Proposed US policy on dual use research of concern

26 February 2013

The US Office of Science and Technology Policy recently released proposed guidelines for maximizing the benefits and minimizing misuse of life sciences research. The measures establish oversight responsibilities for universities and other institutions that receive Federal funding:

Specifically, such institutions would be required to review their current life sciences research involving those pathogens or toxins deemed to be the most dangerous or most amenable to misuse, and then work with the researchers and funding agencies to develop appropriate risk mitigation plans.

This adds to a previously announced internal policy to identify DURC research and institute risk-reducing mitigation plans.

OSTP has requested comments on the proposed policy from researchers, institutions, consumers, security experts, and other stakeholders. The proposed policy can be found at this location (pdf), and instructions on how to submit comments can be found in the Federal Register.

Here is the gist of the proposal. It pertains to you if you get Federal money to work on the following organisms or toxins:

  1. Avian influenza virus (highly pathogenic)
  2. Bacillus anthracis
  3. Botulinum neurotoxin
  4. Burkholderia mallei
  5. Burkholderia pseudomallei
  6. Ebola virus
  7. Foot-and-mouth disease virus
  8. Francisella tularensis
  9. Marburg virus
  10. Reconstructed 1918 Influenza virus
  11. Rinderpest virus
  12. Toxin-producing strains of Clostridium botulinum
  13. Variola major virus
  14. Variola minor virus
  15. Yersinia pestis

And if your research might have the following consequences:

  1. Enhances the harmful consequences of the agent or toxin
  2. Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification
  3. Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies
  4. Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
  5. Alters the host range or tropism of the agent or toxin
  6. Enhances the susceptibility of a host population to the agent or toxin
  7. Generates or reconstitutes an eradicated or extinct agent or toxin listed above

If any of this applies to you, it is necessary for you and your institution to develop and implement a risk mitigation plan which must be approved by the funding agency.

If any of this applies to you, but you do not receive Federal funds for the research, you are strongly encouraged to carry out similar oversight procedures.