[Federal Register: June 10, 2003 (Volume 68, Number 111)]
[Page 34614-34615]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0224]

Premarket Notification for Food Contact Substances; Public 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public meeting: 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.

DATES: The meeting will be held on Wednesday, June 25, 2003, from 11:30 
a.m. to 2:30 p.m.

ADDRESSES: The meeting will be held at the Hyatt Regency Chicago, 151 
East Wacker Dr., Chicago, IL.

FOR FURTHER INFORMATION 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.

I. Background

    In November 1997, Congress passed the Food and Drug Administration 
Modernization Act of 1997 (FDAMA). 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)). The FCN process 
is used to authorize the marketing of an FCS except where the Secretary 
determines that submission of a food additive petition is necessary or 
the Secretary and a manufacturer or supplier agree that a food additive 
petition may be submitted (21 U.S.C. 348(h)(3)(A)).
    Under 21 U.S.C. 348(h), the notification process requires a 
manufacturer or supplier of an FCS to notify FDA at least 120 days 
prior to the introduction or delivery for introduction in interstate 
commerce of an FCS. 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 requires that a notification for an FCS contain 
sufficient scientific information to demonstrate that the FCS that is 
the subject of the notification is safe for the intended use (21 CFR 
170.101). Since the inception of the FCN process in 1999, FDA has found 
that FCNs frequently have deficiencies which cause them to be 
incomplete. 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 June 25, 2003, meeting should 
send their registration information (including name, title, business 
affiliation, address, and telephone and fax number) to the contact 
person (see FOR FURTHER INFORMATION CONTACT). To expedite processing, 
registration information may also be faxed to 202-418-3131 or e-mailed 
to 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 June 13, 2003.

III. Availability of Guidance Documents for FCNs

    Administrative, chemistry, and toxicology guidance documents for 
FCNs are available at the following Web site: http://www.cfsan.fda.gov/[tilde

IV. Agenda and Goals

    FDA will present its recommendations for information necessary to 
make an FCN adequate and complete. Topics to be presented will be 
broadly divided among the general categories of administrative, 
chemical, toxicological, and environmental information. The agenda will 
include the following items:
    (1) Administrative: guidance document, an overview of the review 
process, common FCN deficiencies, Form 3480, confidentiality, one FCS 
per FCN, and conditions under which a food additive petition should be 
    (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 recommended testing; and
    (4) Environmental: requirements, common FCN deficiencies, 

[[Page 34615]]

exclusions, and requirements for an environmental assessment.

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 June 13, 2003, 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 at the following e-mail address: 
fdadockets@oc.fda.gov or via the FDA Web site at http://www.fda.gov.

    Dated: June 5, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-14607 Filed 6-5-03; 2:50 pm]