[Federal Register Volume 61, Number 242 (Monday, December 16, 1996)]
[Rules and Regulations]
[Pages 65941-65942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31809]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 90F-0195]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Curdlan

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of curdlan as a 
formulation aid, processing aid, stabilizer and thickener or texturizer 
in foods. This action is in response to a petition filed by Takeda 
Chemical Industries, Ltd.

DATES: The regulation is effective December 16, 1996. Submit written 
objections and requests for a hearing by January 15, 1997. The Director 
of the Office of the Federal Register approves the incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a 
certain publication in 21 CFR 172.809(b), effective December 16, 1996.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Aydin Orstan, Center for Food Safety 
and Applied Nutrition (HFS-217), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3076.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of July 17, 1990 (55 FR 29106), FDA announced that a food 
additive petition (FAP 0A4200) had been filed by Takeda Chemical 
Industries, Ltd., c/o International Research and Development Corp. (now 
MPI Research), Mattawan, MI 49071, proposing that the food additive 
regulations be amended to provide for the safe use of -1,3-
glucan derived from Alcaligenes faecalis var. myxogenes. In the same 
notice, the agency also announced that the proposed common or usual 
name of the additive was curdlan.
    The agency is accepting curdlan as the common or usual name of the 
additive. Based on the data in the petition and other relevant 
material, the agency reached the following conclusions: (1) Curdlan 
consists of a glucose polymer and a small amount of inorganic salts, 
mainly sodium chloride, (2) curdlan lacks specific toxicity and the 
producing organism, Alcaligenes faecalis var. myxogenes, is 
nonpathogenic and nontoxicogenic, and (3) there is a history of safe 
consumption of similar glucose polymers in food. Based on this 
information, the agency concludes that the proposed food use of curdlan 
is safe, that the additive will achieve its intended technical effect, 
and that therefore, the regulations in 21 CFR part 172 should be 
amended as set forth below.
    In accordance with Sec. 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 Sec. 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.
    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 January 15, 1997 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.

List of Subjects in 21 CFR Part 172

    Food additives, Incorporation by reference, Reporting and 
recordkeeping requirements.
    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 of the Center for Food Safety and Applied 
Nutrition, 21 CFR part 172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

    1. The authority citation for 21 CFR part 172 continues to read as 
follows:

    Authority: Secs. 201, 401, 402, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 348, 371, 
379e).

    2. New Sec. 172.809 is added to subpart I to read as follows:


Sec. 172.809  Curdlan.

    Curdlan may be safely used in accordance with the following 
conditions:
    (a) Curdlan is a high molecular weight polymer of glucose 
(-1,3-glucan; CAS Reg. No. 54724-00-4) produced by pure 
culture fermentation from the nonpathogenic and nontoxicogenic 
bacterium Alcaligenes faecalis var. myxogenes.

[[Page 65942]]

    (b) Curdlan meets the following specifications when it is tested 
according to the methods described or referenced in the document 
entitled ``Analytical Methods for Specification Tests for Curdlan,'' by 
Takeda Chemical Industries, Ltd., 12-10 Nihonbashi, 2-Chome, Chuo-ku, 
Tokyo, 103, Japan, 1996, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the Division of Petition Control (HFS-215), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, Food and Drug Administration, 200 C 
St. SW., rm. 3321, Washington, DC, or at the Office of the Federal 
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (1) Positive for curdlan.
    (2) Assay for curdlan (calculated as anhydrous glucose), not less 
than 80 percent.
    (3) pH of 1 percent aqueous suspension, 6.0-7.5.
    (4) Lead, not more than 0.5 mg/kg.
    (5) Heavy metals (as Pb), not more than 0.002 percent.
    (6) Total nitrogen, not more than 0.2 percent.
    (7) Loss on drying, not more than 10 percent.
    (8) Residue on ignition, not more than 6 percent.
    (9) Gel strength of 2 percent aqueous suspension, not less than 
600x103 dyne per square centimeter.
    (10) Aerobic plate count, not more than 103 per gram.
    (11) Coliform bacteria, not more than 3 per gram.
    (c) Curdlan is used or intended for use in accordance with good 
manufacturing practice as a formulation aid, processing aid, stabilizer 
and thickener, and texturizer in foods for which standards of identity 
established under section 401 of the act do not preclude such use.

    Dated: November 27, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-31809 Filed 12-13-96; 8:45 am]
BILLING CODE 4160-01-F