[Federal Register Volume 61, Number 240 (Thursday, December 12, 1996)]
[Notices]
[Pages 65405-65406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31574]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96F-0477]


Elf Atochem North America, Inc.; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that Elf 
Atochem North America, Inc., has filed a petition proposing that the 
food additive regulations be amended to provide for the safe use of 
polyamide/polyether block copolymers prepared by reacting a copolymer 
of omega-laurolactam and adipic acid with poly(tetramethylene ether 
glycol) for use in the manufacture of rubber articles intended for 
repeated use in contact with food.

DATES: Written comments on the petitioner's environmental assessment by 
January 13, 1997.

ADDRESSES: Submit written comments 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-216), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3081.
SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food 
additive petition (FAP 7B4528) has been filed by Elf Atochem North 
America, Inc., 2000 Market St., Philadelphia, PA 19103-3222. The 
petition proposes to amend the food additive regulations in 
Sec. 177.2600 Rubber articles intended for repeated use (21 CFR 
177.2600) to provide for the safe use of polyamide/polyether block 
copolymers prepared by reacting a copolymer of omega-laurolactam and 
adipic acid with poly(tetramethylene ether glycol) for use in the 
manufacture of rubber articles intended for repeated use in contact 
with food.
    The potential environmental impact of this action is being 
reviewed. To encourage public participation consistent with regulations 
promulgated under the National Environmental Policy Act (40 CFR 
1501.4(b)), the agency is placing the environmental assessment 
submitted with the petition that is the subject of this notice on 
public display at the Dockets

[[Page 65406]]

Management Branch (address above) for public review and comment. 
Interested persons may, on or before January 13, 1997, submit to the 
Dockets Management Branch (address above) written comments. Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. Received comments may be seen 
in the office above between 9 a.m. and 4 p.m., Monday through Friday. 
FDA will also place on public display any amendments to, or comments 
on, the petitioner's environmental assessment without further 
announcement in the Federal Register. If, based on its review, the 
agency finds that an environmental impact statement is not required and 
this petition results in a regulation, the notice of availability of 
the agency's finding of no significant impact and the evidence 
supporting that finding will be published with the regulation in the 
Federal Register in accordance with 21 CFR 25.40(c).

    Dated: November 25, 1996.
George H. Pauli,
Acting Director, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 96-31574 Filed 12-11-96; 8:45 am]
BILLING CODE 4160-01-F