TSCA Handbook

Name: TSCA Handbook
Brand: Government Institutes
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McKenna Long & Aldridge, LLP(Autor*in)

Government Institutes (Verlag)

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Erschienen am 1. November 2005

464 Seiten

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Inhalt

Cover
Title Page
Copyright Page
Acknowledgments
Preface
Table of Contents
Chapter 1: TSCA Overview
1.1. Introduction
1.1.1. Legislative Background
1.1.2. Legislative Goals
1.2. Principal Provisions of TSCA
1.2.1. TSCA § 4-Testing
1.2.2. TSCA § 5-Premanufacture Notification
1.2.3. TSCA § 6-Regulation of Existing Chemicals
1.2.4. TSCA § 6(e)-PCB Regulation
1.2.5. TSCA § 8-Recordkeeping and Reporting
1.2.6. TSCA §§ 11, 15, 16 and 17-Enforcement
1.3. TSCA Amendments-Titles II, III And IV
1.4. EPA'S Implementation of TSCA
Chapter 2: Administration of Epa's Toxic Substances Program
2.1. Office of Pollution Prevention And Toxics
2.1.1. Chemical Control Division
2.1.2. Risk Assessment Division
2.1.3. Economics. Exposure and Technology Division
2.1.4. National Program Chemicals Division
2.1.5. Information Management Division
2.1.6. Pollution Prevention Division
2.1.7. Environmental Assistance Division
2.1.8. TSCA Interagency Testing Committee
2.2. Office Of General Counsel
2.3. Office Of Enforcement And Compliance Assurance
Figure II-1: U.S. Environmental Protection Agency
Figure II-2: Office of Prevention, Pesticides Toxic Substances
Figure II-3: Office of Pollution Prevention And Toxics
Figure II-4: Office of Enforcement And Compliance Assurance
Figure II-5: Telephone List For EPA Offices Related To TSCA
Figure II-6: Contact Information For The Oppt New Chemicals Program
Chapter 3: Activities Subject To TSCA
3.1. "Manufacture
3.1.1. Manufacture "for Commercial Purposes
3.1.2. "Extraction" as "Manufacturing
3.1.3. Toll Manufacturers
3.2. "Process
3.2.1. "Processing" Versus "Use
3.2.2. "Processing" as Defined in TSCA Rules
3.2.3. Toll Processors
3.3. "Distribute
3.4. "Use
3.4.1. SNURs
3.5. "Dispose
3.5.1. TCDD Disposal Regulations
3.5.2. PCB Regulations
3.5.3. Section 5(e) Consent Orders
Chapter 4: The TSCA Inventory
4.1.Initial Compilation of The Inventory
4.1.1. "Chemical Substance
4.1.2. Manufactured or Imported for a "Commercial Purpose
4.1.3. Specifically Excluded Substances
4.1.3.1. Small Quantities for Research and Development
4.1.3.2. Impurities
4.1.3.3. By-products
4.1.3.4. Chemicals Produced from Incidental Reactions
4.1.3.5. Non-Isolated Intermediates
4.2. How Substances Were Reported
4.2.1. Information Reported
4.2.2. Special Reporting Problems
4.2.2.1. Mixtures
4.2.2.2. Polymers
4.2.2.3. Pesticides
4.2.2.4. Articles
4.2.2.5. Quality Control Chemicals
4.3. Correcting An Inventory Submission
4.4. Maintaining And Updating The Inventory Data Base
4.4.1. Inventory Update Rule
4.4.2. Special Reporting Problems
4.4.3. IURA Litigation
4.4.4. Proposed IURA Revision
4.5. How To Use The Inventory
4.5.1. Volume I: TSCA Inventory
4.5.2. Volumes II and III: Substance Name Index
4.5.3. Volume IV: Molecular Formula Index
4.5.4. Volume V: UVCB Index. Section 4 Rule Index, Section 5(e) Order/Sections 5(f)/6(a) Rule Index and Significant New Use Rules (SNUR) Index
4.5.4.1. UVCB Index
4.5.4.2. Section 4 Index, Sections 5(e). 5(f) Index, Significant New Use Rules Index
4.6. Searching The Inventory
4.6.1. Inventory Search Assistance
4.6.2. Searches for Confidential Identities: Bona fide Requests
4.6.3. Bona fide Requests and IUR Reports
Chapter 5: New Chemical Review: Overview And Exemptions
5.1. Overview of TSCA § 5
5.2. PMN Requirements
5.2.1.PMN Review Period
5.2.2. EPA Regulation of PMN Substances
5.3. Exclusions From PMN Requirements
5.4. PMN Exemptions That Require EPA Approval
5.4.1. Test Market Exemption
5.4.2. Low Volume Exemption
5.4.2.1. LVE Review
5.4.2.2. LVE Revocation
5.4.2.3. Customer Notification
5.4.3. LoREX Exemption
5.5. PMN Exemptions That Do Not Require Epa Approval
5.5.1. Research and Development Exemption
5.5.1.1. Meaning of R&D
5.5.1.2. Sale of R&D Chemicals
5.5.1.3. Use and Disposal of Residual R&D Substances
5.5.1.4. Small Quantities
5.5.1.5. Technically Qualified Individual
5.5.1.6. Evaluation, Notification, and Record-Keeping of Risks
5.5.1.7. R&D Pesticides
5.5.2. Polymer Exemption
5.5.2.1. Polymer Definition
5.5.2.2. Ineligible Polymers
5.5.2.3. General Exemption Criteria
5.5.2.4. Exemption Report
5.5.2.5. Record-Keeping
5.5.3. "Polaroid" Exemption
5.5.4. New Chemicals Imported As Part of An Article
5.5.5. Impurities, By-products, and Non-Isolated Intermediates
5.5.6. Chemicals Formed Incidental to Exposure to Other Chemicals
5.5.7. Chemicals Formed During the Manufacture of an Article
5.5.8. Chemicals Formed Incidental to the Use of Certain Additives
5.5.8.1. Polymer Salts
Chapter 6: Preparing The PMN And Seeing It Through EPA
6.1. Determining The Type of PMN
6.1.1. Full PMN
6.1.2. Consolidated PMNs
6.1.3. Joint Submissions
6.1.4. Special Cases: LVE and LoREX Exemption
6.2. Completing The PMN Form
6.2.1. The Submitter's Basic Obligations
6.2.2. PMN Processing Fees
6.2.3. Premarket Data Requirements
6.2.3.1. Agricultural Screening Data
6.2.3.2. All Other Data
6.2.3.3. New Data During Review Period
6.2.4. Practical Tips
6.3. PMN Form Part I: General Information
6.3.1.Submitter Identification-Section A
6.3.1.1. Agents
6.3.1.2. Technical Contact
6.3.1.3. Previous Communications with EPA
6.3.2. Chemical Identity-Section B
6.3.2.1. Class 1 Substances
6.3.2.2. Class 2 Substances
6.3.2.3. Polymers
6.3.2.4. Impurities and By-products
6.3.2.5. Generic Name
6.3.2.6. Synonyms, Trade Identification
6.3.3. Production. Use. and Import Information-Section C.
6.3.3.1. Production Volume
6.3.3.2. Use
6.3.3.3. Hazard Information
6.4. PMN Form Part II: Human Exposure And Environmental Release
6.4.1. Industrial Sites Controlled by the Submitter-Section A
6.4.2. Industrial Sites Controlled by Others-Section B
6.4.3. Pollution Prevention Information (Optional)
6.5. PMN Form Part III: List Of Attachments
6.6. Protecting Confidential Business Information
6.6.1. EPA's Handling of CBI
6.6.2. Asserting CBI in a PMN
6.7. EPA'S Review Procedures For The PMN
6.7.1. Filing and Receiving the PMN
6.7.2. Initial Review
6.7.2.1. Chemical Review (CR) Meeting
6.7.2.2. Structure-Activity Team (SAT) Meeting
6.7.2.3. Profile of Exposure and Release
6.7.2.4. Focus Meeting
6.7.3. Standard Review
6.7.3.1. Workplan Meeting
6.7.3.2. Risk Assessment Disposition
6.7.3.3. Decision Meeting
6.7.4. Submitters' Post Review Duties
6.7.4.1. Notice of Commencement of Manufacture
6.7.4.2. Record-Keeping
Figure VI-I EPA PMN Review Process
Chapter 7: Regulation of New Chemicals And Uses
7.1. EPA Regulation under TSCA $ 5(e)
7.1.1.EPA1s Standard Section 5(e) Consent Order
7.1.2. EPA Evaluation of Section 5(e) Data
7.1.2.1. Invalid Data
7.1.2.2. Equivocal Data
7.1.2.3. Valid, Unequivocal Data
7.1.3. Problems of Section 5(e) Consent Orders
7.1.3.1. Potentially Infinite Duration
7.1.3.2. No Automatic Revocation
7.1.3.3. Anticompetitive Effects
7.1.4. Exposure Controls versus Data Development
7.2. Negotiating Section 5(e) Consent Orders
7.2.1. Intra-Agency Process
7.2.2. Expediting the Process
7.3. Challenges Under Section 5(e) Consent Orders
7.3.1. Petitions under TSCA § 21
7.3.2. Petitions under the Consent Order
7.3.3. Review under the Administrative Procedure Act (APA)
7.4. Unilateral Section 5(e) Orders
7.4.1. Statutory Standard for Unilateral Section 5(e) Orders
7.4.2. Objecting to Unilateral Section 5(e) Orders
7.5. EPA Regulation Under TSCA § 5(f)
7.5.1. Proposed Section 5(f) Rules
7.5.2. Proposed Section 5(f) Orders
7.6. Significant New Use Rules (SNURS)
7.6.1. SNUR Standard
7.6.2. Who Must Report
7.6.3. Determining Inventory Status
7.6.4. Use of SNURs to Support Section 5(e) Consent Orders
7.6.5. Generic SNUR Rule
7.6.5.1. Summary of the Generic SNUR Rule
7.6.5.2. Standardized Significant New Uses
7.6.6. Expedited SNURs for New Chemical Substances Subject to Section 5(e) Orders
7.6.7. Expedited SNURs for New Chemical Substances Not Subject to Section 5(e) Orders
7.6.7.1. Concern Criteria
7.6.7.2. Procedures for Issuing Non-5(e) SNURs
7.6.8. Record-Keeping Requirements
7.6.9. Procedures for Limitation or Revocation of Expedited SNURs
Figure VII-1: Categories Of Chemicals Likely To Be Subject To A Section 5(e) Order
Figure Vll-2: Criteria Triggering TSCA § 5(e) Exposure-Based Consent Orders
Figure Vll-3: Recommended TSCA § 5(e) Exposure-Based Policy: Testing
Figure Vll-4: EPA'S Schedule To Develop Non-Expedited Section 5(e) Consent Orders
Chapter 8: Biotechnology
8.1. 1986 Framework For Regulation Of Biotechnology
8.1.1. Microorganisms as Chemical Substances
8.1.2. PMN Reporting
8.1.3. Substantial Risk Information/TSCA § 8(e) Reporting
8.2. The 1997 Biotechnology Rule
8.2.1. Regulated Microorganisms
8.2.2. Prenotice Consultations and Bona Fide Submissions
8.2.3. Premanufacture Review of Microorganisms Intended for General Commercial Use
8.2.3.1. MCAN Submission
8.2.3.2. General Commercial Exemptions
8.2.3.2.1. Test Marketing Exemption
8.2.3.2.2. Tier I and Tier II Exemptions
8.2.3.2.3. MCAN Submission Statement
8.2.3.2.4. EPA Review of MCAN Submissions
8.2.4. Research and Development
8.2.4.1. Research Conducted in a Contained Structure
8.2.4.2. Research Under Other Federal Agency Jurisdiction
8.2.4.3. Specific Microorganisms
8.2.4.4. TSCA Experimental Release Application
8.2.5. Confidential Business Information
8.2.6. Federal Register Publication
8.2.7. Microorganisms Subject to Significant New Use Rules
8.2.8. Compliance and Enforcement
8.2.9. TSCA § 8(e) Reporting
8.3. Overlap With Other Statutes
8.3.1. Interplay between TSCA and FIFRA
8.3.2. Interplay between EPA under TSCA, and the USDA
8.3.3. Interplay with International Standards
8.4. Conclusion - MCAN And TERA Submission Summary
Table VIII-I: Agency Authority Over Biotechnology Products
Chapter 9: Testing Under TSCA
9.1.Candlda Te Chemicals
9.1.1. Interagency Testing Committee
9.1.2. Master Testing List
9.1.3. EPA Program Offices
9.1.4. Other Federal Agencies
9.2. Testing Triggers
9.2.1. TSCA § 4(a)(1)(A): Risk Trigger
9.2.1.1. Risk Assessment
9.2.1.2. Insufficiency of Data
9.2.1.3. Necessity of Testing
9.2.2. TSCA § 4(a)(1)(B): Exposure Trigger
9.2.3. Elements of a TSCA § 4 Test Rule
9.3. Studies Required Under TSCA § 4
9.3.1. Health Effects
9.3.1.1. Acute Toxicity
9.3.1.2. Subchronic
9.3.1.3. Chronic
9.3.1.4. Oncogenicity
9.3.1.5. Reproduction
9.3.1.6. Developmental Toxicity
9.3.1.7. Mutagenicity Assays
9.3.1.8. Neurotoxicity
9.3.2. Environmental Effects
9.3.3. Chemical Fate
9.3.4. Multi-Chemical End-Point Testing
9.4. Good Laboratory Practice Standards
9.5. Consent Agreements
9.6. Implementing And Enforcing Test Rules
9.6.1. Letters of Intent
9.6.2. Small Quantity Manufacturers
9.6.3. Study Plans
9.6.4. Test Standards
9.6.5. Enforcement
9.7. Exemptions From Testing
9.8. Reimbursement Procedures
9.8.1. Reimbursement by Processors
9.8.2. Section 8(a) Reporting Requirements and Reimbursement
9.8.3. Multiple Testing
9.8.4. Enforcement of Reimbursement Orders
9.9. Joint Data Development
9.9.1. The Organization
9.9.2. Organizing and Administering
9.9.3. Cost Sharing
9.9.4. The Test Substance
9.10. Judicial Review
9.10.1. Jurisdiction, Standing and Venue
9.10.2. The Rule-Making Record
9.10.3. Standard of Review
9.11. TSCA § 4(f) Findings of Significant Risk
9.11.1. Criteria for Risk
9.11.2. Significant Risk of Serious Harm
9.11.3. Significant Risk of Widespread Harm
9.11.4. Review Period
9.12. Voluntary Testing Initiatives
9.12.1. High Production Volume (HPV) Chemicals
9.12.2. The Voluntary Information Submission Innovative Online Network (VISION)
9.12.3. The Voluntary Children's Chemical Evaluation Program (VCCEP)
Chapter 10: Reporting And Retention of Information
10.1. TSCA § 8(a): Reports
10.1.1. The Preliminary Assessment Information Rule (PAIR)
10.1.1.1. Who Must Report
10.1.1.2. Filling Out the Form
10.1.1.3. Certification by Respondent
10.1.1.4. Chemical Identity
10.1.1.5. Preliminary Assessment Information - Plant Site Activities
10.1.1.6.Quantity in Commercial Distribution
10.1.2. The Comprehensive Assessment Information Rule (CAIR)
10.1.3. Inventory Update Rule
10.2. TSCA § 8(c): Records Of Significant Adverse Reactions
10.2.1. Persons Subject to the Rule
10.2.2. What Constitutes a Significant Adverse Reaction
10.2.2.1. Human Health Reactions
10.2.2.2. Environmental Reactions
10.2.3. "Allegations" Trigger Recording Obligations
10.2.4. Record-Keeping Requirements
10.3. TSCA § 8(d): Health And Safety Studies
10.3.1. Model Reporting Rule
10.3.1.1. Who Must Report
10.3.1.2. What Must be Reported
10.3.1.3. Health and Safety Study
10.3.1.4. Exemptions From Reporting
10.3.1.5. File Searches
10.3.1.6. Submission of Copies of Studies
10.3.1.7. Submission of Lists of Studies
10.3.1.8. Confidentiality Claims
10.3.1.9. EPA Requests for Further Information
10.4. Section 8(e): Substantial Risk Information
10.4.1. 1991 Compliance Audit Program
10.4.2. Who Must Report
10.4.3. What Constitutes Substantial Risk Information
10.4.3.1. Human Health Effects
10.4.3.2. Exposure Factors
10.4.3.3. Acute Toxicity Data
10.4.3.4. Subchronic Toxicity Data
10.4.3.5. Neurotoxic Effects
10.4.3.6. Skin/Eye Irritation and Skin Sensitization Tests
10.4.3.7. Non-Emergency Contamination and Environmental Effects
10.4.3.8. Emergency Incidents of Environmental Contamination
10.4.4. Information Not Reportable Under Section 8(e)
10.4.5. Nature and Sources of Section 8(e) Information
10.4.5.1. Designed, Controlled Studies
10.4.5.2. Undesigned, Uncontrolled Circumstances
10.4.6. Submission of Section 8(e) Information by Trade Associations
10.4.7. FYI Submissions versus Section 8(e) Submissions
10.4.8. When to Submit Section 8(e) Reports
10.4.9. How to Make a TSCA § 8(e) Report
10.4.10. Confidentiality Claims and Section 8(e) Reports
10.5. Developing A Reporting And Retention Program
10.5.1. Specific Compliance Suggestions
10.5.1.1. Section 8(a)
10.5.1.2. Sections 8(c) and 8(e)
10.5.1.3. Section 8(d)
Chapter 11: Existing Chemical Regulation
11.1. EPA'S Authority Under Section 6(a)
11.2. Procedures And Standards
11.3. Section 6(a) Regulations
11.3.1. Chlorofluorocarbons
11.3.2. Tetrachlorodibenzo-P Dioxin (TCDD)
11.3.3. Metalworking Fluids
11.3.4. Asbestos
11.3.4.1. Asbestos in Schools
11.3.4.2. Asbestos Abatement Projects
11.3.4.3. Asbestos Product Ban
11.3.5. Hexavalent Chromium
11.3.6. Lead- and Zinc-Containing Fishing Sinkers
11.4. TSCA § 6(e): Polychlorinated Biphenyls (PCBs)
11.4.1. TSCA § 6(e) Authority
11.4.2. EPA Regulation of PCBs
11.4.2.1. 50 ppm PCB Standard
11.4.2.2. Prohibited and Authorized Commercial Activities
11.4.2.3. Marking of PCBs and PCB Items
11.4.2.4. Disposal Requirements
11.4.2.5. Import for Disposal
11.4.2.6. Storage for Disposal
11.4.2.7. PCB Activity Notification and Manifesting Rule
11.4.2.8. Records and Reports
11.4.2.9. PCB Spill Cleanup Policy
11.4.2.10. Decontamination of PCB Waste
Figure XI-1: Permitted Disposal Methods
Chapter 12: Importation And Exportation
12.1. Import Regulation: TSCA § 13
12.1.1. Importer's Certification Requirement
12.1.1.1. Importer Defined
12.1.1.2. Product Coverage
12.1.1.3. Importation of Wastes
12.1.1.4. Unsolicited Samples
12.1.1.5. Exclusions
12.1.1.6. Certification Content
12.1.1.7. Blanket Certification Procedures
12.1.1.8. Blanket Certification Content
12.1.2. Chemicals Imported as Part of an Article
12.1.3. Customs Detention of Shipments
12.1.4. Procedures After Detention
12.2. Export Regulation: TSCA 9 12
12.2.1. Exporter's Notification Requirement
12.2.1.1. New Chemicals
12.2.1.2. Mixtures and Testing
12.2.1.3. Confidentiality
Chapter 13: Relationship Between TSCA And Other Laws
13.1. Tsca's Exclusion for Substances Regulated Under FIFRA And FFDCA
13.1.1. Federal Insecticide, Fungicide, and Rodenticide Act(FIFRA)
13.1.1.1. End-Use Products and Technical or Manufacturing-Use Products
13.1.1.2. Raw Materials, Inert Ingredients, and Intermediates
13.1.1.3. R&D Candidate Pesticides
13.1.1.4. Pesticides Which Are "Disposed
1 3.1.1.5. Biocides Are Treated Similar to Pesticides
13.1.2. Federal Food, Drug. and Cosmetic Act (FFDCA)
13.2. TSCA'S Relationship To Other Federal Laws
13.2.1. Laws Not Administered by EPA
13.2.2. Coordination With Other Agencies
13.2.3. Other Laws Administered by EPA
13.3. TSCA Preemption Of State And Local Laws
Chapter 14: TSCA Inspections And Enforcement
14.1. The Role of EPA Headquarters And Regional Offices
14.2. TSCA Inspections
14.2.1. EPA's Authority to Inspect
14.2.2. Permissible Scope of an Inspection
14.2.3. Consent
14.2.4. Administrative Search Warrants
14.2.5. EPA Warrant Practices
14.2.6. Types of Inspections
14.2.7. Preparing for TSCA Inspections and Protecting CBI
14.2.8. The Inspection
14.2.8.1. Entry and Documentation
14.2.8.2. Opening Conference
14.2.8.3. Tour of Facility, Sampling, and Document Review
14.2.8.4. Closing Conference
14.2.8.5. Company Memorandum of Inspection
14.2.8.6. EPA Follow-up to an Inspection
14.3. EPA'S Authority To Issue Subpoenas
14.3.1.Alyeska Decision
14.3.2. Judicial Review of EPA Subpoena
14.3.3. New River Subpoenas
14.4. Unlawful Acts
14.5. Civil Penal Ties
14.5.1. Statutory Authority
14.5.2. TSCA Civil Penalty Policy
14.5.2.1. Culpability
14.5.2.2. History of Prior TSCA Violations
14.5.2.3. Government Clean-up Costs
14.5.2.4. Gains from Noncompliance
14.5.2.5. Ability to Pay and Ability to Continue in Business
14.5.2.6. "Other Matters as Justice May Require
14.5.3. TSCA Section 4 Enforcement Response Policy
14.5.4. TSCA Section 5 Enforcement Response Policy
14.5.5. TSCA Sections 8, 12, and 13 Enforcement Response Policy
14.5.6. Audits and Compliance Management under EPA'S Self-Policing Policy
14.5.6.1. Incentives to Audit Offered under the Policy
14.5.6.2. Criteria for Eligibility
14.5.6.3. Voluntary Auditing Issues
14.6. Injunctive Authority And Seizure Actions
14.7. Administrative Hearing Procedures
14.7.1. The Complaint
14.7.2. The Answer
14.7.3. Settlement Conference
14.7.4. Motion for Accelerated Decision
14.7.5. Pre-Hearing Exchange
14.7.6. The Hearing
14.7.7. Administrative Appeals
14.7.8. Judicial Review
14.8. Fair Notice/Warning
14.9. Statute Of Limitations For Civil Penalties
14.10. Negotiated Settlements
14.10.1. Settlement Discussions
14.10.2. The Consent Agreement and Consent Order
14.10.3. Supplemental Environmental Projects
14.10.4. Approval of Settlement
14.11. Criminal Liability
14.11.1. TSCA § 16(b)
14.11.1.1. The Knowledge Requirement
14.11.1.2. Liability of Corporation for Acts of its Employees and Employee Liability
14.11.2. The False Statements Act
14.11.3. EPA Criminal Enforcement Policy
14.11.3.1. Criminal Enforcement Priorities
14.11.3.2. EPA Procedures for a Criminal Investigation
14.12. Section 20 Citizens' Suits
14.13. Citizens' Petitions Under TSCA § 21
14.13.1. Statutory Authority
14.13.2. Legal Standard for Review
14.13.3. Guidance for Preparing Citizens' Petitions
Chapter 15: Industry Compliance Programs And Internal Audits
15.1. Compliance Programs
15.1.1. Why Institute a Compliance Program?
15.1.2. Elements of a TSCA Compliance Program
15.2. Audits Under EPA'S Self-Policing Policy
15.2.1. Incentives to Audit Offered under the Policy
15.2.2. Criteria for Eligibility
15.3. Audits Under A Voluntary Agreement
15.4. Audits Under A Consent Agreement
15.5. Audit Procedures
15.5.1. TSCA § 5 Audit Procedures
15.5.2. TSCA § 8(c) Audit Procedures
15.6. Maintaining Confidentiality
15.6.1. The Attorney-Client Privilege
15.6.2. The Attorney Work-Product Doctrine
15.6.3. SEC's Disclosure Requirements
Text of TSCA
List of Acronyms
Index

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