40 CFR 725.428

§ 725.428 Requirements for the Tier II exemption.

United States · 40 CFR — Protection of Environment · Status: effective

Cite this

Citation: 40 CFR 725.428, § 725.428 Requirements for the Tier II exemption, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/194121
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Full text

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: (a) The recipient microorganism is listed in and meets any requirements specified in § 725.420. (b) The introduced genetic material meets the criteria under § 725.421. (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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.