Federal Register / Vol. 60, No. 9 / Friday, January 13, 1995 / Proposed Rules 3171

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this proposed rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

proposed rule is not a significant

regulatory action as defined by the

Executive Order and so is not subject to

review under the Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because the agency believes

only a small number of firms will be

affected by this rule when finalized, the

agency certifies that the proposed rule

will not have a significant economic

impact on a substantial number of small

entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

VII. Request for Comments

Interested persons may, on or before

April 13, 1995, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. Two copies of any comments

are to be submitted except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

List of Subjects in 21 CFR Part 892

Medical devices, Radiation

protection, X-rays.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR part 892 be amended as follows:

PART 892—RADIOLOGY DEVICES

1. The authority citation for 21 CFR

part 892 continues to read as follows:

Authority: Secs. 501, 510, 513, 520, 701 of

the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 351, 360, 360c, 360e, 360j, 371).

2. New § 892.1990 is added to subpart

B to read as follows:

§ 892.1990 Transilluminator for breast

evaluation.

(a) Identification. A transilluminator,

also known as a diaphanoscope or

lightscanner, is an electrically powered

device that uses low intensity emissions

of visible light and near-infrared

radiation (approximately 700–1050

nanometers (nm)), transmitted through

the breast, to visualize translucent tissue

for the diagnosis of cancer, other

conditions, diseases or abnormalities.

(b) Classification. Class III (premarket

approval).

(c) Date premarket approval (PMA) or

notice of completion of a product

development protocol (PDP) is required.

The effective date of the requirement for

premarket approval has not been

established. See § 892.3.

Dated: December 23, 1994.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 95–971 Filed 1–12–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Bureau of Alcohol, Tobacco and

Firearms

27 CFR Parts 4, 5, and 7

[Notice No. 804; Re Notice No. 803]

RIN: AB32

Alteration of Labels on Containers of

Distilled Spirits, Wine, and Beer (CRD–

94–8)

AGENCY: Bureau of Alcohol, Tobacco

and Firearms (ATF), Department of the

Treasury.

ACTION: Corrected Notice of Proposed

Rulemaking.

SUMMARY: On January 4, 1995, the

Bureau of Alcohol, Tobacco and

Firearms (ATF) published a notice of

proposed rulemaking (Notice No. 803,

60 FR 411) in the Federal Register.

Because the notice contained errors

which could cause confusion to the

public, ATF is reprinting the entire

corrected text here, in this correction

notice, as it should have appeared in

Notice No. 803. The original text of

Notice No. 803 should be disregarded;

instead, all interested parties should

refer to the reprinted text in this

document. ATF is extending the

comment period accordingly to allow 60

days from the date of this correction

notice.

ATF is proposing to amend the

regulations in 27 CFR Parts 4, 5, and 7

which implement section 105(e) of the

Federal Alcohol Administration Act of

1935, which makes it unlawful for any

person to alter, mutilate, destroy,

obliterate, or remove any mark, brand or

label on wine, distilled spirits, or malt

beverages held for sale in interstate or

foreign commerce or after shipment

therein. The proposed amendments will

eliminate a requirement that persons

obtain ATF approval before relabeling

wine and malt beverage products.

Instead, persons who intend to relabel

wine, malt beverage, or distilled spirits

products would be required to notify

ATF, in writing, of their intent to

relabel. The proposed amendments will

make it unlawful to relabel a distilled

spirits, wine, or malt beverage container

if the effect of such action is to remove

from the container or label any

information required by ATF

regulations, or a product identification

code placed on the product by the

producer for tracing purposes.

DATES: Written comments must be

received on or before March 14, 1995.

ADDRESSES: Send written comments to:

Chief, Wine, Beer, and Spirits

Regulations Branch, Bureau of Alcohol,

Tobacco and Firearms, P.O. Box 50221,

Washington, DC 20091–0221. [Attn:

Notice No. 804.]

FOR FURTHER INFORMATION CONTACT:

Daniel J. Hiland, Wine, Beer, and Spirits

Regulations Branch, Bureau of Alcohol,

Tobacco and Firearms, 650

Massachusetts Avenue, NW.,

Washington, DC 20226 (202–927–8210)

SUPPLEMENTARY INFORMATION:

Background

Several producers and importers of

alcoholic beverages have complained to

the Bureau of Alcohol, Tobacco and

Firearms (ATF) that product

identification code markings placed on

containers and labels of wines and

distilled spirits by producers for tracing

purposes are being removed or

mutilated after the product has left the

producer’s premises. Such alterations of

labels or packages have been permitted

in foreign trade zones and Customs

bonded warehouses, because ATF

regulations do not specifically address

such activities, and because product

identification codes are not mandatory

information under ATF regulations.

However, the effect of such action is to

make it impossible for the producers to

rely on production codes to trace

mislabeled, adulterated, or unsafe

products.

Federal Alcohol Administration Act

Section 105(e) of the Federal Alcohol

Administration Act (FAA Act), 27

U.S.C. § 205(e), authorizes ATF to

prescribe regulations relating to the

packaging, marking, branding, labeling,

and size and fill of containers as will

prohibit deception of the consumer with

respect to such products or the quantity

thereof.

In order to prevent the sale or

shipment or other introduction of
3172 Federal Register / Vol. 60, No. 9 / Friday, January 13, 1995 / Proposed Rules

distilled spirits, wine, or malt beverages

in interstate or foreign commerce which

are not bottled, packaged, or labeled in

compliance with the regulations, the

FAA Act requires that prior to bottling

distilled spirits, wines, or malt

beverages, the producer or bottler must

obtain a certificate of label approval

covering the product. Similarly, the law

provides that no person shall remove

bottled distilled spirits, wines, or malt

beverages from Customs custody for

consumption in bottles, for sale or any

other commercial purpose, without

having first obtained a certificate of

label approval covering the product.

Thus, the certificate of label approval

requirement ensures that mislabeled

distilled spirits, wines, or malt

beverages cannot be introduced in

interstate or foreign commerce. To

ensure that products with proper labels

were not altered once such products had

been removed from bond, section 205(e)

further provides as follows:

It shall be unlawful for any person to alter,

mutilate, destroy, obliterate, or remove any

mark, brand, or label upon distilled spirits,

wine, or malt beverages held for sale in

interstate or foreign commerce or after

shipment therein, except as authorized by

Federal law or except pursuant to regulations

of the Secretary of the Treasury authorizing

relabeling for purposes of compliance with

the requirements of this subsection or of

State law.

Regulations which implement these

provisions of the FAA Act, as they relate

to wine, distilled spirits, and malt

beverages, are set forth in title 27, Code

of Federal Regulations (CFR), parts 4, 5,

and 7, respectively. These regulations

provide for relabeling in certain

circumstances.

Sections 4.30 and 7.20 provide that

someone wanting to relabel must

receive prior permission from the

Regional Director (Compliance). Section

5.31 does not currently require prior

approval for the relabeling of distilled

spirits, as long as such relabeling is

done in accordance with an approved

certificate of label approval.

The regulations provide that distilled

spirits, wines and malt beverages may

be relabeled as authorized by Federal

law. Such products may also be

relabeled for purposes of compliance

with the requirements of the

regulations, or of State law. Finally,

there may be added to wine and

distilled spirits bottles, after removal

from Customs custody, or prior to or

after removal from bonded premises,

without application for permission to

relabel, a label identifying the wholesale

or retail distributor thereof, and

containing no reference whatever to the

characteristics of the product.

Customs Bonded Warehouses and

Foreign Trade Zones

The statutory prohibition against the

alteration or mutilation of distilled

spirits, wine, or malt beverage labels

applies to all products held for sale in

interstate or foreign commerce. The

terms of the statute thus apply to

nontaxpaid domestic and imported

products held for storage or

manipulation in a Customs bonded

warehouse or foreign trade zone.

However, since domestic nontaxpaid

alcoholic beverages bottled for

exportation are exempt from the

certificate of label approval

requirement, and certificates of label

approval are not required for imported

alcoholic beverages until they are

withdrawn from Customs custody for

consumption in the United States, ATF

has previously taken the position that

relabeling activities could occur in a

Customs bonded warehouse or foreign

trade zone without prior ATF approval.

ATF regulations authorize the relabeling

of alcoholic beverages in Customs

custody in order to bring such products

in compliance with a certificate of label

approval prior to withdrawal for

consumption. However, current

regulations do not specifically set forth

the limitations on other types of

relabeling activities in Customs bonded

warehouses or foreign trade zones. In

general, ATF saw no need to scrutinize

labeling activities involving such

products unless and until they were

withdrawn from Customs custody for

consumption in the United States.

While ATF has not required that

persons relabeling alcoholic beverages

in Customs bonded warehouses or

foreign trade zones obtain prior

approval, such activities are subject to

regulation by the United States Customs

Service (‘‘Customs’’). Because the

current regulations do not clarify the

scope of the prohibition against

alteration of labels, there has been

considerable confusion as to what types

of labeling activities are authorized in a

Customs bonded warehouse or foreign

trade zone.

ATF has taken the position that there

are restrictions as to the removal of

mandatory information from domestic

nontaxpaid distilled spirits, wines, and

malt beverages. Pursuant to parts 19, 24,

and 25, such products must be marked

with certain mandatory information,

which is necessary to protect the

revenue, and to ensure the tracing of the

product in the event of diversion. Thus,

it has been ATF’s policy that such

mandatory information may not be

removed from products, regardless of

the fact that they are in a Customs

bonded warehouse or foreign trade zone

awaiting exportation. However, this

policy is not set forth in the current

regulations.

ATF is thus proposing to amend the

regulations in parts 4, 5, and 7 to clarify

that the prohibition against alteration or

mutilation of labels applies to products

held in a foreign trade zone or customs

bonded warehouse. The proposed

amendments will specify the type of

relabeling activities permissible for both

domestic nontaxpaid alcoholic

beverages and imported alcoholic

beverages stored in a Customs bonded

warehouse or foreign trade zone. Since

current regulations do not authorize

removal of domestic nontaxpaid malt

beverages to Customs bonded

warehouses pending exportation, the

relabeling of malt beverages in Customs

bonded warehouses is not discussed.

The proposed regulations will provide

that relabeling of distilled spirits, wines,

and malt beverages in Customs bonded

warehouses or foreign trade zones can

be accomplished without giving notice

to ATF, as long as such relabeling is

done under the supervision of Customs

officials, in compliance with Customs

requirements, and does not involve the

removal from the label or package of

information made mandatory by ATF

regulations. The proposed language

concerning the supervision of Customs

officials and compliance with Customs

requirements is not intended to impose

any new requirements; instead, this

language merely recognizes current

requirements under Customs

regulations. See 19 C.F.R. 19.11 and

146.51.

Product Identification Codes

The complaints about the mutilation

of product identification codes in

Customs bonded warehouses and

foreign trade zones brought to the

surface an issue which ATF had

previously been considering—whether

lot identification numbers or product

identification codes should be made

mandatory information on consumer

packages of alcoholic beverages. Such

codes are not currently required under

the regulations. Instead, labels on

domestic distilled spirits, wines, and

malt beverages are merely required to

list the name and address of the bottler.

For imported products, the name and

address of the importer is required

information on the label.

Obviously, these requirements

provide enough information so that if a

product is mislabeled, adulterated, or

poses a health hazard, it is possible to

determine the source of the product.

However, this does not allow either ATF

or the producer to trace a particular
Federal Register / Vol. 60, No. 9 / Friday, January 13, 1995 / Proposed Rules 3173

consumer package back to a bottling line

or production shift.

Current regulations in parts 19, 24

and 25 promulgated pursuant to the

Internal Revenue Code require certain

markings on cases of distilled spirits,

wines, and malt beverages. Cases of

distilled spirits and wines must be

marked with serial numbers. These

markings are required in order to protect

the revenue, and to facilitate tracing in

the event of the diversion of nontaxpaid

goods. However, case markings have

limited value in tracing consumer

packages such as bottles and cans. Once

the product is removed from the case,

those markings are obviously of no

value in tracing the product.

The purpose of product identification

codes (i.e., lot identification numbers,

bottling dates, freshness dates, etc.) on

labels or packages of products is to

facilitate the tracing of a product for

safety, compliance or quality control

issues. For example, if an alcoholic

beverage product is found to have been

tampered with, or contaminated, any

type of code which would enable the

tracing of the product back to the

bottling line or production batch would

be extremely valuable in determining

how the tampering or contamination

occurred, and in allowing the producer

to make an informed decision as to the

extent of the problem, and the need for

product recalls.

For this reason, ATF believes that

product identification codes are useful

as a consumer protection measure.

Safety, labeling and quality control

problems often come to light by virtue

of consumer complaints or market place

testing of products by ATF. In such

instances, case markings will generally

be of no avail. However, the use of

product identification codes can help to

readily identify the hazardous or

defective product, and, in the event that

a health hazard exists, assist in a

speedier and more orderly recall of

these products from the marketplace.

The use of lot identification numbers

has already been mandated by the

Council of the European Communities,

in Council Directive 89/396/EEC, dated

June 14, 1989. In view of the fact that

many European countries now require

such markings, and many large

producers in the United States

voluntarily place such codes on product

labels or containers, ATF raised the

issue of mandatory product

identification codes at an industry

meeting held in Washington, D.C. on

July 26, 1994.

The purpose of raising this issue with

industry members was to gather

information on current industry

practices regarding product

identification codes. ATF has learned

that many domestic and foreign

producers of alcoholic beverages

voluntarily place product identification

codes or lot identification numbers on

the labels or containers of wines,

distilled spirits, and malt beverages.

Typically, the label or container of the

product will be marked with a code

indicating the batch from which the

product was made, a bottling date, a

production shift code, or some other

type of mark which will enable the

producer to trace the consumer package

to a specific production batch or

bottling line.

While large producers are more likely

to have their own system of product

codes, small producers often find that

such a system is unnecessary, because

their own records will enable them to

do any necessary tracing. At the

industry meeting, questions were raised

as to whether it was necessary to impose

a product identification code

requirement on small producers.

Rather than impose a mandatory

product identification code requirement

on all producers, ATF is proposing to

leave the decision as to whether to place

product identification codes on

consumer packages to the producer. At

this time, we believe that the consumer

is adequately protected by the

information required under the current

regulations.

However, in order to allow producers

to efficiently develop a system in which

they can ensure the tracing of their own

products, we believe that the voluntary

placement of product identification

codes on consumer packages by

producers should be protected by

regulation. This will address the

specific problem currently faced by

producers—the removal of product

identification codes by distributors or

other third parties.

If a producer believes that the only

way it can efficiently trace products is

to put product identification codes on

the consumer packages, ATF does not

believe it should allow the intent of the

producer to be frustrated by third

parties. It is the producer who will have

to bear the costs of recalls if product

identification codes have been

obliterated by distributors. It is the

consumer who will suffer if the

obliteration of such marks makes it

impossible to trace problems with

contaminated products. Finally, such

actions make it more difficult for ATF

to trace problems with products already

in the market place.

Thus, ATF is proposing an

amendment to the regulations which

will specifically prohibit the labeling or

relabeling of products if the effect of

such action is to remove from labels or

containers ‘‘product identification

codes’’ placed on the label or container

by the producer for tracing purposes.

The term ‘‘product identification code’’

is defined to include any numbers,

letters, symbols, dates, or other codes

placed on the label or container by

which the producer may be able to trace

a product back to a particular

production lot or batch, bottling line, or

date of removal.

Under the proposed regulations, if it

is necessary for anyone but the producer

to remove the original label from the

product, the product identification code

must be put back on the new label. ATF

believes that this proposal will

adequately address the problem before

us, without imposing an undue burden

on any part of the industry. Most

importantly, it will ensure that an

important consumer protection

mechanism voluntarily placed on

consumer packages by manufacturers

will not be thwarted.

Although ATF is not proposing to

require product identification codes on

labels or packages, it is the opinion of

the Bureau that such codes are useful,

and should be encouraged. If at any time

we find that the lack of such codes is

hampering the exercise of our consumer

protection function, we may wish to

reconsider this option.

Products Bottled for Exportation

Although products which are bottled

for exportation are not required to be

covered by certificates of label approval,

ATF believes that the prohibition on

alteration of labels applies to such

products. The alteration or mutilation of

required information on labels, as well

as product identification codes, would

hamper ATF’s efforts in tracing the

illegal diversion of nontaxpaid alcoholic

beverages which were intended for

exportation. One of the purposes of the

FAA Act was to aid in the collection of

taxes on distilled spirits, wines, and

malt beverages. Thus, we have authority

under the FAA Act to extend these

provisions to products which are

intended to be exported.

Elimination of Prior Approval

Requirement

The proposed amendments to parts 4,

5, and 7 relating to the relabeling of

wine, distilled spirits, and malt

beverages would also resolve an

inconsistency in the present regulations.

Currently, persons who wish to relabel

wine and malt beverages are required to

make written application and receive

approval from ATF prior to relabeling

these products. However, persons who

wish to relabel distilled spirits are not
3174 Federal Register / Vol. 60, No. 9 / Friday, January 13, 1995 / Proposed Rules

required to receive prior approval from

ATF, as long as the distilled spirits

products are relabeled in accordance

with an approved label.

The proposed amendments would

eliminate the requirement to receive

approval from the regional director prior

to relabeling wine and malt beverages.

Instead, any persons who wished to

relabel wine, malt beverages, or distilled

spirits would be required to notify the

Director, in writing, of their intent to

relabel. This letterhead notice must be

accompanied by duplicate copies of the

old and new labels, together with a

written statement of the reasons for

relabeling, the quantity and location of

the product to be relabeled, and the

name and address of the person

conducting the relabeling activities.

ATF believes that the proposed

amendment will eliminate the

inconsistencies in the current

regulations, while still enabling the

tracing of products in the event of a

safety hazard or a compliance issue.

Since the requirement for prior approval

is being eliminated, the proposed

amendments will provide that the

notice should be sent to the Director,

rather than the regional director. This

proposal will increase efficiency in the

Bureau’s tracing of labels, since copies

of certificates of label approval are

maintained at Bureau headquarters.

As previously noted, the proposed

regulations will provide that ATF does

not need to be notified of the relabeling

of alcoholic beverage products in

Customs bonded warehouses or foreign

trade zones, as long as all other

requirements are met.

Miscellaneous

ATF is also proposing to add to

section 7.20 a provision which is

already found in slightly different forms

in sections 4.30 and 5.31. This provision

authorizes, without any notice

requirement, the addition of a label

identifying the wholesale or retail

distributor, or identifying the purchaser

or consumer, as long as the label

contains no reference whatever to the

characteristics of the product. The

proposed regulations will standardize

this provision for wines, distilled

spirits, and malt beverages.

Furthermore, the notice procedure in all

three sections is also standardized for

the sake of consistency. Although the

current regulations in sections 4.30 and

7.20 do not specifically condition

approval for relabeling on the existence

of a certificate of label approval for the

new labels, such a policy has always

been enforced by ATF. The proposed

regulations will require submission of

evidence of label approval for label

changes.

Executive Order 12866

It has been determined that this

proposed regulation is not a significant

regulatory action as defined by

Executive Order 12866. Accordingly,

this proposal is not subject to the

analysis required by this Executive

Order.

Regulatory Flexibility Act

It is hereby certified that this

regulation will not have a significant

impact on a substantial number of small

entities. This notice requests comments

on a proposal to make it unlawful for

any person to alter, mutilate, destroy,

obliterate, or remove any mark, brand or

label on wine, distilled spirits, or malt

beverages held for sale in interstate or

foreign commerce or after shipment

therein, including products held in a

foreign trade zone or Customs bonded

warehouse, if the effect of such action

is to remove mandatory information

required by ATF regulations, or to

remove a product identification code

placed on the label or container by the

producer for tracing purposes. The

proposal would also impose a notice

requirement on the relabeling of

distilled spirits, wine, and malt

beverages, while eliminating the prior

approval requirement previously

imposed by the wine and malt beverage

regulations. This proposal does not

mandate new labeling requirements, but

merely protects and preserves

mandatory information already required

under the regulations, and product

identification codes which a producer

voluntarily chooses to put on the

product. Thus, the proposal should not

have a significant economic impact on

a substantial number of small entities.

Accordingly, a regulatory flexibility

analysis is not required because the

proposal, if promulgated as a final rule,

is not expected: (1) To have significant

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.

Paperwork Reduction Act

The collection of information

contained in this notice of proposed

rulemaking has been submitted to the

Office of Management and Budget for

review in accordance with the

Paperwork Reduction Act of 1980, 44

U.S.C. 3504(h).

Comments on the collection of

information should be directed to the

Office of Management and Budget,

Attention: Desk Officer for the

Department of the Treasury, Bureau of

Alcohol, Tobacco and Firearms, Office

of Information and Regulatory Affairs,

Washington, DC 20503, with copies to:

Reports Management Officer,

Information Programs Branch, Room

3450, Bureau of Alcohol, Tobacco and

Firearms, 650 Massachusetts Avenue,

NW., Washington, DC 20226.

The collections of information in this

regulation are in 27 CFR 4.30, 5.31, and

7.20. These sections require that persons

who wish to alter approved labels must

notify ATF. This information is required

by the Bureau of Alcohol, Tobacco and

Firearms to ensure that alterations of

labels are done in compliance with the

regulations. The likely respondents are

businesses or other for-profit

institutions, including small businesses

or organizations. This information

collection requirement is included in

OMB Control Number 1512–0092,

which covers the relabeling of distilled

spirits, wines, and beer. The estimated

total number of label approvals issued

annually under Control Number 1512–

0092 is 54,601. Based on an estimated

average time of 30 minutes to complete

the application for label approval, the

total annual burden associated with

Control Number 1512–0092 is 27,300

hours. We estimate that ATF will

receive about 180 notices of intent to

relabel distilled spirits, wines, and malt

beverages every year.

The amendments proposed in this

document will not change the estimated

number of 54,601 responses, because

any person wanting to relabel an

alcoholic beverage product is already

required to obtain a certificate of label

approval. The requirement for filing a

notice with the Director will not change

the estimated average time of 30

minutes to complete the application for

a certificate of label approval, because

only about 180 of the 54,601 responses

will involve relabeling. The additional

time required for those 180 responses is

not significant enough to affect the

estimated average time of 30 minutes to

complete the application for label

approval. Thus, the total burden

estimate associated with Control

Number 1512–0092 is not affected by

the amendments proposed in this

document.

Public Participation

ATF requests comments from all

interested persons concerning the

amendments proposed by this notice.

Comments received on or before the

closing date will be carefully

considered. Comments received after

that date will be given the same
Federal Register / Vol. 60, No. 9 / Friday, January 13, 1995 / Proposed Rules 3175

consideration if it is practical to do so,

but assurance of consideration cannot

be given except as to comments received

on or before the closing date. ATF will

not recognize any material in comments

as confidential. Comments may be

disclosed to the public. Any material

which the commenter considers to be

confidential or inappropriate for

disclosure to the public should not be

included in the comment. The name of

the person submitting the comment is

not exempt from disclosure.

Any interested person who desires an

opportunity to comment orally at a

public hearing on the proposed

amendments to the regulations should

submit his or her request, in writing, to

the Director within the 60-day comment

period. The Director, however, reserves

the right to determine, in light of all

circumstances, if a public hearing is

necessary.

Disclosure

Copies of this notice and the written

comments will be available for public

inspection during normal business

hours at: ATF Public Reading Room,

Room 6480, 650 Massachusetts Avenue,

NW., Washington, DC 20226

Drafting Information

The principal author of this document

is Daniel J. Hiland, Alcohol and

Tobacco Programs Division, Bureau of

Alcohol, Tobacco and Firearms.

List of Subjects

27 CFR Part 4

Advertising, Consumer protection,

Customs duties and inspection, Imports,

Labeling, Liquors, Packaging and

containers, Wine.

27 CFR Part 5

Advertising, Consumer protection,

Customs duties and inspection, Imports,

Liquors, Packaging and containers.

27 CFR Part 7

Advertising, Consumer Protection,

Customs duties and inspection, Imports,

Labeling.

Issuance

Title 27, Chapter I, is proposed to be

amended as follows:

PART 4—LABELING AND

ADVERTISING OF WINE

Paragraph 1. The authority citation

for 27 CFR Part 4 continues to read as

follows:

Authority: 27 U.S.C. 205.

Par. 2. Section 4.30(b) is revised, and

new paragraphs (c) and (d) are added to

read as follows:

§ 4.30 General.

* * * * *

(b) Alteration of labels. (1) It shall be

unlawful for any person to alter,

mutilate, destroy, obliterate, or remove

any mark, brand, or label upon wine

held for sale in interstate or foreign

commerce or after shipment therein,

including wine held in Customs bonded

warehouses or foreign trade zones,

except as authorized by Federal law, or

as provided for in this section.

(2) Relabeling. (i) Persons may engage

in additional labeling or relabeling of

wine in containers for purposes of

compliance with the requirements of

this subpart or of State law only if the

new labels are covered by certificates of

label approval, and the relabeling will

not result in the removal from the

container or label of a product

identification code placed on the

container or label by the producer for

tracing purposes. For purposes of this

section, the term ‘‘product identification

code’’ includes any numbers, letters,

symbols, dates, or other codes placed on

the label or container by which the

producer may be able to trace a product

back to a particular production lot or

batch, bottling line, or date of removal.

(ii) Persons who wish to relabel in

accordance with paragraph (b)(2)(i) of

this section must give prior written

notice to the Director of their intent to

relabel. A notice of intent to relabel

wine shall be accompanied by two

complete sets of the old labels and two

complete sets of any proposed new

labels, together with a statement of the

reasons for relabeling, the quantity and

the location of the wine, and the name

and address of the person conducting

the relabeling activity. In addition,

persons desiring to relabel wine must

provide evidence that they have applied

for and received a certificate of label

approval, ATF F 5100.31, covering such

products.

(3) Labels identifying wholesale or

retail distributor. There may be added to

the container, after removal from

customs custody, or prior to or after

removal from the premises where

bottled or packed, without notice to

ATF, a label identifying the wholesale

or retail distributor thereof or

identifying the purchaser or consumer,

and containing no references whatever

to the characteristics of the products.

(c) Customs bonded warehouses. (1)

Domestic wines which have been

removed without payment of tax for

transfer to a Customs bonded warehouse

pending exportation may be relabeled

without notice to ATF, as long as such

relabeling is done under the supervision

of Customs officers, in compliance with

all applicable Customs requirements,

and the effect of the relabeling is not to

remove from the container or label any

markings which are required under part

24 of this chapter, or any product

identification code placed on the

container or label by the producer for

tracing purposes.

(2) Imported wines held in a Customs

bonded warehouse may be relabeled

without notice to ATF, as long as such

relabeling is done under the supervision

of Customs officers, in compliance with

all applicable Customs requirements,

and the effect of the relabeling is not to

remove from the container or label any

product identification code placed on

the container or label by the producer

for tracing purposes. As provided in

§ 4.40, imported beverage wine in

containers shall not be released from

Customs custody for consumption

without a certificate of label approval.

(d) Foreign trade zones. (1) Domestic

wines which have been withdrawn

without payment of tax for deposit in a

foreign trade zone pending exportation

may be relabeled without notice to ATF

as long as such relabeling is done under

the supervision of Customs officers, in

compliance with all applicable Customs

requirements, and the effect of the

relabeling is not to remove from the

container or label any markings required

by Part 24 of this chapter, or any

product identification code placed on

the container or label by the producer

for tracing purposes.

(2) Imported wines which have been

entered into a foreign trade zone may be

relabeled without notice to ATF, as long

as such relabeling is done under

Customs supervision and in compliance

with Customs requirements, and the

effect of such relabeling is not to remove

from the label or container any product

identification code placed on the label

or container by the producer for tracing

purposes. As provided in § 4.40,

imported beverage wine in containers

shall not be released from Customs

custody for consumption without a

certificate of label approval.

Par. 3. Section 4.80 is revised to read

as follows:

§ 4.80 Exports.

With the exception of the regulations

at § 4.30(b), (c), and (d), the regulations

in this part shall not apply to wine

exported in bond.

PART 5—LABELING AND

ADVERTISING OF DISTILLED SPIRITS

Par. 4. The authority citation for 27

CFR part 5 continues to read as follows:

Authority: 26 U.S.C. 5301, 7805; 27 U.S.C.

205.
3176 Federal Register / Vol. 60, No. 9 / Friday, January 13, 1995 / Proposed Rules

Par. 5. Section 5.1 is revised to read

as follows:

§ 5.1 General.

The regulations in this part relate to

the labeling and advertising of distilled

spirits. This part applies to the several

States of the United States, the District

of Columbia, and the Commonwealth of

Puerto Rico. With the exception of the

regulations at § 5.31(b), (c), and (d), the

regulations in this part do not apply to

distilled spirits for export.

Par. 6. Section 5.31 (b) is revised, and

new paragraphs (c) and (d) are added to

read as follows:

§ 5.31 General.

* * * * *

(b) Alteration of labels. (1) It shall be

unlawful for any person to alter,

mutilate, destroy, obliterate, or remove

any mark, brand, or label upon distilled

spirits held for sale in interstate or

foreign commerce or after shipment

therein, including distilled spirits held

in Customs bonded warehouses or

foreign trade zones, except as

authorized by Federal law, or as

provided in this section.

(2) Relabeling. (i) Persons may engage

in additional labeling or relabeling of

distilled spirits in containers for

purposes of compliance with the

requirements of this subpart or of State

law only if the new labels are covered

by certificates of label approval, and the

relabeling will not result in the removal

from the container or label of a product

identification code placed on the

container or label by the producer for

tracing purposes. For purposes of this

section, the term ‘‘product identification

code’’ includes any numbers, letters,

symbols, dates, or other codes placed on

the label or container by which the

producer may be able to trace a product

back to a particular production lot or

batch, bottling line, or date of removal.

(ii) Persons who wish to relabel in

accordance with paragraph (b)(2)(i) of

this section must give prior written

notice to the Director of their intent to

relabel. A notice of intent to relabel

distilled spirits shall be accompanied by

two complete sets of the old labels and

two complete sets of any proposed new

labels, together with a statement of the

reasons for relabeling, the quantity and

the location of the distilled spirits, and

the name and address of the person

conducting the relabeling activity. In

addition, persons desiring to relabel

distilled spirits must provide evidence

that they have applied for and received

a certificate of label approval, ATF F

5100.31, covering such products.

(3) Labels identifying wholesale or

retail distributor. There may be added to

the bottle, after removal from customs

custody, or prior to or after removal

from bonded premises, without notice

to ATF, a label identifying the

wholesale or retail distributor thereof or

identifying the purchaser or consumer,

and containing no references whatever

to the characteristics of the product.

(c) Customs bonded warehouses. (1)

Domestic distilled spirits which have

been removed without payment of tax

for transfer to a Customs bonded

warehouse pending exportation may be

relabeled without notice to ATF, as long

as such relabeling is done under the

supervision of Customs officers, in

compliance with all applicable Customs

requirements, and the effect of the

relabeling is not to remove from the

container or label any markings which

are required under part 19 of this

chapter, or any product identification

code placed on the container or label by

the producer for tracing purposes.

(2) Imported distilled spirits held in a

Customs bonded warehouse may be

relabeled without notice to ATF, as long

as such relabeling is done under the

supervision of Customs officers, in

compliance with all applicable Customs

requirements, and the effect of the

relabeling is not to remove from the

container or label any product

identification code placed on the

container or label by the producer for

tracing purposes. As provided in § 5.51,

bottled distilled spirits shall not be

released from Customs custody for

consumption without a certificate of

label approval.

(d) Foreign trade zones. (1) Domestic

distilled spirits which have been

withdrawn without payment of tax for

deposit in a foreign trade zone pending

exportation may be relabeled without

notice to ATF as long as such relabeling

is done under the supervision of

Customs officers, in compliance with all

applicable Customs requirements, and

the effect of the relabeling is not to

remove from the container or label any

markings required by part 19 of this

chapter, or any product identification

code placed on the container or label by

the producer for tracing purposes.

(2) Imported distilled spirits which

have been entered into a foreign trade

zone may be relabeled without notice to

ATF, as long as such relabeling is done

under Customs supervision and in

compliance with Customs requirements,

and the effect of such relabeling is not

to remove from the label or container

any product identification code placed

on the label or container by the

producer for tracing purposes. As

provided in § 5.51, bottled distilled

spirits shall not be released from

Customs custody for consumption

without a certificate of label approval.

PART 7—LABELING AND

ADVERTISING OF MALT BEVERAGES

Par. 7. The authority citation for 27

CFR Part 7 continues to read as follows:

Authority: 27 U.S.C. 205.

Par. 8. Section 7.20 is amended by

revising paragraph (c), and adding new

paragraphs (d) and (e) to read as follows:

§ 7.20 General.

* * * * *

(c) Alteration of labels. (1) It shall be

unlawful for any person to alter,

mutilate, destroy, obliterate, or remove

any mark, brand, or label upon malt

beverages held for sale in interstate or

foreign commerce or after shipment

therein, including malt beverages held

in Customs bonded warehouses or

foreign trade zones, except as

authorized by Federal law, or as

provided in this section.

(2) Relabeling. (i) Malt beverages in

containers may be relabeled for

purposes of compliance with the

requirements of this subpart or of State

law only if the new labels are covered

by certificates of label approval, and the

relabeling will not result in the removal

from the container or label of a product

identification code placed on the

container or label by the producer for

tracing purposes. For purposes of this

section, the term ‘‘product identification

code’’ includes any numbers, letters,

symbols, dates, or other codes placed on

the label or container by which the

producer may be able to trace a product

back to a particular production lot or

batch, bottling line, or date of removal.

(ii) Persons who wish to relabel in

accordance with paragraph (c)(2)(i) of

this section must give prior written

notice to the Director of their intent to

relabel. A notice of intent to relabel malt

beverages shall be accompanied by two

complete sets of the old labels and two

complete sets of any proposed new

labels, together with a statement of the

reasons for relabeling, the quantity and

the location of the malt beverages, and

the name and address of the person

conducting the relabeling activity. In

addition, persons desiring to relabel

malt beverages must provide evidence

that they have applied for and received

a certificate of label approval, ATF F

5100.31, covering such products.

(3) Labels identifying wholesale or

retail distributor. There may be added to

the bottle, after removal from customs

custody, or prior to or after removal

from bonded premises, without notice

to ATF, a label identifying the

wholesale or retail distributor thereof or
Federal Register / Vol. 60, No. 9 / Friday, January 13, 1995 / Proposed Rules 3177

identifying the purchaser or consumer,

and containing no references whatever

to the characteristics of the product.

(d) Customs bonded warehouses.

Imported malt beverages held in a

Customs bonded warehouse may be

relabeled without notice to ATF, as long

as such relabeling is done under the

supervision of Customs officers, in

compliance with all applicable Customs

requirements, and the effect of the

relabeling is not to remove from the

container or label any product

identification code placed on the

container or label by the producer for

tracing purposes. As provided in § 7.31,

no imported malt beverages in

containers shall be released from

Customs custody for consumption

without a certificate of label approval.

(e) Foreign trade zones. (1) Domestic

malt beverages which have been

withdrawn without payment of tax for

deposit in a foreign trade zone pending

exportation may be relabeled without

notice to ATF as long as such relabeling

is done under the supervision of

Customs officers, in compliance with all

applicable Customs requirements, and

the effect of the relabeling is not to

remove from the container or label any

markings required by Part 25 of this

chapter or any product identification

code placed on the container or label by

the producer for tracing purposes.

(2) Imported malt beverages which

have been entered into a foreign trade

zone may be relabeled without notice to

ATF, as long as such relabeling is done

under Customs supervision and in

compliance with Customs requirements,

and the effect of such relabeling is not

to remove from the label or container

any product identification code placed

on the label or container by the

producer for tracing purposes. As

provided in § 7.31, no imported malt

beverages in containers shall be released

from Customs custody for consumption

without a certificate of label approval.

Par. 9. Section 7.60 is revised to read

as follows:

§ 7.60 Exports.

With the exception of the regulations

at § 7.20(c), (d) and (e), the regulations

in this part shall not apply to malt

beverages exported in bond.

Signed: January 10, 1995.

Daniel R. Black,

Acting Director.

[FR Doc. 95–997 Filed 1–11–95; 1:43 pm]

BILLING CODE 4810–31–U

DEPARTMENT OF THE INTERIOR

Minerals Management Service

30 CFR Part 254

RIN 1010–AB81

Response Plans for Facilities Seaward

of the Coast Line

AGENCY: Minerals Management Service

(MMS), Interior.

ACTION: Notice of proposed rulemaking.

SUMMARY: This proposed rule to

implement the Oil Pollution Act of 1990

(OPA) would establish requirements for

spill-response plans for oil handling

facilities seaward of the coast line,

including associated pipelines. The

proposed rule provides guidance to

owners and operators for preparing and

submitting these spill-response plans.

DATES: Comments must be received or

postmarked by March 14, 1995.

ADDRESSES: All comments concerning

this proposed rule should be mailed or

hand-carried to the Minerals

Management Service, Mail Stop 4700;

381 Elden Street; Herndon, Virginia

22070–4817, Attention: Chief,

Engineering and Standards Branch.

FOR FURTHER INFORMATION CONTACT:

John V. Mirabella or Lawrence Ake,

Engineering and Standards Branch,

telephone (703) 787–1600.

SUPPLEMENTARY INFORMATION: In August

1990, Congress passed the OPA

containing various provisions to

strengthen oil-spill prevention efforts

and oil-spill response capability. The

OPA included amendments to section

311 of the Federal Water Pollution

Control Act (FWPCA). The President

signed Executive Order (E.O.) 12777 on

October 18, 1991 (56 FR 54757), to

implement these new authorities.

Section 2(b)(3) of E.O. 12777 delegated

to the Secretary of the Interior

(Secretary) those responsibilities under

section 311(j)(1)(C) of the FWPCA,

requiring the Secretary to establish

procedures, methods, and requirements

for equipment to prevent and contain

discharges of oil and hazardous

substances from offshore facilities,

including associated pipelines. Under

section 2(d)(3) of E.O. 12777, section

311(j)(5) of FWPCA, and section

4202(b)(4) of OPA, the Secretary is

required to issue regulations requiring

the owners or operators of offshore

facilities, including associated

pipelines, to prepare and submit

response plans that ensure the

availability of private spill-response

personnel and equipment and to permit

the operation of offshore facilities,

including associated pipelines, without

approved response plans if certain

conditions are met. Under section

2(e)(3) of E.O. 12777 and section

311(j)(6)(A) of FWPCA, the Secretary

must require periodic inspections of

containment booms and equipment

used to remove discharges at offshore

facilities, including associated

pipelines. The Secretary has redelegated

these responsibilities to the Director,

MMS.

Under OPA and E.O. 12777, MMS is

to administer these new requirements

for all ‘‘offshore’’ facilities in, on, or

under coastal waters of the territorial

sea, rivers, lakes, and other navigable

waters within the States and Territories

of the United States or otherwise subject

to U.S. jurisdiction including State

submerged lands. The MMS negotiated

a redelegation of its responsibilities for

‘‘offshore’’ facilities located landward of

the coast line to other Federal agencies

with existing inland regulatory

capabilities and responsibilities. This

redelegation was published in the

Federal Register on February 28, 1994

(59 FR 9494). Accordingly, this

proposed rule addresses only facilities

seaward of the coast line.

The MMS believes that adequate spillprevention regulations meeting the

requirements of OPA currently exist for

facilities in the Outer Continental Shelf

(OCS) at 30 CFR part 250. In addition,

all States with facilities seaward of the

coast line have existing programs to

prevent spills. For these reasons, MMS

does not propose regulations to

implement the spill-prevention

requirements of section 311(j)(1)(c) of

the FWPCA at this time. The proposed

rule requires that plan submitters

provide information on the prevention

methods they must utilize during

operations in State waters.

The MMS will work with States on

compatible spill-prevention rules for

facilities in State waters seaward of the

coast line. The MMS has executed a

Memorandum of Understanding (MOU)

with the State of Texas General Land

Office and is discussing MOU’s with the

States of Alaska, California, and

Louisiana. Further coordination is

planned with States to ensure that

regulations are compatible. Commenters

are urged to provide comments on the

types of prevention rules that should be

required.

During the preparation of this notice

of proposed rulemaking, MMS

participated with three other Federal

agencies in the drafting of the National

Preparedness for Response Exercise

Program (PREP). The agencies (U.S.

Coast Guard, Environmental Protection

Agency, Research and Special Projects