[Federal Register Volume 64, Number 192 (Tuesday, October 5, 1999)]
[Rules and Regulations]
[Pages 53925-53926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25790]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 99F-1422]


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 expanded safe use of 2,4-di-
tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl]phenyl 
acrylate as an antioxidant and/or stabilizer for polypropylene, 
polystyrene, rubber-modified polystyrene, and styrene block copolymers 
intended for use in contact with food. This action responds to a 
petition filed by Sumitomo Chemical Co., Ltd.

DATES: This regulation is effective October 5, 1999. Submit written 
objections and requests for a hearing by November 4, 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: 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 26, 1999 (64 FR 28501), FDA announced that a food 
additive petition (FAP 9B4661) had been filed by Sumitomo Chemical Co., 
Ltd., 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 expanded safe use of 2,4-
di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl]phenyl 
acrylate as an antioxidant and/or stabilizer for polypropylene, 
polystyrene, rubber-modified polystyrene, and styrene block 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) 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 9B4661 (64 FR 
28501). 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 November 4, 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

[[Page 53926]]

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 
revising the entry for ``2,4-Di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-
hydroxyphenyl)ethyl]phenyl acrylate'' to read as follows:


Sec. 178.2010   Antioxidants and/or stabilizers for polymers.

* * * * *
     (b) * * *

 
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             Substances                           Limitations
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  *                    *                    *                    *
                   *                    *                    *
 2,4-Di-tert-pentyl-6-[1-(3,5-di-     For use only:
 tert-pentyl-2-                       1. At levels not to exceed 0.2
 hydroxyphenyl)ethyl]phenyl           percent by weight of polypropylene
 acrylate (CAS Reg. No. 123968-25-    complying with Sec.   177.1520 of
 2).                                  this chapter in contact with food
                                      under conditions of use D through
                                      G as described in Table 2 of Sec.
                                      176.170(c) of this chapter, except
                                      that polypropylene containing the
                                      additive at levels not to exceed
                                      0.075 percent by weight may
                                      contact food under conditions of
                                      use A through H described in Table
                                      2 of Sec.  176.170(c) of this
                                      chapter.
                                      2. At levels not to exceed 1.0
                                      percent by weight of of styrene
                                      block polymers complying with Sec.
                                       177.1810 of this chapter. The
                                      additive is used under conditions
                                      of use D through G as described in
                                      Table 2 of Sec.  176.170(c) of
                                      this chapter.
                                      3. At levels not to exceed 1.0
                                      percent by weight of polystyrene
                                      and rubber modified polystyrene
                                      complying with Sec.  177.1640 of
                                      this chapter in contact with food
                                      under conditions of use D through
                                      G as described in Table 2 of Sec.
                                      176.170(c) of this chapter.
  *                    *                    *                    *
                   *                    *                    *
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    Dated: September 21, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-25790 Filed 10-4-99; 8:45 am]
BILLING CODE 4160-01-F