[Federal Register Volume 59, Number 232 (Monday, December 5, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29732]
[[Page Unknown]]
[Federal Register: December 5, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178
[Docket No. 91F-0430]
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 2-methyl-4,6-
bis[(octylthio)methyl]phenol as a stabilizer in can-end and side seam
cements and in various polymers intended for use in contact with food.
This action is in response to a petition filed by Ciba-Geigy Corp.
DATES: Effective December 5, 1994; written objections and requests for
a hearing by January 4, 1995.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Richard H. White, Center for Food
Safety and Applied Nutrition (HFS-216), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3094.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of December 2, 1991 (56 FR 61253), FDA announced that a food
additive petition (FAP 1B4283) had been filed by Ciba-Geigy Corp.,
Seven Skyline Dr., Hawthorne, NY 10532-2188. The petition proposed that
Sec. 178.2010 Antioxidants and/or stabilizers for polymers (21 CFR
178.2010) be amended to provide for the safe use of 2-methyl-4,6-
bis[(octylthio)methyl]phenol as a stabilizer in can-end and side seam
cements and in various polymers intended for use in contact with food.
FDA has evaluated data in the petition and other relevant
material. The agency concludes that the proposed food additive use is
safe, and that this use should be listed in Sec. 178.2010, as set forth
below. In addition, FDA is correcting the entry for this additive in
Sec. 178.2010(b), in the table under the heading ``Substances'' to
capitalize the letter ``m'' in ``methyl.'' Thus, it will read ``2-
Methyl-4,6-bis[(octylthio)methyl]phenol.''
A 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) that has been formed by 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 reached its conclusion because the route of administration
was not relevant to food safety, and the fact that tumors were observed
only locally at the portal of entry (nasal turbinates). 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 in a ``Memorandum of Conference,'' dated April
24, 1991, and March 4, 1993, ``* * * 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
histopathologic conclusions, and the use of unusual nomenclature to
describe the tumors. Thus, the committee concluded that there is no
basis to find 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 January 4, 1995, 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
revising the entry for ``2-Methyl-4,6-bis[(octylthio)methyl]phenol''
under the heading ``Substances,'' and by revising entry ``2,'' and by
numerically adding new entries ``5'' and ``6'' under the heading
``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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*******
2-Methyl-4,6- For use only:
bis[(octylthio)methyl]phen
ol (CAS Reg. No. 110553-27-
0).
* * *
2. At levels not to exceed 0.5 percent by
weight of can-end cements and side-seam
cements complying with Sec.
175.300(b)(3)(xxxi) and (xxxii) of this
chapter.
* * *
5. At levels not to exceed 0.1 percent by
weight of petroleum alicyclic 0hydrocarbon
resins complying with Sec. 175.320 of this
chapter; rubber-modified polystyrene
complying with Sec. 177.1640 of this
chapter that contact food only under
conditions of use B through H described in
Table 2, Sec. 176.170(c) of this chapter;
and petroleum hydrocarbon resins and
rosins and rosin derivatives complying
with Sec. 178.3800 of this chapter.
6. At levels not to exceed 0.2 percent by
weight of styrene block polymers complying
with Sec. 177.1810 of this chapter that
contact food of Types I, II, IV-B, VI, VII-
B, and VIII described in Table 1, Sec.
176.170(c) of this chapter, only under
conditions of use C through H described in
Table 2, Sec. 176.170(c) of this chapter.
*******
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Dated: November 22, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-29732 Filed 12-2-94; 8:45 am]
BILLING CODE 4160-01-F
