[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.

* * * * *

[[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