Pesticides/ Agricultural Chemicals
      Other EPA Statutes
  State Laws
  International Regulatory Authorities
Commercial Chemicals
Food Additives and Dietary Supplements
Medical Devices
Pharmaceutical, Biological and Biotechnology Products
Veterinary Drugs

Mandava Associates provides assistance to small, medium and large companies in obtaining EPA registrations under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), establishment of tolerances and tolerance exemptions under the Federal Food, Drug and Cosmetic Act (FFDCA). The Food Quality Protection Act (FQPA) of 1996 amended FIFRA and FFDCA by establishing a new safety standard reasonable certainty of no harm that must be applied to all pesticides for assessing their safety. Mandava Associates provides assistance to companies in handling the required pesticide registration fee under the EPA Pesticide Registration Improvement Act (PRIA) of 2003. This new legislation establishes pesticide registration service fees for registration actions in Antimicrobials, Biopesticides and Pollution Prevention, and the Registration Divisions.

Our services include regulatory strategy and planning, development and interpretation of technical data, and interaction with relevant federal, state, and local regulatory agencies.

    EPA Pesticide Registration and Regulatory Affairs
      Agricultural crop protection products
      Analytical chemistry and certification
      Antimicrobials, fungicides, herbicides, insecticides, and plant growth regulators
      Biopesticides (Biochemical and microbial pesticides)
      Chemistry Evaluations
      Compliance and Enforcement
      Data call-in responses and data waiver requests
      Data compensation
      Data development and evaluations
      Data and fee waivers
      Emergency Exemption (Section 18 registration)
      Environmental fate and effects studies
      Environmental assessments and impact statements
      Experimental use permits (EUP)
      Exposure studies and assessments
      Field studies for product performance, plant metabolism, and residue estimation
      FIFRA amendments and scientific policy issues
      Formulation development and guidance
      FQPA issues, assessments, and compliance
      GLP, compliance and audits
      Ground and surface water issues
      Inert ingredient clearances and master files
      Laboratory chemistry, toxicology, and metabolism studies
      Label development, amendments, expansions, compliance and claims
      Manufacturing compliance, inspections and audits
      Me-Too product registrations
      New product and new use registrations
      Non-agricultural use pest control products
      Obtaining waivers for payment of fees
      Registration acquisitions and transfers
      Reduced-risk, low volume/minor use, and biopesticide designation
      Regulation interpretation
      Reregistration submissions and guidance
      Risk and exposure assessments
      Special local needs (SLN) [24(C)] registration
      State registrations for U.S. territories
      Task force and committee representation
      Tolerances and tolerance exemptions petitions

    Toxicity and ecotoxicity studies and evaluations

      U.S. Agent representation before EPA
      Worker Protection Standards (WPS) and Reentry Intervals
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