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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