FIFRA Compliance & Regulatory Support Services

Regulatory and compliance review to identify FIFRA, jurisdictional, and enforcement issues before or after market entry for Minimum Risk Pesticides (25(b)), Treated Articles and Pesticide Devices. Services include: FIFRA Jurisdiction Determinations (M009), Pre-Submission Meeting Support, Compliance Checks, Enforcement & Market Actions, and Website & Marketing Compliance.

Non-GLP, EPA-regulated Device Lab Testing

Independent, third-party laboratory device testing against insects and non-pathogenic microbial pests (e.g., bacteria) to support performance data for pesticide devices. All pesticide devices with claims against pests require efficacy and performance data to support the claims, otherwise it is considered misbranding and misleading.

Efficacy Data Review for EPA Antimicrobial Pesticides

Independent scientific review of antimicrobial efficacy data to support EPA submissions, label claims, and regulatory decision-making under FIFRA. Services include: analysis of EPA Antimicrobial Efficacy Requirements (40 CFR § 158.2200), Efficacy Protocol Review, Efficacy Data Gap Analysis, Data Citation, Bridging & Product Families, Formulation Similarity & Formulation Changes, Older Studies & Guideline Compatibility, Data Waiver Justifications, Inert Ingredient Review, Antimicrobial Pesticide Label Review, Dossier Assembly & Submission Readiness, Rebuttals & EPA Deficiency Responses, Product Data Call-Ins (pDCIs) – Efficacy, and Master Label–to–Marketing Quality Control.