3168 Federal Register / Vol. 60, No. 9 / Friday, January 13, 1995 / Proposed Rules

(c) Application procedure.

Applications for blanket certificates

must be accompanied by the fee

prescribed in § 381.207 of this chapter

or a petition for waiver pursuant to

§ 381.106 of this chapter, and shall state:

* * * * *

(d) Effect of certificate. (1) Any

certificate granted under this section

will authorize the certificate holder to

engage in transactions of the type

authorized by subparts C and D of this

part.

* * * * *

(e) General conditions. (1) Except as

provided in paragraph (e)(2) of this

section, any transaction authorized

under a blanket certificate is subject to

the same rates and charges, terms and

conditions, and reporting requirements

that apply to a transaction authorized

for an intrastate pipeline under subparts

C and D of this part.

* * * * *

(g) Hinshaw pipeline without blanket

certificate. A Hinshaw pipeline that

does not obtain a blanket certificate

under this section is not authorized to

sell or transport natural gas as an

intrastate pipeline under subparts C and

D of this part.

* * * * *

114. Sections 284.225 and 284.226 are

removed and reserved.

115. In § 284.227, paragraph (d) is

removed, and paragraphs (e), (f), and (g)

are redesignated (d), (e), and (f).

Subpart J—Blanket Certificates

Authorizing Certain Natural Gas Sales

by Interstate Pipelines

§ 284.288 [Removed]

116. Section 284.288 is removed and

reserved.

Subpart L—Certain Sales for Resale by

Non-interstate Pipelines

117. In § 284.402, paragraph (c)(1) is

revised to read as follows and in the

first sentence of paragraph (c)(2) the

word ‘‘criteria’’ in paragraph (c)(2) is

removed, and the word ‘‘criterion’’ is

added in its place:

§ 284.402 Blanket marketing certificates.

* * * * *

(c)(1) The authorization granted in

paragraph (a) of this section will become

effective for an affiliated marketer with

respect to transactions involving

affiliated pipelines when an affiliated

pipeline receives its blanket certificate

pursuant to § 284.284.

* * * * * *

[FR Doc. 95–653 Filed 1–12–95; 8:45 am]

BILLING CODE 6717–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 892

[Docket No. 94N–0345]

Medical Devices; Classification of

Transilluminators (Diaphanoscopes or

Lightscanners) for Breast Evaluation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

classify the transilluminator

(diaphanoscope or lightscanner) for

breast evaluation into class III

(premarket approval). The agency is also

publishing in this document the

recommendations of the Obstetrics and

Gynecology Devices Panel regarding the

classification of the device. After

considering public comments on the

proposed classification, FDA will

publish a final regulation classifying the

device. This action is being taken under

the Federal Food, Drug, and Cosmetic

Act (the act), as amended by the

Medical Device Amendments of 1976

(the 1976 amendments) and the Safe

Medical Devices Act of 1990 (the

SMDA).

DATES: Written comments by April 13,

1995. FDA proposes that any final

regulation that may issue based on this

proposal become effective 30 days after

the date of its publication in the Federal

Register.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Robert A. Phillips, Center for Devices

and Radiological Health (HFZ–470),

Food and Drug Administration, 1390

Piccard Dr., Rockville, MD 20850, 301–

594–1212.

SUPPLEMENTARY INFORMATION:

I. Background

The act, as amended by the 1976

amendments (Pub. L. 94–295) and the

Safe Medical Devices Act of 1990 (Pub.

L. 101–629), established a

comprehensive system for the regulation

of medical devices intended for human

use. Section 513 of the act (21 U.S.C.

360c) established three categories

(classes) of devices, depending on the

regulatory controls needed to provide

reasonable assurance of their safety and

effectiveness. The three categories of

devices are class I (general controls),

class II (special controls), and class III

(premarket approval). Under section 513

of the act, devices that were in

commercial distribution before May 28,

1976 (the date of enactment of the 1976

amendments) are classified after FDA

has: (1) Received a recommendation

from a device classification panel (an

FDA advisory committee); (2) published

the panel’s recommendations for

comment, along with a proposed

regulation classifying the device; and (3)

published a final regulation classifying

the device.

A device that is first offered in

commercial distribution after May 28,

1976, and which FDA determines to be

substantially equivalent to a device

classified under this scheme, is

classified into the same class as the

device to which it is substantially

equivalent. The agency determines

whether new devices are substantially

equivalent to previously offered devices

by means of premarket notification

procedures in section 510(k) of the act

(21 U.S.C. 360(k)) and part 807 of the

regulations (21 CFR part 807). A device

that was not in commercial distribution

prior to May 28, 1976, and that has not

been found by FDA to be substantially

equivalent to a legally marketed device,

is classified automatically by statute

(section 513(f) of the act) into class III

without any FDA rulemaking

proceedings.

In 1980, when other obstetric and

gynecological devices were classified

(45 FR 12684 through 12720, February

26, 1980), FDA was not aware that

transilluminators, also known as

lightscanners or diaphanoscopes, for

breast evaluation were preamendments

devices, and inadvertently omitted them

from the classification process. Based

upon the recommendations the

Obstetrics and Gynecological Devices

Panel made during its January 11, 1991,

meeting (Ref. 24), FDA is now proposing

to classify the transilluminator for breast

evaluation into class III, thereby

requiring each manufacturer of the

device to submit to FDA a PMA by a

date to be set in a future regulation

under section 515(b) of the act (21

U.S.C. 360e(b)). Specifically, a

preamendments class III device may be

commercially distributed without an

approved PMA until 90 days after FDA

issues a final rule requiring premarket

approval of the device or 30 months

after classification of the device under

section 513 of the act, whichever is

later. Each application must include

sufficient valid scientific evidence to

provide reasonable assurance that the

device is safe and effective under the

conditions of use prescribed,
Federal Register / Vol. 60, No. 9 / Friday, January 13, 1995 / Proposed Rules 3169

recommended, or suggested in its

proposed labeling.

II. The Obstetrics and Gynecology

Devices Panel Recommendations

The Obstetrics and Gynecology

Devices Panel, an FDA advisory

committee, made the following

recommendations regarding the

classification of the transilluminator for

breast evaluation.

A. Identification

A transilluminator, also known as a

lightscanner or diaphanoscope, is an

electrically powered device that uses

low intensity emissions of visible light

and near-infrared radiation

(approximately 700 to 1050 nanometers

(nm)), transmitted through the breast, to

visualize translucent tissue for the

diagnosis of cancer, other conditions,

diseases, or abnormalities (Ref. 24).

B. Recommended Classification

Class III (premarket approval). The

Obstetrics and Gynecology Devices

Panel recommended that the

transilluminator for breast evaluation be

classified into class III and that a

regulation requiring submission of

premarket approval applications for this

device be a high priority. The Obstetrics

and Gynecology Devices Panel further

recommended that, at this time, the

device should not be used for breast

examinations, either alone or in

conjunction with other techniques.

C. Summary of Reasons for

Recommendation

The Obstetrics and Gynecology

Devices Panel recommended that

transilluminator devices for breast

evaluation be classified into class III

because the Panel believes that

premarket approval is necessary to

provide reasonable assurance of the

safety and effectiveness of the device.

The Obstetrics and Gynecology Devices

Panel concludes that there are no

published studies or clinical data

demonstrating the safety and

effectiveness of the device. The

Obstetrics and Gynecology Devices

Panel also believes that the device

presents a potential unreasonable risk of

illness or injury to the patient if the

clinician relies on the device. Although

the device’s illumination level,

wavelength, and image quality can be

controlled through tests and

specifications, the Obstetrics and

Gynecology Devices Panel believes that

insufficient evidence exists to determine

that special controls can be established

to provide reasonable assurance of the

safety and effectiveness of the device for

its intended use. The Obstetrics and

Gynecology Devices Panel recommends,

therefore, that the device be subject to

premarket approval to ensure that

manufacturers of this device

demonstrate the device’s safety and

effectiveness in order to market the

device.

D. Summary of Data Upon Which the

Recommendation is Based

The Obstetrics and Gynecology

Devices Panel based its

recommendation on the review of the

studies cited in this document, on

expert testimony presented to the

Obstetrics and Gynecology Devices

Panel, and on the Panel members’

personal knowledge of, and experience

with, the device.

E. Risks to Health

The following risks are associated

with the use of transilluminators:

Missed diagnosis; delayed diagnosis;

delayed treatment; electrical shock; and

optical radiation. Due to the

transilluminator’s questionable

performance, the use of the device could

result in missed or delayed diagnosis of

breast cancer. Such misdiagnoses could

result in more traumatic treatment to the

patient and a potentially higher risk of

death.

III. Proposed Classification

FDA agrees with the Obstetrics and

Gynecology Devices Panel’s conclusions

and recommendations. The National

Cancer Institute (NCI) also agrees that

transilluminators have not been proven

effective for diagnosis of cancer. In a

September 1990 issue of Cancer Facts,

the NCI states, ‘‘Although this technique

has been improved over the years, at

this time transillumination is not an

effective technique for the detection of

early breast cancer,’’ and,

‘‘Transillumination is especially poor at

finding small tumors (less than 1

centimeter).’’ NCI supports the idea of

further research, but states, ‘‘* * * at this

time, transillumination has no role in

breast cancer screening’’ (Ref. 1).

A major study of transillumination

involving 2,763 patients was conducted

by the National Institutes of Health in

the late 1980’s (Ref. 2). In a section

entitled ‘‘Combined Modality Results,’’

the study authors concluded: ‘‘While

the accuracy of clinical exam [in

detecting cancer] is 0.67 and that of

lightscanning is 0.57, there is no

statistically significant difference

between them.’’ That is, there was no

difference between the use of

lightscanning and clinical examination

(palpation). They also stated, ‘‘When the

results of lightscanning, mammography

and physical exam are added, no

additional benefit is seen’’ as a result of

light scanning. This study indicates that

transilluminators, at this time, do not

have clinical benefits as an alternative

to mammography or as an adjunctive

diagnostic tool to mammography.

Following the January 1991 Obstetrics

and Gynecology Devices Panel meeting,

FDA undertook a literature search to

determine if any new and significant

studies had been performed, which

would affect the proposed classification.

The agency reviewed approximately 20

references (Refs. 4 through 23)

published since 1988. None of these

studies recommend the device for

routine clinical use.

One of the largest studies conducted

in a clinical setting was a multicenter

study in Sweden involving 2,568

women (Ref. 3). The study concluded

that lightscanning, as utilized in the

study, is inferior to mammography and

produced a large number of false

positive results.

In summary, FDA’s review of recent

technical and clinical papers did not

reveal any data that would influence the

agency to adopt any classification other

than class III.

FDA believes that insufficient

information exists to determine that

general controls, or special controls,

such as postmarket surveillance, the

development of guidelines, the

establishment of a performance

standard, or other actions will provide

reasonable assurance of the

effectiveness of the transilluminator for

breast evaluation. FDA believes that use

of the transilluminator for breast

evaluation presents a potential health

risk because of the possibility of

misdiagnosis. The evident failure of

transilluminator evaluations to detect

breast cancer in its earliest stages, when

the chance for a cure is highest, requires

FDA to place this preamendment device

in class III in order to require

manufacturers to provide data

establishing reasonable assurance of the

device’s safety and effectiveness.

FDA concurs with the Obstetrics and

Gynecology Devices Panel’s

recommendation that the agency should

give high priority to a regulation to

establish premarket approval

requirements for the transilluminator

because of the public health

considerations involved.

Since the Obstetrics and Gynecology

Devices Panel meeting of January 1991,

FDA has warned manufacturers of

breast transillumination devices that

these devices are in violation of the act

because their labeling is false or

misleading and fails to bear adequate

direction for use under section 502(a)

and (f)(1) of the act (21 U.S.C. 352(a)
3170 Federal Register / Vol. 60, No. 9 / Friday, January 13, 1995 / Proposed Rules

and (f)(1)). FDA took this position

following the Obstetrics and Gynecology

Devices Panel meeting, after considering

the Obstetrics and Gynecology Devices

Panel’s recommendation, after further

evaluation of the available scientific

literature, and following further

consultation with outside medical

experts. FDA concluded that the

transillumination devices are not

clinically effective for the diagnosis or

detection of breast cancer or other breast

abnormalities or conditions, and that

the use of the technique may contribute

to the delay of detection of lesions in

the early stages of cancer, when the

disease is most treatable.

At this time, therefore, the

distribution of breast transillumination

devices or any multipurpose

transillumination device that is labeled,

promoted, or intended for use in the

breast is in violation of the law,

regardless of whether the device is

labeled for independent use or

adjunctive use with mammography.

FDA has initiated enforcement actions

against manufacturers who have

continued to distribute

transilluminators.

When these devices become subject to

the premarket approval process, the

manufacturer of each individual device

will have an opportunity to demonstrate

the safety and effectiveness of the

device for its indicated use. Any further

decision on adjunctive use versus stand

alone use will be based on valid

scientific data presented by

manufacturers in the PMA’s they submit

at that time.

FDA intends to publish pursuant to

section 515(b) of the act, a proposed rule

to establish the effective date of the

requirement for premarket approval for

transilluminators. Such a rule will be

published after the effective date of a

final classification regulation based on

this proposed rule. A PMA may be

required 30 months after the effective

date of the final rule classifying the

device in class III under section 513 of

the act or 90 days after publication of

the final rule requiring premarket

approval under section 515(b),

whichever is later. After the

establishment of an effective date for the

requirement of PMA submissions for

these devices, any transilluminators for

use on breast tissue that are being

marketed without a PMA will be

considered adulterated under section

501(f)(2) of the act (21 U.S.C. 351(f)(2).

However, as noted earlier, FDA has

determined, in light of scientific data

that has become available, that

transilluminators for use in the breast

are already misbranded under sections

502(a) and 502(f)(1) of the act and

should not be marketed at this time.

FDA concludes that because the

transilluminator is a diagnostic imaging

device, it would be more appropriately

classified as a radiological device. The

agency therefore proposes to classify it

in part 892 (21 CFR part 892) of the

regulations (radiology devices) instead

of part 884 (21 CFR part 884) of the

regulations (obstetrical and

gynecological devices).

IV. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

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

through Friday.

1. ‘‘Transillumination Not Effective for

Early Breast Cancer Detection,’’ National

Cancer Institute, Office of Cancer

Communications, September 1990.

2. ‘‘Breast Cancer Diagnosis by Lightscan

(Revised),’’ final report, Grant No. CA37970–

04, Myron Moskowitz, principal investigator,

Breast Imaging Center, University of

Cincinnati Medical Center, December 1989.

3. Alveryd, A. et al., ‘‘Lightscanning Versus

Mammography for the Detection of Breast

Cancer in Screening and Clinical Practice: A

Swedish Multicenter Study,’’ Cancer

(U.S.A.), vol. 65/8 1671–1677, April 15, 1990.

4. Key, H., P. C. Jackson, and P. N. T.

Wells, ‘‘New Approaches to

Transillumination Imaging,’’ Journal of

Biomedical-Engineering, vol. 10, No. 2, 113–

118, 1988.

5. Zhou, X., and R. Gordon, ‘‘Detection of

Early Breast Cancer: An Overview and Future

Prospects,’’ Critical Reviews in Biomedical

Engineering, vol. 17, issue 3, 230–232, 1989.

6. Adams, D. L., ‘‘Reassessment of

Transillumination Light Scanning for the

Diagnosis of Breast Cancer,’’ National Center

for Health Services Research and Health Care

Technology Assessment, U.S. Department of

Health and Human Services, Public Health

Service, Springfield, VA. Available from

National Technical Information Services,

Health Technology Assessment Report; No. 2,

1988.

7. Hebden, J. C., and R. A. Kruger,

‘‘Transillumination Imaging Performance: A

Time-of-Flight-Imaging System,’’ Medical

Physics, vol. 17, No. 3, 1990.

8. Jarlman, O., R. Berg, and S. Svanberg,

‘‘Time-Resolved Transillumination of the

Breast,’’ Acta Radiological, vol. 33, 1992.

9. Key, H., E. R. Davies, P. C. Jackson, and

P. N. T. Wells, ‘‘Optical Attenuation

Characteristics of Breast Tissue at Visible and

Near Infrared Wavelengths,’’ Physics in

Medicine and Biology, vol. 36, No. 5, 1991.

10. Peters, V. G., D. R. Wyman, M. S.

Patterson, and G. L. Frank, ‘‘Optical

Properties of Normal and Diseased Human

Breast Tissue in the Visible and Near

Infrared,’’ Physics in Medicine and Biology,

vol. 35, No. 9, 1990.

11. Profio, A. E., G. A. Navarro, and O. W.

Sartorius, ‘‘Scientific Basis of Breast

Diaphanography,’’ Medical Physics, vol. 16,

No. 1, 1989.

12. Key, H., E. R. Davies, P. C. Jackson, and

P. N. T. Wells, ‘‘Monte Carlo Modelling of

Light Propagation in Breast Tissue,’’ Physics

in Medicine and Biology, vol. 36, No. 5, 1991.

13. Navarro, G. A., and A. Edward Profio,

‘‘Contrast in Diaphanography of the Breast,’’

Medical Physics, 15(2), March/April 1988.

14. Watmough, D. J., ‘‘Breast Compression

to Increase the Sensitivity of Lightscanning

for the Detection of Carcinoma: Potential

Hazard?’’ Letter to the editor, Journal of

Biomedical Engineering, vol. 14, March 1992.

15. Economou, S. G. et al., eds., Imaging

Techniques in Adjuncts to Cancer Surgery.

Lea and Febiger, 51–126, 1991.

16. ‘‘Is Lightscanning a Viable Alternative

to Mammography for Detecting Breast

Cancer?’’ in News Briefs, New York State

Journal of Medicine, June 1990.

17. Jarlman, O., I. Anderson, G. Balldin,

and S. A. Larsson, ‘‘Diagnostic Accuracy of

Lightscanning and Mammography in Women

with Dense Breasts,’’ Acta Radiological 33,

fasc. 1, 1992.

18. He, Ping, Kaneko, Maseo, et al., ‘‘Breast

Cancer Diagnosis by Laser Transmission

Photo-scanning with Spectro-Analysis’’

(Report 4), Radiation Medicine, vol. 8 No. 1,

1–5, 1990.

19. Braddick, M. R., ‘‘Audit of a Breast

Cancer Screening Programme Using Clinical

Examination and Lightscanning,’’ Health

Bulletin 49/6 299–303, November 1991.

20. Gordenne, W., and E. Bauduin,

‘‘Diagnostic Accuracy of New Imaging

Techniques in Breast Diseases,’’ Journal

Belge de Radiologie, 72:35–38, 1989.

21. Heywang-Kobrunner,

‘‘Nonmammographic Breast Imaging

Techniques,’’ Current Opinion in Radiology,

vol. 4, 146–154, 1992.

22. Jarlman, O. et al., ‘‘Relation Between

Lightscanning and the Histologic and

Mammography Appearance of Malignant

Breast Tumors,’’ Acta Radiological 33, 63–68,

fasc. 1992.

23. Monsees, B., J. M. Destouet, and D.

Gersell, ‘‘Lightscanning of Monpalpable

Breast Lesions: Reevaluation,’’ Radiology,

167:352, 1988.

24. Obstetrics and Gynecology Devices

Obstetrics and Gynecology Panel, Forty-fifth

Meeting. Transcript and Meeting Minutes,

January 11, 1991.

V. Environmental Impact

The agency has determined under 21

CFR 25.24(e)(2) 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.

VI. Analysis of Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(Pub. L. 96–354). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory
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