[Federal Register Volume 65, Number 229 (Tuesday, November 28, 2000)]
[Rules and Regulations]
[Pages 70789-70790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30328]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket No. 99F-1719]


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 4-
(diiodomethylsulfonyl) toluene as a slimicide in the manufacture of 
food-contact paper and paperboard. This action is in response to a 
petition filed by Angus Chemical Co.

DATES: This rule is effective November 28, 2000. Submit written 
objections and requests for a hearing by December 28, 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 June 11, 1999 (64 FR 31593), FDA announced that a food 
additive petition (FAP 9B4668) had been filed by Angus Chemical Co., c/
o Phillip A. Johns, 10900 Silent Wood Pl., North Potomac, MD 20878-
4829. The petition proposed to amend the food additive regulations in 
Sec. 176.300 Slimicides (21 CFR 176.300) to provide for the safe use of 
4-(diiodomethylsulfonyl) toluene as a slimicide in the manufacture of 
food-contact paper and paperboard.
    FDA has evaluated data in the petition and other relevant material. 
Based on this information, the agency concludes that: (1) The proposed 
use of the additive as a slimicide in the manufacture of food-contact 
paper and paperboard is safe, (2) the additive will achieve its 
intended technical effect, and therefore, (3) the regulations in 
Sec. 176.300 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 potential 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 collection 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 December 28, 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 176.300 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:

[[Page 70790]]

Sec. 176.300  Slimicides.

* * * * *
    (c) * * *

 
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         List of substances                      Limitations
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  *                    *                    *                    *
                   *                    *                    *
4-(Diiodomethylsulfonyl) toluene     At a maximum level of 0.2 pound per
 (CAS Reg. No. 20018-09-01).          ton (100 grams/1,000 kilograms) of
                                      dry weight fiber.
  *                    *                    *                    *
                   *                    *                    *
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    Dated: November 14, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-30328 Filed 11-27-00; 8:45 am]
BILLING CODE 4160-01-F