[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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    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