Materials and Processes Authorized for the Production of Wine and for the Treatment of Juice, Wine and Distilling Material (93F-059P)

DEPARTMENT OF THE TREASURY

Bureau of Alcohol, Tobacco and Firearms

27 CFR Part 24

[T.D. ATF-371; RE: Notice Nos. 800 and 805]

RIN: 1512-AB26

Materials and Processes Authorized for the Production of Wine and

for the Treatment of Juice, Wine and Distilling Material (93F-059P)

AGENCY: Bureau of Alcohol, Tobacco and Firearms (ATF), Department of

the Treasury.

ACTION: Final rule (Treasury decision).

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SUMMARY: This final rule amends the wine regulations in 27 CFR Part 24

to add or modify the use of 3 wine treating processes and to add the

use of 1 new wine treating material. The use of these new or modified

wine treating processes and materials has been found to be acceptable

in ``good commercial practice'' in the production, cellar treatment,

and finishing of wine, pursuant to the provisions of Section 5382 of

the Internal Revenue Code of 1986, since their use will not alter

vinous character or pose any health, safety, or consumer deception

problems.

EFFECTIVE DATE: July 8, 1996.

FOR FURTHER INFORMATION CONTACT: Robert White, Coordinator, Wine, Beer

and Spirits Regulations Branch, Bureau of Alcohol, Tobacco and

Firearms, 650 Massachusetts Avenue NW., Washington, DC 20226 (202-927-

8230).

SUPPLEMENTARY INFORMATION:

Background

Several members of the wine industry petitioned ATF for approval of

the use of 3 wine treating processes and 1 wine treating material in

the production, cellar treatment, and/or finishing of wine. Only one of

the processes, the spinning cone column, is new and would be used to

reduce the ethyl alcohol content of wine or to remove off flavors in

wine. The other two processes are not new but either would be used in

combination or would be used for a different purpose or at a different

limitation than previously authorized. The processes to be used in

combination are reverse osmosis and ion exchange

[[Page 21077]]

and would be used to remove excess volatile acidity from wine. The

process which would be used at a different limitation is

ultrafiltration. And finally, the new wine treating material, urease

enzyme, would be used to reduce urea in wine, thereby reducing the

possibility of ethyl carbamate formation during wine storage.

Notice No. 800

On September 30, 1994, ATF published a notice of proposed

rulemaking (Notice No. 800) in the Federal Register requesting that all

interested parties submit written comments by November 29, 1994. Nine

comments were received including 2 comments which requested an

extension of the comment deadline. Due to the requests for an extension

of the comment period, ATF published a reopening notice (Notice No.

805) in the Federal Register on January 18, 1995, which reopened the

comment period for 60 days ending on March 20, 1995. Three comments

were received in response to the reopening notice making a total of 12

comments received in response to the 2 wine treating notices.

Summary of Comments

Six of the commenters stated that they fully support the use of the

spinning cone column to reduce the ethyl alcohol content of wine or to

remove off flavors from wine. One of the six commenters, Mr. Vincent

Indelicato of Delicato Vineyards, also asked that the spirits derived

from the spinning cone column process, if at a minimum proof of 100 or

above, be approved for wine spirits additions without any restrictions.

Mr. Indelicato also asked that spinning cone column de-essenced juice

be allowed in all standard winemaking including the fermenting of this

de-essenced juice into standard wine. Five of the six commenters who

addressed the use of the spinning cone column also stated that they

support the additional requests made by Mr. Indelicato.

One of the six commenters mentioned above, Mr. Robert G. Kalik of

the American Vintners Association (AVA), also stated that the AVA fully

supports the 3 new or modified wine treating processes and the 1 new

wine treating material proposed in Notice No. 800.

Another commenter, Mr. Clark Smith and Mr. Rick Jones of

Vinovation, Inc., submitted a joint comment stating that Vinovation

fully supports the use of reverse osmosis and ion exchange in

combination in a closed system to remove excess volatile acidity from

wine. They also state in a separate comment that it is their

understanding that use of the spinning cone column to remove volatile

acidity from wine is not very practical since such removal of volatile

acidity would result in an equal proportion of ethanol being removed

from the wine.

Two additional commenters in the wine industry state that they

fully support the use of reverse osmosis along with ion exchange to

remove excess volatile acidity in wine. Both state that wine which has

undergone this treatment to remove excess volatile acidity has been

greatly improved in quality. Both commenters believe that adoption of

this wine treating process will represent a real benefit to the wine

industry as well as to the consumer.

Two commenters to Notice No. 800 asked for an extension of the

comment period to give them more time to analyze the wine treating

proposals and to prepare a response. One of these commenters represents

the Delegation of the European Commission (EC) and the other represents

the French government.

The final comment was from the Delegation of the European

Commission in response to Notice No. 805 which reopened the comment

period for 60 days. This commenter states that the comment represents

the views of the European Community. The commenter states that the

European Community is concerned at the possibility of introduction into

regular winemaking of the wine treating processes and materials

mentioned in the notice of proposed rulemaking and considers that their

utilization could be problematic for such wines imported into the

European Union. The commenter also states that approval of such

processes and materials could complicate the ongoing negotiations for

an EC/US wine agreement.

The commenter states that the European Community would like to draw

attention to the fact that the processes and materials described in the

notice are not currently authorized by Council Regulation (EEC) No.

822/87, particularly Title II, which lays down European Community rules

governing oenological practices and processes, and Annex VI, which

lists the practices and processes authorized for wines marketed in the

European Union; nor are these processes and materials included in the

Annex to Council Regulation (EEC) No. 1873/84, which details the

oenological practices authorized for wine imported into the European

Union from the United States.

Moreover, the commenter states that the new materials and processes

described in the notice are not included in the International Code of

Oenological Practices of the International Vine and Wine Office (OIV)

which is approved by the governments of the member countries of the

OIV. The commenter states that except for the use of urease, these

practices have not yet even been the subject of preliminary discussions

nor have they been communicated to this international forum.

In conclusion, this commenter states that the European Community

would suggest that utilization of the materials and processes proposed

in Notice No. 800 would best be considered within the bilateral

framework of the ongoing negotiations for an EC/US wine agreement and

within the multilateral framework of the OIV. Consequently, this

commenter states that the European Commission urges that the U.S.

authorities take no action on approving these materials and processes

until such consultations with the EC and OIV have taken place.

ATF Decision

After careful consideration of the comments, ATF has decided to

approve the 3 wine treating processes and 1 wine treating material

proposed in Notice No. 800. These 3 wine treating processes and 1 wine

treating material have the support of the U.S. wine industry and have

been determined to be in accordance with good commercial practice. Use

of these 3 processes and 1 material will be a significant benefit to

consumers and to the wine industry by enabling industry members to

exercise additional quality control in the production of their wines.

ATF acknowledges that the European Community has not currently

approved the use of these 3 wine treating processes and 1 wine treating

material in their wines. However, we have decided to go ahead and

approve these processes and materials for use by U.S. wine producers

because, after careful review, we have concluded that their use

complies with the statutory standard of good commercial practice.

ATF does not believe that it should prevent the use of new wine

treating processes and materials that have been found to be beneficial

to industry members and consumers alike, since it has determined that

the wine treatments do not alter vinous character or pose any health,

safety, or consumer deception problems. In addition, we feel that the

ongoing wine negotiations with the European Community do not foreclose

or restrict our domestic rulemaking decisions implementing statutory

standards under U.S. laws.

In regard to the requests to use spirits derived from the spinning

cone column process for wine spirits additions and the use of de-

essenced juice derived from the spinning cone column process

[[Page 21078]]

in all standard winemaking, we have determined that we need more time

to thoroughly analyze these requests and will address these issues at a

later time.

Wine Treating Processes

Spinning Cone Column

The spinning cone column (SCC) is a gas-liquid contacting device

which can process a wide range of products including slurries with very

high solids contents. It is a multi-stage mass transfer device

consisting of a series of alternating stationary and rotary truncated

cones. During its operation the product is fed at the top of the column

and then flows down the upper surface of the stationary cones under the

influence of gravity and moves across the upper surface of the rotating

cones in a thin film due to the applied centrifugal force. The

stripping gas enters the bottom of the column and flows counter current

to the liquid phase in the spaces between the fixed and rotating cones.

The SCC is used in the production of low alcohol wine, as well as

to remove off flavors in wine (e.g. volatile acidity, ethyl acetate,

hydrogen sulfide, etc.). In the production of low alcohol wine, the

feed wine is initially run through the SCC to recover the volatile wine

flavor essence. In the second stage of processing, the flavor essence

reduced wine is run through the SCC to reduce the alcohol in the wine

to the desired level. The essence, which has previously been removed,

is then added back to the alcohol reduced wine to produce a low alcohol

wine which retains its original flavor. The alcohol which has been

removed from the wine can then either be used in accordance with law

and regulations or be destroyed.

Treatment of wine utilizing the SCC to remove off flavors, or to

reduce the alcohol content of the wine, may not alter the vinous

character of the wine. Otherwise, the wine will no longer be considered

standard wine.

Since the separation of alcohol from a fermented substance is

considered to be a distilling process, the SCC operations cannot be

conducted at winery premises but must instead take place at distilled

spirits plant premises.

The SCC operations must be conducted in accordance with the

following conditions:

1. The SCC removal of any alcohol from the wine will be done on DSP

premises.

2. Records will be maintained for each lot of wine put through the

SCC and the fractions derived from such wine showing the date,

quantity, and disposition of each fraction.

3. In the production of reduced alcohol standard wines using the

SCC, the same amount of essence will be added back to any lot of wine

as was originally removed.

4. The destruction of any alcohol or other fractions derived from

the SCC process must be in accordance with the provisions of 27 CFR

19.691.

Reverse Osmosis and Ion Exchange

In this process, reverse osmosis and ion exchange are used in

combination to remove volatile acidity (VA) from bulk wine. The process

combines two technologies already widely in use in the wine industry.

The process involves utilizing reverse osmosis to separate wine

into various components and then using ion exchange to remove VA. The

wine components, minus the VA, are then recombined in-line to form the

original wine minus the VA. The whole process takes place in a closed

system.

Regulations at 27 CFR 24.248 were previously broad enough to allow

ion exchange to be used to remove volatile acidity from wine or from

various components of wine. However, those regulations did not

authorize reverse osmosis to be used for anything other than to reduce

the ethyl alcohol content of wine. This regulation change will allow

reverse osmosis to also be used to remove off flavors in wine which

will enable it to be used as part of an overall process in a closed

system to remove VA from wine.

Normally, reverse osmosis must be done on distilled spirits plant

premises because it is considered a distilling process resulting in a

distilled spirits by-product. However, in this case, the various

components of wine will only be created temporarily in a closed system

and will be immediately recombined in-line to reconstitute the original

wine minus VA. Consequently, ATF has concluded that this type of

reverse osmosis may be conducted on bonded winery premises since no

separate distilled spirits product is created as a final product or by-

product.

Accumulation of ethyl alcohol outside the closed system is not

allowed. Any accumulation of an ethanol solution on winery premises may

subject the proprietor to the distilled spirits tax of $13.50 per proof

gallon imposed by Section 5001 of the Internal Revenue Code.

The footnote concerning processes which must be done on distilled

spirits plant premises, located at the end of 27 CFR 24.248, has been

revised to state that under certain limited conditions, reverse osmosis

may be used on bonded winery premises if ethyl alcohol is only

temporarily created within a closed system.

Ultrafiltration

Previous regulations at 27 CFR 24.248 allowed ultrafiltration to be

used for various filtration purposes as long as the following

conditions were met:

(a) Permeable membranes are used which are selective for molecules

greater than 500 and less than 25,000 molecular weight with

transmembrane pressures which do not exceed 100 pounds per square inch

(psi).

(b) Use shall not alter vinous character.

This final rule amends the regulations to allow greater

transmembrane pressures to be used and still be considered

ultrafiltration. The revised regulations allow less than 200 psi in

lieu of the current 100 psi. This more liberal pressure limitation will

provide for greater throughput with no change in the vinous character

of the finished wine. Without this increase in throughput, the process

is not economically viable for many industry members since they can

achieve the same result with other methods at a much lower cost.

The less than 200 psi pressure limitation was chosen as the upper

limit in order to maintain a clear distinction between ultrafiltration

and reverse osmosis in terms of pressure. The two processes are also

differentiated by the fact that the membranes specified for reverse

osmosis have a much smaller pore size than those used in

ultrafiltration.

New Wine Treating Material

Urease Enzyme

The use of urease enzyme derived from Lactobacillus fermentum has

been found to reduce levels of naturally occurring urea in wine thereby

helping to prevent the formation of ethyl carbamate during storage.

The enzyme is derived from the nonpathogenic, nontoxicogenic

bacterium Lactobacillus fermentum. It contains the enzyme urease (CAS

Reg. No. 9002-13-5) which facilitates the hydrolysis of urea to ammonia

and carbon dioxide. It is produced by a pure culture fermentation

process and by using materials that are generally recognized as safe

(GRAS) or are food additives that have been approved for this use by

the Food and Drug Administration (FDA).

Urease enzyme from Lactobacillus fermentum was approved for use in

wine by FDA on December 21, 1992,

[[Page 21079]]

effective January 21, 1993. The FDA regulation cite is 21 CFR 184.1924,

Urease Enzyme Derived From Lactobacillus Fermentum.

The enzyme is standardized with glucose syrup solids and the urease

activity is adjusted to 3.5 units/mg. Urease enzyme meets the general

and additional requirements for enzyme preparations in the ``Food

Chemicals Codex,'' 3rd edition (1981). In addition, the urease enzyme

is used in food at levels not to exceed current good manufacturing

practice as defined in 21 CFR 184.1924.

The composition of the urease enzyme preparation is as follows:

Killed whole cells of Lactobacillus fermentum....................20-35%

Glucose Syrup Solids.............................................65-80%

Due to the low usage level (10-200 ppm) and objective of usage,

addition of glucose syrup solids in this case is not considered

``sweetening'' of the beverage, which is prohibited in the State of

California for table wine.

The use of urease enzyme derived from Lactobacillus fermentum is

economically self-limiting due to the high cost of the material. FDA,

in their approval, did not set a specific numerical limit but rather

limited its use to ``good commercial practice.''

Due to the recommendations from industry and from the ATF

laboratory, we have established an upper limit for the use of urease

enzyme in wine of 200 mg/L, provided that the enzyme is filtered prior

to final packaging of the wine, as a ``good commercial practice.''

Regulatory Flexibility Act

It is hereby certified that this regulation will not have a

significant economic impact on a substantial number of small entities.

This regulation is liberalizing in nature and will allow winemakers

more flexibility when producing their wines with no negative impact on

small entities. Accordingly, a regulatory flexibility analysis is not

required because this final rule is not expected: (1) To have

secondary, or incidental effects on a substantial number of small

entities; or (2) to impose, or otherwise cause a significant increase

in the reporting, recordkeeping, or other compliance burdens on a

substantial number of small entities.

Executive Order 12866

It has been determined that this regulation is not a significant

regulatory action as defined by Executive Order 12866. Accordingly this

final rule is not subject to the analysis required by this Executive

Order.

Paperwork Reduction Act

The provisions of the Paperwork Reduction Act of 1980, Public Law

96-511, 44 U.S.C. Chapter 35, and its implementing regulations, 5 CFR

Part 1320, do not apply to this final rule because no requirement to

collect information is imposed.

Drafting Information: The principal author of this document is

Robert L. White, Wine, Beer and Spirits Regulations Branch, Bureau

of Alcohol, Tobacco and Firearms. ATF Wine Technical Advisor Richard

M. Gahagan has provided significant technical assistance in the

evaluation and review of data pertinent to the preparation of this

document.

List of Subjects in 27 CFR Part 24

Administrative practice and procedure, Authority delegations,

Claims, Electronic funds transfers, Excise taxes, Exports, Food

additives, Fruit juices, Labeling, Liquors, Packaging and containers,

Reporting requirements, Research, Scientific equipment, Spices and

flavorings, Surety bonds, Transportation, Warehouses, Wine and vinegar.

Authority and Issuance

27 CFR Part 24--Wine is amended as follows:

PART 24--WINE

Par. 1. The authority citation for Part 24 continues to read as

follows:

Authority: 26 U.S.C. 5001, 5008, 5041, 5042, 5044, 5061, 5062,

5081, 5111-5113, 5121, 5122, 5142, 5143, 5173, 5206, 5214, 5215,

5351, 5353, 5354, 5356-5357, 5361, 5362, 5364-5373, 5381-5388, 5391,

5392, 5551, 5552, 5661, 5662, 5684, 6065, 6091, 6109, 6301, 6302,

6311, 6651, 6676, 7011, 7302, 7342, 7502, 7503, 7606, 7805, 7851; 31

U.S.C. 9301, 9303, 9304, 9306.

Par. 2. Section 24.246 is amended in the table in Paragraph (b)

revising the entry for enzymatic activity, and by adding the new entry,

``Urease'', immediately after and directly under Protease (Trypsin), to

read as follows:

Sec. 24.246 Materials authorized for treatment of wine and juice.

* * * * *

(b) * * *

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Materials and use Reference or limitation

------------------------------------------------------------------------

* * * *

* * *

Enzymatic activity: Various uses as The enzyme preparation used

shown below. shall be prepared from

nontoxic and nonpathogenic

microorganisms in accordance

with good manufacturing

practice and be approved for

use in food by either FDA

regulation or by FDA advisory

opinion.

* * * *

* * *

Urease: To reduce levels of naturally The urease enzyme activity

occurring urea in wine to help prevent shall be derived from

the formation of ethyl carbamate. Lactobacillus fermentum per 21

CFR 184.1924. Use is limited

to not more than 200 mg/L and

must be filtered prior to

final packaging of the wine.

* * * *

* * *

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Par. 3. Section 24.248 is amended in the table by revising the

entries for ``Reverse osmosis'' and ``Ultrafiltration'', by adding the

entry for ``Spinning cone column'', and by revising the footnote at the

end of the section to read as follows:

Sec. 24.248 Processes authorized for the treatment of wine, juice, and

distilling material.

* * * * *

[[Page 21080]]

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Processes Use Reference or limitation

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* * * * * *

Reverse osmosis \1\..................... To reduce the ethyl alcohol Permeable membranes which are selective

content of wine and to for molecules not greater than 500

remove off flavors in molecular weight with transmembrane

wine,. pressures of 200 psi and greater. The

addition of water other than that

originally present prior to processing

will render standard wine ``other than

standard.'' Use shall not alter vinous

character.

Spinning cone column \1\................ To reduce the ethyl alcohol Use shall not alter vinous character. For

content of wine and to standard wine, the same amount of

remove off flavors in essense must be added back to any lot of

wine,. wine as was originally removed.

* * * * * *

*

Ultrafiltration......................... To remove proteinaceous Permeable membranes which are selective

material from wine; to for molecules greater than 500 and less

reduce harsh tannic than 25,000 molecular weight with

material from white wine transmembrane pressures less than 200

produced from white psi. Use shall not alter vinous

skinned grapes; to remove character. 21 CFR 175.300, 177.1520,

pink color from blanc de 177.1550, 177.1630, 177.2440, 177.2600,

noir wine; to separate red and 177.2910.

wine into low color and

high color wine fractions

for blending purposes.

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\1\ This process must be done on distilled spirits plant premises. However, reverse osmosis, under certain

limited conditions, may be used on bonded winery premises if ethyl alcohol is only temporarily created within

a closed system.

(Sec. 201, Pub. L. 85-859, 72 Stat. 1383, as amended (26 U.S.C.

5381, 5382, 5385, 5386, and 5387)).

Signed: March 11, 1996.

Bradley A. Buckles,

Acting Director.

Approved: April 1, 1996.

John P. Simpson,

Deputy Assistant Secretary (Regulatory, Tariff and Trade Enforcement).

[FR Doc. 96-11611 Filed 5-8-96; 8:45 am]

BILLING CODE 4810-31-U