[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.

* * * * * 

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