Tag Archives: food safety

November 4, 2015

The Role of 3rd Party Accreditation in Cannabis Safety

By Roger Brauninger

Living in a world of ever-increasing interdependence and an era of limited state government, financial and human resources, it is imperative that those charged with protecting the health and safety of patients and users of medical and recreational cannabis products leverage what private sector institutions and existing frameworks already offer in setting up quality standards for laboratory testing operations. That this moment arrives now – at a point where state governments are being tasked with undertaking the most significant change in the regulation of this substance whilst the federal government appears unwilling to play a substantial role – makes this partnership both inevitable and absolutely necessary.

Accreditation is an internationally accepted conformity assessment tool for ensuring laboratory competence and confidence in the accuracy and reliability test data. The accreditation infrastructure is well-established through accreditation bodies (ABs) and the Mutual Recognition Arrangement (MRA) of the International Laboratory Accreditation Cooperation (ILAC), supported by regional cooperative arrangements, including those of the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and the Inter-American Accreditation Cooperation (IAAC). ILAC functions as a forum for harmonization of laboratory accreditation procedures and policies, thus reducing technical barriers to trade and promoting laboratory accreditation as a mechanism for establishing confidence in testing facilities. ILAC MRA signatory ABs are recognized, through a rigorous peer evaluation process, as competent to accredit testing organizations. All signatory ABs must meet the requirements of ISO/IEC 17011 and use ISO/IEC 17025 as the basis for accreditation of laboratories. In turn, under the ILAC MRA and the regional co-operations, competent laboratories are recognized globally, thus facilitating acceptance of the test results that accompany goods across international borders.

In other areas, such as the food supply and energy, both state and federal government have been an active participant in accreditation activities. According to The Administrative Conference of the United States in its Agency Use of Third-Party Programs to Assess Regulatory Compliance*, “…agencies in diverse areas of regulation have developed third-party programs to assess whether regulated entities are in compliance with regulatory standards and other requirements. Through these programs, third parties are charged with assessing the safety of imported food… Third parties also ensure that products labeled as organic and energy-efficient meet applicable federal standards. In these regulatory third-party programs, regulated entities generally contract with third parties to carry out product testing and other regulatory compliance assessment activities in the place of regulatory agencies. Regulatory agencies take on new roles in coordinating and overseeing these third-party actors.” While this reference largely deals with areas outside of cannabis regulation, it remains useful and relevant because of the manner in which cannabis products are used.

Traditionally, ABs have worked with regulators to establish specific technical requirements to supplement the ISO/IEC 17025 accreditation framework. In this partnership, the AB is responsible for executing the assessment and accreditation process but the regulator retains responsibility for the ultimate decisions on the acceptance of that organization’s accreditation. In the example of our food supply and its various sources, governmental recognition of accreditation bodies operating in accordance with international standards is much more practical than government agencies themselves accrediting the individual testing organizations or ABs. Thus the public/private partnership paradigm: To assess regulatory compliance a Regulatory Agency approves ABs that accredit organizations that assess whether Regulated Entities or Regulated Products are in conformity with a Regulatory Standard.*

In this example, all of the organizations are treated equally by the regulatory agency since they use the same recognition criteria for ABs and the same accreditation requirements in the assessment of conformity assessment bodies. This approach would also provide consistency at a point in time where many states are grappling with trying to find the best quality standard to use and which, to date, has resulted in many different standards being chosen or considered for implementation. This is especially true when one looks at the requirements put into place by the “early adopter” states. However, in those states that have entered this area more recently, it seems clear that the consensus is use of ISO/IEC 17025 as the most appropriate quality management standard for testing laboratories.

October 23, 2015

Cannabis Coaching & Compliance

Food Safety Training: A Story of Poo

By Maureen McNamara

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Cannabis Trainers: A Story of Poo

Are you an excellent hand washer?
Almost everyone answers this question with a big “YES!”

The reality? Researchers let us know that most people don’t wash their hands thoroughly or frequently. Especially men… sorry fellas!

I know, I understand that this sounds super basic. However, it is an integral part of ensuring that your business doesn’t contribute to any of the millions of food borne illnesses each year in the United States. According to the Center for Disease Control and Prevention, there are approximately 48 million cases of food borne illness, 128,000 hospitalizations and 3000 deaths resulting from food borne illness.

For us in the cannabis industry, many of our products are known as “ready to eat foods” or, foods that do not require heating prior to eating. This allows us to keep things a bit simpler for our customers and patients. The most prevalent foodborne illness is the norovirus, which is linked to ready to eat foods and poor personal hygiene factors.

Keep in mind that even though we [typically] are not working with high risk foods (think: poultry, fish, beef etc.), we may very likely be creating food for a high risk population (patients with compromised immune systems), and great personal hygiene is imperative.

Is your team using gloves or utensils to handle all ready to eat foods?
Do you wash hands prior to gloving?
Are hands being washed with at least 100*F water for 20 seconds?

One tool that I like to use in our food safety classes to illustrate the point that hand washing is typically done quickly and poorly is GloGerm. This highlights where the areas for improvement are for each person with hand washing.

I am often asked about hand sanitizer. For all you busy people out there… listen up! Hand sanitizer does NOT replace hand washing ever.
Seriously- never. Here is my analogy for you:
Hand sanitizer on dirty hands is like whipped cream on poop. You’re welcome for that mental image.

Frequent, thorough hand washing is essential to ensure that your team creates food safely and with integrity. The truth is, fecal contamination is a big deal. And although we may all claim that we are great hand washers, there is often room for improvement.

Ready to learn more? Join us for one of our ServSafe Food Handler courses that we customize to the specific needs of the cannabis industry.

www.CannabisTrainers.com

October 19, 2015

Manufacturing Edibles With Integrity

By Aaron G. Biros

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Without federal guidance on food products containing marijuana (a result of the plant remaining a Schedule I narcotic), state regulators and manufacturers are fighting to keep the market safe for consumers. Manufacturers of marijuana edibles are not only trying to ensure consumer safety, but are also attempting to advance industry and legalization efforts nationwide.

Recent investigations in Colorado revealed that certain marijuana edibles, along with some extracts, tested positive for illegal pesticides. Many cannabis businesses are looking to the industry leaders in edibles manufacturing for advice. Marijuana edibles are a food product, so they must first enlist standard food sanitation procedures and then comply with state regulations for cannabis to ensure safety. Some of the product consumers are patients with weakened immune systems, thus highlighting the need for consistent and accurate dosing in products.

Maureen McNamara, founder of Cannabis Trainers, recently sat on a panel with Bob Eschino, co-founder of incredibles and Krystal Kiathara, CEO of Yummi Karma at the Cannabis World Congress and Business Expo, hosted by the International Cannabis Association in Los Angeles. The panelists discussed the need for integrity in manufacturing edibles.

The regulations are not quite there yet and states are adjusting legislation to help promote safety. “It is our job to educate legislators and make sure that our products are accurate and consistent,” said Bob Eschino, co-founder of incredibles.

Maureen McNamara says there are four criteria for producing edibles with integrity: Compliance, training, research and product testing.

“Starting with the foundation of compliance, utilizing strategies involving HACCP plans and FDA guidance, the first pillar is training,” says McNamara. “Food safety training is essential to ensure your team is aware and making a wholesome product.” She also stressed the importance of shelf-life testing and R&D before the product goes onto shelves.

Because food laboratories often will not test products that contain cannabis, many companies work with food scientists and in-house testing. “Moving forward, we need to ensure that we achieve consistent results from the various testing labs,” said McNamara. “But to make edibles with integrity, laboratory testing is paramount.”

July 28, 2015

Marijuana Edibles: Update on a Rapidly Developing Market

By Aaron G. Biros

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A lot has changed since last year’s article, “Marijuana Edibles: A Regulatory Nightmare.” Marijuana has since catapulted into mainstream thinking via activism, state decriminalization, and medical reforms while investors and banks are beginning to trust the market more, further legitimizing the nascent industry. According to an article from the Washington Post, Colorado’s legal marijuana industry reached $700 million in 2014 and is expected to grow to $1 billion by 2016.

Innovators are beginning to analyze trends on a national level, looking toward federal rescheduling of the drug as a catalyst for more state reforms and wider legalization measures. Federal legalization is in the back of many minds, as the introduction of pivotal state and federal legislative reforms promises more access to banking services, medical research, and more state independence.

While a black market mentality remains prevalent, widespread state reforms, increased venture capital investment, and further legitimization of an industry with less barriers of entry have fostered a perceived reduction in risk. States like Oregon, Washington, and Colorado that have already legalized marijuana for recreational and medical sales are beginning to implement strict packaging rules, requirements for traceability, QA programs, testing and laboratory monitoring requirements, and other regulations that would suggest FDA oversight down the road.

marijuana buds drying in racks biotrackthc — Dried marijuana buds curing with RFID tags as part of the traceability system of BiotrackTHC

State regulatory bodies such as the Colorado Marijuana Enforcement Division (MED) have matured and expanded their oversight to include certifications and requirements for lab testing and analysis. Marijuana testing facilities can now be certified by the MED to test for residual solvents, poisons or toxins, harmful chemicals, dangerous molds, mildew or filth, harmful microbials such as E. coli or Salmonella, pesticides, and THC levels and Cannabinoid potency.

According to an article from theCannabist.com, edible marijuana took 45% of the market share in 2014 and continues to grow, proving that food manufacturers and processors will gain a bigger share of the market.

BioTrackTHC develops a seed-to-sale traceability system that is the state-mandated reporting system used by any business that touches the plant in compliance with Washington’s i502 regulations (The company also won the contract bid for New Mexico’s and New York’s state-run traceability systems). “From day one, all retail products under i502, including infused edibles, must have laboratory-submitted passing test results and data in the traceability system before it can be unlocked for shipment to retailers,” says Patrick Vo, CEO of BioTrackTHC.

Regulations, especially those addressing traceability, are crucial for advancing the industry and fighting the black market, performing recalls, and improving product quality and safety. Vo adds, “As more states adopt a centralized traceability system, food safety will improve as we see the industry grow.”

“Most of the marijuana edibles producers we advise are working comfortably within their state health department regulations versus a year ago when they were struggling to implement routine compliance,” says Stephen Goldner, CEO of Regulatory Affairs Associates. “But there is a long way to go to make this new marketplace meet the standards routinely met by US food producers in other markets such as nutritional supplements and medical foods.”

Many edible producers are sadly mistaken to ignore FDA labeling and production regulations just because the producer only ships within their own state, according to Goldner. “Whenever FDA has found label or food safety violations of products, whether they are food, drugs or any other product, it has always acted quickly to seize the product, inspect the producer and insist that violative labeling or production practices be remedied,” he says, adding that it won’t be surprising to see FDA start to “seize marijuana-infused food products that make drug claims, especially from the leading current producers” as a way for the agency to insert itself into the inspection and compliance process. “These companies need to have FDA food GMP’s solidly in place and properly documented,” says Goldner.

“Those who have experienced the most consistent and long term success in this industry are those who play above board, those who take the extra effort and make the investment in effort, time, and money to treat their business as if it was already federally legal and had to adhere to standards that other industries must follow,” says Vo. He agrees with the view held by many that long term planning is vital in this industry. “Those who have implemented best practices, QA programs, and traceability software will succeed in the long run, and the bad actors will eventually, by their own poor practices, be filtered out by regulatory and market forces.”

In the near future, the industry will look to other states in regulatory experiments on opposite sides of the spectrum. “New York, which legalized medical marijuana in 2014, is handing out 5 licenses to operate 4 dispensaries each, and allowing licensees to have a grow facility to supply their respective dispensaries. The Commissioner of the New York State Department of Health will have authority on licensing, testing, and medical requirements for patients seeking treatment with medical marijuana,” says R. David Marquez, who operates a Long Island law firm focusing on the cannabis industry.

New York is implementing very strict rules regarding cultivating and processing the plant. California, on the other side of the spectrum, already operates a somewhat loosely regulated medical marijuana market and has been doing so since 1996. The bill to legalize marijuana recreationally in the state is widely expected to pass vote and be implemented in 2016. This would open up an enormous market potential and contribute to the growth of the industry on a national level.

Because marijuana edibles are theoretically both a food and a drug, it is only appropriate that the FDA should look to regulate the industry in the future. In the meantime “Those who have invested the time and money in staying compliant now will be far ahead of the game tomorrow,” says Patrick Vo, who is looking toward federal legalization.

It seems that manufacturers and processors at the forefront of quality and safety testing will succeed in the long run.

Footnote: This is a regulatory update on the cannabis industry with an emphasis on edible marijuana. CannabisIndustryJournal.com, the newest publication, will be launched in September of this year. CannabisIndustryJournal.com will educate the marketplace covering news, technology, business trends, safety, quality, and the regulatory environment, aiding in the advancement of an informed and safe market for the global cannabis industry. Stay tuned for more!