04-25739. Materials and Processes Authorized for the Treatment of Wine and Juice (2004R-517P)

AGENCY:

Alcohol and Tobacco Tax and Trade Bureau (TTB), Treasury.

ACTION:

Temporary rule; solicitation of comments.

SUMMARY:

The Alcohol and Tobacco Tax and Trade Bureau is revising its list of materials authorized for the treatment of wine and juice, and its list of processes authorized for the treatment of wine, juice, and distilling material. Specifically, we are adding new material and process listings, and amending the limitations for some existing listings pertaining to wine and juice. We are seeking comments from all interested parties on our view that the materials and processes covered by these changes are consistent with good commercial practice in the production, cellar treatment, or finishing of juice or standard wine.

DATES:

Temporary rule effective November 19, 2004. Comments must be received on or before January 18, 2005.

ADDRESSES:

You may send comments to any of the following addresses—

• Chief, Regulations and Procedures Division, Alcohol and Tobacco Tax and Trade Bureau, Attn: T.D. TTB-17, P.O. Box 14412, Washington, DC 20044-4412;
• 202-927-8525 (facsimile);
• [e-mail] (e-mail);
• http://www.ttb.gov/​alcohol/​rules/​index.htm (an online comment form is posted with this notice on our Web site); or
• http://www.regulations.gov (Federal e-rulemaking portal; follow instructions for submitting comments).

You may view copies of any comments we receive about this temporary rule by appointment at the TTB Library, 1310 G Street, NW., Washington, DC 20220. To make an appointment, call 202-927-2400. You may also access copies of the interim rule and comments online at http://www.ttb.gov/​alcohol/​rules/​index.htm.

See the Public Participation section of this document for specific instructions and requirements for submitting comments, and for information on how to request a public hearing.

FOR FURTHER INFORMATION CONTACT:

Jennifer Berry, Alcohol and Tobacco Tax and Trade Bureau, Regulations and Procedures Division, P.O. Box 18152, Roanoke, Virginia 24014; telephone [phone].

SUPPLEMENTARY INFORMATION:

Background

Section 5382 of the Internal Revenue Code of 1986 (26 U.S.C. 5382) provides that proper cellar treatment of natural wine constitutes those practices and procedures that produce a finished product acceptable in good commercial practice. Section 5382 also authorizes the Secretary of the Treasury to prescribe, by regulation, limitations on the use of methods and materials for clarifying, stabilizing, preserving, fermenting, and otherwise correcting wine and juice.

The regulations administered by the Alcohol and Tobacco Tax and Trade Bureau (TTB) include, in 27 CFR part 24, provisions that implement these statutory requirements. Section 24.246 (27 CFR 24.246) includes a table that lists materials authorized for the treatment of wine and juice; § 24.247 (27 CFR 24.247) includes a table that lists materials authorized for the treatment of distilling material; and § 24.248 (27 CFR 24.248) includes a table that lists processes authorized for the treatment of wine, juice, and distilling materials.

Industry members wishing to experiment with, or commercially use, a treating material or process not specifically authorized in part 24 may file an application with TTB requesting authorization to use the new material or process. Standards regarding the experimental use of a new material or process are set forth in § 24.249 (27 CFR 24.249). The provisions covering applications for commercial use of a new material or process are contained in § 24.250 (27 CFR 24.250). Applications for commercial use must show that the proposed material or process is a cellar treatment consistent with good commercial practice. In general, good commercial practices include those practices that address the reasonable technological or practical need to enhance the keeping, stability, or other qualities of the wine and that achieve the winemaker's desired effect, without creating an erroneous impression about the wine's character and composition.

Over the past few years, TTB has received and approved applications for experimental or commercial use of the wine and juice treating materials and processes discussed below. We believe we have accumulated enough analytical data or other information to add them to the list of materials and processes for wine and juice in §§ 24.246 and 24.248. Since we have already administratively approved the use of these materials and processes for some industry members for bottling and sale of wine under § 24.249(e), or for commercial use under § 24.250, we believe it is appropriate to adopt these additions to the lists as a temporary rule. In this way, all domestic winemakers will be able to use these treatments in the production of standard wine, pending final regulatory action, without first having to file an application under § 24.249 or § 24.250. At the same time, we are soliciting comments from all interested persons on our position that, based on the information set forth below, the use of each of these materials or processes is consistent with good commercial practice.

After we analyze any comments received in response to this notice, we will issue a final rule. Unless we receive evidence contradicting our stated position, we will adopt the temporary additions to the lists in the final rule. On the other hand, if we receive comments that persuade us that the use of a particular material or process is not consistent with good commercial practice, we will remove it from the appropriate list in our final rule. In such a case, all letters approving the experimental or commercial use of the material or process will be superseded as a result and will be rescinded by operation of law on the effective date of the final rule. Wines produced using such materials or processes that are rescinded based upon this rulemaking may nevertheless be labeled as if the materials or processes were authorized, provided they were produced prior to the date of supercession.

Wine and Juice Treating Materials

Acetaldehyde

An industry member applied to use acetaldehyde in grape juice to stabilize color in red grape concentrate. Acetaldehyde is a natural byproduct of yeast metabolism. A normal component of wine and other fermented products, it occurs naturally in California table wines at levels between 32 and 91 mg/L. The Food and Drug Administration (FDA) regulations at 21 CFR 182.60 state that acetaldehyde, when used as a synthetic flavoring substance and adjuvant, is generally recognized as safe (GRAS) with no established regulatory limit other than good manufacturing practice.

Acetaldehyde reacts with grape pigments (anthocyanins) and catechins (proanthocyanidins) to form a more stable color. According to the industry member, wines containing color-stabilized concentrate have an extended shelf life compared to wines containing standard concentrate. The industry member stated that any residual acetaldehyde is removed during the concentration process through the use of evaporators so that the finished concentrate will have no detectable level of acetaldehyde.

The industry member submitted to the TTB Laboratory two 750-milliliter samples of wine, one containing the treated grape concentrate (comprising 1% of the total volume of the sample) and one (the base) without the concentrate. The Laboratory found that the wine containing the concentrate was a darker, more opaque red than the base. The amount of acetaldehyde was slightly lower in the sample with the concentrate, but in other instrumental analyses the two samples were similar.

Consequently, TTB approved the commercial use of acetaldehyde in juice at a level of 300 mg/L to stabilize color in red grape concentrate. TTB gave this approval pending adoption of acetaldehyde as a treating material through the rulemaking process.

TTB is amending the list in § 24.246 to allow the use of acetaldehyde in juice prior to concentration at the rate of 300 mg/L, provided that no residual acetaldehyde remains in the finished concentrate.

Calcium Pantothenate

An industry member applied to use calcium pantothenate as a yeast nutrient in the production of apple wine. Calcium pantothenate is a salt of pantothenic acid, one of the vitamins of the B complex. The FDA regulations at 21 CFR 184.1212 state that calcium pantothenate is GRAS and may be used as a direct human food ingredient at a level consistent with current good commercial practice. Along with its application, the industry member submitted a material safety data sheet from the manufacturer and an excerpt from the Merck Index describing calcium pantothenate's chemical composition.

TTB approved the industry member's request to use calcium pantothenate for the production of apple wine at the rate of 0.1 lb. per 25,000 gallons of juice. TTB gave this approval pending final rulemaking action on the use of calcium pantothenate. This temporary rule document adds this material to the list in § 24.246.

Carbohydrase (Pectinase, Cellulase, Hemicellulse) Enzyme Preparation

TTB has approved several requests from wineries to use a mixed carbohydrase (pectinase, cellulase, hemicellulse) enzyme preparation derived from a nonpathogenic and nontoxigenic strain of Aspergilius aculeatus to facilitate the separation of juice from the fruit. According to technical information supplied by the enzyme's manufacturer, it disintegrates fruit cell walls, resulting in a quicker and more complete release of juice. A supplier of the enzyme stated that it lowers viscosity, improves clarification and filterability, and maximizes yield. The supplier also stated that it allows for more complete color extraction in red grape juice.

The FDA accepted a GRAS affirmation petition for this enzyme preparation from the manufacturer in 1985. In a December 19, 1996, letter regarding the status of the GRAS affirmation petition, the FDA stated that it had no information indicating that the enzyme preparation is not GRAS. Based on the above information, TTB is adding this mixed carbohydrase enzyme preparation derived from Aspergilius aculeatus to the list of authorized enzymatic activities found in § 24.246 authorized materials table.

Cellulase Enzyme Preparation

An industry member applied to use a cellulase enzyme preparation derived from Tricoderma longibrachiatu to facilitate wine clarification and filtering. The enzyme, cellulase, catalyzes the endohydrolysis of 1, 4-beta-glycosidic linkages in cellulose. According to the technical data sheet issued by the enzyme's manufacturer, the preparation is best suited to treat difficult-to-filter wines, such as those produced from Botrytis-infected grapes. The FDA regulations at 21 CFR 184.1250 state that cellulase enzyme preparations derived from Trichoderma longibrachiatu are GRAS for use as a direct human food ingredient and may be used in amounts not exceeding current good manufacturing practice.

TTB approved the industry member's request to use this enzyme preparation at the rate of 1 to 3 grams per hectoliter (g/hl), the usage rate recommended by the manufacturer. TTB gave this approval pending final rulemaking action on the use of this material.

We are amending the list of authorized enzymatic activities in the § 24.246 authorized materials table by adding the use of this cellulase enzyme preparation, at a rate not to exceed 3 g/hl, to facilitate wine clarification and filtering.

Copper Sulfate

Copper sulfate is currently listed in § 24.246 for use in removing hydrogen sulfide and other mercaptans from wine. These chemical compounds can cause off odors in wine that are often compared to those of rotten egg and skunk. The quantity of added copper sulfate (calculated as copper) may not exceed 0.5 part copper per million parts of wine (0.5 mg/L), with the residual level of copper not to exceed 0.5 part per million (0.5 mg/L). This residual level was established by T.D. ATF-350 (See 58 FR 52231, October 7, 1993), which cited studies showing that wine treated with copper sulfate is stable with residual copper levels at 0.5 part per million or less.

A number of wineries applied to TTB to use copper sulfate at a rate of 6 parts per million for specific vintages due to rainy harvest conditions that required them to spray elevated levels of sulfur on their grapes to prevent mold and mildew. These wineries stated that the residual sulfur on the grapes hindered fermentation and caused off odors, problems they were sometimes unable to correct with the approved level of copper sulfate. TTB approved these applications to use up to 6 parts per million for the vintages requested, provided that the residual level of copper sulfate in the wine did not exceed 0.5 part per million. Samples of wine treated with this higher level of copper sulfate were submitted to the TTB Laboratory and found to have residual copper levels below 0.5 part per million.

New technologies developed in recent years enable winemakers to more easily remove added copper from wine. The use of the metal reducing matrix sheet discussed below is an example of one such new technology. Because winemakers occasionally need to use a higher level of copper sulfate, and because new technologies allow winemakers to more readily remove this added copper, TTB is revising the existing listing in § 24.246 to raise the quantity of copper sulfate allowed to 6 parts per million, with the residual level remaining 0.5 part per million.

Lysozyme

TTB has approved several requests from wineries under § 24.249 to use lysozyme, an enzyme derived from egg white, for the purpose of limiting malolactic bacterial growth during wine fermentation. Such growth, if left unchecked, can adversely affect a wine's taste and can cause stuck or sluggish fermentation. Lysozyme attacks the cell walls of gram-positive bacteria, such as Lactobacillus, Pediococcus, and Leuconostoc, causing them to degrade. This use of lysozyme can greatly reduce the need for sulfur dioxide, which poses a health hazard to sulfite-sensitive individuals. The FDA regulations at 21 CFR 184.1550 state that egg white lysozyme is GRAS when used in the production of cheese.

A number of wineries had the results of their initial experimental trials with lysozyme analyzed by independent laboratories, including Oregon State University, which has extensively researched the use of lysozyme in wine production. The wineries submitted the resulting analytical and sensory data, which included data on the shelf life of the treated wine, to the Bureau of Alcohol, Tobacco and Firearms (ATF), TTB's predecessor agency. The wineries were generally pleased with the results of these trials and analyses, which found that lysozyme inhibited the growth of malolactic bacteria without causing negative sensory impact on the wine. The most effective usage level ranged from 250 mg/L to 500 mg/L.

In 1993, ATF requested an advisory opinion from the FDA regarding the safety of using lysozyme in wine to inhibit the growth of malolactic bacteria. The Director of the FDA's Office of Premarket Approval at the Center for Food Safety and Applied Nutrition responded by letter dated December 15, 1993. The Director stated that the FDA was “currently unaware of any safety or health concerns for the general population with regard to the use of lysozyme in wine. Essentially, the use in question consists of adding a chemically unmodified major protein component (lysozyme) of one common food (eggs) to another common food (wine).”

Based on the above information, TTB is adding lysozyme to the list of authorized enzymatic activities in the § 24.246 authorized materials table for the purpose of limiting malolactic bacterial growth during wine fermentation. The approved usage rate may not exceed 500 mg/L.

Milk Products

Pasteurized whole or skim milk is currently listed in § 24.246 as authorized for the fining of white grape wine or sherry. The amount used may not exceed 2.0 liters of pasteurized milk per 1,000 liters of white wine or sherry (0.2 percent by volume).

TTB has approved applications from a few wineries to use milk and half-and-half at the approved usage rate of 0.2% by volume for the fining of red wine. One winery submitted before and after samples of the treated wine to the TTB Laboratory for analysis. The Laboratory conducted chemical and organoleptic analyses, which found that the milk treatment improved the taste of the wine without altering its basic characteristics.

In addition, a few wineries have applied to use milk and half-and-half to remove trichloroanisole (TCA), which causes off flavors, from wine. Laboratory data submitted by these wineries showed that milk and half-and-half were effective at removing TCA taint without altering the phenolic profile of the treated wine. Half-and-half was found to be particularly effective at removing the TCA due to its higher fat content. The level of milk product used ranged from 0.2% to 10% by volume. The wineries removed residual milk from the wine through conventional filtering methods. One winery submitted to the TTB Laboratory samples of treated wine, along with a control sample. Analytical and organoleptic tests performed by the Laboratory found that the treatment did not affect the vinous character of the wine.

Based on the above, TTB believes that § 24.246 should provide for the use of milk and half-and-half to fine all grape wine rather than only white wine and sherry. TTB also believes the present rate of usage (the milk product may not exceed 0.2% by volume of the wine) should remain unchanged. Similarly, § 24.246 should provide for the use of milk and half-and-half to remove off flavors from wine. TTB believes that wineries should have the option of using milk products to remove all off flavors from wine, not just those caused by TCA taint. The amount of milk or half-and-half used for this purpose should not exceed 10 liters per 1,000 liters of wine (1% of the volume of the wine). To effect these changes, we have replaced the heading “milk (pasteurized whole or skim)” with the heading “milk products (pasteurized whole, skim, or half-and-half)” in the § 24.246 authorized materials table.

Silica Gel (Colloidal Silicon Dioxide)

Silica gel (colloidal silicon dioxide) is currently approved in § 24.246 to clarify wine. Its use may not exceed the equivalent of 20 lbs. colloidal silicon dioxide at a 30% concentration per 1,000 gallons of wine (2.4 g/L), and the silicon dioxide must be completely removed by filtration. The FDA regulations at 21 CFR 172.480 permit the use of silicon dioxide as a food additive.

An industry member applied to have the current authorization extended to the clarification of juice. TTB approved this request to use silica gel on juice, subject to the current limitations of § 24.246, and subject to final rulemaking action. The existing listing for silica gel is revised in this document to reflect this approval.

Wine Treating Processes

Electrodialysis

TTB has received and approved numerous requests from wineries to experiment with the procedure known as electrodialysis to remove excess tartrates from wine. Electrodialysis is a process by which certain ions, namely potassium, calcium, and tartrate ions, are extracted from wine by applying an electric field across specialized charged membranes.

As described by the supplier of the electrodialysis apparatus, the process consists of moving bulk wine past two membranes, one on either side of the wine. One membrane is selectively permeable to tartrate salts and the other is selectively permeable to calcium and potassium salts. As the wine passes between the two membranes, a water-based conductant is passed on the other side of both membranes. As both liquids flow through the apparatus, a weak electrical current is introduced, which causes the tartrate salts to migrate towards the positively charged membrane and the potassium and calcium salts to migrate toward the negatively charged membrane. As the tartrate, calcium, and potassium salts pass through the membranes, they enter the conductant stream and are carried out of the apparatus and discarded. The treated wine is then collected for bottling.

As part of the experimentation process described above, the wineries in question submitted before and after samples to the TTB Laboratory for analysis. The Laboratory analyzed the treated and untreated wines and found that the analytical profile of the treated wine was consistent with that of the untreated wine.

Based on the above, TTB is adding electrodialysis to the list of approved processes in § 24.248.

Metal/Sulfide Reducing Matrix Sheets

TTB has approved several applications from wineries to use two types of matrix filter sheets. One removes metals such as copper and iron from wine, while the other removes sulfides.

Both types of sheets contain the active ingredient Polyvinylimadazole (PVI), a terpolymer related to polyvinylpolypyrrolidone (PVPP), which is listed as an approved material in § 24.246. The PVI is immobilized in a cellulose matrix sheet and constitutes, at most, 40 percent of the weight of the sheet. Wine is passed through these sheets at a controlled flow rate using conventional filtering methods.

In the metal reducing sheet, metals are absorbed by the PVI and are thus removed from the wine. In the sulfide reducing sheet, sulfides in the wine bind to copper sites attached to the PVI. According to the manufacturer of the matrix sheets, the PVI and copper stay immobilized in the matrix and are directly not added to the wine, although the manufacturer calculates the possible migration of PVI into the wine to be less than 0.2 parts per billion.

The manufacturer of the matrix sheets filed a Food Contact Substance Notification with the FDA for the use of PVI as a component of matrix filter sheets used to remove metals and sulfides in alcoholic beverages. The FDA accepted this as an effective notification by a letter dated July 10, 2001, with the qualification that the PVI may constitute a maximum level of 40 percent by weight of the matrix sheet.

A number of the wineries seeking approval from TTB also submitted to the TTB Laboratory before and after samples of wines processed with the metal and sulfide reducing matrix sheets. In each case, TTB's analytical and organoleptic testing found that this treatment did not adversely affect the character and analytical profile of the wine.

Based on the above, TTB is amending § 24.248 to permit the use of metal and sulfide reducing matrix sheets in the treatment of wine.

Nanofiltration

TTB received a petition from an industry member to amend the regulations to allow the use of nanofiltration in combination with ion exchange to remove the volatile acidity (VA) from bulk wine. Although ion exchange is already widely used in the wine industry and is listed in § 24.248, the petitioner is requesting that we consider its use in connection with nanofiltration, which is not listed in § 24.248. We have also received and approved several requests from wineries for permission to use this process on an experimental basis.

The petitioner states that nanofiltration is a process by which wine is drawn into a storage tank where it is pressurized and piped through a mechanical sub-micron filtration process using nanotechnology. During the nanofiltration process, the wine is divided into two separate streams. One stream consists of the larger molecular weight compounds, such as flavors, and the second stream consists of the smaller molecular weight compounds, such as alcohol, water, and acetic acid. The second stream is passed through an ion exchange column, which selectively removes the acetic acid and allows the alcohol and water molecules to pass through. Upon exiting the ion exchange column, the second stream is re-combined with the first stream. The petitioner states that the membrane used in nanofiltration has a molecular weight cut-off of 100 Daltons at a pressure of 250 psi and a temperature of 60 degrees Fahrenheit.

As part of the experimentation approval process, the wineries submitted before and after samples to the TTB Laboratory for analysis. Our Laboratory analyzed the treated and untreated wines and found that the levels of volatile acids were indeed reduced without otherwise adversely affecting the wine.

Based on the above, TTB is adding nanofiltration to the list of approved processes in § 24.248.

Osmotic Transport

TTB has approved several requests from wineries to use osmotic transport in the production of reduced alcohol wines. Osmotic transport is also known as isothermal transport, isothermal membrane distillation, or osmotic distillation.

Osmotic transport is a membrane transport process that involves two liquids, typically water solutions, which have different water vapor pressures. The solution to be treated is typically referred to as the “feed” solution and contains volatile components that are soluble or miscible in the receiving solution (typically referred to as the “stripping” solution). The membrane must be completely hydrophobic in order to prevent the stripping solution from passing through the membrane into the feed solution.

In the osmotic transport treatment approved by TTB, wine is pumped along one side of a completely hydrophobic microporous membrane with water on the other side. The wine and the stripping solution run tangential to, and are separated by, the thin membrane. The driving force for the separation is the vapor pressure difference between the alcohol in the wine and the water-based stripping solution. The higher vapor pressure of the alcohol in the wine causes some of the alcohol to evaporate, pass through the microporous membrane, and then condense in the water-based stripping solution. The stripping solution is usually circulated across the membrane until the alcohol content of the feed wine and the stripping solution are essentially equal. The process is performed at ambient temperature without elevated pressures (other than gentle pressure necessary to pump the wine).

As part of an industry member's request to experiment with this treatment, the industry member submitted before and after samples to the TTB Laboratory for analysis. The Laboratory's analysis found that the process did indeed reduce the level of alcohol in the wine.

Since the separation of alcohol from a fermented substance is considered to be a distilling process, osmotic transport operations cannot be conducted at winery premises but must instead take place at a distilled spirits plant. The alcohol-containing stripping solution may be used for distilling material or in the production of other than standard wine. The destruction of any alcohol derived from the osmotic transport process must be in accordance with the provisions of 27 CFR 19.691.

Accordingly, we are adding osmotic transport to the list of authorized processes in § 24.248, subject to the following conditions:

• The treatment must not alter the vinous character of the wine. The stripping solution must not migrate into the wine.
• The treatment must be conducted at a distilled spirits plant premises.

Public Participation

Comments Sought

We request comments from everyone interested. We are especially interested in comments that address the question of whether the use of a particular material or process addressed in this document is consistent with good commercial practice. Please support your comment with specific information about the material or process in question.

All comments must reference T.D. TTB-17 and must include your name and mailing address. They must be legible and written in language acceptable for public disclosure. Although we do not acknowledge receipt, we will consider your comments if we receive them on or before the closing date. We regard all comments as originals.

Confidentiality

All comments are part of the public record and subject to disclosure. Do not enclose any material in your comments that you consider confidential or inappropriate for public disclosure.

Submitting Comments

You may submit comments in any of five ways:

• Mail: You may send written comments to TTB at the address listed in the ADDRESSES section of this document.
• Facsimile: You may submit comments by facsimile transmission to 202-927-8525. Faxed comments must—

(1) Be on 8.5 by 11-inch paper;

(2) Contain a legible, written signature; and

(3) Be no more than five pages long. This limitation ensures electronic access to our equipment. We will not accept faxed comments that exceed five pages.

• E-mail: You may e-mail comments to [e-mail]. Comments transmitted by electronic mail must—

(1) Contain your e-mail address;

(2) Reference T.D. TTB-17 on the subject line; and

(3) Be legible when printed on 8.5 by 11-inch paper.

• Online form: We provide a comment form with the online copy of this document on our Web site at http://www.ttb.gov/​alcohol/​rules/​index.htm. Select the “Send comments via e-mail” link under T.D. TTB-17.
• Federal e-Rulemaking Portal: To submit comments to us via the Federal e-rulemaking portal, visit http://www.regulations.gov and follow the instructions for submitting comments.

You may also write to the Administrator before the comment closing date to ask for a public hearing. The Administrator reserves the right to determine, in light of all circumstances, whether to hold a public hearing.

Public Disclosure

You may view copies of this document and any comments we receive by appointment at the TTB Library at 1310 G Street, NW., Washington, DC 20220. You may also obtain copies at 20 cents per 8.5 by 11-inch page. Contact our librarian at the above address or telephone [phone] to schedule an appointment or to request copies of comments.

For your convenience, we will post this document and any comments we receive on the TTB Web site. We may omit voluminous attachments or material that we consider unsuitable for posting. In all cases, the full comment will be available in the TTB Library. To access the online copy of this document, visit http://www.ttb.gov/​alcohol/​rules/​index.htm. Select the “View Comments” link under this document's number and title to view the posted comments.

Regulatory Flexibility Act

Because no notice of proposed rulemaking is required for temporary rules, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) do not apply.

Executive Order 12866

This temporary rule is not a significant regulatory action as defined by Executive Order 12866. Therefore, it requires no regulatory analysis.

Inapplicability of Prior Notice and Comment and Delayed Effective Date Procedures

Pursuant to the provisions of 5 U.S.C. 553(b)(B), we have determined that prior public notice and comment procedures on these regulations are unnecessary and contrary to the public interest. Issuing a temporary rule rather than a notice of proposed rulemaking allows all domestic winemakers to use new wine treatments that have already been approved for sometime. This will “level the playing field” and reduce the possibility of confusion as to which materials and processes are approved. For the same reason, pursuant to the provisions of 5 U.S.C. 553(d)(1) and (3), we find that there is good cause for dispensing with a delayed effective date.

Drafting Information

The principal author of this document was Jennifer K. Berry, Regulations and Procedures Division, Alcohol and Tobacco Tax and Trade Bureau. However, other personnel participated in its development.

List of Subjects in 27 CFR Part 24

• Administrative practice and procedure
• Claims
• Electronic fund transfers
• Excise taxes
• Exports
• Food additives
• Fruit juices
• Labeling
• Liquors
• Packaging and containers
• Reporting and recordkeeping requirements
• Research
• Scientific equipment
• Spices and flavoring
• Surety bonds
• Vinegar
• Warehouses
• Wine

Amendments to the Regulations

For the reasons discussed in the preamble, TTB amends 27 CFR part 24 as follows:

PART 24—WINE

1. The authority citation for part 24 continues to read as follows:

Authority: 5 U.S.C. 552(a); 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, 5511, 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.

2. The table in § 24.246 is amended:

a. By adding, in appropriate alphabetical order, new listings for “acetaldehyde” and “calcium pantothenate”;

b. By revising the listing for “copper sulfate”;

c. Under the heading for “Enzymatic activity,” by adding, in appropriate alphabetical order, new listings for “carbohydrase (pectinase, cellulase, hemicellulase),” “cellulase (beta-glucanase)” [immediately preceding the current listing for glucose oxidase], and “lysozyme;”

d. By removing the listing for “milk (pasteurized whole or skim)” and adding, in its place, a heading for “milk products (pasteurized whole, skim, or half-and-half)” followed by two use listings; and

e. By revising the listing for “silica gel (colloidal silicon dioxide).”

The additions and revisions read as follows:

§ 24.246

Materials authorized for treatment of wine and juice.

* * * * *

Materials Authorized for Treatment of Wine and Juice

Materials and use	Reference or limitation
*         *         *         *         *         *         *
Acetaldehyde: For color stabilization of juice prior to concentration	The amount used must not exceed 300 ppm, and the finished concentrate must have no detectable level of the material. 21 CFR 182.60 (GRAS).
*         *         *         *         *         *         *
Calcium pantothenate: Yeast nutrient to facilitate fermentation of apple wine	The amount used must not exceed 0.1 lb. per 25,000 gallons. 21 CFR 184.1212 (GRAS).
*         *         *         *         *         *         *
Copper sulfate: To remove hydrogen sulfide and/or mercaptans from wine	The quantity of copper sulfate added (calculated as copper) must not exceed 6 parts copper per million parts of wine (6.0 mg/L). The residual level of copper in the finished wine must not exceed 0.5 parts per million (0.5 mg/L). 21 CFR 184.1261 (GRAS).
*         *         *         *         *         *         *
Enzymatic activity: Various uses as shown below
*         *         *         *         *         *         *
Carbohydrase (pectinase, cellulase, hemicellulase): To facilitate separation of juice from the fruit	The enzyme activity used must be derived from Aspergilius aculeatus. FDA advisory opinion dated12/19/1996.
*         *         *         *         *         *         *
Cellulase (beta-glucanase): To clarify and filter wine	The enzyme activity must be derived from Tricoderma longibrachiatu. The amount used must not exceed 3 g/hl. 21 CFR 184.1250 (GRAS).
*         *         *         *         *         *         *
Lysozyme: To stabilize wines from malolactic acid bacterial degradation	The amount used must not exceed 500 mg/L. FDA advisory opinion dated 12/15/93.
*         *         *         *         *         *         *
Milk products (pasteurized whole, skim, or half-and-half):
Fining agent for grape wine or sherry	The amount used must not exceed 2.0 liters of pasteurized milk per 1,000 liters (0.2 percent V/V) of wine.
To remove off flavors in wine	The amount used must not exceed 10 liters of pasteurized milk per 1,000 liters (1 percent V/V) of wine.
*         *         *         *         *         *         *
Silica gel (colloidal silicon dioxide): To clarify wine or juice	Use must not exceed the equivalent of 20 lbs. colloidal silicon dioxide at a 30% concentration per 1000 gals. of wine. (2.4 g/L). Silicon dioxide must be completely removed by filtration. 21 CFR 172.480.
*         *         *         *         *         *         *

3. The table in § 24.248 is amended by adding, in appropriate alphabetical order, new listings for “electrodialysis,” “metal reducing matrix sheet processing,” “nanofiltration,” “osmotic transport,” and “sulfide reducing matrix sheet processing,” to read as follows:

§ 24.248

Processes authorized for the treatment of wine, juice, and distilling material.

* * * * *

Processes Authorized for the Treatment of Wine, Juice, and Distilling Material

Processes	Use	Reference or limitation
Electrodialysis	To aid in the removal of tartrates	This process must not alter the vinous character of the wine.
*         *         *         *         *         *         *
Metal reducing matrix sheet processing	To reduce the level of metals such as copper and iron in wine	(1) The active ingredient, polyvinylimidazol, must not constitute more than 40% by weight of the sheet. (2) Use of the sheet must not significantly alter the color of the wine.
Nanofiltration	To reduce the level of volatile acidity in wine (used with ion exchange)	This process must use permeable membranes which are selective for molecules not greater than 150 molecular weight with transmembrane pressures of 250 psi or less.
Osmotic transport 1	For alcohol reduction	(1) Use must not alter the vinous character of the wine (2) None of the stripping solution may migrate into the wine.
*         *         *         *         *         *         *
Sulfide reducing matrix sheet processing	To reduce the level of sulfides in wine	(1) The active ingredient, polyvinylimidazol, must not constitute more than 40% by weight of the sheet. (2) Use of the sheet must not significantly alter the color of the wine.
*         *         *         *         *         *         *

Signed: October 1, 2004.

Arthur J. Libertucci,

Administrator.

Approved: October 22, 2004.

Timothy E. Skud,

Deputy Assistant Secretary (Tax, Trade, and Tariff Policy).