[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Rules and Regulations]
[Pages 51587-51588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25258]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178
[Docket No. 95F-0175]
Indirect Food Additives: Adjuvants, Production Aids, and
Sanitizers
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to expand the safe use of sodium 2,2'-methylenebis
(4,6-di-tert-butylphenyl) phosphate as a clarifying agent 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 3, 1996; written objections and requests for a
hearing by November 4, 1996.
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: John R. Bryce, Center for Food Safety
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3023.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of July 13, 1995 (60 FR 36149), FDA announced that a food
additive petition (FAP 5B4458) had been filed by Asahi Denka Kogyo
K.K., c/o Japan Technical Information Center, Inc., 775 South 23d St.,
Arlington, VA 22202. The petition proposed to amend Sec. 178.3295
Clarifying agents for polymers (21 CFR 178.3295) of the food additive
regulations to provide for the safe use of sodium 2,2'-methylenebis
(4,6-di-tert-butylphenyl) phosphate as a clarifying agent in
polypropylene articles intended for contact with food under conditions
of use A and B as described in Table 2 of 21 CFR 176.170(c).
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, and the additive will achieve its intended
technical effect; therefore the regulations in Sec. 178.3295 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, 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.
Any person who will be adversely affected by this regulation may at
any time on or before November 4, 1996, 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:
[[Page 51588]]
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 by revising the entry
for ``Sodium 2,2'-methylenebis (4,6-di-tert-butylphenyl) phosphate'' to
read as follows:
Sec. 178.3295 Clarifying agents for polymers.
* * * * *
----------------------------------------------------------------------------------------------------------------
Substances Limitations
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Sodium 2,2'-methylenebis (4,6-di-tert-butylphenyl) For use only:
phosphate (CAS Reg. No. 85209-91-2).
1. As a clarifying agent at a level not exceeding 0.30
percent by weight of olefin polymers complying with
Sec. 177.1520(c) of this chapter, items 1.1, 3.1, or
3.2 (where the copolymers complying with items 3.1 and
3.2 contain not less than 85 weight percent of polymer
units derived from polypropylene). The finished
polymers contact foods only of types I, II, IV-B, VI-
B, VII-B, and VIII 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), or foods of all types, limited to
conditions of use C through H described in Table 2 of
Sec. 176.170(c).
2. As a clarifying agent at a level not exceeding 0.10
percent by weight of polypropylene complying with Sec.
177.1520(c) of this chapter, item 1.1. The finished
polypropylene may be used in contact with foods of all
types under conditions of use A through H described in
Table 2 of Sec. 176.170(c) of this chapter.
----------------------------------------------------------------------------------------------------------------
Dated: September 26, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-25258 Filed 10-2-96; 8:45 am]
BILLING CODE 4160-01-F
