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Hand Sanitizer from GNS


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As I said somewhere a long time ago in this now too long thread, DISCUS and its likes are better able to deal with this by playing above the rim than a pipsqueak like me is.  I'm copying, below,  two documents from the Distilled Spirits Council's website. 

https://www.distilledspirits.org/news/discus-statement-on-u-s-reps-yarmuth-barr-letter-to-fda-commissioner-urging-flexibility-for-distilleries-producing-hand-sanitizer/

One is a letter members of congress have sent to the FDA on this issue.  The other is the councils statement on the letter..  It's time to let the big boys play.  I'll have one more post on the matter of things other than hand sanitizers and then I'm retiring.  I never want to hear the word hand sanitizer again :-).  I wash my hands of it, so to say.

DISCUS Statement on U.S. Reps. Yarmuth, Barr letter to FDA Commissioner Urging Flexibility for Distilleries Producing Hand Sanitizer

March 29, 2020 1:05 pm

Statement by Distilled Spirits Council of the United States President & CEO Chris Swonger on a letter sent by Co-chairs of the Congressional Bourbon Caucus Chairman John Yarmuth and Congressman Andy Barr and 85 members of the House of Representatives to U.S. Food and Drug Administration Commissioner Stephen Hahn urging the agency to update its guidance to recognize the use of undenatured alcohol in the production of hand sanitizer during the COVID-19 health crisis:

“Distillers across the country are jumping in to produce hand sanitizer for first responders, hospitals and those in need in their communities.  The recently-passed CARES Act includes an important provision to guard distillers from having to pay federal excise taxes on the alcohol used.  Unfortunately, FDA must first update their guidance to permit distillers to use undenatured alcohol, which is recommended by WHO and is the type of alcohol distillers readily have on hand.  We appreciate the support of Chairman Yarmuth, Congressman Barr and the 85 House members in calling on the FDA to be more flexible during this crisis so we can get hand sanitizer to those who need it most.  The Distilled Spirits Council of the United States is committed to working with the FDA to explore appropriate ways to address any safety concerns.”

BACKGROUND:

For weeks DISCUS has been urging FDA to update its Guidance to permit distillers to use undenatured alcohol in its hand sanitizer formula as directed by the WHO Guidance.  Most beverage alcohol companies exclusively make products with undenatured alcohol and may not be able to access the required denaturing materials. Denatured spirits are those that are treated with bittering agents to make them unsuitable for human beverage consumption.

DISCUS has raised concerns with FDA regarding potential shortages of denaturing ingredients as well as the effect the denaturing materials may have on distilling equipment. Due to the highly concentrated nature and toxicity of the bittering agents, these components are very persistent and distillers may have to develop a special cleaning method to remove them before beverage grade product can be reintroduced.  Requiring denaturing could also significantly increase the amount of time it takes to produce this product and get it to those who need it now.

The WHO Formula is a very high proof alcohol with hydrogen peroxide, which is less palatable than other denatured products currently on the market. Thus, further bittering should not be needed, particularly in light of the present need.

###

____________________

 

Friday, March 27, 2020

The Honorable Stephen Hahn

Commissioner

U.S. Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

 

Dear Commissioner Hahn:

We write regarding the U.S. Food and Drug Administration’s (FDA) guidance to manufacturers who are producing hand sanitizer as part of the COVID-19 crisis. As you know, hundreds of distilled spirits producers across the country have immediately responded to the current health crisis by halting their regular operations and quickly turning to the production of hand sanitizer. These distillers are fulfilling a critical need in their communities and providing the hand sanitizer to health care professionals, first responders, and local and state governments. They have diligently followed the guidance released by their regulator, the Alcohol, Tobacco Tax and Trade Bureau (TTB), and are producing hand sanitizer according to the World Health Organization’s (WHO) formula.

Unfortunately, the FDA’s “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19): Guidance for Industry” does not acknowledge the reality that these distillers have stepped up in a time of crisis to produce hand sanitizer using the alcohol they have readily available, which is undenatured. Undenatured alcohol is food grade alcohol that is compliant with the WHO’s hand sanitizer formula and has the same effectiveness as denatured alcohol. The United States largely differentiates between the two types of alcohol for tax purposes – with undenatured alcohol incurring the distilled spirits Federal Excise Tax (FET) and paid to the federal government. A provision was included in the recently-passed COVID-relief package that would temporarily remove the Federal Excise Tax on hand sanitizer production as long as the distiller has followed FDA guidance. Through the current guidance, the FDA is standing in the way of hundreds of thousands of gallons of hand sanitizer from being produced and given to those on the front lines battling this pandemic. We have a responsibility to provide more resources to help flatten the curve and alleviating this burden would allow distilleries the opportunity to step up and help their communities.

We strongly urge the agency to update its guidance to recognize the use of undenatured alcohol in the production of hand sanitizer during the COVID-19 health crisis and work with industry on reasonable safeguards to keep hand sanitizer out of the hands of children. This will ensure distillers do not face a tax bill for filling a vital need in their communities.

 Sincerely,

_________________________ _________________________

John Yarmuth                                                    Andy Barr

Member of Congress                                      Member of Congress

 

 

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The Friday update to FDA Guidance, I believe will have to change.   The label does not have the use of denatured ethanol, although the writeup indicates that we still have to use it.   It also allows for guidance to use isopropyl again as the main ingredient, which the March 24th guidance specifically excludes.   T

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Okay. Looks like my thinking was correct on both fronts. Yes, the law REQUIRES FDA approval, regardless if other parts of the bill suggest the intent was otherwise. But, the FDA, on it's own, went ahead and made use of tert-butanol OPTIONAL when using formula 40B, as I suggested would be the best option!

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Why aren't people just buying Bitrex and using it? I've seen two people say good luck finding denatorium benzoate on this thread, it took me literally four seconds via google.... Emailed them and they responded after hours on a friday and overnighted it to me. I had it by next morning...... I understand if you want to invest absolutely no cost whatsoever in this but if you're at least getting your raw materials covered look into it....  I literally used like 20 grams or an ounce or something for over a thousand gallons of GNS..... Given it's efficiency it's remarkably easy to use and will have minimum impacts downstream..... Treat it with the same respect you do caustic and keep some chocolate close by and denaturing is a breeze.

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4 minutes ago, SlickFloss said:

Why aren't people just buying Bitrex and using it? I've seen two people say good luck finding denatorium benzoate on this thread, it took me literally four seconds via google.... Emailed them and they responded after hours on a friday and overnighted it to me. I had it by next morning...... I understand if you want to invest absolutely no cost whatsoever in this but if you're at least getting your raw materials covered look into it....  I literally used like 20 grams or an ounce or something for over a thousand gallons of GNS..... Given it's efficiency it's remarkably easy to use and will have minimum impacts downstream..... Treat it with the same respect you do caustic and keep some chocolate close by and denaturing is a breeze.

I wasn't aware of this brand name for denatonium benzoate. I imagine the other people posting were in the same boat. Searching for the chemical name only made it very difficult to find a food grade supplier. 

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25 minutes ago, SlickFloss said:

Why aren't people just buying Bitrex and using it? I've seen two people say good luck finding denatorium benzoate on this thread, it took me literally four seconds via google.... Emailed them and they responded after hours on a friday and overnighted it to me. I had it by next morning...... I understand if you want to invest absolutely no cost whatsoever in this but if you're at least getting your raw materials covered look into it....  I literally used like 20 grams or an ounce or something for over a thousand gallons of GNS..... Given it's efficiency it's remarkably easy to use and will have minimum impacts downstream..... Treat it with the same respect you do caustic and keep some chocolate close by and denaturing is a breeze.

Getting tert-butyl alcohol has been our trouble, not denatonium benzoate.   So, this new ruling allows us to denature with just making it taste bad.   Arguably, making it poisonous is questionable.   If child gets ahold of it without tert-butyl, and drinks some, they might have a hangover, but probably won't need a trip to the ER.   We got ahold of some denatured alcohol, USP grade, so that made the process much better.

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21 minutes ago, SlickFloss said:

Why aren't people just buying Bitrex and using it? I've seen two people say good luck finding denatorium benzoate on this thread, it took me literally four seconds via google.... Emailed them and they responded after hours on a friday and overnighted it to me. I had it by next morning...... I understand if you want to invest absolutely no cost whatsoever in this but if you're at least getting your raw materials covered look into it....  I literally used like 20 grams or an ounce or something for over a thousand gallons of GNS..... Given it's efficiency it's remarkably easy to use and will have minimum impacts downstream..... Treat it with the same respect you do caustic and keep some chocolate close by and denaturing is a breeze.

Good tip on the trade name RevolutionSpirits.

Maybe another tip for anyone going this route.  If you aren't doing large batches like 100 gallons at a time it's going to be harder to measure 1/16 of an ounce (weight, not volume).

You could use a gram scale but that's only marginally better since there is 28.3495 grams per ounce.

Get a grain scale (like what's used for hand loading bullets and measuring gun powder). There are  437.5 grains per ounce so 27.34 grains per 100 gallons.

If mixing up 20 gallons batches of Ethanol to denature you would use 5.47 grains for example.

As Bluestar said above, this is the absolute simplest and cheapest method to denature your Ethanol.

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Early on in this thread I had found some denatorium benzoate and I was asked if it was USP, it was not.  I am searching the denaturing spec and I cannot find where it needs to be USP.  Does it need to be USP?  Please point me at the page.

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I am pretty sure DB requires a proprietary process registered to Macfarlan Smith to manufacture. They're a European pharmaceutical manufacturer. The only North American distributor is Market Actives out of Portland, who I have used and recommend. If you're using Bitrex it's probably USP. I would bet that the reason you're not finding it is because it all is.

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22 hours ago, SlickFloss said:

Bitrex is USP per Market Actives representative

Thanks, but I'd really like to know if USP is mandatory, I can't find that requirement in the spec

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6 hours ago, Hudson bay distillers said:

Slick floss do you know the exact amount thats reccomended , like grams per liter or something . 

If you're talking about Bitrex (just the brand name) making sanitizer, then you would use the FDA recommended amount of 1/16 ounce (weight not volume) per 100 gallons of Ethanol.

Probably easiest to measure using grain weight as there are 437.5 grains per ounce so 437.5/16=27.34 grains of Bitrex per 100 gallons Ethanol.  Easy enough to calculate for other size batches.

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23 hours ago, Thatch said:

Thanks, but I'd really like to know if USP is mandatory, I can't find that requirement in the spec

I understand where your at and I think I stand with you, but lawyers  are keeping us on that side of the line

 

22 hours ago, Hudson bay distillers said:

Slick floss do you know the exact amount thats reccomended , like grams per liter or something . 

We're using 4 ounces Bitrex for every 6400 gallons finished product. I believe you could denature the Alcohol itself (GNS as an ingredient in the same ratio 4 ounces for 6400 gallons then batch Sani) and still be compliant, but we want to reuse our GNS totes for finished gin so we are denaturing at very end in stainless steel totes.

Now that.we got it down it's pretty smooth process, took us a minute to figure out how to handle the new ingredients but treat the h202 like caustic and the glycerine like molasses and you've got the hang of it.

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1 hour ago, Hudson bay distillers said:

So the recomendation is 30 grams per 1000 liters of alcohol . This is what we were told but i highly recommend getting the info from your specific supplier. 

Kim

WOW, that's a lot.  The TTB requires 1/16 ounce by weight per hundred gallons which would only be 4.7 grams per 1000 liters.

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Ohhhh ohhhhhh you're supplier isn't Market Actives cause you're in Canada...... that makes sense!

 

Yeah Mitchy "Too Good" gave us that 4 ounces for 6400 gallons number he's the US supplier from MA.

 

That is a lot, but if their country has a different standard for denaturing, then thats what Kimbos stuck with!

 

Keep up the good work Kimbo!

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