Michelle Twaroski, Ph.D., advises Keller and Heckman attorneys and clients using her expertise in toxicology, hazard identification, and risk assessment with regard to various chemical applications with an emphasis on general safety issues impacting food packaging materials.
Michelle provides technical assistance in evaluations regarding safety and compliance of food contact materials for use in the United States (U.S.), Canada, and the European Union (EU). She has also contributed to projects regarding animal feed additives, inert pesticides, and cosmetics, and provided evaluations to support classification and labeling and data submissions under the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. She advises on complex issues regarding in vitro and in vivo preclinical toxicology testing needs and study design, as well as the incorporation of alternative methods into hazard and risk evaluations, such as predictive and surrogate compound approaches.
Prior to joining Keller and Heckman, Michelle was a Branch Chief in the Environmental Protection Agency's (EPA) Risk Assessment Division of the Office of Pollution Prevention and Toxics, where she supervised staff performing human health and ecological safety assessments of new chemicals under the Toxic Substances Control Act (TSCA). Prior to her time at EPA, Michelle served for eleven years as a Toxicologist at the Food and Drug Administration (FDA), the majority of which was spent as a Toxicology Group Supervisor in the Division for Food Contact Notifications, Office of Food Additive Safety. As a reviewer and supervisor at FDA, she specialized in the toxicological evaluation of food contact substances.
During her time at the FDA, Michelle was active in enhancing the safety review of food contact substances through the incorporation of structure activity relationship (SAR) analysis. Her SAR expertise has proven to be especially beneficial to clients dealing with data gaps in hazard identification and risk assessment, especially those adhering to strict policies regarding reducing animal testing.
Michelle has authored and co-authored numerous publications on issues related to food contact substance risk assessment, SAR analysis, and peroxisome proliferation, including articles in Regulatory Toxicology and Pharmacology and Food and Chemical Toxicology.