[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) * * *

------------------------------------------------------------------------
           Materials and use                 Reference or limitation    
------------------------------------------------------------------------
                                                                        
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
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.  
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
------------------------------------------------------------------------

    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         
----------------------------------------------------------------------------------------------------------------
                                                                                                                
*                  *                  *                  *                  *                  *                
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.                                               
----------------------------------------------------------------------------------------------------------------
\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