EA Review #1, NDA 20-358

Page 12

          Water use                  0.08% total

          Energy use                12% total

          Disposal                    075% total natural gas use

Drug Product

          Water use                  0.003% total

          Energy use                0.08%

          Waste disposal        0.01% total energy use

Adequate

b.      Effect on endangered or threatened species and property listed in or eligible for listing in the           National Register of Historic Places:

          The assessment states that the permitted activities were judged not likely to jeopardize critical           habitat nor would the activity impact property listed in or eligible for listing in the National           Registry of Historic Places.

          Adequate.

10.

Mitigation measures:

The company cites various procedures to mitigate release of compounds into the environment including measures descried in 6b.  Also included is a list of titles and brief description of several standard operating procedures relevant to avoiding or mitigating adverse environmental impacts.

Adequate.

11.

Alternatives to the proposed action:

Eliminating the production of this product is listed as a no action alternative.

Adequate.

12.

List of Preparers and their qualifications:

A list of preparers is provided.  Personnel from the contract testing laboratory are cited as being listed in the attachments describing the contracted studies, but their qualifications are not contained in the report.  A statement