[Federal Register Volume 64, Number 105 (Wednesday, June 2, 1999)]
[Rules and Regulations]
[Pages 29553-29554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13858]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. 98F-0823]


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 1-octene as an 
optional monomer in the preparation of polymers for use as resins in 
adhesives for articles used in contact with food. This action responds 
to a petition filed by The Dow Chemical Co.

DATES:  This regulation is effective June 2, 1999. Submit written 
objections and requests for a hearing by July 2, 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 October 6, 1998 (63 FR 53679), FDA announced that a food 
additive petition (FAP 8B4628) had been filed by The Dow Chemical Co., 
2030 Dow Center, Midland, MI 48674. 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 1-octene as an optional monomer in the 
preparation of polymers for use as resins in adhesives for articles 
used in contact with food.

[[Page 29554]]

    -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 rule as announced in the notice of filing for FAP 8B4628. 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 July 2, 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.

* * * * *
    -(c) * * *
    -(5) * * *

 
------------------------------------------------------------------------
             Substances                          Limitations
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  *                    *                    *                    *
                   *                    *                    *
Polymers: Homopolymers and
 copolymers of the following
 monomers: * * *
   1-Octene (CAS Reg. No. 111-66-
   0).
  *                    *                    *                    *
                   *                    *                    *
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    Dated: May 19, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-13858 Filed 6-1-99; 8:45 am]
BILLING CODE 4160-01-F