04-22013. Food Additives: Food Contact Substance Notification System; Withdrawal

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Advance notice of proposed rulemaking; withdrawal.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the withdrawal of our advance notice of proposed rulemaking (ANPRM) published in the Federal Register of May 21, 2002 (67 FR 35764). The ANPRM requested input on whether the agency should establish regulations permitting the licensing of the rights to manufacture and market a food contact substance (FCS) for a use that is the subject of an effective food contact notification (FCN). FDA is withdrawing the ANPRM based upon comments indicating that such a regulation would not be necessary.

DATES:

The advance notice of proposed rulemaking is withdrawn September 30, 2004.

FOR FURTHER INFORMATION CONTACT:

Kenneth McAdams, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3392, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

In the Federal Register of May 21, 2002 (67 FR 35764), FDA published an ANPRM requesting input on whether the agency should establish regulations permitting the licensing of the rights to manufacture and market an FCS for a use that is the subject of an effective FCN. We received five comments on the ANPRM. Three of the comments, from individuals, concerned unrelated issues and did not address the ANPRM. The other two comments, from the American Plastics Council and the Society of the Plastics Industry, stated that a procedure to transfer or license the rights to an FCN is not needed because of the speed and efficiency of the current FCN system. Both comments also stated that if regulations for such a procedure are issued, they should be kept simple, requiring only notification that the transfer has occurred.

After careful consideration of these comments, FDA has concluded that a procedural regulation for transferring or licensing the rights to an FCN is not needed. Therefore, FDA is withdrawing our ANPRM.

Dated: September 17, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.