[Federal Register Volume 65, Number 90 (Tuesday, May 9, 2000)]
[Rules and Regulations]
[Pages 26746-26747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11479]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 99F-1910]


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 2-[4,6-bis(2,4-
dimethylphenyl)-1,3,5-triazin-2-yl]-5-(octyloxy)phenol as a stabilizer 
for olefin polymers intended for use in contact with food. This action 
is in response to a petition filed by Cytec Industries, Inc.

DATES: This rule is effective May 9, 2000. Submit written objections 
and requests for a hearing by June 8, 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 June 22, 1999 (64 FR 33306), FDA announced that a food 
additive petition (FAP 9B4675) had been filed by Cytec Industries, 
Inc., c/o Keller and Heckman LLP, 1001 G St. NW., suite 500 West, 
Washington DC 20001. 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 2-[4,6-
bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5-(octyloxy)phenol as a 
stabilizer for 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) that 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 21 CFR 
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 9B4675. 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 collections 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 June 8, 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) * * *

[[Page 26747]]



 
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             Substances                          Limitations
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  *                    *                    *                    *
                   *                    *                    *
2-[4,6-Bis(2,4-dimethylphenyl)-       For use only:
 1,3,5-triazin-2-yl]-5-               1. At levels not to exceed 0.3
 (octyloxy)phenol (CAS Reg. No.       percent by weight of olefin
 2725-22-6).                          polymers complying with Sec.
                                      177.1520(c) of this chapter in
                                      contact with food types I, II, IV-
                                      B, VI, VII-B, and VIII described
                                      in Sec.  176.170(c) of this
                                      chapter, table 1, under conditions
                                      of use D through G as described in
                                      Sec.  176.170(c), table 2, of this
                                      chapter.
                                      2. At levels not to exceed 0.1
                                      percent by weight of polypropylene
                                      complying with Sec.  177.1520(c)
                                      of this chapter, items 1.1a, 1.2,
                                      and 1.3 in contact with food under
                                      conditions of use A through H as
                                      described in Sec.  176.170(c),
                                      table 2, of this chapter.
                                      3. At levels not to exceed 0.04
                                      percent by weight of polyethylene
                                      and olefin copolymers complying
                                      with Sec.  177.1520(c) of this
                                      chapter, items 2.1, 2.2, 2.3,
                                      3.1a, 3.1b, 3.1c, 3.2a, and 3.2b
                                      having a minimum density of 0.94
                                      gram per cubic centimeter, in
                                      contact with food under conditions
                                      of use A through H as described in
                                      Sec.  176.170, table 2, of this
                                      chapter provided that the finished
                                      articles used in contact with
                                      fatty food types III, IV-A, V, VII-
                                      A, and IX as described in table 1
                                      of Sec.  176.170(c) of this
                                      chapter hold a minimum of 2
                                      gallons (7.6 liters) of food.
                                      4. At levels not to exceed 0.4
                                      percent by weight of ethylene
                                      copolymers complying with Sec.
                                      177.1520(c) of this chapter, items
                                      3.1a, 3.1b, 3.1c, 3.2a, and 3.2b,
                                      having a density of less than 0.94
                                      gram per cubic centimeter, in
                                      contact with food under conditions
                                      of use B through H, as described
                                      in Sec.  176.170(c), table 2, of
                                      this chapter provided that the
                                      finished articles used in contact
                                      with fatty food types III, IV-A,
                                      V, VII-A, and IX hold a minimum of
                                      5 gallons (18.9 liters) of food.
                                      5. At levels not to exceed 0.04
                                      percent by weight of polyethylene
                                      having a density of less than 0.94
                                      gram per cubic centimeter, and
                                      olefin polymers complying with
                                      Sec.  177.1520(c) of this chapter,
                                      items 2.1, 2.2, 2.3, 3.3a, 3.3b,
                                      3.4, 3.5, 3.6, 4, 5, and 6, in
                                      contact with food under conditions
                                      of use D through G as described in
                                      Sec.  176.170(c) of this chapter,
                                      table 2, provided that the
                                      finished articles used in contact
                                      with fatty food types III, IV-A,
                                      V, VII-A, and IX hold a minimum of
                                      5 gallons (18.9 liters) of food.
  *                    *                    *                    *
                   *                    *                    *
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    Dated: April 27, 2000
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-11479 Filed 5-8-00; 8:45 am]
BILLING CODE 4160-01-F