Tag Archives: compliance

SAFE Banking Act Included in COVID-19 Legislation

By Aaron G. Biros
2 Comments

UPDATE: Late in the evening on May 15, the House of Representatives passed the HEROES package, voting 208-199 (with 23 abstentions). The bill now now heads to the Senate where its fate is more uncertain. 


Earlier today, Speaker Nancy Pelosi debuted the latest piece of legislation to help Americans impacted by the coronavirus pandemic. The Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) is a large bill containing emergency supplemental appropriations more than 1,800 pages long.

On page 1,066, those in the cannabis industry will find a very exciting addition: the Secure and Fair Enforcement (SAFE) Banking Act. For the uninitiated, the SAFE Banking Act would ensure access to financial services for cannabis-related businesses and service providers.

Currently, federally regulated financial institutions face penalties for dealing with cannabis companies due to the Controlled Substances Act. The bill, if passed, would eliminate the possibility of any repercussions for doing business with cannabis companies.

The impact of this bill becoming law would be widespread and immediate for both the cannabis market and banks looking to invest in the cannabis industry. With banks given the green light to conduct business with the cannabis industry, there is no doubt that many financial institutions will rush to the opportunity. Cannabis businesses will benefit greatly, no longer having to deal with massive quantities of cash and gain access to things like loans, bank accounts and credit lines. Furthermore, cannabis companies will benefit from the rush of banks getting in the game, leading to a competitive and affordable banking market.

It is no secret that cannabis businesses have had a cash problem for decades now. Given the coronavirus pandemic, CDC guidelines dictate minimizing the handling of cash and encourage payment options like credit cards. Cannabis businesses dealing with large quantities of cash puts them, their employees, their customers and even regulators at risk.

Aaron Smith, executive director of NCIA

According to Aaron Smith, executive director of the National Cannabis Industry Association (NCIA), the cash problem is a serious, unnecessary health risk. “On behalf of the legal cannabis industry, we commend the congressional leadership for prioritizing public health and safety by including sensible cannabis banking policy in this legislation,” says Smith. “Our industry employs hundreds of thousands of Americans and has been deemed ‘essential’ in most states. It’s critically important that essential cannabis workers are not exposed to unnecessary health risks due to outdated federal banking regulations.”

In fact, it was the NCIA and a handful of other industry organizations that lobbied Congress last week to include language from the SAFE Banking Act in the HEROES Act, citing the known fact that cash can harbor coronavirus and other pathogens, along with the “personal proximity required by cash transactions as reasons for urgency in addition to the other safety and transparency concerns addressed by the legislation.”

The SAFE Banking Act was already approved by the House of Representatives. In September of 2019, the bill made a lot of progress through Congress, but stalled once it made it to the Senate Banking Committee.

The HEROES Act will be debated by the House of Representatives prior to a floor vote. If it passes the House, it moves to the Senate, which is about as far as it made it the last go around. However, because the banking reform is included in coronavirus relief legislation, there is a newborn sense of hope that the bill could be signed into law.

The Brand Marketing Byte

The Hottest Edibles Brands in the United States Right Now

By Cannabis Industry Journal Staff
1 Comment

The Brand Marketing Byte showcases highlights from Pioneer Intelligence’s Cannabis Brand Marketing Snapshots, featuring data-led case studies covering marketing and business development activities of U.S. licensed cannabis companies.

In this week’s Byte, we’re taking a look at the top edibles companies in the country. Using a scoring methodology that factors in a wide variety of data sets, Pioneer’s algorithm tracks brand awareness, audience growth and engagement. Using more than 80,000 relevant data points per week, they analyze business activity across social media, earned media and web-related activities.

For April 2020, here are the top 25 hottest U.S. edibles brands:

  1. Kiva Connections
  2. Wyld
  3. Tyson Ranch
  4. Wana Brands
  5. Serra
  6. STIIIZY
  7. 1906
  8. Kushy Punch
  9. Coda Signature
  10. Kush Queen
  11. PLUS
  12. Theory Wellness
  13. Incredibles
  14. Kikoko
  15. Dixie Elixirs
  16. Fairwinds
  17. Deep Roots Harvest
  18. Willie’s Reserve
  19. Chalice Farms
  20. Care By Design
  21. Beboe
  22. District Edibles
  23. Bhang
  24. Satori
  25. Betty’s Eddies

Kaycha Labs Named Designated Lab for Florida’s Hemp Program

By Cannabis Industry Journal Staff
No Comments

Last week, Kaycha Labs, a cannabis testing laboratory company based in Florida, announced that they have executed an agreement with the Florida Department of Agriculture & Consumer Services (FDACS) to be the first “Designated Compliance Laboratory” for the state of Florida’s new hemp program.

As part of the agreement, Kaycha Labs will be procuring samples for the mandatory compliance testing program, as well as providing the required potency analysis for the Division of Plant Industry (an office under the FDACS).

The USDA recently approved the hemp program under the FDACS, and with that comes a host of regulations that producers need to follow.

Florida’s program requires a “designated approved representative” to go out in the field and collect compliance samples for testing from hemp licensees. Those samples then get tested to ensure they have less than 0.3% THC, per state and federal requirements.

Cynthia Brewer, vice president of Kaycha Labs, says this new regulatory framework will help a lot of stakeholders. “I am thrilled that Florida has created a regulatory framework that incorporates both well-defined procedures and high standards,” says Brewer. “Everyone benefits – consumers are protected and hemp producers become known for as- advertised, quality product. All of us at Kaycha are looking forward to working with both and the cultivators and the Department of Plant Industry.”

PJRFSI Accredited for Cannabis Certifications

By Cannabis Industry Journal Staff
No Comments

In a press release published, last week, Perry Johnson Registrars Food Safety, Inc. (PJRFSI) announced they are now officially the first certification body to be granted accreditation for cannabis certification in the United States by ANAB.

PJRFSI has developed a cannabis certification standard that uses GMP- and GAP-based scheme to help growers, manufacturers and retailers meet a wide range of different state regulations. The goal of the standard, according to the press release, is to provide guidelines for cultivation, manufacturing and retail best practices across the country.

Because each state has very different rules and requirements for cannabis companies, the certification requirements can be confusing and vary widely from state to state. With the release of this new standard, PJRFSI wants to simplify cannabis markets in the United States and hopefully get various states on a same or similar page.

According to Terry Boboige and Lauren Maloney, president and accreditation manager at PJRFSI respectively, they have a lot of hope for what the future holds in terms of unifying cannabis rules and requirements. “The team at Perry Johnson Registrars Food Safety Inc. is incredibly excited to be the first company in the United States to achieve formal accreditation for our Cannabis and Hemp Certification Program,” says Boboige and Maloney. “We believe this nationally-recognized program will help the budding cannabis and hemp industries to strengthen, legitimize, and separate themselves from companies that do not have formal certification. Certification to this standard will forever help enhance companies’ image, credibility, and reliability. Accredited certification exemplifies to the public that certified organizations who supply cannabis and hemp products and services have internal safety systems that can inspire confidence.”

Navigating COVID-19 in the Cannabis industry in the UK

By Mike Barnes
1 Comment

There is no doubt all industries are feeling the effects of the coronavirus pandemic; however, cannabis businesses face a unique set of challenges.

Business operations, consumer behavior and financials will be analysed more than ever as businesses seek to position themselves during the pandemic and beyond when lockdowns will eventually be alleviated. As Benjamin Franklin said, “Out of adversity comes opportunity.” COVID-19 is an opportunity for cannabis firms to restructure their business model from a direct, consumer, wholesale and partnership level; eradicate inefficiencies and reassess launch or expansion plans.

Like many other sectors, the cannabis market should still expect to lose revenue due to factors like store closures, disrupted supply chains and restricted transport.

The outlook may seem bleak, but it’s not all doom and gloom when looking at the CBD and medical cannabis markets in more detail.

CBD consumption  

With social distancing measures still in place, cannabis firms which offer an online sales platform are seeing a surge in business. During COVID-19, there has been a greater focus on staying healthy and boosting immune systems which is driving consumers to a variety of health-focused products including CBD.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

Fortunately, many of the physical retailers who stock CBD products in the UK have been permitted to stay open, despite a nation-wide lockdown, so some consumers are bulk buying their usual products while others are turning to e-commerce and delivery services. This demonstrates how quickly some firms have adapted to keep their businesses afloat.

However, border restrictions have tightened and as many supply and logistics workers remain in quarantine, the CBD market could see challenges in maintaining supply lines as the pandemic continues.

This comes in addition to CBD firms working to process a Novel Food Application and fulfill the necessary requirements by March 31, 2021. Despite lobbying from the Cannabis Trades Association (CTA) and despite the impact the global pandemic is having on the sector, the deadline has not been extended.

CBD businesses need to capitalise on the opportunities arising during this downturn; be creative and pin-point ways to keep CBD consumers engaged. By building on their brand and refreshing where necessary, they can attract consumers and develop a loyal customer base. Sustaining a strong online presence and enhancing social media and marketing strategies can lead to an increase of online sales. The brands which can leverage awareness and embody trustworthiness will be the winners.

CBD cannot cure COVID-19

As the epidemic continues into May, there has been no shortage of scammers attempting to try and short-change a fearful, confused population. Unfortunately, the cannabis industry has seen some shameful claims by CBD and hemp companies, notably in the US, who claimed their products could cure or fight off the symptoms of COVID-19.

CBD has been positioned as having several positive health effects by manufacturers and retailers – most notably in reducing pain and inflammation, decreasing anxiety and helping sleep – which may be on the rise within this unsettling environment.

The International Association for Cannabinoid Medicine (IACM), issued a statement on the coronavirus pandemic saying, “there is no evidence that individual cannabinoids or cannabis preparations protect against infection … or could be used to treat COVID-19.” Trials have been launched in Israel to explore whether CBD’s anti-inflammatory properties can be an effective COVID-19 treatment. Until this has been clinically proven, cannabis firms must not make unsupported claims.

Medical Cannabis

During COVID-19, health systems are under unprecedented pressure, which is impacting patient access to all medical treatments, including cannabis.

The medical cannabis industry has swiftly adapted to these challenges by rolling out video consultations and other online consultation services to enhance patient access.

While the Home Office activity for licencing will be limited during this time, companies must work with regulators to keep supply lines open, so that those in need receive their medicine without relying on black-market activity.  On April 29, the government published emergency legislation to allow patients to continue accessing controlled drugs for the duration of the epidemic, from pharmacies, without a prescription. This only applies to patients with ongoing NHS treatment, so there is still a long way to go, as private cannabis clinics must fill the gap in the meantime.

The global pandemic has impacted us all, and many patients are concerned about how they will access vital services. Many patients receiving medical cannabis have underlying health conditions which make them more susceptible to contracting COVID-19 and those with chronic neurologic conditions like epilepsy are in danger of suffering potential side effects.

Several of the qualities needed to survive the coronavirus pandemic – awareness, self-containment and support – are basic skill sets to carers. Beyond the pandemic, policy shifts, investment and education are needed to lift the barriers to medical cannabis access, and this will require all businesses operating in the cannabis industry to drive change.

2020 is a defining year for cannabis 

The cannabis industry is resilient against socio-economic, political and policy drivers- this we’ve seen time and time again. Now we must create an even stronger UK industry, where products are safely and readily available to those who need them. As the cannabis market matures and the competition things out, only quality cannabis products and services will be in play. Those that can innovate their approach to production, distribution and consumption during the pandemic can be the catalyst for long-lasting changes for the cannabis industry to operate for the better.

Scotland Moves Forward With Its First Cannabis Farm

By Marguerite Arnold
No Comments

The village of Langholm, known locally as the “Muckle Toon,” with its most famous descendent being Neil Armstrong (the first man on the moon) is about to get another first. Namely, it will be the location of the first Scottish cannabis farm.

Father and son entrepreneurs William and Neil Ewart (who also own an agricultural farm, raise Angus cattle and have a racehorse stable) have obtained permission to produce enough cannabis to create 200 liters of oils a year. The production facility is also expected to employ about 50 people – from scientists to growers and IT staff.

However, this is just the beginning. Despite being given planning permission, the Ewarts will now have to apply for a license to actually produce medical cannabis.

Reform in the UK marches on

At present, British patients are in one of the toughest situations anywhere cannabis reform has ostensibly started to happen.

Domestic production, in other words, is a vitally needed part of British reform.The UK has moved forward on cannabis reform in fits and starts – one step forward and several back, for the last several years. Late last year, a full year after the drug was approved for prescription, in an abrupt change, cannabis was denied to everyone but Epilepsy and MS patients and those suffering from nausea due to chemo treatments. NICE, the agency in the UK who sets domestic prescription policies, shamefully excluded chronic pain patients from the new guidelines. This is despite the fact that there are chronic pain patients in the UK who had received prescriptions for cannabis after the law changed in 2018. Not to mention the fact that this subset of patients represents the largest percentage of people prescribed the drug in every other jurisdiction, from Colorado to Canada.

Those who have “qualifying conditions” must now find a doctor to prescribe – still no easy task. If GW Pharmaceuticals’ products (Epidiolex and Sativex) do not work, patients must then import the drug, at great expense from overseas. Even though this importing process has gotten significantly easier in the last months, supplies are still highly expensive imports from elsewhere (mostly Holland and Canada). This runs, at minimum, about $1,000 a month.

UKflagDomestic production, in other words, is a vitally needed part of British reform. It is also seen, increasingly, as a high value crop that can be exported elsewhere. Time will tell however, if the expensive British labor market can compete with product grown in Europe (in places like Spain, Portugal and Greece).

So far, the UK has lagged behind Germany, which itself went through a torturous and expensive process to not only approve its first cultivation bid, but is also now in the process of lowering prices. The first German grown cannabis is likely to hit pharmacy shelves by the third or fourth quarter of 2020. Don’t expect any cannabis exports to the UK, at least for now however, as there is not enough domestically cultivated German product to even serve existing German patients.

An Aberdeen clinic plans to be the first Scottish private facility to prescribe
As of mid-February, the privately run Sapphire Medical Clinics announced plans to become the first Scottish private medical clinic to prescribe cannabis. The facility will require a referral from a regular GP. This has so far, not been popular with the National Health Service (NHS). Some administrators have expressed concern that the process will result in doctors using their time to funnel patients into private healthcare to receive treatments not available or recognized by the NHS.

That said, as Sapphire has pointed out, the approximately 1.4 million patients in the UK have few other options beyond the black market.

Cannabis reform, in other words, is clearly inching forward in the British Isles. One cultivation facility and prescribing clinic at a time.

Some CBD Companies Are Getting Millions in Federal Aid

By Aaron G. Biros
No Comments

As we’ve covered previously, the coronavirus pandemic has impacted the cannabis industry in the United States in a number of ways. Many states with legal medical and recreational cannabis markets have deemed those cannabis businesses essential, allowing them to remain open during statewide stay-at-home orders. Congress passed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to help small businesses through the economic downturn, directing trillions of dollars to the Small Business Administration (SBA) to administer emergency loans, paycheck protection programs and other financial assistance to small businesses affected by the coronavirus pandemic.

CV Sciences received $2.9 million in federal aid from the SBA

However, pretty much all state-legal medical and recreational cannabis businesses are ineligible to receive money from the SBA because cannabis is designated as a Schedule 1 controlled substance. While Rep. Earl Blumenauer (D-OR) and Rep. Ed Perlmutter (D-CO) introduced legislation recently that would allow cannabis businesses to become eligible for federal assistance, it is unclear if that bill will become law. Furthermore, even if it does pass, cannabis businesses will likely receive little or no help at all, as a vast majority of the funds administered by the SBA have already been spoken for.

Enter the hemp and CBD products market. Thanks to the 2018 Farm Bill, which removed cannabis containing less than 0.3% THC from the list of controlled substances, hemp and CBD companies are not exempt from the SBA’s relief efforts.

According to VICE News, The Trump Administration has handed out millions of dollars to companies that sell CBD products. When VICE News looked into some SEC filings, they found more than $4 million in federal loans that have been granted to CBD products companies.

They found three CBD companies that scored big with federal assistance:

Despite state-legal medical and recreational cannabis businesses being left to fend for themselves, these large online CBD products retailers have received more than $4 million in federal aid money.

Emergency Cannabis Small Business Health and Safety Act – A Legislative Update

By Steve Levine, Megan Herr, Meghan Brennan
No Comments

On Thursday April 23, 2020, Representatives Earl Blumenauer (D-OR) and Ed Perlmutter (D-CO) introduced the “Emergency Cannabis Small Business Health and Safety Act” in the House. Blumenauer and Perlmutter have been influential in protecting state-legal cannabis businesses from federal interference, most recently under the 2020 federal appropriations rider.

If passed, the Act would allow state-legal medical and recreational cannabis businesses to take advantage of the multi-trillion dollar stimulus packages designed to help small businesses harmed by COVID-19.

As we previously discussed, cannabis businesses harmed by COVID-19 remain ineligible to receive federal financial assistance due to their engagement in “federally illegal” activities. Consequently, cannabis businesses cannot receive assistance from the Small Business Administration (SBA) thereby making them ineligible to receive Paycheck Protection Program (PPP) loans and other SBA financial assistance, including Economic Injury Disaster Loans (EIDLs), traditional 7(a) loans, 504 loans, and microloans.

To provide the industry with much needed economic relief, the legislation states that cannabis businesses would no longer be prohibited from (i) participating in the PPP, (ii) receiving EIDL loans, or (iii) receiving emergency EIDL grants purely on the basis that the business is a “cannabis-related legitimate business”1 or “service provider.”2

Additionally, the Act clarifies that the SBA and its officers, directors and employees would “not be held liable pursuant to any Federal law or regulation solely for providing a loan or a loan guarantee to a cannabis-related legitimate business or a service provider.”

Even though states have varied in their approach to continue medical and retail cannabis operations amid the coronavirus outbreak, a majority of states that allow some form of sale and consumption of cannabis have designated the cannabis industry as “essential” and open for operation.3 Some states have gone as far as allowing home delivery, curbside pick-up, and telemedicine consultations.

Nonetheless, despite the cannabis industry’s designation as “essential,” cannabis businesses (including those who service the cannabis industry) will continue to be precluded from receiving federal financial assistance until the Emergency Cannabis Small Business Health and Safety Act, or similar legislation, is passed. It is important to note that, even if passed, the Emergency Cannabis Small Business Health and Safety Act would likely provide little relief, as the majority of the funds to be administered by the SBA have already been accounted for.

What does this mean to you?

Although the COVID-19 pandemic has highlighted the need for the heavily-taxed and financially burdened cannabis industry to receive assistance under the stimulus packages, the Act, even if passed by Congress, faces an uphill battle in the Republican-held Senate.


References

  1.  The term “cannabis-related legitimate business” means a manufacturer, producer, or any person that – (A) engages in any activity described in subparagraph (B) pursuant to a law established by a State or a political subdivision of a State, as determined by such State or political subdivision; and (B) participates in any business or organized activity that involves handling cannabis or cannabis products, including cultivating, producing, manufacturing, selling, transporting, displaying, dispensing, distributing, or purchasing cannabis or cannabis products.”
  2. The term “service provider” (A) means a business, organization, or other person that – (i) sells goods or services to a cannabis-related legitimate business; or (ii) provides any business services, including the sale or lease of real or any other property, legal or other licensed services, or any other ancillary service, relating to cannabis; and (B) does not include a business, organization, or other person that participates in any business or organized activity that involves handling cannabis or cannabis products, including cultivating, producing, manufacturing, selling, transporting, displaying, dispensing, distributing, or purchasing cannabis or cannabis products.”
  3. State-by-State COVID-19 Announcements Impacting Marijuana Businesses.

Essential Cannabis Businesses Must Protect Employees and Customers During COVID-19 With Sanitation and Social Distancing Practices

By David Laks
No Comments

Unlike their retail neighbors who have been forced to move inventory online to survive, many cannabis businesses are considered essential and remain open during the current pandemic. With that, though, comes a tremendous responsibility to maintain optimal protocol for safe operations and customer shopping.

Whether you run a retail or production operation, allow only essential vendors (i.e. delivery, service companies) into the facility and have non-essential staff telecommute, when possible. Some businesses may want to consider splitting shifts for the management team as well.

Each state and local municipality will have their own rules when it comes to protocols for open retail establishments. Where those are more stringent than the following recommendations, adhere to the more stringent rule.

Cannabis Production Facility Best Practices

While not being face-to-face with cannabis customers on a daily basis, production facilities are the first and possibly only ones to handle the raw product the customer will eventually consume. For this reason, it’s important to conduct a refresh training session on sanitation procedures and new COVID-19 protocol for all production employees. Consider the following critical procedures for cannabis production facilities:

  • Review current production sanitation procedures and adjust accordingly, focusing on high touch points and potentially contaminated surfaces. Include office items such as keyboard, phones, and kitchen areas.
  • Review the business’ call-in sick policy and make sure employees know they can – and should – do so if they’re under the weather.
  • Sanitize high touch points every 30 minutes or less.
  • Instruct employees to wash hands with soap and water for 20 seconds after blowing their nose, coughing, sneezing, going to the bathroom, before eating and when touching any communal surface, including door handles and surfaces. Wear personal protective equipment (PPE) at all times while working with raw product, including gloves and masks.

    control the room environment
    PPE can reduce the risks of spreading disease
  • If an employee coughs or sneezes in a production area, instruct them to do so into the elbow of their outer garment, and immediately change following proper donning techniques. Instruct them to avoid touching their face.

Cannabis Retail Facility Best Practices

Retail cannabis establishments must realize first and foremost that those with compromised immune systems may be frequenting their store to purchase medical cannabis. Consider, evaluate and appropriately publicize protocol relative to employee interactions with customers, including:

  • Enable mobile or order-ahead features along with curbside pickup and contact-less delivery, when possible. Where this isn’t an option, limit the number of customers in the store at a time.
  • Consider moving to appointment-only operations, or restricted hours for those over 65.
  • Reduce store visits by recommending patients order their prescription for the maximum allowable 60 days.
  • Designate an employee to champion personal sanitation and social distancing. Create an entry sanitation station and require all customers to use it upon entry. Maintain social distance of 6-ft. minimum between customers. Place markings on the floor to designate this.
  • Limit sales to only sealed products.
  • Sanitize high touch points twice an hour, including ID check booths, display cases, phones, keyboards, etc. and provide adequate PPE for all, including gloves, masks, etc.
  • Install separation barriers, like thick plastic or plexiglass at each cashier station.

The requirements of keeping an essential business open will vary by location and will likely change as the COVID-19 pandemic evolves. Regularly check for changes to the rules of your local jurisdiction and adapt accordingly.

HACCP

HACCP for Cannabis: A Guide for Developing a Plan

By Radojka Barycki
1 Comment
HACCP

Hazard Analysis and Critical Control Points (HACCP) is a systematic approach that evaluates hazards that may potentially be present in food products that can harm the consumer. The process used to manufacture the product is evaluated from raw material procurement, receiving and handling, to manufacturing, distribution and consumption of the finished product1. The documented process is what is known as HACCP plan. Although HACCP was designed to evaluate hazards in foods, it can be used to assess or evaluate hazards that may potentially be present in cannabis consumable products (edibles and vaping) that can cause harm to the consumer.

HACCP plan development requires a systematic approach that covers 5 preliminary steps and 7 principles. A systematic approach means that each step must be followed as outlined. Skipping a step will result in a HACCP plan that most likely will be ineffective to control potential hazards in the product.

The 5 preliminary steps are:

  1. Establish a HACCP team
  2. Describe the product
  3. Establish the intended use of the product
  4. Develop a flow diagram
  5. Verify the flow diagram

The 7 Principles are:HACCP

  1. Conduct a hazard analysis
  2. Identify the critical control points (CCPs)
  3. Establish critical limits (CL)
  4. Establish monitoring procedures
  5. Establish corrective actions
  6. Establish verification procedures
  7. Establish records and record keeping procedures1,2

It is important to mention that HACCP plans are supported by programs and procedures that establish the minimum operational and sanitary conditions to manufacture safe products. These programs and procedures are known as pre-requisite programs (PRP) or preventative controls1,2.

Figure 1. Flow Diagram

A multidisciplinary team must be established in order to ensure that all inputs of the product manufacturing process are considered during the hazards analysis discussions. The description of the product and its intended use provides detail information on ingredients, primary packaging material, methods of distribution, chemical characteristics, labeling and if any consumer might be vulnerable to the consumption of the product. A verified flow diagram is an accurate representation of the different steps followed during the product manufacturing process and will be used to conduct a hazard analysis. An inaccurate flow diagram will set the stage for an inadequate HACCP plan. Therefore, it is important that the HACCP team members verify the flow diagram. Figure 1 is a flow diagram for a fictional infused apple juice manufacturing plan that I will be using as an example.

The hazard analysis is the backbone of the HACCP plan. There are two elements that must be considered when conducting the hazard analysis:

  • Identification of the hazard associated with the ingredient(s) and/or the product manufacturing steps. These hazards have been categorized as: Biological, chemical (including radiological) and physical. Biological, chemical and physical hazards should be considered for each ingredient, primary packaging and process step. Also, it is important that the team is specific as to what hazard they are referring to. I often find that biological hazards are identified as “pathogens” for example. The team has to be specific on which pathogen is of concern. For example, if you are processing apple juice, the pathogens of concern are pathogenic coli and Salmonella sp. However, if you are processing carrot juice, you need to add Clostridium botulinum as a biological hazard also. If the choice of method to eliminate the hazards is pasteurization for example, the processing temperature-time combinations will differ greatly when manufacturing the apple juice vs. the carrot juice as C. botulinum is an organism that can sporulate and, therefore, is harder to kill.
  • Characterization of the hazard. This implies determining the significance of the potential hazard based on the severity of the consequence if it is consumed and the likelihood of occurrence in the ingredient or process step. Only steps in the process that has significant hazards should be considered further.
Table 1. Ingredient Hazard Analysis

In my professional experience, the hazard analysis is one of the most difficult steps to achieve because it requires the expertise of the multidisciplinary team and a lot of discussion to get to the conclusion of which hazard is significant. I find that a lot of teams get overwhelmed during this process because they consider that everything in the process may represent a hazard. So, when I am working with clients or providing training, I remind everyone that, in the bigger scheme of things, we can get stricken by a lighting in the middle of a thunderstorm. However, what will increase our chances would be whether we are close or not to a body of water for example. If I am swimming in the middle of a lake, I increase my chances to get stricken by the lighting. In comparison, if I am just sitting in my living room drinking a cup of coffee during the thunderstorm, the likelihood of being stricken by a lighting is a lot less. The same rationale should be applied when conducting the hazard analysis for manufactured products. You may have a hazard that will cause illness or death (high on the severity chart) but you also may have a program that mitigates the likelihood of introducing or having the hazard. The program will reduce the significance of the hazard to a level that may not need a critical control point to minimize or eliminate it.

Table 2. Process Hazard Analysis (1)

Clear as mud, right? So, how would this look like on the infused apple juice example? Table 1 shows the hazard analysis for the ingredients. Tables 2 and 3 show the hazard analysis for the part of the process. In addition, I have identified the CCPs: Patulin testing and pasteurization. There is a tool called the CCP decision tree that is often used to determine the CCPs in the process.

Once we have the CCPs, we need to establish the critical limits to ensure that the hazard is controlled. These limits must be validated. In the case of Patulin, the FDA has done several studies and has established 50 ppm as the maximum limit. In the case of pasteurization, a validation study can be conducted in the juice by a 3rd party laboratory. These studies typically are called thermal death studies (TDS) and provide the temperature and time combination to achieve the reduction of the pathogen(s) of concern to an acceptable level that they do not cause harm. In juice, the regulatory requirement is a 5-log reduction. So, let’s say that the TDS conducted in the infused apple juice determined that 165°F for 5 seconds is the critical limit for pasteurization. Note that the 5 seconds will be provided by the flow of the product through the holding tube of the pasteurizer. This is measured based on flow in gallons per minute.

Table 3. Process Hazard Analysis (2)

Monitoring is essential to ensure that the critical limits are met. A monitoring plan that outlines what, how, when and who is responsible for the monitoring is required.

Ideally, the system should not fail. However, in a manufacturing environment, failures can happen. Therefore, it is important to pre-establish steps that will be taken to ensure that the product is not out of the control of the facility in the event of a deviation from the HACCP plan. These steps are called corrective actions and must be verified once they are completed. Corrective actions procedures must address the control of the product, investigation of the event, corrective actions taken so the deviation doesn’t reoccur and product disposition.

Table 4. HACCP Plan Summary

Verification activities ensure that the HACCP plan is being followed as written. Typically, verification is done by reviewing the records associated with the plan. These records include but are not limited to monitoring records, calibration records, corrective action records, and preventive maintenance records for equipment associated with the CCPs. Record review must be done within 7 working days of the record being produced.

Finally, establishing records and record keeping procedures is the last step on developing HACCP plans. Records must be kept in a dry and secure location.

Table 4 show the summary of the HACCP plan for the infused apple juice example.

For more information on how to develop a HACCP plan for your facility, read the resources below:

  1. HACCP Principles and Application Guidelines – The National Advisory Committee on Microbiological Criteria for Foods (NACMCF)
  2. ASTM D8250-19: Standard Practice for Applying a Hazard Analysis Critical Control Points (HACCP) Systems for Cannabis Consumable Products