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.

Publication date (YYYY-MM)SubtopicTitleTopicSource
2025-11Engineering Defaults Common Engineering Defaults Used in EPA's New Chemicals Assessments (pdf) (749.75 KB) Technical Guidance 
2025-09PMN SubmissionInstructions for TSCA New Chemicals Submissions with Request for Priority Review Associated with Data Center Executive Order Qualifying ProjectsPMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/filing-pre-manufacture-notice-epa#datacenter 
2025-05Worker Exposure Calculating fold factors for uncertain worker exposures to mixed metal oxide (MMO) cathode active materials (CAMs) that contain cobalt (pdf) (304.94 KB) Technical Guidance 
2025-01Fluorinated Products of Incomplete Combustion Fluorinated Products of Incomplete Combustion in EPA’s New Chemicals Program (pdf) (146.5 KB) New Chemicals 
2025-01Bioaccumulation Potential of Metals New Approach for Evaluating the Bioaccumulation Potential of Metals in the New Chemicals Division (pdf) (360 KB) New Chemicals 
2015-08CDX Registration User GuideCDX Chemical Safety and Pesticide Programs (CSPP) Registration User Guide (pdf)PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
2015-08CDX User GuideSection 5 Notices and Supports User Guide – Primary Authorized Official (pdf)PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
2015-08CDX User GuideSection 5 Notices and Supports User Guide - Primary Agent/Consultant (pdf)PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
2015-08CDX User GuideSection 5 Notices and Supports User Guide - Primary Support (pdf)PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
2015-08CDX User GuideSection 5 Notices and Supports User Guide - Secondary Authorized Official (pdf)PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
2015-08CDX User GuideSection 5 Notices and Supports User Guide - Secondary Agent/Consultant (pdf)PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
2015-08CDX User GuideSection 5 Notices and Supports User Guide – Secondary Support (pdf)PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
2015-08PMN SubmissionHelpful Hints: Questions and Answers for the e-PMN Thin Client (pdf)PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
2020-01PMN SubmissionSample e-PMN (Thin client) PMN form (pdf)PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
2020-01PMN SubmissionSample e-PMN (Thin client) NOC form (pdf)PMNhttps://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
2009-06PMN SubmissionSample EPA Biotech Form (pdf)PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-documents-and-sample-forms
2023-07CBI Substantiation TemplateSection 5 (PMN/LVE/SNUN) substantiation template (docx)CBIhttps://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
2023-07CBI Substantiation TemplateNotice of Commencement substantiation template (for claims other than chemical identify) (docx)CBIhttps://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
2023-07CBI Substantiation TemplateBona Fide submission substantiation template (docx)CBIhttps://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
2019-05CBI Substantiation TemplatePolymer exemption report substantiation template (docx)CBIhttps://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
2023-07CBI Substantiation TemplateSection 8(e) notice of substantial risk substantiation template (docx)CBIhttps://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
2023-07CBI Substantiation TemplateSection 12(b) export notice substantiation template (docx)CBIhttps://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
2017-03CBI Substantiation TemplateChemical Data Reporting (CDR) substantiation template (docx)CBIhttps://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
2023-08CBI Substantiation TemplateGeneral substantiation template (docx)CBIhttps://www.epa.gov/tsca-cbi/what-include-cbi-substantiations#substantiationtemplates
2017-08Nanomaterial Information GatheringWorking Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce (pdf)Nanotechnologyhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/working-guidance-epas-section-8a
2023-01Nanomaterials on InventoryTSCA Inventory Status of Nanoscale Substances - General Approach (pdf)TSCA Inventoryhttps://www.epa.gov/tsca-inventory/nanoscale-substances-tsca-inventory
2007-02Nanomaterials Cross-Agency EffortsNanotechnology White Paper (pdf)Nanotechnologyhttps://www.epa.gov/osa/nanotechnology-white-paper
2008-10Nanotechnology and RemediationNanotechnology for Site Remediation: Fact Sheet (pdf)Nanotechnologyhttps://www.epa.gov/remedytech/nanotechnology-site-remediation-fact-sheet
2015-04Nanotechnology and RemediationTable of Selected Sites Using or Testing Nanoparticles for Remediation (pdf)Nanotechnologyhttps://www.epa.gov/remedytech/nanotechnology-site-remediation-fact-sheet
2015-04Nanotechnology and RemediationNanotechnology: Applications for Environmental Remediation, CLU-IN Technology Focus Area Fact Sheet (pdf)Nanotechnologyhttps://www.epa.gov/remedytech/nanotechnology-site-remediation-fact-sheet
2023-12OrderOrders for a Significant New Use of Certain Chemical Substances (PFuDA, PFDoA, PFTrDA, PFTeDA, PFHxDA, PFODA) and (PFOA, PFDA, PFNA) [Vacated]New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/orders-significant-new-use-certain
1997-03PMN Chemistry AssistanceChemistry assistance manual for Premanufacture Notification submitters (pdf)PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/chemistry-assistance-manual
2023-12Risk AssessmentRisk Assessment of the Per- and Polyfluoroalkyl Substances (PFAS) in SN-23-0002-0006 and SN-23-0008-0011New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/risk-assessment-and-polyfluoroalkyl
2015-05Section 5 New ChemicalsInstruction Manual for Reporting under TSCA Section 5 New Chemicals Program (pdf)New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/instruction-manual-reporting-under
2015-09Section 5 New ChemicalsQuestions and Answers for the New Chemicals Program (pdf)New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/questions-answers-new-chemicals
2019-09Test GuidelinesOCSPP Test Guidelines Master List (pdf)Pesticides and Toxicshttps://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/master-list-test-guidelines-pesticides-and-toxic
2018-06Access to CBIGuidance for Requesting Access to CBI for State, Tribal, and Local Governments (pdf)CBIhttps://www.epa.gov/tsca-cbi/guidance-requesting-access-confidential-business-information
2018-06Access to CBIGuidance for Requesting Access to CBI for Environmental, Health, and Medical Professionals (pdf)CBIhttps://www.epa.gov/tsca-cbi/guidance-requesting-access-confidential-business-information
2018-06Access to CBIGuidance for Requesting Access to CBI for Emergency Responders (pdf)CBIhttps://www.epa.gov/tsca-cbi/guidance-requesting-access-confidential-business-information
2018-06Generic Names for Confidental ChemicalsGuidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting under TSCA (pdf)New Chemicalshttps://www.epa.gov/tsca-inventory/guidance-creating-generic-names-confidential-chemical-substance-identity-reporting
2023-08TSCA Inventory FileMS Access Non-CBI TSCA Inventory (ZIP) (zip)TSCA Inventoryhttps://www.epa.gov/tsca-inventory/how-access-tsca-inventory
2023-08TSCA Inventory FileCSV Non-CBI TSCA Inventory (ZIP) (zip)TSCA Inventoryhttps://www.epa.gov/tsca-inventory/how-access-tsca-inventory
2022-10Applicability of TSCACompliance Advisory: Applicability of the Toxic Substances Control Act to Mixed Metal Oxides, which Include Cathode Active Materials (CAMs) and Modified CAMs (pdf)TSCA Inventoryhttps://www.epa.gov/tsca-inventory/tsca-inventory-policy-and-guidance
2020-12Applicability 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 DistillatesTSCA Inventoryhttps://www.epa.gov/tsca-inventory/compliance-advisory-applicability-toxic-substances-control-act-chemicals-made
1980sTSCA Inventory Reporting PolicyCombinations of Two or More Substances: Complex Reaction Products on the TSCA Inventory (pdf)TSCA Inventoryhttps://www.epa.gov/tsca-inventory/combinations-two-or-more-substances-complex-reaction-products-tsca-inventory
1980sTSCA Inventory Reporting PolicyTSCA Inventory Guidance Regarding Isotopes (pdf)TSCA Inventoryhttps://www.epa.gov/tsca-inventory/isotopes-tsca-inventory
1980sTSCA Inventory Reporting PolicyProducts Containing Two or More Substances, Formulated and Statutory Mixtures on the TSCA Inventory (pdf)TSCA Inventoryhttps://www.epa.gov/tsca-inventory/products-containing-two-or-more-substances-formulated-and-statutory-mixtures-tsca
1980sTSCA Inventory Reporting PolicyPolymeric Substances on the TSCA Inventory (pdf)TSCA Inventoryhttps://www.epa.gov/tsca-inventory/polymeric-substances-tsca-inventory
1980sTSCA Inventory Reporting PolicyChemical Substances of Unknown or Variable Composition, Complex Reaction Products and Biological Materials (UVCB Substance) on the TSCA Inventory (pdf)TSCA Inventoryhttps://www.epa.gov/tsca-inventory/chemical-substances-unknown-or-variable-composition-complex-reaction-products-and
1980sTSCA Inventory Reporting PolicyCertain Chemical Substances Containing Varying Carbon Chain Lengths (Alkyl Ranges Using the Cx-y Notation) on the TSCA Inventory (pdf)TSCA Inventoryhttps://www.epa.gov/tsca-inventory/certain-chemical-substances-containing-varying-carbon-chain-lengths-alkyl-ranges
2010-08Chemical CategoriesNew Chemicals Program Chemical Categories Document (pdf)New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemicals-program-under-tsca
2023-06PFAS FrameworkFramework for TSCA New Chemicals Review of PFAS Premanufacture Notices (PMNs) and Significant New Use Notices (SNUNs) (pdf)PMN, SNUNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/framework-addressing-new-pfas-and
2018-06Submission GuidancePoints to Consider When Preparing TSCA New Chemical Notifications (pdf)New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/points-consider-when-preparing-tsca
2018-06Response to Comments on Submission GuidanceResponse to Comments Received on Points to Consider (pdf)New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/points-consider-when-preparing-tsca
1999-11PBT Category Policy StatementPolicy Statement on a New Chemicals Category for Persistent, Bioaccumulative, and Toxic (PBT) ChemicalsNew Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/policy-statement-new-chemicals
2023-12Identification of Eye Irritation and Corrosion FrameworkTSCA New Chemicals Program Decision Framework for Hazard Identification of Eye Irritation and Corrosion (pdf)New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/framework-assess-eye-irritation-or
2019-12Section 5 New ChemicalsApproach to Making Determinations on TSCA Section 5 New Chemical Notices (pdf)New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/approach-making-determinations-tsca
2019-10Human Exposure Assessment GuidelinesGuidelines for Human Exposure Assessment (2019) (pdf)New Chemicalshttps://www.epa.gov/risk/guidelines-human-exposure-assessment
2000-09Multimedia 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)Technical Guidancehttps://www.epa.gov/tsca-screening-tools/interim-guidance-using-ready-and-inherent-biodegradability-tests-derive-0
2010-06Nanomaterial ExposureInterim Technical Guidance for Assessing Screening Level Environmental Fate and Transport of, and General Population, Consumer, and Environmental Exposure to Nanomaterials (pdf)Nanotechnologyhttps://www.epa.gov/tsca-screening-tools/interim-technical-guidance-assessing-screening-level-environmental-fate-and
2012-05Nanomaterial ExposureApproaches for Assessing and Controlling Workplace Releases and Exposures to New and Existing Nanomaterials (pdf)Nanotechnologyhttps://www.epa.gov/tsca-screening-tools/interim-approaches-assessing-and-controlling-workplace-releases-and-exposures
2008Section 13 Import ChecklistTSCA Section 13 Import Compliance Checklist (pdf)Export Importhttps://www.epa.gov/tsca-import-export-requirements/tsca-section-13-import-compliance-checklist
2020-01PMN SubmissionSample PMN FormPMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/sample-premanufacture-notification
2022-06Section 5 New ChemicalsAnalysis of Engineering Information Submitted for TSCA Section 5New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-new-chemical-engineering
2022-07Section 5 New ChemicalsTSCA New Chemical Engineering Initiative to Increase Transparency and Reduce Rework: Analysis of New Chemicals Rework IssuesNew Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-new-chemical-engineering
2021-07PFAS LVE StewardshipList of eligible PFAS LVEs (xlsx)LVEhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/pfas-low-volume-exemption
2023-04Chemical Safety TestingU.S. EPA New Approach Methods (NAMs) Conference 2022 (pdf)Technical Guidancehttps://www.epa.gov/chemical-research/past-conferences-state-science-development-and-use-new-approach-methods-nams
2021-12Chemical Safety TestingEPA NAM Work Plan December 2021 (pdf)Technical Guidancehttps://www.epa.gov/chemical-research/new-approach-methods-work-plan
2024-02TSCA FeesFees for the Administration of the Toxic Substances Control ActTSCA Compliancehttps://www.epa.gov/tsca-fees/fee-triggering-events-and-entities-subject-tsca-fees
2014-07PMN SubmissionChemical identity requirements for PMNs and Bona Fides (pdf)PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-avoiding-incomplete
1997-10PMN SubmissionCommon reasons for incomplete PMNs (pdf)PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-avoiding-incomplete
2014-07PMN SubmissionMost common chemistry mistakes in PMNs (pdf)PMNhttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/guidance-avoiding-incomplete
2020-03TSCA FeesTSCA Fees - Instructions for Reporting in CDX (pdf)Technical Guidancehttps://www.epa.gov/tsca-fees/instructions-how-complete-self-identification-and-other-certifications-cdx-epa-initiated
2020-04TSCA FeesInstructions for Amending a Response in CDX (pdf)Technical Guidancehttps://www.epa.gov/tsca-fees/instructions-how-complete-self-identification-and-other-certifications-cdx-epa-initiated
2020-03TSCA FeesTSCA Fees - Accessing and Submitting Payment for an Initial Response in CDX (pdf)Technical Guidancehttps://www.epa.gov/tsca-fees/instructions-how-complete-self-identification-and-other-certifications-cdx-epa-initiated
2008-06Chemical Import ComplianceCompliance Guide for the Chemical Import Requirements of the Toxic Substances Control Act (pdf)Export Importhttps://www.epa.gov/compliance/compliance-guide-chemical-import-requirements-toxic-substances-control-act
2023-10Section 12(b) Export NotificationChemicals Subject to TSCA Section 12(b) Export Notification Requirements (xlsx)Export Importhttps://www.epa.gov/tsca-import-export-requirements/chemicals-subject-tsca-section-12b-export-notification-requirements
2023-01Section 12(b) Export NotificationChemicals Subject to TSCA Section 12(b) Export Notification Requirements (UTF-8 csv) (csv)Export Importhttps://www.epa.gov/tsca-import-export-requirements/chemicals-subject-tsca-section-12b-export-notification-requirements
2021-04Export Notification User GuideSection 12(b) Export Notification Application User Guide – Primary Authorized Official (pdf)Export Importhttps://www.epa.gov/tsca-import-export-requirements/section-12b-export-notification-application-user-guide-primary
2003-02Metal Effluent GuidelinesFinal Effluent Limitations Guidelines and Standards for the Metal Products and Machinery Point Source CategoryTechnical Guidancehttps://www.epa.gov/eg/metal-products-and-machinery-effluent-guidelines-documents
2013-06Polymer AssessmentInterpretive Assistance Document for Assessment of Polymers (pdf)Technical Guidancehttps://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
2015-05Sustainable Futures AssessmentSustainable Futures Summary Assessment Worksheet (blank) (pdf)Technical Guidancehttps://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
2015-05Sustainable Futures AssessmentCompleted Sustainable Futures Summary Assessment Using P2 Framework Models for 1,2-dichloro-4-nitro-5-pentylbenzene (pdf)Technical Guidancehttps://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
2015-05Sustainable Futures AssessmentCompleted Sustainable Futures Summary Assessment Using P2 Framework Models for 1,3,5-triazine-2,4-diamine, 6-nonyl (pdf)Technical Guidancehttps://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
2013-06Sustainable Futures AssessmentInterpretive Assistance Document for Assessment of Discrete Organic Chemicals (pdf)Technical Guidancehttps://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
2015-05Polymer AssessmentP2 Assessment of Polymers (pdf)Technical Guidancehttps://www.epa.gov/sustainable-futures/sustainable-futures-training-materials-developed-epa
2017-01Interagency Biotechnology Regulation2017 Update to the Coordinated Framework for the Regulation of BiotechnologyBiotechnologyhttps://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/update-coordinated-framework-regulation-biotechnology
2015-09MicrobesRegulation of Genetically Engineered Microorganisms Under FIFRA, FFDCA and TSCABiotechnologyhttps://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/regulation-genetically-engineered-microorganisms
2012-09MicrobesMicrobial Products of Biotechnology: Summary of Regulations under TSCA (pdf)Biotechnologyhttps://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/tsca-biotechnology-regulatory-and-policy-related
1997-06MicrobesPoints to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (pdf)Biotechnologyhttps://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/guidance-documents-filing-biotechnology-submission
2020-09AlgaeAlgae Supplement to the Guidance Document Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (pdf)Biotechnologyhttps://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/guidance-documents-filing-biotechnology-submission
2020-09AlgaeAgency Response to Public Comments on EPA’s Draft Algae Guidance for the Preparation of TSCA Biotechnology Submissions (pdf)Biotechnologyhttps://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/guidance-documents-filing-biotechnology-submission
2015-05ChemSTEERChemSTEER Quick Start Guide (pdf)Technical Guidancehttps://www.epa.gov/tsca-screening-tools/chemsteer-quick-start-guide-and-user-guide-tsca-predictive-screening-tool
2015-05ChemSTEERChemSTEER User Guide (pdf)Technical 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
2024-06Consent OrderTSCA Section 5 Order for a New Chemical Substance Boilerplate LanguageNew Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/boilerplate-language-orders-under
1986-11ExemptionsNew Chemical Information Bulletin: Exemptions for Research and Development and Test Marketing (pdf)New Chemicalshttps://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemical-information-bulletin
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Last updated on December 5, 2025