Tag Archives: food

California Manufacturing Regulations: What You Need To Know

By Aaron G. Biros
No Comments

In late November, California released their proposed emergency regulations for the cannabis industry, ahead of the full 2018 medical and adult use legalization for the state. We highlighted some of the key takeaways from the California Bureau of Cannabis Control’s regulations for the entire industry earlier. Now, we are going to take a look at the California Department of Public Health (CDPH) cannabis manufacturing regulations.

According to the summary published by the CDPH, business can have an A-type license (for products sold on the adult use market) and an M-type license (products sold on the medical market). The four license types in extraction are as follows:

  • Type 7: Extraction using volatile solvents (butane, hexane, pentane)
  • Type 6: Extraction using a non-volatile solvent or mechanical method
    (food-grade butter, oil, water, ethanol, or carbon dioxide)
  • Type N: Infusions (using pre-extracted oils to create edibles, beverages,
  • capsules, vape cartridges, tinctures or topicals)
  • Type P: Packaging and labeling only

As we discussed in out initial breakdown of the overall rules, California’s dual licensing system means applicants must get local approval before getting a state license to operate.

The rules dictate a close-loop system certified by a California-licensed engineer when using carbon dioxide or a volatile solvent in extraction. They require 99% purity for hydrocarbon solvents. Local fire code officials must certify all extraction facilities.

In the realm of edibles, much like the rule that Colorado recently implemented, infused products cannot be shaped like a human, animal, insect, or fruit. No more than 10mg of THC per serving and 100mg of THC per package is allowed in infused products, with the exception of tinctures, capsules or topicals that are limited to 1,000 mg of THC for the adult use market and 2,000 mg in the medical market. This is a rule very similar to what we have seen Washington, Oregon and Colorado implement.

On a somewhat interesting note, no cannabis infused products can contain nicotine, caffeine or alcohol. California already has brewers and winemakers using cannabis in beer and wine, so it will be interesting to see how this rule might change, if at all.

CA Universal Symbol (JPG)

The rules for packaging and labeling are indicative of a major push for product safety, disclosure and differentiating cannabis products from other foods. Packaging must be opaque, cannot resemble other foods packaged, not attractive to children, tamper-evident, re-sealable if it has multiple servings and child-resistant. The label has to include nutrition facts, a full ingredient list and the universal symbol, demonstrating that it contains cannabis in it. “Statute requires that labels not be attractive to individuals under age 21 and include mandated warning statements and the amount of THC content,” reads the summary. Also, manufacturers cannot call their product a candy.

Foods that require refrigeration and any potentially hazardous food, like meat and seafood, cannot be used in cannabis product manufacturing. They do allow juice and dried meat and perishable ingredients like milk and eggs as long as the final product is up to standards. This will seemingly allow for baked goods to be sold, as long as they are packaged prior to distribution.

Perhaps the most interesting of the proposed rules are requiring written standard operating procedures (SOPs) and following good manufacturing practices (GMPs). Per the new rules, the state will require manufacturers to have written SOPs for waste disposal, inventory and quality control, transportation and security.

Donavan Bennett, co-founder and CEO of the Cannabis Quality Group

According to Donavan Bennett, co-founder and chief executive officer of the Cannabis Quality Group, California is taking a page from the manufacturing and life science industry by requiring SOPs. “The purpose of an SOP is straightforward: to ensure that essential job tasks are performed correctly, consistently, and in conformance with internally approved procedures,” says Bennett. “Without having robust SOPs, how can department managers ensure their employees are trained effectively? Or, how will these department managers know their harvest is consistently being grown? No matter the employee or location.” California requiring written SOPs can potentially help a large number of cannabis businesses improve their operations. “SOPs set the tempo and standard for your organization,” says Bennett. “Without effective training and continuous improvement of SOPs, operators are losing efficiency and their likelihood of having a recall is greater.”

Bennett also says GMPs, now required by the state, can help companies keep track of their sanitation and cleanliness overall. “GMPs address a wide range of production activities, including raw material, sanitation and cleanliness of the premises, and facility design,” says Bennett. “Auditing internal and supplier GMPs should be conducted to ensure any deficiencies are identified and addressed. The company is responsible for the whole process and products, even for the used and unused products which are produced by others.” Bennett recommends auditing your suppliers at least twice annually, checking their GMPs and quality of raw materials, such as cannabis flower or trim prior to extraction.

“These regulations are only the beginning,” says Bennett. “As the consumer becomes more educated on quality cannabis and as more states come online who derives a significant amount of their revenue from the manufacturing and/or life science industries (e.g. New Jersey), regulations like these will become the norm.” Bennett’s Cannabis Quality Group is a provider of cloud quality management software for the cannabis industry.

“Think about it this way: Anything you eat today or any medicine you should take today, is following set and stringent SOPs and GMPs to ensure you are safe and consuming the highest quality product. Why should the cannabis industry be any different?”

Cannabis, Soil Science and Sustainability Part II: The ‘Roots’ of Sustainable Cultivation

By Drew Plebani
No Comments

The modern chemical agricultural approach is based on the assumption that chemical science has discovered all facets of plant nutritional requirements. It is clear that the traditional NPK approach to plant/soil systems has its limitations, both from an ecological perspective and in terms of its ability to create nutrient-dense food.

Soil and plant systems have existed together for millions of years and have evolved the capacity to coexist in a way that is mutually beneficial. Plants have been fed and evolved with these biological and environmental stimuli over millennia.

Looking to the geologic record for evidence, we can see that it shows that invertebrates, fungi and early vascular plants appeared on land roughly 400 million years ago, the first seed bearing plants about 360 million years ago and the first flowering plants 130 million years ago. What does this mean? The soil food web has been in existence for millions of years and significant evidence exists that plants and soil biology have co-evolved together for millennia.

geologictimescale
The Geologic Time Scale

Between mineral rich soils and the soil food web, this natural system has been able to create and provide significant plant available nutrients, certainly enough to facilitate the successful life cycle of many species. Clearly from an evolutionary context this system has been able to facilitate maximum genetic expression and the ongoing evolution of biologic species.

In the not-too-distant past, agricultural fertilization practices were based on the existence of a diversity of plant and animal byproducts, animal manures, green manures, etc. These were reintroduced to the system and combined with the appropriate biologic populations, resulting in the decomposition of these organic material inputs and their conversion into plant-available nutrients.

An overview of traditional farming practices provides substantial evidence that farming has been occurring for at least 10,000 years. Why, with such a long history of symbiotic interactions between biologic species, are we now witnessing the mass deterioration of arable land, and agricultural commodities containing lower nutritional value?

Mycelium, the vegetative part of a fungus bacteria colony, seen breaking through rock.
Together, indigenous mycelium and plant roots seen turning rock into soil

An interesting common question among the conventional farming community, when the topic of organics or sustainability comes up, is “how are you going to feed the world?” Well that goal certainly will not be well served by the development of shelf stable, but low nutrient-dense foods. A greater volume of low nutrient-value foods certainly does not seem like a winning approach. Supporting agricultural systems that encourage the development of sustainable systems via locally produced, nutrient-dense food is a good start.

And the same holds true for cannabis. In fact, the parallels between the production of high quality nutrient dense foods and high quality cannabis products are quite significant.

Nutrient density in crops results from balanced, mineral rich soils, and a diversity of organic materials and biologic life, these elements provide the framework to facilitate the creation of a highly functional, biologic nutrient cycling system. A highly functional soil system results in more nutrient-dense crops, which contain measurably larger quantities of different phytonutrients, vitamins, minerals, flavonoids, and terpenes as compared to a system operating at a lower level of biologic efficiency.

commercialcultivator
Nutrient-dense cannabis flowers

Benefits that have been observed from nutrient-dense crops are: more pest and disease resistance in the vegetative and fruiting stages, greater yield, more complex and intense flavors and a longer shelf life.

Ultimately advancement in any cultivation system means finding and defining limiting factors in the given system. The objective should be ensuring the maximum biologic vitality of the components of said system and its outputs. Practically speaking, in order to enable the full genetic potential of biologic species, this means identifying and working toward the removal of limiting factors. Minimizing or entirely alleviating the factors that limit maximum plant growth will undoubtedly net positive gains and must be an integral component to any sustainable cultivation strategy.

commcultivator3
Cannabis growing in a polyculture

The Earth has provided us with a highly successful, multi-million-year-old biologic system, capable of providing abundant plant available nutrients on demand, a dynamic which must be integral to appropriate and intelligent systems design.

In the pursuit of sustainability, perhaps it is time to return to our roots and begin to pursue dynamics that are mutually beneficial to all forms of biologic life.

In the next article, we will take a step back from viewing sustainability through the lens of soil and plant specific cultivation methodologies, and focus on the broader context of sustainability in cultivation systems. We will look at sustainability from the context of operational efficiency, and provide a case study from a 400-light commercial indoor cannabis operation. The case study will provide evidence that, in order to achieve higher levels of sustainability, both cultivation strategies and operational efficiency must be factored into the equation. As we will see, true sustainability is created through the efficient design, incorporation, use and management of system elements, all of which can, when appropriately designed, work together to create improved efficiency for the system.

pleabnicrop
Soapbox

Cannabis, Soil Science and Sustainability

By Drew Plebani
5 Comments
pleabnicrop

The average commercial cannabis cultivator seems to be following the modern agricultural paradigm. That model is based on questionable and, one might say, ineffective soil systems management.

In the high-yield cannabis world, amidst decades of prohibition, following the lead of the modern agricultural model has resulted in the adoption of cultural practices that go something like this: Use and destroy the soil, then dispose of it once it is rendered lifeless and useless due to repeated heavy applications of chemical fertilizers, pesticides, and other poisons.

commercialcultivator
(Left) unimproved site soil next to (right) improved site soil. Notice the root mass developing on the right

Certainly conventional agricultural food production and the soil management systems underpinning them are faltering, evidenced by soil systems deteriorating many times faster than they are being improved. This qualifies as a failure in my book.

What will be the fate of profit margins, sustainability and medicine in the cannabis industry if we continue to follow blindly in the footsteps of chemical agriculture? Perhaps it is time to turn over a new leaf.

A little context for the discussion: scientists say the Earth has lost a third of arable land in the past 40 years, and some say soil erosion is the number one challenge facing the world today. Why? How?

Well…world agricultural production accounts for about three-quarters of the soil erosion worldwide. This steep decline in arable soil is occurring during a time when the world’s demand for food is rapidly increasing. It is estimated that the world will need to grow 50% more food by 2050, and it is important to note that, the total volume of food necessary, remains relative to the nutrient density of the food.

Time for a radical solution, and cannabis can lead the way.

Currently, cannabis is the most profitable crop per land area and very likely the most resource-consumptive crop grown (due to the current legal and regulatory climate and thus limited supply vs. demand).

As the cannabis industry continues to grow, now more than ever we have the opportunity, and I believe the responsibility, to cultivate in ecologically mindful ways, improve the end product and it’s positive impacts, increase both short-term and long-term profits, decrease or eliminate waste and lower the carbon footprint of cannabis cultivation operations.

commercialcultivator
A cover crop under trellis’ with cannabis plants

Most importantly, we have the opportunity to fund, implement and lead the way in research and development of sustainable, medical, phytonutrient-dense crop production methodologies.

Only by implementing more rigorous scientific methods to cannabis cultivation can we hope to provide truly meaningful improvements in and contributions to the fields of agriculture, science, medicine and human health.

While dumpsters of potting soil continue to roll off to the landfill, complex health and human science and the cultivators truly engaged in science will continue to provide meaningful data regarding plant compounds and what factors influence the best outcome for the desired end product.

commercialcultivator
The same crop pictured above, now two weeks into flowering, using cover crops

I am willing to bet that what is best will not be coming from the business models employing antiquated, wasteful and destructive cultivation strategies, and that in due time these models will fade into distant memories.

This is the first in a series of articles, in which we will explore topics related to the pursuit of high yield, phytonutrient-dense “high brix” cannabis production.

The next article will provide a historical and geologic context to the cannabis plant, as viewed from the scope of soil biology and the progression of ecosystems and soil types, and how maximized genetic expression, through maximized soil and plant health influence the production of high quality cannabis.

DEA To Consider Rescheduling Cannabis, Could Mean Policy Shift

By Aaron G. Biros
No Comments

In a letter sent to lawmakers last week, the Drug Enforcement Agency (DEA) announced plans to make a decision on rescheduling cannabis by mid-2016. The announcement could represent the culmination of a shift in the federal government’s attitude toward cannabis legalization.Dea_color_logo

Currently, cannabis is a Schedule I narcotic, meaning the government views it as lacking medical benefits and have a high potential for abuse. The rescheduling of cannabis has the potential to open the floodgates for research, including much needed clinical trials.

Derek Peterson, chief executive officer at Terra Tech, a cannabis-focused agriculture company, believes this bodes well for the growth potential of the cannabis industry. “From the perspective of quality and safety standards, I find it unlikely that rescheduling it would negatively impact the degree to which cannabis is examined,” says Peterson. “It’s unnecessarily high position on the DEA drug schedule does nothing but limit the industry’s potential for growth, stall any meaningful pharmaceutical testing and increase law enforcement’s ability to prosecute non-violent drug offenders,” adds Peterson.

The rescheduling could also potentially allow for the prescribing of cannabis for patients. Stephen Goldner, founder of Pinnacle Labs and president of Regulatory Affairs Associates, is hopeful this will lead to a greater shift in public attitude towards cannabis. “The DEA’s announcement is a clear message to all States and possibly even to United Nations policy makers: even the DEA is willing to reconsider cannabis,” says Goldner. “Since the DEA is reconsidering cannabis, state politicians and local police departments can also be flexible and move away from prohibition, towards the regulation of cannabis.”

The rescheduling of cannabis could have a tremendous impact on the growth of the cannabis industry, including more clinical trials, medical research and physician participation. It could also open the door for more federal agency involvement, as the Schedule I status inhibits any EPA research on cannabis pesticide use or FDA guidance on food and drug good manufacturing practices. When reached for comment, the FDA’s press office said they could not speculate on any involvement in the matter.

Are You Ready For an Inspection?

By Maureen McNamara, Lezli Engelking
1 Comment

Would you be proud to have your customers and patients tour your production facility? When health inspectors or enforcement personnel arrive at your location is there sense of panic or pride?

When you have detailed systems in place, inspections should be informative, not stressful. Keep in mind that in the cannabis industry, products are often created for patients. Patients may have a compromised immune system and thus are more susceptible to food borne illnesses, pesticides and other contaminants.

Are you and your team doing everything you can to produce a wholesome and safe product?

According to the World Health Organization, Good Manufacturing Process (GMP) “is a system for ensuring that products are consistently produced according to quality standards.”

GMP is the proactive part of quality assurance. It is designed to minimize the risks involved in all steps of the manufacturing process. A basic tenant of GMP is that quality cannot be tested into a product. It must be built into each batch of product during all stages of the manufacturing process.

GMPs involve much more than most people think. A common misconception is that GMP only covers the process of manufacturing itself. GMPs actually cover all aspects of the production process:

  • Materials
  • Premises
  • Equipment
  • Storage
  • Record Keeping
  • Staff Training to Hygiene
  • How Complaints Are Handled

GMP & The Cannabis Industry

In most industries, agencies that control licensing for the manufacture and sale of a product recommend GMPs, or guidelines to business owners. These guidelines provide minimum requirements that a manufacturer must meet to assure that products are of high quality and do not pose any risk to the consumer or public. The guidelines generally become the basis of regulation for that industry.

In the United States, the Food and Drug Administration (FDA) recommends guidelines for anything food, drug or pharmaceutical related.

Because cannabis still remains illegal at the federal level, none of the federal agencies that would normally develop good manufacturing guidelines have done so. This has left state lawmakers and business owners on their own to navigate this new and rapidly developing industry.

The Foundation of Cannabis Unified Standards (FOCUS) has developed standards with a mission to protect public health, consumer safety and safeguard the environment by promoting integrity in the cannabis industry.

The comprehensive implementation of cannabis specific good manufacturing practices, like the FOCUS standards, across all aspects of the industry will assist business owners and regulators alike, addressing quality proactively at every step in the process, which is critical to protecting consumer safety and public health – and the overall success of a nascent and divisive industry like cannabis.

The FOCUS standards are completing the final phase of development, a thirty-day public review and comment period before being released for use in the marketplace in June. These voluntary consensus-based standards are built on GMPs drawn from agriculture, food production, chemical management, OTCs, pharmaceuticals, and other relevant industries. In addition, the standards draw best practices from the cannabis industry, as well as those published in OSHA, FDA, FTC, CDC, ISO, code of federal regulations and various state-level cannabis regulations.

There are many aspects of creating and implementing GMPs. Here are three to be aware of:

  1. Get the facility design right from the start: It’s much easier to be GMP compliant if the design and construction of the facilities and equipment are right from the start. It is important to embody GMP principles and use GMPs to drive every decision. 
  1. Document what you do and do what you document: Having good procedures in place to ensure a controlled and consistent performance is an essential part of GMP. Procedures should be clear, concise, logical, and available to everyone.
  1. Keep good records: Keeping accurate records is an essential part of GMP. It helps convey that you are following procedures and demonstrates that processes are known and under control. If it’s not written down, it did not happen.

Standards and quality programs in any industry are dynamic by nature. Nothing is static. Standards must constantly be updated to reflect ever-changing market conditions. This is why it is so crucial that regulations are based on them.

To be a standard, there are certain core principals that must be present. However, the goal of a standard is to guide an industry without impeding or controlling it. This is why there is so much inherent value in implementing standards. They bring enough structure to help reduce costs and increase efficiency, but not so much control that individual nuances or creativity is affected.

It is much less expensive to be proactive. Recovering from a recall or contaminated product can not only be costly, it is a massive hit to the company’s reputation. It may take years for sales to recover, and for consumers to trust the product again. Where could you and your team enhance your standards and processes?

Cannabis Coaching & Compliance

What You Need to Know About Food Allergies

By Maureen McNamara
No Comments

I rolled up my sleeve and turned my hand palm up. The doctor placed a medieval looking torture device, 18 needles loaded with potential allergic venom right onto my little kid arm. Then, BAM – shot it right into me. Then we waited to see what, if anything, would happen. Would one of those spots react? Would we see some swelling? Where the hell was my lollipop? Hopefully we wouldn’t discover that I was allergic to sugar.

Okay, so maybe that description is a bit dramatic. I do hope that allergy testing protocol has improved over the decades.

Do you have allergies? Is there a certain time of year that makes you sneeze up a storm, your eyes water and you wonder when the pollen is going to ease up?

It is uncomfortable. And if you have or crossed paths with people that have a food allergy… it is way more than uncomfortable. It can be deadly.

In America alone, there are 15 million+ people with food allergies.

Here are the most common culprits in the world of food allergies:

  • Tree nuts
  • Peanuts
  • Soy
  • Wheat
  • Dairy
  • Milk
  • Eggs
  • Fish & shellfish

Be aware, even if these items are not an ingredient in what you are producing- cross contact (the transferring of allergens from one food to another food) can create reactions as well.

Here are a few of the mild symptoms:

  • Hives
  • Redness of the skin or around the eyes
  • Nausea or vomiting
  • Diarrhea
  • Stomach pain
  • Nasal congestion
  • Sneezing

Here are some of the severe allergic reactions:

  • Obstructive swelling of the lips, tongue, and/or throat
  • Trouble swallowing
  • Shortness of breath or wheezing
  • Drop in blood pressure (feeling faint, confused, weak, passing out)
  • Loss of consciousness
  • Death

Management and kitchen staff must be thoroughly trained regarding the dangers of food allergens and cross contact. Food safety training can help prevent your customers or patients from having a food-allergic reaction, which can lead to a medical emergency.

Here is a document, developed by the Food Allergy Research and Resource Program (FARRP) and the University of Nebraska, that shares details about how to create a manufacturing plan to ensure safe production with a focus on reducing potential allergic reactions.

In the cannabis industry, I know we are committed to contributing to people’s wellness. And when we produce infused products, ensuring that your patients receive a wholesome product is essential.

Here’s to your team increasing their knowledge, creating the best products and your thriving success with raving (hiveless) fans!

Steve Goldner
Marijuana Matters

Food Processing & Cannabis Policy

By Stephen Goldner J.D.
No Comments
Steve Goldner

We have not seen food processing opportunities in the 45 years I’ve been in the industry like we are seeing in the cannabis food segment. There are still many legal, regulatory and policy misconceptions and this column is devoted to giving you some clarity. I hope this helps you make sensible business plans based on sound marketing opportunities.

It’s hard for many people to make the leap from thinking marijuana is illegal to knowing that food infused with marijuana is legal in 50% of the US, and quickly moving toward national legality. Any food processor that does not consider this opportunity to meet changing market dynamics risks losing a huge opportunity.

23 states, the District of Columbia and Guam now have comprehensive cannabis programs in place and many more are expected through Q4 of 2016. The voter approval, tax aspects and improved law enforcement profiles are highly favorable towards legalization and regulation. While marijuana itself can’t be shipped across state lines legally at this time, food-processing equipment is being sold, shipped, and installed every day of the week with no legal ramifications. The remaining problematic business aspects are rapidly moving through the solution phase, specifically labeling, tamper-evident and child resistant packaging, and payment methods.

Unlike other technology introductions, a mass market already exists and is clamoring for these food products. Therefore the ‘early movers’ are developing business relationships state by state to prepare food production lines that incorporate cannabis food production into cannabis processing companies. 

Essentially, any state that allows cannabis dispensaries to exist will require food-processing equipment. In addition, states like Michigan where I reside, there are over 200,000 medical marijuana licenses issued to individuals, and over 250 unlicensed dispensaries. Michigan is getting ready for dispensary licensing and food production. We should anticipate inquiries from companies applying for food production licenses from any and all states as they are carefully attuned to their local state rules.

You can always contact me at this publication by clicking here and I’ll do my best to answer you that day or visit my website, Regulatory Affairs Associates.

Jurisdictions with active cannabis food production in USA: Arizona, California, Colorado, Connecticut, Delaware, Washington, D.C, Guam, Illinois, Maine, Maryland, Massachusetts, Michigan [coming soon], Minnesota, New Hampshire, New Jersey, New Mexico, New York, Rhode Island, Vermont, Washington

The next few articles in this series will focus on making certain your food production equipment will meet cannabis food production regulatory standards, the unusual payment procedures in this new industry, and relationship building since many of the new companies and their advisors will be new to you. Plus you really want to know their expectations of you. 

Cannabis Coaching & Compliance

Food Safety Training: A Story of Poo

By Maureen McNamara
No Comments

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.

  1. Is your team using gloves or utensils to handle all ready to eat foods?

  2. Do you wash hands prior to gloving?

  3. 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