Tag Archives: ISO 17025

USDA’s Hemp Testing Rules: Fast Track Your Lab’s Preparedness with Digitization

By Martha Hernández
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The United States Department of Agriculture (USDA) issued a Final Rule (FR) on hemp testing that went into effect on 22nd March 2021. Consequently, all hemp testing laboratories must familiarize themselves with what is stipulated in the FR and do all that is required to comply.

The 2014 Farm Bill put to an end to years of hemp prohibition, at least to some extent. It also paved the way for the 2018 Farm Bill that brought hemp at par with other agricultural crops. States, through their departments of agriculture and institutions of higher learning, were allowed to cultivate industrial hemp for research purposes, under what was called the hemp pilot programs. Some states also allowed individuals to cultivate hemp to investigate the economic and agronomic viability of the crop. This increased the acreage of industrial hemp from zero to about 90,000 by 2018 when the Agricultural Act that legalized hemp was passed. Some of the states that participated in this program included Colorado, Kentucky, Montana, and Oregon.

As expected of a new project, some challenges cropped up, including:

  • Inconsistency in the quality of hemp produced for research
  • Varying hemp laws between states
  • Maintaining regular supplies of inputs such as seeds and pest control
  • Lack of appropriate knowledge and technology

The 2018 Farm Bill addressed some of these challenges through the Hemp Farming Act that proposed to remove hemp from Schedule 1 of the Controlled Substances Act. Hemp, in this case, refers to cannabis sativa that contains less than 0.3% THC by “dry weight.” Proposals in the hemp act were incorporated into the 2018 U.S. Farm Bill and it became law in December 2018, thus making hemp legal at the federal level.

Unlike other agricultural commodities, hemp is a highly regulated crop because of its close association with cannabis which is still under Schedule 1 controlled substances. Once hemp exceeds the 0.3% THC threshold, it becomes classified as cannabis and is, therefore, governed under a different set of regulations.

The next step after the legalization of hemp was to roll out a nationwide hemp cultivation and distribution program. Consequently, the U.S. Food and Drug Administration (FDA) was instructed to develop a national framework to regulate the production of hemp in the U.S. An Interim Final Rule (IFR) was published in October 2019 to set the ball rolling. A final rule was published as an improvement of the IFR in January 2021. The Final Rule was created based on public comments received during the period as well as direct lessons learned in the 2020 growing season. The Final Rule took effect on 22nd March, 2021.

A schematic representation of the key federal rules for hemp testing laboratories (Figure courtesy of CloudLIMS)

The USDA requires that all hemp be tested by a third-party laboratory to ensure that quality is maintained and that the THC threshold is not exceeded. The Final Rule made significant changes to the USDA’s hemp testing rules that will affect how laboratories carry out their operations. While the guidelines were issued on January 15, 2021, they went into effect on March 22 of the same year. If you are a hemp-testing laboratory, here are the most important changes that you should brace for.

Nine Changes Hemp Testing Labs Must Comply With

  1. Changes in sampling 

Previously, samples to be tested were restricted to the top third portion of the hemp plant. With the Final Rule, samples can be taken anywhere from 5-8 inches from the main stem (including the leaves and flowers). This provision offers greater flexibility and reduces the chances of “hot” hemp.

  1. Laboratories shall use specific testing methods

According to the Final Rule, hemp-testing laboratories must use reliable methods to test for THC concentration. This includes methods such as post-decarboxylation; they take into consideration the conversion of THCA to THC after decarboxylation. Currently, methods that meet these requirements include gas chromatography and liquid chromatography.

The USDA also expects that laboratories demonstrate consistent testing reliability and validity. The test methods used must have high specificity for THC and other tested compounds.

  1. Negligence limit raised to 1% THC

Negligence limit refers to the extra wiggle room that is advanced to hemp farmers in regards to THC testing. In the IFR, hemp that tested above 0.3% THC but lower than 0.5% was considered negligence and not a violation of federal laws. This limit for negligence has now been pushed from 0.5% to 1%. As much as the Final Rule has maintained the THC limit for hemp at 0.3%, growers now have a wider margin of error to work with.

For hemp-testing laboratories, all samples that test above 0.3% THC are still considered hot hemp and must be destroyed or remediated. However, samples testing below 1% THC are considered a negligent violation and not a criminal offense.

  1. All hemp testing laboratories need to be DEA registered

The Final Rule made it mandatory for all hemp-testing laboratories to be registered with the Drug Enforcement Agency (DEA). Getting this registration is time intensive and the number of registered laboratories is few. With this in mind, the USDA had extended the registration deadline to the last day of 2022. After the expiry of this period, laboratories that are not registered with the DEA will be barred from conducting hemp testing.

  1. Laboratories to calculate Measure of Uncertainty (MU)

With the Final Rule, laboratories are expected to calculate and include the MU when reporting test results. The Guide to the Expression of Uncertainty in Measurement (GUM) defines MU as “a parameter, associated with the result of a measurement, which characterizes the dispersion of the values that could reasonably be attributed to the measurand.”

While there is no upper or lower limit for the MU, it is controlled using performance standards such as AOAC Standard Method Performance Requirements. Organizations such as ISO and Eurachem also provide guidelines for calculating MU. Hemp testing laboratories can refer to those guidelines as well.

  1. Adherence to the ISO 17025 standards

While this is not an enforceable rule, the USDA strongly recommends all hemp testing laboratories be ISO 17025 compliant.

  1. Laboratory SOPs

Testing laboratories must have an internal SOP for testing and retesting hemp. This SOP should be available upon request by state sampling agents or other responsible agents. Laboratory managers should ensure that all staff members follow the SOPs.

  1. Reporting of THC

Once a laboratory has completed the test, whether failed or passed, they should share the results with all stakeholders:

  • The licensed producer
  • The appropriate State Department of Agriculture or Tribe
  • The USDA using AMS Form 22.
  • The THC should be reported on a “dry weight” basis.
  1. Remediating and retestingof hot hemp

Once a laboratory finds a sample that has tested above 0.3% THC, it has to flag it as “hot” hemp. Previously, all hot hemp had to be destroyed but with the FR, parts of the hemp (excluding the flowers) can be salvaged.

A Laboratory Information Management System (LIMS) to manage multi-analyte test results and flag hot hemp (Figure courtesy of CloudLIMS)

The licensed producers (LP) are required to shred the hemp into biomass and send a sample back to the laboratory for retesting. The laboratory shall use the same procedure to retest the biomass and report the results back to the LP and the USDA.

The hemp final rule took full effect on the last day of 2021. The only extended deadline is the one requiring that all hemp-testing laboratories be registered with the DEA that still has a few more months to go.

Fast Track Your Laboratory’s Preparedness with a LIMS

Becoming compliant with USDA’s hemp testing rules can be quite challenging for a laboratory simply because there’s too much to keep up with. A laboratory must monitor samples, analyze and report test results, and at the same time maintain internal quality protocols.

Fortunately, digitization can help streamline processes and accelerate the preparedness of laboratories for the new federal rules. A cloud-based Laboratory Management Information System (LIMS) takes the hard work out of compliance by keeping track of compliance processes seamlessly and in real-time.

A LIMS enables laboratories to:

  • Track samples through their lifecycle
  • Automatically share results with stakeholders
  • Flag hot hemp samples
  • Generate certificates of analysis (COAs) in prescribed formats
  • Meet regulatory compliances
  • Manage SOPs, staff training, and QA/QC protocols

Hemp that tests above the 0.3% THC mark is considered cannabis and is therefore illegal under federal law. Consequently, hemp testing is a highly sensitive process that is strictly regulated. Hemp-testing laboratories must optimize their processes to ensure efficiency at all times and assure the validity of their test results. This can be made possible with a LIMS.

Kelab Analitica Becomes First Accredited Cannabis Lab in Colombia

By Cannabis Industry Journal Staff
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Established in 2019, Kelab Analitica is the first laboratory in Colombia to specialize in cannabis and pharmaceutical testing. In March of 2020, the lab began operating and serving the cannabis market in the South American country.

Then in December of 2020, Kelab Analitica obtained ISO/IEC 17025:2017 through Perry Johnson Laboratory Accreditation, making it the very first cannabis testing lab in Colombia to attain accreditation. The lab was also certified shortly after in Good Laboratory Practices by Colombian health authorities for analysis of pharmaceutical products.

The lab has found that ISO 17025 accreditation has helped with their marketing strategy. “As the industry grows, more producers are beginning to understand the importance of working with an accredited laboratory for quality and consistency of results and to comply with international requirements,” says a team member at Kelab Analitica.

In the future, they plan to expand their reach locally in Colombia and look for opportunities to expand in Latin America. They are also engaged in research in chromatography and instrumentation to develop new cannabis testing methods.

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.”

Cannalytics Becomes First Accredited Cannabis Lab in Puerto Rico

By Cannabis Industry Journal Staff
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In a press release sent out this week, A2LA announced they have accredited Cannalytics to ISO 17025:2017. With the finalized accreditation in December 2020, Cannalytics is the first cannabis testing laboratory in Puerto Rico to get accredited to the standard.

Jorge Diaz, owner and director of Cannalytics, says their two main objectives are business excellence and quality. “Being the first ISO/IEC 17025 accredited cannabis laboratory in Puerto Rico affirms our mission to provide continuous quality science to our clients while safeguarding the health of Puerto Rico’s medical cannabis patients,” says Diaz.

Cannalytics is a medical cannabis and hemp testing lab based in San Juan, Puerto Rico. They offer compliance and R&D analysis in their suite of testing services.

“We are glad to see the continued growth of our cannabis program in a new territory, which further promotes the value that accreditation adds in ensuring quality in this emerging industry,” says Anna Williams, A2LA Accreditation Supervisor.

Trichome Analytical Accredited, DEA-Registered

By Cannabis Industry Journal Staff
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In a press release sent out this week, Trichome Analytical, based in Mount Laurel, New Jersey, announced two new developments for their business: They have achieved ISO 17025:2017 accreditation and they are officially registered with the DEA for hemp compliance testing.

The press release also mentions their collaboration with Shimadzu, who supplies 80% of the lab’s equipment and supports the Trichome’s operations with technical guidance.

For the hemp industry, pre-harvest testing for THC levels is a requirement and labs are required to get registered with the DEA in order to perform that testing.

These announcements are somewhat timely, given the results of the election. Voters in New Jersey approved adult use cannabis legalization just last week.

Trichome Analytical Accredited to ISO 17025

By Cannabis Industry Journal Staff
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According to a press release sent out last week, the American Association for Laboratory Accreditation (A2LA) announced the accreditation of Trichome Analytical to ISO/IEC 17025:2017. Trichome Analytical is the first cannabis testing lab accredited to the standard in the state of New jersey.

Based in Mount Laurel, New Jersey, Trichome Analytical is a DEA-registered third-party cannabis testing lab that offers hemp compliance testing for state and federal guidelines.

Kristen Goedde with Trichome Analytical says they are hoping to provide testing for consumer safety and accurate labeling for the state’s new hemp market. “The evolution of the hemp and cannabis industries increasingly demands rigorous, high quality analytical testing,” says Goedde. “Obtaining accreditation is an essential measure for laboratories seeking to ensure consumer safety and reliable labeling. Trichome is honored to have our quality systems validated by A2LA, and we look forward to elevating cannabis and hemp operations to new heights – right here in our home state.”

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.”

ANAB Accredits ABKO Labs

By Cannabis Industry Journal Staff
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The ANSI National Accreditation Board (ANAB) accredited ABKO Labs, LLC, to ISO/IEC 17025. ABKO Labs is a cannabis and hemp testing laboratory based in Warren, Michigan.

According to the press release, ABKO Labs achieved ISO/IEC 17025 accreditation in Michigan with the help of ANAB. The lab earned the accreditation in general requirements for the competence of testing labs, demonstrating competence in chemistry in microbiology.

“We are very proud of our accomplishments in the cannabis lab space in Michigan and we look forward to continuing to offer accurate and prompt results,” says Amy Brown, CEO of ABKO Labs, LLC.

Cannabis Testing Laboratories (CTL) Becomes First ISO-Accredited Hemp Lab in Nebraska

By Cannabis Industry Journal Staff
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In a press release published last week, Cannabis Testing Laboratories (CTL) announced they have achieved ISO 17025 accreditation as part of the Nebraska Department of Agriculture requirements for cannabis labs operating in the state. CTL is a wholly-owned subsidiary of Doane University, a liberal arts college in Crete, Nebraska.

Dr. Arin Sutlief (in back) and Dr. Andrea Holmes preparing samples for cannabinoid analysis by HPLC.

According to the press release, CTL will be renting space on Doane University’s campus for its primary laboratory. Doane University is working on an effort to foster innovation where they create spaces on campus for entrepreneurial startups. Dr. Andrea Holmes, Director of Cannabis Studies and Professor of Chemistry at Doane University, is the founder of CTL.  Dr. Arin Sutlief is the director of the laboratory as well, which means CTL is led by an all-female management team.

Dr. Holmes says hemp testing should be a priority for the state’s new industry. “Being the first ISO-accredited and state approved cannabis testing laboratory in Nebraska will allow farmers, processors, vendors, and even consumers of CBD and hemp products to have local access to high-quality and reliable testing,” says Dr. Holmes. “For farmers, continuous testing is of utmost importance so they don’t grow hemp over 0.3% total THC levels, at which point hemp is categorized as marijuana, which is currently illegal in Nebraska. Consumers of CBD products will also benefit from private testing as oftentimes CBD-infused products don’t actually contain what the label says.”

Hemp weighed for sample preparation for cannabinoid analysis by HPLC.

CTL will operate independently of the university, but the lab will be a resource for faculty and students. There will be internship and experiential learning opportunities available at the lab for students. In addition to that, the lab will also help faculty that teach cannabis-related courses.

Last year, Doane University announced the launch of their Professional Cannabis Certificate Program. In June of this year, the university expanded their course offerings in cannabis, with seven courses available this fall. The addition of CTL to the Crete, Nebraska campus will benefit those new courses and provide more resources to those in the certificate program.

“I am proud to be one of the creators of a fully accredited cannabis testing lab that provides our farmers and processors reliable and quick local testing of hemp,” says Dr. Sutlief. “CTL is among the first ISO-certified cannabis testing labs in the U.S. that is a subsidiary of a university. Innovation, research, entrepreneurship and education will be the central pillars of CTL as we set ourselves apart to become leaders in cannabis testing not only in Nebraska and the Midwest but also nationally.”

ACS Laboratory Get Certified for Cannabis Testing in Florida

By Cannabis Industry Journal Staff
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According to a press release published earlier this week, ACS Laboratory announced the Florida Department of Health Office of Medical Marijuana Use (OMMU) has certified ACS to test products for medical dispensaries in the state.

This certification comes after the Florida Department of Health adopted an emergency rule, requiring dispensaries to only use a certified lab for product testing. Dispensaries (or medical marijuana treatment centers as the state calls them) in Florida have until December 24, 2020 to sell products tested before June 24, 2020.

ACS Laboratory was founded in 2008. They are DEA- and AHCA-licensed, ISO 17025-accredited and CLIA-accredited with the largest testing facility in the eastern United States, according to their press release. They are USDA-compliant and certified by Florida to test hemp in the state and are now also certified to test medical cannabis products.

As a certified cannabis testing lab in Florida, ACS has to meet a list of requirements, similar to rules one might find in other legal states. The Florida rules mandate that labs are ISO-accredited and qualified to accurately test for contaminants, moisture content and cannabinoid potency.

Earlier this year, ACS acquired Botanica Testing, Inc., which added about 500 new hemp and CBD clients to their portfolio. ACS Laboratory now has customers in 44 states.