[Federal Register Volume 67, Number 98 (Tuesday, May 21, 2002)]
[Proposed Rules]
[Pages 35764-35765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12662]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 170

[Docket No. 01N-0234]


Food Additives: Food Contact Substance Notification System

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is requesting input on 
whether the agency should establish regulations permitting the 
licensing of the rights to manufacture and market a food contact 
substance for the use that is the subject of an effective food contact 
notification (FCN). FDA is requesting this input in response to a 
comment on a proposed rule published in the Federal Register of July 
13, 2000. The action requested in the comment concerning the transfer 
of rights granted under the FCN process is beyond the scope of the July 
2000 proposal, and FDA is publishing this document so that interested 
persons may have adequate time to consider and comment on this issue.

DATES: Submit written or electronic comments by August 5, 2002.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Mitchell Cheeseman, Center for Food 
Safety and Applied Nutrition (HFS-205), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 
202-418-3083.

SUPPLEMENTARY INFORMATION:

I. Background

    The Food and Drug Administration Modernization Act of 1997 (Public 
Law 105-115) established a premarket notification process for 
food contact substances (FCSs). The FCN process began to operate on 
October 22, 1999, and is now the primary method for authorizing new 
uses of food additives that are FCSs. In the Federal Register of July 
13, 2000 (65 FR 43269), the agency proposed regulations to facilitate 
implementation of the notification process. FDA provided 75 days for 
comment on the proposed rule. FDA received three comments from trade 
associations representing the food packaging industry. One comment 
requested that FDA issue regulations to permit the transfer of rights 
granted under the FCN process. Because that request is outside the 
scope of the proposed rule, in this advanced notice of proposed 
rulemaking, FDA is soliciting input from interested parties on the 
action requested by that comment. Elsewhere in this issue of the 
Federal Register, FDA is publishing a final rule responding to the 
remaining comments on the proposal and codifying the proposed 
regulations with limited changes.

II. The American Plastics Council Comment

    The comment on the proposed rule received from the American 
Plastics Council (APC) requests that FDA issue regulations to permit a 
manufacturer identified in an effective FCN to transfer by sale, 
licensing, or otherwise to another manufacturer the right to

[[Page 35765]]

manufacture and market the FCS for the use that is the subject of the 
FCN, provided that FDA is advised of the transfer. The APC comment 
argues that such a process would maintain the safety of the FCS because 
the FCS would continue to be manufactured in the manner reviewed by FDA 
and would still be authorized only for the use that was the subject of 
the original FCN. As noted, FDA believes that the issue raised in the 
APC comment is outside the scope of the proposed rule, and thus, the 
agency has not addressed the APC comment in the final rule published 
elsewhere in this issue of the Federal Register. To assist the agency 
in determining what, if any, action it should take, FDA is requesting 
comments from interested parties on whether the agency should permit a 
manufacturer to transfer the rights, granted by an effective FCN, to 
manufacture and market an FCS.

III. FDA's Current Practice

    Under section 409(h)(2)(C) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 348(h)(2)(C)), a notification is only effective for the 
FCS identified in the FCN and not for a similar or identical FCS 
manufactured or prepared by another manufacturer. Currently, FDA 
requires any subsequent manufacturer who wishes to market an FCS for a 
use that is the subject of an effective FCN to submit a new 
notification to FDA. In addition, the manufacturer identified in an 
effective FCN may authorize other manufacturers to reference 
information contained in the effective FCN. Thus, other manufacturers 
may have to provide only limited additional information in subsequent 
FCNs but they must separately notify FDA and wait 120 days for their 
FCN to become effective. One effect of FDA issuing the regulations 
requested in the APC comment would be that subsequent manufacturers 
could more rapidly market FCSs.

IV. Paperwork Reduction Act of 1995

    This advanced notice of proposed rulemaking contains no collections 
of information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

V. Analysis of Impacts

    Executive Order 12866, the Regulatory Flexibility Act, and the 
Unfunded Mandates Reform Act of 1995 require cost-benefit and other 
economic analyses of regulatory alternatives. FDA requests comments on 
economic issues associated with regulations permitting a manufacturer 
or supplier identified in an effective FCN to transfer by sale, 
licensing, or otherwise to another manufacturer or supplier the right 
to manufacture or market the FCS for the use that is the subject of the 
FCN. The agency particularly requests answers or comments on the 
following questions:
    1. What paperwork and other costs will you incur in submitting a 
transfer application?
    2. What health and safety safeguards operate under transfer?
    3. Will consumers benefit from establishing such a transfer right? 
If so, how?
    4. What effect would transfer have on the costs and market position 
of small businesses?
    5. How many transfers do you anticipate issuing for each new FCN?

VI. Environmental Impact

    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded under 21 CFR 25.30(h) that 
this action is of a type that does not individually or cumulatively 
have a significant effect on the human environment. Therefore, neither 
an environmental assessment nor an environmental impact statement is 
required.

VII. Reference

    The following reference has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.

    1. Comment from the American Plastics Council submitted to FDA 
Docket No. 99N-5556, dated September 26, 2000.

VIII. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this notice by 
August 5, 2002. 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.

    Dated: September 28, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-12662 Filed 5-20-02; 8:45 am]
BILLING CODE 4160-01-S