reglab/statecodes huggingface dataset:
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 129 - Adult-Use Marketing and Advertising › Section 129.5 - Adult-Use Marketing and Advertising Violations and Penalties

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A licensee shall immediately remove or
				discontinue advertisements if the Board determines the marketing or advertising
				violates the provisions of Cannabis Law and this Part or if the licensee fails
				to provide records to the Office upon request that establishes the marketing or
				advertising meets the requirements of Cannabis Law and this Part.
(b) In the event a third-party has used a
				licensee's trademarks, brands, names, locations, or other distinguishing
				characteristics in a way that does not comply with this Part or any other
				statute, rule or regulation, the licensee shall immediately notify the Office
				and issue a cease-and-desist notification to the third-party.
(c) The Office may take any action against
				any licensee who fails to comply with this Part, including but not limited to
				recommendations to the Board for suspension, cancellation, or revocation of a
				license, imposition of any fees or fines, requiring a licensee to cease by a
				date determined by the Office the non-compliant marketing and advertising and
				requiring removal by a date determined by the Office of any advertisement still
				being published or displayed, and any other penalties set forth in Cannabis Law
				and Part 133 of this Title.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 129 - Adult-Use Marketing and Advertising › Section 129.6 - Severability

Current through Register Vol. 46, No. 28, July 10, 2024
If any provision of this Part or its application to any
				  particular person or circumstance is held invalid, the remainder of this Part
				  and its application to other persons and circumstances shall not be affected
				  thereby.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 129 - Adult-Use Marketing and Advertising › Section 129.7 - Referenced Material

Current through Register Vol. 46, No. 28, July 10, 2024
Regulations included in Part 129 of this Title contain
				  references to documents for information as to the standards to be met or
				  guidelines and methodologies to be used in meeting the requirements of specific
				  regulations. In addition, copies of referenced materials are available for
				  public inspection and copying at the Albany office of the New York State
				  Department of State.
Table 1
Regulation
Referenced Material
Availability
9 NYCRR Part/sec./etc.
CFR (Code of Federal Regulations) or
								other
129.3(a)(12)
Title 7 §§ 205.600 - 205.619 (January 1,
								2021)
*
129.3(a)(14)
Title 21 § 101.91 (January 1, 2021)
*
* Any printed editions of the Code of Federal Regulations
				  (CFR) can be obtained by calling the Superintendent of Documents, U.S.
				  Government Printing Office, at (202) 512-1800. Electronic copies of CFR
				  sections may also be obtained at Government Printing Office (GPO) which
				  contains the most recent revisions, can be searched directly at:
https://www.ecfr.gov/
**
Any printed editions of the Annual Book of
				  American Society for Testing and Materials can be purchased by calling the
				  Society at (610) 832-9500. Electronic copies of ASTM sections may be purchased
				  online at:
https://www.astm.org/
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.2 - Cannabis Laboratory Permit Application

Current through Register Vol. 46, No. 28, July 10, 2024
(a) No person shall be a cannabis laboratory
				authorized to test medical cannabis and adult- use cannabis and issue
				laboratory test reports required by the Cannabis Law unless they have been
				granted a cannabis laboratory permit. A laboratory certified by the New York
				State Department of Health to conduct medical cannabis testing shall be deemed
				a provisional permittee and must comply with this Part.
(b)
(1) An
				application for a cannabis laboratory permit shall be submitted to the Office
				in a manner and format determined by the Board. The application shall be signed
				by technical directors of a cannabis laboratory, and the following individuals:
(i) by the applicant (if an individual);
(ii) by a managing member (if a
				limited liability company);
(iii) by
				an officer (if a corporation),
(iv)
				by all partners (if a partnership); or
(v) by an officer, director or trustee if an
				institution, trust, estate, or any other legal entity.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.3 - Cannabis Laboratory Fees

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Cannabis
				Laboratory Permit Fee. The fee for an annual permit under this Part shall be
				paid by an applicant. An applicant shall pay the appropriate cannabis
				laboratory permit fee based on its gross annual receipts determined by the
				Board.
(1) A cannabis laboratory which has no
				gross annual receipts because it did not operate in New York State the previous
				permit year shall pay a first-year permit fee of $1,000 regardless of the
				number of months remaining in the permit year. When applying for renewal of
				that permit, a cannabis laboratory shall report its gross receipts for the
				calendar months in which it operated, and these receipts shall be projected to
				a twelve (12)-month basis for the purpose of computing gross annual
				receipts.
(2) A cannabis laboratory
				that had gross annual receipts in the previous permit year and applies for a
				permit after commencement of the permit year shall pay a fee computed as an
				annual fee but prorated for the months remaining in the permit year, or $1,000,
				whichever is greater.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.4 - Cannabis Laboratory Permit Renewal Application

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A cannabis laboratory shall submit a
				renewal application annually with the Office in a manner and format determined
				by the Office.
(b) An application
				to renew a permit issued under this Part shall be filed with the Office not
				more than six (6) months nor less than four (4) months prior to the expiration
				thereof. If a renewal application is not filed within four (4) months prior to
				the expiration thereof, the Board may determine that the permit shall have
				expired and become void on such expiration date.
(c) An application shall be accompanied by an
				application fee, which shall be non-refundable, and a permit fee as set forth
				in this Part. Only an application completed in accordance with this Part as
				determined by the Office and for which the application and permit fees have
				been submitted shall be considered if submitted in a timely manner. The permit
				fee shall be returned to the applicant if the applicant is not granted a
				renewal permit under this section.
(d) The Office shall consider applications
				for preliminary determination for renewal in accordance with the criteria set
				forth in this Part.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.5 - Cannabis Laboratory Permit Issuance

Current through Register Vol. 46, No. 28, July 10, 2024
(a) An
				applicant for a cannabis laboratory permit may be granted a provisional permit
				for a period not to exceed twelve (12) months, provided it has:
(1) obtained ISO/IEC 17025 accreditation, or
				accreditation that is based on ISO/IEC 17025 accreditation by any other
				laboratory accreditation authority approved by the Office;
(2) satisfied the technical direction staff
				requirements as set forth in Sections
				130.11 - 130.14 of this
				Part;
(3) satisfied proficiency
				test requirements;
(4) satisfied
				all fee requirements; and
(5)
				satisfied any other requirements for approval pursuant to this Part other than
				completion of a laboratory regulatory audit.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.6 - Cannabis Laboratory Permit Renewal Denial

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A cannabis laboratory's application for a
				permit, or an application for a renewal of a permit, may be denied for the
				following reasons, among others:
(1) failure
				to submit a completed application;
(2) failure to pay an application
				fee;
(3) failure of laboratory
				staff to meet the personnel qualifications of education, training, and
				experience;
(4) failure to
				successfully analyze and report proficiency test results;
(5) failure to pass a required laboratory
				regulatory audit;
(6) failure to
				respond to a laboratory audit report with a corrective action report;
(7) failure to implement the corrective
				actions detailed in the corrective action report within the required
				timeframe;
(8) failure to implement
				a quality system;
(9)
				misrepresentation of any fact pertinent to receiving or maintaining a permit;
				and
(10) denial of entry during
				normal business hours for a laboratory regulatory audit.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.7 - General Cannabis Laboratory Requirements

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A cannabis laboratory shall maintain
				ISO/IEC 17025 accreditation, or an accreditation that is based on ISO/IEC 17025
				accreditation by any other laboratory accreditation authority approved by the
				Office.
(b) A cannabis laboratory
				shall participate in proficiency tests, if offered by an ISO/IEC 17043 approved
				proficiency test provider, at a frequency specified under this Part and have
				successfully passed two (2) out of the most recent three (3) proficiency tests
				as part of the permit requirements.
(c) A cannabis laboratory shall undergo a
				periodic laboratory regulatory audit by the Office as specified under this Part
				and provide any or all records associated with its ISO/IEC 17025 accreditation,
				or an accreditation that is based on ISO/IEC 17025 accreditation by any other
				laboratory accreditation authority approved by the Office.
(d) A cannabis laboratory shall employ
				qualified staff as set forth in this Part.
(e) Cannabis Laboratory Requirements
				regarding direct or indirect interest.
(1) A
				cannabis laboratory and its true parties of interest may have an interest in
				more than one cannabis laboratory and/or sampling firm if they are:
(i) a passive investor, provided that such
				passive investor complies with all other ownership, control and interests
				requirements and prohibitions of the Cannabis Law and this Chapter;
				or
(ii) a landlord, financier, or
				management services agreement provider to another cannabis laboratory or
				laboratory sampling firm, providing that such cannabis laboratory and its true
				parties of interests do not exceed authorized true party of interest
				limits.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.8 - Required Cannabis Proficiency Testing

Current through Register Vol. 46, No. 28, July 10, 2024
(a) In connection with an application for a
				cannabis laboratory permit, a cannabis laboratory shall examine proficiency
				test samples supplied by a proficiency testing provider recognized by the
				Office, pursuant to this Part.
(b)
				Once a cannabis laboratory completes a proficiency test, a cannabis laboratory
				shall prepare a report for an analyte or group of analytes for which a cannabis
				laboratory is seeking approval and for which samples have been
				supplied.
(c) A cannabis laboratory
				shall submit the report directly to the proficiency testing provider.
(d) Upon the proficiency testing provider's
				review of a cannabis laboratory's report related to a proficiency test sample
				that a cannabis laboratory examined, a cannabis laboratory shall cause the
				proficiency test provider to provide the results of the proficiency test
				directly to the Office and in a manner and format determined by the
				Office.
(e) To obtain approval for
				a given analyte or group of analytes on its permit, a cannabis laboratory shall
				pass two (2) consecutive scheduled or unscheduled or supplemental proficiency
				tests. A cannabis laboratory may continue to attempt to obtain satisfactory
				performances beyond two (2) proficiency tests if the two (2) consecutive
				satisfactory performances are not obtained.
(f) To maintain approval for a given analyte
				or group of analytes on its permit, a cannabis laboratory shall attain
				satisfactory performance as determined by the Office, in at least two (2) of
				three (3) consecutive scheduled or unscheduled or supplemental proficiency test
				in which it has participated in an eighteen (18) month period.
(g) An unscheduled or supplemental
				proficiency test shall be at minimum seven (7) days from the close date of the
				prior scheduled or unscheduled proficiency test. An unscheduled proficiency
				test may also be a supplemental proficiency test that was
				unscheduled.
(h) At least one (1)
				of the satisfactory proficiency tests in which a cannabis laboratory has
				participated in an eighteen (18) month period must be less than six (6) months
				old.
(i) A proficiency test that a
				cannabis laboratory completes must be administered by a proficiency test
				provider that:
(1) is accredited by a
				proficiency test provider accreditor to ISO/IEC 17043;
(2) offers scheduled tests on at least a
				semi-annually basis, and unscheduled tests on at least a monthly
				basis;
(3) agrees to supply the
				Office with proficiency test scores in a manner and format determined by the
				Office; and
(4) agrees to submit
				any other information and documentation requested to resolve any issues
				concerning compliance with this Part.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.9 - Unsatisfactory Proficiency Test Performance

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A cannabis laboratory's analyte or group
				of analytes approval status shall be deemed automatically unapproved for an
				analyte or group of analytes in the event:
(1)
				a cannabis laboratory fails two (2) out of three (3) most recent proficiency
				tests attempted for a particular analyte or group of analytes; or
(2) a cannabis laboratory fails to provide a
				corrective action report to the Office within thirty (30) calendar days of a
				request for a corrective action report from the Office.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.10 - Laboratory Regulatory Audit

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A cannabis laboratory shall maintain an
				ISO/IEC 17025 accreditation, or accreditation that is based on ISO/IEC 17025
				accreditation by any other laboratory accreditation authority approved by the
				Office.
(b) A cannabis laboratory
				shall have a laboratory regulatory audit every two (2) years during a cannabis
				laboratory's normal business hours.
(c) The factors to be considered during a
				laboratory regulatory audit shall include, but not be limited to, the
				competence and qualifications of staff as specified in this Part, adequacy of
				facilities and equipment, appropriateness of sampling protocols, use of
				approved methods, and a cannabis laboratory's quality system, including, but
				not limited to, quality assurance and quality control procedures, and record
				keeping and reporting practices.
(d) A cannabis laboratory shall demonstrate
				effective implementation of its quality system for planning and assessing work
				performed by a laboratory regulatory audit, and for conducting required quality
				assurance and quality control procedures to promote and maintain the accuracy
				and reliability of test results.
(e) A cannabis laboratory, following a
				laboratory regulatory audit, shall obtain an audit report which shall set forth
				any recommendations of the audit and any findings to be corrected.
(f) If findings are found during a laboratory
				regulatory audit, a cannabis laboratory may be granted a grace period not to
				exceed ninety (90) calendar days from the date of audit report to correct the
				findings, provided that, within thirty (30) calendar days of such audit report,
				a cannabis laboratory shall submit, within thirty (30) days of the laboratory
				regulatory audit to the Office or another laboratory accreditation authority as
				approved by the Office performing the audit a written plan of correction to be
				implemented within ninety (90) calendar days from the date of audit report to
				correct the findings. If at the end of the grace period any of the findings
				remain uncorrected, the affected analyte or group of analytes pursuant to this
				Part will be unapproved.
(g) If the
				findings do not have an effect or do not have an immediate effect on either the
				accuracy or reliability of results, and if a cannabis laboratory demonstrates
				in writing that corrections of findings have been delayed for reasons beyond
				its control, the grace period granted pursuant to this subsection may be
				extended further for a period not to exceed ninety (90) calendar days. Such
				extension may not be extended further.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.11 - General Cannabis Laboratory Personnel Qualifications

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A cannabis laboratory shall:
(1) only employ persons who are eighteen (18)
				years of age or older;
(2) develop
				and implement an employee training program, which shall include but not be
				limited to, a training checklist, and an initial and continuing demonstration
				of capabilities, to ensure competency of a laboratory employee for their
				assigned functions;
(3) comply with
				all applicable laws and regulations, including but not limited to:
(i) health and safety training;
(ii) handling hazardous materials;
				and
(iii) handling hazardous
				equipment;
(4) ensure and
				document that a laboratory employee meets the employee
				qualifications;
(5) ensure an
				employee completes data integrity training upon hire and annually thereafter,
				and evidence that such training was performed for an employee shall be
				documented and available upon request; and
(6) ensure an employee does not have a direct
				or indirect interest in a cannabis sampling firm, a registered organization or
				a cannabis permit, registration or license.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.12 - Cannabis Technical Director Qualifications

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
(1) A
				cannabis laboratory shall appoint one or more technical directors, who shall be
				fulltime members of the laboratory's staff, and who shall exercise actual
				supervision of laboratory operations, including the reporting of results from
				testing samples, during normal business hours. The designation of a lead
				technical director shall be documented; and
(2) a technical director shall have the
				requisite credentials and experience for an area of analysis, such as
				microbiology, analytical chemistry, organic chemistry, metals, inorganic
				chemistry, and physical analysis, and shall supervise only the areas of testing
				for which they meet the qualifications required by this section.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.13 - Cannabis Quality Assurance Officer Qualifications

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A cannabis laboratory shall appoint a
				quality assurance officer, who shall exercise oversight of a cannabis
				laboratory's quality system during normal business hours. The individual so
				appointed shall have documented training, and/or experience in quality
				assurance and quality control procedures; be knowledgeable in the required
				quality system; possess a general knowledge of analytical methods for which
				they perform data review; and have a bachelor's degree in the chemical,
				environmental, physical or biological sciences, or engineering, and two (2) or
				more years of experience in implementing a laboratory quality system.
(b) The quality assurance officer shall, at a
				minimum:
(1) serve as the focal point for a
				cannabis laboratory's quality assurance and quality control, and be responsible
				for monitoring and/or review of quality control data;
(2) evaluate data objectively and perform
				independent managerial reviews without outside influence;
(3) arrange for or conduct annual internal
				audits of a cannabis laboratory's entire quality system and testing operation;
				and
(4) notify cannabis laboratory
				management of any deficiencies in the quality system as part of an internal
				audit and monitor required corrective actions.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.14 - Cannabis Laboratory Technician Qualifications

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A cannabis laboratory shall employ
				laboratory technicians. A laboratory technician shall have documented training
				or experience in laboratory procedures; possess a strong working knowledge of
				all methods for which they perform; and perform routine and non-routine sample
				preparations, tests, and analyses using the appropriate equipment,
				instrumentation, reagents, standards, and methods.
(b) A laboratory technician engaged in
				microbiology, analytical chemistry, organic chemistry, metals, inorganic
				chemistry, or physical chemistry testing shall have an associate's degree or
				two years of equivalent college or university studies in the chemical,
				environmental, physical or biological sciences, or engineering, and at least
				six (6) months of experience in testing of representative analyte or group of
				analytes for which the laboratory is permitted or seeking a permit.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.15 - Approval of Laboratory-Developed Methods

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A cannabis laboratory shall obtain
				approval from the Office prior to performing a laboratory-developed method, or
				other method not otherwise approved or given similar recognition as described
				in this Part. The Office may approve such a method, provided a cannabis
				laboratory submits data and other information as required supporting the
				technical merit of the method, and demonstrating that method's precision and
				accuracy are equivalent or superior to that of an approved method. Such data
				and information shall include, but not be limited to:
(1) a description of the method, including
				analyte or group of analytes, sample type, working range, reagents and their
				preparation, equipment specifications, analytical procedures, precision,
				accuracy, related calculations, intended purpose and pertinent literature
				citations;
(2) the anticipated date
				of method implementation;
(3)
				comparative data, if of the same technology, including: sample types, dates and
				times collected, and product or form, whether the sample was spiked, and, if
				so, the spiking procedure, and spiking samples at different concentrations; the
				approved method used; and analytical results for both the approved method and
				the method submitted for approval;
(4) data from two (2) or more proficiency
				tests;
(5) demonstration of
				capability data;
(6) limit of
				detection data, if applicable; and
(7) any other information pertinent to the
				Office's determination of the method's technical merit.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.16 - Laboratory Sampling Firm Approval

Current through Register Vol. 46, No. 28, July 10, 2024
(a) No person may conduct sampling and
				transportation of cannabis product or medical cannabis and any other
				intermediates or forms for purposes of testing such cannabis product or medical
				cannabis by a cannabis laboratory unless they have been granted approval as a
				laboratory sampling firm; except where the registered organization or adult-use
				licensee, are authorized by the Office to submit samples.
(b) Prior to approval, a laboratory sampling
				firm shall submit a description of the sampling and transportation process
				describing how cannabis product or medical cannabis and any other intermediates
				or forms will be sampled and transported in the field or on premises, or a copy
				of the standard operating procedure addressing sampling and
				transportation.
(c) Approval of a
				laboratory sampling firm and its employees shall be conducted in a manner and
				format determined by the Office.
(d) Approval shall be effective for a period
				not to exceed two (2) years and shall expire on March 31.
(e) Approval of a laboratory sampling firm is
				not transferable or assignable, including, without limitation, to another
				laboratory sampling firm.
(f) A
				cannabis laboratory may receive conditional approval as a laboratory sampling
				firm with a written waiver from the Office. The Office may provide a waiver if
				the Office determines that a cannabis laboratory has met the conditions
				specified in sections
				130.16 - 130.21 of this
				Part.
(g) A cannabis laboratory
				sampling firm and its true parties of interest shall have no interest in a
				registered organization, adult-use cultivator, processor, distributor, retail
				dispensary, cooperative, microbusiness, delivery, nursery, on-site consumption,
				registered organization with dispensing or ROD and a registered organization
				non-dispensing or ROND as defined in Part 118 of this Title, or any other
				license pursuant to the Cannabis Law.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.17 - Laboratory Sampling Firm Fee

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Laboratory Sampling Firm Application Fee
				and Approval Fee. A non-refundable application fee for a laboratory sampling
				firm is $500. The approval fee for the two (2) year approval period shall be
				$1000. The approval fee shall be returned to the applicant if the applicant is
				not granted approval under this Part.
(b) Any fee specified in this Part shall be
				paid to the New York State Office of Cannabis Management by the method approved
				by the Office at the time of submission of the application.
(c) Failure of a laboratory sampling firm to
				pay the appropriate fee is grounds for non-reapproval pursuant to this
				Part.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.18 - Laboratory Sampling Firm Reapproval

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A laboratory sampling firm and its
				employees shall submit a reapproval application to the Office in a manner and
				format determined by the Office.
(b) An application to reapprove shall be
				filed with the Office not more than six (6) months nor less than four (4)
				months prior to the expiration thereof. If a reapproval application is not
				filed within four (4) months prior to the expiration thereof, the Office may
				determine that the firm's approval shall have expired and become void on such
				expiration date.
(c) An application
				shall be accompanied by a non-refundable application fee and approval fee as
				set forth in this Part. Only an application completed in accordance with this
				Part as determined by the Office and for which the application and approval
				license fees have been submitted shall be considered if submitted in a timely
				manner.
(d) The Office shall
				consider applications for reapproval in accordance with the criteria set forth
				in this Part.
(e) A denial of a
				cannabis laboratory sampling firm's application for a permit, or an application
				for a reapproval of a permit, including any notices and challenges thereto, if
				any, shall be pursuant to this Title.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.20 - Cannabis Sampling Technician Qualifications

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A laboratory sampling firm shall employ
				sampling and transportation technicians. A sampling and transportation
				technician shall have documented training, and/or experience in sampling and
				transportation procedures; possess a strong working knowledge of all sampling
				and transportation methods for which they perform; and perform routine and
				non-routine sampling and transportation of cannabis product or medical cannabis
				and any other intermediates or forms using appropriate equipment,
				instrumentation, and methods.
(b) A
				technician of a laboratory sampling firm shall be an individual with, at
				minimum, a high school diploma or high school equivalency diploma.
(c) A technician of a laboratory sampling
				firm must be twenty-one (21) years of age.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.21 - Sampling of Cannabis Product and Medical Cannabis

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A laboratory sampling firm shall obtain a
				representative sample of medical cannabis or adult-use cannabis as determined
				by the Office for testing by a cannabis laboratory.
(b) A laboratory sampling firm shall meet the
				standards for sampling cannabis product batch and harvest batch as approved by
				the Office.
(c) An employee of a
				registered organization, cultivator, processor, cooperative, microbusiness, or
				any other person licensed pursuant to the Cannabis Law or authorized to
				cultivate or process medical cannabis or adult-use cannabis pursuant to the
				Cannabis Law that has requested the sampling and testing of medical cannabis or
				adult-use cannabis shall be physically present to observe an employee of a
				laboratory sampling firm obtain the sample of cannabis product or medical
				cannabis and any other intermediates or forms for testing and shall ensure that
				the increments are taken from throughout the batch.
(d) The sampling shall be video-recorded with
				the batch number stated verbally or in writing on the video at the beginning of
				the video and a visible time and date indication on the video recording
				footage. The video recordings shall be maintained for at least ninety (90)
				calendar days by the licensee.
(e)
				After the sample has been selected by a laboratory sampling firm employee, both
				(1) the licensee requesting the sampling and testing, and (2) the laboratory
				sampling firm employee shall sign and date the chain of custody form as set
				forth in this Part, attesting to the sample selection having occurred according
				to the sampling process or procedure a laboratory sampling firm submitted to
				the Office pursuant to this Part and the requirements set forth in this
				Title.
(f) A registered
				organization, cultivator, processor, cooperative, microbusiness, or any other
				person licensed pursuant to the Cannabis Law or authorized to cultivate medical
				cannabis or adult-use cannabis pursuant to the Cannabis Law shall not assist a
				laboratory sampling firm employee nor touch the cannabis product or medical
				cannabis and any other intermediates or forms or the sampling equipment while a
				laboratory sampling employee is obtaining the sample.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.22 - Testing of Cannabis Product and Medical Cannabis

Current through Register Vol. 46, No. 28, July 10, 2024
(a) All testing of samples provided by a
				laboratory sampling firm to a cannabis laboratory shall be conducted by a
				cannabis laboratory employing methods approved by the Office and shall:
(1) be within the scope listed on the
				laboratory's current permit or on any appendices thereto; and
(2) require the prior completion of a
				demonstration of capability conducted at the same site where samples were
				prepared or analyzed using an approved method.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.23 - Certificate of Analysis

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Once a
				cannabis laboratory completes testing a sample, a cannabis laboratory shall
				prepare a certificate of analysis which shall include a summary of analytical
				results of the testing.
(b) A
				cannabis laboratory shall issue confidentially the certificate of analysis to a
				registered organization, cultivator, processor, cooperative, microbusiness, or
				any other person licensed pursuant to the Cannabis Law or authorized to
				cultivate medical cannabis or adult-use cannabis pursuant to the Cannabis Law
				on whose behalf a cannabis laboratory performed the testing.
(c) A certificate of analysis, that is issued
				by cannabis laboratory, shall be reported in a manner and format determined by
				the Office.
(d) A cannabis
				laboratory must report all results of tests that a cannabis laboratory performs
				directly to the Office in a manner and format determined by the Office. The
				results shall be reported to the Office within forty-eight (48) hours of
				release of the certificate of analysis to a registered organization,
				cultivator, processor, cooperative, microbusiness, or any other person licensed
				pursuant to the Cannabis Law or authorized to cultivate medical cannabis or
				adult-use cannabis pursuant to the Cannabis Law on whose behalf a cannabis
				laboratory performed the testing.
(e) A certificate of analysis shall include,
				but not be limited to, the following:
(1) a
				title;
(2) cannabis laboratory
				name, contact person, phone number, and address;
(3) office laboratory permit
				identifier;
(4) permit identifier
				issued by ISO/IEC 17025 accreditation, or accreditation that is based on
				ISO/IEC 17025 accreditation by any other laboratory accreditation authority
				approved by the Office;
(5) client
				name, contact person, phone number, and address;
(6) description or unique identification of
				sample(s) tested;
(7) methods
				used;
(8) analyte or group of
				analytes tested, analyte results and units of measurements;
(9) sample collection site, date and
				time;
(10) analysis date and
				time;
(11) any deviations from
				approved sampling, transportation and testing methods;
(12) reference to approved sampling and
				transportation operating procedures;
(13) name, signature and date of individual
				approving the release of the reported results;
(14) regulatory limits established by the
				Office;
(15) laboratory reporting
				limits;
(16) any non-approved
				methods or analyte or group of analytes reported;
(17) any methods used and analyte or group of
				analyte results reported by another OCM permitted cannabis
				laboratory;
(18) pagination of the
				report if greater than one (1) page in length; and
(19) and any other information requested by
				the Office.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.24 - Cannabis Shipping Manifest

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
				laboratory sampling firm shall ensure and verify that the samples being taken
				into possession for transport at the originating licensed premises are as
				described and accurately reflected in the shipping manifest.
(b) A laboratory sampling firm is responsible
				for any discrepancies between the shipping manifest and the samples in its
				possession during transport, and may be subject to any enforcement or
				disciplinary action related to such discrepancy, including cancelation,
				suspension or revocation of its approval.
(c) A laboratory sampling firm shall not void
				or change a shipping manifest for samples after departing from the originating
				licensed premises with such samples.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.25 - Sample Chain of Custody

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
				cannabis laboratory shall develop and implement a chain of custody (COC)
				procedure to ensure accurate documentation is recorded for the sampling,
				transport, receipt, handling, storage, and destruction of samples.
(b) A COC procedure shall require the use of
				a COC form. A laboratory sampling firm employee shall use the COC to record, at
				a minimum, the following information for a sampled batch:
(1) permitted cannabis laboratory's name,
				permitted premises address, and permit number;
(2) date and time sampling started and
				ended;
(3) name of the licensee
				requesting the sampling, licensed premises address, and license
				number;
(4) batch number of the
				batch from which the representative sample was obtained and assigned unique
				sample identifier;
(5) sample type
				from cannabinoid hemp, cannabis product, or medical cannabis and any other
				intermediates or forms;
(6) total
				batch size, by weight, or unit count;
(7) total weight, or unit count of the
				representative sample;
(8) sampling
				and transportation conditions or problems encountered during the sampling and
				transportation process, if any;
(9)
				printed name and signature of the licensee requesting the sampling;
				and
(10) printed name and signature
				of the laboratory sampling firm employee and name of laboratory sampling
				firm.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.26 - Record Retention

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
				cannabis laboratory shall retain the following records, current, previous, and
				archived versions, either electronically or hardcopy, for no less than five (5)
				years and shall identify accurately and reliably:
(1) the samples transported, collected,
				accepted, prepped, examined, and disposed of;
(2) procedures used and personnel involved;
				and personnel training records;
(3)
				document test conditions, observations, and results of analyses; and
(4) all quality system related records
				including, but not limited to:
(i) quality
				manual or equivalent quality management documents;
(ii)  standard operating
				procedures;
(iii) internal
				audits;
(iv) management
				reviews;
(v) corrective action
				reports;
(vi) analytical
				logbooks;
(vii) equipment
				logs;
(viii) consumable logs;
				and
(ix) purchasing
				records.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.27 - Security, Safety and Storage of Cannabis

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A facility operated by a cannabis
				laboratory shall have a security system to prevent and detect diversion, theft
				or loss of cannabinoid hemp, cannabis product, or medical cannabis and any
				other intermediates or forms, utilizing commercial grade equipment.
(b) A cannabis laboratory shall keep security
				equipment in full operating order and shall test such equipment no less than
				semi-annually. Records of security tests must be maintained for five (5) years
				and made available to the Office upon request.
(c) A cannabis laboratory must be securely
				locked and protected from unauthorized entry at all times.
(d) All cannabinoid hemp, cannabis product,
				or medical cannabis and any other intermediates or forms must be stored in a
				secure area or location within a cannabis laboratory that is accessible to a
				minimum number of employees essential for efficient operation, to prevent
				diversion, theft or loss.
(e) All
				cannabinoid hemp, cannabis product, or medical cannabis and any other
				intermediates or forms must be stored in such a manner as to protect against
				physical, chemical and microbial contamination and deterioration until
				extraction and analyses of the cannabinoid hemp, cannabis product, or medical
				cannabis and any other intermediates or forms begins.
(f) A cannabis laboratory shall ensure the
				safe and secure transport of cannabis product or medical cannabis and any other
				intermediates or forms as specified in this Part when subcontracting the
				analyses of any of the cannabis to another permitted cannabis
				laboratory.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.28 - State Reference Lab

Current through Register Vol. 46, No. 28, July 10, 2024
(a) If the
				Office suspects fraudulent, inaccurate or compromised testing of cannabinoid
				hemp, cannabis product, or medical cannabis, and any other intermediates or
				forms by a permitted cannabis laboratory, the Office may obtain the cannabinoid
				hemp, cannabis product, or medical cannabis, and any other intermediates or
				forms and request the state reference lab to perform testing on the cannabinoid
				hemp, cannabis product, or medical cannabis, and any other intermediates or
				forms in question.
(b) At the
				discretion of the Office, the Office may randomly pull samples of cannabinoid
				hemp, cannabis product, or medical cannabis, and any other intermediates or
				form directly from a registered organization, cultivator, processor,
				cooperative, microbusiness, or any other person licensed pursuant to the
				Cannabis Law or authorized to cultivate medical cannabis or adult-use cannabis
				pursuant to the Cannabis Law. The Office may pull such samples during hours of
				operation. The cannabinoid hemp, cannabis product, or medical cannabis, and any
				other intermediates or forms pulled will be tested by the state reference
				lab.
(c) The state reference lab
				may assist the Office in method development.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.29 - Summary Suspension, Suspension, Cancellation and Revocation

Current through Register Vol. 46, No. 28, July 10, 2024
(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.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.30 - Severability

Current through Register Vol. 46, No. 28, July 10, 2024
If any provision of this Part or its application to any
				  particular person or circumstance is held invalid, the remainder of this Part
				  and its application to other persons and circumstances shall not be affected
				  thereby.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 131 - Severability and Reference Materials › Section 131.1 - Severability and Reference Materials

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Severability.
(1) If any provision of this Title or its
				application to any particular person or circumstance is held invalid, the
				remainder of this Title and its application to other persons and circumstances
				shall not be affected thereby.
(2)
				All conditional licensees shall comply with all adult-use license business and
				operation requirements and prohibitions as required by this Title. Adult-use
				regulations shall prevail should there be any conflict between the conditional
				regulations pursuant to Part 116 of this Title and adult-use business
				operations requirements and prohibitions.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 132 - Cannabis Research License › Section 132.2 - General Provisions

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
				research license shall:
(1) be required in
				order to conduct research studies with investigational product, or on
				populations that use investigational product.
(2) be issued in the name of the applicant
				who will serve as the PI of the research project.
The applicant shall register all research projects they lead,
				  as PI, under the same research license. A PI may serve as a co-principal
				  investigator or sub-investigator on other research projects under a different
				  research license.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 132 - Cannabis Research License › Section 132.4 - Acquisition of Investigational Products

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Research licensees may acquire
				investigational products, by sale or donation, from licensees, permittees, or
				registrants approved by the Board provided that:
(1) the transaction amount is below the
				individual possession limits established in Penal Law; or
(2) if the transaction amount exceeds the
				possession limits, research licensees shall enter into a formal contractual
				agreement with the adult-use licensees, permittees, or registrants.
New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 132 - Cannabis Research License › Section 132.5 - Labeling Requirements

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
				Investigational products stored for research purposes that do not involve human
				subjects must have, at a minimum, affixed to the immediate container:
(1) the description of the product and
				potency, if applicable;
(2) the
				date of production;
(3) the date of
				storage;
(4) name of principal
				investigator;
(5) research protocol
				number;
(6) the following messages:
(i) "NOT FOR HUMAN CONSUMPTION";
(ii) "For research purposes only";
				and
(iii) "Not for sale or
				distribution".