What about regular sanitizer?

[Blackheart]

So just looking ahead, I think we will see a subsequent demand for regular spray sanitizer. Not just hand sanitizer.  

I have been studying the products on List N, and they look not unlike what the hand sanitizer looks like (yea, depending on the product they can be very different).  

Any thoughts from the hive mind on this?  

[DrDistillation]

Once the crisis is over and the waiver is done you'll likely need to meet all requirements per the government and get proper bonds do deal with pharma products.

[Blackheart]

We are having local government institutions ask for a suitable sanitizer spray.  Logic seems to say that following the same use-instructions as similar-composition surface sanitizers would be an acceptable answer.  

Do we know if the FDA is being queried on this?  Anyone have any feedback or thoughts?  Too risky?

[HedgeBird]

70% abv (give or take) is the ideal proof for alcohol used as a disinfectant spray.  That’s a lower proof than 151.  Just get a new label, bottle, pay the FET..  Other than the new COLA I can’t see why we would need additional approval??

If someone was doing a huge volume perhaps it would make sense to denature it to avoid the FET.  At that point it’s not beverage alcohol and maybe then would need additional approval?

[DrDistillation]

You would need approval and new licensing/bonding because you aren't authorized to make that product.  How would you get FDA approval?

Keep in mind, as of right now the temporary waiver for making hand sanitizer expires at the end of June which is only 1.5 months out.

[dhdunbar]

This issue is a mess because both the FDA and the TTB guidelines are for hand sanitizers and only hand sanitizers. 

They did not address other sanitizers. 

Specifically, they do not address  sanitzers used for cleaning surfaces, which is a common use when you sell sanitizer in spray bottles.  Because I do not know squat about the issue, and because there is an emergency need, and because ...  well, just because  it is easier to be quiet sometimes and let things play out, I decided to shut up.   I summarize the current situation as follows:  Someone yelled  "pandemic" (belatedly) in a crowded  room and since it was, hey, a real pandemic,  everyone bolted for the doors without much regard to regulatory decorum.  Consequently, persons with access to alcohol for use in sanitizers have gone off in all directions to fill emergency needs in just about any way imaginable.  Collectively, you've delivered all sort of products to hospitals, doctors offices, fire departments, police, ambulance services, prisons, individuals, and, well, just about anyone who feels they have a need for a santizer for any use for which they feel that they might have that need.  Lines between uses  are blurred - it's a hand sanitize, it's not a hand sanitizer, - if not complexity ignored - who cares if its a hand sanitizer - and the general refrain, in practice, is "Rules.  Rules?  We don't need no stinkin' rules."  That is the nature of an emergency.  

The general who was in charge of federal Katrina aid, when the government decided they had to get serious after it turned out that Brownie had done a hell of a job messing things up, said officials should not make rules they cannot enforce.   I'll say this, TTB tried, but in my opinion, the FDA was just plain officious.

But the dust from the bolting will settle.  This thread asks, "What then?"    

EPA and FDA

This question sent me, via a Google search, to a CDA web site - https://www.cdc.gov/infectioncontrol/guidelines/disinfection/disinfection-methods/regulatory-framework.html.  The document is headed, "The Regulatory Framework for Disinfectants and Sterilants - Guideline for Disinfection and Sterilization in Healthcare Facilities (2008).  Note that it is specifically for health care facilities. It discusses the role of the CDC, EPA, and FDA.  I will not pretend to have any expertise on these matters.  Some excerpts from that site:

• In the United States, chemical germicides formulated as sanitizers, disinfectants, or sterilants are regulated in interstate commerce by the Antimicrobials Division, Office of Pesticides Program, EPA.
• Any substance or mixture of substances intended to prevent, destroy, repel, or mitigate any pest (including microorganisms but excluding those in or on living humans or animals) must be registered before sale or distribution.
• To obtain a registration, a manufacturer must submit specific data about the safety and effectiveness of each product.
• For example, EPA requires manufacturers of sanitizers, disinfectants, or chemical sterilants to test formulations by using accepted methods for microbiocidal activity, stability, and toxicity to animals and humans.
• The manufacturers submit these data to EPA along with proposed labeling.
• If EPA concludes the product can be used without causing “unreasonable adverse effects,” then the product and its labeling are registered, and the manufacturer can sell and distribute the product in the United States.
• FIFRA also requires users of products to follow explicitly the labeling directions on each product.
• The following standard statement appears on all labels under the “Directions for Use” heading: “It is a violation of federal law to use this product in a manner inconsistent with its labeling.”
• Failure to follow the specified use-dilution, contact time, method of application, or any other condition of use is considered a misuse of the product and potentially subject to enforcement action under FIFRA.
• In general, EPA regulates disinfectants and sterilants used on environmental surfaces, and not those used on critical or semicritical medical devices; the latter are regulated by FDA.
• In June 1993, FDA and EPA issued a “Memorandum of Understanding” that divided responsibility for review and surveillance of chemical germicides between the two agencies.
• Under the agreement, FDA regulates liquid chemical sterilants used on critical and semicritical devices, and EPA regulates disinfectants used on noncritical surfaces and gaseous sterilants 793.
• EPA continues to register nonmedical chemical sterilants.
• In January 2000, FDA published its final guidance document on product submissions and labeling.
• Antiseptics are considered antimicrobial drugs used on living tissue and thus are regulated by FDA under the Food, Drug and Cosmetic Act.
• FDA regulates liquid chemical sterilants and high-level disinfectants intended to process critical and semicritical devices. FDA has published recommendations on the types of test methods that manufacturers should submit to FDA for 510[k] clearance for such agents.

I suspect that uses of sanitizers outside of the health services is not regulated at all by the FDA, since it is for neither internal or external human use, but I do not know what I am talking about, so any further comment would be inappropriate.  But the path to a continuing market for sanitizer is a mind field of testing requirements, etc.  Are they enforced?  I don't know.  It's not my bailiwick.

TTB

As to TTB, sanitizes made with alcohol are "articles" under its regulations.  You find the rules for articles in n part 20, which requires that the articles be made with denatured alcohol. There is no provision for using undenatured alcohol as an ingredient in sanitizers,hand or otherwise,  so, you start with denatured alcohol and then add further sanitizing ingredients. 

The formulas for denatured alcohol are in part 21.  Not all formulas are approved for use in sanitzers. 

Any alcohol used to make denatured alcohol must be produced at a plant that is authorized to conduct operations in "industrial alcohol"  That requires a permit issued under part 19 - this is different than the basic permit that beverage plants must have - and a registration, as an industrial alcohol plant, under the same part .  Any DSP conducting operations in industrial alcohol must have a bond.  There is no exemption based on the excise taxes paid, as there is for beverage spirits.  You can be both a beverage plant and an industrial plant, but unless you declare the acohol to be beverage at the itme of the production gauge, you mustd have a bond sufficient to cover the liability for the taxes on the alcohol.  

Only a DSP can denature alcohol.  When a DSP denatures alcohol according to a formula in part 21,  the tax is not due upon removal of the denatured spirits from the DSP.  Because the hand sanitizer is made with denatured alcohol, if it is made in accordance with the guidance formula, there is no tax due.  That is true whether you sell it or give it away.  If it is made with undenatured alcohol, then there is tax due.  That is true whether you sell or give it away., 

A DSP may make articles on the DSP premises.  Persons who are not DSPs and want to make articles must get a users permit under part 2o and buy a bond.  DSPs are exempt from that, but must follow the other rules for making articles in part 20.  The rules require an approved formula for all articles made.  

The hand sanitizer guidance provided a temporary exemption from the the requirements that DSPs have an operating permit, register as an industrial plant, and post bond.  It also removed the formula requirement for hand sanitizers made according to the formulas provided in the guidance document.  TTB initially provided that you could make hand sanitizers - specifically hand sanitizers - using undenatured alcohol, but after the FDA demanded for no good reason that the hand sanitizer be made with denatured alcohol, TTB changed its requirement.  

Under the ruiles, if youy make any sanitizer other than hand sanitizer produced according to the guidance document, taxes are due.  Period.  Whether TTB will ever attempt to collect those taxes is a real question.  I doubt it.  With all the sanitizer that has been sold, it would require that they devote most of their resources to collecting that tax, which is going to be a very small portion of the taxes that it collects each year.  

However, after the emergency ends, all of the requirements come to apply.  You need an operating permit, you need to register as an industrial alcohol plant, you need to make the articles with SDA that is designated for use in sanitizers, you need to have a and you need to have an approved formula.   

What about alcohol delivered to hospitals, state agencies, etc.  That is a different subject.  For it to be withdrawn free of tax, the entity receiving it must have a permit.  I do not want to go there now.  Nor do I want to provide a citation for everything I just said.  

One final statement.  Certificates of label approval are for beverage alcohol only.  You must label industrial alcohol, denatured alcohol and articles according the rules for such products, but you do not get a label approval because they are not beverage products.

I am now going to shut up again.  

 

[DrDistillation]

Great info and THANK YOU!