Jump to content

Hand Sanitizer from GNS


Recommended Posts

On 3/15/2020 at 12:55 AM, DrDistillation said:

For home brew type sanitizer I'd have zero issue using "heads" (I do) from any of the mashes/washes I make.  Just not enough methanol to worry about IMHO.  I'm not drinking it and it's just skin content which I'll wash off anyway.

What I do after being in public is use my alcohol based sanitizer THEN rinse with at least water.  My sanitizer is strong (70%+) of alcohol (from heads runs) so it kills germs but I don't want it lingering on my skin so I at least rinse with water to rinse off any residual alcohol.  Wouldn't want to light a cig or cigar or work around the stove without a quick rinse first to dilute any residual alcohol on the skin even though most would just evaporate and probably never be an issue.

From my own personal/family standpoint I look at it from killing germs, bacteria, virus first then neutralizing alcohol then softening skin with anything of your choosing including aloe if you have it.

We (people here on this forum) understand alcohol and instinctively know to do quick rinse with water after killing germs to not become a fire hazard.  That is part of FDA responsibility to make sure people are safe with products high in alcohol.  Some dumb smuck who doesn't know better could rinse with a high alcohol sanitizer, lean over his kerosene heater in the family room and poof... We on the other hand can can bacteria, virus, etc with alcohol, then rinse with water and then soften skin as 3 separate steps.

Teach your family/friends(if you share) how to use alcohol to kill germs and rinse with water to be safe  and then use something to keep skin soft and not dried out from the alcohol evaporating from skin.

Does that make sense or no?

Also consider that for Denaturing formula NO. 1, the primary agent added is METHANOL, so trace methanol in heads should not be a medical/safety issue. The secondary agent is a KETONE, so having traces of that in the heads should not be an issue either?

Link to comment
Share on other sites

3 hours ago, daveflintstone said:

The plastic bottles are the thing that is out of stock everywhere.

Yup, and for the few plastic bottles I could find, you could not get a dispensing top for them, just a simple screw off. Not sure they were alcohol compatible either.

Link to comment
Share on other sites

On 3/14/2020 at 8:36 PM, DrDistillation said:

dhdunbar, I think you got it pretty well covered

The document is pretty self explanatory as to what the FDA would allow right now for C-19 and by who and you explained the bond (at a high level) and recording properly as far as I can tell.

@dhdunbar, how do you think we are supposed to handle what looks like the allowed production of the sanitizer from beverage spirit (pay tax of course), if we follow WHO formulation? For example, how do we report that in our production and processing monthlies? If we label it, does it have to be labeled as if it were alcoholic beverage? Would a label have to be approved? If so, and we submit a COLA, what has to be on it for description? You get my train of thought? It was not obvious to me from the TTB notice that these go out the window, just because we are allowed to make it...

Link to comment
Share on other sites

52 minutes ago, bluestar said:

Also consider that for Denaturing formula NO. 1, the primary agent added is METHANOL, so trace methanol in heads should not be a medical/safety issue. The secondary agent is a KETONE, so having traces of that in the heads should not be an issue either?

I wouldn't think so either, but I'm not expert in these matters so I'd defer to those with more knowledge.  Considering the fed gov is now allowing those with Alcohol Fuel Permits to make this they seem a bit "desperate" to get sanitizer out in the public so I'd not be to concerned and just "best case" denaturing for tax purposes and just not have extra around for any checks. :)  It seems like the Fed Gov is going to be quite lenient anyway at this point.  Follow guidelines as best you can.

Don't forget to keep tight records of what you give away, costs and fair market value.  It will help you next year at tax time, not that you're worried about it now but all the same, keep good records.

If you make sanitizer, don't forget to reach out to local authorities like police force, rescue squad, nursing homes, but don't forget churches in your area as well as city counsel.  While they themselves might not need it, they might be able to tell you who does.  These are all good/great organizations/departments to have their support behind you.  Don't forget the local liquor store as well for a distribution point.  They will remember your generosity in times like this.

Link to comment
Share on other sites

Hello all,

Christopher Carlsson of Spirits Review sent me the following link to share. It is aggregation of 118 plastic bottle suppliers from around the country.  He knows people are looking for suppliers for he wanted to pass this on.  https://www.thomasnet.com/products/custom-plastic-bottles-96102611-1.html

Link to comment
Share on other sites

All the newest guidance is great, but some things still seems up in the air? WHO does not require denaturing. FDA does require denaturing, per TTB denaturing formula. TTB says if not denatured, you pay tax. But FDA suggests you can not make with un-denatured ethanol. Nowhere can I find from TTB guidance where a DSP will be allowed to denature their beverage product without additional permits. I also note FDA gives required labeling, and says you must register with them you are going to distribute product. I also note that the denaturing elements, like methanol, are NOT listed as ingredients on the FDA labeling (seems misleading to me). Anyone have any further clarification on these issues?

Link to comment
Share on other sites

I am trying top make sense of these issues by sorting through the regulations.  I wiill give what I think are a couple of preliminary answers here.  But I'm also trying to do it with discipline, which is taking time.

The issue of the FDA requiring that the alcohol be denatured   under part 20.  I do not think the FDA means the alcohol must be  denatured under part 20.  I think it means that the sanitizer must be manufactured under a formula for articles in part 20.  I conclude that because the FDA's statement is nonsensical on its face, since no alcohol is denatured under part 20.  The formulas for denaturing are in part 21.  So, the FDA must mean something other than what it says.  What might that be?

  • Part 20 requires formulas to make articles using denatured alcohol. 
  • Since the formulas in part 20 are for articles, not for "denaturation," within the meaning of the the term denaturation in parts 19, 20 and 21,  it appears that the FDA is using "denatured" in a different sense. 
  • To me, it appears that the FDA wants to require that the chemicals added to the alcohol to make a sanitizer  be covered by a formula approved by TTB under part 20.  

I can't speak for the FDA, but that makes sense of the part 20 reference.  It also meets the spirit of the emergency procedures.  If I were guessing, and I will guess here, I would guess that the reference to part 20 formulations was intended to protect TTB's interest in the revenue, because, surely,  the FDA knows that the WHO standard does not call for denatured alcohol.  Now, let's dig a little deeper hole.

  • Part 20 also reacquires that manufacturers articles must have a permit as an SDA user, so DSP's are exempted by part 20 and the permit as an SDA user never a problem for a DSP.  That solves on of the questions posed here.
  • However, parts 19 and 20 do not exempt DSPs from the other requirements of part 20.
  • One of those requirements is that everything made under part 20 is made using SDA (There is a limited exception for some use of alcohol withdrawn free of tax for limited  uses by a limited group of people.  The exception does not apply here, so I won't discuss it..)
  • Part 20 requires that, unless an article is covered by general use formulas set forth in that pare, the manufacturer,which may be either a person holding a SDA User permit or a DSP,  must submit a formula and TTB must approve it.
  • Sanitizers are not covered by a general use formula.
  • However, part 20 also allows TTB to establish a general use formula by ruling.  TTB's guidance document is not a ruling, but it does contain a formula. 
  • I think TTB will consider that guidance formula to be a general use formula and the guidance document to be a ruling.  I think they will not want to split hairs.
  • Next, because it is an emergency, what I take to be the approved general use formula, as it appears in the guidance document, allows you to use either denatured or undenatured alcohol.    
  • The only consequence of using the undenatured alcohol is that you must pay taxes on the proof gallons used to make the sanitizer.  (How you determine the taxes due is another issue,. but I'll get to that in another post a little later)..
  • Now we get to the Philadelphia lawyer's argument:  Since the formula in the TTB guidance document is a general use formula under the provisions of part 20, and since it does not require that the alcohol be denatured, you are making the saqnatizer according to the requirements of part 20, which is what the FDA says you must do.   Durng this time of emergency,   I think the FDA will be no more inclined to split hairs than TTB is

There are other formula related issues. 

  • The WHO formula requires that you use distilled water or water that has been boiled.  I think this flows from the fact that the remote areas in which WHO often operates often have contaminated water.  I think neither TTB or the FDA will require that you use distilled or boiled water in any situation in which the water you use is acceptable for internal use.  If it is acceptable for internal use, it surely must be acceptable to external use as a sanitizer.  To hold otherwise seems inane.  
  • Next, the FDA requires that ingredients be either USP or FCC grade.  This is way above the rim.  it includes both the alcohol and the other chemical ingredients.  I assume that the scientific supply houses that provide the chemicals understand those standards.  But what about the alcohol?   I'm not competent to speculate.  Here are what I think may be the reqauirements.

image.png.dbc96bb20c63fe711a3be704c14a3dcb.png

I'll leave it for others to comment further on that.  It appears that you are going to have to ensure that the congers are within the allowed limis.

I gave up fishing as a kid because I always snarled my line when casting and I did not have the patience to untangle it.  Now I am doing this. 

I'll try to get some more info out soon on taxes, alcohol content, labels, and how to treat the operations and transactions for record keeping and reporting purposes.  I've been thinking about those things,  but don't want to overreaching my welcome and do want to eat lunch.  

Stay save.

 

 

  

Link to comment
Share on other sites

The WHO addition of hydrogen peroxide seems odd. 80% alcohol has some serious killing power.  What is hydrogen peroxide going to add?  It would seem to me that the WHO guidelines are based on production in the developing world, hence the requirement for distilled or boiled water.  oh well

oh dhdunbar just said about the same thing.  I often skim through and over your posts because they are often over my head.

Link to comment
Share on other sites

  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.

 

Link to comment
Share on other sites

13 hours ago, Silk City Distillers said:

Apparently the spores of some of these nasties are particularly resistant.

 

The WHO guidelines go beyond formulas.  Step 7 in the process, ". Immediately divide up the solution into its final containers (e.g. 500 or 100 ml plastic bottles), and place the bottles in quarantine for 72 hours before use. This allows time for any spores present in the alcohol or the new/re-used bottles to be destroyed."   

  • Thumbs up 1
Link to comment
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now
×
×
  • Create New...