[Federal Register Volume 64, Number 245 (Wednesday, December 22, 1999)]
[Rules and Regulations]
[Pages 71637-71639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33094]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 97F-0116]


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 4-methylpentene-1 
copolymers resulting from the copolymerization of 4-methylpentene-1 and 
1-alkenes having from 12 to 18 carbon atoms for use in contact with 
food. This action is in response to a petition filed on behalf of 
Mitsui Petrochemical Industries, Ltd.

DATES: The regulation is effective December 22, 1999; written 
objections and requests for a hearing by January 21, 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: Parvin M. Yasaei, Center for Food 
Safety and Applied Nutrition (HFS-215), 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 April 1, 1997 (62 FR 15526), FDA announced that a food 
additive petition (FAP 7B4534) had been filed by Mitsui Petrochemical 
Industries, Ltd., 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 4-methylpentene-1 copolymers 
manufactured by the catalytic copolymerization of 4-methylpentene-1 
with 1-alkenes having from 12 to 18 carbon atoms in contact with food.

[[Page 71638]]

    FDA has evaluated data in the petition and other relevant material. 
Based on this information, the agency concludes that: (1) The proposed 
use of the additive is safe, (2) the additive will achieve its intended 
technical effect, and that therefore, (3) the regulations in 
Sec. 177.1520 should be amended as set forth below in this document.
    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. 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.
    This final rule contains no collection 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 January 21, 2000, 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 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 177

    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 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: 21 U.S.C. 321, 342, 348, 379e.
    2. Section 177.1520 is amended by revising paragraphs (a)(3)(ii) 
and (c) in the table for items 3.3a and 3.3b under the heading ``Olefin 
polymers'' to read as follows:


Sec. 177.1520  Olefin polymers.

* * * * *
    (a) * * *
    (3) * * *
    (ii) 4-Methylpentene-1 and 1-alkenes having from 6 to 18 carbon 
atoms. Such olefin basic copolymers shall contain not less than 95 
molar percent of polymer units derived from 4-methylpentene-1, except 
that copolymers manufactured with 1-alkenes having from 12 to 18 carbon 
atoms shall contain not less than 97 molar percent of polymer units 
derived from 4-methylpentene-1; or
* * * * *
    (c) * * *

 
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                                                                                   Maximum
                                                                                 extractable     Maximum soluble
                                                                                  fraction          fraction
                                                              Melting Point     (expressed as     (expressed as
                                                                 (MP) or         percent by        percent by
            Olefin polymers                   Density        softening point    weight of the       weight of
                                                              (SP) (Degrees     polymer in N-      polymer) in
                                                               Centigrade)        hexane at         xylene at
                                                                                  specified         specified
                                                                                temperatures      temperatures
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  *                    *                    *                    *                    *                    *
                                                             *
 3.3a Olefin copolymers described in
 paragraph (a)(3)(ii) of this section
 and manufactured with 1-alkenes having
 from 6 to 10 carbon atoms.
 3.3b Olefin copolymers described in
 paragraph (a)(3)(ii) of this section,
 provided that such olefin polymers
 have a melt temperature of 220 C to
 250 C (428 F to 482 F) as determined
 by the method described in paragraph
 (d)(8) of this section and minimum
 intrinsic viscosity of 1.0 as
 determined in paragraph (d)(9) of this
 section.
  *                    *                    *                    *                    *                    *
                                                             *
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[[Page 71639]]

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    Dated: December 8, 1999.
L. Robert Lake,
Director, Office of Policy, Planning, and Strategic Initiatives, Center 
for Food Safety and Applied Nutrion.
[FR Doc. 99-33094 Filed 12-21-99; 8:45 am]
BILLING CODE 4160-01-F