[Federal Register Volume 62, Number 111 (Tuesday, June 10, 1997)]
[Rules and Regulations]
[Pages 31511-31512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15011]



[[Page 31511]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 92F-0279]


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 N,N-bis(2-
hydroxyethyl)dodecanamide as an antistatic agent in polypropylene food-
packaging films. This action responds to a petition filed by Toho 
Chemical Industry Co., Ltd., c/o Parexel International Corp.

DATES: Effective June 10, 1997. Written objections and requests for a 
hearing by July 10, 1997.

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: Mitchell A. Cheeseman, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3083.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 7, 1992 (57 FR 34937), FDA announced that a food 
additive petition (FAP 2B4308) had been filed by Toho Chemical Industry 
Co., Ltd., c/o Parexel International Corp., 195 West St., Waltham, MA 
02154. The petition proposed to amend the food additive regulations in 
Sec. 178.3130 Antistatic and/or antifogging agents in food-packaging 
materials (21 CFR 178.3130) to provide for the safe use of N,N-bis(2-
hydroxyethyl)dodecanamide as an antistatic agent in polypropylene food-
packaging films.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that: (1) The proposed use of the food additive is 
safe, (2) the additive will achieve its intended technical effect, and 
(3) the regulations in Sec. 178.3130 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 July 10, 1997, 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: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

    2. Section 178.3130 is amended in the table in paragraph (b) by 
revising the entry for ``N,N-Bis(2-hydroxyethyl) dodecanamide * * *'' 
to read as follows:

Sec. 178.3130   Antistatic and/or antifogging agents in food-packaging 
materials.

* * * * *
    (b) *      *      *

[[Page 31512]]



                                                                        
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               Substances                          Limitations          
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  *                    *                    *                    *      
                   *                    *                    *          
N,N-Bis(2-hydroxyethyl)dodecanamide      For use only:                  
 produced when diethanolamine is made    1. As an antistatic agent at   
 to react with methyl laurate such that   levels not to exceed 0.5      
 the finished product: Has a minimum      percent by weight of molded or
 melting point of 36 C; has a minimum     extruded polyethylene         
 amide assay of 90 percent; contains no   containers intended for       
 more than 2 percent by weight of free    contact with honey, chocolate 
 diethanolamine; and contains no more     syrup, liquid sweeteners,     
 than 0.5 percent by weight of N,N,       condiments, flavor extracts   
 bis(2-hydroxyethyl)piperazine, as        and liquid flavor             
 determined by paper chromatography       concentrates, grated cheese,  
 method.                                  light and heavy cream, yogurt,
                                          and foods of Type VIII as     
                                          described in Table 1 of Sec.  
                                          176.170(c) of this chapter.   
                                         2. As an antistatic agent at   
                                          levels not to exceed 0.2      
                                          percent by weight in          
                                          polypropylene films complying 
                                          with Sec.  177.1520 of this   
                                          chapter, and used in contact  
                                          with food of Types I, II, III,
                                          IV, V, VI-B, VII, VIII, and IX
                                          described in Table 1 of Sec.  
                                          176.170(c) of this chapter,   
                                          and under conditions of use B 
                                          through H described in Table 2
                                          of Sec.  176.170(c) of this   
                                          chapter. The average thickness
                                          of such polypropylene film    
                                          shall not exceed 0.001 inches 
                                          (30 micrometers).             
  *                    *                    *                    *      
                   *                    *                    *          
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    Dated: May 23, 1997.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 97-15011 Filed 6-9-97; 8:45 am]
BILLING CODE 4160-01-F