Microorganisms

Microorganisms are subject to the same general requirements as chemical substances under Toxic Chemical Control Act (TSCA). TSCA covers any new or existing commercial chemical substances, mixtures, and articles unless they are specifically exempted by the Act. Existing materials include more than 75,000 chemicals that are listed in EPA’s TSCA Chemical Substance Inventory (TSCA Inventory). New materials are added to the list as a result of "premanufacture notice" (PMN) reporting, which is a requirement that must be met by manufacturers or importers prior to producing or importing a new chemical substance. For a new microorganism, the required notice is called a Microbial Commercial Activity Notice (MCAN), rather than a PMN. A "new" microorganism is defined as one "combining genetic material from organisms in different genera." The notice must contain the specific microorganism identity and the date when manufacture or importation will commence. EPA has 90 days to review the MCAN (40 CFR 725.170). When the review is complete and importation actually begins, a notice of commencement (NOC) of manufacture or import is required (40 CFR 725.190). For detailed information go to Toxic Chemical Control Act.

Exports

Export of a microorganism identified in subpart M of 40 CFR 725 is subject to the notification provisions of 12(b) of TSCA. EPA's TSCA Section 12(b) export notification requirements apply to chemical substances or mixtures for which data are required under TSCA Section 5(b), an order has been issued under TSCA Section 5, a proposed or final rule has been issued under TSCA Sections 5 or 6, or an action is pending or relief has been granted under TSCA Sections 5 or 7. With regard to Section 4 of TSCA, only those chemical substances or mixtures listed in final TSCA Section 4 test rules and TSCA Section 4 Enforceable Consent Agreements (ECAs) are subject to the export notice requirements under TSCA Section 12(b). Notification of export is generally not required for articles, as provided by 40 CFR section 707.60(b).

Imports

Import of a microorganism identified in subpart M of 40 CFR 725 is subject to the notification provisions of section 13 of TSCA. TSCA Section 13 requires that any chemical substance, mixture, or article containing a chemical substance or mixture be refused entry into the customs territory of the U.S. if it fails to comply with any rule in effect under TSCA or is offered for entry in violation of section 5, 6, or 7 of TSCA (Go to TSCA). EPA’s Policy Statement, 40 CFR 707.20, requires that importers "certify" their imported chemical substances or mixtures are either: (1) in compliance with TSCA Sections 5, 6 and 7 at the time of import; or (2) not subject to TSCA. The current TSCA Import Rule does not pertain to importation of articles.

In addition, Section 13 provides that the Treasury Department (U.S. Customs), in conjunction with EPA, implement these requirements. For that reason, Customs can refuse entry of any shipment that does not have a TSCA certification. An importer of record provides the certification by signing one of the following statements to be typed, preprinted on the invoice, or otherwise included in the entry documentation:

*Negative Certification Statement: "I certify that all chemicals in this shipment are not subject to TSCA."

**Positive Certification Statement: "I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order under TSCA."