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.

EPA Antimicrobial Efficacy Requirements (40 CFR § 158.2200)

• Were products tested properly and within acceptable time frames?
  
  

• Are studies described in scientifically sound, EPA-acceptable study reports?
  
  

Efficacy Protocol Review

• Is the protocol clearly delineated?
  
  

• Does the study design support the intended label claims?
  
  

Efficacy Data Gap Analysis

• Which required efficacy studies may be missing?
  
  

• Are additional studies needed to meet EPA expectations?
  
  

Data Citation, Bridging & Product Families

• Can efficacy data be cited or bridged across related products?
  
  

• Do dilutions, product types, or hardest-to-kill organisms support the label claims?
  
  

Formulation Similarity & Formulation Changes

• Does a formulation change trigger new efficacy data requirements?
  
  

• Can “me-too” or similar formulations rely on existing data?
  
  

Older Studies & Guideline Compatibility

• Do legacy studies meet current EPA antimicrobial guidelines?
  
  

• Is a new study required to support existing claims?
  
  

Data Waiver Justifications

• Is it possible to avoid a new efficacy study?
  
  

• Can a scientifically defensible waiver be supported?
  
  

Inert Ingredient Review

• Has an inert ingredient been flagged for potential antimicrobial activity?
  
  

• Could inert components impact efficacy or regulatory status?
  
  

Antimicrobial Pesticide Label Review

• Are efficacy claims likely to be flagged during EPA screening or review?
  
  

• Do claims align with available efficacy data?
  
  

Dossier Assembly & Submission Readiness

• Are all required efficacy documents included and complete?
  
  

• Is the submission organized to minimize screening deficiencies?
  
  

Rebuttals & EPA Deficiency Responses

• Scientific responses to EPA questions, rejections, or data deficiencies
  
  

• Support to move submissions forward after screening or review issues
  
  

Product Data Call-Ins (pDCIs) – Efficacy

• Will the product be subject to an efficacy pDCI?
  
  

• Which studies are required to comply?
  
  

Master Label–to–Marketing Quality Control

• Does marketed or printed labeling faithfully derive from the EPA-approved master label?
  
  

FIFRA Compliance & Regulatory Support Services

Regulatory and compliance review to identify FIFRA, jurisdictional, and enforcement issues before or after market entry.

FIFRA Jurisdiction Determinations (M009)

• Is the product a pesticide, pesticide device, treated article, cleaner, or not regulated under FIFRA?
  
  

• Has a marketplace (e.g., Amazon) suspended or removed the product, requiring a letter from EPA?
  
  

Minimum Risk Pesticides (25(b))

• Does the product qualify for the 25(b) exemption?
  
  

• Are claims false or misleading under EPA policy?
  
  

Treated Articles

• Does the product qualify for the treated article exemption?
  
  

• Do claims align with EPA treated article guidance?
  
  

Pesticide Devices

• Is appropriate data available to support device claims?
  
  

• Are claims potentially false or misleading?
  
  

Pre-Submission Meeting Support

• Identification and organization of key efficacy issues prior to engaging EPA
  
  

• Preparation of supporting scientific and regulatory information
  
  

Compliance Checks

• Is the product currently compliant with FIFRA and EPA antimicrobial expectations?
  
  

Enforcement & Market Actions

• Is the product on hold due to false or misleading efficacy claims?
  
  

• Efficacy-related scientific and regulatory analysis related to enforcement actions
  
  

Website & Marketing Compliance

• Are website and marketing claims consistent with EPA-approved labeling?
  
  

• Have online claims triggered compliance or enforcement concerns?