[Federal Register: February 17, 2005 (Volume 70, Number 32)]
[Rules and Regulations]
[Page 8032-8034]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17fe05-4]
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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: fdadockets@oc.fda.gov. 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
<greek-i>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
