[Federal Register Volume 63, Number 124 (Monday, June 29, 1998)]
[Rules and Regulations]
[Pages 35134-35135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17144]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 97F-0440]
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 1,6-hexanediamine,
N, N'-bis(2,2,6,6-tetramethyl-4-piperidinyl)-, polymers with
morpholine-2,4,6-trichloro-1,3,5-triazine reaction products,
methylated, as a stabilizer for olefin polymers intended for use in
contact with food. This action is in response to a petition filed by
Cytec Industries, Inc.
DATES: The regulation is effective June 29, 1998; written objections
and requests for a hearing by July 29, 1998.
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-215), 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 November 6, 1997 (62 FR 60095), FDA announced that a food
additive petition (FAP 8B4562) had been filed by Cytec Industries,
Inc., c/o Keller and Heckman, 1001 G St. NW., suite 500 West,
Washington, DC 20001. 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 1,6-
hexanediamine, N, N'-bis(2,2,6,6-tetramethyl-4-piperidinyl)-, polymers
with morpholine-2,4,6-trichloro-1,3,5-triazine reaction products,
methylated, as a stabilizer for olefin polymers complying with 21 CFR
177.1520 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 and the additive will achieve its intended
technical effect. Therefore, the regulations in Sec. 178.2010 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 the
Committee 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
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
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 previously considered the environmental effects of
this rule as announced in the notice of filing for
[[Page 35135]]
FAP 8B4562 (62 FR 60095, November 6, 1997). No new information or
comments have been received that would affect the agency's previous
determination that there is no significant impact on the human
environment and that an environmental impact statement is not required.
Any person who will be adversely affected by this regulation may at
any time on or before July 29, 1998, 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.
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
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. Biaggi,
``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: 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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* * * *
* * *
1,6-Hexanediamine, N, N'-bis(2,2,6,6- For use only as a stabilizer
tetramethyl-4-piperidinyl)-, polymers at levels not to exceed 0.3
with morpholine-2,4,6-trichloro-1,3,5- percent by weight of olefin
triazine reaction products, methylated polymers complying with
(CAS Reg. No. 193098-40-7). Sec. 177.1520(c) of this
chapter. The finished
polymers are to contact
food only under conditions
of use C, D, E, F, and G,
as described in Table 2 of
Sec. 176.170(c) of this
chapter. Provided that the
finished food-contact
articles have a volume of
at least 18.9 liters (5
gallons).
* * * *
* * *
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Dated: June 19, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-17144 Filed 6-26-98; 8:45 am]
BILLING CODE 4160-01-P