Endangered Species Risk Assessments

Intrinsik’s scientific experts have been at the forefront of Threatened and Endangered Species scientific activities, helping registrants and others navigate the regulatory uncertainty with strong scientific support.

In the United States over the last approximately 15 years issues surrounding potential impacts of pesticides to threatened and endangered species (listed species) have taken on a life of their own from a legal and regulatory policy perspective.  This has been driven by differing protection goals of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), administered by the Environmental Protection Agency (EPA), and the Endangered Species Act (ESA), administered by the Fish and Wildlife Service (FWS) and National Marine Fisheries Services (NMFS) (collectively called the Services).  Numerous lawsuits also began to push the issue of endangered species and pesticides to the foreground.

The endangered species assessment process is constantly evolving.  Many of the stakeholders, specifically the pesticide registrants individually and through CropLife America (CLA) have been very active in developing refined methods or guidance for ecological risk assessments for listed species or developing the tools to conduct endangered species assessments.

Services:

  • National Endangered Species Assessments (e.g. herbicides and organophosphate case studies)
  • ERA (screening and probabilistic/refined) for lawsuit support
  • Comment/Response documents
  • Errors and Omissions reports
  • Peer reviewed journal articles/book chapter support
  • In person meetings with regulatory agencies
  • Expert witness support

Intrinsik’s Experience:

  • Coordinated and assisted with the development of a stakeholder-sponsored framework and guidance document for conducting pesticide ERAs for listed species detailing some of the best practices for conducting the different aspects of a National Endangered Species Assessment and preparing registrant submitted biological assessments
  • Developed a response document to the Agencies case study biological evaluations
  • Prepared an Errors and Omissions report and response documents on behalf of the three OP registrants focussed on specific issues in the BEs for the individual organophosphates (malathion, chlorpyrifos, and diazinon)
  • Conducted initial problem formulations and screening-level risk assessments for each active, for submission to EPA during the 60-day comment period

 

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toxicological health and environmental issues, including product
development and business risks to avoid scientific and regulatory delays.

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