[Federal Register Volume 65, Number 131 (Friday, July 7, 2000)]
[Rules and Regulations]
[Pages 41874-41876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17203]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 99F-1456]


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)-, polymer with 2,4,6-
trichloro-1,3,5-triazine, reaction products with N-butyl-1-butanamine 
and N-butyl-2,2,6,6-tetramethyl-4-piperidinamine as a stabilizer in 
olefin polymers intended for use in contact with food. This action 
responds to a petition filed by Ciba Specialty Chemicals Corp.

DATES: This rule is effective July 7, 2000. Submit written objections 
and requests for a hearing by August 7, 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: Hortense S. Macon, Center for Food 
Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3086.

SUPPLEMENTARY INFORMATION: In a notice published in theFederal Register 
of May 27, 1999 (64 FR 28825), FDA announced that a food additive 
petition (FAP 9B4656) had been filed by Ciba Specialty Chemicals Corp., 
540 White Plains Rd., P.O. Box 2005, Tarrytown, NY 10591-9005. 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)-, polymer with 2,4,6-trichloro-
1,3,5-triazine, reaction products with N-butyl-1-butanamine and N-
butyl-2,2,6,6-tetramethyl-4-piperidinamine as a stabilizer in olefin 
polymers 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) the regulations in 
Sec. 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 9B4656. 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

[[Page 41875]]

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 file with the Dockets Management Branch (address above) 
written objections by August 7, 2000. 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 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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      *         *         *         *         *         *         *
1,6-Hexanediamine, N,N'-bis(2,2,6,6- For use only:
 tetramethyl-4-piperidinyl)-,        1. At levels not to exceed 0.5
 polymer with 2,4,6-trichloro-1,3,5-  percent by weight of propylene
 triazine, reaction products with N-  polymers and copolymers complying
 butyl-1-butanamine and N-butyl-      with Sec.  177.1520(c) of this
 2,2,6,6-tetramethyl-4-               chapter, items 1.1, 1.2, 3.1a,
 piperidinamine (CAS Reg. No.         3.2a, 3.2b, 3.4, or 3.5. The
 192268-64-7)                         finished polymers may contact food
                                      only of the types identified in
                                      Sec.  176.170(c) of this chapter,
                                      table 1, under categories I, II,
                                      IV-B, VI-A, VI-B, VII-B, and VIII,
                                      and under conditions of use B
                                      through H described in table 2 of
                                      Sec.  176.170(c) of this chapter.
                                     2. At levels not to exceed 0.3
                                      percent by weight of propylene
                                      polymers and copolymers complying
                                      with Sec.  177.1520(c) of this
                                      chapter, items 1.1, 1.2, 3.1a,
                                      3.2a, 3.2b, 3.4, or 3.5. The
                                      finished polymers may contact food
                                      only of the types identified in
                                      Sec.  176.170(c) of this chapter,
                                      table 1, under categories III, IV-
                                      A, V, VI-C, VII-A, and IX, and
                                      under conditions of use B through
                                      H described in table 2 of Sec.
                                      176.170(c) of this chapter.
                                     3. At levels not to exceed 0.5
                                      percent by weight of ethylene
                                      polymers and copolymers complying
                                      with Sec.  177.1520(c) of this
                                      chapter, items 2.1, 2.2, 2.3,
                                      3.1a, 3.1b, 3.2a, or 3.6 (where
                                      the density of each of these
                                      polymers is at least 0.94 gram per
                                      cubic centimeter), or 5. The
                                      finished polymers may contact food
                                      only of the types identified in
                                      Sec.  176.170(c) of this chapter,
                                      table 1, under categories I, II,
                                      IV-B, VI-A, VI-B, VII-B, and VIII,
                                      and under conditions of use B
                                      through H described in table 2 of
                                      Sec.  176.170(c) of this chapter.
                                     4. At levels not to exceed 0.05
                                      percent by weight of ethylene
                                      polymers and copolymers complying
                                      with Sec.  177.1520(c) of this
                                      chapter, items 2.1, 2.2, 2.3,
                                      3.1a, 3.1b, 3.2a, or 3.6 (where
                                      the density of each of these
                                      polymers is at least 0.94 gram per
                                      cubic centimeter), or 5. The
                                      finished polymers may contact food
                                      only of the types identified in
                                      Sec.  176.170(c) of this chapter,
                                      table 1, under categories III, IV-
                                      A, V, VI-C, VII-A, and IX, and
                                      under conditions of use B through
                                      H described in table 2 of Sec.
                                      176.170(c) of this chapter.
                                     5. At levels not to exceed 0.5
                                      percent by weight of ethylene
                                      polymers and copolymers complying
                                      with Sec.  177.1520(c) of this
                                      chapter, items 2.1, 2.2, 2.3,
                                      3.1a, 3.1b, 3.2a, 3.4, 3.5, or 3.6
                                      (where the density of each of
                                      these polymers is less than 0.94
                                      gram per cubic centimeter), or 5.
                                      The finished polymers may contact
                                      food only of the types identified
                                      in Sec.  176.170(c) of this
                                      chapter, table 1, under categories
                                      I, II, IV-B, VI-A, VI-B, VII-B,
                                      and VIII, and under conditions of
                                      use C through G described in table
                                      2 of Sec.  176.170(c) of this
                                      chapter.

[[Page 41876]]

 
                                     6. At levels not to exceed 0.01
                                      percent by weight of ethylene
                                      polymers and copolymers complying
                                      with Sec.  177.1520(c) of this
                                      chapter, items 2.1, 2.2, 2.3,
                                      3.1a, 3.1b, 3.2a, 3.4, 3.5, or 3.6
                                      (where the density of each of
                                      these polymers is less than 0.94
                                      gram per cubic centimeter), or 5.
                                      The finished polymers may contact
                                      food only of the types identified
                                      in Sec.  176.170(c) of this
                                      chapter, table 1, under categories
                                      III, IV-A, V, VI-C, VII-A, and IX,
                                      and under conditions of use C
                                      through G described in table 2 of
                                      Sec.  176.170(c) of this chapter.
      *         *         *         *         *         *         *
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    Dated: June 15, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-17203 Filed 7-6-00; 8:45 am]
BILLING CODE 4160-01-F