21076 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Rules and Regulations

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a new animal drug

application (NADA) filed by HoechstRoussel Agri-Vet Co. The NADA

provides for using approved single

ingredient Type A medicated articles to

make Type C medicated turkey feeds

containing halofuginone hydrobromide

and bacitracin methylene disalicylate.

EFFECTIVE DATE: May 9, 1996

FOR FURTHER INFORMATION CONTACT:

James F. McCormack, Center for

Veterinary Medicine (HFV–128), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1607.

SUPPLEMENTARY INFORMATION: HoechstRoussel Agri-Vet Co., Route 202–206,

P.O. Box 2500, Somerville, NJ 08876–

1258, has filed NADA 140–919, which

provides for use of approved Stenorol

(2.72 grams of halofuginone

hydrobromide per pound of Type A

article) and approved BMD (30, 50, or

60 grams of bacitracin methylene

disalicylate per pound) to make Type C

medicated turkey feeds containing 1.36

to 2.72 grams per ton (g/t) halofuginone

hydrobromide and 10 to 50 g/t

bacitracin methylene disalicylate, for

prevention of coccidiosis in growing

turkeys caused by Eimeria adenoeides,

E. meleagrimitis, and E. gallopavonis,

and for increased rate of weight gain.

The NADA 140–919 is approved as of

May 9, 1996, and the regulations are

amended in § 558.265(c)(2)(ii) (21 CFR

558.265(c)(2)(ii)) to reflect the approval.

The basis of approval is discussed in the

freedom of information summary.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 514.11(e)(2)(ii)), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

9 a.m. and 4 p.m., Monday through

Friday.

This approval is for use of single

ingredient Type A medicated articles to

make Type C medicated feeds.

Halofuginone hydrobromide is a

Category II drug which, as provided in

§ 558.4, requires an approved form FDA

1900 for making a Type C medicated

feed. Therefore, use of halofuginone

hydrobromide and bacitracin methylene

disalicylate Type A medicated articles

to make a combination drug Type C

medicated feed as provided in NADA

140–919 requires an approved form

FDA 1900.

The agency has determined under 21

CFR 25.24(d)(1)(ii) that this action is of

a type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Under section 512(c)(2)(F)(ii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(ii)), this

approval for use in food-producing

animals qualifies for 3 years of

marketing exclusivity beginning May 9,

1996, because the application contains

reports of new clinical or field

investigations (other than

bioequivalence or residue studies)

essential to the approval and conducted

or sponsored by the applicant.

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: Secs. 512, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360b, 371).

2. Section 558.265 is amended by

adding new paragraph (c)(2)(ii) to read

as follows:

§ 558.265 Halofuginone hydrobromide.

* * * * *

(c) * * *

(2) * * *

(ii) Amount per ton. Halofuginone

hydrobromide 1.36 to 2.72 grams plus

bacitracin methylene disalicylate 10 to

50 grams.

(A) Indications for use. For prevention

of coccidiosis caused by Eimeria

adenoeides, E. meleagrimitis, and E.

gallopavonis, and for increased rate of

weight gain in growing turkeys.

(B) Limitations. Feed continuously as

sole ration. Withdraw 7 days before

slaughter. Do not feed to laying chickens

or water fowl. Keep out of lakes, ponds,

and streams. Halofuginone is toxic to

fish and aquatic life. Halofuginone is an

irritant to eyes and skin. Avoid contact

with skin, eyes, or clothing.

Dated: April 26, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–11514 Filed 5–8–96; 8:45 am]

BILLING CODE 4160–01–F

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).

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
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Rules and Regulations 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
21078 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Rules and Regulations

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,
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Rules and Regulations 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:

§ 24.246 Materials authorized for treatment

of wine and juice.

* * * * *

(b) * * *

Materials and use Reference or limitation

* * * * * * *

Enzymatic activity: Various uses as shown below ................................... The enzyme preparation used 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 occurring urea in wine to help

prevent the formation of ethyl carbamate.

The urease enzyme activity shall be derived from 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.

* * * * * * *

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:

§ 24.248 Processes authorized for the

treatment of wine, juice, and distilling

material.

* * * * *
21080 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Rules and Regulations

Processes Use Reference or limitation

* * * * * * *

Reverse osmosis 1 ............ To reduce the ethyl alcohol content of

wine and to remove off flavors in

wine,.

Permeable membranes which are selective for molecules not greater than

500 molecular weight with transmembrane pressures of 200 psi and

greater. The addition of water other than that originally present prior to

processing will render standard wine ‘‘other than standard.’’ Use shall not

alter vinous character.

Spinning cone column 1 .... To reduce the ethyl alcohol content of

wine and to remove off flavors in

wine,.

Use shall not alter vinous character. For standard wine, the same amount

of essense must be added back to any lot of wine as was originally removed.

* * * * * * *

Ultrafiltration ..................... To remove proteinaceous material

from wine; to reduce harsh tannic

material from white wine produced

from white skinned grapes; to remove pink color from blanc de noir

wine; to separate red wine into low

color and high color wine fractions

for blending purposes.

Permeable membranes which are selective for molecules greater than 500

and less than 25,000 molecular weight with transmembrane pressures

less than 200 psi. Use shall not alter vinous character. 21 CFR 175.300,

177.1520, 177.1550, 177.1630, 177.2440, 177.2600, and 177.2910.

1This 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

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 60

[FRL–5502–4]

Standards of Performance for New

Stationary Sources; Supplemental

Delegation of Authority to Mississippi

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Delegation of authority.

SUMMARY: On March 7, 1996, the state of

Mississippi, through the Department of

Environmental Quality, requested that

EPA delegate authority for

implementation and enforcement of

eight (8) ammended categories of the

New Source Performance Standards

(NSPS). Since EPA’s review of

Mississippi’s pertinent laws, rules, and

regulations showed them to be adequate

and effective procedures for the

implementation and enforcement of

these Federal standards, EPA has made

the delegation as requested.

EFFECTIVE DATE: The effective date of the

delegation of authority is April 15, 1996.

ADDRESSES: Copies of the request for

delegation of authority and EPA’s letter

of delegation are available for public

inspection during normal business

hours at the following locations:

Environmental Protection Agency,

Region 4, Air Programs Branch, 345

Courtland Street, Atlanta, Georgia

30365

Mississippi Department of

Environmental Quality, Bureau of

Pollution Control, Air Quality

Division, P.O. Box 10385, Jackson,

Mississippi 39289–0385.

Effective immediately, all requests,

applications, reports and other

correspondence required pursuant to

the newly delegated standards should

not be submitted to the Region 4 office,

but should instead be submitted to the

following address: Office of Pollution

Control, Mississippi Department of

Environmental Quality, P.O. Box 10385,

Jackson, Mississippi 39289–0385.

FOR FURTHER INFORMATION CONTACT:

Scott M. Martin, Regulatory Planning

and Development Section, Air Programs

Branch, United States Environmental

Protection Agency, Region 4, 345

Courtland Street N.E., Atlanta, Georgia

30365, (404) 347–3555, x4216.

SUPPLEMENTARY INFORMATION: Section

301, in conjunction with Sections 110

and 111(c)(1) of the Clean Air Act as

amended November 15, 1990,

authorizes EPA to delegate authority to

implement and enforce the standards set

out in 40 CFR Part 60, (NSPS).

On November 10, 1981, EPA initially

delegated the authority for

implementation and enforcement of the

NSPS programs to the state of

Mississippi. On March 7, 1996,

Mississippi requested a delegation of

authority for implementation and

enforcement of the following NSPS

categories found in 40 CFR Part 60.

1. Subpart A—General Provisions

Except § 60.8(b) (1) Thru (5); § 60.11(e)

(7) and (8); § 60.13(g) (i) and (j)(2)

2. Subpart Cb—Municipal Waste

Combustors Constructed On or before

December 19, 1995

3. Subpart Cd—Sulfuric Acid

Production Units

4. Subpart Ea—Municipal Waste

Combustors Constructed After

December 20, 1989 and On or Before

September 20, 1994

5. Subpart Eb—Municipal Waste

Combustors For Which Construction is

Commenced After September 20, 1994

6. Subpart NNN—Volatile Organic

Compound (VOC) Emissions From

Synthetic Organic Chemical

Manufacturing Industry (SOCMI)

Distillation Operations

7. Subpart RRR—Volatile Organic

Compound (VOC) Emissions From

Synthetic Organic Chemical

Manufacturing Industry (SOCMI)

Reactor Process

8. Appendix A—Test Methods

After a thorough review of the

request, the Regional Administrator

determined that such a delegation was

appropriate for this source category with

the conditions set forth in the original

delegation letter of November 30, 1981.

Mississippi sources subject to the