[Federal Register Volume 78, Number 235 (Friday, December 6, 2013)]
[Rules and Regulations]
[Pages 73434-73438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-29073]


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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.

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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: http://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 http://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 http://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).
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    \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)
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                                Maximum use level
   Food category (percent)          (percent)           Intended use
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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.
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    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).
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    \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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    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 http://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 http://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: http://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: 
http://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.
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    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