Section 691-5-2 - General CDC Certification and ISO/IEC 17025: 2017 Accreditation Requirements Prior to Issuance of a Cannabis Testing Facility LicenseSection 2.1 - Certification of Cannabis Testing Facility Required Prior to Issuance of a Full Active or Provisional Active License A cannabis testing facility must obtain certification by DHHS, CDC, as described in this Rule, before DAFS, OCP will issue to that cannabis testing facility a full active or provisional active license. 2.1.1.Cannabis Testing Facility General Requirements. The cannabis testing facility must: A. Be an entity that can be held legally responsible;B. Carry out its testing activities in such a way as to meet the requirements of this rule and to meet the needs of clients in accordance with the cannabis testing facility's quality assurance manual;C. Employ technical management and personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties and identify departures from the management system and initiate actions to prevent or minimize such departures;D. Use personnel employed by, or under contract to, the cannabis testing facility, and where contracted and additional technical and key support personnel are used, ensure that such personnel are supervised and competent and that they work in accordance with the cannabis testing facility's quality system;E. Have a written policy that, as indicated by signature, ensures management and personnel are free from any undue internal and external commercial, financial and other pressures and influences that may adversely affect the quality of their work or diminish confidence in its competence, impartiality, judgement or operational integrity. Submission of this policy for the purposes of certification does not fulfill licensing requirements regarding undue influence evaluated by OCP, such information will be evaluated by OCP independent of any assessment made by the CDC;F. Have policies and procedures to ensure the protection of its clients' confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results;G. Authorize specific personnel to perform particular types of sampling, if applicable, and environmental testing, issue test reports, give opinions and interpretations and operate particular types of equipment; andH. Authorize specific personnel to maintain document control policies, chain of custody forms for each sample tested and control access to certificate of analysis data.2.1.2.Certification may be full or provisional. A cannabis testing facility must receive from the CDC full or provisional certification for at least one analyte and technology to be used for the testing of adult use cannabis and adult use cannabis products before that cannabis testing facility can seek a full active or provisional active license from OCP.A. Full certification will be granted by the CDC to a cannabis testing facility that can demonstrate that it has applied for and received ISO/IEC 17025:2017 or most recent version accreditation and that it meets all other requirements of this Rule.B. Provisional certification will be granted by the CDC to a cannabis testing facility that can demonstrate that it has had an application accepted for, but has not yet received nor been denied, ISO/IEC 17025:2017 or most recent version accreditation and that meets all other requirements of this rule.C. Certification may be denied when an applicant has deficiencies and the certification officer determines that the applicant cannot consistently produce valid data.Section 2.2 - ISO/IEC 17025:2017 or most recent version Accreditation Requirements for CDC Cannabis Testing Facility Certification 2.2.1.The cannabis testing facility must demonstrate ISO/IEC 17025: 2017 accreditation before the CDC will issue a full testing facility certification. The cannabis testing facility may apply for full certification for only those fields of testing accredited by ISO/IEC 17025:2017 or most recent version. The cannabis testing facility may apply for an OCP-issued full active license for only those fields of testing for which it has received ISO/IEC 17025:2017 or most recent version accreditation and CDC certification. An on-site inspection by CDC will be required.2.2.2.The cannabis testing facility must apply for ISO/IEC 17025:2017 or most recent version accreditation before the CDC will issue a provisional testing facility certification. A cannabis testing facility applicant meeting all general requirements for certification, except for ISO/IEC 17025:2017 or most recent version accreditation, may apply to the CDC for provisional certification by submitting a complete application and required fees. Following an on-site inspection of an applicant that has not received ISO/IEC 17025:2017 or most recent version accreditation, the CDC will perform a review of data validation studies and a review of all other proof that the cannabis testing facility has met certification requirements, and if the CDC determines the cannabis testing facility meets all requirements, the CDC may grant the applicant a provisional certification. The provisional certification, if granted, expires 12 months from the date of issuance.A. The cannabis testing facility may apply for an OCP-issued provisional active license for only those fields of testing included in the application for ISO/IEC 17025:2017 or most recent version accreditation.B. Upon receipt of ISO/IEC 17025:2017 or most recent version accreditation, the cannabis testing facility must demonstrate proof of accreditation to OCP and the CDC within 5 business days. Upon receipt of such notice and following confirmation of accreditation, the CDC will issue to the cannabis testing facility full certification for the accredited technologies and analytes which will expire on the same date as the originally issued provisional certification. A cannabis testing facility can request a change in licensure status from provisional active to full active licensure for the remainder of the term of the originally issued provisional active license. Nothing in this section shall be construed to extend the term of certification or licensure beyond the term of the originally issued provisional certification or provisional active licensure.C. Before the expiration of its provisional certification, the cannabis testing facility must obtain ISO/IEC 17025:2017 or most recent version accreditation for at least one field of testing included in its accreditation application; otherwise it must cease all operations until such accreditation is obtained for at least one field of testing.D. If ISO/IEC 17025:2017 or most recent version accreditation is denied to the cannabis testing facility holding provisional certification, the facility must notify the CDC of the denial within one business day of receipt of the denial. The CDC shall revoke the provisional certification, upon the cannabis testing facility's notification of denial of ISO/IEC 17025:2017 or most recent version accreditation. Upon revocation of a provisional certification by the CDC, OCP shall revoke immediately the cannabis testing facility's provisional active license.