[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