[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