[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Rules and Regulations]
[Pages 36176-36177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17545]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 97F-0468]


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 tris(2,4-di-tert-
butylphenyl)phosphite by removing the restrictions on the temperature 
of use in low-density polyethylene films of thickness greater than 
0.051 millimeter (mm) (0.002 inch (in)), provided that the film does 
not contain a total of tris(2,4-di-tert-butylphenyl)phosphite in excess 
of 0.062 milligram (mg) per square inch (in<SUP>2</SUP>) of the food-
contact surface. This action is in response to a petition filed by Ciba 
Specialty Chemicals Corp.

DATES: This regulation is effective July 2, 1998. Written objections 
and requests for a hearing by August 3, 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 November 28, 1997 (62 FR 63350), FDA announced that a food 
additive petition (FAP 8B4563) had been filed by Ciba Specialty 
Chemicals Corp., c/o Keller and Heckman, 1001 G St. NW., suite 500 
West, Washington, DC 20001. 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 tris(2,4-
di-tert-butylphenyl)phosphite by removing the restriction on the 
temperature of use in low-density polyethylene films of thickness 
greater than 0.051 mm (0.002 in), provided that the film does not 
contain a total of tris(2,4-di-tert-butylphenyl)phosphite in excess of 
0.062 mg per in<SUP>2</SUP> of the food contact-surface.
    FDA has evaluated data in the petition and other relevant material. 
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 that therefore, 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 8B4563 (62 FR 
63350). FDA has concluded that the action is of a type that does not 
individually or cumulatively have a significant effect on the human 
environment, and that therefore, neither an environmental assessment 
nor an environmental impact statement is required.
    Any person who will be adversely affected by this regulation may at 
any time on or before August 3, 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 objection 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.
    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

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) by 
revising the entry for ``tris(2,4-di-tert-butylphenyl)phosphite'' in 
item ``6.'' under the heading ``Limitations'' to read as follows:


Sec. 178.2010   Antioxidants and/or stabilizers for polymers.

* * * * *
    (b) * * *

[[Page 36177]]



                                                                                                                
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                       Substances                                              Limitations                      
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Tris(2,4-di-tert-butylphenyl)phosphite. (CAS Reg. No.    For use only:                                          
 31570-04-4).                                             *  *  *                                               
                                                         6. At levels not to exceed 0.2 percent by weight of    
                                                          olefin polymers complying with Sec.  177.1520(c) of   
                                                          this chapter, items 2.1, 2.2, 2.3, 3.1(a), 3.1(b),    
                                                          3.1(c), 3.2(a), or 3.2(b). The finished polymers      
                                                          complying with items 2.1, 2.2, or 2.3 having a density
                                                          less than 0.94 gram per cubic centimeter and a        
                                                          thickness greater than 0.051 millimeter (0.002 inch), 
                                                          either shall have a level of tris(2,4-di-tert-        
                                                          butylphenyl)phosphite that shall not exceed 0.062     
                                                          milligram per square inch of food-contact surface or  
                                                          shall contact all food types identified in Table 1 of 
                                                          Sec.  176.170(c) of this chapter only under conditions
                                                          of use E, F, and G described in Table 2 of Sec.       
                                                          176.170(c) of this chapter.                           
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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    Dated: June 23, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 98-17545 Filed 7-1-98; 8:45 am]
BILLING CODE 4160-01-F