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Nicholas P. Skoulis, Ph.D. ˘

Assistant Director

Dr. Nicholas Skoulis is an assistant director who focuses on regulatory matters involving chemicals, pesticides, and other products. He represents clients before agencies such as the EPA, Health Canada, and European Union authorities on registration, authorization, and compliance issues. Nick has over 35 years of experience in toxicology testing and evaluation for pesticide and chemical registrations under the EPA and EU regulatory programs, including the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), and the EU Biocidal Products Regulation (BPR) and Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).

Nick advises on risk assessment, toxicology, ecotoxicology and environmental fate testing programs, and environmental assessments. He has worked on matters related to many pesticides and antimicrobial products, including wood preservatives, antifouling coatings, household and institutional antimicrobials, skin sanitizers regulated by the FDA, and space and aeronautics products. He has designed and evaluated human clinical studies involving potential chemical exposures; designed, supervised, and reviewed toxicology test programs; and investigated a number of effects and endpoints on mammalian, aquatic, and plant species. Nick has been working with the FDA in designing a Maximal Usage study Trial (MUsT) in support of the Antimicrobial Consumer Monograph. He has also been working on improving the approach to environmental assessments by the EPA for antifouling paints in fresh and saltwater marinas.

Nick has actively participated in industry groups such as the American Chemistry Council’s Strategic Science Team and the ISO Technical Committee on Human Risk Assessments.

Concentrations

  • Pesticide and general chemical regulation
  • Chemical risk assessment
  • Regulatory development and challenges
  • Consumer products regulations
  • Food safety
  • Environmental regulation

Capabilities

Experience

  • Global Head of Toxicology, Lonza Inc.
  • Director of Toxicology, Arch Chemicals Inc.
  • Vice President of Product Stewardship, BBL Sciences
  • Manager of Toxicology, Olin Corporation
  • Senior Project Toxicologist, Texaco

Recognition & Leadership

  • Former Member, American Chemistry Council's Strategic Science Team
  • Former Member, International Organization for Standardization's Technical Committee to Draft Human Risk Assessments

Credentials

Education
  • Ph.D., The National Center for Toxicological Research (NCTR), Administered through the University of Arkansas for Medical Sciences, College of Medicine, 1988
  • Graduate Courses, Pharmacology & Toxicology, University of Cincinnati Medical Center, 1985
  • Graduate Courses, Medicinal Chemistry & Pharmacology, University of Toledo, 1982
  • B.S., Biology, University of Toledo, 1978
˘ Not admitted to the practice of law.