The final rule also details new formatting requirements for GRAS notifications, which should be arranged into the following seven parts: 1) Signed statements and certification; 2) Identity, method of manufacture, specifications, and physical or technical effect; 3) Dietary exposure; 4) Self-limiting levels of use; 5) Experience based on common use in food before 1958, if applicable; 6) Narrative; and 7) List of supporting data and information. All seven parts must be included.
Some of the other notable changes include the following.
- New provisions are included on the submission and treatment of trade secret and confidential information in the GRAS Notice. (The proposed rule assumed that GRAS Notices would not contain any information protected under the Freedom of Information Act. The final rule permits some limited submission of trade secret and confidential information. However, if trade secret or confidential information is included, the notifier must establish how GRAS status can be supported without the trade secret or confidential information having a bearing on the safety determination.)
- FDA will review a GRAS notice within 180 days, with a possible 90-day extension. Up to now the program has been operating without an FDA review time frame.
- A requirement that a GRAS Notice discuss information that is or appears to be inconsistent with the notifier’s conclusion of GRAS status or certification that the notifier is not aware of such information.
- A requirement that a notification include some discussion of technical effect when such information has bearing on the safety evaluation.
- Between 1972 and the proposal of the voluntary GRAS Notification rule in 1997, FDA had in place a voluntary GRAS affirmation petition process. Under that process, companies could petition FDA to review the GRAS status of a substance and, if FDA agreed with the GRAS conclusion, it would issue a food additive regulation affirming that the substance was GRAS. Although the affirmation process was effectively abandoned in 1998 with the advent of the GRAS notification pilot program, FDA never formally ended the process. Thus, the final rule brings the GRAS affirmation petition process to an official end.
The fact that the 1997 proposed GRAS Notification rule was never finalized was criticized both by the Governmental Accountability Office (GAO) and a number of public interest groups. In addition, public interest groups have long argued against the GRAS exemption from the rulemaking process because it permits companies to make a self-determination on the safety of a food ingredient. It was the hope of several of these groups that FDA would severely curtail the use of GRAS self-determinations by industry and require even further scientific data than was proposed in the previous proposal for the GRAS Notification rule. FDA concluded that it did not have the legal standing to eliminate self-determinations and it further decided that its requirements as set forth in the proposed rules was protective of the public health.
In summary, FDA’s final rule on GRAS substances does not represent a significant change in the way that the GRAS notification program operates or a company’s own determination on whether a substance is GRAS. The final rule, however, does provide some needed clarity for industry with respect to how FDA believes GRAS conclusions should be made. For many companies, the GRAS exemption is an important statutory mechanism to establish a suitable legal status for a product, and therefore, the final rule has importance to their businesses.
Hill, a partner with Keller and Heckman LLP, served as chair of the GMA/NSF Joint Committee on Generally Recognized as Safe Publicly Available Standard. Reach him at firstname.lastname@example.org. Dages, an associate at Keller and Heckman, practices in the area of food and drug law and advises clients on product compliance issues involving the FDA. Reach him at email@example.com.