[Federal Register Volume 62, Number 111 (Tuesday, June 10, 1997)]
[Rules and Regulations]
[Pages 31511-31512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15011]
[[Page 31511]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 92F-0279]
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 N,N-bis(2-
hydroxyethyl)dodecanamide as an antistatic agent in polypropylene food-
packaging films. This action responds to a petition filed by Toho
Chemical Industry Co., Ltd., c/o Parexel International Corp.
DATES: Effective June 10, 1997. Written objections and requests for a
hearing by July 10, 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: Mitchell A. Cheeseman, Center for Food
Safety and Applied Nutrition (HFS-215), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3083.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of August 7, 1992 (57 FR 34937), FDA announced that a food
additive petition (FAP 2B4308) had been filed by Toho Chemical Industry
Co., Ltd., c/o Parexel International Corp., 195 West St., Waltham, MA
02154. The petition proposed to amend the food additive regulations in
Sec. 178.3130 Antistatic and/or antifogging agents in food-packaging
materials (21 CFR 178.3130) to provide for the safe use of N,N-bis(2-
hydroxyethyl)dodecanamide as an antistatic agent in polypropylene food-
packaging films.
FDA has evaluated data in the petition and other relevant material.
The agency concludes that: (1) The proposed use of the food additive is
safe, (2) the additive will achieve its intended technical effect, and
(3) the regulations in Sec. 178.3130 should be amended as set forth
below.
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 July 10, 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
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.
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 and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 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 178.3130 is amended in the table in paragraph (b) by
revising the entry for ``N,N-Bis(2-hydroxyethyl) dodecanamide * * *''
to read as follows:
Sec. 178.3130 Antistatic and/or antifogging agents in food-packaging
materials.
* * * * *
(b) * * *
[[Page 31512]]
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Substances Limitations
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N,N-Bis(2-hydroxyethyl)dodecanamide For use only:
produced when diethanolamine is made 1. As an antistatic agent at
to react with methyl laurate such that levels not to exceed 0.5
the finished product: Has a minimum percent by weight of molded or
melting point of 36 C; has a minimum extruded polyethylene
amide assay of 90 percent; contains no containers intended for
more than 2 percent by weight of free contact with honey, chocolate
diethanolamine; and contains no more syrup, liquid sweeteners,
than 0.5 percent by weight of N,N, condiments, flavor extracts
bis(2-hydroxyethyl)piperazine, as and liquid flavor
determined by paper chromatography concentrates, grated cheese,
method. light and heavy cream, yogurt,
and foods of Type VIII as
described in Table 1 of Sec.
176.170(c) of this chapter.
2. As an antistatic agent at
levels not to exceed 0.2
percent by weight in
polypropylene films complying
with Sec. 177.1520 of this
chapter, and used in contact
with food of Types I, II, III,
IV, V, VI-B, VII, VIII, and IX
described in Table 1 of Sec.
176.170(c) of this chapter,
and under conditions of use B
through H described in Table 2
of Sec. 176.170(c) of this
chapter. The average thickness
of such polypropylene film
shall not exceed 0.001 inches
(30 micrometers).
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Dated: May 23, 1997.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 97-15011 Filed 6-9-97; 8:45 am]
BILLING CODE 4160-01-F