Background
The Toxic Substances Control Act (TSCA) authorizes Environmental Protection Agency (EPA) to review new chemicals before they are sold or otherwise used in commerce. In 1986, government policy defined “intergeneric microorganisms” as new chemicals. As a result, EPA regulates certain microorganisms under TSCA. On April 11, 1997, EPA released the rules for “new” microorganisms in commerce and commercial research. These rules require notification for research and the submission of an application to EPA prior to field testing. EPA regulations relating to intergeneric or new microorganisms are in 40 CFR 725.
Key Concepts
Intergeneric or New Microorganisms
Intergeneric microorganisms contain genetic material from microorganisms in more than one taxonomic genus.
Commercial Research or Use
EPA defines research as “commercial research” if a commercial entity directly provides partial or complete funding. It is not important who actually conducts the research.
Microbial Commercial Activity Notice (MCAN)
Companies must submit the MCAN to EPA before using an intergeneric microorganism for any commercial purpose. This notice is due at least 90 days before the use begins. EPA will decide whether the use might pose a serious risk to human health or to the environment.
TSCA Experimental Release Application (TERA)
Companies or researchers must submit a TERA to EPA before field testing intergeneric microorganisms for commercial uses. The application is due 60 days before the use starts.
Does this apply to my campus?
The TSCA Biotechnology Program applies only to intergeneric microorganisms when used commercially. However, the term “commercial” applies broadly in these rules. Campuses should get specific guidance from legal counsel, qualified consultants, or regulators to determine coverage.
These rules apply only if your facility creates or uses these intergeneric microorganisms. If your campus creates or uses these microorganisms, these rules apply. If your facility uses these microorganisms, but not commercially, these rules do not apply.
If your campus plans to conduct field studies with intergeneric microorganisms, you must submit a TERA. The use of these microorganisms in contained structures, such as buildings, greenhouses, etc., is exempt from TERA reporting. In addition, TSCA regulations exempt some field tests on 10 acres or less when the research involves Bradyrhizobium japonicum or Rhizobium meliloti. However, this field testing must meet certain conditions to earn this exemption.
If research on your campus will result in production of intergeneric microorganisms for commerce, you must submit an MCAN. If your campus follows the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules, the research project is exempt from EPA record-keeping requirements.
What do I have to do?
If your facility will produce an intergeneric microorganism for commercial use or research, you must submit an MCAN at least 90 days before production. Facilities that plan field tests of an intergeneric microorganism for commercial purposes must submit a TERA at least 60 days in advance of that production.
If the exemptions for compliance with NIH guidelines or use within contained structures apply to campus activities, you must document your rationale for applying the exemption. Inclusion of NIH guidelines into written laboratory safety rules, use of memos for record, documentation of training, and records of uses will help establish that your campus is eligible for the exemptions.