[Federal Register Volume 61, Number 223 (Monday, November 18, 1996)]
[Rules and Regulations]
[Pages 58628-58629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29393]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket No. 94F-0257]


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 the copolymer of 
the sodium salt of acrylic acid with polyethyleneglycol allyl ether in 
paper mill boilers. This action is in response to a petition filed by 
Betz Laboratories, Inc.

DATES: Effective November 18, 1996; written objections and requests for 
a hearing by December 18, 1996.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: John R. Bryce, Center for Food Safety 
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3023.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 19, 1994 (59 FR 42837), FDA announced that a food 
additive petition (FAP 4B4426) had been filed by Betz Laboratories, 
Inc., 4636 Somerton Rd., Trevose, PA 19053-6783. 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 the copolymer of the sodium 
salt of acrylic acid with polyethyleneglycol allyl ether in paper mill 
boilers.
    FDA has evaluated the data and information in the petition and 
other relevant material. The agency concludes that the proposed use of 
the additive as an anticorrosion agent in paper mill boilers is safe, 
that it will achieve its intended technical effect, and 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 action. In the August 19, 1994, notice of filing, the 
agency announced that it was placing the petitioner's environmental 
assessment on public display and provided 30 days for comments on that 
assessment. FDA received no comments on the assessment. Based upon the 
information available, FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.
    Any person who will be adversely affected by this regulation may at 
any time on or before December 18, 1996, file with the Dockets 
Management Branch (address above) written objections 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

[[Page 58629]]

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 shall be submitted and shall 
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: Secs. 201, 402, 406, 409, 721 of the Federal Food, 
Drug, and Cosmetic Act (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 ``List 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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  *                    *                    *                    *      
                   *                    *                    *          
Acrylic acid, sodium salt copolymer    For use only in paper mill       
 with polyethyleneglycol allyl ether    boilers.                        
 (CAS Reg. No. 86830-15-1).                                             
  *                    *                    *                    *      
                   *                    *                    *          
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    Dated: October 25, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-29393 Filed 11-15-96; 8:45 am]
BILLING CODE 4160-01-F