[Federal Register Volume 61, Number 242 (Monday, December 16, 1996)]
[Rules and Regulations]
[Pages 65942-65943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31808]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178
[Docket No. 96F-0164]
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 expanded safe use of sodium
2,2'-methylenebis(4,6-di-tert-butylphenyl)phosphate as a clarifying
agent in high density polyethylene intended for use in contact with
food. This action is in response to a petition filed by Asahi Denka
Kogyo K.K.
DATES: Effective December 16, 1996; written objections and requests for
a hearing by January 15, 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: 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 30, 1996 (61 FR 27085), FDA announced that a food
additive petition (FAP 6B4504) had been filed by Asahi Denka Kogyo
K.K., 2-13 Shirahata 5-Chome, Urawa City, Saitama 336, Japan. The
petition proposed to amend the food additive regulations in
Sec. 178.3295 Clarifying agents for polymers (21 CFR 178.3295) to
provide for the additional safe use of sodium 2,2'-methylenebis(4,6-di-
tert-butylphenyl)phosphate as a clarifying agent in high density
polyethylene intended for use in contact with food.
FDA has evaluated data in the petition and other relevant material.
Based on this information, the agency concludes that the proposed use
of the additive is safe, that the food additive will achieve its
intended technical effect, and that therefore, the regulations in
Sec. 178.3295 should be amended as set forth below.
FDA's review of this 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 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 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 histopathological 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 January 15, 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
[[Page 65943]]
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 178.3295 is amended in the table in the entry for
``Sodium 2,2'-methylenebis(4,6-di-tert-butylphenyl)phosphate'' by
adding a new entry ``3.'' under the heading ``Limitations'' to read as
follows:
Sec. 178.3295 Clarifying agents for polymers.
* * * * *
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Substances Limitations
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* * * *
* * *
Sodium 2,2'-methylenebis(4,6-di- For use only:
tert-butylphenyl)phosphate (CAS * * * * *
Reg. No. 85209-91-2). 3. As a clarifying agent in olefin
polymers complying with Sec.
177.1520(c) of this chapter, item
2.2, where the finished polymer
contacts foods only of types I,
II, IV-B, VI-A, VI-B, and VII-B as
identified in Table 1 of Sec.
176.170(c) of this chapter and
limited to conditions of use B
through H described in Table 2 of
Sec. 176.170(c) of this chapter,
or foods of types III, IV-A, V, VI-
C, and VII-A as identified in
Table 1 of Sec. 176.170(c) of
this chapter and limited to
conditions of use C through G
described in Table 2 of Sec.
176.170(c) of this chapter.
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Dated: November 27, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-31808 Filed 12-13-96; 8:45 am]
BILLING CODE 4160-01-F
