RegulationContainment & biosafety
TSCA Biotechnology Regulations
EPA explains TSCA review for certain new microorganisms.
Resource
Research field / 11
Containment & biosafety
A living product needs a safety case.
A culture kept in a vessel and one released into soil present different questions. Physical and biological containment, strain stability and institutional oversight must be assessed for the actual organism and use. A laboratory finding is not an environmental release authorization.
Questions that matter
- What are the failure modes of the vessel and culture?
- Who independently evaluates containment and environmental risks?
- Which institutional and regulatory requirements apply to this particular use?
Sources & resources
Read our evidence note, then follow the original source.
GuidanceContainment & biosafety
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition
CDC and NIH's sixth-edition BMBL emphasizes risk assessment and containment.
2020
GuidanceContainment & biosafety
4.1.27 Research Involving Recombinant or Synthetic Nucleic Acid Molecules (including Human Gene Transfer Research)
NIH explains applicability of recombinant and synthetic nucleic-acid guidelines.
2026
GuidanceContainment & biosafety
NOT-OD-25-082: Implementation Update: Promoting Maximal Transparency Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
NIH clarifies transparency expectations for institutional biosafety committees.
2025
ReviewContainment & biosafety
Design and regulation of engineered bacteria for environmental release
Reviews engineering and regulation of microbes intended for environmental release.
2025
ReviewContainment & biosafety
Advances in biocontainment strategies of engineered microbes for use in humans
Surveys containment approaches for engineered microbes used in humans.
2026