{"data":{"id":"us/40-cfr-725.428","jurisdiction":"us","citation":"40 CFR 725.428","heading":"Requirements for the Tier II exemption.","body":"The manufacturer or importer of a new microorganism for commercial purposes may submit to EPA a Tier II exemption request in lieu of a MCAN under subpart D of this part if all of the following conditions are met:\n(a) The recipient microorganism is listed in and meets any requirements specified in § 725.420.\n(b) The introduced genetic material meets the criteria under § 725.421.\n(c) Adequate physical containment and control technologies are used. The criteria listed under § 725.422 for physical containment and control technologies of facilities should be used as guidance to satisfy the Tier II exemption request data requirements listed at § 725.455(d). EPA will review proposed process and containment procedures as part of the submission for a Tier II exemption under this section.","path":["Title 40—Protection of Environment","CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY","SUBCHAPTER R—TOXIC SUBSTANCES CONTROL ACT","PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS","Subpart G—General Exemptions for New Microorganisms"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-40.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:26:04Z","sha256":"b95c241146fa7fbc7c0b3482fd5062e2ca77fadda8df4ee582e5d559f5869e08","source_id":"us-cfr","stale":true,"prev":"us/40-cfr-725.426","next":"us/40-cfr-725.450"},"notice":"GroundRules: Original legal text. Not legal advice."}