DAR File No. 43842

Agriculture and Food, Plant Industry

Rule R68-29

Quality Assurance Testing on Cannabis

Notice of Proposed Rule

(New Rule)

DAR File No.: 43842
Filed: 06/30/2019 03:09:08 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

This proposed rule sets forth the standards for cannabis and cannabis product testing and sets limits for pesticides, residual solvents, heavy metals, and other contaminants pursuant to Subsections 4-41-403(1) and 4-41a-701(3).

Summary of the rule or change:

This proposed rule sets forth the requirements for the testing of cannabis and cannabis products. This rule establishes the levels for pesticides, residual solvents, heavy metals, and other contaminants that products must meet in order to be available.

Statutory or constitutional authorization for this rule:

• Subsection 4-41a-701(3)
• Subsection 4-41-403(1)

This rule or change incorporates by reference the following material:

• Adds United States Pharmacopeia Section 1111, published by United States Pharmacopeia, 05/01/2009

Anticipated cost or savings to:

the state budget:

There are no cost or benefits to the state as this proposed rule only sets limits for that must be followed by the industry. While the Department of Agriculture and Food (Department) may be asked to conduct quality assurance testing, those cost are funded through other related programs.

local governments:

There are no anticipated costs or benefits to local governments as this rule neither requires action from nor provides benefits to local governments.

small businesses:

In the event that a sample does not pass the quality assurance standards as stated in this rule, a small business will not be able to offer their product for sale in the state. They will also have the cost associated with the destruction of the products lots or batch for failure to pass a test. However, it is impossible at this time for the Department to determine those cost at this time.

persons other than small businesses, businesses, or local governmental entities:

This proposed rule establishes limits for pesticides, residual solvents, heavy metals, and other contaminants in cannabis and cannabis products. This proposed rule does not impose any additional financial requirement on persons, nor generate a cost or savings impact to other persons.

Compliance costs for affected persons:

In the event that a sample does not pass the quality assurance standards as stated in this rule, a business will not be able to offer their product for sale in the state. They will also have the cost associated with the destruction of the products lots or batch for failure to pass a test. As cannabis has been previously illegal under state law, the full impact to these businesses cannot be estimated as the necessary data is not available to the Department.

Comments by the department head on the fiscal impact the rule may have on businesses:

In the event that a sample does not pass the quality assurance standards as stated in this rule, a small business will not be able to offer their product for sale in the state. They will also have the cost associated with the destruction of the products lots or batch for failure to pass a test. As cannabis has been previously illegal under state law, the full impact to these businesses cannot be estimated as the necessary data is not available to the Department.

Kerry Gibson, Commissioner

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Agriculture and Food
Plant Industry
350 N REDWOOD RD
SALT LAKE CITY, UT 84116-3034

Direct questions regarding this rule to:

• Melissa Ure at the above address, by phone at 801-538-4978, by FAX at , or by Internet E-mail at mure@utah.gov
• Kelly Pehrson at the above address, by phone at 801-538-7102, by FAX at , or by Internet E-mail at kwpehrson@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

08/14/2019

Interested persons may attend a public hearing regarding this rule:

• 08/08/2019 02:00 PM, Dept. of Agriculture and Food, 350 North Redwood Road, Salt Lake City, UT

This rule may become effective on:

08/21/2019

Authorized by:

Kerry Gibson, Commissioner

Appendix: Regulatory Impact Analysis for Small and Non - Small Businesses

Fiscal Costs	FY 2020	FY 2021	FY 2022
State Government	$0	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other Person	$0	$0	$0
Total Fiscal Costs:	$0	$0	$0
Fiscal Benefits
State Government	$0	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other Persons	$0	$0	$0
Total Fiscal Benefits:	$0	$0	$0
Net Fiscal Benefits:	$0	$0	$0

 

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described above. Inestimable impacts for Non - Small Businesses are described below.

 

Appendix 2: Regulatory Impact to Non - Small Businesses

Subsection 4-41a-701(3) allows for the Department to establish rules for the quality assurance testing on cannabis. This rule establishes the standards cannabis and cannabis products must pass before they are offered for sale in the state. This is to help make sure the products free from harmful contaminants. As cannabis has been previously illegal under state law, the full impact to these businesses cannot be estimated as the necessary data is not available to the Department.

 

The Commissioner of the Department of Agriculture and Food, Kerry Gibson, has reviewed and approved this fiscal analysis.

 

 

R68. Agriculture and Food, Plant Industry.

R68-29. Quality Assurance Testing on Cannabis.

R68-29-1. Authority and Purpose.

1) Pursuant to sections 4-41-403(1) and 4-41a-701(3), this rule establishes the standards for cannabis and cannabis product testing and sets limits for pesticides, residual solvents, heavy metals, and other contaminants.

 

R68-29-2. Definitions.

1) "Analyte" means a substance or chemical component that is undergoing analysis.

2) "Batch" means a quantity of:

a) cannabis extract produced on a particular date and time, following clean up until the next clean up during which lots of cannabis are used;

b) cannabis product produced on a particular date and time, following clean up until the next clean up during which cannabis extract is used; or

c) cannabis flower packaged on a particular date and time, following clean up until the next clean up during which lots of cannabis are being used.

3) "Cannabinoid product" means a chemical compound extracted from a hemp product that:

a) is processed into a medical dosage form; and

b) contains less than 0.3% tetrahydrocannabinol by dry weight.

4) "Cannabis" means any part of the marijuana plant.

5) "Cannabis cultivation facility" means a person that:

a) possesses cannabis;

b) grows or intends to grow cannabis; and

c) sells or intends to sell cannabis to a cannabis cultivation facility or a cannabis processing facility.

6) "Cannabis processing facility" means a person that:

a) acquires or intends to acquire cannabis from a cannabis production establishment or a holder of an industrial hemp processor license under title 4 chapter 41, Hemp and Cannabidiol Act;

b) possesses cannabis with the intent to manufacture a cannabis product;

c) manufactures or intends to manufacture a cannabis product from unprocessed cannabis or cannabis extract; and

d) sells or intends to sell a cannabis product to a medical cannabis pharmacy or the state central fill medical cannabis pharmacy.

7) "Cannabis product" means a product that:

a) is intended for human use; and

b) contains cannabis or tetrahydrocannabinol.

8) "Department" means the Utah Department of Agriculture and Food.

9) "Lot" means the quantity of:

a) flower produced on a particular date and time, following clean up until the next clean up during which the same materials are used; or

b) trim, leaves, or other plant matter from cannabis plats produced on a particular date and time, following clean up until the next clean up.

10) "Pest" means:

a) any insect, rodent, nematode, fungus, weed; or

b) any other form of terrestrial or aquatic plant or animal life, virus, bacteria, or other microorganisms that are injurious to health or to the environment or that the department declares to be a pest.

11) "Pesticide" means any:

a) substance or mixture of substances, including a living organism, that is intended to prevent, destroy, control, repel, attract, or mitigate any insect, rodent, nematode, snail, slug, fungus, weed, or other forms of plant or animal life that are normally considered to be a pest or that the commissioner declares to be a pest;

b) any substance or mixture of substances intended to be used as a plant regulator, defoliant, or desiccant; and

c) any spray adjuvant, such as a wetting agent, spreading agent, deposit builder, adhesive, or emulsifying agent with deflocculating properties of its own used with a pesticide to aid the pesticide's application or effect.

 

R68-29-3. Required Cannabis and Cannabis Product Tests.

1) Prior to the transfer of cannabis, a cannabis cultivation facility shall have an independent cannabis laboratory test a representative sample of a cannabis lot for microbiological contaminants, heavy metals, and pesticide residue.

2) Prior to offering cannabis or a cannabis product for sale, a cannabis processing facility shall have an independent cannabis laboratory test a representative sample of a batch or lot for microbiological contaminants, heavy metals, pesticide, and residual solvent.

3) A cannabinoid product shall be tested by and independent testing laboratory for microbiological contaminants, heavy metals, pesticides, and residual solvents prior to the products being registered with the department in accordance with Utah Code 4-41-402

4) The department may require an independent laboratory to test for toxins.

5) If the sample of cannabis does not pass the toxin, heavy metal, pesticide, or resolvent test based on the standards set forth in this rule, the cannabis cultivation facility or shall dispose of the entire batch or lot from which the sample was taken.

6) If the sample of cannabis does not pass the microbiological test based on the standards set forth in this rule, the cannabis may be used to make a carbon dioxide (CO ₂) or solvent-based extract.

7) If the sample of a cannabis product does not pass the microbiological, toxin, heavy metal, pesticide, or residual solvent test based on the standards set forth in this rule, the cannabis processing facility shall dispose of the entire batch or lot from which the sample was taken.

 

R68-29-4. Microbiological Standards.

1) A sample and related lot or batch of cannabis, cannabis product, or cannabinoid product fail quality assurance testing for microbiological contaminants if the results exceed the limits as set forth in Section 1111 of the United States Pharmacopeia.

2) The Department adopts by reference Section 1111 of the United States Pharmacopeia (May 1,2012).

 

R68-29-5. Standards for Pesticides.

1) Only pesticides allowed by the department may be used in the production of cannabis, cannabis products, or cannabinoid products.

2) If an independent cannabis laboratory identifies a pesticide that is not allowed under R68-29-5(1) and is above the action levels provided in R68-29-5(3) that lot or batch from which the sample was taken has failed quality assurance testing.

3) A sample and related lot or batch of cannabis or cannabis product fail quality assurance testing for pesticides if the results exceed the limits as set forth on the table below.

 

Table 1
Pesticide Analytes and Action Levels

  

  Analyte             Chemical Abstract Service     Action Level
  
                    (CAS) Registry number         ppm
  
Abamectin           71751-41-2                    0.5
  
Acephate            30560-19-1                    0.4
  
Acequinocyl         57960-19-7                    2
  
Acetamiprid         135410-20-7                   0.2
  
Aldicarb            116-06-3                      0.4
  
Azoxystrobin        131860-33-8                   0.2
  
Bifenazate          149877-41-8                   0.2
  
Bifenthrin          82657-04-3                    0.2
  
Boscalid            188425-85-6                   0.4
  
Carbaryl            63-25-2                       0.2
  
Carbofuran          1563-66-2                     0.2
  
Chlorantraniliprole 500008-45-7                   0.2
  
Chlorfenapyr        122453-73-0                   1
  
Chlorpyrifos        2921-88-2                     0.2
  
Clofentezine        74115-24-5                    0.2
  
Cyfluthrin          68359-37-5                    1
  
Cypermethrin        52315-07-8                    1
  
Daminozide          1596-84-5                     1
  
DDVP (Dichlorvos)   62-73-7                       0.1
  
Diazinon            333-41-5                      0.2
  
Dimethoate          60-51-5                       0.2
  
Ethoprophos         13194-48-4                    0.2
  
Etofenprox          80844-07-1                    0.4
  
Etoxazole           153233-91-1                   0.2
  
Fenoxycarb          72490-01-8                    0.2
  
Fenpyroximate       134098-61-6                   0.4
  
Fipronil            120068-37-3                   0.4
  
Flonicamid          158062-67-0                   1
  
Fludioxonil         131341-86-1                   0.4
  
Hexythiazon         78587-05-0                    1
  
Imazal              35554-44-0                    0.2
  
Imidacloprid        138261-41-3                   0.4
  
Kresoxim-methyl     143390-89-0                   0.4
  
Malathion           143390-89-0                   0.2
  
Metalaxyl           57837-19-1                    0.2
  
Methiocarb          2032-65-7                     0.2
  
Methomyl            16752-77-5                    0.4
  
Methyl parathion    298-00-0                      0.2
  
MGK-264             113-48-4                      0.2
  
Myclobutanil        88671-89-0                    0.2
  
Naled               300-76-5                      0.5
  
Oxamyl              23135-22-0                    1
  
Paclobutrazol       76738-62-0                    0.4
  
Permethrins         52645-53-1                    0.2
  
Phosmet             732-11-6                      0.2
  
Piperonyl_butoxide  51-03-6                       2
  
Prallethrin         23031-36-9                    0.2
  
Propiconazole       60207-90-1                    0.4
  
Propoxur            114-26-1                      0.2
  
Pyrethrins          8003-34-7                     1
  
Pyridaben           96489-71-3                    0.2
  
Spinosad            168316-95-8                   0.2
  
Spiromesifen        283594-90-1                   0.2
  
Spirotetramat       203313-25-1                   0.2
  
Spiroxamine         118134-30-8                   0.4
  
Tebuconazole        80443-41-0                    0.4
  
Thiacloprid         111988-49-9                   0.2
  
Thiamethoxam        153719-23-4                   0.2
  
Trifloxystrobin     141517-21-7                   0.2

 

4) Permethrins should be measured as cumulative residue of cis- and trans-permethrin isomers (CAS numbers 54774-45-7 and 51877-74-8).

5) Pyrethrins should be measured as the cumulative residues of pyrethrin 1 (CAS 121-21-1), cinerin 1 (CAS 25402-06-6), and jasmolin 1 (CAS 4466-14-2).

 

R68-29-6. Solvents Standards.

1) A sample and related lot or batch of cannabis, cannabis product, or cannabinoid product fails quality assurance testing for residual solvents if the results exceed the limits provided in the table below.

 

Table 2
List of Solvents and Action Levels

  

  Solvent               Chemical Abstract Service     Action level
  
                      (CAS)Registry number          µg/g
  
1,2 Dimethoxyethane   110-71-4                      100
  
1,4 Dioxane           123-9                         380
  
1-Butanol             71-36-3                       5000
  
1-Pentanol            71-41-0                       5000
  
1-Propanol            71-23-8                       5000
  
2-Butanol             78-92-2                       5000
  
2-Butanol             78-93-3                       5000
  
2-Ethoxyethanol       110-80-5                      160
  
2-methylbutane        78-78-4                       5000
  
2-Propanol (IPA)      67-63-0                       5000
  
Acetone               67-64-1                       5000
  
Acetonitrile          75-05-8                       410
  
Benzene               71-43-2                       2
  
Butane                106-97-8                      5000
  
Cumene                98-82-8                       70
  
Cyclohexane           110-82-7                      3880
  
Dichloromethane       75-09-2                       600
  
2,2-dimethylbutane    75-83-2                       290
  
2,3-dimethylbutane    79-29-8                       290
  
1,2-dimethylbenzene   95-47-6                       See Xylenes
  
1,3-dimethylbenzene   108-38-3                      See Xylenes
  
1,4-dimethylbenzene   106-42-3                      See Xylenes
  
Dimethyl sulfoxide    67-68-5                       5000
  
Ethanol               64-17-5                       5000
  
Ethyl acetate         141-78-6                      5000
  
Ethylbenzene          100-41-4                      See Xylenes
  
Ethyl ether           60-29-7                       5000
  
Ethylene glycol       107-21-1                      620
  
Ethylene Oxide        75-21-8                       50
  
Heptane               142-82-5                      5000
  
n-Hexane              110-54-3                      290
  
Isopropyl acetate     108-21-4                      5000
  
Methanol              67-56-1                       3000
  
Methylpropane         75-28-5                       5000
  
2-Methylpentane       107-83-5                      290
  
3-Methylpentane       96-14-0                       290
  
N,N-dimethylacetamide 127-19-5                      1090
  
N,N-dimethylfromamide 68-12-2                       880
  
Pentane               109-66-0                      5000
  
Propane               74-98-6                       5000
  
Pyridine              110-86-1                      100
  
Sulfolane             126-33-0                      160
  
Tetrahydrofuran       109-99-9                      720
  
Toluene               108-88-3                      890
  
Xylenes               1330-20-7                     2170

 

2) Xylenes is a combination of the following:

a) 1,2-dimethylbenzene;

b) 1,3-dimethylbenzene;

c) 1,4-dimethylbenzene; and

d) ethyl benzene.

 

R68-29-7. Heavy Metals.

A sample and related lot or batch of cannabis, cannabis product, or cannabinoid product fail quality assurance testing for heavy metals if the results exceed the limits provided in the table below.

 

Table 3
Heavy Metals

  

  Metals               Natural Health Products Acceptable
  
                     limits in parts per million
  
Arsenic              <2
  
Cadmium              <0.82
  
Lead                 <1.2
  
Mercury              <0.4

 

R68-29.8. Mycotoxin.

A sample and related lot or batch of cannabis or cannabis product fail quality assurance testing for mycotoxin if the results exceed the limits provided in the table below.

 

Table 4
Mycotoxin

  

  Test                       Specification
  
The total of
  
Aflatoxin B1,
  
Aflatoxin B2,
  
Aflatoxin G1,and
  
Aflatoxin G2               <20 µG/kg of substance
  
Ochratoxin A.              <20 µG/kg of substance

 

KEY: cannabis testing, quality assurance, cannabis laboratory

Date of Enactment or Last Substantive Amendment: 2019

Authorizing, and Implemented or Interpreted Law: 4-41a-701(3); 4-41-403(1)