Modifications which will significantly impact the hydraulic or pollutant loading require notification to the local Publicly Owned Treatment Works (POTW).  Depending on the impact, negotiations with the local authority to allow permit modifications may be required.  As described above, all modifications are reviewed and evaluated in-house by the Environmental Services Department.  Formulation of drug product is not expected to trigger notification or modification of the permit.

 

6.b           Through use of calculation and/or direct measures, estimate to the extent possible quantities and concentrations of substances expected to enter the environment as a result of use and/or disposal of products affected by the action.

 

Calculations of the Maximum Expected Emitted Concentration (MEEC) for the aquatic compartment are included in CONFIDENTIAL Appendix B. (NOT PROVIDED THROUGH FOI ACT)

 

In a worst case situation, assume that one batch of bupropion hydrochloride per year could be conceivably lost during production.  Such an incident would result in a maximum discharge of 500 kg of bupropion hydrochloride from its Greenville Wellcome Co.’s Greenville facility to the Greenville Utilities Commission is 1.2 million gallons (4.54 million liters) per day.  If the total amount were discharged in one day without pretreatment at Burroughs Wellcome Co., this would represent a maximum product concentration of 100 ppm discharged to the Greenville Utilities Commission.  The maximum daily discharge of wastewater at the Greenville Utilities Commission is 10.5 gallons (39.7 million liters) per day.  The efficiency of the Greenville Utilities Commission biological treatment plant has been measured to exceed 85%.  At a worst case of 85%, after treatment, the concentration of the discharge to the Tar River is calculated to be 1.7 ppm.  The annual average 7Q10 flow of the Tar River is 101 million gallons (397 million liters) per day.  At the Greenville Utility Commission’s maximum daily flow rate, the maximum estimated concentration of bupropion hydrochloride in the Tar River would be 0.2 ppm.

 

7. FATE OF EMITTED SUBSTANCES IN THE ENVIRONMENT

 

7.a           Aquatic Compartment

 

In order to assess the effect upon the aquatic compartment, the water solubility, hydrolysis rate and dissociation constant of bupropion hydrochloride were measured.  The aqueous aerobic biodegradation and photodegradation potentials were also determined.  Data for these test are summarized in Section 15a.

 

                Water Solubility

 

The water solubility of bupropion hydrochloride is 11.3x10-1M which is greater than 1 x 10-5 M.  Bupropion hydrochloride has a relatively high solubility in aqueous base solvents. (17)

 

 

 

GCPV/93/0011/03                                  10

 

 

 

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