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Microbial products of biotechnology under TSCA

Intergeneric organisms are ‘‘new’’ microorganisms formed by deliberate combinations of genetic material from organisms classified in different taxonomic genera. Considered a microbial product of biotechnology, intergeneric microorganisms require notification under section 5 of the Toxic Substances Control Act (TSCA).

Companies wishing to commercialize an intergeneric microorganism, or introduce such a microorganism into the environment for research purposes, must submit certain information to the US Environmental Protection Agency (EPA). Submission choices include:

TSCA Experimental Release Application (TERA): For intergeneric microorganisms still in the research and development phase, companies should submit a TSCA Experimental Release Application (TERA) to EPA. This will allow for the intergeneric microorganism to be released into the environment, under controlled conditions, to test its safety.

Microbial Commercial Activity Notice (MCAN): For intergeneric microorganisms that are ready for commercialization, companies should submit a Microbial Commercial Activity Notice (MCAN) (40 CFR 725 subpart D). EPA reviews these submissions to determine if the intergeneric microorganism may impose any unreasonable risk to human health or the environment.

Tier I & II exemptions

After the research and development stage, US Environmental Protection Agency (EPA) regulations establish two exemptions for new microorganisms being manufactured for commerce – Tier I and Tier II exemptions (40 CFR 725 subpart G). To qualify for either exemption, the new microorganism must meet the following criteria:

  • Use of one of the microorganisms included in 40 CFR §725.420
  • The introduced genetic materials must be limited in size, well-characterized, poorly mobilizable, free of certain sequences capable of producing toxins (40 CFR §725.421)
  • Comply with the requirements for physical containment and control technologies (40 CFR §725.422)

If these requirements are met, a company can apply for a Tier I exemption, which allows them to manufacture or import the new microorganism without EPA review. To do this, the manufacturer/importer should submit to EPA a certification of compliance with the requirements, their name and address, date when manufacture or import is expected to begin, and identification of the genus and species of the recipient organism that will be used to create the new organism. This certification must be submitted to EPA 10 days prior to manufacturing/importing a new microorganism that qualifies for this exemption. Certain records must also be kept (40 CFR §725.400).

A manufacturer/importer who meets the first two conditions of the Tier I exemption may modify the specified containment restrictions or level of inactivation provided it submits a Tier II exemption notification (40 CFR §725.428) to request approval for the alternative procedures. The notice is subject to a 45-day review period (40 CFR §725.450 and §725.470). The manufacturer/importer may not proceed until EPA approves the exemption.

A person who manufactures, imports, or processes a microorganism solely for research and development activities, is not subject to the reporting requirements under 40 CFR 725 subpart D), provided all the criteria described at 40 CFR §725.234 are met, or the activities are subject to the jurisdiction of other federal programs or agencies (40 CFR §725.232).

How TSG can help

TSG’s consultants are experienced in all aspects of biotechnology submissions under TSCA. Our scientists understand the requirements for Tier I and Tier II exemptions and are experienced in determining whether submissions require MCAN or TERA.

We can:

  • Assist with microbial characterization for MCAN and TERA
  • Assist with genetic manipulation data per requirements
  • Assist with production process and determine the Quality Control (QC) check points
  • Prepare MCAN and TERA

Want to notify your biotechnology product in the USA?

Why TSG

TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.

Our professionals

TSG’s team of scientists and regulatory consultants manage all aspects of biotechnology compliance for our customers. Our Washington, DC-based Federal Affairs team is led by Abigail Wacek.

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Q&A’s

Microbial biotechnology can be used in a wide range of industries and products for both commercial and research purposes. Examples include: treatment of biological waste; field application to enhance nitrogen fixation on crops; and ethanol (bio-based) biodiesel.

For purposes of TSCA jurisdiction, EPA interprets the definition of the term "chemical substance" (40 CFR §710.3) to include microorganisms. Manufacturers, importers or processors of "new" microorganisms intended for use in commercial R&D in the environment must submit a TERA. Exemptions for commercial use that is not R&D include Tier I and Tier II exemptions. Persons who manufacture, import, or process new intergenetic microorganisms for commercial purposes must submit a Microbial Commercial Activity Notice (MCAN) to EPA.

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Your product is regulated if you have made any kind of genetic alteration to the intended microorganism, for commercial or research purposes. TSG’s experts can assist with making sure all requirements are fulfilled prior to contacting US EPA.

An intergeneric microorganism is formed by deliberately combining genetic material first isolated in a different taxonomic genus; or by deliberate combination of certain mobile genetic elements (DNA).

No. Non-intergeneric organisms are not considered “new” organisms and are already listed on the TSCA Inventory. Therefore, they are not subject to reporting under section 5 of TSCA.

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