Choosing a denaturant for hand sanitizer.

[Foreshot]

Legal denaturants: https://www.law.cornell.edu/cfr/text/27/21.151

I'm starting this thread for people denaturing their product for use as hand sanitizer. I heard that the TTB is taxing GNS put in the WHO formula hand sanitizer unless it is denatured. Given that glycerin is on the list I don't understand that but it's not my call. I personally have no experience with this so I do not know what to use. If there's someone out there than can share this info please do. We do have to watch that whatever denaturant is used that it's as odorless and colorless as possible, not an allergen, and is safe on skin at whatever % is required for legal denaturing. I would rather use the FET money to buy more raw materials for hand sanitizer.

[bluestar]

I am still unclear that the TTB will allow a DSP to denature the alcohol without additional permits. And the FDA just indicated they will require the sanitizer to be made with denatured alcohol. Catch 22 for a DSP?

[CalwiseSpirits]

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. 

[bluestar]

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?

[CalwiseSpirits]

25 minutes ago, bluestar said:

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?

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.

[Thatch]

2 hours ago, CalwiseSpirits said:

For that purpose I'm thinking of just making a denatured ethanol without glycerin or hydrogen peroxide, if TTB will allow us.

Let us know what you find out. 

It appears that 10% methanol gets you to a denatured level.  Given that Methanol is part of the heads and foreshots, are we already producing denatured ethanol but re-introducing our foreshots and heads?  It also appears that acetone is another denaturing agent.

Denatured alcohol (methylated spirits) is ethanol (CAS 64-17-5) that has been treated to make it unfit for human consumption. The main additive is typically methanol (10 percent), but isopropyl alcohol (2-propanol), methyl ethyl ketone, methyl isobutyl ketone, acetone, or other substances may also be used.

How do you determine what level of methanol and acetone you have in heads and foreshots?  If we add back in our heads and foreshots do we have a denatured product that can be used as a sanitizer for wipe downs?

 

[CalwiseSpirits]

33 minutes ago, Thatch said:

Let us know what you find out. 

It appears that 10% methanol gets you to a denatured level.  Given that Methanol is part of the heads and foreshots, are we already producing denatured ethanol but re-introducing our foreshots and heads?  It also appears that acetone is another denaturing agent.

Denatured alcohol (methylated spirits) is ethanol (CAS 64-17-5) that has been treated to make it unfit for human consumption. The main additive is typically methanol (10 percent), but isopropyl alcohol (2-propanol), methyl ethyl ketone, methyl isobutyl ketone, acetone, or other substances may also be used.

How do you determine what level of methanol and acetone you have in heads and foreshots?  If we add back in our heads and foreshots do we have a denatured product that can be used as a sanitizer for wipe downs?

 

This is what is required for methanol purity for denaturing. I'm also wondering if it needs to be USP-grade for this application, if we can even use ethanol denatured with methanol for these purpose. Also, what we consider heads isn't pure methanol... there is actually very little methanol in it... it is actually mostly ethanol. I doubt the heads we produce have the concentration of methanol required. 

[bluestar]

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.

[dhdunbar]

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 denature, 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 part 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, provided that you make the sanitizer using a World Health Organization formula, to which TTB provides a llink, and provided 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 summatrize:  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.  

[bluestar]

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.

[dhdunbar]

9 minutes ago, bluestar said:

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 that either formula 3A or 3C.

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..

[sandytoes]

1 hour ago, dhdunbar said:

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.  

Dave - So do we need to denature or not under this emergency ruling?

[bluestar]

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.

[dhdunbar]

TTB is clear.  You do not need to denature.  The confusion arises with the FDA's requirement that you use " 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 think the use of the word "denatured" here is unfortunate.  We need the FDA to say what it means in the context of its guidance document.  i think it does not mean "denatured" in the sense that the Internal Revenue Code uses the term.  Here are my reasons.

The FDA says you must use alcohol denatured under part 20.  AS TTB USES THE WORD, NO ALCOHOL IS DENATURED UNDER THE PROVISIONS OF PART 20.  For purposes of the Internal Revenue Code, which TTB administers,  alcohol is denatured under the rules of part 21, then it is used, to make an aricle - in this case sanitizer - under the rules of part 20.  Normally it is a two step process.  Make the SDA according to part 21, then use it for purposes authorized by part 21, to makle the sanitizer under a separate formula, for the article, not the SDA, in part 20.  

I can no reason that the FDA would want to demand denatured alcohoi.  What "health" advantage would result from using denatured alcohol rather than undenatured alcohol?  The only reason that the IRC requires denaturants is to protect the revnue the government wants to collect from beverage alcohol.  The denaturation provisions are a way of allowing industrial use without loss of revenue due to diversion form industrial to beverage use.  Because of the emergency, TTB did away with the requirement that you use denatured alcohol to make sanitizes.  I think the FDA would agree to that.  Here is one statement I have found that expresses the FDA's intent, in the case of cosmetics:.  I think it clarifies FDA's intent:

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.

Denatured ethyl alcohol may appear in the ingredient listing under several different names. You may see the abbreviation SD Alcohol (which stands for "specially denatured alcohol"), followed by a number or a number-letter combination that indicates how the alcohol was denatured, according to the formulary of the United States Bureau of Alcohol, Tobacco, Firearms and Explosives. Among the specially denatured alcohols acceptable for use in various cosmetics are SD Alcohol 23-A, SD Alcohol 40, and SD Alcohol 40-B.

See: https://www.fda.gov/cosmetics/cosmetics-labeling-claims/alcohol-free

However, I cannot speak for the FDA and I am not an attorney, so I cannot give legal advice.  I'd bet dollars to donuts (well, donuts have become more expensive of late but I'll stick with the idiom) that FDA has no objection to the use of undenatured alcohol in the production of hand sanitizers.  I've given you the artguments.  Now someone needs to seek clarification.

[dhdunbar]

7 minutes ago, bluestar said:

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.

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.  

[CalwiseSpirits]

3 hours ago, bluestar said:

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.

Yes, isopropyl I think would the best. But finding isopropyl is incredibly difficult right now, hence why we're even having this conversation about ethanol in the first place. I found a flavor manufacturer who can provide me lemon oil for incredibly cheap. I'm going to try denaturing with that.

2 hours 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..

I'm selling sanitizer to agencies in 16oz-1gal jugs. I'm selling it for $15/gal. Excise tax adds another $4.32/gal onto that - a 30% increase. I'd like to pass savings on. Under your understanding of the law, are we legally allowed to denature as a beverage DSP? I think that's what you were getting at in another post but just want to clarify. 

 

[bluestar]

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.

[CalwiseSpirits]

2 minutes ago, bluestar said:

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.

Thank you for the update. I'm trying to denature with lemon oil because it's cheap and readily available but I'm having issues with it coming out of solution when proofed below 85%. I called into TTB a few minutes ago and the woman I spoke to (Kelly) said that she believes we are authorized to denature. She is going to double check and get back to me with the recommended formulas. 

[dhdunbar]

1 hour ago, bluestar said:

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.

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.  

[daveflintstone]

I have a special denaturing wand I crafted from meteor fragments and banana peels.  When I wave that in the general direction of a tank of alcohol or sanitizer it becomes denatured through the chaotic molecular bias inherent in the universe.  And now I don't owe FET.  damn those f'ing torpedoes, I agree.

[bluestar]

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

[Bier Distillery]

Does no one at the FDA realize that ethanol distilled to less than 94.9% ABV is apparently ok to drink but not to put on your hands?  RO water is ok to drink, but not put on your hands? What problems are these requirements trying to solve?

Meanwhile hysteria, sickness, and death run rampant due to not enough hand sanitizer.

[DrDistillation]

I don't see any new information there in the FDA release.

Same regulations in 27 CFR parts 20 and 21 for denaturing.

Same USP Purity grade of 94.9% alcohol.

Did I miss something?

[SlickFloss]

Den. Benz (Bitrex) is easy to work with and available from a distributor on west coast very helpful people. 

[Classick]

On 3/23/2020 at 8:18 AM, 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..

Would not hand sanitizer be considering an external pharmaceutical?  I got a line on some SDA-40B... which was i thought an approved formula for hand sanitizer (im wading through all of these threads to find the page that said which formula's we're allowed to use)

Formula 40B is basically the Bitrex and the tert-butanol if i recall correctly

 

EDIT

per the FDA Download