[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Rules and Regulations]
[Pages 54426-54428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26221]



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[[Page 54427]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178

[Docket No. 92F-0189]


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 2,2'-
methylenebis(4,6-di-tert-butylphenyl)2-ethylhexyl phosphite as an 
antioxidant and/or stabilizer in polypropylene articles intended for 
contact with food. This action is in response to a petition filed by 
Asahi Denka Kogyo K. K.
DATES:  Effective October 24, 1995; written objections and requests for 
a hearing by November 24, 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: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-216), 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 May 20, 1992 (57 FR 21415), FDA announced that a food 
additive petition (FAP 2B4320) had been filed by Asahi Denka Kogyo K. 
K., c/o 775 S. 23d St., Arlington, VA 22202 (formerly 1002 Pennsylvania 
Ave. SE., Washington, DC 20003). 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 2,2'-methylenebis(4,6-di-tert-butylphenyl)2-ethylhexyl phosphite as 
an antioxidant and/or stabilizer in polypropylene articles intended for 
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 the regulations in Sec. 178.2010 should be amended as set forth 
below.
    FDA's review of the subject 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) of 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's 
conclusion was based on the fact that the route of administration 
(inhalation) is not relevant to the safety of formaldehyde residues in 
food and the fact that tumors were observed only locally at the portal 
of entry (nasal turbinates). In addition, 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, ``* * * 
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. Based on the 
Committee's evaluation, the agency has determined that there is no 
basis to conclude 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 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 November 24, 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., 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 
alphabetically adding a new entry under the headings 

[[Page 54428]]
``Substances'' and ``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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  *                    *                    *                    *      
                   *                    *                    *          
2,2'-Methylenebis(4,6-di-tert-            For use only at levels not to 
 butylphenyl)2-ethylhexyl phosphite (CAS   exceed 0.25 percent by weight
 Reg. No. 126050-54-2).                    of polypropylene complying   
                                           with Sec. 177.1520 of this   
                                           chapter. The finished        
                                           polymers may only be used in 
                                           contact with food of the     
                                           types identified in Sec.     
                                           176.170(c) of this chapter,  
                                           Table 1, under Categories I, 
                                           II, IV-B, VI-B, VII-B, and   
                                           VIII under conditions of use 
                                           B through H described in     
                                           Table 2, Sec. 176.170(c) of  
                                           this chapter, and with food  
                                           of the types identified in   
                                           Sec. 176.170(c) of this      
                                           chapter, Table 1, under      
                                           Categories III, IV-A, V, VI- 
                                           A, VI-C, VII-A, and IX under 
                                           conditions of use C through G
                                           described in Table 2, Sec.   
                                           176.170(c) of this chapter.  
  *                    *                    *                    *      
                   *                    *                    *          
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    Dated: October 13, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-26221 Filed 10-23-95; 8:45 am]
BILLING CODE 4160-01-F