bluestar

Sadly, many small distilleries made hand sanitizer in small quantities in an effort as much to be helpful as well to produce perhaps a small supplemental income stream, unaware of the impending fee of this magnitude. For such small facilities, given all the other difficulties during the epidemic, this will probably put them out of business.

On 4/26/2020 at 3:01 PM, Al_The_Chemist said:

@DrDistillation Thanks for the tips. I did bring the spirit down to 80 proof and let is rest. It did improve the issue somewhat, but not to the extent I would hope. Question about the glycerin. Is the goal added body (mouth feel viscosity) or to add sweetness? The spirit has quite a bit of body from the tannin in the barrel. 

 

@bluestar, apologies for the lack of terminology accuracy. I'd be happy to dial in on the difference for future. What are you referring to by heat? From what you're saying, I'm referring to alcohol burn.

As for proof, I tried it at both 110 and 80 proof. The 80 proof was more palatable. Though the rum was FAR less "notably alcoholic" going into the barrel. And there was very little difference in abv. 

Definitely NOT alcohol burn. That is either just a function of proof, or of balance between proof and other flavors in the profile. Heat usually is a result of residual ketones.

On 4/24/2020 at 2:24 PM, Al_The_Chemist said:

My reference to hotter is the feel of alcohol burn in the mouth and throat. Adds to the opposite of smooth oddly this is exactly the profile I was expecting the barrel to mellow out. 

The oak has to be quite dense. Flavor on the rum is great. Like an good aged whisky with rum overtones. Nice and heavy, full of flavor. Wish it was more palatable. 

Blending is definitely an option.  

Hard to tell, since you are not using terminology that most of my friend distillers would employ. Alcohol burn is something very different from the "heat" of a new-make spirit: the latter will mellow with aging, the former changes ONLY with proof, or by being overpowered by other flavors. Are you tasting at 57%? I would expect anything over 100 proof to taste very alcoholic. Does that "heat" go away if you proof down to 80? Generally, I don't consider smooth the opposite of hot.

On 4/18/2020 at 3:13 PM, jrfalcon said:

Thinking of buying a label printer, Are they cost effective and are they user friendly?

I am assuming you don't mean something at the professional end like an HP Indigo? Those require space and expertise, are very expensive, and usually have be run with high % duty cycle to justify operation. If you mean something like the Primera line of printers, a would say they can be cost effective and reasonably straightforward to use. The most recent generation of printers have a reasonable printing rate for runs of a few to a few hundred labels, but too slow for 1000+, IMO. I have used both the older 810 and now the 900 extensively. For spirits, you are going to want to use pigment ink, not dye. And even then, you should consider you will need to coat or fix the labels afterwards, which turns out to be a more difficult problem than the printing if you don't want to do it manually with a spray can.

2 years in a 4 gallon! And little angel's share loss? That must be some dense oak. Don't know what YOU mean by hotter. Normally, I think of heat as resulting from ketones in virgin spirit, that aging almost always reduces. Now harsher is different than hotter. I would expect it to be harsh. Oddly, if you are not getting much angel's share loss, you could just leave it in the barrel, it might mellow out in a year or two. Also, how does it taste if you dilute it with large quantities of unaged rum? Say, 2-5 parts white to your 2yo? If one of those tastes good, you could make "light rum", which is a blend of aged and unaged rum.

On 4/19/2020 at 11:39 AM, SlickFloss said:

Bluestar,

     I will copy paste an email I have with Discus attorney below. I don't think you have to use a notation on a. finished package of sanitizer. Only if your selling alcohol to someone else to make sanitizer. Convoluted and not my interpretation, but see from Discus below.

 

My message:

Subject: Re: COVID-19 Hand Sanitizer: Updated FDA Guidance Documents

Date: April 18, 2020 at 10:46:32 AM CDT 

Joe,

        We are blasting away at sanitizer, thanks for all the guidance.

 

        I do have a question about labeling when we use less than 189.8 proof alcohol.

 

I have some 180.00 proof (90%) I want to use and I don’t want to run it back through the still (energy costs)

 

According to the guidelines:

• Minimum Proof: FDA requests that the alcohol be not less than 94.9% ethanol by volume prior to denaturing, which is consistent with the USP and FCC grade requirements for purity; however, they have provided that lower ethanol content alcohol falls within this policy so long as it is labeled accordingly and the finished hand sanitizer meets the ethanol volume to content concentration of 80%. 

 

So with that in mind, in order to include the lower proof booze in our product we would have to alter the label. Would you want us to ad something like this:

 

 “This product was made with ethanol less than 189.8 proof”

 

 Or something like this:

 

“This product was made with 90% Alcohol”

 

Thanks,

 

 

Here was their response

Begin forwarded message:

From: Courtney Armour <courtney.armour@distilledspirits.org>

Subject: RE: COVID-19 Hand Sanitizer: Updated FDA Guidance Documents  

Date: April 18, 2020 at 2:27:22 PM CDT

Hi Nick,

 

If this is for hand sanitizer (rather than the alcohol being sold as an API to someone else to make hand sanitizer), the label should just provide the final alcohol percentage which needs to be a minimum of 80%.  The recommended labels are provided in the appendices of the FDA temporary policy, starting on page 9.  

 

Let us know if you have any other questions.

 

Courtney 

 

Courtney Armour Chief Legal Officer and Corporate Secretary O: (240) 232-8527 😄 (202) 445-1903       #DistillersUnited4aCause

 

 

In a very convoluted way, this is directly from your own attorneys that you've never met, but will be defending you if anything goes wrong

Okay, my problem is the excerpt on minimum proof in your text could be read differently then the excerpt I provided verbatim from the FDA footnote. The difference in punctuation could be meaningful. I find the Discus reply frustrating, because it doesn't really relay any justification or explanation for the use of lower proof alcohol, just says you only have to label with the final proof, which I already assumed. That is because from the punctuation of the footnote, I don't think the labeling mentioned for less than 189.8% refers to the final product, but to something else, and that is what my question is: what is being labeled at lower proof?

5 hours ago, DrDistillation said:

You could try HorticultureSource.com, GrowersHouse.com, JPC Catalog, LA Garden Supply

Try any local hydroponic stores or Grainger.

Most of these are out of stock or can not ship to most states.

aged product no smaller than 1 micron. unaged can be smaller.

I was always curious about the ethanol inks. Okay, for the most part, everything will evaporate. But carbon black, as a powder (not while bound in ink) is a carcinogen, and the ethanol will be denatured. So you don't want any of that ink to get into your final product. Also, for spills, is the ethanol based ink more permanent than inks that use a different solvent? I've sometimes wondered if one wouldn't be better off with a low-toxicity water-based acrylic?

We have used poly cone fermenters. The 60 gal have a pretty high angle cone, but we found the fermentation provides sufficient agitation for our mash bill to keep the solids moving and suspended until near the end of the fermentation. We have to stir things up before pumping over, otherwise, there is a solid plug at the bottom of the cone where the valve is, and you can't pump out. You need a good size valve on the exit, we are using 2" triclamp hardware there. Still, it was a bit of a challenge, so we switched over to 200 gal, with a much shallower cone. These work much better, although you still want a stir up before pump out.

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!

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.

Just accept the funds as a deposit toward purchase of the bottles when the barrel is bottled for them.

1 hour ago, Thatch said:

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

 

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.

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

On 3/23/2020 at 5:54 PM, dhdunbar said:

Bluestar - did the FDA give any reason why it was demanding SDA?  It's just not logical.  In the meantime, I know a lot of DSPs that are saying damn the torpedoes, full speed ahead.  FDA is going to have a hell of a mess if they insist on denaturants.  not to mention egg on their face. DSP's are looking to TTB's guidance document.  It is a horse that is out of the barn already.  

UPDATE: ACSA obtained an update from FDA. Important points: ethanol must be distilled to 94.9% abv, water added must be boiled or distilled, and ethanol must be denatured with tert-butyl alcohol and either denatonium benzoate or sucrose octaacetate.

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

4 hours ago, dhdunbar said:

See my post above.  I agree.  I think FDA used the word "denatured" in an inopportune way.  I do not think they will stick with it when pressed.  Some has to press them on it.  

American Craft Spirits Assc. webinar just finished, mostly confirmed my own research to date, and what we have discussed here. TTB and FDA difference on undenatured alcohol not yet resolved, FDA still requiring denaturing, and webinar recommended isopropyl alcohol.

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.

1 hour ago, dhdunbar said:

27 CFR 21.141:  

But, why mess with SDA?  It saves the taxes, but if my fingers and toes get it correct, the tax on 160 proof sanitizer is 0.03375 cents and ounce.  Thus, the tax on a 10 ounce bottle is $0.34.  Now, I'm notoriously bad at getting decimal places misplaced, but I've got to figure that, although I have no idea of the cost of chemicals,  the cost of making 1, 3-A, etc., when you throw in the labor to boot, is going to eat into or surpass the tax due if you don't denature.  Youy might even save money by payikng the tax.  Plus, you are able to meet the local quicker..

It's not the tax, it is the current FDA guidance that requires the product be denatured. You can't not denature according to FDA, even though the TTB suggests you can. Unless there is an updated guidance since Saturday? Under normal conditions, the isopropanol could be cheaper in bulk than your beverage grade GNS. But right now you can not get it except in larger quantities.

16 minutes ago, dhdunbar said:

I've been posting on  an other thread on these sorts of issues.  Briefly, denatured alcohol comes in two type, specially and completely denatured.  It is not simply something that should bare a Mr. Yuk sticker.  For purposes of the internal revenue code, which governs the use of alcohol in industrial as well as beverage products - the FDA has standards too - denatured alcohol is a product manufactured in accordance wioth formulas found in 27 CFR part 21.  General, the formulas call for you to use 185 proof or more alchohol as the base ingredient, then add not less than quantities of specific  denaturants.  Each of the formulas is identified by a number,m for example, SDA-1, or SDA 3-A, etc.  To make a sanitizer you use SDA formulas that are approved for use as sanitizers.   Approved uses also have numbers.  Sanitizers are use number 430.  There is a list of SDA approved for each numbered use (§21.141) and a list of formulas that may be made using specific denaturants (§21.151) and a statement of specifications for each authorized denaturant (§21.91). 

Products made with SDA are called "articles."  Sanitizers are an article.   You must be a DSP to denture, but either a DSP or a person who holds a permit as an SDA user may make articles.  27 CFR part 20 has the rules for making articles.   You must make them according to another formula, which paZrt 20 requires you to get, unless you make the product according to a "general use formula."  Part 20 lists a number of general use formulas.  It does not list one for sanitizers.  So you must file for and receive approval of formulas for sanitizers. 

Those are the general rules.  Because of an emergency, TTB exempted DSP's from the requirement that you make sanitizes with SDA or file a formula, if you make the sanitizer using a World Health Organization formula, to which TTB provides a llink, and the final product contained specified quantities of hydrogen peroxide and glycerol .  FDA also waived requirements, adopting language generally the same as TTB's, but FDA does require that the alcohol you use be USP grade.  This would likely preclude the use of heads, but I don't know that.  

To summatriz:e:  There is a rigorous set of rules for making sanitizers, some have been waived and replaced by emergency rules of limited duration.  As a DSP you may make sanitizer under the emergency rules without doing anything else as long as you comply with the conditions of the emergency rules.  Methanol is not an authorized denaturant for sanitizers nor is it an ingredient in the WHO formula.  In any case, heads are not dentured alcohol.  They are, by definition, distilled spirits, and misuse of them can lead to tax liability.  

Thanks for this. Am I correct that 3C as well as 3A can be used for sanitizer (see my post above)? I missed that formula 1 would also qualify, but I found that more problematic than either formula 3A or 3C.

21 hours ago, CalwiseSpirits said:

The paperwork is the least of my concerns right now - if we find out we can denature I'm just going to keep strict record of my activites that I can use to fill the paperwork out with later. 

I think this makes it pretty clear what formulas we need to use - I assume we'd be under "Antiseptic solutions" for hand sanitizer. I'm also finding there are lot of agencies and public servants out there that just need surface cleaner - I have PDs that need it to sanitize their cop cars, fire fighters that need to sanitize gurneys, etc. For that purpose I'm thinking of just making a denatured ethanol without glycerin or hydrogen peroxide, if TTB will allow us.

Okay, if you are correct, let's put the relevant info here for all to easily find: Antiseptic solutions, U.S.P. or N.F: 23-A, 37, 38-B, 38-F. Note that NONE of these formulas use methanol.

Formula 23-A is the simplest: 8 gallons of acetone, U.S.P. for every 100 gallons of ethanol. Formula 37 is interesting: Forty-five fluid ounces of eucalyptol, N.F. XII, 30 avoirdupois ounces of thymol, N.F., and 20 avoirdupois ounces of menthol, U.S.P.; as is Formula 38-B: Ten pounds of any one, or a total of 10 pounds of two or more, of <a long list of aromatic and other oils>. The latter might make a nice product, but there could be issues of sensitivity for some users with any of these additives. Still, in any case, we are talking about a relatively high percentage of acetone or aromatic oils, and I wonder how this does NOT have to appear on the FDA required labeling, since it is not "alcohol" and not a trace amount.

Actually, formulas 3A and 3C might also be applicable, and easier to implement. Formula 3A adds 5 gallons of methanol; Formula 3C 5 gallons of isopropanol. While not indicated for antiseptic solutions USP, it is indicated for disinfectants and for sterilizing solutions. When you consider that the sanitizer can be made with isopropanol, one would think this would be the "safest" solution. Note both formulas are all "alcohol" and the ingredient labeling for FDA lists "alcohol" not "ethanol", so I would presume it is accurately labeled for these formulas. (And, after @dhdunbarsubsequent post, I have added...), and looks like formula 1, adding 4 gallons methanol and gallon MEK or MNBK would do, but it seems easier to use 3A in that case. 

Regarding without additives, it is not the TTB guidance that limits, it is the FDA.

25 minutes ago, CalwiseSpirits said:

Per the TTB authorization:

"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..."

They are expressly giving beverage DSPs permission to make hand sanitizer with denatured alcohol. Do they expect us to get it solely from somewhere else instead of denaturing ourselves? I want to believe that the intent of this is to allow us to denature. Figuring this out should be as easy as making a phone call to them? I also know that DISCUS and others are pressuring TTB to exempt sanitizer made with non-denatured ethanol from FET and that would be an easy fix to this problem. 

Agree, that is the question. I think @dhdunbar said that he thinks we can denature, but then the next questions would be: which formula should we use, and what paperwork to do we do for monthlies and removal from bond? In addition, even if we are exempted from FET for non-denatured, currently the FDA is requiring denatured?

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?

1 hour ago, bierling said:

https://www.ncbi.nlm.nih.gov/books/NBK144054/

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.