[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Rules and Regulations]
[Pages 54424-54425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26358]



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[[Page 54425]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 172

[Docket No. 94F-0223]


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

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 polydextrose 
produced by using phosphoric acid. This action is in response to a 
petition filed by A. E. Staley Manufacturing Co.

DATES: Effective October 24, 1995; written objections and requests for 
a hearing by November 24, 1995.

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

FOR FURTHER INFORMATION CONTACT: Rosalie M. Angeles, Center for Food 
Safety and Applied Nutrition (HFS-207), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3107.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of July 15, 1994 (59 FR 36204), FDA announced that a food 
additive petition (FAP 4A4422) had been filed by A. E. Staley 
Manufacturing Co., c/o P.O. Box 151, Decatur, IL 62525. The petition 
proposed to amend the food additive regulations in Sec. 172.841 
Polydextrose (21 CFR 172.841) to provide for the safe use of 
polydextrose produced using phosphoric acid in place of citric acid.
    The petition provided data that demonstrated that polydextrose 
manufactured using phosphoric acid in place of citric acid is 
equivalent to polydextrose produced in accordance with Sec. 172.841. 
FDA further determined that the very low levels of residual phosphate 
in polydextrose produced using phosphoric acid are both chemically and 
toxicologically insignificant (Ref. 1). Therefore, based on its 
evaluation of the data in the petition and other relevant material, FDA 
concludes that the proposed food additive use is safe, and that the 
regulation 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 (address above) by 
appointment with the information contact person listed above. As 
provided in 21 CFR 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 November 24, 1995, 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.

Reference

    The following reference has 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. Memorandum from M. J. DiNovi, Chemistry Review Branch, CFSAN, 
to R. M. Angeles, Novel Ingredients Branch, CFSAN, October 7, 1994.

List of Subjects in 21 CFR Part 172

    Food additives, 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, 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. Section 172.841 is amended by revising paragraph (a)(1) to read 
as follows:


Sec. 172.841  Polydextrose.

* * * * *
    (a)(1) Polydextrose (CAS Reg. No. 68424-04-4) is a partially 
metabolizable water-soluble polymer prepared by the condensation of a 
melt which consists either of approximately 89 percent D-glucose, 10 
percent sorbitol, and 1 percent citric acid or of approximately 90 
percent D-glucose, 10 percent sorbitol, and 0.1 percent phosphoric 
acid, on a weight basis.
* * * * *

    Dated: October 17, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-26358 Filed 10-23-95; 8:45 am]
BILLING CODE 4160-01-F