Compliance Testing for New York’s Cannabinoid Hemp Program: An Overview

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New York’s market for cannabinoid products is among the largest in the nation—and now it’s also one of the most robust in terms of testing and potency requirements.

The New York Cannabinoid Hemp Program recently released its amended regulations for potency and lab testing. For low-THC hemp businesses, understanding these regulations is key to breaking into this massive and incredibly lucrative market.

Cannabinoid Hemp Program: An Overview of Lab Testing

New York’s testing requirements are among the most robust in the country, and go far beyond simple delta-9 THC hemp potency testing. According to the regulations, all CBD products must be tested by ISO/IEC 17025-accredited laboratories and undergo testing for the following:

• Cannabinoid potency
• Heavy metals
• Microbial impurities
• Residual pesticides
• Mycotoxins
• Residual solvents and processing chemicals
• Terpenoids (if tested)

The specific requirements, outlined in Section 114.10 of the Cannabinoid Hemp Regulations, go into further detail, including the maximum residue level of pesticides allowable in tested hemp products (there are 67 listed pesticides, many with detection levels set at 100-200 parts per billion).

Specific metals called out in the regulations are cadmium, lead, arsenic and mercury, which differ in their allowable limits depending on whether a cannabinoid hemp product is intended for ingestion or inhalation (as a general rule, if it’s going to be inhaled, the allowable amount of contamination is smaller than that of ingestion).

The threshold for microbial impurities such as pathogenic E. coli including Shiga toxin-producing E. coli (aka STEC E. coli) and salmonella is zero / none present. That’s understandably so—when combusted and inhaled, these contaminants can cause a host of consumer safety issues, especially for the immunocompromised.

Total yeast and mold counts must fall below specific measures for colony-forming units per gram. Mycotoxins (total aflatoxin and ochratoxin A, in these regulations) must fall below 20 parts per billion.

And, of course, the cannabinoid hemp product must not contain more than 0.3% D9THC to remain in compliance with federal hemp regulations.

Any cannabinoid hemp product that fails to meet the listed requirements for potency and safety will be considered “adulterated” and cannot be sold within the state. These regulations are intended to strengthen businesses operating in the legal market—not the state’s well-established gray market—and provide opportunities for NY-based companies to thrive.

What it Means for the East Coast (and Beyond)

So, how does this translate to action for hemp businesses across the East Coast and beyond? We recommend you button down your testing, safety and quality management systems now.

Such state-mandated requirements aren’t intended to punish manufacturers or cultivators—they’re built in anticipation of stricter regulations when the FDA steps in to oversee and regulate the continuously growing CBD industry. It’s better for your business’s longevity and competitive advantage to go above and beyond now.

These regulations mandate that all cannabinoid hemp processors adhere to standardized current good manufacturing practices (aka cGMP or GMP) and maintain a third-party certification for the duration of their license. Processors must also: adhere to established SOPs and quality control standards; keep extremely detailed origination records of the hemp or hemp extract they use; ensure any manufacturing areas are clean, safe and sanitary; and provide all employees with proper safety equipment and training.

Where to Start

For existing businesses, we recommend you audit your quality management systems (QMS), bearing in mind that GMP certification is required for processors moving forward. (Here’s a handy audit guidance sheet for your use.)

We also encourage you to evaluate your relationship with your laboratory testing partner to ensure they have the proper ISO/IEC accreditation and can carry out accurately and precisely the numerous testing requirements in the CHP.

For new entrants to the cannabinoid hemp space, you’re in a great position to start strong and establish good habits from the outset—from your QMS to employee training to selecting the right laboratory testing provider.