[Federal Register: March 29, 2005 (Volume 70, Number 59)]
[Rules and Regulations]
[Page 15756-15758]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr05-5]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. 2003F-0471]
Food Additives Permitted for Direct Addition to Food for Human
Consumption; Glycerol Ester of Gum Rosin
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 glycerol ester of
gum rosin (GEGR) to adjust the density of citrus oils used in the
preparation of beverages. This action is in response to a petition
filed by T&R Chemicals, Inc.
DATES: This rule is effective March 29, 2005. Submit written or
electronic objections and requests for a hearing by April 28, 2005.
ADDRESSES: You may submit written or electronic objections and requests
for a hearing, identified by Docket No. 2003F-0471, 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 .
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Follow the instructions for submitting comments on the agency Web
site.
• E-mail: fdadockets@oc.fda.gov. Include Docket No. 2003F-
0471 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: Andrew J. Zajac, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1267.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of October 17, 2003
(68 FR 59794), FDA announced that a food additive petition (FAP 3A4749)
had been filed by T&R Chemicals, Inc., c/o The Environ Health Sciences
Institute, 4350 North Fairfax Dr., suite 300, Arlington, VA 22203. The
petition proposed to amend the food additive regulations in part 172
(21 CFR part 172) to provide for the safe use of GEGR to adjust the
density of citrus oils used in the preparation of beverages.
The proposed additive is intended to substitute for glycerol ester
of wood rosin (GEWR). GEWR is currently permitted under Sec. 172.735
for use in adjusting the density of citrus oils used in the preparation
of beverages at a level not to exceed 100 parts per million (ppm) of
the finished beverage. GEGR would be used at the same level as GEWR. In
evaluating this petition, the agency reviewed data and information
concerning: (1) The chemical composition of GEGR in comparison with
that of GEWR, (2) the process used to manufacture GEGR, (3)
physicochemical properties of GEGR compared to those of GEWR, (4)
conformance of GEGR with the specifications in Sec. 172.735 for GEWR,
(5) the functional equivalence of GEGR to GEWR, and (6) relevant safety
information.
Based on its evaluation, the agency has determined that GEGR is
chemically similar to GEWR, such that any increase in the estimated
daily intake (EDI) of the individual resin acids and resin acid esters
that are the major components of both GEGR and GEWR from the petitioned
use of GEGR would be insignificant and of no toxicological concern. The
agency concludes that the petitioned use of GEGR as a substitute for
GEWR to adjust the density of citrus oils used in the preparation of
beverages at a level not to exceed 100 ppm of the finished beverage is
safe, the additive will achieve its intended technical effect, and
therefore, Sec. 172.735 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 (see FOR
FURTHER INFORMATION CONTACT). As provided in Sec. 171.1(h), the agency
will delete from the documents any materials that are not available for
public disclosure before making the documents available for inspection.
II. Response to Comments
During the course of FDA's evaluation of FAP 3A4749, the agency
received one comment on the petition. This comment objects to the
petitioner's claim that GEGR and GEWR are chemically equivalent. The
comment points to purported differences in raw material sourcing and
processing, compositional differences and variation in gum rosin, and
differences occurring during the esterification process due to
variations in the resin acid content. The comment also challenges the
analytical methodology (i.e., saponification followed by gas
chromatographic analysis) used by the petitioner in comparing GEGR and
GEWR. The comment further objects to the petitioner's reliance on
safety data which support the use of GEWR as the basis for establishing
the safety of GEGR, on the grounds that such use of unpublished
information furnished previously to FDA by another person was not
authorized as required by Sec. 171.1(b).
While FDA agrees that there are differences in raw material
sourcing and processing for GEGR and GEWR, FDA has concluded that the
compositions of these two substances are so similar that any
differences are not of toxicological concern for the petitioned use.
FDA also agrees there will be variability in the composition of the
rosins depending on the source and even from the same source due to
differences in climate and soil conditions (Ref. 1). However, this
natural variability does not result in a qualitatively different
composition of the rosin but rather a typical range of values for the
individual components of the rosin. Because of source variability and
different climates and soils, the composition of GEGR will vary from
batch to batch, although its general composition will fall within a
typical range. The composition of GEWR will vary in an analogous
manner. Furthermore, this variability in the rosin composition does not
result in a significant difference in the EDI for the individual resin
acid components of GEGR and GEWR for the conditions of use. In
addition, GEWR is characterized by its physical properties, which are
specified in Sec. 172.735. GEGR will have to conform to these same
specifications.
As stated previously in this document, the comment also challenges
the analytical methodology (i.e., saponification followed by gas
chromatographic analysis) used by the petitioner in comparing GEGR and
GEWR. The comment claims that this technique is inappropriate because
it can induce isomerization of the resin acids, thereby changing the
composition compared to the starting rosin. No literature references or
data were provided to support this statement. In addition, the
procedure used by the petitioner included a step to decrease the amount
of isomerization. The petitioner also used other appropriate analytical
techniques (e.g., infrared spectroscopy and nuclear magnetic resonance
spectroscopy) to compare GEGR and GEWR. Therefore, the agency concludes
that data from these techniques, as well as the data from the gas
chromatographic analyses, adequately demonstrate that GEGR and GEWR are
chemically similar.
Because the agency has determined that GEGR and GEWR are similar
with respect to the identity of their chemical components and that any
difference in the ranges for the components of GEGR and GEWR are not
significantly different and would be of no toxicological concern, there
is no need for toxicological testing of GEGR to demonstrate that the
petitioned use is safe.
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III. Environmental Impact
The agency has previously considered the environmental effects of
this rule as announced in the notice of filing for FAP 3A4749 (68 FR
59794). 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.
IV. 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.
V. 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 (see DATES). 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.
VI. Reference
The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Memorandum from D. Doell, FDA, Division of Petition Review,
Chemistry Review Group, and David Carlson, FDA, Division of Petition
Review, Toxicology Review Group I, to A. Zajac, FDA Division of
Petition Review, Regulatory Review Group I, February 17, 2005.
List of Subjects in 21 CFR Part 172
Food additives, 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 172.735 is amended by revising the section heading and the
introductory text to read as follows:
Sec. 172.735 Glycerol ester of wood or gum rosin.
Glycerol ester of wood or gum rosin may be safely used in food in
accordance with the following prescribed conditions:
* * * * *
Dated: March 18, 2005.
Leslye M. Fraser,
Director, Officer of Regulations and Policy, Center for Food Safety and
Applied Nutrition.
[FR Doc. 05-6089 Filed 3-28-05; 8:45 am]
BILLING CODE 4160-01-S
