Federal Register / Vol. 60, No. 105 / Thursday, June 1, 1995 / Proposed Rules 28555

2NEMA also notes that the U.S. Department of

Energy (‘‘DOE’’) has published ‘‘interim final rules’’

regarding test procedures for incandescent light

bulbs (and for other lamp products covered by the

Appliance Labeling Rule). See Interim final rule, 59

FR 49468 (1994). NEMA states that, given the

interim final status of the DOE testing rules, an

extension of the comment period in the review of

the Light Bulb Rule ‘‘would more likely enable the

commentators to base their comments and

recommendations upon final Department of Energy

test procedure regulations.’’ The Commission stated

in the Statement of Basis and Purpose for the lamp

labeling amendments to the Appliance Labeling

Rule that it would consider testing performed

according to the test procedures mandated by DOE

in its final testing rules as meeting the reasonable

basis standard required by the Appliance Labeling

Rule, 59 FR 25176, 25200 (1994). Therefore, final

action by DOE on its testing rules is not necessary

for the Commission to conduct the current review

of the Light Bulb Rule.

1995, 60 FR 15200 (1995), in response

to a separate petition from NEMA.2

In light of overlapping labeling

requirements of the Light Bulb Rule and

the Appliance Labeling Rule for

incandescent light bulbs (other than

incandescent reflector bulbs) and the

pending proposed amendments to the

labeling requirements for incandescent

light bulbs (including incandescent

reflector bulbs) under the Appliance

Labeling Rule, the Commission has

determined that an extension of the

comment period is appropriate.

Therefore, to allow all interested

persons the opportunity to supply the

Commission with written data, views

and arguments concerning the

Commission’s review of the Light Bulb

Rule, the Commission grants an

extension of the comment period to

August 7, 1995.

List of Subjects in 16 CFR Part 409

Advertising, Consumer protection,

Energy conservation, Household

appliances, Labeling, Lamp products,

Trade practices.

Authority: 15 U.S.C. 41–58.

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 95–13361 Filed 5–31–95; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 182 and 186

[Docket No. 80N–0196]

Japan Wax; Affirmation of GRAS

Status as an Indirect Human Food

Ingredient; Reproposed Rule

AGENCY: Food and Drug Administration,

HHS.

ACTION: Reproposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

affirm Japan wax as generally

recognized as safe (GRAS) as an indirect

human food ingredient for use as a

constituent of cotton and cotton fabrics

used in dry food packaging. In light of

this action, the agency is withdrawing

its July 9, 1982 (47 FR 29965), proposal

to delete this use of Japan wax from

GRAS status as an indirect human food

ingredient (hereinafter referred to as the

July 1982 proposal). This action results

from FDA’s review of all available

information on Japan wax, including

documents located in food additive

extension file no. 393 (FAX 393)

supporting its history of common use in

food contact cotton bags and an acute

oral toxicity study on mice that has been

obtained since the publication of the

July 1982 proposal to delete this use

from the GRAS list.

DATES: Written comments by August 15,

1995.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Martha D. Peiperl, Center for Food

Safety and Applied Nutrition (HFS–

217), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3077.

SUPPLEMENTARY INFORMATION:

I. Background

FDA has been conducting a

comprehensive review of human food

ingredients classified as GRAS or

subject to a prior sanction. Under this

review, the agency has evaluated the

safety of Japan wax, and FDA has

reconsidered its July 1982 proposal to

remove Japan wax from the GRAS list.

Japan wax (CAS Reg. No. 8001–39–6),

also known as Japan tallow or sumac

wax, is a pale yellow vegetable tallow,

containing glycerides of the C19–C23

dibasic acids and a high content of

tripalmitin. It is prepared from the

mesocarp by hot pressing of immature

fruits of the oriental sumac, Rhus

succedanea (Japan, Taiwan and IndoChina), R. vernicifera (Japan), and R.

trichocarpa (China, Indo-China, India,

and Japan).

Japan wax is listed in § 182.70 (21

CFR 182.70) as GRAS for use as a

substance migrating to food from cotton

and cotton fabrics used in dry food

packaging based upon a final rule

published in the Federal Register of

June 10, 1961 (26 FR 5224). This final

rule was the original GRAS listing for

substances migrating to food from

cotton and cotton fabrics used in dry

food packaging and included only

substances in common use prior to that

time. Japan wax was one of the

substances identified to FDA, in

response to the 1958 Food Additives

Amendment to the Federal Food, Drug,

and Cosmetic Act (the act), by the

National Cotton Council of America as

being in use prior to 1958 in food

contact articles (cotton bags) (Ref. 1).

One member of the Council, SeydelWoolley & Co., had reported using Japan

wax for the sizing of cloth used for food

bags or similar uses (Ref. 2). Japan wax

had been in use in textile finishing for

many years (Refs. 3 and 4). Japan wax

is also listed in § 73.1(b)(2) (21 CFR

73.1(b)(2)) for use in diluents in color

additive mixtures for coloring shell

eggs, in § 175.105 (21 CFR 175.105) for

use as a component of adhesives, in

§ 175.350 (d)(3) (21 CFR 175.350 (d)(3))

for use as an optional substance in vinyl

acetate/crotonic acid copolymer, and in

§ 176.170 (a)(5) (21 CFR 176.170 (a)(5))

for use as a component of paper and

paperboard in contact with aqueous and

fatty foods. This action does not affect

these regulated food additive or color

additive uses of Japan wax.

The July 1982 proposal stated that

insufficient safety data existed to affirm

the GRAS status of the ingredient for

indirect human food use. The July 1982

proposal also stated that the proposed

action would not affect the regulated

uses of Japan wax as a food additive and

as a color additive diluent. The July

1982 proposal was published in

accordance with the announced FDA

review of the safety of GRAS and priorsanctioned food ingredients.

The basis for the July 1982 proposal

was the evaluation of the 1975 final

report of the Select Committee on GRAS

Substances (the Select Committee),

composed of qualified scientists chosen

by the Life Sciences Research Office of

the Federation of American Societies for

Experimental Biology (LSRO/FASEB).

This report was one of a series

concerning the health aspects of using

GRAS and prior-sanctioned food

substances as food ingredients, done by

LSRO/FASEB under contract with FDA.

FDA requested these reviews of the

safety of substances that were listed as

GRAS only on the basis of their

common use in food prior to 1958. The

Select Committee’s report, entitled

‘‘Evaluation of the Health Aspects of

Japan Wax as a Substance Migrating to

Food from Cotton and Cotton Fabrics

Used in Dry Food Packaging’’ (Ref. 5),

included the results of an in vitro

mutagenic evaluation of Japan wax
28556 Federal Register / Vol. 60, No. 105 / Thursday, June 1, 1995 / Proposed Rules

using Saccharomyces cerevisiae, strain

D4, and Salmonella typhimurium,

strains TA–1536, TA–1537, and TA–

1538, with and without metabolic

activation (Ref. 6). In these assays, Japan

wax exhibited no mutagenic activity.

The Select Committee’s report, however,

concluded that there were insufficient

data upon which to evaluate the safety

of Japan wax for use as a substance

migrating to food from cotton and cotton

fabrics used in dry food packaging.

Although FDA proposed to remove this

use from the GRAS list, the July 1982

proposal further stated that if

information was subsequently obtained

to support the safe use of Japan wax in

cotton and cotton fabrics for use in dry

food packaging, FDA would reconsider

the July 1982 proposal.

In the Federal Register of August 28,

1991 (56 FR 42668) (hereinafter referred

to as the August 1991 notice of intent),

FDA published a notice of intent to

review all of the proposed rules that the

agency had published in the Federal

Register on or before December 31,

1985, but for which no final rule or

notice of withdrawal had been

published. The agency then tentatively

concluded that 115 of these pre-1986

proposals should be withdrawn,

including the proposed deletion of

Japan wax from GRAS status, and

invited comments on FDA’s intent to

withdraw these proposals. No

comments were received concerning

Japan wax.

After due consideration of all

comments received in response to the

August 1991 notice of intent, FDA

announced in the Federal Register of

December 30, 1991 (56 FR 67440), that

it was withdrawing 89 proposed rules

that were published in the Federal

Register on or before December 31,

1985, and was deferring a decision on

withdrawal of 26 proposed rules. The

agency also announced that it had, on

its own initiative, further reviewed its

proposal to withdraw the proposed

deletion from GRAS status of Japan wax,

published in the July 1982 proposal,

and had decided to defer the

withdrawal of this proposal.

II. Safety

Since the publication of the Select

Committee’s report, FDA has found

evidence that bears on the safe use of

Japan wax in the treatment of cotton

fabric used for dry food packaging. The

agency has received and considered an

acute oral toxicity study in which mice

were given 15 grams per kilogram body

weight doses of Japan wax for 5 days

(Ref. 7). No mortality was observed and

no adverse effects were noted in this

study. The agency has also conducted a

review of the scientific literature since

the 1975 final report of the Select

Committee and has found no

information that would cause any safety

concerns about this use of Japan wax.

After obtaining the acute oral toxicity

study, FDA reexamined the documents

in its possession and other evidence

supporting the history of common use of

Japan wax in cotton fabrics used in dry

food packaging. The agency found

letters from a textile manufacturer and

from the National Cotton Council of

America in a food additive extension

file (FAX 393), identifying Japan wax as

one of the substances being used in the

sizing of cloth used for food bags prior

to 1958 (Refs. 1 and 2). FAX files

contain the administrative record of

industry requests for continued use of

food ingredients, pending FDA’s

publication of regulations as required by

the 1958 Food Additives Amendment to

the act. The requests were made in the

period immediately following the

passage of the Food Additives

Amendment.

As provided for under § 170.30(b) (21

CFR 170.30(b)), FDA has tentatively

determined that the history of safe use

of Japan wax since before 1958 provides

an adequate basis upon which to affirm

that the use of Japan wax in cotton and

cotton fabrics used in dry food

packaging is GRAS. The GRAS status of

this use is corroborated by the acute

study and by the in vitro mutagenic

evaluation. Therefore, in accordance

with the provisions of §§ 170.30 and

170.35 (21 CFR 170.35), the agency is

proposing to affirm that Japan wax is

GRAS for use as a constituent of cotton

and cotton fabrics used in dry food

packaging, on the basis of its common

use in food prior to 1958, corroborated

by further evidence of its safety

obtained since the Select Committee’s

evaluation.

III. Economic Impact

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

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 proposed rule

would not prohibit any current activity,

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.

IV. Environmental Impact

FDA has determined under 21 CFR

25.24(b)(7) 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.

V. Prior Sanctions

The agency is unaware of any prior

sanction for the use of this ingredient in

foods under conditions different from

those identified in this document. Any

person who intends to assert or rely on

such a sanction shall submit proof of its

existence in response to this proposal.

The action proposed above will

constitute a determination that excluded

uses would result in adulteration of the

food in violation of section 402 of the

act (21 U.S.C. 342), and the failure of

any person to come forward with proof

of such an applicable prior sanction in

response to this proposal constitutes a

waiver of their right to assert or rely on

it later. Should any person submit proof

of the existence of a prior sanction, the

agency hereby proposes to recognize

such use by issuing an appropriate final

rule under part 181 (21 CFR part 181)

or affirming it as GRAS under part 184

or 186 (21 CFR part 184 or 186), as

appropriate.

VI. Comments

Interested persons may, on or before

August 15, 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.

VII. References

The following references have been

placed on display in the Dockets
Federal Register / Vol. 60, No. 105 / Thursday, June 1, 1995 / Proposed Rules 28557

Management Branch (address above)

and may be seen by interested persons

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

through Friday.

1. Letter to the Commissioner, FDA, from

National Cotton Council of America, with

attached Sheet V, (3 pp.), January 25, 1960.

2. Letter to John Howard, National Cotton

Council of America, from Paul Seydel,

Seydel-Woolley & Co., with attached list,

March 25, 1960.

3. Sayre, J. E. and C. J. Marsel, CW Report

‘‘The $100 Million Market for Waxes,’’

Chemical Week, p. 47, September 27, 1952.

4. Warth, A. H., ‘‘Japan wax,’’ The

Chemistry and Technology of Waxes, 2d ed.,

Reinhold Publishing Corp., pp. 270–274,

1956.

5. ‘‘Evaluation of the Health Aspects of

Japan Wax as a Substance Migrating to Food

From Cotton and Cotton Fabrics Used in Dry

Food Packaging,’’ Life Sciences Research

Office, Federation of American Societies for

Experimental Biology, 1975.

6. Litton Bionetics, Inc., LBI Project No.

2468, Mutagenic Evaluation of Compound,

FDA 73–50, MX8001–39–6, Japan Wax,

December 24, 1975.

7. Leberco Laboratories, Assay No. 22753,

Unpublished Acute Oral Toxicity Test of

Japan Wax in Charles River CF–1 Mice,

March 8, 1982.

List of Subjects

21 CFR part 182

Food ingredients, Food packaging,

Spices and flavorings.

21 CFR part 186

Food ingredients, Food packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, the proposed rule

that published in the Federal Register of

July 9, 1982 (47 FR 29965) is

withdrawn; and it is proposed that 21

CFR parts 182 and 186 be amended to

read as follows:

PART 182—SUBSTANCES

GENERALLY RECOGNIZED AS SAFE

1. The authority citation for 21 CFR

part 182 continues to read as follows:

Authority: Secs. 201, 402, 409, 701 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 371).

§ 182.70 [Amended]

2. Section 182.70 Substances

migrating from cotton and cotton fabrics

used in dry food packaging is amended

by removing the entry for ‘‘Japan wax.’’

PART 186—INDIRECT FOOD

SUBSTANCES AFFIRMED AS

GENERALLY RECOGNIZED AS SAFE

3. The authority citation for 21 CFR

part 186 continues to read as follows:

Authority: Secs. 201, 402, 409, 701 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 371).

4. New § 186.1555 is added to subpart

B to read as follows:

§ 186.1555 Japan wax.

(a) Japan wax (CAS Reg. No. 8001–39–

6), also known as Japan tallow or sumac

wax, is a pale yellow vegetable tallow,

containing glycerides of the C19–C23

dibasic acids and a high content of

tripalmitin. It is prepared from the

mesocarp by hot pressing of immature

fruits of the oriental sumac, Rhus

succedanea (Japan, Taiwan, and IndoChina), R. vernicifera (Japan), and R.

trichocarpa (China, Indo-China, India,

and Japan). Japan wax is soluble in hot

alcohol, benzene, and naphtha, and

insoluble in water and in cold alcohol.

(b) In accordance with paragraph

(b)(1) of this section, the ingredient is

used as an indirect human food

ingredient with no limitation other than

current good manufacturing practice.

The affirmation of this ingredient as

generally recognized as safe (GRAS) as

an indirect human food ingredient is

based on the following current good

manufacturing practice conditions of

use:

(1) The ingredient is used as a

constituent of cotton and cotton fabrics

used for dry food packaging.

(2) The ingredient is used at levels not

to exceed current good manufacturing

practice.

(c) Prior sanctions for this ingredient

different from the uses established in

this section do not exist or have been

waived.

Dated: May 16, 1995.

Fred R. Shank,

Director, Center for Food Safety and Applied

Nutrition.

[FR Doc. 95–13293 Filed 5–31–95; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[MN–28–1–6163; FRL–5213–7]

Approval and Promulgation of

Implementation Plans; Minnesota

Carbon Monoxide Contingency

Measure

AGENCY: Environmental Protection

Agency (USEPA).

ACTION: Proposed rule.

SUMMARY: The USEPA is proposing to

approve the carbon monoxide (CO)

contingency measure as a revision to the

Minnesota State Implementation Plan

(SIP) in the Twin-Cities area. This area

is designated moderate nonattainment

for CO. It includes the Twin Cities of

Minneapolis-Saint Paul and the

following counties which comprise the

CO control area: Anoka, Carver,

Chisago, Dakota, Hennepin, Isanti,

Ramsey, Scott, Washington, and Wright.

The USEPA action is based upon a

request that was submitted by the State

to satisfy the requirement of section

172(c)(9) of the Clean Air Act as

amended in 1990 (CAAA). This section

of the CAAA requires States with areas

designated moderate or above CO or

ozone nonattainment to submit

contingency measures by November 15,

1993. These measures must take effect,

without further action by the State or

the USEPA, if an area fails to make

reasonable further progress or to attain

by the attainment date. The State

submittal meets this requirement, of no

further action to implement, because the

State legislation that authorizes this

measure requires the use of oxygenated

gasoline on a year-round basis

beginning October 31, 1995, in areas

classified as CO control areas. In the

State’s plan no trigger event is required.

Ethanol is expected to be the primary

oxygenate in this area and will in large

part be used to meet the year-round

oxygenate requirement. Thus, in

addition to the benefits from the

reduction of CO emissions through the

use of oxygenated gasoline, the expected

use of ethanol in implementing this

contingency measure is consistent with

the longstanding Federal policy of using

renewable fuels for a positive energy

impact and the reduction of emissions

of greenhouse gases.

DATES: Comments on this SIP revision

and on the proposed USEPA rulemaking

action must be received by July 3, 1995,

to be considered in the development of

the USEPA’s final rulemaking action.

ADDRESSES: Written comments should

be addressed to: William L. MacDowell,

Chief, Regulation Development Section,

Air Enforcement Branch (AE–17J),

United States Environmental Protection

Agency, 77 West Jackson Boulevard,

Chicago, Illinois 60604.

Copies of the revision request and

USEPA’s analysis are available for

public inspection during normal

business hours at the following

addresses: United States Environmental

Protection Agency, Region 5, Air and

Radiation Division, 77 West Jackson

Boulevard (AE–17J), Chicago, Illinois

60604; and Office of Air and Radiation

(OAR), Docket and Information Center

(Air Docket (6102) Room M1500, United

States Environmental Protection