[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] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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