[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Rules and Regulations]
[Pages 51587-51588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25258]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178

[Docket No. 95F-0175]


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 expand the safe use of sodium 2,2'-methylenebis 
(4,6-di-tert-butylphenyl) phosphate as a clarifying agent 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 3, 1996; written objections and requests for a 
hearing by November 4, 1996.

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: John R. Bryce, Center for Food Safety 
and Applied Nutrition (HFS-216), 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 July 13, 1995 (60 FR 36149), FDA announced that a food 
additive petition (FAP 5B4458) had been filed by Asahi Denka Kogyo 
K.K., c/o Japan Technical Information Center, Inc., 775 South 23d St., 
Arlington, VA 22202. The petition proposed to amend Sec. 178.3295 
Clarifying agents for polymers (21 CFR 178.3295) of the food additive 
regulations to provide for the safe use of sodium 2,2'-methylenebis 
(4,6-di-tert-butylphenyl) phosphate as a clarifying agent in 
polypropylene articles intended for contact with food under conditions 
of use A and B as described in Table 2 of 21 CFR 176.170(c).
    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, and the additive will achieve its intended 
technical effect; therefore the regulations in Sec. 178.3295 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, concerning the Soffritti study,
``* * * that the 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 detail 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 4, 1996, 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:

[[Page 51588]]

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 by revising the entry 
for ``Sodium 2,2'-methylenebis (4,6-di-tert-butylphenyl) phosphate'' 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-tert-butylphenyl)       For use only:                                          
 phosphate (CAS Reg. No. 85209-91-2).                                                                           
                                                         1. As a clarifying agent at a level not exceeding 0.30 
                                                          percent by weight of olefin polymers complying with   
                                                          Sec.  177.1520(c) of this chapter, items 1.1, 3.1, or 
                                                          3.2 (where the copolymers complying with items 3.1 and
                                                          3.2 contain not less than 85 weight percent of polymer
                                                          units derived from polypropylene). The finished       
                                                          polymers contact foods only of types I, II, IV-B, VI- 
                                                          B, VII-B, and VIII 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), or foods of all types, limited to         
                                                          conditions of use C through H described in Table 2 of 
                                                          Sec.  176.170(c).                                     
                                                         2. As a clarifying agent at a level not exceeding 0.10 
                                                          percent by weight of polypropylene complying with Sec.
                                                           177.1520(c) of this chapter, item 1.1. The finished  
                                                          polypropylene may be used in contact with foods of all
                                                          types under conditions of use A through H described in
                                                          Table 2 of Sec.  176.170(c) of this chapter.          
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    Dated: September 26, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-25258 Filed 10-2-96; 8:45 am]
BILLING CODE 4160-01-F