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Type 1 Extraction Compliance

NYS Office of Cannabis Management Type 1 Extraction Licensee Compliance

The proper utilization of approved extraction methods, equipment, solvents, gases, and mediums:

A processor authorized to perform extraction may only use the methods, equipment, solvents, gases, and mediums set forth in 9 NYCRR §123.6 and approved on the processor's application. Additionally, such extraction methods shall be conducted only in a manner exhibiting minimal risks to worker safety and public health.

What methods may be used in extraction? An authorized processor (e.g. a Type 1 processor, a registered organization, or a microbusiness) may only conduct extraction using the following methods without obtaining prior written approval from the office:

  • Mechanical extraction methods (e.g. ice water, a rosin press, etc);
  • A professional grade, closed-loop CO2 extraction system that is of a supply equivalent to food or beverage grade of at least 99.5% purity; or
  • Ethanol or alcohol-based extraction, provided that all ethanol or alcohol used shall be of a grade that meets or exceeds specifications of official compendiums as defined in section 321 of Title 21 of the United States Code (USC).

In addition to the three methods listed above, an authorized processor may also conduct extraction using a volatile solvent or hydrocarbon extraction method, but that processor must—before conducting any extraction using this method—submit documentation pursuant to 9 NYCRR §123.6(c)(3) related to the equipment used in extraction and receive written approval from the Office.

What if a Licensee wants to use a volatile solvent or hydrocarbon that is not already listed? Pursuant to 9 NYCRR §123.6(c)(2)(iv)(b)(3), a processor who wishes to use a volatile solvent or hydrocarbon that is not already approved for use (i.e. butane or propane) must receive additional written approval related to that solvent prior to its use. Butane and propane are two examples of hydrocarbons that would not require this additional approval beyond the approval of the licensee's equipment as described above. In the case of a solvent not previously approved for use, it is the obligation of the licensee requesting approval to use a solvent to submit documentation which evidences, to the Office's satisfaction, that the solvent does not pose an undue risk to the health and safety of the licensee's employees and to cannabis consumers.

*NEW* Use of the volatile solvent 1,1,1,2-tetrafluoroethane in extraction. The Office has recently received a request to use 1,1,1,2-tetraflouroethane as a solvent in extraction. The Office has reviewed the submitted documentation and believes that the use of 1,1,1,2 tetrafluoroethane does not pose an undue risk to health and safety when it is used as a solvent in extraction for the manufacture of orally ingested or topical products and when the solvent used is of a level of purity that meets or exceeds pharmaceutical standards or other similar standards as determined by the Office. Questions remain regarding the thermal decomposition of this chemical at temperatures exceeding 250 degrees Celsius and, at this time, the solvent is not approved for use in the manufacture of inhalable products (e.g. oil for vaporization) as the Office continues to review information related to this chemical.

Laboratory testing of residual 1,1,1,2-tetrafluoroethane. The Office recently set a maximum limit of 1,000 parts per million of residual 1,1,1,2-tetrafluoroethane that may be present in cannabis products. On May 7, the Office notified permitted laboratories of this testing limit and begun requiring testing for the analyte 1,1,1,2-tetraflouroethane. To date, one permitted laboratory has received the Office's approval to test for this analyte under its approved residual solvent laboratory-developed method, and it is expected that the number of laboratories which test for this analyte will increase in the coming months. Laboratories that have not yet amended their standard operating procedures to test for this chemical, and had those amendments approved by the Office, are required to amend their procedures and submit documentation to the Office by July 7.

PLEASE NOTE: Due to potential risks to health and safety that may be related to improper use of hydrocarbon and volatile solvents, approval is required for each individual processor before any extraction using 1,1,1,2-tetrafluoroethane, or any other volatile solvent, is permitted by a licensee. Failure to obtain an approval from the Office for any volatile solvent before using said solvent will result in a stop work order for extraction using that solvent, as well as any additional penalties pursuant to the Cannabis Law and regulations.

Licensees previously approved to perform volatile solvent or hydrocarbon-based extraction that wish to begin using 1,1,1,2-tetrafluoroethane, must contact the Compliance Unit at [email protected] and receive written approval prior to any use of the solvent.

Licensees that were not previously approved to perform volatile solvent or hydrocarbon-based extraction, but wish to begin doing so, must contact the Licensing Unit at [email protected] to request its license or application be amended with this request and receive written approval prior to conducting any extraction using that method.


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