Pesticides, Regulatory, Toxicology and Agriculture Expert

Expertise

• Pesticide and chemical regulatory consulting for the legal, agriculture, pesticide and regulatory industries. 
• Direct field ecotoxicity, residue studies and regulatory actions to expand uses and formulations of insecticide and herbicide products in U.S and Canada, and processes to develop printed labeling and specimen labeling.
• Toxicology consulting working with domestic and multi-national organizations to develop and present data for registration and re-evaluation of pesticide compounds in Canada and USA.
• Intellectual property: Consulting crop protection industry in concert with Canada PMRA, "Generic Voice" and CropLife Canada to develop mechanisms and regulations for protection of proprietary registration data in Canada (“PPIP”). 
• Key participant in the defense of organophosphorus compound in the EPA re-registration and re-evaluation process for these products in U.S. and Canada. 
• Design, placement, management and monitoring of multiple acute, subchronic, and developmental neurotoxicology studies, and re-examination of past neurotoxicology data - participation is data compensation matters including FIFRA arbitration.
• Cost sharing, and negotiation of data compensation for products.
• Active member of Administrative and Technical committees of generic data task forces including spray drift task force, outdoor residential exposure task force, agricultural re-entry task force.
• Generic data task forces including spray drift task force, outdoor residential exposure task force, agricultural re-entry task force.
• Registrations with U.S. EPA, Canada PMRA, and Canada TPD, with a broad range of products in: 
• Public health, animal health, structural, and agricultural pesticides and biopesticides including:
• Pyrethrins, pyrethroids, neonicotinoids and other classes of insecticides; herbicides and graminicides in the following areas:
• Medical, surgical devices, disinfectant products, for the hospitals, food service, and other sanitizing in Canada and U.S.A. industries. 

Expert Witness Experience

• Provided support in patent dispute litigation. Involved in arbitration, data value cases such as Cheminova v. Griffin, 2,4-D Task Force v. AXSS and Syngenta v. LGLS, and Agracity LLC vs Her Majesty the Queen.
• Litigation Support:   Provided background information development as an expert witness in toxic tort litigation in such cases as the "medfly" litigation in Florida, parathion mis-use in Pascagoula MS, and the Long Island Sound, West Nile mosquito spraying litigation in NYC..
• Fox et al. (class action), v. Cheminova A/S, City of NY, et al. Claim of damage to regional lobster fisheries due to pesticide applications. (Retained by defense.) .
• Multiple exposures to carbon monoxide in a NJ apartment complex. (Retained by plaintiff.). 
• Case settlement required destruction of records. claim of injury due to use of incorrect contrast medium for intrathecal injection to spinal foramen. (Retained by plaintiff.) ,
• Lincoln, Nebraska, claim of persistent effects due to exposure to aerially applied insecticide. (Retained by defense.) Case settlement required destruction of records. 
• Greenwood MS, Havens et al. v. SE Boll Weevil Eradication Program, claim of aplastic anemia due to exposure to aerially applied insecticide. (Retained by defense).
• Tampa FL, Class action suit v. Cheminova et al. Claim of a variety of damages and injuries due to aerially applied insecticides. (Retained by defense).
• Pascagoula MS, Class-action suit v. Cheminova, Terra International, et al, injuries due to misapplication of insecticide. (Retained by 2 corporate defendants).

Experience

Undisclosed Company, President, 2001 - Present 

Regulatory Consulting-Pesticide Chemicals 

• Consulting in toxicology and regulatory affairs in North America (USA, Canada, and the California Republic) for a global array of clients. 
• Services include preliminary cost estimation, basic regulatory filings, study design and monitoring, data and lab audits, risk assessment, litigation support, expert witness, data compensation and arbitration. 
• Conducted a number of neuropathology re-reads and peer reviews, (i.e., Pesticide, Chemical and Regulatory Consulting).
• Actively represent clients to obtain and maintain registrations with U.S. EPA, Canada PMRA, and Canada TPD, of a range of products including: public health, animal health, structural, and agricultural pesticides and biopesticides including pyrethrins, pyrethroids, neonicotinoids and other classes of insecticides; herbicides and graminicides; medical / surgical devices; and disinfectant products for hospitals, food service, and other sanitizing in Canada and USA. 
• Extensive experience in data compensation and arbitration matters for follow-on ("generic") registrants in U.S. and Canada. 
• Key participant in the defense of organophosphorus compound in the EPA re-registration and re-evaluation process for these products in U.S. and Canada. 
• Submitted hundreds of regulatory documents to PMRA and EPA. 

Toxicology consulting 

• Working with domestic and multi-national organizations to develop and present data for registration and re-evaluation of pesticide compounds in Canada and U.S.A.
• Pesticide design, monitoring, and reporting of toxicology studies, especially, but not limited to neurotoxicity, developmental and developmental neurotoxicity studies, and reproductive toxicology studies. 
• Intellectual property, crop protection industry and in concert with Canada PMRA, "Generic Voice" and CropLife Canada to develop mechanisms and regulations for protection of proprietary registration data in Canada (“PPIP”) employing decades of experience. 
• Worked with a number of clients, primarily respondents, but including claimants, in background information search, data cost estimation, negotiation of licensing or data compensation, and expert witness in arbitration of data compensation awards. 

Cheminova Inc., Wayne, NJ, Director, Regulatory Affairs, 1998 - 2001   

• Responding to the President, responsible for the registration and defense of the company end-use pesticide products in North America, and support of Cheminova A/S toxicology and worker exposure activities globally. 
• Interaction with senior scientific and management levels of U.S. EPA and Canadian PMRA to defend products under U.S. FQPA (Food Quality Protection Act) and Canadian special review of organophosphorus compounds
• Supported organophosphorus data needs in Australia and USA; support the cancer risk assessment of OP products under new (draft) guidelines. 
• Hands-on design, placement, management and monitoring of multiple acute, subchronic, and developmental neurotoxicology studies, and re-examination of past neurotoxicology data.
• Participated in data compensation matters including FIFRA arbitration.
• 3(c)(2)(B) cost sharing, and negotiation of data compensation for products being sought by Cheminova - direct field ecotoxicity and residue studies and regulatory actions to expand uses and formulations of insecticide and herbicide products in U.S. and Canada.
• Directed an overhaul of processes to develop printed labeling and specimen labeling for Cheminova products.
• Represented Cheminova in generic data task forces including spray drift task force, outdoor residential exposure task force, agricultural re-entry task force.
• Represented Cheminova on committees of trade associations including chemical producers and distributors associations.
• Registration, Legal, and Government Affairs Ctees, American Crop Protection Association Registration and Toxicology Round Tables, and Crop Protection Institute of Canada. 
• Government Affairs and Technical Committees - responded to caller inquiries in potential adverse effects - reporting under FIFRA 6(a)(2) - serving as advisor and expert witness in litigation regarding potential adverse effects. 

Terra International Inc., Sioux City, IA, Product Registration Manager, 1993 - 1998  

• Reported to the VP, Marketing, responsible for all matters pertaining to registration of over 200 pesticide, fertilizer, and adjuvant products for Terra and its subsidiaries, partners, and certain suppliers in North America (Mexico, Puerto Rico, US, Canada). 
• Managed the registration process internally as well as via consulting firms.
• Contracted, monitored, and submitting studies including toxicology, chemistry, environmental fate.  
• Represented company on generic data task forces and industry associations.
• Managed label production; compliance with DOT and TDG regulations.
• MSDSs and WHMIS (Canada) documentation; review of publicity materials; participation in data compensation issues including estimates of cost and risk, offers to pay, and negotiation of compensation; and participation in product liability litigation.

ICI Agrochemicals (Zeneca Agro), Canada, and DE Manager of Regulatory Affairs, 1986 - 1993 

• Responsible for the registration of active ingredients, pesticide formulations, fertilizers and adjuvants in Canada and certain products (cereal herbicides and seed treatments) in the U.S. 
• Active ingredients included triazole fungicides, triketone fungicides, pyrethroids and resolved isomers of pyrethroids, “-fop” and “-dim” graminicides, diphenyl ether herbicides, and defense of “quat” herbicides, organophosphorus insecticides, pyrimidine insecticides, and others as required.
• Involved interactions with ICI resources in toxicology, environmental fate, residue, environmental tox, to develop packages suited to Canadian registration of actives and end use products.
• Direct participation in field studies included efficacy, crop residue, and environmental fate or toxicity; development of labels, MSDSs and participation in industry associations. I
• Participated in a number of operator exposure studies in the field in Western Canada and Australia.
• Principal toxicology contact for ICI/ Zeneca’s emergency response system in Canada.
• Industry representative on behalf of the Crop Protection Institute in the regulatory reform process in Canada, and later served on the Interim Canadian Pest Management Advisory Council. 
• Significant accomplishment at Zeneca in development and registration of a new cereal graminicide product for Western Canada, receiving ICI Canada President’s Award and shared a (global) ICI “Market Focus” award. 
• Had the privilege to participation in a number of initiatives, instrumental in establishing a pesticide container recycling program operated by CPIC in Canada. 
• Represented the AgChem industry on the National Research Council of Canada Associate Committee on Toxicology, received a certificate of merit. 
• Founding member of the Board of Directors of the Joseph P. Morgan Research Foundation, promoting development and validation of in vitro testing methods. 
• Taught neurotoxicology at University of Guelph. Unfortunately, “re-engineering” all but eliminated the Canadian development and regulatory functions, which were then operated from the U.S. office, and “acquired” by Terra who bought part of the ICI agricultural business in Canada. 

Bio-Research Labs Ltd., Senneville Quebec, Head, Department of Neuromorphology, 1981 - 1986  

• As a principal scientist position with the dual aims of developing a neurotoxicology testing program and developing methods for digital quantitation in toxicologic pathology. 
• The development program was highly successful and provided much of the skeletal framework for current neurotoxicology guidelines. 
• Led a specialized pathology group which continued with neurotoxicology, quantitative pathology, electron microscopic pathology, and other related specialized work including human clinical pathology. 

McGill University, Department of Biochemistry, 1979 - 1981 

• Study Director -  Pathologist for over 20 GLP studies to provide ultrastructural and morphological support to other research staff in biochemistry, focused on virology, DNA structure, and polypeptide hormone receptor binding. 

Montreal Neurological Hospital and Institute, Fellowship, 1978 - 1979 

• Experimental Neurosurgery to develop and begin to utilize a cat model for human focal cerebral ischaemia (“stroke”), and a dog compression model for spinal cord trauma. 
• Initial involvement in neuropathology and quantitative pathology (evaluation of areas of infarct, 2-deoxyglucose autoradiography) began.

Other Activities-Graduate Studies 

• Ultrastructure of tooth enamel protein matrix-Thesis
• LM and EM autoradiographic examination of synthesis of membrane and secretory glycoproteins using 3 Hlabeled sugar moieties. 
• In McGill’s Department of Experimental Medicine, developed and utilized a morphological method to localize polypeptide hormone receptors and follow the sequence of binding and processing within various cell types. 
• Taught Anatomy of the Limbs and Back for Physical Therapy students, Dentistry Head and Neck Anatomy, Medical Histology, Medical Gross Anatomy, and Medical Living Anatomy. 
• Radiation Safety Officer responsible for licensing of the “hot” lab, exposure protection, and inventory control of radiolabeled compound.

Honors & Publications

Credentials 

• Diplomate, American Board of Toxicology (DABT
• (Board Certified in Toxicology) Member
• Society of Toxicology Member
• Society of Toxicologic Pathologists Member 

Languages 

• English and French 
• Nationality: Canadian/ US (Dual)

Academic and Professional Affiliations

• Diplomate, American Board of Toxicology (DABT), Association of Official Analytical Chemists Member, American Association for the Advancement of Science (AAAS) 

Awards

• Ontario Scholar INCO Reserved Scholarship J.W. McConnell Scholarship in Science and Engineering Cyanamid of Canada Scholarship

Publications 

• Author and Co-Author of peer reviewed journals, abstracts, posters and presentations.

Education

• Ph.D.   Biology, Columbia Pacific University, Mill Valley, CA
• M.Sc.   Anatomy and Histology, McGill University, Montreal. Quebec, Canada 
• B.S. (With Honors, Magna Cum Laude), Anatomy and Histology, McGill University, Canada