Lack of Uniform Standards May Impact Consumer and Environmental HealthCurrently, there are no uniform international standards to ensure cannabis is produced and processed in a manner necessary to protect consumer health and safety. Because cannabis and its derivatives are illegal under US federal law, federal agencies responsible for regulating health and safety, like the Food and Drug Administration, do not regulate cannabis in the same comprehensive manner as other substances within their jurisdiction. For example, edibles, extracts, tinctures, and pet foods that would otherwise be regulated by FDA, and required to conform to rigorous manufacturing, testing, and record-keeping requirements, are largely devoid of FDA regulation when these products contain cannabis or its derivatives. Similarly, even though the Federal Insecticide, Fungicide, and Rodenticide Act prohibits the use of pesticides on a crop not listed on the pesticide’s label (i.e., a crop for which the Environmental Protection Agency has established a tolerance for the pesticide) and EPA has not established any tolerances for pesticide use on cannabis crops, to date EPA declined to enforce FIFRA’s requirements in light of cannabis’s status under the Controlled Substances Act. Without uniform regulatory oversight, the content, purity, and potency of cannabis products can vary considerably, increasing the potential for adverse health effects.
Patchwork Attempts at Regulation Innovative, But Imperfect
In the absence of meaningful federal health and safety regulation, states have tried to fill the void—and have made considerable progress in recent years. But given that cannabis has, by and large, been a regulated medical and consumer good for a relatively short time, state regulators have been put in the position to create those rules that federal regulators would ordinarily be required to do. This has resulted in a patchwork of regulations, with requirements differing from state to state, and in some cases no regulation at all. As one of the first states to legalize adult-use cannabis, Colorado, perhaps unsurprisingly, has one of the most robust regulatory schemes, particularly with respect to edibles. For example, in Colorado in 2015 and 2016, testing and enforcement efforts undertaken by the City of Denver resulted in almost weekly reports of tainted cannabis products in the marketplace, resulting in numerous recalls and destruction orders, all while the state sought to establish a regulatory scheme to address pesticide use on cannabis crops. Many of the problems experienced in Denver stemmed from the allegedly invalid results of pesticide residue lab testing. Had uniform standards for such analytical testing been in place, the tainted products could possibly have been prevented from entering the marketplace. Oregon has also recognized the need for more robust regulation of pesticide use. Its legislature recently revised standards for dispensaries, requiring that cannabis be tested for four different classes of pesticides.
In addition to banning and establishing allowable limits for pesticides on cannabis, many states have also begun to establish quality control and assurance standards for cannabis and cannabis-derived products. States that require such testing often, but not always, require products be tested for the presence and amount of specific cannabinoids, residual solvents and water content (to measure likelihood of microbial contamination). However, requirements regarding analytical testing methodology, laboratory certification, and the types and levels of contaminants varies greatly among the states. California’s 2015 Medical Cannabis Regulation and Safety Act (MCRSA) establishes relatively clear standards for mandatory laboratory testing of medical cannabis, but the regulations implementing these requirements and establishing testing requirements for the specific types and allowable levels of cannabinoids and contaminants will not be issued until 2018.
There are also a great many inconsistencies in state requirements for packaging and labeling. Nearly all states with legalized cannabis impose some sort of requirements to prevent use by children, e.g., tamper-resistant packaging (which, if required by federal law, would require compliance with the Poison Prevention Packaging Act). But regulation in this area also continues to evolve to better protect consumer and patient health. For example, Colorado issued new regulations requiring, among other things, that not only the packaging, but also cannabis products themselves be marked, stamped, or imprinted with a new “universal” symbol. Colorado also requires that packaging of edibles list all ingredients in the product, but does not require an allergy warning. In contrast, California requires packaging to include a warning if nuts or other known allergens are used. Oregon requires products to be labeled with the estimated “activation time” for intoxicating effects, whereas California only requires that products warn that the “intoxicating effects” could be delayed by up to two hours following ingestion. For consumers that travel between states where adult use is legal, inconsistencies in labeling have the potential to cause consumer confusion, or in the worst case scenario, lead to adverse reaction due to ingesting too much THC or by inadvertently consuming allergenic substance. State regulators should be commended for innovation and hard work, building entirely new regulatory regimes from the ground up. But the existing patchwork of regulation is far from perfect and could likely benefit from a unified set of standards that could help guide state laws.
As noted above, cannabis is still illegal under federal law, raising additional unknowns within the industry. However, with state legalization of cannabis showing no signs of slowing, mandatory minimum standards applicable to the cannabis industry will be critical, particularly with respect to the use of pesticides on cannabis crops and the testing, labeling, and processing of cannabis products. Standards are technical guidelines that can be used to serve as basis of manufacturing, management, procurement, codes, and regulations. Uniform standards could help guide states and the industry to protect the health and safety of consumers and the environment. Although at least one organization, the Foundation of Cannabis Unified Standards, has sought to establish standards for the entire cannabis industry, and the US Pharmacopeia Convention has hinted that it may develop quality standards for medical cannabis, it is notable that an organization as large and highly respected as ASTM may throw its hat in the ring.
As the Industry Grows, Standards Will Be Critical
It is important to note that the process of drafting and finalizing ASTM’s voluntary cannabis industry standards will take time. As a voluntary standards-developing organization, ASTM’s process for developing and approving standards is designed to draw input from the widest possible cross-section of interested parties, and to ensure a balance in the approval process between producers and users of the product or service for which the standard is being developed. Once the new technical committee for cannabis has been created, ASTM will then establish subcommittees to address individual technical areas (initially planned in the six areas described above). Within each subcommittee, task groups will then be formed to research and draft different aspects of each standard. Once drafted, each standard will first be submitted for balloting to voting members of the technical committee, then to members of the full committee. Not until a standard has undergone this full drafting and approval process will it be published by ASTM. The entire process of drafting, balloting, and final approval can take as short as a few months to more than a year.
Arent Fox has substantial experience in the many regulatory issues facing the cannabis industry and will continue to follow and report on developments involving state and federal regulation of cannabis and related regulatory and safety issues. Please contact James R. Ravitz or Emily M. Leongini for further assistance.