18-691-1 Me. Code R. § app. A

Current through 2023-3, January 18, 2023
Appendix 691-1-A - Maine Adult Use Cannabis Program Sample Collection Standard Operating Procedure for Mandatory Testing

Section 1: Purpose

To explain and standardize the process by which Adult Use Cannabis Program licensees (including without limitation, cultivation facility, products manufacturing facility, cannabis store, sample collector and cannabis testing facility licensees) must collect and transport samples of cannabis, cannabis concentrate and cannabis products for mandatory testing.

Section 2: Compliance Documents

Sample collection must be done in compliance with this standard operating procedure (SOP), Adult Use Cannabis Program Rule, 18-691 CMR, ch. 1 and Rules for the Certification of Cannabis Testing Facilities, 18-691 CMR, ch.

5, using techniques described in the Best Practices Guide published by the Department. All licensees collecting samples for mandatory testing must comply with the recordkeeping requirements of Section 3.11 of 18-691, ch.1.

Section 3: Applicable Matrix or Matrices

This SOP applies to sample collection of cannabis, cannabis concentrate and cannabis products.

Section 4: Scope / Field of Application

This SOP covers the requirements for sample collection and transportation for mandatory testing under Maine's Adult Use Cannabis Program. All licensees collecting samples of cannabis, cannabis concentrate and/or cannabis products for mandatory testing must collect samples in accordance with this SOP.

Section 5: Summary of Procedure

This SOP describes sample collection procedures for licensees collecting samples for mandatory testing.

Section 6: Definitions and Acronyms

1. Aliquot is a portion of a sample that is used in an analysis performed by a testing facility.

2. Analytical Method is a technique used qualitatively or quantitatively to determine the composition of a sample or a microbial contamination of a sample.

3. Best Practices Guide means the Best Practices for the Sampling of Adult Use Cannabis published by the Department available at: https://www.maine.gov/dafs/ocp/adult-use/applications-forms. All licensees and any employee of a licensee collecting samples of cannabis, cannabis concentrate, or cannabis products for mandatory testing must collect samples in accordance with the best practices described in the Guide.

4. CDC means the Maine Center for Disease Control and Prevention, Cannabis Testing Facility Certification Program.

5. Chain of Custody Form means a record, either paper-based or electronic, that documents the possession of the samples at the time of receipt by the cannabis testing facility, in accordance with chain of custody protocol prescribed by the cannabis testing facility. This record, at a minimum, must include the sample location, the number and types of containers, the mode of collection, the authorized individual who collected the sample, the date and time of collection, preservation and requested analyses.

6. Cultivar means a specific variety of cannabis produced by selective breeding. Also commonly referred to as a "strain" of cannabis.

7. Decontaminate or decontamination means cleaning tools, equipment, sample preparation areas and any other required areas or surfaces to neutralize or otherwise remove any analyte of interest, filth and any other material that may be reasonably expected to interfere with the integrity of mandatory test results.

8. Department means Department of Administrative and Financial Services, Office of Cannabis Policy.

9. Harvest Batch means a specific quantity of adult use cannabis harvested from adult use cannabis plants of the same strain, grown under the same conditions, and harvested during a specified period of time from a specified cultivation area within a cultivation facility.

10. Homogeneity means the amount of cannabis or cannabis concentrate and cannabinoids within the product being consistent and reasonably equally dispersed throughout the product or each portion of the product or concentrate, or a representative sample. Sample increments for homogeneity testing must be stored and transported in a separate sample collection container from the larger, combined primary sample.

11. Increment or Sample Increment means a smaller sample that, together with other increments, makes up the primary sample.

12. Licensee means a natural person or business entity licensed pursuant to 28-B MRS, Chapter 1, subchapters 2 and 5 to operate an adult use cannabis establishment.

13. Primary Sample means a portion of cannabis or cannabis products collected from a harvest or production batch for testing. Also referred to as a "composite sample".

14. Production Batch means a specific quantity of cannabis concentrate or a cannabis product that is produced during a specified period of time using the same extraction and/or manufacturing method, formulation and/or recipe and standard operating procedure.

15. Random Sampling is a procedure in which the selection of sample increments from a batch of cannabis product is based on chance, and every element of the batch has a probability of being selected. Random sampling helps produce representative cannabis samples by eliminating certain types of biases.

16. Representative Sample is a sample that accurately reflects the characteristics of the larger batch of cannabis product.

17. Requester means a person who submits a request to a licensed cannabis testing facility for State-mandated testing of cannabis or cannabis products.

18. Sample means, as applicable, an amount of:

a. Cannabis, cannabis concentrate or cannabis product collected from an adult use cannabis establishment for mandatory testing:

i. By an employee of a testing facility in accordance with 28-B MRS §604 and this Rule;

ii. By a sample collector, in accordance with 28-B MRS §604 and this Rule; or iii. By a self-sampler in accordance with 28-B MRS §604-A and this Rule;

b. Cannabis, cannabis concentrate or cannabis product provided to a testing facility by a cannabis establishment or other person for mandatory testing or testing for research and development purposes in accordance with 28-B MRS, chapter 1; or

c. Adult use cannabis or adult use cannabis product collected from a licensee by the Department for the purposes of testing the cannabis or cannabis product for quality control purposes pursuant to 28-B MRS §512(2).

19. Sample Collector means a person licensed pursuant to this Rule and 28-B MRS, ch. 1 to collect samples of cannabis and cannabis products for testing and to transport and deliver those samples to a testing facility. A sample collector must hold a valid individual identification card ("IIC").

20. Self-sampler or Self-sampling licensee means a cultivation facility, products manufacturing facility or cannabis store licensee that collects samples of cannabis, cannabis concentrate and cannabis products for mandatory testing or an employee of a cultivation facility, products manufacturing facility or cannabis store licensee who collects samples of cannabis, cannabis concentrate and cannabis products for that licensee for mandatory testing. Any individual collecting samples for mandatory testing must hold a valid individual identification card ("IIC").

21. Sterilization or Sterilize means cleaning tools, equipment, sample preparation areas and any other required areas or surfaces to destroy and remove all forms of life present in those areas which may be reasonably expected to interfere with the integrity of mandatory test results, specifically, microbiological impurities. In the context of this guide, areas and surfaces that have been cleaned in this manner are "sterile".

Section 7: Safety

The safety rules of each facility to be sampled will be followed with no exceptions.

Each facility will be responsible for educating any sample collector or employee of a cannabis testing facility collecting samples for mandatory testing of the rules and safety requirements of the facility where samples for mandatory testing are collected.

All safety rules will be followed as dictated by Maine motor vehicle and traffic laws.

Cross-contamination from site to site must be considered during every step of the sample collection process. A sample collector or employee of a cannabis testing facility collecting samples for mandatory testing must decontaminate any reusable tools or equipment used for sample collection at more than one facility or sampling site between sample collection events.

Section 8: Pre-Sample Collection Procedure

The following pre-sample collection procedure applies to self-sampling licensees or sample collector licensees collecting samples for mandatory testing:

1) The requester, and if applicable, the sample collector, must keep records of the sample collection information required in Section 3.11 of 18-69 1, ch. 1.

2) The self-sampler or sample collector must contact the cannabis testing facility(ies) conducting analyses for mandatory testing prior to collecting any samples.

3) The self-sampler or sample collector licensee must keep records of the instructions given to the self-sampler or sample collector licensee by the cannabis testing facility conducting the analyses.

4) The self-sampler or sample collector must collect samples for mandatory testing in accordance with this SOP, the Department's Best Practices Guide, and instructions given to the licensee by the cannabis testing facility conducting the mandatory analyses.

The following pre-sample collection procedure applies to a cannabis testing facility licensee collecting samples for mandatory testing:

1) A cannabis testing facility collecting samples for mandatory testing from an adult use licensee must keep records of the sample collection event in accordance with its site-specific sample collection SOP, if any, and this rule.

2) A cannabis testing facility collecting samples for mandatory testing must conduct its sample collection and sample transport in accordance with this SOP, the Department's Best Practices Guide, and any other requirements of the cannabis testing facility's quality system.

Section 9: Materials Required - Equipment and Supplies

The following equipment and supplies must be used for sample collection as applicable:

NOTE: Images and examples of the sample collection equipment and supplies listed below are included in the Department's Best Practices Guide.

Spatulas (disposable or stainless steel). Forceps (disposable or stainless steel). Field balance (capable of 0.01g measurements). Calibrated verification weights appropriate to verify accuracy of field balance. Mylar bags / amber jars / or equivalent, certified clean (for metals, water activity and moisture content, filth and foreign matter analyses). Amber jars or equivalent, certified clean (for pesticide and potency analyses). Borosilicate VOA vials or equivalent, certified clean (for residual solvent analysis). Sterile Amber Bottles/ Whirl-Pak bags/ or equivalent (for microbial analyses). NIST traceable thermometer or infrared thermometer gun calibrated every 6 months. Coolers and ice packs or other appropriate refrigeration to maintain collected samples at required temperature, as appropriate. A transport manifest generated by the inventory tracking system for tracking all collected samples from the sample collection site to the cannabis testing facility. Pens with indelible ink. Security tamper evident tape labeled with "For Testing Purposes Only." Sample labels. Equipment logbook. Disposable 1mL (or larger) syringes or pipettes (for liquid transfer). Sterile/sanitized nitrile, latex, or rubber gloves. Teri-Wipes, Clorox wipes or equivalent. Transport container for cannabis material that is stored at room temperature. Transport container that meets any matrix-specific storage requirements.

NOTE: For sample collectors or employees of cannabis testing facilities, sample collection tools and supplies may be provided by the requester at the location to be sampled; this will minimize the possibility of outside contamination. The requester may also supply all necessary sample collection equipment and sample containers. The requester should receive guidance from the testing facility regarding what types and sizes of sample collection containers should be used. The testing facility may also ship or drop off sample collection containers to the requester in preparation of the sampling event.

Any self-sampler, sample collector or employee of a cannabis testing facility that uses re-usable sample collection tools and equipment must keep a log of cleaning and sterilization for every re-usable sample collection tool and equipment used.

Section 10: Reagents and Standards

The following reagents or standards may be used to clean reusable sample collection tools and equipment:

Cleaning supplies - solvent, bleach, 70% ethanol, etc. Deionized Water The self-sampler, sample collector or employee of a cannabis testing facility that cleans reusable sample collection tools and equipment will be responsible for keeping a log of cleaning and supplies used.

The self-sampler, sample collector or employee of a cannabis testing facility that cleans reusable sample collection tools and equipment will be responsible for keeping a log of cleaning and supplies used.

NOTE: Some cleaning supplies, such as alcohol or ethanol, are solvents which are tested for pursuant to Maine's mandatory testing requirements. To that end, it is important that reusable sample collection tools that are used to collect sample increments for residual solvent testing are not cleaned using alcohol or ethanol.

Section 11: Sample collection, preservation, shipment and storage

Further guidance on how to perform the sample collection procedures outlined below, including selection of appropriate sample collection equipment and tools based upon matrix type, collection of random sample increments, etc. is included in the Department's Best Practice Guide.

Representative Sampling

When sampling a batch, the self-sampler, sample collector, or employee of a cannabis testing facility collecting samples for mandatory testing shall check for any signs of non-uniformity. Some obvious indicators may be different types or sizes of containers, variations in marks and labels, or mixed batch numbers. During sample collection, the self-sampler, sample collector, or employee of a cannabis testing facility shall look for differences in the usable cannabis being sampled such as color, shape, size, and treatment. The batch must be uniform for all factors that appear on the label; hence, variations in the product may indicate nonuniformity in the batch and any sample collected may not be representative for testing. The self-sampler, sample collector, or employee of a cannabis testing facility shall note these anomalies in the sample collection records kept by the licensee in accordance with Section 3.11 of 18-691 CMR, ch.1.

General procedural guidelines that apply to all sample collection include:

a. The self-sampler, sample collector or employee of a cannabis testing facility must be given access to the entire batch.

b. The self-sampler, sample collector or employee of a cannabis testing facility must use of appropriate sampling equipment.

c. The self-sampler, sample collector or employee of a cannabis testing facility must consistently follow sample collection procedures based upon matrix type.

d. The self-sampler, sample collector or employee of a cannabis testing facility must take equal portions for each sample increment.

e. The self-sampler, sample collector or employee of a cannabis testing facility must randomly select sample increments throughout the batch to ensure a representative sample.

f. The self-sampler, sample collector or employee of a cannabis testing facility must obtain at least a minimum number of sample increments.

g. The self-sampler, sample collector or employee of a cannabis testing facility must record all observations and procedures used while collecting the sample increments in the sample collection records kept in accordance with Section 3.11 of 18-691 CMR, ch.1.

h. All samples collection containers must be sealed with tamper evident seals in front of a witness, who must be an individual identification cardholder employed by the requester. Both the self-sampler, sample collector, or employee of a cannabis testing facility and the witness must initial and record the time and date of sealing on the tamper evident seal(s) and must further sign and date an attestation in accordance with the sample collection recordkeeping requirements of Section 3.11 of 18-691 CMR, ch.1.

Random Sampling

Sample increments should be randomly selected from different locations within the batch, which could be comprised of a container or set of containers, including prepackaged units of cannabis products. Random samples are determined by using the procedure below.

a. Determine the size of the batch and how many containers make up the batch.

b. Determine the number of samples needed based on the batch size.

c. Count the number of containers in batch.

d. Randomly select the containers to be sampled. The self-sampler, sample collector, or employee of a cannabis testing facility must have a random number generator or other means of randomly selecting sample increment units.

e. Record the container numbers to be sampled in the sample collection records.

f. Take the same approximate weight from each container that is sampled.

Sampling a Batch of Cannabis Flower, Trim, or Pre-rolled Cannabis Cigarettes

A harvest batch of cannabis flower, trim, or pre-rolled (uninfused) cannabis cigarettes must be sampled in accordance with the following table based upon the weight of the harvest batch after it has been "dried" or "cured".

Harvest Batch Weight Range*

Composite Sample Amount*

<= 2.5 kg

6.5 g (13 increments of 0.5 grams each)

2.5 kg < w <= 5 kg

9.5 g (19 increments of 0.5 grams each)

5 kg < w <= 7.5 kg

16 g (16 increments of 1 gram each)

7.5 kg < w <= 10 kg

22 g (22 increments of 1 gram each)

*For harvest batches in excess of 10 kg, the harvest batch must be divided and sampled in batches of 10 kg or less.

1. Weigh the empty sample container(s) and record the weight in the sample collection records.

2. Locate the batch to be sampled.

3. Review the container label information for harvest lot number, producer, and other pertinent information and match to the sampling request or transport information, as applicable.

4. Record the batch size and number of containers in the batch as reported by the requester.

5. Select the appropriate sampling tool to ensure that it reaches all portions of the container.

6. Visually inspect each test sample increment to assess uniformity, if non-uniformity is identified, record observation in the sample collection record. It is expected there will be variable sizes and appearance of flower material.

7. For harvest batches of cannabis flower, trim or pre-rolled cannabis cigarettes stored in storage containers such as plastic tubs, the harvest batch containers shall be sampled in a spatial pattern to ensure that each region of the container has been sampled.

8. When collecting sample increments, approximately equal amounts of product are to be taken with each increment and from each container. Care must be taken by the self-sampler, sample collector, or employee of a cannabis testing facility to not damage any portion of the product that is being sampled or any portion of the product that remains.

9. Collect sample increments (minimum of twelve) from random locations as determined above throughout the sample batch into a large sterile container. Sample increments for homogeneity testing must be placed in separate, sterile containers.

10. The sample increments should be collected, and each increment should be packaged in accordance with the requirements identified by the cannabis testing facility(ies) conducting the mandatory analyses.

11. Combine all sample increments to form the composite sample(s) as directed by the cannabis testing facility. Please note: sample increments to analyze homogeneity will require separate sample containers.

12. Weigh and record the weight of the sample(s) in the sample collection record.

13. Seal and label the composite sample(s). The self-sampler, sample collector or employee of a cannabis testing facility must seal each container holding sampled material using tamper evident seals bearing a unique tamper seal number in the presence of a witness who is an IIC-holder employed by the requester. Both the self-sampler, sample collector or employee of a cannabis testing facility and the witness must initial and date the seal and sign the required attestation.

14. Complete the sample collection record while at the sampling location and generate an appropriate transport manifest and test sample labels in the inventory tracking system. Make sure all notes, containers sampled, and all field information is appropriately recorded.

Sampling Unpackaged Servings or Prepackaged Retail Units of Cannabis Concentrate and Cannabis Products

For unpackaged or prepackaged samples, based on batch size, the required number of increments collected from each batch is listed in the following chart. Each sample increment is one serving of an unpackaged retail unit or one prepackaged unit for retail sale (i.e. one unpackaged serving or one pre-packaged retail unit containing multiple servings is one sample increment).

# of Unpackaged servings or Prepackaged Units in Production Batch*

Number of Sample increments**

Where to take samples:

<= 50

2 units

One from beginning and one from end

51-150

3 units

Beginning(1), Middle(1), End (1)

151-500

5 units

Beginning (2), Middle (2), End (1)

501-1200

8 units

Beginning (3), Middle (2), End (3)

1201-3200

13 units

Beginning (4), Middle (5), End (4)

3201-10000

20 units

Beginning (6), Middle (7), End (7)

*For production batches in excess of 10,000 units, the production batch must be divided and sampled in batches of 10,000 units or less.

**Depending on the weight of the prepackaged samples, more than the listed number of increments may need to be taken as directed by the cannabis testing facility.

The increments sampled should cover the range of the batch. See table above.

1. Weigh the empty sample container(s) and record the weight in the sample collection record.

2. Locate the batch to be sampled.

3. Review the container label information for production batch number, producer, and other pertinent information and match to the sampling request or transport information.

4. Record the batch size and number of containers in the batch as reported by the requester.

5. For unpackaged sample increments, select the appropriate sampling tool to ensure that it reaches all portions of the container.

6. Visually inspect each test sample increment to assess uniformity, if non-uniformity is identified, record observation in the sample collection record

7. Randomly select unpackaged or prepackaged sample increments from the beginning third, middle third, and end third of the container(s) holding the unpackaged servings or prepackaged retail units. For unpackaged sample increments, sample increments for homogeneity testing must be placed in separate, sterile containers.

8. Weigh and record the weight of the sample(s) in the sample collection record.

9. Seal and label the composite sample(s). The self-sampler, sample collector or employee of a cannabis testing facility must seal each container holding sampled material using tamper evident seals bearing a unique tamper seal number in the presence of a witness who is an IIC-holder employed by the requester. Both the self-sampler, sample collector or employee of a cannabis testing facility and the witness must initial and date the seal and sign the required attestation.

10. Complete the sample collection record while at the sampling location and generate an appropriate transport manifest and test sample labels in the inventory tracking system. Make sure all notes, containers sampled, and all field information is appropriately recorded.

Sampling Shatter/Wax/Slab Concentrates

For cannabis concentrate, based on batch weight, the required number of sample increments is listed in the following chart.

Production Batch Weight*

Composite sample amount

<= 0.5 kg

6 g (12 increments of 0.5 grams each)

0.5 kg < w <= 1 kg

8 g (16 increments of 0.5 grams each)

1 kg < w <= 1.5 kg

10 g (20 increments of 0.5 grams each)

1.5 kg < w <= 2 kg

12 g (24 increments of 0.5 grams each)

2 kg < w <= 5 kg

14 g (28 increments of 0.5 grams each)

*For production batches in excess of 5 kg, the production batch must be divided and sampled in batches of 5 kg or less.

Note: The shatter, wax, or other concentrate slab may have varying degrees of thickness; thus, the amounts of cannabinoids or potential residual solvent(s) may vary with the thickness of the concentrate. It is important that the samples taken are equivalent from each region of thickness to provide a representative sampling of the overall product. The thinner portions of the concentrate slab will have more surface area exposed allowing for a higher rate of diffusion of residual solvents from the wax or shatter than the thicker portions.

1. Weigh the empty sample container(s) and record the weight in the sample collection record.

2. Locate the batch to be sampled.

3. Review the container label information for production batch number, producer, and other pertinent information and match to the sampling request or transport information.

4. Record the batch size and number of containers in the batch as reported by the requester.

5. Identify three (3) thicknesses or regions to the product.

6. Using spatula or forceps, collect the determined number of sample increments needed from each region of the overall production batch to meet the minimum number of increments required above.

7. Collect sample increments (minimum of twelve) from random locations throughout the sample batch into a container. Sample increments for homogeneity testing must be placed in separate, sterile containers.

8. Weigh and record the weight of the sample(s) in the sample collection record..

9. Seal and label the sample containers. The self-sampler, sample collector or employee of a cannabis testing facility must seal each container holding sampled material using tamper evident seals bearing a unique tamper seal number in the presence of a witness who is an IIC-holder employed by the requester. Both the self-sampler, sample collector or employee of a cannabis testing facility and the witness must initial and date the seal and sign the required attestation.

10. Complete the sample collection record while at the sampling location and generate an appropriate transport manifest and test sample labels in the inventory tracking system. Make sure all notes, containers sampled, and all field information is appropriately recorded.

Sampling Oils, Tinctures, and Other Liquids

Unless already prepackaged into individual retail units (see above), sample increments of oils or tinctures will be collected from container(s) holding the production batch of the oil or tincture in accordance with the following chart.

Production Batch Weight*

Composite Sample Amount

<= 0.5 kg

6 g (12 increments of 0.5 grams each)

0.5 kg < w <= 1 kg

8 g (16 increments of 0.5 grams each)

1 kg < w <= 1.5 kg

10 g (20 increments of 0.5 grams each)

1.5 kg < w <= 2 kg

12 g (24 increments of 0.5 grams each)

2 kg < w <= 5 kg

14 g (28 increments of 0.5 grams each)

*For production batches in excess of 5 kg, the production batch must be divided and sampled in batches of 5 kg or less.

Note: The container holding the oil or tincture shall be inverted a minimum of three times to ensure that the oil or tincture is homogenous. Each inversion shall be complete, i.e., the oil shall flow to the cap of the container and back to the base three times. Viscous substances such as oil may need to be allowed to come to room temperature before inversion occurs. A self-sampler, sample collector or employee of a cannabis testing facility may allow viscous substances to come to room temperature to promote inversion.

1. Weigh the empty sample container(s) and record the weight in the sample collection record.

2. Locate the batch to be sampled.

3. Review the container label information for production batch number, producer, and other pertinent information and match to the sampling request or transport information.

4. Record the batch size and number of containers in the batch as reported by the requester.

5. Invert oil as described above.

6. Weigh and record the weight and of the production batch in the sample collection record.

7. Using a 0.5 mL, 1.0 mL, 10.0 mL or other appropriate sterile disposable pipette4 or syringe, remove the sample amount for each sample to be collected into sterile vial or other appropriate container as directed by the cannabis testing facility. The sample increments (minimum of twelve) shall be taken at different depths of the oil or tincture to ensure that the oil or tincture is sampled representatively. The top third of the container, middle third of the container, and bottom third of the container must be sampled. Sample increments for homogeneity testing must be placed in separate, sterile containers.

8. Weigh and record the weight of the sample(s) in the sample collection record.

9. Seal and label the sample containers. The self-sampler, sample collector or employee of a cannabis testing facility must seal each container holding sampled material using tamper evident seal bearing a unique

10. Complete the sample collection record while at the sampling location and generate an appropriate transport manifest and test sample labels in the inventory tracking system. Make sure all notes, containers sampled, and all field information are appropriately record.

Note: Sample amounts collected will be no less than the minimum sample size required by Table 5.5-A in Rules for the Certification of Cannabis Testing Facilities, 18-691 CMR, ch.5. That table is reproduced in sections above. If there is a discrepancy between the tables above and Table 5.5-A, the table in the rule controls. A testing facility may require that additional sample material be taken for quality control samples.

Section 12: Sample Transportation and Receipt

The licensee collecting samples for mandatory testing must transport those samples to the cannabis testing facility(ies) conducting the analyses, except that a cannabis testing facility may offer a service to retrieve samples collected from a self-sampler at the cannabis establishment where the samples were collected. All samples must be accompanied by a transport manifest generated by the METRC inventory tracking system in accordance with the requirements of Section 4 of the Adult Use Cannabis Program Rule 18-691 CMR, ch.1.

Except as noted in Sampling Oils, Tinctures and Other Liquids, samples must be maintained at all times during collection and transport at the temperature at which the cannabis, cannabis concentrate or cannabis product is stored to prevent microbial growth. The self-sampler, sample collector or employee of a cannabis testing facility must provide appropriate refrigeration during transport for samples requiring refrigeration.

Self-samplers and sample collectors must deliver samples to a cannabis testing facility in accordance with any instructions or restrictions indicated by the cannabis testing facility during its pre-sampling discussion with the self-sampler or sample collector.

Cannabis testing facilities must receive and account for all samples for mandatory testing in accordance with the testing facility's SOP regarding sample receipt. A testing facility must inspect all samples upon receipt and promptly notify the requester, and if applicable, the sample collector, if samples are rejected and the reason for such rejection and record the same in the sample collection record and in the inventory tracking system.

Section 13: Recording Sampling Events in METRC Inventory Tracking System

Self-samplers, sample collectors, and employees of a cannabis testing facility must track all inventory, including sample collection events, in accordance with the user guide provided by the Department's required inventory tracking system.

Section 14: Quality Control

A cannabis testing facility may require any licensee to collect and remit additional sample increments or analytic blanks (e.g. equipment, trip, field blanks) as required by the testing facility's quality system.

At all times, licensees, including cannabis testing facilities, must comply with their Department-approved standard operating procedures, including this SOP and the licensee's quality control system.

Section 15: Calibration and Standardization

The field balance must be initially verified as within the standards listed in the National Institute of Standards and Technology (NIST) Handbook by a scale dealer or repairman registered pursuant to 10 MRS §2651, and calibrated on a yearly basis.

The field verification weights must be calibrated on a yearly basis.

The field balance must be verified each day it is use with weights that bracket the range of use. These verifications will be documented and recorded in the equipment log maintained by the self-sampler, sample collector or employee of a cannabis testing facility collecting samples for mandatory testing.

Section 16: Waste Management

All waste must be disposed of in accordance with the Adult Use Cannabis Program Rule, 18-691 CMR, ch.1.

Section 17: Documentation

The following Quality Records shall be generated and managed for every sample collected:

Required Record

Form Steward

Copies to be Retained By

Sample collection record, to be completed by licensee collecting samples

Licensee collecting samples for mandatory testing

Licensee collecting samples for mandatory testing

Transport Manifest, generated by METRC, to accompany every sample from sampling site to cannabis testing facility

Office of Cannabis Policy

2 copies per Adult Use Cannabis Program Rule

Chain-of-Custody Form, per cannabis testing facility SOP

Cannabis Testing Facility Licensees

Per cannabis testing facility SOP as applicable

Section 18: Sample Collector Signatures

By signing below the self-sampler, sample collector, or employee of a cannabis testing facility collecting samples for mandatory testing affirms that they have read, understand and agree to follow this current version of the SOP. They also agree that they have read and understood the Adult Use Cannabis Program Rule, 18-691 CMR, ch. 1, Rules for the Certification of Cannabis Testing Facilities, 18-691 CMR, ch. 5, this SOP and the Best Practices Guide.

Name__________________ Signature:____________________ Date:_______

Name__________________ Signature:____________________ Date:_______

Name__________________ Signature:____________________ Date:_______

Name__________________ Signature:____________________ Date:_______

Name__________________ Signature:____________________ Date:_______

Name__________________ Signature:____________________ Date:_______

Fiscal impact note, included pursuant to 5 MRS §8063: The Department estimates that the changes implemented by this rulemaking will have a de minimus fiscal impact on municipalities and counties.

4Licensees must ensure that samples of liquid or other viscous materials are measured by weight and not volume. tamper seal number in the presence of a witness who is an IIC-holder employed by the requester. Both the self-sampler, sample collector or employee of a cannabis testing facility and the witness must initial and date the seal and sign the required attestation.

18-691 C.M.R. ch. 1, 691-1 app A