[Federal Register Volume 59, Number 189 (Friday, September 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24219]
[[Page Unknown]]
[Federal Register: September 30, 1994]
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DEPARTMENT OF THE TREASURY
Bureau of Alcohol, Tobacco and Firearms
27 CFR Part 24
[Notice No. 800]
RIN: 1512-AA89
Materials and Processes Authorized for the Production of Wine and
for the Treatment of Juice, Wine and Distilling Material (93F-059P)
AGENCY: Bureau of Alcohol, Tobacco and Firearms (ATF), Department of
the Treasury.
ACTION: Notice of proposed rulemaking.
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SUMMARY: This notice solicits comment from winemakers, consumers and
other interested parties as to whether, pursuant to the provisions of
Section 5382 of the Internal Revenue Code of 1986, the use of certain
materials and processes is acceptable in ``good commercial practice''
in the production, cellar treatment, and finishing of wine. If these
new materials and processes are found to be acceptable, then a final
rule will be published adding these new materials/processes to the wine
regulations.
DATES: Written comments to this document must be received by November
29, 1994.
ADDRESSES: Send written comments to: Chief, Wine and Beer Branch,
Bureau of Alcohol, Tobacco and Firearms, P.O. Box 50221, Washington, DC
20091-0221 (Attn: Notice No. 800). Copies of the proposed regulation
and any written comments received will be available for public
inspection during normal business hours at: ATF Reading Room, Office of
Public Affairs and Disclosure, Room 6480, 650 Massachusetts Avenue, NW,
Washington, DC.
FOR FURTHER INFORMATION CONTACT: Robert White, Coordinator, Wine and
Beer Branch, Bureau of Alcohol, Tobacco and Firearms, 650 Massachusetts
Avenue, NW, Washington, DC 20226 (202-927-8230).
SUPPLEMENTARY INFORMATION:
Background
Several members of the wine industry have recently petitioned ATF
for approval of the use of 3 wine treating processes and 1 wine
treating material in the production, cellar treatment, and/or finishing
of wine. Only one of the processes, the spinning cone column, is new
and would be used to reduce the ethyl alcohol content of wine or to
remove off flavors in wine. The other two processes are not new but
either would be used in combination or would be used for a different
purpose or at a different limitation than previously authorized. The
processes to be used in combination are reverse osmosis and ion
exchange and would be used to remove excess volatile acidity from wine.
The process which would be used at a different limitation is
ultrafiltration. And finally, the new wine treating material, urease
enzyme, would be used to reduce urea in wine, thereby reducing the
possibility of ethyl carbamate formation during wine storage.
Wine Treating Processes
Spinning Cone Column
The spinning cone column (SCC) is a gas-liquid contacting device
which can process a wide range of products including slurries with very
high solids contents. It is a multi-stage mass transfer device
consisting of a series of alternating stationary and rotary truncated
cones. During its operation the product is fed at the top of the column
and then flows down the upper surface of the stationary cones under the
influence of gravity and moves across the upper surface of the rotating
cones in a thin film due to the applied centrifugal force. The
stripping gas enters the bottom of the column and flows counter current
to the liquid phase in the spaces between the fixed and rotating cones.
The petitioners who have requested ATF to approve the use of the
SCC wish to use it in the production of low alcohol wine, as well as to
remove off flavors in wine (e.g. volatile acidity, ethyl acetate,
hydrogen sulfide, etc.).
In the production of low alcohol wine, the feed wine is initially
run through the SCC to recover the volatile wine flavor essence. In the
second stage of processing, the flavor essence reduced wine is run
through the SCC to reduce the alcohol in the wine to the desired level.
The essence, which has previously been removed, is then added back to
the alcohol reduced wine to make a low alcohol wine which, according to
the petitioners, retains much of its original flavor. The alcohol which
has been removed from the wine can then either be used in accordance
with law and regulations or be destroyed.
Treatment of wine utilizing the SCC to remove off flavors, or to
reduce the alcohol content of the wine, may not alter the vinous
character of the wine. Otherwise, the wine would no longer be
considered standard wine.
Since the separation of alcohol from a fermented substance is
considered to be a distilling process, SCC operations cannot be
conducted at winery premises but must instead take place at distilled
spirits plant premises.
In 1991, approval was given for several industry members to
experiment with the SCC. Since then, a few industry members have been
given permission, pending the final outcome of the rulemaking process,
to commercially produce reduced alcohol wine and dealcoholized wine
using the SCC process under the following conditions:
1. The SCC removal of any alcohol from the wine will be done on DSP
premises.
2. Records will be maintained for each lot of wine put through the
SCC and the fractions derived from such wine showing the date,
quantity, and disposition of each fraction.
3. In the production of reduced alcohol standard wines using the
SCC, the same amount of essence will be added back to any lot of wine
as was originally removed.
4. Proprietors must contact their ATF Area Supervisor prior to the
destruction of any alcohol or other fractions derived from the SCC
process.
Other persons wishing to use the SCC technology to produce low
alcohol and/or dealcoholized wines, or to remove off flavors from wine,
should submit letter applications to ATF requesting permission to do
so. If it is determined, through this rulemaking process, that the use
of the SCC technology is in accordance with ``good commercial
practice,'' the SCC process will be added to 27 CFR 24.248 at which
time no further letter applications will be required for its use.
Reverse Osmosis and Ion Exchange
One industry member requested ATF to approve the use of reverse
osmosis and ion exchange in combination to remove volatile acidity (VA)
from bulk wine. The process combines two technologies already widely in
use in the wine industry.
The process involves utilizing reverse osmosis to separate wine
into various components and then using ion exchange to remove VA. The
wine components, minus the VA, would then be recombined in-line to form
the original wine minus the VA. The whole process takes place in a
closed system.
Regulations at 27 CFR 24.248 are currently broad enough to allow
ion exchange to be used to remove volatile acidity from wine or from
various components of wine. However, this section of regulations does
not currently authorize reverse osmosis to be used for anything other
than to reduce the ethyl alcohol content of wine. The regulation change
that is being proposed in this document will allow reverse osmosis to
also be used to remove off flavors in wine, which would enable it to be
used as part of an overall process in a closed system to remove VA from
wine.
Normally, reverse osmosis must be done on distilled spirits plant
premises because it is considered a distilling process resulting in a
distilled spirits by-product. However, in this case, the various
components of wine will only be created temporarily in a closed system
and will be immediately recombined in-line to reconstitute the original
wine minus VA. ATF has concluded that this type of reverse osmosis may
be conducted on bonded winery premises since no separate distilled
spirits product is created as a final product or by-product.
Absolutely no accumulation of ethyl alcohol outside the closed
system will be allowed. Such accumulation of an ethanol solution on
winery premises would subject the proprietor to the distilled spirits
tax of $13.50 per proof gallon imposed by Section 5001 of the Internal
Revenue Code.
ATF has approved the application from the industry member, pending
the final outcome of the rulemaking process, to use these two processes
in a closed system to remove VA from wine. Other persons wishing to use
these two processes in a similar fashion should submit letter
applications to ATF requesting permission to do so. If it is
determined, through this rulemaking process, that the use of reverse
osmosis and ion exchange in combination in a closed system to remove VA
from wine is in accordance with ``good commercial practice,'' this
procedure will be authorized in 27 CFR 24.248 by amending the use
column of reverse osmosis to state that it can be used to remove off
flavors in wine. Once this change to the regulations is made, no
further letter applications will be required to use these two processes
in combination in a closed system to remove VA from wine.
The footnote concerning processes which must be done on distilled
spirits plant premises, located at the end of 27 CFR 24.248, has been
revised to state that under certain limited conditions, reverse osmosis
may be used on bonded winery premises if ethyl alcohol is only
temporarily created within a closed system.
Ultrafiltration
An industry member has requested that the limitation imposed on the
use of ultrafiltration by 27 CFR 24.248 be changed to allow
transmembrane pressures greater than 100 pounds per square inch (psi).
The industry member states that they need to employ transmembrane
pressures of up to approximately 200 psi rather than the current
maximum of 100 psi which is provided for in Sec. 24.248. The industry
member indicates that their laboratory tests have shown an increase in
throughput of 4 to 5-fold when the pressure is increased from 100 to
150 psi with no change in the character of the finished wine. Without
this increase in throughput, the industry member states that the
process is not economically viable since they can achieve the same
result with other methods at a much lower cost.
The industry member states that they chose the less than 200 psi
limitation as the upper limit in order to maintain a clear distinction
between ultrafiltration and reverse osmosis in terms of pressure. The
industry member points out that the two processes are also
differentiated by the fact that the membranes specified for reverse
osmosis have a much smaller pore size than those used in
ultrafiltration.
The industry member submitted two samples of ultrafiltered apple
wine to the ATF laboratory for analysis. The first sample was processed
at 95 psi and the second sample was processed at 195 psi. The ATF
laboratory analysis, based on the analytical data and on an
organoleptic evaluation, showed there is no significant difference
between the samples at these different pressure ratings. As a result of
this analysis, the ATF laboratory stated that the basic character of
the wine was not altered by increasing the authorized pressure rating
from 100 psi to 195 psi.
Consequently, ATF approved the industry member's request to be
allowed to use pressures of less than 200 psi when conducting
operations using ultrafiltration. Other industry members wishing to use
ultrafiltration at higher pressures may submit letter applications to
ATF requesting permission to do so. ATF may require samples prior to
giving such approval. If it is determined through the rulemaking
process that ultrafiltration using pressures of less than 200 psi is
considered ``good commercial practice,'' then the regulations will be
changed to incorporate this more liberal pressure limitation.
New Wine Treating Material
Urease Enzyme
An industry member has requested to be allowed to use urease enzyme
derived from Lactobacillus fermentum to reduce levels of naturally
occurring urea in wine to prevent the formation of ethyl carbamate
during storage.
The enzyme is derived from the nonpathogenic, nontoxicogenic
bacterium Lactobacillus fermentum. It contains the enzyme urease (CAS
Reg. No. 9002-13-5) which facilitates the hydrolysis of urea to ammonia
and carbon dioxide. It is produced by a pure culture fermentation
process and by using materials that are generally recognized as safe
(GRAS) or are food additives that have been approved for this use by
the Food and Drug Administration (FDA).
Urease enzyme from Lactobacillus fermentum was approved for use in
wine by FDA on December 21, 1992, effective January 21, 1993. The FDA
regulation cite is 21 CFR 184.1924, Urease Enzyme Derived From
Lactobacillus fermentum.
The manufacturer of the urease enzyme, Takeda Chemical Industries,
Ltd., has also submitted several letters confirming that the urease
enzyme preparation is derived from Lactobacillus fermentum. The company
states that the enzyme is standardized with glucose syrup solids and
the urease activity is adjusted to 3.5 units/mg. The company indicates
that the urease enzyme meets the general and additional requirements
for enzyme preparations in the ``Food Chemicals Codex,'' 3rd edition
(1981). In addition, the urease enzyme is used in food at levels not to
exceed current good manufacturing practice as defined in 21 CFR
184.1924.
Takeda Chemical Industries, Ltd., states that the composition of
the urease enzyme preparation is as follows:
Killed whole cells of Lactobacillus fermentum: 20-35%
Glucose Syrup Solids 65-80%
Takeda also states that they have confirmed that due to the low
usage level (10-200 ppm) and objective of usage, addition of glucose
syrup solids in this case is not considered ``sweetening'' of the
beverage, which is prohibited in the State of California for table
wine.
The industry member states that urease enzyme derived from
Lactobacillus fermentum is economically self-limiting due to the high
cost of the material. In addition, FDA, in their approval, did not set
a specific numerical limit but rather limited its use to ``good
commercial practice.'' The industry member states that if a numerical
limit needs to be set, it should be set no lower than 200 mg/L. The
industry member also indicated that no water is required to use urease
enzyme.
The industry member also submitted to the ATF laboratory two 750-
milliliter samples of wine, one before and one after treatment, as well
as a sample of the material. Based on an analysis of the samples and an
organoleptic evaluation, the ATF laboratory concluded there were no
significant differences between the control and experimental wine
samples. The ATF laboratory stated that they have no objections to this
enzyme preparation being used as a wine treating material at a maximum
usage rate of 200 mg/L provided that the enzyme is filtered prior to
final packaging of the wine as practiced in ``good commercial
practice.''
Consequently, ATF approved the industry member's request to use
urease enzyme derived from Lactobacillus fermentum to reduce levels of
naturally occurring urea in wine to prevent the formation of ethyl
carbamate during storage. This approval was given pending final action
on urease enzyme as a result of the rulemaking process. This approval
is also contingent upon the industry member using urease enzyme at a
level not to exceed 200 mg/L and that the enzyme preparation is
filtered prior to final packaging of the wine.
ATF is requesting all interested parties to comment on whether the
use of this enzyme preparation in wine to reduce ethyl carbamate
formation is in accordance with ``good commercial practice.'' We are
also requesting comments on whether the maximum usage rate of 200 mg/L
is appropriate. Based on the comments received, we will determine
whether the use of urease enzyme for the above stated purpose is in
accordance with ``good commercial practice.'' If so, we will add this
new wine treating material to the authorized list in 27 CFR 24.246.
In the meantime, if other industry members wish to use urease
enzyme in their wines at a maximum usage rate of 200 mg/L to prevent or
reduce the formation of ethyl carbamate, they should submit a letter
application to ATF requesting permission to do so.
Public Participation
Comments to this notice may address any one or all of the
proposals. Comments received on or before the closing date will be
carefully considered. Comments received after that date will be given
the same consideration if it is practical to do so, but assurance of
consideration cannot be given except as to comments received on or
before the closing date.
ATF will not recognize any material or comment as confidential.
Comments may be disclosed to the public. Any material which the
respondent considers to be confidential or inappropriate for disclosure
to the public should not be included in the comment. The names of
commenters are not exempt from disclosure.
Written comments will be available for public inspection during
normal business hours at the following address: ATF Reading Room,
Office of Public Affairs and Disclosure, Room 6480, 650 Massachusetts
Avenue, NW, Washington, DC.
Regulatory Flexibility Act
It is hereby certified that this regulation will not have a
significant economic impact on a substantial number of small entities.
This regulation is liberalizing in nature and will allow winemakers
more flexibility when producing their wines with no negative impact on
small entities. Accordingly, a regulatory flexibility analysis is not
required because the proposal, if promulgated as a final rule, is not
expected (1) to have secondary, or incidental effects on a substantial
number of small entities; or (2) to impose, or otherwise cause a
significant increase in the reporting, recordkeeping, or other
compliance burdens on a substantial number of small entities.
Executive Order 12866
It has been determined that this proposed regulation is not a
significant regulatory action as defined by Executive Order 12866.
Accordingly this proposal is not subject to the analysis required by
this Executive Order.
Paperwork Reduction Act
The provisions of the Paperwork Reduction Act of 1980, Pub. L. 96-
511, 44 U.S.C. Chapter 35, and its implementing regulations, 5 CFR Part
1320, do not apply to this notice because no requirement to collect
information is proposed.
Drafting Information
The principal author of this document is Robert L. White, Wine and
Beer Branch, Bureau of Alcohol, Tobacco and Firearms. ATF Wine
Technical Advisor Richard M. Gahagan and former ATF Chemist Randolph H.
Dyer have provided significant technical assistance in the evaluation
and review of data pertinent to the preparation of this document.
List of Subjects in 27 CFR Part 24
Administrative practice and procedure, Authority delegations,
Claims, Electronic funds transfers, Excise taxes, Exports, Food
additives, Fruit juices, Labeling, Liquors, Packaging and containers,
Reporting requirements, Research, Scientific equipment, Spices and
flavorings, Surety bonds, Transportation, Warehouses, Wine and vinegar.
Authority and Issuance
27 CFR Part 24--Wine is amended as follows:
PART 24--WINE
Par. 1. The authority citation for Part 24 continues to read as
follows:
Authority: 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, 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.
Par. 2. Section 24.246 is amended in the table by revising the
entry for enzymatic activity, by indenting the 13 enzyme entries
immediately following enzymatic activity (ending with Protease
(Trypsin)) to show that these entries all come under enzymatic
activity, and by adding the new enzyme, urease, immediately after and
directly under Protease (Trypsin), to read as follows:
Sec. 24.246 Materials authorized for treatment of wine and juice.
* * * * *
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Materials and use Reference or limitation
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* * * * * * *
Enzymatic activity: Various uses as The enzyme preparation used shall
shown below. be prepared from nontoxic and
nonpathogenic microorganisms in
accordance with good manufacturing
practice and be approved for use
in food by either FDA regulation
or by FDA advisory opinion.
* * * * * * *
Urease: To reduce levels of The urease enzyme activity shall be
naturally occurring urea in derived from Lactobacillus
wine to help prevent the fermentum per 21 CFR 184.1924. Use
formation of ethyl carbamate. is limited to not more than 200 mg/
L and must be filtered prior to
final packaging of the wine.
* * * * * * *
------------------------------------------------------------------------
Par. 3. Section 24.248 is amended in the table by revising the
entries for reverse osmosis and ultrafiltration, by adding the entry
for spinning cone column, and by revising the footnote at the end of
the section to read as follows:
Sec. 24.248 Processes authorized for the treatment of wine, juice, and
distilling material.
* * * * *
------------------------------------------------------------------------
Reference or
Processes Use limitation
------------------------------------------------------------------------
* * * * * * *
Reverse osmosis\1\..... To reduce the ethyl Permeable membranes
alcohol content of which are selective
wine and to remove off for molecules not
flavors in wine. greater than 500
molecular off flavors
in wine weight with
transmembrane
pressures of 200 psi
and greater. The
addition of water
other than that
originally present
prior to processing
will render standard
wine ``other than
standard.'' Use shall
not alter virous
character.
Spinning cone\1\....... To reduce the ethyl Use shall not alter
alcohol content of vinous character. For
wine and to remove off standard wine, the
flavors in wine. same amount of
essense must be added
back to any lot of
wine as was
originally removed.
* * * * * * *
Ultrafiltration........ To remove proteinaceous Permeable membranes
material from wine; to which are selective
reduce harsh tannic for molecules greater
material from white than 500 and less
wine produced from than 25,000 molecular
white skinned grapes; weight with
to remove pink color transmembrane
from blanc de noir pressures less than
wine; to separate red 200 psi. Use shall
wine into low color not alter vinuous
and high color wine character. 21 CFR
fractions for blending 175.300, 177.1520,
purposes.. 177.1550, 177.1630,
177.2440, 177.2600,
and 177.2910.
------------------------------------------------------------------------
\1\This process must be done on distilled spirits plant premises.
However, reverse osmosis, under certain limited conditions, may be
used on bonded winery premises if ethyl alcohol is only temporarily
created within a closed system.
(Sec. 201, Pub. L. 85-859, 72 Stat. 1383, as amended (26 U.S.C.
5381, 5382, 5385, 5386, and 5387)).
August 9, 1994.
Daniel R. Black,
Acting Director.
Approved: August 24, 1994
Dennis M. O'Connell,
Acting Deputy Assistant Secretary, (Regulatory, Tariff and Trade
Enforcement)
[FR Doc. 94-24219 Filed 9-29-94; 8:45 am]
BILLING CODE 4810-31-U
