[Federal Register Volume 72, Number 161 (Tuesday, August 21, 2007)]
[Rules and Regulations]
[Pages 46562-46564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16322]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 2006F-0059]


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 as a 
bulking agent, formulation aid, humectant, and texturizer in all foods, 
except meat and poultry, baby foods, and infant formula. This action is 
in response to a petition filed by Danisco USA, Inc.

DATES: This rule is effective August 21, 2007. Submit written or 
electronic objections and requests for a hearing by September 20, 2007. 
See section VII of the SUPPLEMENTARY INFORMATION section of this 
document for information on the filing of objections. The Director of 
the Office of the Federal Register approves the incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of 
certain publications in Sec.  172.841(b) (21 CFR 172.841(b)) as of 
August 21, 2007.

ADDRESSES: You may submit written or electronic objections and requests 
for a hearing, identified by Docket No. 2006F-0059, by any of the 
following methods:

Electronic Submissions

    Submit electronic objections in the following ways:
     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.
Written Submissions
    Submit written objections in the following ways:
     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.
    To ensure more timely processing of objections, FDA is no longer 
accepting objections submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic objections by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    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 
objections 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: Andrew J. Zajac, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1267.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of February 15, 2006 
(71 FR 7975), amended April 27, 2006 (71 FR 24856), FDA announced that 
a food additive petition (FAP 6A4763) had been filed by Danisco USA, 
Inc., 440 Saw Mill River Rd., Ardsley, NY 10502-2605. The petition 
proposed to amend the food additive regulations in Sec.  172.841 
Polydextrose (21 CFR 172.841). Currently, Sec.  172.841 lists 13 
specific categories of foods in which polydextrose may be used safely 
as a bulking agent, formulation aid, humectant, and texturizer. The 
petition proposed to amend Sec.  172.841 to provide for the safe use of 
polydextrose as a bulking agent, formulation aid, humectant, and 
texturizer in all foods, except meat and poultry.
    The petition also proposed to incorporate by reference the 
specifications for polydextrose in the 5th edition of the Food 
Chemicals Codex (FCC V), effective January 1, 2004. After the petition 
was filed, Danisco amended the petition to exclude the proposed uses of 
polydextrose in baby food and infant formula.

II. Determination of Safety

    Under the general safety standard in section 409 of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348), a food additive 
cannot be approved for a particular use unless a fair evaluation of the 
data available to FDA establishes that the additive is safe for that 
use. FDA's food additive regulations (21 CFR 170.3(i)) define safe as 
``a reasonable certainty in the minds of competent scientists that the 
substance is not harmful under the intended conditions of use.''
    To establish with reasonable certainty that a food additive is not 
harmful under its intended conditions of use, FDA considers the 
projected human dietary intake of the additive, existing toxicological 
data, and other relevant information (such as published literature) 
available to the agency. FDA compares an individual's estimated daily 
intake (EDI) of the additive from all sources to an acceptable intake 
level established by toxicological data. The EDI is determined by 
projections based on the amount of the additive proposed for use in 
particular foods and on data regarding the amount consumed from all 
sources of the additive. The agency commonly uses the EDI for the 90th 
percentile consumer of a food additive as a measure of high chronic 
dietary intake.

[[Page 46563]]

    The petitioner estimates that the cumulative intake of polydextrose 
from all currently-regulated and proposed uses of the additive will 
result in an exposure to the additive of 16 grams per person per day 
(g/p/d) (mean) and 31 g/p/d (90th percentile) for all ages (Ref. 1). 
The previous FDA intake estimate for polydextrose from currently-
regulated uses was 18 g/p/d and 30 g/p/d at the mean and 90th 
percentile, respectively, for persons aged 2 years and above. Despite 
the additional proposed uses, the petitioner's intake estimate for 
polydextrose did not differ significantly from the previous FDA intake 
estimate because it is based on revised use levels and current uses of 
polydextrose that are more representative of actual uses of 
polydextrose in food than those used in FDA's previous intake estimate. 
FDA agrees with the petitioner's intake estimate for polydextrose and 
concludes that it is sufficiently conservative (Ref. 1). Because 
consumer exposure to polydextrose has not changed significantly as a 
result of the petitioned uses, no new toxicological testing is 
necessary to ensure that the additional uses proposed in the petition, 
as amended, will be safe. Therefore, FDA concludes that there is a 
reasonable certainty that no harm from exposure to polydextrose would 
result from the additional petitioned uses.
    The agency also considered the potential for laxation effect due to 
excessive consumption of polydextrose in sensitive individuals. 
Currently, the regulation setting out approved food additive uses for 
polydextrose requires that consumers be informed of this potential 
effect through special labeling of products containing more than 15 g 
of polydextrose per serving (21 CFR 172.841(e)). The agency has 
considered the cumulative effect of the additional petitioned uses and 
has concluded that because there will be effectively no increase in 
dietary exposure to polydextrose the current labeling requirement is 
adequate to protect the public. Accordingly, the agency is amending 
Sec.  172.841 of the food additive regulations to provide for the use 
of polydextrose in all foods, except meat, poultry, baby food, and 
infant formula.

III. Specifications for Polydextrose

    As stated previously, the petition proposes that Sec.  172.841 be 
amended by adopting the specifications for polydextrose in FCC V. 
Currently, Sec.  172.841 incorporates by reference the specifications 
of the 4th edition of the Food Chemicals Codex (FCC IV), 1996. The 
differences between the specifications in the monograph for 
polydextrose in FCC IV and FCC V are discussed in the amended filing 
notice published in the Federal Register of April 27, 2006. FDA 
received no comments on the proposed adoption of the FCC V 
specifications for polydextrose. Subsequent to the publication of the 
amended filing notice, FDA learned that FCC published an erratum to the 
polydextrose monograph in the First Supplement to the 5th Edition of 
the Food Chemicals Codex (effective March 1, 2006). The erratum 
contained additional instructions on preparing a standard curve for the 
assay, but did not include any changes to the specifications.
    FDA has reviewed the specifications in FCC V and agrees that Sec.  
172.841 should be amended by adopting the specifications in FCC V.

IV. Conclusion

    FDA reviewed data and information in the petition and other 
relevant material to evaluate the safety of the proposed use of 
polydextrose in all foods, except meat and poultry, baby food, and 
infant formula. Based on its evaluation, FDA concludes that the uses 
proposed in the petition are safe, and therefore, Sec.  172.841 should 
be amended as set forth in this document. 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 will be made available for inspection at the Center for Food 
Safety and Applied Nutrition by appointment with the information 
contact person (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.

V. Environmental Impact

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

VI. Paperwork Reduction Act of 1995

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

VII. 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. 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 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 between 9 a.m. and 4 p.m., 
Monday through Friday.

VIII. References

    The following reference has 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. Memorandum from Folmer, Chemistry Review Team, Division of 
Petition Review, to DeLeo, Regulatory Group I, Division of Petition 
Review, June 20, 2006.

List of Subjects in 21 CFR Part 172

    Food additives, Incorporation by reference, Reporting and 
recordkeeping requirements.


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 172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

0
1. The authority citation for 21 CFR part 172 continues to read as 
follows:



[[Page 46564]]


    Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

0
2. Section 172.841 is amended by revising paragraphs (b) and (c) to 
read as follows:


Sec.  172.841  Polydextrose.

* * * * *
    (b) The additive meets the specifications of the ``Food Chemicals 
Codex,'' 5th ed. (January 1, 2004), pp. 336-339, and the First 
Supplement to the 5th Edition of the Food Chemicals Codex (March 1, 
2006), p. 37, which are incorporated by reference. The Director of the 
Office of the Federal Register approves this incorporation by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a 
copy from The National Academies Press, 500 Fifth St. NW., Washington, 
DC 20001 (Internet address http://www.nap.edu). You may inspect a copy 
at the Center for Food Safety and Applied Nutrition's Library, Food and 
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 
or at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.
    (c) When standards of identity established under section 401 of the 
act do not preclude such use, polydextrose may be used in accordance 
with current good manufacturing practices as a bulking agent, 
formulation aid, humectant, and texturizer in all foods, except meat 
and poultry, baby food, and infant formula.
* * * * *

    Dated: August 14, 2007.
Leslye M. Fraser,
Director, Office of Regulations and Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. E7-16322 Filed 8-20-07; 8:45 am]
BILLING CODE 4160-01-S