EPA’s Approach to Providing Flexibility Requested by Kodak Sample Clauses

EPA’s Approach to Providing Flexibility Requested by Kodak. For purposes of this XL Project, EPA will allow Kodak simultaneous submissions of TME applications and PMNs on chemical substances for which Kodak makes application and use of the P2 Framework. This would enable Kodak, following approval of the TME by the Agency, to begin manufacture of the chemical substance in accordance with the TME after 45 days. Kodak must continue to meet the exemption requirements for an additional 45 days, at which time the 90-day PMN review may be satisfactorily completed and Kodak may then submit an NOC and begin manufacture for PMN purposes. Under this XL Final Project Agreement Kodak may begin manufacture of qualifying simultaneous PMN/TMEs at 45 days in accordance with the TME. The Agency will contact Kodak within 45 days of receipt of the TMEA to inform the company if its TMEA has been accepted. As described above, most decisions on PMNs or TMEs are made before day 30 of their review periods, which in the case of Kodak TME/PMN submissions, would run concurrently. Kodak’s approval to manufacture at day 45 under the TME will be restricted to those Kodak PMN/TME chemical substances that the Agency, in the case of the PMN, drops from review and, in the case of the TME, grants by the Focus meeting which occurs by day 30 of the 45- or 90-day review period. To qualify for a TME, the Kodak submission must be judged by EPA to meet the requirement that it “will not present an unreasonable risk of injury to human health and the environment,” after which Kodak can commence TME activities at the conclusion of the 45 day TME review period. EPA will also consider the simultaneously submitted PMN, provided the TME is granted and the PMN is dropped during the first 30 days of the 90-day review period. Kodak may then commence full commercialization after day 90 of PMN review and file the NOC. All TME requirements must, however, be met until such time as commencement of manufacture occurs and the NOC is filed, at which point the substance becomes an existing chemical and is placed on the TSCA Inventory. Simultaneous submissions will be accepted only when the Kodak TME is granted and the Kodak PMN is dropped from further review during the first 30 days of the review period. If EPA denies the TME, it will continue its review of the PMN and take action as needed. If EPA grants the TME, but does not drop the PMN during the first 30 days of review, Kodak will be notified that the company must choose, by letter within 15 days of being notified of the...
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