[Federal Register Volume 61, Number 42 (Friday, March 1, 1996)]
[Rules and Regulations]
[Pages 7990-7991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4716]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 180

[Docket No. 94F-0152]


Food Additives Permitted in Food on an Interim Basis or in 
Contact With Food Pending Additional Study; Mannitol

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 permit the manufacture of mannitol by 
fermentation of sugars or sugar alcohols such as glucose, sucrose, 
fructose, or sorbitol by the action of the yeast Zygosaccharomyces 
rouxii. This action is in response to a petition filed by Roquette 
America, Inc.

DATES: Effective March 1, 1996; written objections and requests for a 
hearing by April 1, 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: 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 December 13, 1994 (59 FR 64207), FDA announced that a food 
additive petition (FAP 4A4412) had been filed by Roquette America, 
Inc., c/o Keller and Heckman, 1001 G St. NW., Washington, DC 20001. The 
petition proposed to amend the food additive regulations in Sec. 180.25 
Mannitol (21 CFR 180.25) to permit the manufacture of mannitol by 
fermentation of sugars or sugar alcohols such as glucose, sucrose, 
fructose, or sorbitol by the action of the yeast Z. rouxii.


[[Page 7991]]

    As discussed in the notice of filing (59 FR 64207), in 1973 the 
agency proposed to affirm mannitol as generally recognized as safe 
(GRAS) based on the findings by the Select Committee on GRAS Substances 
from the Life Sciences Research Office of the Federation of American 
Societies for Experimental Biology (38 FR 20046, July 26, 1973). In 
response to the proposal, the agency received comments, including 
information raising questions about the safety of mannitol. Therefore, 
the agency did not affirm the GRAS status of mannitol but instead 
established an interim food additive regulation for mannitol, pending 
additional study of the ingredient (39 FR 34178, September 23, 1974). 
At the time the interim regulation was established, the agency 
concluded that there would be no increased risk to the public health to 
continue existing uses and levels of use of mannitol while additional 
studies were carried out.
    The interim regulation on mannitol specifies manufacturing 
procedures that do not include the fermentation process for 
manufacturing mannitol proposed in the petition. The petitioner 
provided evidence that mannitol produced using the proposed process is 
equivalent to mannitol produced as described in Sec. 180.25. The 
petition, however, proposed no change in the allowed uses of mannitol. 
The agency concludes from its review that no change in consumer 
exposure to mannitol will result from the promulgation of an amendment 
to Sec. 180.25 as proposed in the petition (Ref. 1).
    FDA has evaluated the data in the petition and other relevant 
material. Based upon its review, the agency concludes that the use of 
the proposed manufacturing method for mannitol by fermentation of 
sugars or sugar alcohols such as glucose, sucrose, fructose, or 
sorbitol by the action of the yeast Z. rouxii is appropriate and that 
mannitol produced by this process is equivalent to mannitol produced as 
described in current Sec. 180.25. Therefore, FDA concludes that 
Sec. 180.25 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 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 April 1, 1996, 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 S. E. Carberry, Chemistry Review Branch, 
Center for Food Safety and Applied Nutrition (CFSAN) to R. M. 
Angeles, Novel Ingredients Branch, CFSAN, May 23, 1994.

List of Subjects in 21 CFR Part 180

    Food additives.
    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 180 is amended as follows:

PART 180--FOOD ADDITIVES PERMITTED IN FOOD ON AN INTERIM BASIS OR 
IN CONTACT WITH FOOD PENDING ADDITIONAL STUDY

    1. The authority citation for 21 CFR part 180 continues to read as 
follows:

    Authority: Secs. 201, 402, 403, 409, 701 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 342, 343, 348, 371); sec. 301 
of the Public Health Service Act (42 U.S.C. 241).

    2. Section 180.25 is amended by revising paragraph (a) to read as 
follows:


Sec. 180.25  Mannitol.

    (a) Mannitol is the chemical 1,2,3,4,5,6,-hexanehexol 
(C6H14O6) a hexahydric alcohol, differing from sorbitol 
principally by having a different optical rotation. Mannitol is 
produced by one of the following processes:
    (1) The electrolytic reduction or transition metal catalytic 
hydrogenation of sugar solutions containing glucose or fructose.
    (2) The fermentation of sugars or sugar alcohols such as glucose, 
sucrose, fructose, or sorbitol using the yeast Zygosaccharomyces 
rouxii.
* * * * *

    Dated: February 14, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-4716 Filed 2-29-96; 8:45 am]
BILLING CODE 4160-01-F