At the bottom of nearly every cannabis laboratory website is a cluster of badges indicating the accreditations and affiliations of the laboratory. While laboratories tout participation in these programs, it is rare that the purpose of them is clear to consumers. Accreditation programs like ISO-17025 or TNI are designed to demonstrate a laboratory’s competence in producing tests results that are reliable and accurate, but they were never designed to demonstrate a laboratory’s ethical integrity. Even in the best of cases, accreditation is not a substitute for strong, sensible regulation and auditing by the state.
Cannabis legalization promised consumers that cannabis would become safe in addition to being accessible. The need for testing that would demonstrate that cannabis was free of contaminants created the rapidly developing and highly competitive cannabis testing market. Ultimately, the objective of cannabis lab testing should be to ensure that the products are free from harmful contaminants and that the potency and composition of the products meet labeling requirements for the state.
A Bit About Accreditation
Accreditation is the formal recognition of a laboratory’s technical competence and ability to carry out specific tests. Accreditation by a recognized accrediting body helps to demonstrate that a laboratory is capable of reliably creating accurate test results, and has standard operating procedures and quality management programs in place. Accrediting bodies are third party organizations which assess the laboratory’s quality management system, technical procedures, staff competency, and equipment calibration to ensure that the laboratory is able to produce reliable and accurate results.
In other industries, the federal government asserts authority over manufacturing processes and consumer safety testing. For example, the Food and Drug Administration (FDA) supplies Current Good Manufacturing Processes (CGMP’s). Much like accreditation programs, CGMP’s seek to assure the quality of products by requiring manufacturers to control many facets of their operations. The CGMP’s include rules around quality management systems, raw material acquisition, and operating procedures for the producers in addition to rules regarding testing laboratories. CGMP’s are a minimum set of standards that intend to give manufacturers some flexibility in determining how their processes and operations can meet those requirements.
As cannabis is still federally illegal, the industry operates without federal infrastructure such as the FDA. This means that rules and regulations are created by the state. States often depend on the third-party accreditation process. This means that in cannabis, accreditation increases in importance.
What Does Accreditation Examine?
Generally, accreditation seeks to examine many facets of a laboratory’s operation in order to understand how rigorous their approach to testing is. Common areas that accreditation analyzes are:
Qualifications of Personnel, especially in key roles
Standard Operating Procedures (manual for all tests)
Chain of Custody
Quality Management Program
Results Reporting Mechanism.
One of the most common accreditations that cannabis labs cite is ISO-17025. ISO-17025 is an internationally recognized standard for laboratory best practices that “enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world.” ISO, the International Organization For Standardization, is a non-government organization made up of 167 national standards bodies. The 17025 standard has had three versions, with the latest being published in 2017.
The ISO-17025 accreditation requirements include (1) information on establishing appropriate quality management systems, (2) laboratory personnel duties and requirements, (3) the creation of a quality manual and complete manual of all processes and procedures, and (4) demonstration of a training plan for all employees and records of its implementation, in addition to more technical detail. The standard also specifies that internal audit and other quality programs must be established.
All of these requirements are evaluated during an on-site assessment by a third party before ISO-17025 accreditation is granted to a laboratory.
However, while adherence to standards of laboratory best practices like ISO-17025 can help to demonstrate a laboratory’s commitment to best practices, standards are ineffective at policing behavior by bad-actor cannabis labs or producers.
Chart Data: Arizona Arkansas California Colorado Connecticut District of Columbia Florida Hawaii Illinois Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nevada New Hampshire New Jersey New Mexico New York North Dakota Ohio Oklahoma Oregon Pennsylvania South Dakota Washington
Standards Don’t Test for Lies
Labs that are willing to inflate THC or pass products that have failed pesticide or other tests can and will continue that behavior – even at ISO-17025 accredited laboratories. For example, Washington had to shut down a lab, Praxis, that falsified over 1,200 COA’s to inflate THC results despite having their ISO-17025 certification. It’s true that ISO-17025 requires exacting processes, training programs, and quality systems, but dishonest people can always find a way around a rule if the money is good enough.
The ISO standard includes on-site assessments, but the ISO-17025 on-site assessments are in no way blind. That means, there is no way for these auditors to guarantee that the testing procedures and processes that they evaluate are consistently run that way. We’ve discussed how important blind proficiency testing is to the cannabis industry because of its many nuances, as well as the ‘observer effect’ (the disturbance of a system or process by the act of observing it). Since the on-site assessments are scheduled they are ineffective for trying to catch bad actor labs.
That was never the intention of the ISO-17025 accreditation! Or any accreditation. Accreditations weren’t created to stop bad actors – they’ve been created to demonstrate technical capability.
Laboratory best practice standards such as ISO-17025 were intended to help laboratories who wanted to stand out from the crowd – those who were willing to invest in making their scientific processes conform to a higher standard. They were never meant to ‘catch’ someone in bad behaviors: that’s the job of regulators. Many states have opted to require that laboratories are ISO-17025 accredited, but it’s vital that state regulations enhance and elevate those standards and have mechanisms in place to enforce them.
Sources / Further Reading