TSCA Handbook
- Authors:
- Publisher:
- 2005
Summary
Prompted by important developments that have occurred since the publication of the third edition eight years ago, the newly updated TSCA Handbook provides anyone who manufactures, processes, distributes, or uses chemicals with a comprehensive look at their requirements under the Toxic Substances Control Act (TSCA).
Practical and informative, this ready reference details current regulation under TSCA. It examines the Environmental Protection Agency's program for evaluation and regulating new substances, and it discusses PMN preparations and follow through, inspections and audits, and more.
Developments addressed in this edition include the following: changes to the Inventory Update Rule, new voluntary testing initiatives, new enforcement policies and rules, revised PCB regulations regarding contaminated sites, and increased maximum civil penalties.
Search publication
Bibliographic data
- Copyright year
- 2005
- ISBN-Print
- 978-0-86587-566-1
- ISBN-Online
- 978-1-4616-6158-0
- Publisher
- Government Institutes, Lanham
- Language
- English
- Pages
- 435
- Product type
- Book Titles
Table of contents
- Acknowledgments No access
- Preface No access
- Table of Contents No access
- 1.1.1. Legislative Background No access
- 1.1.2. Legislative Goals No access
- 1.2.1. TSCA § 4-Testing No access
- 1.2.2. TSCA § 5-Premanufacture Notification No access
- 1.2.3. TSCA § 6-Regulation of Existing Chemicals No access
- 1.2.4. TSCA § 6(e)-PCB Regulation No access
- 1.2.5. TSCA § 8-Recordkeeping and Reporting No access
- 1.2.6. TSCA §§ 11, 15, 16 and 17-Enforcement No access
- 1.3. TSCA Amendments-Titles II, III And IV No access
- 1.4. EPA'S Implementation of TSCA No access
- 2.1.1. Chemical Control Division No access
- 2.1.2. Risk Assessment Division No access
- 2.1.3. Economics. Exposure and Technology Division No access
- 2.1.4. National Program Chemicals Division No access
- 2.1.5. Information Management Division No access
- 2.1.6. Pollution Prevention Division No access
- 2.1.7. Environmental Assistance Division No access
- 2.1.8. TSCA Interagency Testing Committee No access
- 2.2. Office Of General Counsel No access
- 2.3. Office Of Enforcement And Compliance Assurance No access
- Figure II-1: U.S. Environmental Protection Agency No access
- Figure II-2: Office of Prevention, Pesticides Toxic Substances No access
- Figure II-3: Office of Pollution Prevention And Toxics No access
- Figure II-4: Office of Enforcement And Compliance Assurance No access
- Figure II-5: Telephone List For EPA Offices Related To TSCA No access
- Figure II-6: Contact Information For The Oppt New Chemicals Program No access
- 3.1.1. Manufacture "for Commercial Purposes" No access
- 3.1.2. "Extraction" as "Manufacturing" No access
- 3.1.3. Toll Manufacturers No access
- 3.2.1. "Processing" Versus "Use" No access
- 3.2.2. "Processing" as Defined in TSCA Rules No access
- 3.2.3. Toll Processors No access
- 3.3. "Distribute" No access
- 3.4.1. SNURs No access
- 3.5.1. TCDD Disposal Regulations No access
- 3.5.2. PCB Regulations No access
- 3.5.3. Section 5(e) Consent Orders No access
- 4.1.1. "Chemical Substance" No access
- 4.1.2. Manufactured or Imported for a "Commercial Purpose" No access
- 4.1.3.1. Small Quantities for Research and Development No access
- 4.1.3.2. Impurities No access
- 4.1.3.3. By-products No access
- 4.1.3.4. Chemicals Produced from Incidental Reactions No access
- 4.1.3.5. Non-Isolated Intermediates No access
- 4.2.1. Information Reported No access
- 4.2.2.1. Mixtures No access
- 4.2.2.2. Polymers No access
- 4.2.2.3. Pesticides No access
- 4.2.2.4. Articles No access
- 4.2.2.5. Quality Control Chemicals No access
- 4.3. Correcting An Inventory Submission No access
- 4.4.1. Inventory Update Rule No access
- 4.4.2. Special Reporting Problems No access
- 4.4.3. IURA Litigation No access
- 4.4.4. Proposed IURA Revision No access
- 4.5.1. Volume I: TSCA Inventory No access
- 4.5.2. Volumes II and III: Substance Name Index No access
- 4.5.3. Volume IV: Molecular Formula Index No access
- 4.5.4.1. UVCB Index No access
- 4.5.4.2. Section 4 Index, Sections 5(e). 5(f) Index, Significant New Use Rules Index No access
- 4.6.1. Inventory Search Assistance No access
- 4.6.2. Searches for Confidential Identities: Bona fide Requests No access
- 4.6.3. Bona fide Requests and IUR Reports No access
- 5.1. Overview of TSCA § 5 No access
- 5.2.1.PMN Review Period No access
- 5.2.2. EPA Regulation of PMN Substances No access
- 5.3. Exclusions From PMN Requirements No access
- 5.4.1. Test Market Exemption No access
- 5.4.2.1. LVE Review No access
- 5.4.2.2. LVE Revocation No access
- 5.4.2.3. Customer Notification No access
- 5.4.3. LoREX Exemption No access
- 5.5.1.1. Meaning of R&D No access
- 5.5.1.2. Sale of R&D Chemicals No access
- 5.5.1.3. Use and Disposal of Residual R&D Substances No access
- 5.5.1.4. Small Quantities No access
- 5.5.1.5. Technically Qualified Individual No access
- 5.5.1.6. Evaluation, Notification, and Record-Keeping of Risks No access
- 5.5.1.7. R&D Pesticides No access
- 5.5.2.1. Polymer Definition No access
- 5.5.2.2. Ineligible Polymers No access
- 5.5.2.3. General Exemption Criteria No access
- 5.5.2.4. Exemption Report No access
- 5.5.2.5. Record-Keeping No access
- 5.5.3. "Polaroid" Exemption No access
- 5.5.4. New Chemicals Imported As Part of An Article No access
- 5.5.5. Impurities, By-products, and Non-Isolated Intermediates No access
- 5.5.6. Chemicals Formed Incidental to Exposure to Other Chemicals No access
- 5.5.7. Chemicals Formed During the Manufacture of an Article No access
- 5.5.8.1. Polymer Salts No access
- 6.1.1. Full PMN No access
- 6.1.2. Consolidated PMNs No access
- 6.1.3. Joint Submissions No access
- 6.1.4. Special Cases: LVE and LoREX Exemption No access
- 6.2.1. The Submitter's Basic Obligations No access
- 6.2.2. PMN Processing Fees No access
- 6.2.3.1. Agricultural Screening Data No access
- 6.2.3.2. All Other Data No access
- 6.2.3.3. New Data During Review Period No access
- 6.2.4. Practical Tips No access
- 6.3.1.1. Agents No access
- 6.3.1.2. Technical Contact No access
- 6.3.1.3. Previous Communications with EPA No access
- 6.3.2.1. Class 1 Substances No access
- 6.3.2.2. Class 2 Substances No access
- 6.3.2.3. Polymers No access
- 6.3.2.4. Impurities and By-products No access
- 6.3.2.5. Generic Name No access
- 6.3.2.6. Synonyms, Trade Identification No access
- 6.3.3.1. Production Volume No access
- 6.3.3.2. Use No access
- 6.3.3.3. Hazard Information No access
- 6.4.1. Industrial Sites Controlled by the Submitter-Section A No access
- 6.4.2. Industrial Sites Controlled by Others-Section B No access
- 6.4.3. Pollution Prevention Information (Optional) No access
- 6.5. PMN Form Part III: List Of Attachments No access
- 6.6.1. EPA's Handling of CBI No access
- 6.6.2. Asserting CBI in a PMN No access
- 6.7.1. Filing and Receiving the PMN No access
- 6.7.2.1. Chemical Review (CR) Meeting No access
- 6.7.2.2. Structure-Activity Team (SAT) Meeting No access
- 6.7.2.3. Profile of Exposure and Release No access
- 6.7.2.4. Focus Meeting No access
- 6.7.3.1. Workplan Meeting No access
- 6.7.3.2. Risk Assessment Disposition No access
- 6.7.3.3. Decision Meeting No access
- 6.7.4.1. Notice of Commencement of Manufacture No access
- 6.7.4.2. Record-Keeping No access
- Figure VI-I EPA PMN Review Process No access
- 7.1.1.EPA1s Standard Section 5(e) Consent Order No access
- 7.1.2.1. Invalid Data No access
- 7.1.2.2. Equivocal Data No access
- 7.1.2.3. Valid, Unequivocal Data No access
- 7.1.3.1. Potentially Infinite Duration No access
- 7.1.3.2. No Automatic Revocation No access
- 7.1.3.3. Anticompetitive Effects No access
- 7.1.4. Exposure Controls versus Data Development No access
- 7.2.1. Intra-Agency Process No access
- 7.2.2. Expediting the Process No access
- 7.3.1. Petitions under TSCA § 21 No access
- 7.3.2. Petitions under the Consent Order No access
- 7.3.3. Review under the Administrative Procedure Act (APA) No access
- 7.4.1. Statutory Standard for Unilateral Section 5(e) Orders No access
- 7.4.2. Objecting to Unilateral Section 5(e) Orders No access
- 7.5.1. Proposed Section 5(f) Rules No access
- 7.5.2. Proposed Section 5(f) Orders No access
- 7.6.1. SNUR Standard No access
- 7.6.2. Who Must Report No access
- 7.6.3. Determining Inventory Status No access
- 7.6.4. Use of SNURs to Support Section 5(e) Consent Orders No access
- 7.6.5.1. Summary of the Generic SNUR Rule No access
- 7.6.5.2. Standardized Significant New Uses No access
- 7.6.6. Expedited SNURs for New Chemical Substances Subject to Section 5(e) Orders No access
- 7.6.7.1. Concern Criteria No access
- 7.6.7.2. Procedures for Issuing Non-5(e) SNURs No access
- 7.6.8. Record-Keeping Requirements No access
- 7.6.9. Procedures for Limitation or Revocation of Expedited SNURs No access
- Figure VII-1: Categories Of Chemicals Likely To Be Subject To A Section 5(e) Order No access
- Figure Vll-2: Criteria Triggering TSCA § 5(e) Exposure-Based Consent Orders No access
- Figure Vll-3: Recommended TSCA § 5(e) Exposure-Based Policy: Testing No access
- Figure Vll-4: EPA'S Schedule To Develop Non-Expedited Section 5(e) Consent Orders No access
- 8.1.1. Microorganisms as Chemical Substances No access
- 8.1.2. PMN Reporting No access
- 8.1.3. Substantial Risk Information/TSCA § 8(e) Reporting No access
- 8.2.1. Regulated Microorganisms No access
- 8.2.2. Prenotice Consultations and Bona Fide Submissions No access
- 8.2.3.1. MCAN Submission No access
- 8.2.3.2.1. Test Marketing Exemption No access
- 8.2.3.2.2. Tier I and Tier II Exemptions No access
- 8.2.3.2.3. MCAN Submission Statement No access
- 8.2.3.2.4. EPA Review of MCAN Submissions No access
- 8.2.4.1. Research Conducted in a Contained Structure No access
- 8.2.4.2. Research Under Other Federal Agency Jurisdiction No access
- 8.2.4.3. Specific Microorganisms No access
- 8.2.4.4. TSCA Experimental Release Application No access
- 8.2.5. Confidential Business Information No access
- 8.2.6. Federal Register Publication No access
- 8.2.7. Microorganisms Subject to Significant New Use Rules No access
- 8.2.8. Compliance and Enforcement No access
- 8.2.9. TSCA § 8(e) Reporting No access
- 8.3.1. Interplay between TSCA and FIFRA No access
- 8.3.2. Interplay between EPA under TSCA, and the USDA No access
- 8.3.3. Interplay with International Standards No access
- 8.4. Conclusion - MCAN And TERA Submission Summary No access
- Table VIII-I: Agency Authority Over Biotechnology Products No access
- 9.1.1. Interagency Testing Committee No access
- 9.1.2. Master Testing List No access
- 9.1.3. EPA Program Offices No access
- 9.1.4. Other Federal Agencies No access
- 9.2.1.1. Risk Assessment No access
- 9.2.1.2. Insufficiency of Data No access
- 9.2.1.3. Necessity of Testing No access
- 9.2.2. TSCA § 4(a)(1)(B): Exposure Trigger No access
- 9.2.3. Elements of a TSCA § 4 Test Rule No access
- 9.3.1.1. Acute Toxicity No access
- 9.3.1.2. Subchronic No access
- 9.3.1.3. Chronic No access
- 9.3.1.4. Oncogenicity No access
- 9.3.1.5. Reproduction No access
- 9.3.1.6. Developmental Toxicity No access
- 9.3.1.7. Mutagenicity Assays No access
- 9.3.1.8. Neurotoxicity No access
- 9.3.2. Environmental Effects No access
- 9.3.3. Chemical Fate No access
- 9.3.4. Multi-Chemical End-Point Testing No access
- 9.4. Good Laboratory Practice Standards No access
- 9.5. Consent Agreements No access
- 9.6.1. Letters of Intent No access
- 9.6.2. Small Quantity Manufacturers No access
- 9.6.3. Study Plans No access
- 9.6.4. Test Standards No access
- 9.6.5. Enforcement No access
- 9.7. Exemptions From Testing No access
- 9.8.1. Reimbursement by Processors No access
- 9.8.2. Section 8(a) Reporting Requirements and Reimbursement No access
- 9.8.3. Multiple Testing No access
- 9.8.4. Enforcement of Reimbursement Orders No access
- 9.9.1. The Organization No access
- 9.9.2. Organizing and Administering No access
- 9.9.3. Cost Sharing No access
- 9.9.4. The Test Substance No access
- 9.10.1. Jurisdiction, Standing and Venue No access
- 9.10.2. The Rule-Making Record No access
- 9.10.3. Standard of Review No access
- 9.11.1. Criteria for Risk No access
- 9.11.2. Significant Risk of Serious Harm No access
- 9.11.3. Significant Risk of Widespread Harm No access
- 9.11.4. Review Period No access
- 9.12.1. High Production Volume (HPV) Chemicals No access
- 9.12.2. The Voluntary Information Submission Innovative Online Network (VISION) No access
- 9.12.3. The Voluntary Children's Chemical Evaluation Program (VCCEP) No access
- 10.1.1.1. Who Must Report No access
- 10.1.1.2. Filling Out the Form No access
- 10.1.1.3. Certification by Respondent No access
- 10.1.1.4. Chemical Identity No access
- 10.1.1.5. Preliminary Assessment Information - Plant Site Activities No access
- 10.1.1.6.Quantity in Commercial Distribution No access
- 10.1.2. The Comprehensive Assessment Information Rule (CAIR) No access
- 10.1.3. Inventory Update Rule No access
- 10.2.1. Persons Subject to the Rule No access
- 10.2.2.1. Human Health Reactions No access
- 10.2.2.2. Environmental Reactions No access
- 10.2.3. "Allegations" Trigger Recording Obligations No access
- 10.2.4. Record-Keeping Requirements No access
- 10.3.1.1. Who Must Report No access
- 10.3.1.2. What Must be Reported No access
- 10.3.1.3. Health and Safety Study No access
- 10.3.1.4. Exemptions From Reporting No access
- 10.3.1.5. File Searches No access
- 10.3.1.6. Submission of Copies of Studies No access
- 10.3.1.7. Submission of Lists of Studies No access
- 10.3.1.8. Confidentiality Claims No access
- 10.3.1.9. EPA Requests for Further Information No access
- 10.4.1. 1991 Compliance Audit Program No access
- 10.4.2. Who Must Report No access
- 10.4.3.1. Human Health Effects No access
- 10.4.3.2. Exposure Factors No access
- 10.4.3.3. Acute Toxicity Data No access
- 10.4.3.4. Subchronic Toxicity Data No access
- 10.4.3.5. Neurotoxic Effects No access
- 10.4.3.6. Skin/Eye Irritation and Skin Sensitization Tests No access
- 10.4.3.7. Non-Emergency Contamination and Environmental Effects No access
- 10.4.3.8. Emergency Incidents of Environmental Contamination No access
- 10.4.4. Information Not Reportable Under Section 8(e) No access
- 10.4.5.1. Designed, Controlled Studies No access
- 10.4.5.2. Undesigned, Uncontrolled Circumstances No access
- 10.4.6. Submission of Section 8(e) Information by Trade Associations No access
- 10.4.7. FYI Submissions versus Section 8(e) Submissions No access
- 10.4.8. When to Submit Section 8(e) Reports No access
- 10.4.9. How to Make a TSCA § 8(e) Report No access
- 10.4.10. Confidentiality Claims and Section 8(e) Reports No access
- 10.5.1.1. Section 8(a) No access
- 10.5.1.2. Sections 8(c) and 8(e) No access
- 10.5.1.3. Section 8(d) No access
- 11.1. EPA'S Authority Under Section 6(a) No access
- 11.2. Procedures And Standards No access
- 11.3.1. Chlorofluorocarbons No access
- 11.3.2. Tetrachlorodibenzo-P Dioxin (TCDD) No access
- 11.3.3. Metalworking Fluids No access
- 11.3.4.1. Asbestos in Schools No access
- 11.3.4.2. Asbestos Abatement Projects No access
- 11.3.4.3. Asbestos Product Ban No access
- 11.3.5. Hexavalent Chromium No access
- 11.3.6. Lead- and Zinc-Containing Fishing Sinkers No access
- 11.4.1. TSCA § 6(e) Authority No access
- 11.4.2.1. 50 ppm PCB Standard No access
- 11.4.2.2. Prohibited and Authorized Commercial Activities No access
- 11.4.2.3. Marking of PCBs and PCB Items No access
- 11.4.2.4. Disposal Requirements No access
- 11.4.2.5. Import for Disposal No access
- 11.4.2.6. Storage for Disposal No access
- 11.4.2.7. PCB Activity Notification and Manifesting Rule No access
- 11.4.2.8. Records and Reports No access
- 11.4.2.9. PCB Spill Cleanup Policy No access
- 11.4.2.10. Decontamination of PCB Waste No access
- Figure XI-1: Permitted Disposal Methods No access
- 12.1.1.1. Importer Defined No access
- 12.1.1.2. Product Coverage No access
- 12.1.1.3. Importation of Wastes No access
- 12.1.1.4. Unsolicited Samples No access
- 12.1.1.5. Exclusions No access
- 12.1.1.6. Certification Content No access
- 12.1.1.7. Blanket Certification Procedures No access
- 12.1.1.8. Blanket Certification Content No access
- 12.1.2. Chemicals Imported as Part of an Article No access
- 12.1.3. Customs Detention of Shipments No access
- 12.1.4. Procedures After Detention No access
- 12.2.1.1. New Chemicals No access
- 12.2.1.2. Mixtures and Testing No access
- 12.2.1.3. Confidentiality No access
- 13.1.1.1. End-Use Products and Technical or Manufacturing-Use Products No access
- 13.1.1.2. Raw Materials, Inert Ingredients, and Intermediates No access
- 13.1.1.3. R&D Candidate Pesticides No access
- 13.1.1.4. Pesticides Which Are "Disposed" No access
- 1 3.1.1.5. Biocides Are Treated Similar to Pesticides No access
- 13.1.2. Federal Food, Drug. and Cosmetic Act (FFDCA) No access
- 13.2.1. Laws Not Administered by EPA No access
- 13.2.2. Coordination With Other Agencies No access
- 13.2.3. Other Laws Administered by EPA No access
- 13.3. TSCA Preemption Of State And Local Laws No access
- 14.1. The Role of EPA Headquarters And Regional Offices No access
- 14.2.1. EPA's Authority to Inspect No access
- 14.2.2. Permissible Scope of an Inspection No access
- 14.2.3. Consent No access
- 14.2.4. Administrative Search Warrants No access
- 14.2.5. EPA Warrant Practices No access
- 14.2.6. Types of Inspections No access
- 14.2.7. Preparing for TSCA Inspections and Protecting CBI No access
- 14.2.8.1. Entry and Documentation No access
- 14.2.8.2. Opening Conference No access
- 14.2.8.3. Tour of Facility, Sampling, and Document Review No access
- 14.2.8.4. Closing Conference No access
- 14.2.8.5. Company Memorandum of Inspection No access
- 14.2.8.6. EPA Follow-up to an Inspection No access
- 14.3.1.Alyeska Decision No access
- 14.3.2. Judicial Review of EPA Subpoena No access
- 14.3.3. New River Subpoenas No access
- 14.4. Unlawful Acts No access
- 14.5.1. Statutory Authority No access
- 14.5.2.1. Culpability No access
- 14.5.2.2. History of Prior TSCA Violations No access
- 14.5.2.3. Government Clean-up Costs No access
- 14.5.2.4. Gains from Noncompliance No access
- 14.5.2.5. Ability to Pay and Ability to Continue in Business No access
- 14.5.2.6. "Other Matters as Justice May Require" No access
- 14.5.3. TSCA Section 4 Enforcement Response Policy No access
- 14.5.4. TSCA Section 5 Enforcement Response Policy No access
- 14.5.5. TSCA Sections 8, 12, and 13 Enforcement Response Policy No access
- 14.5.6.1. Incentives to Audit Offered under the Policy No access
- 14.5.6.2. Criteria for Eligibility No access
- 14.5.6.3. Voluntary Auditing Issues No access
- 14.6. Injunctive Authority And Seizure Actions No access
- 14.7.1. The Complaint No access
- 14.7.2. The Answer No access
- 14.7.3. Settlement Conference No access
- 14.7.4. Motion for Accelerated Decision No access
- 14.7.5. Pre-Hearing Exchange No access
- 14.7.6. The Hearing No access
- 14.7.7. Administrative Appeals No access
- 14.7.8. Judicial Review No access
- 14.8. Fair Notice/Warning No access
- 14.9. Statute Of Limitations For Civil Penalties No access
- 14.10.1. Settlement Discussions No access
- 14.10.2. The Consent Agreement and Consent Order No access
- 14.10.3. Supplemental Environmental Projects No access
- 14.10.4. Approval of Settlement No access
- 14.11.1.1. The Knowledge Requirement No access
- 14.11.1.2. Liability of Corporation for Acts of its Employees and Employee Liability No access
- 14.11.2. The False Statements Act No access
- 14.11.3.1. Criminal Enforcement Priorities No access
- 14.11.3.2. EPA Procedures for a Criminal Investigation No access
- 14.12. Section 20 Citizens' Suits No access
- 14.13.1. Statutory Authority No access
- 14.13.2. Legal Standard for Review No access
- 14.13.3. Guidance for Preparing Citizens' Petitions No access
- 15.1.1. Why Institute a Compliance Program? No access
- 15.1.2. Elements of a TSCA Compliance Program No access
- 15.2.1. Incentives to Audit Offered under the Policy No access
- 15.2.2. Criteria for Eligibility No access
- 15.3. Audits Under A Voluntary Agreement No access
- 15.4. Audits Under A Consent Agreement No access
- 15.5.1. TSCA § 5 Audit Procedures No access
- 15.5.2. TSCA § 8(c) Audit Procedures No access
- 15.6.1. The Attorney-Client Privilege No access
- 15.6.2. The Attorney Work-Product Doctrine No access
- 15.6.3. SEC's Disclosure Requirements No access
- Text of TSCA No access Pages 353 - 420
- List of Acronyms No access Pages 421 - 424
- Index No access Pages 425 - 435





