Sector

Animal Health

We provide data evaluation, exposure modeling, and regulatory support to meet the requirements of animal health product legislation. Our regulatory consultants specialize in the preparation of EU Environmental Risk Assessments (ERA), US Environmental Assessments (EA), and EU User Risk Assessments (URA).

We also provide commercial and pet food manufacturing facility and product registration, renewal, and tonnage reporting services across the US.

Experienced Support For:

  • Global Regulatory Strategy
  • Dossier Preparation & Submission
  • Regulatory Agency Liaison
  • Human Health & Environmental Risk Assessment
  • Task Force Representation & Administration
  • Applied Economic Support

Animal health products used in the US are potentially subject to Food and Drug Administration (FDA) environmental assessment (FDA-EA) requirements. The FDA’s Center for Veterinary Medicine (CVM) is responsible for environmental evaluations. Registrants are required to prepare an EA or, if applicable, submit a categorical exclusion for their product.

 

If required, the FDA-EA includes tests for physical/chemical characterization, biodegradation properties, microbial inhibition, environmental fate, and environmental effects. We can coordinate study placement and monitoring for these tests to aid in meeting these requirements.

We also offer support for animal health products where the US Environmental Protection Agency (EPA) or US Department of Agriculture (USDA) have jurisdiction over product registration.

Environmental safety of veterinary medicinal products and animal feed additives in the EU is regulated under Directive 2001/82/EC, to be replaced by 2019/6 in January 2022.

Our staff can provide data evaluation and regulatory support to meet these requirements including:

  • Risk evaluation for aquatic and terrestrial systems.
  • Exposure modeling.
  • Calculation of predicted environmental concentrations (PECs).
  • Coordination of necessary higher-tier aquatic and terrestrial field studies.

Phase I and Phase II environmental risk assessments are prepared in compliance with EU guidance. We can also provide advice on the impact that legislative amendments may have on the continued authorization of product lines.

Animal Health Contacts

Warren Scott's Picture

Warren Scott

Principal Consultant

Scotland

Jeremy Wilson's Picture

Jeremy Wilson

Business Development

Oregon

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Warren Scott
Principal Business Development Consultant

Expertise: Business Development & Regulatory Consulting

Warren shares a direct consulting role for Industrial Chemicals (REACH), Biocides and Cosmetics, with a Business Development remit for CSI’s European office.

Warren has over 30 years’ experience in laboratory contract research, business development for contract research organizations, and the consulting sector. His experience encompasses projects in various business sectors including plant protection, chemical, biocidal and cosmetic products. Warren qualified as a Soil Scientist and prior to joining CSI held scientific and business development positions at Inveresk Research and Wildlife International.

EDUCATION
BSc (Hons) Soil Science, University of Aberdeen.

Jeremy Wilson
Business Development

Expertise: Business Development & Marketing

Jeremy leads marketing and business development efforts in North America and Latin America. He represents CSI at various industry trade associations and professional societies.

Jeremy has over 23 years of experience in regulatory affairs and product registration compliance with Federal, State, and International chemical regulations. His experience includes government agency interactions and determination of appropriate regulatory pathways to meet product registration objectives. He has prepared numerous registration submissions, placed and monitored necessary Good Laboratory Practice (GLP) studies to develop data and documentation, and served as the primary agency liaison for the registration process. Jeremy has expertise with biorational/biopesticide registration and Latin America regulatory requirements.

EDUCATION
BS, Environmental Science; Minor in Biology, Washington State University.