[Federal Register Volume 66, Number 45 (Wednesday, March 7, 2001)]
[Rules and Regulations]
[Pages 13653-13655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5512]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 175, 176, and 178

[Docket No. 99F-2081]


Indirect Food Additives: Adhesives and Components of Coatings and 
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 butanedioic acid, 
sulfo-1,4-diisodecyl ester, ammonium salt as a surface active agent in 
adhesive formulations, and in components of paper and paperboard 
intended to contact food. This action is in response to a petition 
filed by Troy Corp.

DATES: This rule is effective March 7, 2001. Submit written objections 
and requests for a hearing by April 6, 2001.

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: Mark A. Hepp, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3098.

[[Page 13654]]


SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of July 2, 1999 (64 FR 36021), FDA announced that a food 
additive petition (FAP 9B4678) had been filed by Troy Corp., c/o S. L. 
Graham & Associates, 1801 Peachtree Lane, Bowie, MD 20721. The petition 
proposed to amend the food additive regulations in Sec. 175.125 
Pressure-sensitive adhesives (21 CFR 175.125) to provide for the safe 
use of butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt as a 
surface active agent in pressure sensitive adhesives.
    Subsequent to the publication of the filing notice, the petition 
was amended to include a proposal to further amend the food additive 
regulations in Secs. 175.105 Adhesives (21 CFR 175.105), 176.170 
Components of paper and paperboard in contact with aqueous and fatty 
foods (21 CFR 176.170), 176.180 Components of paper and paperboard in 
contact with dry food (21 CFR 176.180), and 178.3400 Emulsifiers and/or 
surface active agents (21 CFR 178.3400) to provide for the safe use of 
butanedioic acid, sulfo-1, 4-diisodecyl ester, ammonium salt as a 
surface active agent in adhesives, and in paper and paperboard intended 
to contact food. Therefore, in a notice published in the Federal 
Register of January 3, 2001 (66 FR 375), FDA announced that it was 
amending the filing notice of July 2, 1999, to indicate that the 
petitioner requests that the food additive regulations be amended to 
provide for the safe use of butanedioic acid, sulfo-1,4-diisodecyl 
ester, ammonium salt as a surface active agent in adhesives, pressure 
sensitive adhesives, and paper and paperboard intended to contact food.
    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. 175.105, 
175.125, 176.170, 176.180, and 178.3400 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 potential environmental 
effects of this rule as announced in the notices of filing for FAP 
9B4678. 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 April 6, 2001. 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

21 CFR Part 175

    Adhesives, Food additives, Food packaging.

21 CFR Parts 176 and 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 parts 175, 176, and 178 are amended as follows:

PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF 
COATINGS

    1. The authority citation for 21 CFR part 175 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 379e.
    2. Section 175.105 is amended in the table in paragraph (c)(5) by 
alphabetically adding an entry under the headings ``Substances'' and 
``Limitations'' to read as follows:


Sec. 175.105  Adhesives.

* * * * *
    (c) *  *  *
    (5) *  *  *

 
------------------------------------------------------------------------
                         Substances                          Limitations
------------------------------------------------------------------------
*                  *                  *                  *
                  *                  *                  *
Butanedioic acid, sulfo-1,4-di-(C<INF>9</INF>-C<INF>11</INF> alkyl) ester,         For use as
 ammonium salt (also known as butanedioic acid, sulfo-1,4-   a surface
 diisodecyl ester, ammonium salt [CAS Reg. No. 144093-88-    active
 9]).                                                        agent in
                                                             adhesives.
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------

    3. Section 175.125 is amended by adding paragraph (a)(9) and by 
revising paragraph (b)(1) to read as follows:


Sec. 175.125  Pressure-sensitive adhesives.

* * * * *
    (a) *  *  *
    (9) Butanedioic acid, sulfo-1,4-di-(C<INF>9</INF>-C<INF>11</INF> 
alkyl) ester, ammonium salt (also known as butanedioic acid sulfo-1, 4-
diisodecyl ester, ammonium salt [CAS Reg. No. 144093-88-9]) as a 
surface active agent at a level not to exceed 3.0 percent by weight of 
the finished pressure-sensitive adhesive.
    (b) *  *  *
    (1) Substances listed in paragraphs (a)(1), (a)(2), (a)(3), (a)(5), 
(a)(6), (a)(7), (a)(8), and (a)(9) of this section, and those 
substances prescribed by paragraph (a)(4) of this section that are not 
identified in paragraph (b)(2) of this section.
* * * * *

[[Page 13655]]

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

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

    Authority: 21 U.S.C. 321, 342, 346, 348, 379e.
    5. Section 176.170 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. 176.170  Components of paper and paperboard in contact with 
aqueous and fatty foods.

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

 
------------------------------------------------------------------------
                     List of substances                      Limitations
------------------------------------------------------------------------
*                  *                  *                  *
                  *                  *                  *
Butanedioic acid, sulfo-1,4-di-(C<INF>9</INF>-C<INF>11</INF> alkyl) ester,         For use as
 ammonium salt (also known as butanedioic acid, sulfo-1,4-   a surface
 diisodecyl ester, ammonium salt [CAS Reg. No. 144093-88-    active
 9]).                                                        agent in
                                                             package
                                                             coating
                                                             inks at
                                                             levels not
                                                             to exceed 3
                                                             percent by
                                                             weight of
                                                             the coating
                                                               ink.
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------

    6. 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
------------------------------------------------------------------------
*                  *                  *                  *
                  *                  *                  *
Butanedioic acid, sulfo-1,4-di-(C<INF>9</INF>-C<INF>11</INF> alkyl) ester,         For use as
 ammonium salt (also known as butanedioic acid, sulfo-1,4-   a surface
 diisodecyl ester, ammonium salt [CAS Reg. No. 144093-88-    active
 9]).                                                        agent in
                                                             package
                                                             coating
                                                             inks at
                                                             levels not
                                                             to exceed 3
                                                             percent by
                                                             weight of
                                                             the coating
                                                               ink.
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------

PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS

    7. The authority citation for 21 CFR part 178 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 379e.
    8. Section 178.3400 is amended in the table in paragraph (c) by 
alphabetically adding an entry under the headings ``List of 
substances'' and ``Limitations'' to read as follows:


Sec. 178.3400  Emulsifiers and/or surface active agents.

* * * * *
    (c) *  *  *

 
------------------------------------------------------------------------
                     List of substances                      Limitations
------------------------------------------------------------------------
*                  *                  *                  *
                  *                  *                  *
Butanedioic acid, sulfo-1,4-di-(C<INF>9</INF>-C<INF>11</INF> alkyl) ester,         For use as
 ammonium salt (also known as butanedioic acid, sulfo-1,4-   a surface
 diisodecyl ester, ammonium salt [CAS Reg. No. 144093-88-    active
 9]).                                                        agent as
                                                             provided in
                                                             Secs.  175.
                                                               105,
                                                             175.125,
                                                             176.170,
                                                             and 176.180
                                                             of this
                                                             chapter.
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------

* * * * *

    Dated: February 21, 2001.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 01-5512 Filed 3-6-01; 8:45 am]
BILLING CODE 4160-01-S