i table of contents page list tables iv figures ix executive summary es 1 introduction a background b current policy and the final rule 3 c overview regulatory requirements 6 d structure ria 11 ii regulated community microbial applications subject to tsca biotechnology industry 2 university research 12 iii benefits risks novel microorganisms risk reduction from regulation qualitative assessment incremental 8 costs cost methodology results types numbers submissions epa unit mcans tier exemptions teras 10 post review monitoring reporting controls 23 e other 25 f per product 36 g alternatives sensitivity analysis v government peer advisory committee
