"By electronic mail, the United States Department of Health and Human Services (HHS) notified Dr. Peter Daszak, related to his role as the former President of EcoHealth Alliance, Inc. (EHA), in a May 21, 2024, Notice of Suspension and Proposed Debarment (Notice), and Action Referral Memorandum (ARM), and a December 11, 2024, Amended Notice and Amended ARM, that HHS had suspended and proposed Dr. Daszak for debarment from participating in United States Federal Government procurement and nonprocurement programs. This action was initiated pursuant to the Nonprocurement Common Rule, found at 2 C.F.R. Part 180, which HHS adopted and gave regulatory effect to at 2 C.F.R. Subpart 376.10."
"Information in the Record
A [chronological] summary of the information in the record upon which the suspension and proposed debarment were based appears below:
1. In a NoA [Notice of Award] dated May 27, 2014, the NIH/NIAID [National Institutes of Health/National Institute of Allergy and Infectious Disease] awarded Grant Number 1R01AI110964-01, 'Understanding the Risk of Bat Coronavirus Emergence,' to EHA [EcoHealth Alliance], with a project period from June 1, 2014 through May 31, 2019...
3. Dr. Peter Daszak was the President and Chief Executive Officer of EHA from 2009 until his termination, effective January 6, 2025. Dr. Daszak was the Project Director (PD)/Principal Investigator (PI) for Grant Number 1R01AI110964-01.
4. WIV [Wuhan Institute of Virology], located in Wuhan, China, was listed as a consortium participant in the NoA for Grant Number 1R01AI110964-01.
5. As stated in the NIH GPS [Grants Policy Statement], the prime recipient is accountable to the NIH for the performance of the project, the appropriate expenditure of grant funds by all parties, applicable reporting requirements, and all other obligations of the recipient...
7. Grant Number 1R01AI110964-01 involved the study of highly pathogenic agents, which required the grant prime awardee’s (EHA’s) and subrecipient’s (WIV’s) adherence to specific biocontainment safety (biosafety) requirements; this was a term of the award...
8. On October 17, 2014, the White House announced that the United States Federal Government was instituting a government wide funding pause on gain-of-function (GoF) research projects that may be reasonably anticipated to confer attributes to influenza, Middle East respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS) viruses such that the virus would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route...
11. Based on the information provided by EHA, the NIAID concluded that the proposed work was not subject to the GoF research pause. In a letter dated July 7, 2016, however, the NIAID informed EHA that should any of the MERS-like or SARS-like chimeras generated under the grant show evidence of enhanced virus growth greater than 1 log over the parental backbone strain, EHA must stop all experiments with these viruses...
16. In a letter dated April 19, 2020, the NIH notified EHA that it was reviewing allegations that WIV released the coronavirus that was responsible for the COVID-19 global pandemic. While it reviewed the allegations, the NIH instructed EHA to cease providing any funds from Grant Number R01AI110964 to WIV...
19. In a letter dated July 8, 2020 ... [t]he NIH stated that it had received reports that WIV had been conducting research at its facilities in China that posed serious biosafety concerns and, as a result, created health and welfare threats to the public in China and other countries, including the United States... NIH also directed EHA to arrange for WIV to submit to an outside inspection team charged to review the lab facilities and lab records, with specific attention to addressing the question of whether WIV staff had SARS-CoV-2 in their possession prior to December 2019...
21. On August 3, 2021, EHA submitted the Year 5 I-RPPR for Grant Number 5R01AI110964-05, nearly two years after the report due date. The NIH’s review of the Year 5 I-RPPR determined that an experiment, shown in Figure 13 of the report, had possibly yielded a greater than 1 log increase in viral activity. However, there were no facts to show that EHA notified the NIAID Program Officer and Grants Management Specialist, as required by the NoA...
24. In a letter dated November 5, 2021, the NIH requested that EHA provide WIV’s original laboratory notebook entries and original electronic files...
28. In a letter dated August 19, 2022, the NIH notified EHA that it was terminating the subaward from EHA to WIV under Grant Number R01AI110964 due to material noncompliance with terms and conditions of award...
32. As of the date of the original May 21, 2024, ARM, EHA had the following three active NIH-funded grant awards:
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- 5U01AI151797-04, 'Understanding Risk of Zoonotic Virus Emergence in Emerging Infectious Diseases (EID) Hotspots of Southeast Asia;'
- 5U01AI153420-04, 'Study of Nipah virus (NiV) dynamics and genetics in its bat reservoir and of human exposure to NiV across Bangladesh to understand patterns of human outbreaks;' and,
- 5R01AI163118-02, 'Analyzing the potential for future bat coronavirus emergence in Myanmar, Laos, and Vietnam.'
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33. A review of the abstract text from the NIH RePORTER database documents showed that... [these grant awards] were uniquely focused on either emerging infectious disease, highly transmissible pathogens, or novel viruses.
34. On October 18, 2024, the NIH submitted an ROI [Referral of Information] to the HHS SDO [Suspension and Debarment Official], recommending that EHA and Dr. Daszak be considered for suspension and debarment action...
41. According to the October 18, 2024, NIH ROI, as of October 2024, nearly three years after the initial request, the NIH had yet to receive any records in response to the original safety-related records request of November 5, 2021...
43. According to the October 18, 2024, NIH ROI, in Dr. Daszak’s October 26, 2021, letter to the NIH, he stated that EHA was unable to submit the Interim Year 5 RPPR in a timely manner because of a systems lockout.
49. According to the SSCP [Select Subcommittee on the Coronavirus Pandemic] Final Report, Dr. Daszak’s November 14, 2023, testimony that EHA was locked out of eRA Commons 'does not stand up to further scrutiny,' citing the NIH’s forensic audit across its systems to attempt to confirm Dr. Daszak’s claim, and that the NIH was unable to verify the claim....
50. According to the SSCP Final Report, Dr. Daszak, himself, publicly and via e-mail appeared to contradict his own claims that he was 'locked out' from submitting the Year 5 Report on time...
51. According to the SSCP Final Report, EHA failed to timely report a potentially dangerous experiment to the NIH, due to the fact that the experiment published in EHA’s Year 5 Report exhibited greater than one log growth and should have been reported to NIAID, but was not...
54. ... According to the SSCP Final Report, it appears that Dr. Daszak never explicitly requested the original lab notebooks from WIV in writing...
57. According to the SSCP Democrats’ Final Report... EHA did not adequately monitor virus growth WIV’s experiments [sic] and WIV’s compliance (and thus, its own compliance) with the 1 log rule. Moreover, virus growth presented in EHA’s Year 4 RPPR and Year 5 I-RPPR arguably show enhanced virus growth greater than 1 log...
Discussion
... As the HHS SDO, I may also consider other factors, as appropriate, in light of the circumstances of a particular case. The following aggravating and mitigating factors were taken into consideration for this matter to determine that a five-year debarment for Dr. Daszak is appropriate:
- 2 C.F.R § 180.860(a) – The actual or potential harm or impact that results or may result from the wrongdoing.
Dr. Daszak, failed to comply with safety-related reporting requirements and records requests. Safety is a consideration in all biomedical research, and the type of research that Dr. Daszak led at EHA, in particular, poses biosafety and public health concerns. These stem from interactions with infected wildlife, handling of specimens that may contain novel or dangerous viruses and increased viral activity following recombinant manipulations...
In this matter, Dr. Daszak’s failure to adhere to the 1-log immediate reporting requirement, failure to submit a progress report on time, inaccurate claim that experiments described in the Year 4 and Year 5 progress reports were the same, failure to take robust active steps to obtain records from WIV to address the safety concerns, and inaccurate claim that the delay in submitting the Year 5 progress report was due to a computer system lockout – are all reflective of a culture in which safety is not valued. A research organization lacking a culture of safety and integrity is one that constitutes a threat to public safety and public health...
I find that Dr. Daszak’s past wrongdoing continues to present harm, due to the seriousness of the misconduct and the fact that Dr. Daszak has not sufficiently accepted or acknowledged the wrongdoing...
Therefore, I have determined that this is an aggravating factor for consideration that additionally supports my decision to debar Dr. Daszak for a period of five years.
... EHA submitted the Year 5 IRPPR for Grant Number 5R01AI110964-05, on August 3, 2021, nearly two years after the report due date. I do not find that Dr. Daszak’s explanation for the late submission of the report, being locked out of eRA Commons, is credible, based on the forensic evidence presented by the NIH. In addition, the NIH first formally requested that EHA provide WIV’s laboratory notebooks on November 18, 2021, and again on January 6, 2022. To date, WIV’s laboratory notebooks have not been provided...
Findings
... I find the serious and egregious nature of the misconduct committed by Dr. Daszak indicates a lack of business integrity and business honesty, thereby directly affecting its present responsibility, and provides cause for the debarment of EHA."
Federal DEPARTMENT OF HEALTH & HUMAN SERVICES letter - in public domain.