifying the production batch associated with manufacturing and processing; vi) a list of ingredients and possible allergens; vii) a use-by date, if applicable; and, viii) the following statement, including capitalization: “This product has not been analyzed or approved by the FDA. There is limited information on the side effects of using this product, and there may be associated health risks. Marijuana use during pregnancy and breast-feeding may pose potential harms. It is against the law to drive or operate machinery when under the influence of this product. KEEP THIS PRODUCT AWAY FROM CHILDREN.” Licensees must ensure the ability to demonstrate to the commission that such products’ label information has been verified.
(c) Notwithstanding any special or general law to the contrary, no marijuana or marijuana product shall be sold or otherwise marketed within the Commonwealth of Massachusetts that has not first been tested by a licensed independent testing laboratory and meets the Commission’s testing protocols issued pursuant to subsection (a) of this section.
(d) Notwithstanding any general or special law to the contrary, a licensed independent testing laboratory shall report any results indicating contamination directly to the commission within 72 hours of identification.
(e) No laboratory agent or employee of an independent testing laboratory shall receive direct or indirect financial compensation, other than such reasonable contractual fees to conduct such testing, from any entity for which it is conducting testing ursuant to chapter 94G of the General Laws or Chapter 369 of the Acts of 2012.
Section 3. A registered laboratory agent shall not be subject to arrest, prosecution, or civil penalty, sanctions or disqualifications, and shall not be subject to seizure or forfeiture of assets under Massachusetts law for actions taken under the authority of a independent testing laboratory, including possessing, processing, storing, transferring or testing marijuana or marijuana products provided he or she presents his or her registration card or other appropriate identification demonstrating employment by a testing laboratory to any law enforcement official who questions the laboratory agent concerning their marijuana related activities, and is acting in accordance with all the requirements of this law.