[Federal Register Volume 61, Number 242 (Monday, December 16, 1996)]
[Rules and Regulations]
[Pages 65942-65943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31808]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178

[Docket No. 96F-0164]


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 expanded safe use of sodium 
2,2'-methylenebis(4,6-di-tert-butylphenyl)phosphate as a clarifying 
agent in high density polyethylene intended for use in contact with 
food. This action is in response to a petition filed by Asahi Denka 
Kogyo K.K.

DATES: Effective December 16, 1996; written objections and requests for 
a hearing by January 15, 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: 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 30, 1996 (61 FR 27085), FDA announced that a food 
additive petition (FAP 6B4504) had been filed by Asahi Denka Kogyo 
K.K., 2-13 Shirahata 5-Chome, Urawa City, Saitama 336, Japan. The 
petition proposed to amend the food additive regulations in 
Sec. 178.3295 Clarifying agents for polymers (21 CFR 178.3295) to 
provide for the additional safe use of sodium 2,2'-methylenebis(4,6-di-
tert-butylphenyl)phosphate as a clarifying agent in high density 
polyethylene intended for use in contact with food.
    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 food additive will achieve its 
intended technical effect, and that therefore, the regulations in 
Sec. 178.3295 should be amended as set forth below.
    FDA's review of this 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 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, concerning 
the Soffritti study, ``* * * that data, 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 histopathological 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 January 15, 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

[[Page 65943]]

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 178.3295 is amended in the table in the entry for 
``Sodium 2,2'-methylenebis(4,6-di-tert-butylphenyl)phosphate'' by 
adding a new entry ``3.'' under the heading ``Limitations'' to read as 
follows:


Sec. 178.3295  Clarifying agents for polymers.

* * * * *

                                                                        
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             Substances                          Limitations            
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  *                    *                    *                    *      
                   *                    *                    *          
Sodium 2,2'-methylenebis(4,6-di-     For use only:                      
 tert-butylphenyl)phosphate (CAS     * * * * *                          
 Reg. No. 85209-91-2).               3. As a clarifying agent in olefin 
                                      polymers complying with Sec.      
                                      177.1520(c) of this chapter, item 
                                      2.2, where the finished polymer   
                                      contacts foods only of types I,   
                                      II, IV-B, VI-A, VI-B, and VII-B as
                                      identified in Table 1 of Sec.     
                                      176.170(c) of this chapter and    
                                      limited to conditions of use B    
                                      through H described in Table 2 of 
                                      Sec.  176.170(c) of this chapter, 
                                      or foods of types III, IV-A, V, VI-
                                      C, and VII-A as identified in     
                                      Table 1 of Sec.  176.170(c) of    
                                      this chapter and limited to       
                                      conditions of use C through G     
                                      described in Table 2 of Sec.      
                                      176.170(c) of this chapter.       
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    Dated: November 27, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-31808 Filed 12-13-96; 8:45 am]
BILLING CODE 4160-01-F