Environmental Services

• Environmental 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

• 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.

Times Beach-Related
Successful remediation of Times Beach (Missouri) Superfund site

• Provided executive management and oversight over the project, one of the largest and most highly publicized dioxin-contaminated sites in the United States; negotiated with federal, state, and local governmental agencies, engineering contractors, and incinerator vendors for siting an incinerator on the Times Beach site; completed project under budget and ahead of schedule.
• Provided technical and public relations (risk communication) support throughout 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.
• Critically reviewed blood study conducted by Missouri Department of Health of residents living near the Times Beach incinerator.

Personal injury litigation support

• 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
• Technical advocacy on dioxin-related issues
• Submitted comments to:
  • EPA on its dioxin reassessment documents
  • ATSDR on its draft Toxicological Profile on 2,3,7,8-TCDD
  • National Academy of Sciences (NAS) on health effects to Vietnam veterans exposed to Agent Orange
  • National Toxicology Program (NTP) on cancer reclassification of 2,3,7,8-TCDD
  • National Institute of Occupational Safety and Health (NIOSH) on numerous draft manuscripts of studies involving worker exposure to 2,3,7,8-TCDD and on worker notification materials informing workers of study outcomes.
• Participated on Chemical Manufacturers Association (CMA) dioxin work group; efforts included helping to prepare a public relations document on dioxins, identifying experts to critique and develop an alternative to the toxic equivalency factors (TEFs) approach for dioxins, and advising food industry trade organizations when dioxins were discovered in chickens in unexpected levels.

Other Projects

• Assisted a multinational client in identifying causative agent(s) that produced chloracne in chemists handling small quantities of novel compounds that exhibited dioxin-like properties in a research laboratory; provided appropriate laboratory cleaning and re-entry criteria.
• Advised a client regarding significance of finding low levels of dioxins in its fertilizer products.
• Provided dioxin risk communication training to a metals refining client.