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EPA Records Schedule 372

Status: (to be superseded) Final, 08/31/2011

Title: TSCA Section 8 Information and Reporting Files

Program: Toxic Substances

Applicability: Headquarters

Function: 108-025-06-02 - Manage Toxic Substances

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:

Records consist of a wide variety of reports, notices and health and safety studies submitted per statute under the Toxic Substances Control Act (TSCA) Section 8 or voluntarily to EPA pertaining to a chemical or group of chemicals' identity, use, manufacturing production, importation, processing, health and environmental effects and fates, associated by-products, human exposure, and/or disposal data of chemicals or chemical mixtures.

The submissions vary and are as follows: Section 8(a) requires, by rulemaking, manufacturers, importers and processors of chemical substances to maintain records and/or report such data as may be required. Section 8(a) regulations can be tailored to unique information needs, such as chemical specific or information can be obtained through the use of standardized reporting rules such as:

The Preliminary Assessment Information Rule (PAIR) - This document is designed to gather information from certain chemical manufacturers and importers of identified substances to support the preliminary stages of chemical assessment.

The Comprehensive Assessment Information Rule (CAIR) - This is a standardized, flexible information gathering tool. Persons are required to report under the rule for each site of a subject chemical's manufacture, import, and/or processing.

Inventory Update Rule (IUR) - This standardized form is used to gather information such as Plant Site and Production Volume which is used to update the Chemical Inventory.

Section 8(a) Specific - This is a special collection of information, submitted on letterhead rather than a special form.

Section 8(b) mandates the establishment and publication of a chemicals list. The listing includes substances for which Section 5 (PMNs, SNURs) notices are submitted from the earliest date of manufacture or processing in the U.S. The list excludes all chemical substances manufactured or processed (however reported) before October 11, 1973. The list also excludes chemicals produced in low volume quantities. This list is updated at two year intervals.

Section 8(c) requires companies to record allegations of significant adverse reactions to any substance/mixture that they manufacture, import, process or distribute. These records are submitted to EPA, upon request. However, companies must maintain these records for 30 years.

Section 8(d) health and safety studies are used to support the TSCA testing program and set priorities for risk assessment. The reporting obligation ends no later than 10 years after the effective date of the required filing for removal of the substances mixture from the rule.

Section 8(e) Notice to Administrator of Substantial Risk is submitted by any person who manufactures, processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such a substance or mixture presents a substantial risk of injury to health or the environment.

FYI Submissions are distinguished from Section 8(e) submissions in that they are not mandatorily reported but do contain information on human exposure, epidemiology, toxicity test results, monitoring studies, environmental fate and other information that may be pertinent to risk assessment.

Asbestos files includes data provided by asbestos manufacturers, processors, and importers on asbestos production, importation, exportation, processing, worker exposure, waste and disposal, and pollution control. The data were reported on EPA form 7710-36, Reporting Chemical and Industrial Users of Asbestos, and EPA form 7710-37, Reporting Secondary Processing and Importation of Asbestos Mixtures.

Disposition Instructions:

Item a(1): Record copy - Nonelectronic

Item a(2): Record copy - Electronic

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

Guidance:

The nonconfidential record copies are maintained by the program office and the Nonconfidential Information Business Center (NCIC). All confidential record copies are maintained by the Confidential Information Business Center (CBIC). Documents from the NCIC and CBIC should be retired to the FRC together.

All records, regardless of media, claimed as confidential business information (CBI) under Section 14 of TSCA must be handled in accordance with the TSCA Confidential Business Information Security Manual. The program office is responsible for maintenance and disposition of sensitive information not included in the NCIC files.

The Comprehensive Assessment Information Rule Database (CAIR) is covered in EPA 089 for information tracking systems. The TSCA Chemical Inventory File is scheduled as EPA 371.

This schedule covers a significant collection of records that support program decisions regarding the assessment and identification and testing of substance mixtures that may present substantial risk or injury to the health or the environment.

Due to the complexity of the Section 8 process, the submissions vary. However, file closures for all the documents generated in response to Section 8 of TSCA occur 1 year following the year of submissions or other Agency decision. In addition, for CAIR documents, data entry must be completed before the file closure.

Specific legal citation: Toxic Substances Control Act, as amended, 15 USC 2606, Sec. 8

Reasons for Disposition:

The following changes were made in the 02/29/2008 version:

Item b for electronic copies created with word processing and electronic mail applications was deleted 08/09/2006 pursuant to NARA Bulletin 2006-04.

Custodians:

Office of Chemical Safety and Pollution Prevention, Office of Pollution Prevention and Toxics, Chemical Control Division

Related Schedules:

EPA 089, EPA 371

Previous NARA Disposal Authority:

NC1-412-85-12/17, N1-412-01-5

Entry: 12/02/1992

EPA Approval: 06/05/2006

NARA Approval: 12/18/2006

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