[Federal Register Volume 59, Number 232 (Monday, December 5, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29732]


[[Page Unknown]]

[Federal Register: December 5, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 21 CFR Part 178

 [Docket No. 91F-0430]

 

 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 2-methyl-4,6-
bis[(octylthio)methyl]phenol as a stabilizer in can-end and side seam 
cements and in various polymers intended for use in contact with food. 
This action is in response to a petition filed by Ciba-Geigy Corp.

DATES: Effective December 5, 1994; written objections and requests for 
a hearing by January 4, 1995.

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

FOR FURTHER INFORMATION CONTACT: Richard H. White, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3094.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of December 2, 1991 (56 FR 61253), FDA announced that a food 
additive petition (FAP 1B4283) had been filed by Ciba-Geigy Corp., 
Seven Skyline Dr., Hawthorne, NY 10532-2188. The petition proposed that 
Sec. 178.2010 Antioxidants and/or stabilizers for polymers (21 CFR 
178.2010) be amended to provide for the safe use of 2-methyl-4,6-
bis[(octylthio)methyl]phenol as a stabilizer in can-end and side seam 
cements and in various polymers intended for use in contact with food.
     FDA has evaluated data in the petition and other relevant 
material. The agency concludes that the proposed food additive use is 
safe, and that this use should be listed in Sec. 178.2010, as set forth 
below. In addition, FDA is correcting the entry for this additive in 
Sec. 178.2010(b), in the table under the heading ``Substances'' to 
capitalize the letter ``m'' in ``methyl.'' Thus, it will read ``2-
Methyl-4,6-bis[(octylthio)methyl]phenol.''
    A review of the petition indicates that the additive may contain 
trace amounts of formaldehyde as an impurity. The potential 
carcinogenicity of formaldehyde was reviewed by the Cancer Assessment 
Committee (the committee) that has been formed by FDA's Center for Food 
Safety and Applied Nutrition. The committee noted that for many years 
formaldehyde has been known to be a carcinogen by the inhalation route, 
but it concluded that these inhalation studies are not appropriate for 
assessing the potential carcinogenicity of formaldehyde in food. The 
committee reached its conclusion because the route of administration 
was not relevant to food safety, and the fact that tumors were observed 
only locally at the portal of entry (nasal turbinates). The agency has 
received literature reports of two drinking water studies on 
formaldehyde: (1) A preliminary report of a carcinogenicity study 
purported to be positive by Soffritti et al. (1989), conducted in 
Bologna, Italy (Ref. 1) and (2) a negative study by Til, et al. (1989), 
conducted in The Netherlands (Ref. 2). The committee reviewed both 
studies and concluded in a ``Memorandum of Conference,'' dated April 
24, 1991, and March 4, 1993, ``* * * that data concerning the Soffritti 
study reported were unreliable and could not be used in the assessment 
of the oral carcinogenicity of formaldehyde'' (Ref. 3). This conclusion 
is based on a lack of critical details in the study, questionable 
histopathologic conclusions, and the use of unusual nomenclature to 
describe the tumors. Thus, the committee concluded that there is no 
basis to find that formaldehyde is a carcinogen when ingested.
    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 21 CFR 
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 January 4, 1995, 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.
References
    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Soffritti, M., C. Maltoni, F. Maffei, and R. Biagi, 
``Formaldehyde: An Experimental Multipotential Carcinogen,'' Toxicology 
and Industrial Health, Vol. 5, No. 5:699-730, 1989.
    2. Til, H. P., R. A. Woutersen, V. J. Feron, V. H. M. Hollanders, 
H. E. Falke, and J. J. Clary, ``Two-Year Drinking-Water Study of 
Formaldehyde in Rats,'' Food Chemical Toxicology, Vol. 27, No. 2, pp. 
77-87, 1989.
    3. Memorandum of Conference concerning ``Formaldehyde,'' Meeting of 
the Cancer Assessment Committee, FDA, April 24, 1991, and March 4, 
1993.

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, 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 178.2010 is amended in the table in paragraph (b) by 
revising the entry for ``2-Methyl-4,6-bis[(octylthio)methyl]phenol'' 
under the heading ``Substances,'' and by revising entry ``2,'' and by 
numerically adding new entries ``5'' and ``6'' under the heading 
``Limitations'' to read as follows:


Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

 * * * * *
     (b) * * *

------------------------------------------------------------------------
         Substances                          Limitations                
------------------------------------------------------------------------
                                 *******                                
 2-Methyl-4,6-                For use only:                             
 bis[(octylthio)methyl]phen                                             
 ol (CAS Reg. No. 110553-27-                                            
 0).                                                                    
                              * * *                                     
                             2. At levels not to exceed 0.5 percent by  
                              weight of can-end cements and side-seam   
                              cements complying with Sec.               
                              175.300(b)(3)(xxxi) and (xxxii) of this   
                              chapter.                                  
                              * * *                                     
                             5. At levels not to exceed 0.1 percent by  
                              weight of petroleum alicyclic 0hydrocarbon
                              resins complying with Sec. 175.320 of this
                              chapter; rubber-modified polystyrene      
                              complying with Sec. 177.1640 of this      
                              chapter that contact food only under      
                              conditions of use B through H described in
                              Table 2, Sec. 176.170(c) of this chapter; 
                              and petroleum hydrocarbon resins and      
                              rosins and rosin derivatives complying    
                              with Sec. 178.3800 of this chapter.       
                                                                        
                             6. At levels not to exceed 0.2 percent by  
                              weight of styrene block polymers complying
                              with Sec. 177.1810 of this chapter that   
                              contact food of Types I, II, IV-B, VI, VII-
                              B, and VIII described in Table 1, Sec.    
                              176.170(c) of this chapter, only under    
                              conditions of use C through H described in
                              Table 2, Sec. 176.170(c) of this chapter. 
                                 *******                                
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    Dated: November 22, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-29732 Filed 12-2-94; 8:45 am]
BILLING CODE 4160-01-F