Food Additives Permitted for Direct Addition to Food for Human Consumption; Polydextrose, 46562-46564 [E7-16322]
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Federal Register / Vol. 72, No. 161 / Tuesday, August 21, 2007 / Rules and Regulations
Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You
must comply with these requirements in
order for documents to be timely
received and accepted. You can obtain
paper copies of the EDGAR Filer
Manual from the following address:
Public Reference Room, U.S. Securities
and Exchange Commission, 100 F
Street, NE., Room 1580, Washington, DC
20549, on official business days
between the hours of 10 a.m. and 3 p.m.,
or by calling Thomson Financial at (800)
638–8241. Electronic copies are
available on the Commission’s Web site.
The address for the Filer Manual is
https://www.sec.gov/info/edgar.shtml.
You can also photocopy the document
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Administration (NARA). For
information on the availability of this
material at NARA, call 202–741–6030,
or go to: https://www.archives.gov/
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ibr_locations.html.
Dated: August 15, 2007.
By the Commission.
Florence E. Harmon,
Deputy Secretary .
[FR Doc. E7–16414 Filed 8–20–07; 8:45 am]
BILLING CODE 8010–01–P
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.
rmajette on PROD1PC64 with RULES
ACTION:
Final rule.
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
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16:11 Aug 20, 2007
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accordance with 5 U.S.C. 552(a) and 1
CFR part 51 of certain publications in
§ 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: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: https://
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 email. 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 https://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 https://
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:
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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
§ 172.841 Polydextrose (21 CFR
172.841). Currently, § 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 § 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.
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Federal Register / Vol. 72, No. 161 / Tuesday, August 21, 2007 / Rules and Regulations
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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 § 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 § 172.841 be amended by
adopting the specifications for
polydextrose in FCC V. Currently,
§ 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
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15:05 Aug 20, 2007
Jkt 211001
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 § 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, § 172.841 should be amended
as set forth in this document. In
accordance with § 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
§ 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.
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46563
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.
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:
I
PART 172—FOOD ADDITIVES
PERMITTED FOR DIRECT ADDITION
TO FOOD FOR HUMAN
CONSUMPTION
1. The authority citation for 21 CFR
part 172 continues to read as follows:
I
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46564
Federal Register / Vol. 72, No. 161 / Tuesday, August 21, 2007 / Rules and Regulations
Authority: 21 U.S.C. 321, 341, 342, 348,
371, 379e.
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]
2. Section 172.841 is amended by
revising paragraphs (b) and (c) to read
as follows:
I
§ 172.841
BILLING CODE 4160–01–S
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 https://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: https://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.
*
*
*
*
*
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R09–OAR–2006–0526; FRL–8446–1]
Approval and Promulgation of
Implementation Plans; Arizona—
Phoenix PM–10 Nonattainment Area;
Salt River Area Plan for Attainment of
the 24-hour PM–10 Standard
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: EPA is finalizing approval
under the Clean Air Act (CAA) of
provisions of the Revised PM–10 State
Implementation Plan (SIP) for the Salt
River Area submitted by the State of
Arizona to EPA in October and
November 2005. These submittals
include adopted rules, resolutions and
measures that address particulate matter
(PM–10) emissions from fugitive dust
sources.
Effective Date: This rule is
effective on September 20, 2007.
ADDRESSES: EPA has established docket
number EPA–R09–OAR–2006–0526 for
this action. The index to the docket is
available electronically at
www.regulations.gov and in hard copy
DATES:
at EPA Region IX, 75 Hawthorne Street,
San Francisco, California. While all
documents in the docket are listed in
the index, some information may be
publicly available only at the hard copy
location (e.g., copyrighted material), and
some may not be publicly available in
either location (e.g., Confidential
Business Information). To inspect the
hard copy materials, please schedule an
appointment during normal business
hours with the contact listed in the FOR
FURTHER INFORMATION CONTACT section.
FOR FURTHER INFORMATION CONTACT: Mae
Wang, EPA Region IX, (415) 947–4124,
wang.mae@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document, ‘‘we,’’ ‘‘us’’
and ‘‘our’’ refer to EPA.
Table of Contents
I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Statutory and Executive Order Reviews
I. Proposed Action
On July 12, 2006 (71 FR 39251), EPA
proposed to approve the rules,
resolutions and measures listed below
into the Arizona PM–10 SIP pursuant to
the cited CAA sections. We also
proposed on July 12, 2006, to approve
Maricopa County Air Quality
Department (MCAQD) Rule 316,
‘‘Nonmetallic Mineral Processing,’’
adopted on June 8, 2005. In this final
rule we are approving all the items
listed below. EPA is not, however,
including Rule 316 in this final action
because we are re-evaluating the rule
and expect to address it in a separate
rulemaking.
TABLE I
Rule/measure/commitment
Relevant CAA section(s)
Maricopa County Air Quality Department (MCAQD) Rule 325, ‘‘Brick and Structural Clay Products (BSCP) Manufacturing,’’ adopted August 10, 2005.
MCAQD Rule 310, ‘‘Fugitive Dust,’’ adopted April 7, 2004 ............................................................
MCAQD Rule 310.01, ‘‘Fugitive Dust From Open Areas, Vacant Lots, Unpaved Parking Lots,
and Unpaved Roadways,’’ adopted February 17, 2005.
MCAQD Appendix C, ‘‘Fugitive Dust Test Methods,’’ adopted April 7, 2004 ................................
MCAQD Appendix F, ‘‘Soil Designations,’’ adopted April 7, 2004 .................................................
MCAQD ‘‘Application for Dust Control Permit,’’ adopted June 22, 2005 1 .....................................
MCAQD ‘Guidance for Application for Dust Control Permit,’’ adopted June 22, 2005 2 ................
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Maricopa County Board Resolution No. C–85–05–005–0–00, adopted January 19, 2005 ...........
City of Phoenix Resolution No. 20114, adopted June 16, 2004 ....................................................
Resolutions from 17 municipalities 3 and the Arizona Department of Transportation, adopted on
various dates.
189(b)(1)(B) and 188(e).
189(b) and 188(e) for subsections 304.5 and
502. 110(a) for other subsections.
110(a).
189(b) and 188(e) for subsection 3.3.2. 110(a)
for other subsections.
189(b) and 188(e).
189(b) and 188(e) for Section 2, subsections
10 and 11, and Section 3, subsection I.
110(a) for other subsections.
189(b) and 188(e) for Section 2, subsection 13,
and Section 3. 110(a) for other subsections.
189(b) for enforcement resource provisions of
Measures 1 through 4. 110(a) for other provisions, including Measure 5.
110(a).
110(a).
1 The
reference to an adoption date of July 1, 2005, in the proposed rule was a clerical error (71 FR at 39253).
footnote 1.
3 The reference to resolutions from 18 municipalities in the proposed rule was a clerical error (71 FR at 39253).
2 See
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]]>Agencies
[Federal Register Volume 72, Number 161 (Tuesday, August 21, 2007)]
[Rules and Regulations]
[Pages 46562-46564]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16322]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: https://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 https://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 https://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 https://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: https://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
