[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Rules and Regulations]
[Pages 54426-54428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26221]
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[[Page 54427]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178
[Docket No. 92F-0189]
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 2,2'-
methylenebis(4,6-di-tert-butylphenyl)2-ethylhexyl phosphite as an
antioxidant and/or stabilizer in polypropylene articles intended for
contact with food. This action is in response to a petition filed by
Asahi Denka Kogyo K. K.
DATES: Effective October 24, 1995; written objections and requests for
a hearing by November 24, 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: 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 May 20, 1992 (57 FR 21415), FDA announced that a food
additive petition (FAP 2B4320) had been filed by Asahi Denka Kogyo K.
K., c/o 775 S. 23d St., Arlington, VA 22202 (formerly 1002 Pennsylvania
Ave. SE., Washington, DC 20003). The petition proposed to amend the
food additive regulations in Sec. 178.2010 Antioxidants and/or
stabilizers for polymers (21 CFR 178.2010) to provide for the safe use
of 2,2'-methylenebis(4,6-di-tert-butylphenyl)2-ethylhexyl phosphite as
an antioxidant and/or stabilizer in polypropylene articles intended for
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 the regulations in Sec. 178.2010 should be amended as set forth
below.
FDA's review of the subject 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 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.
Any person who will be adversely affected by this regulation may at
any time on or before November 24, 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., 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
[[Page 54428]]
``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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* * * *
* * *
2,2'-Methylenebis(4,6-di-tert- For use only at levels not to
butylphenyl)2-ethylhexyl phosphite (CAS exceed 0.25 percent by weight
Reg. No. 126050-54-2). of polypropylene complying
with Sec. 177.1520 of this
chapter. The finished
polymers may only be used in
contact with food of the
types identified in Sec.
176.170(c) of this chapter,
Table 1, under Categories I,
II, IV-B, VI-B, VII-B, and
VIII under conditions of use
B through H described in
Table 2, Sec. 176.170(c) of
this chapter, and with food
of the types identified in
Sec. 176.170(c) of this
chapter, Table 1, under
Categories III, IV-A, V, VI-
A, VI-C, VII-A, and IX under
conditions of use C through G
described in Table 2, Sec.
176.170(c) of this chapter.
* * * *
* * *
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Dated: October 13, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-26221 Filed 10-23-95; 8:45 am]
BILLING CODE 4160-01-F