Dr. Van Trump is a microbiologist with a decade of regulatory consulting experience within the pesticide, chemical, and medical device industries. He provides both scientific and regulatory support for the research, development, state/federal registration, and ongoing regulatory compliance of various products regulated by the U. S. Environmental Protection Agency (EPA) under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA), including antimicrobial pesticides, conventional agricultural pesticides, biopesticides, and pesticide devices. Dr. Van Trump also has experience with the premarket clearance of medical devices such as high-level disinfectants, wound cleansers, and other devices regulated by the U.S. Food and Drug Administration (FDA) which incorporate antimicrobial technologies.
Dr. Van Trump has a long and successful history of working with clients to create strategic product development plans which integrate both scientific and regulatory considerations. He has assisted clients in all stages of product development, ranging from initial technology screening, through regulatory approval, and into post-approval matters such as product stewardship and defense.
Dr. Van Trump has a strong relationship with many contract research organizations (CROs), and a track record of working closely with laboratories to ensure that standard studies conducted for regulatory purposes meet the applicable acceptability criteria. He also has extensive experience working with clients, CROs, and regulators to develop novel testing strategies for regulated products which cannot be evaluated via standard methods. He is skilled at communicating with regulators and building consensus between clients and regulators. As part of his consensus-building efforts, Dr. Van Trump has engaged both EPA and FDA to help resolve jurisdictional ambiguities for products which may be regulated by one or both authorities.
In addition to working with pesticides and medical devices, Dr. Van Trump provides regulatory, chemistry, and microbiology support for California Proposition 65 compliance, soil and organism permitting under the United States Department of Agriculture (USDA), and food contact notifications for antimicrobial food-contact substances regulated by the FDA. Furthermore, as a trained environmental microbiologist, Dr. Van Trump has a strong academic and research background in (bio)geochemistry and the environmental fate, transport, and biodegradation of compounds. Dr. Van Trump also has experience providing expert testimony on microbiology- and pesticide-related matters.
CREDENTIALS & PROFESSIONAL HONORS
- Ph.D., Microbiology, University of California, Berkeley
- B.S., Microbiology, University of Oklahoma
Van Trump, J. I., K. C. Wrighton, J. C. Thrash, K. A. Weber, G. L. Andersen, J. D. Coates. (2011). Humic Acid-Oxidizing, Nitrate-Reducing Bacteria in Agricultural Soils. mBio 2(4): e00044-11. doi:10.1128/mBio.00044-11.
Weber, K. A., J. C. Thrash, J. I. Van Trump, L.A. Achenbach, J. D. Coates. (2011). Environmental and Taxonomic Bacterial Diversity of Anaerobic Uranium(IV) Bio-Oxidation. Appl. Environ. Microbiol., 77(13):4693-4696.
Van Trump, J. I., and J. D. Coates. (2009). Thermodynamic targeting of microbial perchlorate reduction by selective electron donors. ISME J., 3: 466-476.
Thrash, J. C., J. I. Van Trump, K. A. Weber, E. Miller, L. A. Achenbach, J. D. Coates. (2007). Electrochemical stimulation of microbial perchlorate reduction. Environ. Sci. and Technol. 41(5): 1740-1746.
Van Trump, J. I., Y. Sun, and J. D. Coates. (2006). Microbial interactions with humic substances. Adv. Appl. Microbiol. 60: 55-96.
Van Trump, J. I. and J. D. Coates. (2008). Primary energy production by photoreduced humic materials. 14th Meeting of the International Humic Substances Society (IHSS)
Van Trump, J. I. and J. D. Coates. (2007). Microbial oxidation of model humic substances. SESS Symposia: Advanced Photon Source at Argonne National Laboratory.
Van Trump, J. I. and J. D. Coates. (2007). Microbial oxidation of humic substances supports denitrification reactions in agricultural soils. American Geophysical Union Fall Meeting 2007.
Van Trump, J. I., R. A. Bruce, R. Chakraborty, J. D. Coates. (2006). Microbial oxidation of the hydroquinone content of humic substances and its potential application for the bioremediation of perchlorate. 13th Meeting of the IHSS.
Western Plant Health Association
Household & Commercial Products Association
Assisted in the development and implementation of product development and registration strategies for antimicrobial pesticides, conventional pesticides, and biopesticides. Developed agenda and advocacy strategies for meetings with regulatory authorities at both the federal and state level.
Placed, monitored, and provided regulatory guidance for standard studies conducted by contract laboratories. Developed of novel testing protocols for pesticides, pesticide devices, medical devices, and food contact substances, and worked with regulatory agencies to ensure test method acceptability via formal protocol review.
Prepared FDA pre-submission meeting packages and 510(k) notifications. Represented client interests in Pre-Sub meetings with FDA.
Conducted preemptive feasibility evaluations for microorganisms being considered for use in biopesticide products and assisted clients in developing strategic product development plans.
Research and drafted scientific rationales to satisfy regulatory data requirements for EPA and FDA.
Applied for and obtained USDA permits for interstate organisms and soil transport. Assisted sites with the drafting of standard operating procedures (SOPs) for soil handling and storage.
Conducted site-wide Good Laboratory Practice (GLP) compliance audits.
Provided technical support for exposure assessments and safe use determinations (SUDs) under California’s Proposition 65.
Assisted pesticide device sponsors with testing strategies, labeling/claims development, and product defense matters, including the provision of expert testimony.