Achieving Reduced Testing Allowance

May 15, 2024

Reduced testing allowance by July 2024 requires the creation and implementation of a HACCP plan. Some money spent now to get this right with iComply will save thousands of dollars in the long run in testing – let alone any notices of destruction or embargo from NOT following these new regulations regarding reduced testing allowance and HACCP.

Quite a few things have changed regarding Reduced Testing Allowance for contamination.

One, is that you must have SOPs around you Microbial Control Steps which is part of what is reviewed during the 12mo RTA period.

The $4000 you’re paying is for additional enforcement and oversight. While this hasn’t changed much for potency RTA, it has changed ALOT for contamination. Paying $4k and signing the attestation means you understand and are ready for the following:

I’d make sure of all these points in your SOPs and train all staff members along with the entity doing the microbial control step before paying money and putting yourself under more scrutiny. HACCP will be required as of July which requires additional documentation and compliance as well.

Achieving Reduced Testing Allowance 

Once SOPs are in place and the fee is paid to the MED, the 12 month clock begins to achieve RTA. 

All regulated marijuana harvested is required to achieve and maintain process validation. For cultivations, this requires the analysis, creation, implementation, and ongoing assessment of a Hazard Analysis and Critical Control Point (HACCP) System containing elements defined in ASTM D8250-19: “Standard Practice for Applying a Hazard Analysis Critical Control Points (HACCP) System for Cannabis Consumable Products” that addresses each product type to receive Reduced Testing Allowance for microbial contaminant testing.

This requires an understanding of the components of this standard and how to implement it in the cultivation’s operations. For purposes of this Rule, a Critical Control Point (CCP) means a step in the creation of Regulated Marijuana at which control can be applied. 

CCPs are essential to prevent or eliminate a safety hazard or reduce it to an acceptable level and have the same meaning as defined and used in ASTM Standard D8250-19, which the MED has a copy available to the public for inspection. 

Effective July 1, 2024, the HACCP System will require:

Regulated Marijuana Cultivation Facilities to be able to achieve a Reduced Testing Allowance specifically for microbial contaminant testing if they have a Hazard Analysis and Critical Control Point (HACCP) System in place as defined in ASTM D8250-19. The HACCP System should address each product type for which reduced testing is sought.

The HACCP System must address biological hazards at a minimum, and it may also address chemical and physical hazards.

If a Critical Control Point (CCP) falls outside established Critical Limits (CLs) during production, the affected Harvest Batch must undergo microbial contaminant testing. Passing this testing allows the Harvest Batch to be transferred.

Detailed documentation and record-keeping of the HACCP System are essential.

The HACCP System must be documented as per ASTM D8250- The following records must be kept during the time that a Cultivation Facility qualifies for and maintains RTA for microbial contaminants and for one year after the RTA expires for any reason. 

A. List of the HACCP team, including relevant experience; 

B. Product description and intended use for each product type receiving a Reduced Testing Allowance for microbial contaminants; 

C. Verified Process Flow Diagram, including Critical Control Points (CCPs); 

D. Hazard Analysis; 

E. List of CCPs and reasoning as to how they were identified; 

F. List of Critical Limits (CLs) and reasoning as to how they were selected; 

G. List of Monitoring Procedures for CCPs;

H. List of pre-planned Corrective Actions in case of deviations; 

I. List of verification procedures; 

J. HACCP system summary page that includes: 

1. CCPs; 

2. Critical Limits (CLs); 

3. Monitoring Procedures; 

4. Corrective Actions related to specific CCPs; 

5. Verification procedures; and 

6. Record Titles associated with the CCP activities (i.e. The Water Activity Monitoring Logbook, etc.); 

K. Support documentation of the CCP validation (i.e. microbial contaminants testing results for Reduced Testing Allowance qualification and maintenance periods); and 

L. Documents generated during operational activities related to the HACCP system, including at minimum: Verified Monitoring Logs for CCPs, Corrective and Preventive Actions documentation related to CCPs, and Material Changes related to HACCP system.

Regulated Marijuana Cultivation Facilities must maintain various records related to their HACCP System, including a list of the HACCP team, product descriptions, process flow diagrams, hazard analyses, lists of CCPs and CLs, monitoring procedures, corrective actions, verification procedures, and more.

Effective July 1, 2024, to achieve a RTA for microbial contaminants, a Cultivation Facility must conduct an internal audit to assess substantial compliance with specific standards in the HACCP System and rules 3-10, 3-330, 3-336, 4-110, 4-120, 6-210(D), and 6-120(E). This internal audit will be performed and scored per the rubric listed in Rule 4-120(B)(1)(b)(i) and a copy of this internal audit must be retained as business records for one year. 

Internal Audit Scoring Rubric. The internal audit will be scored as follows:

i. Scoring System: 0% – 100%

ii. Passing Score: 80% – 100%

iii. Non-Conformance Finding Deductions: 

A. Minor: -1% 

B. Major: -5% 

C. Critical: -100% 

iv. Definition of Non-Conformances:

A. Minor: A deficiency in the compliance to Rule that reasonably could lead to a risk in product safety. 

B. Major: A deficiency in compliance to Rule that carries a highly likely-to-definite risk to product safety. 

C. Critical: A clear deficiency in compliance to Rule that could lead to serious injury or death; or if any falsification of records is found

An authorized representative of the facility must also sign an attestation of substantial compliance with the relevant rules (3-330 and 4-120) to achieve the RTA or Microbial Contaminants. This rule sets forth conditions and requirements for reducing microbial contaminant testing in cannabis cultivation facilities, emphasizing the need for comprehensive documentation, compliance with rules, and internal audits to ensure product safety.