Global Product Stewardship

Product stewardship is the effort to synthesize regulatory compliance, human and environmental safety, and sustainability goals into responsible design, development, and management of products throughout their life cycle and value chain. Product stewardship is a continuous process that is interdisciplinary in nature and global in reach. The core competencies of ToxStrategies Consulting Services – chemistry, exposure assessment, toxicology, risk assessment, and risk communication – are critical aspects of product stewardship.

Our staff experts have decades of experience in risk-based regulations, advanced capabilities in product exposure and hazard assessment, and risk communication skills. We understand how to develop assessments of human and environmental safety that can be readily incorporated into product stewardship decision-making. ToxStrategies’ consulting services include:

  • Regulatory Integration Support
    • Extensive experience with the United Nation’s Globally Harmonized System (GHS); Amended TSCA; REACH; OSHA HazCom; Classification, Labeling and Packaging of Substances and Mixtures (CLP); and other relevant regulations
    • Coordinating and integrating product safety demonstrations where multiple regulations are applicable
  • Product Safety Evaluations
    • Product-specific life-cycle exposure and risk assessment, including REACH and new and existing chemical and article risk evaluations under Amended TSCA
    • Consumer products, existing or under development
    • Food clearances and cross-contamination tolerance levels in shared facilities
    • Food additives and ingredients, including Generally Recognized as Safe (GRAS) and Food Safety Modernization Act (FSMA)
    • Biopharmaceutical and pharmaceutical toxicology monographs and risk/safety assessments
    • Non-animal/alternative testing
      • Evaluation of in vitro high-throughput screening assay data
      • Read across and categorization, structural activity relationships (QSAR), weight-of-evidence, ECHA data waiving
      • Big-data mining and simulations to prioritize hazards, identify susceptible populations, and compare hazards of alternatives
    • Clinical and pre-clinical study design, placement, and monitoring
  • Product Claims and Product Liability
    • Assistance with evaluation of new health claims, including qualified health, structure, function, and nutrient content claims
    • Consumer complaints, including assistance with foreign material assessment or contaminant/allergen issues
    • Product recalls, including risk communication and litigation support
    • External influencing strategies to address state and federal regulatory challenges
    • Patent dispute technical support
    • Exposure assessments and development of safe harbor levels (NSRLs/MADLs) under California’s Proposition 65
  • Green Chemistry

For more information about ToxStrategies’ consulting services, please contact us.