[Federal Register Volume 64, Number 247 (Monday, December 27, 1999)]
[Rules and Regulations]
[Pages 72273-72274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33397]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 99F-1421]
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 tetradecanoic acid,
lithium salt as a stabilizer for polypropylene and certain
polypropylene copolymers intended for use in contact with food. This
action is in response to a petition filed by Asahi Denka Kogyo K.K.
DATES: This regulation is effective December 27, 1999. Submit written
objections and requests for a hearing by January 26, 2000.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
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 May 24, 1999 (64 FR 28000), FDA announced that a food
additive petition (FAP 9B4665) had been filed by Asahi Denka Kogyo
K.K., 5-2-13, Shirahata, Urawa City, Saitama 336-0022, Japan. The
petition proposed to amend the food additive regulations to provide for
the safe use of tetradecanoic acid, lithium salt as a stabilizer in
polypropylene and certain olefin copolymers intended for use in contact
with food.
FDA has evaluated the data in the petition and other relevant
material. Based on this information, the agency concludes that: (1) The
proposed use of the additive is safe, (2) the additive will achieve its
intended technical effect, and therefore, (3) that the regulations in
21 CFR 178.2010 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 previously considered the environmental effects of
this rule as announced in the notice of filing for FAP 9B4665. 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.
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
Any person who will be adversely affected by this regulation may at
any time on or before January 26, 2000, 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 are to be
submitted and are to 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 office above 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: 21 U.S.C. 321, 342, 348, 379e.
2. Section 178.2010 is amended in the table in paragraph (b) by
alphabetically adding an entry under the headings ``Substances'' and
``Limitations'' to read as follows:
Sec. 178.2010 Antioxidants and/or stabilizers for polymers.
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(b) * * *
[[Page 72274]]
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Substances Limitations
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Tetradecanoic acid, lithium salt For use only at levels not to
(CAS Reg. No. 20336-96-3). exceed 0.15 percent by weight of
polypropylene and polypropylene
copolymers complying with Sec.
177.1520(c) of this chapter, items
1.1a, 1.1b, 3.1a, 3.1b, 3.1c,
3.2a, and 3.2b. The finished
polymers may only be used in
contact with food of Types I, II,
IV-B, VII-B, and VIII as described
in table 1 of Sec. 176.170(c) of
this chapter under conditions of
use B through H as described in
table 2 of Sec. 176.170(c) of
this chapter, and with food of
Types III, IV-A, V, VI-A, VI-B, VI-
C, VII-A, and IX described in
table 1 of Sec. 176.170(c) of
this chapter under conditions of
use C through G as described in
table 2 of Sec. 176.170(c) of
this chapter.
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Dated: December 17, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 99-33397 Filed 12-23-99; 8:45 am]
BILLING CODE 4160-01-F
