Experien Health Sciences personnel have addressed a broad range of regulatory toxicology and risk assessment challenges relating to industrial chemicals, cosmetic and personal care products, food additives, and pesticide active and inert ingredients. Of special concern for many products are chemicals that are known or suspected to be carcinogenic, mutagenic, cause reproductive or developmental effects, are endocrine disruptors, bioaccumulate, are sensitizers, or that have the potential to cause toxicologically significant changes to the function or morphology of a tissue/organ or that have produced serious changes to the biochemistry or hematology. In addition, chemical substances for which a reliable assessment cannot be made because of insufficient data are also a concern. With more than 50 years of combined experience, our regulatory toxicologists and exposure assessment experts are available to help individual companies and industry trade groups in the following areas:
- Provide regulatory support for chemicals, cosmetics, pesticides, food contact / food packaging materials, art and craft materials, and children’s toys.
- Prepare a written Toxicological Risk Assessment (TRA) when required.
- Assess the need for California Prop. 65 Warnings by completing Safe Use Determinations (SUD) using published Safe Harbor Levels and by deriving valid Safe Harbor Levels where none exist.
- Complete regulatory notifications/registrations for the European Union, the USA and parts of the Asia-Pacific region.
- Defend existing chemicals that have been prioritized by EPA under their TSCA Section 6(b) risk evaluation process.
- Develop cost-effective testing strategies that include competitive bids from competent testing laboratories and the use of data waivers, published data, QSAR models, in silico models, weight-of-evidence arguments, and analog or read-across arguments.
- Interpret toxicological data and serve as an advocate for your products.
- Perform exposure assessments and risk assessments using standard and special-purpose models.
Litigation support and forensic investigation of cases involving known or suspected harm caused by exposure to hazardous chemicals, including expert dermal exposure and inhalation exposure assessment using state-of-the-art modeling.
