Share Your Views on Proposed Revisions to Biosafety Policy

Funding News Edition: September 20, 2023
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In our last issue, we identified a request for information (RFI) in the Federal Register published by the White House Office of Science and Technology Policy (OSTP) covering Potential Changes to the Policies for Oversight of Dual Use Research of Concern (DURC) and the Potential Pandemic Pathogen Care and Oversight (P3CO) Policy Framework. Here, we’ll fill in a few more of the details.

Keep in mind, responses from the research community are due by October 16, 2023, at 11:59 p.m. Eastern Time.

Background Information

DURC is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security.

Potential pandemic pathogens (PPP) are 1) likely highly transmissible and likely capable of wide and uncontrollable spread in human populations and 2) likely highly virulent and likely to cause significant morbidity or mortality in humans. An enhanced PPP (ePPP) is a PPP that results from enhancing the transmissibility or virulence of a pathogen; the starting pathogen does not need to be a PPP.

In March 2023, the National Science Advisory Board for Biosecurity (NSABB) published Proposed Biosecurity Oversight Framework for the Future of Science, which recommended a more comprehensive and integrated framework for the oversight of research with pathogens and toxins that may pose significant biosafety or biosecurity risks.

Since then, OSTP has conducted a policy review to:

  • Assess whether and how to merge existing DURC, P3CO, and related policies into a single harmonized policy.
  • Consider revising the scope of existing biosecurity policies to include a broader set of pathogens and toxins.
  • Examine ways to strengthen effective implementation of oversight for life sciences research on pathogens and toxins.

As a next step, OSTP seeks public feedback on proposed policy changes.

Where Your Feedback Is Needed

There are several related matters up for discussion, as summarized below.

Expanding Responsible Parties

Given the premise that a Revised Policy will integrate existing DURC, P3CO, and related policies, and that the Revised Policy will apply to federal departments and agencies, all U.S. institutions, and non-U.S. institutions that receive U.S. government funds to conduct applicable research:

  • What are the anticipated benefits and challenges of applying a Revised Policy to the scope of entities outlined above?
  • What are the anticipated benefits and challenges of investigators and institutions having primary responsibility for identifying both DURC and ePPP research?
  • What types of resources or tools would be useful for researchers and institutions to determine if their research falls into a revised policy scope that is risk-based rather than list-based, and adequately conduct risk assessments to identify DURC and ePPP research?

Range of Applicable Pathogens and Agents

NSABB recommended that the scope of research requiring review for potential DURC should include research that directly involves any human, animal, or plant pathogen, toxin, or agent that is reasonably anticipated to result in one or more of the seven experimental effects outlined in the DURC policy (not merely the current list of 15 listed agents or toxins).

  • If the scope of research expanded, what would be the effect on policy implementation and research programs at the institutional level?
  • Rather than including any pathogen within the scope of DURC review, the definition could instead include DURC experiments that utilize:
    • HHS and Overlap Biological Select Agent and Toxins (BSAT) List
    • Pathogen risk group (RG) classification of 3 or 4
    • Any pathogen where the conduct of work (e.g., one of the DURC experimental categories) would require biosafety level 3 or 4 containment
  • Would a modification in line with the outlined scope above be useful for policy implementation? What specific benefits, challenges, or gaps are anticipated by this revised scope?
  • Are there other risk-based approaches that would facilitate the identification of research that poses significant risks by investigators and institutions while not resulting in undue burdens?
  • What modifications to the current DURC policy list of 7 experimental effects should be considered to capture appropriate research without hampering research progress?
  • What resources or tools would be valuable to assist with implementation of a DURC policy with a scope that is revised to include more than the current list of 15 agents and toxins?

Definition of Potential Pandemic Pathogens

NSABB recommended that the definition of PPP, provided in the background section above, be modified to include: (3) Likely to pose a severe threat to public health, the capacity of public health systems to function, or national security.

  • How would the change in the definition of PPP affect the overall scope of a Revised Policy and its subsequent implementation?
  • One possible modification to the NSABB PPP definition is to specify a respiratory route of transmission within the first clause. Would that definition of PPP be an appropriate scope to mitigate risks and enhance effective implementation?
  • Do you have additional suggestions to modify the PPP definition to mitigate the most significant risks not currently addressed and enhance effective implementation, while limiting negative or unintended consequences and burden on researchers, institutions, and the Federal government?
  • Are there characteristics related to human pathology, pathogen characteristics, or other features that would be helpful to clarify the intent of “moderately virulent”? Are there characteristics related to human pathology that would be helpful to clarify the intent of “moderately transmissible”?

Accountability for Risk Assessments

A standard definition of “reasonably anticipated” would ensure consistency in identifying research that falls within scope of a Revised Policy. One definition of reasonably anticipated is “an assessment of an outcome that an individual with scientific expertise relevant to the research in question would expect this outcome to occur with a non-trivial likelihood. It does not require high confidence that the outcome will definitely occur and excludes experiments in which an expert would anticipate the outcome to be technically possible, but highly unlikely.”

  • Does this definition of “reasonably anticipated” provide additional clarity to ensure greater consistency in identifying research that falls within scope of the Revised Policy? What modifications to this definition would be most helpful?

Exemptions and Exclusion

NSABB recommends the removal of blanket exclusions for research activities associated with surveillance and vaccine development or production for research with ePPPs.

  • Should exemptions for certain activities be included in a Revised Policy?
  • What are the benefits and drawbacks of including exemptions for domestic and international pandemic preparedness, biosafety, biosecurity, and global health security?
  • If exemptions are included, how could they be bounded to maximize safety and security and minimize negative impact on domestic and global public health including outbreak and pandemic preparedness and response?

Accounting for in silico Approaches

NSABB recommends that continued assessment of the risks and benefits associated with advances and applications of bioinformatics, modeling, and other in silico experimental approaches and research involving genes from or encoding pathogens, toxins, or other agents must inform future evaluations of the scope of research oversight policies to help ensure that associated risks are appropriately identified and managed. This type of research is not currently included in the DURC and ePPP oversight policies.

  • Is there a subset of such in silico research that should require risk assessment and review in a Revised Policy, and if so, how should this research be defined so that the Policy captures the appropriate research without hampering activities with limited biosecurity risks?
  • One possible way to define this category of in silico research within a Revised Policy would be to include experiments that are reasonably anticipated to:
    • Develop in silico models that directly enable the predictive design of an enhanced potential pandemic pathogen or novel pathogen or toxin covered under a Revised Policy that could be constructed via genomic editing or de novo synthesis; and/or
    • Develop a dataset(s) connecting nucleic acid or amino acid sequences with experimentally-determined pathogenic functions in a manner sufficient to enable the development of in silico models described above.
  • If a new category of research, similar to the examples provided above, were to require risk assessment and review in a Revised Policy, what would be the benefits and challenges with implementation?

Once again, responses are due on October 16, 2023. Take care not to include any private, proprietary, confidential, or sensitive information in your submission.

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