FDA Guidance for Environmental Risk Assessment Veterinary Products

1
FDA Guidance for Environmental Risk Assessment
Veterinary Products

• Phase 1 finalized
• Phase 2 adopted
• PEC for Terrestrial working group
• PEC for Aquaculture- working group

2
FDA - EPA Cooperative Environmental Work

• CVM ONADE
• Concentrated Aquatic Animal Production Effluent
  Limitations and New Source Standards
• Determination of regulatory responsibilities
• FDA NEPA review for new drugs
• EPA CWA enforcement for new drugs in surface
  water
• MOA for aquaculture for review and enforcement
• Need to explore for terrestrial

3
FDA - EPA Cooperative Environmental Work

• CVM OSC
• Determination of review responsibilities for new
  products
• Joint compliance action
• e.g., pharmaceutical manufacturing
• Other activities are possible
• Headquarters and regions
• CVM OR
• Research activities
• Antimicrobial resistance

4
FDA - EPA Cooperative Environmental Work

• FDA Office of the Commissioner
• OSTP Working Group on Pharmaceuticals in the
  Environment
• Human and veterinary medicinal products
• Other products (cosmetics and personal care
  products
• Biotechnology
• Nanotechnology
• FDA USGS
• Since 1998