Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 /Rules and Regulations 38743

1Final rule [and Statement of Basis and Purpose]

(‘‘SBP’’), 59 FR 25176 (1994) (codified at 16 CFR

Part 305 (1997)). The lamp labeling requirements

became effective May 15, 1995.

2Pub. L. No. 102–486, 106 Stat. 2776, 2817–2832

(Oct. 24, 1992) (codified at 42 U.S.C. 6201, 6291–

6309).

3 42 U.S.C. 6291 et seq.

4Section 305.11(e)(1)(iii), 16 CFR 305.11(e)(1)(iii),

requires that the light output, wattage and life

disclosures for general service incandescent lamps

and medium base compact fluorescent lamps be

measured at 120 volts, regardless of the lamp’s

design voltage. If a lamp’s design voltage is 125

volts or 130 volts, section 305.11(e)(1)(iii) requires

that the disclosures each be followed by the phrase

‘‘at 120 volts.’’ It allows manufacturers and private

labelers of 125 or 130 design voltage lamps to add

disclosures of light output, wattage, and life at the

lamp’s design voltage if those disclosures are each

followed by the phrase ‘‘at (125/130) volts,’’ and if

all panels of the package that contain a claimed

light output, wattage, or life clearly and

conspicuously identify the lamp as ‘‘(125 volt/130

volt).’’ If the disclosures on the principal display

panel of the package are for operation at 125 or 130

volts, and if the disclosures at 120 volts are made

on a separate panel, the principal display panel

must clearly and conspicuously disclose the

following statement: ‘‘This product is designed for

(125/130) volts. When used on the normal line

voltage of 120 volts, the light output and energy

efficiency are noticeably reduced. See (side/back)

panel for 120 volt ratings.’’

Since no other part of the regulatory

information has been changed, the final

rule is not being republished.

The effective date of the AD remains

April 8, 1998.

In rule FR Doc. 98–7414 published on

March 24, 1998 (63 FR 14026), make the

following corrections:

§ 39.13 [Corrected]

(1) On page 14027, in the first column

under Supplementary Information,

change ‘‘December 2, 1996’’ to ‘‘April

17, 1997.’’

(2) On page 14028, in paragraphs

(c)(1), (d), and (g), change ‘‘December 2,

1996’’ to ‘‘April 17, 1997.’’

Issued in Fort Worth, Texas, on July 10,

1998.

Larry M. Kelly,

Acting Manager, Rotorcraft Directorate,

Aircraft Certification Service.

[FR Doc. 98–19178 Filed 7–17–98; 8:45 am]

BILLING CODE 4910–13–P

FEDERAL TRADE COMMISSION

16 CFR Part 305

Rule Concerning Disclosures

Regarding Energy Consumption and

Water Use of Certain Home Appliances

and Other Products Required Under

the Energy Policy and Conservation

Act (‘‘Appliance Labeling Rule’’)

AGENCY: Federal Trade Commission.

ACTION: Final rule.

SUMMARY: The Federal Trade

Commission (‘‘Commission’’) amends

the package labeling requirements for

lamp products under the Commission’s

Appliance Labeling Rule (‘‘Rule’’) in

response to a petition from Osram

Sylvania, Ltd. (‘‘Petitioner’’). The

Petitioner requests that it be allowed to

distribute to consumers, through

retailers, lamp products without

individual packaging or labeling, where

the bulk shipping cartons include the

disclosures currently required by the

Rule and where retailers display the

lamp products for sale to consumers in

the bulk shipping cartons. The

interpretative amendment the

Commission adopts clarifies that

manufacturers and private labelers of

lamp products that are not packaged for

individual retail sale may meet the

labeling disclosure requirements of the

Rule by making the disclosures on

labeling on the bulk shipping carton,

where the bulk shipping carton is used

to display the lamps for retail sale.

EFFECTIVE DATE: July 20, 1998.

FOR FURTHER INFORMATION CONTACT: Kent

C. Howerton, Attorney, Federal Trade

Commission, Bureau of Consumer

Protection, Division of Enforcement,

Sixth St. and Pennsylvania Ave., NW,

Room S–4302, Washington, D.C. 20580,

(202) 326–3013 (voice), (202) 326–3259

(fax).

SUPPLEMENTARY INFORMATION:

I. Introduction

Petitioner, Osram Sylvania, Ltd., a

manufacturer of lamp products, requests

the Commission’s authorization to

market certain general service nonreflector incandescent light bulbs in

bulk-pack shipping cartons that are

labeled with the disclosures required by

the Rule, instead of packaging and

labeling the light bulbs for individual

retail sale to consumers, where the light

bulbs will be displayed for retail sale in

the bulk-pack shipping cartons, under

specific, limited conditions. The

Petitioner’s request, the Commission’s

analysis, and the interpretative

amendment to the Rule adopted by the

Commission are described below.

II. Overview of Rule’s Labeling

Requirements

On May 13, 1994, the Commission

promulgated labeling requirements for

various types of light bulbs and other

lamp products as amendments to the

Appliance Labeling Rule 1 in response to

amendments the Energy Policy Act of

1992 (‘‘EPACT’’) 2 made to the Energy

Policy and Conservation Act (‘‘EPCA’’).3

As amended, EPCA directed the

Commission to prescribe rules requiring

that the labeling of specific lamp

products indicate conspicuously on the

packaging of the lamps, in a manner

prescribed by the Commission, such

information as the Commission deemed

necessary to enable consumers ‘‘to

select the most energy efficient lamps

which meet their requirements.’’

Congress gave the Commission the

discretion to determine what specific

disclosures were necessary, and where

and how they should be made. The

covered lamp products include: general

service fluorescent lamps, general

service (both non-reflector and reflector)

incandescent lamps, and medium screw

base compact fluorescent lamps.

To provide consumers with the

information they need to select the most

energy efficient lamps that meet their

requirements, the Commission adopted

labeling provisions, under section

305.11(e)(1)(i) of the Rule, 16 CFR

305.11(e)(1)(i), that require that the

principal display panel on package

labels of general service incandescent

light bulbs (both non-reflector and

reflector) and medium screw base

compact fluorescent lamps disclose

clearly and conspicuously light output

(in lumens), energy used (in watts), and

life (in hours).4 The labeling provisions

also mandate that the principal display

panel disclose the number of lamps

included in the package (if more than

one), and the design voltage of each

lamp included in the package (if other

than 120 volts). For multi-filament

incandescent light bulbs, section

305.11(e)(1)(vii), 16 CFR

305.11(e)(1)(vii), requires that the

principal display panel disclose clearly

and conspicuously the bulb’s light

output and energy used at each of the

bulb’s levels of light output, and the

bulb’s life measured on the basis of the

filament that fails first. Section

305.11(e)(1)(ii), 16 CFR 305.11(e)(1)(ii),

specifies how the disclosures must

appear on the label.

Labels for incandescent spot lights,

flood lights, and down lights and for

general service fluorescent lamps must

include a capital letter ‘‘E’’ printed

within a circle and followed by an

asterisk referring to a specific statement

that the encircled ‘‘E’’ means the lamp

meets federal minimum efficiency

standards. The encircled ‘‘E’’ must be

disclosed clearly and conspicuously in

color-contrasting ink, and in a typeface

at least as large as either the

manufacturer’s name or logo or another

logo disclosed on the label, whichever

is larger. If the required statement is not

disclosed on the principal display

panel, the asterisk must be followed by

the statement: ‘‘*See [Back, Top, Side]
38744 Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 /Rules and Regulations

5Manufacturers and private labelers that do not

individually package, or put labels on, their general

service fluorescent lamp products may meet the

labeling disclosure requirements by permanently

marking the lamp clearly and conspicuously with

the encircled ‘‘E.’’ See SBP, 59 FR at 25198.

6The reference to beam spread is required only

on labels of incandescent spot lights, flood lights,

and down lights.

7The Rule already authorizes the use of an

alternative to disclosures on individual package

labeling for general service fluorescent lamps. See

note 5, supra.

8SBP, 59 FR at 25185.

9See Repeal of rule [Statement of Basis and

Purpose for repeal of the Light Bulb Rule, 16 CFR

Part 409], 61 FR 33308, at 33311–12 (1996). In

comments supporting the repeal of the Light Bulb

Rule, which had required product marking, General

Electric Co. stated that manufacturers would

continue marking individual light bulbs with

wattage and design voltage as a sound business

practice that reduces liability and gives consumers

important information, and the National Electrical

Manufacturers Association stated that an

international safety standard issued by the

International Electrotechnical Commission requires

panel for details.’’ 16 CFR 305.11(e)(2)–

(2)(i).5

Section 305.11(e)(1)(vi), 16 CFR

305.11(e)(1)(vi), requires that the

principal display panel for each of these

lamp products also clearly and

conspicuously disclose the following

Advisory Disclosure:

To save energy costs, find the bulbs with

the (beam spread and) light output you need,

then choose the one with the lowest watts.6

Section 305.11(e)(4), 16 CFR

305.11(e)(4), requires that cartons in

which lamp products covered by the

Rule are shipped in the United States or

imported into the United States disclose

clearly and conspicuously: ‘‘These

lamps comply with Federal energy

labeling requirements.’’

Last, section 305.4(a)(1), 16 CFR

305.4(a)(1), prohibits manufacturers and

private labelers from distributing

covered lamp products that are not

labeled in accordance with the Rule’s

requirements; and section 305.4(a)(2),

16 CFR 305.4(a)(2), prohibits retailers

and others from removing the labels or

rendering them illegible.

III. Osram Sylvania’s Petition

The Petitioner requests the

Commission’s authorization to market

single-wattage 40, 60, 75, and 100 watt

general service non-reflector

incandescent light bulbs in bulk-pack

shipping cartons that are labeled with

the disclosures required by the Rule,

instead of packaging and labeling the

light bulbs for individual retail sale to

consumers, where the light bulbs will be

displayed for retail sale in the bulk-pack

shipping cartons. In connection with its

request, the Petitioner proposes the

following conditions:

• Individual light bulbs would be etched

with brand name identification, voltage, and

wattage (which the Petitioner describes as

current industry practice).

• Outer cartons would display the labeling

disclosures that the Rule requires on the

principal display panel of product packages.

The Petitioner states, for example, that the

cartons could be printed so that the required

disclosures of light output, energy used, and

life for all four wattages occupy a large area

on every side of the outer carton to ensure

that the required disclosures are visible no

matter how the cartons are mixed or

displayed.

• The authorization for these bulk-pack

shipments would be limited to general

service non-reflector incandescent light bulbs

with a design voltage of 120 volts.

• The authorization would be limited to

unusual or rare events such as ‘‘store

openings’’ or ‘‘manager specials.’’

IV. Analysis and Amendment

Except for general service fluorescent

lamp products (which were being

distributed for retail sale to consumers

in bulk packaging), 7 at the time of the

original rulemaking proceeding all other

light bulbs and other lamp products

under discussion were being sold in

individual retail-sale packages

containing one or more lamps. As a

result, the discussion of labeling

requirements assumed that covered light

bulbs and other lamp products would be

packaged and labeled in retail-sale

packaging units. The Rule, however,

does not define the terms ‘‘label,’’

‘‘principal display panel,’’ or ‘‘package,’’

as they are used in the Rule, and, except

for general service fluorescent lamps,

the Rule does not specify how

manufacturers and private labelers of

lamp products sold to consumers

without retail-sale packaging must make

the required labeling disclosures.

In considering the Petition, the

Commission has determined that

making the disclosures required by the

Rule on the labels of the bulk shipping

carton, where the bulk shipping carton

is used to display the lamps for retail

sale (‘‘bulk shipping/retail display

carton’’), is acceptable. Making the

required labeling disclosures on these

bulk shipping/retail display cartons

satisfies the statutory mandate that

package labeling disclose ‘‘such

information as the Commission deems

necessary to enable consumers to select

the most energy efficient lamps which

meet their requirements,’’ and it is

consistent with the Rule’s labeling

requirements. Where the bulk shipping/

retail display carton is used to display

these lamps for retail sale, labeling the

carton with the required disclosures

will ensure that: (1) The disclosures are

made prior to purchase; (2) the

disclosures enable consumers to select

the most energy efficient lamps that

meet their requirements; and (3) the

disclosures are made in a manner and

form that allow consumers to compare

competing lamp products in making

their purchase selections. For purposes

of making the required labeling

disclosures, therefore, the Commission

interprets the terms ‘‘label,’’ ‘‘principal

display panel,’’ and ‘‘package’’ in the

Rule to include the shipping carton/

retail display carton for lamp products

that are not packaged for individual

retail sale.

The Petitioner requested a limited,

conditional authorization to make the

required disclosures on bulk shipping

cartons only for single-wattage, general

service non-reflector incandescent light

bulbs with a design voltage of 120 volts.

The Commission, however, has

determined that labeling the bulk

shipping/retail display carton for lamp

products that are not packaged for

individual retail sale, under the

circumstances described above, will

provide consumers with the

prepurchase information required by the

Rule. This alternative to individual,

retail-sale package labeling, therefore, is

acceptable for all general service

fluorescent lamps, medium screw base

compact fluorescent lamps, and general

service (both non-reflector and reflector)

incandescent light bulbs covered by the

Rule.

The Petitioner also suggested that

certain conditions might be necessary to

ensure that the labeling on the bulk

shipping/retail display carton meets the

requirements of the Rule. The

Commission has determined that it is

not necessary to impose the following

conditions that were suggested by the

Petitioner:

• Marking individual lamps—Some kind

of marking or other identification on each

individual bulb or tube enables consumers to

select the specific bulb or tube they desire

from the bulk carton. Marking or otherwise

identifying each lamp with wattage and

voltage is especially important for

incandescent light bulbs because it is unsafe

to use an incandescent light bulb with a

higher wattage than the rating of the fixture

in which it is used. 8 Manufacturers and

private labelers, however, currently

voluntarily mark incandescent light bulbs

and other types of lamp products with

wattage and design voltage information so

that consumers can use them safely. The

Commission believes that the marketplace

provides incentives for manufacturers and

private labelers to continue marking this

information on lamp products, so it is

unnecessary for the Commission to require

such marking on lamp products marketed

through bulk shipping/retail display

cartons. 9
Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 /Rules and Regulations 38745

marking wattage and voltage on general service

incandescent light bulbs.

10As they currently must do under the Rule,

manufacturers and private labelers also will have to

disclose, clearly and conspicuously, on all cartons

in which the lamps are shipped in the United States

or imported into the United States, that: ‘‘These

lamps comply with Federal energy labeling

requirements.’’

11The interpretations of the terms ‘‘principal

display panel,’’ ‘‘label,’’ and ‘‘package’’ in this Rule,

are consistent with the requirements of, and the

definitions of these terms in, the Fair Packaging and

Labeling Act (‘‘FPLA’’), 15 U.S.C. 1541 et seq., and

in the Commission’s Regulations under section 4 of

the FPLA, 16 CFR Part 500.

12These reporting requirements currently have

been stayed by the Commission.

• Making disclosures on all sides of the

carton—When lamps that are not packaged

for individual retail sale are distributed to

retailers in these bulk shipping/retail display

cartons, the bulk shipping/retail display

cartons will constitute the required labeling.

The Rule already prohibits retailers from

removing the required labels or rendering

them illegible. Retailers, therefore, will be

required to display these bulk-packaged lamp

products for retail sale to consumers in the

bulk shipping/retail display carton with the

required labeling disclosures visible to

consumers at the point of retail sale. It is

unnecessary, therefore, for the Commission

to require that the disclosures be made on

labeling on multiple sides of the bulk

shipping/retail display carton. Of course,

manufacturers may choose to make the

disclosures on all sides of the carton to

facilitate display by the retailer.

• Limiting use to unusual or rare sales

events—Because labeling on the bulk

shipping/retail display cartons will contain

the disclosures required by the Rule (to

provide consumers with prepurchase

information they need) and the cartons must

be displayed at the point of retail sale with

the required disclosures clearly visible to

consumers prior to purchase, it is

unnecessary to limit use of this labeling

approach to unusual or rare sales events.

For the reasons explained above, the

Commission adopts an interpretative

amendment to the Rule to clarify that

manufacturers and private labelers of all

types of covered lamp products may

meet the Rule’s labeling disclosure

requirements by making the required

disclosures on the bulk shipping carton,

where the lamps are not packaged or

labeled for individual retail sale and

where the lamps are displayed for retail

sale in the bulk shipping/retail display

carton. 10 The Rule continues to require

that individual retail-sale packages of

lamps be labeled with the disclosures

required by the Rule, regardless of

whether they are packaged in bulk

shipping/retail display cartons that also

contain the required labeling

disclosures.

V. Exemption From Notice and

Comment Requirements

The amendment the Commission

adopts today interprets and clarifies the

Rule by stating that, for any covered

lamp product that is not packaged and

labeled for individual retail sale,

manufacturers and private labelers may

meet the labeling requirements of the

Rule by making the required disclosures

on the labels of the bulk shipping/retail

display carton, where the bulk

shipping/retail display carton is used to

display the lamps for retail sale. The

information that will be provided to

consumers, and the time at which it will

be provided to them, is the same as that

currently required by the Rule. This

interpretative amendment does not

create any new obligations, but only

clarifies how the Commission interprets

the terms ‘‘principal display panel,’’

‘‘label,’’ and ‘‘package’’ for lamp

products that are shipped in bulk

shipping/retail display cartons without

individual retail-sale packaging, where

the lamps are displayed for retail sale in

the bulk shipping/retail display

cartons. 11 For these reasons, the

Commission has determined that the

amendment constitutes an interpretative

rule, for which notice and public

comment are not required under section

553(b)(A) of the Administrative

Procedure Act (‘‘APA’’), 5 U.S.C.

553(b)(A). The amendment is effective

today. Because the amendment is

merely an interpretative rule, section

553(d)(2) of the APA, 5 U.S.C. 553(d)(2),

which requires publication or service of

a substantive rule not less than 30 days

before its effective date, does not apply.

VI. Regulatory Flexibility Act

Because this amendment is an

interpretative rule that is not covered by

the notice and comment provisions of

section 553(b) of the APA, the

Regulatory Flexibility Act (‘‘RFA’’), 5

U.S.C. 601 et seq., does not apply.

Nevertheless, the Commission has

considered the potential effect of the

amendment on small entities. The Rule

requires that manufacturers and other

lamp product sellers: (1) disclose

specific information in labels and

catalogs; (2) submit annual reports to

the Commission for certain lamp

products; 12 and (3) substantiate the

required disclosures and maintain

records of that substantiating data. In

promulgating these disclosure

requirements, the Commission certified

that the lamp labeling requirements in

the Appliance Labeling Rule would not

have ‘‘a significant economic impact on

a substantial number of small entities.’’

The interpretative amendment adopted

today does not impose any new

obligations on sellers, large or small.

The Commission has concluded that the

impact of the amendment on small

businesses as well as other entities

within the affected industry, if any, will

be minimal. Accordingly, this notice

does not contain a regulatory analysis

under section 604 of the RFA, 5 U.S.C.

604.

VII. Paperwork Reduction Act

The Paperwork Reduction Act

(‘‘PRA’’), 44 U.S.C. 3501 et seq., requires

government agencies, before

promulgating rules or other regulations

that require ‘‘collections of information’’

(i.e., recordkeeping, reporting, or thirdparty disclosure requirements), to obtain

approval from the Office of Management

and Budget (‘‘OMB’’), 44 U.S.C. 3502.

The Commission currently has OMB

clearance for the Rule’s information

collection requirements (OMB No.

3084–0069). This interpretative

amendment does not create any new

information collection requirements.

List of Subjects in 16 CFR Part 305

Advertising, Consumer protection,

Energy conservation, Household

appliances, Labeling, Lamp products,

Penalties, Reporting and recordkeeping

requirements.

Authority: 42 U.S.C. 6294.

Text of Amendments

In consideration of the foregoing, the

Commission amends title 16, chapter I,

subchapter C of the Code of Federal

Regulations, as follows:

PART 305—RULE CONCERNING

DISCLOSURES REGARDING ENERGY

CONSUMPTION AND WATER USE OF

CERTAIN HOME APPLIANCE AND

OTHER PRODUCTS REQUIRED

UNDER THE ENERGY POLICY AND

CONSERVATION ACT (‘‘APPLIANCE

LABELING RULE’’)

1. The authority for part 305

continues to read as follows:

Authority: 42 U.S.C. 6294.

§ 305.11 [Amended]

2. Section 305.11(e) is amended by

revising paragraph (e)(2), redesignating

paragraphs (e)(3) and (e)(4) as

paragraphs (e)(4) and (e)(5), and adding

a new paragraph (e)(3) to read as

follows:

* * * * *

(e) * * *

(2) Any covered product that is a

general service fluorescent lamp or an

incandescent reflector lamp shall be

labeled clearly and conspicuously with

a capital letter ‘‘E’’ printed within a

circle and followed by an asterisk. The
38746 Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 /Rules and Regulations

1This is consistent with the memorandum of

understanding (MOU) between FDA and the

Environmental Protection Agency (EPA) on the

jurisdiction over substances in drinking water (44

FR 42775, July 20, 1979). Moreover, an

antimicrobial that is added to water used in food

and for food processing is an antimicrobial that is

used in or on a ‘‘processed food.’’ The use of an

antimicrobial in or on processed food is subject to

FDA’s regulatory authority as a food additive under

section 409 of the act. Such use is not a pesticide

use because pests that are in or on processed food

are excepted from the definition of fungus in 7

U.S.C. 136(k) and from the definition of pest in 40

CFR 152.5. Therefore, such an antimicrobial is

neither a ‘‘pesticide’’ under the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C.

136(u)) nor a ‘‘pesticide chemical’’ under section

201(q) of the act (21 U.S.C. 321(q)).

2Such nonraw agricultural commodities include,

for example, those that are cut, peeled, sliced,

chopped, ground, irradiated, or cooked.

label shall also clearly and

conspicuously disclose, either in close

proximity to that asterisk or elsewhere

on the label, the following statement:

*[The encircled ‘‘E’’] means this bulb

meets Federal minimum efficiency standards.

(i) If the statement is not disclosed on

the principal display panel, the asterisk

shall be followed by the following

statement:

See [Back,Top, Side] panel for details.

(ii) For purposes of this paragraph (e),

the encircled capital letter ‘‘E’’ shall be

clearly and conspicuously disclosed in

color-contrasting ink on the label of any

covered product that is a general service

fluorescent lamp and will be deemed

‘‘conspicuous,’’ in terms of size, if it

appears in typeface at least as large as

either the manufacturer’s name or logo

or another logo disclosed on the label,

such as the ‘‘UL’’ or ‘‘ETL’’ logos,

whichever is larger.

(3)(i) A manufacturer or private

labeler who distributes general service

fluorescent lamps, compact fluorescent

lamps, or general service incandescent

lamps (including incandescent reflector

lamps) without labels attached to the

lamps or without labels on individual

retail-sale packaging for one or more

lamps may meet the disclosure

requirements of paragraphs (e)(1) and

(e)(2) of this section by making the

required disclosures, in the manner and

form required by those paragraphs, on

the bulk shipping cartons that are to be

used to display the lamps for retail sale.

(ii) Instead of labeling any covered

product that is a general service

fluorescent lamp with the encircled ‘‘E’’

and with the statement described in

paragraph (e)(2) of this section, a

manufacturer or private labeler who

would not otherwise put a label on such

a lamp may meet the disclosure

requirements of that paragraph by

permanently marking the lamp clearly

and conspicuously with the encircled

‘‘E’’.

* * * * *

By direction of the Commission,

Commissioner Thompson dissenting.

Donald S. Clark,

Secretary.

[FR Doc. 98–19212 Filed 7–17–98; 8:45 am]

BILLING CODE 6750–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 94F–0040]

Secondary Direct Food Additives

Permitted in Food for Human

Consumption

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of chlorine dioxide as an

antimicrobial agent in water used to

wash certain fruits and vegetables. This

action is in response to a petition filed

by the National Food Processors

Association.

DATES: The regulation is effective July

20, 1998; written objections and

requests for a hearing by August 19,

1998.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Robert L. Martin, Center for Food Safety

and Applied Nutrition (HFS–217), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204–0001, 202–418–

3074.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

March 24, 1994 (59 FR 13970), FDA

announced that a food additive petition

(FAP 4A4415) had been filed by the

National Food Processors Association,

1401 New York Ave. NW., Washington,

DC 20005. The petition proposed that

the food additive regulations be

amended to provide for the safe use of

chlorine dioxide to disinfect waters in

contact with fresh fruits and vegetables

intended for human consumption. In its

evaluation of the petition, the agency

has concluded that the water is not

disinfected, but the microbial

contamination of the water is reduced.

An antimicrobial added to water used

to wash fruits and vegetables may be

subject to regulation as a food additive

under section 409 of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 348), or may be subject to

regulation as a pesticide chemical under

section 408 of the act (21 U.S.C. 346a),

depending upon the status of the fruit

or vegetable which is washed with the

antimicrobial solution. FDA regulates

antimicrobials added to water used in

food and for food processing.1 An

antimicrobial substance added to water

used to wash fruits and vegetables that

are not raw agricultural commodities2 is

an antimicrobial ‘‘used in food and for

food processing.’’ EPA regulates, as

pesticides under FIFRA (7 U.S.C.

136(u)) and as pesticide chemicals

under section 201(q) of the act,

antimicrobial substances directed

against microbes in water used to wash

raw agricultural commodities.

The petition proposed the use of

chlorine dioxide in water for contact

with fresh fruits and vegetables,

regardless of whether such fruits and

vegetables are raw agricultural

commodities or processed food. This

proposed use would include uses

subject to EPA regulatory authority, as

well as FDA jurisdiction. Because FDA

can act only to approve those uses

subject to its jurisdiction, the approval

set out in this final rule is limited to the

use of chlorine dioxide in water used to

wash fruits and vegetables that are not

raw agricultural commodities. Any

person who wishes to request an

approval for the use of chlorine dioxide

in water used to wash raw agricultural

commodities should consult with EPA

to ascertain whether a FIFRA pesticide

registration and a section 408 of the act

tolerance or exemption from the

requirement for such tolerance would be

required by EPA.

FDA has evaluated data in the

petition and other relevant material.

Based on this information, the agency

concludes that the proposed use of

chlorine dioxide to reduce the microbial

contamination of water used to wash

fruits and vegetables, other than raw

agricultural commodities, is safe and

that the additive will achieve its

intended technical effect. FDA has also

considered the safety of chlorine

dioxide breakdown products, i.e.,

chlorite and chlorate, and concludes