Course Resources
Learn More About Cannabinoid Hemp Processing in NYS
Cannabinoid Hemp vs. High-THC Cannabis
There are over 100 cannabinoids found in the cannabis plant (Cannabis sativa). Although the dominant type(s) of cannabinoids can vary depending on the cultivar, cannabidiol (CBD) and tetrahydrocannabinol (THC) are two of the most commonly found natural compounds.
Cannabinoid Hemp (< 0.3% ∆9-THC, dry basis)
- Cannabinoid hemp does not produce a feeling of being high and contains low concentrations of the main psychoactive cannabinoid Δ9-THC (< 0.3% DW).
- Cannabidiol (CBD) is often the dominant cannabinoid found in industrial hemp and has medicinal properties such as anti-inflammatory, analgesic, antioxidant, antimicrobial, neuroprotective and anticonvulsant properties. It is also touted for wellness benefits online.
- Examples of cannabinoid hemp products include: tinctures, oils, pills, capsules, and other food, beverages or dietary supplements that contain cannabinoids and are intended for human consumption.
High-THC Cannabis (> 0.3% ∆9-THC, dry basis)
- High-THC cannabis is a psychoactive drug that contains up to 35% Δ9-THC. It gives a feeling of being high (i.e., altered time and sensory perception caused by Δ9-THC).
- High-THC cannabis is categorized in two different ways.
- Adult/recreational use high-THC cannabis.
- Medical cannabis or medical use high-THC cannabis for qualifying health conditions.
New York State Cannabis Licensing and Regulatory Agencies
Oversight for both cannabinoid hemp and high-THC cannabis is under the New York State Office of Cannabis Management (OCM) and the Cannabis Control Board.
Laws & Regulations
- The Marijuana Regulation and Taxation Act (MRTA) established the cannabis law (Chapter 7-A), which authorizes a person to apply for a license to process, manufacture and sell cannabinoid hemp products in New York State (Article 5 Cannabinoid Hemp and Hemp Extract).
- On November 3, 2021, the Cannabis Control Board under the Office of Cannabis Management (OCM), approved the Part 114 Cannabinoid Hemp regulations for New York State’s Cannabinoid Hemp Program. They later approved amendments to part 114 in October 2022 and established emergency regulations in August 2023. The emergency regulations were then adopted and became effective in December 2023. These regulations provide standards for industry to produce cannabinoid products with consistency and quality and include requirements for manufacturing, laboratory testing, packaging and labeling.
- Visit this page from the OCM to view the regulations that have been adopted or are otherwise in effect.
Additional Requirements for Processing Cannabinoid Hemp Products
Processors who manufacture cannabinoid hemp food, beverages or dietary supplements must adhere to more stringent requirements than those who process food, beverages or dietary supplements not produced from cannabinoid hemp. Some of the more stringent requirements include obtaining a qualified third-party good manufacturing practice (GMP) audit of the processing facility, applying for a cannabinoid hemp processor license, and having a testing laboratory perform specific analytical analyses of cannabinoid hemp products. These added requirements also increase the costs associated with manufacturing cannabinoid hemp products compared to other food, beverages or dietary supplements.
Good Manufacturing Practice (GMP) Audit of Your Processing Facility
GMPs are quality control systems to ensure product quality and consistency, which is required to meet federal regulations established by FDA. Cannabinoid hemp processors should meet the requirements for one of the following GMP regulations as appropriate for the type of product being manufactured:
- 21 CFR part 117, subpart B (for food and beverage products); or
- 21 CFR part 111 (for dietary supplements).
In addition to meeting the requirements outlined in the GMP regulations, you will need to have an accredited, third-party certification body conduct a GMP audit of your processing facility. The New York State Office of Cannabis Management (OCM) has published a Cannabinoid Hemp Processor GMP Audit Guidance and a list of approved third-party GMP auditors on their website.
Important note: The requirement for a third-party GMP audit is not applicable to cannabinoid hemp farm processors.
Cannabinoid Hemp Processor Licenses
Who
Any person who processes cannabinoid hemp or hemp extract used for human consumption in New York State must obtain a cannabinoid hemp processor license.
- The Cannabis Law § 92: Cannabinoid hemp processor license.
- Persons processing cannabinoid hemp or hemp extract used for human consumption, whether in intermediate or final form, shall be required to obtain a cannabinoid hemp processor license from the board.
Types
There are three types of licenses for cannabinoid hemp processors, and include:
- Cannabinoid Hemp Processors Extracting and Manufacturing
- Cannabinoid Hemp Processors Manufacturing Only or
- Cannabinoid Hemp Farm Processor License.
How
Apply on the Office of Cannabis Management’s website.
Fees
There are application and licensing fees that apply.
- For an “extracting and manufacturing” license, it costs a total of $4,500 ($1,000 application fee + $3,500 license fee).
- For a “manufacturing only” license, it costs a total of $1,500 ($500 application fee + $1,000 license fee).
- For a “hemp farm processor” license, it costs a total of $400 ($100 application fee + $300 license fee).
Analytical Tests on Cannabinoid Hemp Products
You will need to contract an ISO/IEC 17025 accredited third-party laboratory to perform one or more analytical tests. The testing laboratory must be approved to test cannabis pursuant to Part 130. Lab testing requirements are available on the Office of Cannabis Management’s website.
Online Courses and Training Opportunities
According to the part 114 cannabinoid hemp regulation, cannabinoid hemp processors must comply with the federal regulations for food labeling (21 CFR 101), preventive controls for human food (21 CFR 117), and/or current GMP for dietary supplements (21 CFR 111) that apply to the type of product being produced.
- § 114.8 Cannabinoid hemp product requirements. (a) All cannabinoid hemp products distributed or offered for retail sale in New York State shall: (1) be manufactured in accordance with Parts 101, 111 or 117 of Title 21 of the Code of Federal Regulations, as appropriate for the type of product being manufactured and as otherwise determined appropriate by the office in guidance or future regulation.
For processors who utilize cannabinoid hemp or hemp extract in their food, beverage or dietary supplement production, the following Cornell courses and training opportunities are offered to meet the state and federal regulations:
- Online Good Manufacturing Practices Part 117 course (for human food and beverages).
- Online Good Manufacturing Practices Part 111 course (for dietary supplements).
- NYS Regulations for Cannabinoid Hemp (Cannabis sativa) Processors course.
Assistance from Cornell University
Cornell Hemp Extension Team
- Extension team members can assist producers with growing hemp in NYS and hemp agronomy.
Cornell Hemp Program (School of Integrative Plant Science)
- Hosts annual Hemp Research Field Day.
- Provides resources for growing hemp.
- Hosts FAQ web page addressing questions about hemp, how to grow it, the difference between THC and CBD, and more.
- Upcoming events can also be found on their website.
Cornell Food Venture Center (CFVC) and Pilot Plant
- Offers assistance for hemp-based products that need to comply with current regulations, product development as well as process validation for product safety and stability.
Institute for Food Safety at Cornell University (IFS@CU)
- Offers Good Manufacturing Practices Part 117 online training for human food and beverages.
- Offers Good Manufacturing Practices Part 111 online training for dietary supplements.
- Offers NYS Regulations for Cannabinoid (Cannabis sativa) Hemp Processors online training.
Module List
Module 1 – Page 1
- Fike, J. (2016) Industrial Hemp: Renewed Opportunities for an Ancient Crop. Critical Reviews in Plant Sciences, 35(5-6), pp. 406-424.
- NYS Office of Cannabis Management. (2023) Marihuana Regulation and Taxation Act (MRTA) Laws and Regulations: Adult Use, Medical Cannabis, and Cannabinoid Hemp Programs.
Module 1 – Page 3
- Lapierre, E, Monthony, AS and Torkamaneh, D. (2023). Genomics-based taxonomy to clarify cannabis classification. Genome, 66(8), 202-211.
- Grassa, C. J., Weiblen, G. D., Wenger, J. P., Dabney, C., Poplawski, S. G., Timothy Motley, S., Michael, T. P., & Schwartz, C. J. (2021). A new Cannabis genome assembly associates elevated cannabidiol (CBD) with hemp introgressed into marijuana. The New phytologist, 230(4), 1665–1679.
- Linder, E. R., Young, S., Li, X., Henriquez Inoa, S., & Suchoff, D. H. (2022). The Effect of Harvest Date on Temporal Cannabinoid and Biomass Production in the Floral Hemp (Cannabis sativa L.) Cultivars BaOx and Cherry Wine. Horticulturae, 8(10), 959.
- Lynch, R. C., Vergara, D., Tittes, S., White, K., Schwartz, C. J., Gibbs, M. J., Ruthenburg, T. C., Land, D. P., and Kane, N. C. 2016. Genomic and Chemical Diversity in Cannabis. Crit. Rev. Plant Sci. 35: 349–363.
- Massuela, D.C., Hartung, J., Munz, S., Erpenbach, F., & Graeff-Hönninger, S. (2022). Impact of Harvest Time and Pruning Technique on Total CBD Concentration and Yield of Medicinal Cannabis. Plants (Basel, Switzerland), 11(1), 140.
- Sawler, J., Stout, J. M., Gardner, K. M., Hudson, D., Vidmar, J., Butler, L., Page, J. E., & Myles, S. (2015). The Genetic Structure of Marijuana and Hemp. PloS one, 10(8), e0133292.
- Small, E., and Cronquist, A. (1976). A Practical and Natural Taxonomy for Cannabis. Taxon, 25(4), 405–435.
- Vergara, D, Baker, H, Clancy, K, Keepers, KG, Mendieta, JP, Pauli, CS, Tittes, SB, White, KH & Kane, NC (2016) Genetic and Genomic Tools for Cannabis sativa, Critical Reviews in Plant Sciences, 35:5-6, 364-377.
- Vergara, D., Feathers, C., Huscher, E. L., Holmes, B., Haas, J. A., & Kane, N. C. (2021). Widely assumed phenotypic associations in Cannabis sativa lack a shared genetic basis. PeerJ, 9, e10672.
Module 1 – Page 4
- Izzo, A. A., Borrelli, F., Capasso, R., Di Marzo, V., & Mechoulam, R. (2009). Non-psychotropic plant cannabinoids: new therapeutic opportunities from an ancient herb. Trends in pharmacological sciences, 30(10), 515–527.
- Andre CM, Hausman J-F and Guerriero G (2016) Cannabis sativa: The Plant of the Thousand and One Molecules. Front. Plant Sci. 7:19.
- Alves, P., Amaral, C., Teixeira, N., & Correia-da-Silva, G. (2020). Cannabis sativa: Much more beyond Δ9-tetrahydrocannabinol. Pharmacological research, 157, 104822.
- Office of Cannabis Management (2023) Cannabinoid Hemp.
- Office of Cannabis Management (2023) Adult Use.
- Office of Cannabis Management (2023) Medical Cannabis.
Module 1 – Page 5
- Andre CM, Hausman J-F and Guerriero G (2016) Cannabis sativa: The Plant of the Thousand and One Molecules. Front. Plant Sci. 7:19.
- Gould J. (2015). The cannabis crop. Nature, 525, S2–S3.
Module 1 – Page 6
- Milay L, Berman P, Shapira A, Guberman O and Meiri D (2020) Metabolic Profiling of Cannabis Secondary Metabolites for Evaluation of Optimal Postharvest Storage Conditions. Front. Plant Sci. 11:583605.
- Kopustinskiene, D. M., Masteikova, R., Lazauskas, R., & Bernatoniene, J. (2022). Cannabis sativa L. Bioactive Compounds and Their Protective Role in Oxidative Stress and Inflammation. Antioxidants (Basel, Switzerland), 11(4), 660.
- Thomas, BF and ElSohly, MA (2016) Chapter 2 - Biosynthesis and Pharmacology of Phytocannabinoids and Related Chemical Constituents. In Thomas, BF and ElSohly, MA (Eds.) The Analytical Chemistry of Cannabis (pp. 27-41). Elsevier, ISBN 9780128046463.
Module 1 – Page 7
Module 1 – Page 8
- GRAS Notice for Hulled Hemp Seeds (GRN765)
- GRAS Notice for Hemp Seed Protein Powder (GRN771)
- GRAS Notice for Hemp Seed Oil (GRN778)
- Cerino, P., Buonerba, C., Cannazza, G., D'Auria, J., Ottoni, E., Fulgione, A., Di Stasio, A., Pierri, B., & Gallo, A. (2021). A Review of Hemp as Food and Nutritional Supplement. Cannabis and cannabinoid research, 6(1), 19–27.
- Iftikhar, A., Zafar, U., Ahmed, W., Shabbir, M. A., Sameen, A., Sahar, A., Bhat, Z. F., Kowalczewski, P. Ł., Jarzębski, M., & Aadil, R. M. (2021). Applications of Cannabis Sativa L. in Food and Its Therapeutic Potential: From a Prohibited Drug to a Nutritional Supplement. Molecules (Basel, Switzerland), 26(24), 7699.
- Addo, P. W., Poudineh, Z., Shearer, M., Taylor, N., MacPherson, S., Raghavan, V., Orsat, V., & Lefsrud, M. (2023). Relationship between Total Antioxidant Capacity, Cannabinoids and Terpenoids in Hops and Cannabis. Plants (Basel, Switzerland), 12(6), 1225.
- Gabriela Boscariol Rasera, Andre Ohara, Ruann Janser Soares de Castro, Innovative and emerging applications of cannabis in food and beverage products: From an illicit drug to a potential ingredient for health promotion, Trends in Food Science & Technology, Volume 115, 2021, Pages 31-41, ISSN 0924-2244.
- Atalay, S., Jarocka-Karpowicz, I., & Skrzydlewska, E. (2019). Antioxidative and Anti-Inflammatory Properties of Cannabidiol. Antioxidants (Basel, Switzerland), 9(1), 21.
- Genetic and Genomic Tools for Cannabis sativa. Daniela Vergara, Halie Baker, Kayla Clancy, Kyle G. Keepers, J. Paul Mendieta, Christopher S. Pauli, Silas B. Tittes, Kristin H. White & Nolan C. Kane. Pages 364-377 | Published online: 25 Feb 2017.
- Chang Chen, Zhongli Pan, Cannabidiol and terpenes from hemp – ingredients for future foods and processing technologies, Journal of Future Foods, Volume 1, Issue 2, 2021, Pages 113-127, ISSN 2772-5669.
Module 1 – Page 9
- Atalay, S., Jarocka-Karpowicz, I., & Skrzydlewska, E. (2019). Antioxidative and Anti-Inflammatory Properties of Cannabidiol. Antioxidants (Basel, Switzerland), 9(1), 21.
- Mark, T, Shepherd, J, Olson, D, Snell, W, Proper, S and Thornsbury, S (2020). Economic Viability of Industrial Hemp in the United States: A Review of State Pilot Programs. USDA Economic Research Service, Economic Information Bulletin Number 217.
- USDA National Agricultural Statistics Service (2023, April 19) National Hemp Report.
Module 1 – Page 10
Module 1 – Page 11
- Model Code for Consumable Hemp Products | AFDO & FOCUS
- Processing and extraction methods of medicinal cannabis: a narrative review | Journal of Cannabis Research
- Lazarjani, M. P., Young, O., Kebede, L., & Seyfoddin, A. (2021). Processing and extraction methods of medicinal cannabis: a narrative review. Journal of cannabis research, 3(1), 32.
- Moreno et al. Teresa Morenoa, Fernando Montanesa, Stephen J. Tallona, Tina Fentona, Jerry W. Kingb (2020) Extraction of cannabinoids from hemp (Cannabis sativa L.) using high pressure solvents: An overview of different processing option. The Journal of Supercritical Fluids, 161.
- Nahar, L., Uddin, S. J., Alam, M. A., & Sarker, S. D. (2021). Extraction of naturally occurring cannabinoids: an update. Phytochemical analysis : PCA, 32(3), 228–241.
- Szalata, M., Dreger, M., Zielińska, A., Banach, J., Szalata, M., & Wielgus, K. (2022). Simple Extraction of Cannabinoids from Female Inflorescences of Hemp (Cannabis sativa L.). Molecules, 27(18), 5868.
- Valizadehderakhshan, M., Shahbazi, A., Kazem-Rostami, M., Todd, M. S., Bhowmik, A., & Wang, L. (2021). Extraction of Cannabinoids from Cannabis sativa L. (Hemp)—Review. Agriculture, 11(5), 384.
Module 2 – Page 2
- 2014 Farm Bill (Agriculture Improvement Act of 2014)
- 2018 Farm Bill ( Agriculture Improvement Act of 2018)
- Domestic Hemp Production Program (7 CFR Part 990)
- Adesina, I., Bhowmik, A., Sharma, H., & Shahbazi, A. (2020). A review on the current state of knowledge of growing conditions, agronomic soil health practices and utilities of hemp in the United States. Agriculture, 10(4), 129.
Module 2 – Page 3
Module 2 – Page 4
- 2014 Farm Bill (Agriculture Improvement Act of 2014)
- Adesina, I., Bhowmik, A., Sharma, H., & Shahbazi, A. (2020). A review on the current state of knowledge of growing conditions, agronomic soil health practices and utilities of hemp in the United States. Agriculture, 10(4), 129.
Module 2 – Page 5
- 2018 Farm Bill ( Agriculture Improvement Act of 2018)
- Domestic Hemp Production Program (7 CFR Part 990)
- Adesina, I., Bhowmik, A., Sharma, H., & Shahbazi, A. (2020). A review on the current state of knowledge of growing conditions, agronomic soil health practices and utilities of hemp in the United States. Agriculture, 10(4), 129.
Module 2 – Page 6
- Establishment of a Domestic Hemp Production Program (7 CFR 990)
- Status of State and Tribal Hemp Production Plans for USDA Approval
- Laboratories registered with the DEA
- 2018 Farm Bill ( Agriculture Improvement Act of 2018)
- Domestic Hemp Production Program (7 CFR Part 990)
Module 2 – Page 7
- 2014 Farm Bill (Agriculture Improvement Act of 2014)
- 2018 Farm Bill ( Agriculture Improvement Act of 2018)
- Domestic Hemp Production Program (7 CFR Part 990)
- Adesina, I., Bhowmik, A., Sharma, H., & Shahbazi, A. (2020). A review on the current state of knowledge of growing conditions, agronomic soil health practices and utilities of hemp in the United States. Agriculture, 10(4), 129.
Module 2 – Page 9
- FDA Statement
- FDA: A New Way Forward for Cannabidiol (CBD) and Other Hemp Products
- GRAS Notice for Hulled Hemp Seeds (GRN765)
- GRAS Notice for Hemp Seed Protein Powder (GRN771)
- GRAS Notice for Hemp Seed Oil (GRN778)
Module 2 – Page 10
- GRAS Notice for Hulled Hemp Seeds (GRN765)
- GRAS Notice for Hemp Seed Protein Powder (GRN771)
- GRAS Notice for Hemp Seed Oil (GRN778)
Module 2 – Page 11
- 2018 Farm Bill ( Agriculture Improvement Act of 2018)
- Domestic Hemp Production Program (7 CFR Part 990)
- Status of State and Tribal Hemp Production Plans for USDA Approval
- Hemp Analytical Testing Laboratories
- FDA Regulation of Dietary Supplement & Conventional Food Products Containing Cannabis and Cannabis-Derived Compounds
- FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)
- FDA Questions and Answers: Is it legal for me to sell CBD products?
- FDA Questions and Answers: Is it legal, in interstate commerce, to sell a food to which THC or CBD has been added?
- FDA Questions and Answers: Can THC or CBD products be sold as dietary supplements?
- FDA Questions and Answers: Can hulled seed, hemp seed protein powder, and hemp seed oil be used in human food?
- FDA What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD
- FDA Stakeholder Webinar (slides): "A New Way Forward for Cannabidiol (CBD) and Other Hemp Products"
- FDA GRAS Notifications
- GRAS Notice for Hulled Hemp Seeds (GRN765)
- GRAS Notice for Hemp Seed Protein Powder (GRN771)
- GRAS Notice for Hemp Seed Oil (GRN778)
Module 2 – Page 14
- NYSDAM Hemp Grower Licensing
- New York State Approved Sampling Firms
- New York State Permitted Laboratories
- USDA Status of State and Tribal Hemp Production Plans for USDA Approval
- USDA State, Territory, and Tribal Hemp Program Contact Information
- USDA Hemp Analytical Testing Laboratories
Module 2 – Page 15
Module 2 – Page 16
Module 2 – Page 17
Module 3 – Page 4
Module 3 – Page 16
Module 3 – Page 19
Module 4 – Page 2
Module 4 – Page 3
- OCM’s Website for Approved GMP Auditors
- OCM's Licensing & Cannabinoid Hemp Processor Application Requirements
- OCM’s GMP Audit Guidance
- OCM’s Website for Approved GMP Auditors
- International Organization for Standardization (ISO)
- MyGFSI: Home
- American National Standards Institute – ANSI Home
- NYS OCM
Module 4 – Page 5
- Office of Cannabis Management Approved Cannabinoid Hemp Good Manufacturing Practices (GMP) Auditors
- Cannabinoid Hemp Third Party GMP Auditor Application Form
- OCM’s Website for Approved GMP Auditors
- OCM’s GMP Audit Guidance
- Example of Audit Checklist from SQF Fundamentals for Manufacturing-Basic
- NYS OCM
- Oregon Department of Agriculture: How to Prepare for a 3rd-Party Food Safety Audit
- OSU Robert M. Kerr Food and Agricultural Products Center | Food Safety Audits: Frequently Asked Questions
Module 4 – Page 9
Module 5 – Page 2
Module 5 – Page 3
- FDA's Food Labeling Regulation (21 CFR Part 101)
- FDA’s Food Labeling & Nutrition
- FDA’s Guidance for Nutrition and Food Labeling
- FDA’s Small Entity Compliance Guide: Revision of the Nutrition and Supplement Facts Labels
- FDA's Label Claims for Food & Dietary Supplements
- FDA's Gluten-Free Labeling of Foods
- FDA's Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)
Module 5 – Page 4
Module 5 – Page 5
- Preventive Controls for Human Food (PCHF) rule (21 CFR part 117)
- Information about Facilities that would be Exempt
Module 5 – Page 7
Module 5 – Page 15
Module 5 – Page 16
Module 5 – Page 22
Module 6 – Page 2
- International Organization for Standardization (ISO)
- International Electrotechnical Commission
- International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) for Testing
Module 6 – Page 3
Module 6 – Page 4
Module 6 – Page 7
Module 6 – Page 8
Module 6 – Page 12
Module 6 – Page 13
- Marihuana Regulation & Taxation Act (MRTA)
- Part 114 Cannabinoid Hemp Regulation
- Cannabinoid Hemp Regulations Guidance for Licensees
- GMPs for Food and Beverages (21 CFR 117, Subpart B)
- GMPs for Dietary Supplements (21 CFR 111)
- Food Safety and FSMA Regulations for Small Food Processors
- Hazard Analysis and Critical Control Points (HACCP)
- Preventive Controls for Human Food
- Better Process Control School for Acidified and Low-acid Foods (21 CFR 108, 113 and 114)
- Cornell Food Venture Center: Cannabinoid hemp letter of safety (for food and beverages or dietary supplements)