[Federal Register: November 15, 2004 (Volume 69, Number 219)]
[Rules and Regulations]
[Page 65540-65542]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15no04-12]
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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: fdadockets@oc.fda.gov. 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
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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