Action Referral Memorandum — Department of Health & Human Services, EcoHealth Alliance, Inc. (EHA), Amended Notice and Amended ARM

Summary

An Action Referral Memorandum of the United States Department of Health and Human Services (HHS) debarring EcoHealth Alliance, Inc. (EHA) for five years, following a May 15, 2024 notice and a December 11, 2024 amended notice, under 2 C.F.R. Part 180 as adopted at 2 C.F.R. Subpart 376.10. It lists the materials relied on, including an October 18, 2024 referral from the National Institutes of Health concerning EHA and its former President, Dr. Peter Daszak, the history of Grant Number 1R01AI110964-01 with the Wuhan Institute of Virology (WIV) as consortium participant, the gain-of-function funding pause, the award condition on virus growth greater than 1 log, and EHA's responses. The Suspension and Debarment Official finds that EHA has not demonstrated present responsibility and debars it, counting the suspension from May 15, 2024, so that it remains ineligible through May 14, 2029.

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DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary
Washington, D.C. 20201

ACTION REFERRAL MEMORANDUM

By electronic mail, the United States Department of Health and Human Services (HHS)
notified EcoHealth Alliance, Inc. (EHA), in a May 15, 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 EHA 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.

The suspension and proposed debarment actions were based on information from the
following, indicating that EHA lacks the present responsibility to participate in United States
Federal Government procurement and nonprocurement programs:

x October 18, 2024, Referral of Information (ROI), from the National Institutes of Health
(NIH) to the HHS Suspension and Debarment Official (SDO), concerning EHA and Dr.
Peter Daszak, former President and Chief Executive Officer of EHA, which included the
following 13 attachments:
x List of active NIH awards to EHA;
x June 4, 2019, Closeout Notification letter to EHA;
x October 20, 2021, Letter from NIH to EHA, requesting additional information;
x October 26, 2021, Response from EHA to NIH’s October 20, 2021, Letter;
x Slide deck presented to OIG regarding RPPR analysis;
x November 5, 2021, Letter from NIH to EHA;
x November 18, 2021, Response from EHA to NIH’s November 5, 2021, Letter;
x January 6, 2022, Letter from NIH to EHA;
x January 21, 2022, Response from EHA to NIH’s January 6, 2022, Letter;
x eRA Forensic Analysis of RPPR related activities for R01AI110964 -05;
x Select Subcommittee on the Coronavirus Pandemic (SSCP) Committee on
Oversight & Accountability Interim Staff Report – “An Evaluation of the
Evidence Surrounding EcoHealth Alliance, Inc.’s Research Activities” (May 1,
2024);
x SSCP Democratic Staff Report – “EcoHealth Alliance Did Not Cause the
COVID-19 Pandemic but Did Engage in Questionable Professional Conduct”
(May 2024); and,
x May 9, 2024, Email from EHA to NIH;
x SSCP Final Report – “After Action Review of the COVID-19 Pandemic: The Lessons
Learned and a Path Forward” (December 4, 2024);
x SSCP Democrats’ Final Report – “Partisan Probes Over Pandemic Prevention and
Preparedness” (December 2024).
x October 1, 2013, National Institutes of Health Grants Policy Statement (NIH GPS) for
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 2

Fiscal Years 2013-2014;
x May 27, 2014, Notice of Award (NoA) for Grant Number 1R01AI110964 -01, awarded
by the NIH/National Institute of Allergy and Infectious Disease (NIAID) to EHA;
x May 28, 2016, letter from the NIAID to EHA;
x June 8, 2016, letter from EHA to the NIAID;
x July 7, 2016, letter from the NIAID to EHA;
x November 30, 2016, Revised NoA for Grant Number 5R01AI110964-03, awarded by the
NIAID to EHA;
x May 26, 2017, NoA for Grant Number 5R01AI110964-04, awarded by the NIAID to
EHA;
x HHS Framework for Guiding Funding Decisions about Proposed Research Involving
Enhanced Potential Pandemic Pathogens (HHS P3CO Framework), published on
December 19, 2017;
x June 18, 2018, NoA for Grant Number 5R01AI110964-05, awarded by the NIAID to
EHA;
x July 24, 2019, NoA for Grant Number 2R01AI110964 -06, awarded by the NIAID to
EHA;
x April 19, 2020, letter from the NIH to EHA;
x April 24, 2020, letter from the NIH to EHA;
x May 22, 2020, letter from the law firm of Tarter Krinsky & Droggin LLP, to the NIH;
x July 8, 2020, letter from the NIH to EHA;
x July 23, 2021, letter from the NIH to EHA;
x October 20, 2021, letter from the NIH to EHA;
x October 26, 2021, letter from EHA to the NIH;
x Year 4 Research Performance Progress Report (RPPR), for Grant Number
5R01AI110964-05;
x Year 5 Interim-Research Performance Progress Report (I-RPPR) for Grant Number
R01AI110964-05;
x November 5, 2021, letter from the NIH to EHA;
x November 15, 2021, email from EHA to Wuhan Institute of Virology (WIV);
x November 18, 2021, letter from EHA to the NIH;
x January 6, 2022, letter from the NIH to EHA;
x January 21, 2022, letter from EHA to the NIH;
x August 19, 2022, letter from the NIH to EHA;
x January 25, 2023, HHS Office Of Inspector General (OIG) Audit Report Number A-
05-21-00025, titled, “The National Institutes Of Health And EcoHealth Alliance Did Not
Effectively Monitor Awards And Subawards, Resulting In Missed Opportunities To
Oversee Research And Other Deficiencies;”
x July 17, 2023, HHS Notice and ARM for the Suspension and Proposed Debarment and
of WIV;
x September 19, 2023, HHS Notice and ARM for the Debarment of WIV;
x May 6, 2024, NIH forensics summary report of the eRA Commons reporting system
logs for RPPR related activities for R01AI110964-05;
x NIH RePORTER database documents for Grant Numbers 5U01AI151797 -04,
5U01AI153420-04, and 5R01AI163118-02;
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 3

x May 15, 2024, HHS Notice and ARM for EHA;
x July 22, 2024, Response to the May 15, 2024, Notice and ARM from EHA and Dr.
Daszak;
x September 19, 2024, Proposed Administrative Agreement from EHA and Dr. Daszak;
x December 11, 2024, Amended Notice and Amended ARM for EHA;
x January 13, 2025, Response to the December 11, 2024, Notice and ARM from EHA; and,
x January 15, 2025, Information from EHA for consideration by the HHS SDO, submitted
subsequent to the January 15, 2025, Presentation of Matters in Opposition (PMIO)
meeting conducted between HHS and EHA and its attorney representatives.

INFORMATION IN THE RECORD

A summary of the information in the record upon which the suspension and proposed
debarment were based appears below:

1. In a NoA dated May 27, 2014, the NIH/NIAID awarded Grant Number
1R01AI110964-01, “Understanding the Risk of Bat Coronavirus Emergence,” to
EHA, with a project period from June 1, 2014 through May 31, 2019.

2. EHA is a United States-based nonprofit organization that focuses on research that
aims to prevent pandemics and promote conservation in hotspot regions worldwide.
The stated mission of EHA is protecting people, animals, and the environment from
emerging infectious diseases.

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, 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, 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. In
addition, the terms and conditions flow down to subrecipients in accordance with 2
C.F.R. Part 200.101(b)(2).

6. The NIH GPS defines a consortium agreement as a formalized agreement whereby a
research project is carried out by the grantee and one or more other organizations that
are separate legal entities. Under the agreement, the grantee must perform a
substantive role in the conduct of the planned research and not merely serve as a
conduit of funds to another party or parties. These agreements typically involve a
specific level of effort from the consortium organization’s PD/PI and a categorical
breakdown of costs, such as personnel, supplies, and other allowable expenses,
including F&A costs. The relationship between the recipient and the collaborating
organizations is considered a subaward relationship.
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 4

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. This grant was subject to biosafety requirements set forth in the NIH
GPS, a term and condition of every NIH grant award, Section 4.1.24 “Public Health
Security” and the Notice of Award, Section IV (e.g., requiring that “Research funded
under this grant must adhere to the [CDC/NIH Biosafety in Microbiological and
Biomedical Laboratories (BMBL)]).”

8. On October 17, 2014, the White House announced that the United States Federal
Government was instituting a governmentwide 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.

9. In a letter dated May 28, 2016, the NIAID contacted EHA concerning possible GoF
research based on information submitted in its most recent Year 2 RPPR. The NIAID
notified EHA that GoF research conducted under Grant Number 5R01AI110964 -03
would be subject to the October 17, 2014, United States Federal Government funding
pause, and that per the funding pause announcement, new United States Federal
Government funding would not be released for GoF research projects that may be
reasonably anticipated to confer attributes to influenza, MERS, or SARS viruses such
that the virus would have enhanced pathogenicity and/or transmissibility in mammals
via the respiratory route. In the letter, the NIAID requested that EHA provide a
determination within 15 days of the date of the letter as to whether EHA’s research
under Grant Number 5R01AI110964-03 did or did not include GoF work subject to
the funding pause.

10. In a letter dated June 8, 2016, EHA provided a response to the NIAID’s May 28,
2016 letter. EHA explained that the goal of its proposed work was to construct MERS
and MERS-like chimeric CoVs in order to understand the potential origins of MERS-
CoV in bats by studying bat MERS-like CoVs in detail. EHA stated that it believed it
was highly unlikely that the proposed work would have any pathogenic potential, but
that should any of these recombinants show evidence of enhanced virus growth
greater than certain specified benchmarks involving log growth increases, or grow
more efficiently in human airway epithelial cells, EHA would immediately: (1) stop
all experiments with the mutant, (2) inform the NIAID Program Officer of these
results, and (3) participate in decision-making trees to decide appropriate paths
forward.

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
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 5

than 1 log over the parental backbone strain, EHA must stop all experiments with
these viruses and provide the NIAID Program Officer and Grants Management
Specialist, and WIV Institutional Biosafety Committee, with the relevant data and
information related to these unanticipated outcomes.

12. This issue formed the basis for the special term and condition that was included in
Section IV of the revised NoA for R01AI110964-03, issued on November 30, 2016,
to remind EHA that it was prohibited from using funds to support GoF research. The
full text of the special term and condition was included in Section IV of the NoA, as
follows:

No funds are provided and no funds can be used to support gain-of-
function research covered under the October 17, 2014 White House
Announcement (NIH Guide Notice NOT-OD-15-011). Per the letter dated
July 7, 2016 to [Senior Coordinator of Operations] at EHA, should any of
the MERS-like or SARS-like chimeras generated under this grant show
evidence of enhanced virus growth greater than 1 log over the parental
backbone strain you must stop all experiments with these viruses and
provide the NIAID Program Officer and Grants Management Specialist,
and WIV Institutional Biosafety Committee with the relevant data and
information related to these unanticipated outcomes.

13. On January 9, 2017, the White House issued Recommended Policy Guidance for
Departmental Development of Review Mechanisms for Potential Pandemic Pathogen
Care and Oversight (P3CO), which described procedures for United States Federal
agencies to adopt in order to lift the funding pause. The HHS Framework for Guiding
Funding Decisions about Proposed Research Involving Enhanced Potential
Pandemic Pathogens (HHS P3CO Framework), which was published on December
19, 2017, satisfied the January 9, 2017, White House guidance to address certain
gain-of-function research and to lift the requirement for the research funding pause.
The HHS P3CO Framework is intended to guide HHS funding decisions on research
that is reasonably anticipated to create, transfer, or use enhanced potential pandemic
pathogens (ePPPs).

14. In the June 18, 2018, NoA non-competing grant renewal for 5R01AI110964-05 1, the
language of the Section IV Special Award Condition was revised as follows: “If any
experiments proposed in this award result in a virus with enhanced growth by more
than 1 log compared to wild type strains, you must notify your NIAID Program
Officer and Grants Management Specialist immediately. Further research involving
the resulting virus(es) may require review by the Department of Health and Human
Services in accordance with the Framework for Guiding Funding Decisions about
Proposed Research Involving Enhanced Potential Pandemic Pathogens . . . .”. The

1
The NoA for grant renewal 5R01AI110964-04, issued on May 26, 2017, inadvertently omitted the special term and
condition from Section IV special term and condition. In an effort to ensure the terms was clear, it was correctly
added to the subsequent year NoA, 5R01AI110964-05. At this time, all terms have been updated by NIH to ensure
that all terms are accurate.
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 6

project was renewed with this version of the special term and condition, included in
Section IV of the NoA, for the period covering from June 1, 2014 through May 31,
2019.

15. On November 5, 2018, the NIH received a renewal application from EHA (Type 2),
and on April 23, 2019, the NIH approved the application for funding. On July 24,
2019, a NoA was issued for Grant Number 2R01AI110964 -06, with a project period
from June 1, 2014 through June 30, 2024. The proposed work in the renewal
application for Grant Number 2R01AI110964-06 was to investigate more divergent
animal viruses, and the NIAID determined that the HHS P3CO policies did not apply
to the work proposed under the competitive renewal application. As such, the NoA
for Grant Number 2R01AI110964-06 did not include the special term and condition
in Section IV. Although the NIAID determined that the work under 2R01AI110964 -
06 was ultimately not subject to either to the GoF pause or the HHS P3CO policies,
the special term and condition was included for the remainder of the original
competitive segment of the award, which was from June 1, 2014 through May 31,
2019. Accordingly, the special term and condition cited to above in paragraph 11 was
applicable to the grant as revised in R01AI110964-03 through the grant renewal
period corresponding to 5R01AI110964-05. After processing the grant renewal
2R01AI110964-06, the NIH performed routine grant administration activities and
monitoring.

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.

17. In a letter dated April 24, 2020, the NIH notified EHA that it had elected to terminate
Grant Number R01AI110964, for convenience. The NIH stated that in accordance
with the NIH GPS, “the decision not to award a grant, or to award a grant at a
particular funding level, is at the discretion of the agency, in accordance with NIH’s
dual review system.”

18. In a letter dated May 22, 2020, Tarter Krinsky & Droggin LLP, the law firm
representing EHA, notified the NIH that it was appealing the termination of Grant
Number R01AI110964.

19. In a letter dated July 8, 2020, the NIH notified EHA that it withdrew its termination
of Grant Number R01AI110964, and reinstated the grant. However, the NIH
informed EHA that all activities related to R01AI110964 were programmatically
suspended in accordance with 45 C.F.R. § 75.371, Remedies for Noncompliance,
which permits suspension of award activities in cases of non -compliance, and the
NIH GPS, Section 8.5.2, which permits NIH to take immediate action to susp end a
grant when necessary to protect the public health and welfare. The 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
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 7

threats to the public in China and other countries, including the United States. The
letter stated that during the period of programmatic suspension, the NIH would
continue to review the activities under the grant, taking into consideration information
provided by EHA to further assess compliance by EHA and WIV. Among the
information and materials requested by the NIH from EHA, 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.

20. In a letter dated July 23, 2021, the NIH requested that EHA provide WIV’s records
validating expenditures specific to R01AI110964 as well as any and all monitoring,
safety, and financial reports specific to R01AI110964 that WIV submitted to EHA, in
order to analyze EHA’s and WIV’s compliance with the terms and conditions of the
grant. The NIH noted that as a term and condition of award and in accordance with 45
C.F.R. § 75.364, the awarding agency must have the right of access to any
documents, papers, or other records of the non-Federal entity which are pertinent to
the Federal award, in order to make audits, examinations, excerpts, and transcripts,
and that this right of access applies to both awardee and subawardee records. See 45
C.F.R. § 75.364(a). The NIH also informed EHA that it was delinquent in the
submission of the Year 5 I-RPPR, for the reporting period from June 1, 2018 to May
31, 2019. The report was due to be submitted within 120 days after the end of the
project period, which was September 30, 2019. The NIH requested that EHA provide
the remaining documents and outstanding reports by August 27, 2021.

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, Section IV special term and
condition of the grant, identified above in paragraph 13.

22. In a letter dated October 20, 2021, the NIH informed EHA that in order to continue its
analysis of the Year 5 I-RPPR, the NIH required verification that WIV received
approval from the Institutional Animal Care & Use Committee (IACUC), for fie ld
work (e.g., work in caves to collect materials from live bats) supported by
R01AI110964, as required by the NIH GPS, Section 4.1.1.2. As such, the NIH
requested WIV provide documentation verifying IACUC approval. The NIH also
requested that EHA provide all unpublished data supported by the grant that had not
already reported in its RPPRs. The NIH requested that the materials be provided by
no later than October 27, 2021.

23. In a letter dated October 26, 2021, EHA challenged the NIH’s assertion that the
experiment reported in the Year 5 I-RPPR had possibly yielded a greater than 1 log
increase in viral activity. EHA stated that Figure 13 of Year 5 I-RPPR and Figure 35
of the Year 4 RPPR for Grant Number 5R01AI110964 -05, which covered the
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 8

reporting period from June 1, 2017 through May 31, 2018, were taken from the same
experiment. EHA asked that “these facts be acknowledged.” Experts from the NIH,
however, reviewed the corresponding figures and text and concluded that it was more
likely than not that the Year 5 I-RPPR was describing a different experiment than was
described in the Year 4 RPPR.

24. In a letter dated November 5, 2021, the NIH requested that EHA provide WIV’s
original laboratory notebook entries and original electronic files to support the
information that was reported in the Year 4 RPPR Figure 35 and the Year 5 I-RPPR
Figure 13 for Grant Number 5R01AI110964-05. The NIH requested the laboratory
notebooks in order to examine and analyze critical data supporting EHA’s claim that
the experiment shown in Figure 13 of the I-RPPR was in fact the same experiment
shown in Figure 35 of the Year 4 RPPR. The NIH requested that the documentation
be provided by November 19, 2021.

25. In a letter dated November 18, 2021, EHA informed the NIH that it did not have
copies of the requested laboratory notebooks and electronic files, which were created
by WIV. EHA stated that it forwarded the NIH’s November 5, 2021, letter to WIV
and would provide the NIH with WIV’s response upon receipt.

26. In a letter dated January 6, 2022, the NIH again requested that EHA provide WIV’s
complete and dated original laboratory notebook entries and original electronic files
for Grant Number R01AI110964. The requested records were not provided to the
NIH.

27. In a letter dated January 21, 2022, EHA informed the NIH that it had forwarded its
January 6, 2022, letter to WIV, but that no further information had been received.
EHA stated that it would inform the NIH when and if WIV provided a response.

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 non-
compliance with terms and conditions of award that cannot be remedied by specific
award conditions. The NIH stated that this would be accomplished as a partial
termination of the award to EHA under 45 C.F.R. § 75.371(c). In making this
decision, the NIH noted that to date it had still not received the materials requested in
its previous correspondence, dated November 5, 2021, and January 6, 2022, complete
and dated copies of the original laboratory notebook entries and of the original
electronic files from WIV that led to the generation of the Year 4 RPPR Figure 35
and the Year 5 I-RPPR Figure 13, along with all their accompanying texts. The NIH
also stated that its examination of the subaward agreement from EHA to WIV found
that the agreement did not include “a requirement that the subrecipient [WIV] permit
the pass-through entity [EHA] and auditors to have access to the subrecipient's
records and financial statements as necessary for the pass-through entity to meet the
requirements of this part,” as required under 45 C.F.R. § 75.352. The subaward
agreement also did not include “all requirements imposed by the pass-through entity
on the subrecipient so that the [United States] Federal [Government] award is used in
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 9

accordance with United States Federal Government statutes, regulations and the terms
and conditions of the [United States] Federal [Government] award[.]” See 45 C.F.R. §
75.352.

29. On January 25, 2023, the HHS-OIG issued Audit Report Number A-05-21-00025,
titled, “The National Institutes of Health And EcoHealth Alliance Did Not Effectively
Monitor Awards And Subawards, Resulting In Missed Opportunities To Oversee
Research And Other Deficiencies.” The HHS-OIG recommended that the NIH
consider whether it was appropriate to refer WIV to the HHS SDO for potential
administrative actions, based on information provided in the audit and any other
information available to the NIH. The HHS-OIG also recommended that EHA submit
progress reports by the required due date, comply with immediate notification
requirements, ensure access to all subrecipient records, properly account for
subawards, and refund to the Federal Government $89,171 in unallowable costs. In
written comments, EHA disagreed with the HHS-OIG’s findings regarding the
timeliness of the submission of the Year 5 I-RPPR and claimed that the report could
not be submitted due to EHA being locked out of the NIH reporting system. In
response to EHA’s comments, the HHS-OIG stated, “We acknowledge in our report
that [EHA’s] Year 5 progress report was initiated on NIH’s online portal in July
2019; however, we have no evidence that the progress report was fully uploaded to
the online portal at that time. Furthermore, we have no evidence that there was any
correspondence between [EHA] and NIH describing technical difficulties with
uploading the progress report on time.”

30. In a July 17, 2023, Notice of Suspension and Proposed Debarment and ARM, HHS
suspended WIV and proposed WIV for debarment from participating in United States
Federal Government procurement and nonprocurement programs. The suspension
was pursuant to 2 C.F.R. § 180.700(b) and (c) and the proposed debarment was
pursuant to 2 C.F.R. 180.800(d) – “Any other cause of so serious or compelling
nature that it affects your present responsibility.” WIV failed to send or make
arrangements to appear and present information and argument in opposition to the
Notice of Suspension and Proposed Debarment within 30 days after the receipt of the
Notice of Suspension and Proposed Debarment. Accordingly, on September 19, 2023,
HHS debarred WIV for a period of ten years.

31. On May 5, 2024, the NIH provided the HHS SDO with a forensics summary report of
the eRA Commons reporting system logs for RPPR related activities for
R01AI110964-05, documenting that EHA was never locked out of the system, as
EHA claimed in written comments in HHS-OIG Audit Report Number A-05-21-
00025. The logs show that on July 24, 2019, the PI initiated the Year 5 I-RPPR
through the link provided but did not route it to the Signing Official (SO). On May
26, 2020, the PI accessed the Year 5 I-RPPR to upload a document and to enter data.
On July 26, 2021, the PI linked their account to Login.gov. On July 27, 2021, the PI
unsuccessfully attempted to change their eRA Commons password; the password was
locked, but the PI continued accessing eRA using Login.gov. On July 27, 2021, the PI
routed the Year 5 I-RPPR to the SO. On August 2, 2021, the SO uploaded documents
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 10

for Year 5 I-RPPR. On August 3, 2021, the SO submitted the Year 5 I-RPPR to the
NIH.

32. As of the date of the original May 15, 2024, ARM, EHA had the following three
active NIH-funded grant awards:

x 5U01AI151797-04, “Understanding Risk of Zoonotic Virus Emergence in
Emerging Infectious Diseases (EID) Hotspots of Southeast Asia;”
x 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,
x 5R01AI163118-02, “Analyzing the potential for future bat coronavirus
emergence in Myanmar, Laos, and Vietnam.”

33. A review of the abstract text from the NIH RePORTER database documents showed
that Grant Numbers 5U01AI151797-04, 5U01AI153420-04, and 5R01AI163118-02,
were uniquely focused on either emerging infectious disease, highly transmissible
pathogens, or novel viruses.

34. On October 18, 2024, the NIH submitted an ROI to the HHS SDO, recommending
that EHA and Dr. Daszak be considered for suspension and debarment action.

35. According to the October 18, 2024, NIH ROI, On October 20, 2021, the NIH sent a
letter to EHA regarding recently received materials, including an interim Year 5
RPPR that was submitted nearly two years. The interim Year 5 RPPR included text
and a figure (Figure 13) which described experiments in which certain viral chimeras
led to substantially greater mortality rates and to more than a 1 -log increase in viral
activity. The NIH had previously imposed a term and condition of award stating that
any experiment that led to a greater than 1-log increase in viral would need to be
reported immediately to the agency, thus giving the agency an opportunity to consider
possible safety concerns and possible need for additional oversight.

36. According to the October 18, 2024, NIH ROI states that on October 26, 2021, Dr.
Daszak wrote to the NIH, stating that the experiment shown in Figure 13 of the Year
5 I-RPPR was the “same experiment” as one reported in April 2018 in Figure 35 of
the Year 4 RPPR. He went on to write that “It is very important that these facts be
acknowledged.” NIH staff reviewed Dr. Daszak’s October 26, 2021, letter, as well as
the experiment description from the Year 4 RPPR and the Year 5 I-RPPR, and NIH
staff noted a number of differences which suggested that contrary to Dr. Daszak’s
assertions, the two RPPRs were describing two distinct experiments, not “the same
experiment.”

37. According to the October 18, 2024, NIH ROI, the NIH’s November 5, 2021, letter to
EHA, requested “complete and dated copies of the original laboratory notebook
entries and of the original electronic files that led to the generation of the Year 4
RPPR Figure 35 and the Year 5 I-RPPR Figure 13, along with all their accompanying
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 11

texts (e.g., the Year 5 I-RPPR text in which you stated that “rWIV1-SHC014 was
detected at all time points and showed an increasing viral titer after infection…”).”
The NIH’s letter reminded EHA of its regulatory obligations to honor the records
request by citing 45 CFR 75.364, which implements 2 CFR 200.337, as well as the
NIH GPS.

38. According to the October 18, 2024, NIH ROI, on November 18, 2021, Dr. Daszak’s
November 18, 2021, letter to NIH acknowledged the records request and admitted
that EHA did not have the records supporting the experiments described in EHA’s
RPPRs and noting that the NIH request had been forwarded to WIV.

39. According to the October 18, 2024, NIH ROI, on January 6, 2022, the NIH again
requested the records and again described in detail NIH’s regulatory authority to
make the records request and fully expect that EHA would honor the request.

40. According to the October 18, 2024, NIH ROI, on January 21, 2022, Dr. Daszak wrote
to the NIH, indicating that EHA was unable to honor the records request at that time,
(“We have not received any information from [WIV]. We will inform you if and
when we receive a response.”).

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.

42. According to the October 18, 2024, NIH ROI, at no time in 2021, 2022, or 2023, did
EHA ever challenge the NIH’s regulatory authority to make the safety-related records
request of November 5, 2021, which it formally requested again on January 6, 2022.

43. According to the October 18, 2024, NIH ROI, in EHA’s October 26, 2021, letter to
the NIH, Dr. Daszak stated that EHA was unable to submit the Interim Year 5 RPPR
in a timely manner because of a systems lockout.

44. According to the October 18, 2024, NIH ROI, NIH conducted a detailed forensic
investigation indicating that Dr. Daszak and EHA were never locked out of the NIH
eRA grants system after June 19, 2021, when the NIH notified EHA of required
document submissions. To date, the NIH has not seen any documentation or phone
logs indicating that EHA was complaining about a systems lockout.

45. According to the October 18, 2024, NIH ROI, EHA as an entity, and Dr. Daszak as
an individual, failed to honor their regulatory requirements to respond appropriately
to safety-related records request. The request was triggered by Dr. Daszak’s claim
that experiments described in two different RPPRs were the same along with Dr.
Daszak’s demand from NIH that, “It is very important that these facts be
acknowledged.” To address possible serious safety-related noncompliance concerns,
NIH gave EHA and Dr. Daszak an opportunity to support his claims by submitting
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 12

original electronic files and lab notebook entries that informed their own progress
reports.

46. According to the October 18, 2024, NIH ROI, it is undisputed that EHA did not
provide the NIH with the requested records, and that EHA did not, at the time of the
request, challenge the NIH’s regulatory authority to make the request, which raised
serious concerns for NIH about possible non-compliance with the “1 log rule,” a
safety-related term and condition of award, and, therefore, the NIH’s concerns remain
regarding EHA’s ability to comply with grant award terms and conditions and
adherence to safety requirements.

47. On December 2, 2024, the SSCP Final Report was issued , titled, “After Action
Review of the COVID-19 Pandemic: The Lessons Learned and a Path Forward,”
which was officially submitted to the Congressional record on December 4, 2024.
The SSCP Final Report was the conclusion of a two-year investigation into the
COVID-19 pandemic.

48. According to the SSCP Final Report, EHA “could have chosen to submit its Year
5 RPPR and chose not to.” The SSCP Final Report stated that for project years one
through four, Dr. Daszak, in addition to submitting the annual report via the NIH
online reporting system, would routinely also send it via e-mail to its NIAID program
officer. However, when asked why he did not continue this pattern for the Year 5
Report, Dr. Daszak testified that he “wish[ed]” he did email the Year 5 Report to the
NIH grants office but did not. According to its NIAID program officer, Dr. Daszak
did not send an e-mail with the Year 5 Report until Dr. Daszak officially submitted it
August 3, 2021. In Dr. Daszak’s November 14, 2023, testimony, he testif ied that “the
information from the Year 5 Report was in the resubmitted - - [year 6 competitive]
renewal submission, in the first part of that renewal submission.” However, after a
review of the Year 6 competitive renewal, the SSCP stated that it did not b elieve the
experiment in question in the Year 5 Report was in the renewal application.
Regardless, the SSCP Final Report concluded that simply because there was a
renewal application, it did not exempt EHA from following the terms of its grant and
submitting its Year 5 Report on time. The SSCP Report cited that multiple NIH
witnesses testified that the Year 5 Report was still due on time, regardless of the
competitive renewal application.

49. According to the SSCP Final Report, Dr. Daszak’s November 14, 20 23, 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. The forensic analysis of the
NIH reporting system concluded “[t]he user was never locked out of the system.”
Further, the analysis determined that EHA accessed the reporting system at least once
a day for 72 days between July 24, 2019 and July 27, 2021. The analysis stated,
“[e]ach of those times accessing Commons was an opportunity to route the RPPR so
it could be submitted to NIH.”
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 13

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. On October 1, 2021, Dr. Daszak wrote in an email regarding
the late Year 5 Report, “[f]or your interest, here’s the truth behind the mystery: We
got our report ready to file for yr5 of the grant, but when it was re-funded, we
assumed we didn’t need to…eventually NIH wrote to us and told us to file, so we
did.”

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. EHA argued that if an experiment did violate the one
log notification requirement, it was previously reported in its Year 4 Report, which is
an argument that was contested by the NIH. The SSCP Final Report found that,
regardless, the grant term required “immediate notification,” and that simply adding
the experiment to an annual report does not satisfy that requirement.

52. According to the SSCP Final Report, to support Dr. Daszak’s claim that the Year 4
and 5 experiments were the same, he called Dr. Zhengli Shi, his collaborator at WIV,
who assured him they were the same. The NIH stated that calling Dr. Shi to “verify”
when the experiment occurred is not sufficient and that production of the underlying
data and original lab notebooks was necessary and required. The SSCP cited that in
Dr. Daszak’s November 14, 2023, testimony he stated that he was not required to
have access to or produce WIV’s underlying original lab notebooks. While Dr.
Daszak forwarded the NIH’s request for the original lab notebooks to WIV, he never
explicitly requested the notebooks from the WIV, but instead simply informed it of
the request from NIH. As such, the SSCP Final Report concluded that Dr. Daszak’s
claim that the Year 4 and 5 experiments conducted by WIV were the same, without
verifiable evidence, “lacks credibility.”

53. On December 3, 2024, the SSCP Democrats’ Final Report was issued titled, “Partisan
Probes Over Pandemic Prevention and Preparedness.” According to the SSCP
Democrats’ final report, several of the allegations in HHS’s original suspension and
proposed debarment action of EHA mirrored the SSCP’s bipartisan findings. The
report states that it identified information that draws into question EHA’s professional
conduct as a grantee and recipient of federal taxpayer funding, including that Dr.
Daszak and EHA may have misled the Federal Government about their work and
participated in other questionable conduct. The report found that as a grantee, EHA’s
questionable conduct spanned administrative issues, such as annual reporting
requirements, and substantive scientific issues, such as representations of its work in
communications with NIAID staff. Dr. Daszak also engaged in conduct outside the
scope of EHA’s grant that raises reasonable questions regarding his professional
integrity.

54. According to the SSCP Democrats’ Final Report, during Dr. Daszak’s November 14,
2023, SSCP interview, and again during his May 1, 2024, SSCP hearing, Dr. Daszak
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 14

testified that EHA was not required to have access to or produce WIV’s underlying
original lab notebooks. According to the SSCP Final Report, it appears that Dr.
Daszak never explicitly requested the original lab notebooks from WIV in writing,
and did nothing further to respond to the NIH’s requests for the notebooks after
passively forwarding the NIH’s November 15, 2021, email to WIV.

55. According to the SSCP Democrats’ Final Report, questions were raised regarding
EHA’s truthfulness, citing EHA’s assertion that it attempted an early upload of the
Year 5 RPPR in July 2019 but claimed to be locked out, and the NIH’s electronic
forensic investigation, which found no evidence supporting EHA’s claim of being
locked out. The SSCP Democratic Staff Final Report also noted that the HHS OIG
was unable to validate EHA’s assertions. The SSCP Democrats’ Final Report stated
that EHA staff have consistently maintained that they uploaded the Year 5 RPPR in
July 2019, but that when they tried to officially submit the report, they were locked
out of NIH’s electronic filing system. EHA claims that NIH never responded to
outreach or asked for the report, which EHA took to mean that its submission was not
required. The report states that he documentary evidence available to the SSCP
appears to be inconsistent with a July 2019 upload and system lockout, and that the
SSCP received no records or communication to corroborate a late July 2019 upload or
a system lockout.

56. According to the SSCP Democrats’ Final Report, at Dr. Daszak’s November 14,
2023, transcribed interview, he suggested that the absence of documentary evidence
was consistent with EHA’s later unsuccessful efforts to communicate with the grants
officer exclusively by phone. The SSCP Democrat’s Final Report stated that given
that EHA had emailed the grants officer regarding the report at least twice in the final
two weeks of July 2019, it was difficult to conceive that EHA would shift and persist
in a different pattern of communication despite their unsuccessful efforts. The SSCP
Democrats’ Final Report found that EHA’s claimed reliance on a resolution over
phone is particularly questionable considering Dr. Daszak had emailed copies of
EHA’s RPPRs to grants or program of ficers in previous years, and, on occasion,
ahead of official submission.

57. According to the SSCP Democrats’ Final Report, based on the available evidence,
EHA did not adequately monitor virus growth WIV’s experiments 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, notwithstanding EHA’s arguments to the
contrary.

RESPONDENT’S RESPONSE TO MAY 15, 2024, NOTICE AND ARM

The May 15, 2024, Notice and ARM, for EHA were transmitted to Dr. Peter Daszak,
EHA’s President and Chief Executive Officer at that time, via electronic mail to his email
address of record at that time, daszak@ecohealthalliance.org. The May 15, 2024, Notice and
ARM provided Dr. Daszak with the opportunity to submit information and argument in
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 15

opposition to the suspension and proposed debarment actions within 30 days of receipt of the
documents. On June 3, 2024, Dr. Daszak’s and, at that time, EHA’s designated attorney
representative in this matter, Paul Hurst, Partner at Steptoe LLP, requested an extension to
provide a response by July 22,2024, which was granted by the HHS SDO.

On July 22, 2024, on behalf of EHA and Dr. Daszak, Mr. Hurst submitted a response to
the suspension and proposed actions, which were added to the administrative record for this
matter. In addition, on September 19, 2024, Mr. Hurst submitted a proposed Administrative
Agreement on behalf of EHA and Dr. Daszak to resolve the suspension and debarment
proceedings, which was also added to the administrative record for this matter.

As stated in the December 11, 2024, Amended Notice and Amended ARM, I reviewed
the July 22, 2024, response and found that it did not sufficiently address the following concerns
regarding EHA and Dr. Daszak, identified in the information in the record: 1) ongoing safety
concerns regarding a lack of technical oversight of high-risk virology research being conducted
through EHA’s grant awards; 2) questions about EHA’s and Dr. Daszak’s professiona l integrity
due to providing inaccurate and misleading information; and 3) EHA’s ongoing administrative
management issues of its active grant awards and subawards. Also, as stated in the December 11,
2024, Notice and ARM, I found that the September 19, 20 24, proposed Administrative
Agreement stated that EHA represented that all written materials and other information supplied
to HHS by its authorized representatives during the course of discussion with HHS preceding the
proposed Administrative Agreement were true and accurate in all material respects, to the best of
EHA’s information and belief. However, as stated in the December 11, 2024, Amended Notice
and Amended ARM, I found that the information in the proposed Administrative Agreement was
inconsistent with the information in the record, as further indicated in the October 18, 2024, NIH
ROI and the SSCP Final Reports. In addition, I found that the proposed Administrative
Agreement did not provide adequate detail regarding internal controls and policies a nd
procedures that EHA had implemented/would implement, to ensure compliance with its grant
awards related to allowable costs, reporting, subaward agreements, etc.

RESPONDENT’S RESPONSE TO THE DECEMBER 11, 2024, AMENDED
NOTICE AND AMENDED ARM

The December 11, 2024, Amended Notice and Amended ARM for EHA, which amended
the May 15, 2024, Notice and ARM, were sent by electronic mail to Mr. Hurst, at
phurst@steptoe.com, on December 12, 2024. On January 7, 2025, EHA notified HHS that it was
no longer being represented by Steptoe LLP in this matter, and that EHA had retained the law
firm of Arnold & Porter Kaye Scholer LLP as its representation in this matter. EHA also
informed HHS that, effective January 6, 2025, Dr. Peter Daszak was no longer employed by
EHA.

On January 13, 2025, Alex Sirio and Charles Blanchard from Arnold & Porter submitted
a response to the December 11, 2024, Amended Notice and Amended ARM, on behalf of EHA,
which included a proposed Administrative Agreement. On January 15, 2025, a PMIO meeting
was conducted between HHS and EHA and its attorney representatives. Following the meeting,
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 16

Mr. Blanchard submitted additional information, on behalf of EHA, all of which has been added
to the administrative record and has been taken into consideration in my final decision.

The January 13, 2025, and January 15, 2025, responses stated the following:

x EHA believes that it has demonstrated its present responsibility with the remedial actions
that the organization has already undertaken, including the closure of a number of federal
audits of EcoHealth Alliance and the reduction of some special conditions imposed by
NIH, along with the following undertakings: (1) the termination of Dr. Peter Daszak as
President and Chief Executive Officer, effective January 6, 2025; (2) the appointment of
an experienced interim leadership team dedicated to enhancing the organizatio n’s ethics,
compliance, and monitoring policies and practices; (3) the appointment of an independent
monitor; (4) the emplacement of new leadership at the Board of Directors level; and (5) a
commitment to focus on One Health-principled research.
x EHA will return to its focus on One Health principles, including understanding the
conservation and health impacts of ecological disruption on human and animal
populations. The organization commits not to directly conduct nor directly fund nor
financially support any recombinant virus research. EcoHealth Alliance scientists will
strictly adhere to best biosafety practices while conducting research and ensure that all
field and laboratory work is conducted at appropriate biosafety levels in compliance
with—or exceeding—U.S. federal regulations.
x EHA takes its legal and ethical obligations as a federal grant recipient very seriously. The
organization is committed to operating with the highest standards of integrity and
transparency and, in that vein, has implemented a number of corrective actions
specifically designed to ensure that both EcoHealth Alliance and its subrecipients
maintain full compliance with federal grant laws and regulations.
x EHA understands that fostering a culture of compliance, integrity, and transparency
begins at the top: the organization’s executive leadership must exemplify and reinforce
the fundamental importance of these values at all times and in all respects. EcoHealth
Alliance is therefore dedicated to selecting a management team of individuals whose
credentials and accomplishments demonstrate a strong commitment to those core values.
x On January 2, 2025, EcoHealth Alliance’s Board of Directors voted to terminate Dr.
Daszak as President and CEO of the organization. The Board took this action bec ause it
no longer had confidence in Dr. Daszak’s leadership. Dr. Daszak’s termination became
effective on January 6, 2025. Going forward, Dr. Daszak will not have any involvement
in the operation or management of EcoHealth Alliance.
x Effective January 6, 2025, EHA’s Board appointed Dr. Kevin Olival, EHA’s Vice
President for Research, and Dr. Jonathan Epstein, EHA’s Vice President for Science and
Outreach, who have been with EHA for over thirty-seven years between them, were
appointed by the Board to co-lead the EHA’s interim leadership team. Drs. Olival and
Epstein are in the process of developing plans and procedures to enhance EHA’s
compliance policies and procedures and to implement a search guided by both external
experts and stakeholders as well as the Board for a new President/CEO. Joseph Riccardi
will continue in his role as Chief Financial Officer. The EHA Board recently signed an
agreement with Dr. William Karesh, under which Dr. Karesh will serve as the
organization’s Special Consultant for Interim Management Affairs. On August 2, 2024,
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 17

Stephen Shapiro was named interim EHA Board Chair. Mr. Shapiro is Managing Partner
of BSR Investments and the Benjamin Shapiro Realty LLC.
x EHA has updated its Policy on Subaward Contracts and Monitoring, which applies to all
subawards issued by EHA under federally and privately sponsored programs.
x EHA has updated its NIH Subaward Agreement Template, which applies to all
subawards entered into by EHA with outside organizations to perform NIH grant-
supported research activities.
x EHA has updated its Guidance on Foreign Subrecipient Risk Mitigation, to acknowledge
EHA’s responsibility for monitoring subrecipients to ensure compliance with federal
regulations and grant terms and conditions.
x EHA has updated its Employee Handbook, which implements an organization-wide
standard of conduct for all employees and requires employees to comply with applicable
laws, regulations, and policies.
x EHA has developed a Policy on Principal Investigator Eligibility that establishes key
responsibilities for all Principal Investigators, including timely reporting to the project
sponsor as required by the terms of the award, completing required trainings, including
training on subrecipient monitoring, animal biosafety requirements, and research security.
x EHA is in the process of developing Guidelines for Field Biosafety to ensure that field
research is being conducted in accordance with the highest safety standards, which will
address hazard identification, risk management, risk mitigation (including elimination
and substitution control protocols, engineering control protocols, administrative control
protocols, and personal protective equipment control protocols), pathogen exposure and
response, biosecurity during animal activities, field biosafety levels, and the
organization’s prohibition on any recombinant virus research.
x EHA is in the process of developing a Research Security Program, designed to be
consistent with National Security Presidential Memorandum–33, that will enhance
EHA’s ability to safeguard against improper or illicit activity, including misuse of federal
funds, and alleviate the risks and concerns presented by the global landscape for research
institutions.
x EHA is creating a Business Ethics and Conduct Code which will, among other things,
provide notice to all employees that the highest standard of business ethics is expected
and will also address key ethics and compliance risks associated with EHA’s federal
grants.
x EHA is in the process of creating an Employee Ethics “Hotline” through which
employees may report anonymously any ethics or compliance concerns, including
suspected violations
x All EHA Principal Investigators/Project Directors and responsible personnel (including
Finance, Operations, and Program Management Teams) at EHA will engage in additional
training related to federal grants and will be subject to the oversight of a new committee
managed by, and reporting to, EHA’s Board of Directors.
x EHA has updated its policy to specify procedures and timelines for preparing any federal
award report and implemented internal review controls and deadlines.
x EHA has updated its policy and all subaward contracts to require that subaward reporting
is due no later than one month prior to any EcoHealth Alliance repo rting deadline to a
funder, to allow time for information synthesis and inclusion.
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 18

x EHA has expanded its Funding Action Board to include those with roles in Research
Administration who have responsibility to help prepare and track reports, and meets
weekly and serves as a forum for tracking deadlines and other compliance items on active
awards.
x EHA has implemented grant management software, which allows EHA to configure
automated reminders to Principal Investigators and Research Administrators at repeated,
specified amounts of time prior to any deadline.
x EHA now requires review and any necessary revision of its policies at least annually, but
more frequently as necessary to remain current with federal regulations.
x EHA has installed checks and balances to ensure the least possible risk of compliance
failure.
x The EHA Executive Team, which includes the Vice President for Grant Compliance and
Policy, meets regularly (at least once per week).
x The proposed Administrative Agreement submitted for the SDO’s consideration stated
the following:
o EHA shall have a values-based Ethics and Compliance Program with the
following components: Policy on Subaward Contracts and Monitoring; EHA-NIH
Subaward Agreement Template; Policy and Procedure for Reporting on Federal
Awards; Semi-Annual Reporting Addendum; Guidance on Foreign Subrecipient
Risk Mitigation; Guidelines for Field Biosafety; Employee Handbook; Research
Security Program; Malign Foreign Talent Recruitment Program (MFTRP) Policy;
and Policy on Principal Investigator Eligibility.
o EHA shall adopt a separate Code of Business Ethics and Conduct.
o EHA will create a “hotline” for reporting potential violations of federal laws and
EHA's policies and procedures, which must be available to receive information 24
hours a day, 7 days a week.
o EHA will develop and Ethics and Compliance Training Program.
o EHA’s Board of Directors will continue to take a more active role in overseeing
the organization’s compliance enhancements.
o EcoHealth Alliance will maintain a Funding Action Board to oversee active
awards issued to EHA and to tracks reporting deadlines.
o EHA will appoint an Independent Monitor to oversee and review its compliance
with the proposed Administrative Agreement.
o EHA will not directly conduct nor directly fund nor financially support any
recombinant virus research.

DISCUSSION

The Nonprocurement Common Rule at 2 C.F.R. § 180.860 lists a number of mitigating
and aggravating factors a debarring official may consider in determining whether to debar an
entity or individual in determining the length of the debarment period. The appropriateness of the
mitigating and aggravating factors provided in 2 C.F.R. §180.860 are evaluated in the context of
the seriousness of the cause(s) and conditions that gave rise to the suspension and proposed
debarment. 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 EHA is appropriate:
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 19

x 2 C.F.R § 180.860(a) – The actual or potential harm or impact that results or may result
from the wrongdoing.

EHA failed to comply with safety-related reporting requirements and records
request. Safety is a consideration in all biomedical research. The kind of research
conducted by 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. To
assure the government that research will be conducted safely, and that public health will
not be endangered, it is essential that the work is conducted with in an organizational
culture of safety and follows sponsored project’s reporting requirements.

Failure to do so as observed in this matter significantly poses a threat to public
safety and public health. In an organizational culture of safety, concerns are addressed
quickly, seriously, and with the highest degrees of integrity. In this matter, EHA’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 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 EHA’s past wrongdoing continues to present harm. EHA only appeared
to recognize the seriousness of HHS’ and the NIH’s concerns upon being suspende d and
proposed for debarment in May 2024, despite the numerous written letters and emails
from NIH to EHA documenting concerns going back several years. This leads to
questions regarding whether EHA’s statements claiming to recognize the seriousness of
the concerns identified are genuine. Though I initially took exclusion action against EHA
in May of 2024, and through Amended Notice and Amended ARM in December of 2024,
it was not until January 6, 2025, and days thereafter, that I received notice of Dr.
Daszak’s termination, and was presented with a proposed Administrative Agreement
shortly thereafter. In both instances of the Notice and Amended Notice, opportunities
were provided to present a meaningful Administrative Agreement. EHA did not take
advantage of these opportunities that were given to present a meaningful agreement until
it was clear that HHS had lost confidence in its ability to manage any federal award. In
short, EHA’s changes came too late, so I do not believe in their authenticity. Therefore,
based on the information in the record, I find this to be an applicable aggravating factor
for consideration in this case.

Therefore, I have determined that EHA’s noncompliance with Government award
regulations, and failure to acknowledge and failed attempts to correct this violation, is an
aggravating factor for consideration that additionally supports my decision to debar EHA
for a period of five years.
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 20

x 2 C.F.R. § 180.860 (b) – The frequency of incidents and/or duration of the wrongdoing.

As established in the information in the record, EHA submitted the Year 5 I-
RPPR for Grant Number 5R01AI110964-05, on August 3, 2021, nearly two years after
the report due date. 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. I find the duration of the two
occurrences of wrongdoing to be substantial and significant since they inhibited the
NIH’s ability to thoroughly assess the research being conducted under NIH-funded grant
awards.

Also as previously stated, EHA only appeared to recognize the seriousness of
HHS’ and the NIH’s concerns upon being suspended and proposed for debarment in May
2024, despite the numerous written letters and emails from NIH to EHA documenting
concerns going back several years. This leads to questions regarding whether EHA’s
statements claiming to recognize the seriousness of the concerns identified are genuine.
Though I initially took exclusion action against EHA in May of 2024, and through
Amended Notice and Amended ARM in December of 2024, it was not until January 6,
2025, and days thereafter, that I received notice of Dr. Daszak’s term ination, and was
presented with a proposed Administrative Agreement shortly thereafter. In both instances
of the Notice and Amended Notice, opportunities were provided to present a meaningful
Administrative Agreement. EHA did not take advantage of these op portunities that were
given to present a meaningful agreement until it was clear that HHS had lost confidence
in its ability to manage any federal award. In short, EHA’s changes came too late, so I do
not believe in their authenticity. Further, there has not been enough time to assess the
efficacy of the EHA’s updates.

x 2 C.F.R. § 180.860 (c) – Whether there is a pattern or prior history of wrongdoing. For
example, if you have been found by another Federal agency or a State agency to have
engaged in wrongdoing similar to that found in the debarment action, the existence of
this fact may be used by the debarring official in determining that you have a pattern or
prior history of wrongdoing.

Based on the information in the record, I find that there is not enough information
to assess the applicability of this factor to the circumstances of this case.

x 2 C.F.R. § 180.860 (d) – Whether you are or have been excluded or disqualified by an
agency of the Federal Government or have not been allowed to participate in State or
local contracts or assistance agreements on a basis of conduct similar to one or more of
the causes for debarment specified in this part.
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 21

I note that Congress has limited the use of Department of Defense fun ds for
certain work performed by EcoHealth Alliance. See, e.g., the Further Consolidated
Appropriations Act of 2024 (P.L. 118-47), Division A (Department of Defense
Appropriations Act, 2024), Sec. 8143: “None of the funds made available by [Division
A] may be used to fund any work to be performed by EcoHealth Alliance, Inc. in China
on research supported by the government of China unless the Secretary of Defense
determines that a waiver to such prohibition is in the national security interests of the
United States…” (applicable to FY 2025 through continuing resolution, P.L. 118 -158,
Dec. 21, 2024).

x 2 C.F.R. § 180.860 (e) – Whether you have entered into an administrative agreement with
a Federal agency or a State or local government that is not governmentwide but is based
on conduct similar to one or more of the causes for debarment specified in this part.

Based on the information in the record, I find that there is not enough information
to assess the applicability of this factor to the circumstances of this case.

x 2 C.F.R. § 180.860 (f) – Whether and to what extent you planned, initiated, or carried out
the wrongdoing.

Based on the information in the record, I find that there is not enough information
to assess the applicability of this factor to the circumstances of this case.

x 2 C.F.R. § 180.860 (g) – Whether you have accepted responsibility for the wrongdoing
and recognize the seriousness of the misconduct that led to the cause for debarment.

According to the January 15, 2025, response, “EHA believes that it has
demonstrated its present responsibility with the remedial actions that the organization has
already undertaken, including the closure of a number of federal audits of EcoHealth
Alliance and the reduction of some special conditions imposed by NIH, along with the
following undertakings: (1) the termination of Dr. Peter Daszak as President and Chief
Executive Officer, effective January 6, 2025; (2) the appointment of an experienced
interim leadership team dedicated to enhancing the organization’s ethics, compliance, and
monitoring policies and practices; (3) the appointment of an independent monitor; (4) the
emplacement of new leadership at the Board of Directors level; and (5) a commitment to
focus on One Health-principled research.”

While I acknowledge receiving EHA’s statement that it has accepted
responsibility, I do not believe the information in the record adequately demonstrates that
EHA has fully accepted responsibility for its role in the wrongdoing. For instance, to
date, EHA still claims that it did not submit its Year 5 I-RPPR on time due to being
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 22

locked out of eRA Commons, despite the forensic evidence presented by the NIH, and
the findings presented in the two final Congressional Staff reports.

In addition, as previously stated, the changes made by EHA are not sufficient for
consideration in EHA’s acceptance of responsibility. EHA only appeared to recognize the
seriousness of HHS’ and the NIH’s concerns upon being suspended and proposed for
debarment in May 2024, despite the numerous written letters and emails from NIH to
EHA documenting concerns going back several years. This leads to questions regarding
whether EHA’s statements claiming to recognize the seriousness of the concerns
identified are genuine. Though I initially took exclusion action against EHA in May of
2024, and through Amended Notice and Amended ARM in December of 2024, it was not
until January 6, 2025, and days thereafter, that I received notice of Dr. Daszak’s
termination, and was presented with a proposed Administrative Agree ment shortly
thereafter. In both instances of the Notice and Amended Notice, opportunities were
provided to present a meaningful Administrative Agreement. EHA did not take advantage
of these opportunities that were given to present a meaningful agreement u ntil it was
clear that HHS had lost confidence in its ability to manage any federal award. In short,
EHA’s changes came too late, so I do not believe in their authenticity.

x 2 C.F.R. § 180.860 (h) – Whether you have paid or agreed to pay all criminal, civil and
administrative liabilities for the improper activity, including any investigative or
administrative costs incurred by the government, and have made or agreed to make full
restitution.

Based on the information in the record, I find that there is not enough information
to assess the applicability of this factor to the circumstances of this case.

x 2 C.F.R. § 180.860 (i) – Whether you have cooperated fully with the government agencies
during the investigation and any court or administrative action. In determining the extent
of cooperation, the debarring official may consider when the cooperation began and
whether you disclosed all pertinent information known to you.

The October 18, 2024, ROI submitted by NIH raised serious concerns of doubt in
EHA’s cooperation in responding truthfully to questions to fully assess EHA’s
compliance practices with NIH grant awards. Full cooperation in compliance assessments
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 23

require disclosure of all pertinent information requested. Specifically, there were three
instances that demonstrated a lack of full cooperation:

1. The claim that the experiments in the Year 4 and Year 5 progress report were the
same.
2. The claim that the delay in submitting the Year 5 progress report was due to a
computer system lockout.
3. The failure to make any reasonable effort to obtain records from a subrecipient in
response to NIH’s multiple safety-related requests.

I find that EHA’s conduct in each of these three instances represents a failure on the part
of EHA to cooperate fully with the NIH as it was conducting its compliance review.

x 2 C.F.R. § 180.860 (j) – Whether the wrongdoing was pervasive within the organization.

Based on the information in the record, I find that there is not enough information
for me to assess the applicability of this factor to the circumstances of this case.

x 2 C.F.R. § 180.860 (k) – The kind of positions held by the individuals involved in the
wrongdoing.

As established in the information in the record, Dr. Daszak was the President and
Chief Executive Officer of EHA from 2009 until his termination, effective January 6,
2025. Dr. Daszak was also the PD/PI for Grant Number R01AI110964. The NIH PD/PI
has overall responsibility for the design, conduct, reporting and scientific integrity of the
research. As a PD/PI, Dr. Daszak was responsible for ensuring full compliance with
applicable HHS and NIH regulations and guidelines, and the terms and conditions of the
grant awards.

x 2 C.F.R. § 180.860 (l) – Whether the organization took appropriate corrective action or
remedial measures, such as establishing ethics training and implementing programs to
prevent recurrence.

Also as previously stated, EHA only appeared to recognize the seriousness of
HHS’ and the NIH’s concerns upon being suspended and proposed for debarment in May
2024, despite the numerous written letters and emails from NIH to EHA documenting
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 24

concerns going back several years. This leads to questions regarding whether EHA’s
statements claiming to recognize the seriousness of the concerns identified are genuine.
Though I initially took exclusion action against EHA in May of 2024, and through
Amended Notice and Amended ARM in December of 2024, it was not until January 6,
2025, and days thereafter, that I received notice of Dr. Daszak’s termination, and was
presented with a proposed Administrative Agreement shortly thereafter. In both instances
of the Notice and Amended Notice, opportunities were provided to present a meaningful
Administrative Agreement. EHA did not take advantage of these opportunities that were
given to present a meaningful agreement until it was clear that HHS had lost confidence
in its ability to manage any federal award. In short, EHA’s changes came too late, so I do
not believe in their authenticity. Further, there has not been enough time to assess the
efficacy of the EHA’s updates.

x 2 C.F.R. § 180.860 (m) – Whether the principals tolerated the offense.

Based on the information in the record, I find that there is not enough information
to assess the applicability of this factor to the circumstances of this case.

x 2 C.F.R. § 180.860 (n) – Whether the activity cited as a basis for the debarment was
brought to the attention of the appropriate government agency in a timely manner.

Based on the information in the record, I find that there is not enough information
to assess the applicability of this factor to the circumstances of this case.

x 2 C.F.R. § 180.860 (o) – Whether the circumstances surrounding the cause for
debarment have been fully investigated and, if so, the results of the investigation have
been made available to the debarring official.

Based on the information in the record, I find that there is not enough information
to assess the applicability of this factor to the circumstances of this case.

x 2 C.F.R. § 180.860 (p) – Whether there were effective standards of conduct and internal
control systems in place at the time the questioned conduct occurred.

As established in the record and by EHA’s and Dr. Daszak’s own admissions,
EHA had significant failings in its internal control systems and policies and procedures at
the time the questioned conduct and wrongdoing occurred. Therefore, I have determined
that EHA’s noncompliance with Government award regulations, and failure to
acknowledge and failed attempts to correct this violation, is an aggravating factor for
consideration that additionally supports my decision to debar EHA for a period of five
years.
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 25

x 2 C.F.R. § 180.860 (q) – Whether appropriate disciplinary action has been taken against
the individuals responsible for the activity which constitutes the cause for debarment.

As previously noted, Dr. Daszak was terminated by EHA, effective January 6,
2025. I acknowledge EHA’s action to terminate Dr. Daszak demonstrates that EHA holds
him largely responsible for the misconduct and activity that constitutes the cause for
debarment in this case, as he was the President of EHA at the time the misconduct
occurred, and the PD/PI for Grant Number RO1AI110964. However, despite ongoing
exchanges between EHA and NIH over safety concerns related to inadequate oversight of
high-risk virology research funded through EHA’s grants—concerns that spanned several
years—EHA failed to take disciplinary action until after the issuance of the Amended
Proposal for Debarment by HHS on December 11, 2024. This delayed response
highlights a lack of accountability within EHA and reflects an organizational culture that
deprioritizes biosafety in high-risk research.

Furthermore, Select Subcommittee reports made public in May 2024 raised
significant questions about the professional integrity of both EHA and Dr. Daszak. Yet,
EHA did not act until January 6, 2025, to terminate Dr. Daszak, and even now, EHA can
only point to ongoing policy changes without clear evidence of a cultural shift that
prioritizes biosafety or integrity. This inaction underscores a concerning lack of present
responsibility for managing federal awards.

Therefore, while this is a mitigating factor, I am giving less weight to this because
of the timing and my ongoing concerns about EHA’s organizational culture.

x 2 C.F.R. § 180.860 (r) – Whether there has been adequate time to eliminate the
circumstances within the organization that led to the cause for the debarment.

As previously state, EHA submitted the Year 5 I-RPPR for Grant Number
5R01AI110964-05, on August 3, 2021, nearly two years after the report due date. 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. I find the duration of the two occurrences of
wrongdoing to be substantial and significant since they inhibited the NIH’s ability to
thoroughly assess the research being conducted under NIH-funded grant awards.

Also as previously stated, EHA only appeared to recognize the seriousness of
HHS’ and the NIH’s concerns upon being suspended and proposed for debarment in May
2024, despite the numerous written letters and emails from NIH to EHA documenting
concerns going back several years. This leads to questions regarding whether EHA’s
statements claiming to recognize the seriousness of the concerns identified are genuine.
Though I initially took exclusion action against EHA in May of 2024, and through
Amended Notice and Amended ARM in December of 2024, it was no t until January 6,
2025, and days thereafter, that I received notice of Dr. Daszak’s termination, and was
presented with a proposed Administrative Agreement shortly thereafter. In both instances
of the Notice and Amended Notice, opportunities were provided to present a meaningful
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 26

Administrative Agreement. EHA did not take advantage of these opportunities that were
given to present a meaningful agreement until it was clear that HHS had lost confidence
in its ability to manage any federal award. In short, EHA’s changes came too late, so I do
not believe in their authenticity. Further, there has not been enough time to assess the
efficacy of the EHA’s updates. Considering the length of time that lapsed during EHA’s
performance as a grant recipient, the potential health consequences and repercussions
stemming from their violations, represents that there is continued potential harm and
health risks caused by EHA.

x 2 C.F.R. § 180.860 (s) – Whether any business, technical, or professional license(s) has
been suspended, terminated, or revoked.

Based on the information in the record, I find this to be inapplicable to the
circumstances in this case.

x 2 C.F.R. § 180.860 (t) – Other factors that are appropriate to the circumstances of a
particular case.

Pursuant to 45 C.F.R 75.303(a), Federal grant recipients are required by law to
“establish and maintain effective internal control over the Federal award that provides
reasonable assurance that the non-Federal entity is managing the Federal award in
compliance with Federal statutes, regulations, and the terms and conditions of the Federal
award”. NIH’s interactions with Dr. Daszak in his capacity as President and Chief
Executive Officer at EHA, as well as numerous other examples cited in the Republican
and Democratic House Committee reports, indicate that the “Tone at the Top” of EHA
did not demonstrate present responsibility with Dr. Daszak as the leader. While it is true
that as of January 6, 2025, EHA has terminated Dr. Daszak, this only came after a long
delay. Furthermore, the culture that Dr. Daszak has established over his many years of
leading EHA (since 2009) is one that cannot be transformed overnight.

FINDINGS

As stated in the May 15, 2024, Notice and ARM, and December 11, 2024, Amended
Notice and Amended ARM, pursuant to 2 C.F.R. § 180.800, a federal agency may debar an
entity or individual for “any other cause of so serious or compelling a nature that it affects their
present responsibility.” See 2 C.F.R. § 180.800(d). I find the serious and egregious nature of the
Action Referral Memorandum for the Debarment of EcoHealth Alliance, Inc. page 27

misconduct committed by EHA indicates a lack of business integrity and business honesty,
thereby directly affecting its present responsibility, and provides cause for the debarment of
EHA, pursuant to 2 C.F.R. § 180.800(d).

DECISION

Pursuant to 2 C.F.R. §180.865, if the suspending and debarring official determines that a
period of debarment is necessary, the length of the period of debarment will be based on the
seriousness of the cause(s) upon which the respondent’s debarment is based. While the typical
debarment period should not exceed three years, if circumstances warrant, the suspending and
debarring official may impose a longer period of debarment. In these types of cases, the
suspending and debarring official considers the seriousness of the conduct (“acts or omissions”)
and its effect on the respondent’s present responsibility and any mitigating or aggravating factors
identified in the record. See 2 C.F.R. § 180.845(a).

Based on the information presented in the administrative record and the aggravating and
mitigating factors set forth in this document, including EHA’s aforementioned responses to the
suspension and proposed debarment actions, I have determined that a five-year debarment period
for EHA is necessary to protect the United States Federal Government’s interests. I acknowledge
and understand that debarment is an administrative remedy that is serious in nature and is not an
action to be taken lightly. However, given the seriousness of the misconduct, as presented in the
administrative record, the Federal Government’s interests must be protected accordingly. In
making this determination, I reviewed the totality of the information in the administrative record,
including all information submitted by EHA in response to the suspension and debarment
actions, and determined that EHA has not demonstrated, to my satisfaction, that it is presently
responsible to be a steward of federal funds. Therefore, I have determined that a debarment
period is necessary to protect the Federal Government’s interests.

Pursuant to 2 C.F.R. Part 180, which was adopted and given regulatory effect by HHS at
2 C.F.R. Subpart 376.10, and based upon the administrative record and the findings herein, EHA
is hereby debarred for a period of five years. The debarment is effective from the date of this
ARM and the accompanying Notice. The period of ineligibility during EHA’s suspension and
proposed debarment, which was effective May 15, 2024, will be included in the period of
debarment. Therefore, under the five-year period of debarment, EHA will remain ineligible
through May 14, 2029. The debarment is effective for covered transactions subject to the
prohibitions of 2 C.F.R. §180 and contracts that are subject to the Federal Acquisition Regulation
(48 C.F.R. chapter 1), throughout the executive branch of the United States Federal Government,
unless an agency head or an authorized designee grants an exception in writing.

Suspension & Debarment Official and
Deputy Assistant Secretary for Acquisitions

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