[Federal Register Volume 61, Number 138 (Wednesday, July 17, 1996)]
[Rules and Regulations]
[Pages 37208-37210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18072]


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[[Page 37209]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 176

[Docket No. 96F-0070]


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

DATES: Effective July 17, 1996; written objections and requests for a 
hearing by August 16, 1996.

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

FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-216), 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 8, 1996 (61 FR 9462), FDA announced that a food 
additive petition (FAP 6B4497) had been filed by Sequa Chemicals, Inc., 
One Sequa Dr., Chester, SC 29706-0070. The petition proposed to amend 
the food additive regulations in Sec. 176.170 Components of paper and 
paperboard in contact with aqueous and fatty foods (21 CFR 176.170) to 
provide for the safe use of ammonium zirconium lactate-citrate 
complexes for use as insolubilizers with protein binders in coatings 
for paper and paperboard intended for food-contact applications.
    FDA has evaluated the data in the petition and other relevant 
material and concludes that the proposed use of the additive in paper 
and paperboard products in contact with food is safe. Based on this 
information, the agency has also concluded that the additive will have 
the intended technical effect. Therefore, Sec. 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 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 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 August 16, 1996, 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 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, 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 
revising the entry for ``Ammonium zirconium citrate (CAS Reg. No. 
149564-62-5)'' 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 Reg. No 149564-62-5),    For use as insolubilizers with protein binders in      
 ammonium zirconium lactate-citrate (CAS Reg. No.         coatings for paper and paperboard, at a level not to  
 149564-64-7), ammonium zirconium lactate (CAS Reg. No.   exceed 1.4 percent by weight of coating solids.       
 149564-63-6).                                                                                                  
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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    Dated: June 28, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-18072 Filed 7-16-96; 8:45 am]
BILLING CODE 4160-01-F