Guidance Documents for Filing a Biotechnology Submission under TSCA

The following guidance documents are to assist stakeholders with filing a biotechnology submission under the Toxic Substances Control Act (TSCA).

• EPA's "Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms.” This document provides stakeholders with important information on how to prepare a biotechnology submission for microorganisms, setting up a prenotice consultation, and the type of information that should be included in the submission.
• The “Algae Supplement to the Guidance Document Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms.” This document supplements the original points to consider document by addressing submissions for genetically engineered algae.
• The agency’s response to public comments on the draft version of the algae guidance (Algae Supplement). EPA hosted two public workshops in 2015 and 2016 to develop and refine this supplemental guidance, and incorporated feedback from public commenters.

• Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (pdf) (1.26 MB)
• Algae Supplement to the Guidance Document Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (pdf) (662.68 KB)
• Agency Response to Public Comments on EPA’s Draft Algae Guidance for the Preparation of TSCA Biotechnology Submissions (pdf) (474.06 KB)