FDA Hemp Regulation Commentary- Working Draft

Hempire Building
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This is going to be an iterative process and wanted to get a clean thread going because there is a lot of ground to cover and many of us are going to have different perspectives on how to approach this.

I want to thank all those offering contributions to this in advance and specifically @BrotanicalMatt for reaching out to assist.

The most effective means for effecting policy are to own the space and have broad community support. We can approach this as an industry trade organization (like many others) or we can operate as a Consensus Standards Organization for the hemp/cannabis industry. I will say that in my experience, CSOs carry more influence with regulatory bodies and facilitate freedom to operate. Youā€™re probably more familiar with CSOs than you think if youā€™ve needed an ASME pressure vessel, CE, UL, or ANSI stamp on a product.

Iā€™d really like to hear your thoughts on the following issues as we begin compiling, developing, and refining our FDA commentary.

Cultivation
Seed sales/standardsā€¦ fem/non-fem, fiber, seed, cbd
Susceptibility to airborne cross pollination & pesticide crop contamination
Database of varieties currently in use & date of first useā€¦ to baseline/refute/ support Plant Variety Protection Act applications.
Develop preferred GACP practices for hemp/cannabis, specifically regarding plant inspection, testing (w/ or without homogenization?), lot sizes, industry definitions (harvested, bucked, shucked, trim, flower, bud, biomass, etc.) acceptable moisture content, dockage/rejection criteria for out of spec biomass, pesticide thresholds for rejection.
Standard/boilerplate contracts/terms of sale.
Crop insurance
Bonding

Processing
High level outline of process methods currently used in industry
Outline of business practices used in industry (tolling, splits, vertical integration, spot buys)
Distinction between process intermediates sold or transferred between processers in interstate commerce and finished products for sale ā€¦need guidance, data to support THC concentrations in intermediate extractsā€¦ i.e. for an extract being transferred over state lines to a THC remediation processor.
Labeling of process intermediates
Acceptable solvents/levels of residual solvents
Standards for food/product contact surfaces in production equipment & cleaning protocol
Poor practices we do not reccomend
Industry support for ā€˜many ways to skin a catā€™ to develop a similar finished product.
Focus on flexibility (craft beer industry).

Finished products available for sale
Packaging, labeling, & testing of finished products for sale, including finished product definitions
Common Look & Feel for presenting active botanical content, active cbd content, and active thc content

Existing legal Pathways for selling finished products, including food, drugs, and/or cosmetics
Farm to table flow charts showing compliance with existing legal pathways for taking a product to market, fold or otherwise.

Disposal
Disposal pathways for spent biomass
Beneficial reuse - feed, Biofuels, etc
Municipal waste
Compost
Hazardous waste classification
Thc disposal practices

Financial Services & Safety

Consensus Standards Organizational Structure
Charter
Bylaws
Membership criteria
Board nomination/election
Board compositionā€¦ all tiers (labs, breeders/genetics development, nurseries, growers, processors, retailers, consumers, researchers, financial services, regulatory, vertically integrated firms, etc)
Establishment of Collaborating Organizations Committee(regulatory agencies, medical advocacy organizations, research organizations, etc.) ā€¦clearinghouse for information exchange between organizations.

FDA Hearingā€¦Testimony Review
Quantitative support or rebuttal of key points/claims.
Potential answers to FDAs questions

Iā€™ll get a doc going for this, but what are we missing in terms of topics?

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Bump! Iā€™ll be contributing to this soon, and I look forward to seeing what other people do with this

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not sure how far ASTM got down this road.
would make some sense to figure that out

even if itā€™s just a vocab document at this point, we probably shouldnā€™t ignore itā€¦

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Thank you so much for putting this together. I dont have time now but ill edit this with my thoughts later.

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@sidco has a wiki too. letā€™s populate it

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Hello everybody, Iā€™ve got invited to talk with yā€™all about these subjects and will help any way possible. I come from a petrochemical background. The reason I got invited was from the TT thread. If you have not read it please do. Itā€™s long but itā€™s my only crediation of intergerty. Iā€™ll be willing to meet anybody to prove my worth and that Iā€™m trying to only help better the business and keep out of corporate tycoon greed. We have a lot of subjects to cover. We need to organize this better. Like a flow/tree chart so we know how to keep organized. Maybe set up a google drive so we can input data but through an encrypted network or closed discussion bc these issuses and solutions will show our weakness and can counter act our plans so if itā€™s completly open we can get hit where it hurts if not the right people are viewing it

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I donā€™t know if I missed it, but eventually we will get into the realm of QC, Validation and QA with regards to cleaning/sterilization, monitoring the environment of a manufacturing space (bacteria, fungi, air quality, surface cleanliness).

Most industrial scale plants will have to demonstrate the effectiveness of processes and post-process procedures through test protocols.

Itā€™s all goin GMP baby

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@Dirteagle would we have two standards for indoor vs outdoor?

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Cultivation side i have an older gentleman and i consider him a true master grower. His schooling background i think he told me was geology and micro climates. Also he was raised under a microbiologist. he is 100% organic. you dont feed the plant you feed the soil. Ill get in touch with him in the next day or two but if i get some time and ask if he wants to take part in this. Like i said he is older and im not sure him time schedule. Also i thought of another solution for terpene situation. I know the coowner of cannabinder.This program will help us tremendously and start a terp profile and what it does to the mind/body. Both these people i regard highly as people who want the best for everybody and love what they do. I want to address one concern OSHA. Has OSHA visited any facilities? bc as i have read they just been doing meetings. If they implement anything like the have in petrochemical field than businesses can be fined so hard they will have to shut down. We need to start finding resources who are safety engineers or osha consultants. We use proccess equipment as they do and a lot of the regulation will be the same. A good start is to recommend at least one person from a lab to do get an OSHA-30 certifications. Every lab iā€™ve been too has infractions but the thing is they dont know better. They want to know what they are doing wrong. Thats why i always start with the OSHA 30 card bc i dont know exact information on this side and its been a decade since ive received my card. An example i see a lot is i ask where is the msds? is it ready access available for all employees to see the MSDS? Its a workers right to know. @TheGratefulPhil A good start would to look at the food industry. I worked as a bartender for years. A few things i remeber we had to do or we woud get fine. No open water source of still water sitting in open containers or puddles. Two we had use organic sterilizing agents such as simple green with HOT water.

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We definitely should. Bc eventually the process units will be to large to facilitate in a building or certain parts of it will be outside such as cooling towers.

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following

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Ok, so maybe compile a list indoor will not be susceptible to cross pollination or pesticide contamination when outdoor will. Also nutrient dosing can be controlled very precisely indoors where outdoor plant are subject to Heavy metals and pesticides in the soil.
Another thing that indoor cultivators do not have to worry about is CEQA regulations. As long as the structure is existing they are exempt.
The more I think about this it is going to be a monumental task that will require an all start team to really work together.

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@TheGratefulPhil I just remembered. Labs have different levels of cleanliness like 1-10 scale. Extreme side of the levels are ones who deal with deadly airborne and pathogenic deadly/viruses that require a full suit with aspirator and decontamination station. We of course are not close to this but they have regulated standards in place for labs if im not mistaken. @MagisterChemist im not sure if you want to help on this thread but can you at least confirm this?

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Certainly an option. Probably the biggest thing associated with GACP is the culling/removal of out of spec plants (those not falling in tolerance of a reference standard plant) from the harvest. Those that show disease, improper structure, excessive damage or contamination need to be removed prior to harvest. Goal is uniformity across the crop.

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This is correct about the labs. I have someone on our team that this is his space. Even the air conditioning system and air filtration goes with your grade or level.

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We have looked into this. The easiest way to accomplish this is thru tissue culture. We have been in the process of building ā€œclean atmosphere controledā€ cultivation areas.

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I dont followā€¦ testing of each plant? Or tissue culture for clones? Bc some of the market will grow from seed, which is acceptable. It the culling of males, really whack phemothypes, and diseased plants thats in line w/ GACP, regarless of seed, clone, tissue, etc.

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17 posts were split to a new topic: Cultivation Regs for FDA

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the level is classified thru the NFPA standards, but each state can also set their own regulations.

little bit of a spoon, didnā€™t realty read it

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@BG305 Im about this. Its been a while since i used dropbox but we have to make sure restrictions are in so nobody can come in delete everything. i seen this happen at one of my last jobs in the south.