[Federal Register Volume 62, Number 132 (Thursday, July 10, 1997)]
[Rules and Regulations]
[Pages 36982-36984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17976]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 91F-0324]


Indirect Food Additives: Adjuvants, Production Aids, and 
Sanitizers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of an 
alkylthiophenolic mixture formed by the acid-catalyzed condensation 
reaction of 4-nonylphenol, formaldehyde, and 1-dodecanethiol as an 
antioxidant for adhesives, pressure-sensitive adhesives, and rubber 
articles intended for repeated use in contact with food. This action is 
in response to a petition filed by Goodyear Tire & Rubber Co.

DATES: The regulation is effective July 10, 1997. Submit written 
objections and requests for a hearing by August 11, 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: Andrew J. Zajac, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3095.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of September 12, 1991 (56 FR 46439), FDA announced that a food 
additive petition (FAP 1B4259) had been filed by the Goodyear Tire & 
Rubber Co. (currently c/o Keller and Heckman, 1001 G St. NW., suite 500 
West, Washington, DC 20001). The petition proposed to amend the food 
additives regulations in Sec. 178.2010 Antioxidants and/or stabilizers 
for polymers (21 CFR 178.2010) to provide for the safe use of the acid-
catalyzed condensation reaction product of p-nonylphenol, formalin, and 
1-dodecanethiol as an antioxidant for adhesives, listed under 21 CFR 
175.105, and repeat-use rubber articles, listed under 21 CFR 177.2600. 
In a notice published in the Federal Register of January 26, 1995 (60 
FR 5184), corrected on February 9, 1995 (60 FR 7774), FDA amended the 
September 12, 1991, notice to state that upon further review of the 
petition, the agency noted that the petitioner intended to use the 
additive in pressure-sensitive adhesives rather than adhesives 
generally; however, the agency also stated the petitioner had 
subsequently amended the petition also to include the use of the 
additive in adhesives. Additionally, for clarification purposes, the 
nomenclature for the additive was being modified to 
``alkylthiophenolics formed by the acid-catalyzed condensation reaction 
of p-nonylphenol, formaldehyde, and 1-dodecanethiol''. Upon further 
review, the agency has decided that the additive is more accurately 
described as alkylthiophenolics formed by the acid-catalyzed 
condensation reaction of 4-nonylphenol, formaldehyde, and 1-
dodecanethiol.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that the proposed use of the additive in 
adhesives, pressure-sensitive adhesives, and rubber articles intended 
for repeated use in contact with food is safe, that the food additive 
will achieve its intended technical effect, and that Sec. 178.2010 
should be amended as set forth below.
    FDA's review of the subject petition indicates that the additive 
may contain

[[Page 36983]]

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.
    No comments were received during the 30-day comment period 
specified in the filing notice for comments on the environmental 
assessment submitted with the petition.
    Any person who will be adversely affected by this regulation may at 
any time on or before August 11, 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 
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 
alphabetically adding a new entry under the headings ``Substances'' and 
``Limitations'' to read as follows:


Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

* * * * *
    (b) * * *

                                                                        
------------------------------------------------------------------------
               Substances                          Limitations          
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
Alkylthiophenolics: acid-catalyzed       For use only at levels not to  
 condensation reaction products of 4-     exceed 2 percent by weight of 
 nonylphenol, formaldehyde, and 1-        adhesives complying with Sec. 
 dodecanethiol (CAS Reg. No. 164907-73-   175.105 of this chapter, of   
 7).                                      pressure-sensitive adhesives  
                                          complying with Sec.  175.125  
                                          of this chapter, and of rubber
                                          articles complying with Sec.  
                                          177.2600 of this chapter.     
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------



[[Page 36984]]

    Dated: June 20, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-17976 Filed 7-9-97; 8:45 am]
BILLING CODE 4160-01-F