[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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-(C9-C11 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-(C9-C11
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-(C9-C11 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-(C9-C11 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-(C9-C11 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