[Federal Register Volume 65, Number 113 (Monday, June 12, 2000)]
[Rules and Regulations]
[Pages 36786-36787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14700]



[[Page 36786]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket No. 99F-1581]


Indirect Food Additives: Paper and Paperboard Components

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 imidazolium 
compounds, 2-(C<INF>17</INF> and C<INF>17</INF>-unsaturated alkyl)-1-
[2-(C<INF>18</INF> and C<INF>18</INF>-unsaturated amido)ethyl]-4,5-
dihydro-1-methyl, methyl sulfates as a debonding agent in the 
manufacture of paper and paperboard intended for use in contact with 
aqueous and fatty food and in contact with dry food. This action is in 
response to a petition filed by Witco Corp.

DATES: This rule is effective June 12, 2000. Submit written objections 
and requests for a hearing by July 12, 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 4, 1999 (64 FR 30038), FDA announced that a food 
additive petition (FAP 9B4669) had been filed by Witco Corp., One 
American Lane, Greenwich, CT 06831-2559. The petition proposed to amend 
the food additive regulations in Sec. 176.170 Components of paper and 
paperboard in contact with aqueous and fatty foods (21 CFR 176.170) and 
Sec. 176.180 Components of paper and paperboard in contact with dry 
food (21 CFR 176.180) to provide for the safe use of imidazolium 
compounds, 2-(C<INF>17</INF> and C<INF>17</INF>-unsaturated alkyl)-[2-
(C<INF>18</INF> and C<INF>18</INF>-unsaturated amido)ethyl]-4,5-
dihydro-1-methyl, methyl sulfates as a debonding agent in the 
manufacture of paper intended for use in contact with food. The name of 
the additive was incorrect in the June 4, 1999, notice, but is being 
used correctly as imidazolium compounds, 2-(C<INF>17</INF> and 
C<INF>17</INF>-unsaturated alkyl)-1-[2-(C<INF>18</INF> and 
C<INF>18</INF>-unsaturated amido)ethyl]-4,5-dihydro-1-methyl, methyl 
sulfates in this document.
    FDA has evaluated 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 achieve its intended 
technical effect, and therefore, that the regulations in Secs. 176.170 
and 176.180 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 environmental effects of 
this rule as announced in the notice of filing for the petition. 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 July 12, 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 176

    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 176 is amended as follows:

PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

    1. The authority citation for 21 CFR part 176 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 342, 346, 348, 379e.


    2. Section 176.170 is amended in the table in paragraph (a)(5) by 
alphabetically adding an entry under the headings ``List of 
substances'' and ``Limitations'' to read as follows:


Sec. 176.170  Components of paper and paperboard in contact with 
aqueous and fatty foods.

* * * * *
    (a) * * *
    (5) * * *

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         List of substances                      Limitations
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*                    *                    *                    *
                  *                    *                    *
Imidazolium compounds, 2-(C<INF>17</INF> and    For use only at a level not to
 C<INF>17</INF>-unsaturated alkyl)-1-[2-(C<INF>18</INF>     exceed 0.5 percent by weight of
 and C<INF>18</INF>-unsaturated amido)ethyl]-    the dry paper and paperboard.
 4,5-dihydro-1-methyl, methyl
 sulfates (CAS Reg. No. 72749-55-
 4).
 
*                    *                    *                    *
                  *                    *                    *
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[[Page 36787]]

* * * * *
    3. Section 176.180 is amended in the table in paragraph (b)(2) by 
alphabetically adding an entry under the headings ``List of 
substances'' and ``Limitations'' to read as follows:


Sec. 176.180  Components of paper and paperboard in contact with dry 
food.

* * * * *
    (b) * * *
    (2) * * *

------------------------------------------------------------------------
         List of substances                      Limitations
------------------------------------------------------------------------
 
*                    *                    *                    *
                  *                    *                    *
Imidazolium compounds, 2-(C<INF>17</INF> and    For use only at levels not to
 C<INF>17</INF>-unsaturated alkyl)-1-[2-(C<INF>18</INF>     exceed 0.5 percent by weight of
 and C<INF>18</INF>-unsaturated amido)ethyl]-    the dry paper and paperboard.
 4,5-dihydro-1-methyl, methyl
 sulfates (CAS Reg. No. 72749-55-
 4).
 
*                    *                    *                    *
                  *                    *                    *
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    Dated: May 31, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-14700 Filed 6-9-00; 8:45 am]
BILLING CODE 4160-01-F