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Hoban Law Group Files Lawsuit Against DEA

The Hoban Law Group filed a petition on behalf of three clients against the DEA in the U.S. Court of Appeals for the Ninth District on January 13th, according to a press release. The clients represented by Hoban Law Group in the suit are Hemp Industries Association, RMH Holdings, LLC and Centuria Natural Foods, Inc. The companies are based in California, Colorado and Nevada respectively and are all active in the legal hemp trade. The press release says RMH Holdings “sources its products from industrial hemp lawfully cultivated pursuant to the Agricultural Act of 2014 (also known as the Farm Bill).”

San Francisco's United States Court of Appeals for the Ninth Circuit Photo: Ken Lund, Flickr
San Francisco’s United States Court of Appeals for the Ninth Circuit
Photo: Ken Lund, Flickr

In December, the DEA published a ‘Final Rule’ that classifies cannabis-derived extracts, such as CBD oil, in their own category with a code number to “better track these materials and comply with treaty provisions.” The announcement by the DEA ultimately serves to make any cannabis extract a Schedule 1 narcotic. “Extracts of marihuana will continue to be treated as Schedule I controlled substances,” says the document.

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Bob Hoban, managing partner

Bob Hoban, managing partner of Hoban Law Group says the action is clearly beyond the DEA’s authority. “This Final Rule serves to threaten hundreds, if not thousands, of growing businesses, with massive economic and industry expansion opportunities, all of which conduct lawful business compliant with existing policy as it is understood and in reliance upon the Federal Government,” says Hoban.

The lawsuit states that they want a judicial review of the DEA’s actions “on the grounds that the Final Rule is (1) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law, e.g. the CSA, the Farm Bill, and the DEA’s regulations; (2) contrary to constitutional right, power, privilege, or immunity; (3) in excess of statutory jurisdiction, authority, or limitations; and, (4) without observance of procedure required by law.” The suit also claims that the ‘Final Rule’ conflicts with other federal laws like the Data Quality Act, Regulatory Flexibility Act and Congressional Review Act.

According to Garrett Graff, associate attorney at Hoban Law Group, the entire Cannabis genus is not unlawful and the DEA is overstepping its authority. “As the Ninth Circuit found in 2003 and 2004 there are certain parts of the plant like the stalk and seed that are congressionally exempted from the Controlled Substances Act and thus the DEA’s rulemaking authority,” says Graff. “By creating a drug code for ‘marihuana extract’, the DEA is saying that they are a controlled substance, but that goes against a number of existing laws.”

Garrett Graff, associate partner at Hoban Law Group
Garrett Graff, associate partner at Hoban Law Group

The definition of ‘marihuana extract’ under the ‘Final Rule’ also references extracts containing one or more cannabinoids, which goes beyond the realm of cannabis altogether, according to Graff. “The DEA and many other sources have acknowledged and confirmed that cannabinoids can be derived from other varieties of flowers, cacao and other sources, making it virtually impossible to distinguish which cannabinoids would be subject to this drug code,” says Graff. “The DEA’s rule effectively makes the presence of cannabinoids a determinative factor of a controlled substance, which is inconsistent with what Congress has said.”

The petition filed is essentially the initiation or commencing of a lawsuit. Graff says their case is rooted in statute. “We hope to accomplish a striking of the rule, permanent injunction of the rule and for the DEA to engage in the appropriate processes and procedures when making rules in the future,” says Graff. “Alternatively, an amendment to the rule to make the definition of ‘marihuana extract’ consistent with existing law and reflect those portions and varieties of the plant which are in fact lawful could be considered.” It may still be roughly 30 days before the DEA responds with briefing and possibly an oral argument to follow on the various issues surrounding the petition, says Graff. The Ninth Circuit petition, including briefings and hearings, is likely to take at least several months.

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States in Northeast Push Legalization Bills Following Massachusetts, Maine

On Election Day in November, two major states in the Northeast legalized recreational cannabis: Maine and Massachusetts. It seems that a handful of other states in the region are looking to legalize recreational cannabis now that their neighbors have done so.

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New Hampshire Capitol Photo: Jim Bowen, Flickr

In New Hampshire, a bipartisan bill was introduced on January 4th to establish “a commission to study the legalization, regulation, and taxation of marijuana.” The commission formed by House Bill 215 aims to “study the experiences of states that have or are in the process of legalizing and regulating the recreational use of marijuana by adults, with particular attention to be given to the ways the changes in marijuana laws in Maine and Massachusetts, as well as Canada, impact our state,” the bill states. Notably, the bill provides for a representative from the Marijuana Policy Project to be a member of the committee.

Photo: David L, Flickr
Photo: David L, Flickr

New Hampshire Senate Minority Leader Jeff Woodburn (D) says he plans to sponsor a recreational legalization bill separate from House Bill 215. According to the New Hampshire Union Leader, Woodburn would work with lawmakers and stakeholders to set a timeline and regulatory framework.

In Connecticut, a number of lawmakers have sponsored bills this session that would legalize recreational cannabis. Senate President Martin Looney (D) filed a bill that would legalize, regulate and tax cannabis, with the tax revenue going to the state’s general fund, according to the New Haven Register. State Rep. Melissa Ziobron (R) introduced a piece of legislation that would legalize adult use over the age of 21. Lawmakers are optimistic that with Massachusetts legalizing it, perhaps the outcome will be different than previous failed attempts to push cannabis legalization.

Providence, RI Photo: David Wilson, Flickr
Providence, RI
Photo: David Wilson, Flickr

Lawmakers in Rhode Island told reporters they want to be the first state to legalize recreational cannabis via the state legislature, rather than a ballot initiative, the most common path to legalization for other states. Sen. Joshua Miller and Rep. Scott Slater of Rhode Island, both Democrats, plan to introduce a legalization bill, the seventh year in a row that such a bill has been introduced in the state. They are also hopeful that after Massachusetts’ legalized it in November, they will have more success this time around. “Our constituents think it is time for lawmakers to pass this legislation, and we should listen to them,” says Miller. “If we fail to pass the bill this year, we will lose significant ground to Massachusetts.” Their bill would tack on a 23% tax on cannabis sales.

In each state’s case, lawmakers are keeping a close eye on Massachusetts and Maine’s regulations and tracking their progress. While the bills in the state legislatures are nascent in their journey to becoming law, the important takeaway is that geographic proximity to states with legalized cannabis is a catalyst for reform in New England.

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Green Man Cannabis Recalls Due to Pesticide Residue Detection

Denver-based Green Man Cannabis last week voluntarily recalled batches of cannabis sold to both medical patients and recreational consumers. The recall comes after the discovery of off-label pesticides during inspections in both dry-flower cannabis and infused products.

Photo: Sheila Sund, Flickr
Photo: Sheila Sund, Flickr

According to the Denver Department of Environmental Health (DEH), the products have labels that list an OPC License number of 403-00738, 403-00361, or 403R-00201. The cannabis in question is not a specific batch, rather, “All plant material and derived products originating from these cultivation facilities are subject to the recall.” The DEH’s statement includes contact information for the company (email: recall@greenmancannabis.com) and the DEH Public Health Inspections Division (email: phicomments@denvergov.org or 720-913-1311).

The DEH statement does not mention which pesticides were detected or the levels at which they were detected. Christian Hagaseth, founder of Green Man Cannabis, says the chemical detected was Myclobutanil. “We had used Eagle 20 in the past, [the pesticide that contains Myclobutanil] but we stopped using it as soon as it was banned,” says Hagaseth. “The DEH found the residues in the growing environment so we immediately performed a voluntary recall.” Green Man has three cultivation facilities, one of which they suspect is contaminated from pesticides sprayed a few years ago.

Christian Hageseth, founder of Green Man Cannabis
Christian Hageseth, founder of Green Man Cannabis

As far as corrective actions being taken, Hagaseth says they are doing a thorough cleaning and sanitation in two of their grows and a complete remediation plan in the suspected contaminated grow. “This was a good learning experience- the key takeaway for us is we need to clean these environments more consistently,” says Hagaseth. “I am grateful that the system is working; public health and environmental safety are being looked after here.” Hagaseth says the facility in question was operating almost without interruption since 2009, but they adjusted and learned to implement preventative actions following the recall.

The DEH says there have been zero reports of illness related to the recall. “The possible health impact of consuming marijuana products with unapproved pesticide residues is unknown,” the statement reads. “Short and long-term health impacts may exist depending on the specific product, duration, frequency, level of exposure and route of exposure.” The DEH advises consumers that may be concerned to reach out to their physician.

The DEH performs routine inspections of cannabis infused product manufacturers and retail locations in Denver, as well as investigating complaints. “I am sorry that it happened to us, but I am happy the system is working and we are more than happy to comply,” says Hagaseth.

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Analyzing The Emerald Test Results: Cannabis Labs Making Progress

The Emerald Test advisory panel recently convened to review the results from the Fall 2016 round of the semi-annual Inter-Laboratory Comparison and Proficiency Test (ILC/PT), ahead of the third annual Emerald Conference just a few weeks away. After reviewing and analyzing the results, the panel noticed a significant improvement across the board over their Spring 2016 round of proficiency testing.rsz_emerald-scientific_letterhead-1

Emerald Scientific’s ILC/PT program is a tool laboratories use to check how accurate their testing capabilities are compared to other labs. A lab receiving The Emerald Test badge indicates their testing meets the criteria established by the panel to demonstrate competency. This means that they were within two standard deviations of the consensus mean for all analytes tested, according to Wes Burk, vice president of Emerald Scientific. He says the labs performed better than expected on both the microbial and pesticide tests.

Wes Burk, vice president of Emerald Scientific.
Wes Burk, vice president of Emerald Scientific.

emerald test retailEach lab has access to raw, anonymized data including a consensus mean, z-scores and kernel density plots. This round measured how well 35 cannabis labs perform in testing for potency, pesticides, residual solvents and microbial contaminants such as E. coli, Salmonella, Coliform, yeast and mold.

The advisory panel includes: Robert Martin, Ph.D., founder of CW Analytical, Cynthia Ludwig, director of technical services at AOCS, Rodger Voelker, Ph.D., lab director, OG Analytical, Tammie Mussitsch, QA manager at RJ Lee Group, Shawn Kassner, senior scientist at Neptune & Company, Inc., Jim Roe, scientific director at Steep Hill Labs, Chris Hudalla, Ph.D., founder and chief scientific officer at ProVerde Labs, Sytze Elzinga, The Werc Shop and Amanda Rigdon, Chief Technical Officer at Emerald Scientific.

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Amanda Rigdon, chief technical officer at Emerald Scientific

According to Amanda Rigdon, chief technical officer at Emerald Scientific, the labs performed very well in potency, residual solvents and microbial testing PTs. This is the first year the proficiency testing includes pesticides. “All of the labs did a great job identifying every pesticide in our hemp-based PT, but some more work will most likely have to be done to bring quantitative results in line,” says Rigdon. “Since this was the first pesticide PT we had offered, we were pretty conservative when choosing analytes and their levels. For the most part, analytes and levels were taken from the Oregon pesticide list, which is widely recognized to be the most reasonable and applicable pesticide list out there to date.” They covered pesticides of high concern, like abamectin and Myclobutanil, but also included a wide range of other pesticides that labs are expected to encounter.

Shawn Kassner, senior scientist at Neptune
Shawn Kassner, senior scientist at Neptune & Company, Inc.

Shawn Kassner, senior scientist at Neptune & Company, Inc., believes microbial contamination proficiency testing should be a priority for improving public health and safety going forward. Although five participating labs did not receive badges for the microbial contamination PTs, panel members say the overall performance was really quite good. “Microbiology testing are essential analyses for all cannabis products and it’s just slower in regulatory implementation than potency testing,” says Kassner. “The risk of Salmonella and E. coli to an individual using a medical cannabis product could be very life threatening. Microbiology contamination is a huge concern for any public health agency, which is why we have seen that microbiology testing is usually the first analytical test required after potency.” Kassner notes that there were few outliers and with each Emerald PT program, he is seeing an improvement in overall laboratory performance.

For The Emerald Test’s next round, the panel hopes to make some improvements in the test’s robustness and consistency, like obtaining assigned values for all samples and comparing to a consensus mean. “We want to develop permanent badge criteria, streamline the appeals process and possibly implement a qualitative performance review in the pesticide PT,” says Burk. For the next round of pesticide PTs, they want to build a better list of pesticides to cover more states, allowing labs to pick a set based on their state’s regulations. Burk says they also want to collect data on whether or not matrix-matched curves were used for pesticides.

Rodger Voelker, Cynthia Ludwig and Shawn Kassner, all members of the advisory panel, will be speaking at the Emerald Conference, discussing some of their findings from this round of proficiency testing. The Emerald Conference will take place February 2nd and 3rd in San Diego, CA.

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Jeff Sessions’ Stance on Cannabis: Uphold Federal Law

President-elect Donald Trump nominated Sen. Jeff Sessions (R-AL) for Attorney General back in November. For Sessions to become a member of the cabinet and head of the Department of Justice, the Senate must approve the nomination during a confirmation hearing, taking place today in Washington D.C.

Sen. Jeff Sessions (R-AL) Photo: Gage Skidmore, Flickr
Sen. Jeff Sessions (R-AL)
Photo: Gage Skidmore, Flickr

According to CNN’s coverage of the events, Sen. Mike Lee (R-Utah) mentioned the Obama Administration’s tolerance of states with legal cannabis. “There are federal laws prohibiting the use of marijuana, the sale of marijuana, the production of marijuana, that apply regardless of whether a state has independently criminalized the drug,” says Senator Lee. He then asks if Obama’s actions were indicative of a breach of “the understanding that we [Congress] are the lawmaking body.”

Sessions replied to that by saying that as federal law stands, cannabis is illegal. He says if keeping cannabis illegal is “not desired any longer, Congress should pass a law to change the rule.” He adds that it’s not the AG’s job to enforce or not enforce certain laws. “We should do our job and enforce laws as effectively as we’re able,” says Sessions.

In April of 2016 according to USA Today, Sen. Jeff Sessions was quoted saying “Good people don’t smoke marijuana.” Sessions has a history of making inflammatory remarks, including racist statements. He has also previously mentioned his proud support for the War on Drugs.

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Aaron Smith, executive director of NCIA

Sessions’ comments during the exchange today shed some much-needed light on his stance toward legal cannabis. National Cannabis Industry Association (NCIA) executive director Aaron Smith issued a statement on Sessions’ comments made today. In the statement, Smith sounds optimistic regarding Sessions’ comments. “In today’s hearing, Sen. Sessions indicated that the Justice Department’s current guidelines for marijuana policy enforcement are ‘truly valuable’ in setting departmental priorities,” says Smith. “That belief, along with the support for state sovereignty on cannabis policy expressed by President-elect Trump and his team, should lead Sen. Sessions to maintain the current federal policy of respect for state-legal, regulated cannabis programs if he is confirmed as Attorney General.”

“Sen. Sessions also highlighted the conflict created by a Congress that has failed to reflect the will of the voters on cannabis policy,” says Smith. “Voters in 28 states, representing approximately 60% of the nation’s population, have now chosen some form of legal, regulated cannabis program. National polling shows that 60% of Americans believe cannabis should be legalized. It’s time for federal lawmakers to represent the clear choices of their constituents.” Given the Republican support for state sovereignty and Sessions’ comments on Congressional lawmaking, Smith is hopeful that if Sessions becomes the new Attorney General, he will respect states with legal cannabis programs.

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Canadian Cannabis Recalls Raise Questions About Choices in Testing Methods

Cannabis sold between August and December of 2016 is being voluntarily recalled by Organigram, a Canadian cannabis producer, due to the detection of unapproved pesticides, according to a press release. Organigram is a licensed medical cannabis producer in Canada, which received an organic certification back in 2014 by ECOCERT, a third-party organic certification organization based in France.

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Organigram and Health Canada deemed it a Type III recall, meaning “a situation in which the use of, or exposure to, dried marijuana, fresh marijuana or cannabis oil, marijuana plants or seeds is not likely to cause any adverse health consequences,” according to that press release. They don’t know how the products were contaminated as routine use of pesticides is barred under their organic certification. Organigram is cooperating with Health Canada to conduct a full investigation to determine how the cannabis was contaminated.

About a month before Organigram’s recall, Mettrum Health Corp., a Toronto-based licensed medical cannabis producer, voluntarily recalled medical cannabis products that might have contained trace levels of pyrethrin, an insecticide not approved for use on cannabis, but generally regarded as safe with a low toxicity. That press release only mentions the detection of pyrethrin and downplays the health effects. “While the ingredient is not harmful and there is no negative effect on product quality and safety, we are doing everything possible to ensure client satisfaction and confidence is upheld,” says Michael Haines, director and chief executive officer of Mettrum Health Corp.

Pesticide Use was a major issue of 2016 Photo: Michelle Tribe, Flickr
Photo: Michelle Tribe, Flickr

Reporting in an article last week, The Globe and Mail discovered that Mettrum’s recall included lots where they detected trace levels of Myclobutanil, a hazardous and illegal pesticide that is banned in a number of states as well. Myclobutanil has been discovered as the culprit in a slew of pesticide-related recalls in Colorado and Washington.

But Mettrum’s updated press release doesn’t include any mention of Myclobutanil. Health Canada also didn’t make any public disclosures addressing the detection of Myclobutanil. The Globe and Mail only found out that the recall included the banned pesticide after asking a Mettrum employee.

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Tegan Adams, business development manager at Eurofins-Experchem

Tegan Adams, business development manager at Eurofins-Experchem Laboratories, Inc., a Toronto-based GMP testing lab, indicated that while the regulations are clear in their statement on zero tolerance for pesticides- reasons for inconsistent testing results are in part related to variations in rigor of testing methods available to monitor for pesticides in cannabis. “Licensed producers do not have to release routine test results to the public,” says Adams. “There is a group of us, inclusive of representatives from licensed producers (LPs), working on proposing a new federal cannabis accreditation standard that would make testing results, grading quality, DNA and a few other things public for each cannabis batch legally released to the public to be accredited. Making information like this public would help remove a lot of consumer scrutiny on LPs, as it currently exists in the marketplace. Most of them care so much about their products and patients, they work very hard to create safe quality products”

According to Adams, routine pesticide testing typically scans for roughly 100 pesticides. She says a more rigorous test could scan for 500-700 different pesticides, a more accurate representation of what’s on the market. Adams says the regulations have zero tolerance for any detection of pesticides, not necessarily an action level for what is a safe amount to be present.

Toronto Photo: Paul Bica, Flickr
Toronto
Photo: Paul Bica, Flickr

More research is needed on the smoking and inhalation aspects of pesticide products to say what is safe and what is not. “There are different methods available to test for pesticides, and SOPs to follow to avoid their application,” says Adams. “But if a licensed producer chose a testing method that doesn’t for some reason cover a pesticide they are later found to have on their product, that could present the need for a recall if Health Canada or another entity were to somehow to detect it using a different method.”

Health Canada determined both of those recalls to be Type III recalls. Both companies said they are cooperating fully with the regulatory body. By embracing the proposed new cannabis testing accreditation standard, Health Canada could remedy the testing methodology discrepancies and require a greater level of transparency.

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PA Cannabis Banking Committee Announces Formation

The Hoban Law Group announced today the formation of a committee to address banking access issues for the Pennsylvania cannabis market. Steve Schain, Esq., nationally recognized consumer finance litigation, banking law and cannabis law expert practicing with national cannabis law firm Hoban Law Group, is the committee’s spokesman and chair.

Steve Schain, Esq. practicing at Hoban law Group and chairperson of the committee.
Steve Schain, Esq. chair and spokesperson of the committee.

Limited access to banking is an ongoing issue plaguing cannabis businesses due to its federally illegal status. According to Steve Schain, cannabis businesses across the country are forced to pay their vendors, utility bills, payroll, taxes and insurance in cash. “At any time, a dispensary or cultivation operation could have up to $200,000 in cash on site- not having a place to bank opens opportunities for criminal activity,” says Schain. It also presents operational issues for business owners like record keeping or even personal bank accounts getting shut down.

“All of those issues could mean less jobs, less economic activity and less tax revenue for the state,” says Schain. “Fully compliant operations should not have to deal with this.”

Schain formed the committee for a number of reasons, including “Setting the table and starting a dialogue. We want this to be scalable. In the past, the great flaws in banking efforts for cannabis were a lack of cohesion and operating credibility- we hope to approach it from a multi-disciplinary angle and change that,” says Schain.

State Senator Daylin Leach introduced the bill
State Senator Daylin Leach

The committee’s members include three PA politicians: Daylin Leach, State Senator of the 17th District, who introduced the bill that legalized medical cannabis in Pennsylvania, Derek Green, Philadelphia City Councilman and Mary Jo Daley, Representative of the 148th District. Tom Fleming, former assistant director of the Office of Compliance at the Treasury Department’s Financial Crimes Enforcement Network, is also a member of the committee.

A number of committee members are actively involved in the legal cannabis industry and cannabis banking initiatives. Sundie Seefried, a member of the committee, is the chief executive officer of Partner Colorado Credit Union, which is

Lindy Snider, advisor at Greenhouse Ventures and KIND Financial
Lindy Snider, advisor at Greenhouse Ventures and KIND Financial

currently handling over half of Colorado’s estimated billion-dollar cannabis banking market, according to Schain. Lindy Snider, founder and chief executive officer of LindiSkin, advisory board member of KIND Financial and Greenhouse Ventures, is also listed as a member of the committee.

“According to the treasury department, only 301 financial institutions have reported banking cannabis cash,” says Schain. “Few federally chartered banks or credit unions will work with cannabis businesses, but two states-Washington and Maine- have banking regulators sensitive to cannabis banking and we have found 36 banks and credit unions providing financial services to cannabis enterprises.”

The goal with forming this committee is to change that and create an environment where banking for cannabis businesses is much easier. “We plan on drafting a white paper with best practices on compliant and profitable banking on behalf of cannabis-related businesses and financial institutions,” says Schain.

Working from a banker’s perspective is the key here, says Schain. They want to create a working, compliant and profitable system for banks to do business with cannabis cash. One of the problems in the meantime is the high-risk nature of dealing with cannabis companies, leading to an inability to get insurance on those accounts. In the eyes of the federal government currently, conducting cannabis-related transactions may be deemed money laundering and highly illegal. “The real issue is with the federal government and I strongly suspect this is not an issue at the top of the Trump White House agenda.”

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