[Federal Register Volume 69, Number 219 (Monday, November 15, 2004)]
[Rules and Regulations]
[Pages 65540-65542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25243]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 180

[Docket No. 2004F-0066]


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 such as fructose, glucose, or maltose by the 
action of the microorganism Lactobacillus intermedius (fermentum). This 
action is in response to a petition filed by zuChem, Inc.

DATES: This rule is effective November 15, 2004. Submit written or 
electronic objections and requests for a hearing by December 15, 2004.

ADDRESSES: You may submit written objections and requests for a 
hearing,

[[Page 65541]]

identified by Docket No. 2004F-0066, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
     E-mail: [email protected]. Include Docket No. 2004F-
0066 in the subject line of your e-mail message.
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and docket number for this rulemaking. All objections received will be 
posted without change to http://www.fda.gov/ohrms/dockets/default.htm, 
including any personal information provided. For detailed instructions 
on submitting objections, see the ``Objections'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Celeste Johnston, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1282.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of February 19, 2004 
(69 FR 7759), FDA announced that a food additive petition (FAP 4A4754) 
had been filed by zuChem, Inc., c/o Hyman, Phelps and McNamara, P.C., 
700 13th Street NW., Washington, DC 20005. 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 
such as fructose, glucose, and maltose by the action of the 
microorganism L. intermedius (fermentum).
    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. Rather than affirm the GRAS status of mannitol, the agency 
instead decided to establish an interim food additive regulation for 
mannitol, pending additional study of the ingredient (39 FR 34178, 
September 23, 1974) and based on the conclusion 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 regulation was subsequently amended (61 FR 7990, March 1, 1996) to 
permit the manufacture of mannitol by fermentation of sugars or sugar 
alcohols by the action of the yeast Zygosaccharomyces rouxii.
    The proposed fermentation organism, L. fermentum, is currently used 
in various food applications. For example, strains of L. fermentum are 
used in sourdough bread and pressed curd cheeses, and FDA has affirmed 
as GRAS a urease preparation from L. fermentum for use in the 
manufacture of wine. The petitioner has submitted data in support of 
the microbiological safety of mannitol produced by this bacterium. In 
addition, the petitioner has provided detailed information on the 
process used to produce mannitol by this fermentation method, including 
information on the purification steps that are used. FDA concludes, 
having considered the evidence concerning the production organism and 
the purification procedures, that L. intermedius (fermentum) will not 
be present in the final product and can be safely used in the 
fermentation of fructose and other sugars to produce mannitol provided 
that the purity of the culture is maintained, and that a nonpathogenic, 
nontoxicogenic strain of L. intermedius (fermentum) is used (Ref. 1).

II. Conclusion

    The current interim regulation for mannitol specifies manufacturing 
procedures that do not include the proposed fermentation process. FDA 
has reviewed data and information in the petition on the chemical 
equivalence of mannitol produced using L. intermedius (fermentum) and 
mannitol produced by the currently-regulated methods. Based on its 
review, the agency concludes that mannitol manufactured by fermentation 
of sugars by the action of L. intermedius (fermentum) is equivalent to 
mannitol produced by the currently-regulated methods as described in 
Sec.  180.25. In addition, mannitol manufactured by the proposed 
fermentation process will have the same intended technical effect and 
uses as mannitol produced by the currently-regulated methods. 
Consequently, there will be no change in exposure to mannitol (Refs. 2 
and 3). Therefore, FDA concludes that Sec.  180.25 should be amended as 
set forth in this document.

III. Public Disclosure

    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 (see FOR FURTHER INFORMATION 
CONTACT). 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.

IV. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the notice of filing for FAP 4A4754. No new 
information or comments have been received that would affect the 
agency's previous determination that there is no significant impact on 
the human environment and that an environmental impact statement is not 
required.

V. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VI. Objections

    Any person who will be adversely affected by this regulation may 
file with the Division of Dockets Management (see ADDRESSES) written or 
electronic objections (see DATES). 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

[[Page 65542]]

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 are 
to be submitted and are to 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 Division of Dockets 
Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through 
Friday.

VII. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

    1. FDA memorandum from P. C. DeLeo, Division of Petition Review, 
to C. Johnston, Division of Petition Review, April 21, 2004.
    2. FDA memorandum from D. E. Folmer, Division of Petition 
Review, to C. Johnston, Division of Petition Review, April 20, 2004.
    3. FDA memorandum from D. E. Folmer, Division of Petition 
Review, to C. Johnston, Division of Petition Review, July 29, 2004.

List of Subjects in 21 CFR Part 180

    Food additives.

0
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

0
1. The authority citation for 21 CFR part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 343, 348, 371; 42 U.S.C. 241.

0
2. Section 180.25 is amended by adding paragraph (a)(3) to read as 
follows:


Sec.  180.25  Mannitol.

    (a) * * *
    (3) A pure culture fermentation of sugars such as fructose, 
glucose, or maltose using the nonpathogenic, nontoxicogenic bacterium 
Lactobacillus intermedius (fermentum).
* * * * *

    Dated: October 27, 2004.
Leslye M. Fraser,
Director, Office of Regulations and Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 04-25243 Filed 11-12-04; 8:45 am]
BILLING CODE 4160-01-S