Jump to main content.


Biotechnology Publications

You will need Adobe Reader to view some of the files on this page. See EPA's PDF page to learn more.

Revisions to Recipient Organisms Eligible for Tier I and Tier II Exemptions

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)

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)

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)

  • Local Navigation


    Jump to main content.