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Biotechnology 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
PDF version of Federal Register: Microbial Products of Biotechnology; Final Regulation Under the Toxic Substances Control Act; Final Rule (PDF) (50 pp, 337K)

Final Rule: Supplementary Documents

Microbial Assessments (1996 Final)

• Acetobacter aceti Decision Document
  PDF version of Final Decision Document: TSCA Section 5(h)(4) Exemption for Acetobacter aceti (PDF) (12 pp, 29K)

• Acetobacter aceti Risk Assessment
  PDF version of Final Risk Assessment of Acetobacter aceti (PDF) (13 pp, 31K)

• Saccaromyces cerevisiae Decision Document
  PDF version of Final Decision Document: TSCA Section 5(h)(4) Exemption for Saccharomyces cerevisiae (PDF) (12 pp, 29K)

• Saccaromyces cerevisiae Risk Assessment
  PDF version of Final Risk Assessment of Saccharomyces cerevisiae (PDF) (13 pp, 30K)

• Clostridium acetobutylicum Decision Document
  PDF version of Final Decision Document: TSCA Section 5(h)(4) Exemption for Clostridium acetobutylicum (PDF) (12 pp, 30K)

• Clostridium acetobutylicum Risk Assessment
  PDF version of Final Risk Assessment of Clostridium acetobutylicum (PDF) (17 pp, 40K)

• Escherichia coli K12 Decision Document
  PDF version of Final Decision Document: TSCA Section 5(h)(4) Exemption for Escherichia coli K-12 (PDF) (12 pp, 29K)

• Escherichia coli K12 Risk Assessment
  PDF version of Final Risk Assessment of Escherichia coli K-12 derivatives (PDF) (16 pp, 36K)

• Bacillus licheniformis Decision Document
  PDF version of Final Decision Document: TSCA Section 5(h)(4) Exemption for Bacillus licheniformis (PDF) (13 pp, 33K)

• Bacillus licheniformis Risk Assessment
  PDF version of Final Risk Assessment of Bacillus licheniformis (PDF) (20 pp, 44K)

• Aspergillus niger Decision Document
  PDF version of Final Decision Document: TSCA Section 5(h)(4) Exemption for Aspergillus niger (PDF) (12 pp, 29K)

• Aspergillus niger Risk Assessment
  PDF version of Final Risk Assessment of Aspergillus niger (PDF) (24 pp, 52K)

• Aspergillus oryzae Decision Document
  PDF version of Final Decision Document: TSCA Section 5(h)(4) Exemption for Aspergillus oryzae (PDF) (13 pp, 31K)

• Aspergillus oryzae Risk Assessment
  PDF version of Final Risk Assessment of Aspergillus oryzae (PDF) (26 pp, 57K)

• Penicillium roqueforti Decision Document
  PDF version of Final Decision Document: TSCA Section 5(h)(4) Exemption for Penicillium roqueforti (PDF) (13 pp, 30K)

• Penicillium roqueforti Risk Assessment
  PDF version of Final Risk Assessment of Penicillium roqueforti (PDF) (26 pp, 58K)

• Bacillus subtilis Decision Document
  PDF version of Final Decision Document: TSCA Section 5(h)(4) Exemption for Bacillus subtilis (PDF) (13 pp, 30K)

• Bacillus subtilis Risk Assessment
  PDF version of Final Risk Assessment of Bacillus subtilis (PDF) (17 pp, 38K)

• Saccaromyces uvarum Decision Document
  PDF version of Final Decision Document: TSCA Section 5(h)(4) Exemption for Saccharomyces uvarum (PDF) (12 pp, 29K)

• Saccaromyces uvarum Risk Assessment
  PDF version of Final Risk Assessment of Saccharomyces uvarum (PDF) (13 pp, 30K)

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
PDF version of 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) (122 pp, 263K)

Microbial Products of Biotechnology: Final Regulations Under the Toxic Substances Control Act - Fact Sheet
PDF version of Microbial Products of Biotechnology: Final Regulations Under the Toxic Substances Control Act - Fact Sheet (PDF) (2 pp, 12K)

Official Index to the Rulemaking Recording Microbial Products of Biotechnology (PDF) (31 pp, 818K)

Identification of Microorganisms Currently Listed on the TSCA Chemical Substance Inventory (1994) (PDF) (7 pp, 13K)

Microbial Products of Biotechnology: Final Rule (62 FR 17910) - Related Documents

Notifications under TSCA Section 5

Notifications, FY 1998 to Present

Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (1997) (PDF) (71 pp, 654K)

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 (PDF) (12 pp, 29K)

• Table of Contents
  PDF version of Table of Contents (PDF) (14 pp, 50K)

• Chapter I: Introduction
  PDF version of Chapter I: Introduction (PDF) (8 pp, 26K)

• Chapter II: The Regulated Community
  PDF version of Chapter II: The Regulated Community (PDF) (14 pp, 35K)

• Chapter III: Benefits of the Final Rule
  PDF version of Chapter III: Benefits of the Final Rule (PDF) (12 pp, 32K)

• Chapter IV: Industry Costs
  PDF version of Chapter IV: Industry Costs (PDF) (43 pp, 678K)

• Chapter V: Government Costs
  PDF version of Chapter V: Government Costs (PDF) (19 pp, 46K)

• Chapter VI: Effects of the Final Rule on Innovative Activity
  PDF version of Chapter VI: Effects of the Final Rule on Innovative Activity (PDF) (8 pp, 261K)

• Chapter VII: International Considerations
  PDF version of Chapter VII: International Considerations (PDF) (12 pp, 34K)

• Chapter VIII: Effects of the Proposed Rule on Small Businesses
  PDF version of Chapter VIII: Effects of the Proposed Rule on Small Businesses (PDF) (12 pp, 32K)

• List of References
  PDF version of List of References (PDF) (12 pp, 36K)

• Appendix Cover
  PDF version of Appendix Cover (PDF) (1 pg, 18K)

• Appendix A: Results of ICF Biotechnology Survey
  PDF version of Appendix A: Results of ICF Biotechnology Survey (PDF) (49 pp, 924K)

• 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 (PDF) (12 pp, 38K)

• Appendix C: Numbers of Submissions
  PDF version of Appendix C: Numbers of Submissions (PDF) (12 pp, 34K)

• Appendix D: Industry Cost Calculations and Options/Sensitivity Analyses
  PDF version of Appendix D: Industry Cost Calculations and Options/Sensitivity Analyses (PDF) (43 pp, 549K)

• Appendix E: Confidential Business Information
  PDF version of Appendix E: Confidential Business Information (PDF) (11 pp, 353K)

• Appendix F: Regulatory Costs on a Per-Product Basis
  PDF version of Appendix F: Regulatory Costs on a Per-Product Basis (PDF) (27 pp, 311K)

• Appendix G: Development Costs and Expected Returns
  PDF version of Appendix G: Development Costs and Expected Returns (PDF) (5 pp, 18K)

• 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 (PDF) (20 pp, 807K)

• Appendix I: International Regulation of Genetically Modified Microorganisms
  PDF version of Appendix I: International Regulation of Genetically Modified Microorganisms (PDF) (22 pp, 75K)

Status Report, FY 1987-FY 1997: TSCA Biotechnology Submissions (PDF) (31 pp, 72K)

Status Report, FY 1987-FY 1997: TSCA Biotechnology Submissions (PDF) (28 pp, 66K)

Status Report: Biotechnology Premanufacture Notifications (PMNs): Status Reports for Fiscal Years 1987-1995 (PDF) (23 pp, 64K)

Status Report: Biotechnology Premanufacture Notifications (PMNs): Status Reports for Fiscal Years 1987-1995 (PDF) (23 pp, 62K)

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 Experimental Release Application (TERA) for Bradyrhizobium japonicum (B. japonicum) (2000)

TSCA Experimental Release Application Approved for Bradyrhizobium japonicum strains (fact sheet) (1998)

TSCA Experimental Release Application (TERA) for Pseudomonas putida (P. putida) (2000)

TSCA Experimental Release Application Approved for Pseudomonas putida strains (fact sheet) (1998)

Two TSCA Experimental Release Applications (TERAs) for Bradyrhizobium japonicum (B. japonicum) (April 1999)

Two TSCA Experimental Release Applications (TERAs) for Pseudomonas putida (P. Putida) (2001)

Note: EPA no longer updates the following information but it may be useful as a reference or resource.

Information Collection Request

Information Collection Request Supporting Statement (PDF) (40 pp, 100K)

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