[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.
[[Page 8578]]
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 vgilliam@bangate.fda.gov''.
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 ``FDADockets@bangate.fda.gov'' 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
