[Federal Register Volume 65, Number 88 (Friday, May 5, 2000)]
[Rules and Regulations]
[Pages 26129-26130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11201]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 99F-5111]


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 acid-catalyzed 
condensation reaction products of branched 4-nonylphenol, formaldehyde, 
and 1-dodecanethiol for use as an antioxidant in adhesives, pressure-
sensitive adhesives, and repeated-use rubber articles intended for use 
in contact with food. This action is in response to a petition filed by 
Goodyear Tire & Rubber Co.

DATES: This rule is effective May 5, 2000. Submit written objections 
and requests for a hearing by June 5, 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 theFederal Register 
of December 2, 1999 (64 FR 67575), FDA announced that a food additive 
petition (FAP 0B4703) had been filed by Goodyear Tire & Rubber Co., 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 acid-catalyzed condensation 
reaction products of branched 4-nonylphenol, formaldehyde, and 1-
dodecanethiol for use as an antioxidant in adhesives, pressure-
sensitive adhesives, and repeated-use rubber articles 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 (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 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 0B4703 (64 FR 
67575). 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 on or before June 5, 2000, file with the Dockets Management 
Branch (address above) written objection 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 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 
revising the entry for ``Alkylthiophenolics'' to read as follows:


Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

* * * * *
    (b) * * *

[[Page 26130]]



 
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             Substances                           Limitations
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  *                    *                    *                    *
                   *                    *                    *
Alkylthiophenolics:                   For use only:
1. Acid-catalyzed condensation        1. At levels not to exceed 2
 reaction products of 4-              percent by weight of adhesives
 nonylphenol, formaldehyde, and 1-    complying with Sec.  175.105 of
 dodecanethiol (CAS Reg. No. 164907-  this chapter, of pressure-
 73-7).                               sensitive adhesives complying with
                                      Sec.  175.125 of this chapter, and
                                      of rubber articles complying with
                                      Sec.  177.2600 of this chapter.
2. Acid-catalyzed condensation        2. Do.
 reaction products of branched 4-
 nonylphenol, formaldehyde, and 1-
 dodecanethiol (CAS Reg. No. 203742-
 97-6).
  *                    *                    *                    *
                   *                    *                    *
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    Dated: April 25, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-11201 Filed 5-4-00; 8:45 am]
BILLING CODE 4160-01-F