[Federal Register Volume 60, Number 233 (Tuesday, December 5, 1995)]
[Rules and Regulations]
[Pages 62208-62209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29478]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 182 and 186

[Docket No. 80N-0196]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to affirm Japan wax as generally recognized as safe (GRAS) 
as an indirect food ingredient for use as a constituent of cotton and 
cotton fabrics used in dry food packaging. The safety of this indirect 
food use of Japan wax has been evaluated under the comprehensive safety 
review conducted by the agency.

DATES: Effective December 5, 1995.

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:
    In the Federal Register of June 1, 1995 (60 FR 28555), FDA 
published a proposal to affirm the GRAS status of the use of Japan wax 
as an indirect human food ingredient migrating to food from cotton and 
cotton fabrics used in dry food packaging. The proposal was published 
in accordance with the announced FDA review of the safety of GRAS and 
prior-sanctioned food ingredients.
    In accordance with Sec. 170.35 (21 CFR 170.35), copies of the 
scientific literature review and the report of the Select Committee on 
GRAS Substances (the Select Committee) on Japan wax, as well as 
documents in the possession of FDA and further evidence of the safety 
of Japan wax obtained by FDA since publication of the Select 
Committee's report, have been made available for public review in the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
    The proposal gave interested parties an opportunity to submit 
comments. FDA received no comments on its proposal. The agency is, 
therefore, adopting the proposal without any changes.

Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule that published in the 
Federal Register of June 1, 1995 (60 FR 28555). No new information or 
comments have been received that would affect the agency's 
determination that there is no significant impact on the human 
environment, and that neither an environmental assessment nor an 
environmental impact statement is required.

Analysis of Impacts

    FDA has examined the impacts of the final 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 Regulatory 
Flexibility Act requires analyzing options for regulatory relief for 
small businesses.
    The agency finds that this rule is not a significant regulatory 
action as defined by Executive Order 12866. Furthermore, in accordance 
with the Regulatory Flexibility Act, the agency previously considered 
the potential effects that this rule would have on small entities, 
including small businesses, and determined that this rule will have no 
significant adverse impact on a substantial number of small businesses. 
FDA has received no new information or comments that would alter its 
previous determination.

Effective Date

    As this rule recognizes an exemption from the food additive 
definition in the Federal Food, Drug, and Cosmetic Act, and from the 
approval requirements applicable to food additives, no delay in 
effective date is required by the Administrative Procedure Act (5 
U.S.C. 553(d)). The rule will therefore be effective December 5, 1995 
(5 U.S.C. 553(d)(1)).

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, 21 CFR parts 182 and 186 are 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.

[[Page 62209]]

    (c) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

    Dated: November 24, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-29478 Filed 12-04-95; 8:45 am]
BILLING CODE 4160-01-F