Premarket Notification for Food Contact Substances; Public Meeting

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

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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