[Federal Register Volume 61, Number 99 (Tuesday, May 21, 1996)]
[Rules and Regulations]
[Pages 25395-25396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12761]



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


DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178

[Docket No. 93F-0385]


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 formaldehyde, 
polymer with 1-naphthylenol, as a release agent, applied on the 
internal parts of reactors employed in the production of polyvinyl 
chloride and acrylic copolymers intended for food-contact applications. 
This action is in response to a petition filed by Compagnia Italiana di 
Ricerca e Sviluppo, srl (CIRS).

DATES: Effective May 21, 1996; written objections and requests for a 
hearing by June 20, 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: 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 November 18, 1993 (58 FR 60859), FDA announced that a food 
additive petition (FAP 3B4380) had been filed by Compagnia Italiana di 
Ricerca e Sviluppo, srl (CIRS),
c/o AAC Consulting Group, 1730 Rhode Island Ave. NW., Washington, DC 
20036. The petition proposed to amend the food additive regulations in 
part 178 (21 CFR part 178) to provide for the safe use of formaldehyde, 
polymer with 1-naphthylenol, as an antiscaling agent, applied on the 
internal parts of reactors employed in the production of polyvinyl 
chloride and acrylic copolymers intended for food-contact applications. 
During its review, the agency determined that the use of the additive 
as an antiscaling agent has essentially the same technical effect as 
that of a release agent. This final rule reflects this conclusion and 
therefore FDA is listing the additive in Sec. 178.3860 Release agents.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that the proposed use of the additive is safe and 
that the regulations in Sec. 178.3860 should be amended as set forth 
below.
    FDA's 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) 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 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 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 June 20, 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., F. Maltoni, 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.

[[Page 25396]]

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 178.3860 is amended in the table in paragraph (b) by 
alphabetically adding a new entry under the headings ``List of 
substances'' and ``Limitations'' to read as follows:


Sec. 178.3860  Release agents.

* * * * *
    (b)  *  *  *

                                                                        
------------------------------------------------------------------------
            List of substances                      Limitations         
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
Formaldehyde, polymer with 1-naphthylenol  For use only as an           
 (CAS Reg. No. 25359-91-5).                 antiscaling or release      
                                            agent, applied on the       
                                            internal parts of reactors  
                                            employed in the production  
                                            of polyvinyl chloride and   
                                            acrylic copolymers, provided
                                            that the residual levels of 
                                            the additive in the polymer 
                                            do not exceed 4 parts per   
                                            million.                    
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------


    Dated: May 15, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-12761 Filed 5-20-96; 8:45 am]
BILLING CODE 4160-01-F