[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]
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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.
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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.
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(b) * * *
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Substance Limitations
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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.
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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]
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