[Federal Register: November 19, 2004 (Volume 69, Number 223)]
[Rules and Regulations]
[Page 67639-67645]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19no04-4]
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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);
nprm@ttb.gov (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 nprm@ttb.gov. 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