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Sens. Ron Wyden (D-OR) and Jeff Merkley (D-OR) sent a letter to the head of the U.S. Department of Agriculture (USDA) on Wednesday, requesting a series of changes to draft rules for hemp that the department released last month . The senators said they appreciate that USDA issued the proposed regulations, which is a “necessary step to establish a domestic federal hemp production program.” However, they wanted to highlight “several concerns about the unintended and potentially harmful effects this interim final rule would have on hemp production in Oregon and across the country.” In the letter to Agriculture Sec. Sonny Perdue, they listed five issues with the regulations and suggested potential fixes. Many of the concerns echoed those that stakeholders have submitted to USDA as part of a public comment period the department launched on October 31. Here’s what the senators highlighted: —As written, the draft rules call for hemp to be tested within 15 days before harvest. Farmers have argued that’s far too little time, and the senators said it presents an “impossible obstacle for growers to overcome.” Oregon regulations require testing within 28 days, so they said USDA should adopt a similar timeline. —USDA said that testing must be completed at a laboratory registered with the Drug Enforcement Administration. The senators said that will produce a bottleneck and delays for hemp producers, and that independent laboratories such as those operating in Oregon should be allowed to conduct the tests. —The senators said that USDA should allow for forms of THC concentration testing that do not involve post-decarboxylation and also argued that the congressional intent of hemp legalization was not to require testing of all THC compounds but rather just delta-9 THC in particular. —USDA requires that testing samples come from the top one-third of the flower portion of the plant. Instead, the senators said, samples should follow established protocol in states like Oregon, which stipulates that samples should be taken from the flowering tops when they’re present and be eight inches long. —While the Farm Bill defines hemp as cannabis containing no more than 0.3 percent THC on a dry weight basis, USDA gave slight margin of error and considers any plants with more than 0.5 percent THC to be in violation of the regulations. Farmers have called that limitation arbitrary and the senators said it would be more reasonable to set the negligence threshold at 1 percent, if there must be a THC restriction at all. “Farmers in Oregon and across the country are on the precipice of an agricultural boom that, with the right regulatory framework, stands to boost rural economies in every corner of the country,” they wrote . Wyden and Merkley have been some of the most vocal proponents of developing USDA regulations that bolster the hemp industry since the passage of the Farm Bill, through which they worked to legalize the crop in the first place. As early as February, Wyden and Senate Majority Leader Mitch McConnell (R-KY) were knocking at USDA’s door, urging the department to expedite the rulemaking process . Read the full senators’ letter to USDA on hemp regulations on our blog. Written By: Kyle Jaeger Original Article: https://www.marijuanamoment.net/senators-push-usda-to-adopt-five-changes-to-proposed-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/