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Everything posted by dhdunbar

  1. Good. Because that means you are not doing what I hoped you were not doing. It sounded as if you might not be bottling on the DSP premises - "We are at that point where we want to slowly begin bottling." .The "taproom" reference was "concerning" because of, well, the tap. But I see that you make reference to " filled into standard size bottles that we pour out of. " So I take it that you are filling the bottles on the DSP premises, then bringing them to the tasting room, then pouring them from the hand filled bottles into glasses for on premises consumption. A couple of points -
  2. If taproom, etc, as you describe, means what I think you mean by it, I hate to wade into this. There no provisions for growler type operations in distilled spirits. This is a classic case of the difference between "can" and "may." You "can" fill growers out of a tap in your tasting room because there is no one there to stop you. For the same reason, you also "can" make beer on your DSP premises. But you "may" not do either. Because TTB is short handed, they might never find out about the growler type operation. But if they do, they will have a few more words than this to say about it.
  3. Here we go again. from TTB's newsletter today:: EXTENSION OF HAND SANITIZER GUIDANCE On March 26, 2020, TTB issued guidance providing certain exemptions and waivers to distilled spirits permittees to facilitate the production of alcohol-based hand sanitizers, see TTB G 2020-1A, Production of Hand Sanitizer to Address the COVID 19 Pandemic. On March 27, 2020, the CARES Act was signed into law, providing for additional flexibility with regard to removals of distilled spirits free of tax for use in or contained in hand sanitizer that is produced and distributed in a manner c
  4. TTB's specialists have adopted a mantra, "Floor to ceiling." If you submit an application showing a retail area that is adjacent to the DSP premises, they are likely to send a "correction request" - which is what they call any request for additional information, as well as changes - asking, "Please confirm that the separation is floor to ceiling." So, in practice, they are requiring floor to ceiling separation between a DSP and any place you make sales of the product at retail. I don't care how many exceptions you may have seen to this "rule," TTB now asks about it with regularly.
  5. 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
  6. I recommend that everyone read the Notice in full, to understand what changes to the regulations TTB made and how TTB decided to make those changes (or not make them). It is one of the best ways to gain an understanding of how the pieces fit together, especially when the final rule is for a major revision like this one. For part 19, can look to TD TTB–92 for an equally informative explanation of the regulations that govern DSP operations. You can access all TD's through TTB's websit at https://www.ttb.gov/rrd/treasury-decisions. This is the shortest and probably best advice I've every
  7. The guidance in the document is precisely worded. The excerpt you quote has three separate sentences, each describing a different set of circumstances. The three sentences are clear, but you have to carefully parse them. First Sentence - Part 19, 20, and 223 requirements Any existing DSP Can immediately commence production of; Hand sanitizer or Distilled spirits (ethanol) for use in hand sanitizer, As described below, Without having to first obtain authorization. What does that allow and prohibit? The sentence is relative
  8. I have avoided getting further involved in this because it is a rats nest. The FDA guidance documents say that it contains nonbinding recommendations. WTF does that mean? The whole thing centers on FDA's concern about it GRAS ruies. Whai Would call the FD's overly cautious approach to covid 19 testing poked a stick into the spokes of an essential program. It put us way behind the wave. It's caution on hand sanitzers is having the same effect. In 1996 and 2009 and nine the FDA was prepared to recognize undenatured alcohol as GRAS in hand sanitizers, but in 2016 it reversed that, c
  9. 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
  10. 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) C
  11. 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
  12. 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
  13. 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, congre
  14. 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 mu
  15. 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.
  16. 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 Foo
  17. 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.
  18. 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
  19. 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..
  20. 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
  21. 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 y
  22. 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 t
  23. Personal Comments I want to say a few personal things before saying anything more on this thread. i think the observations are germane to the issues. I post here in sterile terms. This, I say, is what I think the regulations say. It seems officious. Bureaucratic. Uncaring. It is "i" dotting and "t" crossing in a time of public need and social upheaval. Where is the perspective? So, I want to offer a little personal, hopefully humane, perspective before getting back to the officious. It begins with some observations on which I will not elaborate. Bureaucracies do not
  24. 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."
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