[Federal Register Volume 63, Number 166 (Thursday, August 27, 1998)]
[Rules and Regulations]
[Pages 45715-45716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23029]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 98F-0057]


Indirect Food Additives: Adjuvants, Production Aids, and 
Sanitizers

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 calcium 
bis[monoethyl(3,5-di-tert-butyl-4-hydroxybenzyl)phosphonate] as a 
stabilizer for polyethylene phthalate polymers intended for use in 
contact with food. This action is in response to a petition filed by 
Ciba Specialty Chemicals Corp.

DATES:  The regulation is effective August 27, 1998; written objections 
and requests for a hearing by September 28, 1998.

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 February 6, 1998 (63 FR 6193), FDA announced that a food 
additive petition (FAP 8B4578) had been filed by Ciba Specialty 
Chemicals Corp., 540 White Plains Rd., Tarrytown, NY 10591-9005. The 
petition proposed to amend the food additive regulations in 
Sec. 178.2010 Antioxidants and/or stabilizers for polymers (21 CFR 
178.2010) to provide for the safe use of calcium bis[monoethyl(3,5-di-
tert-butyl-4-hydroxybenzyl)phosphonate] as a stabilizer for 
polyethylene phthalate polymers complying with 21 CFR 177.1630, 
intended for use in contact with food.
    FDA has evaluated data in the petition and other relevant material.

[[Page 45716]]

 Based on this information, the agency concludes that the proposed use 
of the additive is safe, that the additive will achieve its intended 
technical effect, and therefore, that the regulations in Sec. 178.2010 
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 8B4578 (63 FR 
6193). 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 28, 1998, 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 178

    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 178 is amended as follows:

PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS

    1. The authority citation for 21 CFR part 178 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 342, 348, 379e.

    2. Section 178.2010 is amended in the table in paragraph (b) for 
the entry ``calcium bis[monoethyl(3,5-di-tert-butyl-4-
hydroxybenzyl)phosphonate]'' by adding entry ``15'' under the heading 
``Limitations'' to read as follows:

Sec. 178.2010   Antioxidants and/or stabilizers for polymers.

* * * * *
     (b) * * *

                                                                        
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             Substances                          Limitations            
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  *                    *                    *                    *      
                   *                    *                    *          
Calcium bis[monoethyl(3,5-di-tert-   For use only:                      
 butyl-4-hydroxybenzyl)phosphonate]  * * *                              
 (CAS Reg. No. 65140-91-2).          15. At levels not to exceed 0.3    
                                      percent by weight of polyethylene 
                                      phthalate polymers, complying with
                                      Sec.  177.1630 of this chapter.   
                                      Provided, that the finished       
                                      polymers contact food only under  
                                      conditions of use B through H     
                                      described in Table 2 of Sec.      
                                      176.170(c) of this chapter.       
  *                    *                    *                    *      
                   *                    *                    *          
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    Dated: August 17, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 98-23029 Filed 8-26-98; 8:45 am]
BILLING CODE 4160-01-F