• Persons who wish to commercialize an intergeneric microorganism must submit a MCAN to EPA at least 90 days prior to commercialization.

Toxic Substances Control Act (TSCA) section 5, as interpreted in EPA’s Microbial Products of Biotechnology final rule (April 11, 1997), authorizes EPA to regulate new genetically engineered microorganisms.

According to the rule, new microorganisms are those that, through deliberate human intervention, contain genetic material from dissimilar source organisms. Specifically, intergeneric microorganisms are those formed by either the deliberate combination of genetic material from organisms classified in different taxonomic genera or constructed with synthetic genes that are not identical in DNA that would be derived from the same genus as the recipient microorganism.

Section 5 of TSCA requires the submission of certain information to EPA if a person wishes to:

• Commercialize an intergeneric microorganism; or
• Introduce such microorganisms into the environment for research purposes.

Persons who wish to commercialize an intergeneric microorganism must submit a Microbial Commercial Activity Notice (MCAN) to EPA at least 90 days prior to commercialization. These microorganisms are subject to the same determinations and potential regulatory controls as new chemical substances that undergo the premanufacture notice (PMN) notification and review process.

The e-PMN software enables manufacturers (including importers) of TSCA chemical substances to use the Internet, through EPA’s Central Data Exchange (CDX), to submit TSCA section 5 notices to EPA. There is no required format for biotech submissions in the e-PMN software; therefore, in the “Forms” screen of the e-PMN program, a submitter should choose to create a new form and then select “Biotechnology.” Submitters will be required to enter contact information regarding the submitting company and the technical contact. (EPA offers a sample header sheet, entitled “EPA Biotech Form” for anyone to view.)

MCAN is one of the five biotechnology submission choices. After selecting a submission type, the submitter can enter the submission information in a cover letter and as attachments.

Claims of confidentiality must be made in accordance with the procedures described in 40 CFR 703, except as modified in 40 CFR 725.80.