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EPA Records Schedule 261

Status: (to be superseded) Final, 08/31/2011

Title: TSCA Section 5 New Chemical 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 document the screening of risk and the regulation of new chemicals to be manufactured or imported. Records include test data, communications between EPA and the submitter, Focus Reports, SAT reviews, telephone logs, and related documents.

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:

All records, regardless of media, claimed as confidential business information (CBI) under Section 14 of the Toxic Substances Control Act (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.

At close out, the files held by the NCIC and the CBIC eligible for transfer to the FRC should be accessioned at the same time. All reference copies can be destroyed when no longer needed to support program operations.

Microform copies are to be produced in accordance with standards in 36 CFR 1230.10 and 1230.20.

Unless otherwise noted, the official records are maintained by CBIC and NCIC.

This schedule covers a major collection of records that support program decisions regarding the screening and regulation of new chemicals. Due to the nature of the Section 5 process, the decision documents vary. Based on routine processing, file closure could occur up to 60 days following each document's mandated review period or other Agency decision.

The review periods are as follows: PMN - 90 days, NOC - Date of receipt, *Bonafide - 30 days, *TMEA - 45 days, "LVE - 30 days, *Polymers - 21 days, *SNUN - 90 days, "LoREX - 30 days. *Time frames are also applicable to the modification of documents where appropriate.

Agency Regulatory decisions include: Revocation of 5(e) order, Focus Drop, CRSS Drop, Found on Inventory, Invalid, Disposition Drop, Division Director's Drop, 5(e) Consent Order, 5(e) Adversarial Order, Incomplete, Excluded from Reporting, 5(f) Order/Rule, Exemption Grants, Exemption Conditionally Granted, Denial.

The NCIC maintains two types of Section 5 files: (1) Sanitized versions of submissions which include, but is not limited to, the PMN, TME, Y and L, I and LV Modification. The Federal Register notice is also included in the file; (2) 5(e) documents that are negotiations between EPA and a company delineating certain restrictions associated with the production or importation of a chemical.

The CBIC maintains three types of files: (1) the official file, (2) the EPA user copy, and (3) the reference copy. The files are arranged by major types of submission that include, but are not limited to: Premanufacture Notice (PMN), Incomplete Premanufacture Notice (PMNI), Low Volume Exemptions (LV), Low Release and Low Exposure Exemption (LoREX), Test Market Exemption Application (TMEA), Bonafide (B), Polymer Exemption (Y), Significant New Use Notice (SNUN), Significant New Alternative Policy (SNAP), Notice of Commencement (NOC), and Significant New Use Rule (SNUR). All subsequent documentation (support documents) relating to an individual Section 5 submission, namely correspondence between EPA and the submitter (company) and all EPA generated communications/reports are filed with the primary submission. However, some support documents such as NOC's, may be organized by type and filed by Document Control Number and fiscal year.

The Section 5 dockets maintained in NCIC are established upon publication of a proposed rule or notice of public comment in the Federal Register. This collection of dockets contains documentation on a variety of issues and decisions. Some of the major collections are for Significant New Use Rule (SNUR) and Amendment to the PMN Rule. These records should be according to EPA 149 for regulations, standards, and guidelines, and EPA 150 for dockets.

Specific legal citations include:

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. Item b for microformed paper copy was deleted and incorporated into item a. The retention of the record copy is unchanged.

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

Item c for electronic copies created with word processing and electronic mail applications deleted 08/18/2006 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 149, EPA 150

Previous NARA Disposal Authority:

N1-412-90-1, N1-412-01-2

Entry: 12/20/1993

EPA Approval: 12/19/2006

NARA Approval: 01/28/2008

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