2016 OMB Summer Meeting

AOAC OMB Meeting Book

212

PALMA ANN MARONE, Ph.D. 1804 Keelingwood Lane Virginia Beach, VA 23454 (757) 450 7191 PAMarone@verizon.net

Work Experience 2014 – Present Toxicology and Pathology Associates LLC, Virginia Beach, VA

Independent customized full service food product safety and regulation services to the food, beverage and dietary supplement industry in compliance with FDA directorates and GRAS notification 2014 - Present Adjunct Professor, Department of Pharmacology and Toxicology, Virginia Commonwealth University, Richmond, VA, USA Academic – Toxicology course lecturer and student career assistance

2013-2014

Eurofins/Product Safety Labs: Chief Scientific Officer and Executive Director, Toxicology,

Dayton, NJ, USA

Scientific/Technical -

Head Toxicologist for Eurofins NA, major global contract research organization - Certified European Registered Toxicologist - Toxicologic risk assessment officer for Eurofins Scientific - Technical/Scientific Director for Eurofins/Product Safety Labs toxicology - Toxicological study design- specialization in food safety testing - Direct technical oversight, program/project development and toxicologic assessment of preclinical testing for dietary supplement and food (initiated at PSL), agrochemical and industrial chemical, cosmetic, biotechnology, consumer products, and medical device (initiated at PSL) industries - Specialization in dietary supplement and nutraceutical safety testing - Program Director for national and inter/multi-national trade food consortia and associations - Program Director for multi-national, Fortune 500, food, industrial and agrochemical clients - Initiated, developed, implemented and trained personnel for chronic, reproductive/developmental, immunologic, neurologic and genetic toxicology, and endocrine disruptor in vivo repeated-dose toxicology capabilities - Pathological (clinical and anatomic) evaluation determination and support - Evaluated and implemented electronic data acquisition system (Provantis) for lab; data analysis - Review and prepare protocols, internal and consultation reports, SOPs, peer-reviewed manuscripts - Train and mentor technical personnel Regulatory - NDI and GRAS dietary supplement notifications with manuscript preparation and successful publishing record in coordination with Food Safety Modernization Act (2011) - Specialist in Food and Beverage on-site safety testing for industry consortia (FEMA, colorants, enzymes, botanicals, additives, packaging, etc.) under FDA, ISO, OECD, EFSA, EU, JECFA, FSANZ, FAO/WHO, HACCP - Ensure compliance with ISO 10993, ISO 17025, ISO 13485, USDA, AALAC, DEA, OSHA - Provide technical and strategic leadership for preclinical toxicology testing for US (FDA, EPA) and global (China, Japan, EU, Brazil) regulatory submission - FDA- approved medical device and consumer products risk assessment - Liaison with governmental, regulatory agencies and potential partners - Monitor changes to regulatory guidelines to insure all methods and procedures are current - Monitor technical advancements and implement