[Federal Register Volume 61, Number 91 (Thursday, May 9, 1996)]
[Rules and Regulations]
[Pages 21076-21080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11611]
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DEPARTMENT OF THE TREASURY
Bureau of Alcohol, Tobacco and Firearms
27 CFR Part 24
[T.D. ATF-371; RE: Notice Nos. 800 and 805]
RIN: 1512-AB26
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: Final rule (Treasury decision).
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SUMMARY: This final rule amends the wine regulations in 27 CFR Part 24
to add or modify the use of 3 wine treating processes and to add the
use of 1 new wine treating material. The use of these new or modified
wine treating processes and materials has been found to be acceptable
in ``good commercial practice'' in the production, cellar treatment,
and finishing of wine, pursuant to the provisions of Section 5382 of
the Internal Revenue Code of 1986, since their use will not alter
vinous character or pose any health, safety, or consumer deception
problems.
EFFECTIVE DATE: July 8, 1996.
FOR FURTHER INFORMATION CONTACT: Robert White, Coordinator, Wine, Beer
and Spirits Regulations 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 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
[[Page 21077]]
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.
Notice No. 800
On September 30, 1994, ATF published a notice of proposed
rulemaking (Notice No. 800) in the Federal Register requesting that all
interested parties submit written comments by November 29, 1994. Nine
comments were received including 2 comments which requested an
extension of the comment deadline. Due to the requests for an extension
of the comment period, ATF published a reopening notice (Notice No.
805) in the Federal Register on January 18, 1995, which reopened the
comment period for 60 days ending on March 20, 1995. Three comments
were received in response to the reopening notice making a total of 12
comments received in response to the 2 wine treating notices.
Summary of Comments
Six of the commenters stated that they fully support the use of the
spinning cone column to reduce the ethyl alcohol content of wine or to
remove off flavors from wine. One of the six commenters, Mr. Vincent
Indelicato of Delicato Vineyards, also asked that the spirits derived
from the spinning cone column process, if at a minimum proof of 100 or
above, be approved for wine spirits additions without any restrictions.
Mr. Indelicato also asked that spinning cone column de-essenced juice
be allowed in all standard winemaking including the fermenting of this
de-essenced juice into standard wine. Five of the six commenters who
addressed the use of the spinning cone column also stated that they
support the additional requests made by Mr. Indelicato.
One of the six commenters mentioned above, Mr. Robert G. Kalik of
the American Vintners Association (AVA), also stated that the AVA fully
supports the 3 new or modified wine treating processes and the 1 new
wine treating material proposed in Notice No. 800.
Another commenter, Mr. Clark Smith and Mr. Rick Jones of
Vinovation, Inc., submitted a joint comment stating that Vinovation
fully supports the use of reverse osmosis and ion exchange in
combination in a closed system to remove excess volatile acidity from
wine. They also state in a separate comment that it is their
understanding that use of the spinning cone column to remove volatile
acidity from wine is not very practical since such removal of volatile
acidity would result in an equal proportion of ethanol being removed
from the wine.
Two additional commenters in the wine industry state that they
fully support the use of reverse osmosis along with ion exchange to
remove excess volatile acidity in wine. Both state that wine which has
undergone this treatment to remove excess volatile acidity has been
greatly improved in quality. Both commenters believe that adoption of
this wine treating process will represent a real benefit to the wine
industry as well as to the consumer.
Two commenters to Notice No. 800 asked for an extension of the
comment period to give them more time to analyze the wine treating
proposals and to prepare a response. One of these commenters represents
the Delegation of the European Commission (EC) and the other represents
the French government.
The final comment was from the Delegation of the European
Commission in response to Notice No. 805 which reopened the comment
period for 60 days. This commenter states that the comment represents
the views of the European Community. The commenter states that the
European Community is concerned at the possibility of introduction into
regular winemaking of the wine treating processes and materials
mentioned in the notice of proposed rulemaking and considers that their
utilization could be problematic for such wines imported into the
European Union. The commenter also states that approval of such
processes and materials could complicate the ongoing negotiations for
an EC/US wine agreement.
The commenter states that the European Community would like to draw
attention to the fact that the processes and materials described in the
notice are not currently authorized by Council Regulation (EEC) No.
822/87, particularly Title II, which lays down European Community rules
governing oenological practices and processes, and Annex VI, which
lists the practices and processes authorized for wines marketed in the
European Union; nor are these processes and materials included in the
Annex to Council Regulation (EEC) No. 1873/84, which details the
oenological practices authorized for wine imported into the European
Union from the United States.
Moreover, the commenter states that the new materials and processes
described in the notice are not included in the International Code of
Oenological Practices of the International Vine and Wine Office (OIV)
which is approved by the governments of the member countries of the
OIV. The commenter states that except for the use of urease, these
practices have not yet even been the subject of preliminary discussions
nor have they been communicated to this international forum.
In conclusion, this commenter states that the European Community
would suggest that utilization of the materials and processes proposed
in Notice No. 800 would best be considered within the bilateral
framework of the ongoing negotiations for an EC/US wine agreement and
within the multilateral framework of the OIV. Consequently, this
commenter states that the European Commission urges that the U.S.
authorities take no action on approving these materials and processes
until such consultations with the EC and OIV have taken place.
ATF Decision
After careful consideration of the comments, ATF has decided to
approve the 3 wine treating processes and 1 wine treating material
proposed in Notice No. 800. These 3 wine treating processes and 1 wine
treating material have the support of the U.S. wine industry and have
been determined to be in accordance with good commercial practice. Use
of these 3 processes and 1 material will be a significant benefit to
consumers and to the wine industry by enabling industry members to
exercise additional quality control in the production of their wines.
ATF acknowledges that the European Community has not currently
approved the use of these 3 wine treating processes and 1 wine treating
material in their wines. However, we have decided to go ahead and
approve these processes and materials for use by U.S. wine producers
because, after careful review, we have concluded that their use
complies with the statutory standard of good commercial practice.
ATF does not believe that it should prevent the use of new wine
treating processes and materials that have been found to be beneficial
to industry members and consumers alike, since it has determined that
the wine treatments do not alter vinous character or pose any health,
safety, or consumer deception problems. In addition, we feel that the
ongoing wine negotiations with the European Community do not foreclose
or restrict our domestic rulemaking decisions implementing statutory
standards under U.S. laws.
In regard to the requests to use spirits derived from the spinning
cone column process for wine spirits additions and the use of de-
essenced juice derived from the spinning cone column process
[[Page 21078]]
in all standard winemaking, we have determined that we need more time
to thoroughly analyze these requests and will address these issues at a
later time.
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 SCC is used 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 produce a low alcohol
wine which retains 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 will no longer be considered
standard wine.
Since the separation of alcohol from a fermented substance is
considered to be a distilling process, the SCC operations cannot be
conducted at winery premises but must instead take place at distilled
spirits plant premises.
The SCC operations must be conducted in accordance with 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. The destruction of any alcohol or other fractions derived from
the SCC process must be in accordance with the provisions of 27 CFR
19.691.
Reverse Osmosis and Ion Exchange
In this process, reverse osmosis and ion exchange are used 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, are then 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 were previously broad enough to allow
ion exchange to be used to remove volatile acidity from wine or from
various components of wine. However, those regulations did not
authorize reverse osmosis to be used for anything other than to reduce
the ethyl alcohol content of wine. This regulation change will allow
reverse osmosis to also be used to remove off flavors in wine which
will 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. Consequently, 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.
Accumulation of ethyl alcohol outside the closed system is not
allowed. Any accumulation of an ethanol solution on winery premises may
subject the proprietor to the distilled spirits tax of $13.50 per proof
gallon imposed by Section 5001 of the Internal Revenue Code.
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
Previous regulations at 27 CFR 24.248 allowed ultrafiltration to be
used for various filtration purposes as long as the following
conditions were met:
(a) Permeable membranes are used which are selective for molecules
greater than 500 and less than 25,000 molecular weight with
transmembrane pressures which do not exceed 100 pounds per square inch
(psi).
(b) Use shall not alter vinous character.
This final rule amends the regulations to allow greater
transmembrane pressures to be used and still be considered
ultrafiltration. The revised regulations allow less than 200 psi in
lieu of the current 100 psi. This more liberal pressure limitation will
provide for greater throughput with no change in the vinous character
of the finished wine. Without this increase in throughput, the process
is not economically viable for many industry members since they can
achieve the same result with other methods at a much lower cost.
The less than 200 psi pressure limitation was chosen as the upper
limit in order to maintain a clear distinction between ultrafiltration
and reverse osmosis in terms of pressure. 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.
New Wine Treating Material
Urease Enzyme
The use of urease enzyme derived from Lactobacillus fermentum has
been found to reduce levels of naturally occurring urea in wine thereby
helping 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,
[[Page 21079]]
effective January 21, 1993. The FDA regulation cite is 21 CFR 184.1924,
Urease Enzyme Derived From Lactobacillus Fermentum.
The enzyme is standardized with glucose syrup solids and the urease
activity is adjusted to 3.5 units/mg. 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.
The composition of the urease enzyme preparation is as follows:
Killed whole cells of Lactobacillus fermentum....................20-35%
Glucose Syrup Solids.............................................65-80%
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 use of urease enzyme derived from Lactobacillus fermentum is
economically self-limiting due to the high cost of the material. FDA,
in their approval, did not set a specific numerical limit but rather
limited its use to ``good commercial practice.''
Due to the recommendations from industry and from the ATF
laboratory, we have established an upper limit for the use of urease
enzyme in wine of 200 mg/L, provided that the enzyme is filtered prior
to final packaging of the wine, as a ``good commercial practice.''
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 this 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 regulation is not a significant
regulatory action as defined by Executive Order 12866. Accordingly this
final rule is not subject to the analysis required by this Executive
Order.
Paperwork Reduction Act
The provisions of the Paperwork Reduction Act of 1980, Public Law
96-511, 44 U.S.C. Chapter 35, and its implementing regulations, 5 CFR
Part 1320, do not apply to this final rule because no requirement to
collect information is imposed.
Drafting Information: The principal author of this document is
Robert L. White, Wine, Beer and Spirits Regulations Branch, Bureau
of Alcohol, Tobacco and Firearms. ATF Wine Technical Advisor Richard
M. Gahagan has 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 in Paragraph (b)
revising the entry for enzymatic activity, and by adding the new entry,
``Urease'', immediately after and directly under Protease (Trypsin), to
read as follows:
Sec. 24.246 Materials authorized for treatment of wine and juice.
* * * * *
(b) * * *
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Materials and use Reference or limitation
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* * * *
* * *
Enzymatic activity: Various uses as The enzyme preparation used
shown below. shall 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 naturally The urease enzyme activity
occurring urea in wine to help prevent shall be derived from
the formation of ethyl carbamate. Lactobacillus fermentum per 21
CFR 184.1924. Use is limited
to not more than 200 mg/L and
must be filtered prior to
final packaging of the wine.
* * * *
* * *
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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.
* * * * *
[[Page 21080]]
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Processes Use Reference or limitation
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* * * * * *
Reverse osmosis \1\..................... To reduce the ethyl alcohol Permeable membranes which are selective
content of wine and to for molecules not greater than 500
remove off flavors in molecular weight with transmembrane
wine,. 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 vinous
character.
Spinning cone column \1\................ To reduce the ethyl alcohol Use shall not alter vinous character. For
content of wine and to standard wine, the same amount of
remove off flavors in essense must be added back to any lot of
wine,. wine as was originally removed.
* * * * * *
*
Ultrafiltration......................... To remove proteinaceous Permeable membranes which are selective
material from wine; to for molecules greater than 500 and less
reduce harsh tannic than 25,000 molecular weight with
material from white wine transmembrane pressures less than 200
produced from white psi. Use shall not alter vinous
skinned grapes; to remove character. 21 CFR 175.300, 177.1520,
pink color from blanc de 177.1550, 177.1630, 177.2440, 177.2600,
noir wine; to separate red and 177.2910.
wine into low color and
high color wine fractions
for blending purposes.
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\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)).
Signed: March 11, 1996.
Bradley A. Buckles,
Acting Director.
Approved: April 1, 1996.
John P. Simpson,
Deputy Assistant Secretary (Regulatory, Tariff and Trade Enforcement).
[FR Doc. 96-11611 Filed 5-8-96; 8:45 am]
BILLING CODE 4810-31-U
