Senators Push USDA To Adopt Changes To Hemp Regulations

Federal health regulators say the lack of scientific data about cannabidiol explains their delay issuing new guidance on over-the-counter CBD. The  U.S. Food and Drug Administration continues to accept comments on hemp- and cannabis-derived ingredients, months after the comment period closed, according to Sharon Lindan Mayl, senior policy adviser in the FDA’s Office of Food Policy and Response. Mayl said this week that the FDA needs more data about CBD, despite the more than 4,500 comments it has received since it began its review of regulations for hemp-derived CBD. A  landmark public meeting  about cannabis at FDA headquarters in May and the many online submissions didn’t yield enough scientific evidence in support of CBD, reported Informa Pharma Intelligence, a health care industry news source. At that hearing, an exchange between FDA analysts and a Colorado doctor underscored the problem. FDA officials asked Dr. Kevin Chapman, who was testifying on behalf of the American Epilepsy Society, how parents of epileptic children know how much CBD to give them. “They’re making it up as they go along,” Chapman said. The request for public comments about CBD research wasn’t much better, according to Mayl. “It’s safe to say that in 4,500 comments, we did not receive a lot of hard data around the issues that we specifically requested comments on,” Mayl told a group of attorneys and regulators at a conference on Monday. Law Blocked Research Mayl said the FDA recognizes that safety studies on CBD and other cannabis extracts were rare prior to hemp being descheduled as a controlled substance last December. The agency is open to being convinced through scientific data about the safety of CBD as an ingredient, Mayl said. Particularly, Mayl said, the agency needs to see total exposure data, as the use of CBD in the consumed products raises concerns about the potential risk to consumers. (Safety data related to the FDA-approved drug Epidiolex is not being considered in the agency’s evaluation of CBD safety for use in nondrug products.) Mayl reiterated comments made a week ago by Lowell Schiller, the FDA’s principal associate commissioner for policy, who told a gathering of nutritionists that there is no bias for or against CBD. “We do not hold CBD to a higher standard of safety – but we won’t hold it to a lower standard, either,” she said. The FDA also has to weigh whether or not the lawful use of CBD and other cannabis derivatives in food, beverages and dietary supplements will hinder further drug development, Mayl said. Read more about Mayl’s comments here . Original Article: https://hempindustrydaily.com/fda-says-more-scientific-data-needed-to-move-forward-with-cbd-regulation/

Hemp farmers and industry advocates are alarmed that federal agriculture officials have brought drug enforcement back into the fold to ensure that cannabis produced for hemp in the United States does not exceed the acceptable limit of 0.3% THC. The U.S. Department of Agriculture’s  interim federal rules for hemp production , released Oct. 31, require that only laboratories registered with the U.S. Drug Enforcement Agency (DEA) will be qualified to conduct THC testing of hemp crops. Industry members worry the limitation could delay THC testing and create bottlenecks, especially in remote areas far from a DEA-registered lab. “It appears that many of the existing (DEA) labs don’t have the equipment and capacity to service the hemp industry,” cannabis attorney Shawn Hauser of Denver-based firm Vicente Sederberg said last week  during a webcast with Hemp Industry Daily . The rules propose that the U.S. Department of Agriculture (USDA) may establish an approval process for labs that want to offer THC testing services. Those labs would need certification by the International Organization for Standardization (ISO), which could be a suitable alternative, according to Hauser. If the USDA chooses to approve testing labs, it could accredit laboratories that perform to a certain quality, in addition to requiring a particular ISO accreditation. This is a departure for the DEA, which does not require labs to be accredited to handle narcotics. However, the USDA-approved labs would still have to be registered with the DEA. The alternate testing protocol “would give USDA the proper oversight of the laboratories doing the testing, providing quality assurance and control procedures that ensure a validated and qualified analysis, and defensible data,” the interim rules state. The USDA is requesting comments on the requirements for laboratories and will likely need to make changes regarding this issue, Hauser said. Lab Availability a Mystery The rules state that DEA-registered labs – and, potentially, USDA-approved labs –  will ultimately be listed on the Agriculture Department’s Domestic Hemp Production website. However, DEA spokeswoman Katherine Pfaff told Hemp Industry Daily  that agency policy conflicts with that statement. “DEA is still working through many of these details with USDA,” Pfaff wrote in an email to Hemp Industry Daily,  which asked about the testing plans. “We do not release information about specific DEA registrants, so we do not provide a list of labs registered with the DEA.” Meanwhile, laboratories looking for information on becoming DEA-registered to perform chemical analysis should visit the DEA Diversion Control Division website to apply for an analytical lab registration. Form DEA-225 should be used, according to Pfaff. DEA Anxiety For some, the idea that the DEA is involved at all is upsetting. Denver attorney Frank Robison said he counted the number of times DEA was mentioned in the rule. By his calculation, the agency had 42 mentions, compared with two references about banking. “It just shows that the priorities within the rule are skewed against the farmer in a way that would prohibit and restrict commerce as opposed to promoting commerce,” Robison told Hemp Industry Daily . “And, in my view, the intent of Congress is to promote a commercial environment and commercial industry for hemp. “We’re worried about 1,000 parts-per-million THC, when we should be worried about getting this industry off the ground and helping American farmers, providing them access to capital and making sure that their crops are insured.” Hemp industry consultant Ryan Pettigrew said it makes sense the DEA would be involved, considering that crops testing hot would technically be marijuana, which remains a Schedule 1 drug on the controlled substances list. “That one was obvious – there was really no argument to it,” Pettigrew told Hemp Industry Daily . “Granted, in a perfect world, they would just deregulate everything,” he continued. “But that’s just not going to happen.” The USDA predicted that about 20% of hemp samples collected in 2020 would exceed the 0.3% THC limit and need to be destroyed. The USDA rule lays out no plan to appeal testing results. Criminals, Not Farmers Robison contends that for the micro levels of THC involved with hemp production, the USDA shouldn’t have to involve drug law enforcement. “The USDA should have the capacity to manage 1,000 parts-per-million THC,” Robison said. The DEA should be focusing on drug criminals, not farmers, he said. “The folks that know how to work with crops are the people that should be managing the data and working with these farmers, not a law enforcement agency charged with pursuing crystal meth and fentanyl criminals,” Robison said. “They should not be even in the same ballpark.” Further, he continued, the U.S. Congress did not mean to scare farmers and put them on a watch list, but that’s the message the USDA rules send. Legitimate American farmers may have been sold “bogus seeds” or seeds that tested below 0.2% THC in Europe but went hot when grown in a warmer U.S. climate, he said. “Now, all of the sudden, because they wanted to be part of this congressionally opened-up market, why now are they in a DEA database?” Robison said. “Congress passed a law to promote the hemp industry in the United States of America,” he said. “The regs that just came down, the No. 1 thing that they accomplished, if I was a farmer, was to scare me and to provide me with a doubt of whether I should be entering this market until there is additional clarity about whether or not I’m committing a criminal activity.” Written By: Laura Drotleff Original Article: https://hempindustrydaily.com/the-dea-is-mentioned-42-times-hemp-industry-disturbed-by-agencys-involvement-in-thc-testing-rules/

Among the most critical decisions a hemp cultivator makes is where to source seeds. Without a reliable provider for hemp seed genetics, cultivators risk losing an entire crop to disease, or worse, harvesting plants that test over acceptable limits for THC. In Kentucky, for example, a company called Elemental Processing is suing HP Farms (an Oregon-based hemp seed supplier) for selling seeds that were mostly male instead of feminized, which produce hemp plants that are high in CBD (female plants are those that are grown to full maturity for eventual harvesting, whereas male plants die off shortly after having complete pollination). Elemental Processing is claiming damages of approximately $44 million in lost profits from the mix-up. The suit underscores the tremendous risk that cultivators take when purchasing uncertified, high-CBD hemp seed genetics, says Robert Hoban, managing partner at Hoban Law Group and chairman of International Hemp Solutions (IHS). Through its Bija Hemp subsidiary , IHS licenses certified hemp seed varieties from the Polish Institute of Natural Fibers and Medicinal Plants, the world's oldest industrial hemp institute. According to Hoban, most hemp varieties that purportedly produce high yields of CBD come from sources which may or not deliver as promised, given that high-CBD hemp strains remain relatively new. With little known about how such strains will perform under different circumstances, it is difficult to predict outcomes for germination rates, male-to-female ratios, or whether the plant will meet compliance-testing standards once it reaches maturity. In contrast, yields from certified hemp varieties are more predictable because those strains have a long history of use. Hoban added that it is far cheaper to use certified hemp seed genetics than high-yield CBD strains. High-yield CBD hemp seed genetics, on average, are worth around $0.60 to $5.00 per seed, and thus can cost farmers roughly $10,000 to $12,000 per acre to cultivate. Conversely, certified hemp seed genetics are usually priced around $20 per pound, and can cost about $600 per acre to cultivate. It is for those reasons that Hoban recommends that cultivators use certified hemp seeds, even if the yield on CBD is not quite as high. "Farmers are misinformed that they have to go out and spend a lot of money on high-CBD genetics," Hoban said. "Those genetics are not stable, they're not certified, and they cost a lot more per acre to grow." He added that companies which cultivate hemp only to extract CBD unintentionally exclude themselves from profiting through all the other uses for hemp (e.g., grain, fiber, or plastics). "When you plant a feminized, uncertified hemp variety that's high in CBD, it has no other purpose than to service the CBD market," he explained. "There's not much else that you can really do with that plant." While CBD is in high demand, as markets adjust to meet it, prices will inevitably decline. Growing hemp for multiple industries not only adds more revenue streams for farmers, but also serves to insulate cultivators from falling CBD prices. "Certain people would have you to believe that CBD is the only reason we have a hemp market," Hoban noted. "That's not entirely accurate when there is a very stable and in-demand hemp grain and fiber market." While there are advantages to using certified hemp seed genetics, the federal government has yet to embrace implementing a national seed certification program. In its interim hemp regulations, the U.S. Department of Agriculture (USDA) held off on implementing a certification program because it was too difficult to predict how certain hemp varieties would fare under differing climates and growing conditions. Nevertheless, at least five states have enacted laws which require the establishment of a hemp seed certification program, including Colorado, Missouri, Texas, Washington, and Wisconsin. Another four states — Kentucky, Montana, North Dakota, and Rhode Island — require that cultivators use certified seeds. including. Though it may be difficult to predict how high-yield CBD strains will behave in various circumstances, Hoban forecasted that over the next few years organizations like the Association of Official Seed Certifying Agencies (AOSCA) will develop a program for high-CBD strains. "Certification standards exist, but they don't make it easy for uncertified high-CBD genetics to enter the market," he said. "However, you're going to see AOSCA begin to develop a seed registration program that will allow breeders to bring new seed genetics into the marketplace, demonstrate and establish consistency, and put them on a path towards registration." Written By: William Sumner Original Article: https://newfrontierdata.com/marijuana-insights/seeking-certainty-between-certified-hemp-seeds-versus-high-yield-cbd-strains/