A Holiday Present to the Human and Animal Food Industries: FDA Reopens Comment Period on 1997 GRAS Notice Proposed Rule

January 4, 2011

By Diane B. McColl & Ricardo Carvajal

On December 28th, FDA reopened the public comment period for its 1997 proposed rule that outlined the voluntary GRAS notification process intended to replace the voluntary GRAS affirmation petition process.   FDA stopped accepting GRAS affirmation petitions and implemented the ongoing GRAS notification process when the 1997 proposed rule published.  According to the agency, publication of the December 28th  notice is the first step in FDA’s effort to at long last finalize the proposed rule.

FDA seeks comments not only on the 1997 proposal, but also on numerous issues raised by CFSAN's 13-year experience with the GRAS notification process for human foods, as well as some of the recent GAO recommendations (for our take on the GAO report, see here and here).  Because the notice raises several issues that were not explicitly addressed in the 1997 proposed rule, it should be carefully reviewed by anyone with an interest in FDA’s voluntary GRAS notification process, including those with long-pending GRAS affirmation petitions.  Note also that the agency requests input on issues relating to the GRAS notification process for animal feed and pet food ingredients newly implemented by CVM. Among the issues on which FDA requests comments:

  • FDA’s proposed revisions to the regulation that states the eligibility criteria for GRAS classification (21 C.F.R. § 170.30);
  • incorporation by reference of previously submitted data in a GRAS notice;
  • requests to cease evaluation of a GRAS notice;
  • inclusion in a GRAS notice of information claimed to be confidential;
  • submission of specific descriptive information such as biological source, known toxicants, and particle size (the latter recommended by GAO due to concerns about nanotechnology)
    submission of information about dietary exposure;
  • submission of species-specific information in the case of animal feed ingredients;
    coordination of FDA’s evaluations with USDA/FSIS;
  • potential issuance by FDA of guidance on conflicts of interest among GRAS expert panelists (as recommended by GAO);
  • potential issuance by FDA of additional guidance on documentation of GRAS conclusions (as recommended by GAO); and
  • FDA’s disposition of pending GRAS affirmation petitions.

Any public comments submitted previously to FDA in response to the 1997 proposed rule need not be resubmitted.  New public comments are due by March 28, 2011.