Publications
- Bradyrhizobium japonicum TSCA Experimental Release Applications (TERA) for Field Trials: Fact Sheet
- Bradyrhizobium japonicum Strains: TSCA Experimental Release Applications (TERA) Approval (Fact Sheet) (March 1999)
- Commercialization of Sinorhizobium (Rhizobium) Meliloti, RMBPC-2 (fact sheet)
- Diversa Corporation's Submission of a Microbial Commercial Activity Notice (MCAN) for an Intergeneric Strain of Pseudomonas flourescens
- Federal Register: Microbial Products of Biotechnology; Final Regulation Under the Toxic Substances Control Act; Final Rule
Federal Register: Microbial Products of Biotechnology; Final Regulation Under the Toxic Substances Control Act; Final Rule [PDF] (337KB, 50 pages)
- Final Rule: Supplementary Documents
- Microbial Assessments (1996 Final)
- Acetobacter aceti Decision Document
Final Decision Document: TSCA Section 5(h)(4) Exemption for Acetobacter Aceti [PDF] (29KB, 12 pages)
- Acetobacter aceti Risk Assessment
Attachment 1 -- Final Risk Assessment of Acetobacter Aceti [PDF] (31KB, 13 pages)
- Saccaromyces cerevisiae Decision Document
Final Decision Document: TSCA Section 5(h)(4)Exemption for Saccharomyces Cerevisiae [PDF] (29KB, 12 pages)
- Saccaromyces cerevisiae Risk Assessment
Attachment 1 -- Final Risk Assessment of Saccharomyces Cerevisiae [PDF] (30KB, 13 pages)
- Clostridium acetobutylicum Decision Document
- Final Decision Document: TSCA Section 5(h)(4) Exemption for Clostridium Acetobutylicum [PDF] (30KB, 12 pages)
- Clostridium acetobutylicum Risk Assessment
Attachment 1 -- Final Risk Assessment of Clostridium Acetobutylicum [PDF] (40KB, 17 pages)
- Escherichia coli K12 Decision Document
Final Decision Document: TSCA Section 5(h)(4) Exemption for Escherichia Coli K-12 [PDF] (29KB, 12 pages)
- Escherichia coli K12 Risk Assessment
Attachment 1 -- Final Risk Assessment of Escherichia Coli K-12 Derivatives [PDF] (36KB, 16 pages)
- Bacillus licheniformis Decision Document
Final Decision Document: TSCA Section 5(h)(4) Exemption for Bacillus Licheniformis [PDF] (33KB, 13 pages)
- Bacillus licheniformis Risk Assessment
Attachment 1 -- Final Risk Assessment of Bacillus Licheniformis [PDF] (44KB, 20 pages)
- Aspergillus niger Decision Document
Final Decision Document: TSCA Section 5(h)(4) Exemption for Aspergillus Niger [PDF] (29KB, 12 pages)
- Aspergillus niger Risk Assessment
Attachment 1 -- Final Risk Assessment of Aspergillus Niger [PDF] (52KB, 24 pages)
- Aspergillus oryzae Decision Document
Final Decision Document: TSCA Section 5(h)(4) Exemption for Aspergillus Oryzae [PDF] (31KB, 13 pages)
- Aspergillus oryzae Risk Assessment
Attachment 1 -- Final Risk Assessment of Aspergillus Oryzae [PDF] (57KB, 26 pages)
- Penicillium roqueforti Decision Document
Final Decision Document: TSCA Section 5(h)(4) Exemption for Penicillium Roqueforti [PDF] (30KB, 13 pages)
- Penicillium roqueforti Risk Assessment
Attachment 1 -- Final Risk Assessment of Penicillium Roqueforti [PDF] (58KB, 26 pages)
- Bacillus subtilis Decision Document
Final Decision Document: TSCA Section 5(h)(4) Exemption for Bacillus Subtilis [PDF] (30KB, 13 pages)
- Bacillus subtilis Risk Assessment
Attachment 1 -- Final Risk Assessment of Bacillus Subtilis [PDF] (38KB, 17 pages)
- Saccaromyces uvarum Decision Document
Final Decision Document: TSCA Section 5(h)(4) Exemption for Saccharomyces Uvarum [PDF] (29KB, 12 pages)
- Saccaromyces uvarum Risk Assessment
Attachment 1 -- Final Risk Assessment of Saccharomyces Uvarum [PDF] (30KB, 13 pages)
- Acetobacter aceti Decision Document
- Microbial Commercial Activity Notices (MCANs) for transgenic E. coli from Third Wave Technologies
- Microbial Products of Biotechnology Final Regulation Under the Toxic Substances Control Act: A Summary of the Public's Comments and the Agency's Response
Microbial Products of Biotechnology Final Regulation Under the Toxic Substances Control Act: A Summary of the Public's Comments and the Agency's Response [PDF] (263KB, 122 pages)
- Microbial Products of Biotechnology: Final Regulations Under the Toxic Substances Control Act - Fact Sheet
Microbial Products of Biotechnology: Final Regulations Under the Toxic Substances Control Act - Fact Sheet [PDF] (12KB, 2 pages)
- Official Index to the Rulemaking Recording Microbial Products of Biotechnology [PDF] (818KB, 31 pages)
- Identification of Microorganisms Currently Listed on the TSCA Chemical Substance Inventory (1994) [PDF] (13KB, 7 pages)
- Information Collection Request
Information Collection Request Supporting Statement [PDF] (100KB, 40 pages)
- Microbial Products of Biotechnology: Final Rule (62 FR 17910) - Related Documents
- Notifications under TSCA Section 5
- Notifications, FY98 to Present
- Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (1997) (654KB, 71 pages)
- Pseudomonas fluorescens Microbial Commercial Activity Notice (MCAN) from Diversa Corporation
- Regulatory Impact Analysis for the Regulation of Microbial Products of Biotechnology under the Toxic Substances Control Act (TSCA)
- Executive Summary for the Regulatory
Imact Analysis
PDF version of Executive Summary for the Regulatory Imact Analysis
- Table of Contents
PDF version of Table of Contents
- Chapter I: Introduction
PDF version of Chapter I: Introduction
- Chapter II: The Regulated Community
PDF version of Chapter II: The Regulated Community
- Chapter III: Benefits of the
Final Rule
PDF version of Chapter III: Benefits of the Final Rule
- Chapter IV: Industry Costs
PDF version of Chapter IV: Industry Costs
- Chapter V: Government Costs
PDF version of Chapter V: Government Costs
- Chapter VI: Effects of the Final
Rule on Innovative Activity
PDF version of Chapter VI: Effects of the Final Rule on Innovative Activity
- Chapter VII: International Considerations
PDF version of Chapter VII: International Considerations
- Chapter VIII: Effects of the
Proposed Rule on Small Businesses
PDF version of Chapter VIII: Effects of the Proposed Rule on Small Businesses
- List of References
PDF version of List of References
- Appendix Cover
PDF version of Appendix Cover
- Appendix A: Results of ICF Biotechnology
Survey
PDF version of Appendix A: Results of ICF Biotechnology Survey
- Appendix B: Summary of Information
Collected From Telephone Conversations With Industry Representatives
and University Researchers
PDF version of Appendix B: Summary of Information Collected From Telephone Conversations With Industry Representatives and University Researchers
- Appendix C: Numbers of Submissions
PDF version of Appendix C: Numbers of Submissions
- Appendix D: Industry Cost Calculations
and Options/Sensitivity Analyses
PDF version of Appendix D: Industry Cost Calculations and Options/Sensitivity Analyses
- Appendix E: Confidential Business
Information
PDF version of Appendix E: Confidential Business Information
- Appendix F: Regulatory Costs
on a Per-Product Basis
PDF version of Appendix F: Regulatory Costs on a Per-Product Basis
- Appendix G: Development Costs
and Expected Returns
PDF version of Appendix G: Development Costs and Expected Returns
- Appendix H: Cost Memoranda for
Determining EPA Per Submission Reporting Costs and EPA's Review
Process
PDF version of Appendix H: Cost Memoranda for Determining EPA Per Submission Reporting Costs and EPA's Review Process
- Appendix I: International Regulation
of Genetically Modified Microorganisms
PDF version of Appendix I: International Regulation of Genetically Modified Microorganisms
- Executive Summary for the Regulatory
Imact Analysis
- Status Report, FY87-FY97: TSCA Biotechnology Submissions [PDF] (72KB, 31 pages)
- Status Report, FY87-FY97: TSCA Biotechnology Submissions [PDF] (66KB, 28 pages)
- Status Report: Biotechnology Premanufacture Notifications (PMNs): Status Reports for Fiscal Years 87-95 [PDF] (64KB, 23 pages)
- Status Report: Biotechnology Premanufacture Notifications (PMNs): Status Reports for Fiscal Years 87-95 [PDF] (62KB, 23 pages)
- Summary Information about Bacillus amyloliquefaciens strain MOL1350 and Bacillus lentus strain PL2958 Microbial Commercial Activity Notices (MCANs), submitted by Novo Nordisk Biochem North America, Inc.
- Text of Press Release for Microbial Products of Biotechnology: Biotechnology Final Rule (March 27, 1997)
- TSCA Environmental Release Application (TERA) for Bradyrhizobium japonicum (B. japonicum) (2000)
- TSCA Experimental Release Application Approved for Bradyrhizobium japonicum Strains (fact sheet) (1998)
- TSCA Environmental Release Application (TERA) for Pseudomonas putida (P. putida) (2000)
- TSCA Experimental Release Application Approved for Pseudomonas putida Strains (fact sheet) (1998)
- Two TSCA Environmental Release Applications (TERAs) for Bradyrhizobium japonicum (B. japonicum) (April 1999)
- Two TSCA Environmental Release Applications (TERAs) for Pseudomonas putida (P. Putida) (2001)