15 Miss. Code. R. 22-5.4 - Testing Requirements and Standards

5.4.1 Testing Requirements for Cannabis and Cannabis Products.

A. All sample increments collected must be homogenized prior to sample analyses, notwithstanding foreign material testing.

B. Every harvest batch of cannabis flower shall be tested for the following prior to sale or distribution to a qualified patient or caregiver:

1. Pesticides in accordance with Rule 5.4.3 of this Part;

2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part;

3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part;

4. Heavy Metals in accordance with Rule 5.4.7 of this Part;

5. Mycotoxins in accordance with Rule 5.4.8 of this Part;

6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part;

7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part;

8. Foreign material in accordance with Rule 5.4.10 of this Part.

C. Every production batch of raw pre-rolls shall be tested in the final form intended for sale or distribution to a qualified patient or caregiver for the following prior to sale or transfer:

1. Pesticides in accordance with Rule 5.4.3 of this Part;

2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part;

3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part;

4. Heavy Metals in accordance with Rule 5.4.7 of this Part;

5. Mycotoxins in accordance with Rule 5.4.8 of this Part;

6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part;

7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part;

8. Foreign material in accordance with Rule 5.4.10 of this Part.

D. Every production batch of cannabinoid concentrate and extract shall be tested in the final form intended for sale or distribution to a qualified patient or caregiver for the following prior to sale or transfer:

1. Pesticides in accordance with Rule 5.4.3 of this Part;

2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part;

3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part;

4. Heavy Metals in accordance with Rule 5.4.7 of this Part;

5. Mycotoxins in accordance with Rule 5.4.8 of this Part;

6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part;

7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part;

8. Foreign material in accordance with Rule 5.4.10 of this Part.

9. A processing entity is exempt from testing concentrates for solvents under this Rule if the processing entity:

a. Did not use any solvent listed in Appendix A, Table 1; and,

b. Solvents in Used a mechanical extraction process to separate cannabinoids from the cannabis; or

c. Used only water, animal fat or vegetable oil as a solvent to separate the cannabinoids from the cannabis.

E. Every production batch of infused cannabis products shall be tested in the final form intended for sale or distribution to a qualified patient or caregiver for the following prior to sale or transfer:

1. Pesticides in accordance with Rule 5.4.3 of this Part;

2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part;

3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part;

4. Heavy Metals in accordance with Rule 5.4.7 of this Part;

5. Mycotoxins in accordance with Rule 5.4.8 of this Part;

6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part;

7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part;

8. Foreign material in accordance with Rule 5.4.10 of this Part; and

9. Homogeneity.

10. Final form edible cannabis products shall meet the following additional requirements:

a. Produced and sold with a standardized concentration of cannabinoids not to exceed ten milligrams (10 mg) of total tetrahydrocannabinol (THC) per serving with an allowable variance of ±10% when testing.

b. Must demonstrate uniform disbursement of cannabinoids throughout the product when sampled and tested.

11. Infused non-edible products and beverages are exempt from water activity and moisture content testing.

F. Every production batch of Kief shall be tested in the final form intended for sale or distribution to a qualified patient or caregiver for the following prior to sale or transfer:

1. Pesticides in accordance with Rule 5.4.3 of this Part;

2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part;

3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part;

4. Heavy Metals in accordance with Rule 5.4.7 of this Part;

5. Mycotoxins in accordance with Rule 5.4.8 of this Part;

6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part;

7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part; and

8. Foreign material in accordance with Rule 5.4.10 of this Part; and

G. Every production batch of infused pre-rolls and inhalable compound concentrate products shall be tested in the final form intended for sale or distribution to a qualified patient or caregiver for the following prior to sale or transfer:

1. Pesticides in accordance with Rule 5.4.3 of this Part;

2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part;

3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part;

4. Heavy Metals in accordance with Rule 5.4.7 of this Part;

5. Mycotoxins in accordance with Rule 5.4.8 of this Part;

6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part;

7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part; and

8. Foreign material in accordance with Rule 5.4.10 of this Part.

H. Testing Standards: All compliance testing requirements by product type are summarized in Appendix D and all compliance testing requirements by final packaging are summarized in Appendix E.

5.4.2 Standards for Testing Microbiological Contaminants.

A. Medical cannabis and medical cannabis products required to be tested for microbiological contaminants shall be sampled using appropriate aseptic technique and tested by a Mississippi licensed and registered cannabis testing entity for microbial impurities.

B. The cannabis testing entity shall report the result of the microbial impurities testing by indicating "pass" or "fail" on the Certificate of Analysis.

C. All cannabis products shall be deemed to have passed the microbial impurities testing if all of the following conditions are met:

1. Total coliform is not detected above 100 colony forming units/gram.

2. Shiga toxin-producing Escherichia coli is not detected in 1 gram;

3. Salmonella spp. is not detected in 1 gram; and

4. Pathogenic Aspergillus species A. fumigatus, A. flavus, A. niger, and A. terreus are not detected in 1 gram.

5. Total Yeast and Mold is not detected above 10,000 colony-forming units/gram.

D. Microbial impurities testing shall include an optimized incubation period for all plating-based methods used to report total coliform and total yeast and mold results.

E. If the sample fails microbial impurities testing, the batch from which the sample was collected fails microbial impurities testing and shall not be released for retail sale.

F. The testing entity shall follow the protocol or product instructions provided by the equipment manufacturer, including any enrichment steps. If enrichment is recommended but not required, the enrichment shall be performed.

G. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion.

5.4.3 Standards for Testing Pesticides

A. Medical cannabis and medical cannabis products required to be tested for pesticides shall be tested by a Mississippi licensed, and registered cannabis testing entity approved for the analytes listed in Appendix A, Table 1.

B. The cannabis testing entity shall report whether any Residual Pesticides are detected above the limit of detection (LOD) and shall report the result of the testing in ppms on the Certificate of Analysis. The cannabis testing facility shall indicate "pass" or "fail" on the Certificate of Analysis.

C. A batch fails pesticide testing if a cannabis testing entity detects the presence of a pesticide above the action levels listed in Appendix A, Table 1 in a sample:

1. During an initial test where no reanalysis is requested; or

2. Upon reanalysis as described in Rule 5.5.1 of this Part.

5.4.4 Standards for Testing Solvents.

A. Medical cannabis products required to be tested for solvents shall be tested by a Mississippi licensed, and registered cannabis testing entity approved for the analytes listed in Appendix A, Table 1.

B. The cannabis testing entity shall report the result of the residual solvents testing in ppm on the Certificate of Analysis and indicate "pass" or "fail" on the Certificate of Analysis.

C. A batch fails solvent testing if a cannabis testing entity, during an initial test where no reanalysis is requested or upon reanalysis as described in section 5.5 of this Part:

1. Detects the presence of a solvent above the action level listed in Appendix A, Table 1; or

2. Calculates a RPD of more than twenty percent (20%) between the field primary result of the sample and the field duplicate result.

5.4.5 Standards for Testing Water Activity and Moisture Content.

A. Medical cannabis and medical cannabis products required to be tested for water activity and moisture content shall be tested by a currently Mississippi licensed and registered cannabis testing entity. If a sample has a water activity rate of more than 0.65 aw the sample fails except for an edible infused cannabis product.

B. An edible cannabis-infused product fails water activity testing if the water activity rate of more than 0.85 aw.

C. Non-edible infused products are not subject to water activity testing.

D. The cannabis testing entity shall report the result of the water activity test on the COA and indicate "pass" or "fail" on the COA.

E. If a sample has a moisture content of more than fifteen percent (15%), the sample fails. The cannabis testing entity shall report the result of the moisture content on the COA and indicate "pass" or "fail" on the COA.

F. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion.

5.4.6 Standards for Potency (THC and CBD) Testing.

A. In the preparation of samples intended for potency analysis, the testing entity may not adulterate or attempt to manipulate the total potency of the sample by any means, including by the addition of trichomes that were removed during the grinding and homogenization process.

B. All flower material used for potency testing shall be representative of the product used by the end consumer and homogenized in such a way that it is representative of the way a consumer would be using the product. Kief shall not be reintroduced to the flower sample during the homogenization process.

C. A licensed cannabis testing entity shall test for the following at a minimum when testing medical cannabis and medical cannabis products for potency without any corrective factor taken for moisture content:

1. Delta-8- tetrahydrocannabinol;

2. Delta-8- tetrahydrocannabinolic acid;

3. Delta-9-tetrahydrocannabinol;

4. Delta-9-tetrahydrocannabinolic acid;

5. Cannabidiol (CBD);

6. Cannabidiolic acid (CBDA);

7. THC content;

8. Cannabinol (CBN); and

9. Any other cannabinoid determined by the department.

D. A cannabis testing entity shall establish a limit of quantitation of 1.0 mg/g or lower for all cannabinoids analyzed and reported.

E. A cannabis testing entity shall report the result of the cannabinoid testing on the Certificate of Analysis, including, at minimum:

1. A percentage for THC, THCA, CBD, and CBDA. The dry-weight percent shall be calculated using the below equation: Dry-weight percent cannabinoid = wet-weight percent cannabinoid/(1 - percent moisture/100);

2. A percentage for Total THC and Total CBD, if applicable;

3. Milligrams per gram (mg/g) if by dry-weight or milligrams per milliliter (mg/mL) if by volume for THC, THCA, CBD, and CBDA;

4. Milligrams per gram (mg/g) if by dry-weight or milligrams per milliliter (mg/mL) if by volume for Total THC and Total CBD, if applicable;

5. Total cannabinoid concentration shall be calculated for concentration expressed in weight: Total cannabinoid concentration (mg/g) = (cannabinoid acid form concentration (mg/g) x 0.877) + cannabinoid concentration (mg/g);

6. Milligrams per package for THC and CBD;

7. Milligrams per package for Total THC and Total CBD, if applicable;

8. Milligrams per serving for THC and CBD, if any;

9. Milligrams per serving for Total THC and Total CBD, if any and if applicable;

10. For edible cannabis products, the cannabis testing entity shall also report, the concentration in milligrams per serving (mg/serving) and milligrams per package (mg/package).

11. The results of all other cannabinoids analyzed on the COA both as a percentage and in either milligrams per gram (mg/g) if by weight or milligrams per milliliter (mg/mL) if by volume.

12. The sample shall be deemed to have passed the cannabinoid testing if the amount of THC does not exceed the limits below:

a. Cannabis flower or trim potency [LESS THAN IS EQUAL TO] 30% total THC;

b. Cannabis tinctures, oils or concentrates [LESS THAN IS EQUAL TO] 60% total THC.

F. A cannabis testing entity shall report the test results and indicate an overall "pass" or "fail" for the cannabinoid testing on the Certificate of Analysis.

G. Total THC, and/or Total CBD claimed to be present on a label shall not be considered inaccurate if the difference in percentage on the certificate of analysis is plus or minus 10.0%.

H. A production batch of cannabinoid concentrate or extract fails potency testing if, based on an initial test where no reanalysis is requested or upon reanalysis, the amount of THC, as calculated pursuant to Rule 5.4.6 of this Part, between samples taken from the batch exceeds twenty percent (20%) RSD.

I. The testing facility shall enter all test results into the seed-to-sale system within three (3) business days of test completion.

5.4.7 Standards for Testing for Heavy Metals.

A. Medical cannabis and medical cannabis products shall be tested by a current Mississippi licensed and registered cannabis testing entity for the metals listed in Appendix A.

B. A cannabis testing entity shall report the result of the heavy metals test on the Certificate of Analysis and indicate "pass" or "fail" on the COA.

C. A batch fails metals testing if a cannabis testing entity, during an initial test where no reanalysis is requested or upon reanalysis as described in section 5.5 of this Part detects the presence of metals above the action level listed in Appendix A, Table 1.

D. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion.

5.4.8 Standards for Mycotoxin Testing.

A. Medical cannabis and medical cannabis products shall be tested by a Mississippi licensed and registered cannabis testing entity for the following mycotoxins: Aflatoxin B1, B2, G1, and G2 Ochratoxin A.

B. A batch shall be deemed to have passed mycotoxin testing if both the following conditions are met:

1. Total of aflatoxin B1, B2, G1, and G2 does not exceed 20 µg/kg of substance, and

2. Ochratoxin A does not exceed 20 µg/kg of substance.

C. A cannabis testing entity shall report the result of the mycotoxin testing on the Certificate of Analysis and indicate "pass" or "fail" on the COA.

D. A batch fails mycotoxin testing if a cannabis testing entity, during an initial test where no reanalysis is requested or upon reanalysis as described in section 5.5 of this Part detects the presence of mycotoxins above the action level listed in Appendix A, Table 1.

E. The testing facility shall enter all test results into the seed-to-sale system within three (3) business days of test completion.

5.4.9 Standards for Terpenoid Testing.

A. Terpene analysis is not required. However, if terpene content is listed on product packaging or label, a terpene analysis from a Mississippi licensed and registered cannabis testing entity shall be performed to confirm the product label.

B. A cannabis testing facility shall report the result of the terpenoid testing on the COA both as a percentage and in either milligrams per gram (mg/g) if by weight or milligrams per milliliter (mg/mL) if by volume.

C. The terpenoid testing results on the label of any one terpenoid claimed to be present shall not be considered inaccurate if the difference in percentage on the COA is plus or minus 10.0%.

D. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion.

5.4.10 Standards for Foreign Material Testing.

A. Medical cannabis and medical cannabis products shall be tested by a Mississippi licensed and registered cannabis testing entity to determine whether foreign material is present.

B. A cannabis testing entity shall report the result of the foreign material test by indicating "pass" or "fail" on the COA.

C. A cannabis testing entity shall perform foreign material testing on the total representative sample prior to sample homogenization.

D. When the licensed testing entity performs foreign material testing, at minimum, it shall do all of the following:

1. Examine both the exterior and interior of the dried flower sample and;

2. Examine the exterior of the cannabis product sample.

E. The sample shall be deemed to have passed the foreign material testing if the presence of foreign material does not exceed:

1. One-fourth (1/4) of the total sample area covered by sand, soil, cinders, or dirt;

2. One-fourth (1/4) of the total sample area covered by mold;

3. One (1) insect fragment, 1 hair, or 1 count mammalian excreta per 3.0 grams; or

4. One-fourth (1/4) of the total sample area covered by an embedded foreign material.

F. If the sample fails foreign material testing, the batch from which the sample was collected fails foreign material testing and shall not be released for retail sale.

G. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion.

5.4.11 Standards for Homogeneity Testing.

A. Infused cannabis products must be homogenous, with the THC and CBD content evenly distributed throughout.

B. Infused cannabis products shall only be considered homogenous if the concentration of total THC and/or CBD in milligrams per serving for three (3) units from the batch is +/- 15% of the stated THC/CBD per serving.

C. Each type of infused product shall be tested every six (6) months and any time the manufacturing process or ingredient(s) change.

D. An infused cannabis product that fails homogeneity testing shall not be released for retail sale. All subsequent production batches of the failed item type shall undergo homogeneity testing until three (3) consecutive batches pass.

E. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion.

F. The processor shall maintain copies of the test results for each product type for at least one (1) year after the specific item is discontinued.

5.4.12 If a testing entity is not accredited for the full scope of state-required tests, the testing facility will need to subcontract with another Department-licensed testing facility for the relevant tests needed. All subcontracted testing shall be documented in the seed-to-sale system and be transferred using appropriate transport processes and chain of custody.

5.4.13 If a testing entity performs research and development testing, the laboratory shall comply with these rules.

A. Punitive action shall not be taken against a licensed medical cannabis establishment for conducting research and development testing when permitted.

B. The Department may publish guidance for research and development testing that shall be followed by all licensed medical cannabis establishments.

C. Research and development testing is only permitted BEFORE compliance testing for all analytes except Terpenes, which shall always be ordered as an R&D test.

D. All research and development testing shall be fully completed and reported into the seed-to-sale system by the testing entity BEFORE the final compliance testing can be ordered by the licensee.

E. Research and development testing shall not replace the Department's required safety compliance testing.

5.4.14 The Department shall take immediate disciplinary action, including sanctions, fines, or both, against any testing entity that falsifies records or fails to comply with the provisions of this Part.

5.4.15 A testing entity shall comply with random compliance checks at the request of the Department. The Department or its authorized agents may collect a random sample of a medical cannabis product from a testing entity or designate another testing entity to collect a random sample of a medical cannabis product in a secure manner to test that sample for compliance pursuant to these Rules.

Notes

15 Miss. Code. R. 22-5.4

Adopted 1/13/2024