New Chemicals Division Reference Library

This page contains an index of EPA documents related to the work of EPA’s New Chemicals Division (NCD). Under the Toxic Substances Control Act, when EPA receives a notice for a new chemical  under TSCA Section 5(a)(1), the Agency must make an affirmative determination on whether the chemical presents an unreasonable risk to human health or the environment. 

This resource includes guidance documents, compliance advisories, templates, manuals and other materials useful to a variety of stakeholders. The reference library will continue to be updated as new materials are developed.

The table can be sorted alphabetically, by publication date, or by topic and contains the source page of the document for more context. Select the arrow in each column heading to sort the table by ascending or descending order.

Subtopic Title Publication date Topic Source
CDX Registration User Guide CDX Chemical Safety and Pesticide Programs (CSPP) Registration User Guide (pdf) 08-2015 PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
CDX User Guide Section 5 Notices and Supports User Guide – Primary Authorized Official (pdf) 08-2015 PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
CDX User Guide Section 5 Notices and Supports User Guide - Primary Agent/Consultant (pdf) 08-2015 PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
CDX User Guide Section 5 Notices and Supports User Guide - Primary Support (pdf) 08-2015 PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
CDX User Guide Section 5 Notices and Supports User Guide - Secondary Authorized Official (pdf) 08-2015 PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
CDX User Guide Section 5 Notices and Supports User Guide - Secondary Agent/Consultant (pdf) 08-2015 PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
CDX User Guide Section 5 Notices and Supports User Guide – Secondary Support (pdf) 08-2015 PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
PMN Submission Helpful Hints: Questions and Answers for the e-PMN Thin Client (pdf) 08-2015 PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
PMN Submission Sample e-PMN (Thin client) PMN form (pdf) 01-14-2020 PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
PMN Submission Sample e-PMN (Thin client) NOC form (pdf) 01-14-2020 PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
PMN Submission XML Schema for e-PMN Thin Client (pdf)   PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
PMN Submission Sample EPA Biotech Form (pdf) 06-2009 PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
CBI Substantiation Template Section 5 (PMN/LVE/SNUN) substantiation template (docx) 07-2023 CBI https://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
CBI Substantiation Template Notice of Commencement substantiation template (for claims other than chemical identify) (docx) 07-2023 CBI https://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
CBI Substantiation Template Bona Fide submission substantiation template (docx) 07-2023 CBI https://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
CBI Substantiation Template Polymer exemption report substantiation template (docx) 05-2019 CBI https://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
CBI Substantiation Template Section 8(e) notice of substantial risk substantiation template (docx) 07-2023 CBI https://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
CBI Substantiation Template Section 12(b) export notice substantiation template (docx) 07-2023 CBI https://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
CBI Substantiation Template Chemical Data Reporting (CDR) substantiation template (docx) 03-2017 CBI https://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
CBI Substantiation Template General substantiation template (docx) 08-2023 CBI https://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
Nanomaterial Information Gathering Working Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce (pdf) 08-2017 Nanotechnology https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/working-guidance-epas-section-8a
Nanomaterials on Inventory TSCA Inventory Status of Nanoscale Substances - General Approach (pdf) 01-2023 TSCA Inventory https://www.epa.gov/tsca-inventory/nanoscale-substances-tsca-inventory
Nanomaterials Cross-Agency Efforts Nanotechnology White Paper (pdf) 02-2007 Nanotechnology https://www.epa.gov/osa/nanotechnology-white-paper
Nanotechnology and Remediation Nanotechnology for Site Remediation: Fact Sheet (pdf) 10-2008 Nanotechnology https://www.epa.gov/remedytech/nanotechnology-site-remediation-fact-sheet
Nanotechnology and Remediation Table of Selected Sites Using or Testing Nanoparticles for Remediation (pdf) 04-2015 Nanotechnology https://www.epa.gov/remedytech/nanotechnology-site-remediation-fact-sheet
Nanotechnology and Remediation Nanotechnology: Applications for Environmental Remediation, CLU-IN Technology Focus Area Fact Sheet (pdf) 04-2015 Nanotechnology https://www.epa.gov/remedytech/nanotechnology-site-remediation-fact-sheet
PMN Chemistry Assistance Chemistry assistance manual for Premanufacture Notification submitters (pdf) 03-1997 PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/chemistry-assistance-manual
Section 5 New Chemicals Instruction Manual for Reporting under TSCA Section 5 New Chemicals Program (pdf) 05-26-2015 New Chemicals https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/instruction-manual-reporting-under
Section 5 New Chemicals Questions and Answers for the New Chemicals Program (pdf) 09-2015 New Chemicals https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/questions-answers-new-chemicals
Test Guidelines OCSPP Test Guidelines Master List (pdf) 09-2019 Pesticides and Toxics https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/master-list-test-guidelines-pesticides-and-toxic
Access to CBI Guidance for Requesting Access to CBI for State, Tribal, and Local Governments (pdf) 06-2018 CBI https://www.epa.gov/tsca-cbi/guidance-requesting-access-confidential-business-information
Access to CBI Guidance for Requesting Access to CBI for Environmental, Health, and Medical Professionals (pdf) 06-2018 CBI https://www.epa.gov/tsca-cbi/guidance-requesting-access-confidential-business-information
Access to CBI Guidance for Requesting Access to CBI for Emergency Responders (pdf) 06-2018 CBI https://www.epa.gov/tsca-cbi/guidance-requesting-access-confidential-business-information
Generic Names for Confidental Chemicals Guidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting under TSCA (pdf) 06-2018 New Chemicals https://www.epa.gov/tsca-inventory/guidance-creating-generic-names-confidential-chemical-substance-identity-reporting
TSCA Inventory File MS Access Non-CBI TSCA Inventory (ZIP) (zip) 08-2023 TSCA Inventory https://www.epa.gov/tsca-inventory/how-access-tsca-inventory
TSCA Inventory File CSV Non-CBI TSCA Inventory (ZIP) (zip) 08-2023 TSCA Inventory https://www.epa.gov/tsca-inventory/how-access-tsca-inventory
Applicability of TSCA Compliance Advisory: Applicability of the Toxic Substances Control Act to Mixed Metal Oxides, which Include Cathode Active Materials (CAMs) and Modified CAMs (pdf) 10-2022 TSCA Inventory https://www.epa.gov/tsca-inventory/tsca-inventory-policy-and-guidance
Applicability of TSCA Compliance Advisory: Applicability of the Toxic Substances Control Act to Chemicals made from Petroleum and Renewable Sources Used as Fuels and Fuel Additives and Distillates 12-2020 TSCA Inventory https://www.epa.gov/tsca-inventory/compliance-advisory-applicability-toxic-substances-control-act-chemicals-made
TSCA Inventory Reporting Policy Combinations of Two or More Substances: Complex Reaction Products on the TSCA Inventory (pdf) 1980s TSCA Inventory https://www.epa.gov/tsca-inventory/combinations-two-or-more-substances-complex-reaction-products-tsca-inventory
TSCA Inventory Reporting Policy TSCA Inventory Guidance Regarding Isotopes (pdf) 1980s TSCA Inventory https://www.epa.gov/tsca-inventory/isotopes-tsca-inventory
TSCA Inventory Reporting Policy Products Containing Two or More Substances, Formulated and Statutory Mixtures on the TSCA Inventory (pdf) 1980s TSCA Inventory https://www.epa.gov/tsca-inventory/products-containing-two-or-more-substances-formulated-and-statutory-mixtures-tsca
TSCA Inventory Reporting Policy Polymeric Substances on the TSCA Inventory (pdf) 1980s TSCA Inventory https://www.epa.gov/tsca-inventory/polymeric-substances-tsca-inventory
TSCA Inventory Reporting Policy Chemical Substances of Unknown or Variable Composition, Complex Reaction Products and Biological Materials (UVCB Substance) on the TSCA Inventory (pdf) 1980s TSCA Inventory https://www.epa.gov/tsca-inventory/chemical-substances-unknown-or-variable-composition-complex-reaction-products-and
TSCA Inventory Reporting Policy Certain Chemical Substances Containing Varying Carbon Chain Lengths (Alkyl Ranges Using the Cx-y Notation) on the TSCA Inventory (pdf) 1980s TSCA Inventory https://www.epa.gov/tsca-inventory/certain-chemical-substances-containing-varying-carbon-chain-lengths-alkyl-ranges
Chemical Categories New Chemicals Program Chemical Categories Document (pdf) 08-2010 New Chemicals https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemicals-program-under-tsca
PFAS Framework Framework for TSCA New Chemicals Review of PFAS Premanufacture Notices (PMNs) and Significant New Use Notices (SNUNs) (pdf) 06-28-2023 PMN, SNUN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/framework-addressing-new-pfas-and
Submission Guidance Points to Consider When Preparing TSCA New Chemical Notifications (pdf) 06-2018 New Chemicals https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/points-consider-when-preparing-tsca
Response to Comments on Submission Guidance Response to Comments Received on Points to Consider (pdf) 06-2018 New Chemicals https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/points-consider-when-preparing-tsca
PBT Category Policy Statement Policy Statement on a New Chemicals Category for Persistent, Bioaccumulative, and Toxic (PBT) Chemicals 11-04-1999 New Chemicals https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/policy-statement-new-chemicals
Identification of Eye Irritation and Corrosion Framework TSCA New Chemicals Program Decision Framework for Hazard Identification of Eye Irritation and Corrosion (pdf) 12-13-2023 New Chemicals https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/framework-assess-eye-irritation-or
Section 5 New Chemicals Approach to Making Determinations on TSCA Section 5 New Chemical Notices (pdf) 12-20-2019 New Chemicals https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/approach-making-determinations-tsca
Human Exposure Assessment Guidelines Guidelines for Human Exposure Assessment (2019) (pdf) 10-2019 New Chemicals https://www.epa.gov/risk/guidelines-human-exposure-assessment
Multimedia Fate Model Guidance Interim Guidance for Using Ready and Inherent Biodegradability Tests to Derive Input Data for Multimedia Models and Wastewater Treatment Plants (WWT) Models (9/1/2000) (pdf) 09-01-2000 Technical Guidance https://www.epa.gov/tsca-screening-tools/interim-guidance-using-ready-and-inherent-biodegradability-tests-derive-0
Nanomaterial Exposure Interim Technical Guidance for Assessing Screening Level Environmental Fate and Transport of, and General Population, Consumer, and Environmental Exposure to Nanomaterials (pdf) 06-17-2010 Nanotechnology https://www.epa.gov/tsca-screening-tools/interim-technical-guidance-assessing-screening-level-environmental-fate-and
Nanomaterial Exposure Approaches for Assessing and Controlling Workplace Releases and Exposures to New and Existing Nanomaterials (pdf) 05-2012 Nanotechnology https://www.epa.gov/tsca-screening-tools/interim-approaches-assessing-and-controlling-workplace-releases-and-exposures
Section 13 Import Checklist TSCA Section 13 Import Compliance Checklist (pdf) 2008 Export Import https://www.epa.gov/tsca-import-export-requirements/tsca-section-13-import-compliance-checklist
PMN Submission Sample PMN Form 01-14-2020 PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/sample-premanufacture-notification
Section 5 New Chemicals Analysis of Engineering Information Submitted for TSCA Section 5 06-23-2022 New Chemicals https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-new-chemical-engineering
Section 5 New Chemicals TSCA New Chemical Engineering Initiative to Increase Transparency and Reduce Rework: Analysis of New Chemicals Rework Issues 07-22-2022 New Chemicals https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-new-chemical-engineering
PFAS LVE Stewardship List of eligible PFAS LVEs (xlsx) 07-12-2021 LVE https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/pfas-low-volume-exemption
Chemical Safety Testing U.S. EPA New Approach Methods (NAMs) Conference 2022 (pdf) 04-2023 Technical Guidance https://www.epa.gov/chemical-research/past-conferences-state-science-development-and-use-new-approach-methods-nams
Chemical Safety Testing EPA NAM Work Plan December 2021 (pdf) 12-02-2021 Technical Guidance https://www.epa.gov/chemical-research/new-approach-methods-work-plan
TSCA Fees Fees for the Administration of the Toxic Substances Control Act 02-05-2024 TSCA Compliance https://www.epa.gov/tsca-fees/fee-triggering-events-and-entities-subject-tsca-fees
PMN Submission Chemical identity requirements for PMNs and Bona Fides (pdf) 07-2014 PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-avoiding-incomplete
PMN Submission Common reasons for incomplete PMNs (pdf) 10-24-1997 PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-avoiding-incomplete
PMN Submission Most common chemistry mistakes in PMNs (pdf) 07-2014 PMN https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-avoiding-incomplete
TSCA Fees TSCA Fees - Instructions for Reporting in CDX (pdf) 03-2020 Technical Guidance https://www.epa.gov/tsca-fees/instructions-how-complete-self-identification-and-other-certifications-cdx-epa-initiated
TSCA Fees Instructions for Amending a Response in CDX (pdf) 04-2020 Technical Guidance https://www.epa.gov/tsca-fees/instructions-how-complete-self-identification-and-other-certifications-cdx-epa-initiated
TSCA Fees TSCA Fees - Accessing and Submitting Payment for an Initial Response in CDX (pdf) 03-2020 Technical Guidance https://www.epa.gov/tsca-fees/instructions-how-complete-self-identification-and-other-certifications-cdx-epa-initiated
Chemical Import Compliance Compliance Guide for the Chemical Import Requirements of the Toxic Substances Control Act (pdf) 06-2008 Export Import https://www.epa.gov/compliance/compliance-guide-chemical-import-requirements-toxic-substances-control-act
Section 12(b) Export Notification Chemicals Subject to TSCA Section 12(b) Export Notification Requirements (xlsx) 10-25-2023 Export Import https://www.epa.gov/tsca-import-export-requirements/chemicals-subject-tsca-section-12b-export-notification-requirements
Section 12(b) Export Notification Chemicals Subject to TSCA Section 12(b) Export Notification Requirements (UTF-8 csv) (csv) 01-09-2023 Export Import https://www.epa.gov/tsca-import-export-requirements/chemicals-subject-tsca-section-12b-export-notification-requirements
Export Notification User Guide Section 12(b) Export Notification Application User Guide – Primary Authorized Official (pdf) 04-2021 Export Import https://www.epa.gov/tsca-import-export-requirements/section-12b-export-notification-application-user-guide-primary
Metal Effluent Guidelines Final Effluent Limitations Guidelines and Standards for the Metal Products and Machinery Point Source Category 02-2003 Technical Guidance https://www.epa.gov/eg/metal-products-and-machinery-effluent-guidelines-documents
Polymer Assessment Interpretive Assistance Document for Assessment of Polymers (pdf) 06-2013 Technical Guidance https://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
Sustainable Futures Assessment Sustainable Futures Summary Assessment Worksheet (blank) (pdf) 05-2015 Technical Guidance https://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
Sustainable Futures Assessment Completed Sustainable Futures Summary Assessment Using P2 Framework Models for 1,2-dichloro-4-nitro-5-pentylbenzene (pdf) 05-2015 Technical Guidance https://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
Sustainable Futures Assessment Completed Sustainable Futures Summary Assessment Using P2 Framework Models for 1,3,5-triazine-2,4-diamine, 6-nonyl (pdf) 05-2015 Technical Guidance https://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
Sustainable Futures Assessment Interpretive Assistance Document for Assessment of Discrete Organic Chemicals (pdf) 06-2013 Technical Guidance https://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
Polymer Assessment P2 Assessment of Polymers (pdf) 05-2015 Technical Guidance https://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
Interagency Biotechnology Regulation 2017 Update to the Coordinated Framework for the Regulation of Biotechnology 01-2017 Biotechnology https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/update-coordinated-framework-regulation-biotechnology
Microbes Regulation of Genetically Engineered Microorganisms Under FIFRA, FFDCA and TSCA 09-2015 Biotechnology https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/regulation-genetically-engineered-microorganisms
Microbes Microbial Products of Biotechnology: Summary of Regulations under TSCA (pdf) 09-2012 Biotechnology https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/tsca-biotechnology-regulatory-and-policy-related
Microbes Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (pdf) 06-02-1997 Biotechnology https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/guidance-documents-filing-biotechnology-submission
Algae Algae Supplement to the Guidance Document Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (pdf) 09-14-2020 Biotechnology https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/guidance-documents-filing-biotechnology-submission
Algae Agency Response to Public Comments on EPA’s Draft Algae Guidance for the Preparation of TSCA Biotechnology Submissions (pdf) 09-14-2020 Biotechnology https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/guidance-documents-filing-biotechnology-submission
ChemSTEER ChemSTEER Quick Start Guide (pdf) 05-2015 Technical Guidance https://www.epa.gov/tsca-screening-tools/chemsteer-quick-start-guide-and-user-guide-tsca-predictive-screening-tool
ChemSTEER ChemSTEER User Guide (pdf) 05-2015 Technical Guidance https://www.epa.gov/tsca-screening-tools/chemsteer-quick-start-guide-and-user-guide-tsca-predictive-screening-tool
ChemSTEER Scenarios Documents for Screening Level Exposure and Release Assessment (zip)   Technical Guidance https://www.epa.gov/tsca-screening-tools/chemsteer-chemical-screening-tool-exposures-and-environmental-releases
Consent Order TSCA Section 5 Order for a New Chemical Substance Boilerplate Language 06-2024 New Chemicals https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/boilerplate-language-orders-under
Exemptions New Chemical Information Bulletin: Exemptions for Research and Development and Test Marketing (pdf) 11-1986 New Chemicals https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemical-information-bulletin
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Last updated on June 26, 2024