Yes. New York requires all marijuana and marijuana products sold to residents in the state to be tested before sales. Cannabis goes through a long process from seed to plant to processing before ending up on the retail shelf in pot shops. Along the way, there are multiple potential sources for contamination. Cannabis comes from the ground and may have been contaminated by heavy metals or fertilizers. Heavy metals in the soil can be absorbed through cannabis roots and later become concentrated in the plant. The natural moisture in cannabis can also aid microbial growth.
Many of the contaminations can be found through testing, which makes the testing of marijuana and marijuana products imperative to maintain consumer safety. Testing of cannabis products helps ensure that product offerings to consumers are of the highest quality possible. Per Section 1004.14 of the New York Codes, Rules, and Regulations, medical marijuana products produced by registered organizations in the state must be tested in the Bureau of Narcotic Enforcement-licensed laboratories in New York State. The products are also required to be approved for the analysis in accordance with Article 5 of the Public Health Law and Subpart 55-2 of the New York Codes, Rules, and Regulations.
Cannabis testing in New York must be for each lot of fully produced and packaged medical marijuana products manufactured by the registered organizations. Marijuana product forms to be tested include but are not limited to tablets, capsules, oral sprays, lozenge, powders, oils, tinctures, topical lotions, soft-gel chews, vaporization cartridges, suppositories, metered ground flower for vaporization, and multi-dose inhalers.
Testing must be performed on the following analytes:
Cannabinoid potency (initial)
Stability of THC and CBD (based on potency)
Growth regulators and pesticides
Any other analyte as required by the NYSDOH Commissioner
Yes. New York issues licenses to independent laboratories that meet the required guidelines to become accredited testing centers in the state. You can search accredited laboratories in New York by using the search tool available on the New York State Department of Health website. The tool allows users to narrow down search results to specific cities in New York.
To be recognized as a cannabis testing laboratory by the New York State Department of Health (NYSDOH), the laboratory must maintain an ISO/IEC 17025 accreditation for the testing of cannabinoids, heavy metals, residual pesticides, microbial impurities, mycotoxins, residual solvents and processing chemicals, and terpenes.
ISO/IEC 17025 is a quality management system and the main standard for testing and calibration laboratories. ISO/IEC 17025 is used to assess technical competence in laboratory testing and calibration services and applies to businesses that generate testing and calibration results. ISO (International Organization for Standardization), which is the accreditation’s regulatory authority, is a non-governmental organization with over 160 national standards organizations as members. ISO brings together professionals to share knowledge and produce voluntary, consensus-based, market-relevant International Standards that foster innovation and address global issues via the efforts of its members. According to ISO, over 100,000 labs worldwide rely on the ISO/IEC 17025 standard as their primary source of laboratory accreditation.
ISO/IEC 17025 accreditation establishes that a laboratory operates under an appropriate quality management system and is competent to deliver testing and calibration findings. Accredited laboratories conduct tests in accordance with international standards (ISO 17025), and the results are accepted by many governmental and regulatory agencies. The agreement between accrediting bodies is that accredited members' test results will satisfy the same minimal quality level regardless of the accreditation body, and that calibration results will be regarded as if the accredited member did the calibration themselves.
To get ISO/IEC 17025 accreditation, a third party assesses the laboratory's quality management system and technical ability. Regular audits are undertaken to ensure accreditation is maintained. An ISO/IEC 17025 accreditation can be given only by a certified accreditation organization. Accreditation signifies that the laboratory has complied with the ISO/IEC17025 management and technical requirements and is regarded as technically competent to produce calibration and testing results.
Some of the factors taken into consideration before an ISO/IEC 17025 accreditation is issued are:
A laboratory seeking accreditation must demonstrate compliance with the ISO/IEC 17025 standards as administered by the “third-party” accreditation body. Following the latest update to the ISO/IEC 17025 standards in 2017, there are now five standard requirements for an ISO/IEC 17025 accreditation: General, Structural, Resource, Process, and Management System.
General Requirements: Requirements in this section emphasizes confidentiality and impartiality. This section establishes the laboratory's commitment to impartiality and that the risks associated with impartiality are identified on a continuous basis. Meanwhile, confidentiality guarantees that consumers are notified prior to the material being released into the public realm.
Confidentiality also includes avoiding disclosing information received from sources other than the customer, as well as the source of the information, to the customer unless the source has permitted it. Additionally, this section highlights the need of disclosing sensitive information when required by law or permitted by contractual obligations. The laboratory is expected to commit to maintaining the confidentiality of data across all procedures, treatments, and interactions.
Structural Requirements: This section stresses the laboratory's legal status, organization, identification of people and management, as well as the availability of individuals responsible for implementing and maintaining the management system's integrity. Additionally, it highlights the need of documenting processes to the degree necessary to maintain the consistency of laboratory operations and the validity of the results.
Resource Requirements: This section demonstrates the importance of laboratories ensuring the availability of staff, facilities, equipment, systems, and support services necessary for the efficient performance or operations and administration of all their activities. Calibration of equipment should be performed when measurement accuracy or measurement uncertainty impairs the validity of reported results, thereby assisting in establishing metrological traceability of reported results. Additionally, the laboratory should guarantee that it communicates to its clients about all externally provided products and services, including subcontracting operations, procuring services, and supplies in accordance with established standards and procedures.
Process Requirements: This section details the procedures and other means by which requests, tenders, and contracts are reviewed. The section addresses customer requests, the decision-making process, and the distinctions between tenders and requests that should be applied to consumers prior to the commencement of any other laboratory activity.
Process requirements also reveal the selection, verification, and validation processes used in the laboratory. This guarantees that the laboratory's operations are conducted according to suitable methodologies and procedures. Additionally, the laboratory will guarantee that it is utilizing the most up-to-date procedures that take into account recent technological advancements.
When a laboratory wants to sample substances, materials, or products for later testing or calibration, it will be able to establish a sampling strategy using relevant or current technology or technique. Additionally, the section covers the handling of test or calibration items, technical records, uncertainty evaluation, guaranteeing the validity of results, reporting results, complaints, nonconforming work, data control, and information management.
Management System Requirements: ISO/IEC 17025 management system requirements provide two separate options (A and B) for establishing a management system. The minimum requirements for implementing a management system under Option A are outlined in the ISO/IEC 17025 clauses below:
Laboratories that implement Clauses 4-7 and Option A of clause 8 of the ISO/IEC 17025 standard are considered to have complied with the general principles of ISO 9001.
Option B provides for establishing and maintaining a management system pursuant to ISO 9001 requirements. Under this option, laboratories that have established and maintained management system in compliance with the requirements of ISO 9001, with satisfactory evidence of compliance with Clauses 4 -7 of the ISO/IEC 17025 can be said to fulfill, at least the intent of the management system requirements set out in Clauses 8.2 - 8.9 of the ISO/IEC 17025 standard. Summarily, if a laboratory has implemented ISO 9001, Option B may allow for greater flexibility in implementing ISO/IEC 17025.
Both Option A and Option B are designed to provide high-quality outcomes in terms of the laboratory's management system's performance and conformity with ISO/IEC 17025 Clauses 4–7. A laboratory only needs to conform to one of these options, not both.
To obtain a cannabis testing license in New York, the laboratory must be located in the state and also possess a valid controlled drug license issued by the New York State Department of Health Bureau of Narcotic Enforcement (BNE). To acquire a controlled drug license from the BNE, call (866) 811-7957 and follow the prompts for further information. The license application form and related instructions are available on the BNE licensing requirements page of the NYSDOH website. Laboratories with valid BNE approvals may proceed to apply for the NYSDOH Environmental Laboratory Approval Program (ELAP) approval for testing.
A laboratory applying for an ELAP accreditation must submit:
In addition, the laboratory will be required to demonstrate proficiency for all requested analytes listed in Certification Manual Items 316. You must pass at least two of three consecutive proficiency exams administered at least seven days apart from the close of one study and the start of another. At least one of the scores must be recent (within the last six months). As a result, you may combine the following actions:
Note that an inspection by an ELAP consultant may be required prior to accreditation. A fee of $500 will also be required after the laboratory has been certified by ELAP.
If a laboratory has more than one testing facility and the facilities are housed in separate buildings, the laboratory may seek in writing, a waiver to have all the testing facilities treated as a single laboratory. This application should include the location of each testing facility, the laboratory's name, the technical director who will oversee all testing facilities, and proof that individual testing facilities do not duplicate analytical reporting and record-keeping tasks. A decision will be made following an examination of all of these testing facilities and an evaluation of the application.
The period of an ELAP approval lasts one year (April 1 through March 31). Also, application form 107 must be filed anytime the laboratory's ownership, address, or technical personnel changes. If a laboratory desires to appeal the application or accreditation decision, it may contact ELAP by calling (518) 485-5570 or on 1-800-682-6056, the ELAP Regulatory Affairs Laboratory Investigative Unit's Hotline. You can also send a mail to email@example.com or visit the agency's location at:
Environmental Laboratory Approval Program (ELAP)
NYS Department of Health
Wadsworth Center, Biggs
Empire State Plaza
Albany, NY 12237
There are no application fees for a cannabis laboratory testing license, however, an accreditation fee of $500 applies after a laboratory is fully approved.
The legalities of establishing a cannabis testing laboratory can vary from one locality to the other. Local regulations may apply in some municipalities in New York. Typical ordinances in most places include regulations on air quality, chemical exposure, ventilation, heat output, and odor control. You need to research what regulations are in place in the city and county where you intend to establish your testing laboratory.