[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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