[Federal Register Volume 72, Number 162 (Wednesday, August 22, 2007)]
[Rules and Regulations]
[Pages 46895-46896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16558]



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  Federal Register / Vol. 72, No. 162 / Wednesday, August 22, 2007 / 
Rules and Regulations  

[[Page 46895]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 2006F-0225]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Glycerol Ester of Tall Oil 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 
tall oil rosin (GETOR) to adjust the density of citrus oils used in the 
preparation of beverages and to provide for the use of steam stripping 
as a purification method for producing glycerol ester of wood rosin, 
gum rosin, or tall oil rosin. This action is in response to a petition 
filed by Georgia-Pacific Resins, Inc.

DATES: This rule is effective August 22, 2007. Submit written or 
electronic objections and requests for a hearing by September 21, 2007. 
See section VI of this document for information on the filing of 
objections.

ADDRESSES: You may submit written or electronic objections and requests 
for a hearing, identified by Docket No. 2006F-0225, by any of the 
following methods:

Electronic Submissions

    Submit electronic objections in the following ways:
     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.
Written Submissions
    Submit written objections in the following ways:
     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.
    To ensure more timely processing of objections, FDA is no longer 
accepting objections submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic objections by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    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 
objections received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number(s), 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: Blondell Anderson, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1304.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of June 15, 2006 (71 
FR 34623), FDA announced that a food additive petition (FAP 6A4765) had 
been filed by Georgia-Pacific Resins, Inc., P.O. Box 105734, Atlanta, 
GA 30348. The petition proposed to amend the food additive regulations 
in 21 CFR 172.735 (Sec.  172.735) Glycerol ester of wood or gum rosin 
to provide for the following: (1) The safe use of GETOR to adjust the 
density of citrus oils used in the preparation of beverages; and (2) 
the use of steam stripping as a purification method for producing 
glycerol ester of wood rosin, gum rosin, or tall oil rosin.
    GETOR, as well as glycerol ester of wood rosin (GEWR) and glycerol 
ester of gum rosin (GEGR), are approved for use in chewing gum bases 
(Sec.  172.615 (21 CFR 172.615)) and for several indirect additive uses 
(e.g., 21 CFR 175.125 and 178.3870). The proposed additive, GETOR, is 
intended to substitute for GEWR or GEGR in adjusting the density of 
citrus oils used in the preparation of beverages at the same use level 
(up to 100 parts per million of the finished beverage).
    On March 29, 2005, FDA published a final rule that amended Sec.  
172.735 by approving the use of GEGR as a substitute for GEWR for 
adjusting the density of citrus oils in the preparation of beverages 
(70 FR 15756). The rule was issued in response to a petition and was 
based on FDA's conclusion 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 (the major components of both GEGR 
and GEWR) would be insignificant and of no toxicological concern. The 
current petitioner has taken a similar approach to demonstrate that 
GETOR may be safely substituted for GEWR, and thereby for GEGR.

II. Evaluation of Safety

    The petitioner provided information concerning the following: (1) 
The chemical composition of GETOR in comparison with GEWR; (2) the 
process used to manufacture GETOR; (3) physiochemical properties of 
GETOR in comparison to GEWR; (4) conformance of GETOR with the 
specifications in Sec.  172.735; (5) the functional equivalence of 
GETOR to GEWR; and (6) relevant safety information.
    Based on its evaluation of the information provided by the 
petitioner and other available information, the agency has determined 
that GETOR is chemically and functionally similar to GEWR and GEGR and 
that any increase in the EDI of the individual resin acids and resin 
acid esters resulting from the proposed use of GETOR will not be of 
toxicological concern. Therefore, the agency concludes that the 
proposed use of GETOR is safe, that the additive will achieve the 
intended technical effect, and that Sec.  172.735 should be amended as 
set forth in this document.

[[Page 46896]]

    To encompass the three glycerol ester of rosins (wood, gum, and 
tall oil) in the section heading for Sec.  172.735, the petitioner has 
requested, and the agency concurs, that the section heading for Sec.  
172.735 should be changed from Glycerol ester of wood or gum rosin to 
Glycerol ester of rosin.
    FDA also considered the petitioner's request to include steam 
stripping as an alternative method to countercurrent steam distillation 
(presently listed in Sec.  172.735) for purifying the rosin esters in 
Sec.  172.735. Steam stripping is the method listed in the chewing gum 
base regulation (Sec.  172.615) for purifying GEWR, GEGR, and GETOR. As 
additional information, the petitioner provided the most recent 
specifications for GEWR adopted by the Joint Food and Agriculture 
Organization/World Health Organization (FAO/WHO) Expert Committee on 
Food Additives (JEFCA, 46th session, 1996), which lists steam 
stripping, as well as countercurrent steam distillation as purification 
methods. FDA concludes that steam stripping is an acceptable method for 
purifying the rosin esters in Sec.  172.735 and that this method, along 
with the specifications in the regulation, will ensure that the 
additive is of suitable purity for the intended use. Therefore Sec.  
172.735 is amended to include steam stripping as a purification method.

III. Inspection of Documents

    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 will be made available for inspection 
at the Center for Food Safety and Applied Nutrition by appointment with 
the information contact person (see FOR FURTHER INFORMATION CONTACT). 
As provided in Sec.  171.1(h), the agency will delete from the 
documents any material that is not available for public disclosure 
before making the documents available for inspection.

IV. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the notice of filing for FAP 6A4765 (71 FR 
34623). 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.

V. 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.

VI. 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, 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, 
introductory text, and paragraph (a) to read as follows:


Sec.  172.735  Glycerol ester of rosin.

    Glycerol ester of wood rosin, gum rosin, or tall oil rosin may be 
safely used in food in accordance with the following prescribed 
conditions:
    (a) It has an acid number of 3 to 9, a drop-softening point of 88 
to 96 [deg]C; and a color of N or paler as determined in accordance 
with Official Naval Stores Standards of the United States. It is 
purified by countercurrent steam distillation or steam stripping.
* * * * *

    Dated: August 15, 2007.
Leslye M. Fraser,
Director, Office of Regulations and Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. E7-16558 Filed 8-21-07; 8:45 am]
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