```

[Federal Register Volume 65, Number 103 (Friday, May 26, 2000)]
[Rules and Regulations]
[Pages 34081-34082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-13209]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket No. 00F-0813]

Indirect Food Additives: 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 sodium 
xylenesulfonate as a component of paper and paperboard intended to 
contact food. This action is in response to a petition filed by Tritex 
Co., Inc.

DATES: This rule is effective May 26, 2000. Submit written objections 
and requests for a hearing by June 26, 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: 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.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of March 7, 2000 (65 FR 12015), FDA announced that a food 
additive petition (FAP 0B4719) had been filed by Tritex Co., Inc., 1001 
Boul. Industriel, Saint-Eustache (Quebec), CANADA J7R 6C3 (zip code was 
incorrectly identified as J7H 6C3 in the March notice). 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) to provide for the safe use of sodium xylene 
sulfonated as a component of paper and paperboard intended to contact 
food. Although the additive was identified as sodium xylene sulfonated 
in the notice of filing, FDA feels that it is more appropriately listed 
as sodium xylenesulfonate in this final rule.
    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 Sec. 176.170 
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 notice of filing for FAP 
0B4719. 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 June 26, 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 (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
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
 
Sodium xylenesulfonate (CAS Reg.     For use only in paper and
 No. 1300-72-7)                       paperboard coatings at levels not
                                      to exceed 0.01 percent by weight
                                      of the finished paper and
                                      paperboard.
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------

[[Page 34082]]

* * * * *

    Dated: May 11, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-13209 Filed 5-25-00; 8:45 am]
BILLING CODE 4160-01-F
```