EPA Records Schedule 460
Status: 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.
- N1-412-07-71/8
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Includes peer review records, key and difficult-to-find reference material such as unpublished studies, EPA reports, and foreign translations.
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Permanent
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Close inactive records when individual chemical assessment is re-accomplished.
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Transfer to the National Archives 20 years after file closure.
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Includes peer review records, key and difficult-to-find reference material such as unpublished studies, EPA reports, and foreign translations.
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Permanent
-
Close inactive records when individual chemical assessment is re-accomplished.
-
Transfer to the National Archives 5 years after file closure, with any related documentation or external finding aids, as specified in 36 CFR 1235.44-1235.50 or standards applicable at the time.
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.
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Disposable
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Close file upon transfer to the National Archives.
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Delete after electronic record copy is successfully transferred to the National Archives.
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.
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Disposable
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Close file when program discontinued
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Destroy after file closure.
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.
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Disposable
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Close inactive records at end of year.
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Destroy after file closure.
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.
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Disposable
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Close inactive records 4 years after receipt of material
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Destroy 20 years after file closure.
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:
- Divided item a into three subitems, a(1)-(3).
- Revised the titles of disposition items a(1)-(3).
- Revised the disposition instruction for item a(3).
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
- Contact: Brenda Washington
- Telephone: 703-347-8581
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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