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twowheels

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  1. @jamesking I'm bumping this up again despite the age of the last post because I have exactly the same question. Did you ever confirm this? To recap the processing report operations in question: Multiple barrels move from Part 1 to Part II (Bottled or Packaged, 9c) part of this batch is bottled (28b) and part of the batch is put back in a barrel (28c). That blended barrel hangs out in the packaged column until it's ready and is then dumped for further processing (40c, 6c) and bottled (9c, 28c). Any comments most welcome. Thanks!
  2. My understanding is that TTB G 2020-1A superseded TTB G 2020-1. I haven’t been able to find a newer release. Is this available somewhere?
  3. TTB G 2020-1A requires DSPs to sell to permitted entities in government and medical fields and provides streamlined permitting for these entities. I didn’t see anything about restrictions on selling it to these entities to recoup costs. Anyone else have a different read on legality of selling these products?
  4. Are DSPs being asked to absorb all the costs?
  5. The relaxing of TIB restrictions allows large orders of GNS or denatured spirit to be split among several DSPs. Is anyone taking advantage of this?
  6. TTB G 2020-1A Production of Hand Sanitizer to Address the COVID-19 Pandemic This guidance appears to promote two paths to getting ethanol products from DSPs to consumers. One path allows ethanol (denatured or undenatured) to be removed tax-free for non-beverage use at government or health facilities. Correct me if I'm wrong, but this path does not seem to require ~95% neutral spirit. Another path allows tax-free production of hand sanitizer products per FDA interpretation of WHO rules. This either requires denaturing in house or purchase of bulk denatured product. Transfer in bond applications are waived. With appropriate record keeping, bulk product can move around between DSPs more efficiently.
  7. FDA guidance relevant to hand sanitizer production at DSPs (all documents found here: 3/14/20 FDA-2020-D-1106 Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency 3/19/20 FDA-2020-D-1106 Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) 3/24/20 FDA-2020-D-1106 Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry TTB guidance relevant to hand sanitizer production at DSPs: 3/26/20 TTB G 2020-1A Production of Hand Sanitizer to Address the COVID-19 Pandemic (supersedes prior guidance). Note: The TTB guidance above (TTB G 2020-1A) has a reference to a March 23 FDA guidance document but the hypertext link appears to download a copy of the 3/19/20 FDA-2020-D-1106 version linked above. It's difficult to tell which is which when you're clicking around (I haven't seen any document revision tracking system beyond stating the month of publication). Also linked above is the 3/24/20 version of FDA-2020-D-1106, which has direct instructions about denaturing ethanol: ."..FDA does not intend to take action against alcohol production firms that manufacture alcohol [for use in] alcohol-based hand sanitizers ... provided the following circumstances are present: ... 3.The alcohol is denatured ... using the formulas in Appendix C of this document. ... Beyond alcohol, water, and denaturants (if added at the point of production), the alcohol production firm does not add other ingredients. Different or additional ingredients in the API may impact the quality and potency of the finished hand sanitizer product. ...
  8. Further guidance from TTB: https://www.ttb.gov/public-guidance/ttb-pg-2020-1a Summary Tax-free ethanol may be used to produce hand sanitizer if it is denatured according to TTB regulations and Food and Drug Administration (FDA) guidance. Alcohol, whether or not denatured, may be delivered tax-free to state and local governments for non-beverage purposes. The same is true for hospitals, blood banks, sanitariums, certain pathological laboratories, non-profit clinics, and qualifying educational institutions, if not for resale or use in the manufacture of any product for sale. TTB is temporarily waiving certain formula approvals for the manufacture of hand sanitizer using and expediting certain permit requirements. Guidance regarding transfers in bond: ...TTB is exempting DSPs from the requirements to request approval from TTB to receive denatured or undenatured distilled spirits from another DSP and to obtain additional bond coverage..."
  9. Hi all, Below is a summary of the conversation as I've been hearing it from a variety of sources . My goal is to put this logic in front of people who do regulatory work. Anyone care to comment on the logic, pick apart my arguments, or add information? Thanks! A few facts: It's established that we need large volumes of hand sanitizer across the country. There are upwards of 1800 craft distillers distributed across the country, and even more licensed DSPs (rectifiers, etc.). Every DSP has personnel trained and licensed to work with ethanol products safely and most are situated in populated areas for efficient local distribution. Craft spirits sales follow discretionary income, which means that the craft industry has an unknown future in an uncertain economy and will likely need help Conclusions: The craft industry should be making hand sanitizer to assist medical personnel and their local communities to fight the pandemic In order to support economic recovery *after* addressing the acute emergency, the craft industry should be able to offset at least the cost of raw materials, if not recover some of the lost sales revenue, by offering hand sanitizer for sale to the public Challenges: Hand sanitizer has to be made with 96% +/- 5% ethanol as one of the starting ingredients Even with a rectification column, neutral spirit is difficult and expensive to produce from fermented substrate at the levels needed by health care providers. At best, production of neutral spirits from fermentable substrates at the craft level is inefficient, at worst, impossible GNS is usually available from bulk suppliers, but the supply chains are supporting existing accounts and/or large industrial suppliers of hand sanitizer. Bulk suppliers are not responding to small DSPs. Other ingredients (emollients, isopropanol, essential oils) are also difficult to source right now There's lack of guidance from regulatory bodies concerning legal formulas, sales and pricing Questions: Can formulas be further relaxed to allow other ingredients? Can transfer in bond rules be relaxed (or applications processed) to allow bulk orders to be split among small producers so that bulk suppliers are incentivized to support an alternate supply chain? Can regulatory agencies provide clear and cohesive guidance on formulas and pricing? Are there enough DSPs interested in a cooperative effort that these ideas make sense to pursue? Or is it everyone for themselves?
  10. Greetings! I'm an independent spirits bottler in Berkeley, California and am trying to do some research on the best way for craft producers to navigate the hurdles involved in in hand sanitizer production. I spoke to two bulk alcohol suppliers today who were not able to reassure me about current or continued availability of GNS, especially for new customers and at smaller quantities (~1000 liters). From the bulk supplier's point of view, the supply chain supporting large manufacturers is more efficient at distributing this needed resource. This opinion was reiterated by someone who runs a column still capable of producing GNS efficiently and also works with large volumes (tens of tanker trucks) of bulk product. A few questions for everyone: What has been your experience with sourcing GNS recently / in the last week or so? If GNS is unavailable, or at least unavailable in small enough quantities to be appropriate for craft bottling operations, how many craft distillers are able to produce 192 proof (or 185 proof per dhdunbar's analysis above) spirits and at what volume? If supply chains supporting small producers are not working, do we need to discuss an effort to organize transfer-in-bond operations (and any other legal issues?) that could facilitate a cooperative bulk order? Is this practical? I have heard of craft producers selling hand sanitizer to recoup costs and others giving it away. Is hand sanitizer a viable means to cushion the financial impact of the COVID-19 effect on a small business or an opportunity for community service? Can it be both? Thanks for your help, Nate
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