[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Proposed Rules]
[Pages 83752-83771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27581]


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DEPARTMENT OF THE TREASURY

Alcohol and Tobacco Tax and Trade Bureau

27 CFR Part 24

[Docket No. TTB-2016-0010; Notice No. 164]
RIN 1513-AB61


Wine Treating Materials and Related Regulations

AGENCY: Alcohol and Tobacco Tax and Trade Bureau.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Alcohol and Tobacco Tax and Trade Bureau (TTB) is 
proposing to amend its regulations pertaining to the production of wine 
and in particular in regard to the permissible treatments that may be 
applied to wine and to juice from which wine is made. These proposed 
amendments are in response to requests from wine industry members to 
authorize certain wine treating materials and processes not currently 
authorized by TTB regulations. TTB invites comments on the proposed 
regulatory changes described in this document, as well as on other wine 
treatment issues for which regulatory amendments are not proposed in 
this document.

DATES: Comments must be received by January 23, 2017.

ADDRESSES: Please send your comments on this document to one of the 
following addresses:
     https://www.regulations.gov (via the online comment form 
for this document as posted within Docket No. TTB-2016-0010 at 
Regulations.gov, the Federal e-rulemaking portal);
     U.S. Mail: Director, Regulations and Rulings Division, 
Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW., Box 12, 
Washington, DC 20005; or
     Hand delivery/courier in lieu of mail: Alcohol and Tobacco 
Tax and Trade Bureau, 1310 G Street NW., Suite 400, Washington, DC 
20005.
    See the Public Participation section of this document for specific 
instructions and requirements for submitting comments, and for 
information on how to request a public hearing or view or obtain copies 
of the petition and supporting materials.

FOR FURTHER INFORMATION CONTACT: Kara Fontaine, Regulations and Rulings 
Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW., 
Box 12, Washington, DC 20005; phone 202-453-1039, ext. 103.

SUPPLEMENTARY INFORMATION: 

Background

TTB Authority

    Chapter 51 of the Internal Revenue Code of 1986, as amended (IRC), 
26 U.S.C. chapter 51, contains provisions concerning the taxation and 
production of distilled spirits, wines, and beer. The Alcohol and 
Tobacco Tax and Trade Bureau (TTB) has been delegated authority to 
promulgate regulations pertaining to wine under Chapter 51 of the IRC. 
The statutory provisions of the IRC related to the distilled spirits 
and wine regulations that TTB promulgates include, but are not limited 
to, the following:
     Section 5002(a)(4) of the IRC (26 U.S.C. 5002(a)(4)), 
which defines the term ``distiller,'' in pertinent part, as including 
any person who ``(A) produces distilled spirits from any source or 
substance'' or ``(C) by any process separates alcoholic spirits from 
any fermented substance * * *.''
     Section 5171(a) of the IRC (26 U.S.C. 5171(a)), which 
requires that operations ``as a distiller'' only be conducted on the 
bonded premises of a distilled spirits plant by a person who is 
qualified under subchapter B of chapter 51 of the IRC.
     Section 5373 of the IRC (26 U.S.C. 5373), which authorizes 
the promulgation of regulations regarding the type of wine spirits that 
may be used in wine production.
     Section 5381 of the IRC (26 U.S.C. 5381), which provides 
that natural wine is the product of the juice or must of sound, ripe 
grapes or other sound, ripe fruit, made with such cellar treatment as 
may be authorized under section 5382.
     Section 5382(a) of the IRC (26 U.S.C. 5382(a)), which 
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) 
also authorizes the promulgation of regulations setting forth 
limitations on the preparation and use of methods and materials for 
clarifying, stabilizing, preserving, fermenting, and correcting wine 
and juice.
     Section 5387(a) of the IRC (26 U.S.C. 5387(a)), which 
authorizes the production of agricultural wine, classed as ``standard 
agricultural wine,'' from agricultural products other than the juice of 
fruit. 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. Also, 
section 5387(b) prohibits the addition of wine spirits, coloring 
material or herbs, or other flavoring material (except hops in the case 
of honey wine) to agricultural wine, as well as the blending together 
of wines from different agricultural commodities.
    The regulations promulgated under the IRC regarding the production 
of wine are set forth in part 24 of title 27 of the Code of Federal 
Regulations (27 CFR part 24) and include, but are not limited to, the 
following provisions:
     27 CFR 24.10, which contains the definitions of certain 
terms used in 27 CFR part 24.
     27 CFR 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.
     27 CFR 24.246, which includes a table that lists the 
materials authorized for the treatment of wine and juice.
     27 CFR 24.247, which includes a table that lists materials 
authorized for the treatment of distilling material.
     27 CFR 24.248, which includes a table that lists processes 
authorized for the treatment of wine, juice, and distilling materials.
    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 
various authorities through Treasury Department Order 120-01, dated 
December 10, 2013 (superseding Treasury Order 120-01 dated January 24, 
2003), to the TTB Administrator to perform the functions and duties in 
the administration and enforcement of these laws.
    In addition, TTB 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

[[Page 83753]]

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. The use of a food additive in food must be authorized by FDA 
either through a food additive regulation or an effective food contact 
notification (FCN). 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). For the purpose of this rulemaking, we use 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.
    Based on TTB's experience in administering the statutory and 
regulatory provisions mentioned above, TTB is proposing in this 
document a number of amendments to the TTB regulations and inviting 
comments from the public on these proposed regulatory changes. In 
addition, TTB is outlining in this document a number of other issues 
that are not the subject of proposed regulatory changes. TTB invites 
comments from the public on those issues to assist TTB in determining 
whether any of those issues warrant specific regulatory changes.

Terms Used in This Document

    TTB is providing the following definitions to assist in the 
comprehension of this final rule. The definitions of agricultural wine, 
amelioration, brix, natural wine, standard wine, and wine spirits come 
from Sec.  24.10, the definition of essences is derived from 27 CFR 
24.85, and the definition of special natural wine is derived from 27 
CFR 24.10 and 24.195. The definitions of ``natural wine'' and 
``standard wine'' are consistent with statutory provisions at sections 
5381 and 5392, respectively. The definitions of ``agricultural wine,'' 
``amelioration,'' and ``special natural wine'' reflect language used in 
statutory provisions at sections 5387, 5383, and 5386, respectively. 
The definition of ``brix'' is derived, in part, from statutory 
provisions at sections 5382 and 5393. Definitions of industry member 
and yeast nutrients also are provided, although these terms are not 
specifically defined in statutory provisions or elsewhere in the 
regulations.
     Agricultural wine: Wine made from suitable agricultural 
products other than the juice of grapes, berries, or other fruits.
     Amelioration: The addition to juice or natural wine 
before, during, or after fermentation, of either water or pure dry 
sugar, or a combination of water and sugar to adjust the acid level.
     Brix: The quantity of dissolved solids expressed as grams 
of sucrose in 100 grams of solution at 68 degrees F (20 degrees C.) 
(Percent by weight of sugar). (The definition of ``Brix'' in Sec.  
24.10 incorrectly refers to 60 degrees F rather than 68, which is the 
equivalent of 20 degrees C; TTB is proposing to correct this 
typographical error in this document.)
     Essences: Preparations of natural constituents extracted 
from fruit, herbs, berries, etc.
     Industry member: For the purposes of this document, a 
proprietor of a bonded wine premises.
     Natural wine: The product of the juice or must of sound, 
ripe grapes or other sound, ripe fruit (including berries) made with 
any cellar treatment authorized by 27 CFR part 24, subparts F and L, 
and containing not more than 21 percent by weight (21 degrees Brix 
dealcoholized wine) of total solids.
     Special natural wine: A product produced from a base of 
natural wine (including heavy bodied blending wine) to which natural 
flavorings are added, and made pursuant to an approved formula in 
accordance with 27 CFR part 24, subpart H. In subpart H, Sec.  24.195 
additionally explains that, among other things, natural flavorings are 
added in quantities or proportions such that the resulting product 
derives character and flavor distinctive from the base wine and 
distinguishable from other natural wine.
     Standard wine: Natural wine, specially sweetened natural 
wine, special natural wine, and standard agricultural wine, produced in 
accordance with 27 CFR part 24, subparts F, H, and I.
     Wine spirits: Brandy or wine spirits authorized under 26 
U.S.C. 5373 for use in wine production.
     Yeast nutrients: For the purposes of this document, 
vitamins and minerals that aid in the fermentation of juice to wine by 
acting as food for yeast.

TTB Administrative Approvals of Wine and Juice Treatments

    Industry members who wish to experiment with, or commercially use, 
a treating material or process not specifically authorized in 27 CFR 
part 24 must file an application with TTB requesting authorization to 
use the new material or process. TTB may approve such requests as 
experiments under 27 CFR 24.249 or allow for the continual use of the 
new material or process under 27 CFR 24.250.
    Standards regarding approval of the experimental use of a new 
treating material or process are set forth in Sec.  24.249. The 
provisions covering applications for commercial use of a new material 
or process are contained in Sec.  24.250. Consistent with Sec. Sec.  
24.246 and 24.248, TTB may approve the use of wine treating materials 
and processes that are determined to be acceptable in good commercial 
practice. In general, good commercial practice includes 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 without creating an erroneous impression 
about the character and composition of the wine.
    If TTB believes that it would be appropriate to approve the 
request, whether as an experiment under Sec.  24.249 or for continued 
commercial use under Sec.  24.250, it will send a letter to the 
industry member authorizing use of the material or process and setting 
forth the conditions for that use. Also, when TTB approves the 
continued commercial use of a wine treatment material or process under 
Sec.  24.250, it will provide public notice of such approval on its Web 
site at https://www.ttb.gov/wine/wine_treating_materials.shtml. The 
listing of administrative approvals on the TTB Web site affords all 
industry members the opportunity to use an administratively approved 
wine treating material or process pending future rulemaking.
    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 for several reasons. First, when TTB administratively 
approves wine treatments for continued commercial use under Sec.  
24.250, TTB makes an initial determination that such material

[[Page 83754]]

or process is consistent with ``good commercial practice.'' 
Administrative approval provides a more expeditious process than 
rulemaking for industry members to obtain approval to use new materials 
and processes. On the other hand, the rulemaking process allows 
industry members and the public an opportunity to comment on, and 
specifically to confirm or refute, TTB's initial determination that the 
use of a material or process is consistent with good commercial 
practice. TTB believes that input from industry members, the users and 
potential users of these treatments commercially, should be obtained 
before making a final determination concerning the acceptability of the 
treatment in good commercial practice.
    Similarly, TTB might not approve a request for administrative 
approval of a wine treatment because the Bureau is reluctant to approve 
the use of that particular wine treatment without input from industry 
members and the public concerning the treatment's acceptability in good 
commercial practice. After obtaining information and comments through 
rulemaking, TTB may determine that the wine treatment is consistent 
with good commercial practice and approve the use of such treatment. As 
discussed below, through this document, TTB is seeking comments on the 
approval of the use of several proposed treatments that have not been 
administratively approved by the Bureau.
    In addition, administrative approval of a wine treatment under 
Sec.  24.250 does not guarantee acceptance in foreign markets of any 
wine so treated, and conducting rulemaking and adding wine treating 
materials and processes to Sec. Sec.  24.246 through 24.248 results 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 listed in Annex I 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. For new wine treatments 
administratively approved in the United States, TTB provides such 
public notice and opportunity to comment through the regulatory 
rulemaking process.
    TTB's most recent amendment of Sec. Sec.  24.246 through 24.248 to 
reflect treating material and process approvals was published as 
Treasury Decision (T.D.) TTB-61 in the Federal Register (72 FR 51707) 
on September 11, 2007. Since that time, TTB has received and approved a 
number of applications for experimental or commercial uses. These 
include the 15 wine and juice treating materials and the combined use 
of two existing wine treatment processes, discussed below, on which TTB 
believes it has accumulated enough analytical data or other information 
to propose adding them to the list of approved materials and processes 
in the TTB regulations at Sec. Sec.  24.246 and 24.248.
    TTB is soliciting comments from all interested persons on TTB's 
position that, based on the information set forth below, the use of 
each of these materials or processes is consistent with good commercial 
practice.

Yeast Nutrients

    Seven of the administrative approvals mentioned above authorize the 
use of additional yeast nutrients in the treatment of wine. TTB and its 
predecessor agencies have recognized the need to supply yeast with 
appropriate nutrients to facilitate healthy fermentation and to prevent 
``stuck fermentation'' (fermentation that has halted before completion 
due to, among other things, high sugar levels or nutrient 
deficiencies). The following yeast nutrients are currently listed in 
Sec.  24.246 as authorized wine and juice treating materials:
     Ammonium phosphate;
     Calcium pantothenate (for apple wine);
     Soy flour (defatted);
     Thiamine hydrochloride;
     Yeast, autolyzed; and
     Yeast, cell wall/membrane of autolyzed yeast.
    In 2007, TTB received a petition from Gusmer Enterprises Inc. 
(Gusmer) to amend Sec.  24.246 to allow the use of 19 vitamins and 
minerals as yeast nutrients in the production of wine. Gusmer provided 
the names, descriptions, functional roles for yeast metabolism, 
conditions of use, and suggested maximum amounts for the proposed 
vitamins and minerals. The petitioner also provided documentation on 
the regulatory status of the uses of 15 of the 19 proposed vitamins and 
minerals. Four materials identified by the petitioner, selenium, boron, 
molybdenum, and chromium, are not included in this proposal because no 
information was provided to demonstrate that their uses would be 
consistent with the food additive requirements under the FD&C Act.
    Of the remaining 15 vitamins and minerals proposed as yeast 
nutrients for the production of wine by the petitioner, seven have been 
administratively approved by TTB for continued commercial use as yeast 
nutrients under Sec.  24.250 in response to industry member requests 
which were received by TTB subsequent to TTB's receipt of the Gusmer 
petition. TTB is proposing, in this document, to amend the regulations 
to add six of these vitamins and minerals to the list of approved 
treating materials and expand the approved use of a seventh that 
already appears on the list. Specifically, TTB is proposing 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, as described later in this 
document.
    For each of these seven yeast nutrients TTB is proposing to limit 
the amount of usage to the amounts provided in the Gusmer petition. 
While many of these yeast nutrients are vitamins that are authorized 
for use in food, in the recent past FDA has advised TTB that the 
fortification of ``alcoholic beverages'' with nutrients is not 
consistent with FDA's fortification policy in 21 CFR 104.20 or the 
Dietary Guidelines for Americans. In addition, 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. Nonetheless, FDA has stated to TTB that these vitamins could 
be used for the purpose of providing nutrients to the yeast, and not to 
fortify the wine, where the levels of the vitamin remaining in the wine 
would be of a de minimis level. For these reasons, TTB believes it is 
important to place limitations on the use of these substances that 
permit their use as nutrients for yeast growth but not as food 
additives for human consumption.
    For reasons discussed below in the section titled ``Other Issues 
for Public Comment and Possible Regulatory Action,'' TTB is not 
proposing in this document to add the eight vitamins and minerals that 
TTB has not approved administratively under Sec.  24.250 to the list of 
authorized wine and juice treating

[[Page 83755]]

materials in Sec.  24.246. However, TTB is seeking comments on whether 
these eight additional vitamins and minerals should be approved as 
authorized wine treating materials.

Proposed Regulatory Amendments

Wine Treating Materials

General Comment on Yeast Nutrients
    The six new yeast nutrients that TTB is proposing for the first 
time, based on the Gusmer petition described above, and the six yeast 
nutrients already authorized for use by regulation, as listed in Sec.  
24.246 (including calcium pantothenate), have been grouped together in 
the proposed Sec.  24.246 table below under the heading ``Yeast 
nutrients.'' This format is similar to the one that currently exists 
for ``Enzymatic activity.'' TTB is also broadening the use of those 
yeast nutrients that are currently listed in Sec.  24.246 to allow for 
their use in all juice and wine.
Blends and Other Combinations of Approved Treating Materials
    TTB notes that, while the table in Sec.  24.246 includes some 
references to approved materials used in combination (see, for example, 
the entry for potassium carbonate), there is no general statement to 
the effect that one or more approved materials may be used as a blend 
or otherwise in combination with another. TTB believes that such 
combined uses should be permitted, provided that the use of each 
material conforms to the conditions specified for that material (that 
is, the reason or purpose for its use and the references and 
limitations that apply to its use). TTB is proposing, in this document, 
to amend Sec.  24.246 accordingly. This revision appears in proposed 
Sec.  24.246(b), with the current Sec.  24.246(b) moved to the proposed 
Sec.  24.246(c).
Specific Wine Treating Materials
    Acacia (gum arabic): TTB is proposing to authorize a maximum use 
rate of 8 pounds of acacia per 1,000 gallons (1.92 grams per Liter (g/
L)) of wine in the list of authorized wine and juice treating materials 
in Sec.  24.246. Acacia is currently listed in Sec.  24.246 as an 
authorized treating material to clarify and stabilize wine, subject to 
a limitation that its use shall not exceed 2 pounds per 1,000 gallons 
(0.24 g/L) of wine. TTB has administratively approved several requests 
from industry members to use acacia to treat wine at levels exceeding 
the current maximum. The current limitation in Sec.  24.246 was based 
on earlier evaluations of treated wine and was adopted through a public 
rulemaking procedure on September 24, 1984 (T.D. ATF-182, 49 FR 37522). 
Acacia also has a long record of use at the level prescribed in the 
regulation.
    While the increased amounts specified in those requests ranged as 
high as 25 pounds of acacia per 1,000 gallons of wine, 16 pounds per 
1,000 gallons was the highest level that TTB approved. In those reviews 
and approvals, TTB referenced FDA's regulation (21 CFR 184.1330) for 
the use of acacia at a rate greater than the amount listed in Sec.  
24.246, and TTB reviewed and considered relevant submitted data 
required under Sec.  24.250(b). TTB notes that some of the requests to 
use higher amounts of acacia also requested approval for an additional 
purpose, that is, to improve ``mouthfeel''; however, TTB's authority 
under 26 U.S.C. 5382 to authorize wine treating materials only extends 
to correcting or stabilizing the wine or the fruit juice from which it 
is made. As reflected in its implementing regulations in Sec.  24.246, 
TTB policy is to allow for wine treating materials that filter, 
clarify, or purify wine or juice as materials that correct or stabilize 
wine. Accordingly, TTB did not approve the use of acacia for the 
purpose of improving the ``mouthfeel'' of wine.
    TTB's administrative approvals authorized the use of acacia in the 
treatment of wine at a level of 16 pounds per 1,000 gallons of wine, 
which is equivalent to a maximum usage level of 2 percent. Subsequent 
to those administrative approvals, TTB learned that although the FDA 
regulation cited for acacia gum in Sec.  24.246 (Sec.  184.1330) is the 
correct citation, the beverage category listed in the table of FDA's 
regulation does not cover TTB's intended use in wine. This is because 
the FDA regulation further cites the food category definition in 21 CFR 
170.3(n)(3), which does not cover use in wine. Accordingly, the correct 
category from the table in Sec.  184.1330 is ``all other food 
categories.'' This category has a limit of one percent acacia gum 
(rather than 2 percent); the functional effects for this category match 
TTB's uses as clarifying and stabilizing wine. TTB is correcting this 
mistake in this rulemaking by proposing to increase the maximum use 
rate of acacia gum in wine to 8 pounds per 1,000 gallons of wine. TTB's 
earlier administrative approvals authorizing the use of acacia at 
levels greater than 8 pounds per 1,000 gallons of wine are revoked.
    Bakers yeast mannoprotein: TTB is proposing 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.
    TTB administratively approved the use of bakers yeast mannoprotein 
to stabilize wine from the precipitation of potassium bitartrate 
crystals, in response to a number of requests from industry members. In 
response to GRAS Notice No. GRN 000284, the FDA stated that it had no 
questions regarding the notifier's conclusion that bakers yeast 
mannoprotein is GRAS for use as a stabilizing agent in wines at levels 
ranging from 50-400 milligrams per liter (mg/L), to prevent tartaric 
acid precipitation. In its administrative approval, TTB restricted the 
use of bakers yeast mannoprotein to 50-400 mg/L.
    Beta-glucanase having an enzyme activity derived from Trichoderma 
harzianum: TTB is proposing to add beta-glucanase, at a use rate of 30 
parts per million (ppm) of wine, to the list of approved wine and juice 
treating materials contained in Sec.  24.246. TTB administratively 
approved the use of beta-glucanase having an enzyme activity derived 
from Trichoderma harzianum. Several industry members requested approval 
to treat wine with an enzymatic blend consisting of pectinase and beta-
glucanase having an enzyme activity derived from Trichoderma harzianum. 
Pectinase is an approved wine treating material listed with 
carbohydrase in Sec.  24.246. While beta-glucanase is also approved as 
a wine treating material listed with cellulose in Sec.  24.246, that 
approval is limited to beta-glucanase having an enzyme activity derived 
from Trichoderma longibrachiatum. In response to GRAS Notice No. GRN 
000149, FDA stated that it had no questions concerning the notifier's 
conclusion that the beta-glucanase enzyme preparation derived from 
Trichoderma harzianum is GRAS at the minimum levels necessary to 
achieve the desired effect, typically ranging from 1 to 3 grams per 
hectoliter of wine (10-30 ppm). In its administrative approval posted 
on https://www.ttb.gov/wine/wine_treating_materials.shtml in 2010, TTB 
inadvertently stated that the amount of beta-glucanase derived from 
Trichoderma harzianum used must not exceed 300 ppm. TTB is correcting 
this mistake in this rulemaking by aligning the proposed use rate with 
the rate stated in GRAS Notice No. GRN 000149. Accordingly, TTB is 
proposing to amend the table in Sec.  24.246 by adding to the entry on 
``Enzymatic activity: Cellulase (beta-glucanase)'' a second source, 
Trichoderma harzianum, stating that its use must not exceed 30 ppm, and 
by referencing GRAS Notice No.

[[Page 83756]]

GRN 000149. TTB is soliciting comments on this proposed addition, the 
limitation of 30 ppm, and also on whether beta-glucanase enzymatic 
activity derived from Trichoderma longibrachiatum is still relevant for 
wine treatments.
    Biotin: TTB is proposing the addition of biotin to the list of 
authorized wine and juice treating materials in Sec.  24.246 as a yeast 
nutrient at a use rate not to exceed 25 parts per billion (ppb). TTB 
administratively approved an industry member's request to use biotin as 
a yeast nutrient in the production of wine. FDA has stated to TTB in an 
informal opinion that biotin can be used for the purpose of providing 
nutrients to yeast, and not to fortify the wine, where the levels of 
biotin remaining in the wine would be of a de minimis level. The Gusmer 
petition proposed a maximum use rate for biotin of 25 ppb.
    Calcium pantothenate (vitamin B5): TTB is proposing to amend Sec.  
24.246 to expand the current authorized use of calcium pantothenate 
from use as a yeast nutrient in just apple wine to use as a yeast 
nutrient in all wine. TTB administratively approved an industry 
member's request to use calcium pantothenate as a yeast nutrient in the 
production of wine. FDA has stated to TTB in an informal opinion that 
calcium pantothenate can be used for the purpose of providing nutrients 
to yeast, and not to fortify the wine, where the levels of calcium 
pantothenate remaining in the wine would be of a de minimis level. 
TTB's administrative approval restricted its use to that which is 
consistent with good commercial practice. TTB is proposing to apply the 
same use limit as is provided for the use of calcium pantothenate in 
apple wine, that is, a use rate of 0.1 pound of calcium pantothenate 
per 25,000 gallons (1.5 ppm), and to allow for the use of calcium 
pantothenate for all juice and wine by removing the current apple wine 
limitation specified in Sec.  24.246.
    Chitosan: TTB is proposing to add chitosan from Aspergillus niger, 
at a use rate not to exceed 10 grams per 100 liters of wine, to the 
list of approved wine and juice treating materials contained in Sec.  
24.246. TTB administratively approved several industry member requests 
to use chitosan from Aspergillus niger to remove spoilage organisms, 
such as Brettanomyces, from wine. In its response to GRAS Notice No. 
GRN 000397, FDA stated that it had no questions regarding the 
notifier's conclusion that chitosan from Aspergillus niger is GRAS for 
use as a secondary direct food ingredient in alcoholic beverage 
production at levels between 10 and 500 grams per hectoliter (100 
liters). In its administrative approvals, TTB restricted the use of 
chitosan from Aspergillus niger to an amount not to exceed 10 grams per 
100 liters of wine.
    Folic acid: TTB is proposing to add folic acid to the list of 
authorized wine and juice treating materials in Sec.  24.246 for use as 
a yeast nutrient at a use rate not to exceed 100 ppb. TTB 
administratively approved an industry member's request to use folic 
acid as a yeast nutrient in the production of wine. FDA has stated to 
TTB in an informal opinion, that folic acid can be used for the purpose 
of providing nutrients to the yeast, and not to fortify the wine, where 
the levels of folic acid remaining in the wine would be of a de minimis 
level. In TTB's administrative approval, TTB limited the use of folic 
acid to that which is consistent with good commercial practice and did 
not provide a specific use limit. The Gusmer petition proposed a 
maximum use rate of 100 ppb for folic acid when used as a yeast 
nutrient in the production of wine. Such a use rate will ensure that 
any folic acid remaining in the wine would be of a de minimis level.
    Inositol (myo-inositol): TTB is proposing to add inositol to the 
list of authorized wine and juice treating materials in Sec.  24.246 to 
be used as a yeast nutrient at a use rate not to exceed 2 ppm. TTB 
administratively approved an industry member's request to use inositol 
as a yeast nutrient in the production of wine. FDA has stated to TTB in 
an informal opinion that inositol could be used for the purpose of 
providing nutrients to the yeast, and not to fortify the wine, where 
the levels of inositol remaining in the wine would be of a de minimis 
level. In TTB's administrative approval, TTB restricted the use of 
inositol to that which is consistent with good commercial practice and 
did not provide a specific use limit. The Gusmer petition proposed a 
maximum use rate of 2 ppm for inositol when used as a yeast nutrient in 
the production of wine. The maximum use rate of 2 ppm will ensure that 
any inositol remaining in the wine would be of a de minimis level.
    L(+) tartaric acid: TTB administratively approved several industry 
member requests to use L(+) tartaric acid, prepared using an enzyme 
from immobilized Rhodococcus ruber cells, to correct natural acid 
deficiencies and to reduce pH when ameliorating material is used in the 
production of grape wine. Tartaric acid is currently listed in Sec.  
24.246 as a material authorized for the treatment of wine and juice for 
these same purposes; however, the current reference in Sec.  24.246 is 
to the FDA regulation at 21 CFR 184.1099, which specifies that tartaric 
acid with the L configuration is obtained as a byproduct of wine 
manufacturing.
    In response to GRAS Notice No. GRN 000187 for L(+) tartaric acid 
(alternative method) prepared using an enzyme from immobilized 
Rhodococcus ruber cells, FDA stated that it had no questions regarding 
the notifiers' conclusion that the substance is GRAS for use as an 
alternative source of L(+) tartaric acid in food at levels not to 
exceed current good manufacturing practices for use as a firming agent, 
a flavor enhancer, a flavoring agent, a humectant, and a pH control 
agent, as described in 21 CFR 184.1099. The FDA also noted that the 
material is chemically identical to the tartaric acid affirmed as GRAS 
in 21 CFR 184.1099.
    Based on the FDA response to the GRAS notice and TTB's analysis of 
wine treated with L(+) tartaric acid, TTB is proposing 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 or the method specified in GRAS 
Notice No. GRN 000187, and to add the citation to the FDA GRAS notice 
in the ``Specific limitation'' column.
    Magnesium sulfate: TTB is proposing to add magnesium sulfate to the 
list of authorized wine and juice treating materials in Sec.  24.246 to 
be used as a yeast nutrient at a use rate not to exceed 15 ppm. TTB 
administratively approved an industry member's request to use magnesium 
sulfate as a yeast nutrient in the production of wine. FDA has stated 
to TTB in an informal opinion that magnesium sulfate can be used for 
the purpose of providing nutrients to yeast, and not to fortify the 
wine, where the levels of magnesium sulfate remaining in the wine would 
be of a de minimis level. In TTB's administrative approval, TTB 
restricted the use of magnesium sulfate as a yeast nutrient to that 
which is consistent with good commercial practice and did not provide a 
specific use limit. The Gusmer petition proposed a maximum use rate of 
15 ppm for magnesium sulfate when used as a yeast nutrient in the 
production of wine.
    Niacin (vitamin B3): TTB is proposing to add niacin to the list of 
authorized wine and juice treating materials in Sec.  24.246 to be used 
as a yeast nutrient at a use rate not to exceed 1 ppm. TTB 
administratively approved an industry member's request to use niacin as 
a yeast nutrient in the production of wine. FDA has stated to TTB in an 
informal opinion that niacin can be used for the purpose of providing 
nutrients to yeast,

[[Page 83757]]

and not to fortify the wine, where the levels of niacin remaining in 
the wine would be of a de minimis level. In TTB's administrative 
approval, TTB restricted the use of niacin as a yeast nutrient to that 
which is consistent with good commercial practice and did not provide a 
specific use limit. The Gusmer petition proposed a maximum use rate of 
1 ppm for niacin when used as a yeast nutrient in the production of 
wine.
    Polyvinyl-pyrrolidone (PVP)/polyvinylimadazole (PVI) polymer: In 
2005, TTB began administratively approving industry member requests to 
use a polyvinyl-pyrrolidone (PVP) and polyvinylimadazole (PVI) 
copolymer (PVP/PVI) as a wine treating material to be used for 
clarifying and stabilizing alcohol beverages. PVP had once been listed 
as an authorized wine treating material in ATF regulations at 27 CFR 
240.1051, Materials Authorized for Treatment of Wine. Specifically, it 
was authorized as a clarifying agent for wine. After a 1990 
recodification of 27 CFR part 240, ATF rescinded its approval of PVP as 
a wine treating material because it was no longer in use by wine 
producers. See T.D. ATF-299 (55 FR 24974). However, in the past several 
years TTB has received a number of requests to use the PVP/PVI 
copolymer as an authorized wine treating material. The PVP/PVI 
copolymer binds heavy metal ions and sulfides present in juice and 
wine, after which the bound materials and the PVI/PVP can be removed 
from the liquid during filtration.
    On July 5, 2003, FDA allowed BASF Corporation's Food Contact 
Substance (FCS) Notification for their PVP/PVI copolymer to become 
effective (FCN No. 320). Under section 409(h)(2)(C) of the FD&C Act (21 
U.S.C. 348 (h)(2)(C)) a food contact notification (FCN) is only 
effective for the manufacturer or supplier identified in the 
notification. Persons who market a FCS based on an effective 
notification must be able to demonstrate that the notification is 
effective for their food contact substance. All persons who purchase a 
food contact substance manufactured or supplied by a manufacturer or 
supplier identified in an effective notification may rely on that 
notification to legally market or use the food contact substance for 
the use that is the subject of the notification, consistent with any 
limitations in that notification. According to FDA FCN No. 320, the 
blend ``is intended to be added directly to alcoholic beverages during 
the maturation process . . . is to be completely removed by filtration 
. . . and is limited to single use applications.'' The amount must not 
exceed 80 grams per 100 liters of wine.
    Based on FDA FCN No. 320, TTB's experience with the use of sulfide 
and metal reducing matrix sheets (which contain PVI and are approved 
wine treating processes listed in Sec.  24.248), and TTB's analysis of 
wine treated with the PVP/PVI copolymer, TTB is proposing to amend the 
table at the end of Sec.  24.246 by adding the PVP/PVI copolymer as 
described by FDA FCN No. 320 for use at a level not to exceed 80 grams 
per 100 liters of wine to remove heavy metal ions and sulfides from 
wine.
    Potato protein isolates: TTB is proposing 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 wine and juice 
treating materials contained in Sec.  24.246. TTB administratively 
approved an industry member's request to use potato protein isolates as 
a fining agent for wine. In response to GRAS Notice No. GRN 000447, FDA 
stated that it had no questions regarding the notifier's conclusion 
that potato protein isolates are GRAS for various technical effects in 
a variety of foods that include alcoholic beverages at levels ranging 
from 0.01 to 15 percent. In its administrative approval, TTB restricted 
the use of potato protein isolates to an amount not to exceed 500 ppm 
or 50 g/hL of wine for the purpose of fining wine. The proposed 
limitation is consistent with that of other countries.
    Pyridoxine hydrochloride (vitamin B6): TTB is proposing to add 
pyridoxine hydrochloride to the list of authorized wine and juice 
treating materials in Sec.  24.246 to be used as a yeast nutrient at a 
use rate not to exceed 150 ppb. TTB administratively approved an 
industry member's request to use pyridoxine hydrochloride as a yeast 
nutrient in the production of wine. FDA has stated to TTB in an 
informal opinion that pyridoxine hydrochloride can be used for the 
purpose of providing nutrients to yeast, and not to fortify the wine, 
where the levels of pyridoxine hydrochloride remaining in the wine 
would be of a de minimis level. In its administrative approval, TTB 
restricted the use of pyridoxine hydrochloride as a yeast nutrient to 
that which is consistent with good commercial practice and did not 
provide a specific use limit. The Gusmer petition proposed a maximum 
use rate of 150 ppb for pyridoxine hydrochloride when used as a yeast 
nutrient in the production of wine.
    Sodium carboxymethyl cellulose: TTB is proposing to add sodium 
carboxymethyl cellulose to the list of authorized wine and juice 
treating materials in Sec.  24.246, to be used to stabilize wine from 
tartrate precipitation at a level not to exceed 0.8 percent of the 
wine. TTB administratively approved several industry member requests to 
use sodium carboxymethyl cellulose to stabilize wine by preventing 
tartrate precipitation. FDA regulations at 21 CFR 182.1745 state that 
sodium carboxymethyl cellulose is GRAS when used in accordance with 
good manufacturing practice. In TTB's administrative approval, TTB 
restricted the use of sodium carboxymethyl cellulose to stabilize wine 
by preventing tartrate precipitation to an amount not to exceed 0.8 
percent of the wine.

Processes for the Treatment of Wine, Juice, and Distilling Material

    TTB is proposing 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. Please note that 
industry members are responsible for ensuring that any component used 
in an approved process, including materials in contact with wine or 
juice, is used in a way that is consistent with any applicable FDA 
regulations, including FDA food contact regulations.
Cross Flow Filtration
    TTB is proposing to expand the authorized uses of nanofiltration 
and ultrafiltration in Sec.  24.248 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 pink color 
from blanc de noir wine; and to separate red wine into high color and 
low color wine fractions for blending purposes. Ultrafiltration has 
also been administratively approved to separate red juice into low 
color and high color fractions. (The administrative approval for 
ultrafiltration is discussed later in this document.)
    Both nanofiltration and ultrafiltration are capable of reducing 
alcohol content in wine, and this proposed liberalization will provide 
industry members with more tools to reduce the alcohol content of wine. 
However, as required with those processes for dealcoholization 
currently authorized in Sec.  24.248 (reverse osmosis, osmotic

[[Page 83758]]

transport, and spinning cone column), ultrafiltration and 
nanofiltration, when used to reduce the alcohol content of wine, must 
take place on distilled spirits plant premises. TTB also is proposing 
to place nanofiltration, ultrafiltration, and reverse osmosis under the 
umbrella term ``cross flow filtration.'' 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. TTB is adding this definition of ``cross 
flow filtration'' as a footnote to the table at the end of Sec.  
24.248.
Reverse Osmosis in Combination With Osmotic Transport
    TTB administratively approved several requests to use reverse 
osmosis in combination with osmotic transport to reduce the ethyl 
alcohol content in wine. Reverse osmosis and osmotic transport are both 
separately listed in Sec.  24.248 as approved wine treatment processes 
to reduce the ethyl alcohol content of wine. Under this combined 
process, the wine to be treated is separated by reverse osmosis into 
two portions called permeate and concentrate streams. The alcohol rich 
permeate is then degassed, warmed, and pumped along one side of a 
completely hydrophobic microporous osmotic transport membrane, which is 
used to separate out the alcohol. The dealcoholized permeate is then 
recombined with the wine from which it was extracted, thus lowering the 
alcohol content of the wine.
    TTB is proposing to amend the table at the end of 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.
Ultrafiltration
    In two separate requests, an industry member requested to use 
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. As described above, ultrafiltration is 
authorized for use under Sec.  24.248 to remove proteinaceous material 
from wine; to reduce harsh tannic material from white wine produced 
from white skinned grapes; to remove pink color from blanc de noir 
wine; and to separate red wine into low color and high color wine 
fractions for blending purposes. Since ultrafiltration is currently 
authorized under Sec.  24.248 to separate red wine into low color and 
high color fractions for blending, TTB administratively approved use of 
ultrafiltration to separate red grape juice into low and high color 
fractions and is proposing to amend the table at the end of Sec.  
24.248 accordingly. TTB did not administratively approve the use of 
ultrafiltration to separate high and low colored fractions of 
discolored white grape juice, but as discussed under the heading 
``Other Issues for Public Comment and Possible Regulatory Action'' in 
this document, invites comments on whether this practice constitutes 
good commercial practice.
Use of Wood To Treat Natural Wine
    Section 24.246 currently authorizes the use of uncharred and 
untreated oak chips or particles to smooth wine. TTB's predecessor 
agency had a longstanding policy allowing the use of ``toasted'' wood 
as a wine treating material, and TTB has issued several private letter 
rulings allowing this use. In addition, wooden storage tanks used for 
the addition of spirits to wine may be used for the baking of wine 
under Sec.  24.225.
    TTB is proposing a new 27 CFR 24.185 to clarify TTB's policy on the 
treatment of wine with wood contact. Section 24.185(a) would clarify 
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, hasn't 
been burned or blackened). TTB is authorizing the use of toasted wood 
in this proposal. Section 24.185(b) would state TTB's position on the 
use of wood essences and extracts in the production of wine.
    TTB is also proposing 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, and 
to remove the reference to oak chips from Sec.  24.246 and include it 
in new Sec.  24.185, in an effort to maintain in one location all 
regulatory provisions pertaining to the treatment of wine with wood.
Wine Spirits/Revision of Sec.  24.225
    TTB is proposing to amend Sec.  24.225 by removing the last 
sentence as described above, by revising the section heading, and by 
dividing the text into paragraph (a), covering withdrawal of spirits, 
paragraph (b), covering production and use of wine spirits, and 
paragraph (c), covering spirits other than wine spirits, and by 
otherwise revising the text, in order to accomplish the following:
     To incorporate the terms of section 5373(a) of the IRC 
related to standards for the production of wine spirits, including that 
portion of section 5373(a) that reads, ``where, in the production of 
natural wine or special natural wine, sugar has been used, the wine or 
the residuum thereof may not be used if the unfermented sugars therein 
have been refermented.'' The proposed text clarifies and simplifies 
this statutory language without changing the meaning or intent, which 
TTB believes is to prevent the production of wine spirits by 
refermenting wine to develop alcohol from sugar added to the wine after 
fermentation.
     To allow the use of lower-proof spirits in wine production 
in certain circumstances. 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 for two exceptions to this rule: (1) 
Distillation may be at less than 140 degrees of proof if regulations so 
provide; and (2) commercial brandy aged in wood for not less than 2 
years, and barreled at not less than 100 degrees of proof, is deemed to 
be wine spirits for purposes of section 5373(a). TTB believes that 
allowing the byproducts of alcohol reduction to be used as wine spirits 
if they are 100 degrees of proof or more is consistent with the intent 
of the statute. TTB notes that these alcohol reduction treatments, 
which are listed in Sec.  24.248, must be performed at a qualified 
distilled spirits plant because they result in a spirits byproduct. 
Thus, when the wine subjected to alcohol reduction is natural wine or 
special natural wine (and is subject to the other conditions of section 
5373(a) and Sec.  24.225), the alcohol-containing byproduct would still 
constitute wine spirits even though the spirits may not have been 
distilled at or above 140 degrees of proof. Accordingly, TTB is 
proposing, in revised Sec.  24.225, to allow spirits derived from 
authorized alcohol reduction treatments to be used as wine spirits if 
the spirits were distilled at 100 degrees of proof or more and if the 
spirits conform to the other terms of section 5373(a) as reflected in 
the revised regulatory text.
     To clarify the status of wine spirits derived from special 
natural wine. This source of spirits was codified in section 5373(a) of 
the IRC, which also authorized the Secretary of the Treasury

[[Page 83759]]

to impose conditions on the use of special natural wine to make wine 
spirits. TTB is proposing to specify in the revised text that wine 
spirits derived from special natural wine may only be used in the 
production of special natural wine when such wine spirits contain a 
distinctive flavor from the ingredients used in the originating special 
natural wine.
    Within the proposed new paragraph (b) text, subparagraphs (1) 
through (3) primarily reflect the terms of section 5373(a) of the IRC 
that TTB believes should be reflected in the regulatory text as 
discussed above, and subparagraph (4) primarily reflects the existing 
Sec.  24.225 text.
Accidental Water Additions
    TTB is proposing to add 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. Accidental 
water additions can occur during production of wine at various stages, 
for example during filtration when water is accidentally left in a tank 
that is later filled with wine. TTB has received requests from industry 
members who wish to be allowed to take corrective action regarding 
these water additions. To correct wine that has been diluted with water 
is referred to within TTB as ``to salvage.''
    The most common way to salvage wine is to remove the water 
accidentally added to the wine through the use of reverse osmosis, in 
combination with distillation. The reverse osmosis creates a colorless 
and flavorless permeate, essentially consisting of alcohol and water. 
The permeate is distilled to create a high ethanol fraction and a low 
ethanol fraction. The high ethanol fraction is returned to the wine and 
the low ethanol fraction is discarded. Through the use of reverse 
osmosis and distillation, the industry member removes the accidentally 
added water and raises the alcohol by volume of the wine back to its 
level before the accidental water addition, without affecting the 
vinous character of the wine.
    TTB has approved the use of reverse osmosis and distillation to 
remove water from wine under TTB's authority in Sec.  24.249. In those 
reviews, TTB considered how the accidental water addition occurred, the 
ratio of water to wine, and whether or not the requesting industry 
member has submitted similar requests in the past. TTB applied the 
following conditions to those approvals. The industry member must:
     Return the wine to its original condition;
     Transfer the wine to and from the distilled spirits plant 
for treatment in bond;
     Not remove more water than was accidentally added;
     Not alter the vinous character of the wine; and
     Keep the usual and customary records of the processing.
    TTB believes that proprietors should have the authority to remove 
small amounts of accidentally added water from wine using reverse 
osmosis and distillation without first seeking TTB approval. Proposed 
Sec.  24.251 sets forth 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. Proposed Sec.  24.251 also allows the appropriate TTB officer 
to 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 specifies that, 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 dilutions of water to wine and of compliance with other 
regulations in part 24.
    TTB has also 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. The requesters have asserted that, since 
Sec.  24.246 provides that when a wine or juice treating material is 
used and water is added to facilitate the solution or dispersal of the 
material, the volume of water added may not exceed 1 percent of the 
juice or wine, reduction of the accidentally added water to less than 1 
percent by blending wines meets the intent of the regulations. TTB has 
not approved these requests because the accidental addition of water 
renders the wine an ``other than standard'' wine, and such wine cannot 
be blended with standard wine. Also, TTB's authority to approve 
experimental or new wine treatments under Sec. Sec.  24.249 and 24.250 
does not extend to blending of wine, which is not a wine treatment or 
process. Additionally, wine diluted with water in excess of that 
permitted in part 24 renders the wine ``other than standard'' (see 27 
CFR 24.218). Section 24.218 provides that other than standard wine must 
be segregated from standard wine, and accordingly the blending of 
standard and other than standard wine generally is not permitted under 
TTB's regulations.
    While TTB has not previously approved these requests, TTB notes 
that current Sec.  24.246 permits the addition to wine of a limited 
amount of water with a wine treating material without affecting the 
classification of the wine as a standard wine. Accordingly, TTB 
believes that the regulations should be changed to recognize that the 
accidental addition of water to a standard wine that represents 1 
percent or less of the total volume of the wine does not render the 
wine other than standard. TTB also believes that blending wine should 
be permitted to reduce the accidentally added water to 1 percent or 
less of the total volume of the blended wine, and the resultant blended 
wine should be considered standard wine. Accordingly, TTB has 
incorporated these two provisions into a new section, proposed Sec.  
24.186, with a reference to a new Sec.  24.251, regarding accidental 
additions of water to wine.

Other Proposed Regulatory Amendments

    In addition to the changes discussed above, this document includes 
the following proposed regulatory amendments:
Definitions
    As a consequence of the proposed changes to Sec.  24.225(a), 
discussed above, TTB is proposing to revise the definition of ``wine 
spirits'' in Sec.  24.10 to include a reference to that regulatory 
provision.
Wood Essences
    TTB is proposing to amend Sec.  24.85, which concerns essences, by 
adding the term ``wood'' as an additional example of a source material 
for essences used in the production of formula wine. (The TTB 
regulations at 27 CFR 24.10 define formula wine as special natural 
wine, agricultural wine, and other than standard wine (except for 
distilling material and vinegar stock) produced on bonded wine permises 
under an approval formula.) TTB believes that it is appropriate to add 
wood to this provision to reflect a longstanding policy that an extract 
of wood made using any solvent but wine should be treated as an essence 
or flavoring material.
List of Authorized Wine and Juice Treating Materials
    TTB is proposing to amend the heading in paragraph (a) of Sec.  
24.246 to read ``Wine and juice'' rather than just ``Wine.'' This is a 
clarifying change. TTB is also proposing numerous

[[Page 83760]]

technical and clarifying changes to the table in Sec.  24.246. A 
significant portion of these technical changes involves 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 are only in U.S. 
Common (English) units or SI (International Standard, or metric) units, 
TTB is adding the other unit of measure for reference purposes, where 
appropriate. Since the majority of the units are expressed in U.S. 
Common units first and then in SI units, TTB is proposing to continue 
with that convention. TTB is including a footnote reference after each 
use of ppm and ppb in the chart to indicate parts per million and parts 
per billion, respectively. TTB is also including a definition of the 
word ``stabilize'' at the end of the chart and footnoting every 
appearance of the word ``stabilize'' with a ``1'' in the table. TTB is 
also adding a third column to the table in Sec.  24.246 titled ``FDA 
reference''. This new column contains references to relevant FDA 
regulations in title 21 of the CFR, FDA GRAS notifications, and FDA 
advisory opinions. These references have been moved to this new column 
wherever such a reference appears in the table. The ``FDA reference'' 
column provides a limit or reference where there is no ``Specific 
limit'' listed for a wine treating material.
    FDA recently provided TTB with a new advisory opinion dated 
September 8, 2016, updating their acceptance of TTB's approval for 
certain materials as wine and juice treating materials. This new 
advisory opinion was necessary because in some cases, TTB's current 
listing of FDA's acceptance of the material as a wine treating material 
was not entirely accurate because those references were not specific to 
the use of wine. In other cases, references to old advisory opinions 
were subsequently revoked by FDA rulemaking. TTB is replacing the 
current FDA references in Sec.  24.246 with an updated reference to an 
advisory opinion in which FDA stated ``We have evaluated the list of 
substances * * * along with their proposed limitations for use in wine 
and juice treatment and conclude that they are safe under the 
conditions of their intended use. We would not question a conclusion 
that these uses of substances added to wine would be generally 
recognized as safe (GRAS).'' Accordingly, TTB is updating the FDA 
reference for: Acetaldehyde, activated carbon, albumen (egg white), 
casein, potassium salt of casein, gelatin, potassium bi-tartrate, 
silica gel (colloidal silicon dioxide), and tannin.
    FDA also provided TTB with an advisory opinion dated August 29, 
2016, regarding the use of current and proposed yeast nutrients. With 
regard to current yeast nutrients, FDA indicated that the use of yeast 
nutrients as a treatment for wine is not listed in its regulations or 
GRAS notices. FDA did, however, state: ``We have evaluated the list of 
yeast nutrients * * * along with their proposed limitations for use 
prior to and during juice fermentations for wine production, taking 
into consideration: (1) Their likely consumption by yeasts and bacteria 
[is] likely to be largely consumed during fermentations and (2) their 
likely presence in finished wine products at levels that would not 
exceed those in unprocessed grape juice. We conclude that [the] 
increase in human dietary exposure to the substances resulting from 
their addition to wine juice is de minimis with respect to human 
nutrition, [and that] they are safe under the conditions of their 
intended use. Such levels would be far below any level that would 
result in a safety concern for any of these substances. Thus, we would 
not consider this very low level exposure to be significant and we 
would not question a conclusion that these uses of substances added to 
wine as yeast nutrients would be GRAS.'' Accordingly, TTB is updating 
the FDA reference for calcium panthothenate, soy flour, thiamine, yeast 
autolyzed, and yeast cell wall/membranes of autolyzed yeast.
    Due to the large number of proposed changes to Sec.  24.246, this 
document presents those changes as a revision of the entire section. 
Finally, TTB is proposing to make the following other changes to the 
current entries in the table:
     Activated carbon: One of the entries in the ``Materials 
and use'' column currently refers to removing color in wine and/or 
juice from which the wine was produced. TTB is proposing to refer 
instead to removing color from wine and/or juice, for clarity.
     Albumen: In the ``Specific limitation'' column, TTB is 
adding the words ``of brine'' in the second sentence after the word 
``Usage'' and removing the words ``of solution.''
     Ammonium phosphate (mono- and di basic): TTB is revising 
the name of the material to include ``diammonium phosphate'' and 
including it on the list of yeast nutrients in the table in Sec.  
24.246. (TTB is also making a conforming change revising the name of 
the material in Sec.  24.247.)
     Calcium carbonate: TTB is adding the abbreviation 
``CaCO3'' and, in the ``Materials and use'' column, TTB is 
replacing the word ``and'' with the word ``or'' in the first use entry 
and replacing the word ``A'' with the words ``As a'' in the second use 
entry.
     Casein, potassium salt of casein: In the ``Specific 
limitation'' column, TTB is referring only to the citation ``27 CFR 
24.243'' and removing references to FDA's GRAS opinions.
     Citric acid: In the ``Materials and use'' column, TTB is 
adding the words ``certain juice or'' after the word ``in'' in the 
first use entry. The limitations on what types of juice or wine may be 
treated with citric acid may be found in the regulations cited in the 
``Specific limitation'' column.
     Copper sulfate: In the ``Specific limitation'' column, TTB 
is removing the word ``added'' after the word ``sulfate'' and adding 
the words ``added to wine'' after the first parenthetical.
     Dimethyl dicarbonate: For purposes of clarity, TTB is 
adding the abbreviation ``(DMDC)'' after the material name ``Dimethyl 
dicarbonate'' and removing the phrases ``dealcoholized wine,'' and 
``low alcohol wine,'' from the entry to reduce redundancy.
     Ferrocyanide: 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. Accordingly, TTB is removing 
``ferrocyanide'' from the list of authorized wine treating materials.
     Milk products: With the publication of T.D. ATF-350 (58 FR 
52222) in the Federal Register on October 7, 1993, ATF approved the use 
of milk products as a fining agent in white grape wine or sherry. With 
the publication of T.D. TTB-17 (69 FR 67639) in the Federal Register on 
November 19, 2004, TTB extended this approval to all wines. The listing 
in Sec.  24.246 for the use of milk products, revised in 2004, reads, 
``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. Accordingly, TTB is amending the first 
listed use in the ``Materials and use'' column for this entry to read: 
``Fining agent for grape wine.''
     Oxygen and compressed air: In the ``Materials and use'' 
column, TTB is replacing the words ``May be used in juice and wine'' 
with the words ``Various uses in juice and wine.''
     Polyvinyl-polypry-rolidone (PVPP): In the ``Materials and 
use'' column, TTB is making a technical change by

[[Page 83761]]

removing the phrase ``black wine.'' In the ``Specific limitation'' 
column, TTB is replacing the two asterisk footnote references with a 
reference to footnote ``3'' after the abbreviation ``AOAC.''
     Sorbic acid and potassium salt of sorbic acid: In the 
``Materials and use'' column, TTB is adding the words ``potassium 
sorbate'' in parentheses before the colon.
     Sulfur dioxide: Sulfur dioxide was added to the list of 
approved materials with the issuance of T.D. Internal Revenue Service 
(IRS)-6475 (25 FR 6184) in 1960. At that time, the stated use of sulfur 
dioxide was to sterilize and preserve wine. The list of authorized 
treating materials in 1960 was codified in 26 CFR 240.1051 and was 
titled ``Materials authorized for treatment of wine.''
    Through the publication of T.D. ATF-182 (49 FR 37510) in 1984, ATF 
retitled the list of authorized wine treating materials as ``Materials 
authorized for treatment of wine and juice.'' In T.D. ATF-182, the 
comment discussion refers to the use of sulfur dioxide in wine as 
``necessary, common to, and historically documented in winemaking,'' 
and it is further referred to in the use of juice for purposes of 
winemaking twice on page 37513, under the subheading Antimicrobial 
Agents. Sulfur dioxide is GRAS in the FDA regulations at 21 CFR 
182.3862 as a chemical preservative. Section 182.3862 states that 
sulfur dioxide cannot be applied to fruit that is intended to be served 
or sold raw to consumers. Juice to be used in the production of wine is 
not fruit to be served or sold raw to consumers; thus, the use of 
sulfur dioxide in juice that will be used in the production of wine is 
GRAS. Further, 27 CFR 24.176 authorizes the use of sterilizing agents 
in juice. Accordingly, TTB is correcting the entry for sulfur dioxide 
to include its use in juice.
     Thiamine hydrochloride: As noted above, the yeast nutrient 
Thiamine hydrochloride will be re-organized and grouped under the 
heading, ``Yeast nutrients'' with the other yeast nutrients.
     Shall vs. must: Finally, to promote the use of plain 
language, TTB is also proposing to change ``shall'' to ``must'' 
wherever the former appears in the affected regulations.
    TTB is proposing to amend Sec.  24.250(a)(4) to require that an 
industry member must provide documentary evidence from the FDA showing 
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. This differs from 
the original text in that it is not requiring documentary evidence that 
the FDA has ``approved'' the use of the proposed material. This 
editorial change is consistent with similar changes in Sec. Sec.  
24.246 and 24.248.

Other Issues for Public Comment and Possible Regulatory Action

    In addition to the comments TTB is soliciting on the proposed 
regulatory changes contained in this document, as discussed above, TTB 
is inviting public comments on a number of other regulatory issues to 
assist TTB in determining whether it would be appropriate to 
incorporate additional changes to part 24 in a final rule. Most of 
these issues were raised in petitions for rulemaking or arose in 
connection with wine treatment approval requests under Sec. Sec.  
24.249 or 24.250, and in each case, TTB determined that more 
information would be required before a decision could be taken on 
whether, and if so how, appropriate regulatory changes should be 
proposed. The issues in question, and the specific points on which TTB 
is requesting public comments, are outlined below.
    TTB requests comments and, where appropriate, evidence supporting 
the position that the particular wine treatment is consistent with good 
commercial practice. If applicable, use rates should be recommended, 
and the rationale as to why those use rates are recommended should be 
stated in any comments.

Alcoholic Oak Extract

    In 2008, Oak Tannin Technologies submitted a petition to amend the 
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 understands that South 
Africa passed legislation that actually prohibits the use of such 
extracts in natural wines. In addition, 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 except agricultural wine.
    As noted earlier in this document, TTB approves the use of wine 
treating materials for, among other things, the stabilization, 
clarification, and filtration of natural wine based on the materials' 
acceptance in good commercial practice. In order to assist TTB in 
determining whether it would be appropriate to propose a specific 
regulatory change in response to this petition, TTB is inviting 
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 advises that a manufacturer of 
alcoholic oak extract must contact FDA and go through the FDA pre-
market review processes.

Lactic Acid

    In 2007, Hyman, Philips, & McNamara, P.C. petitioned TTB to amend 
27 CFR 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 then 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 lactic 
acid may be added before fermentation in certain other countries. 
Further, the petitioner noted that lactic acid is less expensive and 
more reliably available than tartaric acid.
    TTB is not proposing any changes to the regulations concerning the 
use of lactic acid in this document; however, TTB invites comments 
regarding whether or not the use of lactic acid prior to fermentation 
is good commercial practice in the production of natural wine. Comments 
should address whether or not lactic acid should be authorized for use 
prior to the fermentation of natural wine and provide detailed evidence 
supporting the stated position.

[[Page 83762]]

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. However, in 2014, Constellation Wines U.S. Inc. 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. The petition included the following arguments in support 
of this change:
     Reverse osmosis can effectively eliminate the weak and 
watery character of the retentate (which, as a product of the reverse 
osmosis process, is considered to be standard wine but with reduced 
levels of alcohol and water), resulting in a wine with improved phenol 
and flavor characteristics.
     The present situation puts U.S. winemakers at a 
competitive disadvantage in the global marketplace in two ways. First, 
the petitioner asserts 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. Exported U.S. wines, 
which cannot be produced in this way under the current regulations, 
would not reflect these characteristics in those foreign markets. 
Second, under the terms of section 5382 of the IRC, most imported wines 
that were subjected to such a process would be allowed to compete in 
the U.S. market against domestic wines to which that process may not be 
applied.
     Reverse osmosis benefits grape growers, winemakers, and 
consumers. The expanded use of reverse osmosis would allow grape 
growers to sell more grapes, particularly those of marginal quality, to 
winemakers who could produce better quality standard wine with such 
grapes. Winemakers would be able to produce better quality wine at 
lower costs, and consumers would be able to purchase better quality 
wine at lower prices.
     The expanded use of reverse osmosis would provide 
winemakers with better ability to regulate the alcohol content of 
wines.
    TTB notes that the byproduct of reverse osmosis (the retentate) is 
only considered to be standard wine if the wine that was processed with 
reverse osmosis was standard wine. TTB understands that the European 
Union (EU) only authorizes the use of reverse osmosis to remove water 
from wine in cold and wet regions and that wine produced with the use 
of reverse osmosis in the EU must be labeled as ``table wine.'' TTB's 
counterparts in Australia indicate that while authorized, reverse 
osmosis is not a process officially recognized in the Australia New 
Zealand Food Standards Code, and is not used frequently. TTB 
understands that South Africa authorizes the use of reverse osmosis on 
juice but not wine.
    TTB has not received other requests from industry members to use 
reverse osmosis to improve the phenol and flavor character of wine. 
However, TTB did receive a request to use reverse osmosis to improve 
the ``sensory quality'' of finished wines and to evaluate the potential 
sensory benefit of water content reduction compared to the resultant 
loss of volume.
    TTB has received and approved industry member requests to use 
reverse osmosis in combination with distillation to reduce the water 
content of wine only for the purpose of salvage, discussed above, 
rather than as a winemaking process to improve the character of the 
wine. In salvage, the removal of water returns the wine to its previous 
condition and, as a condition of approval, TTB strictly limited the 
amount of water to be removed to no more than the amount that had been 
accidentally added to the wine.
    TTB believes that it should provide the public the opportunity to 
comment before it makes a decision on whether the removal of water from 
wine to improve the characteristics of the wine would be acceptable in 
good commercial practice. To assist TTB in deciding whether to adopt 
any specific regulatory change in this regard, TTB is inviting 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.
    If you believe that the use of reverse osmosis for these purposes 
is consistent with good commercial practice, your comments should 
explain your position in detail, as well as provide guidelines/
standards concerning how much water (maximum percentage) may be 
removed. If you believe that the use of reverse osmosis for these 
purposes is not consistent with good commercial practice, your comments 
should explain your position in detail.

Ultrafiltration

    As previously discussed, an industry member requested 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. Ultrafiltration 
is authorized for use under Sec.  24.248 to separate red wine into low 
color and high color wine fractions for blending purposes; but the 
regulations do not provide for the use of ultrafiltration to separate 
white wine.
    TTB believes it should provide the public with the opportunity to 
comment before it makes a decision on whether the use of 
ultrafiltration to separate discolored wine for blending as described 
above would be acceptable in good commercial practice. If you wish to 
submit a comment on this matter, your comment should explain in detail 
your position as to why the use of ultrafiltration in this manner is or 
is not acceptable in good commercial practice.

Yeast Nutrients (Gusmer Petition)

    The following list of vitamins and minerals were proposed in the 
Gusmer petition as yeast nutrients in the production of wine but have 
not been administratively approved by TTB pursuant to Sec.  24.250: 
Cobalamin (vitamin B12), iodine (potassium iodide), iron, manganese 
sulfate, nickel, potassium chloride, riboflavin (Vitamin B2), and zinc 
sulfate. With the exception of riboflavin, TTB has not received 
requests under Sec. Sec.  24.249 or 24.250 to use these vitamins and 
minerals as yeast nutrients in the production of wine. TTB did not 
administratively approve the use of riboflavin as a yeast nutrient 
because the evidence submitted with the request was not sufficient to 
conclude that the use of riboflavin as a yeast nutrient is consistent 
with good commercial practice. Gusmer provided information on the FDA 
regulatory status, functional roles, and use rates for the following 
vitamins and minerals as yeast nutrients. TTB is interested in 
receiving 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. Unless otherwise 
noted, the information that follows was supplied by Gusmer.
     Cobalamin (vitamin B12): Cobalamin is used to promote 
growth of yeast, and Gusmer proposed that cobalamin be used at a rate 
not to exceed 15 ppb.
     Iodine (potassium iodide): Iodine is required for yeast 
growth and fermentation, and Gusmer proposed that iodine be used at a 
rate not to exceed 10 ppb.

[[Page 83763]]

     Iron: Iron is a catalyst for oxidation reactions, and 
Gusmer proposed that iron be used at a rate not to exceed 2 ppm.
     Manganese sulfate: Manganese sulfate is a pale pink, 
odorless powder that is freely soluble in water and insoluble in 
alcohol. Gusmer proposed that manganese sulfate be used at a rate not 
to exceed 100 ppb.
     Nickel: Nickel is a catalyst for hydrogenation, and Gusmer 
proposed that nickel be used at a rate not to exceed 5 ppm.
     Potassium chloride: Potassium chloride is a salt that 
disassociates into ions that are necessary for phosphate uptake by 
yeast. Gusmer proposed that potassium chloride be used at a rate not to 
exceed 100 ppm.
     Riboflavin (vitamin B2): Riboflavin is used as a coenzyme 
in oxidation/reduction reactions, and Gusmer proposed riboflavin be 
used at a rate not to exceed 600 ppb.
     Zinc sulfate: Zinc sulfate increases alcohol tolerance, 
and Gusmer proposed zinc sulfate be used at a rate not to exceed 1.5 
ppm.

Public Participation

Comments Sought

    TTB requests comments from the public and all interested parties. 
TTB is particularly interested in comments that address the question of 
whether a particular material, process, or practice addressed in this 
document is consistent with good commercial practice. Please support 
your comment with specific information about the material, process, or 
practice in question.
    After TTB analyzes any comments received in response to the 
regulatory amendments TTB has proposed in this document, we plan to 
issue a final rule. If TTB receives comments and evidence that persuade 
it that the use of a particular wine treating material or process is 
not consistent with good commercial practice, TTB will not include it 
in the final rule. As a result, and as stated in previously issued 
administrative approvals, if TTB has determined that the use of a wine 
or juice treating material or process is not consistent with good 
commercial practice, previous approvals of that wine or juice treating 
material or process will be rescinded by operation of law on the 
effective date of the final rule.
    Additionally, if TTB has determined that the authorized amount of a 
wine or juice treating material should be decreased because its current 
authorized amount is not consistent with good commercial practice, 
previous approvals authorizing the higher amount of that wine or juice 
treating material will be rescinded on the effective date of the final 
rule. Wines produced using treatments pursuant to an administrative 
approval that has been rescinded based upon this rulemaking may 
nevertheless be labeled as if the materials or processes were 
authorized, provided such treatments were used prior to the date of 
rescission.

Submitting Comments

    You may submit comments on the proposals described in this document 
by using one of the following three methods:
     Federal e-Rulemaking Portal: You may send comments via the 
online comment form linked to this document in Docket No. TTB-2016-0010 
on ``Regulations.gov,'' the Federal e-rulemaking portal, at https://www.regulations.gov. Direct links to the comment form and docket are 
available under Notice No. 164 on the TTB Web site at https://www.ttb.gov/wine/wine-rulemaking.shtml. Supplemental files may be 
attached to comments submitted via Regulations.gov. For information on 
how to use Regulations.gov, click on the site's Help tab.
     U.S. Mail: You may send comments via postal mail to the 
Director, Regulations and Rulings Division, Alcohol and Tobacco Tax and 
Trade Bureau, 1310 G Street NW., Box 12, Washington, DC 20005.
     Hand Delivery/Courier: You may hand-carry your comments or 
have them hand-carried to the Alcohol and Tobacco Tax and Trade Bureau, 
1310 G Street NW., Suite 400, Washington, DC 20005.
    Please submit your comments by the closing date shown above in this 
document. Your comments must reference Notice No. 164 and include your 
name and mailing address. Your comments also must be made in English, 
be legible, and be written in language acceptable for public 
disclosure. TTB does not acknowledge receipt of comments, and TTB 
considers all comments as originals.
    In your comment, please clearly state if you are commenting for 
yourself or on behalf of an association, business, or other entity. If 
you are commenting on behalf of an entity, your comment must include 
the entity's name, as well as your name and position title. If you 
comment via Regulations.gov, please enter the entity's name in the 
``Organization'' blank of the online comment form. If you comment via 
postal mail or hand delivery/courier, please submit your entity's 
comment on letterhead.
    You may also write to the Administrator before the comment closing 
date to ask for a public hearing. The Administrator reserves the right 
to determine whether to hold a public hearing.

Confidentiality

    All submitted comments and attachments are part of the public 
record and subject to disclosure. Do not enclose any material in your 
comments that you consider to be confidential or that is inappropriate 
for public disclosure.

Public Disclosure

    On the Federal e-rulemaking portal, Regulations.gov, TTB will post, 
and the public may view, copies of this document, selected supporting 
materials, and any electronic or mailed comments TTB receives about 
this proposal. A direct link to the Regulations.gov docket containing 
this document and the posted comments on it is available on the TTB Web 
site at https://www.ttb.gov/wine/wine-rulemaking.shtml under Notice No. 
164. You may also reach the docket containing this document and the 
posted comments received on it through the Regulations.gov search page 
at https://www.regulations.gov.
    All posted comments will display the commenter's name, organization 
(if any), city, and State, and, in the case of mailed comments, all 
address information, including email addresses. TTB may omit voluminous 
attachments or material that TTB considers unsuitable for posting.
    You and other members of the public may view copies of this 
document, all supporting materials, and any electronic or mailed 
comments TTB receives about these proposals by appointment at the TTB 
Information Resource Center, 1310 G Street NW., Washington, DC 20005. 
You may also obtain copies at 20 cents per 8.5- x 11-inch page. Contact 
TTB's information specialist at the above address or by telephone at 
202-453-2270 to schedule an appointment or to request copies of 
comments or other materials.

Regulatory Flexibility Act

    Pursuant to the requirements of the Regulatory Flexibility Act (5 
U.S.C. chapter 6), TTB certifies that these proposed regulations, if 
adopted, would not have a significant economic impact on a substantial 
number of small entities. This proposed rule provides for the voluntary 
use of additional wine and juice treating materials and

[[Page 83764]]

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 letterhead application to TTB. This rule, if adopted, 
would allow for certain treatments, under limited circumstances, 
without the submission of a letterhead application to TTB. TTB 
estimates that the proposed 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 proposal as wineries subject to this part still will be required 
to maintain those usual and customary records. This proposal has a 
neutral effect on the current recordkeeping requirements.
    Because this proposed rule will not have a significant economic 
impact on a substantial number of small entities no regulatory 
flexibility analysis is required. Pursuant to 26 U.S.C. 7805(f), TTB 
will submit the proposed regulations to the Chief Counsel for Advocacy 
of the Small Business Administration for comment on the impact of the 
proposed regulations on small businesses.

Paperwork Reduction Act

    Two collections of information approved by the Office of Management 
and Budget (OMB) would be affected by the adoption of the proposed 
regulatory changes described in this document. These collections of 
information, approved in accordance with the Paperwork Reduction Act of 
1995 (44 U.S.C. 3507), are assigned control numbers 1513-0057, titled, 
``Letterhead Applications and Notices Relating to Wine (TTB REC 5120/
2),'' and 1513-0115, titled ``Usual and Customary Business Records 
Relating to Wine (TTB REC 5120/1).'' An 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.

OMB Control Number 1513-0057

    TTB authorizes new wine treating materials and processes by 
evaluating proprietors' requests to experiment with such materials and 
processes under Sec.  24.249. Section 24.249 states, in part, that such 
requests must be made in the form of an application filed with TTB. 
Under this authorization, TTB has approved proprietors' requests to 
take corrective action when water has been accidentally added to wine 
in amounts exceeding those authorized for the production of standard 
wine under 27 CFR part 24. In this notice, TTB is proposing to add a 
new Sec.  24.251 to provide for the correction of accidentally diluted 
wine under certain circumstances without the submission of a letterhead 
application to TTB. TTB estimates that the proposed regulation will 
reduce the number of respondents by approximately 10 applicants per 
year and, therefore, will slightly reduce the information collection's 
overall burden.
    TTB estimates that, as a result of the proposed amendments, the new 
annual burden for control number 1513-0057 will be as follows:
     Estimated total annual reporting and/or recordkeeping 
burden: 820 hours.
     Estimated average annual burden hours per respondent: 0.5 
hours (30 minutes).
     Estimated number of respondents: 1,640.
     Estimated annual frequency of respondents: 1.
    Comments on this collection of information should be sent to OMB to 
Office of Management and Budget, Attention: Desk Officer for the 
Department of the Treasury, Office of Information and Regulatory 
Affairs, Washington, DC 20503; or email to [email protected]. 
A copy also should be sent to the Alcohol and Tobacco Tax and Trade 
Bureau by any of the methods previously described. Comments on the 
information collection should be submitted not later than January 23, 
2017.

OMB Control Number 1513-0115

    Under TTB's authority in 26 U.S.C. 5367, 5369, 5370, and 5555, TTB 
requires wineries to maintain usual and customary business records. 
Included in these records are those evidencing the details and results 
of experiments approved by TTB under Sec.  24.249. The proposed 
regulations contained in this document provide for a recordkeeping 
requirement in new Sec.  24.251 when wine is corrected for accidental 
water dilutions. The recordkeeping requirement in this proposed section 
is already accounted for under OMB Control Number 1513-0115 because 
such requests currently are treated as experiments under Sec.  24.249. 
Therefore, TTB does not believe that there is a change in the burden 
for this recordkeeping requirement, even for those wineries that are 
exempted from submitting a letterhead request under Sec.  24.251 
because still they will be required to maintain the currently required 
usual and customary business records.
    Comments on this collection of information should be sent to OMB to 
Office of Management and Budget, Attention: Desk Officer for the 
Department of the Treasury, Office of Information and Regulatory 
Affairs, Washington, DC 20503; or email to [email protected]. 
A copy also should be sent to the Alcohol and Tobacco Tax and Trade 
Bureau by any of the methods previously described. Comments on the 
information collection should be submitted not later than January 23, 
2017.

Executive Order 12866

    Certain TTB regulations issued under the IRC, including this one, 
are exempt from the requirements of Executive Order 12866, as 
supplemented and reaffirmed by Executive Order 13563. Therefore, a 
regulatory impact assessment is not required.

Drafting Information

    Kara Fontaine of the Regulations and Rulings Division, Alcohol and 
Tobacco Tax and Trade Bureau drafted this document.

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 in the preamble, TTB proposes to amend 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:

[[Page 83765]]

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'' to read 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 of this part for use in wine production.


Sec.  24.85   [Amended]

0
3. In Sec.  24.85, the first sentence is amended by adding the word 
``wood,'' after the word ``berries.''
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 by contact 
with any wood that is consistent with the food additive requirements 
under the Federal Food, Drug, and Cosmetic Act for food contact (see 21 
CFR part 7). 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), but not charred, and the wood must not be 
otherwise treated.
    (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. If any solvent other than alcohol or water 
is used to make a wood extract, the resulting extract must be 
consistent with the food additive requirements under the Federal Food, 
Drug, and Cosmetic Act for that purpose and may be used only in ``other 
wine'' in accordance with Sec.  24.218. This paragraph 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.

(Sec. 201, Pub. L. 85-859, 72 Stat. 1383-1384, 1386, as amended (26 
U.S.C. 5382, 5386))

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 
either:
    (1) Blending the diluted wine with a quantity of wine of the same 
kind so that the amount of water accidentally added does not exceed 1 
percent of the total volume of the blended wine; or
    (2) Removal of the accidentally added water from the wine in 
accordance with Sec.  24.251.

(Sec. 201, Pub. L. 85-859, 72 Stat. 1383-1384, as amended (26 U.S.C. 
5382))

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 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 100 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 wine premises only 
for the production of nonbeverage wine and nonbeverage wine products.

(Sec. 201, Pub. L. 85-859, 72 Stat. 1381-1384, as amended, and sec. 
455, Pub. L. 98-369, (26 U.S.C. 5214, 5362, 5373, 5382, 5383, 5386))

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,

[[Page 83766]]

where applicable, in the treatment of juice, within the ``Specific TTB 
limitation'' of this section and subject to the following conditions:
    (1) If the 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 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.

          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 8
                                   pounds per 1000
                                   gallons (1.92 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,\2\ and     September 8,
                                   the finished        2016.
                                   concentrate must
                                   have no
                                   detectable level
                                   of the material.
Activated carbon:
    To assist precipitation       27 CFR 24.176.....  FDA advisory
     during fermentation.                              opinion dated
                                                       September 8,
                                                       2016.
    To clarify and purify wine..  The amount used to  FDA advisory
                                   clarify and         opinion dated
                                   purify wine must    January 26, 1979.
                                   be included in
                                   the total amount
                                   of activated
                                   carbon used to
                                   remove excessive
                                   color in wine. 27
                                   CFR 24.241 and
                                   24.242.
    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
                                   the wine was
                                   produced, must
                                   not exceed 25
                                   pounds per 1000
                                   gallons (3 g/L).
                                   If the amount
                                   necessary exceeds
                                   this limit, a
                                   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 182.2727,
 e.g., Bentonite (Wyoming clay)                        182.2729,
 and Kaolin: To clarify and                            184.1155 and
 stabilize \1\ wine or juice.                          186.1256.
                                                      FDA advisory
                                                       opinion dated
                                                       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 Notice No.
 stabilize \1\ wine from the       must not exceed     GRN 284.
 precipitation of potassium        3.3 pounds per
 bitartrate crystals.              1000 gallons (400
                                   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
                                   (5 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.  0.8 pounds per
                                   1000 gallons (10
                                   g/hL) of wine.

[[Page 83767]]

 
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.
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.\2\
                                   The residual
                                   level of copper
                                   in the finished
                                   wine must not
                                   exceed 0.5 ppm
                                   \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 \2\.
Dimethyl dicarbonate (DMDC): To   DMDC may be added   Must meet the
 sterilize and stabilize \1\       to wine in a        conditions
 wine.                             cumulative amount   prescribed by FDA
                                   not to exceed 200   in 21 CFR
                                   ppm \2\.            172.133.
Enzymatic activity: Various       The enzyme
 enzymes and uses, as shown        preparation used
 below:                            must be prepared
                                   from nontoxic and
                                   nonpathogenic
                                   microorganisms in
                                   accordance with
                                   good
                                   manufacturing
                                   practice and be
                                   consistent with
                                   FDA's regulations.
    Carbohydrase (alpha-          The amylase enzyme  FDA advisory
     Amylase): To convert          activity must be    opinion of August
     starches to fermentable       derived from:       18, 1983.
     carbohydrates.               Aspergillus niger,  ..................
                                   Aspergillus        ..................
                                   oryzae, Bacillus
                                   subtilis, or
                                   barley malt; or.
                                     from Rhizopus    21 CFR 173.130.
                                      oryzae: or.
                                     from Bacillus    21 CFR 184.1027.
                                      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
                                   niger,
                                   Aspergillus
                                   oryzae, or.
                                  from Rhizopus       21 CFR 173.130.
                                   oryzae,.
                                  or from Rhizopus    21 CFR 173.110.
                                   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
                                   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-gucanase
     To clarify and filter wine.   activity must be    derived from
                                   derived from        Trichoderma
                                   Trichoderma         longibrachiatum,
                                   longibrachiatum     21 CFR 184.1250.
                                   or Trichoderma     For beta-glucanase
                                   harzianum. The      derived from
                                   amount used must    Trichoderma
                                   not exceed 30 ppm   harzianum, GRAS
                                   \2\.                Notice No. GRN
                                                       149.
Glucose oxidase: To clarify and   The enzyme          FDA advisory
 stabilize \1\ wine.               activity must be    opinion of August
                                   derived from        18, 1983.
                                   Aspergillus niger.
Lysozyme: To stabilize \1\ wines  The amount used     FDA advisory
 from malolactic acid bacterial    must not exceed     opinion dated
 degradation.                      500 ppm.\2\.        December 15,
                                                       1993.
Pectinase: To clarify and         The enzyme          FDA advisory
 stabilize \1\ wine and to         activity used       opinion dated
 facilitate separation of juice    must be derived     August 18, 1983.
 from the fruit.                   from Aspergillus
                                   niger.
Protease (general): To reduce or  The enzyme          FDA advisory
 to remove heat labile proteins.   activity must be    opinion dated
                                   derived from:       August 18, 1983.
                                  Aspergillus niger
                                   or Bacillus
                                   subtilis or from;.
                                     Bacillus         21 CFR 184.1027.
                                      licheniformis.
    Protease (Bromelin): To       The enzyme          FDA advisory
     reduce or remove heat         activity must be    opinion dated
     labile proteins.              derived from        August 18, 1983.
                                   Ananus comosus or
                                   Ananus bracteatus
                                   (L).
    Protease (Ficin): To reduce   The enzyme          FDA advisory
     or remove heat labile         activity must be    opinion dated
     proteins.                     derived from        August 18, 1983.
                                   Ficus spp.
    Protease (Papain): To reduce  The enzyme          21 CFR 184.1585.
     or remove heat labile         activity must be
     proteins.                     derived from
                                   Carica papaya (L).

[[Page 83768]]

 
    Protease (Pepsin): To reduce  The enzyme          FDA advisory
     or remove heat labile         activity must be    opinion dated
     proteins.                     derived from        August 18, 1983.
                                   porcine or bovine
                                   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.
    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
                                   \2\ and must be
                                   filtered prior to
                                   final packaging.
Ethyl maltol: To stabilize \1\    Use authorized at   FDA advisory
 wine.                             a maximum level     opinion dated
                                   of 100 ppm \2\ in   December 1, 1986.
                                   all standard
                                   wines except
                                   natural wine
                                   produced from
                                   Vitis vinifera
                                   grapes.
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.
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,      21 CFR 184.1069.
 acid deficiencies in juice or     24.192.
 wine.
Malo-lactic bacteria: To          Malo-lactic         FDA advisory
 stabilize \1\ grape wine.         bacteria of the     opinion dated
                                   type Leuconostoc    February 25,
                                   oenos may be used   1985.
                                   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 (250
                                   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.
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.
Polyvinyl-polypyr-rolidone        The amount used to  21 CFR 173.50.
 (PVPP): To clarify and            treat the wine,
 stabilize \1\ wine and to         including the
 remove color from red wine or     juice from which
 juice.                            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.
                                   The finished wine
                                   must retain
                                   vinous character
                                   and must have
                                   color of not less
                                   than 0.6 Lovibond
                                   in a one-half
                                   inch cell or not
                                   more than 95
                                   percent
                                   transmittance per
                                   AOAC Method
                                   11.003-11.004
                                   (14th Ed.) \3\.
Polyvinyl-pyrrolidone (PVP)/      The amount used to  21 CFR 173.55 and
 polyvinylimadazole (PVI)          treat the wine      FDA FCN No. 320.
 polymer: To remove heavy metal    must not exceed
 ions and sulfides from wine.      6.7 pounds per
                                   1000 gallons (80
                                   g/hL) of 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).

[[Page 83769]]

 
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.
Potato protein isolate: Fining    Use must not        GRAS Notice No.
 agent for wine.                   exceed 500 ppm      GRN 000447.
                                   \2\ (50 g/hL) of
                                   wine.
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:   The amount used     21 CFR 182.1745.
 To stabilize \1\ wine by          must not exceed
 preventing tartrate               0.8% of the wine.
 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    \2\ of sorbic
 growth and secondary              acid.
 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
                                   \2\ by the
                                   addition of
                                   tannic acid
                                   (polygalloylgluco
                                   se).
    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 \2\ by the
                                   addition of
                                   tannic acid (poly-
                                   galloylglucose).
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
     or wine and to reduce the     and 24.192.        GRAS Notice No.
     pH of grape juice or wine                         GRN 000187.
     where ameliorating material
     is used in the production
     of grape wine.
Yeast nutrients: 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......................  The amount used     FDA advisory
                                   must not exceed     opinion dated
                                   25 ppb \4\.         August 29, 2016.
    Calcium pantothenate          The amount used     FDA advisory
     (vitamin B5).                 must not exceed     opinion dated
                                   1.5 ppm \2\.        August 29, 2016.
    Folic acid (folate).........  The amount used     FDA advisory
                                   must not exceed     opinion dated
                                   100 ppb \4\.        August 29, 2016.
    Inositol (myo-inositol).....  The amount used     FDA advisory
                                   must not exceed 2   opinion dated
                                   ppm \2\.            August 29, 2016.
    Magnesium sulfate...........  The amount used     FDA advisory
                                   must not exceed     opinion dated
                                   15 ppm \2\.         August 29, 2016.
    Niacin (vitamin B3).........  The amount used     FDA advisory
                                   must not exceed 1   opinion dated
                                   ppm \2\.            August 29, 2016.
    Pyridoxine hydrochloride      The amount used     FDA advisory
     (vitamin B6).                 must not exceed     opinion dated
                                   150 ppb \4\.        August 29, 2016.
    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.
------------------------------------------------------------------------
\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\ Official Methods of Analysis of AOAC INTERNATIONAL, Volumes I & II,
  AOAC INTERNATIONAL, 481 North Frederick Avenue, Suite 500,
  Gaithersburg, MD 20877-2417.
\4\ Parts per billion--1ppb = 0.000128 ounces per 1000 gallons = 1 mg/
  1000L.


[[Page 83770]]

* * * * *
0
8. Section 24.247 is amended by:
0
a. Revising the introductory text;
0
b. Revising the entry in the table for ``Ammonium phosphate (mono- and 
di basic''; and
0
c. Removing the footnote at the end of the table.
    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. Removing the entries for ``Nanofiltration,'' ``Reverse osmosis,'' 
and ``Ultrafiltration'';
0
c. Adding an entry for ``Cross flow filtration'', including subentries 
for ``Nanofiltration'', ``Reverse osmosis'', and ``Ultrafiltration'', 
at the top of the table;
0
d. Revising the entries for ``Osmotic transport'', ``Spinning cone 
column'', and ``Thin-film evaporation under reduced pressure''; and
0
e. Removing footnote 1 at the end of the table and adding new footnotes 
1 and 2.
    The additions and revisions to the table and its footnotes 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       This process must
                                   level of volatile   use permeable
                                   acidity in wine     membranes which
                                   (used with ion      are selective for
                                   exchange), to       molecules not
                                   reduce the ethyl    greater than 150
                                   alcohol content     molecular weight
                                   of wine.            with
                                                       transmembrane
                                                       pressures of 250
                                                       psi or less.
    Reverse osmosis \2\.........  To reduce the       Permeable
                                   ethyl alcohol       membranes that
                                   content of wine     are selective for
                                   and to remove off   molecules not
                                   flavors in wine.    greater than 500
                                                       molecular weight
                                                       with
                                                       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.
    Ultrafiltration \2\.........  To remove           Permeable
                                   proteinaceous       membranes that
                                   material from       are selective for
                                   wine; to reduce     molecules greater
                                   harsh tannic        than 500 and not
                                   material from       less 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 juice and
                                   wine into low
                                   color and high
                                   color fractions
                                   for blending
                                   purposes, to
                                   reduce the ethyl
                                   alcohol content
                                   of wine.
 
                              * * * * * * *
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.
 

[[Page 83771]]

 
                              * * * * * * *
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 preasure \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 nanofilitration, under certain limited conditions, may be
  used on bonded winery premises if ethyl alcohol is only temporarily
  created within a closed system.

* * * * *
0
10. Paragraph (b) of Sec.  24.250 is amended to read as follows:


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

    (b) 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 24.251 is added to read as follows:


Sec.  24.251   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 subparts F and L of this part, the 
accidentally diluted wine may be returned to its original condition 
through the use of reverse osmosis and distillation without prior 
application to TTB provided that:
    (1) The accidentally added water represents no more than 10 percent 
of the original volume of the wine;
    (2) 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;
    (3) The vinous character of the wine is not altered;
    (4) The proprietor transfers the wine in bond to a distilled 
spirits plant for treatment; and
    (5) 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 
part 24.
    (c) Records. The proprietor must, with respect to removals of water 
from wine 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.

    (Sec. 201, Pub. L. 85-859, 72 Stat. 1383-1384, as amended (26 
U.S.C. 5382))

    Signed: June 16, 2016.
John J. Manfreda,
Administrator.
    Approved: October 25, 2016.
Timothy E. Skud,
Deputy Assistant Secretary. (Tax, Trade, and Tariff Policy).
[FR Doc. 2016-27581 Filed 11-21-16; 8:45 am]
 BILLING CODE 4810-31-P