[Federal Register Volume 65, Number 60 (Tuesday, March 28, 2000)]
[Rules and Regulations]
[Pages 16313-16314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7540]



[[Page 16313]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 98F-0567]


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 expanded safe use of ethylene-
octene-1 copolymers, containing not less than 50 weight-percent of 
polymer units derived from ethylene, as articles or components of food-
contact articles. This action is in response to a petition filed by The 
Dow Chemical Co.

DATES: This rule is effective March 28, 2000. Submit written objections 
and requests for a hearing by April 27, 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: Julius Smith, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3091.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of July 28, 1998 (63 FR 40297), FDA announced that a petition 
(FAP 8B4601) had been filed by The Dow Chemical Co., 2030 Dow Center, 
Midland, MI 48674. The petition proposed to amend the food additive 
regulations in Sec. 177.1520 Olefin polymers (21 CFR 177.1520) to 
expand the safe use of ethylene-octene-1 copolymers as articles or 
components of articles contacting food by lowering the required level 
of polymer units derived from ethylene to not less than 50 weight-
percent.
    FDA has evaluated the 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 therefore, (3) the regulations 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. 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 file with the Dockets Management Branch (address above) 
written objections by April 27, 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 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, 379(e).

    2. Section 177.1520 is amended by adding paragraph (a)(3)(i)(a)(4), 
and in the table in paragraph (c) by adding item ``3.2c'' in numerical 
order to read as follows:


Sec. 177.1520  Olefin polymers.

* * * * *
    (a) * * *
    (3) * * *
    (i) * * *
    (a) * * *
    (4) Olefin basic copolymers manufactured by the catalytic 
polymerization of ethylene and octene-1 shall contain not less than 50 
weight-percent of polymer units derived from ethylene.
* * * * *
    (c) * * *

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                                                                                                                          Maximum extractable fraction
                                                                              Melting Poing (MP) or softening point    (expressed as percent by weight of    Maximum soluble fraction (expressed
           Olefin polymers                            Density                       (SP) (Degrees Centigrade)         the polymer in N-hexane at specified   as percent by weight of polymer) in
                                                                                                                                  temperatures                xylene at specified temperatures
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                                *                    *                    *                    *                    *                    *                    *
3.2c Olefin copolymers described in          0.85-0.92
 paragraph (a)(3)(i)(a)(4) of this
 section have a melt flow index no
 greater than 50 grams per 10 minutes
 as determined by the method
 described in paragraph (d)(7) of
 this section. Articles manufactured
 using these polymers may be used
 with all types of food under
 conditions of use C through H as
 described in table 2 of Sec.
 176.170(c) of this chapter.
                                *                    *                    *                    *                    *                    *                    *
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* * * * *

    Dated: February 29, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-7540 Filed 3-27-00; 8:45 am]
BILLING CODE 4160-01-F