[Federal Register Volume 66, Number 141 (Monday, July 23, 2001)]
[Rules and Regulations]
[Pages 38152-38153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18221]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 99F-2533]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Change in Specifications for Gum or Wood Rosin Derivatives 
in Chewing Gum Base

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 a change in the softening point 
specifications of currently listed gum or wood rosin derivatives and to 
provide for their safe use as plasticizing materials (softeners) in 
chewing gum base. This action is in response to a petition filed by 
Hercules, Inc.

DATES: This rule is effective July 23, 2001. Submit written objections 
and requests for a hearing by August 22, 2001.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mary E. LaVecchia, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3072.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register on August 5, 1999 (64 
FR 42699), FDA announced that a food additive petition (FAP 9A4655) had 
been filed by Hercules, Inc., c/o 1001 G St. NW., Washington, DC 20001. 
The petition proposed to amend the food additive regulations in 
Sec. 172.615 Chewing gum base (21 CFR 172.615) to permit a change in 
the softening point specifications of currently listed gum or wood 
rosin derivatives and provide for their safe use as plasticizing 
materials (softeners) in chewing gum base. More specifically, the 
petition proposed to eliminate the upper limits on the permissible 
softening point ranges for these gum or wood rosin derivatives.
    The gum or wood rosin derivatives, which are the subject of this 
petition, include glycerol ester of partially dimerized rosin, glycerol 
ester of partially hydrogenated gum or wood rosin, glycerol ester of 
polymerized rosin, glycerol ester of gum rosin, pentaerythritol ester 
of partially hydrogenated gum or wood rosin, and pentaerythritol ester 
of gum or wood rosin. Specifications for rosin derivatives conforming 
to this regulation include a melting point range (for glycerol ester of 
polymerized rosin) or a drop softening point range for other 
derivatives. The petitioner is proposing to modify these specifications 
by listing only a minimum melting point or softening point.

II. Conclusion

    FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency concludes that the 
change in the melting point or softening point specifications for 
glycerol ester of partially dimerized rosin, glycerol ester of 
partially hydrogenated gum or wood rosin, glycerol ester of polymerized 
rosin, glycerol ester of gum rosin, pentaerythritol ester of partially 
hydrogenated gum or wood rosin, and pentaerythritol ester of gum or 
wood rosin is safe and that gum or wood rosin derivatives with the 
revised specifications will achieve their intended technical effect. 
Therefore, the agency concludes that the regulations in Sec. 172.615 
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 listed above. 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.

III. Environmental Impact

    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

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 at 
any time file with the Dockets Management Branch (address above) 
written objections by August 22, 2001. 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 Dockets Management Branch 
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.
    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:

[[Page 38153]]

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

    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.

    2. Section 172.615 is amended in paragraph (a) by revising the 
following entries in the table under the subheading ``Plasticizing 
Materials (Softeners)'' to read as follows:


Sec. 172.615  Chewing gum base.

* * * * *
    (a) *  *  *  

 
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                                       Plasticizing Materials (Softeners)
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Glycerol ester of partially dimerized       Having an acid number of 3-8, a minimum drop-softening point of 109
 rosin.                                      deg.C, and a color of M or paler.
Glycerol ester of partially hydrogenated    Having an acid number of 3-10, a minimum drop-softening point of 79
 gum or wood rosin.                          deg.C, and a color of N or paler.
Glycerol ester of polymerized rosin.......  Having an acid number of 3-12, a minimum melting-point of 80  deg.C,
                                             and a color of M or paler.
Glycerol ester of gum rosin...............  Having an acid number of 5-9, a minimum drop-softening point of 88
                                             deg.C, and a color of N or paler. The ester is purified by steam
                                             striping.
 
*                  *                  *                  *                  *                  *
                                                        *
Pentaerythritol ester of partially          Having an acid number of 7-18, a minimum drop-softening point of 102
 hydrogenated gum or wood rosin.              deg.C, and a color of K or paler.
Pentaerythritol ester of gum or wood rosin  Having an acid number of 6-16, a minimum drop-softening point of 109
                                              deg.C, and a color of M or paler.
 
*                  *                  *                  *                  *                  *
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    Dated: July 9, 2001.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 01-18221 Filed 7-20-01; 8:45 am]
BILLING CODE 4160-01-S