[Federal Register Volume 64, Number 34 (Monday, February 22, 1999)]
[Notices]
[Pages 8577-8579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4402]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0235]


Premarket Notification for Food Contact Substances; Public 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public meeting: ``FDA Implementation of the Notification 
Process for Food Contact Substances.'' FDA is seeking comments from 
industry, consumer groups, and other members of the public prior to 
formally announcing the availability of guidance documents for the 
notification program. FDA will consider the comments received as a 
result of this meeting as the agency develops its plan for implementing 
the notification process for food contact substances, as well as the 
guidance documents for the notification program, which will be made 
available for public comment, at a later date.

Dates: The meeting will be held on Friday, March 12, 1999, from 8:30 
a.m. to 5 p.m. Submit written comments by March 22, 1999.


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ADDRESSES: The meeting will be held on the campus of the National 
Institutes of Health, 9000 Rockville Pike, Bldg. 10, Masur Auditorium, 
Bethesda, MD, 20892.

FOR FURTHER INFORMATION CONTACT: Vivian M. Gilliam, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3167, 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 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. A food contact substance 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 food contact substances (21 U.S.C. 
348(h)(3)(A)), once the notification program begins to operate (see 21 
U.S.C. 348(h)(5)). FDA expects that the majority of new uses of food 
contact substances that are now the subject of food additive petitions 
or threshold of regulation exemption requests under Sec. 170.39 (21 CFR 
170.39) will be the subject of premarket notifications once the 
notification program is operating.
    Under 21 U.S.C. 348(h), the notification process requires a 
manufacturer or supplier of a food contact substance to notify FDA at 
least 120 days prior to marketing a food contact substance 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 (21 U.S.C. 348(a)(3)(B)).

II. Registration, Written Questions, and Requests for Oral 
Presentations

    Persons interested in attending the March 12, 1999, meeting should 
send their registration information (including name, title, business 
affiliation, address, telephone, and fax number), any questions they 
wish to have considered at the meeting, and any request to make an oral 
presentation to the contact person (address above). In addition, any 
person who wishes to distribute written material at the meeting should 
send copies of such material to the contact person at the time of 
registration. To expedite processing, registration information may also 
be faxed to 202-418-3131. Requests to make oral presentations should 
include an estimate of the time desired for the presentation, which 
will be accommodated as time permits. Per person time limits for oral 
presentations may be set to allow all interested persons an opportunity 
to speak. If you need special accommodations due to disability, please 
notify the contact person at least 7 days in advance.

III. Availability of Information for Discussion at the Meeting

    FDA will make available to all registrants prior to the meeting an 
information packet, including material on FDA's current thinking on 
administration of the premarket notification (PMN) process and 
chemistry and toxicological data recommendations for notifications. FDA 
also hopes to make available three draft guidance documents 
(administrative, chemistry, and toxicology) on the FDA website at 
``http//www.fda.gov'' in the very near future.

IV. Agenda and Goals

    This meeting will provide manufacturers and suppliers of food 
contact substances, consumer groups, and other interested members of 
the public with an overview of FDA's current plans for the 
implementation of the notification process. FDA will also present the 
agency's current thinking on specific issues or questions of interest 
to the public.
    At the meeting, FDA will present highlights of its administrative 
plan for the PMN program, its expected chemistry and toxicology data 
requirements, and its plans for transition to the notification process. 
There will be an open question and answer period for FDA to answer 
questions from participants regarding these matters. The agency will 
also give its current thinking on any questions submitted in writing to 
the agency prior to February 26, 1999. Participants who, prior to the 
meeting have registered to make oral presentations, will be permitted 
to do so as time permits.
    FDA is seeking the views of interested parties on all aspects of 
the notification process for food contact substances. However, FDA is 
particularly interested in comments that address the following: (1) 
Realistic estimates of the number and complexity of notifications that 
would be submitted under the notification program; (2) the application 
of the requirements of the National Environmental Policy Act (NEPA) to 
the notification process; (3) the confidentiality of third-party 
information submitted in support of notifications; (4) FDA's proposed 
requirements and recommendations on the content of notifications; and 
(5) the conditions, if any, under which premarket review of a food 
additive petition would be necessary to assure the safety of a food 
contact substance (see 21 U.S.C. 348(h)(3)(B)).

A. Number and Complexity of Submissions

    FDA believes that full implementation of the notification process 
for food contact substances could largely replace the food additive 
petition process for such substances and could replace completely the 
threshold of regulation exemption process in Sec. 170.39. FDA also 
believes that the predictability of the notification process and the 
proprietary nature of notifications will increase the number of 
notifications for food contact substances compared to the current 
number of petitions and threshold of regulation submissions for such 
substances. FDA has estimated that it will receive approximately 400 
submissions annually, based on an analysis of the type and number of 
submissions the agency currently receives and the number of industry 
participants in different areas of chemical production. However, FDA is 
interested in comments from the public regarding the number and 
complexity of notifications for food contact substances that would 
likely be submitted.

B. Environmental Considerations

    Currently, food additive petitions and threshold of regulation 
exemptions must contain either a claim for categorical exclusion or an 
environmental assessment. FDA's current view is that, if NEPA is 
applicable to the notification process, the present categorical 
exclusions and requirements for an environmental assessment would apply 
to the notification process. However, FDA seeks comments on the 
applicability, to the notification process, of current environmental 
requirements for food additive petitions and threshold of regulation 
exemptions.

C. Proprietary Third-Party Data

    Currently, FDA receives many food additive petitions and threshold 
of regulation requests that reference proprietary information submitted 
by third parties. In some cases, the proprietary information is 
necessary to describe adequately either the food

[[Page 8579]]

contact substance or appropriate limitations on its use. FDA has 
tentatively concluded that a company submitting proprietary information 
that is necessary to identify adequately the food contact substance or 
the notified use implicitly agrees that such information may be 
publicly disclosed to the extent that it is necessary to describe the 
food contact substance and the notified use. However, FDA is seeking 
comments on how FDA should manage third-party information claimed to be 
confidential that is referenced in a notification where such 
information is necessary to provide adequate identification of the food 
contact substance or the proposed conditions of use.

D. Format and Content of a Notification

    Under 21 U.S.C. 348(h)(1), a manufacturer or supplier of a food 
contact substance is required, prior to marketing a food contact 
substance, to notify FDA of its determination that the intended use of 
the substance is safe within the meaning of 21 U.S.C. 348(c)(3)(A). FDA 
believes that the notifier's determination of safety must be presented 
in such a way that the agency is able to review and verify the most 
important aspects of the notifier's safety determination within the 
120-day notification period. FDA is requesting comments on 
recommendations in the material provided regarding the form and content 
of notifications.

E. When a Petition Shall be Required

    Under 21 U.S.C. 348(h)(3)(B), FDA is authorized to issue 
regulations to identify the circumstances under which a petition shall 
be filed for the use of a food contact substance, and is to consider 
such factors as the probable consumption of the substance and its 
potential toxicity. FDA has tentatively concluded that there are 
substances whose intake level or potential toxicity present a level of 
potential risk high enough that the use of such substances should be 
subject to premarket review and approval and a determination of safety 
by the agency in order to assure their safe use. The agency is 
considering using a cumulative intake of 500 parts per billion or more 
in the diet as one criterion for requiring submission of a petition. 
FDA is seeking comments on this approach, and requests suggestions from 
the public on other potential criteria.

V. Comments

    Interested persons may, on or before March 22, 1999, submit written 
comments 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 ``FDAD[email protected]'' or via the FDA 
website ``http://www.fda.gov''. Comments should be annotated and 
organized to identify the the specific issues to which they refer. 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 Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

VI. Transcripts

    Transcripts of the meeting 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 10 cents per page. The 
transcript of the meeting will also be available for public examination 
after March 22, 1999, at the Dockets Management Branch (address above) 
between 9 a.m. and 4 p.m., Monday through Friday, as well as on the FDA 
website ``http://www.fda.gov''.

    Dated: February 16, 1999.
 William K. Hubbard,
 Acting Deputy Commissioner for Policy.
[FR Doc. 99-4402 Filed 2-18-99; 11:53 am]
BILLING CODE 4160-01-F