[Federal Register Volume 70, Number 32 (Thursday, February 17, 2005)]
[Rules and Regulations]
[Pages 8032-8034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-3026]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 2003F-0023]


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) is amending the food 
additive regulations to provide for the safe use of acacia (gum arabic) 
as a thickener, emulsifier, or stabilizer in alcoholic beverages at a 
maximum use level of 20 percent. This action is in response to a 
petition filed by Kerry, Inc.

DATES: This rule is effective February 17, 2005. Submit written 
objections and requests for a hearing by March 21, 2005. 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 21 CFR 172.780 as of February 17, 2005.

ADDRESSES: You may submit written objections and requests for a 
hearing, identified by Docket No. 2003F-0023, by any of the following 
methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
     E-mail: [email protected]. Include Docket No. 2003F-
0023 in the subject line of your e-mail message.
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and docket number for this rulemaking. All objections received will be 
posted without change to http://www.fda.gov/ohrms/dockets/default.htm, 
including any personal information provided. For detailed instructions 
on submitting objections, see the ``Objections'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mical Honigfort, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1278.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Introduction
    A. Identity
    B. Regulated Food Uses
III. Safety Evaluation
    A. Proposed Use and Exposure
    B. Safety Assessment
IV. Conclusions
V. Environmental Impact
VI. Paperwork Reduction Act of 1995
VII. References
VIII. Objections

I. Background

    The petition was initially filed as a generally recognized as safe 
(GRAS) affirmation petition (GRASP 3G0287) as announced in a notice 
published in the Federal Register on October 13, 1983 (48 FR 46626). 
The GRAS affirmation petition was filed by Beatrice Foods Co. (now 
Kerry, Inc.) and proposed to amend part 184 (21 CFR part 184) in Sec.  
184.1330 Acacia (gum arabic) to permit the use of gum acacia (arabic) 
in alcoholic beverages up to a maximum level of 20 percent in the 
finished preparation (liqueur).
    In a letter dated September 21, 2000, Kerry, Inc., requested that 
FDA convert the filed GRAS affirmation petition to a GRAS notice in 
accordance with the agency's proposed rule for Substances Generally 
Recognized as Safe published April 17, 1997 (62 FR 18938). Consistent 
with this request, FDA converted the GRAS affirmation petition to GRAS 
Notice No. GRN 000058. In its evaluation of this GRAS notice (Ref. 1), 
the agency considered that Sec.  184.1(b)(2) was established at the 
same time that the GRAS status of some uses of acacia were affirmed and 
that the limitations in Sec.  184.1(b)(2) were intended to apply to the 
GRAS listing for acacia. According to Sec.  184.1(b)(2), if an 
ingredient is affirmed as GRAS with specific limitations on the 
conditions of use, any use of the ingredient not in full compliance 
with the limitations requires a food additive regulation. Given the 
options discussed in the agency response letter to GRN 000058 (Ref. 1), 
Kerry, Inc., requested in a letter dated September 6, 2001, that FDA 
convert GRN 000058 to a food additive petition.
    In a notice published in the Federal Register on February 13, 2003 
(68 FR 7381), FDA announced that a food additive petition (FAP 1A4730) 
had been filed by Kerry, Inc., c/o Bell, Boyd, and Lloyd, LLC, Three 
First National Plaza, 70 West Madison St., suite 3300, Chicago, IL 
60602-4207. The petition proposes to amend the food additive 
regulations in part 172 (21 CFR part 172) to provide for the safe use 
of acacia (gum arabic) as a thickener, emulsifier, or stabilizer in the 
manufacture of

[[Page 8033]]

creamers for use in alcoholic beverages at a maximum use level of 20 
percent.

II. Introduction

A. Identity

    Acacia is the dried gummy exudate from stems and branches of trees 
of various species of the genus Acacia, family Leguminosae. Numerous 
species have been attributed to this genus. Most of the acacia used in 
the United States is obtained from Acacia senegal. The gum consists of 
the calcium, magnesium, and potassium salts of arabic acid, a 
polysaccharide acid. The polysaccharide is a sugar polymer that is 
composed of L-arabinose, D-galactose, L-rhamnose, and D-glucuronic 
acid. The relative proportions of the sugars differ among different 
species of acacia.

B. Regulated Food Uses

    In the Federal Register of September 23, 1974 (39 FR 34203), FDA 
published a proposed rule to affirm that the use of acacia as a direct 
human food ingredient is GRAS, with specific limitations. In the 
Federal Register of December 7, 1976 (41 FR 53608), FDA issued a final 
rule based on this proposal, amending the regulations in part 121 (21 
CFR part 121) to affirm that acacia (gum arabic) is GRAS. In the 
Federal Register of March 15, 1977 (42 FR 14302 at 14653), acacia (gum 
arabic) was redesignated from Sec.  121.104(g)(19) to part 184 by 
adding Sec.  184.1330 Acacia (gum arabic). 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, including alcoholic beverages, is currently limited to 
not more than 1.0 percent.
    The petitioner in this proceeding has requested the approval of the 
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.

III. Safety Evaluation

    In order to establish, with reasonable certainty, that a new food 
additive is not harmful under its intended conditions of use, FDA 
considers the projected human dietary exposure to the additive, the 
additive's toxicological data, and other relevant information available 
to the agency.

A. Proposed Use and Exposure

    The petitioner proposes to use acacia in alcoholic beverages where 
a creamy consistency was desired. The petitioner relies on the 1973 
report of the Select Committee on GRAS Substances (the Select 
Committee) (Ref. 2, p. 2) and the previously approved uses of acacia 
under Sec.  184.1330 to demonstrate that acacia is effective as a 
thickener, emulsifier, or stabilizer in alcoholic beverages.
    The petitioner estimates that the exposure to acacia from the 
proposed use would be 0.75 gram per person per day (g/p/d) based on 
these factors: (1) The total number of cases of cordials, liqueurs, and 
prepared cocktails (which are the types of beverages likely to contain 
acacia) sold in the United States in 1992, (2) the portion of the 
population that could legally drink alcoholic beverages in the United 
States in 1980, and (3) the acacia use-level range in such beverages of 
12 to 20 percent. Based on the legal drinking-age limit, only a subset 
of the population will be exposed to acacia in alcoholic beverages.
    FDA has reviewed the petitioner's exposure data and concurs that 
the proposed use of acacia in alcoholic beverages will increase intake 
for that subset of the population that consumes these alcoholic 
beverages by no more than 0.75 g/p/d (Ref. 3), an increase of 
approximately 30 percent over the cumulative estimated daily intake of 
acacia for existing uses, estimated previously to be 2.5 g/p/d (Ref. 
4).

B. Safety Assessment

    The petitioner relied on toxicological data contained in the 1973 
report of the Select Committee (Ref. 2) to support the safety of the 
use of acacia in alcoholic beverages. In its report, the Select 
Committee evaluated all of the available safety information on acacia 
and concluded that acacia poses no safety hazard to the public when it 
is used at the then current levels (Ref. 2, p. 10). The Select 
Committee believed, however, that because of the potential for 
allergies to acacia, it was not possible without additional data to 
determine whether significant increases in consumption of acacia would 
constitute a dietary hazard (Ref. 2, pp. 9 and 10).
    FDA conducted literature searches that updated the information that 
had formed the basis of the Select Committee report. The agency 
reviewed toxicological data from a 1982 National Toxicology Program 
(NTP) report of 2-year carcinogenicity feeding studies on acacia in 
F344 rats and B6C3F1 mice. The agency evaluated the carcinogenicity of 
acacia and concluded that F344 rats and B6C3F1 mice consuming diets 
containing up to 5-percent acacia for 2 years showed no increased 
incidences of tumors at any site (Ref. 5).
    The Joint FAO/WHO (Food and Agriculture Organization/World Health 
Organization) Expert Committee on Food Additives (JECFA) evaluated 
acacia for acceptable daily intake and did not place a limit on 
acacia's dietary use beyond the criterion that it should be used within 
the bounds of good manufacturing practice, i.e., it should be 
technologically efficacious and should be used at the lowest level 
necessary to achieve this effect, it should not conceal inferior food 
quality or adulteration, and it should not create nutritional imbalance 
(Ref. 6).
    In 1983, 1987, 1988, and 1992, the agency conducted searches of the 
scientific literature on acacia with a special emphasis on potential 
hypersensitivity and allergic reaction. Based on a review of the 
reference materials obtained through these literature searches, the 
agency concluded that while there was evidence that acacia is 
associated with dermal/bronchial hypersensitivity in workers handling 
acacia dust in the workplace (e.g., printing industry), the evidence 
for the allergic potential of acacia was extremely weak (Refs. 7 and 
8).
    Based on its review of the safety data (Ref. 9), FDA concludes that 
the additional use of acacia in alcoholic beverages is safe.

IV. Conclusions

    From the review of the available information, the agency concludes 
that acacia may be safely used as a thickener, emulsifier, or 
stabilizer in alcoholic beverages at a maximum use level of 20 percent 
in the final beverage. Therefore, the regulations in part 172 should be 
amended as set forth below.
    In accordance with Sec.  171.1(h) (21 CFR 171.1(h)), the petition 
and the documents that FDA considered and relied upon in reaching its 
decision to approve the petition are available for inspection at the 
Center for Food Safety and Applied Nutrition by appointment with the 
information contact person. 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 previously considered the environmental effects of 
this rule as announced in the notice of filing for FAP 1A4730 (68 FR 
7381). No new information or comments have been received that would 
affect the agency's previous determination that there is no significant 
impact on the human environment and that an environmental impact 
statement is not required.

[[Page 8034]]

VI. 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.

VII. References

    The following references have been placed on display in the 
Division of Dockets Management (address above) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

    1. Letter from A. Rulis, Office of Food Additive Safety, to J. 
Lemker, Bell, Boyd, and Lloyd, LLC, ``Agency Response Letter, GRAS 
Notice No. GRN 000058,'' October 1, 2001, Internet address: http://
www.cfsan.fda.gov/rdb/opa-g058.html.
    2. Select Committee on GRAS Substances, Life Sciences Research 
Office, Federation of American Societies for Experimental Biology, 
``Evaluation of the Health Aspects of Gum Arabic as a Food 
Ingredient,'' March, 1973.
    3. Memorandum from M. DiNovi, Chemistry Review Branch, to R. 
Martin, Direct Additives Branch, ``GRP 3G0287: Beatrice Foods. Gum 
Arabic as a Stabilizer in Alcoholic Beverage Mixes,'' March 7, 1994.
    4. Memorandum from J. Modderman, Food Additive Chemistry Review 
Branch, to L. Mansor, GRAS Review Branch, ``GRASP 3G0287--Gum 
Arabic. Beatrice Foods Co.,'' November 21, 1983.
    5. Memorandum of Conference, Cancer Assessment Committee 
Meeting, ``Gum Arabic,'' January 6, 1998.
    6. ``Toxicological Evaluation of Certain Food Additives and 
Contaminants,'' WHO Food Additives Series 26, No. 686, 1990.
    7. Memorandum from J. Griffiths, Additives Evaluation Branch, to 
C. Coker, Case and Advisory Branch, ``Gum Arabic and Immunogenicity; 
updated literature survey,'' March 8, 1988.
    8. Memorandum from J. Griffiths, Additives Evaluation Branch, to 
E. Flamm, Direct Additives Branch, ``Gum Arabic and Immunogenicity; 
literature from Dr. D. M. W. Anderson,'' November 9, 1988.
    9. Memorandum from C. Johnson, Additives Evaluation Branch 
1, to R. Martin, Direct Additives Branch, ``Gum Arabic in 
Alcoholic Beverages: Final Toxicology Evaluation,'' April 8, 1996.

VIII. 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.

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:

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

0
2. Section 172.780 is added to subpart H to read as follows:


Sec.  172.780  Acacia (gum arabic).

    The food additive may be safely used in food in accordance with the 
following prescribed conditions:
    (a) Acacia (gum arabic) is the dried gummy exudate from stems and 
branches of trees of various species of the genus Acacia, family 
Leguminosae.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 5th Ed. (2004), pp. 210 and 211, 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 National Academies Press, 
500 Fifth St. NW., Washington, DC 20001 (Internet address: http://www.nap.edu). Copies may be examined at the Center for Food Safety and 
Applied Nutrition's Library, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html.
    (c) The ingredient is used as a thickener, emulsifier, or 
stabilizer in alcoholic beverages at a use level not to exceed 20 
percent in the final beverage.

    Dated: November 16, 2004.
Leslye M. Fraser,
Director, Office of Regulations and Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 05-3026 Filed 2-16-05; 8:45 am]
BILLING CODE 4160-01-S