[Federal Register Volume 60, Number 167 (Tuesday, August 29, 1995)]
[Rules and Regulations]
[Pages 44756-44757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21380]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 176

[Docket No. 93F-0335]


Indirect Food Additives; Paper and Paperboard Components

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 ammonium zirconium 
lactate-citrate complexes for use as insolubilizers for clay coatings 
with protein binders in coatings for paper and paperboard intended for 
use in contact with food. This action is in response to a food additive 
petition filed by Sequa Chemicals, Inc.

DATES: Effective August 29, 1995; written objections and requests for a 
hearing by September 28, 1995.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Daniel N. Harrison, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3084.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of October 15, 1993 (58 FR 53518), FDA announced that a food 
additive petition (FAP 3B4386) had been filed by Sequa Chemicals, Inc., 
One Sequa Dr., Chester, SC 29706-0070. The petition proposed that the 
food additive regulations be amended to provide for the safe use of 
ammonium zirconium lactate-citrate complexes for use as insolubilizers 
for binders used in clay coatings for paper and paperboard intended for 
use in contact with food.
    FDA has evaluated data in the petition and other relevant material. 
Based upon its review, the agency concludes that the use of ammonium 
zirconium lactate-citrate complexes should be limited to use as 
insolubilizers only for clay coatings with protein binders in coatings 
for paper and paperboard. The agency also concludes that, as so 
limited, the proposed food additive use is safe, and that Sec. 176.170 
Components of paper and paperboard in contact with aqueous and fatty 
foods (21 CFR 176.170) 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 21 CFR 
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 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.
    Any person who will be adversely affected by this regulation may at 
any time on or before September 28, 1995 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 

[[Page 44757]]
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 176

    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 of the Center for Food Safety and Applied 
Nutrition, 21 CFR part 176 is amended as follows:

PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

    1. The authority citation for 21 CFR part 176 continues to read as 
follows:

     Authority: Secs. 201, 402, 406, 409, 721 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 342, 346, 348 379e).

    2. Section 176.170 is amended in the table in paragraph (a)(5) by 
alphabetically adding a new entry under the headings ``List of 
substances'' and ``Limitations'' to read as follows:


Sec. 176.170  Components of paper and paperboard in contact with 
aqueous and fatty foods.

* * * * *
    (a) * * *
    (5) * * *

                                                                        
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         List of substances                      Limitations            
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                      *      *      *      *      *                     
Ammonium zirconium citrate (CAS      For use as insolubilizers only for 
 Reg. No. 149564-62-5), ammonium      clay coatings with protein binders
 zirconium lactate-citrate (CAS       in coatings for paper and         
 Reg. No. 149564-64-7), ammonium      paperboard, at a level not to     
 zirconium lactate (CAS Reg. No.      exceed 1.4 percent by weight of   
 149564-63-6).                        coating solids.                   
                      *      *      *      *      *                     
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* * * * *

    Dated: August 17, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-21380 Filed 8-28-95; 8:45 am]
BILLING CODE 4160-01-F