not-yet-known not-yet-known not-yet-known unknown International genotoxicity standards Shortly after I joined CDRH, I was recruited by the Center for Drugs (CDER) along with Mike Prival from CFSAN (foods) and Lenny Schechtman from Veterinary Medicine (CVM) to negotiate the first International Committee on Harmonization (ICH) genotoxicity safety standards for pharmaceuticals), ICH S2A and B. At that time, CDER didn’t have any genetic toxicologists in house, and we had been consulting for CDER on submissions. This was quite a fraught exercise and we were not popular with our industry counterparts. This was the beginning of a knowledgeable core of genotoxicity experts at FDA who understood immediately when sponsors chose assays that would miss one or the other major class of DNA damaging agents, such as clastogens. After our group gained consensus on the ICH document, we decided to work on harmonizing genotoxicity standards FDA-wide. Joining the single genotoxicity experts in several product centers into one group provided critical mass and a forum for discussion of difficult product reviews and consistency in policy. I led this effort by establishing the FDA Genetox Network, an inter-center group. This was unusual at the time. We worked together below the radar, center by center, as genotoxicity standards-setting arose. We negotiated the VICH (veterinary standards), established a genotoxicity testing paradigm for the new assessment of food packaging/food contact materials, revised the CFSAN Redbook, and contributed to the ISO medical device standards (my center). This was entirely unsung. Eventually we added NCTR to our group, as they developed a powerhouse genotoxicity group. Later we worked mainly with CDER on problematic drug submissions. Ironically, turf battles left me out of my own center’s approach to genotoxicity for about 20 years, while I succeeded in working productively for other FDA centers. CDRH mainly followed the CDER ICH document, which was fine except for the animal assays. Eventually we had 4 international standards that were consistent for genotoxicity assessment. About 5 years before leaving FDA, I became the US leader of the ISO 10993-3 genotoxicity testing standard for CDRH, but international leaders left the standard in limbo for about 2 years and it was not finished by the time I left in December of 2022, nor finished yet apparently.