Regulatory Support for Biotechnology Submissions under TSCA

Intertek can provide support with TSCA Microorganism Notification, including Microbial Commercial Activity Notice (MCAN), TSCA Experimental Release Applications (TERAs), and Tier I & II Exemptions.

Under TSCA, any microorganism including intergeneric (i.e., genetically modified) microorganisms that are not listed in the TSCA Inventory of Chemical Substances are considered as “new” and are subject to pre-manufacture/import/use review, unless otherwise exempt.

A wide range of commercial, industrial, and consumer applications of microbial biotechnology are considered to be TSCA applications, including but not limited to:

microbial biotechnology products for industrial enzyme production;
biofuel production;
mining and oil field applications;
waste remediation and pollution control;
non-pesticidal agriculture applications such as biofertilizers;
various consumer applications; and
all other applications of microbial biotechnology products not otherwise excluded under TSCA.

Food and food additives, drugs, cosmetics, medical devices, pesticides (but not pesticide intermediates), tobacco, nuclear material, and firearms are excluded under TSCA.

Depending on whether the microorganism is ready for commercialization or still in the research and development stage, companies should submit to the EPA either:

a Microbial Commercial Activity Notice (MCAN); or
a TSCA Experimental Release Application (TERA)

Tier I & Tier II exemptions may apply to microorganisms solely used for research and development activities under certain conditions. There may be opportunities for other exemptions.

Intertek’s multi-disciplinary notification team consists of toxicologists and subject matter regulatory experts to assist with preparation of the complex submission package. We can work with your technical experts and help you navigate through complex regulations. Through years of working with EPA, Intertek can anticipate potential roadblocks and mitigate them prior to submission.