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Biotechnology
Highlights
September 5, 2012 -- EPA is proposing to add two microorganisms to the list of 10 recipient microorganisms (40 C.F.R. 725.420) that are eligible for exemptions from full chemical notification requirements under TSCA. The microorganisms are:
- Specific strains of the fungus Trichoderma reesei
- Specific subspecies of the bacterium Bacillus amyloliquefaciens
Resources
EPA created this site to allow more efficient public, governmental and educational access to the Toxic Substances Control Act (TSCA) Biotechnology Program. At this site, you will find the regulation under which the TSCA Biotechnology Program functions and the supplementary documents created to support this regulation, as well as status reports on the submissions, reviews, and agreements undertaken by the Program.
For those seeking different, or more specific information, we list links to other governmental biotechnology sites, both foreign and domestic, and provide information on the program representative in each EPA regional office. On each page, we have also included an e-mail link to a program representative at EPA Headquarters in Washington, D.C.
If you submit a biotechnology submission for a microorganism ("biotech submission") to EPA, you are required to use the electronic-PMN ("e-PMN") software as discussed in the "e-PMN" final rule (75 FR 773) (PDF) (18 pp, 140K, about PDF). You must use the PMN module within the e-PMN software to submit your SNUN. On page 1 of the PMN module, be sure to check the box stating the type of notice you are submitting is a SNUN. During the first year following the effective date of the final rule, SNUN submissions will be permitted via Central Data Exchange (CDX), optical disc or paper. One year after the rule's effective date, i.e., as of April 6, 2010, EPA no longer accept paper submissions. Two years after the final rule's effective date, i.e., as of April 6, 2011, all submissions will be required to be submitted electronically via CDX. Refer to www.epa.gov/cdx, the CDX Registration Guide (PDF) (44 pp, 8.5MB, about PDF), or the CDX Helpful Hints (PDF) (10 pp, 41K, about PDF) for directions on how to register and submit notices via CDX.
There is no required form for biotech submissions in the e-PMN software but you must use the e-PMN software "header sheet." In the opening screen of the e-PMN program, choose to create a new project and then select "Biotechnology." You will be required to enter contact information into the Header Sheet regarding the submitting company and the technical contact. There are five biotechnology submission choices covered in this module: MCANs, TERAs, Tier I and Tier II exemptions, and Biotechnology TMEAs. After selecting a submission type, you can enter the submission information in a cover letter and as attachments. Refer to the Helpful Hints for Use of the eTSCA/e-PMN Submission Software (PDF) (16 pp, 54K, about PDF) for more information on how to submit notices using the e-PMN software.
Also, learn more about existing chemicals programs under TSCA.