[Federal Register Volume 65, Number 75 (Tuesday, April 18, 2000)]
[Rules and Regulations]
[Pages 20727-20729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9570]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 175 and 176

[Docket No. 99F-0925]


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 2,2-dibromo-3-
nitrilopropionamide as a preservative for adhesives and coatings used 
in the manufacture of paper and paperboard intended for contact with 
food. This action responds to a petition filed by The Dow Chemical Co.

DATES: This rule is effective April 18, 2000; submit written objections 
and requests for a hearing by May 18, 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: Hortense S. Macon, Center for Food 
Safety and Applied Nutrition (HFS-205), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3086.

SUPPLEMENTARY INFORMATION: In a notice published in theFederal Register 
of April 22,1999 (64 FR 19790), FDA announced that a food additive 
petition (FAP 9B4641) had been filed by The Dow Chemical Co., Midland, 
MI 48674. The petition proposed to amend the food additive regulations 
in Sec. 175.105 Adhesives (21 CFR 175.105) and 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 2,2-dibromo-3-
nitrilopropionamide as a preservative for adhesives and coatings in the 
manufacture of paper and paperboard intended for contact with food.
    FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency

[[Page 20728]]

concludes that: (1) The proposed uses of the additive are safe, (2) the 
additive will achieve its intended technical effect, and therefore, (3) 
the regulations in Secs. 175.105 and 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 environmental effects of 
this final rule as announced in the notice of filing for FAP 9B4641 (64 
FR 19790). 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 May 18, 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

21 CFR 175

    Adhesives, Food additives, Food packaging.

21 CFR 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 parts 175 and 176 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
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *
                                                             *
2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No. 10222-   For use as a preservative only.
 01-2).
  *                    *                    *                    *                    *                    *
                                                             *
----------------------------------------------------------------------------------------------------------------

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 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.

* * * * *
    (a) * * *
    (5) * * *

 
----------------------------------------------------------------------------------------------------------------
                   List of Substances                                          Limitations
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *
                                                             *
2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No.10222-01- For use as a preservative at a level not to exceed 100
 2).                                                      parts per million in coating formulations and in
                                                          component slurries and emulsions, used in the
                                                          production of paper and paperboard and coatings for
                                                          paper and paperboard.
  *                    *                    *                    *                    *                    *
                                                             *
----------------------------------------------------------------------------------------------------------------


[[Page 20729]]

* * * * *

    Dated: March 28, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-9570 Filed 4-17-00; 8:45 am]
BILLING CODE 4160-01-F