Tag Archives: regulations

By Cori Goldberg, Adam Brownrout, John Kendzior

On October 29, 2019, the USDA released its long-awaited draft rule establishing a domestic hemp production plan, providing clarity to growers and ancillary businesses about how the USDA will regulate the hemp crop. The USDA, under authority provided by the 2018 Agricultural Improvement Act (2018 Farm Bill), was tasked with promulgating regulations and guidelines to establish and administer a program for the production of hemp in the United States. This rule has now arrived and been published in the Federal Register. The rule provides requirements for all state and tribal hemp production plans including requirements for testing hemp, licensing growers, disposing of non-compliant hemp, and collecting and storing information related to hemp production. The USDA will now accept public comment on the rule until December 30, 2019.

Although the USDA rule will greatly contribute to the expansion of legally grown hemp in the United States, this rule does not alter the law regarding CBD foods and CBD dietary supplement products. This is because the 2018 Farm Bill left intact FDA’s authority to regulate the sale and marketing of CBD foods, dietary supplements, drugs, and cosmetics, as those product types fall under FDA’s purview generally. FDA has allowed the sale of CBD cosmetics, with certain restrictions, and companies may submit CBD products to FDA through FDA’s drug approval process. However, it has maintained that the addition of CBD to foods and dietary supplements is illegal. Under the federal Food, Drug, and Cosmetic Act (FDCA), once a substance is approved as an Active Pharmaceutical Ingredient (API) in an FDA-approved drug, that substance may not be placed into interstate commerce in a food. Also under the FDCA, once a substance is approved as an API in an FDA-approved drug, that substance is excluded from the definition of a dietary supplement. FDA approved the pediatric epilepsy drug, Epidiolex, whose API is CBD. Therefore, FDA has concluded that CBD may not be placed into foods in interstate commerce and that CBD products are excluded from the dietary supplement definition and therefore may not be sold as dietary supplements. The USDA rule does nothing to change the legal status of CBD food or dietary supplement products. Thus, despite the expected increase of hemp availability following the passage of the USDA rule, CBD companies must wait for the FDA green-light in order to manufacture or sell hemp-derived CBD food products lawfully.Learn more about important regulatory & quality issues in the cannabis space from Cannabis Industry Journal

However, the rule does state that additional hemp is necessary to support the growing CBD market, and it notably put pressure on FDA by stating that if “FDA does not provide clarity about their plans for future regulation of CBD, there will continue to be uncertainty and downward pressure on the CBD portion of the hemp market.”

So what does the USDA rule do? Under the USDA rule, states and tribes will have the option of either submitting a proposed hemp regulation plan to the USDA for approval or agreeing to submit to the USDA’s general requirements. All state and tribal plans must include certain provisions, including but not limited to:

Land used for production: State and tribal plans must identify a process for collecting, storing and maintaining relevant information regarding land used for growing hemp in the state. This includes information regarding the description, acreage, and boundaries of the farm land.
Sampling and testing for delta-9 tetrahydrocannabinol (THC): State and tribal plans must implement testing procedures to ensure that plants do not exceed THC levels above 0.3% (as provided in the 2018 Farm Bill). All testing facilities must be DEA approved, as non-compliant product with THC levels over 0.3% would be considered “marihuana” and a schedule 1 substance under the Controlled Substances Act of 1970 (CSA). Additionally, laboratories will be required to report a “measure of uncertainty” in their testing, designed to provide a buffer for the potential variation in sampling and testing procedures. Accordingly, plants testing higher than 0.3% THC but still within the “measure of uncertainty” will be considered compliant.
Disposal of non-compliant products: States and tribes must develop a procedure for destroying non-compliant cannabis containing more than 0.3% THC. Because non-compliant product is considered a controlled substance, all product must be disposed of in a manner consistent with the CSA. Therefore, product must be collected and destroyed by a DEA agent or law enforcement officer.
Inspection of hemp producers: States and tribes must develop procedures for inspecting hemp producers on an annual basis and also for inspecting random samples. The state must also develop procedures to identify and attempt to correct certain negligent acts such as not obtaining licenses or producers exceeding acceptable hemp THC levels.
Information sharing: State and tribal plans must include procedures for reporting information to the USDA. This information must be provided to the USDA within 30 days of receipt from the hemp producers and includes contact information for all hemp producers in the state, legal descriptions of the land used for hemp production, and the license status of all hemp producers in the state.
In states and tribes without an approved or proposed plan, hemp producers will be subject to the USDA general plan. The general plan also provides similar requirements for the testing and sampling of hemp. The USDA will provide licenses directly to hemp producers in states without an approved or submitted plan as some states may not want to have primary regulatory authority of hemp. These states will essentially hand over regulatory responsibility to the USDA. These licenses will be available by application 30 days after the final rule is published. Notably, the draft USDA rule also provides that states and tribes are restricted from prohibiting the transportation or shipment of hemp or hemp products produced under a state plan, tribal plan or a license issued under the FDA. The interstate commerce provision should put an end to the arrests of those transporting legally produced hemp from one state to another. For example, in July 2019, a trucker was arrested and charged with felony possessions of marijuana and intent to distribute while transporting legally grown hemp through South Dakota (South Dakota still considers hemp a controlled substance).

So while the USDA rule is much anticipated and grabbed the attention of many when published, food and dietary supplement manufacturers, distributors, and retailers are still stuck where they were before. We will all continue to wait and see what FDA will do.

Resource

“Establishment of a Domestic Hemp Production Program”. (October 31, 2019). Federal Register. Retrieved from https://www.federalregister.gov/documents/2019/10/31/2019-23749/establishment-of-a-domestic-hemp-production-program.

October 22, 2019

FST Soapbox

Modeling Cannabis Safety from Food and Beverage Quality Regulations

By Jill Ellsworth

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There’s a reason you can eat or drink pretty much anything you want from American grocery stores and not get sick. Food manufacturing is highly regulated and subject to rigorous quality control.

Before food and beverages hit store shelves, the manufacturer must have a Hazard Analysis Critical Control Point (HACCP) system in place. The HACCP system requires that potential hazards—biological, chemical and physical— be identified and controlled at specific points in the manufacturing process. In addition, fresh foods undergo a kill-step. This is the point in the manufacturing or packaging process where food is treated to minimize and remove deadly pathogens like bacteria, mold, fungus and E. coli.

Generally speaking, when cannabis hits dispensary shelves, a less stringent set of rules apply, despite the fact that cannabis is ingested, inhaled and used as medicine. Cultivators are required to test every batch, but each state differs in what is required for mandated testing. Compared to the way food is regulated, the cannabis industry still has a long way to go when it comes to consumer safety—and that poses a considerable public health risk. In the early stages of legalization, the handful of legal states did not have rigid cannabis testing measures in place, which led to inconsistent safety standards across the country. State governments have had a reactionary approach to updating testing guidelines, by and large implementing stricter standards in response to product recalls and customer safety complaints. While local regulators have had the best intentions in prioritizing consumer safety, it is still difficult to align uniform cannabis testing standards with existing food safety standards while cannabis is a Schedule I substance.

The stark differences in safety measures and quality controls were first obvious to me when I moved from the food and beverage industry into the cannabis industry. For five years, I operated an organic, cold-pressed juice company and a natural beverage distribution company and had to adhere to very strict HACCP guidelines. When a friend asked me for advice on how to get rid of mold on cannabis flower, a light bulb went off: Why was there no kill step in cannabis? And what other food safety procedures were not being followed?

What to know more about all things quality, regulatory and compliance in the cannabis industry? Check out Cannabis Industry Journal and sign up for the weekly newsletterThe current patchwork of regulations and lack of food safety standards could have dire effects. It not only puts consumer health in jeopardy, but without healthy crops, growers, dispensaries and the entire cannabis supply chain can suffer. When a batch of cannabis fails microbial testing, it cannot be sold as raw flower unless it goes through an approved process to eliminate the contamination. This has severe impacts on everyone, starting with the cultivator. There are delays in harvesting and delivery, and sometimes producers are forced to extract their flower into concentrates, which really cuts into profits. And in the worst cases, entire crop harvests may have to be destroyed.

So, what do cannabis cultivators and manufacturers have to fear the most? Mold. Out of all the pathogens, mold is the most problematic for cannabis crops, perhaps because it is so resilient. Mold can withstand extreme heat, leaving many decontamination treatments ineffective. And most importantly, mold can proliferate and continue to grow. This is commonplace when the cannabis is stored for any length of time. Inhaling mold spores can have serious adverse health effects, including respiratory illness, and can even be deadly for immunocompromised consumers using it for medical reasons.

What the industry needs is a true kill step. It’s the only way to kill mold spores and other pathogens to ensure that they will not continue to grow while being stored. States that mandate microbial testing will benefit from the kill step because more cultivators will be in compliance earlier in the process. In states that don’t require comprehensive microbial testing, like Washington and Oregon, the kill step is a critical way to provide consumers with a preemptive layer of protection. Microbial testing and preventative decontamination measures encourage customer brand loyalty and prevents negative press coverage.

Adopting a HACCP system would also build additional safeguards into the system. These procedures provide businesses with a step-by-step system that controls food safety, from ingredients right through to production, storage and distribution, to sale of the product and service for the final consumer. The process of creating HACCP-based procedures provides a roadmap for food safety management that ultimately aligns your staff around the goal of keeping consumers safe.

It’s high time for the cannabis industry to adopt FDA-like standards and proactively promote safety measures. Cannabis growers must implement these quality controls to ensure that their products are as safe to consume as any other food or drink on the market. Let’s be proactive and show our consumers that we are serious about their safety.

Ravi Ramadhar, Food Safety Business Director for Life Sciences Solutions, Thermo Fisher Scientific

August 6, 2014

In the Food Lab

Molecular Diagnostics – Generation 3: 2005 to Present

By Ravi Ramadhar

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In my previous blog, I covered the first two generations of Molecular Diagnostics: Generation one, was the advent of these tests prior to 1995, while the second generation saw the evolution of molecular diagnostics with the emergence of standardized food molecular and method workflow.

The advent of automated DNA sequencing and use of multiple fluorescent dyes by companies like Applied Biosystems and Roche led to the development of multiple fluorescent dyes and real- time quantitative PCR systems (qPCR). At first these qPCR systems were only used in the research environment, but quickly found their way to the food industry.

Applications such as quantitation of GMOs and multiple pathogen targets became common. Real-time PCR systems permitted users to visualize amplification as it happened and enabled simultaneous detection of multiple targets. With the use of newer chemistries and improved enzymes, shorter amplification cycles – sometimes as low as 40 minutes – could be achieved. The real-time systems offered faster time-to-result with additional target probes and thus higher target specificity. As with most molecular methods, the workflow was sensitive to food matrix inhibition and required alternative sample preparation methods to meet the wide variety of food matrixes.

Within this generation of solutions, alternatives were introduced, that promised faster, easier or more sensitive results. These included alternative to either the detection method or enzymes utilized Iisothermal amplification, for example without need for multiplexing capability of qPCR or internal controls, as well as targeting alternative nucleic acid such as RNA were introduced to the food market. These incremental improvements did not lead to any significant new paradigms or improvements to the food testing workflow. Their emergence instead led to an explosion of additional and alternative molecular platforms for food, without any real innovation. Within this, solutions introduced to the food industry eventually brought us to where we are today.

Directly taking systems from the clinical diagnostics workflow and introducing these platforms and systems as food solutions. While these systems automate the entire workflow or automate the PCR setup it remains to be seen if with their higher complexity and high maintenance these systems can survive the food industry. The basic molecular workflow for food has remained intact since its introduction in the late 1990s with innovation more or less stagnant. What’s needed is for someone to truly develop a platform from the ground up with the food laboratory in mind.

Today’s landscape and what’s next

Today, there are some early signals of where innovations and changes for food labs will emerge. A recent poster by Nestle, for example, highlighted the uses of next-generation sequencing (NGS) and DNA sequencing to develop a DNA method to allow the identification of coffee varieties through the value chain, from the field to the finished product. The method is applied on routine basis to guarantee the purity and authenticity of raw material used by Nespresso.

Applications of NGS in outbreak response and trace back investigations are being used in parallel with existing technologies. Finally, availability of new sequencing data enables better assay design and development of adjacent technologies.

NGS was preceded by emulsion amplification and sequencing by synthesis. These developments led to the development and introduction of digital PCR. Within a digital PCR reaction, millions of simultaneous reactions from one sample occur. The advantages of dPCR include lower and absolute, not relative gene copy number. The data has high precision and has better tolerance to inhibitors. These characteristics can lead to better and more precise molecular tests in food. , Before dPCR wide spread adoption is seen, however, the limitations of high cost and limited dynamic range must be addressed.

It’s not only in the testing labs and adjacent technologies that NGS is having an impact. In the labs driving innovation in food and food ingredient development, applications of NGS are being used to develop targeted food ingredients.

Nestle is the leader in this convergence of food, health and nutrition and over the last three years, the company has acquired and formed partnerships targeting the space. In its formation of the Nestle Institute of Health Sciences, Emmanuel Baetge, head of NHIS, emphasized NHIS expertise and research capabilities using systems biology, next generation sequencing, and human genetics.

The world of food safety is as dynamic as the natural flora of food itself. Changing regulations, evolving organisms, technological change and consumers’ changing tastes require new solutions. The requirements of the food laboratory have not changed. They are the protectors of brands and the teams we trust to deliver safe and quality foods. However, how they do that has and will continue to change.

Next time… molecular serotyping.

References:

Wetterstrand KA. DNA Sequencing Costs: Data from the NHGRI Genome Sequencing Program (GSP) Available at: www.genome.gov/sequencingcosts. Accessed 1/13/2014 [DOA 1/13/12014].
Beilei Ge and Jianghong Meng , 2009 14: 235 Advanced Technologies for Pathogen and Toxin Detection in Foods: Current Applications and Future Journal of Laboratory Automation DOI: 10.1016/j.jala.2008.12.012.
Morisset D, Sˇ tebih D, Milavec M, Gruden K, Zˇ el J (2013) Quantitative Analysis of Food and Feed Samples with Droplet Digital PCR. PLoS ONE 8(5):e62583. doi:10.1371/journal.pone.0062583.
http://www.nestle-nespresso.com/asset-libraries/Related%20documents%20not%20indexed/Nespresso%20poster%20ASIC2012%20DNA%20traceability.pdf

Resource

Today’s landscape and what’s next

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