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dhdunbar

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    Retired from ATF and began consulting for DSP's in 2012. When I'm not working, I like to head outdoors. That can mean simply sitting on the deck reading. Regulation bores me. Helping others deal with it does not.

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  1. As I said somewhere a long time ago in this now too long thread, DISCUS and its likes are better able to deal with this by playing above the rim than a pipsqueak like me is. I'm copying, below, two documents from the Distilled Spirits Council's website. https://www.distilledspirits.org/news/discus-statement-on-u-s-reps-yarmuth-barr-letter-to-fda-commissioner-urging-flexibility-for-distilleries-producing-hand-sanitizer/ One is a letter members of congress have sent to the FDA on this issue. The other is the councils statement on the letter.. It's time to let the big boys play. I'll have one more post on the matter of things other than hand sanitizers and then I'm retiring. I never want to hear the word hand sanitizer again :-). I wash my hands of it, so to say. DISCUS Statement on U.S. Reps. Yarmuth, Barr letter to FDA Commissioner Urging Flexibility for Distilleries Producing Hand Sanitizer March 29, 2020 1:05 pm Statement by Distilled Spirits Council of the United States President & CEO Chris Swonger on a letter sent by Co-chairs of the Congressional Bourbon Caucus Chairman John Yarmuth and Congressman Andy Barr and 85 members of the House of Representatives to U.S. Food and Drug Administration Commissioner Stephen Hahn urging the agency to update its guidance to recognize the use of undenatured alcohol in the production of hand sanitizer during the COVID-19 health crisis: “Distillers across the country are jumping in to produce hand sanitizer for first responders, hospitals and those in need in their communities. The recently-passed CARES Act includes an important provision to guard distillers from having to pay federal excise taxes on the alcohol used. Unfortunately, FDA must first update their guidance to permit distillers to use undenatured alcohol, which is recommended by WHO and is the type of alcohol distillers readily have on hand. We appreciate the support of Chairman Yarmuth, Congressman Barr and the 85 House members in calling on the FDA to be more flexible during this crisis so we can get hand sanitizer to those who need it most. The Distilled Spirits Council of the United States is committed to working with the FDA to explore appropriate ways to address any safety concerns.” BACKGROUND: For weeks DISCUS has been urging FDA to update its Guidance to permit distillers to use undenatured alcohol in its hand sanitizer formula as directed by the WHO Guidance. Most beverage alcohol companies exclusively make products with undenatured alcohol and may not be able to access the required denaturing materials. Denatured spirits are those that are treated with bittering agents to make them unsuitable for human beverage consumption. DISCUS has raised concerns with FDA regarding potential shortages of denaturing ingredients as well as the effect the denaturing materials may have on distilling equipment. Due to the highly concentrated nature and toxicity of the bittering agents, these components are very persistent and distillers may have to develop a special cleaning method to remove them before beverage grade product can be reintroduced. Requiring denaturing could also significantly increase the amount of time it takes to produce this product and get it to those who need it now. The WHO Formula is a very high proof alcohol with hydrogen peroxide, which is less palatable than other denatured products currently on the market. Thus, further bittering should not be needed, particularly in light of the present need. ### ____________________ Friday, March 27, 2020 The Honorable Stephen Hahn Commissioner U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Dear Commissioner Hahn: We write regarding the U.S. Food and Drug Administration’s (FDA) guidance to manufacturers who are producing hand sanitizer as part of the COVID-19 crisis. As you know, hundreds of distilled spirits producers across the country have immediately responded to the current health crisis by halting their regular operations and quickly turning to the production of hand sanitizer. These distillers are fulfilling a critical need in their communities and providing the hand sanitizer to health care professionals, first responders, and local and state governments. They have diligently followed the guidance released by their regulator, the Alcohol, Tobacco Tax and Trade Bureau (TTB), and are producing hand sanitizer according to the World Health Organization’s (WHO) formula. Unfortunately, the FDA’s “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19): Guidance for Industry” does not acknowledge the reality that these distillers have stepped up in a time of crisis to produce hand sanitizer using the alcohol they have readily available, which is undenatured. Undenatured alcohol is food grade alcohol that is compliant with the WHO’s hand sanitizer formula and has the same effectiveness as denatured alcohol. The United States largely differentiates between the two types of alcohol for tax purposes – with undenatured alcohol incurring the distilled spirits Federal Excise Tax (FET) and paid to the federal government. A provision was included in the recently-passed COVID-relief package that would temporarily remove the Federal Excise Tax on hand sanitizer production as long as the distiller has followed FDA guidance. Through the current guidance, the FDA is standing in the way of hundreds of thousands of gallons of hand sanitizer from being produced and given to those on the front lines battling this pandemic. We have a responsibility to provide more resources to help flatten the curve and alleviating this burden would allow distilleries the opportunity to step up and help their communities. We strongly urge the agency to update its guidance to recognize the use of undenatured alcohol in the production of hand sanitizer during the COVID-19 health crisis and work with industry on reasonable safeguards to keep hand sanitizer out of the hands of children. This will ensure distillers do not face a tax bill for filling a vital need in their communities. Sincerely, _________________________ _________________________ John Yarmuth Andy Barr Member of Congress Member of Congress
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. Does anyone know anything more about the tax relief mentioned by DISCUS in this news release? News Statement by Distilled Spirits Council of the United States President Chris Swonger on House Passage of COVID-19 Relief Package Which Includes Critical Tax Waiver for Distillers’ Production of Hand Sanitizer: March 27, 2020 1:36 pm “We are grateful that Congress recognizes the significant contributions of the nation’s distillers in producing hand sanitizer to help fight COVID-19, and for waiving the federal excise tax on these much-needed products so that these distillers are not subjected to a tax bill for their goodwill. We urge the FDA to update its guidance for distillers to ensure this tax provision can be implemented. The hospitality industry is one of the hardest hit by COVID-19, and many craft distilleries are facing the very real possibility that they may not be able to open their doors again when this crisis is over. There is more to be done, and we look forward to working with Congress and the administration to ensure future success for distilleries across the United States.”
  7. 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.
  8. i sent the following to a couple of people I know in TTB who are in a position to get something done or at least put it into the hands of persons who can do that.. We'll have to see if it works. “Houston, we have a problem.” Many distillers want to supply hand sanitizers to local agencies and health providers who are in need. TTB and FDA recognized the emergency and each agency issued emergency “guidance.’ TTB allows the use of either undenatured or denatured alcohol. The FDA has a different position. It requires that the sanitizers be made with “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 have been contacted by several clients concerning the FDA’s “denatured” standard. They want to comply. This is also a hot topic on ADI’s forum. I have pointed out that; · No alcohol is denatured under part 20, it is manufactured under the provisions of part 21. · Part 20 governs the use of SDA, already produced under part 21, in the manufacture of articles; · DSP’s may make articles, but they must do so according to either a general use formula or an approved formula. · There is no general use formula for santizers (use .430 under part 21), but the guidance document served to create one. · TTB requires denatured only to protect the revenue. · In the past, FDA has stated, “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.’ · The FDA states no other reason for requiring denaturants. · In this time of emergency TTB determined that the production of santizer was more important than protecting the revenue, and so allowed the use of undenatured alcohol. · Thus FDA should not have an objection to the use of undenatured ethyl alcohol, for a limited time, in the emergency production of sanitizers. I point out that I am not an employee of either TTB or FDA and cannot speak for either agency. I also point out that I am not an attorney and I am not giving legal advice. I request, on behalf of my clients and those who have expressed concerns by posts to the ADI forum, that TTB and the FDA clarify the situation, by stating whether the FDA intends to require denatured alcohol or whether it will, as TTB has done, allow the use of undenatured alcohol for a limite time, to meet the emergency demand for sanitizers. Thank you for your consideration of these matters. Clarification will mean a lot to the proprietors of distilled spirits plants who want to assist their local health organizations, fire departments and others until such time as normal commercial channels can meet the need for sanitizers.
  9. 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.
  10. 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.
  11. 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..
  12. 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.
  13. Records and Reports My brain is fried. I will provide information on records and reports soon. In the meantime, keep a log of what you do. Show all gauges that you make, the quantity of ingredients that you use to compound the sanitize (dump/batch record), the proof of the sanitizer you package (bottling tank and gauge record), the size of the containers into which you package it, the numbers of containers per case, the serial numbers that you place on those cases, the number of cases that you fill (bottling record), the cases or other packages that you remove and the person to whom you sold them (tax determination record), which may be an invoice from your normal sequence or a separate shipping record, each of which has a unique serial number. I've probably omitted one or more pieces of information you should be capturing. I'll try and get this done with some rigor sometime this coming week.
  14. Alcohol Content and Tolerances Background The WHO guidelines, which both TTB and FDA say you must follow, call for 192 proof (96% abv) alcohol. Must you use that high a proof? Or is this a gray area? As I read the situation, TTB and the FDA both recognized that regulations were getting in the way of emergency needs for sanitizers and so used existing, emergency authority to wave rules that were preventing persons who had alcohol that could be used from using it to fill the need for sanitizers. They needed extra-regulatory measures to allow this. To avoid rulemaking and the need for temporary regulations, each agency established the policy through guidance documents, which adopted the equivalent of the WHO's local production guidelines. The WHO guidelines, that is, provided some structure to the manufacturing and distribution process, while allowing fairly rapid localized production until such time as more traditional production and distribution practices can fill the distribution chain and meet needs. They are of a stopgap nature. To respond to the emergency need for santizers, the agencies issued with guidance documents with haste. They are not all consistent. I try to make sense of that here. These are my opinions and we should look to TTB and FDA for further guidance. In the meantime, I think my conclusions may be useful in letting you begin to meet emergency needs before TTB and FDA can iron out the differences. Conclusions Here are my conclusions. My reasoning follows: Since we know that TTB and FDA allow the use of denatured alcohol, which the WHO formula never mentions, neither TTB nor FDA appear to require strict adherence to the the letter of the whole formula. This creates a gray area. Is the 192 proof requirement absolute even though the type of alcohol is not? However, the TTB and FDA standards appear to place a lower limit on the proof of the alcohol you may use. Specifically: I would not venture to use alcohol of less than 185 proof, since alcohol of less than 185 proof is not authorized for use in manufacturing SDA. I would be mindful of the FDA's limits on impurities in the alcohol used and would not use alcohol of less than 192 proof unless I knew that it conformed to USP's acceptance criteria. Finally, since the glycerol and hydrogen peroxide standard are the same for all three agencies, I presume that TTB and FDA want to require that the final product conforms to the WHO standard, i..e., ethanol 80% (v/v); Glycerol 1.45% (v/v); and hydrogen peroxide 0.125% (v/v), with a tolerance of ± 5% of the target concentration, which, perhaps coincidentally, comports to the tolerance for articles under §20.132(d). Thus, until we find out whether TTB and FDA intend to enforce the 196 proof standard of the WHO formula: I would not hesitate to use alcohol of 185 proof or more as long as the impurities do not exceed the USP "acceptance criteria." I would not use alcohol of less than 185 proof as an ingredient. Finally, I would gauge the finished product to ensure that it is between 150 and 170 proof (the WHO target proof is 160, but they have a tolerance of ± 5% of the target concentration (75%–85% for ethanol). That tolerance comports to the tolerance found in 27 CFR part 20. Findings Here is what TTB says: 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, 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. This "formula guidance" incorporates two separate standards. The first standard, which I will call the formula, provides that that, as a DSP, you are authorized to manufacture hand sanitizer products consistent with WHO guidance. TTB conveniently includes a link to the WHO guidance document, so that the WHO guidance to which TTB refers is not in doubt. That document is a "guide to Local Production of WHO-recommended Handrub Formulations." Its apparent purpose is informing person who need hand sanitizers, but who cannot obtain them from regulated, commercial, sources, , how to make them on site. The on-site approach does not work when the alcohol is not conveniently available because the governments regulate its production and distribution. As I read the situation, TTB and the FDA both recognized that regulations were getting in the way of emergency needs and so used existing, emergency authority to wave rules that were preventing persons who had alcohol that could be used from using it to fill the need for sanitizers. They needed extra-regulatory measures to fill allows this. They did that through the guidance documents, which authorized the equivalent of the WHO's local production guidelines. Both agencies adopted those existing guidelines to avoid rulemaking and the need for temporary regulations. The WHO guidelines, that is, provided some structure to the manufacturing and distribution process, while allowing fairly rapid localized production until such time as more traditional production and distribution practices can fill the distribution chain and meet needs. It is stopgap. Next, so that it is very clear to all, TTB included, in the guidance, composition requirements. Any sanitizers you make (using either denatured or denatured alcoho) must contain 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). The guidance statement makes no mention of the alcohol content. Indeed, the "not less than language" would seem to allow you to have a product of fairly low proof. A WHO standard saves that day. The WHO guidance to which TTB directs us, contains two standards. One is a the formula, which calls for 192 proof alcohol. it is a formula. For every 1000 ml you want to produce, you use Ethanol 96%: 8333 ml; Hydrogen peroxide 3%: 417 ml; and Glycerol 98%: 145 ml. You then add distilled or boiled water to make 1000 ml. The second standard of identity. The finished product must contain ethanol 80% (v/v); Glycerol 1.45% (v/v); and Hydrogen peroxide 0.125% (v/v). Silk City and someone else have discussed these numbers elsewhere and frankly, I do not understand them. Presumably the formula c=quantities produce a product that meets the standard of identity. I leave the calculations to others. The WHO standard then allows a tolerance fore the finished alcohol content. It provides, "The accepted limits should be fixed to ± 5% of the target concentration (75%–85% for ethanol)"." I do not know if this also applies to the other ingredients. Thus, the WHO allows the final product to be anywhere between 150 to 170 proof. I note, as a matter of interest, that if you use SDA to make an article under the provisions of part 20. §20.132(d) provides for an analytical tolerance of ±5% in the amount of ingredients, including denatured alcohol, used in formulas that specify exact amounts. Thus, a sanitizer made in accordance with the presumptive general use formula in TTB’s guidance documents, which specifies exact amounts of ingredients, would be subject to the ±5% tolerance. Next, since part 21 anticipates that you will use one of the acceptable SDA formulations, I checked. Section 21.31(b) provides the general guideline for proof of spirits to be denatured, "Alcohol of not less than 185 proof shall be used in the manufacture of all formulas of specially denatured alcohol, unless otherwise specifically stated or unless otherwise authorized by the appropriate TTB officer. Rum for denaturation shall be of not less than 150 proof and may be denatured only in accordance with Formula No. 4. Therefore I would not, in any case, use, as an ingredient, alcohol of less than 185 proof. Finally, the WHO standards do not specify a grade for the alcohol used. Neither do the TTB standards. The FDA requires USP grade ingredients, which would include the alcohol. I am not an competent to comment on the USP grade ingredients. An internet search for which I cannot vouch and which I will not attempt to interpret, provided the following table of acceptable criteria (see https://www.usp.org/sites/default/files/usp/document/harmonization/excipients/alcohol-m1238.pdf I have no idea at what proof the alcohol you collect would contain not more than the quantities of other impurities allowed by USP, nor do I know that this is the standard that should be applied. Those are all the "facts" that I have found. What do I conclude? Again: First, since we know that TTB and FDA allow the use of denatured alcohol, which the WHO formula never mentions, neither TTB nor FDA appear to require strict adherence to the the letter of the whole formula. This creates the gray area. I would not venture to use alcohol of less than 185 proof, since alcohol of less than 185 proof is not authorized for use in manufacturing SDA. I would be mindful of the FDA's limits on impurities and would not use alcohol of less than 192 proof unless I knew that it conformed to USP's acceptance criteria. Next, since the glycerol and hydrogen peroxide standard are the same for all three agencies, I presume that TTB and FDA want to require that the final product conforms to the WHO standard, i..e., ethanol 80% (v/v); Glycerol 1.45% (v/v); and hydrogen peroxide 0.125% (v/v), with a tolerance of ± 5% of the target concentration, which would, perhaps coincidentally, comport to the tolerance for articles under §20.132(d).
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