Developmental & Reproductive Toxicology
Assessing the potential developmental and reproductive effects of pharmaceutical and agrochemical agents is a critical step in safety assessment. The recognition that environmental factors can affect prenatal and postnatal development as well as reproductive health has led to the implementation of legislative measures such as The Food Quality Protection Act (FQPA) and amendments to the Safe Drinking Water Act (SDWA) as well as changes to the Pregnancy and Lactation Label for pharmaceuticals. The World Health Organization (WHO) also has promoted a number of programs and alliances to address environmental impacts on childhood development and recently authored a report on the potential for chemical compounds to disrupt the endocrine system. Recent concern about the consumer safety of toys and baby bottles further emphasizes the importance of specialized expertise in developmental and reproductive toxicology in assessing the health risks associated with different exposures.
Exponent’s developmental and reproductive toxicologists have extensive experience in the chemical and pharmaceutical industries, academia, and government and have worked on projects at the state, national, and international levels. In particular, our team of scientists has considerable regulatory experience as senior scientists/directors at the US EPA and the UK Pesticides Safety Directorate, and as members of national and international expert committees on developmental and reproductive issues. They have been involved in developing regulatory guidelines for reproductive and developmental toxicity testing and risk assessment, developmental neurotoxicology, endocrine disruption, cancer risk assessment as it relates to children, and quantitative risk assessment.
Exponent toxicologists have practical experience in planning, conducting and coordinating regulatory guideline-based toxicity studies and investigative human studies to address potential developmental and reproductive issues. This includes interpreting study data relative to children’s health and developmental and reproductive toxicity for standard-setting and risk/safety assessment, screening assays for endocrine disruptors, quantitative benchmark dose analysis and risk assessment, and conducting and interpreting gene-environment interaction studies of environmental exposures and genetic susceptibility in human fetuses and infants.
Using an integrated approach, our team of scientists advises clients on issues such as product testing and registration, data and literature analysis of potential children’s health issues, and product stewardship. Studies necessary for any given regulatory authority may have implications in other parts of the world (e.g., classification and labeling restrictions; acute reference dose; FQPA factors). Exponent’s international team of scientists offers an array of services to help navigate these issues, from interpretation and advice to directing programs and risk management proposals. Exponent is unique in that we can bring to bear powerful multi-disciplinary expertise in industrial hygiene, epidemiology, toxicology, and risk assessment on solving scientific problems in developmental and reproductive toxicology and human health risk assessment.
DeSesso, JM, Williams AL, Ahuja A, Bowman CJ, Hurtt ME. The placenta, transfer of immunoglobulins, and safety assessment of biopharmaceuticals in pregnancy. Crit Rev Toxicol 2012; 42:185–210.
DeSesso JM, Watson RE, Keen CL, Hazelden KP, Haws LC, Li AA. Analysis and integration of developmental neurotoxicity and ancillary data into risk assessment: A case study of dimethoate. J Toxicol Environ Health Part A: Current Issues 2009; 72:94–109.
DeSesso JM, Lavin Williams A. Contrasting the gastrointestinal tracts of mammals: factors that influence absorption. Ann Rep Medicinal Chem 2008, 43:353-371.
Watson RE, DeSesso JM, Hurtt ME, Cappon GD. Postnatal growth and morphological development of the brain: A species comparison. Birth Def Res (Part B): Develop Reprod Toxicol 2006; 77:471-484.
Carney EW, Scialli AR, Watson RE, DeSesso JM. Mechanisms regulating toxicant disposition to the embryo during early pregnancy: An interspecies comparison. Birth Def Res (Part C): Embryol Today 2004; 72:345360.
Julien EA, Willhite CC, Richard AM, DeSesso JM. Challenges in constructing statistically based structure-activity relationship models for developmental toxicity. Birth Def Res (Part A): Clin Molec Teratol 2004; 70:902911.
Morford LL, Henck JW, Breslin WJ, DeSesso JM. Hazard identification and predictability of children’s health risks from animal data. Environ Health Perspect 2004; 112:266271.
John M. DeSesso, Ph.D., DABFM, DABFE, FACFEI, DABCHS, Fellow ATSHealth SciencesPrincipal ScientistAlexandria