federal_register: 99-33831
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 99-33831 | Consolidation of Good Laboratory Practice Standards | Proposed Rule | EPA is proposing to consolidate its Good Laboratory Practice Standards (GLPS), which currently exist in two separate regulations at 40 CFR part 160 and 40 CFR part 792. The proposed consolidated GLPS rule would be applicable to programs under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA) to which the current rules apply. In addition to the proposed consolidation, EPA is also proposing amendments to the GLPS that streamline and ease compliance while still maintaining the rule's data integrity assurance purpose. The consolidation will reduce the volume of regulations administered by EPA without adversely affecting current data integrity requirements. GLPS are intended to ensure the integrity of data gathered from studies in a wide variety of disciplines such as toxicology, ecological effects, chemical fate, residue chemistry, and product performance testing. Under FIFRA, compliance with regulations on GLPS applies to all studies required to be submitted in support of pesticide registrations, reregistrations, and experimental use permits. Under TSCA, GLPS are required for testing conducted pursuant to consent agreements/orders and test rules issued under sections 4 and 5 of that Act. Failure to comply with applicable GLPS is an actionable violation which may result in civil or criminal penalties, and can render data from non-compliant studies unacceptable for consideration by EPA. | 1999-12-29 | 1999 | 12 | https://www.federalregister.gov/documents/1999/12/29/99-33831/consolidation-of-good-laboratory-practice-standards | https://www.govinfo.gov/content/pkg/FR-1999-12-29/pdf/99-33831.pdf | Environmental Protection Agency | 145 | EPA is proposing to consolidate its Good Laboratory Practice Standards (GLPS), which currently exist in two separate regulations at 40 CFR part 160 and 40 CFR part 792. The proposed consolidated GLPS rule would be applicable to programs under the... |