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
Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 /Rules and Regulations 38747

that residues of these compounds would

be removed from the treated produce if

the treatment with chlorine dioxide is

followed by a potable water rinse or by

blanching, cooking or canning.

Therefore, the agency is including in the

regulation the requirement that

treatment of fruits and vegetables with

chlorine dioxide shall be followed by a

potable water rinse or by blanching,

cooking or canning. Based on the

agency’s conclusions concerning this

proposed use, the regulations in 21 CFR

173.300 should be amended as set forth

below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in § 171.1(h),

the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

In the notice of filing, FDA gave

interested parties an opportunity to

submit comments on the petitioner’s

environmental assessment. FDA

received no comments in response to

that notice. The agency has carefully

considered the potential environmental

effects of this action. FDA has

concluded that the action will not have

a significant impact on the human

environment, and that an environmental

impact statement is not required. The

agency’s finding of no significant impact

and the evidence supporting that

finding, contained in an environmental

assessment, may be seen in the Dockets

Management Branch (address above)

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

through Friday.

Any person who will be adversely

affected by this regulation may at any

time on or before August 19, 1998, file

with the Dockets Management Branch

(address above) written objections

thereto. Each objection shall be

separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

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

through Friday.

This final rule contains no collections

of information. Therefore, clearance of

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

List of Subjects in 21 CFR Part 173

Food additives.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 173 is

amended as follows:

PART 173—SECONDARY DIRECT

FOOD ADDITIVES PERMITTED IN

FOOD FOR HUMAN CONSUMPTION

1. The authority citation for 21 CFR

part 173 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348.

2. Section 173.300 is amended by

revising paragraph (b) to read as follows:

§ 173.300 Chlorine dioxide.

* * * * *

(b)(1) The additive may be used as an

antimicrobial agent in water used in

poultry processing in an amount not to

exceed 3 parts per million (ppm)

residual chlorine dioxide as determined

by Method 4500–ClO2 E, referenced in

paragraph (a) of this section, or an

equivalent method.

(2) The additive may be used as an

antimicrobial agent in water used to

wash fruits and vegetables that are not

raw agricultural commodities in an

amount not to exceed 3 ppm residual

chlorine dioxide as determined by

Method 4500–ClO2 E, referenced in

paragraph (a) of this section, or an

equivalent method. Treatment of the

fruits and vegetables with chlorine

dioxide shall be followed by a potable

water rinse or by blanching, cooking, or

canning.

Dated: July 9, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–19314 Filed 7–17–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 97F–0405]

Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

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 aluminum borate as an

antistatic agent and/or antifogging agent

for olefin polymers intended for use as

packaging materials in contact with

food. This action is in response to a

petition filed by Shikoku Chemical

Corp.

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: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

September 25, 1997 (62 FR 50387), FDA

announced that a food additive petition

(FAP 7B4559) had been filed by

Shikoku Chemical Corp., c/o SRS

International Corp., suite 1000, 1625 K

St. NW., Washington, DC 20006–1604.

The petition proposed to amend the

food additive regulations in § 178.3130

Antistatic and/or antifogging agents in

food-packaging materials (21 CFR

178.3130) to provide for the safe use of

aluminum borate as an antistatic and/or

antifogging agent for olefin polymers

complying with 21 CFR 177.1520(c) as

packaging materials intended for use in

contact with food.

FDA has evaluated data in the

petition and other relevant material.

Based on this information, the agency

concludes that the proposed use of the

additive is safe, that the additive will

achieve its intended technical effect,

and therefore, that the regulations in

§ 178.3130 should be amended as set

forth below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the