Product-Focused Toxicological and Exposure Assessments
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Geosyntec has been retained by a leading consumer and industrial product registration specialist to serve as their product and chemical toxicology and safety experts related to multiple regulatory and supply chain program requirements. The client specifically requires human health and ecological risk evaluation along with related receptor exposure evaluations to determine margins of safety (MOS) for product consumers through comparison to health-based points of departure (PODs) and regulatory standards.

Geosyntec's Scope of Services

Geosyntec has been tasked with supporting product market evaluation and registration assignments for pesticide products under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) administered by the United States Environmental Protection Agency (USEPA); over-the-counter (OTC) and antimicrobial products under the Federal Food, Drug and Cosmetic Act administered by the United States Food and Drug Administration (FDA); and cleaning products subject to the Federal Hazardous Substances Act administered by the Consumer Product Safety Commission (CPSC). Geosyntec completed the following:

  • Assessed exposures associated with active ingredients from animal pesticide products for consumers. Followed the USEPA (2012) Standard Operating Procedure (SOP) for Residential Pesticide Exposure Assessment to assess residential handler exposure and post-application exposure to chemicals. Estimated MOS for product consumers by comparing the estimated exposures to health-based PODs.
  • Assessed exposures associated with active ingredients from agricultural pesticide products for occupational handlers and applicators. Followed the USEPA (2021) Occupational Pesticide Handler Exposure Calculator to assess chemical handler exposure and post-application exposure to chemicals. Estimated MOS for handlers and applicators by comparing the estimated exposures to health-based PODs.
  • Prepared supporting risk assessment documentation for a pesticide active ingredient concerning nontarget plant toxicity, Inhibition Concentration 25 (IC25), volatility, and persistence addressing product use in terrestrial pesticide formulations. Converted an existing IC25 to an IC50 figure and application rates appropriate active ingredient/acre standards and conducted research to identify other applicable data on the active ingredient and its volatility/persistence. Prepared a supplemental regulatory memorandum addressing gaps and bolstering the risk assessment document to further address the active ingredient and plant toxicity.
  • Conducted a regulatory applicability and risk screening for a disinfectant sanitizing application system. Evaluated FIFRA and FDA programs to determine pesticide or medical device status. Assessed chemical toxicity and potential human health exposures through product application. Prepared a findings memorandum and market alternatives assessment for the product.
  • Reviewed the public docket regarding the USEPA’s Inorganic Halides Amended Interim Registration Review Decision (ID) (September 27, 2021) to assess the supporting risk assessment documents and applicability of the ID to multiple active FIFRA pesticide product registrations formulated with subject active ingredients. Assisted in revisions to product labels in accordance with the ID to ensure that the products continued to meet the safety standards of FIFRA.

Geosyntec’s ability to rapidly assess portfolios of products and chemicals has provided our client with immediately usable data for product registration documents and regulatory negotiations under tight timeframes. We have been able to engage with parallel client, end-user and regulatory stakeholders to deliver targeted technical and regulatory information to address gaps identified from previous submittals and move registration and approval decisions to completion.

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Project Summary

  • Location: United States
  • Client: Confidential Client
  • Project Practice Areas: Environmental Management
  • Type of Facility: Product Registration
  • Services Provided: Toxicology and Regulatory Subject Matter Expertise; FIFRA; FDA; Chemicals Management; Product Safety Assessment; Risk Assessment; Data Management
  • Type of Work: Product Safety, Risk Assessment, Toxicology, Regulatory Review
  • Governing Regulation: Federal