EPA Records Schedule 322
Status: Final, 09/30/2008
Title: Good Laboratory Practice (GLP) and Audit Report File
Program: Compliance Monitoring
Function: 301-092 - Program Evaluation
NARA Disposal Authority:
This schedule authorizes the disposition of the record copy in any media (media neutral), excluding any records already in electronic form. Records designated for permanent retention must be transferred to the National Archives in accordance with NARA standards at the time of transfer.
Pertains to audits of laboratories involved in performing studies for registrants prior to product registration. Records contain inspector's worksheets, correspondence, support documents to justify claims made in the field, and follow-up actions required.
Item a: Record copy
Close inactive records upon completion of laboratory audit.
Destroy 25 years after file closure.
Records containing sensitive information must be shredded or otherwise definitively destroyed to protect confidentiality.
Specific legal citations include:
- Federal Insecticide, Fungicide, and Rodenticide Act, as amended, Sec. 3-6, 8, 18, 24(c), 25(a)
- 40 CFR Part 160
Reasons for Disposition:
The disposition instructions have been rewritten as media neutral to allow for maintaining the record copy in EPA's electronic recordkeeping system. The retention has not changed.
Item b for electronic copies created with word processing and electronic mail applications deleted 08/18/2006 pursuant to NARA Bulletin 2006-04.
Office of Enforcement and Compliance Assurance, Laboratory Data Integrity Branch
- Contact: Doris Dyson
- Telephone: 202-564-4129
Previous NARA Disposal Authority:
EPA Approval: 07/26/2007
NARA Approval: 08/07/2008