[Federal Register Volume 64, Number 162 (Monday, August 23, 1999)]
[Rules and Regulations]
[Pages 45872-45873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21727]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 175
[Docket No. 99F-0487]
Indirect Food Additives: Adhesives and Components of Coatings
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 fatty acids,
C10-13-branched, vinyl esters as a comonomer in polymers
used as components of adhesive formulations intended for use in contact
with food. This action responds to a petition filed by Exxon Chemical
Co.
DATES: This regulation is effective August 23, 1999. Submit written
objections and requests for a hearing by September 22, 1999.
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: Vir D. Anand, Center for Food Safety
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3081.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of March 25, 1999 (64 FR 14451), FDA announced that a food
additive petition (FAP 9B4650) had been filed by Exxon Chemical Co.,
P.O. Box 3272, Houston, TX 77253-3272. The petition proposed to amend
the food additive regulations in Sec. 175.105 Adhesives (21 CFR
175.105) to provide for the safe use of fatty acids, C10-13-
branched, vinyl esters as a comonomer in polymers used as components of
adhesives intended for use in contact with food.
FDA has evaluated data in the petition and other relevant material.
Based on this information, the agency concludes that: (1) The proposed
use of the additive is safe, (2) the additive will achieve its intended
technical effect, and therefore, (3) the regulations in Sec. 175.105
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.
The agency has previously considered the environmental effects of
this final rule as announced in the notice of filing for FAP 9B4650. 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.
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.
Any person who will be adversely affected by this regulation may at
any time on or before September 22, 1999, file with the Dockets
Management Branch (address above) written objections thereto. 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 shall be
submitted and shall 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 175
Adhesives, Food additives, Food packaging.
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 175 is amended as follows:
PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF
COATINGS
1. The authority citation for 21 CFR part 175 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
2. Section 175.105 is amended in the table in paragraph (c)(5) by
alphabetically adding an entry under the category ``Polymers:
Homopolymers and copolymers of the following monomers'' under the
heading ``Substances'' to read as follows:
Sec. 175.105 Adhesives.
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[[Page 45873]]
(c) * * *
(5) * * *
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Substances Limitations
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* * * *
* * *
Polymers: Homopolymers and copolymers of
the following monomers:
* * *
Fatty acids, C10-13-branched, vinyl esters
(CAS Reg. No. 184785-38-4).
* * * *
* * *
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Dated: August 5, 1999.
Janice F. Oliver,
Deputy Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 99-21727 Filed 8-20-99; 8:45 am]
BILLING CODE 4160-01-F
