[Federal Register Volume 62, Number 155 (Tuesday, August 12, 1997)]
[Rules and Regulations]
[Pages 43075-43076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21292]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. 92F-0261]


Indirect Food Additives: Adhesives and Components of Coatings

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 3-pentadecenyl 
phenol mixture (obtained from cashew nutshell liquid) reacted with 
formaldehyde and ethylenediamine in a ratio of 1:2:2 as an epoxy curing 
agent in resins and coatings intended for contact with food. This 
action is in response to a petition filed by Cardolite Corp.

DATES: The regulation is effective August 12, 1997. Submit written 
objections and requests for a hearing by september 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: Ellen M. Waldron, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3089.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of July 21, 1992 (57 FR 32226), FDA announced that a food 
additive petition (FAP 2B4326) had been filed by Cardolite Corp., c/o 
1414 Fenwick Lane, Silver Spring, MD 20910 (now c/o Regulatory 
Assistance Corp., 17 Clearview Circle, Hopewell Junction, NJ 12533). 
The petition proposed to amend the food additive regulations in 
Sec. 175.300 Resinous and polymeric coatings (21 CFR 175.300) to 
provide for the safe use of 3-pentadecenyl phenol mixture (obtained 
from cashew nutshell liquid) reacted with formaldehyde and 
ethylenediamine in a ratio of 1:2:2 (CAS Reg. No. 68413-28-5) as an 
epoxy curing agent in resins and coatings intended for contact with 
food.
    FDA's review of the subject petition indicates that the additive 
may contain trace amounts of formaldehyde and ethylenediamine as 
impurities. The potential carcinogenicity of formaldehyde and 
ethylenediamine 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 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.
     The Committee also evaluated the results of a 2-year study 
submitted by the petitioner on ethylenediamine dihydrochloride 
(EDA2HCl) in Fisher 344 rats (Ref. 4). The committee concluded 
that data from this study do not demonstrate carcinogenic potential for 
(EDA2HCl) in Fisher 344 rats (Ref. 5). Based on the Committee's 
evaluation, the agency has determined that based upon the available 
data and information, there is no basis to conclude that 
ethylenediamine is a carcinogen.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that the proposed use of the additive is safe, 
that the additive will have its intended technical effect, and 
therefore, that the regulations in Sec. 175.300 should be amended as 
set forth below.
    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 September 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

[[Page 43076]]

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, pp. 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.
    4. Bushy Run Research Center, ``Ethylenediamine Dihydrochloride 
Two-Year Feeding Study in the Rat; Report 46-27,'' Mellon Institute-
Union Carbide Corp., Export, PA.
    5. Memorandum of conference concerning ``Ethylenediamine 
Dihydrochloride (EDA2HCl);'' meeting of the Cancer 
Assessment Committee, FDA; June 7, 1996.

List of Subjects in 21 CFR Part 175

    Adhesives, 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 
175 is amended as follows:

PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF 
COATINGS

    1. The authority citation for 21 CFR part 175 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 175.300 is amended in paragraph (b)(3)(viii)(b) by 
alphabetically adding a new entry to read as follows:


 Sec. 175.300  Resinous and polymeric coatings.

* * * * *
    (b) *  *  *
    (3) *  *  *
    (viii) *  *  *
    (b) *  *  *
* * * * *
3-Pentadecenyl phenol mixture (obtained from cashew nutshell liquid) 
reacted with formaldehyde and ethylenediamine in a ratio of 1:2:2 (CAS 
Reg. No. 68413-28-5).
* * * * *

    Dated: August 5, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-21292 Filed 8-11-97; 8:45 am]
BILLING CODE 4160-01-F