Cannabis companies and investors are becoming more dependent on experienced cannabis consultants to help them minimize their risk. Darwin Millard from Millard Masonek Solutions DBA Phytologix is on of the worlds most in-demand cannabis consultant. He joins Joy Beckerman to talk about exciting extraction breakthroughs and opportunities. Produced by PodCONX https://podconx.com/guests/darwin-millard
Cannabis companies and investors are becoming more dependent on experienced cannabis consultants to help them minimize their risk. Darwin Millard from Millard Masonek Solutions DBA Phytologix is on of the worlds most in-demand cannabis consultant. He joins Joy Beckerman to talk about exciting extraction breakthroughs and opportunities.
https://podconx.com/guests/darwin-millard
Dan Humiston: [00:00:08] Welcome to another episode of Hemp Barons. On today's show, Joy is joined by one of the world's foremost authorities on mechanical and solvent based extraction methodology. His experience with Cannabis extraction goes far beyond Hemp and they take a deep dove into everything from processing Tasso p.'s to compliance issues to ethics. Let's join Joy's conversation with Darwin Malard from Malard The Sonic Solutions.
Joy Beckerman: [00:00:41] Well, welcome, Darwin, thank you so much for being with us on Hemp Barons today.
Darwin Millard: [00:00:45] Hey, Joy. It's so great to be here.
Joy Beckerman: [00:00:47] Well, you're one of the busiest men. Talk about humans, not just man, men and women alike in consulting in the Cannabis space, both Hemp and adults and medical forms as Cannabis, particularly where extract is concerned. You have made your mark for several years now, has been really a leader here globally in the extract processing extract as Opie's all manner of the operations and compliance issues and high standards and ethics that go into extracting the Cannabis plant again, whether we're talking about Hemp derived extract or other forms of Cannabis. It's been my great pleasure to know you for a number of years to be able to work with you. And we're just so glad to have you on the show today. I want to get right into it. And we usually start by asking what got you into Hemp and any other form of Cannabis? Let's just learn a little bit about Darwin and what led you to this amazing versatile plant.
Darwin Millard: [00:01:51] Well, thank you so much, Joy. I want to take this opportunity. I appreciate so much for having me on and getting to chat with you. I do. And I appreciate the praise that you gave me. That said, you know, I still haven't quite made the 100 people in the industry to know. I think that's what the Hemp kind of saw that releases that. So maybe one of those days I'll get our kit in there. But yeah. So I've been working in the Cannabis space now for TS 13 years. Just a cool decade. And so I'm a mechanical engineer by training and I specialize in the mechanical and solvent based extraction methodologies for isolating purposeand I like secondary metabolites from botanicals. And so for me it was kind of like as a mechanical engineer graduating from college back, I could have either created and designed and built Florie pumps for the fracking industry to rape the planet for the last few fossil fuels. Or I could dove headfirst into the fledgling Cannabis industry in Colorado. And I guess you could say I wouldn't change it for the world.
Joy Beckerman: [00:03:08] Amazing, of course, that you are a Colorado boy. That's where your family is from. And were you born and raised in Colorado as well? Darwin.
Darwin Millard: [00:03:17] Douglasville, Georgia was where I was born. Most of my family's actually all from the south. And just my parents live in Colorado now.
Joy Beckerman: [00:03:25] Amazing. And I think you were I know you were in Colorado when we first commenced our work together, really starting to try to understand and create standards for the emerging, as we called it. Phyto cannabinoid industry. We now basically dropped the phyto just in terms of our common vernacular. And so I know that standards and compliance and really just again, giving the highest, healthiest possible quality products that could be given to consumers and particularly, of course, to patients and those with compromised immune situations. And that's really what you have always been about. You have always been an industry leader and driving force. And let me get a little more into our talk here. We'll talk about the very big and responsible leadership role that you have with ASTM and their D 37 committee on Cannabis. But you started in and I'd love to if you could tell the listeners a little bit about how you got started in the in the legal space and eventually came to form the large Masonic solutions, which does business as phyto logic's again one of the most in-demand consultancies out there. In fact, as you well know, I took on a role and I'm currently the regulatory officer in industry liaison for allit's and all which has its CBB products in 50 countries all over the world.
Joy Beckerman: [00:04:54] And as a result of that, I don't do any consulting in Hemp extracts anymore because that would just be ridiculous and unfair to itlooks in. All right. They they pay me very well and they own my extract brain. And but many people call me for that for that consultancy. And of course, I have to deny the work, but don't want to leave them empty handed. And I always send them first and foremost to phyto logic's and warn them. Keep in mind, this is the most in-demand consultant that I know of in North America and probably beyond. We know well that you have lots of relationships in other parts of the world, in particular India and others. So I don't know how many of those folks. Actually get to serve as busy as you are, but it's just so important for me that, you know, that you're just the number one brain. I think for extracts consultancy, that's everything from processes to standards to compliance. So tell us if you'd like to inform us how you came to form phyto logic, phyto logic, or just starting with what phyto logic's is doing. We'd love to hear about it.
Darwin Millard: [00:06:05] Sure. Well, I appreciate that. You know, back when we kind of formed or working together, that was of fledgeling Time Bramer, I guess. Who Wild West of CBD from Hemp and did kind of just trying to flesh out and make this marketplace safer for consumers and manufacturers alike. I started mladin a sonic solutions about where her three year old company now. And that was just after another consulting company that I had created with a friend of mine, Miss Tamar Weiss, who has gone off and has doing. I believe it's a wise consulting that she does now as we both kind of branched off and done our own niche services. She focuses on formulation. I do process train engineering. So that's specifically what we do is helping our clients understand how to make those products that they have in their mind. So we help them take it from conceptualisation to commercialization and actually help them through every step in between in regards to the design and implementation of a process that can be used to manufacture their own products. And lately we've been working with clients and helping them adhere to GMP and get certified, especially within the Hemp space with their bulk Hemp ingredients that they've been manufacturing, whether those are phyto cannabinoids or other nutritional based goods to get them ready for FDA inspection and certification, as well as going from either food grade or pharmaceutical grade GMP compliance. So we've been working with clients not only to help them design and build and then commission their extraction facilities, but help them get through the GMP process as well. As you were saying from the very beginning, I've always been an eye on quality.
Darwin Millard: [00:08:13] I guess 13 years ago now jumping into this, right. There weren't really any standards being applied to the marketplace. And as an engineer, I could see some major gaps.
Darwin Millard: [00:08:25] And also as a consumer wanting to have safe and reliable product to consume and being an enthusiast for extracts and exact artist, you might say looking into those, I wanted to produce better, safer and higher quality product, but also understand what my yields were and my costs of goods at a time when really that didn't matter to anybody because this stuff sold like hotcakes. So I've really just been applying those principles to the marketplace ever since and just opened fire on every scale of extraction and product manufacturing. Figure out what it is that they actually want to make and how to do that in the most efficient way possible.
Joy Beckerman: [00:09:10] And boy, aren't you amazing at it. While we're on this subject, let's talk a little bit about the current marketplace for CBD products here in America. You have such a global reach. I feel like I have to specify. Let's just keep our talk down to the United States at present, although certainly other countries and jurisdictions share our same challenges. Give us a summary of how you see, particularly with an eye to all of the smaller brands or cottage industry. And and also keeping in mind that you and I both know that, you know, the Hemp industry in particular industries were built on the backs of cottage industry and small businesses. And yet when we look at GMP compliance, current good manufacturing practices, GMP, which in particular, if we keep it down to dietary supplements, food and cosmetics, which for Hemp derived extracts right now are what are out there there. And and that I'll also gone on a further tangent here and expand the question by an underscore. As you know, we had to sort of birth the US sympathy pretty when I say we had to birth this certification program into those into the world. And the original thinking for the US Hemp authority was to out of respect for and to provide some cover in fact, for those small businesses. Cottage industry that we thought at the time, and believe me, as with everything with Hemp, you pivot as new information and data and science and regs come into your field of awareness.
Joy Beckerman: [00:10:50] But we thought these small businesses and cottage industries, when they really get a load at what's 21 CFR one, one one, which is DMP for food, 21 CFR 1 1 7, which is GMP regs for dietary supplements and so on. When they look at those like they're going to freak out when they realize what regulations are required in the United States of America. If you are making products for human or animal, even ingestion or even topical application. And so we're going to make this sort of see GMP light is how we do. We even cause I described it for this first version to get these small businesses and cottage industries able to position themselves and be a player in the market. And then when version 2.0 comes out where we're going to have to increase the GMP compliance and of course, version 2.0 now the very baseline for version 2.0 is CGM compliance with the additional specific standards on top of that. So with that sort of foundation, how you see the market right now with what's going to happen to all of these, not the smaller brands that are white labeling and potentially sourcing from a GMP compliant facility, will we know that that is more the exception, not the rule, but the small businesses that are actually processing and manufacturing and are are trying to stay in this game?
Darwin Millard: [00:12:22] Well, you certainly don't make these questions easy.
Joy Beckerman: [00:12:24] Do you join only only for the ones that I know who can handle the complicated issues for sure?
Darwin Millard: [00:12:33] Well, it's a great point that you've brought up in regards to making sure that people are aware that now that campus legal, that means it's now under the purview of the feds. It's no longer well, while it well, it is still very much a state by state play. There is the overlying, I guess, the pressure that it's now also a federal marketplace that you have to be compliant with. And one of those being, of course, is complying with the FDA and their regulations for manufacturing food products. Unfortunately, as you are very well aware, the USDA, which currently has regulatory authority over cultivation of Hemp plants, doesn't have anything to do or any say, really, when it comes to processors of this product, of this agricultural commodity. What do you do once you have flowers to sell or process? I guess it's more of as a as a farmer, it's easy. You've you're selling your your biomass that you're sure a commodity that you're selling or you're selling your seed or selling your fiber. But there hasn't been any any rules laid out from the FDA on how to process that in a safe and compliant manner for producing foods.
Darwin Millard: [00:14:02] There are rules that are out there that exist for producing foods, of course, in this country, but they haven't yet been applied to the Cannabis industry, to Hemp in general. It's new. And, you know, regulators are scared. The reefer madness was a very effective campaign and we're still trying to flush out all of that. I would say the misinformation that still exists or as I often say, that the social engineering of it where we're trying to d engineer it, absolute work, you know, coming out of prohibition with any with anything else.
Darwin Millard: [00:14:37] Right. You have to adhere with rules. But we're in this position that there aren't any to adhere to. So we have to provide the industry has to create its own has to provide guidelines and assurances to the regulators that they're doing something in an appropriate way. Well, the FDA kind of figures out what they're going to do. But at looming that looming FDA presence, is there an ever growing? So I like to call it you're asking kind of what I think about the marketplace and there's an inevitable consolidation that is coming for those that can't meet the GMP compliance requirements that are under FISMA, which is what everyone really needs to be focusing on, which is the Food Safety Modernization Act, which took effect in 2016 and is codified under 21 CFR 117. Which effectively establishes the which is a part of FISMA. But it just abolishes the preventative control rules. Current good manufacturing practices and other controls for the manufacturer of human foods and currently actually within ASTM International's Technical Committee B37 on Cannabis. We are currently working on creating a compliance guide for processors and Cannabis based whether those are marijuana or Hemp for adhering to and being in compliance with FISMA. So if you're a manufacturer producing any type of Cannabis product, whether that's from marijuana or Hemp that is intended to be eaten by human.
Darwin Millard: [00:16:31] Then we have a guideline that's we're hoping will be that arem document that can help regulators alike establish the protocols for food manufacturers who want to use Cannabis derived ingredients or products as an ingredient.
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Joy Beckerman: [00:17:36] Outstanding. Really just fantastic, fantastic work. And in fact, this is a great segue way for us to talk about ASTM, which again is just doing such important work, American standards or testing and measurement folks may be familiar. If things not aren't familiar with me saying ASTM, then try to visualize it on a building material package with an ASTM rating. And ASTM is responsible for standards on a number of industries in practically every industry. And we were so thrilled about and I think you'll correct me if I'm wrong. Darling, four or five might even be five years back. Time is going so quickly, it could be possible to more close to four when ASTM created it. D Thirty seven committee on Cannabis. It was like we have arrived. Cannabis is coming. ASTM is taking it on. And you have very many roles and wear lots of hats within ASTM because that's just the kind of advocate that you are. We're cut from the same cloth and you are the you are the industrial Hemp liaison to the committee, as well as vise chair and co-chair of some of the most critical subcommittees. Could you tell us a little bit about those subcommittees and the work that they're doing?
Darwin Millard: [00:18:57] Yeah, absolutely.
Darwin Millard: [00:18:59] So ASTM International is one of the oldest standards development organizations in the world. They're actually established in 1898 in the United States when they were originally called the American Society for Testing and Materials. But that that acronym has since been dropped. And they are just a ASTM international now. And that actually happened in 1974 when they became an official international standards development organization and not just a U.S. based group, but they were formed to actually standardize railroad ties so that they were to be the same. GAIGE Or the rails, excuse me, because trains would go effectively from one rail manufacturers rails to another and would fall off the tracks because they weren't the same. So this was, of course, during the industrial revolution. Major expansion within the United States that there had to be a quick way to fix that. So ASTM was established to do so. And so since then, there are now 148 technical committees within ASTM International that have established some twelve thousand seven hundred different standards that are codified within the United States as well as other several other countries. We had something like thirty 30 thirty somewhat thousand members. Eight thousand of those members are from one hundred and forty different countries with seventy seven hundred roughly of the standards that you've mentioned being used or referenced in countries, wrap up roughly seventy five countries from around the world.
Darwin Millard: [00:20:42] And the standards.
Darwin Millard: [00:20:44] Astm International and 2017 was essentially approached by the industry. The Cannabis industry with the need for standards help us create safer, higher quality products and help us eliminate misinformation that's been out there and lower regulatory burden that that's essentially these are coal by creating these standards is to establish a foundation from which alledged a legitimate commodity marketplace can be created and established from the Cannabis plant.
Joy Beckerman: [00:21:20] Thank you for that. And before we talk about your specific cause committees that you vise chair and co-chair, a general question, because it's fascinating how ASTM has taken this. How has ASTM decided to define or categorize the different types of Cannabis and and listeners? So, you know, when in this in this respect, when I talk about Cannabis, I'm talking about the genus Cannabis in all of its forms. So medical and adult use and sacramental type, some are more potentially intoxicating type of Cannabis or the industrial purposes, the more low resin or extract fiber grain types of of Cannabis. So how has ASTM defined or categorize the very many different types of Cannabis or uses, as it were, for Cannabis?
Darwin Millard: [00:22:09] Well that's I mean that's a great question there. joy. or put it another one. You're put me on the spot there. So technically within the ASTM international structure and within the D thirty seven committee itself, you know, we are a membership made up of stakeholders, made up of people who enjoy these products and are just. General consumers of them or people who may have interests and or activists and enthusiasts in this space or government regulators. So it's a body of many different membership types and I guess roles. So everyone has an individual vote or are you an equal vote?
Darwin Millard: [00:22:54] So it's not that these proposed terminologies have been accepted or adopted by everyone quite yet, but they are certainly proposed terminologies that we have been floating around that would shift how one refers to the Cannabis play plant and instead of referring to it by an arbitrary set of constituents that vary from one authority to another. If it's based on the the end use or the purpose for which that plant is being cultivated, or for which the product is for, I guess with which stream, which marketplace is going to be sold and is, you know, is it a food? Is it a pharmaceutical product? Is an adult use product and creating something that's more fit for purpose sort of speak. So we within the g37 have recently just passed our terminology standard.
Darwin Millard: [00:23:59] It has not yet been published because it's still going through fleshing out of formatting and structure, at which point actually the terminology document is one of the most heated in regards to getting it through the balloting process.
Darwin Millard: [00:24:14] Each individual term will then go under re balloting because we would like to say that they are maybe adequate enough to adequate isn't a right word. So that's really tricky. Acceptable or adequate or some other type of synonym that makes it so that getting something out there is better than having no words at all. No, no standardised terminology. But that said, there are several terms that are going to be changed. And that's the great thing about ASTM standards, actually, is that they're not fixed or set in stone when, say, they are passed, which isn't exactly the same as some other standards development organizations that are out there when ASTM standard is published. If something there's an error that's determined by either a membership or someone identifies it, there is an opportunity to immediately update it.
Joy Beckerman: [00:25:14] So we're taking that into our own hands as membership's as once this initial draft is published. Oh, actually, I guess it's once the initial set of terms are published, myself and a few others will be taking up individual terms to submit revisions so that they can be more appropriate in a manner. Amongst those revisions would be some of the fit for purpose terminologies in regards to defining the Cannabis plant by the purpose for which is being cultivated, whether that's for the reasons or some nutritional purpose or a true industrial purpose or some type of multi use purpose. So incredible. And I think one of the important things of the of the great response and thorough response that you just gave us is, of course, the democratic process of what's going on with ASTM. And I think underscoring the fact that because these definitions in these terms have been labored upon by these dedicated folks and members of the committees and subcommittees of D thirty seven for quite some time. But the reality is, you know, until folks feel comfortable, at least as you say, comfortable enough to come to consensus to say, all right, let's release these, we're going to update them and we have the ability to update them. But let's get them out into the world. And folks thus far have had not that it sounds like you've gotten or ASTM has gotten this far, this that it's gotten so far in this process where it's at right now in trying to get something out into the world, just the amount of debate and intellect and time investment. And I just know it so well from all of my years of advocacy work and of course, working on the US sympathy, worry, which also has a glossary of terms and all of those things. It's so appreciated that commitment and that time completely uncompensated. So much of our work is totally pro bono and volunteer based on our dedication and commitment to and belief in delivering on the promise of this incredible plant. Just so, so appreciated. Darwin. Could you give us some information? It's. Specific to the two subcommittees that you vise chair and co-chair.
Darwin Millard: [00:27:38] Sure, of course.
Darwin Millard: [00:27:40] Before I get there, I did want to say that we're about a three year old organization now built up of stakeholders in this industry, just like yourself and myself. And as I said, government agencies and others in this time, well, even we are all voluntary and not being paid anything to do this. We have approved and published 14 standards. And in these three years, first three years, several of those have been adopted by a few different countries, namely Canada, as well as the Jamaican Bureau of Standards adopted the first four standards we published. We also approved two new subcommittees within the last year, the D thirty seven of seven on Hemp, which I happen to be a co-chair. I co-chair that with Ted Handley from the Canadian Hemp Trade Alliance, and we have been working on that in that committee. It's specific to developing standards for the characterization and use of Hemp and the applications first derived products such as but not limited to food, natural health products, animal feed and non consumable products like construction materials and fabrics and other stuff like that. And we recently just approved 37 0 8 on devices and appliances for personal use. So such as vape pens which were in the news so much I guess last year in regards to the deaths of four.
Darwin Millard: [00:29:15] That was more related to the formulations of the vape vape pens and things like that. But this subcommittee specifically addresses safety and quality of the hardware, including at home clothing about growing appliances as well. But within the D 37 structure we have, how many committees now is it? One, two, three, four, five, six, seven, eight, nine technical committees, each one focusing on a specific area within industry. We've got cultivation that does indoor and outdoor horticulture in our agricultural standards, as well as quality management and laboratory test methods. And then 37 0 4, which is the other committee I am passionate about of course, because I am a extraction artist and process trained engineer. The D thirty, 37 or four is on processing and handling and I vice-chair that committee. But we also have security and transportation as well as personnel training, assessment and credentialing. So creating the type of Prudential's and assessment criteria that should be in place for keeping the personnel who actually work and do these processes in these large facilities, how to keep them safe and ensure that their quality of life is maintained.
Darwin Millard: [00:30:34] Of course, we've got standards for Hemp coming out, devices and appliances. Like I said in the hardest one to get everybody to agree on terminology.
Joy Beckerman: [00:30:45] Indeed. And even for the US Empathy Treaty, we will spend hours and talk to experts and Cannabis intellectuals all over the United States and universities within the United States and other countries. And finally, after agonizing over one definition, finally we've come up with it. And then we'll publish it. And literally a week later be like, wow, that's flawed. There's a flaw. I mean, it's just it is so challenging because you're trying to come up with terminology that is fair to the industry while also closing as many loopholes as you can possibly close for the unscrupulous actors. And it's such a delicate balance. Amazing works are win for folks who want to read, too, particularly if they're looking for your world class consulting services through Malard with Sonic Solutions, which does business as phyto logic. And by the way, that's all. Oh gee I x phyto logic's how kinsfolk three to Darwin.
Darwin Millard: [00:31:46] Sure. Well, they can check out our Web site, which is Malard Masonic Solutions dot com. You can also find it at Phyto Logic's Scott Solutions. I know that's a fun, fun u._r._l there. But easiest way is you can email either me myself directly, which is my name. So that's Darwin. I'd like to scientist D.A.R.E. W I N at Phyto Logic's which is spelled P as in Paul H y t o l o gee i x dot solutions. There's no dot com no no anything else after that. It's just a fancy new u._r._l beautiful.
Joy Beckerman: [00:32:29] And for folks who want to find out more about ASTM, where could they go to get more and.
Darwin Millard: [00:32:34] So I would highly recommend that they check out the D Thirty seven website on ASTM International's Web page. It's very easy to go to you just search for or go to ASTM dot org and in the main search bar at the top.
Darwin Millard: [00:32:50] Type in D 37 and you'll actually come up with every single search reference on the committee. So not only the committee page, but also the pages on the three workshops we've done in Europe so far or a while too. Technically, we have a third scheduled for this year that we're all crossing. Our fingers will still occur October 22nd and 23rd in Prague, as well as of the subcommittee meeting minutes. All of the various different current work items that are being taken out by all the different technical committees as well as all of the published standards are all available for reference and review simply by just going to ASTM dot org and at the main search bar typing in the letter D as in Douglas and the numbers three and seven.
Joy Beckerman: [00:33:42] Fantastic. Again, I'm so grateful for your time today. A very busy day for you, regardless of any stay at home order. And for me as well. Of course, as you know, brother, just so grateful to have you on. Can't wait to have you on again. And we're wishing phyto logic's everything good in the world and certainly again. Thank you so much. ASTM for your work on ASTM. Thank you to everyone.
Darwin Millard: [00:34:04] Much appreciated, Joy. Thank you for the opportunity to be on your show. It was great. And hopefully we can catch up soon. Excellent. Thanks again.
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