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.

SubtopicTitlePublication date (YYYY-MM)TopicSource
Worker Exposure Calculating fold factors for uncertain worker exposures to mixed metal oxide (MMO) cathode active materials (CAMs) that contain cobalt (pdf) (304.94 KB) 2025-05Technical Guidance 
Fluorinated Products of Incomplete Combustion Fluorinated Products of Incomplete Combustion in EPA’s New Chemicals Program (pdf) (146.5 KB) 2025-01New Chemicals 
Bioaccumulation Potential of Metals New Approach for Evaluating the Bioaccumulation Potential of Metals in the New Chemicals Division (pdf) (360 KB) 2025-01New Chemicals 
CDX Registration User GuideCDX Chemical Safety and Pesticide Programs (CSPP) Registration User Guide (pdf)2015-08PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
CDX User GuideSection 5 Notices and Supports User Guide – Primary Authorized Official (pdf)2015-08PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
CDX User GuideSection 5 Notices and Supports User Guide - Primary Agent/Consultant (pdf)2015-08PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
CDX User GuideSection 5 Notices and Supports User Guide - Primary Support (pdf)2015-08PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
CDX User GuideSection 5 Notices and Supports User Guide - Secondary Authorized Official (pdf)2015-08PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
CDX User GuideSection 5 Notices and Supports User Guide - Secondary Agent/Consultant (pdf)2015-08PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
CDX User GuideSection 5 Notices and Supports User Guide – Secondary Support (pdf)2015-08PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
PMN SubmissionHelpful Hints: Questions and Answers for the e-PMN Thin Client (pdf)2015-08PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
PMN SubmissionSample e-PMN (Thin client) PMN form (pdf)2020-01PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
PMN SubmissionSample e-PMN (Thin client) NOC form (pdf)2020-01PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
PMN SubmissionXML Schema for e-PMN Thin Client (pdf) PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
PMN SubmissionSample EPA Biotech Form (pdf)2009-06PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
CBI Substantiation TemplateSection 5 (PMN/LVE/SNUN) substantiation template (docx)2023-07CBIhttps://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
CBI Substantiation TemplateNotice of Commencement substantiation template (for claims other than chemical identify) (docx)2023-07CBIhttps://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
CBI Substantiation TemplateBona Fide submission substantiation template (docx)2023-07CBIhttps://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
CBI Substantiation TemplatePolymer exemption report substantiation template (docx)2019-05CBIhttps://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
CBI Substantiation TemplateSection 8(e) notice of substantial risk substantiation template (docx)2023-07CBIhttps://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
CBI Substantiation TemplateSection 12(b) export notice substantiation template (docx)2023-07CBIhttps://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
CBI Substantiation TemplateChemical Data Reporting (CDR) substantiation template (docx)2017-03CBIhttps://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
CBI Substantiation TemplateGeneral substantiation template (docx)2023-08CBIhttps://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
Nanomaterial Information GatheringWorking Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce (pdf)2017-08Nanotechnologyhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/working-guidance-epas-section-8a
Nanomaterials on InventoryTSCA Inventory Status of Nanoscale Substances - General Approach (pdf)2023-01TSCA Inventoryhttps://www.epa.gov/tsca-inventory/nanoscale-substances-tsca-inventory
Nanomaterials Cross-Agency EffortsNanotechnology White Paper (pdf)2007-02Nanotechnologyhttps://www.epa.gov/osa/nanotechnology-white-paper
Nanotechnology and RemediationNanotechnology for Site Remediation: Fact Sheet (pdf)2008-10Nanotechnologyhttps://www.epa.gov/remedytech/nanotechnology-site-remediation-fact-sheet
Nanotechnology and RemediationTable of Selected Sites Using or Testing Nanoparticles for Remediation (pdf)2015-04Nanotechnologyhttps://www.epa.gov/remedytech/nanotechnology-site-remediation-fact-sheet
Nanotechnology and RemediationNanotechnology: Applications for Environmental Remediation, CLU-IN Technology Focus Area Fact Sheet (pdf)2015-04Nanotechnologyhttps://www.epa.gov/remedytech/nanotechnology-site-remediation-fact-sheet
OrderOrders for a Significant New Use of Certain Chemical Substances (PFuDA, PFDoA, PFTrDA, PFTeDA, PFHxDA, PFODA) and (PFOA, PFDA, PFNA) [Vacated]2023-12New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/orders-significant-new-use-certain
PMN Chemistry AssistanceChemistry assistance manual for Premanufacture Notification submitters (pdf)1997-03PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/chemistry-assistance-manual
Risk AssessmentRisk Assessment of the Per- and Polyfluoroalkyl Substances (PFAS) in SN-23-0002-0006 and SN-23-0008-00112023-12New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/risk-assessment-and-polyfluoroalkyl
Section 5 New ChemicalsInstruction Manual for Reporting under TSCA Section 5 New Chemicals Program (pdf)2015-05New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/instruction-manual-reporting-under
Section 5 New ChemicalsQuestions and Answers for the New Chemicals Program (pdf)2015-09New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/questions-answers-new-chemicals
Test GuidelinesOCSPP Test Guidelines Master List (pdf)2019-09Pesticides and Toxicshttps://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/master-list-test-guidelines-pesticides-and-toxic
Access to CBIGuidance for Requesting Access to CBI for State, Tribal, and Local Governments (pdf)2018-06CBIhttps://www.epa.gov/tsca-cbi/guidance-requesting-access-confidential-business-information
Access to CBIGuidance for Requesting Access to CBI for Environmental, Health, and Medical Professionals (pdf)2018-06CBIhttps://www.epa.gov/tsca-cbi/guidance-requesting-access-confidential-business-information
Access to CBIGuidance for Requesting Access to CBI for Emergency Responders (pdf)2018-06CBIhttps://www.epa.gov/tsca-cbi/guidance-requesting-access-confidential-business-information
Generic Names for Confidental ChemicalsGuidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting under TSCA (pdf)2018-06New Chemicalshttps://www.epa.gov/tsca-inventory/guidance-creating-generic-names-confidential-chemical-substance-identity-reporting
TSCA Inventory FileMS Access Non-CBI TSCA Inventory (ZIP) (zip)2023-08TSCA Inventoryhttps://www.epa.gov/tsca-inventory/how-access-tsca-inventory
TSCA Inventory FileCSV Non-CBI TSCA Inventory (ZIP) (zip)2023-08TSCA Inventoryhttps://www.epa.gov/tsca-inventory/how-access-tsca-inventory
Applicability of TSCACompliance Advisory: Applicability of the Toxic Substances Control Act to Mixed Metal Oxides, which Include Cathode Active Materials (CAMs) and Modified CAMs (pdf)2022-10TSCA Inventoryhttps://www.epa.gov/tsca-inventory/tsca-inventory-policy-and-guidance
Applicability of TSCACompliance Advisory: Applicability of the Toxic Substances Control Act to Chemicals made from Petroleum and Renewable Sources Used as Fuels and Fuel Additives and Distillates2020-12TSCA Inventoryhttps://www.epa.gov/tsca-inventory/compliance-advisory-applicability-toxic-substances-control-act-chemicals-made
TSCA Inventory Reporting PolicyCombinations of Two or More Substances: Complex Reaction Products on the TSCA Inventory (pdf)1980sTSCA Inventoryhttps://www.epa.gov/tsca-inventory/combinations-two-or-more-substances-complex-reaction-products-tsca-inventory
TSCA Inventory Reporting PolicyTSCA Inventory Guidance Regarding Isotopes (pdf)1980sTSCA Inventoryhttps://www.epa.gov/tsca-inventory/isotopes-tsca-inventory
TSCA Inventory Reporting PolicyProducts Containing Two or More Substances, Formulated and Statutory Mixtures on the TSCA Inventory (pdf)1980sTSCA Inventoryhttps://www.epa.gov/tsca-inventory/products-containing-two-or-more-substances-formulated-and-statutory-mixtures-tsca
TSCA Inventory Reporting PolicyPolymeric Substances on the TSCA Inventory (pdf)1980sTSCA Inventoryhttps://www.epa.gov/tsca-inventory/polymeric-substances-tsca-inventory
TSCA Inventory Reporting PolicyChemical Substances of Unknown or Variable Composition, Complex Reaction Products and Biological Materials (UVCB Substance) on the TSCA Inventory (pdf)1980sTSCA Inventoryhttps://www.epa.gov/tsca-inventory/chemical-substances-unknown-or-variable-composition-complex-reaction-products-and
TSCA Inventory Reporting PolicyCertain Chemical Substances Containing Varying Carbon Chain Lengths (Alkyl Ranges Using the Cx-y Notation) on the TSCA Inventory (pdf)1980sTSCA Inventoryhttps://www.epa.gov/tsca-inventory/certain-chemical-substances-containing-varying-carbon-chain-lengths-alkyl-ranges
Chemical CategoriesNew Chemicals Program Chemical Categories Document (pdf)2010-08New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemicals-program-under-tsca
PFAS FrameworkFramework for TSCA New Chemicals Review of PFAS Premanufacture Notices (PMNs) and Significant New Use Notices (SNUNs) (pdf)2023-06PMN, SNUNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/framework-addressing-new-pfas-and
Submission GuidancePoints to Consider When Preparing TSCA New Chemical Notifications (pdf)2018-06New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/points-consider-when-preparing-tsca
Response to Comments on Submission GuidanceResponse to Comments Received on Points to Consider (pdf)2018-06New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/points-consider-when-preparing-tsca
PBT Category Policy StatementPolicy Statement on a New Chemicals Category for Persistent, Bioaccumulative, and Toxic (PBT) Chemicals1999-11New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/policy-statement-new-chemicals
Identification of Eye Irritation and Corrosion FrameworkTSCA New Chemicals Program Decision Framework for Hazard Identification of Eye Irritation and Corrosion (pdf)2023-12New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/framework-assess-eye-irritation-or
Section 5 New ChemicalsApproach to Making Determinations on TSCA Section 5 New Chemical Notices (pdf)2019-12New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/approach-making-determinations-tsca
Human Exposure Assessment GuidelinesGuidelines for Human Exposure Assessment (2019) (pdf)2019-10New Chemicalshttps://www.epa.gov/risk/guidelines-human-exposure-assessment
Multimedia Fate Model GuidanceInterim 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)2000-09Technical Guidancehttps://www.epa.gov/tsca-screening-tools/interim-guidance-using-ready-and-inherent-biodegradability-tests-derive-0
Nanomaterial ExposureInterim Technical Guidance for Assessing Screening Level Environmental Fate and Transport of, and General Population, Consumer, and Environmental Exposure to Nanomaterials (pdf)2010-06Nanotechnologyhttps://www.epa.gov/tsca-screening-tools/interim-technical-guidance-assessing-screening-level-environmental-fate-and
Nanomaterial ExposureApproaches for Assessing and Controlling Workplace Releases and Exposures to New and Existing Nanomaterials (pdf)2012-05Nanotechnologyhttps://www.epa.gov/tsca-screening-tools/interim-approaches-assessing-and-controlling-workplace-releases-and-exposures
Section 13 Import ChecklistTSCA Section 13 Import Compliance Checklist (pdf)2008Export Importhttps://www.epa.gov/tsca-import-export-requirements/tsca-section-13-import-compliance-checklist
PMN SubmissionSample PMN Form2020-01PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/sample-premanufacture-notification
Section 5 New ChemicalsAnalysis of Engineering Information Submitted for TSCA Section 52022-06New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-new-chemical-engineering
Section 5 New ChemicalsTSCA New Chemical Engineering Initiative to Increase Transparency and Reduce Rework: Analysis of New Chemicals Rework Issues2022-07New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-new-chemical-engineering
PFAS LVE StewardshipList of eligible PFAS LVEs (xlsx)2021-07LVEhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/pfas-low-volume-exemption
Chemical Safety TestingU.S. EPA New Approach Methods (NAMs) Conference 2022 (pdf)2023-04Technical Guidancehttps://www.epa.gov/chemical-research/past-conferences-state-science-development-and-use-new-approach-methods-nams
Chemical Safety TestingEPA NAM Work Plan December 2021 (pdf)2021-12Technical Guidancehttps://www.epa.gov/chemical-research/new-approach-methods-work-plan
TSCA FeesFees for the Administration of the Toxic Substances Control Act2024-02TSCA Compliancehttps://www.epa.gov/tsca-fees/fee-triggering-events-and-entities-subject-tsca-fees
PMN SubmissionChemical identity requirements for PMNs and Bona Fides (pdf)2014-07PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-avoiding-incomplete
PMN SubmissionCommon reasons for incomplete PMNs (pdf)1997-10PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-avoiding-incomplete
PMN SubmissionMost common chemistry mistakes in PMNs (pdf)2014-07PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-avoiding-incomplete
TSCA FeesTSCA Fees - Instructions for Reporting in CDX (pdf)2020-03Technical Guidancehttps://www.epa.gov/tsca-fees/instructions-how-complete-self-identification-and-other-certifications-cdx-epa-initiated
TSCA FeesInstructions for Amending a Response in CDX (pdf)2020-04Technical Guidancehttps://www.epa.gov/tsca-fees/instructions-how-complete-self-identification-and-other-certifications-cdx-epa-initiated
TSCA FeesTSCA Fees - Accessing and Submitting Payment for an Initial Response in CDX (pdf)2020-03Technical Guidancehttps://www.epa.gov/tsca-fees/instructions-how-complete-self-identification-and-other-certifications-cdx-epa-initiated
Chemical Import ComplianceCompliance Guide for the Chemical Import Requirements of the Toxic Substances Control Act (pdf)2008-06Export Importhttps://www.epa.gov/compliance/compliance-guide-chemical-import-requirements-toxic-substances-control-act
Section 12(b) Export NotificationChemicals Subject to TSCA Section 12(b) Export Notification Requirements (xlsx)2023-10Export Importhttps://www.epa.gov/tsca-import-export-requirements/chemicals-subject-tsca-section-12b-export-notification-requirements
Section 12(b) Export NotificationChemicals Subject to TSCA Section 12(b) Export Notification Requirements (UTF-8 csv) (csv)2023-01Export Importhttps://www.epa.gov/tsca-import-export-requirements/chemicals-subject-tsca-section-12b-export-notification-requirements
Export Notification User GuideSection 12(b) Export Notification Application User Guide – Primary Authorized Official (pdf)2021-04Export Importhttps://www.epa.gov/tsca-import-export-requirements/section-12b-export-notification-application-user-guide-primary
Metal Effluent GuidelinesFinal Effluent Limitations Guidelines and Standards for the Metal Products and Machinery Point Source Category2003-02Technical Guidancehttps://www.epa.gov/eg/metal-products-and-machinery-effluent-guidelines-documents
Polymer AssessmentInterpretive Assistance Document for Assessment of Polymers (pdf)2013-06Technical Guidancehttps://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
Sustainable Futures AssessmentSustainable Futures Summary Assessment Worksheet (blank) (pdf)2015-05Technical Guidancehttps://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
Sustainable Futures AssessmentCompleted Sustainable Futures Summary Assessment Using P2 Framework Models for 1,2-dichloro-4-nitro-5-pentylbenzene (pdf)2015-05Technical Guidancehttps://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
Sustainable Futures AssessmentCompleted Sustainable Futures Summary Assessment Using P2 Framework Models for 1,3,5-triazine-2,4-diamine, 6-nonyl (pdf)2015-05Technical Guidancehttps://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
Sustainable Futures AssessmentInterpretive Assistance Document for Assessment of Discrete Organic Chemicals (pdf)2013-06Technical Guidancehttps://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
Polymer AssessmentP2 Assessment of Polymers (pdf)2015-05Technical Guidancehttps://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
Interagency Biotechnology Regulation2017 Update to the Coordinated Framework for the Regulation of Biotechnology2017-01Biotechnologyhttps://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/update-coordinated-framework-regulation-biotechnology
MicrobesRegulation of Genetically Engineered Microorganisms Under FIFRA, FFDCA and TSCA2015-09Biotechnologyhttps://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/regulation-genetically-engineered-microorganisms
MicrobesMicrobial Products of Biotechnology: Summary of Regulations under TSCA (pdf)2012-09Biotechnologyhttps://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/tsca-biotechnology-regulatory-and-policy-related
MicrobesPoints to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (pdf)1997-06Biotechnologyhttps://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/guidance-documents-filing-biotechnology-submission
AlgaeAlgae Supplement to the Guidance Document Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (pdf)2020-09Biotechnologyhttps://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/guidance-documents-filing-biotechnology-submission
AlgaeAgency Response to Public Comments on EPA’s Draft Algae Guidance for the Preparation of TSCA Biotechnology Submissions (pdf)2020-09Biotechnologyhttps://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/guidance-documents-filing-biotechnology-submission
ChemSTEERChemSTEER Quick Start Guide (pdf)2015-05Technical Guidancehttps://www.epa.gov/tsca-screening-tools/chemsteer-quick-start-guide-and-user-guide-tsca-predictive-screening-tool
ChemSTEERChemSTEER User Guide (pdf)2015-05Technical Guidancehttps://www.epa.gov/tsca-screening-tools/chemsteer-quick-start-guide-and-user-guide-tsca-predictive-screening-tool
Generic ScenariosScenarios Documents for Screening Level Exposure and Release Assessment (zip) Technical Guidancehttps://www.epa.gov/tsca-screening-tools/chemsteer-chemical-screening-tool-exposures-and-environmental-releases
Consent OrderTSCA Section 5 Order for a New Chemical Substance Boilerplate Language2024-06New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/boilerplate-language-orders-under
ExemptionsNew Chemical Information Bulletin: Exemptions for Research and Development and Test Marketing (pdf)1986-11New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemical-information-bulletin
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Last updated on August 5, 2025