New Jersey Cannabis Reporting of Test Results Procedure

$177.00 – $247.00

From the recently published CRC Regulations:

§ 17:30-13.1 PROCESSING OF CANNABIS ITEMS; RELEASE FOR DISTRIBUTION

(a) Each cannabis cultivator and cannabis manufacturer shall contract with a testing laboratory to obtain and test samples of usable cannabis and cannabis products.

(b) A cannabis cultivator or cannabis manufacturer shall process usable cannabis or manufacture cannabis products in a safe and sanitary manner to protect consumers from adulterated cannabis items, which shall be: 1. For usable cannabis, well cured and free of seeds and stems; 2. Free of dirt, sand, debris or other foreign matter; and 3. Free of mold, rot or other fungus or bacterial diseases.

(c) After curing is complete and usable cannabis is in its final dried form, or after manufacturing is complete and cannabis products are in their final form, as applicable, before packaging and release for distribution, a cannabis cultivator or cannabis manufacturer shall ensure that a licensed testing laboratory, in accordance with N.J.A.C. 17:30-16: 128 1. Obtains a representative sample from a batch of usable cannabis or a lot of cannabis products; 2. Tests the representative sample; and 3. Provides a written report to the cannabis cultivator or cannabis manufacturer.

(d) The cannabis cultivator or cannabis manufacturer shall hold the batch of usable cannabis or lot of cannabis products in secure, segregated storage until it receives a written report from the licensed testing laboratory confirming that the representative sample meets specifications.

(e) After it receives a written report confirming that the representative sample meets specifications, the cannabis cultivator or cannabis manufacturer may: 1. Assign an expiration date to the batch or lot; 2. Package the batch or lot and release it for distribution; and 3. Revise the status of the batch or lot in the inventory control.

(f) When the cannabis cultivator or cannabis manufacturer receives a written report confirming that the test results of the representative sample do not meet specifications, the cannabis cultivator or cannabis manufacturer shall not sell the batch or lot to another cannabis business and shall destroy the batch or lot and render it unusable. 1. Except that if the written report confirms that the test results for usable cannabis do not meet specifications for total yeast and mold count, pursuant to subsection (f) of the Cannabis Testing Guidance, the cannabis cultivator may sell the batch to a cannabis manufacturer to manufacture the batch into a cannabis extract or cannabis-infused product using a process involving a solvent that leaves no yeast or mold, and where the final cannabis product is tested again prior to sale or transfer. 2. Except for the opportunity to retest and remediate pursuant to subparagraph (c) of paragraph (13) of subsection (a) N.J.S.A. 24:6I-35. (g) The cannabis cultivator or cannabis manufacturer shall submit a copy of the written report to the Commission on a form developed by the Commission.

§ 17:30-16.1 COMMISSION QUALITY CONTROL TESTING; SAMPLE COLLECTION; CHAIN OF CUSTODY

(a) To ensure the safety of consumers, a cannabis business shall provide upon request of the Commission one or more samples of usable cannabis or cannabis product to the Commission during announced and unannounced inspections for product quality control, including but not limited to: 144 1. A sample from a batch of usable cannabis from the first harvest of a new cultivar; and 2. A unit or units of packaged usable cannabis or cannabis product available for distribution to consumers.

(b) To implement the requirement in (a) above, the Commission shall: 1. Collect soil and plant samples and samples of usable cannabis or cannabis product from the cannabis business, as applicable; 2. Place the license number of the cannabis business on each sample container; 3. Label the sample containers with the date of the sampling, the name of the cultivar/strain, and the quantity of its contents by weight; 4. Seal the sample containers; 5. Have a member of the cannabis business staff and Commission staff initial each sample container; and 6. Have Commission staff transport all sample containers in a lockable box to the New Jersey Department of Health’s Public Health and Environmental Laboratories (PHEL) or a licensed testing laboratory for testing.

(c) The Commission shall maintain documentation of the chain of custody of any sample taken in accordance with this chapter. 1. The Commission shall provide a receipt for any collected sample to the licenseholder representative of the cannabis business. 2. The Commission shall maintain an accounting of all collected sample containers for control purposes, including the Medicinal Marijuana Testing Laboratories Specimen Submittal form as amended or supplemented and found on its website at https://www.nj.gov/health/phel/documents/ECLS/CTL-1.pdf.

(d) The Commission shall use PHEL or a licensed testing laboratory to test samples. 1. Sample testing may include tests for, among other things, cannabinoid content, the presence of pests, mold and mycotoxins, mildew, heavy metals and pesticides and to ensure the accuracy of labeling. 2. PHEL shall conduct testing according to the following “Laboratory SOPs for Medicinal Marijuana” as amended or supplemented and found on its website at https://www.nj.gov/health/phel/env-testing/chemical-terrorism-lab/: i. Standard Operation Procedure for Qualitative and Quantitative Determination of Major Cannabinoids in Cannabis Plant Material; ii. Standard Operating Procedure for the Screening of Marijuana for Toxic Metals by Inductively Coupled Plasma Mass Spectrometry; and iii. Assessing Presence of Aflatoxins and Ochratoxin A in Medical Marijuana Using HPLC. 145 3. The Department shall issue written reports of the results of its testing to the cannabis business. 4. The cannabis business shall pay the expenses for the testing.

(e) The first harvest of a new cultivar shall be segregated until the cannabis business receives the written report that the sample meets specifications, and the batch may be released for distribution.

(f) A written report that the sample does not meet specifications shall yield further testing by PHEL or a testing laboratory of that batch or lot and other batches from the same growth area or lots from the same manufacturing area and may yield a recall and destruction of the usable cannabis or cannabis products, as determined by the Commission.

§ 17:30-16.2 TESTING OF EVERY BATCH AND LOT

(a) In addition to testing of usable cannabis and cannabis products by the Commission in accordance with N.J.A.C. 17:30-16.1, each batch of usable cannabis and each lot of cannabis products manufactured shall be tested in accordance with the requirements of N.J.S.A. 24:6I-35 and this subchapter by a testing laboratory licensed pursuant to N.J.S.A. 24:6I-18 and subchapter 15 of this chapter.

(b) Before any usable cannabis or cannabis product is packaged and prepared for distribution pursuant to N.J.A.C. 17:30-13.2, they shall be sampled and tested by a licensed testing laboratory and then the cannabis business shall hold them in secure, segregated storage. 1. After the cannabis business receives a written report from a licensed testing laboratory confirming the representative sample meets specifications, the cannabis business may release the usable cannabis or cannabis products for distribution.

(c) The testing laboratory may charge a reasonable fee for any test performed pursuant to this subchapter, which the cannabis business or consumer of cannabis, as applicable, shall pay.

§ 17:30-16.3 TESTING LABORATORY SAMPLE COLLECTION; CHAIN OF CUSTODY

(a) Upon request of a cannabis business when a batch or lot is ready for testing, a testing laboratory employee shall initiate sample collection for all applicable tests before packaging: 1. After usable cannabis is in its final usable form, ready to be manufactured into a cannabis product or ready to be distributed for personal use; or 146 2. After a cannabis product is in its final processed form, including placement of vaporized formulation in its electronic smoking device or oil in its pressurized metered dose inhaler, ready to be distributed for personal use.

(b) A testing laboratory employee shall collect a representative initial sample and a representative retention sample from each batch of usable cannabis from a cannabis business that cultivates and from each lot of cannabis products from a cannabis business that manufactures according to a statistically valid sampling method. 1. A cannabis business employee shall be physically present to observe the testing laboratory employee collect any sample. 2. The cannabis business employee shall not touch the usable cannabis, cannabis product or the sampling equipment while the testing laboratory employee is collecting the samples. 3. The testing laboratory employee shall collect a representative initial sample and a representative retention sample of each batch or lot by removing increment samples of material or units from throughout the container(s) in the batch or lot in the manner required at (b)3.i and ii below. i. Where appropriate for the purpose of the sample and the nature of the material being sampled, sample portions are removed from the top, middle, and bottom of containers. ii. Containers from which samples have been taken shall be marked to indicate that samples have been removed from them. 4. A representative initial sample of usable cannabis shall be .5% of a batch or lot, with the following increment sample amounts: i. < 10 lbs. of usable cannabis, 5 increment samples; ii. 10.1-20 lbs. of usable cannabis, 10 increment samples; iii. 20.1-30 lbs. of usable cannabis, 15 increment samples; iv. 30.1-40 lbs. of usable cannabis, 20 increment samples; v. 40.1-50 lbs. of usable cannabis, 25 increment samples; and vi. > 50 lbs. of usable cannabis, 30 increment samples. 5. A representative initial sample of non-homogenizable cannabis product shall be: i. < 50 total units, 2 increment units; ii. 51-150 total units, 3 increment units; iii. 151-500 total units, 5 increment units; iv. 501-1200 total units, 8 increment units; v. 1201-3200 total units, 16 increment units; 147 vi. 3201-10,000 total units, 40 increment units; and vii. 10,001-35,000 total units, 125 increment units. 6. A representative retention sample shall be two times the amounts listed for representative initial samples of a batch or lot in (b)4 and 5 above. 7. When collecting representative samples, the testing laboratory employee shall: i. Clean, open, sample, and reseal the containers in a manner designed to prevent introduction of contaminants; and ii. Use sterile equipment and aseptic sampling techniques when necessary.

(c) After completing sample collection, the testing laboratory employee shall place the cannabis business license number and affix a label with a description and the quantity of the content on each sample container.

(d) The testing laboratory employee shall seal each sample container.

(e) The cannabis business employee and the testing laboratory employee shall initial each sample container.

(f) The testing laboratory employee shall provide a receipt for the collected samples to the cannabis business employee.

(g) The cannabis business employee shall record the samples removed from a batch or lot in the inventory record for the batch or lot.

(h) The testing laboratory employee shall transfer the representative retention samples to the cannabis business employee, who shall store them pursuant to N.J.A.C. 17:30- 16.5.

(i) The testing laboratory employee shall securely transport any usable cannabis and cannabis product representative initial samples in a secure lockbox. 1. The testing laboratory employee shall not leave cannabis or cannabis products in an unattended transfer vehicle unless the vehicle is locked and equipped with an active vehicle alarm system. 2. The testing laboratory employee engaged in a transfer of cannabis or cannabis products shall have access to a secure form of communication with the testing laboratory, such as a cellular telephone, at all times that the testing laboratory employee is in possession of cannabis or cannabis products for transfer. 3. The testing laboratory employee shall carry a copy of his or her Cannabis Business Identification Card when performing a transfer and shall produce it upon request of Commission staff or law enforcement officials. 4. The transfer vehicle shall be equipped with a secure lockbox in a secured cargo area, which shall be used for the sanitary and secure transport of cannabis or cannabis products. 5. The testing laboratory shall maintain current hired and non-owned automobile liability insurance sufficient to insure all transfer vehicles in the amount of not less than one million dollars per occurrence or accident. 6. The testing laboratory shall ensure that transfer vehicles used to transport cannabis or cannabis products bear no markings that would either identify or indicate that the vehicle is used to transport cannabis. 7. The testing laboratory shall ensure that transfers are completed in a timely and efficient manner. While performing transfers of cannabis or cannabis products, the testing laboratory employee shall travel only from the premises of the cannabis business to the testing laboratory. The testing laboratory employee shall not deviate from the route described in this paragraph, except in the event of emergency or as necessary for rest, fuel, or vehicle repair stops, or because road conditions make continued use of the route or operation of the vehicle unsafe, impossible, or impracticable. 8. The testing laboratory shall report any vehicle accidents, diversions, losses, or other reportable events that occur during transfer to the Commission within 7 days.

(j) At the testing laboratory, a testing laboratory employee shall record the receipt of the samples, including the following: 1. Name, contact information for the cannabis business or individual who provided the samples; 2. Description of cannabis or cannabis product; 3. Batch or lot number; 4. Unique sample identifier; 5. Quantity of sample by net and gross weight or volume during sample collection; 6. Date and time of receipt of sample; 7. Testing laboratory employee who collected the sample; 8. Cannabis business employee who observed sample collection; 9. Testing laboratory employee who received sample; and 10.Quantity of sample by gross weight during sample receipt.