2016 OMB Summer Meeting

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

AOAC OMB Meeting Book

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