[Federal Register Volume 64, Number 93 (Friday, May 14, 1999)]
[Rules and Regulations]
[Pages 26281-26282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12177]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 91F-0399]
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 1,3-propanediamine,
N,N''-1,2-ethanediylbis-, polymer with N-butyl-2,2,6,6-tetramethyl-4-
piperidinamine and 2,4,6-trichloro-1,3,5-triazine as a light stabilizer
for polypropylene and polyethylene complying with 21 CFR 177.1520. This
action responds to a petition filed by 3-V Chemical Corp.
DATES: The regulation is effective May 14, 1999. Submit written
objections and requests for a hearing by June 14, 1999.
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: Julius Smith, Center for Food Safety
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3091.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of January 3, 1992 (57 FR 291), FDA announced that a petition
(FAP 1B4277) had been filed by 3-V Chemical Corp., P.O. Box Drawer Y,
Georgetown, SC 29442, proposing to amend Sec. 178.2010 Antioxidants
and/or stabilizers for polymers (21 CFR 178.2010), to provide for the
safe use of 1,3-propanediamine, N,N''-1,2-ethanediylbis-, polymer with
N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-
triazine as a light stabilizer for polyethylene and polypropylene
complying with 21 CFR 177.1520.
FDA has evaluated the 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 additive will have the
intended technical effect, and therefore, that the regulations 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.
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.
[[Page 26282]]
Any person who will be adversely affected by this regulation may
at any time on or before June 14, 1999, 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: 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.
* * * * *
(b) * * *
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Substances Limitations
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* * * * * *
*
1,3-Propanediamine, N,N''-1,2-ethanediylbis-, polymer For use only:
with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 1. At levels not to exceed 0.3 percent by weight of
2,4,6-trichloro-1,3,5-triazine (CAS Reg. No. 136504-96- polypropylene complying with Sec. 177.1520(c) of this
6). chapter, items 1.1, 1.2, and 1.3.
2. At levels not to exceed 0.2 percent by weight of
olefin polymers having a density greater than or equal
to 0.94 grams per cubic centimeter and complying with
Sec. 177.1520(c) of this chapter, items 2.1, 2.2,
2.3, 3.1, and 3.2.
3. At levels not to exceed 0.3 percent by weight of
olefin polymers having a density less than 0.94 grams
per cubic centimeter and complying with Sec.
177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1,
3.2, 3.3, 3.4, 3.5, 3.6, and 4.0. The finished
polymers are to contact food only under conditions of
use B through H described in Table 2 of Sec.
176.170(c) of this chapter, and when used in contact
with fatty foods of Types III, IV-A, V, VII-A, and IX
as described in Table 1 of Sec. 176.170(c) of this
chapter, the finished articles are to have a volume of
at least 18.9 liters (5 gallons).
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*
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Dated: May 3, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 99-12177 Filed 5-13-99; 8:45 am]
BILLING CODE 4160-01-F
