[Federal Register Volume 63, Number 35 (Monday, February 23, 1998)]
[Rules and Regulations]
[Pages 8851-8852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4372]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 97F-0336]


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 change the intrinsic viscosity specifications 
for the poly(2,6-dimethyl-1,4-phenylene) oxide resins intended for use 
in contact with food from ``not less then 0.40 deciliter per gram'' to 
``not less than 0.30 deciliter per gram'' as determined by ASTM method 
D1243-79. This action is in response to a petition filed by General 
Electric Co.

DATES: Effective February 23, 1998. Written objections and requests for 
a hearing by March 25, 1998.

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: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3081.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 14, 1997 (62 FR 43535), FDA announced that a food 
additive petition (FAP 7B4551) had been filed by General Electric Co., 
One Lexan Lane, Mt. Vernon, IN 47620-9364. The petition proposed to 
amend the food additive regulations in Sec. 177.2460 Poly(2,6-dimethyl-
1,4-phenylene) oxide resins (21 CFR 177.2460) to change the intrinsic 
viscosity specifications for the poly(2,6-dimethyl-1,4-phenylene) oxide 
resins intended for use in contact with food from ``not less then 0.40 
deciliter per gram'' to ``not less than 0.30 deciliter per gram'' as 
determined by ASTM method D1243-79.

[[Page 8852]]

    In the Federal Register of August 14, 1997 (62 FR 43535), the 
filing notice for the petition stated that the action resulting from 
the petition qualified for a categorical exclusion under previous 21 
CFR 25.24[(a)](9). Upon further review, the agency determined that such 
a categorical exclusion, which is based on a technical change in a 
regulation, is not appropriate for this proposed action because the 
proposed amendment is not simply a technical change. Consequently, the 
agency considered the environmental effects of this action.
    FDA has evaluated data in the petition supporting the chemical 
identity of the additive and other relevant material. The agency finds 
that the petitioner has adequately demonstrated that poly(2,6-dimethyl-
1,4-phenylene) oxide resins with an intrinsic viscosity of not less 
than 0.30 deciliter per gram (dL/g), which replaces the current 
intrinsic viscosity of 0.40 dL/g meet the specifications and extractive 
limitations for poly(2,6-dimethyl-1,4-phenylene) oxide resins as 
prescribed in Sec. 177.2460. 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 (3) the 
regulations in Sec. 177.2460 should be amended as set forth 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.
    Any person who will be adversely affected by this regulation may at 
any time on or before March 25, 1998. 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.


Sec. 177.2460   [Amended]

    2. Section 177.2460 Poly(2,6-dimethyl-1,4-phenylene) oxide resins 
is amended in the first sentence of paragraph (c)(1) by removing 
``0.40'' and adding in its place ``0.30''.
* * * * *

    Dated: February 11, 1998.
L. Robert Lake,
Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 98-4372 Filed 2-20-98; 8:45 am]
BILLING CODE 4160-01-F