Standardization News

The emerging market for cannabis is evolving rapidly on a global scale.

On Oct. 17, 2018, Canada became the first G7 country to legalize the medical and recreational use of cannabis, joining Uruguay as one of two nations to do so.

Earlier in 2018, the U.S. Food and Drug Administration approved a medication for a cannabis-based drug to treat childhood epilepsy.  And 33 states now allow various cannabis-derived products to be used for medicinal purposes, with 10 states also allowing recreational use.

Elsewhere, some nations (such as Argentina, Germany, Israel, the Netherlands, Portugal) have legalized cannabis use for medical purposes. A few (Argentina, Portugal, South Africa) have decriminalized personal use.

A TECHNICAL COMMITTEE TAKES ACTION

In the midst of this landscape, ASTM International’s cannabis committee (D37) has been working to develop voluntary consensus standards for all stakeholders. Formed in February 2017, the committee has already produced two important standards, with many more underway.

Fostering product safety is an important goal of many standards development efforts. Darwin Millard of PhytoLogix believes the committee’s work will help regulators in this regard.

“Consumer safety will be impacted by all aspects of this industry’s supply chain — from seed to sale — and standards will play a critical role in ensuring safety, efficiency, and quality of the various processes and products utilized by each market sector,” Millard says.

The committee’s nine subcommittees have generated more than three dozen draft standards covering quality management systems, grading potency, analyzing pesticide residues, transportation security, and much more.

WATER ACTIVITY

The two approved standards address water activity in the cannabis flower.

Water activity describes the degree to which water is “bound” in the cannabis flower. Free, or unbound, water is available to microbes as a food source, and this can lead to spoilage. “[Water activity] is an important property that can be used to predict the stability and safety of food or cannabis,” says Peter Maguire, chairman of the subcommittee on processing and handling (D37.04) and vice president of system applications at Lighthouse Worldwide Solutions.

One of the new standards (D8196) spells out the practice for determining water activity in dried cannabis flowers intended for human consumption. The other standard (D8197) is a specification for maintaining that water activity within acceptable levels. Millard, vice chairman of the subcommittee, explains their significance: “Simply put, these standards, when used together, can help cannabis operators better prepare their products to prevent the growth of microbial contamination while ensuring a longer shelf life and higher quality.”

QUALITY CONTROL

Another critical element of the cannabis industry supply chain is quality control. The subcommittees on quality management systems (D37.02) and laboratories (D37.03) have been examining this issue and have drafted two standards that are working their way through the approval process.

One proposed standard is a guide to help organizations develop corrective and preventive action processes and procedures that support formalized quality management systems (WK60084). The other outlines best practices, recommended certifications, various types of analyses, and quality assurance functions for labs working with cannabis (WK60319). Committee member Kathleen May, co-owner of MP Consulting, proposed the corrective and preventive action standard.

“Many organizations lack the understanding of how to address quality issues and how to properly conduct a root-cause investigation,” May says. “They make assumptions on root cause and start implementing actions without verifying or validating that those actions truly address the issue.”

May believes equipment qualification and process validation, as well as batch sampling protocols, are other areas needing attention. “Equipment is purchased, taken out of the box, and placed into production for use. No process exists to properly test and verify that the equipment will perform per its intended purpose,” she says.

Labs also need to know how to appropriately take samples from a batch of cannabis. May notes that procedures to ensure that a sample is random and representative of the batch are in need of standardization: “If process validation is not properly executed, there is no way to confirm homogeneity of the batch and little to no confidence that the samples submitted for testing are a representation of the homogeneity of the entire batch.”

PACKAGING

When it comes to public health and safety, the packaging and labeling of cannabis products is crucial. A subcommittee (D37.04) has been working to create a new standard guide in this area.

Andy Heins, who chairs this group and is vice president of All Packaging Co., cites several specific issues that he and his peers are grappling with.

For example, he says that the current patchwork of labeling regulations is a major challenge for the industry’s supply chain. “Many jurisdictions have different requirements for what must be included on the label and, moreover, the requirements change frequently,” Heins says. “We see variations from state to state in what is allowed and prohibited with regard to the use and placement of specific language, colors, graphics, fonts and font sizes, as well as the use and placement of ‘universal symbols’ indicating the potential dangers related to the consumption of cannabis.”

This dynamic causes companies to order packaging and labels in lower-than-optimal quantities for fear of having to dispose of packaging that becomes obsolete due to frequent changes in various jurisdictions.

A more coordinated approach to packaging and labeling requirements could be supported by the framework in the draft ASTM International standard that provides guidance on packaging and labeling products for sale to adult consumers, authorized medical cannabis users, and caregivers in a business-to-consumer-retail environment (WK60446). “Harmonization is a key opportunity for supply chain cost reduction and efficiency,” Heins adds.

The subcommittee is also discussing standards related to special “child-resistant” and “senior friendly” packaging. He says that there is agreement that certain product forms, such as edibles and other “activated” products, should be placed in a container that is certified to be child-resistant. The current draft version of the guide also calls for “non-activated” products (e.g., cannabis flowers) to be in such packaging, he notes, though debate continues regarding whether cannabis-related products unlikely to cause illness or injury should be packaged in additional plastic and laminate films that could have a negative environmental impact.

PARTNERSHIPS AND ACTIVITIES EXPAND

In-person dialogue among the world’s leading minds in cannabis standardization has never been more important.

That’s why ASTM International’s cannabis committee has sponsored events such as a workshop in Berlin in 2017 that helped lay the groundwork for the memorandum of understanding signed in 2018 between ASTM International and the International Cannabis and Cannabinoids Institute in Europe.

Under the agreement, the committee will coordinate standards development activities for the global cannabis and hemp industry while ICCI, based in the Czech Republic, will gain recognition of its technical contributions, free temporary ASTM membership for its members, and other benefits. Another workshop is planned for Rome in February to keep the momentum going.

Ralph Paroli, Ph.D., the committee’s chairman and the director of research and development in measurement science and standards at the National Research Council of Canada, notes that many D37 members have encouraged their global peers to join the committee, resulting in a roster now numbering more than 500 people from universities, private companies, government agencies, trade organizations, and other interested groups. “This is truly an international committee, with members from about 15 different countries,” he adds.

Efforts to ensure that the committee addresses the wide range of concerns of the worldwide cannabis industry also extend to the area of industrial hemp. As Millard explains, “The cannabis industry is a multifaceted beast encompassing everything from building materials, clothing, and high-tech semiconductors to nutritional, dietary, and pharmaceutical goods.” Those first two areas — building materials (e.g., insulation) and clothing — are particularly relevant to hemp and will be among the product categories to be tackled by a new subcommittee on industrial hemp (D37.07) formed last summer, he notes.
Jeremy Applen, who is vice chairman of the committee as well as chief science officer at Bhang Corp., welcomes this new subcommittee. “Industrial hemp is burgeoning globally and has the potential to impact everything from construction materials to the environment,” says Applen.

Perhaps the most well-known example of hemp’s potential is in the area of textiles. Millard points out, “The cannabis fiber industry is dominated by China, but no standards are in place to ensure that when you buy cannabis fiber the product you get will be 100 percent cannabis fiber. For a clothing manufacturer to claim 100 percent cannabis fiber products, they will need a standard to validate their claim.”

This standards gap is one of many that currently exist in the cannabis space. The stunning overall growth of the committee speaks to the importance of its mission.

Millard sums it up this way: “ASTM International and the cannabis committee provide an unparalleled opportunity for anyone who is a stakeholder in the cannabis industry — whether operator, employee, grower, researcher, or regulator, or anyone who is passionate about the cannabis plant — to have a say in the development of market-relevant standards that will be used to grow the industry for years to come.”

Sidebar

ASTM International has hired a technical consultant in cannabis to support standards development and related needs. Charles P. Rutherford II, CPR Squared, Inc., will create an outreach strategy to engage key cannabis-related organizations and networks, liaise with existing standardization activities, help prioritize and strategize a focused approach to standards development, and more.

Sidebar

MOU Signed with Canadian Hemp Organization

In December, ASTM International and the Canadian Hemp Trade Alliance signed a memorandum of understanding to work together on standards for the cannabis industry.

Under the agreement, ASTM’s cannabis committee (D37) will coordinate standards development activities for global cannabis and hemp industries, while CHTA will participate in the process and provide technical expertise. In particular, CHTA will share insight into previously developed food standards and will contribute to the subcommittee on industrial hemp.

“We are excited to partner with ASTM International to continue developing standards for the emerging industrial hemp industry,” according to Ted Haney, executive director of CHTA. “The shared technical experience of CHTA and ASTM International’s members will help set a framework for many standards development activities to come.”

“CHTA’s expertise in industrial hemp is well-known,” said Ralph Paroli, Ph.D., the cannabis committee chair and the director of research and development in measurement science and standards at the National Research Council of Canada. “CHTA’s engagement in the committee will strengthen ASTM International’s renowned global standards, specifically in the development of standards for industrial hemp.”

ASTM International has previously signed similar agreements with the Foundation of Cannabis Unified Standards, the American Herbal Products Association, and the American Trade Association of Cannabis and Hemp.

CHTA is a national organization that promotes Canadian hemp and hemp products globally. Established in 2003, the alliance represents those involved in Canada’s hemp industry. Members include farmers, processors, manufacturers, researchers, entrepreneurs, and marketers. The organization’s key functions are to disseminate information, promote the use of nutritional and industrial hemp, and coordinate research.