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Cannabis Testing Facility License Application in Maine


Testing Facility License Application in Maine

Are you ready to establish a cannabis testing facility in Maine?  Join our cannabis laboratory consulting team we review the steps needed to navigate Maine's regulatory landscape. This overview will review the following topics related to prepare a successful application for a testing facility license Maine.

 

Table of Contents

 

Legal Status of Cannabis in Maine


Maine was the fifth state to permit medical cannabis use as a response to growing evidence supporting its efficacy in treating various medical conditions, including chronic pain, epilepsy, and nausea under the Maine Medical Marijuana Act in 1999.  This was further expanded and refined through subsequent regulations, such as the Maine Medical Use of Cannabis Act and Program Rules.  Additionally, LD 1719 — An Act To Implement a Regulatory Structure for Adult Use Marijuana — became law on May 2, 2018.

 

Together these new statues and updated rules legalized the possession, use, cultivation, and sale of recreational cannabis for adults aged 21 and older and established a framework for licensing cultivation, manufacturing, testing, and retail operations, with strict guidelines to ensure public safety and responsible consumption.

 

License Certification Types

During the application process, The Maine Center for Diseases Control (CDC) grants three possible outcomes: Provisional certification, full certification, and application denial.

 

A full certification is granted upon demonstration of ISO/IEC 17025/2017 accreditation.

 

A provisional certification is granted upon demonstration of application accepted for ISO/IEC 17025/2017 accreditation.

 

Certification may be denied for any deficiency in the application and cannot produce valid data.

 

License application requirements must meet all administrative requests outlined by the CDC.

 

Rules and Requirements for Cannabis Testing Laboratories

At the time of article publication (March 2024), Maine did not have any testing requirements for medical cannabis.  While the E4 Bioscience team vehemently disagrees with this regulatory position, the larger adult use market is required to pass safety and quality testing.

 

On Sept 8, 2022 the Maine Department of Administrative and Financial Services (DAFS), acting through its Office of Cannabis Policy (OCP), established a certification process for testing facilities analyzing cannabis and cannabis products.  Like testing rules in all states, they are intended to protect public health by establishing standards for testing cannabis and providing assurance that results of testing for contaminants do not exceed the maximum level standards where testing is required.

 

The Rules for the Certification of Cannabis Testing Facilities is a key document for potential applicants since it provides a comprehensive overview of the operational requirements to offer laboratory testing.  These include:

 

The major sectional requirements are very similar to most other states and include:

  • A requirement to obtain ISO/IEC 17025:2015 accreditation to graduate from a provisional to full active license.

  • Quality Assurance Program and Manual

  • Standard Operating Procedures (SOP’s)

  • Proficiency Testing

  • Conducting an Annual Internal Audit

  • Personal requirements

  • Verification and Maintenance of Personnel Documentation

  • Personnel Requirements including: Facility Director, Quality Assurance Officer, and Testing Facility Analyst.

  • Verification and Maintenance of Personnel Documentation

  • Personnel Training and Supervision

  • Sample Collection Procedures

  • Protocols for Acceptance of Samples Collected by Licensees or Other Qualified Persons

  • Chain of Custody and Document Control Requirements

  • Sample Rejection

  • Sample Preparation and Testing

  • Mandatory Testing and Additional Analysis

  • Testing Methodology, Certificates of Analysis, Analytes/Action Limits

  • Bookkeeping Requirements

  • Data Package Results

  • Waste Disposal Plan

Application Process

The licensure application process takes three steps: 1) Conditional licensure, 2) Local Authorization, and 3) Active Licensure. 

 

The conditional licensure review process by the OCP takes up to 90 days and requires the following items:

  • Criminal history check

  • Fingerprinting

  • Obtaining an OCP issued Individual Identification Card (IIC)

  • Conditional license application

  • Paid fee

 

The local authorization process may take up to 180 days simply to receive a response for an application.   This authorization requires applicants to satisfy all municipality expectations for meeting local regulations and licensing requirements. 


Applicants should expect inconsistent municipality requirements and will need to review each potential business location independently.  

 

Within 10 days of receiving an approved local authorization from, OCP will request supplemental information and updated documents from the applicant. The active licensure is granted immediately after all supplemental information is provided to and approved by the OCP:

 

  • Evidence of compliance with all electrical and permitting requirements

  • Appropriate tax information and documents

  • Any changes to original application

  • Official Plan of Record - Facility Plan

  • Paid Fee

 

An active license is valid for 1 yr before an renewal must be submitted.

 

As a final note, while much of the application timeline will be determined by the speed at which the applicant completes its planning activities, the review time at the OCP and municipality level could be as long >280 days, even if there are no denials. This stresses the importance of submitting a high qualify business license application.

 

Next Steps

Starting a Maine cannabis testing laboratory is a time consuming and complex matter.  The application process requires hundreds of pages of technical documentation that must comply with federal, state, and local laws.

 

Luckily, our cannabis testing consultants at E4 Bioscience are experts at winning licenses and starting labs.  Schedule a call today to learn how we do the heavy lifting for you and guide you to successfully starting a cannabis testing facility in Maine.  Or, if our prefer email, please contact us: info@e4bioscience.com.

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