Federal Register 67 FR 35764, May 21, 2002 -- Food Additives: Food Contact Substance Notification System; Advance Notice of Proposed Rulemaking

[Federal Register: May 21, 2002 (Volume 67, Number 98)]
[&thnsp;Proposed Rules]
[Page 35764-35765]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my02-17]
 
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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