[Federal Register Volume 64, Number 99 (Monday, May 24, 1999)]
[Rules and Regulations]
[Pages 27914-27915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12961]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket No. 98F-0584]


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 
monoisopropanolamine as a dispersant for pigments intended to be used 
either as fillers or colorants in food-contact paper and paperboard. 
This action is in response to a petition filed by DuPont Chemicals and 
White Pigments and The Dow Chemical Co.

DATES: This regulation is effective May 24, 1999; written objections 
and requests for a hearing by June 23, 1999.
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 July 31, 1998 (63 FR 40912), FDA announced that a food 
additive petition (FAP 8B4607) had been jointly filed by DuPont 
Chemicals and White Pigments, Edge Moor Plant, 104 Hay Rd., Wilmington, 
DE 19809, and The Dow Chemical Co., 2030 Dow Center, Midland, MI 48674. 
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 
monoisopropanolamine as a dispersant for pigments intended to be used 
as fillers or colorants in food-contact paper and paperboard.
    FDA has evaluated the 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 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 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 on or before June 23, 1999, file with the Dockets Management 
Branch (address above) written objection thereto. 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 
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 shall be submitted and shall 
be identified with the docket number found in brackets in the

[[Page 27915]]

heading of this document. Any objection 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 a new entry under the headings ``Lists 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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                      *      *      *      *      *
Monoisopropanolamine (CAS Reg. No. 78-96-   For use as a dispersant for
 6).                                         titanium dioxide
                                             suspensions at a level not
                                             to exceed 0.68 percent by
                                             weight of titanium dioxide.
                                             The finished paper and
                                             paperboard will be used in
                                             contact with all food types
                                             under conditions of use E
                                             through G described in
                                             table 2 of paragraph (c) of
                                             this section.
                      *      *      *      *      *
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    Dated: May 7, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-12961 Filed 5-21-99; 8:45 am]
BILLING CODE 4160-01-F