Hand Sanitizer from GNS

[DrDistillation]

Just the same tax waiver that has been talked about in this thread.

So we don't pay taxes on the denatured alcohol used for making sanitizer.

[dhdunbar]

No,  I think it is not the same waiver that has been talked about on this thread.  That is why I asked this question.  I think it  is far more reaching.

Here is how my argument goes:

• There is a general presumption in law that  congress acts purposefully.
• Under the Internal Revenue Code there already was no excise tax due on any alcohol used to produce a denatured alcohol, in accordance with part 21. 
• Because those provisions already existed,  there was no need for congress to purposefully act to waive a tax on denatured alcohol used in sanitizers.
• Therefore, congress must have meant something more.
• I would conclude that congress meant what it plainly said it meant;  it waived the tax on undenatured spirits used to make hand sanitizers.
• If congress waived the tax on undenatured alcohol used to make hand sanitizers, then congress must have intended to permit the use of undenatured alcohol in the production of hand sanitizers.
• The wavier  was an unambiguous expression of congressional intent that undenatured alcohol may be used, as long as the bill is in effect, to make hand sanitizer.
• Therefore, while TTB and FDA may make rules that govern the use of undenatured alcohol in hand sanitizers, they may not prohibit such use.
• Thus, both agencies should issue new guidance, consistent with the statutory language,  on the rules for the use of  undenatured alcohol in the production of hand sanitizers.
• Because the provisions are emergency provisions, they should issue the rules immediately.

That is why I want to see the language of the bill itself. I want to see what rules would seem to be consistent with congressional intent.

But without seeing the statutory language,  I think it is likely it is  the nail in the coffin of the FDA's ridiculous position in this matter. 

If I am correct,then the silliness will end. 

I assume that if I have figured it out correctly, DISCUS, ACSA,  and attorneys for the large producers, who lobbied for this change,  will figure it out too.  But I intend to add my voice to those calling on TTB and the FDA to provide guidance documents that comport to congresses intent that taxes be waived to expedite the use of beverage grade alcohol in the production of hand sanitizers. 

Large distillers have argued, "“If we could get the FDA to say yes you can use the beverage grade and for the duration of this emergency at least for some point in time here for the next two weeks you can waive the denaturant we would literally have millions of gallons of hand sanitizer available within a matter of days,” said Monte Shaw, CEO of Iowa Renewable Fuels Association, an ethanol trade group. “Every one of our plants has gotten contacted by people who want this stuff and we can’t send it to them.”  https://time.com/5811201/ethanol-producers-hand-sanitizer/. 

But, as small distillers, I think you are a more effective distribution channel,  at least initially, for sanitizes than the large producers are.  You can deliver to the hospital down the street without having to establish and fill a distribution channel that brings the spirits from the large producer to the far away warehouses for subsequent delivery to those who need them to protect the lives of health workers, etc.  Such delays cannot be justified.

So now we ask that TTB let you do that. 

I will post my analysis  of why the ban on undenatured alcohol should end even if the FDA takes issue with my arguments here about congressional intent.   I've been silent here while I worked on a "shame on you, FDA" argument.  But, if I am right, about the import of congress' recent action, there is no need for such an argument none.  Congress already made it.

 

[RevolutionSpirits]

On 3/28/2020 at 10:17 AM, bluestar said:

For me the most IMPORTANT take away from this update, is the ADDITION of Formula 3C (adding 5% isopropanol) to Formulas 40A and 40B in the updated guidance. This means those already using Formula 3C can continue to do so. This also adds to the guidance the denaturing  method I previously suspected would be most appropriate.

This is huge. Isopropyl isn't easy to find right now but still probably way easier than denatonium benzoate.

[Thatch]

1 hour ago, dhdunbar said:

But without seeing the statutory language,  I think it is likely it is  the nail in the coffin of the FDA's ridiculous position in this matter. 

Dave,  is this what you're looking for?  Supposedly this is the text The federal excise tax is waived on any distilled spirits used for or contained in hand sanitizer that is produced and distributed in a manner consistent with guidance issued by the Food and Drug Administration and is effective for calendar year 2020.

Seems like the FDA is driving the bus.

[bluestar]

52 minutes ago, Thatch said:

Dave,  is this what you're looking for?  Supposedly this is the text The federal excise tax is waived on any distilled spirits used for or contained in hand sanitizer that is produced and distributed in a manner consistent with guidance issued by the Food and Drug Administration and is effective for calendar year 2020.

Seems like the FDA is driving the bus.

Correct, the newest law does NOT override the FDA, although I understand why @dhdunbar might have suspected so, and in fact I would not be surprised if the legislators intent might have been along those lines, but it is the language of the bill that matters. HOWEVER, there is another solution to this problem, I think. I think the FDA does not want to use undenatured alcohol because they are afraid if hand sanitizer is distributed as coming from a liquor distillery, there is a great likely the item could be consumed accidentally or intentionally, so they want it denatured to prevent that. But the TTB makes the rules on denatured formulas, so they wanted to point to a preapproved TTB formula for denaturing. Since their primary concern is preventing drinking, they chose 40A and 40B, I think, because of the use of Bitrex or similar agent. But those formulas also require tert butanol. Whenever the recommend a formula, the other ingredients disappear from the marketplace. The tert butanol is not really required to make the product impossible to consume, it is the Bitrex. The Bitrex is a very commonly available ingredient, and the amount use is extremely small, so it likely can be obtained. So, if the TTB were to announce that using Bitrex alone (call it formula 40D?) for use in hand sanitizer explicitly is now an allowed formula for denaturing, then the FDA could point to that formula, and almost all of us could probably produce the hand sanitizer or supply denatured alcohol for that purpose! And the two agencies won't being going out of their jurisdictions.

[dhdunbar]

Yes Thatch.  And I had found it.  Here are my comments.on that:

I want to remind everyone that this whole brouhaha is over the use of alcohol in a specific product, alcohol based hand sanitizer.  It is not about alcohol based disinfectants in general.

I managed to find a searchable copy of the CARE Act.   §2308 applies.  It amends §5214(a) to add a new paragraph, paragraph 14.  That section now provides:

(a) Purposes Distilled spirits on which the internal revenue tax has not been paid or determined may, subject to such regulations as the Secretary shall prescribe, be withdrawn from the bonded premises of any distilled spirits plant in approved container –

(14) with respect to distilled spirits removed after December 31, 2019, and before January 1, 2021, free of tax for use in or contained in hand sanitizer produced and distributed in a manner consistent with any guidance issued by the Food and Drug Administration that is related to the outbreak of virus SARS–CoV–2 or coronavirus disease 2019 (COVID–19).

Paragraph 14 clearly gives FDA the power issue guidance on the distribution of alcohol removed free of tax, but I cannot read the language to allow the FDA to prohibit all such removals.  That clearly would be contrary to congressional intent.  

So, it is likely that FDA would still be able to require that alcohol used in hand sanitizers be USP grade.  I am out of my depths here, but the standard appears to be:

-          Methanol – Not more than 0.5 corresponding to 200 uL/L

-          Acetaldehyde and acetal - Not more than 10 uL/L expressed as Acetaldehyde

-          Benzene – NMT 2 uL/KL

-          Sum of all other impurities - Not more than 300 uL/L

I have no idea what that means in practice.  Check it out at https://www.usp.org/sites/default/files/usp/document/harmonization/excipients/alcohol-m1238.pdf.

Further, it appears to define ethyl alcohol as having not less than 94.9% and not more than 96.0% abv.  That is 189.8 and 192 proof, respectively, which is a very narrow range.

Finally, they conceivably can impose all sorts of standards that would prevent most small distillers from making product in compliance with the agency's guidance.  For example, there are "sterile environment provisions."   

In anticipation of such stick in the spoke requirements that deny consumers, health care professionals, first responders and anyone else who is endangered by the shortage of f hand sanitizers, you need to be prepared to either practice "civili disaobedience,"and suffer the potential consequences, as some obviously are doing, or find a stick big enough to knock some sense into some very dense heads.  

 

[dhdunbar]

blustar: wrote:  Correct, the newest law does NOT override the FDA, although I understand why @dhdunbar might have suspected so, and in fact I would not be surprised if the legislators intent might have been along those lines, but it is the language of the bill that matters. 

No, I think I am right.  I think the provisions unambiguous express congregational intent that persons who manufacture hand sanitizer may do so using alcohol that has not been denatured according to part 21.  The language of the bill gives the FDA the authority to provide guidance on how a person may use undenatured alcohol in hand sanitizer, not on whether it may be used.  Otherwise the provision makes no sense. 

So,  it also gives FDA authority to regulate how the undenatured alcohol is used.  That is what I address above.

In that regard, it is very interesting (:"very" is a word I do not use very often 🙂) that each page of the FDA guidance document is headed "Contains Nonbinding Recommendations; " has this prominent heading:

and states, within the text.  "In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited [emphasis added].  The use of the word should in Agency guidance means that something is suggested or recommended, but not required."

I find no citation to any section other than in the footnotes which state the sections that the FDA will not enforce under the stated conditions.  Why this coy approach? I do not know.  Ask an attorney familiar with FDA practices.  I sure don't know.

TTB then made mandatory, under TTB's  authority in part 20 ( not part 21) to require formulas for articles,  the FDA's guidance recommendations, which may be nonbinding under FDA FDA's authoritativeness at the time. 

Whether the CARE Act provisions somehow extend FDA authorities is another matter for attorneys who are familiar with the FDA statutes and regulations.  

One might use Bill Gates' observation about not being able to "ignore the pile of bodies in the corner" as a bludgeon to get FDA to take a reasonable position on necessary emergency measures.  

it's easy for me to argue what you might have to argue in court, because it does not endanger my business.  I just as the disclaimer that I'm not an attorney, that what I write here should not be considered legal advice, and you should consult an attorney before taking any action,.  It would be different if it were my DSP.  I know that. 

 

[DrDistillation]

I think the explanation is much simpler.

Normally most of us here would not be able to produce alcohol used for sanitizer.  We do not have the proper license or BOND to do so.  We would also be paying tax on the alcohol produced.

So when I read about the "waiver" I'm reading this as the waiver we have already received not something else.

We were given permission to make sanitizer (normally not allowed), we are exempt from taxes on it (normally not) if denatured, we are allowed to remove from bond and give to another party for making sanitizer without tax (normally not allowed), etc.  These are the waivers they are talking about AS I READ IT.

[John Bassett]

Good luck getting the denaturing chemicals.  Tert-butyl alcohol is highly flammable.  Does denaturing require it or just the chemicals to make it taste bad?  This process is really confusing.

[DrDistillation]

You can also use isopropyl alchohol.

(a) Formula. To every 100 gallons of alcohol add:

Five gallons of isopropyl alcohol

 

If you are making sanitizer for a local hospital they may already have it in stock and could contribute it to you for production.  It's 20:1 ratio so for every gallon they have you match them 20 for a 25 gallon batch.  LOL

[John Bassett]

11 minutes ago, DrDistillation said:

You can also use isopropyl alchohol.

(a) Formula. To every 100 gallons of alcohol add:

Five gallons of isopropyl alcohol

 

If you are making sanitizer for a local hospital they may already have it in stock and could contribute it to you for production.  It's 20:1 ratio so for every gallon they have you match them 20 for a 25 gallon batch.  LOL

I presume this means you add the isopropyl to the ethanol before adding HP and glycerin. Then use the combo in the WHO formula?

I also question the proofing too with all these ingredients.  WHO shows using an alcometer, but bench stilling probably would be more accurate.  Although it looks like we can be off +/- 5%.

What is the % of isopropyl to mix with ethanol?

[Thatch]

27 minutes ago, John Bassett said:

What is the % of isopropyl to mix with ethanol?

I'm not a lawyer and I'm not a chemist.  But, the spec says "95 parts by vol.; and Isopropyl Alcohol, 5 parts by vol."  Therefore my answer is 80% since the WHO spec for Ethanol is 80%.  I expect someone with a Doctorate in chemistry to correct this.

[DrDistillation]

TTB says

§21.37   Formula No. 3-C.

(a) Formula. To every 100 gallons of alcohol add:

Five gallons of isopropyl alcohol.

----

Thus if you start with 100 gallons of 96% Ethanol and add 5 gallons of 91% isopropyl you will have 105 gallons of denatured Ethanol at 95.76%

Thus if you start with 100 gallons of 95.1% Ethanol and add 5 gallons of 91% isopropyl you will have 105 gallons of denatured Ethanol at 94.9%

Note if you can only get 71% isopropyl you could use 100 gallons of 96.1% Ethanol and 5 Gallons of 71% isopropyl and you'll have 105 gallons at 94.9%.

you might get a slight bit of contraction due to the water in the alcohols so you may need to adjust ever so slightly with sterile water to top back up to 105 gallons but use your alcoholmeter to test ABV. Without adjusting you are clearly in the margin of error and good to go.

FDA uses the following formula:

The hand sanitizer is compounded using only the following ingredients in the preparation of the product:

a. Alcohol (ethanol) that is not less than 94.9% ethanol by volume (denatured from above)

b. Glycerin (glycerol) United States Pharmacopeia (USP) or Food Chemical Codex (also known as “food grade”)

c. Hydrogen peroxide

d. Sterile water (e.g., by boiling, distillation, or other process that results in water that meets the specifications for Purified Water USP). Water should be used as quickly as possible after it is rendered sterile or purified.

 

If anyone is having trouble with the math just post what you have, what % your Hydrogen peroxide is as well as your isopropyl %, your ethanol % and what size batches you wish to make.  State if you want to work in gallons or liters and I'll give you the ingredient list and how much of each to use.  Liter/mL are far easier to work with and measure in my opinion.

[Thatch]

1 hour ago, Thatch said:

I'm not a lawyer and I'm not a chemist.  But, the spec says "95 parts by vol.; and Isopropyl Alcohol, 5 parts by vol."  Therefore my answer is 80% since the WHO spec for Ethanol is 80%.  I expect someone with a Doctorate in chemistry to correct this.

My Bad, the text above is from Part 27 CFR part 20.  Dr. D has the correct info.

[John Bassett]

Does the TTB require us to call what we make "Hand Sanitizer"?   If we can call it "Hand Wash", then it's considered a cosmetic and not an over the counter drug.  Then, only TTB has authority and not FDA.  I tried calling TTB.  The person answering said it was above her pay grade and referred me to a higher up.  Who never called back.

In that case, you just have to list ingredients, etc and make no claims about what it does.  I am fortunate to have an FDA hand sanitizer attorney for a daughter in law.  But, she only knows FDA rules 

[John Bassett]

1 hour ago, DrDistillation said:

TTB says

§21.37   Formula No. 3-C.

(a) Formula. To every 100 gallons of alcohol add:

Five gallons of isopropyl alcohol.

----

Thus if you start with 100 gallons of 96% Ethanol and add 5 gallons of 91% isopropyl you will have 105 gallons of denatured Ethanol at 95.76%

Thus if you start with 100 gallons of 95.1% Ethanol and add 5 gallons of 91% isopropyl you will have 105 gallons of denatured Ethanol at 94.9%

Note if you can only get 71% isopropyl you could use 100 gallons of 96.1% Ethanol and 5 Gallons of 71% isopropyl and you'll have 105 gallons at 94.9%.

you might get a slight bit of contraction due to the water in the alcohols so you may need to adjust ever so slightly with sterile water to top back up to 105 gallons but use your alcoholmeter to test ABV. Without adjusting you are clearly in the margin of error and good to go.

FDA uses the following formula:

The hand sanitizer is compounded using only the following ingredients in the preparation of the product:

a. Alcohol (ethanol) that is not less than 94.9% ethanol by volume (denatured from above)

b. Glycerin (glycerol) United States Pharmacopeia (USP) or Food Chemical Codex (also known as “food grade”)

c. Hydrogen peroxide

d. Sterile water (e.g., by boiling, distillation, or other process that results in water that meets the specifications for Purified Water USP). Water should be used as quickly as possible after it is rendered sterile or purified.

 

If anyone is having trouble with the math just post what you have, what % your Hydrogen peroxide is as well as your isopropyl %, your ethanol % and what size batches you wish to make.  State if you want to work in gallons or liters and I'll give you the ingredient list and how much of each to use.  Liter/mL are far easier to work with and measure in my opinion.

Thanks for the detailed reg.  I can figure out the math from the formula given.

[SlickFloss]

We are 1200 gallons in on denatured WHO compliant hand sani in 5 gallon buckets here in Wisco. Keep fighting comrades. Answer the call now in every way you can and these people will pay us back later

Edited March 30, 2020 by SlickFloss
Gender neutrality

[DrDistillation]

8 hours ago, John Bassett said:

Does the TTB require us to call what we make "Hand Sanitizer"?   If we can call it "Hand Wash", then it's considered a cosmetic and not an over the counter drug.  Then, only TTB has authority and not FDA.  I tried calling TTB.  The person answering said it was above her pay grade and referred me to a higher up.  Who never called back.

In that case, you just have to list ingredients, etc and make no claims about what it does.  I am fortunate to have an FDA hand sanitizer attorney for a daughter in law.  But, she only knows FDA rules 

You can't do this.  As a DSP without bond to make anything but drinking spirits you don't make the rules.  Essentially, DSP live but what the TTB allow/authorizes them to do.  In this case you have been given a waiver to make sanitize by following strict rules and LABELING per the FDA.

https://www.fda.gov/media/136118/download

Look at step 6 (labeling).

Front of package is required to say:

• Alcohol Antiseptic 80%
• Topical Solution
• Hand Sanitizer
• Non-sterile Solution
• [Insert Volume of Product in mL]

The back is required to have the DRUG FACTS LABEL info as shown.

Don't forget the TTB waiver specifies you must register with the FDA as a producer of sanitizer.

 

BTW, a "wash" infers it's a cleanser not a sanitizer which is alcohol based.  For example take a look at Dove Hand Wash and it's many lists of ingredients.  I'm sure the FDA has requirements for that type of thing but is way beyond the scope here.  In our case the TTB has mandated what goes on the label and it's "Hand Sanitizer".

 

[daveflintstone]

oh for goodness sakes, just make your sanitizer and call it a day.  The US is full of distilleries doing just that, and frankly I don't believe when all this is over the FDA is going to track down all the distilleries who supplied a nation in need and pursue cases against them because they didn't follow the daily changing guidances of bureaucratic minutae.  Come for me first.

[DrDistillation]

Bad advise!

Make product per the TTB and FDA or don't make product at all if in the USA.  You have a waiver to make a product PER SPEC if you wish, but are not being forced to make it.  If you make it, best do it by the book or you risk your bond, DSP license and people's health or death.  You are agreeing to the FDA spec when you register with them which is mandated per your bond/license.

How anyone can deal with all the normal paper work of running a DSP, but then make this out to be a big deal is beyond me.  A half hour of reading two documents and following the proper instructions is not rocket science.  It's far easier than bringing any distilled product to market for sure.  This is not hard to do if you can follow directions as they give you the formulas to use!  If you don't have the proper ingredients or can't follow the directions, then don't make the product, simple as that. But don't encourage people to go rouge.

What we don't want or need is people making a product and distributing it that isn't going to work effectively as it could or be dangerous and giving people a false sense of security using a product not designed correctly.  Shit, there are well known people on this forum saying they are making sanitizer using feints which isn't 96% Ethanol.  It matters!

This is an incredible opportunity for DSPs long term, but a few bad apples can ruin this for everyone.   Just follow the directions as given (not hard) and be risk free and know you are doing it correct and helping people.  There are reasons the formulas are the way they are and why denaturing is required in the USA and many other countries.

[Roger]

This is the kind of ignorance that predicated my no longer wasting time posting on this site. "Rocket scientists" with literally no common sense, or for that matter, sense of business. 

[DrDistillation]

If the TTB/FDA gives you a waiver to make a SPECIFIC product a SPECIFIC way, what gives you authority to change it?  Do you know more than the doctors and scientist? Do you know more then the FDA whom you must register with to produce the product?  Do you want to take on full responsibility of the product if it does harm to someone and is produced out of spec?

Do you know more then those who have tested it for other safety reasons, like what happens when a 1 year old ingests the product, how it's treated from a poison control standpoint, etc... This is where "common sense" goes out the window.  You have no control what/how the product is used after it leaves you. But regulatory bodies study and try to take these things into consideration.

If the TTB tells you that you can't produce a product a specific way, do you do it anyway and bottle it?  The TTB & FDA are allowing you to produce a new product per an approved recipe without seeking approval.  How is it any different?  You make the product per the approved cola.  You have been given a cola for how to make this product, follow it OR seek out an approved alternative from them.  But you can't go rouge and you don't have permission to deviate from it as a DSP standpoint.

[Roger]

Yo Doc - That's what I meant. I am absolutely against any deviation whatsoever. 

[DrDistillation]

Got ya, reading your post again make sense. Sorry about that.

 

[dhdunbar]

Since my last post here, I have had a private conversation with someone who was once much higher in the TTB pantheon than I and whose opinion I respect.  I'll not name the person, because it was a private conversation.  I will share the opinion.  The person wrote me:

"I do think it gives FDA the leeway to set whatever guidance it wants to adopt including that the spirits be denatured.  Attached is the Senate final explanation of the bill.  Look at page 13 and the description of section 2308.  Congress intentionally relied on FDA here.  Under rules of statutory construction (as you note) Congress is assumed to know what FDA had in place and could have used different language to directed FDA to allow the use of undenatured spirits.  Moreover, the spirits lobbyists who got this  added minute to the bill knew what the FDA conditions were and could have find a way to get around it by the legislation.  I am not sure why they did not do so."

So I take back my claim about the CARE Act provisions being an unambiguous expression of congressional intent.  I'll rephrase my conclusion this way, "the language of the CARE Act amendment clearly establishes that congress does not object to making hand sanitizer with  of alcohol that has not been denatured if the FDA choses to allow that." The curious thing is that the FDA guidance document contains what the FDA calls, on the heading to each page,  "Non bonding recommendations," then states, in the text, "In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required."  They offer no further explanation of what they mean by that, but invite discussion of an "alternative approach."  

Now I will do as I said I would and write to both FDA and TTB requesting that for matters of public safety they allow you to make hand sanitizer using undenatured alcohol.  That's the job I've given myself for the morning.  

Hang in there; be safe.