Regulatory Environmental Toxicologist & Medical Device Risk
Resume:
LEWIS ROSS BROWN, III
***** ********* ******, **** ****, Virginia 22193. 703-***-**** (H) 919-***-**** / 919-***-**** (C) 804-***-****. ************************@*******.***
PROFESSIONAL BACKGROUND:
An internationally renowned Regulatory Executive and Environmental Toxicologist with over 28 years of experience in Human Health, Ecological Risk, and Medical Device Risk Assessment.
CORE COMPETENCIES:
Expertise:
Occupational Health Assessment
Hazard & Risk Communications
Medical Device Risk Assessment
Chemical Safety Standards
Regulatory Leadership:
Maintains deep knowledge of:
EPA (FIFRA, TSCA, FQPA)
ECHA-REACH international safety frameworks and processes
Risk Assessment & Management:
Expert in:
Human Health and Ecological Risk Assessments (HHRA/ERA)
GHS/CLP classifications
Medical Device Environmental Risk Assessments, Medical Device
Human Health Assessment
EU MDR
FFDCA
ISO 13485:2016
ISO 14971
ANVISA
INVIMA ANIMAT DIGEMID.
Prop 65
SES
PROFESSIONAL EXPERIENCE:
SC JOHNSON AND SONS Remote. Contract Associate Environmental Toxicologist September 2025 – June 26, 2026 (Concluded)
Conducted toxicological and ecotoxicological formula reviews to ensure global EH&S alignment for different consumer portfolios
Reviewed Pest Control, Air Care, and Home Cleaners safety profiles in line with EPA, EU, Other and international standards
Conducted and updated Pure Substance Reviews (PSRs) to ensure technical integrity in compliance with TSCA and ECHA-REACH
Facilitated technical mentoring to company team members on field expectations and practical regulatory application
REMOTE INDEPENDENT REGULATORY AFFAIRS SPECIALIST/CONSULTANT/ TOXICOLOGY CONSULTANT / MEDICAL DEVICE RISK ASSESSOR Dale City, VA August 2009 – July 2025.
Utilized knowledge of federal and state laws and regulations related to pesticide registration to ensure compliance of product entries
Developed and implemented a comprehensive working knowledge of relevant federal and state regulatory programs including FIFRA, TSCA, and Prop 65
Created and managed different types of complex projects related to pesticide product registration, safety, compliance, and EHS
Registered FIFRA registrations for conventional pesticides with preparation, submission and submission of product applications to the EPA
Managed multiple product registrations and cross-functional project teams for product registration and cross-functional projects within scope, budget and schedule requirements for all product registrations and kept quality standards of deliverables to a minimum
Supported the development of Safety Data Sheet (SDS) and label claims, ingredient disclosure and ingredients to meet 100% on-time compliance with GHS requirements
Gathered and entered the data and information into third-party compliance systems as per the requested documentation requirements.
Worked with cross-functional teams to ensure product regulatory compliance and provide regulatory documentation as necessary.
Developed and documented specialized programs and processes to comply with laws and regulations and government guidelines.
Assisted with raw material, formulation and packaging compliance reviews in the US and Canada to confirm that new laundry and home care product development projects are in compliance with local, state and federal laws and policy, and to ensure the product and services are in compliance with local, state and federal laws
Conducted high-profile Human Health and Ecological risk assessments to close the regulatory gap with a robust scientific defense and exposure model
Advised and trained multi-disciplinary teams in air quality management, pollution control and ergonomics to gain advanced training in EH&S
Mentored adult employees in the corporate world in managing complex compliance challenges
Developed technical-regulatory frameworks for international programs (FIFRA, TSCA, PMRA) that reduced client risk by 51% through early warning risk management
Wrote and edited detailed Food and Nutritional Ecological and Toxicological Risk Assessments based on the US FDA, USEPA (OPP), CDC/ATSDR, and USDA guidelines
Reviewed operational guidelines for FQPA, FIFRA, and FFDCA (in particular, FQPA sections 402, 408 and 409)
US EPA – OFFICE OF PESTICIDE PROGRAMS (OPP) Washington, DC Environmental Biologist/Toxicologist (GS-13) June 1997 - August 2019.
Developed national policies to manage more than 150 active ingredients for the protection of public health and the environment
Bridged critical gaps in 40+ Registration Review Documents in the Environmental Fate & Effects Division.
Co-authored the Federally Listed and Endangered Species Database (ESA Sections 1-7) to accelerate federal consultation time by 50%.
Co-hosted high-level technical briefings with senior leadership to communicate science to broader and non-technical audiences
Conducted Environmental and Ecological Risk Assessments for new and existing pesticide applications to various agricultural crops designated for food use and intake by humans, domestic animals, and plants
Analyzed fine sections of the FQPA related to Ecological Risk Assessments on food products for living organism consumption
NORTHERN VIRGINIA COMMUNITY COLLEGE Alexandria/Woodbridge, VA. Adjunct Professor, Environmental Science & Chemistry 1999-2002
Advised and educated adult students on environmental chemistry and toxicological principles, using real-world case studies and laboratory safety protocols to foster professional growth
EDUCATION:
Master of Science / Master of Science in Public Health (MS/MSPH). Environmental Toxicology & Chemistry Southern University and A&M College
Bachelor of Science (BS) Biology and Chemistry Dillard University
TECHNICAL SKILLS & LANGUAGES:
Systems:
EPA PSP
EPA Workfront
PBTK & PBPK Modeling
ANSES
ANVISA
CESIO
RIFM databases
REGULATIONS:
FIFRA
TSCA
REACH
FQPA
ESA Sections 1-7,
GHS/CLP Classification
EU MDR
ANVISA
SOR/98-282
UK MDR 2002
COFEPRIS
Prop 65
Languages:
Fluent in:
English
Spanish
French
Contact this candidate