The manufacturer must meet all of the following criteria for physical containment and control technologies for any facility in which the new microorganism will be used for a Tier I exemption; these criteria also serve as guidance for a Tier II exemption.
(a) Use a structure that is designed and operated to contain the new microorganism.
(b) Control access to the structure.
(c) Provide written, published, and implemented procedures for the safety of personnel and control of hygiene.
(d) Use inactivation procedures demonstrated and documented to be effective against the new microorganism contained in liquid and solid wastes prior to disposal of the wastes. The inactivation procedures must reduce viable microbial populations by at least 6 logs in liquid and solid wastes.
(e) Use features known to be effective in minimizing viable microbial populations in aerosols and exhaust gases released from the structure, and document use of such features.
(f) Use systems for controlling dissemination of the new microorganism through other routes, and document use of such features.
(g) Have in place emergency clean-up procedures.