OMB control number

Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (Renewal)

OMB 2070-0012 · EPA/OCSPP.

OMB 2070-0012

This ICR covers the information collection activities that implement the statutory mandates in section 5 of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act of 2016, 15 U.S.C. 2604, and the implementing regulations codified in 40 CFR parts 700, 720, 721, 723, and 725. Specifically, TSCA section 5 requires that any person who proposes to manufacture (which includes import) a new chemical substance (i.e., a chemical substance not listed on the TSCA section 8(b) Inventory) or a significant new use of a chemical substance (as identified by EPA rule) must provide a notice to EPA at least 90 days prior to commencing the manufacture of that chemical substance. EPA must review the notice, make an affirmative determination on the safety of the new chemical substance or significant new use, and, if appropriate, regulate the chemical substance to address any unreasonable risks identified before it can proceed to the marketplace. The submitter of a premanufacture notice (PMN), significant new use notice (SNUN), or microbial commercial activity notice (MCAN) is also required to inform EPA when non-exempt commercial manufacture of the substance in question actually begins by submitting a Notice of Commencement (NOC).

The latest form for Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (Renewal) expires 2022-12-31 and is listed under ICR 201811-2070-005.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form EPA Form 7710-25 Pre-Manufacture NotificationsForm and Instruction
Form EPA Form 7710-56 Notice of CommencementForm and Instruction
Form EPA Form 7710-25 Non-Testing Activities under Section 5(e)/5(f) Consent OrdersForm and Instruction
Form EPA Form 6300-07 Tier I/Tier II ExemptionsForm and Instruction
Form EPA Form 6300-07 TSCA Experimental Release Applications (TERAs)Form and Instruction
Form EPA Form 7710-25 Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX)Form and Instruction
Form EPA Form 6300-07 Microbial Commercial Activity Notices (MCANs)Form and Instruction
Form EPA Form 7710-25 PMN-Related Significant New Use Notices (SNUNs)Form and Instruction
0574-18 Attachment P.docx Supplementary Document
0574-18 Attachment O.pdf Supplementary Document
0574.18_ss_AttachN_Consultation.pdf Supplementary Document
0574.18_ss_AttachM_CommentsResponse.pdf Supplementary Document
0574.18_ss_AttachL_Comment-ACC.pdf Supplementary Document
0574.18_ss_AttachK_Comment-Silvon.pdf Supplementary Document
0574.18_ss_AttachJ_PtC-Guide.pdf Supplementary Document
0574.18_ss_AttachH_instructionmanual.pdf Supplementary Document
0574.18_ss_AttachF_40CFR725.pdf Supplementary Document
0574.18_ss_AttachE_40CFR723.pdf Supplementary Document
0574.18_ss_AttachD_40CFR721.pdf Supplementary Document
0574.18_ss_AttachC_40CFR720.pdf Supplementary Document
0574.18_ss_AttachB_40CFR700.pdf Supplementary Document
0574.18_ss_AttachA_15USC2604.pdf Supplementary Document
0574-18_ss_2019-10-16.docxSupporting Statement A
Pre-Manufacture Notifications Form and Instruction
Rule Familiarization Instruction
CDX Registration Instruction
Notice of Commencement Form and Instruction
Research and Development Exemption Instruction
Instant Photographic Film Articles Exemption Instruction
Polymer Exemption Post-Manufacture Annual Reports Information collection
Non-Testing Activities under Section 5(e)/5(f) Consent Orders Form and Instruction
Test Data Submissions under Section 5(e)/5(f) Consent Orders Instruction
Bona Fide Intent Notifications (Bona Fides) Instruction
Tier I/Tier II Exemptions Form and Instruction
TSCA Experimental Release Applications (TERAs) Form and Instruction
Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX) Form and Instruction
Test-Marketing Exemptions (TMEs) Instruction
Microbial Commercial Activity Notices (MCANs) Form and Instruction
PMN-Related Significant New Use Notices (SNUNs) Form and Instruction

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
201811-2070-005 Revision of a currently approved collection 2018-11-27 Approved with change
201806-2070-001 Revision of a currently approved collection 2018-06-08 Approved with change
201507-2070-003 Revision of a currently approved collection 2015-07-20 Approved with change
201112-2070-001 Extension without change of a currently approved collection 2011-12-07 Approved without change
201004-2070-002 No material or nonsubstantive change to a currently approved collection 2010-04-14 Approved without change
200712-2070-005 Extension without change of a currently approved collection 2007-12-18 Approved with change
200409-2070-001 Extension without change of a currently approved collection 2004-09-03 Approved without change
200005-2070-002 Extension without change of a currently approved collection 2000-05-17 Approved without change
199701-2070-001 Revision of a currently approved collection 1997-01-07 Approved without change
199609-2070-002 Extension without change of a currently approved collection 1996-09-24 Approved without change
199504-2070-002 Revision of a currently approved collection 1995-04-19 Approved without change
199408-2070-004 Revision of a currently approved collection 1994-08-25 Comment filed on proposed rule and continue
199308-2070-001 Revision of a currently approved collection 1993-08-06 Approved without change
199302-2070-004 Revision of a currently approved collection 1993-02-11 Comment filed on proposed rule
199010-2070-002 Reinstatement with change of a previously approved collection 1990-10-12 Approved without change
199004-2070-002 Revision of a currently approved collection 1990-04-11 Withdrawn and continue
198906-2070-001 No material or nonsubstantive change to a currently approved collection 1989-06-12 Approved with change
198705-2070-001 Revision of a currently approved collection 1987-05-15 Approved without change
198603-2070-009 No material or nonsubstantive change to a currently approved collection 1986-03-13 Approved with change
198405-2070-006 Revision of a currently approved collection 1984-05-17 Approved without change
198302-2070-001 New collection (Request for a new OMB Control Number) 1983-02-10 Approved without change

OMB Details

Pre-Manufacture Notifications

Federal Enterprise Architecture: Environmental Management - Pollution Prevention and Control

Information collection instruments
FormNameElectronic accessType
Form www.epa.gov/sites/production/files/2018-06/documents/points_to_consider_document_2018-06-19_resp_to_omb.pdfInstruction
Form EPA Form 7710-25Pre-manufacture Notificationepa.gov/oppt/newchems/epmn/epmn-index.htmForm and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.