J. ENVIRONMENTAL IMPACT ANALYSIS - 21 CFR 25.31 -->25.31a(a)6

I. ENVIRONMENTAL LABORATORY MONITORING

1. Organization

2. Assignments

3. Regulations

II. ENVIRONMENTAL ASSESSMENT

Site of Production:

Active Pharmaceutical Ingredient Produced:

1. Substances expected to be emitted:

2. Controls for each Substance:

3. Citation of Applicable Occupational and Emission Requirements set forth by Federal, State, and Local Authorities:

4. Quantities and Concentrations of Substances Expected to Enter the Environment as a Result of Use and/or Disposal of the Active Pharmaceutical Ingredient:

This signed and dated statement is based on 21 CFR 25.31 -->25.31a(a)6. We can assist you on compiling the details based on our knowledge of current requirements.