R68-30-4. Independent Cannabis Testing Laboratory Requirements

  1) An independent testing laboratory shall employ a scientific director responsible for:

  a) ensuring that the laboratory achievement and maintenance of quality standards of practice; and

  b) supervising laboratory staff.

  2) The scientific director for an independent laboratory shall have:

  a) a doctorate in chemical or biological sciences from an accredited college or university and have at least 2 years of post-degree laboratory experience;

  b) a master's degree in chemical or biological sciences from an accredited college or university and have at least 4 years of post-degree laboratory experience; or

  c) a bachelor's degree in chemical or biological sciences from an accredited college or university and have a least 6 years of post-degree laboratory experience.

  3) An independent cannabis testing laboratory shall follow validated analytical methods, such as those published by AOAC, American Herbal Pharmacopoeia, EPA, FDA, or other reputable scientific organizations or notify the department of alternative scientifically valid testing methodology the lab is following for each required test.

  4) An independent cannabis testing laboratory may not use an alternative testing method without prior review from the department.

  5) The department shall review any monograph or analytical method followed by an independent cannabis testing laboratory to ensure the methodology produces scientifically accurate results prior to the use of alternative testing methods to conduct the required tests.

  6) An independent cannabis testing laboratory shall establish written standard operating procedures for each test being conducted.

  7) An independent cannabis testing laboratory shall obtain and keep the International Organization for Standardization (ISO) 17025:2017 accreditation.

  8) An independent cannabis testing laboratory may be licensed prior to ISO 17025:2017 accreditation provided the independent cannabis testing laboratory:

  a) adopt and follow minimum good laboratory practices which satisfy the OECD Principles of Good Laboratory Practice and Compliance Monitoring published by the Organization for Economic Co-operation and development; and

  b) becomes ISO 17025:2017 accredited within 18 months.

  9) The department incorporates the following materials by reference:

  a) Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control (2014 Revisions) published by the American Herbal Pharmacopoeia; and

  b) OECD Principles of Good Laboratory Practice and Compliance Monitoring (1997) published by the Organization for Economic Co-operation and Development.

  10) An independent cannabis testing laboratory shall have written emergency procedures to be followed in case of:

  a) fire;

  b) chemical spill; or

  c) other emergencies at the laboratory.

  11) An independent cannabis testing laboratory shall compartmentalize all areas in the facility based on function and shall limit access to the compartments to the appropriate authorized agents.