Tag Archives: certify

ISO/IEC 17025 Accreditation Falls Short for Cannabis Testing Laboratories

By Kathleen May
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What is the role of the Quality Control (QC) Laboratory?

The Quality Control (QC) laboratory serves as one of the most critical functions in consumer product manufacturing. The QC laboratory has the final say on product release based on adherence to established product specifications. Specifications establish a set of criteria to which a product should conform to be considered acceptable for its intended use. Specifications are proposed, justified and approved as part of an overall strategy to ensure the quality, safety, and consistency of consumer products. Subsequently, the quality of consumer products is determined by design, development, Good Manufacturing Practice (GMP) controls, product and process validations, and the specifications applied throughout product development and manufacturing. These specifications are specifically the validated test methods and procedures and the established acceptance criteria for product release and throughout shelf life/stability studies.

The Code of Federal Regulations, 21 CFR Part 211, Good Manufacturing Practice for Finished Pharmaceuticals, provides the minimum requirements for the manufacture of safe products that are consumed by humans or animals. More specifically, 21 CFR Part 211: Subpart I-Laboratory Controls, outlines the requirements and expectations for the quality control laboratory and drug product testing. Additionally, 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food: Subpart B-Processes and Controls states that appropriate QC operations must be implemented to ensure food products are safe for consumption and food packing materials and components are safe and fit for purpose. Both food and drug products must be tested against established specifications to verify quality and safety, and laboratory operations must have the appropriate processes and procedures to support and defend testing results.

ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories is used to develop and implement laboratory management systems. Originally known as ISO/IEC Guide 25, first released in 1978, ISO/IEC 17025 was created with the belief that “third party certification systems [for laboratories] should, to the extent possible, be based on internationally agreed standards and procedures”7. National accreditation bodies are responsible for accrediting laboratories to ISO/IEC 17025. Accreditation bodies are responsible for assessing the quality system and technical aspects of a laboratory’s Quality Management System (QMS) to determine compliance to the requirements of ISO/IEC 17025. ISO/IEC 17025 accreditation is pursued by many laboratories as a way to set them apart from competitors. In some cannabis markets accreditation to the standard is mandatory.

The approach to ISO/IEC 17025 accreditation is typically summarizing the standard requirements through the use of a checklist. Documentation is requested and reviewed to determine if what is provided satisfies the item listed on the checklist, which correlate directly to the requirements of the standard. ISO/IEC 17025 covers the requirements for both testing and calibration laboratories. Due to the wide range of testing laboratories, the standard cannot and should not be overly specific on how a laboratory would meet defined requirements. The objective of any laboratory seeking accreditation is to demonstrate they have an established QMS. Equally as critical, for product testing laboratories in particular, is the objective to establish GxP, “good practices”, to ensure test methods and laboratory operations verify product safety and quality. ISO/IEC 17025 provides the baseline, but compliance to Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and even Good Safety Practices (GSP) are essential for cannabis testing laboratories to be successful and demonstrate testing data is reliable and accurate.

Where ISO/IEC 17025 accreditation falls short

Adherence to ISO/IEC 17025, and subsequently receiving accreditation, is an excellent way to ensure laboratories have put forth the effort to establish a QMS. However, for product testing laboratories specifically there are a number of “gaps” within the standard and the accreditation process. Below are my “Top Five” that I believe have the greatest impact on a cannabis testing laboratory’s ability to maintain compliance and consistency, verify data integrity and robust testing methods, and ensure the safety of laboratory personnel.

Standard Operating Procedures (SOPs)

The understanding of what qualifies as a Standard Operating Procedure (SOP) is often misunderstood by cannabis operators. An SOP is a stand-alone set of step-by-step instructions which allow workers to consistently carry out routine operations, and documented training on SOPs confirms an employee’s comprehension of their job tasks. Although not required per the current version of the standard, many laboratories develop a Quality Manual (QM). A QM defines an organization’s Quality Policy, Quality Objectives, QMS, and the procedures which support the QMS. It is not an uncommon practice for cannabis laboratories to use the QM as the repository for their “procedures”. The intent of a QM is to be a high-level operations policy document. The QM is NOT a step-by-step procedure, or at least it shouldn’t be.

Test Method Transfer (TMT)

Some cannabis laboratories develop their own test methods, but a common practice in many cannabis laboratories is to purchase equipment from vendors that provide “validated” test methods. Laboratories purchase equipment, install equipment with pre-loaded methods and jump in to testing products. There is no formal verification (what is known as a Test Method Transfer (TMT)) by the laboratory to demonstrate the method validated by the vendor on the vendor’s equipment, with the vendor’s technicians, using the vendor’s standards and reagents, performs the same and generates “valid” results when the method is run on their own equipment, with their own technician(s), and using their own standards and reagents. When discrepancies or variances in results are identified (most likely the result of an inadequate TMT), changes to test methods may be made with no justification or data to support the change, and the subsequent method becomes the “validated” method used for final release testing. The standard requires the laboratory to utilize “validated” methods. Most laboratories can easily provide documentation to meet that requirement. However, there is no verification that the process of either validating in house methods or transferring methods from a vendor were developed using any standard guidance on test method validation to confirm the methods are accurate, precise, robust and repeatable. Subsequently, there is no requirement to define, document, and justify changes to test methods. These requirements are mentioned in ISO/IEC 17025, Step 7.2.2, Validation of Methods, but they are written as “Notes” and not as actual necessities for accreditation acceptance.

Change Control

The standard speaks to identifying “changes” in documents and authorizing changes made to software but the standard, and subsequently the accreditation criteria, is loose on the requirement of a Change Control process and procedure as part of the QMS. The laboratory is not offered any clear instruction of how to manage change control, including specific requirements for making changes to procedures and/or test methods, documented justification of those changes, and the identification of individuals authorized to approve those changes.

Out of Specification (OOS) results

The documentation and management of Out of Specification (OOS) testing results is perhaps one of the most critical liabilities witnessed for cannabis testing laboratories. The standard requires a procedure for “Nonconforming Work”. There is no mention of requiring a root cause investigation, no requirement to document actions, and most importantly there is no requirement to document a retesting plan, including justification for retesting. “Testing into compliance”, as this practice is commonly referred to, was ruled unacceptable by the FDA in the highly publicized 1993 court case United States vs. Barr Laboratories.

Laboratory Safety

FDAlogoSafe laboratory practices are not addressed at all in ISO/IEC 17025. A “Culture of Safety” (as defined by the Occupational Safety and Health Administration (OSHA)) is lacking in most cannabis laboratories. Policies and procedures should be established to define required Personal Protective Equipment (PPE), the safe handling of hazardous materials and spills, and a posted evacuation plan in the event of an emergency. Gas chromatography (GC) is a common test method utilized in an analytical testing laboratory. GC instrumentation requires the use of compressed gas which is commonly supplied in gas cylinders. Proper handling, operation and storage of gas cylinders must be defined. A Preventative Maintenance (PM) schedule should be established for eye wash stations, safety showers and fire extinguishers. Finally, Safety Data Sheets (SDSs) should be printed and maintained as reference for laboratory personnel.

ISO/IEC 17025 accreditation provides an added level of trust, respect and confidence in the eyes of regulators and consumers. However, the current process of accreditation misses the mark on the establishment of GxP, “good practices” into laboratory operations. Based on my experience, there has been some leniency given to cannabis testing laboratories seeking accreditation as they are “new” to standards implementation. In my opinion, this is doing cannabis testing laboratories a disservice and setting them up for failure on future accreditations and potential regulatory inspections. It is essential to provide cannabis testing laboratory owners and operators the proper guidance from the beginning and hold them up to the same rigor and scrutiny as other consumer product testing laboratories. Setting the precedence up front drives uniformity, compliance and standardization into an industry that desperately needs it.


References:

  1. 21 Code of Federal Regulations (CFR) Part 211- Good Manufacturing Practice for Finished Pharmaceuticals.
  2. 21 Code of Federal Regulations (CFR) Part 117;Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food: Subpart B-Processes and Controls.
  3. ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; Laboratory Controls.
  4. World Health Organization (WHO).
  5. International Building Code (IBC).
  6. International Fire Code (IFC).
  7. National Fire Protection Association (NFPA).
  8. Occupational Safety and Health Administration; Laboratories.
  9. ASTM D8244-21; Standard Guide for Analytical Operations Supporting the Cannabis/Hemp Industry.
  10. org; ISO/IEC 17025.

Americans for Safe Access Accredited to ISO 17065

By Cannabis Industry Journal Staff
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Late last week, the American Association for Laboratory Accreditation (A2LA) granted ISO/IEC 17065 accreditation to Americans for Safe Access (ASA). This is the first accreditation ever issued to a product certification body in the cannabis market.

ASA is a member-based organization founded in 2002 that seeks to ensure safe and legal access to cannabis for medical purposes and research. Back in 2016, A2LA and ASA partnered on a collaboration to develop the Patient Focused Certification (PFC) program.

What started as a supplement to ISO 17025 for cannabis testing labs to demonstrate a dedication to patient safety, has grown into a more comprehensive certification and consulting program that offers training, business services, company certifications. With the ISO 17065 accreditation, ASA can now deliver PFC certifications that confidently identify reliable and high-quality medical cannabis products, business and services.

Jonathan Fuhrman, program manager at A2LA, says this is a big milestone for ASA’s platform. “ISO/IEC 17065 and product certification can play a decisive role in the evolution of cannabis as medicine,” says Fuhrman. “With its high standards for competence and impartiality, adopting ISO/IEC 17065 represents a major win for healthcare providers and patients.”

Heather Despres, the director of ASA’s Patient Focused Certification program, says she is thrilled to be the first cannabis compliance organization to attain the accreditation. “The PFC program was developed by ASA in an effort to continue our commitment to protect patients, many of whom are medically fragile, and consumers who may be seeking medicine outside of conventional medicinal channels,” says Despres. “There is no other process that can demonstrate that continued commitment more than achieving ISO 17065 accreditation.”

QIMA/WQS to Audit Cannabis Companies as CSQ Certification Body

By Cannabis Industry Journal Staff
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Back in July of 2020, ASI Global Standards announced the launch of their newest audit standard: The Cannabis Safety & Quality Scheme (CSQ). The scheme is built around ISO requirements and the Global Food Safety Initiative (GFSI) requirements.

In a press release published in December of 2020, CSQ announced they have added a new licensed certification body to the program: QIMA/WQS, which is a provider of independent third-party certification, inspection, and training services for the food industry.

The CSQ program is marketed as the world’s first cannabis certification to meet GFSI criteria, which is expected to get benchmarked in 2022.

The CSQ scheme is built on four standards:

  • Growing and Cultivation of Cannabis Plants
  • Manufacturing and Extraction of Cannabis
  • Manufacturing and Infusion of Cannabis into Food & Beverage Products
  • Manufacturing of Cannabis Dietary Supplements

The first CSQ certifications are expected to be awarded this month. Being a licensed certification body for the CSQ program means QIMA/WQS will conduct document evaluations as well as on-site inspections to ensure companies are meeting the CSQ standards prior to certification.

“At QIMA WQS, we see an enormous potential to support and provide quality certification to the entire cannabis supply chain. Joining CSQ and its innovative approach is an exciting step into the diversification of our services and growth,” says Mario Berard, CEO of QIMA/WQS.

C4 Labs Accredited, Ready for Compliance Testing

By Cannabis Industry Journal Staff
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Since Arizona legalized medical cannabis in 2011 , regulators have not required testing for cannabis products. That is about to change in a little more than a month.

After a long and hard-fought battle by patients and stakeholders in the Arizona cannabis industry, Governor Ducey signed SB1494 into law last year, a bill that requires independent labs to test cannabis products for contaminants. More specifically, the bill requires that cannabis products be tested “to determine unsafe levels of microbial contamination, heavy metals, pesticides, herbicides, fungicides, growth regulators and residual solvents and confirm the potency of the marijuana to be dispensed.”

Ryan Treacy, co-founder of the ACLA and founder/CEO at C4 Labs.

Ryan Treacy, CEO/Founder of C4 Labs and co-founder of the Arizona Cannabis Laboratory Association (ACLA), has been a vocal advocate for mandatory product safety testing since 2016. After several failed lobbying attempts and forming the ACLA with three other labs in Arizona, SB1494 finally passed in May of 2019.

Under this bill, the Arizona Department of Health Services has been in charge of building the new laboratory regulations. Those rules include certifying and regulating labs, establishing requirements like health and safety protocols, mandatory quality assurance program and standards, chain of custody and sampling policies, adequate records, accreditation, proficiency testing, among other requirements.

In a press release published by Perry Johnson Laboratory Accreditation (PJLA), they announced that C4 Laboratories was accredited to ISO/IEC 17025 this week, in time for the new requirement in Arizona.

According to Treacy, the Department of Health Services is still in the process of finalizing the technical accreditation for labs in the state. He says C4 Labs will be ready to accept compliance samples in the coming weeks. “There will no doubt be a flood of samples and a lot will be asked of the lab operators to continue to build their business to better accommodate sample volume,” says Treacy. They want to minimize any disruption to the supply chain, keeping patients and clients at top of mind.

C4 Labs has been preparing for the flood of compliance testing samples beyond just their accreditation. “Over the last 16 months we have added a new fully renovated lab space, doubled our lab staff and have invested significant monetary resources in additional state of the art analytical instruments to allow for more analysis and expanded lab sample capacity,” says Treacy. “We intend to make efficiency and capacity our focus while maintaining our commitment to sound science and data integrity for our clients and patients alike.”

C4 Labs is currently in its sixth year of operating and was one of the original labs to serve Arizona patients. “We are very proud of the work we have put in to advocate for safe, lab-tested cannabis products and we intend to continue to lead from the front as Arizona’s premier cannabis testing laboratory.”

Why Organic Should be the Future of CBD

By Josh Epstein
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The hemp industry is rapidly growing, but it’s no secret that it suffers from a major legitimacy problem. When manufacturers choose to certify their products and processes under a third-party agency, such as the USDA, it is a way for those companies to gain credibility with new customers.

USDA LogoThe USDA’s organic certification program is a great way to increase transparency and trust with both ingredients and processes used within the hemp industry. Organic certification is a rigorous audit program to review both manufacturing facility design and production process plans with the ultimate goal of increasing supply chain sustainability.

Investing in organic certification is a smart business decision – especially in today’s competitive CBD market. A recent Bloomberg report has shown that COVID-19 has actually accelerated organic food sales in the US due to increased demand for health-conscious foods and drinks. “Sales of organic food and drinks surged 25% during the 17-week period ended June 27,” according to Nielsen Data.

Organic certification is one way to differentiate between the thousands of seemingly identical CBD products being sold in the marketplace today. From a consumer perspective, organic certification provides both supply chain transparency and increases confidence with brands and products they already love. It also provides a form of quality assurance to skeptical consumers, especially those who avidly read product labels prior to making a purchasing decision. Members of this “label reader” demographic will consistently choose organic products for the quality and transparency it provides with pure and natural ingredients.

Not only does certification support ethical practices, it’s also good for business. According to the USDA, “Food labeling can be confusing and misleading, which is why certified organic is an important choice for consumers. Consumers are willing to pay a premium for food that carries the USDA organic seal, or that contains organic ingredients.”

Organic farming and production processes significantly contribute to increasing sustainability within the CBD industry. In general, organic farming is a growing practice for farmers across the US. According to the Pew Research Center, “There were more than 14,000 certified organic farms in the United States in 2016, according to the latest available data from the U.S. Department of Agriculture’s National Agricultural Statistics Service. This represents a 56% increase from 2011, the earliest comparable year.” The USDA has found that organic production practices can improve water quality, conserve energy, increase biodiversity and contribute to soil health. In terms of organic farming, soil ecology and water quality are both protected by farmers committing to working within regulated guidelines.

Organic certification ensures transparency and trust with a consumer-friendly approach to ingredient products. This comes on the heels of research showing that the CBD market lacks credibility. Organic CBD should be the next step all brands should take to ensure they’re adapting to changing consumer preferences.

ASI Global Launches Cannabis Safety & Quality Audit Standards

By Cannabis Industry Journal Staff
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According to a press release published July 1, ASI Global Standards announced the launch of their newest audit standard: the Cannabis Safety & Quality Scheme (CSQ). The scheme is built around ISO requirements and the Global Food Safety Initiative (GFSI) requirements.

With input from a number of stakeholders in the cannabis space, the CSQ scheme is designed for the cannabis industry and by the cannabis industry. Each standard was developed by industry professionals and stakeholders, like growers, manufacturers and processors, to meet market, consumer and regulatory requirements from seed-to-sale.

The CSQ scheme is built on four standards:

  • Growing and Cultivation of Cannabis Plants
  • Manufacturing and Extraction of Cannabis
  • Manufacturing and Infusion of Cannabis into Food & Beverage Products
  • Manufacturing of Cannabis Dietary Supplements

There is a public comment period in effect now, and those wishing to provide input have until July 31 to do so. If certification bodies or accreditation bodies want to find more information and get involved in the CSQ certification or accreditation process, they are encouraged to reach out via email at info@csqcertification.com.

Moving Towards Greater Competency in Cannabis Testing

By Ravi Kanipayor
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While legalization of recreational cannabis remains in a fluid state in the United States, the medical application of cannabis is gaining popularity. As such, the  diversification of  pharmaceutical and edible cannabis products will inevitably lead to increased third party testing, in accordance with Food and Drug Administration (FDA) mandates. Laboratories entering into cannabis testing, in addition to knowing the respective state mandates for testing procedures, should be aligned with Federal regulations in the food and pharmaceutical industries.

In 2010, the American Herbal Products Association (AHPA)1 established a cannabis committee with the primary objective of addressing issues related to the practices and safe use of legally-marketed cannabis and cannabis-related products. The committee issued a set of recommendations, outlining best practices for the cultivation, processing, testing and distribution of cannabis and cannabis products. The recommendations for laboratory operations sets some basic principles for those performing analysis of cannabis products. These principles, complementary to existing good laboratory practices and international standards, focus on the personnel, security, sample handling/disposal, data management and test reporting unique to laboratories analyzing cannabis samples.

As local and federal regulations continue to dictate medical and recreational cannabis use, many will venture into the business of laboratory testing to meet the demands of this industry. Thus, it is not surprising that cannabis producers, distributors and dispensaries will need competent testing facilities to provide reliable and accurate results. In addition, our understanding of cannabis from an analytical science perspective will derive from test reports received from these laboratories. Incorrect or falsified results can be costly to their business and can even lead to lawsuits when dealing with consumer products. Examples of fines and/or suspensions related to incorrect/false reporting of results have already gained coverage in news media. This sets up the need for the cannabis industry to establish standardized protocols for laboratory competency.

The international standard, ISO 17025 – ‘General requirements for the competence of testing and calibration laboratories’ – plays an important role in providing standard protocols to distinguish labs with proven quality, reliability and competency. The industry needs to rely not only on the initial accreditation received, but also on the ongoing assessment of the labs to ensure continuous competency.

Receiving accreditation involves an assessment by an International Laboratory Accreditation Cooperation (ILAC) recognized accrediting body, which ensures that laboratories have the competency, resources, personnel and have successfully implemented a sound quality management system that complies with the international standard ISO/IEC 17025:2017. This ISO standard is voluntary, but recognized and adopted globally by many industries for lab services. Cannabis companies can ensure that the test services they receive from accredited laboratories will meet the requirements of the industry, as well as the state and federal regulatory agencies. The International Organization for Standardization (ISO) is an independent, non-governmental organization with over 160 memberships of national standards bodies, and all with a unified focus on developing world-class standards for services, systems, products, testing to ensure quality, safety, efficiency and economic benefits.

ILAC is a non-profit organization made up of accreditation bodies (ABs) from various global economies. The member bodies that are signatories to the ILAC Mutual Recognition Arrangement (ILAC MRA) have been peer evaluated to demonstrate their competence. The ILAC MRA signatories, in turn, assess testing labs against the international standard, ISO/IEC 17025 and award accreditation. Accreditation is the independent evaluation of conformity assessment in accordance with the standard and related government regulations to ensure the lab carry out specific activities (called the ‘Scope’) impartially and competently. Through this process, cannabis industry stakeholders and end users can have confidence in the test results they receive from the labs.

Understanding the principles of accreditation and conformity to ISO standards is the beginning of the ISO 17025 accreditation process. Similar to other areas of testing, accreditation gives cannabis testing labs global recognition such that their practices meet the highest standards in providing continuous consistency, reliability and accuracy.

Many government agencies (state and federal) in the US and around the world are mandating cannabis testing laboratories to seek accreditation to ISO/IEC 17025:2017, in an effort to standardize their practice and provide the industry with needed assurance. Conformance with the standard enables labs to demonstrate their competency in generating reliable results, thereby providing assurance to those who hire their services.

Testing of cannabis can be very demanding and challenging given that state and federal regulations require that the performance and quality of the testing activities must provide consistent, reliable and accurate results. Hence, labs deciding to set up cannabis testing will have to take extra care in setting up a laboratory facility, acquiring all necessary and appropriate testing equipment, hiring qualified and experience staff and developing and implementing test methods to ensure the process, sample throughput, data integrity and generated output are continuously reliable, accurate and meet the need of the clients and requirements of the regulatory bodies. This demands the lab to establish and implement very sound quality assurance program, good laboratory practices and a quality management system (QMS).

Some expected challenges are:

  1. Standardization of test methods and protocols
    1. Since there is no federal guidance in standardization of test methods and protocols for cannabis testing in US, it is challenging for laboratories to research and validate other similar, established methods and gain approval from the local and state authorities.
  2. Facility
    1. Cannabis testing activities must be physically isolated from other testing activities for those labs conducting business in other areas of testing such as environment, food, mining, etc.
    2. Microbiological testing requires additional physical isolation within the testing facility, maintaining sterility of the environment, test area and test equipment.
  3. Equipment
    1. The test equipment such as Chromatographs (GC/LC), Spectrometers (ICP-MS, ICP-OES, UV-Vis), and other essential analytical instruments must meet the specifications required to detect and quantify and statistically justify the test parameters at the stipulated concentration levels. That means the limit of detection and limit of quantitation of each parameter must be well below the regulatory limits and the results are statistically sound.
    2. Calibration, maintenance and operation of analytical equipment must be appropriate to produce results traceable to international standards such as International System of Units and National Institute of Standards and Technology (SI and NIST).
  4. Staff
    1. The qualification and experience of the staff should ensure standard test methods are implemented and verified to meet the specifications.
    2. They should have a sound understanding of the QA/QC protocols and effective implementation of a quality management system which conforms to ISO/IEC 17025:2017 standard.
    3. Staff should be properly trained in all standard operating procedures (SOPs) and receiving schedule re-training as needed. Training should be accurately documented.
  5. QMS
    1. The QMS should not only meet the requirements of ISO 17025, but also be appropriate to the scope of the laboratory activities. Such a system must be planned, implemented, verified and continuously improved to ensure effectiveness.

Finally, stakeholders should seek expert advice in establishing a cannabis testing lab prior to initiating the accreditation. This can be achieved through a cyclic PLAN-DO-CHECK-ACT process. Labs that are properly established can attain the accreditation process in as little as 3-5 months. An initial ‘Gap Analysis’ can be extremely helpful in this matter.

IAS, an ILAC MRA signatory and international accrediting body based in California is one such organization that provides training programs for those interested in attaining accreditation to ISO/IEC 17025:2017. It is a nonprofit, public-benefit corporation that has been providing accreditation services since 1975. IAS accredits a wide range of companies and organizations including governmental entities, commercial businesses, and professional associations worldwide. IAS accreditation programs are based on recognized national and international standards that ensure domestic and/or global acceptance of its accreditations.2


References

  1. American Herbal Products Association , 8630 Fenton Street, Suite 918 , Silver Spring, MD 20910 , ahpa.org.
  2. International Accreditation Services, iasonline.org.

PJRFSI Accredited for Cannabis Certifications

By Cannabis Industry Journal Staff
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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.”

The Beginner’s Guide to Integrated Pest Management

By David Perkins
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Formulating a Plan

In this article you will learn how to control pests and improve the health of your cannabis plants using integrated pest management, commonly referred to as IPM. This involves a multi-point strategy – there is no quick fix, nor is there one solution that will wipe out all your pest problems. Proper pest management requires patience, consistency and determination.

It is important to understand that not all pesticides are bad. While many are incredibly harmful not only to pests, but also humans, in this article I will educate you about some of the safer alternatives to traditional pesticides. It is possible to safely control unwanted pests in your cannabis garden without harming yourself, your employees or the natural habitat around you.

Every cultivation facility should have a well-thought-out plan for their pest management program. This program should account for the prevention, and if necessary, eradication of: spider mites, russet mites, fungus gnats, root aphids, thrips and caterpillars. These are just a few of the more common pests you’ll find in a cannabis garden. There could also be many other less commonly known bugs, so you have to be vigilant in looking closely at your plants, and the soil, at all times. Complete eradication of a targeted pest can be difficult. Once a pest has established itself, decimating or decreasing the population will require an aggressive regimen that includes spraying daily to control populations and prevent other pests from getting established.

Spraying or applying pesticides to the foliage of plants isn’t the only way to control or eradicate pest populations. There are many other ways that you can minimize the spread of pests without the use of pesticides. In greenhouse and outdoor grows, growing specific types of plants around the cultivation area will attract both beneficial and predator bugs that will naturally control pest populations. Some plants that attract these bugs are: mint, peppers, and marigold. Beneficial and predator bugs, such as ladybugs, predator wasps and predator mites, can control unwanted pest populations in the area before they even have a chance to become a problem in your garden. Plants and flowers that attract bees, birds and insects will also create helpful bio- diversity, making it more difficult for the unwanted pests to thrive.

For indoor cultivation, it is imperative that you have your cultivation facility set up for a proper workflow. If you already have pests, you need to make sure you are not contaminating the rest of your facility when going from one area to the next. Make sure that you only go to contaminated areas at the very end of your day, and when you’re done working in that area, you must immediately exit the building. Do not ever walk back through the uncontaminated parts of your facility or the pests will spread quickly.

An aphid on a plant in a greenhouse

When most people think of pests in their cannabis garden they think of the more common varieties: spider mites, russet mites, aphids and thrips. However, there are also soil-dwelling pests that can exist, without your knowledge. These will decrease the health and vigor of your plants, without you even knowing they’re there, if you’re not careful to check for them. Some of the soil dwelling pests that plague cannabis plants are: root aphids, fungus gnat larvae and grubs. It is just as important to control the pests below the soil, feeding on your roots, as it is to control the pests that feed above soil on your plants.

Maintaining healthy plants is essential to controlling pest populations, both on the foliage and below the soil. Healthy plants will have an easier time fighting off pests than unhealthy plants. Plants have immune systems just like humans, and the stronger the plant’s immune system, the more likely it will be able to ward off pests and diseases. Allowing a plant to reach its full potential, by minimizing pests, means your plants will also have a better quality, smell and flavor, not to mention a bigger yield.

Worker Safety, Regulation and REI times

The application of pesticides requires certification from the state agricultural department. In certain situations, depending on the type of pesticide and method of application, a license may even be required. The application of pesticides without proper certification is against the law. Applying pesticides in a manner that is not in accordance with the label and instructions is also a violation of law.

The proper personal protective equipment (PPE) is required for anybody handling, mixing or applying pesticides. Employees can be a liability to your company if they are applying pesticides improperly. Make sure you and your entire staff are well educated about pesticide use requirements and limitations, prior to usage, and that only a properly certified person is handling the mixing and application at your facility.

The author, David Perkins, In his greenhouse after using insect killing soap.

After a pesticide is applied, you must abide by the re-entry interval (REI). This is the required time period limiting all workers from re-entry into areas where pesticides have been applied. This time period will vary depending on the type of pesticide used and the method of application. In some instances, pesticides applied in the last 30 days may require employee training before work can be done in those areas.

The misuse of or improper handling of pesticides is not only unlawful and dangerous to human health, but can also cause environmental damage to waterways and wildlife. The direct effects of pesticides on wildlife include acute poisoning, immunotoxicity, endocrine disruption, reproductive failure, altered morphology and growth rates and changes in behavior. Pesticides can indirectly impact wildlife through reduction of food resources and refuses, starvation due to decreased prey availability, hypothermia and secondary poisoning. Section 1602 of the California Fish and Game Code governs requirements for permitting of any project where pesticides will be used, and strictly regulates the disposal of all waste and run-off. It is imperative to know the regulations and to abide by them, or heavy fines will ensue!

Using Pesticides in a Regulated Market

Knowing which pesticides you can’t use, to avoid failing mandatory state testing, is just as important as knowing which ones you can use safely to pass required testing. Most states with regulated markets have strict limitations on the pesticides that can be used in cannabis cultivation. Pesticide use in the cultivation of cannabis is the most strictly regulated in the agriculture industry; the pesticides allowed for use in cannabis cultivation are far more limited than any other crop.

Photo: Michelle Tribe, Flickr

Just because a product is certified organic does not mean that it can be used, or that it is safe to be consumed or ingested. Oftentimes when cannabis flower alone is tested it will not fail or show a detectable amount of pesticides or heavy metals. However, when that flower is turned into concentrates, banned substances are then detected in testing, leading to test failures.

Cannabis cultivation facilities that are located on land that was previously used for conventional agriculture, or located near vineyards or other agricultural crops that are heavily sprayed with harmful pesticides, run a very high-risk failing testing. This is because of either spray drift from nearby agriculture, or residual pesticides and heavy metals left in the soil from previous crops that were using pesticides banned for cannabis cultivation. Accordingly, if you’re going to be growing outdoors or in a greenhouse, it is imperative that you get a soil and water test prior to cultivation, so you can determine if there is any potential for test failures due to pesticides or heavy metals in the soil or water in that area. 

Proper Application – Using the Right Tools in the Right Way at the Right Time

One of the most important factors in pest management is proper identification of pests and proper application and coverage of pesticides. It does not require an entomology degree to identify insects, these days there is a lot of information online that can help you identify cannabis pests. Proper identification of insects can make the difference between success and failure. With a good eye and a microscope, if you do your research, you can control most insects in your garden.

In order to control pests in your garden you must get proper coverage of the foliage of the plant when you are applying pesticides. There are different types of equipment that are commonly used to apply pesticides in cannabis cultivation: backpack sprayers, foggers, and airless paint sprayers are the most common. An alternative method involves using an automated dosing system such as a dosatron, which injects fertilizer or pesticides at a specific ratio into your water lines, allowing you to use only the exact amount of pesticide you need. That way you avoid wasting money on unused pesticides. It is also safer for employees because it minimizes employee exposure, since there is no mixing required, and it allows for a large volume to be sprayed, without refilling a tank or a backpack sprayer.

No matter what you are using you must ensure you get the proper coverage on your plants in order to control pests. The temperature and humidity of your cultivation area, as well as the PH and temperature of the pesticide solution, all factor into the success of your IPM. For example, PFR 97 needs to be applied at a higher humidity range, around 70% to be most effective. In some areas this is not possible so repeated applications may be required to ensure the application is effective. A high PH or alkaline PH can cause alkaline hydrolysis which will make your pesticide solution less effective and will dictate how long your pesticides remain effective after they are mixed. It is therefore important to use your pesticide solution as soon as you make it; don’t let it sit around for long periods of time before use or it will be less effective.

In cannabis cultivation there are two different primary growth cycles: vegetative and flower. These cycles require different IPM strategies. In general, during the flowering cycle, pesticides should not be applied after the second week, with some limited exceptions i.e. for outdoor cultivation there is a longer window to spray since the flower set takes longer than a plant being grown inside, or in a light deprivation greenhouse, where there is a 12/12 flowering cycle.

Starting with an immaculate vegetation room is crucial to maintaining pest and mold free plants in the flowering cycle.

For the vegetative (non-flowering) cycle, a strict rotation of foliage spray applications targeting not only pests, but also molds and pathogens, will be necessary to avoid a quick onset of infestation. Starting with an immaculate vegetation room is crucial to maintaining pest and mold free plants in the flowering cycle. Preventative sprays that are safe for use include: safer soap (contact kill) for soft bodied chewing insects; Regalia (biological control) for powdery mildew; and PFR 97 (biological control) for soft bodied chewing insects. It is also helpful to spray kelp, which strengthens the cell walls of plants, making the plant healthier, and thus enabling the plant to better defend itself from pests and diseases. Also, Bacillus thuringiensis (Bt) is useful to prevent or kill caterpillars.

The best way to control a pest infestation in the flowering cycle is at the very beginning on day one. You must start aggressively, with a three-way control consisting of a contact kill and preventative during days 1-14; preventative and biological control during days 10-18; and then release predator bugs on day 25, for optimal results. Knocking back the population with an effective contact kill pesticide early on is essential to ultimately lowering populations throughout the grow cycle, so that you can spray a biological control to preclude them from returning, before you release the predatory bugs at the end of the cycle.

Biological controls can take anywhere from 3 to 10 days before they are effective. Biological pesticides are selected strains of bacteria or fungus. When the plant tissue is eaten by a targeted pest, the bacteria kills the pest from the inside providing control without having to spray pesticides repeatedly. Predator bugs are the last line of defense, used in late flowering. They can be used indoors, outdoors and in greenhouses. An example of a common predator bug is Amblyseius californicus used to control low populations of spider mites, but there are many different varieties and they are specific depending on the type of pest population you seek to control.

A common concern with the use of predatory bugs, is whether they will be present when the flowers are harvested. However, if there is no food for the bugs (i.e. pests) the predator bugs will leave in search of food elsewhere. Further, indoor predator bugs are usually very small in size and difficult to see to an untrained eye. It is very unlikely to see any signs of predator bugs near the end of the flowering cycle, or in the finished flower product. Even when using bigger predator bugs, the bugs will leave the plants when harvested and dried.

Having pests can be very stressful. It is not uncommon to have bugs, pests, rodents, animals and birds cause damage in cannabis gardens. Making an informed decision based on science and not on unproven assumptions can determine how successful you are at pest management. There are many factors that go into pest management and no one situation is the same. You must be dedicated and consistent; pest management never stops. You will always have something ready to invade your garden. Prepare, plan, prevent and repeat!

european union states

International Supply Chains: Considerations for European Imports

By Marguerite Arnold
1 Comment
european union states

The recent decision in Germany on the reclassification of CBD (kudos to the European Industrial Hemp Association) as something other than “novel” has now opened an interesting new discussion in Germany and by extension, Europe.

It basically means that hemp plants, if they are European in origin, can be grown (under the right regulatory structure starting with organic) and even extracted without ever being considered a “novel food.”

Look for (hopefully) similar discussions now across Europe and the UK where the Food Safety Authority is also examining similar policies.

What this ultimately means, however, is that the market is clearly opening on the CBD front, but only for products that make the grade.

What should the average producer or manufacturer from North America think about when setting up a supply chain for export?

Regulations

Thanks to the new treaties in place between the United States, Canada and Europe right now, there are market openings in the cannabis industry in Europe. Starting with the fact that the cannabis bug has clearly hit the continent, but there is actually not enough regulated product to be found yet and just about anywhere.

This is keeping prices high right now, but do not expect that to last.

european union states
Member states of the EU, pre-Brexit

Regardless, pricing of imports will not be like anything you have experienced if your background is state or even national market in the U.S. or Canada. There are higher regulations in every direction in Europe. Understanding how to translate the same into equivalencies that do not bankrupt you, overprice your products, or worse, get you in trouble with authorities is a critical first step, and not one to be taken lightly.

Get professional guidance from the country you are hoping to export to, at minimum. And that includes the legal kind. Every step of the way, you have to be certified with, at minimum, federal if not at an international certification.

No matter what cannabinoid is in the mix, this is ultimately a plant-based product. All rules one would normally think about when talking about other food products (for starters) are in the room.

While it is far from “this easy” (although thanks to the USDA’s decision about hemp, not to mention the FDA update on its own deliberations, there are now federal standards), think about the problem this way: If you were the world’s best chocolate bar, or even tomato juice, how would you hit Europe right now?

They have tomatoes here, and unbelievably great chocolate already. What is it about your offering that can stand out?  This is the million-dollar question. There are a few people and companies doing this right now, but it takes experience, and understanding the multiple regulatory guidelines involved. Once you figure that out, then you need to look at your supply chain, piece by piece and literally from the plant through end production for where you fit, and where you might not, into the regulatory discussion and market you hope to enter.

The Medical Discussion

There is now the possibility of exporting medical grade hemp and hemp extracts from the United States to Europe. However, everything must be GMP-certified to a medical standard, from organic production on up. This is an international standard, not an American one.

GMPThat qualification does not exist much in the cannabis industry in the United States (although ISO very much is) yet. Although it is dawning. On the Canadian side, there are plenty of companies in the discussion, because there is already a beaten path to export.

As the German cultivation bid proved, European certification, certainly is a high barrier to reach. Indeed, it is not only GMP certification in the room on the medical side but also rules about the import of all plant products.

From this perspective, it is also easier to import “finished” product rather than plant.

The Recreational Discussion

Before anyone gets too excited about recreational reform, the reality is that Europe is not going to step ahead of the UN (which has now pushed its next deliberation on the topic to the end of 2020). Yes, there are trials in a couple of places, but far from earth-shaking (recreational trials in the land of the coffee shop anyone?)

More interesting, of course, is what has just happened on the CBD side. But before American hemp farmers get too excited about this, they have hemp and farmers in Europe. And quite a few people have seen the light on this one already.

Sure New York state exports to Europe are probably in the offing, but so are hemp exports from the Southern states where the weather is warmer and the labor cheaper.

The European Union’s logo that identifies organic goods.

Certified labs, processing and extraction, and labelling are all in the mix. And every step must be documented as you go.

How to Proceed?

Whatever your crop or product is, take stock of the certifications you have now. If your plant was not organic, forget export anywhere. You are out of the international game.

However, with this taken care of, look at the certification requirements in Europe for extraction, processing and import of food and plant products and obtain production partners with the same – either in the US or abroad.

With luck, patience, skill and knowledge, yes, the doors are slowing opening, even to U.S.-based cannabis trade of the international kind.

Just don’t expect it to be easy, and leave lots of time for workarounds, pivots and even re-engineering at every point of the way.