[Federal Register: September 18, 2002 (Volume 67, Number 181)]
[Notices]
[Page 58809-58810]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18se02-90]
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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: wjt@cfsan.fda.gov.
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: wjt@cfsan.fda.gov. 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 fdadockets@oc.fda.gov 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