The Food and Drug Administration is a government agency that uses scientific principals and tools to determine if food items are safe from harmful substances, including human pathogens.  The FDA funds and publishes up to date, relevant, and cutting-edge research investigating microbiology, genomics, toxicology, and chemistry.  This research is geared towards equating the myriad of varying processes and environments that food items and dietary supplements are produced within.  From a biological standpoint, three main bacterial pathogenic genus/species of concern are Escherichia coli, Salmonella spp., and Listeria spp.  Two out of these three types of bacteria have been regularly included within regulated cannabis biological adulteration testing across multiple states and countries.  The third, Listeria spp. which is arguably one of the most resilient to abiotic stress, has not been addressed as widely as the first two types of bacteria.


Bacterial Pathogen – Escherichia coli

The most infamous serotype of pathogenic E. coli is O157:H7, but there are other types that can make consumers sick.  These nasty bugs are transmitted via a fecal to oral route, meaning that they are present in the intestines of animals, including humans.  Contact with excreted material that harbors these germs or contaminated water sources, will result in transmission of E. coli cells, which may colonize cannabis.  This germ is widely associated with beef, however, raw produce that has not been processed via a heat-kill step has been identified as a vehicle for E. coli transmission.  E. coli can be controlled for with a stringent hand washing policy, QC of any organic fertilizers, treated water, and zero animal contact with plants, including instruments that have been in contact with animals.  Vegetative cells can be eradicated with an appropriately monitored dry step, but this will not remove any DNA evidence left behind which can insinuate unsanitary processing conditions. For more information on how drying to an appropriate level of water activity fits into a HACCP program, see this post.


Bacterial Pathogen – Salmonella spp.

According to the FDA’s “Big Bad Bug” book, while Salmonella has traditionally been associated with animal products, there has been a spike in Salmonella outbreaks from produce and ready-to-eat food items.  This is partially owed to the ability of this germ to persist in a dry environment with high plant metabolite content, such as spices.  Salmonella is also transmitted via fecal oral route and there are serotypes that can be found in contaminated water supplies.  Controlling Salmonella is similar to controlling E. coli within a production environment.  Proper hand-washing, QC of raw materials used within the production of cannabis flower, treating the water, and no contact with animals or instruments that have come in contact with animals, is sufficient to control for bacterial pathogen contamination, including Salmonella contamination in most cases.


Bacterial Pathogen – Listeria spp. 

What makes Listeria unique is that serotypes of this genus have the ability to survive in salty environments and grow at temperatures as low as 1° C.  While a majority of recorded outbreaks of this group of bacteria are linked to processed animal products, raw produce can harbor this bacterium as well, along with finished processed food items, such as ice cream.  Like Salmonella, Listeria is a hardy germ, it has been recorded that the same isolates have been isolated from the same production facility over a 12-year span in one case.  There have been instances where the FDA has put a facility on notice or completely suspended facilities that could not control Listeria spp. emergence on the production site, asserting that the environment presented a high level of risk to consumers of products processed within the facility.  Processors must be very diligent in monitoring for this type of bacteria and ensuring that it does not contaminate high traffic areas within a facility or is not already present within a facility to be purchased, as it is particularly difficult to eradicate.  Environmental swab assays can be of major help in finding unwanted microbial species within a cultivation environment so that the area may be thoroughly sanitized and re-swabbed to ensure complete eradication.


Minimizing Risks of Exposure to Bacterial Pathogens


One of the best ways to minimize risks of pathogenic contamination within a supply chain, is to establish an employee hygiene policy that outlines proper hand washing technique, glove use, and reminds employees to stay home when feeling under the weather.  Another way to minimize risk of contamination, is to design the facility to inhibit instances of cross contamination especially where there are raw plant or animal items present within or near the facility.  Facility buildout can be a major boon not only to flow and efficiency of production processing, but also mitigation of biological and chemical cross-contamination.  It is always advisable plan a facility around a process prior to physically building it out, in order to ensure optimal production flow.


Finally, keep in mind that animals such as cows and horses that produce waste that is processed into fertilizer may be infected with E. coli or other pathogens.  Quality checking these items prior to widespread application onto agricultural goods that will be consumed by humans is a fantastic way to ensure that the supply chain is guarded against biological threats.


Contact Us.

Orion GMP Solutions is a Pharmaceutical Engineering Firm based out of Denver Colorado.  We specialize in the implementation and auditing cGMPs for GMP Cannabis Manufacturers.  If you would like to get more information, please send us an email at

This content was written and sponsored by Orion GMP Solutions.

Hazard Analysis and Critical Control Points.

Hazard Analysis and Critical Control Point (HACCP) program have scientifically established critical limits.  The Codex Alimentarius as well as the National Advisor Committee on Microbiological Criteria of Food both recognize that this systematic approach to food safety consists of three aspects: identification, evaluation, and control.  The aim of an effective HACCP program is to identify points within a process that are essential to producing a safe, high quality product.

Closely monitoring CCPs will ensure that tough decisions about recalls never happen or happens on minimal occasion.  Recalls may occur due to product adulteration or a product being improperly formulated and therefore, still adulterated.  Recall associated risks are mitigated purposefully and methodically when a process has designated points where data is collected and recorded which indicates that action needs to be taken to avoid adulterating a product.  An effective HACCP program is especially critical for high throughput or continuous production lines, batch production lines with high risk for improper compounding or formulation, and batch processes producing end products that are easy to contaminate.  It is interesting to note that the international standard for Food Safety Management System, known as ISO 22000, combines HACCP and ISO 9001:2000 along with pre-requisite programs that GMPs, QMS, and other related programs into a thorough and comprehensive management system.  This addresses facilities from farm to fork.

In 2011, President Obama signed into effect the Food Safety and Modernization Act.  This new legislation shifted the focus of food safety from a responsive one to a preventative and risk-based approach.  FSMA mandated the development of HACCP programs for food producers, beverage producers, farms, and holding points for agricultural goods.  The primary aim is to prevent food-borne illness.  A second aim is to protect the food supply from both intentional and unintentional bioterrorism.

Why do I need a Cannabis HACCP program?

Identifying CCPs, establishing critical limits for CCPs, monitoring CCPs, and record keeping is valuable because it provides additional details about each batch that is produced.  Holding critical control points within a designated range contributes to consistency of product quality.  Scaling up an operation and maintaining product quality and compliance is difficult if processes are not standard and validated with state or federal guidelines intentionally addressed within SOPs and GMPs.  Compiling the recorded data from monitoring CCPs and other critical steps within an SOP into a batch record will prove that quality between batches remains the same.

Developing a strong, thorough, and customized Cannabis HACCP program provides control over a production line, this control is fed by insight into the process on a mostly continuous basis.  Cannabis HACCP programs also establish corrective actions to follow prior to instances where CCPs fall out of their established critical limits.  Having corrective actions already established makes production much smoother, minor issues that can potentially become halts in production flow or decrease end product quality, cease to be large headaches costing hours upon hours of meeting time and back and forth conversations concerning what to do.  Instead, correcting a CCP becomes yet another procedure that is already established and the staff can be trained to handle in a semi-autonomous manner.

Water Activity in Cannabis.

Water activity is the ratio of water vapor pressure in matrix over the vapor pressure of pure water at the same temperature.

It is a measure of the “free water” within a matrix.  Cannabis flowers should be dried to a water activity level less than Aw=.65, if it is not, spoilage microbes can grow on flowers during the cure and give them an undesirable look and smell.  It can possibly even make patients sick and probably will not pass visual inspection by a regulated cannabis lab.

Water Activity’s Critical Limit is AW=.65.

“When we get our flower from harvest, we have to think about the drying and curing process, where mold and bacteria can spoil our harvest,” said Dr. Markus Roggen, Co-Chair of the Scientific Advisory Committee of NCIA and Vice President of Extraction at OutCo.  It has been scientifically proven that decreasing water activity inhibits spoilage microbe growth.  Therefore, water activity should have a value based critical limit that is monitored and logged at multiple points between the initial harvest, the dry process, curing/aging and packaging for distribution.  The critical limit for drying Cannabis flowers is Aw of .65.  An internal standard may be less than this value.  This limit, again, was established to stop growth of bacteria and mold on Cannabis, especially flowers that are intended for combustion.  Control of any critical control point must be considered when engineering a manufacturing process, especially a critical control point that can easily fluctuate and that is entirely dependent upon environmental factors.  Read about the Cannabis HACCP implementation for monitoring water activity that Dr. Roggen completed here.

Mycotoxin Production within Cannabis Batches with Aw>.65.

Too much free water within the cannabis matrix can also allow for metabolizing of secondary metabolites from mold and fungi that may germinate in an environment above Aw=.65.  These metabolites include types of mycotoxin that are not allowed to be present within cannabis matrix intended for any retail or sometimes even further refinement.  Extraction optimization experimentation may reveal an optimal moisture content range, nevertheless, flower water activity should still fall below Aw=.65 if it is going to be stored.  Mycotoxins have been detected within cannabis extract, therefore, flowers with confirmed presence of Aspergillus mycotoxin producing species and testing positive for mycotoxin may not be allowed to be processed into extract and depending on the amount cannot go to market.  Monitoring water activity can help prevent this from occurring.

There are many variables that contribute to variance of product quality within batches of that product.  Identifying critical control points will ensure, at minimum, anything that can be hazardous to human health is monitored and there is assurance that no adulterating or contaminating substances are present.  Limits are established based on solid scientific research often funded by regulating bodies and completed by universities and public health agencies.  The limits should be monitored, and a system established for supervising large scale production environments.


Contact Us.

Orion GMP Solutions is a Pharmaceutical Engineering Firm based out of Denver Colorado.  We specialize in the implementation and auditing cGMPs for GMP Cannabis Manufacturers.  If you would like to get more information, please send us an email at

This content was written and sponsored by Orion GMP Solutions.