RICHARD A. DAVIS, Ph.D., D.A.B.T.

Regulatory Toxicology Consultant

ToxSolutions

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SUMMARY

Board Certified Toxicology Consultant with broad experience in the agricultural, pharmaceutical and chemical industries. Background includes international regulatory affairs, occupational health and product stewardship. Particular expertise in:

• Safety Evaluation
• Health / Environmental Risk Assessment
• Toxicology Study Design
• Exposure Assessment
• Registration Strategy
• Regulatory Negotiations
• Industry Representation
• Quality Improvement
• Management Presentation
• Policy / Issue Management

PROFESSIONAL EXPERIENCE

ToxSolutions, Flemington, NJ

Regulatory Toxicology Consultant (1999 - Present)

Independent toxicology consultant to agricultural, pharmaceutical and chemical companies on product safety evaluation, risk assessment and occupational health issues.

• Reviewed and edited pharmacology and safety pharmacology studies, and prepared NDA summaries for submission to FDA.
• Peer reviewed an environmental health risk assessment of air emissions from a consumer health product manufacturing plant as basis for risk communication with local community.
• Evaluated potential chronic effects and proposed health surveillance of workers exposed during a production accident at an aerospace company.
• Developed an exposure control program proposal for a pharmaceutical production facility.
• Authored response to the UK Pesticide Safety Directorate on additional metabolism and carcinogenicity data requirements for reregistration of a product.
• Prepared HPV robust summaries on related chemical compounds for submission to EPA.
• Wrote review of FDA PMN requirements for food contact substances.
• Critiqued the risk assessment of pharmaceutical degradation products for FDA submission, satisfying Agency concerns and allowing approval of NDAs.
• Wrote generic ISO and ANSI MSDSs for a group of similar consumer products.
• Negotiated fewer toxicology, ecotoxicology, phys/chem, and e-fate requirements for a pesticide reregistration in the EU with Rapporteur Member State (Dutch) Authorities.
• Conducted TSCA 8(e) audit and prepared criteria for submission of toxicity data for a Fortune 100 corporation.
• Prepared risk assessment of chemicals emitted from printing equipment.
• Prepared safety assessment of chemicals imparted to drinking water for NSF 61 certification.

University of Medicine and Dentistry of New Jersey, Newark

Assoc. Professor, School of Health Related Professions Toxicology Program (1999 - Present)

Part-time faculty member, teaching lecture, laboratory and seminar courses in toxicology. Also responsible for operation of the Student Internship Program and participates in the development and conduct of continuing education courses for the professional community.

Academics Page

American Cyanamid Company, Agricultural Products Research Division, Princeton NJ

Senior Product Registration Manager, International Regulatory Affairs (1994 - 1999)

Managed registration of insecticide and fungicide products used in crop and public health outlets. International Division consultant on regulatory toxicology and operator exposure. Developed successful regulatory strategies to resolve health and ecological risk issues.

• Key contributor to AHP Occupational Exposure Guidelines for determination of drug and agricultural product active ingredient permissible exposure levels.
• Developed first toxicology and ecotoxicology bridging strategy ever accepted by Japanese Authorities for an agricultural product registration, saving over $2M.
• Company lead on pesticide operator exposure assessment methods used in the US, EU, UK, Germany and The Netherlands.
• As Aquatic Risk Assessment Team member, promoted development of creative new evaluations of insecticide spray drift for submission to German Authorities.

Program Manager, Toxicology Department, Cyanamid Ag Research Center (1992 - 1994)

Designed, monitored and evaluated the complete spectrum of toxicology studies on crop protection chemicals, veterinary drugs and animal feed additives. Interpreted results, wrote summaries and rebuttals for submission to EPA, FDA and international agencies.

• Corporate consultant on environmental health risk assessment for acquisition of Shell Ag products business.
• Conceived FDA GRAS petition strategy for a critical animal drug incipient, successfully clearing a major hurdle to product registration.

Manager, Toxicology Operations (1989 - 1992)

Toxicology Program Manager (1983 - 1989)

Toxicology and Product Safety Department

Cyanamid Chemicals Group

Responsible for Chemicals Group $1M toxicology testing program and safety evaluations in support of product registration and hazard communications activities. Supervised Associate and Assistant Toxicologists handling contract administration, quality assurance and MSDS/label preparation.

• Gave invited testimony before the NJ DEPE Commissioner on health risk assessment as the basis for environmental cleanup standards.
• Lead industry response to revision of formaldehyde TLV by the ACGIH.

Celanese Corporation, New York, NJ

Staff Toxicologist, Department of Environmental, Health and Safety Affairs

USAF Aerospace Medical Research Laboratory, Wright-Patterson AFB, OH

Pharmacologist/Physiologist, Toxic Hazards Division (1975 - 1979)

EDUCATION

Ph.D., Pharmacology: The Ohio State University, College of Medicine (1975)

B.S., Cell biology: The Ohio State University (1970)

BOARD CERTIFICATION

Diplomate, American Board of Toxicology

Certified 1980 in General Toxcology, Re-Certified 1985, 1990, 1995, 2000, 2005

PROFESSIONAL MEMBERSHIP and APPOINTMENTS

• Society of Toxicology
• American College of Toxicology
• International Society of Regulatory Toxicology and Pharmacology
• Society for Risk Analysis
• European Crop Protection Assessment Toxicology Expert Group (1996 - 1999)
• New Jersey Environment Advisory Task Force (1993)
• Chairman, Health and Safety Committee, Acrylonitrile Group (1991 - 1992)
• Health Effects Advisory Board, NJ Haz. Substance Mgmt. Res. Center (1988 - 1992)
• Board of Directors and Chair, Science Policy Comm., Formaldehyde Inst. (1989 - 1991)

Committee Assignments

• 1996 - 1999
• European Crop Protection Association
• Toxicology Expert Group
• 1994 - 1997
• American Home Products Corporation
• Occupational Health Committee
• 1993 - 1994
• Chemical Industry Council/New Jersey
• Risk Assessment Task Force
• 1992 - 1994
• American Cyanamid Company
• Agricultural Research Division
• Institutional Animal Care and Use Committee
• 1992 - 1994
• American Cyanamid Company
• Corporate Occupational Health Committee
• 1993
• New Jersey Environment Advisory Task Force
• Appointed by the NJ State Senate President
• 1991 - 1992
• Acrylonitrile Group
• Chairman, Health and Safety Committee
• Steering Committee
• 1990 - 1992
• Amerian Industrial Health Council
• Scientific Committee
• 1990 - 1992
• New Jersey Hazardous Substances Management Research Center
• Health Effects Assessment Division
• Advisory Board
• 1989 - 1991
• The Formaldehyde Institute
• Board of Directors
• Chairman, Science and health Committee
• 1982 - 1983
• Chemical Manufacturers Association
• Alcohold Panel
• Alkyl Epoxides Panel
• 1982 - 1983
• Ethylene Oxide Industry Council
• 1981 - 1983
• Acrylate Industry Ad Hoc Testing Group
• 1981 - 1982
• Chemical Manufacturers Association
• Toxic Substances Control Act Testing Committee

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PUBLICATIONS

Over twenty publications and numerous scientific presentations on general toxicology, neurotoxicology, metabolism, carcinogenicity and cardiovascular pharmacology.

Articles:

1. Davis, Richard, Michael Dourson, Bette Meek, Margaret Miller, Jay Murray, Bruce Naumann and Edward Ohanian. "A National and International Debate on Default Uncertainty Factors vs. Data-Derived Uncertainty Factors." Human and Ecological Risk Assessment, 8(4), 895-911, 2002.
2. Kadry, Abdelrazak M., Chukwuemeka S. Okereke, Mohamed S. Abdel-Rahman, Marvin A. Friedman, and Richard A. Davis. "Pharmacokinetics of Benzophenone-3 After Oral Exposure in Male Rats." Journal of Applied Toxicology, 15 (2), 97-102, 1995 .
3. Okereke, Chukwuemeka S., Abdelrazak M. Kadry, Hosni Hosni, Mohamed S. Abdel-Rahman, Richard A. Davis, and Marvin A. Friedman. "Metabolism of Benzophenone-3 in Rats." Drug Metabolism and Disposition, 21 (5): 788-791, 1993.
4. Grammer, Leslie C., Martha A. Shaughnessy, Richard A. Davis and Roy Patterson. "Exposure to TMXDI® (meta) Aliphatic Isocyanate and TMI® (meta) Unsaturated Aliphatic Isocyanate." Journal of Occupational Medicine, 35 (3): 287-290, 1993.
5. Daston, G.P., S.D. Gettings, B.D. Carlton, M. Chudkowski, R.A. Davis, A.L. Kraus, C.F. Luke, R.E. Quellette, T.A. Re, A.M. Hoberman and C.P. Sambuco. "Assessment of the Reproductive Toxic Potential of Dermally Applied 2-Hydroxy-4-Methoxybenzophenone to Male B6C3F1 Mice." Fundamental and Applied Toxicology, 20 (1): 120-124, 1993.
6. Daston, G.P., S.D. Gettings, B.D. Carlton, M. Chudkowski, R.A. Davis, A.L. Kraus, C.F. Luke, R.E. Quellette, T.A. Re, A.M. Hoberman and C.P. Sambuco. "Assessment of the Reproductive Toxic Potential of Dermally Applied 2-Hydroxy-4-Methoxybenzophenone to Male B6C3F1 Mice." Fundamental and Applied Toxicology, 20 (1): 120-124, 1993.
7. Davis, Richard A. "The Assessment of Safe Formaldehyde Occupational Exposure Limits." Comments on Toxicology, 4 (4): 331-347, 1992.
8. Davis, Richard A. "Current Issues in Formaldehyde: An Overview." Comments on Toxicology, 4 (4): 265-267, 1992.
9. Abdel-Nabi, Ismail M., Addelrazak M. Kadry, Richard A. Davis and Mohamed S. Abdel-Rahman. "Development and Validation of a High-Performance Liquid Chromatographic Method for the Determination of Benzophenone-3 in Rates." Journal of Applied Toxicology 12 (4): 255-259, 1992.
10. Davis, Richard A.. "Toxicology of Powder Coating Crosslinkers." Modern Paint and Coatings, pp 44-45, April 1992.
11. Goodrich, Mark S., Mark J. Melancon, Richard A. Davis and John J. Lech. "The Toxicity, Bioaccumulation, Metabolism, and Elimination of Dioctyl Sodium Sulfosuccinate DSS in Rainbow Trout (Oncorhynchus Mykiss)." Water Research, 25 (2): 119-124, 1991.
12. Pereira, M.A., M.M. Khoury, H.P. Glauert and R.A. Davis. "Screen of Five Alkyl Carbamates for Initiating and Promoting Activity in Rat Liver." Cancer Letters, 57: 37-44, 1991.
13. Vernon, Patricia A. and Richard A. Davis. "Acute Toxicologic Evaluation of m-TMXDI/TMP Adduct." Acute Toxicity Data 1 (2): 106-107, 1990.
14. Vernon, Patricia A. and Richard A. Davis. "Acute Toxicologic Evaluation of MAGME." Acute Toxicity Data 1 (1): 46-47, 1990.
15. Vernon, Patricia A. and Richard A. Davis. "Acute Toxicologic Evaluation of m-TMXDI." Acute Toxicity Data 1 (1): 45-46, 1990.
16. Vernon, Patricia A. and Richard A. Davis. "Acute Toxicologic Evaluation of meta-DIPEB." 1(1): 44-45, 1990.
17. Vernon, Patricia A. and Richard A. Davis. "Acute Toxicologic Evaluation of meta-TMI." Acute Toxicity Data 1 (1): 43-44, 1990.
18. Miller, G.A., R.A. Davis, and J.C. Caporossi. "Toxic Gas Replacements For Semiconductor Processing." Semiconductor Safety Association Journal 4 (3): 7-11, 1990.
19. Mackenzie, K., S. Henwood, G. Foster, F. Akin, R. Davis, P. DeBaeke, G. Sisson and G. McKinney. "Three-Generation Reproduction Study with Dioctyl Sodium Sulfosuccinate (DSS) in Rats." Fundamental and Applied Toxicology, 15:53-62, 1990.
20. Davis, R.A., C.T. Olson, R.N. Terpolilli and K.C. Back. "Acute Toxicity Studies of Triaminoguanidine Nitrate." Proceedings of the JANNAF Interagency Propulsion Committee, 1978.
21. Davis, R.A., C.T. Olson, R.N. Terpolilli and K.C. Back. "Toxicity Studies of Triaminoguanidine Nitrate." AMRL Report No. AMRL-TR-77-16, 1977.
22. Davis, Richard A., Ralph N. Terpolilli and Kenneth C. Back. "Toxic Point Determination of Selected Hazardous Materials." Dept. of Transportation Report No. DOT/MTB/OHMO - 75/4, 1975.

Monographs and Chapters

1. Davis, Richard A. "Aliphatic Nitro, Nitrate and Nitrite Compounds," Chapter 10 in Patty's Industrial Hygiene and Toxicology, Fourth Edition, Volume 2, Part A, G.D. Clayton and F.E. Clayton eds., John Wiley and Sons, Inc., 1993.
2. Davis, Richard A. "Studies on Emetine Cardiotoxicity in Guinea Pigs." Ph.D. Dissertation, The Ohio State University, 1975.

Presentation Abstracts

1. Ford, R., R. Davis and D. Gardner. "Development of Inhalation Thresholds of Concern for the Evaluation of Tobacco Additives" The Toxicologist, 90 (1): #2317, 2006.
2. Davis, Richard A. "Uncertainty Factor Accuracy: Data-Derived Factors are Better Than Default Factors" A National and International Debate on Default Uncertainty Factors vs. Data-Derived Uncertainty Factors, 5th Annual Conference on 10X Uncertainty Factors. University of Medicine and Dentistry of New Jersey, Newark, NJ. June 1, 2001.
3. Okereke, C.S., A.M. Kadry, M.S. Abdel-Rahman, R.A. Davis, and M.A. Friedman. "Species Differences in Disposition of Benzophenone-3 After Oral Administration in Male Rat and Mouse." The Toxicologist, 13 (1): 286, 1993.
4. Kadry, A.M., H. Hosni, C.S. Okereke, M.S. Abdel-Rahman, R.A. Davis and M.A. Friedman. "Pharmacokinetics of Benzophenone-3 in Rats." The Pharmacologist 34 (3): 182, 1992.
5. Okereke, C.S., H. Hosni, A.M. Kadry, M.S. Abdel-Rahman, R.A. Davis and M.A. Friedman. "Metabolism of Benzophenone-3 in Rats." The Pharmacologist 34 (3): 179, 1992.
6. Grammer, L.D., M.A. Schaughnessy, R.A. Davis and R. Patterson. "Clinical and Immunologic Evaluation of 95 Workers Exposed to Meta-Tetramethylene Xylene Diisocyanate (TMXDI) and Dimethyl-M-Isopropenyl Benzyl Isocyanate (TMI)." Journal of Allergy and Clinical Immunology 87 (1, Part 2), #245, 1991.
7. Davis, R.A., T.M. Federici and M.A. Friedman. "A Dermal Carcinogenicity Study of MAGME®-100 Monomer." The Toxicologist 11 (1): 333, 1991
8. Burleigh-Flayer, H.D., D.E. Dodd, M.A. Friedman and R.A. Davis. "The Effects of Meta-Tetramethylene Diisocyanate (m-TMXDI) Vapor on Respiratory Rate and Tidal Volume of Swiss Webster Mice and Sprague-Dawley Rats." The Toxicologist 10 (1): 205, 1990.
9. Davis, R.A., H.D. Burleigh-Flayer, D.E. Dodd and M.A. Friedman. "A 90-Day Inhalation Toxicity Study of m-TMXDI (Meta-Tetramethylene Diisocyanate) in Mice and Rats." The Toxicologist 10 (1): 204, 1990.
10. Pereira, M.A., H.P. Glauert, M.M. Khoury, P. Barnwell, M. Hensley and R.A. Davis. "Test of Alkyl Carbamates for Tumor Initiation and for Tumor Promotion in Rat Liver." The Toxicologist 9(1): 214, 1989.
11. Ouelette, R.E., C.S. Auletta and R.A. Davis. "Closed-Patch Repeated Insult Dermal Sensitization Study in Guinea Pigs with Glyoxal." The Toxicologist 9 (1): 242, 1989.
12. Davis, R.A. and M.A. Friedman. "A Canine 90-Day Gavage Study of MAGME®-100 Monomer." The Toxicologist 9 (1): 198, 1989.
13. Mackenzie, K., S. Henwood, G. Foster, F. Akin, R. Davis, P. DeBaeke, G. Sisson and G. McKinney." Three-Generation Reproduction Study with Dioctyl Sodium Sulfosuccinate (DSS) in Rats." The Toxicologist 7 (1): 176, 1987.
14. Rodwell, D.E., R.A. Davis, E.J. Tasker and M. A. Friedman. "A Fertility and General Reproductive Performance Study in Rats with a Teratology Phase on Diethylene Glycol." The Toxicologist 7(1): 145, 1987.
15. Davis, Richard A., and Marvin A. Friedman. "m-TMXDI: An Isocyanate Which Does Not Cause Pulmonary Sensitization in Guinea Pigs." The Pharmacologist 28 (3): 178, 1986.
16. Davis, R.A., J.C. Siglin, P.J. Becci, M.A. Friedman. "Acute Toxic Effects of Acrylic Monomers on the Rat Forestomach with Gavage Administration." The Toxicologist 6 (1): 188, 1986.
17. Davis, R.A., J.C. Siglin, P.J. Becci, M.A. Friedman. "Concentration Dependence and Reversibility of Gastric Lesions Induced By Repeated Gavage of Acrylic Monomers." The Toxicologist 6 (1): 188, 1986.
18. Davis, R.A., C.S. Auletta, and M.A. Friedman. "Isocyanate Dose-Related Dermal Irritation and Delayed Contact Hypersensitization in Guinea Pigs." The Toxicologist 5 (1): 251, 1985.
19. Koshchier, F.J., M.A. Friedman, R.A. Davis, and R. Gay. "Rabbit Alveolar Macrophage (RAM) Cytotoxicity Assay Performed on Metal Coated Graphite Fibers." The Toxicologist 4 (1): 2, 1984.
20. Davis, R.A., C.S. Auletta, G.M. Benke and J.J. Clary. "Tripropylene Glycol Diacrylate (TRPGDA) Toxicity with Repeated Dermal Exposure." The Toxicologist 3 (1): 152,1983.
21. Davis, R.A., M.E. George, K.C. Back. "Muscimol Antagonizes Methyhydrazine Induced Convulsions." Toxicology and Applied Pharmacology 48 (1): A197, 1979.
22. Terpolilli, R.N., R.A. Davis, K.C. Back. "A Comparative Study of the Effects of Three Halogenated Methanes on Cardiovascular Dynamics and Myocardial Energy Metabolism." Toxicology and Applied Pharmacology 48 (1): A22, 1979.
23. Davis, R.A., and K.C. Back. "The Effects of Bromochlorodifluoromethane (BCF) and MN++ on Rate Dependent Changes in Contractility of Isolated Atria." Toxicology and Applied Pharmacology 45 (1): 227, 1978.
24. Davis, R.A., J.O. Lindower and P.B. Hollander. "Uptake, Subcellular Distribution and Toxicity of 3H-Emetine During Chronic Administration." Federation Proceedings 33 (3 Part I): 1656, 1974.
25. Davis, R.A. and P.B. Hollander. "Subcellular Distribution of Emetine-3H in Isolated Perfused Guinea-Pig Heart." The Pharmacologist 15 (2): #329, 1973.
26. Hollander, P.B., R.A. Davis, and B.H. Marks. "Influence of Extracellular Potassium Concentrations on Ouabain-Induced Changes of Transmembrane Potential and Contractile Characteristics." The Pharmacologist 13 (2): #40, 1971.
27. Davis, Richard and Philip B. Hollander. "Alteration of Transmembrane Potential Configuration Coincident with Glycoside-Induced Cardiac Arrhythmia." The Pharmacologist 13 (2): #42, 1971.

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• Richard A. Davis, PhD, DABT
• Regulatory Toxicology Consultant
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• 24th Mar 2006

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