Rule2022-18060
Wine Treating Materials and Related Regulations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 24, 2022
Effective
August 24, 2022
Issuing agencies
Treasury DepartmentAlcohol and Tobacco Tax and Trade Bureau
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 163 (Wednesday, August 24, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.ttb.gov/wine/treating-materials">https://www.ttb.gov/wine/treating-materials</a>. 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\ <a href="https://www.fda.gov/food/packaging-food-contact-substances-fcs/inventory-effective-food-contact-substance-fcs-notifications">https://www.fda.gov/food/packaging-food-contact-substances-fcs/inventory-effective-food-contact-substance-fcs-notifications</a>.
\2\ <a href="https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=GRASNotices">https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=GRASNotices</a>.
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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 <a href="http://Regulations.gov">Regulations.gov</a> website (<a href="http://www.regulations.gov">www.regulations.gov</a>). 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\ <a href="http://home.treasury.gov/system/files/136/Competition-Report.pdf">home.treasury.gov/system/files/136/Competition-Report.pdf</a>.
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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:
<bullet> Biotin: 25 parts per billion (ppb).
<bullet> Folic acid: 100 ppb.
<bullet> Inositol (myo-inositol): 2 parts per million (ppm).
<bullet> Magnesium sulfate: 15 ppm.
<bullet> Niacin (vitamin B3): 1 ppm.
<bullet> 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 <a href="http://www.ttb.gov">www.ttb.gov</a> 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:
<bullet> 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;
<bullet> 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
<bullet> 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:
<bullet> 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
<bullet> 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.''
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\7\ <a href="https://www.ttb.gov/agreements/us-eu-wine-agreement.pdf">https://www.ttb.gov/agreements/us-eu-wine-agreement.pdf</a>.
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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.''
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\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:
<bullet> Albumen. In the ``Specific limitation'' column, TTB
proposed to revise the words ``of solution'' in the second sentence to
read ``of wine.''
<bullet> Calcium carbonate. In the ``Materials and use'' column,
TTB proposed to add the abbreviation ``CaCO<INF>3</INF>'' 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.
<bullet> Citric acid. In the ``Materials and use'' column, TTB
proposed revising the phrase ``deficiencies in wine'' to read
``deficiencies in juice and wine.''
<bullet> 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.''
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.''
<bullet> 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.''
<bullet> 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.''
<bullet> Sulfur dioxide. TTB proposed to correct the entry for
sulfur dioxide to include its use in juice.
<bullet> 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\
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\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.''
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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 (<a href="https://www.oiv.int/public/medias/4054/e-coei-1-balact.pdf">https://www.oiv.int/public/medias/4054/e-coei-1-balact.pdf</a>) 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
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</html>Indexed from Federal Register on August 24, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.