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Hand Sanitizer from GNS


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3 hours ago, bierling said:

Misleading or are these ingredients actually not there?

If you are denaturing, they are there. NB: the label from the FDA does not say ETHANOL, it says ALCOHOL, and I think that is how they get around this, because methanol is also alcohol, so the mixture would be, I guess?

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1 hour ago, bierling said:

One of the interesting points regarding meeting WHO formulation and FDA /TTB requirements, is that while the FDA is asking for denatured alcohol, which using formula #1 would mean adding methanol and methylethylketone (both, by the way, likely to be found in foreshots), the WHO guidelines specifically recommend not including MEK because of its limited efficacy in preventing consumption and because of its unknown toxicity for long term exposure.

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16 hours ago, dhdunbar said:

  Let's talk about who can make sanitizer under TTB's guidelines..  I'll talk about the FDA elsewhere.  When I talk about TTB, I feel comfortable commenting and reasonably sure that what I say is right.  ""Reasonably" is a wiggle room word. 

  • Normally, hand sanitizer is an "article" made under the provisions of part 20 by  either (1) a person holding a SDA Users permit or (2) a person whose DSP registration authorizes operation in industrial alcohol, who separately elected, when submitting the application, or amended the registration,  to be a processor conducting distilled spirits operations, and who holds an operating permit under the Internal Revenue Code. 
  • The FAA basic permit does not cover operations and transactions in industrial alcohol. 
  • Persons who are qualified to conduct industrial alcohol operations are also required to obtain a bond, without regard to the excise taxes they pay each year.  Under §19.151(d)(2), industrial spirits are not exempted  from the bond requirement.  This gets a little complicated when you produce both industrial and nonindustrial (beverage) alcohol, but don't worry about that now, because, as we will see, under the guidance document, you are exempted from the bond requirement during the emergency.
  • A distilled spirits plant does not need to obtain an SDA Users permit, because it is exempt from that requirement under the provisions of 27 CFR 20.41(d)(1).  However, it still must produce articles in compliance with the requirements of [part 20 (§19.395)).

So, in normal times, a TTB can produce articles if it jumps through the registration, permit, and bond hoops, but it still must comply with the other requirements of part 20, including filing formulas as necessary.  I've discussed formulas separately  in this thread and will not repeat it here.

Basically, the TTB guidance wipes out all of these requirements.  It states, "Any existing DSP therefore can immediately commence production of hand sanitizer or distilled spirits (ethanol) for use in hand sanitizer, as described below, without having to obtain authorization first."  It goes on, ""TTB is exempting ...  beverage DSPs from the requirement to obtain additional permits or bonds to manufacture hand sanitizer or to supply ethanol for use in the manufacture of hand sanitizer to other TTB permittees who are authorized to receive such distilled spirits."  As long as the emergency is in effect, need not amend your registration to included industrial alcohol operations, qualify as a processor who denatures,. get an operating permit, or file a formula, if you comply with the conditions stated in the guidance document.  

The conditions are simple stated, "TTB is authorizing the manufacture of hand sanitizer products consistent with World Health Organization (WHO) guidance. All TTB-permitted DSPs (including AFPs and beverage DSPs) may manufacture hand sanitizer products that are comprised of denatured or undenatured ethanol, glycerol (not less than 1.45% of the finished hand sanitizer product on a volume basis), and hydrogen peroxide (not less than 0.125% of the finished hand sanitizer product on a volume basis), without first obtaining formula approval from TTB.

Note that since TTB states what you may use its formula and also requires that you be consistent with WHO guidance, TTB holds that its formula is consistent with WHO guidance.  I see no other way to read that.

 

Great, @dhdunbar, I think you answered my question: we can, in principle as a DSP, make the product. And, if the FDA, as I read it, requires us to denature it, we can do so, even without special permits, so long as we follow CFR normal rules for doing so. Practically, how should we denature it to meet the requirements? The WHO does not requires us to denature it, but FDA does, but does not indicate which formula we should use. Do you have a recommendation for which formula (I am still trying to read through the relevant CFR sections to understand that)? And if we denature that, how do we, as a DSP, report that change in our monthlies? And when/how do we remove that from bond, to distribute that?

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Personal Comments

I want to say a few personal things before saying anything more on this thread.  i think the observations are germane to the issues.

 I post here in sterile terms.  This, I say, is what I think the regulations say.  It seems officious.  Bureaucratic.  Uncaring.  It is "i" dotting and "t" crossing in a time of public need and social upheaval.  Where is the perspective? 

So, I want to offer a little personal, hopefully humane,  perspective  before getting back to the officious.  It begins with some observations on which I will not elaborate.  Bureaucracies do not exist without the people who staff them.  They act only through those people.  if they are composed of mean people, then they do mean things.  TTB as I know it has never been composed of mean people.  There are a few bastards, but by and large, TTB employees care.

Before TTB issued the more detailed guidelines I've been discussing, , back when DISCUS had said that they were talking with TTB about sanitizers and that DISCUS understood that guidelines would be coming out,  I got a call from a client.  He said something like this, "The firemen down the street are looking for hand sanitizer.  They can't get any.  They are asking for help.  What can I do?" 

I started by  saying this rule says this, that rule says that, etc., and then got personal.  I told him that I could not advise anyone about the risks they might want to take.  That is not my business.  My business is to say what I think is required, so that others  can evaluate the risks of any "civil disobedience" in which their conscience might dictate they  engage.  I said, if it were me, I'd adopt the Nike motto and "Just do it," make a clear record of what I had done, and be prepared to suffer the consequences later. I added that I doubted that there would be any consequences unless what I did demonstrated a reckless disregard for public safety or indefensible  profiteering in the face of an emergency..

I still feel that way. 

I live far enough to the east of the Washington State hotbed that, as of yesterday, my rural county had recorded only four known cases of Covid-19.  However, I know two of those people - no recent contact - and also know, by one or two degrees of separation, at least 20 more in Western Washington who have tested positive, one of whom died.  This morning's reports on the 15,000 plus cases in New York state only fuels my conviction.  I "know," in the visceral sense, that this is going to get catastrophic. Fast.   It is not a time for fuddy-duddy concerns.  So, I would without hesitation take action, on the local level, to meet  the  needs, which  cannot now be filled by a national supply chain. of the local health care providers and other public service agencies on which my community depends. To do so, I would assume gray areas were a go.   But I would not open a store front business selling the stuff unless I knew that the gray areas where in fact white.  That is what I would do.  I do not advocate that you do it.  

But the concerns are mostly unnecessary.  In most cases, the TTB guidelines provide a reasonable way for you to meet local needs.  There is no need to set your own rules to get things done.  If you want t to make a product that works, then it is no more difficult to do so following TTB's guidance document than it is to  ignore them and do your own thing. 

With that, I'll return to the more officious analysis, identifying the gray areas as I find them, and trying to tell you how I would argue, if I had to, that they permit what I did, especially in times of emergency when being absolutely sure one is right can hog tie action that is need immediately.

Stay safe

 

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Alcohol Content and Tolerances

Background

The WHO guidelines, which both TTB and FDA say you must follow, call for 192 proof (96% abv) alcohol.  Must you use that high a proof?  Or is this a gray area?

As I read the situation, TTB and the FDA both recognized that regulations were getting in the way of emergency needs for sanitizers and so used existing,  emergency authority to wave rules that were preventing persons who had alcohol that could be used from using it to fill the need for sanitizers.  They needed extra-regulatory  measures to  allow this.  To avoid rulemaking and the need for temporary regulations, each agency established the policy through guidance documents, which adopted the equivalent of the WHO's local production guidelines.  The WHO guidelines, that is, provided some structure to the manufacturing and distribution process, while allowing fairly rapid localized production until such time as more traditional production and distribution practices can fill the distribution chain and meet needs. They are of a stopgap nature.

To respond to the emergency need for santizers,  the agencies issued with guidance documents with  haste.  They are not all consistent.  I try to make sense of that here.  These are my opinions and we should look to TTB and FDA  for further guidance.  In the meantime, I think my conclusions may be useful in letting you begin to meet emergency needs before TTB and FDA can iron out the differences. 

Conclusions

Here are my conclusions.  My reasoning follows:

Since we know that TTB and FDA allow the use of denatured alcohol, which the WHO formula never mentions, neither TTB nor FDA appear to require strict adherence to the the letter of the whole formula.  This creates a gray area.  Is the 192 proof requirement absolute even though the type of alcohol is not?  

However, the TTB and FDA standards appear to place a lower limit on the proof of the alcohol you may use.  Specifically:

  • I would not venture to use alcohol of less than 185 proof, since alcohol of less than 185 proof is not authorized for use in manufacturing SDA.
  • I would be mindful of the FDA's limits on impurities in the alcohol used and would not use alcohol of less than 192 proof unless I knew that it conformed to USP's acceptance criteria.
  • Finally,  since the  glycerol and hydrogen peroxide standard are the same for all three agencies, I presume that TTB and FDA want to require that the final product conforms to the WHO standard, i..e., ethanol 80% (v/v);  Glycerol 1.45% (v/v);  and hydrogen peroxide 0.125% (v/v), with a tolerance of ± 5% of the target concentration, which, perhaps coincidentally, comports  to the tolerance for articles under §20.132(d). 

Thus, until we find out whether TTB and FDA intend to enforce the 196 proof standard of the WHO formula:

  •  I would not hesitate to use alcohol of 185 proof or more as long as the impurities do not exceed the USP "acceptance criteria."
  • I would not use alcohol of less than 185 proof as an ingredient. 

Finally, I would gauge the finished product to ensure that it is between 150 and 170 proof (the WHO target proof is 160, but they have a tolerance of ± 5% of the target concentration (75%–85% for ethanol).  That tolerance comports to the tolerance found in 27 CFR part 20.

Findings

Here is what TTB says:

  • Formula guidance for the manufacture of hand sanitizer: TTB is authorizing the manufacture of hand sanitizer products consistent with World Health Organization (WHO) guidance. All TTB-permitted DSPs (including AFPs and beverage DSPs) may manufacture hand sanitizer products that are comprised of denatured or undenatured ethanol, glycerol (not less than 1.45% of the finished hand sanitizer product on a volume basis), and hydrogen peroxide (not less than 0.125% of the finished hand sanitizer product on a volume basis), without first obtaining formula approval from TTB.

This "formula guidance" incorporates two separate standards. 

The first standard, which I will call  the formula, provides that that, as a DSP, you are authorized to manufacture hand sanitizer products consistent with WHO guidance. TTB conveniently includes a link to the WHO  guidance document, so that the WHO guidance to which TTB refers is not in doubt.  That document is a "guide to Local Production of WHO-recommended Handrub Formulations."  Its apparent purpose is informing person who need hand sanitizers, but who cannot obtain them from regulated, commercial, sources, , how to make them on site.  The on-site approach does not work when the alcohol is not conveniently available because the governments regulate its production and distribution. 

As I read the situation, TTB and the FDA both recognized that regulations were getting in the way of emergency needs and so used existing,  emergency authority to wave rules that were preventing persons who had alcohol that could be used from using it to fill the need for sanitizers.  They needed extra-regulatory  measures to fill allows this.  They did that through the guidance documents,  which authorized the equivalent of the WHO's local production guidelines.  Both agencies adopted those existing guidelines to avoid rulemaking and the need for temporary regulations.  The WHO guidelines, that is, provided some structure to the manufacturing and distribution process, while allowing fairly rapid localized production until such time as more traditional production and distribution practices can fill the distribution chain and meet needs.  It is stopgap.

Next, so that it is very clear to all,  TTB included, in the guidance, composition requirements.  Any sanitizers you make (using either denatured or denatured alcoho)  must contain glycerol (not less than 1.45% of the finished hand sanitizer product on a volume basis), and hydrogen peroxide (not less than 0.125% of the finished hand sanitizer product on a volume basis).  The guidance statement makes no mention of the alcohol content.  Indeed, the "not less than language" would seem to allow you to have a product of fairly low proof.  A WHO standard saves that day.

The WHO guidance to which TTB directs us, contains two standards.  One is a the formula, which calls for 192 proof alcohol.  it is a formula.  For every 1000 ml you want to produce, you use Ethanol 96%: 8333 ml;  Hydrogen peroxide 3%: 417 ml; and Glycerol 98%: 145 ml.  You then add distilled or boiled water to make 1000 ml.  The second standard of identity.  The finished product must contain ethanol 80% (v/v);  Glycerol 1.45% (v/v);  and Hydrogen peroxide 0.125% (v/v).  Silk City and someone else have discussed these numbers elsewhere and frankly, I do not understand them.  Presumably the formula c=quantities produce a product that meets the standard of identity.  I leave the calculations to others. 

The WHO standard then allows a tolerance fore the finished alcohol content.  It provides, "The accepted limits should be fixed to ± 5% of the target concentration (75%–85% for ethanol)"."  I do not know if this also applies to the other ingredients.  Thus, the WHO allows the final product to be anywhere between 150 to 170 proof. I note, as a matter of interest, that if you  use SDA to make an article under the provisions of part 20.  §20.132(d) provides for an analytical tolerance of ±5% in the amount of ingredients, including denatured alcohol, used in formulas that specify exact amounts.  Thus, a sanitizer made in accordance with the presumptive general use formula in TTB’s guidance documents, which specifies exact amounts of ingredients, would be subject to the ±5% tolerance.

Next, since part 21 anticipates that you will use one of the acceptable SDA formulations, I checked.  Section 21.31(b) provides the general guideline for proof of spirits to be denatured, "Alcohol of not less than 185 proof shall be used in the manufacture of all formulas of specially denatured alcohol, unless otherwise specifically stated or unless otherwise authorized by the appropriate TTB officer. Rum for denaturation shall be of not less than 150 proof and may be denatured only in accordance with Formula No. 4.  Therefore I would not, in any case, use, as an ingredient, alcohol of less than 185 proof.

Finally, the WHO standards do not specify a grade for the alcohol used.  Neither do the TTB standards.  The FDA requires USP grade ingredients, which would include the alcohol.    I am not an competent to comment on the USP grade ingredients.  An internet search  for which I cannot vouch and which I will not attempt to interpret, provided the following table of acceptable criteria

image.png.e9d3f1d8470e1b3f8907c38f4d91c1ad.png

 

(see https://www.usp.org/sites/default/files/usp/document/harmonization/excipients/alcohol-m1238.pdf:)

I have no idea at what proof the alcohol you collect would contain not more than the quantities of other impurities allowed by USP, nor do I know that this is the standard that should be applied.

Those are all the "facts" that I have found.    What do I conclude?  Again:

  • First, since we know that TTB and FDA allow the use of denatured alcohol, which the WHO formula never mentions, neither TTB nor FDA appear to require strict adherence to the the letter of the whole formula.  This creates the gray area.
  • I would not venture to use alcohol of less than 185 proof, since alcohol of less than 185 proof is not authorized for use in manufacturing SDA.
  • I would be mindful of the FDA's limits on impurities and would not use alcohol of less than 192 proof unless I knew that it conformed to USP's acceptance criteria.
  • Next, since the  glycerol and hydrogen peroxide standard are the same for all three agencies, I presume that TTB and FDA want to require that the final product conforms to the WHO standard, i..e., ethanol 80% (v/v);  Glycerol 1.45% (v/v);  and hydrogen peroxide 0.125% (v/v), with a tolerance of ± 5% of the target concentration, which would, perhaps coincidentally, comport  to the tolerance for articles under §20.132(d).

 

 

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Records and Reports

My brain is fried.  I will provide information on records and reports soon.  In the meantime, keep a log of what you do.  Show all gauges that you make, the quantity of ingredients that you use to compound the sanitize (dump/batch record), the proof of the sanitizer you package (bottling tank and gauge record), the size of the containers into which you package it, the numbers of containers per case, the serial numbers that you place on those cases,  the number of cases that you fill (bottling record), the cases or other packages that you remove and the person to whom you sold them (tax determination record), which may be an invoice from your normal sequence or a separate shipping record, each of which has a unique serial number.

I've probably omitted one or more pieces of information you should be capturing.  I'll try and get this done with some rigor sometime this coming week.    

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On 3/22/2020 at 7:29 AM, bierling said:

Misleading or are these ingredients actually not there?

Actually, if you are denaturing only with methanol or isopropanol, as per formulas 3A and 3C, the combination is still "alcohol" which is how the ingredient is described in the FDA provided back label.

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i sent the following to a couple of people I know in  TTB who are in a position to get something done or at least put it into the hands of persons who can do that..  We'll have to see if it works.  

“Houston, we have a problem.”

Many distillers want to supply hand sanitizers to local agencies and health providers who are in need.  TTB and FDA recognized the emergency and each agency issued emergency “guidance.’  TTB allows the use of either undenatured or denatured alcohol.  The FDA has a different position.  It requires that the sanitizers be made with “Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or Isopropyl Alcohol (75%, v/v) in an aqueous solution.”

I have been contacted by several clients concerning the FDA’s “denatured” standard.  They want to comply.  This is also a hot topic on ADI’s forum.  I have pointed out that;

·         No alcohol is denatured under part 20, it is manufactured under the provisions of part 21.

·         Part 20 governs the use of SDA, already produced under part 21, in the manufacture of articles;

·         DSP’s may make articles, but they must do so according to either a general use formula or an approved formula.

·         There is no general use formula for santizers (use .430 under part 21), but the guidance document served to create one.

·         TTB requires denatured only to protect the revenue.

·         In the past, FDA has stated, “To prevent the ethyl alcohol in a cosmetic from being diverted illegally for use as an alcoholic beverage, it may be "denatured." This means that it contains an added "denaturant" that makes it undrinkable.’

·         The FDA states no other reason for requiring denaturants.

·         In this time of emergency TTB determined that the production of santizer was more important than protecting the revenue, and so allowed the use of undenatured alcohol.

·         Thus FDA should not have an objection to the use of undenatured ethyl alcohol, for a limited time,  in the emergency production of sanitizers.

I point out that I am not an employee of either TTB or FDA and cannot speak for either agency.  I also point out that I am not an attorney and I am not giving legal advice. 

I request, on behalf of my clients and those who have expressed concerns by posts to the ADI forum, that TTB and the FDA clarify the situation, by stating whether the FDA intends to require denatured alcohol or whether it will, as TTB has done, allow the use of undenatured alcohol for a limite time, to meet the emergency demand for sanitizers.

Thank you for your consideration of these matters.  Clarification will mean a lot to the proprietors of distilled spirits plants who want to assist their local health organizations, fire departments and others until such time as normal commercial channels can meet the need for sanitizers.

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I've been lurking and learning. thank you all for this post. As confusing as some of this stuff already is, this current state of the union makes it even more so! Wish I had something to add other than hopefully by the time this bug comes back around, there will be some more concise guidelines in place, oh, and I have my DSP!

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Greetings!  I'm an independent spirits bottler in Berkeley, California and am trying to do some research on the best way for craft producers to navigate the hurdles involved in in hand sanitizer production.  

I spoke to two bulk alcohol suppliers today who were not able to reassure me about current or continued availability of GNS, especially for new customers and at smaller quantities (~1000 liters).  From the bulk supplier's point of view, the supply chain supporting large manufacturers is more efficient at distributing this needed resource.  This opinion was reiterated by someone who runs a column still capable of producing GNS efficiently and also works with large volumes (tens of tanker trucks) of bulk product.  

A few questions for everyone:

  1. What has been your experience with sourcing GNS recently / in the last week or so?
  2. If GNS is unavailable, or at least unavailable in small enough quantities to be appropriate for craft bottling operations, how many craft distillers are able to produce 192 proof (or 185 proof per dhdunbar's analysis above) spirits and at what volume?
  3. If supply chains supporting small producers are not working, do we need to discuss an effort to organize transfer-in-bond operations (and any other legal issues?) that could facilitate a cooperative bulk order?  Is this practical?
  4. I have heard of craft producers selling hand sanitizer to recoup costs and others giving it away.  Is hand sanitizer a viable means to cushion the financial impact of the COVID-19 effect on a small business or an opportunity for community service?  Can it be both?

Thanks for your help,

Nate

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Quote

New York state has also started manufacturing its own hand sanitizer. It’s being produced—in what critics have called “slave labor”—by incarcerated people, who usually earn 65 cents per hour, at the Great Meadow Correctional Facility in Washington County. New York Gov. Andrew Cuomo said the state will produce 100,000 gallons of the sanitizer—which he described as having hints of “lilac, hydrangea, tulips”—per week.

 

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3 hours ago, Classick said:

Dont want to muddy the waters as i think this has been a very informative thread.... just wanted folks to be aware of this by the American Craft Spirits Association  (???) 

 

https://americancraftspirits.org/product/complimentary-webinar-hand-sanitizer-from-regulation-to-production/

The link doesn't work for me.  

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24 minutes ago, dhdunbar said:

 

The link doesn't work for me.  

it was really slow for my browser too.. i had to switch to a different browser.. but the link did eventually work

 

 

EDIT.. i just checked the link again and it loaded WAY faster.. maybe their system was overloaded earlier

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23 minutes ago, dhdunbar said:

The link doesn't work for me.  

I let it spin for 10 minutes at the "checkout" and it never loaded.  The link seems to be correct.

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22 hours ago, twowheels said:

Greetings!  I'm an independent spirits bottler in Berkeley, California and am trying to do some research on the best way for craft producers to navigate the hurdles involved in in hand sanitizer production.  

Nate

Nate, are you only a bottler or do you have any stills at all?

If you own a still, you can make your own spirit to be used for this pretty easily.  Even with a pot still you can do this. (just not as easily).  You can actually produce it faster than normal spirits and you don't care about taste of the spirit and really don't need to worry about cuts per say.  You might also be able to partner with local grocery stores for "free sugar" which is easier/faster to use than grains and work just fine for this as you can ferment at roughly 2-3x normal ABV you would do with grains.  You could produce the most awful tasting spirit (think Everclear 190) this way but the ABV would be high enough to use for the sanitizer base since really only the ABV matters assuming you denature it.

What kind of demand do you have for spirits, i.e. how much do you need?

Probably more important do you have adequate bottles?  This right now is a struggle for many as bottles are getting very hard to come by.  Maybe consider self/serve refill stations where people bring there own bottles and you supply 5 gallon "carboys" at fill stations around you city (maybe partners who contribute ingredients).

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Anyone have a current source for NGS? We don't use any in our process and Ultrapure won't sell us any until they fill needs of current customers. We are making what we can from our own spirits to donate but would obviously prefer to use a sourced NGS for this purpose. Appreciate any help! 

EDIT - sources for suitable bottles would be helpful too. 

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Sourcing GNS seems to be a no go unless you were already a customer. It's cost prohibitive for a small operation like us to produce our own base for sanitizer and it's a damned shame we can't use fores/ heads for this purpose.

Apparently the FDA is now saying it must denatured.

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53 minutes ago, StonesRyan said:

Sourcing GNS seems to be a no go unless you were already a customer. It's cost prohibitive for a small operation like us to produce our own base for sanitizer and it's a damned shame we can't use fores/ heads for this purpose.

Apparently the FDA is now saying it must denatured.

well per the link above from bluestar https://americancraftspirits.org/wp-content/uploads/2017/02/Ethanol-for-Hand-Sanitizer-FINAL-3.24.20.pdf , these agencies are not talkin to each other... no real shock there

Formula guidance for the manufacture of hand sanitizer: TTB is authorizing the manufacture of hand sanitizer products consistent with World Health Organization (WHO) guidance. All TTB-permitted DSPs (including AFPs and beverage DSPs) may manufacture hand sanitizer products that are comprised of denatured or undenatured ethanol, glycerol (not less than 1.45% of the finished hand sanitizer product on a volume basis), and hydrogen peroxide (not less than 0.125% of the finished hand sanitizer product on a volume basis), without first obtaining formula approval from TTB.

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