[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51364-51365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25122]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 91F-0289]


Indirect Food Additives: Polymers

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 methyl 
methacrylate/butyl acrylate-grafted polypropylene copolymer containing 
methyl methacrylate/butyl acrylate-grafted polypropylene, methyl 
methacrylate/butyl acrylate copolymer, methyl methacrylate homopolymer, 
and polypropylene, resulting from the reaction of a mixture of methyl 
methacrylate and butyl acrylate with polypropylene, as a component of 
food-contact materials. This action is in response to a food additive 
petition filed by Rohm and Haas Co.

DATES: Effective October 2, 1996; written objections and requests for a 
hearing by November 1, 1996. The Director of the Office of the Federal 
Register approves the incorporation by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51 of a certain publication listed in 21 
CFR 177.1520(b), effective October 2, 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: Hortense S. Macon, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3086.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 23, 1991 (56 FR 41850), FDA announced that a food 
additive petition (FAP 1B4272) had been filed by Rohm and Haas Co., c/o 
1150 17th St. NW., Washington, DC 20036 (currently c/o Keller and 
Heckman, 1001 G St. NW., suite 500 West, Washington, DC 20001). The 
petition proposed to amend the food additive regulations in 
Sec. 177.1520 Olefin polymers (21 CFR 177.1520) to provide for the safe 
use of methyl methacrylate/butyl acrylate-grafted polypropylene as a 
component of propylene homopolymer and copolymer food-contact 
materials.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that the proposed use of the food additive is safe 
and that Sec. 177.1520 should be amended as set forth below. The agency 
further concludes that methyl methacrylate/butyl acrylate-grafted 
polypropylene copolymer containing methyl methacrylate/butyl acrylate-
grafted polypropylene, methyl methacrylate/butyl acrylate copolymer, 
methyl methacrylate homopolymer, and polypropylene, resulting from the 
reaction of a mixture of methyl methacrylate and butyl acrylate with 
polypropylene, is a more accurate and descriptive name for the food 
additive than the name given in the petition. Therefore, FDA is using 
this name to identify the additive in the final rule.
    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 21 CFR 
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. 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 November 1, 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 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 regulation. 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 177

    Food additives, Food packaging, Incorporation by reference.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner

[[Page 51365]]

of Food and Drugs and redelegated to the Director, Center for Food 
Safety and Applied Nutrition, 21 CFR part 177 is amended as follows:

PART 177--INDIRECT FOOD ADDITIVES: POLYMERS

    1. The authority citation for 21 CFR part 177 continues to read as 
follows:

    Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

    2. Section 177.1520 is amended in the table in paragraph (b) by 
alphabetically adding a new entry under the headings ``Substance'' and 
``Limitations'' to read as follow:

Sec. 177.1520  Olefin polymers.

* * * * *
    (b) * * *

                                                                        
------------------------------------------------------------------------
              Substance                           Limitations           
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
Methyl methacrylate/butyl acrylate-    For use only at levels not to    
 grafted polypropylene copolymer        exceed 6 percent by weight of   
 containing methyl methacrylate/butyl   olefin polymers complying with  
 acrylate-grafted polypropylene (CAS    paragraph (c) of this section,  
 Reg. No. 121510-09-6), methyl          items 1.1, 3.1a, 3.2a, and 3.2b,
 methacrylate/butyl acrylate            where the copolymers complying  
 copolymer (CAS Reg. No. 25852-37-3),   with items 3.1a, 3.2a, and 3.2b 
 methyl methacrylate homopolymer (CAS   contain not less than 85 weight-
 Reg. No. 9011-14-7), and               percent of polymer units derived
 polypropylene (CAS Reg. No. 9003-07-   from propylene.                 
 0), resulting from the reaction of a                                   
 mixture of methyl methacrylate and                                     
 butyl acrylate with polypropylene.                                     
 The finished product contains no                                       
 more than 55 percent by weight of                                      
 polymer units derived from methyl                                      
 methacrylate and butyl acrylate as                                     
 determined by a method entitled,                                       
 ``Determination of the Total Acrylic                                   
 in PP-MMA/BA Polymers,'' which is                                      
 incorporated by reference in                                           
 accordance with 5 U.S.C. 552(a) and                                    
 1 CFR part 51. Copies are available                                    
 from the Office of Premarket                                           
 Approval, Center for Food Safety and                                   
 Applied Nutrition (HFS-200), Food                                      
 and Drug Administration, 200 C St.                                     
 SW., Washington, DC 20204, or may be                                   
 examined at the Center for Food                                        
 Safety and Applied Nutrition's                                         
 Library, 200 C. St. SW., rm. 3321,                                     
 Washington, DC, or at the Office of                                    
 the Federal Register, 800 North                                        
 Capitol St. NW., suite 700,                                            
 Washington, DC.                                                        
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

* * * * *

    Dated: September 23, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-25122 Filed 10-1-96; 8:45 am]
BILLING CODE 4160-01-F