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EPA Records Schedule 501

Status: (to be superseded) Final, 04/30/2011

Title: Applied and Directed Scientific Research

Program: Research and Development Laboratories

Applicability: Agency-wide

Function: 316-258 - Applied Science

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.

Description:

Includes project files of all scientific research projects conducted by Agency personnel in the Office of Research and Development laboratories that directly support rule-making, enforcement, regulatory, or policy decisions and research of high programmatic relevance which, in conjunction with other ongoing or planned studies, is expected to provide support of Agency rule-making, regulatory, or policy decisions. Also includes research of significant national interest, such as projects which might be monitored by the Administrator, or technology transfer projects which may be critical to the award of a patent or other important commercial or legal decision.

Disposition Instructions:

Item a(1): Project files - Nonelectronic

Includes documentation related to the formulation and approval of the research plan, the selection of the research methodology, questionnaires, quality assurance project plans, raw data, laboratory notebooks, project- or study-related correspondence, or other data collection media, copies of interim reports showing data tabulation results and interpretations, copies of the final reports, peer reviews, and quality assurance assessments.

Item a(2): Project files - Electronic

Includes documentation related to the formulation and approval of the research plan, the selection of the research methodology, questionnaires, quality assurance project plans, raw data, laboratory notebooks, project- or study-related correspondence, or other data collection media, copies of interim reports showing data tabulation results and interpretations, copies of the final reports, peer reviews, and quality assurance assessments.

Item a(3): Project files - Electronic copy of records transferred to the National Archives

Item b: Project workpapers and administrative correspondence

Includes completed questionnaires or other documents used for data collection, drafts or copies of interim progress reports, and other workpapers created in the course of the study.

Item c: Maintenance and calibration and inspection of equipment

Guidance:

Scientific research project files related to basic, exploratory research for the Office of Research and Development laboratories are covered in EPA 503.

Tissue samples and specimens, including wet specimens, samples of test, control, or reference substances, and specially prepared material that are relatively fragile and differ markedly in stability and quality during storage, are to be retained only as long as the quality of the preparation affords evaluation. Specimens obtained from mutagenicity tests, specimens of soil, water, and plants, and wet specimens of blood, urine, feces, biological fluids, do not need to be retained after quality assurance verification. In some research studies involving humans, the agreement with the human subjects requires samples to be destroyed immediately after the analysis and quality assurance verification is complete. In that case, the sample is retained as specified in the agreement.

Other tissue samples and specimens not listed above are to be retained 5 years, then destroyed.

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.

The following change was made in the 06/30/2008 version:

The following changes were made in the 01/31/2008 version:

Item d for electronic copies created with word processing and electronic mail applications deleted 08/22/2006 pursuant to NARA Bulletin 2006-04.

Custodians:

Office of Research and Development

Related Schedules:

EPA 503

Previous NARA Disposal Authority:

NC1-412-78-3/5, NC1-412-85-23/5, N1-412-04-6

Entry: 06/08/1993

EPA Approval: 08/27/2007

NARA Approval: 06/22/2008

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