[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Rules and Regulations]
[Pages 51880-51904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18060]


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DEPARTMENT OF THE TREASURY

Alcohol and Tobacco Tax and Trade Bureau

27 CFR Part 24

[Docket No. TTB-2016-0010; T.D. TTB-185; Re: Notice No. 164]
RIN 1513-AB61


Wine Treating Materials and Related Regulations

AGENCY: Alcohol and Tobacco Tax and Trade Bureau, Treasury.

ACTION: Final rule; Treasury decision.

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SUMMARY: The Alcohol and Tobacco Tax and Trade Bureau (TTB) is amending 
its regulations pertaining to the production of wine to add to the list 
of materials and processes authorized for the treatment of wine and of 
the juice from which wine is made, and to expand the authorized uses of 
certain materials already authorized under the regulations. TTB is 
finalizing amendments to the regulations proposed in a notice of 
proposed rulemaking, Notice No. 164, with some changes in response to 
comments received. Adding these wine treating materials and processes 
to the TTB regulations will increase the acceptability in export 
markets of wine produced using these materials and processes.

DATES: This final rule is effective August 24, 2022.

FOR FURTHER INFORMATION CONTACT: Karen A. Thornton, Regulations and 
Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G 
Street NW, Box 12, Washington, DC 20005; telephone 202-453-1039, ext. 
175.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. TTB Authority
    B. Process for Approval of Wine Treating Materials
    C. Consultation With U.S. Food and Drug Administration
II. Publication of Notice of Proposed Rulemaking
III. Scope of Rulemaking and Petition for Additional Changes
IV. Discussion of Comments
    A. Comment Overview
    B. General Support for the Regulatory Amendments
    C. General Comment of Opposition
    D. Wine Treating Materials
    1. Blends and Other Combinations of Approved Treating Materials
    2. Yeast Nutrients
    3. Specific Wine Treating Materials
    E. Proposed Processes for the Treatment of Wine, Juice, and 
Distilling Material
    1. Cross Flow Filtration
    2. Reverse Osmosis in Combination With Osmotic Transport
    3. Ultrafiltration
    4. Use of Wood to Treat Wine
    F. Wine Spirits
    G. Accidental Water Additions
    H. Other Proposed Regulatory Amendments
    1. Technical Amendments to the List of Authorized Wine and Juice 
Treating Materials
    2. Application for Use of New Treating Material or Process
    I. Other Issues for Public Comment and Possible Regulatory 
Action Discussed in Notice No. 164
    1. Alcoholic Oak Extract
    2. Lactic Acid
    3. Reverse Osmosis To Enhance the Phenol Flavor and 
Characteristics of Wine and To Reduce the Water Content of Standard 
Wine
    4. Ultrafiltration To Separate White Grape Juice
    5. Additional Yeast Nutrients
    6. Comments on Matters on Which TTB Did Not Seek Comments

I. Background

A. TTB Authority

    TTB authorizes the use of certain wine treating materials and 
processes under the authority of chapter 51 of the Internal Revenue 
Code of 1986, as amended (IRC), 26 U.S.C. chapter 51. Specifically, 
certain provisions of the IRC apply to the production of ``natural 
wine,'' which is defined at 26 U.S.C. 5381 as the product of the juice 
or must of sound, ripe grapes or other sound, ripe fruit, made with 
such cellar treatment as authorized under the IRC at 26 U.S.C. 5382. 
Section 5382(a) of the IRC (26 U.S.C. 5382(a)) provides that proper 
cellar treatment of natural wine constitutes those practices and 
procedures in the United States, of using various methods and materials 
to correct or stabilize the wine, or the fruit juice from which it is 
made, so as to produce a finished product acceptable in good commercial 
practice as prescribed by regulation. Section 5382(c) authorizes the 
Secretary of the Treasury (Secretary) to prescribe, by regulation, 
limitations on the preparation and use of methods and materials for 
clarifying, stabilizing, preserving, fermenting, and correcting wine 
and juice. In addition, section 5387(a) of the IRC (26 U.S.C. 5387(a)), 
which authorizes the production of agricultural wine from agricultural 
products other than the juice of fruit, provides that such agricultural 
wine must be made in accordance with good commercial practice as 
prescribed by regulation and may be cellar treated in accordance with 
sections 5382(a) and (c) of the IRC.
    TTB administers chapter 51 of the IRC and its implementing 
regulations pursuant to section 1111(d) of the Homeland Security Act of 
2002, as codified at 6 U.S.C. 531(d). The Secretary has delegated 
certain administrative and enforcement authorities to TTB through 
Treasury Order 120-01.
    The regulations promulgated under these authorities are set forth 
in part 24 of title 27 of the Code of Federal Regulations (27 CFR part 
24). The TTB regulations at 27 CFR 24.246 list materials authorized for 
the treatment of wine and juice; 27 CFR 24.247 lists materials 
authorized for the treatment of distilling material used in the 
production of wine; and 27 CFR 24.248 lists processes authorized for 
the treatment of wine, juice, and distilling material. The materials 
and processes listed in these regulatory sections are approved as being 
consistent with good commercial practice in the production, cellar 
treatment, or finishing of wine, and where applicable in the treatment 
of juice and distilling material, within limitations provided.

B. Process for Approval of Wine Treating Materials

    Industry members wanting to use a treating material or process not 
specifically authorized in part 24 may request authorization to do so. 
TTB may administratively approve the use of treating materials and 
processes not listed in the regulations, either as an experiment under 
27 CFR 24.249 or for continual use (acceptable in good commercial 
practice) under 27 CFR 24.250. Applicants for such approvals must 
submit to TTB a request describing the material or process and the 
purpose, manner, and extent to which the material or process is to be 
used; certain samples and test results; and any other relevant 
information, as described in the regulations. If the request is for the 
approval of a material, the applicant must also submit documentary 
evidence of the U.S. Food and Drug Administration (FDA) approval of the 
material for its intended purpose in the amounts, along with the 
recommended minimum and maximum amounts of the material, if any. 
Consistent with Sec. Sec.  24.246, 24.247, and 24.248, TTB may approve 
the use of treating materials

[[Page 51881]]

and processes that are determined to be acceptable in good commercial 
practice. In Notice No. 164, TTB explained that it considers good 
commercial practice to include addressing the reasonable technological 
or practical need to enhance the keeping, stability, or other qualities 
of the wine, and achieving the winemaker's desired effect but not 
creating an erroneous impression about the character and composition of 
the wine.
    When TTB approves the continued commercial use of a treating 
material or process under Sec.  24.250, it provides public notice of 
such approval on its website at https://www.ttb.gov/wine/treating-materials. The listing of such administrative approvals on the TTB 
website affords all industry members the opportunity to use an 
administratively approved wine treating material or process pending 
future rulemaking.
    For several reasons, TTB conducts rulemaking to consider adding to 
or amending the materials and processes authorized in the regulations 
for treating wine, juice, and distilling material listed in Sec. Sec.  
24.246 through 24.248. One reason is that when TTB administratively 
approves wine treatments or processes for continued commercial use 
under Sec.  24.250, TTB is making an initial determination that the 
treatment is consistent with ``good commercial practice.'' The 
subsequent rulemaking process allows industry members and other members 
of the public an opportunity to publicly comment on, and specifically 
to confirm or refute, the initial determination that the use of a 
material or process is consistent with good commercial practice. TTB 
can then determine whether to add the material or process to its 
regulations.
    Administrative approval of a wine treatment under Sec.  24.250 does 
not guarantee acceptance in foreign markets of any wine so treated. 
Therefore, conducting rulemaking to add wine treating materials and 
processes to the regulations may also result in acceptance of the 
treated wines in certain foreign jurisdictions. For example, under 
Article 4.2 of the 2006 Agreement between the United States of America 
and the European Community on Trade in Wine (Wine Agreement), the 
United States and the European Union agreed not to restrict ``on the 
basis of either wine-making practices or product specifications, the 
importation, marketing or sale of wine originating in the territory of 
the other Party that is produced using wine-making practices that are 
authorized under laws, regulations and requirements of the other Party 
. . . and published or communicated to it by that other Party.'' 
Article 5.1 of the Wine Agreement also contains provisions to authorize 
new or modified wine-making practices if a party to the Wine Agreement 
provides public notice and specific notice to the other party, and 
provides a reasonable opportunity for comment and to have those 
comments considered. Through the rulemaking process, TTB provides such 
public notice and opportunity to comment on wine treating materials and 
processes that had been administratively approved. As a result, 
incorporation of the treating materials and processes in the 
regulations provides domestic winemakers with greater flexibility in 
producing wines for sale in foreign markets.

C. Consultation With U.S. Food and Drug Administration

    TTB also consults with the U.S. Food and Drug Administration (FDA) 
on whether alcohol beverages are adulterated under the Federal Food, 
Drug, and Cosmetic Act (FD&C Act), including whether a substance added 
to an alcohol beverage is an unapproved food additive. Alcohol 
beverages are considered ``food'' under the FD&C Act. A substance added 
to food is a food additive unless it is otherwise excluded from the 
definition of a food additive under the FD&C Act. For example, the use 
of a substance in food that is generally recognized as safe by 
qualified experts (GRAS) is excluded from the definition of a food 
additive under the FD&C Act. See 21 U.S.C. 321(s), 21 CFR 170.30. The 
use of a food additive in food must be authorized by FDA either through 
a food additive regulation in 21 CFR or an effective food contact 
notification (FCN).\1\ FDA has listed certain GRAS uses in its 
regulations. In addition, FDA has a voluntary notification procedure by 
which any person may notify FDA of a conclusion that a use of a 
substance is GRAS. FDA evaluates whether the notice provides a 
sufficient basis for a GRAS conclusion (which results in a ``no 
questions'' response) or whether FDA believes there is an insufficient 
basis for a GRAS conclusion (which results in an ``insufficient basis'' 
response).\2\ For the purpose of this rulemaking, TTB is using the term 
``consistent with the food additive requirements under the FD&C Act'' 
to refer to: (1) Authorized food additive uses; (2) uses that are GRAS 
under FDA's regulations, that are the subject of a ``no questions'' 
letter from FDA in response to a GRAS notice or that are subject to an 
opinion letter from FDA stating that the use is GRAS or otherwise 
permissible; or (3) uses that are otherwise excluded from regulation as 
a food additive.
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    \1\ https://www.fda.gov/food/packaging-food-contact-substances-fcs/inventory-effective-food-contact-substance-fcs-notifications.
    \2\ https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=GRASNotices.
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II. Publication of Notice of Proposed Rulemaking

    On November 22, 2016, TTB published in the Federal Register (81 FR 
83752) a notice of proposed rulemaking, Notice No. 164, proposing to 
amend its regulations to incorporate 15 wine and juice treating 
materials and the combined use of two existing wine treatment processes 
it had administratively approved. TTB also proposed some clarifying and 
editorial changes. In response to requests by commenters, TTB reopened 
the comment period for 90 days and then subsequently extended it for 
another 90 days. The comment period finally closed on April 9, 2018. 
TTB received 33 comments from major trade organizations, suppliers of 
wine treating materials and processes, winemakers, the public, and the 
European Union. The comments generally support the treating materials 
and processes proposed in Notice No. 164. Notice No. 164 and the 
comments received may be viewed in their entirety in Docket No. TTB-
2016-0010 at the Regulations.gov website (www.regulations.gov). The 
primary proposals, comments received, and TTB responses to those 
comments are discussed in the following sections of this document. The 
clarifying and editorial changes to the regulations are described in 
detail in Notice No. 164, and unless subject of comments received, are 
incorporated in the final regulations below and not further discussed 
here.

III. Scope of Rulemaking and Petition for Additional Changes

    On March 5, 2015, the Wine Institute, a wine industry trade 
association, petitioned TTB to amend Sec. Sec.  24.246 and 24.247 to 
replace many of the numerical limits for wine treating materials and 
processes with a usage standard of ``good manufacturing practice.'' 
Wine Institute noted in its petition that the current provisions 
generally limit the authorized usage of a material to the particular 
use of the material by the industry member who originally petitioned 
for its use. It also submitted a comment to Notice No. 164 and 
reiterated its request for ``a default limit of good manufacturing 
practice (GMP) for those [treating] materials unless otherwise dictated 
by health concerns.''

[[Page 51882]]

    TTB agrees that the current process, as described above, results in 
TTB's authorizing materials at specific usage levels reflecting the 
parameters detailed in requests by winemakers, and therefore reflects 
winemakers' actual use, or expressed interest in use, and TTB's 
evaluation of wine or juice to which the materials and processes have 
been applied, rather than potential use. This reflects TTB's 
longstanding application of ``good commercial practice'' as that term 
is described above. TTB intends to publish separate rulemaking to 
obtain public comment on the broader approach proposed in the Wine 
Institute's petition. TTB is not addressing the entirety of the 
petition in this rulemaking as it would entail many more amendments to 
the relevant regulations than were proposed in Notice No. 164. In this 
final rule, TTB is addressing the proposals regarding materials and 
processes that already had been the subject of notice and comment under 
Notice No. 164.

IV. Discussion of Comments

A. Comment Overview

    TTB received 33 comments in response to Notice No. 164, of which 3 
were requests for extension of the comment period (Wine Institute (2 
requests), and David Douglas). The remainder were comments submitted by 
or on behalf of: Six members of the public (Alice Feiring, Dr. Robert 
Kreisher (2 comments), Heather Nenow, Coleman Reardon, and Samantha 
Hunter); 13 wine industry members (vineyards and/or wineries) 
(Adelsheim Vineyard, Bear Creek Winery; Clover Hill Winery, Deerfield 
Ranch, Domaine Serene, Don Sebastiani and Sons, E&J Gallo Winery, 
Firestone Vineyard, Halter Ranch Vineyard, South Coast Winery Resort 
and Spa, Toni Stockhausen, Wine by Joe, WX Brands); 2 trade 
organizations (Enzyme Technical Association and Wine Institute); 4 
companies that produce wine treating materials or processes (Beverage 
Supply Group, Erbsl[ouml]h Geisenheim (2 comments), ConeTech, and 
Laffort USA); 1 industry consultant (Richard Gahagan); and the European 
Union (2 comments).
    Eleven of the commenters submitted essentially the same letter 
containing no substantive differences (Adelsheim Vineyard, Bear Creek 
Winery, Deerfield Ranch Winery, Domaine Serene, Don and Sons, Firestone 
Winery, Halter Ranch Vineyard, Laffort, South Coast Winery Resort and 
Spa, Wine by Joe, and WX Brands). These comments will be referred as 
the ``11 form letter comments'' for ease of reference.

B. General Support for the Regulatory Amendments

    The 11 form letter comments expressed support for amending the 
regulations to incorporate the proposed additional wine treating 
materials, stating that these additions would positively affect their 
ability to export their wine and allow them to continue to grow their 
business in export markets by offering wines with better stability and 
quality. They also provided specific support for certain of the 
materials, and their comments are included in the comment discussion 
for each of these materials below. They further noted that the 
materials they addressed in their comment are used in multiple 
countries, including all countries following the International 
Organization of Vine and Wine (OIV), in good commercial practice at 
dose rates like those suggested by TTB in Notice No. 164.
    The Wine Institute also expressed general agreement that the 
administratively approved wine and juice treating materials and 
processes proposed for authorization in Notice No. 164 ``have 
accumulated sufficient analytical data and should be added to 
Sec. Sec.  24.246 and 24.248 as appropriate.''

C. General Comment of Opposition

    One commenter, Alice Feiring, expressed discontent with the number 
of authorized wine and juice treating materials for wine, stating that 
they ``interfere with the taste and liveliness of the wine.'' The 
commenter asserted that ``none of these additives--other than sulfite 
addition . . . --are evaluated for their health impact and allergen 
potential,'' and that ``tannins and enzymes are the primary materials 
that trigger allergic reactions.'' The commenter pointed to the 
proposal in Notice No. 164 to add polyvinylpyrrolidone (PVP) to the 
list of authorized wine and juice treating materials in Sec.  24.246 
and raised concerns regarding the safety of its use, which TTB 
addresses in the discussion of PVP later in this document. The 
commenter further suggested that TTB consider requiring the labeling of 
ingredients in wine.
    TTB Response. As discussed in Notice No. 164, all proposed wine and 
juice treating materials authorized for use under Sec.  24.246 must 
have documentary evidence from the FDA that the material is consistent 
with the food additive requirements under the FD&C Act for its intended 
purpose in the amounts proposed for the particular treatment 
contemplated. Therefore, TTB disagrees with the assertion that the wine 
and juice treating materials currently authorized in Sec.  24.246 and 
proposed in Notice No. 164 for addition to the authorized list are not 
evaluated for their impact on health, and TTB notes that the table in 
Sec.  24.246 includes references to the relevant FDA regulations and 
advisory opinions for each material. Further, TTB consulted with FDA on 
the proposed amendments in Notice No. 164 prior to its publication, and 
the materials proposed in Notice No. 164 have been found to be 
consistent with the FD&C Act.
    Concerning the labeling of ingredients in wine, TTB is separately 
considering rulemaking regarding ingredient labeling, as noted in 
Treasury's February 2022 report on ``Competition in the Markets for 
Beer, Wine, and Spirits,'' \3\ issued in response to Executive Order 
14036, ``Promoting Competition in the American Economy.''
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    \3\ home.treasury.gov/system/files/136/Competition-Report.pdf.
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D. Wine Treating Materials

    Below is a summary of the actions TTB is taking in this final rule, 
including a discussion of, and response to, comments received regarding 
the wine treating materials that were the subject of TTB proposals in 
Notice No. 164.
1. Blends and Other Combinations of Approved Treating Materials
    TTB proposed to include in Sec.  24.246(b) a general, clarifying 
statement that approved materials may be used in a blend or otherwise 
in combination with other approved materials, provided that each 
material is used for its specified use and in accordance with any 
limitation specified for that use.
    Comments. In its comment, Wine Institute agreed that approved wine 
treating materials may be blended or used in combination provided that 
each material is used in accordance with the individual limitations and 
allowable uses for that material.
    The 11 commenters who submitted the form letter did not directly 
address the proposed language pertaining to blends; however, they did 
comment on the use of blends for yeast nutrients. These commenters 
stated in part that yeast nutrient blends mitigate the risk of sluggish 
or stuck fermentation.
    TTB Response. TTB agrees that blends of authorized wine treating 
materials, including yeast nutrients, are consistent with good 
commercial practice, provided that the use of each material conforms to 
the conditions specified for that material (that is, the reason or

[[Page 51883]]

purpose for its use and the references and limitations that apply to 
its use). Accordingly, TTB is finalizing the proposal on blends in 
Sec.  24.246.
2. Yeast Nutrients
    In Notice No. 164, TTB proposed to add six ``yeast nutrients'' to 
the list of approved treating materials and expand the approved use of 
a seventh that already appears on the list. Specifically, TTB proposed 
to add biotin, folic acid, inositol, magnesium sulfate, niacin, and 
pyridoxine hydrochloride to the list of authorized wine and juice 
treating materials in Sec.  24.246, and to expand the current permitted 
use of calcium pantothenate in that section. The inclusion of these 
yeast nutrients was in response to a petition and to industry member 
requests. The specific proposals, comments, and final action are 
described below.
i. Use of the Term ``Yeast Nutrients''
    As described in Notice No. 164, TTB and its predecessor agencies 
have recognized the need to supply yeast with appropriate nutrients to 
facilitate fermentation of juice to wine and to prevent ``stuck 
fermentation'' (fermentation that has halted before completion due to, 
among other things, high sugar levels or nutrient deficiencies). In 
both the current and proposed regulations, TTB has referred to these 
nutrients as ``yeast nutrients.''
    Comments. The 11 submitters of the form letter, as well as Wine 
Institute and Richard Gahagan, addressed the use of the term ``yeast 
nutrients.'' The 11 form letter submitters requested that TTB omit the 
word ``yeast'' or conversely include the word ``bacteria'' in the 
heading used in the regulations. Wine Institute stated their belief 
that the term ``yeast nutrients'' is ``misleading'' and expressed a 
concern that ``[t]he use of the word `nutrient' suggests there is some 
nutritive value to humans, which is not the case.'' Instead of ``yeast 
nutrients'', Wine Institute suggested TTB use the term ``Fermentation 
Aids'', noting that ``yeast nutrients'' serve no purpose after 
completion of fermentation. Rather, they ``are for the sole purpose of 
creating and maintaining a robust environment for yeast and/or 
malolactic bacteria during the fermentation process.''
    Mr. Gahagan also opposed the use of the term ``yeast nutrients'' 
and suggested that a more appropriate heading would be ``fermentation 
aids'' or ``fermentation adjuncts.'' Mr. Gahagan points out that 
``yeast cell walls/membranes'', which are authorized for use in Sec.  
24.246 and proposed under the heading ``yeast nutrients'' in Notice No. 
164, ``are not yeast nutrients.'' Mr. Gahagan cited scientific 
literature in support of his argument.
    TTB Response. TTB agrees with the comments and is replacing the 
term ``yeast nutrients'' with the term ``fermentation aids'' in the 
regulations, where applicable. TTB is using the term ``yeast 
nutrients'' and ``fermentation aid'' as synonyms throughout the rest of 
this document, as the former reflects the terminology used in the 
proposal.
ii. Specific Yeast Nutrients
    In Notice No. 164, TTB proposed to add biotin (vitamin B7), folic 
acid, inositol (myo-inositol), magnesium sulfate, niacin (vitamin B3), 
and pyridoxine hydrochloride (vitamin B6) to the list of authorized 
materials in Sec.  24.246 for use as yeast nutrients. TTB had 
previously administratively approved all six materials but had not yet 
included them in the list of authorized materials in Sec.  24.246. The 
proposed use limitations for each material were as follows:
     Biotin: 25 parts per billion (ppb).
     Folic acid: 100 ppb.
     Inositol (myo-inositol): 2 parts per million (ppm).
     Magnesium sulfate: 15 ppm.
     Niacin (vitamin B3): 1 ppm.
     Pyridoxine hydrochloride (vitamin B6): 150 ppb.
    Additionally, TTB proposed to expand the authorized use of calcium 
pantothenate (vitamin B5) from use solely as a yeast nutrient in apple 
wine to use as a yeast nutrient in all juice and wine. The use 
limitation of 0.1 pound of calcium pantothenate per 25,000 gallons 
(0.48 ppm) would remain unchanged.
    Comments. The Wine Institute and the 11 form letter comments 
supported including all six administratively approved materials as 
authorized materials in Sec.  24.246, as well as approving calcium 
pantothenate for use in all juices and wines. While the 11 form letter 
comments supported the use of the materials at the usage rates proposed 
in Notice No. 164, Wine Institute requested that the usage rate for the 
materials be ``good manufacturing practice.''
    Additionally, Richard Gahagan supported the addition of magnesium 
sulfate to the list of authorized wine and juice treating materials in 
Sec.  24.246 but concludes that the ``qualitative limits'' proposed in 
Notice No. 164 ``may not be adequate in all cases.'' Mr. Gahagan 
referenced scientific articles for his assertion that the proposed use 
level for magnesium sulfate ``is not adequate'' and recommended a use 
rate not to exceed 200 ppm (200 mg/L).
    Mr. Gahagan also expressed his concern that the use rates for the 
proposed yeast nutrients in Notice No. 164 consist ``essentially of the 
Gusmer commercial product'', which in his opinion, ``would limit the 
United States wine industry to the use of only the Gusmer product, or 
products that contain no more of any one of the materials contained in 
Gusmer's product.'' He argued that ``commercial fermentation aid 
products would be excluded, severely limiting the choices of available 
fermentation aides [sic] to domestic winemakers.'' Mr. Gahagan referred 
to the proposed yeast nutrients with use rates (``quantitative 
limitations'') and the fact that the use rates were proposed by the 
petitioner. Mr. Gahagan asserted that the FDA advisory opinion of 
August 29, 2016, referenced in Notice No. 164, states that the proposed 
yeast nutrients can be used in accordance with ``good manufacturing 
practice.'' He further pointed to www.ttb.gov where the list of 
administratively approved yeast nutrients are listed and noted that as 
a use rate for the listed yeast nutrients, the website reads ``the 
amount used must not exceed that of good commercial practice'' and 
includes a reference to the appropriate FDA regulation followed by the 
acronym GRAS, for ``Generally Recognized As Safe.'' He further stated 
that ``[t]he limitations on all the fermentation aids should be good 
commercial practice or GRAS, rather than quantitative limits.''
    TTB Response. TTB is finalizing the proposals for all seven 
materials, including the proposed use rates. TTB believes that 
additional public comment is needed to authorize a usage rate other 
than what was proposed in Notice No. 164 for any of the yeast 
nutrients, since the proposed rule did not include the prospect of 
different usage rates. However, TTB is considering the request to 
consider the yeast nutrient usage rate at ``good manufacturing 
practice'' for separate rulemaking in which TTB intends to address Wine 
Institute's petition, described above, to authorize usage rates of 
``good manufacturing practice'' more broadly.
    With respect to Mr. Gahagan's comment about the proposed use rate 
limits, under the regulatory provisions of Sec. Sec.  24.249 and 
24.250, TTB reviews and approves or denies proposed wine treating 
materials based on the information provided by the industry member who 
submitted the request. TTB does not have reason or resources to test 
experimentally treated wine containing a new wine treating material

[[Page 51884]]

at a use rate greater than that which is being requested. In the case 
of the yeast nutrients that were administratively approved subsequent 
to the Gusmer petition, TTB proposed in Notice No. 164 to limit the 
amount of usage to the amounts provided in the Gusmer petition because 
TTB believes it is important to place limitations on the use of 
vitamins and minerals as nutrients for yeast growth. This belief is 
consistent with FDA's fortification policy in 21 CFR 104.20, as 
discussed in Notice No. 164. The FDA advisory opinion cited in the 
proposed regulations and referred to by Mr. Gahagan does not state that 
vitamins and minerals used in the production of wine are limited only 
by good manufacturing practice. Rather, in their advisory opinion, FDA 
referred to its regulations in which certain vitamins and minerals may 
be used in accordance with good manufacturing practice \4\ if they are 
used in accordance with the intended purpose as stated by the 
regulations.
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    \4\ FDA defines ``good manufacturing practice'' in the context 
of food additives and GRAS substances in 21 CFR 172.5, 174.5, 182.1, 
and 184.1.
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    As noted in Notice No. 164, many of the yeast nutrients are 
vitamins and minerals that are authorized for use in food, and FDA has 
informed TTB that FDA regulations for certain vitamins (e.g., folic 
acid and inositol) would not authorize their use in alcohol beverages 
as nutrients. Therefore, a cross-reference to the FDA regulations is 
not appropriate for yeast nutrients. Notice No. 164 further states that 
FDA has stated to TTB that the proposed vitamins and minerals could be 
used for the purpose of providing nutrients to the yeast, where the 
levels of the vitamins and minerals remaining in the wine would be of a 
de minimis level, and not to fortify the wine. In the interim, TTB is 
placing limitations on these substances to permit their use as 
nutrients for yeast growth but not as a source of nutrients in the 
finished wine.
    TTB notes that among the 11 submitters of the form letter is 
Laffort U.S.A., a supplier of wine treating materials. Laffort U.S.A. 
wrote that they support the addition of yeast nutrients proposed by TTB 
``at the levels recommended by TTB.'' This support indicates that 
Laffort U.S.A. is not concerned that the proposed use rates for yeast 
nutrients would exclude any of their products from the market. Another 
supplier of wine treating materials (including yeast nutrients), 
Beverage Supply Group, commented on Notice No. 164, and while they did 
not specifically express support for the proposed use rates of the 
proposed yeast nutrients, they did not expressly voice concern that the 
proposed use rates are insufficient and possibly exclude their products 
from the marketplace.
3. Specific Wine Treating Materials
i. Acacia (Gum Arabic)
    In Notice No. 164, TTB proposed to amend its regulations in Sec.  
24.246 to identify, for the purpose of clarifying and stabilizing wine, 
a maximum use rate of 8 pounds of acacia per 1,000 gallons (0.96 grams 
per liter (g/L)) of wine. Acacia (gum arabic) is listed in Sec.  24.246 
as authorized for such purposes, but currently subject to the 
limitation that its use not exceed 2 pounds per 1,000 gallons (0.24 g/
L) of wine. TTB explained in Notice No. 164 that TTB had 
administratively approved several requests from industry members for 
use rates up to 16 pounds per 1,000 gallons of wine, but was proposing 
a use rate of 8 pounds per 1,000 gallons of wine as it believed that 
rate was consistent with the maximum rate authorized in FDA regulations 
at 21 CFR 184.1330. Based on that, TTB noted that any administrative 
approvals authorizing use rates greater than 8 pounds per 1,000 gallons 
of wine would be revoked.
    Comments. The 11 submitters of the form letter indicated that 
acacia is necessary for the stabilization of coloring matter and 
potassium bitartrates as well as to clarify wine. They also stated that 
the dose rate recommended by TTB in the proposed rule is appropriate 
for good commercial practice. In its comment, the Wine Institute 
welcomed the proposal to increase the allowable level for acacia when 
used for its intended purpose of clarifying and stabilizing wine.
    TTB Response. The regulations finalized through this rulemaking 
authorize the use of acacia for clarifying and stabilizing wine at a 
use rate of 16 pounds per 1,000 gallons of wine (1.9 g/L), or 0.19 
percent, which is within the 1 percent use rate limitation set forth in 
the FDA regulations for these purposes. In Notice No. 164, TTB had 
erroneously calculated that 8 pounds per 1,000 gallons of wine was the 
maximum allowable within the FDA limitations. As a result, instead of 8 
pounds per 1,000 gallons of wine, TTB is amending its regulations to 
correspond to the administrative approvals of 16 pounds per 1,000 
gallons of wine, as discussed in Notice No. 164, as TTB believes this 
limit is consistent with good commercial practice for clarifying and 
stabilizing wine.
    With regard to the comment that refers to acacia's use for 
stabilization of ``coloring matter,'' TTB notes that the stabilization 
of anthocyanins for color is consistent with how TTB interprets 
``stabilization'' under Sec.  24.246.
ii. Bakers Yeast Mannoprotein
    TTB proposed to add bakers yeast mannoprotein, at a use rate of 50-
400 milligram per liter (mg/L) of wine, to the list of approved wine 
and juice treating materials contained in Sec.  24.246, for the purpose 
of stabilizing wine from the precipitation of potassium bitartrate 
crystals. TTB had already administratively approved the use of bakers 
yeast mannoprotein for this purpose and with that limit.
    Comments. The 11 commenters who submitted the form letter stated 
their support of TTB's proposal to add bakers yeast mannoprotein to the 
list of authorized treating materials contained in Sec.  24.246 to 
stabilize wine from the precipitation of potassium bitartrate crystals. 
The commenters noted that bakers yeast mannoprotein is an efficient 
alternative for the stabilization of red wines and that it is 
appropriate for good commercial practice at the dose rates proposed by 
TTB.
    The Wine Institute suggested GMP as the appropriate limit for 
bakers yeast mannoprotein, without a numerical limit, but stated that, 
if numerical limits are to be required, the proposed limit is ``too 
low.'' The Wine Institute stated that ``a quick review of recommended 
usage rates . . . by Suppliers of this material to the Industry suggest 
usage rates up to 1500 mg/L as a more appropriate limit.''
    The European Union (EU), in its comment, informed TTB that the EU 
does not have a fixed limit for bakers yeast mannoproteins, ``which 
means that their use is based on the best manufacturing practice 
criteria.'' They further state that the proposed limit for bakers yeast 
mannoproteins ``may be insufficient for tartaric stabilization thus 
creating a possible barrier to trade.''
    TTB Response. TTB received no additional comments from industry 
members regarding the usage rates, and has not received requests from 
industry members for approval to use bakers yeast mannoprotein at a 
rate higher than 400 mg/L. TTB notes that the proposed use for bakers 
yeast mannoprotein in TTB Notice No. 164 (not to exceed 400 mg/L) is 
consistent with the use rate considered by FDA in GRAS Notice No. GRN 
000284. TTB does not approve the use of a material at a rate greater 
than that which FDA has determined is consistent with the food additive 
requirements under the FD&C Act.

[[Page 51885]]

Considering this and the rulemaking record before it, TTB does not 
believe there is an adequate basis for establishing a limit different 
from that proposed in Notice No. 164, but will consider the comments of 
the European Union and the Wine Institute as suggestions for further 
broader rulemaking relating to GMP. This rulemaking finalizes the 
proposed use of bakers yeast mannoprotein to stabilize wine from the 
precipitation of potassium bitartrate crystals at an amount not to 
exceed 400 mg/L.
iii. Beta-Glucanase Having an Enzyme Activity Derived From Trichoderma 
harzianum and Beta-Glucanase Having an Enzyme Activity Derived From 
Trichoderma longibrachiatum
    TTB proposed in Notice No. 164 to add beta-glucanase derived from 
Trichoderma harzianum, at a use rate not to exceed 30 parts per million 
(ppm) of wine, as an approved treating material in Sec.  24.246 for the 
purpose of clarifying and filtering wine. Trichoderma harzianum had 
been administratively approved prior to the proposed rulemaking. Beta-
glucanase derived from Trichoderma longibrachiatum is currently listed 
in Sec.  24.246 as approved for use for clarifying and filtering wine 
at a rate not to exceed 3 grams per hectoliter of wine (30 ppm), and in 
Notice No. 164 TTB also solicited comments on whether Beta-glucanase 
derived from Trichoderma longibrachiatum is still relevant and should 
be retained as an authorized treatment.
    Comments. The form letter submitted by 11 commenters specifically 
addressed beta-glucanase, as did comments from the Wine Institute, the 
Enzyme Technical Association, and an individual commenter. The 11 
submitters of the form letter stated that the use rate of beta-
glucanase proposed in Notice No. 164 is appropriate for good commercial 
practice to filter wine, whether the enzymatic activity is derived from 
Trichoderma harzianum or Trichoderma longibrachiatum. They also 
proposed that beta-glucanase should be authorized for use in juice 
prior to fermentation. In support of this, the commenters wrote that 
mold growth, specifically from Botrytis cinera, on grapes increase the 
content of glucans in the resultant wine. The commenters claimed that 
the glucans ``can render the wine difficult or impossible to filter 
using available filter media.'' Adding beta-glucanase to the juice or 
wine ``will allow the reduction of glucan levels and improved 
filterability.'' The commenters noted that unfiltered wines ``can 
potentially have negative flavor profiles due to instabilities.''
    Wine Institute recommended using GMP as a use rate for beta-
glucanase. In the absence of GMP, Wine Institute recommended a use rate 
of 80 mg/L based on a review it performed of usage rates recommended by 
suppliers of this material to the industry. Wine Institute also noted 
TTB's comment in Notice No. 164 about the agency inadvertently stating 
that the amount of beta-glucanase derived from Trichoderma harzianum 
used must not exceed 300 ppm, and suggested that industry members are 
currently using beta-glucanase at higher use levels than 30 ppm because 
suppliers recommend a level higher than 30 ppm and because TTB 
administratively approved usage up to 300 ppm. As a result, Wine 
Institute argued that reducing the authorized use rate of beta-
glucanase from an amount not to exceed 300 ppm to an amount not to 
exceed 30 ppm may cause difficulty to winemakers and impact the quality 
of resulting wines. With regard to beta-glucanase derived from 
Trichoderma longibrachiatum, Wine Institute supported retaining its 
authorized use.
    The Enzyme Technical Association supported the addition of 
Trichoderma harzianum as a source of beta-glucanase. However, the 
association recommended TTB align the use rate of beta-glucanase 
derived from Trichoderma harzianum and that derived from Trichoderma 
longibrachiatum, and that the usage rate limitation for both should be 
``good manufacturing practice.'' The association indicated that the 
proposed use rate limit of 30 ppm for beta-glucanase derived from 
Trichoderma harzianum is insufficient. It expressed its position that 
the FDA GRAS Notice No. GRN 000149, which TTB cites for its support of 
a 30 ppm limitation on beta-glucanase derived from Trichoderma 
harzianum, actually supports a higher use rate. Enzyme Technical 
Association argued that the range provided in GRAS Notice No. GRN 
000149 ``was not set as a maximum use'' and stated that ``what was not 
discussed in the FDA No Questions Letter is the wide safety margin of 
the beta-glucanase enzyme preparation that was included in the 
notifier's original submission.'' It further stated that ``[A] wide 
safety margin suggests that the enzyme preparation can be used well 
outside the range of 30 ppm with no toxic effects.'' Enzyme Technical 
Association ``agrees that beta-glucanase enzymatic activity derived 
from Trichoderma longibrachiatum (also known as T. reesei) is still 
relevant for and used in wine treatments.''
    In its second comment submitted in response to Notice No. 164, 
Erbsl[ouml]h Geisenheim suggested that TTB add the microorganism 
species Penicillium funiculosum (synonym: Talaromyces versatilis) as a 
third source besides Trichoderma longibrachiatum and Trichoderma 
harzianum for the entry ``Enzymatic activity, intended for clarifying 
and filtering wine.'' It noted that FDA already considers Penicillium 
funiculosum as GRAS for ``use in various food applications in the US.'' 
It also stated that both the International Oenological Codex and the 
European Commission recognize Penicillium funiculosum as a wine 
treating material.
    TTB Response. After considering the comments, TTB is finalizing 
regulations that remove any specific use rate limitation other than 
that set forth in the FDA regulations at 21 CFR 184.1250. In effect, 
this implements the limitation that has applied during the time TTB had 
inadvertently authorized 300 ppm rather than 30 ppm, as described 
above, as use of the material above the 30 ppm rate would still have 
been subject to any limit set forth in FDA regulation. Similarly, TTB 
is also finalizing its proposal in Notice No. 164, to add to the 
regulations authorization for beta-glucanase derived from Trichoderma 
harzianum as an approved treating material in Sec.  24.246 for the 
purpose of clarifying and filtering wine, with the only use rate 
limitation specified by a reference to FDA GRAS Notice No. GRN 000149. 
TTB has confirmed with FDA that a limitation of ``good manufacturing 
practice'' would be consistent with both 21 CFR 184.1250 and GRAS 
Notice No. GRN 000149, and that additional advisory opinions specifying 
that would be unnecessary. With regard to the use of the materials in 
juice, TTB is authorizing the use of both beta-glucanase derived from 
Trichoderma harzianum and beta-glucanase derived from Trichoderma 
longibrachiatum in juice, which is consistent with GRAS Notice No. GRN 
000149 and 21 CFR 184.1250,\5\ respectively.
---------------------------------------------------------------------------

    \5\ 21 CFR 184.1250 describes a type of a cellulase that is also 
known as endo-1,4-beta-glucanase.
---------------------------------------------------------------------------

    With respect to the use of Penicillium funiculosum, TTB notes that 
it has not received any requests from winemakers to use this 
microorganism as a source of beta-glucanase for clarifying or filtering 
wine. Therefore, TTB has not had the opportunity to analyze wine 
treated with Penicillium funiculosum and cannot add it to its list of 
approved wine treating materials at this time. However, TTB would 
consider requests from

[[Page 51886]]

individual industry members under Sec. Sec.  24.249 and 24.250 for use 
of Penicillium funiculosum as a wine treating material.
iv. Chitosan
    In Notice No. 164, TTB proposed to authorize chitosan for the 
removal of spoilage organisms from wine at a usage rate not to exceed 
10 grams per 100 liters (or 10g/hL) of wine.
    Comments. The 11 submitters of the form letter agreed with TTB's 
proposal that chitosan should be authorized for use in the treatment of 
wine to remove spoilage organisms such as Brettanomyces from wine. They 
stated that the ``unchecked growth of Brettanomysces [sic] organisms in 
wine can lead to highly negative flavor profiles'' and that chitosan is 
``an efficient and effective treatment to destroy these spoilage 
organisms.'' Further, submitters of the form letter confirmed that 
chitosan is consistent with good commercial practice at the levels 
proposed by TTB.
    In its comment, Wine Institute welcomed the proposed addition of 
chitosan to the list of allowable treating materials but suggested that 
GMP is a more appropriate usage limit.
    In his comment, Richard Gahagan supported the inclusion of chitosan 
but stated that the limitation should be ``GRAS, or if TTB decides on a 
quantitative limit, 100 g/hL would be consistent with the OIV 
limitation.'' Mr. Gahagan's comment regarding the authorized use of 
chitosan with OIV limitations was consistent with that of the EU, which 
stated that the TTB proposed use rate of 10 g/hL for chitosan is ``10 
times lower than the EU limit,'' and indicated that the use rate 
proposed by TTB for chitosan ``could create a trade barrier.'' (TTB 
notes that OIV's use rate for chitosan was raised in 2015, to a rate 
not to exceed 500 g/hL of wine.)
    TTB Response. Since TTB's publication of Notice No. 164, TTB has 
received numerous requests to experiment with chitosan at levels 
greater than 10 g/hL of wine. The most recent requests for 
experimentation sought to use chitosan at a rate of no more than 500 g/
hL. TTB approved the experimentation of those requests because in GRAS 
Notice No. GRN 000397, FDA had ``no questions'' with regard to the 
stated intended use rate of 10 to 500 g/hL of wine. After the 
evaluation of numerous samples of wine experimentally treated with 
chitosan at rates exceeding 10 g/hL and including 500 g/hL, TTB 
administratively approved an increased use rate of chitosan not to 
exceed 500 g/hL of wine in 2021.
    After considering comments from Wine Institute, the EU, and Mr. 
Gahagan supporting an increased level of chitosan, the use range 
specified in GRAS Notice No. 000397, and TTB's experience with recent 
administrative approvals, TTB is amending Sec.  24.246 to include 
chitosan from Aspergillus niger, with a use rate not to exceed 500 g/hL 
of wine, for use in removing spoilage organisms, such as Brettanomyces, 
from wine.
v. L(+) Tartaric Acid
    Tartaric acid is currently listed in Sec.  24.246 as a material 
authorized for the treatment of wine and juice for the purpose of 
correcting natural acid deficiencies in grape juice or wine and to 
reduce the pH of grape juice or wine. In Notice No. 164, TTB proposed 
to amend the entry for ``tartaric acid'' in the table at the end of 
Sec.  24.246 to indicate that tartaric acid may be manufactured by 
either the method specified in 21 CFR 184.1099 (which allows for L(+) 
tartaric acid obtained as a byproduct of wine production) or the method 
specified for L(+) tartaric acid in GRAS Notice No. GRN 000187 (which 
allows L(+) tartaric acid manufactured using an enzyme from immobilized 
Rhodococcus ruber cells). TTB also proposed to add the citation for the 
FDA GRAS notice in the ``Specific limitation'' column.
    Comments. In its comment, the EU stated that it and the OIV both 
authorize the use of L(+) tartaric acid with limits of 2.5g/L and 4g/L, 
respectively. The EU argued that ``[t]hese limits are justified by the 
assessment made by JECFA fixing the acceptable daily intake (ADI) is 
between 0 and 30mg/kg of body weight.'' Accordingly, the EU does not 
believe that GMP is an appropriate use rate for L(+) tartaric acid. The 
EU further stated that an excess of L(+) tartaric may ``modify the 
natural and essential characteristics of the wine'', resulting in a 
possible breach of the Article 80(3)(d) of Regulation No. 1380/2013, 
which states that oenological practices shall ``allow the preservation 
of the natural and essential characteristics of the wine and not cause 
a substantial change in the composition of the product.''
    In her comment, Toni Stockhausen argued that ``synthetically 
derived L(+) Tartaric Acid, or L(+) Tartaric Acid (alternate method) 
per FDA GRAS notice GRN 000187 . . . should not be considered Good 
Manufacturing Practice for use in winemaking in the USA.'' In support 
of this, Ms. Stockhausen stated: (1) That FDA GRAS Notice No. GRN 
000187 for L(+) tartaric acid ``does not comment on the source of the 
maleic acid or on the safety of potentially unconverted maleic acid or 
other contaminants unique to the alternate production method;'' (2) 
``Despite GRN 000187, issued in 2006, in 10 years the FDA has not 
updated the list of direct food substances affirmed as generally 
regarded as safe;'' and, (3) ``For the purposes of exportation, 
jurisdictions including the European Union have confirmed or amended 
their food safety regulations to specify the source of Tartaric Acid as 
wine or grape derived, including the most recent European Pharmacopeia 
(9th Edition, effective January 1, 2017).''
    In its comment, Wine Institute stated that it understands that 
``synthetic (L(+)) tartaric acid, which was administratively approved 
by TTB,'' is not currently being used for the production of wine within 
the United States.
    TTB Response. TTB is finalizing in this rulemaking document the 
proposal in Notice No. 164 to include in the TTB regulations a 
reference to tartaric acid manufactured using an enzyme from 
immobilized Rhodococcus ruber cells (as described in FDA GRAS Notice 
No. GRN 000187) to correct natural acid deficiencies in grape juice/
wine and to reduce the pH of grape juice/wine. TTB believes that this 
form of tartaric acid is the form commenters refer to as ``synthetic.'' 
The regulatory text uses the spelling ``L-(+)-tartaric acid,'' as TTB 
understands that this is the scientifically preferred spelling for the 
material, rather than the ``L(+) tartaric acid'' spelling used in the 
proposed rule document.
    In response to the comments submitted by the EU and Wine Institute, 
TTB notes that with regard to the use rates for tartaric acid, the 
current regulations refer to TTB regulations at 27 CFR 24.182 and 
24.192 that provide additional detail about its use, and to FDA 
regulations in 21 CFR 184.1099. The uses prescribed in the TTB 
regulations do not authorize a use rate that would ``modify the natural 
and essential characteristics of the wine.'' TTB did not propose to 
change the limitations on the use of tartaric acid, and is not changing 
those limits at this time. However, TTB will consider including the 
more limited use rates in any subsequent rulemaking for additional 
comment.
    In her comment, Ms. Stockhausen claimed that the EU only allows 
tartaric acid derived from wine or grapes. TTB notes that in its 
comments on the proposal in Notice No. 186, the EU only addressed its 
belief that GMP was not an appropriate use rate for L(+) tartaric

[[Page 51887]]

acid. The EU did not distinguish between L(+) tartaric acid derived 
from wine or grapes and L(+) tartaric acid manufactured using 
Rhodococcus ruber cells. Therefore, TTB does not believe that the EU 
objects to TTB's proposal to allow the alternate method of producing 
L(+) tartaric acid.
    In response to Ms. Stockhausen's comments regarding GRAS Notice No. 
GRN 000187, the FDA has stated to TTB that GRAS Notice No. GRN 000187 
does not specifically state the source of maleic acid, and that maleic 
acid may be an impurity in the starting material (i.e., maleic 
anhydride), or it can be a byproduct of the reaction of maleic 
anhydride and hydrogen peroxide that is used to produce tartaric acid. 
GRAS Notice No. GRN 000187 does specify that the content of maleic acid 
in the final tartaric acid must be less than or equal to 0.05 percent. 
FDA also noted that the GRAS Notice process is an alternative to GRAS 
affirmation petitions, and that the FDA regulations do not provide a 
comprehensive list of GRAS substances.
vi. Polyvinylpyrrolidone (PVP)/Polyvinylimidazole (PVI) Polymer
    TTB proposed to add polyvinylpyrrolidone (PVP)/polyvinylimidazole 
(PVI) polymer (terpolymer of 1-vinylimidazole, 1-vinylpyrrolidone, and 
1,2-divinylimidazolidinone; CAS 87865-40-5 \6\) to remove heavy metal 
ions and sulfides from wine to the list of authorized wine and juice 
treating materials in Sec.  24.246.
---------------------------------------------------------------------------

    \6\ CAS = Chemical Abstracts Service Registration Number.
---------------------------------------------------------------------------

    Comments. In their comment, the 11 submitters of the form letter 
expressed support for the proposal in Notice No. 164 to add 
polyvinylpyrrolidone (PVP)/polyvinylimadazole (PVI) polymer to the list 
of authorized wine and juice treating materials in Sec.  24.246 to 
remove heavy metal ions and sulfides from wine at a level not to exceed 
80 grams per 100 liters of wine. They stated that PVP/PVI polymer would 
``provide the US wineries with an effective tool to eliminate these 
metals'', and further stated that the ``current US regulations provide 
unfair trade advantage for non-US wine producers in both domestic and 
international markets.''
    The 11 commenters of the form letter also recommended that the 
approval of PVP/PVI be extended to use in juice and must. They argued 
that this will give wineries the ability to ``remove excessive copper 
(from vineyard treatments) before starting fermentation or the early 
stages.'' They also stated that adoption of this recommendation ``would 
align the US regulation with other countries.''
    One commenter, Alice Feiring, raised concerns regarding the safety 
of PVP. She described PVP as a material that should not be authorized 
for use in the production of wine, stating that it ``is classified as 
`expected to be toxic or harmful,' by the Environment Canada Domestic 
Substance List.''
    TTB Response. TTB is finalizing the use of PVP/PVI polymer as 
proposed in TTB Notice No. 164, for use at a level not to exceed 80 
grams per 100 liters of wine to remove heavy metal ions and sulfides 
from wine. TTB did not propose the use of PVP/PVI in juice and has not 
had the opportunity to analyze juice treated with PVP/PVI. Accordingly, 
TTB is not including such authorization in its regulations at this 
time, but will consider for future action.
    With regards to the comment regarding the Canadian classification 
of PVP, TTB notes that under the Canada Food and Drug Regulations (see 
C.R.C., c 807 B.02.100(b)(xii)(D)), PVP may be used in the production 
of wine ``in an amount that does not exceed 2 parts per million in the 
finished product.''
vii. Potato Protein Isolates
    In Notice No. 164, TTB proposed to add potato protein isolates, at 
a use rate of 500 ppm or 50 grams per 100 liters (50 g/hL) of wine, as 
a fining agent, to the list of approved treating materials contained in 
Sec.  24.246.
    Comments. In their form letter, 11 commenters supported the 
addition of potato protein isolate to the list of authorized treating 
materials in Sec.  24.246 and stated that ``potato protein isolate is 
an effective fining agent for both juice and wine to remove phenolic 
components effecting [sic] astringency and bitterness, as well as to 
aid in settling juice and wine . . .'' at the use rate of 500 ppm (50 
g/hL), which is the proposed use rate in wine, not juice. These 
commenters suggested that TTB authorize the use of potato protein 
isolate in the use of juice because ``it is equally effective in 
application.'' They also stated that in its first additional 
correspondence to GRAS Notice No. GRN 000447, the FDA considered the 
use of potato proteins in wine-must, which the commenters noted is 
``considered as `grape juice' prior to fermentation.'' According to the 
commenters, ``Many winemakers choose to use fining products on juice in 
preference to wine as the process is more efficient and ha[s] less 
impact on resulting wine flavor.''
    In its comment, the Wine Institute indicated its support of the 
addition of potato protein isolates to the list of authorized treating 
materials contained in Sec.  24.246. It also recommended the use rate 
of good manufacturing practice for the use of potato protein isolates 
as a ``clarification'' material.
    Erbsl[ouml]h Geisenheim indicated its support of the addition of 
potato protein isolates to the list of authorized treating materials 
contained in Sec.  24.246, noting that proteins from plant origins, 
including potatoes, have been authorized by the International 
Oenological Codex as a wine and juice treating material. It further 
stated, ``Vegetable based fining agents have become increasingly 
important for the production of beverages that are suitable for a 
vegetarian or vegan diet.''
    TTB Response. TTB is finalizing the proposal to authorize 
fractionated potato protein isolate for use at a rate of 500 ppm or 50 
grams per 100 liters (50 g/hL) of wine, as a fining agent. TTB believes 
the use of fractionated potato protein isolate in juice should be 
subject to public comment, and plans to include such use among other 
proposals in a separate rulemaking.
viii. Sodium Carboxymethyl Cellulose
    TTB proposed to add sodium carboxymethyl cellulose (CMC) to the 
list of authorized wine and juice treating materials in Sec.  24.246 at 
a level not to exceed 0.8 percent of the wine, to stabilize wine from 
tartrate precipitation.
    Comments. In their form letter, 11 commenters supported TTB's 
proposal in Notice No. 164 to add CMC to the list of authorized wine 
and juice treating materials contained in Sec.  24.246. These 
commenters stated that the 0.8 percent use rate proposed by TTB is 
appropriate for good commercial practice. They also stated that CMC 
``is one of many tools the wine industry can use to stabilize wines, 
depending on unique wine chemistry and consumer preferences.''
    Wine Institute supported the addition of CMC to the list of 
authorized wine and juice treating materials; however, they recommended 
a use rate of GMP. Wine Institute recommended that if TTB does not 
adopt GMP, it should decrease the authorized amount of CMC from 
proposed 0.8% (8,000 mg/L) to 0.1% (1,000 mg/L), which according to 
Wine Institute, is the standard in international markets. It is Wine 
Institute's belief that the use of CMC at the maximum proposed level of 
8,000 mg/L ``could create quality issues in wines.''
    TTB response. As noted in Notice No. 164, FDA regulations at 21 CFR 
182.1745 state that CMC is GRAS when used in accordance with good 
manufacturing practice. In light of this

[[Page 51888]]

and the concern expressed in the Wine Institute's comment, this final 
rule amends the proposal to remove a specific use rate other than that 
contained in the reference to the FDA's regulations in 21 CFR 182.1745.

E. Proposed Processes for the Treatment of Wine, Juice, and Distilling 
Material

    TTB proposed to amend the regulations in Sec.  24.248, which set 
forth certain processes that TTB has approved as being consistent with 
good commercial practice for use by proprietors in the production, 
cellar treatment, or finishing of wine, juice, and distilling 
materials, within the limitations of that section. A discussion of the 
specific proposals, comments received, and TTB responses follows.
1. Cross Flow Filtration
    TTB proposed to expand the authorized use of nanofiltration and 
ultrafiltration in Sec.  24.248 (Processes authorized for the treatment 
of wine, juice, and distilling material) to include dealcoholization 
(reduction of the alcohol content). Currently, nanofiltration is 
authorized to reduce the level of volatile acidity in wine when used 
with ion exchange. Ultrafiltration is authorized for use to remove 
proteinaceous material from wine; to reduce harsh tannic material from 
white wine produced from white skinned grapes; to remove color from 
blanc de noir wine; and to separate red wine into high color and low 
color wine fractions for blending purposes. Because both nanofiltration 
and ultrafiltration are capable of reducing alcohol content in wine, 
the proposed liberalization will provide industry members with more 
tools to reduce the alcohol content of wine.
    Comments. In its comment, Wine Institute agreed with the proposal 
in Notice No. 164 to group nanofiltration, ultrafiltration, and reverse 
osmosis under the general category of ``cross flow filtration'' and 
welcomed the expansion of authorized uses for this category to include 
reduction of alcohol content.
    In his comment, Dr. Robert Kreisher disagreed with TTB's proposal 
to expand the authorized uses of nanofiltration and ultrafiltration to 
include dealcoholization. Dr. Kreisher indicated that TTB considered 
nanofiltration for purposes of alcohol reduction in 2007 and found that 
such a process is not consistent with good commercial practice because 
``nanofiltration permeate contained too great a quantity of volatile 
esters and fixed acids.'' Dr. Kreisher further stated that 
ultrafiltration has the same problems as nanofiltration, at a greater 
magnitude. If authorized, Dr. Kreisher advised TTB that it should be 
made clear that nanofiltration, ultrafiltration, and reverse osmosis 
may only be used in combination with distillation.
    TTB Response. This rulemaking finalizes TTB's proposal in Notice 
No. 164 to expand the use of nanofiltration and ultrafiltration to 
include dealcoholization (reduction of alcohol).
    In 2007, TTB reviewed a petition for the use of nanofiltration and 
ultrafiltration for purposes of removing off-flavors in wine. It did 
not review the processes for the purpose of alcohol reduction. However, 
TTB reviewed nanofiltration and ultrafiltration for purposes of alcohol 
reduction in 2013 and found that on a preliminary basis nanofiltration 
and ultrafiltration were acceptable for alcohol reduction pending 
future rulemaking.
    In Notice No. 164, TTB proposed amending Sec.  24.248 to state that 
nanofiltration, ultrafiltration, and reverse osmosis must be conducted 
on distilled spirits plant premises when used to remove ethyl alcohol 
(dealcoholization). The proposed amendment also provided a specific 
exemption to this rule for reverse osmosis and nanofiltration if ethyl 
alcohol is only temporarily created within a closed system. In this 
rulemaking document, TTB is adopting these amendments as final.
2. Reverse Osmosis in Combination With Osmotic Transport
    TTB proposed to amend the table of authorized processes in Sec.  
24.248 by revising the listings for reverse osmosis and osmotic 
transport to state that each process can be used in combination with 
the other to reduce the ethyl alcohol content of wine. These processes, 
whether used separately or in combination, must take place on distilled 
spirits plant premises.
    Comment. Wine Institute expressed its support of the proposal and 
also requested that TTB expand the authorized use of osmotic transport 
to include removal of off flavors, indicating that this would maintain 
consistency between reverse osmosis and osmotic transport.
    TTB Response. TTB is finalizing the proposal as set forth in Notice 
No. 164 to amend Sec.  24.248 to allow reverse osmosis and osmotic 
transport to be used in combination with the other. TTB is not 
expanding the authorized use of osmotic transport to remove off flavors 
at this time, and intends to include that proposal in separate 
rulemaking as TTB believes that additional public comment is needed. 
TTB would consider individual industry member requests under Sec. Sec.  
24.249 and 24.250 for use of osmotic transport to remove off flavors 
from wine.
3. Ultrafiltration
    In Notice No. 164, TTB proposed amending Sec.  24.248 to allow the 
use of ultrafiltration to separate red grape juice into high and low 
color fractions for blending purposes, and to separate white grape 
juice that had darkened due to oxidation during storage into high and 
low color fractions for blending purposes. TTB had previously 
administratively approved the use of ultrafiltration to separate red 
grape juice into low and high color fractions, and the proposed 
amendment would amend the table at Sec.  24.248 accordingly. However, 
TTB had not administratively approved the use of ultrafiltration to 
separate high and low colored fractions of discolored white grape 
juice, so, in Notice No. 164, TTB did invite comments on whether this 
practice constitutes good commercial practice.
    Comments. In its comment, Wine Institute welcomed TTB's proposal to 
authorize the use of ultrafiltration to separate red grape juice into 
low and high color fractions. Wine Institute also made two 
recommendations for the ``Reference or limitation'' column for 
ultrafiltration in Sec.  24.248. The first recommendation was to change 
the phrase ``greater than 500 and less than 25,000 molecular weight'' 
to ``not less than 500 and not greater than 25,000'' molecular weight. 
This change, which Wine Institute implied would be an ``edit'', would 
have the effect of including molecular weights of ``500'' and 
``25,000'' as opposed to excluding them, which is what the current 
regulatory language does. Wine Institute's second recommendation was to 
allow transmembrane pressure up to 500 psi rather than limit the 
transmembrane pressure to less than 200 psi. Wine Institute stated that 
``limiting the transmembrane pressure to 200 psi incorporates obsolete 
technology into the regulation'' and allowing transmembrane pressure up 
to 500 psi will ``allow use of recent improvements in technology that 
allow more effective use of Ultrafiltration . . . without altering 
vinous character.''
    TTB Response. TTB is finalizing in this rulemaking its proposal to 
expand the use of ultrafiltration to separate red grape juice into low 
and high color fractions. TTB does not consider the language change 
suggested by Wine Institute to be an editorial change, because the 
change would effectively allow the inclusion of molecular

[[Page 51889]]

weights of 500 and 25,000, which are currently not permitted and were 
not proposed to be allowed in Notice No. 164. TTB also did not propose 
in Notice No. 164 an increase to the transmembrane pressure from less 
than 200 psi to 500 psi. TTB believes further notice and comment on 
these proposed substantive changes is needed. TTB would consider 
requests from industry members under Sec. Sec.  24.249 and 24.250 to 
use membranes that are selected for weights outside what is currently 
authorized and to increase the authorized limit on transmembrane 
pressure for ultrafiltration.
4. Use of Wood To Treat Natural Wine
    TTB proposed a new 27 CFR 24.185 to maintain in one location all 
regulatory provisions pertaining to the treatment of wine with wood. 
Section 24.185(a) clarifies TTB's current policy that natural wine may 
be treated by contact with any wood that is consistent with the food 
additive requirements under the FD&C Act and that wood may be toasted, 
but not charred. Toasted wood refers to wood that has been heated but 
has not undergone combustion (that is, has not been burned or 
blackened).
    Proposed Sec.  24.185(b) states TTB's position on the use of wood 
essences and extracts in the production of wine. In the proposal, wood 
preparations made with an alcohol solution stronger than 24 percent 
alcohol by volume would be considered ``essences'' and must be used in 
accordance with Sec.  24.85. Wood essences and extracts must be 
consistent with the food additive requirements of the FD&C Act for that 
purpose and could only be used in ``other wines'' in accordance with 
Sec.  24.218.
    TTB also proposed to remove the last sentence from Sec.  24.225 
(``Wooden storage tanks used for the addition of spirits may be used 
for the baking of wine'') and include it in the new Sec.  24.185. 
Additionally, the proposal would remove the reference to oak chips from 
Sec.  24.246 and include it in the new Sec.  24.185.
    Comment. In response to the proposals related to the use of wood to 
treat natural wine, Wine Institute expressed concern with the language 
in proposed Sec.  24.185(a) ``that would not allow the use of charred 
barrels in winemaking.'' Wine Institute pointed to the standard of 
identity in TTB regulations for ``Bourbon whisky'', which requires use 
of charred new oak containers (see 27 CFR 5.22(b)(1)(i)) and to the 
longstanding use of bourbon barrels by both winemakers and brewers and 
requested ``equal regulatory treatment with respect to barrel 
requirements across all alcohol types and sectors.''
    Wine Institute also noted that TTB did not propose language 
indicating how it will determine whether wood has been charred. Wine 
Institute noted that the proposed regulation would allow ``toasting'', 
which does not include ``undergoing combustion.'' Wine Institute 
refuted this by arguing that ``during the toasting process, minor 
blisters may occur on the wood, which can be significantly darker in 
color than the rest of the wood and thus suggests--inaccurately--that 
combustion has occurred.'' For this reason Wine Institute believed that 
a color test would be ``insufficient to determine if combustion, and 
thus charring, has occurred'' and asked TTB to clarify how it would 
``identify improperly `charred' wood containers.''
    TTB response. TTB notes that, in part, the proposed change in 
Notice No. 164 regarding the treatment of wine with wood stems from 
current Sec.  24.246, which authorizes the use of uncharred and 
untreated oak chips or particles to smooth wine. TTB proposed to 
liberalize the current restriction on the treatment of wine with wood 
by authorizing the use of any wood that is consistent with the food 
additive requirements under the FD&C Act (not just oak) and to allow 
wood that has been toasted to be used for the purpose of smoothing 
wine. It was not TTB's intent to indicate that used distilled spirits 
barrels that were charred prior to use for storage of distilled spirits 
could not be used to store wine. TTB has considered Wine Institute's 
comment and has determined that the proposed language in Sec.  24.185 
may cause confusion. TTB has also determined that the restriction on 
charred wood as a treatment for wine is no longer necessary because one 
concern with charred wood was that it may, depending on the amount of 
charring, remove color from wine. However, TTB regulations have for 
many decades authorized the use of activated carbon to remove color 
from wine. Accordingly, TTB is finalizing new Sec.  24.185 as proposed, 
with the exception that charred wood that is consistent with the 
requirements under the FD&C Act may be used to treat natural wine. 
Also, if charred wood is used to treat wine, it cannot remove color 
from the wine. TTB is retaining the restriction that the wood must not 
be otherwise treated.

F. Wine Spirits

    TTB proposed to amend Sec.  24.225, which sets forth rules under 
which proprietors of a bonded wine premises may withdraw and receive 
spirits without payment of tax from the bonded premises of a distilled 
spirits plant and add the spirits to natural wine on bonded wine 
premises. The proposals included amendments to:
     Incorporate the terms of section 5373(a) of the IRC 
related to standards for the production of wine spirits (that is, 
spirits distilled from fresh or dried fruit, or the wine or wine 
residue therefrom), to clarify that natural wine or special natural 
wine to which sugar has been added after fermentation may not be 
refermented to develop alcohol from the added sugar and then used to 
produce wine spirits;
     Specify that wine spirits derived from special natural 
wine (that is, a wine produced from a base of natural wine and to which 
natural flavorings are added) may be used only in the production of a 
special natural wine if those spirits retain any flavor characteristics 
of the special natural wine; and
     Specify that spirits derived from authorized alcohol 
reduction treatments may be used as wine spirits, if such spirits are 
distilled at a rate of 100 degrees proof or more (rather than the 
general IRC standard of 140 degrees proof or more), and if the spirits 
conform to the other terms of section 5373(a) of the IRC.
    TTB also proposed the following non-substantive technical 
amendments:
     Moving the sentence allowing the use of wooden storage 
tanks used for the addition of spirits for the baking of wine to a new 
Sec.  24.185 that is related solely to the use of wood to treat natural 
wine; and
     Reorganizing the entire Sec.  24.225 to improve 
readability and clarity.
    Comment. Wine Institute agreed with the proposals set out in Notice 
No. 164 for Sec.  24.225 and welcomed the ``use of clarifying and 
simplified language to amend the regulation.'' Wine Institute believed 
that TTB's proposal of allowing the byproducts of alcohol reduction to 
be used as wine spirits if they are 100 degrees proof or more ``will 
provide a useful opportunity for the by-products of the alcohol 
reduction process.'' Wine Institute also stated that it ``welcomes the 
clarifying language concerning wine spirits produced from special 
natural wine.''
    TTB Response. TTB is finalizing all the amendments to Sec.  24.225 
as proposed in Notice No. 164. However, TTB is lowering the degrees of 
proof for which spirits byproducts of alcohol reduction processing 
deemed as wine spirits may be distilled from the proposed ``100 degrees 
of proof or more'' to ``not less than 90 degrees proof.'' As discussed 
in

[[Page 51890]]

the preamble of Notice No. 164, section 5373(a) of the IRC sets a 
general standard of 140 degrees of proof or above for wine spirits used 
in wine production but also provides exceptions for other wine spirits 
``if regulations so provide.'' The IRC allows for regulations to 
provide for distillation at less than 140 degrees of proof, and TTB did 
not receive any comments objecting to its original proposal of ``100 
degrees of proof or more.'' TTB has previously authorized experiments 
for the use of the byproduct of spinning cone column at 90 degrees of 
proof for use as wine spirits. Because of its experience with the 
experimental use of lower-proof byproducts of alcohol reduction 
methods, and because TTB believes the use of such byproducts are 
consistent with the intent of the IRC, TTB is incorporating the 90 
degrees of proof rate into its regulations to provide winemakers 
greater flexibility in their winemaking processes.

G. Accidental Water Additions

    TTB proposed to add what would have been a new 27 CFR 24.251, to 
provide for the correction of standard wine when the wine becomes other 
than standard wine due to accidental water additions in excess of the 
authorized levels provided for in 27 CFR part 24, subparts F and L. The 
proposed text set forth the authority and standards to allow for 
removal of accidental additions of water of not more than 10 percent of 
the original volume of the wine without the need to first seek TTB 
approval. The proposal also stated that the appropriate TTB officer 
could approve other removals of accidentally added water upon 
application by a proprietor and sets forth the requirements for 
submitting an application to TTB. It also specified that, in evaluating 
any request under this section, TTB may consider as a factor whether 
the proprietor has demonstrated good commercial practices, taking into 
account the proprietor's prior history of accidental additions of water 
to wine and of compliance with other regulations in part 24.
    Comment: In its comment, the Wine Institute expressed its support 
for the proposal to allow for removal of accidental additions of water 
of not more than 10 percent of the original volume of the wine without 
the need to first seek TTB approval. It also agreed with ``the 
conditions of usage of reverse osmosis and distillation as outlined'' 
in the proposed regulations for the purpose of removing accidentally 
added water. However, Wine Institute pointed out that the regulations 
were proposed for ``new'' Sec.  24.251, which already exists.
    Additionally, Wine Institute expressed its support for language in 
proposed Sec.  24.186(a), which provides that wine shall remain 
``standard wine'' if water is accidentally added to standard wine in an 
amount that does not exceed 1 percent of the total volume of the wine, 
and the proprietor need not take any action to correct the wine. Wine 
Institute also suggested amending Sec.  24.186(b), which allows for the 
correction of accidental water additions, to allow ``the addition of 
grape juice concentrate to correct an accidental dilution of grape 
wine.'' Wine Institute argued that since grape juice and grape juice 
concentrate is authorized to be added to standard wine (see 27 CFR 
24.186), TTB should authorize the addition of grape juice and grape 
juice concentrate to wine that has been accidentally diluted with 
water. Wine Institute expressed its belief that water accidentally 
added can be completely or partially accounted for by an appropriate 
amount of juice concentrate because water is necessary to reconstitute 
juice concentrate back to original Brix. It argued that this approach 
eliminates the need for processing (such as reverse osmosis) that, 
according to Wine Institute, is expensive and can potentially impact 
the quality of the wine. Wine Institute further suggested that the 
process proposed in Sec.  24.251 be used on a portion of the wine if 
concentrate does not fully account for the accidental water addition.
    Clover Hill Winery expressed concern that the authority of removing 
accidentally added water from wine under the standards as proposed 
could be abused by winemakers to fortify wines by distilling ``slightly 
past the original concentration.'' With no record of this distillation, 
Clover Hill Winery stated ``there would be no red flags at the 
regulatory agencies and customers would be none the wiser.''
    In its comment, the EU quoted the EU-US agreement \7\ on wine in 
article 3, which provides that ``the term wine shall cover beverages 
which contain no added water beyond technical necessity.'' As stated in 
their comment, the ``EU considers adding water intentionally to wine 
products as fraud.'' They further noted, ``[I]n EU, any addition of 
water for facilitating the solution or dispersion of oenological 
products must be reported in a register held by the producer.'' It is 
for these reasons that the EU recommended that ``any accidental 
addition of water should be reported to the competent authority and 
duly recorded even if it is in the context of its subsequent removal.'' 
The EU further commented that ``the blending of a watered wine with a 
non-watered wine is not considered by EU as an acceptable solution to 
reduce the proportion of added water within the limit of 1 percent, 
this limit being accepted only in the context of the addition of water 
for facilitating solution or dispersion of oenological products.'' They 
also corrected a statement made in Notice No. 164 by stating that 
``concentration techniques including reverse osmosis are allowed in EU 
for the enrichment of musts used to produce any category of wine under 
the conditions referred to in Annex VIII(I)(B)(1)(b) to regulation (EU) 
No 1308/2017.''
---------------------------------------------------------------------------

    \7\ https://www.ttb.gov/agreements/us-eu-wine-agreement.pdf.
---------------------------------------------------------------------------

    TTB Response. In Notice No. 164, TTB referenced having received 
requests to allow wine to be salvaged by blending the accidentally 
diluted wine with standard wine to reduce the level of unauthorized 
water addition to less than 1 percent of the volume of the blended 
wine. TTB also stated that it has not approved these requests because, 
in accordance with Sec.  24.218, the accidental addition of water 
renders the wine an ``other than standard wine.'' Further, Sec.  24.218 
provides that other than standard wine must be segregated from standard 
wine, thus generally prohibiting the blending of other than standard 
wine with standard wine.
    TTB proposed in new Sec.  24.186 to permit the blending of other 
than standard wine with standard wine to reduce the amount of 
accidentally added water to 1 percent or less of the total volume of 
the blended wine. The intent was that the resulting wine would be 
considered to be standard wine.
    In response to the comment received by the EU, TTB has reconsidered 
this proposal and is removing it from Sec.  24.186 in this final 
rulemaking document. Accordingly, this final rule will not allow for 
the ``salvage'' of wine by blending the accidentally diluted wine 
(other than standard wine) with a standard wine. However, in response 
to the Wine Institute's suggestion of allowing the addition of juice 
concentrate to wine that has been diluted with water, TTB has added 
language to proposed Sec.  24.251 (which is redesignated as Sec.  
24.252 in this document) that authorizes the salvage of wine that has 
been diluted with water by adding concentrate under certain conditions.
    TTB is codifying these provisions in a new section, Sec.  24.252. 
TTB originally proposed them in Sec.  24.251. However,

[[Page 51891]]

that section was added by a rulemaking subsequent to the publication of 
Notice No. 164. TTB notes that the provisions in Sec.  24.252 only 
apply to wine that contains water in excess of the limits provided for 
standard wine in part 24 that was ``accidentally added,'' not 
``intentionally.'' TTB also notes that the recordkeeping requirements 
in Sec.  24.252 provide that the industry member retain records that 
document the accidental addition of water, the use of any treatment or 
process to remove the water from the wine, and the fact that only the 
amount of water that was accidentally added to the wine was removed as 
a result of the treatment or process. Because the regulations already 
address these matters, TTB does not believe that there is a need to 
amend the proposed regulations to further clarify that the water must 
be ``accidentally'' added in order to take advantage of the provisions 
of Sec.  24.252, nor does TTB believe that additional recordkeeping 
requirements are necessary.
    In response to Clover Hill Winery's comment, TTB notes that in 
general, wine spirits are authorized to be added to standard wine (see 
27 CFR part 24, subpart K). It is unclear to TTB what is meant by 
``distill slightly past the point of concentration.'' Currently, there 
are no labeling requirements in 27 CFR part 24 that require an industry 
member to indicate on the label of their product that it contains wine 
spirits. In fact, such practices are generally prohibited for wines 
that are required to be covered by a Certificate of Label Approval 
(COLA) under TTB's regulations in 27 CFR part 4.
    Labeling concerns aside, the issue at hand is that alcohol that was 
removed from the permeate stream resulting from reverse osmosis is 
distilled and returned to the wine. As provided in the proposed 
regulations, the wine must be returned to its original condition by 
removing an amount of water equal to the amount that was accidentally 
added to the wine. ``Returned to its original condition'' includes 
alcohol content. TTB is adding clarifying language to the provisions of 
Sec.  24.252 to address this issue.

H. Other Proposed Regulatory Amendments

    In addition to the changes discussed previously, TTB Notice No. 164 
included the following proposed regulatory amendments.
1. Technical Amendments to the List of Authorized Wine and Juice 
Treating Materials
i. General Amendments to Sec.  24.246
    TTB proposed numerous technical and clarifying changes to Sec.  
24.246. First, TTB proposed to amend the heading in paragraph (a) of 
Sec.  24.246 to read ``Wine and juice'' rather than just ``Wine.'' TTB 
also proposed a number of technical changes to the table in Sec.  
24.246. A significant portion of these technical changes involve 
revising the measurement references specified for the limitation on use 
of the authorized wine treating materials by making the notation of 
units of measurement consistent throughout the chart, supplying closing 
parentheses where they were absent, and removing decimal points 
followed only by zeroes. In addition, where units were only in U.S. 
Common (English) units or SI (International Standard, or metric) units, 
TTB proposed adding the other unit of measure for reference purposes, 
where appropriate. Other technical changes in the proposed rule 
include: (1) Adding a footnote reference after each use of ppm and ppb 
in the chart to address parts per million and parts per billion, 
respectively; (2) including a definition of the word ``stabilize'' at 
the end of the chart; (3) adding a third column to the table in Sec.  
24.246 titled ``FDA reference'' to provide references to relevant FDA 
regulations in title 21 of the CFR, FDA GRAS Notices, and FDA advisory 
opinions; and (4) updating references to FDA opinions.
    Comments. Wine Institute submitted the only comment specifically 
referencing the technical amendments to Sec.  24.246. In its comment, 
Wine Institute expressed its support of TTB's proposal of ``expressing 
units first in U.S. common units and then in SI units'' for the 
specified limitations of use in the list of authorized wine and juice 
treating materials listed in Sec.  24.246. Wine Institute ``appreciates 
the fact that the limits are expressed using both conventions'', and 
suggested ``that a common SI unit form, i.e. mg/L or g/L, be expressed 
wherever possible.'' Wine Institute argues that ``mg/L or g/L'' is a 
``more correct from a scientific perspective than `ppm' or `ppb.' '' 
Wine Institute also stated that ``in some instances, limits are 
expressed in grams per hectoliter or similar; use of mg/L would be more 
consistent and more useful and relevant to the Industry.''
    TTB Response. TTB is amending its regulations to add the 
appropriate SI unit to the specified limitations of use in the list of 
authorized wine and juice treating materials listed in Sec.  24.246. 
TTB notes that many of the limitations in the table in Sec.  24.246 
include both common and SI units. Adding the actual SI units to the 
remaining limitations in the table, in addition to the footnote 
regarding the relationship between ppm or ppb and the common SI units, 
would not change the substance of the limitations and would be useful 
to industry members and provide consistency within the table.
ii. Activated Carbon
    In the entry for activated carbon in Sec.  24.246, TTB proposed to 
amend one of the entries in the ``Materials and use'' column for 
clarity by revising the phrase ``remove color in wine and/or juice'' to 
read ``remove color from wine and/or juice.''
    Comments. Although Wine Institute stated that the simplified 
proposed language for activated carbon would assist in clarification, 
it was uncertain as to why a limit on the use of activated carbon is 
necessary, provided that the wine retains its vinous character after 
the decoloring process is complete. Instead, Wine Institute suggested 
GMP as an appropriate limit under the belief that ``[t]he need to limit 
color removal is unnecessary.''
    TTB Response. TTB is finalizing its proposal for the entry for 
activated carbon in Sec.  24.246, and notes that Notice No. 164 did not 
include a specific proposal to change the use rate of activated carbon. 
TTB intends to seek comment on the Wine Institute recommendation in 
separate rulemaking. As a result, TTB is not adopting the 
recommendation at this time, but will consider requests from individual 
industry members under Sec. Sec.  24.249 and 24.250 to use different 
levels of activated carbon to remove color from juice and/or wine as 
needed.
iii. Ammonium Phosphate (mono- and di- basic)
    TTB proposed to revise the name of the material to ``Ammonium 
phosphate/diammonium phosphate (mono and di basic)'' and place the 
entry under a new entry for ``Yeast nutrients'' in the table in Sec.  
24.246. (TTB also proposed a conforming change revising the name of the 
material in Sec.  24.247.)
    Comments. Wine Institute expressed its belief that the current use 
rate of ammonium phosphate ``is insufficient in certain 
circumstances.'' Wine Institute stated ``[a]n addition of 8lbs. DAP per 
1000 gallons of juice results in an addition of approximately 200 mg/L 
of Nitrogen to the juice.'' Wine Institute referred to scientific 
articles (Butzke et

[[Page 51892]]

al. (U.C. Davis, 1998)) \8\ that suggested ``[i]n juices with high Brix 
levels, . . . as much as 350 mg/L of Nitrogen will be required for a 
healthy fermentation, thus it is possible that if the high Brix juice 
is naturally deficient in Nitrogen, then an addition of 8lbs/1000 
gallons may be insufficient.''
---------------------------------------------------------------------------

    \8\ Butzke, C.E. 1998. Survey of yeast assimilable nitrogen 
status in musts from California, Oregon and Washington. American 
Journal of Enology and Viticulture. 49(2):220-224.
---------------------------------------------------------------------------

    In her comment, Heather Nenow expressed her concern that the 
current authorized use rate of ammonium/diammonium phosphate at 8 
pounds per 1000 gallons of wine is insufficient to finish fermentation 
with grapes grown in certain regions of the country. Ms. Nenow referred 
to uncited studies that indicate yeast-assimilable nitrogen of 250 to 
350 ppm is required to finish fermentation. According to Ms. Nenow, 1 
pound of diammonium phosphate added to juice provides 22 ppm of yeast-
assimilable nitrogen. With a limit of 8 pounds per 1000 gallons for 
addition of diammonium phosphate, the maximum increase of yeast-
assimilable nitrogen the winemaker can add is 176 ppm, which is well 
below the 250-to-350 ppm of yeast-assimilable nitrogen that Ms. Nenow 
indicated is necessary to complete fermentation. She recommended a use 
rate for diammonium phosphate of 15 pounds per 1000 gallons of wine.
    TTB Response. TTB is revising the name of the material to 
``Ammonium phosphate/diammonium phosphate (mono and di basic)'' and 
adding it to the new entry ``Fermentation aid'' in the table in Sec.  
24.246 (as noted above, for clarity, TTB is replacing the term ``Yeast 
nutrients'' with the term ``Fermentation aids'' in the regulations). 
TTB notes that it has not yet received requests from winemakers to use 
ammonium phosphate at levels higher than proposed. TTB plans to include 
this recommendation in separate rulemaking in relation to Wine 
Institute's recommendation of GMP.
iv. Casein, Potassium Salt of Casein
    In the ``Specific limitation'' column, TTB proposed to remove the 
references to FDA's GRAS opinions. The opinions were from 1960 and 
1961, and copies were no longer available from either TTB or FDA.
    Comments. The 11 submitters of the form letter stated that casein, 
which is currently authorized for use to clarify wine under Sec.  
24.246, should also be authorized for use in grape juice. They argued 
that the use of casein in juice is as effective as its use in wine. 
They further stated that ``[m]any winemakers choose to use fining 
products on juice in preference to wine as the process is more 
efficient and ha[s] less impact on resultant wine flavor.''
    TTB Response. TTB notes that it has not received applications from 
winemakers submitted under Sec.  24.250 for the approval of the use of 
casein as a clarifying agent for juice. As a result, TTB did not 
propose to extend its authorized use to include juice in Notice No. 
164. TTB believes that additional notice and opportunity for comment is 
necessary, and plans to include this recommendation in separate 
rulemaking. Thus, TTB is not authorizing the use of casein in grape 
juice in the production of wine at this time, but will consider 
requests from individual industry members under Sec. Sec.  24.249 and 
24.250 for the use of casein as a treatment material for grape juice.
v. Technical Amendments to Other Specific Wine Treating Materials
    TTB also proposed to make the following technical changes to the 
current entries in the table in Sec.  24.246:
     Albumen. In the ``Specific limitation'' column, TTB 
proposed to revise the words ``of solution'' in the second sentence to 
read ``of wine.''
     Calcium carbonate. In the ``Materials and use'' column, 
TTB proposed to add the abbreviation ``CaCO3'' to the 
material name, to revise the phrase ``and juice'' to read ``or juice'' 
in the first use entry, and to revise the phrase ``A fining agent'' to 
read ``As a fining agent'' in the second use entry.
     Citric acid. In the ``Materials and use'' column, TTB 
proposed revising the phrase ``deficiencies in wine'' to read 
``deficiencies in juice and wine.''
     Copper sulfate. In the ``Specific limitation'' column, TTB 
proposed to revise the phrase ``sulfate added (calculated as copper)'' 
to read ``sulfate (calculated as copper) added to wine.''
     Dimethyl dicarbonate. For purposes of clarity, in the 
``Materials and use'' column, TTB proposed to add the abbreviation 
``(DMDC)'' after the material name and also proposed to remove the 
phrases ``dealcoholized wine'' and ``low alcohol wine'' from the entry 
to reduce redundancy.
     Ferrocyanide. TTB proposed to remove ``ferrocyanide'' from 
the list of authorized wine treating materials because TTB believes 
that ferrocyanide compounds are no longer available on the United 
States market and no longer being used by the U.S. wine industry.
     Milk products. Because milk products are currently 
approved for use as fining agents in all wines, TTB proposed to remove 
the phrase ``Fining agent for grape wine or sherry.'' TTB believes this 
phrase may cause confusion because under the standards of identity in 
Sec.  4.21(a), sherry is a grape wine.
     Oxygen and compressed air. In the ``Materials and use'' 
column, TTB replaced the words ``May be used in juice and wine'' with 
the words ``Various uses in juice and wine.''
     Polyvinylpolypyrrolidone (PVPP). In the ``Materials and 
use'' column, TTB proposed removing the phrase ``black wine'' because 
this term for a very dark red wine is no longer commonly used by 
industry members; the material will still be allowed in red wines, 
which covers so-called ``black wines.''
     Sorbic acid and potassium salt of sorbic acid. In the 
``Materials and use'' column, TTB proposed adding the words ``potassium 
sorbate'' in parentheses immediately after the material name because 
``potassium salt of sorbic acid'' is commonly referred to as 
``potassium sorbate.''
     Sulfur dioxide. TTB proposed to correct the entry for 
sulfur dioxide to include its use in juice.
     Thiamine hydrochloride. TTB proposed to move the material 
thiamine hydrochloride under a new heading, ``Yeast nutrients.''
    Comments. In its comment, Wine Institute agreed with the proposed 
clarifying changes for albumen, ammonium phosphate (mono- and di 
basic), calcium carbonate, casein, citric acid, copper sulfate, 
dimethyl dicarbonate, ferrocyanide compounds, milk products, oxygen and 
compressed air, polyvinylpolypyrrolidone (PVPP), sorbic acid, sulfur 
dioxide, and thiamine hydrochloride.
    TTB Response. This rule will finalize the technical changes to 
albumen, calcium carbonate, citric acid, copper sulfate, dimethyl 
dicarbonate, ferrocyanide compounds, milk products, oxygen and 
compressed air, polyvinylpolypyrrolidone (PVPP), sorbic acid, sulfur 
dioxide, and thiamine hydrochloride as proposed in Notice No. 164.
2. Application for Use of New Treating Material or Process
    TTB proposed a technical amendment to clarify the requirements in 
Sec.  24.250 for applications for use of new wine treating materials or 
processes. The amendment would require evidence that the proposed 
material is ``consistent with the food additive requirements under the 
FD&C Act for its intended purpose in the amounts proposed for the 
particular treatment contemplated.'' TTB believes the proposed language 
is

[[Page 51893]]

clearer than the current language which requires proof of FDA 
``approval of the material.'' TTB received no comments specifically 
related to this proposed amendment. Therefore, TTB is adopting the 
amendment as proposed in Notice No. 164 as final.

I. Other Issues for Public Comment and Possible Regulatory Action 
Discussed in Notice No. 164

    In Notice No. 164, TTB invited public comments on a number of 
additional potential changes to part 24. Most of these issues had been 
raised in petitions for rulemaking or arose in connection with wine 
treatment approval requests under Sec.  24.249 or Sec.  24.250. The 
issues in question, and the specific points on which TTB requested 
public comments, are outlined below.
1. Alcoholic Oak Extract
    In 2008, Oak Tannin Technologies submitted a petition to amend the 
TTB regulations to allow ``alcoholic oak extracts for use in natural 
wines as a stabilizing, enriching and integrating agent.'' The 
petitioner stated that use of such extracts in wine is approved by the 
South African Wine and Spirit Board. However, TTB and its predecessor 
agencies' longstanding policy has been to treat such materials as 
essences or extracts, which, under Sec.  24.85, may be used only in the 
production of formula wines \9\ except agricultural wine.\10\
---------------------------------------------------------------------------

    \9\ 27 CFR 24.10 defines ``formula wine'' as ``Special natural 
wine, agricultural wine, and other than standard wine (except for 
distilling material and vinegar stock) produced on bonded wine 
premises under an approved formula.''
    \10\ 27 CFR 24.10 defines ``agricultural wine'' as ``Wine made 
from suitable agricultural products other than the juice of grapes, 
berries, or other fruit.''
---------------------------------------------------------------------------

    In Notice No. 164, TTB sought comments regarding the use of an 
alcoholic oak extract in the production of natural wines, in 
particular, as a material for use as a wine stabilizer, but also for 
any other purpose that is consistent with good commercial practice. TTB 
also advised that a manufacturer of alcoholic oak extract must contact 
FDA and go through the FDA pre-market review process.
    Comment. In its comment, Clover Hill Winery indicated its support 
for the use of alcoholic oak extract in the production of standard 
wines because it ``may be beneficial to smaller wineries.'' However, 
they also expressed concern that the authorized use of alcoholic oak 
extract in standard wine would detract ``from the individuals who take 
time to age in barrels or with oak substitutes.'' To resolve this 
concern and dispel possible consumer confusion, Clover Hill Winery 
offered a ``middle ground'' suggestion, which would include a statement 
on the label indicating whether or not wine was aged in oak or with 
alcoholic oak.
    TTB Response. TTB appreciates Clover Hill Winery's comment and will 
take it into consideration in any future decisions regarding the use of 
alcoholic oak extract. TTB notes that as of the date of this document, 
the use of alcoholic oak extract as a stabilizing, enriching, and 
integrating agent has not gone through the FDA pre-market review 
processes. Therefore, TTB is not amending its regulations to allow the 
use of alcoholic oak extract at this time.
2. Lactic Acid
    In 2007, Hyman, Philips, & McNamara, P.C. petitioned TTB to amend 
Sec. Sec.  24.182 and 24.246 to allow use of lactic acid in juice, 
must, and wine prior to fermentation. Lactic acid is most commonly 
found in dairy products and is a common component in both plant and 
animal metabolic processes. Under Sec.  24.246, lactic acid is 
currently authorized for use in grape wine to correct natural acid 
deficiencies. In the table in Sec.  24.246, the entry in the 
``Reference or limitation'' column for lactic acid simply provides a 
citation to 27 CFR 24.182 and 24.192. Section 24.192 refers back to the 
limitations on the use of acid, among other things, prescribed in Sec.  
24.182. The regulations in Sec.  24.182 state that acids of the kinds 
occurring in grapes or other fruit (including berries) may be added 
within the limitations of Sec.  24.246 to juice or wine in order to 
correct natural deficiencies. Section 24.182 also states that, after 
fermentation is completed, citric acid, fumaric acid, malic acid, 
lactic acid, or tartaric acid, or a combination of two or more of these 
acids, may be added to correct natural deficiencies. The petitioner 
noted that lactic acid is currently allowed by Sec.  24.246 for 
treatment of wine after fermentation and provided evidence that certain 
other countries allow the addition of lactic acid before fermentation. 
Further, the petitioner noted that lactic acid is less expensive and 
more reliably available than tartaric acid.
    In Notice No. 164, TTB did not propose any changes to the 
regulations concerning the use of lactic acid. However, TTB invited 
comments regarding whether or not the use of lactic acid prior to 
fermentation is good commercial practice in the production of natural 
wine.
    Comments. Wine Institute noted that L(+) tartaric acid, malic acid, 
citric acid, and lactic acid are commonly grouped together in the 
regulations of other wine producing countries as allowed for 
acidification purposes. Wine Institute thus suggested that the 
limitation on use of lactic acid be expanded to allow its use in both 
juice and wine.
    TTB Response. TTB's understanding of Wine Institute's comment is 
that it was responding to the request for comment in support of 
allowing the use of lactic acid for use prior to fermentation of 
natural wine. TTB believes that the Wine Institute's suggestion would 
benefit from additional public comment and plans to include it in a 
separate rulemaking document. TTB would also consider requests from 
individual industry members under Sec. Sec.  24.249 and 24.250 for the 
use of lactic acid in juice prior to fermentation.
3. Reverse Osmosis To Enhance the Phenol Flavor and Characteristics of 
Wine and To Reduce the Water Content of Standard Wine
    Section 24.248 currently provides for the use of reverse osmosis to 
reduce the ethyl alcohol content of wine and to remove off flavors in 
wine. In 2014, Constellation Wines U.S. Inc. (Constellation) submitted 
a petition to TTB requesting an expansion of the authorized uses of 
reverse osmosis in Sec.  24.248 to include: (1) improving the phenol 
and flavor character of wine; and (2) reducing the water content in 
standard wine. In Notice No. 164, TTB invited comments on whether the 
use of reverse osmosis to reduce the water content of wine, improve the 
phenol and flavor character of wine, or to improve the sensory quality 
of the wine would be acceptable in good commercial practice. TTB did 
not, however, propose any amendments to add these uses to the list of 
authorized uses for reverse osmosis.
    TTB stated that if commenters believed that the use of reverse 
osmosis for these purposes is consistent with good commercial practice, 
their comments should explain their position in detail, as well as 
provide guidelines/standards concerning how much water (maximum 
percentage) may be removed. If commenters believed that the use of 
reverse osmosis for these purposes is not consistent with good 
commercial practice, their comments should explain their position in 
detail.
    Comments. In its comment, Wine Institute expressed strong support 
for the use of reverse osmosis as described in Notice No. 164. It 
stated that this process ``is consistent with good commercial 
practice'' and suggested that it be added to the list of allowable uses 
for reverse osmosis. Wine Institute

[[Page 51894]]

stated that the practice of using reverse osmosis to improve the phenol 
flavor and character of wine and reduce the water content of wine ``is 
allowed in other wine producing countries such as Australia and New 
Zealand,'' and argued that ``the lack of ability in the U.S. to use the 
technology in the proposed manner places the U.S. Industry at a 
significant competitive disadvantage.'' Wine Institute further stated 
``Australia and New Zealand do not set limits on the amount of water 
that can be removed.'' Rather than setting a numerical use rate on the 
reverse osmosis for the proposed uses, Wine Institute stressed its 
desire to base a use rate/limitation on the resultant wine needing to 
retain vinous character.
    In his comment, Coleman Reardon also expressed support for the use 
of reverse osmosis as requested by Constellation. Mr. Reardon argued 
that the concentration of standard wine via reverse osmosis would 
result in wine producers using more grapes in the production of wine, 
which would benefit grape growers. He also stated that ``[i]ncluding 
less water in the production of wine would also inherently increase the 
flavor of wine's other ingredients and characteristics.'' Mr. Reardon 
further argued that the U.S. is at an international disadvantage by not 
allowing the proposed use of reverse osmosis because such practice is 
authorized in some other countries.
    In his second comment to Notice No. 164, Dr. Robert Kreisher 
opposed the proposed use of reverse osmosis and disagreed with 
Constellation's assertion that wine resulting from reverse osmosis to 
improve the phenol flavor and character of wine and reduce the water 
content ``is considered to be standard wine but with reduced levels of 
alcohol and water.'' Dr. Kreisher stated that Constellation's assertion 
was incorrect because, under current regulation, the concentration of 
wine via reverse osmosis is not authorized and, therefore, such a 
practice does not result in a standard wine.
    Dr. Kreisher also argued that Constellation's statement that 
concentration of wine via reverse osmosis will result in ``reduced 
levels of alcohol and water'' is inaccurate. Dr. Kreisher indicated 
that concentration of wine cannot result in both a reduction of alcohol 
and water. He stated that reverse osmosis passes water (through a 
membrane) preferentially to alcohol and thus reduces water content, 
while concentrating (increasing) alcohol in the wine. Therefore, the 
alcohol in the retentate, i.e, ``wine'', is increased.
    Dr. Kreisher also refuted Constellation's assertion ``that many 
foreign countries permit the use of reverse osmosis as an acceptable 
winemaking practice to concentrate phenols and flavors in wine and in 
grape must'' and that ``[t]he expanded use of reverse osmosis would 
provide winemakers with better ability to regulate the alcohol content 
of wines.'' He argued that the alcohol content of wine would only be 
regulated upward when reverse osmosis is used and further indicated 
that the claim that foreign countries authorize such practices is 
incorrect.
    Finally, Dr. Kreisher argued that the prohibition on the 
concentration of wine to improve phenolic flavor and character and to 
reduce the water content does not subject anyone to unfair competition 
because wine produced with the use of such practices ``may not be sold 
in any major market, including the U.S.'' Dr. Kreisher stated ``[t]his 
isn't unfair, it's parity.''
    In her comment, Alice Feiring opposed the proposed use of reverse 
osmosis, stating that such a practice would be used ``to cover up 
sloppy and unclean winemaking.''
    TTB Response. TTB has decided not to set out regulations pertaining 
to this issue in this rulemaking. However, TTB will consider seeking 
additional comment in separate rulemaking.
4. Ultrafiltration To Separate White Grape Juice
    In Notice No. 164, TTB discussed an industry member's request to 
use ultrafiltration to separate white grape juice that had darkened due 
to oxidation during storage into high and low color fractions for 
blending purposes. The low color fraction would be blended with white 
wine, and the high color fraction would be blended with red wine. TTB 
sought comment on whether the use of ultrafiltration to separate 
discolored wine for blending would be acceptable in good commercial 
practice. In its request for comment, TTB stated that a comment should 
explain in detail the commenter's position as to why the use of 
ultrafiltration in this manner is or is not acceptable in good 
commercial practice.
    Comments. In its comment, E&J Gallo Winery (Gallo) acknowledged 
that TTB's request for comments on this matter was in response to a 
request the agency received from Gallo. Gallo responded that 
``ultrafiltration should be permitted to be used for both discolored 
white grape juice and discolored white wine.'' In support of its 
position, Gallo noted that ``unprocessed discolored white grape juice 
and/or discolored white wine can currently be blended with red grape 
juice and/or red grape wine without any limitations.'' It further 
argued that ``[u]sing a processing step to separate white juice into 
color fractions should not alter where it can subsequently be used as 
is currently allowed today.''
    In his second comment in response to Notice No. 164, Dr. Robert 
Kreisher expressed support for extending the authorized use of 
ultrafiltration to separate discolored white wine. He further argued 
that the use of ultrafiltration gives winemakers greater control over 
the wine they produce.
    TTB Response. Because TTB did not receive any negative comments in 
its request for comments, the agency is authorizing the use of 
ultrafiltration to separate white grape juice into low and high color 
fractions.
5. Additional Yeast Nutrients
    In 2007, TTB received a petition from Gusmer Enterprises Inc. 
(Gusmer) requesting approval of eight vitamins and minerals for use as 
yeast nutrients in the production of wine--cobalamin (vitamin B12), 
iodine (potassium iodide), iron, manganese sulfate, nickel, potassium 
chloride, riboflavin (Vitamin B2), and zinc sulfate. Prior to the 
publication of Notice No. 164, TTB had not administratively approved 
these vitamins and minerals under Sec.  24.250. In Notice No. 164, TTB 
sought comments supporting or rejecting the argument that the use of 
these vitamins and minerals as yeast nutrients in the production of 
wine is consistent with good commercial practice.
    Comments. In response to TTB's request for comment on the eight 
vitamins and minerals, Wine Institute said that it has ``no position on 
whether any of the other materials identified in the Gusmer 
Enterprises, Inc. petition should be approved as authorized wine 
treatment materials.''
    In its comment, Beverage Supply Group stated support for Gusmer's 
petition, specifically the use of zinc sulfate and manganese sulfate as 
yeast nutrients. Beverage Supply Group expressed their belief that the 
use of zinc sulfate and manganese sulfate is consistent with good 
commercial practice and also provided scientific data that they believe 
supports allowing the use of these two materials as yeast nutrients.
    TTB Response. TTB did not receive comments supporting the addition 
of cobalamin (vitamin B12), iodine (potassium iodide), iron, nickel, 
potassium chloride, and riboflavin (vitamin B2), to the list of 
authorized wine and juice treating materials in Sec.  24.246. TTB also 
has not had an opportunity to analyze wine or juice

[[Page 51895]]

treated with these substances. Accordingly, TTB does not believe it has 
enough information to add these vitamins and nutrients to the list of 
authorized wine and juice treating materials at this time. However, TTB 
would consider requests from individual industry members under the 
procedures of Sec. Sec.  24.249 and 24.250 for use of any of these 
materials to aid in the fermentation of wine.
6. Comments on Matters on Which TTB Did Not Seek Comments
i. Flowers and Botanical Wines
    Comment. In her comment, Samantha Hunter asked TTB to ``highlight'' 
flower and botanical wines to ``preserve historical methodologies and 
treatments in [w]inemaking.'' Ms. Hunter further suggested that TTB add 
``flowers or botanicals'' to the definition of ``essences.'' She also 
suggested that TTB amend its regulations pertaining to ``other wine'' 
to allow wine to be made ``by blending wines or co-fermenting flowers 
with fruits or, juice.''
    TTB Response. TTB notes that wine made with flowers, such as 
dandelions, are considered ``agricultural wines'' under its regulations 
in 27 CFR part 24, subpart I. Wine derived from flowers may be blended 
with wine made from fruit; TTB considers this type of wine to be an 
``other than standard wine.'' TTB will propose clarifying language to 
resolve this issue in future rulemaking. With regard to adding flowers 
and botanicals to the regulations pertaining to essences, TTB will 
consider this issue for future rulemaking.
ii. Malolactic Bacteria
    Comments. In their form letter, 11 commenters notified TTB that the 
type of malolactic bacteria authorized by Sec.  24.246 (Leuconostoc 
oenos) for use in wine is no longer current. The commenters cited a 
scientific article which proposes assigning Leuconostoc oenos to a new 
genus, Oenococcus oeni. The 11 commenters, who are mostly winemakers, 
stated that Oenococcus oeni ``was adopted by the wine industry and the 
U.S. regulations should be updated to reflect that.'' The 11 commenters 
also expressed concern over competing with wines produced in other 
countries because those producers are authorized to use other types of 
malolactic bacteria, such as those belonging to Leuconostoc, 
Lactobacillus, and Pediococcus genus. They believed that this creates 
an unfair trade advantage for wines produced in other countries and 
stated that ``[a]ligning the designation of the authorized bacteria 
with current OIV standards as outlined in document OIV-Oeno 328-2009, 
Oeno 494-2012 (https://www.oiv.int/public/medias/4054/e-coei-1-balact.pdf) would provide U.S. wine producers with relative competitive 
equality in all trade markets.''
    In his comment, Richard Gahagan stated that he does not believe 
that malolactic fermentation should be limited to Leuconostoc oenos. He 
stated that ``taxonomists have reclassified this organism to Oenococcus 
oeni (Dicks, Dellaglio and Collins (1995).'' He also stated that 
researchers from University of California Davis isolated three genera 
of lactic acid bacteria (Lactobacillus, Leuconostoc, and Pediococcus) 
from California wine (references to scientific articles were provided).
    TTB Response. TTB is amending its regulations to add the name 
Oenococcus oeni as a synonym for Leuconostoc oenos. TTB has considered 
these comments and notes that the agency received several requests in 
the past to experiment with a different type of malolactic bacteria 
than that which is authorized for use in Sec.  24.246, namely, 
Lactobacillus plantarum. In the responses to these previous requests, 
TTB stated that although the use of Leuconostic oenos as a stabilizing 
agent in wine is considered GRAS by FDA, the Bureau has been unable to 
ascertain that Lactobacillus plantarum is likewise considered GRAS by 
FDA. Therefore, TTB did not approve commercial use of Lactobacillus 
plantarum. In 2021, FDA did evaluate Lactobacillus plantarum in GRAS 
Notice No. GRN 000953, but only for use in ``conventional foods, such 
as yogurt and other dairy products, soy products, chewing gum, and 
confectionary snacks.'' Alcohol beverages were not among the uses 
evaluated. As a result, TTB is still not approving commercial use of 
Lactobacillus plantarum in wine.
    TTB has not received requests to experiment with malolactic 
bacteria belonging to the genera Leuconostoc, Lactobacillus, or 
Pediococcus. Further, because these types of malolactic bacteria were 
not discussed in the proposed rule, the public has not had the 
opportunity to review a proposal on this matter. Accordingly, TTB is 
not incorporating the commenters' recommendations in this final rule 
but plans to include them in future rulemaking.
iii. Pea Protein
    Comments. The 11 submitters of the form letter, in addition to the 
Wine Institute and Erbsl[ouml]h Geisenheim (in its first comment), all 
commented that they support the addition of pea protein to the list of 
authorized wine and juice treating materials in Sec.  24.246 as a 
source of plant protein. It is TTB's understanding that pea protein is 
intended to be used as a clarifying material. The 11 submitters of the 
form letter stated that: ``Current US regulations provide unfair trade 
advantage for non-US wine producers in both domestic and international 
markets.'' The Wine Institute's comment agreed with this assertion. The 
11 commenters further argued that pea protein should be in the list of 
authorized treating materials because TTB has received ``multiple'' 
submissions from wineries requesting experimentation under Sec.  
24.246.
    TTB Response. Since the publication of Notice No. 164, TTB has 
administratively approved the use of pea protein as a fining agent and 
to remove off flavors from wine and juice. Because TTB did not propose 
pea protein for such uses in Notice No. 164, the public has not had 
sufficient opportunity to comment. TTB is not adding pea protein to the 
list of approved treating materials in Sec.  24.246 at this time but 
will include it in a future rulemaking document.
iv. Potassium Polyaspartate
    Comment. In its comment, the Wine Institute suggested that TTB 
consider the addition of potassium polyaspartate to the list of 
approved materials. It stated that ``potassium polyaspartate has 
recently been approved for use in winemaking in the European Union as a 
tartrate stabilization tool, similar to CMC.''
    TTB Response. TTB understands that the potassium polyaspartate that 
the Wine Institute is recommending for addition to the authorized list 
of wine treating materials is ``potassium polyaspartate A-5D K/SD.'' 
Since the publication of Notice No. 164, the FDA has evaluated 
potassium polyaspartate for use as a wine stabilizer (see GRAS Notice 
No. GRN 000770) and TTB has administratively approved its use to 
stabilize wine by preventing tartrate crystal precipitation. However, 
because Notice No. 164 did not include a proposal to add this material 
to the authorized list of wine treating materials, TTB believes the 
public needs an opportunity to comment. TTB plans to include potassium 
polyaspartate in a separate rulemaking document.
v. Use of Spinning Cone Column for Adding the Original Water Back to 
Wine
    Comment. In its comment, ConeTech argued that the ``Reference or 
limitation'' column for spinning cone column in Sec.  24.248 should be 
amended to allow for addition of the original

[[Page 51896]]

water that was removed via spinning cone column back to the wine, with 
the resulting wine being considered standard wine. ConeTech supplied 
arguments in its comments for the addition of this proposal to the 
final rule.
    TTB Response. TTB administratively approved the process proposed by 
ConeTech subsequent to the publication of Notice No. 164. Because TTB 
has not aired this proposal for public comment, it is not incorporated 
in this final rule, but TTB plans to include it in a separate 
rulemaking document.
vi. Use of Spinning Cone Column on Winery Premises
    Comment. In its comment, Clover Hill Winery recommended that TTB 
authorize the use of spinning cone column for purposes of alcohol 
reduction on winery premises rather than requiring it be used on a 
distilled spirits plant premises.
    TTB Response. Spinning cone column is considered to be a 
distillation process. In general, statutory requirements require that 
distillation processes take place on distilled spirits plant premises. 
Therefore, TTB is not authorizing the use of spinning cone column on 
winery premises.
vii. Thin-Film Evaporation
    Comment. In its comment, Wine Institute suggested that TTB 
authorize the use of thin-film evaporation to separate juice into low 
Brix and high Brix fractions. It claims that such an authorization 
``would conform the allowable use of Thin-film evaporation to the 
allowable use of thermal gradient processing.''
    TTB Response. Because TTB did not air this proposal for public 
comment in Notice No. 164, it is not incorporated in this final rule, 
but TTB plans to include it in a separate rulemaking document.

Regulatory Analysis and Notices

Executive Order 12866

    It has been determined that this rule is not a significant 
regulatory action for purposes of Executive Order 12866. Therefore, a 
regulatory assessment is not required.

Regulatory Flexibility Act

    Pursuant to the requirements of the Regulatory Flexibility Act (5 
U.S.C. chapter 6), TTB certifies that these final regulations will not 
have an economic impact on a substantial number of small entities. This 
final rule provides for the voluntary use of additional wine and juice 
treating materials and processes in the production of wine. This 
authorization does not impose any required change to current winemaking 
practices, nor does it impose additional compliance burden on small 
businesses. TTB authorizes new wine treating materials and processes by 
evaluating proprietors' requests to experiment with such materials and 
processes, such requests being made via application to TTB. This rule 
allows for certain treatments, under limited circumstances, without the 
submission of an application to TTB. TTB estimates that the regulation 
will reduce the number of respondents by approximately 10 applicants 
per year, thus slightly reducing the overall burden of the information 
collection.
    In addition, TTB currently requires wineries to maintain usual and 
customary business records. Included in these records are those records 
that evidence the details and results of experiments approved by TTB 
under Sec.  24.249. This recordkeeping requirement remains unchanged by 
this rule as wineries subject to part 24 still will be required to 
maintain those usual and customary records.
    Pursuant to section 7805(f) of the IRC (26 U.S.C. 7805(f)), the 
notice of proposed rulemaking preceding these regulations was submitted 
to the Chief Counsel for Advocacy of the Small Business Administration 
for comment on their impact on small business, and no comments were 
received.

Paperwork Reduction Act

    Regulations in this document contain current collections of 
information that have been previously reviewed and approved by the 
Office of Management and Budget (OMB) in accordance with the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3507) and assigned control numbers 
1513-0057, titled ``Letterhead Applications and Notices Related to Wine 
(TTB REC 5120/2),'' and 1513-0115, titled, ``Usual and Customary 
Business Records Relating to Wine (TTB REC 5120/1).'' Any agency may 
not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a valid control number 
assigned by OMB.
    In conjunction with Notice No. 164, TTB submitted revisions to OMB 
control numbers 1513-0057 to OMB for review. That revision accounted 
for the anticipated reduction in the number of respondents as a result 
of the proposal to no longer require proprietors to submit an 
application to TTB prior to correcting accidentally diluted wine. The 
proposal was included in Notice No. 164 and is adopted as final in this 
document. The revision and its connection to the proposed regulatory 
amendments are described in detail in Notice No. 164, which also 
solicited comments regarding the information collection revision. TTB 
received no comments in response to the revision, which OMB has now 
approved.

Administrative Procedure Act

    TTB finds good cause under 5 U.S.C. 553(d)(3) to dispense with the 
effective date limitation in 5 U.S.C. 553(d)(3). A 30-day delayed 
effective date is unnecessary because the regulatory changes in this 
final rule that authorize the use of wine treating materials are 
optional, and making the changes effective immediately upon publication 
will give wineries the option of using these newly-approved materials 
and processes as soon as possible.

List of Subjects in 27 CFR Part 24

    Administrative practice and procedure, Claims, Electronic fund 
transfers, Excise taxes, Exports, Food additives, Fruit juices, 
Labeling, Liquors, Packaging and containers, Reporting and 
recordkeeping requirements, Research, Scientific equipment, Spices and 
flavoring, Surety bonds, Vinegar, Warehouses, Wine.

Amendments to the Regulations

    For the reasons discussed above in the preamble, TTB amends 27 CFR 
part 24 as follows:

PART 24--WINE

0
1. The authority citation for 27 CFR part 24 continues to read as 
follows:

    Authority:  5 U.S.C. 552(a); 26 U.S.C. 5001, 5008, 5041, 5042, 
5044, 5061, 5062, 5121, 5122-5124, 5173, 5206, 5214, 5215, 5351, 
5353, 5354, 5356, 5357, 5361, 5362, 5364-5373, 5381-5388, 5391, 
5392, 5511, 5551, 5552, 5661, 5662, 5684, 6065, 6091, 6109, 6301, 
6302, 6311, 6651, 6676, 7302, 7342, 7502, 7503, 7606, 7805, 7851; 31 
U.S.C. 9301, 9303, 9304, 9306.

0
2. Section 24.10 is amended by:
0
a. Removing the number ``60'' in the definition of ``Brix'' and adding, 
in its place, the number ``68''; and
0
b. Revising the definition of ``Wine spirits''.
    The revision reads as follows:


Sec.  24.10   Meaning of terms.

* * * * *
    Wine spirits. Brandy or wine spirits authorized under 26 U.S.C. 
5373 and Sec.  24.225 for use in wine production.


Sec.  24.85   [Amended]

0
3. Section 24.85 is amended by:
0
a. In the first sentence adding the word ``wood,'' after the word 
``berries,''; and
0
b. Removing the parenthetical authority citation at the end of the 
section.

[[Page 51897]]


0
4. Section 24.185 is added to read as follows:


Sec.  24.185   Use of wood to treat natural wine.

    (a) Treatment by contact. Natural wine may be treated with any wood 
that is consistent with the food additive requirements under the 
Federal Food, Drug, and Cosmetic Act. The wood may be in the form of 
barrels, staves, chips, particles, or storage tanks that were used for 
the addition of wine spirits if the tanks are used for the baking of 
wine. The wood may be toasted (that is, heated to low, medium, or high, 
temperature without undergoing combustion), or charred and the wood 
must not be otherwise treated. If wine is treated with charred wood, 
the wood may not remove color from the wine.
    (b) Use of wood essences and extracts. A proprietor may make or 
purchase for blending purposes wine that has been heavily treated with 
wood; however, wood preparations made with an alcohol solution stronger 
than 24 percent alcohol by volume are essences and must be used in 
accordance with Sec.  24.85. Wood essences and extracts must be 
consistent with the requirements of the Federal Food, Drug, and 
Cosmetics Act for that purpose and may be used only in ``other wine'' 
in accordance with Sec.  24.218. This paragraph (b) applies to liquid 
extracts and essences and to the extracts and essences in powder form 
or dissolved in water after the solvent has been evaporated.
    (c) Use of wooden storage tanks. Wooden storage tanks used for the 
addition of spirits may be used for the baking of wine.

0
5. Section 24.186 is added to read as follows:


Sec.  24.186   Accidental additions of water.

    (a) Accidental additions of water totaling 1 percent or less of the 
volume of standard wine. When in the production, storage, treatment, or 
finishing of standard wine, water is accidentally added to a standard 
wine in an amount that does not exceed 1 percent of the total volume of 
the wine, such wine shall remain standard wine and the proprietor need 
not take any action to correct the wine.
    (b) Correction of accidental additions of water. When in the 
production, storage, treatment, or finishing of standard wine water is 
accidentally added to a standard wine in an amount that exceeds 1 
percent of the volume of the wine, such wine may be corrected by 
removal of the accidentally added water from the wine in accordance 
with Sec.  24.252.

0
6. Section 24.225 is revised to read as follows:


Sec.  24.225   Production and use of spirits.

    (a) Withdrawal of spirits. The proprietor of a bonded wine premises 
may withdraw and receive wine spirits without payment of tax from the 
bonded premises of a distilled spirits plant for use as provided in 
this section.
    (b) Production and use of wine spirits--(1) In general. The only 
products considered to be wine spirits authorized for use in wine 
production under this section are brandy or wine spirits produced in a 
distilled spirits plant (with or without the use of water to facilitate 
the extraction and distillation) exclusively from:
    (i) Fresh or dried fruit or their residues;
    (ii) Natural wine or wine residues from fresh or dried fruit, 
including spirits byproducts of authorized wine treatments to reduce 
alcohol; or
    (iii) Special natural wine. If wine spirits produced from special 
natural wine contain any flavor characteristics of the special natural 
wine, those wine spirits may be used only in the production of a 
special natural wine.
    (2) Distillation proof requirements. The proof of wine spirits at 
distillation must not be reduced by the addition of water. In addition, 
a product is not considered to be wine spirits if it is distilled at 
less than 140 degrees of proof except in the following cases:
    (i) Commercial brandy aged in wood for a period of not less than 2 
years, and barreled at not less than 100 degrees of proof, shall be 
deemed wine spirits for purposes of this section; and
    (ii) Spirits byproducts of alcohol reduction processing authorized 
under Sec.  24.248 that are produced at a distilled spirits plant and 
distilled, if necessary, at not less than 90 degrees of proof shall be 
deemed wine spirits for purposes of this section.
    (3) Addition of sugar after fermentation. When, in the production 
of natural wine or special natural wine, sugar has been added after 
fermentation, the wine may not be refermented to develop alcohol from 
such added sugar and then used in the production of wine spirits.
    (4) Addition of wine spirits to natural wine. (i) Wine spirits 
produced in the United States may be added to natural wine on bonded 
wine premises if both the wine and the spirits are produced from the 
same kind of fruit.
    (ii) In the case of natural still wine, wine spirits may be added 
in any State only to wine produced by fermentation on bonded wine 
premises located within the same State.
    (iii) If wine has been ameliorated, wine spirits may be added 
(whether or not wine spirits were previously added) only if the wine 
contains not more than 14 percent of alcohol by volume derived from 
fermentation.
    (c) Spirits other than wine spirits. Spirits other than wine 
spirits may be received, stored, and used on bonded premises only for 
the production of nonbeverage wine products.

0
7. Section 24.246 is revised to read as follows:


Sec.  24.246   Materials authorized for the treatment of wine and 
juice.

    (a) Wine and juice. Materials used in the process of filtering, 
clarifying, or purifying wine may remove cloudiness, precipitation, and 
undesirable odors and flavors, but the addition of any substance 
foreign to wine that changes the character of the wine, or the 
abstraction of ingredients so as to change the character of the wine, 
if not consistent with good commercial practice, is not permitted on 
bonded wine premises. The materials listed in this section are approved 
as being consistent with good commercial practice in the production, 
cellar treatment, or finishing of wine and, where applicable, in the 
treatment of juice, within the ``Specific TTB limitation'' of this 
section and subject to the following conditions:
    (1) If the U.S. Food and Drug Administration (FDA) informs TTB that 
a specified use or limitation of any material listed in this section is 
inconsistent with the food additive requirements under the Federal 
Food, Drug, and Cosmetic Act, the appropriate TTB officer may cancel or 
amend the approval for use of the material in the treatment of wine and 
juice in the production, cellar treatment, or finishing of wine; and
    (2) Where water is added to facilitate the solution or dispersal of 
a material, the volume of water added, whether the material is used 
singly or in combination with other water-based treating materials, may 
not total more than 1 percent of the volume of the treated wine or 
juice, or of both the wine and the juice, from which the wine is 
produced.
    (b) Use in combination or in multiple lots. Subject to the 
conditions specified in paragraph (a) of this section, a proprietor may 
use the materials listed in this section in combination, provided that 
each material is used for its specified use and in accordance with any 
limitation specified for that use. If a proprietor uses several lots 
that contain the same material, it is the proprietor's responsibility 
to ensure that

[[Page 51898]]

the cumulative amount of the material does not exceed the limitation 
specified in this section for that material.
    (c) Formula wine. In addition to the materials listed in this 
section, other materials may be used in formula wine if approved for 
such use.

Table 1 to Paragraph (c)--Materials Authorized for Treatment of Wine and
                                  Juice
------------------------------------------------------------------------
                                     Specific TTB
        Materials and use           limitation (if       FDA reference
                                      applicable)
------------------------------------------------------------------------
Acacia (gum arabic): To clarify   The amount used     21 CFR 184.1330.
 and stabilize \1\ wine.           must not exceed
                                   16 pounds per
                                   1,000 gallons
                                   (1.9 g/L) of wine.
Acetaldehyde: For color           The amount used     FDA advisory
 stabilization of juice prior to   must not exceed     opinion dated
 concentration.                    300 ppm (300 mg/    September 8,
                                   L), and the         2016.
                                   finished
                                   concentrate must
                                   have no
                                   detectable level
                                   of the
                                   material.\2\.
Activated carbon:
    To assist precipitation       27 CFR 24.176.....  FDA advisory
     during fermentation.                              opinion dated
                                                       September 8,
                                                       2016, which
                                                       states that the
                                                       activated carbon
                                                       must meet the
                                                       specifications in
                                                       the Food
                                                       Chemicals Codex
                                                       and be removed
                                                       from the wine.
    To clarify and purify wine..  The amount used to  FDA advisory
                                   clarify and         opinion dated
                                   purify wine must    January 26, 1979,
                                   be included in      which states that
                                   the total amount    the activated
                                   of activated        carbon must meet
                                   carbon used to      the
                                   remove excessive    specifications in
                                   color from wine     the Food
                                   and/or juice. 27    Chemicals Codex
                                   CFR 24.241 and      and be removed
                                   24.242.             from the wine.
    To remove color from wine     The amount used to  FDA advisory
     and/or juice from which       treat the wine,     opinion dated
     wine is produced.             including the       January 26, 1979,
                                   juice from which    which states that
                                   the wine was        the activated
                                   produced, must      carbon must meet
                                   not exceed 25       the
                                   pounds per 1000     specifications in
                                   gallons (3 g/L).    the Food
                                   If the amount       Chemicals Codex
                                   necessary exceeds   and be removed
                                   this limit, a       from the wine.
                                   notice is
                                   required pursuant
                                   to 27 CFR 24.242.
Albumen (egg white): Fining       May be prepared in  FDA advisory
 agent for wine.                   a light brine 1     opinion dated
                                   ounce (28.35        September 8,
                                   grams) potassium    2016.
                                   chloride, 2
                                   pounds (907.2
                                   grams) egg white,
                                   1 gallon (3.785
                                   L) of water.
                                   Usage of brine
                                   not to exceed 1.5
                                   gallons per 1,000
                                   gallons (1.5
                                   milliliters per
                                   liter) of wine.
Alumino-silicates (hydrated)      None..............  21 CFR 184.1155
 e.g., Bentonite (Wyoming clay)                       FDA advisory
 and Kaolin: To clarify and                            opinion dated
 stabilize \1\ wine or juice.                          July 26, 1985.
Ascorbic acid iso-ascorbic acid   May be added to     21 CFR 182.3013
 (erythorbic acid): To prevent     grapes, other       and 182.3041.
 oxidation of color and flavor     fruit (including
 components of juice or wine.      berries), and
                                   other primary
                                   wine making
                                   materials, or to
                                   the juice of such
                                   materials, or to
                                   the wine, within
                                   limitations which
                                   do not alter the
                                   class or type of
                                   the wine.
Bakers yeast mannoprotein: To     The amount used     GRAS (generally
 stabilize \1\ wine from the       must not exceed     recognized as
 precipitation of potassium        3.3 pounds per      safe) Notice No.
 bitartrate crystals.              1000 gallons (400   GRN 000284.
                                   mg/L) of wine.
Calcium carbonate (CaCO3) (with
 or without calcium salts of
 tartaric and malic acids):
    To reduce the excess natural  The natural or      21 CFR 184.1069,
     acids in high acid wine, or   fixed acids must    184.1099, and
     in juice prior to or during   not be reduced      184.1191.
     fermentation.                 below 40 pounds
                                   per 1000 gallons
                                   (4.79 g/L).
    As a fining agent for cold    The amount used
     stabilization.                must not exceed
                                   30 pounds per
                                   1000 gallons
                                   (3.59 g/L) of
                                   wine..
Calcium sulfate (gypsum): To      The sulfate         21 CFR 184.1230.
 lower pH in sherry wine.          content of the
                                   finished wine
                                   must not exceed
                                   1.67 pounds per
                                   1000 gallons (0.2
                                   g/L), expressed
                                   as potassium
                                   sulfate. 27 CFR
                                   24.214.
Carbon dioxide (including food    See 27 CFR 24.245.  21 CFR 184.1240.
 grade dry ice): To stabilize
 \1\ and preserve wine.
Casein, potassium salt of         See 27 CFR 24.243.  FDA advisory
 casein: To clarify wine.                              opinion dated
                                                       September 8,
                                                       2016.
Chitosan from Aspergillus niger:  The amount used     GRAS Notice No.
 To remove spoilage organisms      must not exceed     GRN 000397.
 such as Brettanomyces from wine.  0.04 pounds per 1
                                   gallon (500 g/100
                                   L) of wine.
Citric acid:
    To correct natural acid       See 27 CFR 24.182   21 CFR 184.1033.
     deficiencies in certain       and 24.192.
     juice or wine.
    To stabilize \1\ wine other   The amount of       21 CFR 184.1033.
     than citrus wine.             citric acid must
                                   not exceed 5.8
                                   pounds per 1000
                                   gallons (0.7 g/
                                   L). 27 CFR 24.244.

[[Page 51899]]

 
Copper sulfate: To remove         The quantity of     21 CFR 184.1261.
 hydrogen sulfide and/or           copper sulfate
 mercaptans from wine.             (calculated as
                                   copper) added to
                                   wine must not
                                   exceed 6 ppm (6mg/
                                   L).\2\ The
                                   residual level of
                                   copper in the
                                   finished wine
                                   must not exceed
                                   0.5 ppm (0.5 mg/
                                   L).\2\.
Defoaming agents                  Defoaming agents    21 CFR 173.340 and
 (polyoxyethylene 40               which are 100       184.1505.
 monostearate, silicon dioxide,    percent active
 dimethylpoly-siloxane, sorbitan   may be used in
 monostearate, glyceryl mono-      amounts not
 oleate and glyceryl dioleate):    exceeding 0.15
 To control foaming,               pounds per 1000
 fermentation adjunct.             gallons (18 mg/L)
                                   of wine.
                                   Defoaming agents
                                   which are 30
                                   percent active
                                   may be used in
                                   amounts not
                                   exceeding 0.5
                                   pounds per 1000
                                   gallons (60 mg/L)
                                   of wine. Silicon
                                   dioxide must be
                                   completely
                                   removed by
                                   filtration. The
                                   amount of silicon
                                   remaining in the
                                   wine must not
                                   exceed 10 ppm (10
                                   mg/L).\2\.
Dimethyl dicarbonate (DMDC): To   DMDC may be added   21 CFR 172.133.
 sterilize and stabilize \1\       to wine in a
 wine.                             cumulative amount
                                   not to exceed 200
                                   ppm (200 mg/
                                   L).\2\.
Enzymatic activity: Various       The enzyme
 enzymes and uses, as shown in     preparation used
 the following entries:.           must be prepared
                                   from nontoxic and
                                   nonpathogenic
                                   microorganisms..
    Carbohydrase (alpha-          The amylase enzyme
     Amylase): To convert          activity must be
     starches to fermentable       derived from:.
     carbohydrates.
                                  Aspergillus niger,  FDA advisory
                                   Aspergillus         opinion of August
                                   oryzae, Bacillus    18, 1983.
                                   subtilis, or       21 CFR 173.130.
                                   barley malt; or.   21 CFR 184.1027.
                                  from Rhizopus
                                   oryzae; or.
                                  from Bacillus
                                   licheniformis..
    Carbohydrase (beta-Amylase):  The amylase enzyme  FDA advisory
     To convert starches to        must be derived     opinion dated
     fermentable carbohydrates.    from barley malt.   August 18, 1983.
    Carbohydrase (Glucoamylase,   The amylase enzyme  FDA advisory
     Amylogluco-sidase): To        activity must be    opinion dated
     convert starches to           derived from        August 18, 1983.
     fermentable carbohydrates.    Aspergillus        21 CFR 173.130.
                                   niger,             21 CFR 173.110.
                                   Aspergillus
                                   oryzae, or.
                                  from Rhizopus
                                   oryzae,.
                                  or from Rhizopus
                                   niveus..
    Carbohydrase (pectinase,      The enzyme          FDA advisory
     cellulase, hemicellulase):    activity must be    opinion dated
     To facilitate separation of   derived from        December 19,
     juice from the fruit.         Aspergillus         1996.
                                   aculeatus..
    Catalase: To clarify and      The enzyme          FDA advisory
     stabilize \1\ wine.           activity must be    opinion dated
                                   derived from        August 18, 1983.
                                   Aspergillus niger  21 CFR 184.1034.
                                   or bovine liver.
    Cellulase: To clarify and     The enzyme          FDA advisory
     stabilize \1\ wine and        activity must be    opinion dated
     facilitate separation of      derived from        August 18, 1983.
     the juice from the fruit.     Aspergillus niger.
    Cellulase (beta-glucanase):   The enzyme          For beta-glucanase
     To clarify and filter wine    activity must be    derived from
     and juice.                    derived from        Trichoderma
                                   Trichoderma         longibrachiatum,
                                   longibrachiatum     21 CFR 184.1250.
                                   or Trichoderma
                                   harzianum..
                                                      For beta-glucanase
                                                       derived from
                                                       Trichoderma
                                                       harzianum, GRAS
                                                       Notice No. GRN
                                                       000149.
    Glucose oxidase: To clarify   The enzyme          FDA advisory
     and stabilize \1\ wine.       activity must be    opinion of August
                                   derived from        18, 1983.
                                   Aspergillus niger.
    Lysozyme: To stabilize \1\    The amount used     FDA advisory
     wines from malolactic acid    must not exceed     opinion dated
     bacterial degradation.        500 ppm (500 mg/    December 15,
                                   L).\2\.             1993.
    Pectinase: To clarify and     The enzyme          FDA advisory
     stabilize \1\ wine and to     activity used       opinion dated
     facilitate separation of      must be derived     August 18, 1983.
     juice from the fruit.         from Aspergillus
                                   niger.
    Protease (general): To        The enzyme          FDA advisory
     reduce or to remove heat      activity must be    opinion dated
     labile proteins.              derived from:.      August 18, 1983.
                                  Aspergillus niger   21 CFR 184.1027.
                                   or Bacillus
                                   subtilis; or.
                                  from Bacillus
                                   licheniformis.
    Protease (Bromelin): To       The enzyme          FDA advisory
     reduce or remove heat         activity must be    opinion dated
     labile proteins..             derived from        August 18, 1983.
                                   pineapple (Ananas
                                   comosus (L.) or
                                   Ananas bracteatus
                                   (L.)).
    Protease (Ficin): To reduce   The enzyme          21 CFR 184.1316.
     or remove heat labile         activity must be
     proteins.                     derived from fig
                                   (Ficus spp.).
    Protease (Papain): To reduce  The enzyme          21 CFR 184.1585.
     or remove heat labile         activity must be
     proteins.                     derived from
                                   papaya (Carica
                                   papaya (L.)).
    Protease (Pepsin): To reduce  The enzyme          21 CFR 184.1595,
     or remove heat labile         activity must be    FDA advisory
     proteins.                     derived from        opinion dated
                                   porcine or bovine   August 18, 1983.
                                   stomachs.
    Protease (Trypsin): To        The enzyme          FDA advisory
     reduce or remove heat         activity must be    opinion dated
     labile proteins.              derived from        August 18, 1983.
                                   porcine or bovine
                                   pancreas.

[[Page 51900]]

 
    Urease: To reduce levels of   The enzyme          21 CFR 184.1924.
     naturally occurring urea in   activity must be
     wine to help prevent the      derived from
     formation of ethyl            Lactobacillus
     carbamate.                    fermentum. Use is
                                   limited to not
                                   more than 200 ppm
                                   (200 mg/L) and
                                   must be filtered
                                   prior to final
                                   packaging.\2\.
Ethyl maltol: To stabilize \1\    Use authorized at   FDA advisory
 wine.                             a maximum level     opinion dated
                                   of 100 ppm (100     December 1, 1986.
                                   mg/L) in all
                                   standard wines
                                   except natural
                                   wine produced
                                   from Vitis
                                   vinifera
                                   grapes.\2\.
Fermentation aids: To facilitate
 fermentation of juice and wine..
    Ammonium phosphate/           The amount used     FDA advisory
     diammonium phosphate (mono-   must not exceed 8   opinion dated
     and di basic).                pounds per 1000     August 29, 2016.
                                   gallons (0.96 g/
                                   L).
    Biotin (vitamin B7).........  The amount used     FDA advisory
                                   must not exceed     opinion dated
                                   25 ppb (25 ng/      August 29, 2016.
                                   mL).\3\.
    Calcium pantothenate          The amount used     FDA advisory
     (vitamin B5).                 must not exceed     opinion dated
                                   1.5 ppm (1.5 mg/    August 29, 2016.
                                   L).\2\.
    Folic acid (folate).........  The amount used     FDA advisory
                                   must not exceed     opinion dated
                                   100 ppb (100 ng/    August 29, 2016.
                                   mL).\3\.
    Inositol (myo-inositol).....  The amount used     FDA advisory
                                   must not exceed 2   opinion dated
                                   ppm (2 mg/L).\2\.   August 29, 2016.
    Magnesium sulfate...........  The amount used     FDA advisory
                                   must not exceed     opinion dated
                                   15 ppm (15 mg/      August 29, 2016.
                                   L).\2\.
    Niacin (vitamin B3).........  The amount used     FDA advisory
                                   must not exceed 1   opinion dated
                                   ppm (1 mg/L).\2\.   August 29, 2016.
    Pyridoxine hydrochloride      The amount used     FDA advisory
     (vitamin B6).                 must not exceed     opinion dated
                                   150 ppb (150 ng/    August 29, 2016.
                                   mL).\3\.
    Soy flour (defatted)........  The amount used     FDA advisory
                                   must not exceed 2   opinion dated
                                   pounds per 1000     August 29, 2016.
                                   gallons (0.24 g/
                                   L) of wine.
    Thiamine hydrochloride......  The amount used     FDA advisory
                                   must not exceed     opinion dated
                                   0.005 pounds per    August 29, 2016.
                                   1000 gallons (0.6
                                   mg/L) of wine or
                                   juice.
    Yeast, autolyzed............  None..............  FDA advisory
                                                       opinion dated
                                                       August 29, 2016.
    Yeast, cell wall/membranes    The amount used     FDA advisory
     of autolyzed yeast.           must not exceed 3   opinion dated
                                   pounds per 1000     August 29, 2016.
                                   gallons (0.36 g/
                                   L) of wine or
                                   juice.
Ferrous sulfate: To clarify and   The amount used     21 CFR 184.1315.
 stabilize \1\ wine.               must not exceed 3
                                   ounces per 1000
                                   gallons (0.022 g/
                                   L) of wine.
Fractionated potato protein       Use must not        GRAS Notice No.
 isolates: Fining agent for wine.  exceed 500 ppm      GRN 000447.
                                   \2\ (50 g/hL) of
                                   wine.
Fumaric acid:
    To correct natural acid       The fumaric acid    21 CFR 172.350.
     deficiencies in grape wine.   content of the
                                   finished wine
                                   must not exceed
                                   25 pounds per
                                   1000 gallons (3 g/
                                   L). 27 CFR 24.182
                                   and 24.192.
    To stabilize \1\ wine.......  The fumaric acid    21 CFR 172.350.
                                   content of the
                                   finished wine
                                   must not exceed
                                   25 pounds per
                                   1000 gallons (3 g/
                                   L). 27 CFR 24.244.
Gelatin (food grade): To clarify  None..............  FDA advisory
 juice or wine.                                        opinion dated
                                                       September 8,
                                                       2016.
Granular cork: To smooth wine...  The amount used     FDA advisory
                                   must not exceed     opinion dated
                                   10 pounds per       February 25,
                                   1000 gallons of     1985.
                                   wine (1.2 g/L).
Isinglass: To clarify wine......  None..............  FDA advisory
                                                       opinion dated
                                                       February 25,
                                                       1985.
Lactic acid: To correct natural   27 CFR 24.182 and   21 CFR 184.1061.
 acid deficiencies in grape wine.  24.192.
Malic acid: To correct natural    27 CFR 24.182 and   21 CFR 184.1069.
 acid deficiencies in juice or     24.192.
 wine.
Malolactic bacteria: To           Malolactic          FDA advisory
 stabilize \1\ grape wine.         bacteria of the     opinion dated
                                   type Leuconostoc    February 25,
                                   oenos (Oenococcus   1985.
                                   oeni) may be used
                                   in treating wine.
Maltol: To stabilize \1\ wine...  Use authorized at   FDA advisory
                                   a maximum level     opinion dated
                                   of 2 pounds per     December 1, 1986.
                                   1000 gallons (240
                                   mg/L) in all
                                   standard wine
                                   except natural
                                   wine produced
                                   from Vitis
                                   vinifera grapes.
Milk products (pasteurized
 whole, skim, or half-and-half):
    Fining agent for grape wine.  The amount used
                                   must not exceed 2
                                   parts of milk
                                   products per
                                   1,000 parts (0.2
                                   percent V/V) of
                                   wine.
    To remove off flavors in      The amount used
     wine.                         must not exceed
                                   10 parts of milk
                                   products per
                                   1,000 parts (1
                                   percent V/V) of
                                   wine.

[[Page 51901]]

 
Nitrogen gas: To maintain         None..............  21 CFR 184.1540.
 pressure during filtering and
 bottling or canning of wine and
 to prevent oxidation of wine.
Oxygen and compressed air:        None..............
 Various uses in juice and wine.
Polyvinylpolypyrrolidone (PVPP):  The amount used to  21 CFR 173.50.
 To clarify and stabilize \1\      treat the wine,
 wine and to remove color from     including the
 red wine or juice.                juice from which
                                   the wine was
                                   produced, must
                                   not exceed 60
                                   pounds per 1000
                                   gallons (7.19 g/
                                   L) and must be
                                   removed during
                                   filtration. PVPP
                                   may be used in a
                                   continuous or
                                   batch process.
Polyvinylpyrrolidone (PVP)/       The amount used to  FDA FCN No.
 polyvinylimidazole (PVI)          treat the wine      000320.\4\
 polymer (terpolymer of 1-         must not exceed
 vinylimidazole, 1-                6.7 pounds per
 vinylpyrrolidone, and 1,2-        1000 gallons (80
 divinylimidazolidinone; CAS       g/hL) of wine.
 87865-40-5 (Chemical Abstracts
 Service Registration Number)):
 To remove heavy metal ions and
 sulfides from wine.
Potassium bitartrate: To          The amount used     FDA advisory
 stabilize \1\ grape wine.         must not exceed     opinion dated
                                   35 pounds per       September 8,
                                   1000 gallons        2016.
                                   (4.19 g/L) of
                                   grape wine.
Potassium carbonate and/or        The natural or      21 CFR 184.1619
 potassium bicarbonate: To         fixed acids must    and 184.1613.
 reduce excess natural acidity     not be reduced
 in wine and in juice prior to     below 0.668
 or during fermentation.           ounces per gallon
                                   (5 g/L).
Potassium citrate: pH control     The amount of       21 CFR 184.1625.
 agent and sequestrant in the      potassium citrate
 treatment of citrus wines.        must not exceed
                                   25 pounds per
                                   1000 gallons (3 g/
                                   L) of finished
                                   wine. 27 CFR
                                   24.182.
Potassium meta-bisulfite: To      The sulfur dioxide  21 CFR 182.3637.
 sterilize and preserve wine.      content of the
                                   finished wine
                                   must not exceed
                                   the limitations
                                   prescribed in 27
                                   CFR 4.22.
Silica gel (colloidal silicon     Use must not        FDA advisory
 dioxide): To clarify wine or      exceed the          opinion dated
 juice.                            equivalent of 20    September 8,
                                   pounds colloidal    2016.
                                   silicon dioxide
                                   at a 30 percent
                                   concentration per
                                   1000 gallons (2.4
                                   g/L) of wine.
                                   Silicon dioxide
                                   must be
                                   completely
                                   removed by
                                   filtration.
Sodium carboxymethyl cellulose:                       21 CFR 182.1745.
 To stabilize \1\ wine by
 preventing tartrate
 precipitation.
Sorbic acid and potassium salt    The finished wine   21 CFR 182.3089
 of sorbic acid (potassium         must not contain    and 182.3640.
 sorbate): To sterilize and        more than 300 ppm
 preserve wine; to inhibit mold    (300 mg/L) of
 growth and secondary              sorbic acid.\2\.
 fermentation.
Sulfur dioxide: To sterilize and  The sulfur dioxide  21 CFR 182.3862.
 to preserve wine or juice.        content of the
                                   finished wine
                                   must not exceed
                                   the limitations
                                   prescribed in 27
                                   CFR 4.22(b)(1).
Tannin:
    To adjust tannin content in   The residual        FDA advisory
     apple juice or in apple       amount of tannin    opinion dated
     wine.                         must not exceed     September 8,
                                   24 pounds per       2016.
                                   1000 gallons (3 g/
                                   L), calculated as
                                   gallic acid
                                   equivalents
                                   (GAE). Total
                                   tannin must not
                                   be increased by
                                   more than 150 ppm
                                   (150 mg/L; 0.150
                                   g/L) by the
                                   addition of
                                   tannic acid
                                   (polygalloylgluco
                                   se).\2\.
    To clarify, or adjust tannin  The residual        FDA advisory
     content of, juice or wine     amount of tannin,   opinion dated
     (other than apple).           calculated in       September 8,
                                   GAE, must not       2016.
                                   exceed 6.4 GAE
                                   per 1000 gallons
                                   of wine (800 mg/
                                   L) in white wine
                                   and 24 pounds per
                                   1000 gallons (3 g/
                                   L) in red wine.
                                   Only tannin which
                                   does not impart
                                   color may be used
                                   in the cellar
                                   treatment of
                                   juice or wine.
                                   Total tannin must
                                   not be increased
                                   by more than 150
                                   ppm (150 mg/L;
                                   0.150 g/L) by the
                                   addition of
                                   tannic acid (poly-
                                   galloylglucose).\
                                   2\.
Tartaric acid (L-(+)-tartaric
 acid):
    To correct natural acid       Use as prescribed   21 CFR 184.1099
     deficiencies in grape juice   in 27 CFR 24.182    and GRAS Notice
     or wine and to reduce the     and 24.192.         No. GRN 000187.
     pH of grape juice or wine
     where ameliorating material
     is used in the production
     of grape wine.
------------------------------------------------------------------------
\1\ To stabilize--To prevent or to retard unwanted alteration of
  chemical and/or physical properties.
\2\ Parts per million--1 ppm = 0.128 ounces per 1000 gallons = 1 mg/L =
  1000 ppb.
\3\ Parts per billion--1ppb = 0.000128 ounces per 1000 gallons = 1 mg/
  1000L.

[[Page 51902]]

 
\4\ An effective food contact notification (FCN) applies only to the
  food contact substance that is the subject of the FCN and is
  applicable only to the manufacturer/supplier listed within the
  notification.


0
8. Section 24.247 is amended by:
0
a. Revising the introductory text;
0
b. Removing the entry in the table for ``Ammonium phosphate (mono- and 
di basic'' and adding the entry for ``Ammonium phosphate/diammonium 
phosphate (mono-and di basic)'' in its place; and
0
c. Removing the footnote at the end of the table and the parenthetical 
authority citation at the end of the section.
    The revisions read as follows:


Sec.  24.247  Materials authorized for the treatment of distilling 
material.

    The materials listed in this section as well as the materials 
listed in Sec.  24.246 are approved as being acceptable in good 
commercial practice for use by proprietors in the treatment of 
distilling material within the limitations specified in this section. 
If, however, the U.S. Food and Drug Administration (FDA) informs TTB 
that a specified use or limitation of any material listed in this 
section is inconsistent with the food additive requirements under the 
Federal Food, Drug, and Cosmetic Act, the appropriate TTB officer may 
cancel or amend the approval for use of the material in the treatment 
of distilling material.

------------------------------------------------------------------------
                                                         Reference or
            Materials                     Use             limitation
------------------------------------------------------------------------
Ammonium phosphate/diammonium     Yeast nutrient in   The amount used
 phosphate (mono-and di basic).    distilling          shall not exceed
                                   material.           10 pounds per
                                                       1000 gallons (1.2
                                                       g/L). 21 CFR
                                                       184.1141a and
                                                       184.1141b.
 
                              * * * * * * *
------------------------------------------------------------------------


0
9. Section 24.248 is amended by:
0
a. Revising the introductory text;
0
b. Adding in alphabetical order an entry for ``Cross flow filtration'', 
including subentries for ``Nanofiltration'', ``Reverse osmosis'', and 
``Ultrafiltration'';
0
c. Removing the entry for ``Nanofiltration'' following the entry 
``Metal reducing matrix sheet processing'';
0
d. Revising the entry for ``Osmotic transport'';
0
e. Removing the entry for ``Reverse osmosis'' following the entry 
``Osmotic transport'';
0
f. Revising the entry for ``Spinning cone column'';
0
g. Removing the entry for ``Thin-film evaporation under reduced 
pressure'' and adding the entry ``Thin film evaporation under reduced 
pressure'' in its place;
0
h. Removing the entry for ``Ultrafiltration'' following the entry 
``Thin film evaporation under reduced pressure'';
0
i. Revising footnote 1 and adding footnote 2; and
0
j. Removing the parenthetical authority citation at the end of the 
section.
    The additions and revisions read as follows:


Sec.  24.248  Processes authorized for the treatment of wine, juice, 
and distilling material.

    The processes listed in this section are approved as being 
consistent with good commercial practice for use by proprietors in the 
production, cellar treatment, or finishing of wine, juice, and 
distilling material, within the general limitations of this section. 
If, however, the U.S. Food and Drug Administration (FDA) informs TTB 
that a specified use or limitation of any material listed in this 
section is inconsistent with the food additive requirements under the 
Federal Food, Drug, and Cosmetic Act, the appropriate TTB officer may 
cancel or amend the approval for use of the process in the production, 
cellar treatment, or finishing of wine, juice, and distilling material.

  Processes Authorized for the Treatment of Wine, Juice, and Distilling
                                Material
------------------------------------------------------------------------
                                                         Reference or
             Process                      Use             limitation
------------------------------------------------------------------------
Cross flow filtration...........  Various processes   ..................
                                   and uses.\1\.
    Nanofiltration \2\..........  To reduce the       Permeable
                                   level of volatile   membranes that
                                   acidity in wine     are selective for
                                   (used with ion      molecules not
                                   exchange), to       greater than 500
                                   reduce the ethyl    molecular weight
                                   alcohol content     with
                                   of wine..           transmembrane
                                                       pressures of 200
                                                       pounds per square
                                                       inch (psi) and
                                                       greater. The
                                                       addition of water
                                                       other than that
                                                       originally
                                                       present prior to
                                                       processing will
                                                       render standard
                                                       wine ``other than
                                                       standard.'' Use
                                                       must not alter
                                                       the vinous
                                                       character of the
                                                       wine. May be used
                                                       in combination
                                                       with osmotic
                                                       transport.
    Reverse osmosis \2\.........  To reduce the       This process must
                                   ethyl alcohol       use permeable
                                   content of wine     membranes which
                                   and to remove off   are selective for
                                   flavors in wine..   molecules not
                                                       greater than 150
                                                       molecular weight
                                                       with
                                                       transmembrane
                                                       pressures of 250
                                                       psi or less.
    Ultrafiltration \2\.........  To remove           Permeable
                                   proteinaceous       membranes that
                                   material from       are selective for
                                   wine; to reduce     molecules greater
                                   harsh tannic        than 500 and less
                                   material from       than 25,000
                                   white wine          molecular weight
                                   produced from       with
                                   white skinned       transmembrane
                                   grapes; to remove   pressures less
                                   pink color from     than 200 psi.
                                   blanc de noir       Shall not alter
                                   wine; to separate   vinous character.
                                   red and white
                                   juice and wine
                                   into low color
                                   and high color
                                   fractions for
                                   blending
                                   purposes, to
                                   reduce the ethyl
                                   alcohol content
                                   of wine..
 

[[Page 51903]]

 
                              * * * * * * *
Osmotic transport \2\...........  For alcohol         (1) Use must not
                                   reduction..         alter the vinous
                                                       character of the
                                                       wine.
                                                      (2) None of the
                                                       stripping
                                                       solution may
                                                       migrate into the
                                                       wine.
                                                      (3) May be used in
                                                       combination with
                                                       reverse osmosis.
 
                              * * * * * * *
Spinning cone column \2\........  To reduce the       Use shall not
                                   ethyl alcohol       alter vinous
                                   content of wine     character. For
                                   and to remove off   standard wine,
                                   flavors in wine..   the same amount
                                                       of essence must
                                                       be added back to
                                                       any lot of wine
                                                       as was originally
                                                       removed.
 
                              * * * * * * *
Thin film evaporation under       To separate wine    Use shall not
 reduced pressure \2\.             into a low          alter vinous
                                   alcohol wine        character. Water
                                   fraction and into   separated with
                                   a higher alcohol    alcohol during
                                   distillate..        processing may be
                                                       recovered by
                                                       refluxing in a
                                                       closed continuous
                                                       system and
                                                       returned to the
                                                       wine. The
                                                       addition of water
                                                       other than that
                                                       originally
                                                       present in the
                                                       wine prior to
                                                       processing, will
                                                       render standard
                                                       wine ``other than
                                                       standard'' wine.
------------------------------------------------------------------------
\1\ In cross-flow filtration, the wine is passed across the filter
  membrane (tangentially) at positive pressure relative to the permeate
  side. A proportion of the wine which is smaller than the membrane pore
  size passes through the membrane as permeate or filtrate; everything
  else is retained on the feed side of the membrane as retentate.
\2\ When used to remove ethyl alcohol (dealcoholization), this process
  must be done on distilled spirits plant premises. However, reverse
  osmosis and nanofiltration, under certain limited conditions, may be
  used on bonded winery premises if ethyl alcohol is only temporarily
  created within a closed system.


0
10. Amend Sec.  24.250 by:
0
a. Revising paragraph (b); and
0
b. Removing the parenthetical authority citation at the end of the 
section.
    The revision reads as follows:


Sec.  24.250   Application for use of new treating material or process.

* * * * *
    (b) Data required. The application must include documentary 
evidence from the U.S. Food and Drug Administration that the material 
is consistent with the food additive requirements under the Federal 
Food, Drug, and Cosmetic Act for its intended purpose in the amounts 
proposed for the particular treatment contemplated.
* * * * *

0
11. Section 24.252 is added prior to the undesignated center heading 
``Bottling, Packing, and Labeling of Wine'' to read as follows:


Sec.  24.252   Salvaging accidentally diluted wine.

    (a) Removal of accidentally added water without prior TTB approval. 
If a proprietor accidentally adds to standard wine water in excess of 
limitations specified in subpart F of this part and this subpart, the 
accidentally diluted wine may be returned to its original condition 
through:
    (1) The use of reverse osmosis and distillation without prior 
application to TTB provided that:
    (i) The accidentally added water represents no more than 10 percent 
of the original volume of the wine;
    (ii) The wine is returned to its original condition by removing an 
amount of water equal to the amount that was accidentally added to the 
wine;
    (iii) The vinous character of the wine is not altered;
    (iv) The proprietor transfers the wine in bond to a distilled 
spirits plant for treatment; and
    (v) Records are maintained in accordance with paragraph (c) of this 
section; or
    (2) By adding juice concentrate under the conditions outlined in 
Sec.  24.180 without prior application to TTB provided that:
    (i) The accidentally added water represents no more than 10 percent 
of the original volume of the wine;
    (ii) The solids content of the finished wine do not exceed 21 
percent by weight;
    (iii) The proprietor complies with any State or local rules 
regarding the addition of juice concentrate; and
    (iv) Records are maintained in accordance with paragraph (c) of 
this section.
    (b) Removal of accidentally added water with TTB approval. If a 
proprietor accidentally adds water to standard wine and the 
accidentally added water represents more than 10 percent of the 
original volume of the wine, then the proprietor must request 
permission from TTB prior to treating the wine. A proprietor may submit 
an application requesting permission to treat the wine to remove the 
water and return the wine to its original condition. The removal of 
water may not be conducted until the appropriate TTB officer has 
approved the request. The application which is to be submitted to the 
appropriate TTB officer, must be in writing, must provide evidence of 
the exact amount of water accidentally added to the wine and an 
explanation of how the water was accidentally added, and must specify 
the method the proprietor will use to remove the water from the wine. 
In approving any request under this section, the appropriate TTB 
officer may require the proprietor to take steps to prevent future 
accidental additions of water to wine. In evaluating any request under 
this section, the appropriate TTB officer may consider as a factor 
whether the proprietor has demonstrated good commercial practices, 
taking into account the proprietor's prior history of accidental 
addition of water to wine and of compliance with other regulations in 
this part.
    (c) Records. The proprietor must, with respect to removals of water 
from wine and addition of concentrate authorized under this section, 
maintain records that document the accidental addition of water, the 
use of any treatment or process to remove the water from the wine, and 
the fact that only the amount of water that was accidentally added to 
the wine was removed as a result of the treatment or process or that 
only an amount of concentrate sufficient to make up for the amount of 
water accidentally added is used.


[[Page 51904]]


    Signed: August 17, 2022.
Mary G. Ryan
Administrator.
    Approved: August 18, 2022.
Thomas C. West, Jr.
Deputy Assistant Secretary (Tax Policy).
[FR Doc. 2022-18060 Filed 8-23-22; 8:45 am]
BILLING CODE 4810-31-P