N.Y. Comp. Codes R. & Regs. tit. 9 § 130.29

Current through Register Vol. 46, No. 51, December 18, 2024

Section 130.29 - Summary Suspension, Suspension, Cancellation and Revocation

(a) A cannabis laboratory's permit shall be deemed summarily suspended for the following reasons:

(1) failure to submit an application for a change in laboratory ownership, major instrumentation, technical direction, or location, and;

(2) failure to remit the annual permit fee.

(b) A cannabis laboratory's permit may be suspended in part or in full for the following reasons:

(1) a pattern of deficiencies on a laboratory regulatory audit or other demonstration that a cannabis laboratory lacks an effective quality system for planning and assessing work performed by the laboratory, and for conducting required quality assurance and quality control procedures to promote and maintain the accuracy and reliability of test results;

(2) except as provided in this Part, failure to undergo a laboratory regulatory audit or failure to demonstrate, during a laboratory regulatory audit so conducted: compliance with the staffing, methodological and other requirements of this Part; and effective implementation of a quality system for planning and assessing work performed by a cannabis laboratory and for conducting required quality assurance and quality control procedures to promote and maintain the accuracy and reliability of test results;

(3) failure of a cannabis laboratory technical director to meet the required qualifications of this Part;

(4) misrepresentation of any material fact pertinent to obtaining or retaining approval for any cannabis laboratory owned or directed by an owner or technical director listed on the application including, but not limited to, inclusion of false reports on or related to a laboratory analysis or submission of proficiency test results which were, in fact, generated by a laboratory other than the laboratory to which the samples were distributed;

(5) failure to remit the required application and permit fees;

(6) failure to respond to a laboratory regulatory audit report with a corrective action plan within the required thirty (30) calendar days after receipt of the audit report;

(7) failure to respond to a laboratory regulatory audit report with an acceptable corrective action plan within the specified timeframe; and

(8) failure to maintain ISO/IEC 17025 accreditation, or accreditation that is based on ISO/IEC 17025 accreditation by any other laboratory accreditation authority approved by the Office.

(c)

(1) A cannabis laboratory's permit may be revoked in an affected analyte or group of analytes for reasons including:

(i) failure to respond to a laboratory regulatory audit report with an acceptable corrective action plan within the specified timeframe;

(ii) a pattern of deficiencies on a laboratory regulatory audit, or other demonstration that a cannabis laboratory lacks an effective quality system for planning and assessing work performed by the laboratory, and for conducting required quality assurance and quality control procedures to promote and maintain the accuracy and reliability of test results;

(iii) failure to implement the responsive actions detailed in the corrective action plan within the specified timeframe;

(iv) failure to correct the deficiencies meriting suspension within six (6) months of the effective date of the suspension; or

(v) for a cannabis laboratory suspended pursuant to this Section, unsatisfactory performance in the next proficiency test, resulting in three (3) consecutive failed proficiency tests.

(2) A cannabis laboratory whose permit is revoked pursuant to paragraph (1) above shall retain approval for an analyte or group of analytes for which it continues to meet Office requirements, and a cannabis laboratory may reapply for a permit once the deficiencies meriting revocation have been corrected.

(3) A cannabis laboratory's permit may be revoked, in total, for reasons including:

(i) failure to respond to a laboratory regulatory audit report which includes findings or deficiencies with a corrective action plan within the required thirty (30) calendar days after receipt of the audit report;

(ii) falsification of any report on or related to a laboratory test or analysis, including, but not limited to, submission of proficiency test results which were, in fact, generated by a laboratory other than the laboratory to which the samples were distributed;

(iii) misrepresentation of any material fact pertinent to obtaining or maintaining approval;

(iv) denial of laboratory entry to perform a laboratory regulatory audit during normal business hours;

(v) sustained charges of administrative violations of state or federal laws, rules and regulations related to the provision of cannabis laboratory services, or reimbursement for such services, against the owner or technical director, individually or jointly, or against any cannabis laboratory owned or directed by such individuals;

(vi) conviction of any crime, including, but not limited to, any offense related to furnishing of, or billing for, cannabis laboratory services, which is considered an offense involving theft or fraud;

(vii) failure to remit the annual approval fee, or, for partial fee payments, failure to remit such payments within the timeframes established by the Office;

(viii) aiding and/or abetting in the violation of any of the provisions of this Part; and/or

(ix) a finding by a municipality that a cannabis laboratory has violated a local ordinance.

(4) If cannabis laboratory's permit has been revoked pursuant to paragraph (3) above and the Office finds that the violation was willful, or due to recklessness or gross negligence, no application shall be accepted, for a period of time to be determined by the Office from any person who was an owner or technical director of such cannabis laboratory on the date of notification of proposed revocation.

(d) A summary suspension, suspension, cancelation, or revocation of a cannabis laboratory permit, including any notices and challenges thereto, if any, shall be pursuant to this Title.

(e) In addition to summary suspension, suspension, cancelation, or revocation of a cannabis laboratory permit, a cannabis laboratory that fails to comply with this Part may be subject to any fines, fees or any other penalties pursuant to Cannabis Law.

(f) A person who does not hold a valid permit pursuant to this Part or who otherwise does not comply with this Part shall be subject to any fines, fees, or any other penalties pursuant to Cannabis Law.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 130.29

Adopted New York State Register March 22, 2023/Volume XLV, Issue 12, eff. 3/22/2023