Legend Technical Services informed us that 29 hemp lots were impacted because the total THC fell between 0.40 and 0.45%. The impacted lots came from 16 growers. This event occurred during the pilot program when the MDA identified any sample with Total THC less than or equal to 0.399% as in compliance and any result greater than or equal to 0.40% as out of compliance, a failure.
Legend Technical Services informed us that 29 hemp lots were impacted because the total THC fell between 0.40 and 0.45%. The impacted lots came from 16 growers. This event occurred during the pilot program when the MDA identified any sample with Total THC less than or equal to 0.399% as in compliance and any result greater than or equal to 0.40% as out of compliance, a failure.
The calibration standard was purchased from Thermo Fisher Scientific but manufactured by Restek. Restek is an ISO 17034:2016 accredited analytical standard manufacturer. (Answer provided by Legend Technical Services)
The calibration standard was purchased from Thermo Fisher Scientific but manufactured by Restek. Restek is an ISO 17034:2016 accredited analytical standard manufacturer. (Answer provided by Legend Technical Services)
The MDA has identified four changes to their protocols for testing.
- The MDA will require their regulatory lab to store samples at -20°C so that a sample can be retested. Any sample with a failing result should be stored until the case is closed.
- The MDA will require that proficiency test results are provided within 10 business days from receipt. Proficiency testing is performed by accredited laboratories to compare their analytical procedures to a known sample and determine any variability that may exist. This allows the accredited laboratory to determine if acceptable limits of variance are being met to ensure the most accurate sample reading. The MDA will review results for every proficiency test and take appropriate action if proficiency test results do not meet acceptance criteria. This action may include suspending regulatory decisions until the lab can demonstrate proficiency or utilizing another accredited lab for regulatory testing.
- The MDA will develop a process to validate the accuracy of lab results.
- Future contracts for hemp regulatory testing will require the MDA be notified within 24 to 48 hours for any event that impacts testing.