Good Laboratory Practices Standards Compliance Monitoring Program
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
- 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:
- GLP Advisories
- Standard Operating Procedures that labs should adopt
- A list of the GLPS violations most likely to lead to study rejection.
- Question and answers about the program