Best Practices for Convening a GRAS Panel: Draft Guidance for Industry; Availability

See attached for EDF's full comments. The Environmental Defense Fund (EDF) appreciates the opportunity to comment on the Food and Drug Administration's (FDA) submission to Office of Management and Budget (OMB) for review of its proposed information collection activities in support of its draft guidance entitled "Substances Generally Recognized as Safe: Best Practices for Convening a GRAS Panel." In our 2018 comments on the draft guidance, joined by the Center for Science in the Public Interest and Consumer Federation of America, we supported it but had concerns. Specifically, we questioned whether the draft guidance would have a significant effect because FDA would have little knowledge if food companies chose not to seek voluntary FDA review. In this situation, the agency will be unable to fulfill its mission of ensuring food supply is safe. In summary, FDA's estimate of the burden on food companies from the proposed information collection activities reveals in stark terms how little knowledge it has on the secret GRAS safety determinations. The agency's estimate reinforces our concerns and appears to significantly underestimate the information collection burden if food companies were to follow the guidance. FDA acknowledges the shortcomings of its approach when it states that "we have very little information about the number of proponents who have documented a GRAS conclusion without reporting that GRAS conclusion to FDA in the form of a GRAS notice" and "we have not previously estimated the annual number of documented GRAS conclusions that are not reported to FDA as a GRAS notice." FDA provides no defensible rationale for assuming the AIBMR's inventory only catches half of the secret GRAS determinations. The agency makes no reference to the 2011 peer-reviewed journal article in the Institute of Food Technologists' Comprehensive Reviews of Food Science and Food Safety by Neltner et al. titled "Navigating the U.S. Food Additive Regulatory Program." That article estimated there were 1,000 secret GRAS self-determinations as of 2011 that had not been reviewed by FDA. This number has only grown during the past 10 years. In attachment A, we provide announcements of ten secret GRAS determinations made by food companies in the span of eight weeks from September 20 to November 15, 2022. 1.Farlong Nutraceutical on September 20, 2022; 2.Remilk on September 28, 2022; 3.Nammex on October 6, 2022; 4.Nutrition21 on October 19, 2022; 5.BioCell Technology on October 25, 2022; 6.Geno on November 3, 2022; 7.Bartek on November 11, 2022; 8.EPI Ingredients on November 11, 2022; 9.CINA Corp on November 11, 2022; and 10.Nurita on November 15, 2022 FDA appears not to have conducted a similar search. At this rate, there would be almost 65 secret GRAS determinations annually that are publicly announced, and an unknown number are not made public. We also note that none of these are captured in the current online version of the AIMBR inventory. We suspect that the rate of secret GRAS safety determinations has increased dramatically since FDA issued its GRAS rule in 2016 that officially sanctioned the practice. The fact that the rate of voluntary notices submitted to FDA has increased is only a reflection of the increased innovation by companies that produce new substances for conventional foods as well as the dietary supplement companies seeking to bypass FDA's new dietary review by using the GRAS exemption. Lacking an alternative, we use FDA's approach of doubling the number to cover those secret GRAS safety determinations not publicly announced. Using this approach, we estimate that the draft guidance will affect 130 secret GRAS safety determinations annually and 2,430 previously made. This estimate may still underestimate the burden.

The Center for Science in the Public Interest (CSPI), Consumer Federation of America (CFA), Environmental Defense Fund (EDF), respectfully submit the following comments regarding FDAs Best Practices for Convening a GRAS Panel draft guidance. The draft guidance is intended to reduce bias, minimize conflicts of interest and appearance issues, ensure balance, and otherwise improve the credibility, reliability, and transparency of panels used in making determinations that an ingredient is generally recognized as safe (GRAS).