[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]
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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.
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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) * * *
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Substances Limitations
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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.
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[[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