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EPA Records Schedule 460

Status: (to be superseded) Final, 05/31/2011

Title: Integrated Risk Information System (IRIS) Documentation Files

Program: Research and Development

Applicability: Headquarters

Function: 316-258-03 - Human Health Research

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:

The Integrated Risk Information System (IRIS) documentation contains information related to human health risk assessment. These paper input records are the IRIS program's primary records. IRIS is the Agency's primary vehicle for communication of chronic health hazard information representing EPA consensus positions following comprehensive review by intra-Agency scientists. It is a useful information resource tool that points the user to the underlying human and/or animal data used to support the Agency's opinion. The system contains hazard identification and dose-response risk information for more than 500 chemicals.

Disposition Instructions:

Item a(1): IRIS complete decision files consisting of case files for those chemicals listed in IRIS - Nonelectronic

Includes peer review records, key and difficult-to-find reference material such as unpublished studies, EPA reports, and foreign translations.

Item a(2): IRIS complete decision files consisting of case files for those chemicals listed in IRIS - Electronic

Includes peer review records, key and difficult-to-find reference material such as unpublished studies, EPA reports, and foreign translations.

Item a(3): IRIS complete decision files consisting of case files for those chemicals listed in IRIS - Electronic copy of records transferred to the National Archives

Includes peer review records, key and difficult-to-find reference material such as unpublished studies, EPA reports, and foreign translations.

Item b: Full sets of RfD/RfC and CRAVE files (prior to 1995)

Includes work group notes for chemical assessments completed or not completed for IRIS.

Item c: Non-decisional file reference and background records

Includes reference material on chemical assessments where no decision was made, miscellaneous internal correspondence, and former IRIS information on health advisories and regulatory actions, and supplemental data prior to 1997.

Item d: Submissions from the public

Includes unsolicited and solicited submissions from the public with information on chemicals for consideration in new or future IRIS assessments.

Item e: (Reserved)

Guidance:

Disposition covers only the official record copy of the Office of Research and Development, National Center for Environmental Assessment's Integrated Risk Information System (IRIS) program. The Integrated Risk Information System (IRIS) is scheduled as EPA 468.

Confidential business information, including copies of documents pertaining to chemicals completed or not completed for IRIS (i.e., decisional or non-decisional) are to be returned to the issuing office.

Decision files prior to 1995 include dose/reference concentration (RfD/RfC), and Carcinogen Review and Verification Endeavor (CRAVE) workgroup notes. Decision files from 1995 onward include a decision memo, and summary of Agency consensus review comments and response to those comments.

Records containing sensitive information must be shredded or otherwise definitively destroyed to protect confidentiality.

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

Item e for confidential business information returned to issuing offices was deleted and added to guidance in the 08/31/2006 version.

Item f for electronic copies created with word processing and electronic mail applications deleted 08/21/2006 pursuant to NARA Bulletin 2006-04.

Custodians:

Office of Research and Development, National Center for Environmental Assessment

Related Schedules:

EPA 468

Previous NARA Disposal Authority:

N1-412-01-1/1

Entry: 05/20/1993

EPA Approval: 08/27/2007

NARA Approval: 06/22/2008

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