Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Rules and Regulations 67639

rule’’ under Department of 

Transportation (DOT) Regulatory 

Policies and Procedures (44 FR 11034, 

February 26, 1979); and (3) if 

promulgated, will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, 

Navigation (air).

Adoption of the Amendment

■ Accordingly, the Federal Aviation 

Administration amends 14 CFR part 71 

as follows:

PART 71—DESIGNATION OF CLASS A, 

CLASS B, CLASS C, CLASS D, AND 

CLASS E AIRSPACE AREAS; 

AIRWAYS; ROUTES; AND REPORTING 

POINTS

■ 1. The authority citation for part 71 

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389.

§ 71.1 [Amended]

■ 2. The incorporation by reference in 14 

CFR 71.1 of Federal Aviation 

Administration Order 7400.9M, dated 

August 30, 2004, and effective 

September 16, 2004, is amended as 

follows:

* * * * *

Paragraph 6005 Class E airspace areas 

extending upward from 700 feet or more 

above the surface of the earth.

* * * * *

ACE IAE5 Boone, IA 

Boone Municipal Airport, IA 

(Lat. 42°02′58′′ N., long. 93°50′51′′ W.) 

Boone NDB 

(Lat. 42°03′16′′ N., long. 93°51′11′′ W.)

That airspace extending upward from 700 

feet above the surface within a 6.5-mile 

radius of Boone Municipal Airport; and 

within 7 miles north and 3 miles south of the 

048° bearing from the Boone NDB extending 

from the 6.5-mile radius of the airport to 10 

miles northeast of the NDB; and within 2.5 

miles each side of the 143° bearing from the 

NDB extending from the 6.5-mile radius of 

the airport to 7 miles southeast of the NDB; 

and within 2.5 miles each side of the 333°

bearing from the NDB extending from the 6.5-

mile radius of the airport to 7 miles 

northwest of the NDB.

* * * * *

Issued in Kansas City, MO, on November 

4, 2004. 

Anthony D. Roetzel, 

Acting Area Director, Western Flight Services 

Operations.

[FR Doc. 04–25699 Filed 11–18–04; 8:45 am] 

BILLING CODE 4910–13–M

DEPARTMENT OF THE TREASURY

Alcohol and Tobacco Tax and Trade 

Bureau 

27 CFR Part 24

[T.D. TTB–17] 

RIN 1513–AA96

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); 

• nprm@ttb.gov (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 

540–344–9333.

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 

67640 Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Rules and Regulations 

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 colorstabilized 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 

Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Rules and Regulations 67641

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-andhalf 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 

67642 Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Rules and Regulations 

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 waterbased 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 recombined 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 

Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Rules and Regulations 67643

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 nprm@ttb.gov. 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 202–927–

2400 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 

67644 Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Rules and Regulations 

‘‘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 (betaglucanase)’’ [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. 

Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Rules and Regulations 67645

PROCESSES AUTHORIZED FOR THE TREATMENT OF WINE, JUICE, AND DISTILLING MATERIAL—Continued

Processes Use Reference or limitation 

* * * * * * * 

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).

[FR Doc. 04–25739 Filed 11–18–04; 8:45 am] 

BILLING CODE 4810–31–P

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[CA–295–0470a; FRL–7834–2] 

Revisions to the California State 

Implementation Plan, Great Basin and 

Ventura County Air Pollution Control 

Districts

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: EPA is taking direct final 

action to approve revisions to the Great 

Basin Air Pollution Control District 

(GBAPCD) and Ventura County Air 

Pollution Control District (VCAPCD) 

portions of the California State 

Implementation Plan (SIP). Under 

authority of the Clean Air Act as 

amended in 1990 (CAA or the Act), we 

are approving local rules that are 

administrative and address changes for 

clarity and consistency.

DATES: This rule is effective on January 

18, 2005 without further notice, unless 

EPA receives adverse comments by 

December 20, 2004. If we receive such 

comments, we will publish a timely 

withdrawal in the Federal Register to 

notify the public that this direct final 

rule will not take effect.

ADDRESSES: Send comments to Andy 

Steckel, Rulemaking Office Chief (AIR–

4), U.S. Environmental Protection 

Agency, Region IX, 75 Hawthorne 

Street, San Francisco, CA 94105–3901 

or e-mail to steckel.andrew@epa.gov, or 

submit comments at http://

www.regulations.gov.

You can inspect copies of the 

submitted SIP revisions, EPA’s technical 

support documents (TSDs), and public 

comments at our Region IX office during 

normal business hours by appointment. 

You may also see copies of the 

submitted SIP revisions by appointment 

at the following locations: 

Air and Radiation Docket and 

Information Center, U.S. Environmental 

Protection Agency, Room B–102, 1301 

Constitution Avenue, NW., (Mail Code 

6102T), Washington, DC 20460. 

California Air Resources Board, 

Stationary Source Division, Rule 

Evaluation Section, 1001 ‘‘I’’ Street, 

Sacramento, CA 95814. 

Great Basin Unified Air Pollution 

Control District, 157 Short Street, Suite 

6, Bishop, CA 93514–3537. 

Ventura County Air Pollution Control 

District, 669 County Square Dr., 2nd Fl., 

Ventura, CA 93003–5417. 

A copy of the rule may also be 

available via the Internet at http://

www.arb.ca.gov/drdb/drdbltxt.htm.

Please be advised that this is not an EPA 

Web site and may not contain the same 

version of the rule that was submitted 

to EPA.

FOR FURTHER INFORMATION CONTACT:

Cynthia G. Allen, EPA Region IX, (415) 

947–4120, allen.cynthia@epa.gov.

SUPPLEMENTARY INFORMATION:

Throughout this document, ‘‘we,’’ ‘‘us’’

and ‘‘our’’ refer to EPA.

Table of Contents 

I. The State’s Submittal 

A. What Rules Did the State Submit? 

B. Are There Other Versions of These 

Rules? 

C. What is the Purpose of the Submitted 

Rule Revisions? 

II. EPA’s Evaluation and Action 

A. How is EPA Evaluating the Rules? 

B. Do the Rules Meet the Evaluation 

Criteria? 

C. Public Comment and Final Action 

III. Statutory and Executive Order Reviews

I. The State’s Submittal 

A. What Rules Did the State Submit? 

Table 1 lists the rules we are 

approving with the dates that they were 

adopted by the local air agencies and 

submitted by the California Air 

Resources Board (CARB).