Japan Wax; Affirmation of GRAS Status as an Indirect Human Food Ingredient; Reproposed Rule

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.

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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

5.

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 Indo-China), R.

vernicifera (Japan), and R. trichocarpa (China, Indo-China, India, and

Japan).

Japan wax is listed in Sec. 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, Seydel-

Woolley & Co., had reported using Japan wax for the sizing of cloth

used for food bags or similar uses (Ref. 2)

nces

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, Seydel-

Woolley & 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 Sec. 73.1(b)(2) (21 CFR 73.1(b)(2)) for use in diluents in

color additive mixtures for coloring shell eggs, in Sec. 175.105 (21

CFR 175.105) for use as a component of adhesives, in Sec. 175.350

(d)(3) (21 CFR 175.350 (d)(3)) for use as an optional substance in

vinyl acetate/crotonic acid copolymer, and in Sec. 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

prior-sanctioned 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

e 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

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

g, 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

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 Sec. 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 Secs. 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

ore, in

accordance with the provisions of Secs. 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

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

ckets 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

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

emoving 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 Sec. 186.1555 is added to subpart B to read as follows:

Sec. 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 Indo-China), 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]

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