Contaminated Site Risk Assessment



 



 

  • Chemically contaminated foods and nutritional supplements
  • Expert witness/litigation support
  • Risk assessments for chemicals in cosmetics, fragrances and other personal care products including Cosmetic Product Safety Reports per European Union Regulation 1223/2009
  • GRAS (Generally Recognized as Safe) food safety expert panels and toxicology support for new nutritional supplements and medical foods
  • Proposition 65 compliance evaluations, including Maximum Allowable Dose Level (MADL) and No Significant Risk Level (NSRL) development for listed chemicals lacking Safe Harbor Levels

Damian Applied Toxicology, LLC has applied toxicology and risk assessment expertise to a wide variety of health and environmental chemical exposure issues. Representative examples of these services include:

  

Our Services

Damian Applied Toxicology, LLC

 

      Drug Impurity Risk Assessment


  • Elemental impurity risk assessment per ICH/FDA Guidance Q3D

  • Calculation of Compound-Specific Acceptable Intakes for mutagenic drug impurities per ICH/FDA Guidance M7

  • Calculation of Permitted Daily Exposures (PDEs) for residual solvent impurities in drugs per ICH/FDA Guidance Q3C

Computational and Predictive Toxicology (Predicting the Toxicity of

    Novel Chemicals and Drugs Using QSAR and Read-Across Methods)


  • Veteran's disability claims due to chemical exposure
  • Workers' compensation cases (chemical exposures only)
  • Pesticide risk assessments
  • Honey bee risk assessments
  • Toxicity literature searches and reviews
  • Crystalline silica exposure and toxicity
  • Lead exposure and toxicity
  • Microcystin (blue-green algae) exposure and toxicity

Proposition 65, Food Safety, and Consumer Product 

   Risk Assessment

  • Leadscope Model Applier (bacterial mutagenicity per FDA/ICH Guidance M7)
  • OECD QSAR Toolbox (mammalian and aquatic/ecotoxicity, environmental fate properties)
  • PBT Profiler (persistence, bioaccumulation and toxicity profile)
  • AIM (chemical analog identification methodology)
  • EPI Suite (environmental fate properties)
  • OncoLogic (carcinogenicity)
  • Toxtree (mammalian toxicity)
  • ECOSAR (aquatic/ecotoxicity)

(530) 220-0454

Other Specialty Areas

  • Expert witness/litigation support

  • Health risk-based site closure strategy to support Brownfield site redevelopment

  • Mine and smelter site health and ecological risk assessments

  • Probabilistic (Monte Carlo) risk assessments

  • Industrial site health and ecological risk assessments

  • Vapor intrusion and indoor air health risk assessments

  • Hazardous waste site risk assessments

  • Radionuclide site risk assessments

  • Ecorisk-based cleanup levels for radionuclides

  • Health risk-based cleanup level development

  • Regulatory agency negotiation and response to comments

  • Third-party independent review of risk assessments