raw water supply from the Tar River.  The amount of water used during formulation is approximately 0.003% of total plant use per year.  Energy use will constitute less than 0.08% of total plant consumption.

 

Waste Disposal

 

Energy consumption required to dispose of product waste from formulation is estimated to be less than 0.01% of total plant consumption.

 

Transportation of Drug Product

 

Burroughs Wellcome Co. will use commercial carriers to transport the drug product from the production site.

 

9.b           Effects on Endangered or Threatened Species and upon Property Listed in or Eligible for Listing in the National Register of Historic Places.

 

The National Historic Preservation Act of 1966 and the Endangered Species Act have been considered prior to issuance of Federal and State environmental permits.  No special permit conditions are required as the permitted activity was judged not likely to jeopardize critical habitat nor would the activity impact property listed in or eligible for listing in the National Register of Historic Places.  The applicable permits are described in sections 6.a93) for the Greenville, N.C. (USA) facility.

 

Approval of the action proposed in this document will not require reevaluation of site environmental permits for their impact on either of these Federal Laws on land management.

 

10.                MITIGATION MEASURES

 

Burroughs Wellcome Co. will use existing facilities on site or off site to ensure that releases from this proposed action will have minimal environmental impact.  No special measures outside current Standard Operating Procedures are anticipated or believed required.  Burroughs Wellcome Co. will implement appropriate procedures established for response to spills or releases in the product formulation areas, and in the unlikely event of a release to the environment.  The procedures developed to control such releases as well as corporate standards for waste minimization and recycling are described below.  These procedures and standards are listed according to the specific area where control is appropriate.  The areas relevant to manufacture and formulation of WELLBUTRIN (bupropion hydrochloride) Sustained Release Tablets are the Primary Manufacturing Division (PMD), Solid Dose Formulations Manufacturing Department (SDFMD), and the Environmental Services Department (ES).

 

10.a        Primary Manufacturing Division (PMD)

 

Manufacture of the drug substance will take place in the Primary Manufacturing Division (PMD).  Following a list of PMD SOP’s by title, and a brief description:

 

 

 

 

 

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