[Federal Register Volume 67, Number 181 (Wednesday, September 18, 2002)]
[Notices]
[Pages 58809-58810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23690]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0403]


Premarket Notification for Food Contact Substances; Public 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public meeting entitled ``FDA Workshop on the Notification 
Process for Food Contact Substances.'' The purpose of the meeting is to 
discuss the food contact notification (FCN) process so that notifiers 
and/or their representatives, consumer interest groups, and other 
interested members of the general public can have a better 
understanding of the FCN process, the information requirements of an 
FCN, and the common deficiencies to be avoided.
    Date and Time: The meeting will be held on Tuesday, October 15, 
2002, from 8 a.m. to 5 p.m.
    Location: The meeting will be held on the campus of the National 
Institutes of Health (NIH) in the Lister Hill Center Auditorium, Bldg. 
38A, National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 
20894. The NIH campus is accessible by the Washington, DC area 
Metrorail system using the Medical Center station. Attendees must bring 
photo identification to gain admittance.
    Contact: William J. Trotter, Center for Food Safety and Applied 
Nutrition (HFS-275), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, 202-418-3088, FAX 202-418-3131, or e-
mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In November 1997, Congress passed the Food and Drug Administration 
Modernization Act (FDAMA) of 1997. Section 309 of FDAMA amended section 
409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
348) to establish a notification process for food contact substances 
(FCSs). An FCS is defined as any substance intended for use as a 
component of materials used in manufacturing, packing, packaging, 
transporting, or holding food if such use is not intended to have a 
technical effect in such food (21 U.S.C. 348(h)(6)). Congress intended 
the notification process to be the primary route for authorizing the 
use of FCSs (21 U.S.C. 348(h)(3)(A)).
    Under section 409(h) of the act, the notification process requires 
a manufacturer or supplier of an FCS to notify FDA at least 120 days 
prior to marketing an FCS for a new use. If FDA does not object to the 
notification within 120 days, the notification becomes effective (21 
U.S.C. 348(h)(2)(A)) and the substance may be legally marketed for the 
requested use by the notifier (21 U.S.C. 348(a)(3)(B)).
    In the Federal Register of May 21, 2002 (67 FR 35724), FDA 
published a final rule amending the food additive regulations regarding 
the premarket notification process for FCSs. The rule became effective 
on June 20, 2002, and required that a notification for an FCS must 
contain sufficient scientific information to demonstrate that the FCS 
that is the subject of the notification is safe for the intended use 
(21 U.S.C. 348(h)(1)). Since the inception of the FCN process in 1999, 
FDA has observed that FCNs frequently have deficiencies such that the 
FCNs are not complete. FDA is having this public meeting to discuss the 
data requirements for an FCN and the commonly observed deficiencies, 
and to assist notifiers and/or their representatives in submitting 
adequate and complete FCNs.

II. Registration and Written Questions

    Persons interested in attending the October 15, 2002, meeting 
should send their registration information (including name, title, 
business affiliation, address, and telephone and fax numbers) and any 
questions they wish to have answered at the meeting to the contact 
person. To expedite processing, fax registration information to 202-
418-3131 or e-mail: [email protected]. There will be no registration 
charges for attending the meeting.
    If you need special accommodations due to disability, please notify 
the contact person by October 1, 2002.

III. Availability of Guidance Documents for FCNs

    Administrative, chemistry, and toxicology guidance documents for 
FCNs are available at http://www.cfsan.fda.gov/dms/opa-notf.html.

IV. Agenda and Goals

    FDA will present what information the agency requires in an FCN to 
make it adequate and complete. Topics to be presented will be broadly 
divided among the general categories of administrative, chemical, 
toxicological, and environmental. There will also be workshops in which 
questions from the audience will be encouraged. The issues to be 
discussed include the following:
    1. Administrative: Guidance document, number of copies of the FCN 
to submit and where to submit the FCN, common FCN deficiencies, Form 
3480, confidentiality, one FCS per FCN, and conditions under which a 
food additive petition should be submitted;
    2. Chemical: Guidance document, common FCN deficiencies, approaches 
for determining migrant levels in food, estimated daily intake, and 
cumulative estimated daily intake;
    3. Toxicological: Guidance document, common FCN deficiencies, 
acceptable daily intake, risk assessments, structure activity 
relationships, and genetic toxicology; and
    4. Environmental: Guidance document, common FCN deficiencies, the 
National Environmental Policy Act as applied to the notification 
process, categorical exclusions, and requirements for an environmental 
assessment.

[[Page 58810]]

V. Comments

    Written comments regarding the agenda may be submitted and should 
be identified with the docket number found in brackets in the heading 
of this document. Comments should be annotated and organized to 
identify the specific issues to which they refer. These comments should 
be submitted by October 1, 2002, to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Comments may also be sent to the Dockets 
Management Branch via e-mail to [email protected] or via the FDA 
Web site http://www.fda.gov.
    Transcripts: An electronic transcript of this meeting will be 
prepared and may be requested in writing from the Freedom of 
Information Office (HFI-35), Food and Drug Administration, 5600 Fishers 
Lane, rm. 12A-16, Rockville, MD 20852, approximately 15 working days 
after the meeting at a cost of $18.25. The transcript of the meeting 
will also be available for public examination as soon as possible after 
the meeting, at the Dockets Management Branch (see ADDRESSES) between 9 
a.m. and 4 p.m., Monday through Friday, as well as on the FDA Office of 
Food Additive Safety Web site at http://www.cfsan.fda.gov/lrd/foodadd.html.

    Dated: September 12, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-23690 Filed 9-17-02; 8:45 am]
BILLING CODE 4160-01-S