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  2. Compliance

Good Laboratory Practices Standards Compliance Monitoring Program

Resources and Guidance Documents
  • 40 CFR part 160 — FIFRA
  • 40 CFR part 792 — TSCA
  • Compliance Monitoring Resources and Guidance Documents

EPA's Good Laboratory Practice Standards (GLPS) compliance monitoring program ensures the quality and integrity of test data submitted to the Agency in support of a pesticide product registration under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), section 5 of the Toxic Substances Control Act (TSCA), and pursuant to testing consent agreements and test rules issued under section 4 of TSCA.

Data obtained through laboratory inspections and data audits is used by the Agency to regulate the use of pesticides and industrial chemicals. Two EPA enforcement policies address the GLPS program:

  • Enforcement Response Policy (ERP) for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Good Laboratory Practices (GLP) Regulations
  • Final Enforcement Response Policy (ERP) for the Toxic Substances Control Act (TSCA) Good Laboratory Practice (GLP) Regulations

EPA conducts inspections as part of its GLP program:

  • to monitor compliance with the regulations
  • to assure that studies submitted to the Agency in support of a pesticide registration or under a testing consent agreement for an industrial chemical were done with integrity, are of good quality and valid

GLP inspectors:

  • conduct inspections and investigations to detect violations and collect evidence necessary to successfully prosecute FIFRA and TSCA violators
  • collect physical samples and documentary evidence

EPA Good Laboratory Practices Inspections

EPA offers several tools to assist companies submitting data under the GLPS:

  • A list of the GLPS violations most likely to lead to study rejection.

Compliance

  • Addressing Noncompliance
    • How We Monitor Compliance
    • Compliance Monitoring Programs
      • CAA
      • CERCLA
      • CWA
      • FIFRA
      • RCRA
      • SDWA
      • TSCA
    • Audit Policy
    • Compliance Monitoring Resources and Guidance Documents
  • Assisting Regulated Entities
    • Compliance Assistance Centers
    • Compliance Advisors
    • Compliance Assistance Resources and Guidance Documents
  • Training EPA and its Partners
    • National Enforcement Training Institute (NETI)
  • Engaging State and Tribal Partners
    • State Review Framework
    • State Oversight Resources and Guidance Documents
  • Advancing EPA's National Planning and Results
    • Compliance Learning Agenda
  • Compliance Assurance Data Tools
    • NPDES Electronic Reporting
Contact Us about Compliance
Contact Us about Compliance to ask a question, provide feedback, or report a problem.
Last updated on October 30, 2024
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