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Hand Sanitizer from GNS

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From https://americancraftspirits.org/wp-content/uploads/2017/02/Ethanol-for-Hand-Sanitizer-FINAL-3.24.20.pdf :
 

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Appendix C.

Formulas That May Be Used To Denature Alcohol Before It Is Used in Alcohol Based Hand Sanitizers (Antiseptic Hand Rubs)

Preferred Formula

27 CFR 21.76 Formula No. 40-B

To every 100 gallons of alcohol add: One-sixteenth avoirdupois ounce of denatonium benzoate, N.F., and 1⁄8 gallon of tert-butyl alcohol

Alternative Formula

27 CFR 21.75 Formula No. 40-A To every 100 gallons of alcohol add: One pound of sucrose octaacetate and 1⁄8 gallon of tert-butyl alcohol

 

 

So.  The former FDA guidance implied but did not state outright that denaturing must be done using Isopropyl alcohol.

The new FDA guidance gets specific about denaturing, and doesn't allow Isopropyl, but several questions remain:

* Are beverage (non-industrial) DSPs actually authorized to denature ethyl alcohol under TTB's emergency guidance? 

* How can you comply with TTB guidance and produce according to WHO formula, when FDA now specifically forbids any glycerine or hydrogen peroxide? 

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Beyond alcohol, water, and denaturants (if added at the point of production), the alcohol production firm does not add other ingredients.

* Where in the )(*#$u&$# are we supposed to get denatonium benzoate, N.F. or the other agents?

* Is it even legal to sell (assuming you abide by anti-gouging laws) hand sanitizer to individuals and/or businesses?

Above all, I"m just very sad that we (DSPs) appear to be in a worse situation (under even more conflicting guidance) thanks to this updated FDA document.  I'm sure our friends at TTB are working hard on this problem, but the uncertainty is tough to bear amid so much other uncertainty.

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43 minutes ago, SCLabGuy said:

From https://americancraftspirits.org/wp-content/uploads/2017/02/Ethanol-for-Hand-Sanitizer-FINAL-3.24.20.pdf :
 

 

So.  The former FDA guidance implied but did not state outright that denaturing must be done using Isopropyl alcohol.

The new FDA guidance gets specific about denaturing, and doesn't allow Isopropyl, but several questions remain:

* Are beverage (non-industrial) DSPs actually authorized to denature ethyl alcohol under TTB's emergency guidance? 

* How can you comply with TTB guidance and produce according to WHO formula, when FDA now specifically forbids any glycerine or hydrogen peroxide? 

* Where in the )(*#$u&$# are we supposed to get denatonium benzoate, N.F. or the other agents?

* Is it even legal to sell (assuming you abide by anti-gouging laws) hand sanitizer to individuals and/or businesses?

Above all, I"m just very sad that we (DSPs) appear to be in a worse situation (under even more conflicting guidance) thanks to this updated FDA document.  I'm sure our friends at TTB are working hard on this problem, but the uncertainty is tough to bear amid so much other uncertainty.

I think you are misreading the most recent FDA guidance.  That is for producing the alcohol to be used in the hand sanitizer formula, not the entire hand sanitizer formula itself.  Hence, the lack of glycerin and hydrogen peroxide mentions.  

Also it specifically says RO water is acceptable for diluting the alcohol.

Anyhoo, denaturing is a dumb guidance and has been, and probably will continue to be, widely unused.

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12 hours ago, SCLabGuy said:

 

* Is it even legal to sell (assuming you abide by anti-gouging laws) hand sanitizer to individuals and/or businesses?

 

I was wondering the same thing. We intend to give ours away to places that need it, and I thought that was the whole intention. I've seen a number of places selling it or starting GoFundMes, possibly as a way around selling it. Obviously there is a production cost on all our ends, but selling this stuff seems totally against the point.

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55 minutes ago, kleclerc77 said:

I was wondering the same thing. We intend to give ours away to places that need it, and I thought that was the whole intention. I've seen a number of places selling it or starting GoFundMes, possibly as a way around selling it. Obviously there is a production cost on all our ends, but selling this stuff seems totally against the point.

In my state of Maine it is estimated that the hospitals and healthcare facilities need 400-500 gallons of sanitizer per day. They are expecting the local distillers to supply that amount for free; for how long who knows. Obviously not a sustainable model.

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No idea how many bottles you need to make but if you have or can throw a keg reflux still together you could likely run this while doing other things.

If you made a 15% sugar wash with enzymes and ran 14 gallons at a time you could produce approximately 5.5 to 6 liters a run on a keg still.  Depending on work day could likely get 2 runs in even on a small Hobby size still and produce 11 to 12 liters of ethanol per day.

If you follow the WHO recipe 1 from https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf you would end up with about of 6 liters of sanitizer per run.  If you package that up in 8 oz to 250mL bottles of some kind you get 26 to 27 bottles from each run.  Not going to be setting the world on fire but it's better than nothing and might be able to keep local police, fire fighters/rescue squads, etc in stock and allow them to divvy up what you produce.  Of course those numbers could double if doing two runs a day on a hobby/home size still easily.  This amount would be easy to keep up with fermentations using just a couple of brute trash cans you could use to not bother other operations.

If you did 2 runs a day that's 50 bottles a day x 5 working days or 250 bottles a week.  That's not insignificant in some communities as every bottles helps especially when it goes to the right people who have no choice but to be around other people.

Of course if you have a bigger reflux still available the numbers climb quickly. If you have an old pot still you could strip first, then you could put higher ABV in the reflux still, etc...

Keep in mind you don't have to be making 100 bottles an hour to be helping the community, just do what you can, using the equipment you already have or can throw together for this purpose quickly and see that the bottles you are making go to those who need it most.

Just food for thought.

 

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1 hour ago, kkbodine said:

In my state of Maine it is estimated that the hospitals and healthcare facilities need 400-500 gallons of sanitizer per day. They are expecting the local distillers to supply that amount for free; for how long who knows. Obviously not a sustainable model.

Yeah absolutely not. We're making what we can afford to give away (not hundreds of gallons) because I can't find anywhere that says we're even allowed to sell it. Is anyone aware of any literature stating we're allowed to sell it? If that were the case, we could produce a lot more. We don't even have our spirits available to the public yet, so definitely can't afford to just switch to a hand sanitizer production facility.

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14 hours ago, daveflintstone said:

I think you are misreading the most recent FDA guidance.  That is for producing the alcohol to be used in the hand sanitizer formula

I think you are exactly right.  Insert excuses about long days and stress here.

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Does anyone know what the rules are for shippers for hand sanitizer.  I assume 70-80% alcohol of a certain quantity requires hazmat shipping.   I cannot find anything definitive on this. 

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Hi all,

Below is a summary of the conversation as I've been hearing it from a variety of sources .  My goal is to put this logic in front of people who do regulatory work.  Anyone care to comment on the logic, pick apart my arguments, or add information?  

Thanks!

A few facts:

  1. It's established that we need large volumes of hand sanitizer across the country.
  2. There are upwards of 1800 craft distillers distributed across the country, and even more licensed DSPs (rectifiers, etc.).  Every DSP has personnel trained and licensed to work with ethanol products safely and most are situated in populated areas for efficient local distribution.
  3. Craft spirits sales follow discretionary income, which means that the craft industry has an unknown future in an uncertain economy and will likely need help

Conclusions:

  1. The craft industry should be making hand sanitizer to assist medical personnel and their local communities to fight the pandemic
  2. In order to support economic recovery *after* addressing the acute emergency, the craft industry should be able to offset at least the cost of raw materials, if not recover some of the lost sales revenue, by offering hand sanitizer for sale to the public

Challenges:

  1. Hand sanitizer has to be made with 96% +/- 5% ethanol as one of the starting ingredients 
  2. Even with a rectification column, neutral spirit is difficult and expensive to produce from fermented substrate at the levels needed by health care providers.  At best, production of neutral spirits from fermentable substrates at the craft level is inefficient, at worst, impossible
  3. GNS is usually available from bulk suppliers, but the supply chains are supporting existing accounts and/or large industrial suppliers of hand sanitizer.  Bulk suppliers are not responding to small DSPs.
  4. Other ingredients (emollients, isopropanol, essential oils) are also difficult to source right now
  5. There's lack of guidance from regulatory bodies concerning legal formulas, sales and pricing

Questions:

  1. Can formulas be further relaxed to allow other ingredients?
  2. Can transfer in bond rules be relaxed (or applications processed) to allow bulk orders to be split among small producers so that bulk suppliers are incentivized to support an alternate supply chain?
  3. Can regulatory agencies provide clear and cohesive guidance on formulas and pricing?
  4. Are there enough DSPs interested in a cooperative effort that these ideas make sense to pursue?  Or is it everyone for themselves?

 

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I got a batch of sugar wash started today, but even sugar is getting difficult to get these days. Locally I'm only allowed to buy 100#s at a time, if they have any, and feel a bit guilty for buying them out repeatedly. 

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Find a restaurant supply place. They wouldn't even flinch if you bought a pallet of sugar from them.

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fyi if you're having problems sourcing hydrogen peroxide: grow stores aka hydroponic stores aka where people go to get weed growing supplies, regularly sell gallon containers of 34%.

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26 minutes ago, daveflintstone said:

fyi if you're having problems sourcing hydrogen peroxide: grow stores aka hydroponic stores aka where people go to get weed growing supplies, regularly sell gallon containers of 34%.

great call!

I just bought out my smart and final, they only had 4 gal of 3%.. but ill be getting some 30-35% from our local labpro tomorrow.

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Add questions about guidance for reporting which really hasn't been given much detail and will cause problems later for many DSPs not sure of how to report transactions.

Would the federal government be willing supply ingredients & bottles (maybe under FEMA) to DSPs who can supply equipment and labor to turn raw ingredients into products?  After all the federal government should be able to purchase in massive bulk and transport it as well streamlining the process.

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We’re in on Sani. Peroxide and glycerine arrive Friday and we will produce all weekend for Monday pick ups. Already have 4000 liters accounted for. We are filling and labeling 5 gallon buckets with affixed compliant labels. Wish us luck we will send the same your way- we have a reoccurring new weekly order of 70 gallons a week to a hospital, 500 gallon 3 week split order to state energy company, four old folks homes in town....

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Posted (edited)

So this guy just unsolicitedly messaged me..... weird...... happy hunting folks!

 

Hello, I have tankers and totes of ethanol 200pf USP and SDA 40-B in stock and ready to go. Please give me a call if interested.

 

                                               Doug the Ethanol Guy,

 

 

 

Edited by SlickFloss
guy is a fraud

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Just a thought... I am not a lawyer and this is not intended to be advice...

If you are a DSP who can produce or blend to ~82% ABV (164pf) you have an avenue to help that may be more appealing than actually making sanitizer.

Assuming your state law allows it, you can take an existing formula/COLA and print new labels with the proof set to 164 and everything else the same.  Batch / distill your product as usual except for the higher proof.  Bottle, label, record, pay excise and sell through normal (or non-normal) licensed channels.  At this point you are just delivering usual, taxpaid beverage alcohol to a licensee like any other day.  The fact that it is at a convenient proof for the end user to add a touch of glycerine and hydrogen peroxide and yield a formula that roughly matches WHO's guidelines is purely coincidental.

Bonus points for submitting a formula/COLA that includes Glycerine (a commonly used, food safe additive) at 1.45% to make it even easier.  But the method above can be implemented as quickly as you can acquire new labels, and you can probably get that done same-day if you really put your mind to it.

This idea, while having drawbacks and requiring the end user to pay at least your laid-in cost plus one cent, is at least free of uncertainty and excess liability.  (Handling/bottling 164pf product is dangerous, take proper precautions)

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EDIT: I read the label wrong, sorry it's actually 70% not 65% final.  Was looking at multiple bottles from different suppliers.  But it's still lower than what many are producing right now.

Curious, how many of you guys have noticed the WHO formula targets 80% ABV but commercial sanitizer like Purell only start with only 70% ABV before adding other ingredients including water?

"Ingredients: Active Ingredients: Ethyl Alcohol (70%) (v/v). Purpose: Antimicrobial. Inactive Ingredients: Water (Aqua), Isopropyl Alcohol, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum)."

Purell is basically selling a 65% or so formula while the WHO is pushing an 80% formula.

Purell is the Canadian Club living in a cask strength world of sanitizers. :)

 

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10 minutes ago, DrDistillation said:

Curious, how many of you guys have noticed the WHO formula targets 80% ABV but commercial sanitizer like Purell only start with only 70% ABV before adding other ingredients including water?

"Ingredients: Active Ingredients: Ethyl Alcohol (70%) (v/v). Purpose: Antimicrobial. Inactive Ingredients: Water (Aqua), Isopropyl Alcohol, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum)."

Purell is basically selling a 65% or so formula while the WHO is pushing an 80% formula.

Purell is the Canadian Club living in a cask strength world of sanitizers. :)

 

I've been wondering this very thing.

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Guys, this discussion has gone on for a long time on multiple threads.  If you're still discussing rather than saying "dam the torpedoes" you will find that there are few of the components left for you to purchase to do any formula.  

The World Health Organization has given a simple formula to follow.  The formula has been acknowledged by the TTB and we are being told we will not be taxed on the spirits used in this sanitizer.   The Cleveland Clinic is known the world over, they are using the WHO formula.

I'm in this to try to save lives and do a good thing.  Isn't it time to stop talking and start doing?  My 2 cents worth.

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Some of us have "been doing" for 2 weeks... Doesn't mean  we can't be cerebral about it

Good luck out there

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Well I was just asking a question.  The difference between 80% and 70% is quite a bit and many more bottles could be produced from the same alcohol. (edit, I was looking at other products beside Purell when I wrote 65% before.  It appears Purell is produced at 70%.)

Purell and many other similar sanitizers have been the standard for a long time and don't get anywhere near the 80% ABV mark.

The Centers for Disease Control and prevention recommends using a hand sanitizer with at least 60 percent alcohol.  The FDA put out a publication https://www.fda.gov/media/136118/download using the formula many have repeated here but fail to see the footnote #6.

"Consistent with the 1994 TFM, alcohol should be used in a final product concentration between 60-95% (v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; isopropyl alcohol should be used in a concentration between 70-91.3% (v/v). This guidance is consistent with WHO’s recommended formulation specifications of 80% alcohol and 75% isopropyl alcohol."

So is the WHO being overly high on the ABV needed or is the mass market of commercial sanitizers not really doing a proper job?  I think this is a common sense thing to question and talk about.

It also appears that a solution of 70% final ABV is fine to use as well according to WHO, FDA & CDC.  A target of 70% vs 80% allows a lot more product to be made from the same base spirit. 

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20 hours ago, SlickFloss said:

So this guy just unsolicitedly messaged me..... weird...... happy hunting folks!

 

Hello, I have tankers and totes of ethanol 200pf USP and SDA 40-B in stock and ready to go. Please give me a call if interested.

 

                                               Doug the Ethanol Guy,

 

 

Doug Towle (Co-Founder)

Green Buffalo Group LLC

Cell (562)357-0360

DougT@grbuffalo.com

www.grbuffalo.com

Has anyone tried purchasing from this guy?

I reached out, and they only have 200 proof in stock.

I've asked several times for their DSP number and company info so we could fill out a transfer in bond, and both times the request has been ignored.

He did send a pro-forma invoice.. but the information on that invoice is for a company called Chrome Diagnostics... https://www.chromediagnostics.com/ which apparently does indoor LED lighting and doesnt appear to have anything to do with spirits production

This is starting to raise some red flags for me. Just curious if anyone has had similar contact.

Thanks

image.thumb.png.4ecf6edf4fa1ea3976aa2e493de3ed42.png

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If I cannot fulfill through my normal channel we will reach out to him just to sniff and I'll let you know what I think his shit smells like

 

 

unsolicited solicitations are always horse shit except in Las Vegas 

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