[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