[Federal Register Volume 60, Number 105 (Thursday, June 1, 1995)]
[Proposed Rules]
[Pages 28555-28557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13293]



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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

    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). 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. 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 
[[Page 28556]] 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 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

    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 
[[Page 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).

Sec. 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 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]
BILLING CODE 4160-01-F