[Federal Register Volume 63, Number 15 (Friday, January 23, 1998)]
[Rules and Regulations]
[Pages 3463-3465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1539]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 175 and 178

[Docket No. 95F-0210]


Indirect Food Additives: Adhesives and Components of Coatings; 
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 2,2'-(2,5-
thiophenediyl)-bis(5-tert-butylbenzoxazole) as an optical brightener in 
pressure-sensitive adhesives and in all polymers used in contact with 
food. This action is in response to a petition filed by Ciba-Geigy 
Corp.

DATES: The regulation is effective January 23, 1998. Submit written 
objections and requests for a hearing by February 23, 1998.
ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.


[[Page 3464]]


FOR FURTHER INFORMATION CONTACT: John R. Bryce, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3023.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 18, 1995 (60 FR 43157), FDA announced that a food 
additive petition (FAP 5B4471) had been filed by Ciba-Geigy Corp., 
Seven Skyline Dr., Hawthorne, NY 10532-2188. The petition proposed to 
amend the food additive regulations in Sec. 178.3297 Colorants for 
polymers (21 CFR 178.3297) to provide for the safe use of 2,2'-(2,5-
thiophenediyl)-bis(5-tert-butylbenzoxazole) in all polymers intended 
for use in food packaging and in adhesives complying with Sec. 175.125 
Pressure-sensitive adhesives (21 CFR 175.125).
    In order to clarify the use of this additive as an optical 
brightener, the petition also proposed to list the use of the additive 
in adhesives complying with Sec. 175.105 (21 CFR 175.105) in 
Sec. 178.3297. Because the additive is currently listed in Sec. 175.105 
without limitation, use of the additive as an optical brightener in 
adhesives complying with Sec. 175.105 is a currently permitted use that 
requires no further safety evaluation. Accordingly, this final rule 
lists the use of the additive in adhesives complying with Sec. 175.105 
in Sec. 178.3297 Colorants for polymers. 
    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 as an optical brightener in pressure-sensitive 
adhesives in Sec. 175.125, and in all polymers intended for use in food 
packaging in Sec. 178.3297, is safe; that the additive will have the 
intended technical effect; and that therefore, the regulations in 
Secs. 175.125 and 178.3297 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 February 23, 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

21 CFR Part 175

    Adhesives, Food additives, Food packaging.

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 parts 175 and 178 are amended to read as follows:

PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF 
COATINGS

    1. The authority citation for 21 CFR part 175 continues to read as 
follows:

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

    2. Section 175.125 is amended by adding paragraph (a)(7) and by 
revising paragraph (b)(1) to read as follows:

Sec. 175.125  Pressure-sensitive adhesives.

* * * * *
    (a) *  *  *
    (7) 2,2'-(2,5-Thiophenediyl)-bis(5-tert-butylbenzoxazole) (CAS Reg. 
No. 7128-64-5) as an optical brightener at a level not to exceed 0.05 
percent by weight of the finished pressure-sensitive adhesive.
* * * * *
    (b) *  *  *
    (1) Substances listed in paragraphs (a)(1), (a)(2), (a)(3), (a)(5), 
(a)(6), and (a)(7) of this section, and those substances prescribed by 
paragraph (a)(4) of this section that are not identified in paragraph 
(b)(2) of this section.
* * * * *

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

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

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

    4. Section 178.3297 is amended in the table in paragraph (e) by 
revising the entry for ``2,2'-(2,5-Thiophenediyl)-bis(5-tert-
butylbenzoxazole)'' under the headings ``Substances'' and 
``Limitations'' to read as follows:


Sec. 178.3297  Colorants for polymers.

* * * * *
    (e) *  *  *

[[Page 3465]]



                                                                        
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             Substances                          Limitations            
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  *                    *                    *                    *      
                   *                    *                    *          
2,2'-(2,5-Thiophenediyl)-bis(5-tert- For use as an optical brightener:  
 butylbenzoxazole) (CAS Reg. No.     1. In all polymers at levels not to
 7128-64-5).                          exceed 0.015 percent by weight of 
                                      the polymer. The finished articles
                                      are to contact food only under    
                                      conditions of use A through H     
                                      described in Table 2 of Sec.      
                                      176.170(c) of this chapter.       
                                     2. In all polymers at levels not to
                                      exceed 0.05 percent by weight of  
                                      the polymer. The finished articles
                                      shall contact foods only of the   
                                      types identified in Table 1 of    
                                      Sec.  176.170(c) of this chapter, 
                                      under Categories I, II, IV-B, VI- 
                                      A, VI-B, VI-C, VII-B, and VIII    
                                      under conditions of use A through 
                                      H described in Table 2 of Sec.    
                                      176.170(c) of this chapter.       
                                     3. In adhesives complying with Sec.
                                       175.105 of this chapter and in   
                                      pressure-sensitive adhesives      
                                      complying with Sec.  175.125 of   
                                      this chapter.                     
  *                    *                    *                    *      
                   *                    *                    *          
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    Dated: January 5, 1998.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 98-1539 Filed 1-22-98; 8:45 am]
BILLING CODE 4160-01-F