Food Additives Permitted for Direct Addition to Food for Human Consumption; Acacia (Gum Arabic), 73434-73438 [2013-29073]
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Order No.
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This directive is redundant with the directive in paragraph 1147, which has already been addressed and is reflected
in section A above.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Attachment B
Food and Drug Administration
Commenters on the Notice of Proposed
Rulemaking
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Note: Attachment B will not appear in the
Code of Federal Regulations.
21 CFR Part 172
The American Public Power
Association, Edison Electric Institute,
Electricity Consumers Resource
Council, Electric Power Supply
Association, Large Public Power
Council, and Transmission Access
Policy Group (collectively, Trade
Associations)
Canadian Electricity Association (CEA)
Dominion Resources Services, Inc., on
behalf of Virginia Electric and Power
Company, doing business as
Dominion Virginia Power; Dominion
Nuclear Connecticut, Inc.; Dominion
Energy Brayton Point, LLC; Dominion
Energy Manchester Street, Inc.;
Elwood Energy, LLC; Kincaid
Generation, LLC; and Fairless Energy,
LLC
International Transmission Company d/
b/a ITCTransmission, Michigan
Electric Transmission Company, LLC,
ITC Midwest LLC and ITC Great
Plains, LLC (ITC)
ISO/RTO Council
National Rural Electric Cooperative
Association (NRECA)
North American Electric Reliability
Corporation (NERC)
[Docket No. FDA–2011–F–0765]
[FR Doc. 2013–28516 Filed 12–5–13; 8:45 am]
Food Additives Permitted for Direct
Addition to Food for Human
Consumption; Acacia (Gum Arabic)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA or we) is
amending the food additive regulations
to provide for the expanded safe use of
acacia (gum arabic) in foods. This action
is in response to a petition filed by
Nexira.
SUMMARY:
This rule is effective December 6,
2013. See section IX of this document
for information on filing objections.
Submit either electronic or written
objections and requests for a hearing by
January 6, 2014. The Director of the
Office of the Federal Register approves
the incorporation by reference of a
certain publication listed in the rule as
of December 6, 2013.
ADDRESSES: You may submit either
electronic or written objections and
requests for a hearing identified by
Docket No. FDA–2011–F–0765, by any
of the following methods:
DATES:
Electronic Submissions
BILLING CODE 6717–01–P
Submit electronic objections in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
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This directive is redundant with the directive in paragraph 1147, which has already been addressed and is reflected
in section A above.
This directive is redundant with the directive in paragraph 1147, which has already been addressed and is reflected
in section A above.
Written Submissions
Submit written objections in the
following ways:
• Mail/Hand delivery/Courier (for
paper 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 No. FDA–2011–F–0765 for this
rulemaking. All objections received will
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
detailed instructions on submitting
objections, see the ‘‘Objections’’ heading
of the SUPPLEMENTARY INFORMATION
section.
Docket: For access to the docket to
read background documents or
objections received, go to https://
www.regulations.gov 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:
Ellen Anderson, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–1309.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal
Register on December 20, 2011 (76 FR
78866), we announced that Nexira, c/o
Keller and Heckman LLP, 1001 G St.
NW., suite 500 West, Washington, DC
20001 (petitioner) had filed a food
additive petition (FAP 1A4784). The
petition proposed to amend the food
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Federal Register / Vol. 78, No. 235 / Friday, December 6, 2013 / Rules and Regulations
additive regulations in § 172.780,
Acacia (gum arabic) (21 CFR 172.780) to
provide for the expanded safe use of
acacia (gum arabic) in food. Specifically,
the petition proposed to list the use of
acacia in § 172.780 as a source of dietary
fiber in the existing food categories
listed in § 184.1330(c) (21 CFR
184.1330(c)), excluding meat, poultry,
and foods for which standards of
identity have been issued under section
401 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
341), and as a source of dietary fiber and
as an emulsifier and emulsifier salt,
flavoring agent and adjuvant,
formulation aid, processing aid,
stabilizer and thickener, surfacefinishing agent, and texturizer in four
additional food categories (i.e., breakfast
cereals, certain baked products, grainbased bars, and soups). The petitioner
subsequently clarified that it only
proposed to list the use of acacia in
soups and soup mixes that are not
subject to regulation by the U.S.
Department of Agriculture (USDA)
under the Federal Meat Inspection Act
or the Poultry Products Inspection Act.
Under 21 CFR 171.1(c), paragraph H,
either a claim of categorical exclusion
under 21 CFR 25.30 or § 25.32 (21 CFR
25.32) or an environmental assessment
under 21 CFR 25.40 must be submitted
in a food additive petition. A claim of
categorical exclusion under § 25.32(k),
which applies to substances added
directly to food that are intended to
remain in food through ingestion by
consumers and that are not intended to
replace macronutrients in food, was
initially submitted with the petition. We
reviewed the claim of categorical
exclusion submitted by the petitioner
and stated in the original filing notice
(76 FR 78866) our determination that,
under § 25.32(k), the proposed action
was of a type that does not individually
or cumulatively have a significant effect
on the human environment, and
therefore, neither an environmental
assessment nor an environmental
impact statement is required. However,
upon further review of the petition, we
decided that the food additive may
replace macronutrients in food and,
therefore, the categorical exclusion in
§ 25.32(k) was not applicable for the
proposed action. Accordingly, in an
amended filing notice published in the
Federal Register of September 4, 2012
(77 FR 53801), we announced that the
petitioner had submitted an
environmental assessment for the
petition in lieu of the claim of
categorical exclusion, and that we
would review the potential
environmental impact of the petition.
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We placed the environmental
assessment on display in the Division of
Dockets Management for public review
and comment.
II. Introduction
A. Identity
Acacia is the dried gummy exudate
from the stems and branches of trees of
various species of the genus Acacia,
family Leguminosae. The precise
molecular structure of acacia is not
known, but it is generally depicted as a
group of compacted polysaccharide
bundles individually linked to a linear
proteinaceous core. The polysaccharide
is composed of the following: Larabinose, D-galactose, L-rhamnose, and
D-glucuronic acid and its 4–O methyl
derivative. The composition of acacia,
with respect to the proportion of sugars
and to the amino acids comprising the
proteins, varies depending on the
species of Acacia used to produce the
gum.
B. Regulated Food Uses
In the Federal Register of September
23, 1974 (39 FR 34203), we published a
proposed rule to affirm that the use of
acacia as a direct human food ingredient
is generally recognized as safe (GRAS),
with specific limitations. In the Federal
Register of December 7, 1976 (41 FR
53608), we issued a final rule based on
this proposal, amending the regulations
in then 21 CFR part 121 to affirm that
acacia as a direct human food ingredient
is GRAS with specific limitations. In the
Federal Register of March 15, 1977 (42
FR 14302 at 14653), acacia was
redesignated from § 121.104(g)(19) to
part 184 by adding § 184.1330 Acacia
(gum arabic). To ensure that acacia is
not added to the U.S. food supply at
levels that could raise safety concerns,
we affirmed acacia as GRAS with
specific limitations as listed in
§ 184.1330.
Under § 184.1330, acacia is affirmed
as GRAS for use in various specific food
categories at levels ranging from 1.3 to
85.0 percent. Use of acacia in all other
food categories was limited to not more
than 1.0 percent. Under § 184.1(b)(2) (21
CFR 184.1(b)(2)), an ingredient affirmed
as GRAS with specific limitations may
be used in food only within such
limitations, including the category of
food, functional use, and level of use.
Any addition of acacia to food beyond
those limitations set out in § 184.1330
requires either a food additive
regulation or an amendment of
§ 184.1330. Consistent with
§ 184.1(b)(2), a food additive petition
(FAP 1A4730) was filed in the Federal
Register on February 13, 2003 (68 FR
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73435
7381) to amend the food additive
regulations in part 172 (21 CFR part
172) to provide for the safe use of acacia
as a thickener, emulsifier, or stabilizer
in alcoholic beverages at a use level not
to exceed 20 percent in the final
beverage. In response to this petition,
we issued a final rule in the Federal
Register of February 17, 2005 (70 FR
8032), that added § 172.780 to provide
for this use.
III. Evaluation of Safety
Under the general safety standard in
section 409 of the FD&C 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. Our 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, we consider
the projected human dietary exposure to
the additive, the additive’s toxicological
data, and other available relevant
information (such as published
literature).
A. Proposed Uses, Exposure, and
Specifications
The petitioner proposes to use acacia
as a source of dietary fiber in those food
categories and at the use levels listed in
§ 184.1330(c), excluding meat and
poultry and foods for which standards
of identity have been issued under
section 401 of the FD&C Act. The
petitioner also proposes for acacia to be
used in several new food categories as
described in table 1.1 We evaluated the
exposure to acacia based on 2009
poundage data obtained from the
October 2010 Chemical Economics
Handbook report on hydrocolloid usage
in the United States (Acacia can be
classified as a hydrocolloid, which are
substances that form a gel with water
1 During our evaluation of this petition, we
consulted with the Food Safety and Inspection
Service (FSIS) of the USDA, consistent with 21 CFR
171.1(n) and with a memorandum of understanding
(MOU) between the two Agencies for reviewing the
safety of substances used in the production of meat
and poultry products. Under the MOU, FDA is
responsible for reviewing an ingredient’s safety, and
USDA/FSIS is responsible for evaluating suitability.
(MOU 225–00–2000; see also 65 FR 51758 at 51759,
August 25, 2000). However, during our consultation
with FSIS, the petitioner clarified that it did not
propose for acacia to be used in meat or poultry
products, including soups and soup mixes
containing meat or poultry products that are subject
to regulation by USDA under the Federal Meat
Inspection Act or the Poultry Products Inspection
Act.
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and are often used as thickeners,
stabilizers, or emulsifiers in food
applications.) We calculated the per
capita exposure of acacia to be 127
milligrams per person per day. Because
acacia may be used in a wide variety of
foods, the entire U.S. population could
consume at least one of the foods
containing acacia. Therefore, the use of
a per capita exposure assessment is
appropriate, as it represents the entire
U.S. population (Ref. 1).
TABLE 1—PROPOSED USES OF ACACIA THAT ARE BEYOND THOSE REGULATED UNDER § 184.1330(c)
Food category
(percent)
Maximum use level
(percent)
Breakfast cereals ....................................................................
6
Cakes, brownies, pastries, biscuits, muffins, and cookies .....
Grain-based bars (e.g., breakfast and snack bars, granola,
rice cereal bars).
Soups and soup mixes that are not subject to USDA regulation under the Federal Meat Inspection Act or the Poultry
Products Inspection Act.
3
35
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The current regulation for the use of
acacia as a thickener, emulsifier, or
stabilizer in alcoholic beverages
(§ 172.780) indicates that the additive
must meet the specifications in the Food
Chemicals Codex, 7th Edition (FCC 7).
The most current FCC is the 8th Edition
(FCC 8) and given that the specifications
for acacia in FCC 8 are identical to those
in FCC 7, we are amending § 172.780 by
adopting the specifications for acacia in
FCC 8 in place of FCC 7.
Additionally, on our own initiative,
we are amending § 172.780(b) to update
the address at which copies of FCC 8
may be examined. The existing
regulation refers to an FDA address at
‘‘5100 Paint Branch Pkwy., College Park,
MD 20740.’’ However, in 2013, we
consolidated our library holdings at our
main library at 10903 New Hampshire
Ave., Bldg. 2, 3d Floor, Silver Spring,
MD 20993. Therefore, we are amending
§ 172.780(b) to reflect the current FDA
address at which copies of FCC 8 may
be examined.
B. Safety Assessment
To support the safety of the proposed
expanded use of acacia, the petitioner
referenced toxicological studies and
other relevant information previously
reviewed by FDA (70 FR 8032). The
petitioner referenced data from a 1973
report on acacia by the Select
Committee on GRAS Substances; a 1982
National Toxicology Program report on
2-year carcinogenicity feeding studies;
literature searches performed in 1983,
1987, 1988, and 1992; and a 1990
evaluation of acacia by the Joint Food
and Agriculture Organization/World
Health Organization Expert Committee
on Food Additives (JECFA).
Of the publications submitted by the
petitioner, only two papers relevant to
the safety assessment of acacia had not
been previously reviewed by FDA. One
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2.5
Intended use
Source of dietary fiber; emulsifier and emulsifier salt; flavoring agent and adjuvant; formulation aid; processing
aid; stabilizer and thickener; surface-finishing agent;
texturizer.
Same as above.
Same as above.
Same as above.
publication was an extensive review of
the scientific literature available before
2004 and focused on the general safety
and allergenicity of acacia as used in
cosmetic products. The review
concluded that the available safety data
for acacia was sufficient to ensure its
safe use in cosmetics. The other
publication evaluated the digestive
tolerance of acacia in humans and its
possible role as a prebiotic fiber. The
publication claimed high doses of acacia
(>50 grams per day (g/d)) are generally
well tolerated based on reports of only
mild physiologic responses. We
reviewed both publications and concur
with the conclusions (Ref. 2).
The petitioner also presented a
literature review on acacia’s potential as
an allergen. We had previously
reviewed the allergenicity literature
through 1992 and concluded there was
no strong evidence that acacia is
allergenic in food. In reviewing the
current petition, we conducted another
search of literature spanning from 1992
through 2012. This recent search of the
literature did not find any published
articles directly addressing the
allergenicity or toxicity of acacia that
were not included in the petitioner’s
submission, nor did this search reveal
any new toxicological issues pertaining
to acacia 2 (Ref. 2).
In our safety evaluations, we have
chosen not to establish an acceptable
daily intake (ADI) for acacia due to
2 In March 2011, we received a report of a food
product containing acacia that tested positive for
peanut protein. After ruling out the possibility of
cross-contamination in the food production process,
FDA investigations concluded that no peanut
protein was present and that the positive findings
were probably due to the presence of cross-reactive
proteins. Although we do not view this as a food
safety issue, the possibility for false positives may
indicate a problem with the current analytical tests
used to monitor allergens in acacia-containing
foods.
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convincing evidence that acacia is noncarcinogenic and poorly absorbed, and
that mild physiologic responses were
reported in humans only when acacia
was ingested at high doses (>50 g/d)
(Ref. 2). Furthermore, JECFA has
confirmed a ‘‘not specified’’ ADI for
acacia when it is used in accordance
with good manufacturing practices.
Based on our review of the safety data
and estimated dietary exposure to acacia
from current and proposed food uses,
we conclude that the proposed
expanded use of acacia in foods is safe.
IV. Labeling
Under section 403(a) of the FD&C Act
(21 U.S.C. 343), a food is misbranded if
its labeling is false or misleading in any
particular. Section 403(q)(1)(D) of the
FD&C Act specifies that certain
nutrients and their amounts, including
dietary fiber, must be included on the
label or in labeling. Similarly, section
403(r) of the FD&C Act lays out the
statutory framework for the use of
labeling claims that characterize the
level of a nutrient in a food (e.g., ‘‘high
in fiber’’) or that characterize the
relationship of a nutrient to a disease or
health-related condition. The petitioner
cited reports and published studies to
support the recognition of acacia as a
source of dietary fiber. We concur that
acacia supplies dietary fiber. In
accordance with 21 CFR 101.9(g)(2), for
food labeling compliance purposes,
appropriate methods cited in Official
Methods of Analysis of the AOAC
International, 15th edition (e.g., AOAC
985.29) would be used for measuring
the amount of dietary fiber in a food.
Furthermore, if products containing
acacia bear any health and/or nutrient
content claims on the label or in
labeling, such claims must be in
compliance with current labeling
regulations.
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V. Conclusion
Based on the data and information in
the petition and other relevant material,
we conclude that the proposed uses of
acacia in food are safe. Therefore, we are
amending the regulations in part 172 as
set forth in this document.
VI. Public Disclosure
In accordance with § 171.1(h) (21 CFR
171.1(h)), the petition and the
documents that we considered and
relied upon in reaching our decision to
approve the petition will be made
available for public disclosure (see FOR
FURTHER INFORMATION CONTACT). As
provided in § 171.1(h), we will delete
from the documents any materials that
are not available for public disclosure.
VII. Environmental Impact
We have carefully considered the
potential environmental effects of this
action. We have concluded that the
action will not have a significant impact
on the human environment, and that an
environmental impact statement is not
required. Our 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.
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VIII. 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.
IX. Objections
If you will be adversely affected by
one or more provisions of this
regulation, you may file with the
Division of Dockets Management (see
ADDRESSES) either electronic or written
objections. You must separately number
each objection, and within each
numbered objection you must specify
with particularity the provision(s) to
which you object, and the grounds for
your objection. Within each numbered
objection, you must specifically state
whether you are requesting a hearing on
the particular provision that you specify
in that numbered objection. If you do
not request a hearing for any particular
objection, you waive the right to a
hearing on that objection. If you request
a hearing, your objection must include
a detailed description and analysis of
the specific factual information you
intend to present in support of the
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objection in the event that a hearing is
held. If you do not include such a
description and analysis for any
particular objection, you waive the right
to a hearing on the objection.
It is only necessary to send one set of
documents. Identify documents 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, and
will be posted to the docket at https://
www.regulations.gov.
X. Section 301(ll) of the FD&C Act
Our review of this petition was
limited to section 409 of the FD&C Act.
This final rule is not a statement
regarding compliance with other
sections of the FD&C Act. For example,
the Food and Drug Administration
Amendments Act of 2007, which was
signed into law on September 27, 2007,
amended the FD&C Act to, among other
things, add section 301(ll) of the FD&C
Act (21 U.S.C. 331(ll)). Section 301(ll) of
the FD&C Act prohibits the introduction
or delivery for introduction into
interstate commerce of any food that
contains a drug approved under section
505 of the FD&C Act (21 U.S.C. 355), a
biological product licensed under
section 351 of the Public Health Service
Act (42 U.S.C. 262), or a drug or
biological product for which substantial
clinical investigations have been
instituted and their existence has been
made public, unless one of the
exemptions in section 301(ll)(1) to (ll)(4)
of the FD&C Act applies. In our review
of this petition, we did not consider
whether section 301(ll) of the FD&C Act
or any of its exemptions apply to food
containing this additive. Accordingly,
this final rule should not be construed
to be a statement that a food containing
this additive, if introduced or delivered
for introduction into interstate
commerce, would not violate section
301(ll) of the FD&C Act. Furthermore,
this language is included in all food
additive final rules and therefore should
not be construed to be a statement of the
likelihood that section 301(ll) of the
FD&C Act applies.
XI. 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, and are available
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electronically at https://
www.regulations.gov.
1. Memorandum from D. Doell, Chemistry
Review Team, CFSAN, FDA, to E.
Anderson, Regulatory Review Team II,
CFSAN, FDA, November 20, 2012.
2. Memorandum from T. Thurmond,
Toxicology Review Team, CFSAN, FDA,
to E. Anderson, Regulatory Team II,
CFSAN, FDA, January 17, 2013.
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:
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:
■
Authority: 21 U.S.C. 321, 341, 342, 348,
371, 379e.
2. In § 172.780, revise paragraphs (b)
and (c) to read as follows:
■
§ 172.780
Acacia (gum arabic).
*
*
*
*
*
(b) The ingredient meets the
specifications of the Food Chemicals
Codex, 8th ed. (2012), p. 516, which is
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 copies
from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address:
https://www.usp.org). Copies may be
examined at the Food and Drug
Administration’s Main Library, 10903
New Hampshire Ave., Bldg. 2, 3d Floor,
Silver Spring, MD 20993, 301–796–
2039, 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) The ingredient is used in food in
accordance with good manufacturing
practices under the following
conditions:
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MAXIMUM USAGE LEVELS PERMITTED
Food (as served)
Percent
Function
Beverages, alcoholic .........................................................
Breakfast cereals, § 170.3(n)(4) of this chapter ...............
20.0 ....................................
6.0 ......................................
Cakes, brownies, pastries, biscuits, muffins, and cookies
Grain-based bars (e.g., breakfast bars, granola bars,
rice cereal bars).
Soups and soup mixes, § 170.3(n)(40) of this chapter,
except for soups and soup mixes containing meat or
poultry that are subject to regulation by the U.S. Department of Agriculture under the Federal Meat Inspection Act or the Poultry Products Inspection Act.
Food categories listed in § 184.1330 of this chapter, except for meat, poultry, and foods for which standards
of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act preclude the use
of acacia.
3.0 ......................................
35.0 ....................................
Thickener, emulsifier, or stabilizer.
Dietary fiber; emulsifier and emulsifier salt; flavoring
agent and adjuvant; formulation aid; processing aid;
stabilizer and thickener; surface-finishing agent;
texturizer.
Do.
Do.
Dated: December 2, 2013.
Susan M. Bernard,
Director, Office of Regulations, Policy and
Social Sciences, Center for Food Safety and
Applied Nutrition.
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Parts 3, 100, and 165
[Docket No. USCG–2013–0251]
RIN 1625–ZA32
Reorganization of Sector Baltimore
and Hampton Roads; Conforming
Amendments
Coast Guard, DHS.
Final rule.
AGENCY:
The Coast Guard is amending
the Code of Federal Regulations (CFR) to
reflect changes it has made to the
boundaries of Sector Baltimore’s and
Sector Hampton Roads’ Marine
Inspection Zone and Captain of the Port
Zones. These conforming amendments
are necessary to ensure the CFR
accurately reflects these boundary
changes that were made November 22,
2013. These amendments are not
expected to have a substantive impact
on the public.
DATES: This rule is effective December 6,
2013.
ADDRESSES: Materials mentioned in this
preamble as being available in the
docket are part of docket [USCG–2013–
0251] and are available for inspection or
copying at the Docket Management
maindgalligan on DSK5TPTVN1PROD with RULES
16:51 Dec 05, 2013
Dietary fiber.
Table of Acronyms
SUMMARY:
VerDate Mar<15>2010
Levels prescribed in
§ 184.1330 of this chapter.
Do.
Facility (M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
You may also find this docket, USCG–
2013–0251, online at https://
www.regulations.gov. The following link
will take you directly to the docket:
https://www.regulations.gov/
#!docketDetail;D=USCG-2013-0251.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
email Mr. Troy Luna, Fifth Coast Guard
District, Coast Guard; telephone 757–
398–7766, email Troy.T.Luna@uscg.mil.
If you have questions on viewing the
docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone
202–366–9826.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2013–29073 Filed 12–5–13; 8:45 am]
ACTION:
2.5 ......................................
Jkt 232001
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
§ Section
U.S.C. United States Code
A. Regulatory History
We did not publish a notice of
proposed rulemaking (NPRM) before
this final rule. The Coast Guard finds
that this rule is exempt from notice and
comment rulemaking requirements
under 5 U.S.C. 553(b)(A) because the
changes it makes are conforming
amendments involving agency
organization. The Coast Guard also finds
good cause exists under 5 U.S.C.
553(b)(B) for not publishing an NPRM
because the changes will have no
substantive effect on the public, and
notice and comment are therefore
PO 00000
Frm 00060
Fmt 4700
Sfmt 4700
unnecessary. For the same reasons, the
Coast Guard finds good cause under 5
U.S.C. 553(d)(3) to make the rule
effective fewer than 30 days after
publication in the Federal Register.
B. Basis and Purpose
On November 22, 2013, the Coast
Guard reassigned Station Ocean City 1
to Sector Baltimore and redefined the
boundary lines separating Sector
Baltimore and Sector Hampton Roads.
See Operating Facility Change Order
(OFCO) No. 024–13 Change One which
is available in the docket for this rule.
Under 14 U.S.C. 93, the Commandant of
the Coast Guard has authority to change
the location of Coast Guard shore
establishments. The previous
organization of Sector Baltimore and
Sector Hampton Roads is described and
reflected in regulations, which also
contain contact details and other
references to Sector Baltimore and
Hampton Roads. These conforming
amendments update those regulations
so that they contain current information.
C. Background
During 2011, Sector Baltimore
requested that the Coast Guard Fifth
District examine the feasibility of
shifting Operational Control of Ocean
City and Worcester County, Maryland
from Sector Hampton Roads to Sector
Baltimore. The analysis reviewed
potential workload increases to offshore
Search and Rescue, and increased
activities for Prevention, Response and
Logistics Departments at Sector
Baltimore.
The Coast Guard has approved the
shift of Ocean City and Worcester
County, Maryland Operational Control
to Sector Baltimore. This move is
intended to improve field-level
E:\FR\FM\06DER1.SGM
06DER1
Agencies
[Federal Register Volume 78, Number 235 (Friday, December 6, 2013)]
[Rules and Regulations]
[Pages 73434-73438]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29073]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA-2011-F-0765]
Food Additives Permitted for Direct Addition to Food for Human
Consumption; Acacia (Gum Arabic)
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
food additive regulations to provide for the expanded safe use of
acacia (gum arabic) in foods. This action is in response to a petition
filed by Nexira.
DATES: This rule is effective December 6, 2013. See section IX of this
document for information on filing objections. Submit either electronic
or written objections and requests for a hearing by January 6, 2014.
The Director of the Office of the Federal Register approves the
incorporation by reference of a certain publication listed in the rule
as of December 6, 2013.
ADDRESSES: You may submit either electronic or written objections and
requests for a hearing identified by Docket No. FDA-2011-F-0765, by any
of the following methods:
Electronic Submissions
Submit electronic objections in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written objections in the following ways:
Mail/Hand delivery/Courier (for paper 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 No. FDA-2011-F-0765 for this rulemaking. All objections
received will be posted without change to https://www.regulations.gov,
including any personal information provided. For detailed instructions
on submitting objections, see the ``Objections'' heading of the
SUPPLEMENTARY INFORMATION section.
Docket: For access to the docket to read background documents or
objections received, go to https://www.regulations.gov 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: Ellen Anderson, Center for Food Safety
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-1309.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register on December 20, 2011
(76 FR 78866), we announced that Nexira, c/o Keller and Heckman LLP,
1001 G St. NW., suite 500 West, Washington, DC 20001 (petitioner) had
filed a food additive petition (FAP 1A4784). The petition proposed to
amend the food
[[Page 73435]]
additive regulations in Sec. 172.780, Acacia (gum arabic) (21 CFR
172.780) to provide for the expanded safe use of acacia (gum arabic) in
food. Specifically, the petition proposed to list the use of acacia in
Sec. 172.780 as a source of dietary fiber in the existing food
categories listed in Sec. 184.1330(c) (21 CFR 184.1330(c)), excluding
meat, poultry, and foods for which standards of identity have been
issued under section 401 of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 341), and as a source of dietary fiber and as
an emulsifier and emulsifier salt, flavoring agent and adjuvant,
formulation aid, processing aid, stabilizer and thickener, surface-
finishing agent, and texturizer in four additional food categories
(i.e., breakfast cereals, certain baked products, grain-based bars, and
soups). The petitioner subsequently clarified that it only proposed to
list the use of acacia in soups and soup mixes that are not subject to
regulation by the U.S. Department of Agriculture (USDA) under the
Federal Meat Inspection Act or the Poultry Products Inspection Act.
Under 21 CFR 171.1(c), paragraph H, either a claim of categorical
exclusion under 21 CFR 25.30 or Sec. 25.32 (21 CFR 25.32) or an
environmental assessment under 21 CFR 25.40 must be submitted in a food
additive petition. A claim of categorical exclusion under Sec.
25.32(k), which applies to substances added directly to food that are
intended to remain in food through ingestion by consumers and that are
not intended to replace macronutrients in food, was initially submitted
with the petition. We reviewed the claim of categorical exclusion
submitted by the petitioner and stated in the original filing notice
(76 FR 78866) our determination that, under Sec. 25.32(k), the
proposed action was of a type that does not individually or
cumulatively have a significant effect on the human environment, and
therefore, neither an environmental assessment nor an environmental
impact statement is required. However, upon further review of the
petition, we decided that the food additive may replace macronutrients
in food and, therefore, the categorical exclusion in Sec. 25.32(k) was
not applicable for the proposed action. Accordingly, in an amended
filing notice published in the Federal Register of September 4, 2012
(77 FR 53801), we announced that the petitioner had submitted an
environmental assessment for the petition in lieu of the claim of
categorical exclusion, and that we would review the potential
environmental impact of the petition. We placed the environmental
assessment on display in the Division of Dockets Management for public
review and comment.
II. Introduction
A. Identity
Acacia is the dried gummy exudate from the stems and branches of
trees of various species of the genus Acacia, family Leguminosae. The
precise molecular structure of acacia is not known, but it is generally
depicted as a group of compacted polysaccharide bundles individually
linked to a linear proteinaceous core. The polysaccharide is composed
of the following: L-arabinose, D-galactose, L-rhamnose, and D-
glucuronic acid and its 4-O methyl derivative. The composition of
acacia, with respect to the proportion of sugars and to the amino acids
comprising the proteins, varies depending on the species of Acacia used
to produce the gum.
B. Regulated Food Uses
In the Federal Register of September 23, 1974 (39 FR 34203), we
published a proposed rule to affirm that the use of acacia as a direct
human food ingredient is generally recognized as safe (GRAS), with
specific limitations. In the Federal Register of December 7, 1976 (41
FR 53608), we issued a final rule based on this proposal, amending the
regulations in then 21 CFR part 121 to affirm that acacia as a direct
human food ingredient is GRAS with specific limitations. In the Federal
Register of March 15, 1977 (42 FR 14302 at 14653), acacia was
redesignated from Sec. 121.104(g)(19) to part 184 by adding Sec.
184.1330 Acacia (gum arabic). To ensure that acacia is not added to the
U.S. food supply at levels that could raise safety concerns, we
affirmed acacia as GRAS with specific limitations as listed in Sec.
184.1330.
Under Sec. 184.1330, acacia is affirmed as GRAS for use in various
specific food categories at levels ranging from 1.3 to 85.0 percent.
Use of acacia in all other food categories was limited to not more than
1.0 percent. Under Sec. 184.1(b)(2) (21 CFR 184.1(b)(2)), an
ingredient affirmed as GRAS with specific limitations may be used in
food only within such limitations, including the category of food,
functional use, and level of use. Any addition of acacia to food beyond
those limitations set out in Sec. 184.1330 requires either a food
additive regulation or an amendment of Sec. 184.1330. Consistent with
Sec. 184.1(b)(2), a food additive petition (FAP 1A4730) was filed in
the Federal Register on February 13, 2003 (68 FR 7381) to amend the
food additive regulations in part 172 (21 CFR part 172) to provide for
the safe use of acacia as a thickener, emulsifier, or stabilizer in
alcoholic beverages at a use level not to exceed 20 percent in the
final beverage. In response to this petition, we issued a final rule in
the Federal Register of February 17, 2005 (70 FR 8032), that added
Sec. 172.780 to provide for this use.
III. Evaluation of Safety
Under the general safety standard in section 409 of the FD&C 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. Our 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, we consider the projected human dietary exposure to
the additive, the additive's toxicological data, and other available
relevant information (such as published literature).
A. Proposed Uses, Exposure, and Specifications
The petitioner proposes to use acacia as a source of dietary fiber
in those food categories and at the use levels listed in Sec.
184.1330(c), excluding meat and poultry and foods for which standards
of identity have been issued under section 401 of the FD&C Act. The
petitioner also proposes for acacia to be used in several new food
categories as described in table 1.\1\ We evaluated the exposure to
acacia based on 2009 poundage data obtained from the October 2010
Chemical Economics Handbook report on hydrocolloid usage in the United
States (Acacia can be classified as a hydrocolloid, which are
substances that form a gel with water
[[Page 73436]]
and are often used as thickeners, stabilizers, or emulsifiers in food
applications.) We calculated the per capita exposure of acacia to be
127 milligrams per person per day. Because acacia may be used in a wide
variety of foods, the entire U.S. population could consume at least one
of the foods containing acacia. Therefore, the use of a per capita
exposure assessment is appropriate, as it represents the entire U.S.
population (Ref. 1).
---------------------------------------------------------------------------
\1\ During our evaluation of this petition, we consulted with
the Food Safety and Inspection Service (FSIS) of the USDA,
consistent with 21 CFR 171.1(n) and with a memorandum of
understanding (MOU) between the two Agencies for reviewing the
safety of substances used in the production of meat and poultry
products. Under the MOU, FDA is responsible for reviewing an
ingredient's safety, and USDA/FSIS is responsible for evaluating
suitability. (MOU 225-00-2000; see also 65 FR 51758 at 51759, August
25, 2000). However, during our consultation with FSIS, the
petitioner clarified that it did not propose for acacia to be used
in meat or poultry products, including soups and soup mixes
containing meat or poultry products that are subject to regulation
by USDA under the Federal Meat Inspection Act or the Poultry
Products Inspection Act.
Table 1--Proposed Uses of Acacia That Are Beyond Those Regulated Under
Sec. 184.1330(c)
------------------------------------------------------------------------
Maximum use level
Food category (percent) (percent) Intended use
------------------------------------------------------------------------
Breakfast cereals............ 6 Source of dietary
fiber; emulsifier
and emulsifier salt;
flavoring agent and
adjuvant;
formulation aid;
processing aid;
stabilizer and
thickener; surface-
finishing agent;
texturizer.
Cakes, brownies, pastries, 3 Same as above.
biscuits, muffins, and
cookies.
Grain-based bars (e.g., 35 Same as above.
breakfast and snack bars,
granola, rice cereal bars).
Soups and soup mixes that are 2.5 Same as above.
not subject to USDA
regulation under the Federal
Meat Inspection Act or the
Poultry Products Inspection
Act.
------------------------------------------------------------------------
The current regulation for the use of acacia as a thickener,
emulsifier, or stabilizer in alcoholic beverages (Sec. 172.780)
indicates that the additive must meet the specifications in the Food
Chemicals Codex, 7th Edition (FCC 7). The most current FCC is the 8th
Edition (FCC 8) and given that the specifications for acacia in FCC 8
are identical to those in FCC 7, we are amending Sec. 172.780 by
adopting the specifications for acacia in FCC 8 in place of FCC 7.
Additionally, on our own initiative, we are amending Sec.
172.780(b) to update the address at which copies of FCC 8 may be
examined. The existing regulation refers to an FDA address at ``5100
Paint Branch Pkwy., College Park, MD 20740.'' However, in 2013, we
consolidated our library holdings at our main library at 10903 New
Hampshire Ave., Bldg. 2, 3d Floor, Silver Spring, MD 20993. Therefore,
we are amending Sec. 172.780(b) to reflect the current FDA address at
which copies of FCC 8 may be examined.
B. Safety Assessment
To support the safety of the proposed expanded use of acacia, the
petitioner referenced toxicological studies and other relevant
information previously reviewed by FDA (70 FR 8032). The petitioner
referenced data from a 1973 report on acacia by the Select Committee on
GRAS Substances; a 1982 National Toxicology Program report on 2-year
carcinogenicity feeding studies; literature searches performed in 1983,
1987, 1988, and 1992; and a 1990 evaluation of acacia by the Joint Food
and Agriculture Organization/World Health Organization Expert Committee
on Food Additives (JECFA).
Of the publications submitted by the petitioner, only two papers
relevant to the safety assessment of acacia had not been previously
reviewed by FDA. One publication was an extensive review of the
scientific literature available before 2004 and focused on the general
safety and allergenicity of acacia as used in cosmetic products. The
review concluded that the available safety data for acacia was
sufficient to ensure its safe use in cosmetics. The other publication
evaluated the digestive tolerance of acacia in humans and its possible
role as a prebiotic fiber. The publication claimed high doses of acacia
(>50 grams per day (g/d)) are generally well tolerated based on reports
of only mild physiologic responses. We reviewed both publications and
concur with the conclusions (Ref. 2).
The petitioner also presented a literature review on acacia's
potential as an allergen. We had previously reviewed the allergenicity
literature through 1992 and concluded there was no strong evidence that
acacia is allergenic in food. In reviewing the current petition, we
conducted another search of literature spanning from 1992 through 2012.
This recent search of the literature did not find any published
articles directly addressing the allergenicity or toxicity of acacia
that were not included in the petitioner's submission, nor did this
search reveal any new toxicological issues pertaining to acacia \2\
(Ref. 2).
---------------------------------------------------------------------------
\2\ In March 2011, we received a report of a food product
containing acacia that tested positive for peanut protein. After
ruling out the possibility of cross-contamination in the food
production process, FDA investigations concluded that no peanut
protein was present and that the positive findings were probably due
to the presence of cross-reactive proteins. Although we do not view
this as a food safety issue, the possibility for false positives may
indicate a problem with the current analytical tests used to monitor
allergens in acacia-containing foods.
---------------------------------------------------------------------------
In our safety evaluations, we have chosen not to establish an
acceptable daily intake (ADI) for acacia due to convincing evidence
that acacia is non-carcinogenic and poorly absorbed, and that mild
physiologic responses were reported in humans only when acacia was
ingested at high doses (>50 g/d) (Ref. 2). Furthermore, JECFA has
confirmed a ``not specified'' ADI for acacia when it is used in
accordance with good manufacturing practices.
Based on our review of the safety data and estimated dietary
exposure to acacia from current and proposed food uses, we conclude
that the proposed expanded use of acacia in foods is safe.
IV. Labeling
Under section 403(a) of the FD&C Act (21 U.S.C. 343), a food is
misbranded if its labeling is false or misleading in any particular.
Section 403(q)(1)(D) of the FD&C Act specifies that certain nutrients
and their amounts, including dietary fiber, must be included on the
label or in labeling. Similarly, section 403(r) of the FD&C Act lays
out the statutory framework for the use of labeling claims that
characterize the level of a nutrient in a food (e.g., ``high in
fiber'') or that characterize the relationship of a nutrient to a
disease or health-related condition. The petitioner cited reports and
published studies to support the recognition of acacia as a source of
dietary fiber. We concur that acacia supplies dietary fiber. In
accordance with 21 CFR 101.9(g)(2), for food labeling compliance
purposes, appropriate methods cited in Official Methods of Analysis of
the AOAC International, 15th edition (e.g., AOAC 985.29) would be used
for measuring the amount of dietary fiber in a food. Furthermore, if
products containing acacia bear any health and/or nutrient content
claims on the label or in labeling, such claims must be in compliance
with current labeling regulations.
[[Page 73437]]
V. Conclusion
Based on the data and information in the petition and other
relevant material, we conclude that the proposed uses of acacia in food
are safe. Therefore, we are amending the regulations in part 172 as set
forth in this document.
VI. Public Disclosure
In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition
and the documents that we considered and relied upon in reaching our
decision to approve the petition will be made available for public
disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in Sec.
171.1(h), we will delete from the documents any materials that are not
available for public disclosure.
VII. Environmental Impact
We have carefully considered the potential environmental effects of
this action. We have concluded that the action will not have a
significant impact on the human environment, and that an environmental
impact statement is not required. Our 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.
VIII. 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.
IX. Objections
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Division of Dockets Management (see
ADDRESSES) either electronic or written objections. You must separately
number each objection, and within each numbered objection you must
specify with particularity the provision(s) to which you object, and
the grounds for your objection. Within each numbered objection, you
must specifically state whether you are requesting a hearing on the
particular provision that you specify in that numbered objection. If
you do not request a hearing for any particular objection, you waive
the right to a hearing on that objection. If you request a hearing,
your objection must include a detailed description and analysis of the
specific factual information you intend to present in support of the
objection in the event that a hearing is held. If you do not include
such a description and analysis for any particular objection, you waive
the right to a hearing on the objection.
It is only necessary to send one set of documents. Identify
documents 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, and will be posted to the docket at https://www.regulations.gov.
X. Section 301(ll) of the FD&C Act
Our review of this petition was limited to section 409 of the FD&C
Act. This final rule is not a statement regarding compliance with other
sections of the FD&C Act. For example, the Food and Drug Administration
Amendments Act of 2007, which was signed into law on September 27,
2007, amended the FD&C Act to, among other things, add section 301(ll)
of the FD&C Act (21 U.S.C. 331(ll)). Section 301(ll) of the FD&C Act
prohibits the introduction or delivery for introduction into interstate
commerce of any food that contains a drug approved under section 505 of
the FD&C Act (21 U.S.C. 355), a biological product licensed under
section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug
or biological product for which substantial clinical investigations
have been instituted and their existence has been made public, unless
one of the exemptions in section 301(ll)(1) to (ll)(4) of the FD&C Act
applies. In our review of this petition, we did not consider whether
section 301(ll) of the FD&C Act or any of its exemptions apply to food
containing this additive. Accordingly, this final rule should not be
construed to be a statement that a food containing this additive, if
introduced or delivered for introduction into interstate commerce,
would not violate section 301(ll) of the FD&C Act. Furthermore, this
language is included in all food additive final rules and therefore
should not be construed to be a statement of the likelihood that
section 301(ll) of the FD&C Act applies.
XI. 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,
and are available electronically at https://www.regulations.gov.
1. Memorandum from D. Doell, Chemistry Review Team, CFSAN, FDA, to
E. Anderson, Regulatory Review Team II, CFSAN, FDA, November 20,
2012.
2. Memorandum from T. Thurmond, Toxicology Review Team, CFSAN, FDA,
to E. Anderson, Regulatory Team II, CFSAN, FDA, January 17, 2013.
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:
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:
Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.
0
2. In Sec. 172.780, revise paragraphs (b) and (c) to read as follows:
Sec. 172.780 Acacia (gum arabic).
* * * * *
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 8th ed. (2012), p. 516, which is 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 copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet
address: https://www.usp.org). Copies may be examined at the Food and
Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2,
3d Floor, Silver Spring, MD 20993, 301-796-2039, 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) The ingredient is used in food in accordance with good
manufacturing practices under the following conditions:
[[Page 73438]]
Maximum Usage Levels Permitted
------------------------------------------------------------------------
Food (as served) Percent Function
------------------------------------------------------------------------
Beverages, alcoholic.......... 20.0............. Thickener,
emulsifier, or
stabilizer.
Breakfast cereals, Sec. 6.0.............. Dietary fiber;
170.3(n)(4) of this chapter. emulsifier and
emulsifier salt;
flavoring agent and
adjuvant;
formulation aid;
processing aid;
stabilizer and
thickener; surface-
finishing agent;
texturizer.
Cakes, brownies, pastries, 3.0.............. Do.
biscuits, muffins, and
cookies.
Grain-based bars (e.g., 35.0............. Do.
breakfast bars, granola bars,
rice cereal bars).
Soups and soup mixes, Sec. 2.5.............. Do.
170.3(n)(40) of this chapter,
except for soups and soup
mixes containing meat or
poultry that are subject to
regulation by the U.S.
Department of Agriculture
under the Federal Meat
Inspection Act or the Poultry
Products Inspection Act.
Food categories listed in Sec. Levels prescribed Dietary fiber.
184.1330 of this chapter, in Sec.
except for meat, poultry, and 184.1330 of this
foods for which standards of chapter.
identity established under
section 401 of the Federal
Food, Drug, and Cosmetic Act
preclude the use of acacia.
------------------------------------------------------------------------
Dated: December 2, 2013.
Susan M. Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2013-29073 Filed 12-5-13; 8:45 am]
BILLING CODE 4160-01-P