Safebridge

AIHA Laboratory Accreditation Program

Environmental Services

  • Environmental ServicesEnvironmental Studies- coordinate and interpret environmental fate and effects studies; characterize and assess site emission profiles (air/wastewater); determine the environmental impact (fate and persistence) of potent compounds in wastewater; develop appropriate disposal recommendations and/or discharge limits (link this to Approaches to Fate and Effects Testing.doc)
  • Dioxin and Endocrine Disruptor Issues- assess community and environmental impact of facility emissions and contamination; develop and support regulatory advocacy strategies
  • FDA Environmental Assessments- technical support for US and EMEA Environmental Risk Assessments IND and NDA submissions and EMEA submissions
  • Remediation- provide project planning and management, define scope of work
  • Environmental Risk Management- provide technical support on waste minimization, waste characterization and regulatory compliance

 

Environmental Services Projects
  • Developed cost-effective process wastewater disposal recommendations and acceptable discharge limits for a major pharmaceutical company.
  • Assessed environmental risks and Proposition 65 compliance of research activities by performing in-depth screening modeling of emissions for a research and development organization.
  • Successfully prepared the Request for Categorical Exclusion (RCE) in support of a NDA submittal to the FDA for several pharmaceutical companies.
  • Provided technical and public relations (risk communication) support throughout successful remediation of Times Beach (Missouri) Dioxin Superfund project, including critical reviews of several multi-pathway risk assessments conducted in conjunction with the project (incinerator emissions, ash delisting, worker safety) and strategizing and participating in public meetings and new media releases.
  • Provided technical support to attorneys in preparation of personal injury lawsuits involving 2,3,7,8-TCDD. Activities included assistance in:
    • Identifying appropriate medical and scientific expert witnesses,
    • Preparing attorneys in taking depositions of medical and scientific experts
    • Reviewing testimonies
    • Developing courtroom strategies
  • Coordinated environmental fate and effects studies, provided interpretation and wrote US FDA and EU EMEA submissions for API.