What We Do
DOC provides regulatory and scientific services for all types of pesticides and specialty fertilizers, as well as antimicrobial therapeutic products including:
DOC has the knowledge and software needed for 100% electronic submission to US EPA as well as Canada PMRA. Saving paper also saves you time and money.
(PMRA e-Index Builder is available without charge at the PMRA website http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_training-formation/application/index-eng.php)
Software for electronic submission to EPA is availablefor a modest fee as "SubmissionBuilder" from www.pestisoft.com
DOC provides intellectual property / data compensation and arbitration support for all types of pesticides in USA and Canada
DOC provides support in Mandatory Reporting under FIFRA 6(a)(2), TSCA 8(e), (Canada) PCPA Sect. 13 for all types of pesticides in USA and Canada
DOC provides expert services in development of all regulatory science / data development
DOC provides expert witness services and litigation support in toxic tort and similar claims of injury due to chemical, pharmaceutical, or medical device exposure
Conventional / Agricultural Pesticides, US EPA and Canada PMRA:
Plan and manage a full range of regulatory studies, from basic chemistry, through toxicology, field studies, and efficacy of public health and termiticide products.
Antimicrobials, US EPA and Canadian Agencies:
NOTE: In the USA, disinfectant / sanitizer products, in cluding those for food contact surfaces and hospital surfaces, are regulated by US EPA as pesticides. In Canada (and in Australia) hospital-grade disinfectants are regulated as "therapeutic products". Health Canada - TPD (equivalent to FDA in USA) registers these in Canada, while food contact sanitizers are regulated by the Canadian Food Inspection Agency.
Biopesticides / Plant Growth Regulators:
Intellectual Property, Data Compensation and Arbitration
Don O'Shaughnessy has managed and / or been an expert witness in several landmark FIFRA arbitration proceedings in recent years. For approximately 19 years, I have been a vigorous participant in the development of a new system for data protection, data compensation, and arbitration in Canada under the PCP Act.
Services available include:
Mandatory Reporting Under FIFRA 6(a)(2), TSCA 8(e), PCPA Sect. 13
DOC can manage your incident reporting system, or assist in training and set-up of an in-house system to manage incidents and reporting.
State Registrations and Fertilizers
All pesticides sold in the USA must have a State registration in every state (and DC) where it is manufactured, packaged, sold, or used (e.g. if sold in Sioux City IA and used in South Sioux City NE, it must also be registered in NE). DOC is able to manage all your initial Sate registrations and renewals. No Provinicial registrations are required in Canada.
DOC has experience in managing Canada and US State registrations of fertilizer products for the agricultural and consumer markets.
Scientific Consulting / Data Development
Don O'Shaughnessy is a Board Certified Toxicologist (DABT), and member of the Society of Toxicology (Neurotoxicology Specialty Section, Immunotoxicology Specialty Section, Regulatory Toxicology Specialty Section), Society of Toxicologic Pathology, American College of Toxicology, Association of Official Analytical Chemists (AOAC) and other groups. I have had extensive experience in planning and managing large-scale studies of neurotoxicology, developmental neurotoxicology, immunotoxicity, reproduction, and many other routine regulatory studies. I have also planned and managed field studies of efficacy, crop residue, soil dissipation or metabolism, ecotoxicity and in-the-field studies of worker exposure in Canada, USA, Australia, and Europe, in parallel with laboratory human metabolism / urinary excretion studies.
Dr. O'Shaughnessy was a pioneer in the use of microsurgical techniques, semi-thin optical microscopy and electron microscopy and digital image analysis in regulatory neurotoxicology and neuropathology
Litigation Support / Expert Witness:
In addition to support in FIFRA or PCPA data compensation actions, DOC works with insurers and law firms to provide review of claims, review of data citations, and expert witness testimony in litigation such as toxic tort, workers compensation, and regulatory actions by State or Federal agencies.
As examples of toxic tort, I have provided expert testimony in defense of chemical suppliers and applicators in Florida Medfly claims, or use of insecticides in the New York City outbreak of West Nile Fever. Other examples are listed in the available CV.
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