D. O'Shaughnessy Consulting, Inc - Your Total Resource for Chemical Registration and Regulatory Sciences

What We Do

DOC provides regulatory and scientific services for all types of pesticides and specialty fertilizers, as well as antimicrobial therapeutic products including:

  • Conventional / Agricultural Pesticides,  US EPA and Canada PMRA
  • Antimicrobials, US EPA and Canadian Agencies
  • Biopesticides / Plant Growth Regulators
  • Fertilizer (US States and Canada)
  • US State registrations and renewals

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.

  • Conduct dietary or worker exposure / risk assessments.
  • Work with formulation chemists to verify acceptable formulants.
  • Draft labeling (English and French) while being conscious of copyright issues.
  • Assemble and submit application packages, including electronic submission.
  • Assemble and submit petitions for tolerances or exemptions.
  • Manage data compensation matters.
  • Work with EPA or PMRA to resolve issues and pull through a registration


Antimicrobials, US EPA and Canadian Agencies:

  • Work with US EPA to agree data needs.
  • Work with Health Canada PMRA (antimicrobials for plant protection).
  • Work with Health Canada TPD (disinfectants for non-food contact surfaces.)
  • Work with Canadian Food Inspection Agency for food contact sanitizers.
  • Plan and manage regulatory studies including disinfectant efficacy.
  • Work with formulation chemists to verify acceptable formulants.
  • Draft labeling (English and French) while being conscious of copyright issues.
  • Assemble and submit application packages, including electronic submission.
  • Work with EPA or Health Canada to resolve issues and pull through a registration

 

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´╗┐:

 

  • Work with EPA - BPPD and Canada PMRA to agree data needs 
  • Plan and manage regulatory studies including disinfectant efficacy 
  • Work with formulation chemists to verify acceptable formulants  
  • Draft labeling (English and French) while being conscious of copyright issues 
  • Assemble and submit application packages, including electronic submission 
  • Work with EPA or PMRA to resolve issues and pull through a registration

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:

  • Presubmission estimates of possible compensation 
  • Evaluation of compensation claims, including validity and cost of data 
  • Post-submission negotiation of compensation due 
  • Expert opinion regarding obviousness or prior art in pesticide-related patent litigation 

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.

 

Services include:

  • Protocol development
  • Negotiation with EPA, PMRA of protocols
  • Study contracting and monitoring
  • Data audit, report review
  • Review / re-reads of neuropathology slides

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.

  • Review of injury claims and medical records
  • Review of or development of exposure data and risk assessment
  • Review of pertinent scientific references
  • Review of possible alternate causes of injury or damage
  • Review of data used in evidence and development of cross examination

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.

D.

 

O'Shaughnessy

 
Consulting Inc.


Phone Number:

(270) 524-5633 

 

Fax Number:

(270) 524-5634 

 

Email:

doconslt@earthlink.net 

 

Website:

www.regtox.net

M-F 9am to 5:30pm Central

270-524-5633270-537-5139

Doconslt@Earthlink.net

427 Hide Away Circle, Cub Run, KY 42729 US

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Regulatory Toxicology, Chemical Toxicology, Toxicology Studies, EPA Regulations, Toxicology Expert, Toxicology Expert Witness, Forensic Toxicology, Pesticide Registration, Pesticide Regulation, EPA pesticide registration