[Federal Register Volume 69, Number 223 (Friday, November 19, 2004)]
[Rules and Regulations]
[Pages 67639-67645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25739]


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DEPARTMENT OF THE TREASURY

Alcohol and Tobacco Tax and Trade Bureau

27 CFR Part 24

[T.D. TTB-17]
RIN 1513-AA96


Materials and Processes Authorized for the Treatment of Wine and 
Juice (2004R-517P)

AGENCY: Alcohol and Tobacco Tax and Trade Bureau (TTB), Treasury.

ACTION: Temporary rule; solicitation of comments.

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SUMMARY: The Alcohol and Tobacco Tax and Trade Bureau is revising its 
list of materials authorized for the treatment of wine and juice, and 
its list of processes authorized for the treatment of wine, juice, and 
distilling material. Specifically, we are adding new material and 
process listings, and amending the limitations for some existing 
listings pertaining to wine and juice. We are seeking comments from all 
interested parties on our view that the materials and processes covered 
by these changes are consistent with good commercial practice in the 
production, cellar treatment, or finishing of juice or standard wine.

DATES: Temporary rule effective November 19, 2004. Comments must be 
received on or before January 18, 2005.

ADDRESSES: You may send comments to any of the following addresses--
     Chief, Regulations and Procedures Division, Alcohol and 
Tobacco Tax and Trade Bureau, Attn: T.D. TTB-17, P.O. Box 14412, 
Washington, DC 20044-4412;
     202-927-8525 (facsimile);
     [email protected] (e-mail);
     http://www.ttb.gov/alcohol/rules/index.htm (an online 
comment form is posted with this notice on our Web site); or
     http://www.regulations.gov (Federal e-rulemaking portal; 
follow instructions for submitting comments).
    You may view copies of any comments we receive about this temporary 
rule by appointment at the TTB Library, 1310 G Street, NW., Washington, 
DC 20220. To make an appointment, call 202-927-2400. You may also 
access copies of the interim rule and comments online at http://www.ttb.gov/alcohol/rules/index.htm.
    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.

FOR FURTHER INFORMATION CONTACT: Jennifer Berry, Alcohol and Tobacco 
Tax and Trade Bureau, Regulations and Procedures Division, P.O. Box 
18152, Roanoke, Virginia 24014; telephone 540-344-9333.

SUPPLEMENTARY INFORMATION:

Background

    Section 5382 of the Internal Revenue Code of 1986 (26 U.S.C. 5382) 
provides that proper cellar treatment of natural wine constitutes those 
practices and procedures that produce a finished product acceptable in 
good commercial practice. Section 5382 also authorizes the Secretary of 
the Treasury to prescribe, by regulation, limitations on the use of 
methods and materials for clarifying, stabilizing, preserving, 
fermenting, and otherwise correcting wine and juice.
    The regulations administered by the Alcohol and Tobacco Tax and 
Trade Bureau (TTB) include, in 27 CFR part 24, provisions that 
implement these statutory requirements. Section 24.246 (27 CFR 24.246) 
includes a table that lists materials authorized for the treatment of 
wine and juice; Sec.  24.247 (27 CFR 24.247) includes a table that 
lists materials authorized for the treatment of distilling material; 
and Sec.  24.248 (27 CFR 24.248) includes a table that lists processes 
authorized for the treatment of wine, juice, and distilling materials.
    Industry members wishing to experiment with, or commercially use, a 
treating material or process not specifically authorized in part 24 may 
file an application with TTB requesting authorization to use the new 
material or process. Standards regarding the experimental use of a new 
material or process are set forth in Sec.  24.249 (27 CFR 24.249). The 
provisions covering applications for commercial use of a new material 
or process are contained in Sec.  24.250 (27 CFR 24.250). Applications 
for commercial use must show that the proposed material or process is a 
cellar treatment consistent with good commercial practice. In general, 
good commercial practices include those practices that address the 
reasonable technological or practical need to enhance the keeping, 
stability, or other qualities of the wine and that achieve the 
winemaker's desired effect, without creating an erroneous impression 
about the wine's character and composition.
    Over the past few years, TTB has received and approved applications 
for experimental or commercial use of the wine and juice treating 
materials and processes discussed below. We believe we have accumulated 
enough analytical data or other information to add them to the list of 
materials and processes for

[[Page 67640]]

wine and juice in Sec. Sec.  24.246 and 24.248. Since we have already 
administratively approved the use of these materials and processes for 
some industry members for bottling and sale of wine under Sec.  
24.249(e), or for commercial use under Sec.  24.250, we believe it is 
appropriate to adopt these additions to the lists as a temporary rule. 
In this way, all domestic winemakers will be able to use these 
treatments in the production of standard wine, pending final regulatory 
action, without first having to file an application under Sec.  24.249 
or Sec.  24.250. At the same time, we are soliciting comments from all 
interested persons on our position that, based on the information set 
forth below, the use of each of these materials or processes is 
consistent with good commercial practice.
    After we analyze any comments received in response to this notice, 
we will issue a final rule. Unless we receive evidence contradicting 
our stated position, we will adopt the temporary additions to the lists 
in the final rule. On the other hand, if we receive comments that 
persuade us that the use of a particular material or process is not 
consistent with good commercial practice, we will remove it from the 
appropriate list in our final rule. In such a case, all letters 
approving the experimental or commercial use of the material or process 
will be superseded as a result and will be rescinded by operation of 
law on the effective date of the final rule. Wines produced using such 
materials or processes that are rescinded based upon this rulemaking 
may nevertheless be labeled as if the materials or processes were 
authorized, provided they were produced prior to the date of 
supercession.

Wine and Juice Treating Materials

Acetaldehyde

    An industry member applied to use acetaldehyde in grape juice to 
stabilize color in red grape concentrate. Acetaldehyde is a natural 
byproduct of yeast metabolism. A normal component of wine and other 
fermented products, it occurs naturally in California table wines at 
levels between 32 and 91 mg/L. The Food and Drug Administration (FDA) 
regulations at 21 CFR 182.60 state that acetaldehyde, when used as a 
synthetic flavoring substance and adjuvant, is generally recognized as 
safe (GRAS) with no established regulatory limit other than good 
manufacturing practice.
    Acetaldehyde reacts with grape pigments (anthocyanins) and 
catechins (proanthocyanidins) to form a more stable color. According to 
the industry member, wines containing color-stabilized concentrate have 
an extended shelf life compared to wines containing standard 
concentrate. The industry member stated that any residual acetaldehyde 
is removed during the concentration process through the use of 
evaporators so that the finished concentrate will have no detectable 
level of acetaldehyde.
    The industry member submitted to the TTB Laboratory two 750-
milliliter samples of wine, one containing the treated grape 
concentrate (comprising 1% of the total volume of the sample) and one 
(the base) without the concentrate. The Laboratory found that the wine 
containing the concentrate was a darker, more opaque red than the base. 
The amount of acetaldehyde was slightly lower in the sample with the 
concentrate, but in other instrumental analyses the two samples were 
similar.
    Consequently, TTB approved the commercial use of acetaldehyde in 
juice at a level of 300 mg/L to stabilize color in red grape 
concentrate. TTB gave this approval pending adoption of acetaldehyde as 
a treating material through the rulemaking process.
    TTB is amending the list in Sec.  24.246 to allow the use of 
acetaldehyde in juice prior to concentration at the rate of 300 mg/L, 
provided that no residual acetaldehyde remains in the finished 
concentrate.

Calcium Pantothenate

    An industry member applied to use calcium pantothenate as a yeast 
nutrient in the production of apple wine. Calcium pantothenate is a 
salt of pantothenic acid, one of the vitamins of the B complex. The FDA 
regulations at 21 CFR 184.1212 state that calcium pantothenate is GRAS 
and may be used as a direct human food ingredient at a level consistent 
with current good commercial practice. Along with its application, the 
industry member submitted a material safety data sheet from the 
manufacturer and an excerpt from the Merck Index describing calcium 
pantothenate's chemical composition.
    TTB approved the industry member's request to use calcium 
pantothenate for the production of apple wine at the rate of 0.1 lb. 
per 25,000 gallons of juice. TTB gave this approval pending final 
rulemaking action on the use of calcium pantothenate. This temporary 
rule document adds this material to the list in Sec.  24.246.

Carbohydrase (Pectinase, Cellulase, Hemicellulse) Enzyme Preparation

    TTB has approved several requests from wineries to use a mixed 
carbohydrase (pectinase, cellulase, hemicellulse) enzyme preparation 
derived from a nonpathogenic and nontoxigenic strain of Aspergilius 
aculeatus to facilitate the separation of juice from the fruit. 
According to technical information supplied by the enzyme's 
manufacturer, it disintegrates fruit cell walls, resulting in a quicker 
and more complete release of juice. A supplier of the enzyme stated 
that it lowers viscosity, improves clarification and filterability, and 
maximizes yield. The supplier also stated that it allows for more 
complete color extraction in red grape juice.
    The FDA accepted a GRAS affirmation petition for this enzyme 
preparation from the manufacturer in 1985. In a December 19, 1996, 
letter regarding the status of the GRAS affirmation petition, the FDA 
stated that it had no information indicating that the enzyme 
preparation is not GRAS. Based on the above information, TTB is adding 
this mixed carbohydrase enzyme preparation derived from Aspergilius 
aculeatus to the list of authorized enzymatic activities found in Sec.  
24.246 authorized materials table.

Cellulase Enzyme Preparation

    An industry member applied to use a cellulase enzyme preparation 
derived from Tricoderma longibrachiatu to facilitate wine clarification 
and filtering. The enzyme, cellulase, catalyzes the endohydrolysis of 
1, 4-beta-glycosidic linkages in cellulose. According to the technical 
data sheet issued by the enzyme's manufacturer, the preparation is best 
suited to treat difficult-to-filter wines, such as those produced from 
Botrytis-infected grapes. The FDA regulations at 21 CFR 184.1250 state 
that cellulase enzyme preparations derived from Trichoderma 
longibrachiatu are GRAS for use as a direct human food ingredient and 
may be used in amounts not exceeding current good manufacturing 
practice.
    TTB approved the industry member's request to use this enzyme 
preparation at the rate of 1 to 3 grams per hectoliter (g/hl), the 
usage rate recommended by the manufacturer. TTB gave this approval 
pending final rulemaking action on the use of this material.
    We are amending the list of authorized enzymatic activities in the 
Sec.  24.246 authorized materials table by adding the use of this 
cellulase enzyme preparation, at a rate not to exceed 3 g/hl, to 
facilitate wine clarification and filtering.

Copper Sulfate

    Copper sulfate is currently listed in Sec.  24.246 for use in 
removing hydrogen

[[Page 67641]]

sulfide and other mercaptans from wine. These chemical compounds can 
cause off odors in wine that are often compared to those of rotten egg 
and skunk. The quantity of added copper sulfate (calculated as copper) 
may not exceed 0.5 part copper per million parts of wine (0.5 mg/L), 
with the residual level of copper not to exceed 0.5 part per million 
(0.5 mg/L). This residual level was established by T.D. ATF-350 (See 58 
FR 52231, October 7, 1993), which cited studies showing that wine 
treated with copper sulfate is stable with residual copper levels at 
0.5 part per million or less.
    A number of wineries applied to TTB to use copper sulfate at a rate 
of 6 parts per million for specific vintages due to rainy harvest 
conditions that required them to spray elevated levels of sulfur on 
their grapes to prevent mold and mildew. These wineries stated that the 
residual sulfur on the grapes hindered fermentation and caused off 
odors, problems they were sometimes unable to correct with the approved 
level of copper sulfate. TTB approved these applications to use up to 6 
parts per million for the vintages requested, provided that the 
residual level of copper sulfate in the wine did not exceed 0.5 part 
per million. Samples of wine treated with this higher level of copper 
sulfate were submitted to the TTB Laboratory and found to have residual 
copper levels below 0.5 part per million.
    New technologies developed in recent years enable winemakers to 
more easily remove added copper from wine. The use of the metal 
reducing matrix sheet discussed below is an example of one such new 
technology. Because winemakers occasionally need to use a higher level 
of copper sulfate, and because new technologies allow winemakers to 
more readily remove this added copper, TTB is revising the existing 
listing in Sec.  24.246 to raise the quantity of copper sulfate allowed 
to 6 parts per million, with the residual level remaining 0.5 part per 
million.

Lysozyme

    TTB has approved several requests from wineries under Sec.  24.249 
to use lysozyme, an enzyme derived from egg white, for the purpose of 
limiting malolactic bacterial growth during wine fermentation. Such 
growth, if left unchecked, can adversely affect a wine's taste and can 
cause stuck or sluggish fermentation. Lysozyme attacks the cell walls 
of gram-positive bacteria, such as Lactobacillus, Pediococcus, and 
Leuconostoc, causing them to degrade. This use of lysozyme can greatly 
reduce the need for sulfur dioxide, which poses a health hazard to 
sulfite-sensitive individuals. The FDA regulations at 21 CFR 184.1550 
state that egg white lysozyme is GRAS when used in the production of 
cheese.
    A number of wineries had the results of their initial experimental 
trials with lysozyme analyzed by independent laboratories, including 
Oregon State University, which has extensively researched the use of 
lysozyme in wine production. The wineries submitted the resulting 
analytical and sensory data, which included data on the shelf life of 
the treated wine, to the Bureau of Alcohol, Tobacco and Firearms (ATF), 
TTB's predecessor agency. The wineries were generally pleased with the 
results of these trials and analyses, which found that lysozyme 
inhibited the growth of malolactic bacteria without causing negative 
sensory impact on the wine. The most effective usage level ranged from 
250 mg/L to 500 mg/L.
    In 1993, ATF requested an advisory opinion from the FDA regarding 
the safety of using lysozyme in wine to inhibit the growth of 
malolactic bacteria. The Director of the FDA's Office of Premarket 
Approval at the Center for Food Safety and Applied Nutrition responded 
by letter dated December 15, 1993. The Director stated that the FDA was 
``currently unaware of any safety or health concerns for the general 
population with regard to the use of lysozyme in wine. Essentially, the 
use in question consists of adding a chemically unmodified major 
protein component (lysozyme) of one common food (eggs) to another 
common food (wine).''
    Based on the above information, TTB is adding lysozyme to the list 
of authorized enzymatic activities in the Sec.  24.246 authorized 
materials table for the purpose of limiting malolactic bacterial growth 
during wine fermentation. The approved usage rate may not exceed 500 
mg/L.

Milk Products

    Pasteurized whole or skim milk is currently listed in Sec.  24.246 
as authorized for the fining of white grape wine or sherry. The amount 
used may not exceed 2.0 liters of pasteurized milk per 1,000 liters of 
white wine or sherry (0.2 percent by volume).
    TTB has approved applications from a few wineries to use milk and 
half-and-half at the approved usage rate of 0.2% by volume for the 
fining of red wine. One winery submitted before and after samples of 
the treated wine to the TTB Laboratory for analysis. The Laboratory 
conducted chemical and organoleptic analyses, which found that the milk 
treatment improved the taste of the wine without altering its basic 
characteristics.
    In addition, a few wineries have applied to use milk and half-and-
half to remove trichloroanisole (TCA), which causes off flavors, from 
wine. Laboratory data submitted by these wineries showed that milk and 
half-and-half were effective at removing TCA taint without altering the 
phenolic profile of the treated wine. Half-and-half was found to be 
particularly effective at removing the TCA due to its higher fat 
content. The level of milk product used ranged from 0.2% to 10% by 
volume. The wineries removed residual milk from the wine through 
conventional filtering methods. One winery submitted to the TTB 
Laboratory samples of treated wine, along with a control sample. 
Analytical and organoleptic tests performed by the Laboratory found 
that the treatment did not affect the vinous character of the wine.
    Based on the above, TTB believes that Sec.  24.246 should provide 
for the use of milk and half-and-half to fine all grape wine rather 
than only white wine and sherry. TTB also believes the present rate of 
usage (the milk product may not exceed 0.2% by volume of the wine) 
should remain unchanged. Similarly, Sec.  24.246 should provide for the 
use of milk and half-and-half to remove off flavors from wine. TTB 
believes that wineries should have the option of using milk products to 
remove all off flavors from wine, not just those caused by TCA taint. 
The amount of milk or half-and-half used for this purpose should not 
exceed 10 liters per 1,000 liters of wine (1% of the volume of the 
wine). To effect these changes, we have replaced the heading ``milk 
(pasteurized whole or skim)'' with the heading ``milk products 
(pasteurized whole, skim, or half-and-half)'' in the Sec.  24.246 
authorized materials table.

Silica Gel (Colloidal Silicon Dioxide)

    Silica gel (colloidal silicon dioxide) is currently approved in 
Sec.  24.246 to clarify wine. Its use may not exceed the equivalent of 
20 lbs. colloidal silicon dioxide at a 30% concentration per 1,000 
gallons of wine (2.4 g/L), and the silicon dioxide must be completely 
removed by filtration. The FDA regulations at 21 CFR 172.480 permit the 
use of silicon dioxide as a food additive.
    An industry member applied to have the current authorization 
extended to the clarification of juice. TTB approved this request to 
use silica gel on juice, subject to the current limitations of Sec.  
24.246, and subject to final rulemaking action. The existing listing 
for silica gel

[[Page 67642]]

is revised in this document to reflect this approval.

Wine Treating Processes

Electrodialysis

    TTB has received and approved numerous requests from wineries to 
experiment with the procedure known as electrodialysis to remove excess 
tartrates from wine. Electrodialysis is a process by which certain 
ions, namely potassium, calcium, and tartrate ions, are extracted from 
wine by applying an electric field across specialized charged 
membranes.
    As described by the supplier of the electrodialysis apparatus, the 
process consists of moving bulk wine past two membranes, one on either 
side of the wine. One membrane is selectively permeable to tartrate 
salts and the other is selectively permeable to calcium and potassium 
salts. As the wine passes between the two membranes, a water-based 
conductant is passed on the other side of both membranes. As both 
liquids flow through the apparatus, a weak electrical current is 
introduced, which causes the tartrate salts to migrate towards the 
positively charged membrane and the potassium and calcium salts to 
migrate toward the negatively charged membrane. As the tartrate, 
calcium, and potassium salts pass through the membranes, they enter the 
conductant stream and are carried out of the apparatus and discarded. 
The treated wine is then collected for bottling.
    As part of the experimentation process described above, the 
wineries in question submitted before and after samples to the TTB 
Laboratory for analysis. The Laboratory analyzed the treated and 
untreated wines and found that the analytical profile of the treated 
wine was consistent with that of the untreated wine.
    Based on the above, TTB is adding electrodialysis to the list of 
approved processes in Sec.  24.248.

Metal/Sulfide Reducing Matrix Sheets

    TTB has approved several applications from wineries to use two 
types of matrix filter sheets. One removes metals such as copper and 
iron from wine, while the other removes sulfides.
    Both types of sheets contain the active ingredient 
Polyvinylimadazole (PVI), a terpolymer related to 
polyvinylpolypyrrolidone (PVPP), which is listed as an approved 
material in Sec.  24.246. The PVI is immobilized in a cellulose matrix 
sheet and constitutes, at most, 40 percent of the weight of the sheet. 
Wine is passed through these sheets at a controlled flow rate using 
conventional filtering methods.
    In the metal reducing sheet, metals are absorbed by the PVI and are 
thus removed from the wine. In the sulfide reducing sheet, sulfides in 
the wine bind to copper sites attached to the PVI. According to the 
manufacturer of the matrix sheets, the PVI and copper stay immobilized 
in the matrix and are directly not added to the wine, although the 
manufacturer calculates the possible migration of PVI into the wine to 
be less than 0.2 parts per billion.
    The manufacturer of the matrix sheets filed a Food Contact 
Substance Notification with the FDA for the use of PVI as a component 
of matrix filter sheets used to remove metals and sulfides in alcoholic 
beverages. The FDA accepted this as an effective notification by a 
letter dated July 10, 2001, with the qualification that the PVI may 
constitute a maximum level of 40 percent by weight of the matrix sheet.
    A number of the wineries seeking approval from TTB also submitted 
to the TTB Laboratory before and after samples of wines processed with 
the metal and sulfide reducing matrix sheets. In each case, TTB's 
analytical and organoleptic testing found that this treatment did not 
adversely affect the character and analytical profile of the wine.
    Based on the above, TTB is amending Sec.  24.248 to permit the use 
of metal and sulfide reducing matrix sheets in the treatment of wine.

Nanofiltration

    TTB received a petition from an industry member to amend the 
regulations to allow the use of nanofiltration in combination with ion 
exchange to remove the volatile acidity (VA) from bulk wine. Although 
ion exchange is already widely used in the wine industry and is listed 
in Sec.  24.248, the petitioner is requesting that we consider its use 
in connection with nanofiltration, which is not listed in Sec.  24.248. 
We have also received and approved several requests from wineries for 
permission to use this process on an experimental basis.
    The petitioner states that nanofiltration is a process by which 
wine is drawn into a storage tank where it is pressurized and piped 
through a mechanical sub-micron filtration process using 
nanotechnology. During the nanofiltration process, the wine is divided 
into two separate streams. One stream consists of the larger molecular 
weight compounds, such as flavors, and the second stream consists of 
the smaller molecular weight compounds, such as alcohol, water, and 
acetic acid. The second stream is passed through an ion exchange 
column, which selectively removes the acetic acid and allows the 
alcohol and water molecules to pass through. Upon exiting the ion 
exchange column, the second stream is re-combined with the first 
stream. The petitioner states that the membrane used in nanofiltration 
has a molecular weight cut-off of 100 Daltons at a pressure of 250 psi 
and a temperature of 60 degrees Fahrenheit.
    As part of the experimentation approval process, the wineries 
submitted before and after samples to the TTB Laboratory for analysis. 
Our Laboratory analyzed the treated and untreated wines and found that 
the levels of volatile acids were indeed reduced without otherwise 
adversely affecting the wine.
    Based on the above, TTB is adding nanofiltration to the list of 
approved processes in Sec.  24.248.

Osmotic Transport

    TTB has approved several requests from wineries to use osmotic 
transport in the production of reduced alcohol wines. Osmotic transport 
is also known as isothermal transport, isothermal membrane 
distillation, or osmotic distillation.
    Osmotic transport is a membrane transport process that involves two 
liquids, typically water solutions, which have different water vapor 
pressures. The solution to be treated is typically referred to as the 
``feed'' solution and contains volatile components that are soluble or 
miscible in the receiving solution (typically referred to as the 
``stripping'' solution). The membrane must be completely hydrophobic in 
order to prevent the stripping solution from passing through the 
membrane into the feed solution.
    In the osmotic transport treatment approved by TTB, wine is pumped 
along one side of a completely hydrophobic microporous membrane with 
water on the other side. The wine and the stripping solution run 
tangential to, and are separated by, the thin membrane. The driving 
force for the separation is the vapor pressure difference between the 
alcohol in the wine and the water-based stripping solution. The higher 
vapor pressure of the alcohol in the wine causes some of the alcohol to 
evaporate, pass through the microporous membrane, and then condense in 
the water-based stripping solution. The stripping solution is usually 
circulated across the membrane until the alcohol content of the feed 
wine and the stripping solution are essentially equal. The process is 
performed at ambient temperature without elevated pressures (other than

[[Page 67643]]

gentle pressure necessary to pump the wine).
    As part of an industry member's request to experiment with this 
treatment, the industry member submitted before and after samples to 
the TTB Laboratory for analysis. The Laboratory's analysis found that 
the process did indeed reduce the level of alcohol in the wine.
    Since the separation of alcohol from a fermented substance is 
considered to be a distilling process, osmotic transport operations 
cannot be conducted at winery premises but must instead take place at a 
distilled spirits plant. The alcohol-containing stripping solution may 
be used for distilling material or in the production of other than 
standard wine. The destruction of any alcohol derived from the osmotic 
transport process must be in accordance with the provisions of 27 CFR 
19.691.
    Accordingly, we are adding osmotic transport to the list of 
authorized processes in Sec.  24.248, subject to the following 
conditions:
     The treatment must not alter the vinous character of the 
wine. The stripping solution must not migrate into the wine.
     The treatment must be conducted at a distilled spirits 
plant premises.

Public Participation

Comments Sought

    We request comments from everyone interested. We are especially 
interested in comments that address the question of whether the use of 
a particular material or process addressed in this document is 
consistent with good commercial practice. Please support your comment 
with specific information about the material or process in question.
    All comments must reference T.D. TTB-17 and must include your name 
and mailing address. They must be legible and written in language 
acceptable for public disclosure. Although we do not acknowledge 
receipt, we will consider your comments if we receive them on or before 
the closing date. We regard all comments as originals.

Confidentiality

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

Submitting Comments

    You may submit comments in any of five ways:
     Mail: You may send written comments to TTB at the address 
listed in the ADDRESSES section of this document.
     Facsimile: You may submit comments by facsimile 
transmission to 202-927-8525. Faxed comments must--
    (1) Be on 8.5 by 11-inch paper;
    (2) Contain a legible, written signature; and
    (3) Be no more than five pages long. This limitation ensures 
electronic access to our equipment. We will not accept faxed comments 
that exceed five pages.
     E-mail: You may e-mail comments to [email protected]. Comments 
transmitted by electronic mail must--
    (1) Contain your e-mail address;
    (2) Reference T.D. TTB-17 on the subject line; and
    (3) Be legible when printed on 8.5 by 11-inch paper.
     Online form: We provide a comment form with the online 
copy of this document on our Web site at  http://www.ttb.gov/alcohol/rules/index.htm. Select the ``Send comments via e-mail'' link under 
T.D. TTB-17.
     Federal e-Rulemaking Portal: To submit comments to us via 
the Federal e-rulemaking portal, visit http://www.regulations.gov and 
follow the instructions for submitting comments.
    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, in light of all circumstances, whether to hold a public 
hearing.

Public Disclosure

    You may view copies of this document and any comments we receive by 
appointment at the TTB Library at 1310 G Street, NW., Washington, DC 
20220. You may also obtain copies at 20 cents per 8.5 by 11-inch page. 
Contact our librarian at the above address or telephone 202-927-2400 to 
schedule an appointment or to request copies of comments.
    For your convenience, we will post this document and any comments 
we receive on the TTB Web site. We may omit voluminous attachments or 
material that we consider unsuitable for posting. In all cases, the 
full comment will be available in the TTB Library. To access the online 
copy of this document, visit http://www.ttb.gov/alcohol/rules/index.htm. Select the ``View Comments'' link under this document's 
number and title to view the posted comments.

Regulatory Flexibility Act

    Because no notice of proposed rulemaking is required for temporary 
rules, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 
et seq.) do not apply.

Executive Order 12866

    This temporary rule is not a significant regulatory action as 
defined by Executive Order 12866. Therefore, it requires no regulatory 
analysis.

Inapplicability of Prior Notice and Comment and Delayed Effective Date 
Procedures

    Pursuant to the provisions of 5 U.S.C. 553(b)(B), we have 
determined that prior public notice and comment procedures on these 
regulations are unnecessary and contrary to the public interest. 
Issuing a temporary rule rather than a notice of proposed rulemaking 
allows all domestic winemakers to use new wine treatments that have 
already been approved for sometime. This will ``level the playing 
field'' and reduce the possibility of confusion as to which materials 
and processes are approved. For the same reason, pursuant to the 
provisions of 5 U.S.C. 553(d)(1) and (3), we find that there is good 
cause for dispensing with a delayed effective date.

Drafting Information

    The principal author of this document was Jennifer K. Berry, 
Regulations and Procedures Division, Alcohol and Tobacco Tax and Trade 
Bureau. However, other personnel participated in its development.

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

0
For the reasons discussed in the preamble, TTB amends 27 CFR part 24 as 
follows:

PART 24--WINE

0
1. The authority citation for 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, 5081, 5111-5113, 5121, 5122, 5142, 5143, 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, 7011, 7302, 7342, 
7502, 7503, 7606, 7805, 7851; 31 U.S.C. 9301, 9303, 9304, 9306.


0
2. The table in Sec.  24.246 is amended:
0
a. By adding, in appropriate alphabetical order, new listings for

[[Page 67644]]

``acetaldehyde'' and ``calcium pantothenate'';
0
b. By revising the listing for ``copper sulfate'';
0
c. Under the heading for ``Enzymatic activity,'' by adding, in 
appropriate alphabetical order, new listings for ``carbohydrase 
(pectinase, cellulase, hemicellulase),'' ``cellulase (beta-glucanase)'' 
[immediately preceding the current listing for glucose oxidase], and 
``lysozyme;''
0
d. By removing the listing for ``milk (pasteurized whole or skim)'' and 
adding, in its place, a heading for ``milk products (pasteurized whole, 
skim, or half-and-half)'' followed by two use listings; and
0
e. By revising the listing for ``silica gel (colloidal silicon 
dioxide).''
    The additions and revisions read as follows:


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

* * * * *

          Materials Authorized for Treatment of Wine and Juice
------------------------------------------------------------------------
           Materials and use                 Reference or limitation
------------------------------------------------------------------------
 
                              * * * * * * *
Acetaldehyde: For color stabilization    The amount used must not exceed
 of juice prior to concentration.         300 ppm, and the finished
                                          concentrate must have no
                                          detectable level of the
                                          material. 21 CFR 182.60
                                          (GRAS).
 
                              * * * * * * *
Calcium pantothenate: Yeast nutrient to  The amount used must not exceed
 facilitate fermentation of apple wine.   0.1 lb. per 25,000 gallons. 21
                                          CFR 184.1212 (GRAS).
 
                              * * * * * * *
Copper sulfate: To remove hydrogen       The quantity of copper sulfate
 sulfide and/or mercaptans from wine.     added (calculated as copper)
                                          must not exceed 6 parts copper
                                          per million parts of wine (6.0
                                          mg/L). The residual level of
                                          copper in the finished wine
                                          must not exceed 0.5 parts per
                                          million (0.5 mg/L). 21 CFR
                                          184.1261 (GRAS).
 
                              * * * * * * *
Enzymatic activity: Various uses as
 shown below
 
                              * * * * * * *
    Carbohydrase (pectinase, cellulase,  The enzyme activity used must
     hemicellulase): To facilitate        be derived from Aspergilius
     separation of juice from the fruit.  aculeatus. FDA advisory
                                          opinion dated12/19/1996.
 
                              * * * * * * *
    Cellulase (beta-glucanase): To       The enzyme activity must be
     clarify and filter wine.             derived from Tricoderma
                                          longibrachiatu. The amount
                                          used must not exceed 3 g/hl.
                                          21 CFR 184.1250 (GRAS).
 
                              * * * * * * *
    Lysozyme: To stabilize wines from    The amount used must not exceed
     malolactic acid bacterial            500 mg/L. FDA advisory opinion
     degradation.                         dated 12/15/93.
 
                              * * * * * * *
Milk products (pasteurized whole, skim,
 or half-and-half):
    Fining agent for grape wine or       The amount used must not exceed
     sherry.                              2.0 liters of pasteurized milk
                                          per 1,000 liters (0.2 percent
                                          V/V) of wine.
    To remove off flavors in wine......  The amount used must not exceed
                                          10 liters of pasteurized milk
                                          per 1,000 liters (1 percent V/
                                          V) of wine.
 
                              * * * * * * *
Silica gel (colloidal silicon dioxide):  Use must not exceed the
 To clarify wine or juice.                equivalent of 20 lbs.
                                          colloidal silicon dioxide at a
                                          30% concentration per 1000
                                          gals. of wine. (2.4 g/L).
                                          Silicon dioxide must be
                                          completely removed by
                                          filtration. 21 CFR 172.480.
 
                              * * * * * * *
------------------------------------------------------------------------


0
3. The table in Sec.  24.248 is amended by adding, in appropriate 
alphabetical order, new listings for ``electrodialysis,'' ``metal 
reducing matrix sheet processing,'' ``nanofiltration,'' ``osmotic 
transport,'' and ``sulfide reducing matrix sheet processing,'' to read 
as follows:


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

* * * * *

  Processes Authorized for the Treatment of Wine, Juice, and Distilling
                                Material
------------------------------------------------------------------------
                                                         Reference or
            Processes                     Use             limitation
------------------------------------------------------------------------
Electrodialysis.................  To aid in the       This process must
                                   removal of          not alter the
                                   tartrates.          vinous character
                                                       of the wine.
 

[[Page 67645]]

 
                              * * * * * * *
Metal reducing matrix sheet       To reduce the       (1) The active
 processing.                       level of metals     ingredient,
                                   such as copper      polyvinylimidazol
                                   and iron in wine.   , must not
                                                       constitute more
                                                       than 40% by
                                                       weight of the
                                                       sheet.
                                                      (2) Use of the
                                                       sheet must not
                                                       significantly
                                                       alter the color
                                                       of the wine.
Nanofiltration..................  To reduce the       This process must
                                   level of volatile   use permeable
                                   acidity in wine     membranes which
                                   (used with ion      are selective for
                                   exchange).          molecules not
                                                       greater than 150
                                                       molecular weight
                                                       with
                                                       transmembrane
                                                       pressures of 250
                                                       psi or less.
Osmotic transport \1\...........  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.
 
                              * * * * * * *
Sulfide reducing matrix sheet     To reduce the       (1) The active
 processing.                       level of sulfides   ingredient,
                                   in wine.            polyvinylimidazol
                                                       , must not
                                                       constitute more
                                                       than 40% by
                                                       weight of the
                                                       sheet.
                                                      (2) Use of the
                                                       sheet must not
                                                       significantly
                                                       alter the color
                                                       of the wine.
 
                              * * * * * * *
------------------------------------------------------------------------


    Signed: October 1, 2004.
Arthur J. Libertucci,
Administrator.
    Approved: October 22, 2004.
Timothy E. Skud,
Deputy Assistant Secretary (Tax, Trade, and Tariff Policy).
[FR Doc. 04-25739 Filed 11-18-04; 8:45 am]
BILLING CODE 4810-31-P