EA Review #1, NDA 20-358

Page 6

b.      Controls (Air, Liquid Effluent, Solid):

          See Attachments 1 and 2 .

          The controls exercised to prevent emission into the environment are described for both drug           substance manufacture and formulation of drug product.

          On page 6 off-site disposal is indicated.  The disposal locations should be identified and           appropriate permits/license numbers given.

          DEFICIENT.

c.       Compliance with Federal, State and Local Emission Requirements:

          A list of applicable regulations and laws as well as a statement of compliance is included.

          Adequate.

d.      Effect of Approval on Compliance with Current Emissions Requirements:

          It is stated that air emissions, solid waste, or liquid waste resulting from the action will not have           an adverse impact on compliance.

          Adequate.   

e.       Estimated Expected Emitted Concentration/Quantities:

          The quantities of materials generated by production of 1 kg of drug substance are given in           confidential Appendix B.  All materials are removed by incineration or wastewater pretreatment           and are not released.

          The Maximum Expected Emitted Concentration (MEEC) for the use of the drug product was           calculated in confidential Appendix B for the production volume of drug substance predicted for           year four.

          The maximum concentration of drug substance in the receiving water bodies that would result           from loss of a day’s production (at each facility) into the production facility effluent was also           calculated.