Environmental Risk Assessment for Pharmaceuticals

Regulatory agencies around the globe require environmental impact evaluations as part of the approval process for human and veterinary medicines. Exponent has expertise in all aspects of conducting environmental risk assessments for pharmaceuticals, including evaluating fate and transport properties, developing exposure scenarios, assessing ecological effects on non-target organisms, and calculating risk for all potentially affected environmental compartments. Our scientists are involved in the global dialogue surrounding the detection of trace concentrations of pharmaceuticals in surface water, wastewater, and drinking water and the related issues of potential treatment, risk, and regulation.

Exponent scientists can assist pharmaceutical and biotechnology companies in meeting the growing requirements for the United States, European Union, and worldwide product approvals and product defense. Our environmental risk assessment consultants have provided valuable support and assistance to clients at every step, from initial strategy development through placement and monitoring of studies, preparation of the environmental assessment, and regulatory negotiations. Our experience includes complex issues involving nanotechnology, endocrine disruptors, biologicals, genetically modified organisms, and traditional human and veterinary pharmaceuticals. Our assessments have ranged from simple justifications for categorical exclusion to complex multi-parameter, multi-receptor watershed-scale risk assessments.

Examples of pharmaceutical environmental assessments that were submitted to the US FDA and received a Finding of No Significant Impact include:

  • Aquaflor® (Florfenicol) 50% Type A Medicated Article to control bacterial disease mortality in freshwater-reared finfish
  • Banamine Transdermal (flunixin transdermal solution) Pour-On for Cattle
  • Cystorelin® (gonadorelin) (flunixin transdermal solution) Pour-On for Cattle

 

Environmental Risk Assessment Services 

  • Strategy development and negotiation 
  • Literature search and critical review 
  • Justification for categorical exclusion 
  • Data gap analysis 
  • Study placement, monitoring, and evaluation 
  • Physico-chemical properties evaluation
  • Environmental fate assessment
  • Ecotoxicity assessment
  • Field studies 
  • Environmental assessment (EA) for submission to U.S. FDA 
    • Per Guidance for Industry CMC 6 (CDER and CBER) and 89 and 166 (CVM)
  • Environmental risk assessment (ERA) for submission in Europe 
    • Per EMA CHMP and CVMP guidance
  • Environmental risk assessment (ERA) for submission in other jurisdictions 
  • Preparation for and representation at regulatory agency meetings 
  • Risk communication.

Professionals