In Case You Missed It: Unpacking the Aspergillus Lawsuit
Unpacking the Aspergillus Lawsuit Full Presentation & Detailed SlidesThis week on Tuesday, Jacoby Law hosted a webinar reviewing in robust detail, the 2023 Aspergillus lawsuit. Over the last year since this win we have observed similar regulation challenges with Aspergillus in other states. This webinar features a round table discussion of what legal and industry experts predict for the future in other states regarding over regulation and aspergillus testing, misinformation campaigns, and broad stroke recommendations.
Please see the link above for detailed slides containing all information covered in the webinar. Below, after the video recording, is the same information in blog form. You can contact our firm to set up a consultation with Kevin Jacoby by calling 503-208-4470, or by submitting an inquiry through the consultation form at the bottom of our website.
History What is Aspergillus?
According to the CDC, Aspergillus is a species of fungus that “is very common both indoors and outdoors, so most people breathe in fungal spores every day.”
- https://www.cdc.gov/aspergillosis/about/?CDC_AAref_Val=https://www.cdc.gov/fungal/diseases/aspergillosis/causes.html
- While there about 180 species of Aspergillus, most regulations target four species that are known to cause health issues in certain populations – A. flavus, A. fumigatus, A. niger and A. terreus. According to the CDC, these four species also happen to be the most common.
- Aspergillus is ubiquitous in most outdoor and indoor environments. You are more than likely breathing in hundreds of Aspergillus spores every day.
What is aspergillosis?
- Aspergillosis is an infection caused by breathing in the spores of Aspergillus, but most people don’t get any infection.
- According to the CDC, breathing in Aspergillus isn’t harmful for people with healthy immune systems.
- Aspergillosis has two basic manifestations – an allergic reaction that has mild symptoms, and invasive infections that can have more severe consequences.
- According to the CDC, allergic reactions occur in 1 to 15% of cystic fibrosis patients and about 2.5% of adults who have asthma.
- Invasive infections are uncommon and occur primarily in immunocompromised people. One study suggests a yearly rate of 1 to 2 cases of invasive aspergillosis per 100,000 population.
- Invasive aspergillosis is a serious infection that can cause death in immunocompromised patients. Allergic aspergillosis is generally not life-threatening.
- https://www.cdc.gov/aspergillosis/statistics/index.html
- Risk factors for invasive aspergillosis include:
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- Stem cell or organ transplant recipients
- People undergoing cancer chemotherapy treatment
- People who are taking high doses of corticosteroids
- Patients with severe respiratory infections
- https://www.cdc.gov/aspergillosis/prevention/index.html
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How to prevent aspergillosis?
- According to the CDC, it is difficult, if not impossible, to avoid breathing in Aspergillus spores “because the fungus is common in the environment.”
- The CDC has certain recommendations for people with weakened immune systems to avoid developing a severe Aspergillus infection, but those recommendations “haven’t been proven to prevent aspergillosis.”
Bottom line: You only need to worry about aspergillosis if you are severely immunocompromised.
Then why are regulators requiring testing for Aspergillus in cannabis?
- Because there are companies with a vested financial interest in causing a panic among regulators. These include, but are not necessarily limited to:
- Companies who develop and manufacture testing kits – they have an interest in overhyping the risk because they make money selling the testing kits to labs. If they convince regulators that Aspergillus testing of every batch of cannabis is necessary to protect human health, they make money.
- Companies who sell remediation or mitigation solutions to producers.
- Regulatory bias against inhalation of any substance considered a vice – think tobacco and nicotine vape products.
- There are some bad studies out there, many quite dated, that those with vested interests against smoking cannabis have cited to suggest that the cannabis consuming population is more likely to be immunocompromised, and therefore more likely to be susceptible to invasive aspergillosis.
- However, those studies are now more than a decade old, before the prevalence of adult-use legalization, and are likely relics of medical-only legalization regimes.
- One such claim, made by OLCC in a press release announcing a recall of products in June 2023, was that “Recent research has found that fungal infections – nearly half of which were attributable to aspergillosis – are 3.5 times more likely in cannabis users.”
- But the study they cited didn’t support this statement. The study involved statistical analysis of a health insurance claim database in 2016, and stated that “it was not possible to determine the source of infection,” cautioning that any number of factors could contribute to this correlation.
- The study only establishes that among this one insurer database in 2016, self-identified cannabis users were more likely to be immunocompromised than non-cannabis users, which the study’s authors noted was likely a remnant of medial marijuana-only regimes.
- In other words, when only people who have qualifying medical conditions are legally allowed to possess and consume cannabis, of course self-identified cannabis users are going to skew immunocompromised.
- The study also did not differentiate between method of delivery. Self-identified immunocompromised cannabis users who had an aspergillosis diagnosis could have exclusively ingested cannabis via edibles, which means they did not get aspergillosis from smoking cannabis.
Aspergillus testing is not required for any other agricultural product.
Oregon’s Aspergillus Testing Rule
- Beginning March 1, 2023, Oregon regulators began requiring all usable marijuana intended for human ingestion via smoking (that is, flower and prerolls) be tested for the presence of the four most common species of Aspergillus.
- The regulation required a DNA test of a batch sample. The presence of any DNA of the four species of Aspergillus resulted in a failed test. In other words, a zero-tolerance standard.
- Batches could be as much as 50 pounds.
- Samples must represent a minimum of 0.5 percent of the batch.
- Thus, the presence of a single strand of DNA in any one gram of the sample would cause as much as 50 pounds to fail.
- Given the prevalence of Aspergillus in the general environment, there is no way to ensure that a positive test wasn’t the result of exposure during the testing process.
- The regulation required that cannabis producers ensure that their flower and prerolls were entirely devoid of Aspergillus, essentially requiring their products to be cleaner than the air consumers breathe every day.
- The regulation wasn’t about getting “moldy weed” out of the regulated market.
- Cannabis producers had very little information to determine how this rule would impact them until only a few months before the requirement went into effect.
- In the face of questions from the industry as to how this rule might affect the flower and preroll markets, OLCC encouraged producers to get R&D tests prior to the requirement to see what the fail rate was.
- The fail rates for indoor, controlled-air environment grows who invested heavily in mold and microbe mitigation were relatively low, but still non-zero and seemingly random.
- The fail rates for outdoor greenhouses, particularly those utilizing living soil or other organic growing methods, were alarmingly high.
- Overall, an astounding 38% of producers who submitted samples for Aspergillus testing reported at least one failed test. And this was before the outdoor crop was even available for testing.
- Despite OLCC encouraging R&D testing, in June 2023 they ended up issuing recalls for product that had failed prior to the date the testing was required, declaring Aspergillus a “contaminant.”
Rule Challenge
- On July 28, 2023, CIAO, along with other petitioners, submitted a petition to the Oregon Court of Appeals to declare the Aspergillus testing rule invalid.
- In connection with that petition, we also submitted a motion to stay enforcement of the rule pending judicial review, citing irreparable harm to the industry and a likelihood of success on the merits.
Legal Argument
- ORS 475C.544 assigned to Oregon Health Authority, in consultation with OLCC and the Department of Agriculture, the responsibility to establish standards for testing of marijuana items.
- ORS 475C.544(8)(b) states that OHA “may not adopt rules that are more restrictive than reasonably necessary to protect the public health and safety.”
- In promulgating the rule, OHA examined testing regimes in eight other states: Colorado, Arizona, Washington, California, Nevada, Ohio, Maryland and New York.
- Of those states, Washington, Ohio, and Maryland did not require testing for the presence of Aspergillus at all.
- Arizona does require a test for Aspergillus, but it was not zero-tolerance. It allowed for the presence of Aspergillus spores equal to or less than one CFU (colony forming unit).
- OHA inaccurately claimed that the “vast majority of states” had a testing rule similar to what they promulgated, but that wasn’t true. Only half of them did.
- OHA failed to explain why the three states who didn’t test for Aspergillus were not adequately protecting the health and safety of their citizens.
On August 25, 2023, the Court of Appeals issued an order granting our motion for stay.
- The court found that OHA had “not raised a clear response to petitioners’ contention that OHA does not appear to have considered whether there were less restrictive alternatives to the rule it adopted and/or determined that less restrictive alternatives that were in the record (in the form of lesser testing requirements in other states surveyed by OHA) would adequately protect public health and safety.”
- “Given the legislature’s clear directive that rules adopted by OHA establishing standards for testing marijuana and identifying appropriate tests for microbiological contaminants to protect public health and safety ‘may not’ be more restrictive than reasonably necessary, the court is persuaded that petitioners have shown a likelihood of success on judicial review sufficient to weigh in favor of a stay in this case.”
- Following this ruling, OHA issued a rule repealing the Aspergillus testing requirement.
Looking Ahead
The court’s ruling does not prohibit OHA from issuing a new Aspergillus testing requirement that is less restrictive. However, OHA has not taken steps to do so and there is no indication that they plan on doing so in the near future.
- But industry must remain vigilant.
What does this mean for other states that have stringent Aspergillus testing requirements?
- Most state statutes have a provision similar to Oregon’s requiring some measure of restraint on agencies from over-regulating. For example:
- Cal. Bus. & Prof. Code § 26013(c) (“Regulations issued under this division shall be necessary to achieve the purposes of this division, based on best available evidence, and shall mandate only commercially feasible procedures, technology, or other requirements, and shall not unreasonably restrain or inhibit the development of alternative procedures or technology to achieve the same substantive requirements, nor shall the regulations make compliance so onerous that the operation under a cannabis license is not worthy of being carried out in practice by a reasonably prudent businessperson.”)
- Given the prevalence of Aspergillus and the science about its limited risk to healthy individuals, these regulations are likely susceptible to similar legal challenges in other states.
Many of the advocates for stricter testing requirements are researching other possible “contaminants” to test for and raise a panic about. The fight is likely to continue on these other fronts.
Most important takeaway: industry advocates must invest in educating legislators and regulators.
What Is ASTM and Why It Matters to Our Industry:
ASTM (American Society for Testing and Materials) is a globally recognized organization that develops voluntary standards across a wide range of industries, including cannabis. Since 2017, ASTM Committee D37 On Cannabis has focused on creating standards specifically for our industry, covering areas such as cultivation, processing, testing, packaging, transportation, and security.
ASTM standards are frequently adopted into federal and state regulations, making them mandatory.
How You Can Get Involved:
- If you’re not a member, sign up to become a participating member of the ASTM D37 Committee. Membership costs only $115 a year.