Declaration of Gorka Garcia-Malene — Empower Oversight v. National Institutes of Health
Summary
Declaration of Gorka Garcia-Malene, the Freedom of Information Act (FOIA) Officer, National Institutes of Health, filed 06/10/22 as Document 37-1 in Case No. 1:21-cv-1275 (LMB/JFA), Empower Oversight Whistleblowers & Research v. National Institutes of Health, in the Eastern District of Virginia. The declarant says its purpose is to describe NIH's administrative handling and processing of Plaintiff's FOIA requests, and describes NIH's standard review process. It describes Plaintiff's FOIA Request 56712, received July 15, 2021, which sought communications about the posting and withdrawal of SARS-CoV-2 sequences on the Sequence Read Archive and an NIH statement released on June 23, 2021. It says NIH denied expedited processing on August 4, 2021 and that Plaintiff filed suit on November 17, 2021.
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Cite this document
“Declaration of Gorka Garcia-Malene — Empower Oversight v. National Institutes of Health.”
Original at archive.org. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/gov-uscourts-vaed-516270-37-1-845f4f804d/
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DEX 1
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IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF VIRGINIA
Alexandria Division
EMPOWER OVERSIGHT )
WHISTLEBLOWERS & RESEARCH, )
)
Plaintiff, )
) Case No. 1:21-cv-1275 (LMB/JFA)
v. )
)
NATIONAL INSTITUTES OF HEALTH, )
)
Defendant. )
)
)
DECLARATION OF GORKA GARCIA-MALENE
I, Gorka Garcia-Malene, declare as follows:
1. I am the Freedom of Information Act (“FOIA”) Officer, National Institutes of
Health (“NIH”), U.S. Department of Health and Human Services (“HHS” or the “Department”).
I have held this position with NIH since October 15, 2017.
2. My duties include responding to requests for NIH records under FOIA, 5 U.S.C.
§ 552. These duties include managing searches for NIH records in response to FOIA requests,
providing guidance to NIH record custodians or personnel regarding these searches, and
determining whether to release or withhold records or portions of records in accordance with
FOIA and HHS regulations implementing FOIA.
3. I make this declaration based upon my personal knowledge and information
available to me in my official capacity. I have reviewed all documents at issue in the above-
captioned litigation.
4. The purpose of this declaration is to describe NIH’s administrative handling and
processing of Plaintiff’s FOIA requests that are at issue in the above-captioned litigation.
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NIH’s Standard Review Process
5. NIH is the nation’s medical research agency, seeking to make discoveries that
improve health and save lives. It is made up of 27 different components, each of which has its
own research agenda.
6. The NIH FOIA program is decentralized. Each institute or center (IC) has a
FOIA staff dedicated to responding to requests. Requesters can send requests to the IC of
interest or to the NIH Office of the Director (OD). When an IC receives a request, it is placed
into one of two tracks: Simple or Complex.
7. When responding to a FOIA request, the FOIA staff conducts a page-by-page,
word-by-word review of all potentially responsive records to determine whether the document
is responsive to the request, whether the information is publicly available, whether information
should be withheld under one or more of the nine exemptions to the FOIA, and whether the
records contain the equities of other federal agencies or third-party stakeholders. During the
review process, FOIA staff will consult with HHS program offices, federal agencies, or any
other stakeholders of the records involved, as appropriate.
8. When a request requires a partial or full denial under a FOIA exemption, or
relates to COVID, the request is transferred to the OD FOIA program. In these cases, my
office conducts a word-by-word review to evaluate any proposed withholding.
9. When the records are finalized, a response letter is prepared detailing the number
of pages processed, the number of pages withheld in part, the number of pages withheld in full,
the number of pages sent for referral, and the reasons for any withholdings. If the records have
been made available to the public during the time between the FOIA request and my office’s
review, we send a letter to the requestor detailing where they may access the publicly-available
2
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records.
Administrative Processing of Plaintiff’s FOIA Requests
Plaintiff’s FOIA Request 56712
10. On July 15, 2021, Defendant received a FOIA request via electronic mail sent to
“nihfoia@mail.nih.gov” dated July 14, 2021 which stated, in relevant parts:
1) All communications regarding the request to post the SARS-CoV-2 sequences
to the Sequence Read Archive in March 2020. This request covers all
communications between March 1, 2020 to March 31, 2020.
2) All communications regarding the request to withdraw the SARS-CoV-2
sequences from Sequence Read Archive in June 2020. This request covers all
communications between June 1, 2020 to June 31, 2020.
3) All communications regarding these withdrawn sequences as reported by a
preprint titled “Recovery of deleted deep sequencing data sheds more light on the
early Wuhan SARS-CoV-2 epidemic” by Jesse Bloom, a virologist at the Fred
Hutchinson Cancer Research Center. This request covers all communications
between Jesse Bloom and the NIH, from January 1, 2021 and the present. This
request all covers all communications inside the NIH regarding the preprint from
June 21, 2021 to the present.
.
4) All communications to, from, and within the NIH press office about the NIH
statement released on June 23, 2021, and about reports that these sequences were
removed from the Sequence Read Archive. This includes all emails related to the
drafting of the statement, communications about the reported removal, and
communications with reporters. This request covers all communications between
June 21, 2021 to June 25, 2021.
11. A complete and accurate copy of this correspondence is attached hereto as
Attachment A.
12. On the same day it received it, July 15, 2021, NIH assigned Plaintiff’s FOIA
Request, the internal control number 56712 (“Plaintiff’s FOIA Request 56712”).
13. On August 4, 2021, NIH sent Plaintiff a letter indicating that it had denied
Plaintiff’s request for expedited processing. A copy of this correspondence is attached to this
Declaration as Attachment B.
3
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14. On November 17, 2021, Plaintiff filed suit against NIH in the United States
District Court, Eastern District of Virginia, Alexandria Division. A copy of this Complaint is
attached to this Declaration as Attachment C. Plaintiff also filed an Amended Complaint on
March 1, 2022. A copy of this Amended Complaint is attached to this Declaration as
Attachment D.
15. The NIH Sequence Read Archive, or SRA, is a repository for high-throughput
sequencing data. It is hosted by the National Center for Biotechnology Information (NCBI) at
the National Library of Medicine (NLM).
16. For purposes of background and related to Items 1 and 2 of Plaintiff’s FOIA
Request 56712, NCBI normally uses a database for tracking communications between curators
and submitters to NCBI databases (including SRA). In response to Items 1 and 2 of Plaintiff’s
FOIA Request 56712, NCBI searched that database for communications between SRA curators
and the submitter of the withdrawn SARS-CoV2 sequences at Wuhan University. As applied
here specifically, the submitter involved in Plaintiff’s FOIA Request 56712 had provided the
withdrawn sequences under the project ID PRJNA612766. As a result, the NCBI team used that
project ID “PRJNA612766” as search term to pull responsive documents from the database for
the dates requested.
17. In response to Item 3 of Plaintiff’s FOIA Request 56712, Stephen Sherry, Acting
Director of NCBI, searched for responsive emails using the following keywords: “preprint”,
“jesse bloom” or “biorxiv” for the dates requested.
18. The reason why Dr. Sherry used the search terms mentioned in Paragraph 17
above was that on June 22, 2021, Jesse Bloom of Fred Hutchinson Cancer Research Center, who
is the individual mentioned in Plaintiff’s FOIA Request 56712, published a manuscript on
4
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bioRxiv, “the server for biology preprints”. Mr. Bloom’s also published an article, Recovery of
deleted deep sequencing data sheds more light on the early Wuhan SARS-CoV2 epidemic
(available: https://www.biorxiv.org/content/10.1101/2021.06.18.449051v1), which identifies
several early obtained SARS-CoV2 sequences that he recovered from the Google Cloud after
they were “deleted from the NIH’s Sequence Read Archive”. Both manuscript and article
related to the topics of “biorxiv,” “Jesse Bloom,” and “preprints” representing the keywords used
in the search.
19. In response to Item 4 of Plaintiff’s FOIA Request 56712, the Communications
program at the OD (defined above in Paragraph 6) searched for emails containing the keywords
“NIH statement sequence read archive” for the dates requested. These keywords were used
because Plaintiff’s FOIA Request 56712 specifically mentioned communications regarding the
NIH statement on Sequence Read Archive.
20. As a result of the above searches by NIH OD and NCBI, the agency identified,
reviewed, and processed 238 pages of records. The records retrieved consisted of draft media
outreach materials and communications with the submitter and Dr. Bloom.
21. Of the 238 responsive pages NIH located, NIH released these pages to Plaintiff
on February 7, 2022, in their entirety or in part, with information redacted pursuant to FOIA
Exemptions 5 or 6. A copy of this correspondence is attached to this Declaration as Attachment
E.
22. Exemption 5 permits the withholding of internal government records which are
pre-decisional and contain staff advice, opinion, and recommendations. This exemption is
intended to preserve free and candid internal dialogue leading to decision-making.
23. Exemption 5 was applied here because much of the internal discussion among
5
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NIH staff members regarding the preprint, sequence submission procedures and policies for the
SRA database, and a public response strategy are deliberative and pre-decisional. A public
response was published by multiple news outlets after these internal conversations occurred.
24. Exemption 6 mandates the withholding of information that if disclosed “would
constitute a clearly unwarranted invasion of personal privacy.” 5 U.S.C. § 552(b)(6).
25. Exemption 6 was applied here due to the heightened public scrutiny with
anything remotely related to COVID-19. Consequently, all email addresses, direct telephone
numbers, identities of the submitter and NIH database curators that the submitter dealt with, have
been withheld. Conversely, there is no public interest in the disclosure of this information.
26. NIH conducted a segregability review of the records released. Following its
segregability review, NIH released the information, withholding only information subject to
Exemptions 5 or 6 of the FOIA.
27. Information protected by Exemptions 5 and 6 was so intertwined with non-
exempt information that NIH could not reasonably segregate any portion of those documents for
release to provide any meaningful information.
Plaintiff’s FOIA Request 57203
28. On October 12, 2021, Defendant received another FOIA request via electronic
mail sent to “nihfoia@mail.nih.gov” dated September 30, 2021 which stated, in relevant parts:
1) All communications regarding the letter by Senators Grassley and Blackburn dated
June 28, 2021.
2) All communications regarding the NIH’s response to Senators Grassley and Blackburn
dated September 8, 2021.
3) All communications regarding the letter by Senators Grassley and Blackburn dated
September 16, 2021.
6
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29. A complete and accurate copy of this correspondence is attached hereto as
Attachment F.
30. On the same day it received it, October 12, 2021, NIH assigned Plaintiff’s FOIA
Request the internal control number 57203 (“Plaintiff’s FOIA Request 57203”).
31. The NIH Office of Executive Secretariat searched their database for records
responsive to Plaintiff’s FOIA Request 57203 using the following keywords: ”Grassley” and / or
“Blackburn” for the dates requested.
32. The reason why NIH used these keywords was that the words “Grassley” and
“Blackburn” were specifically mentioned in Plaintiff’s FOIA Request 57203.
33. As a result of the above search, NIH identified, reviewed, and processed
approximately 17 pages of records, all of which were released to Plaintiff. The records that NIH
had retrieved consisted of draft correspondence with Congress. They were released in part to
Plaintiff on February 7, 2022, together with the records responsive to Plaintiff’s FOIA Request
56712.
34. Exemption 5 permits the withholding of internal government records which are
pre-decisional and contain staff advice, opinion, and recommendations. This exemption is
intended to preserve free and candid internal dialogue leading to decision-making.
35. Exemption 5 was applied here because the records in question were comprised
of draft correspondence that had not been finalized.
36. Exemption 6 mandates the withholding of information that if disclosed “would
constitute a clearly unwarranted invasion of personal privacy.” 5 U.S.C. § 552(b)(6).
37. Exemption 6 was applied here due to the heightened public scrutiny on anything
remotely related to COVID-19. Consequently, all email addresses, direct telephone numbers and
7
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signatures have been withheld.
38. NIH conducted a segregability review of the records released. Following its
segregability review, NIH released the information, withholding only information subject to
Exemptions 5 or 6 of the FOIA.
39. Information protected by Exemptions 5 and 6 was so intertwined with non-
exempt information that NIH could not reasonably segregate any portion of those documents for
release to provide any meaningful information.
Appeal
40. On February 24, 2022, Plaintiff transmitted two administrative appeal letters in
response to the NIH’s production corresponding to Plaintiff’s FOIA Request 56712 and
Plaintiff’s FOIA Request 57203. A copy of this correspondence is attached to this Declaration as
Attachments G and H, respectively.
41. In the appeal, Plaintiff appeals the NIH’s February 7, 2022, initial determination
and requests that the NIH review the nature and scope of its FOIA staff’s records search and
review, correct any deficiencies that are identified, and apprise Plaintiff of the results of such
review on the grounds that NIH’s FOIA staff:
x Did not perform a search for records that was reasonably calculated to find
all responsive records;
x Claimed FOIA Exemption b(5)—specifically for the deliberative process
privilege—for records that were not both pre-decisional and deliberative;
x Claimed FOIA Exemption b(6) for records that do not invoke a legitimate
personal privacy interest. Id.
42. While NIH admits that as Plaintiff states in its cover correspondence, it had not
8
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extended appeals rights in its February 7, 2022 letter, NIH posits that it had not done so because
given that these FOIA requests were now before the court and in litigation status, NIH was
expecting that as is customary when a matter is before the court, Plaintiff would have either
conferred with Defendant’s counsel on some of its concerns to try to resolve the matter, or as an
alternative brought the matter to the court’s attention. A copy of this cover correspondence is
attached to this Declaration as Attachments G-1 and H-1, respectively. Extending appeal rights
would make no sense in terms of NIH limited resources given that the outcome of any appeal
could be superseded by the court’s decision.
CONCLUSION
43. In summary, NIH avers that it conducted searches reasonably calculated to locate
records responsive to Plaintiff’s request.
44. NIH only withheld information pursuant to Exemptions 5 and 6 and determined
that none of the withheld information is segregable for release.
Pursuant to 28 U.S.C. § 1746, I declare under penalty of perjury the foregoing to be true
and correct, to the best of my knowledge, information and belief.
Executed this 30th day of March 2022.
Digitally signed by
Gorka Garcia- Gorka Garcia-malene -S
Date: 2022.03.30
malene -S 15:38:24 -04'00'
GORKA GARCIA-MALENE
9
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Attachment A
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July 14, 2021
VIA ELECTRONIC TRANSMISSION: NIHFOIA@MAIL.NIH.GOV
National Institutes of Health
Building 31 Room 5B35
9000 Rockville Pike
Bethesda, MD 20892
RE: RECORDS REGARDING NIH’S SARS-COV-2 (COVID19) DATABASE
Dear FOIA Officer:
Empower Oversight Whistleblowers & Research (“Empower Oversight”) is a
nonpartisan, nonprofit educational organization dedicated to enhancing independent oversight
of government and corporate wrongdoing. We work to help insiders safely and legally report
waste, fraud, abuse, corruption, and misconduct to the proper authorities help to hold those
authorities accountable to act on such reports.
We respectfully request records be delivered from the National Institutes of Health
(NIH) pursuant to this request under the Freedom of Information Act (FOIA), 5 U.S.C. 552
within the next 20 business days. As detailed below, we request access to certain records
regarding SARS-CoV-2 sequences submitted for posting to the Sequence Read Archive in March
2020 by Chinese researchers and subsequently requested to be withdrawn by the submitting
investigator in June 2020. Sequences of SARS-CoV-2 virus are critical to understanding how this
pandemic (which has killed more than 600,000 Americans) started, in order to prevent future
pandemics.1 Furthermore, the State Department has noted that China has not been transparent
in its handling of the SARS-CoV-2 origin question and has removed virus sequences from its own
online databases that could help uncover how the pandemic started.2
The New York Times and the Washington Post have reported on requests to remove
these sequences and this removal has added fuel to the SARS-CoV-2 origin debate.3
1 “COVID Mortality Data,” Johns Hopkins University (https://coronavirus.jhu.edu/data/mortality).
2 “Fact Sheet on Activity at the Wuhan Institute of Virology,” U.S. State Dep’t (https://2017-2021.state.gov/fact-
sheet-activity-at-the-wuhan-institute-of-virology/index.html)
3 “Scientist Finds Early Virus Sequences That Had Been Mysteriously Deleted,” New York Times (Jun 23, 2021);
“Seattle scientist digs up deleted coronavirus genetic data, adding fuel to the covid origin debate,” Washington Post
(Jun 23, 2021).
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According to the Washington Post, “The NIH released a statement Wednesday saying
that a researcher who originally published the genetic sequences asked for them to be removed
from the NIH database so that they could be included in a different database.”4 In a statement to
the Washington Post, the NIH said:
These SARS-CoV-2 sequences were submitted for posting in SRA in March 2020
and subsequently requested to be withdrawn by the submitting investigator in June
2020. The requestor indicated the sequence information had been updated, was
being submitted to another database, and wanted the data removed from SRA to
avoid version control issues.5
And, according to the New York Times:
“These SARS-CoV-2 sequences were submitted for posting in SRA in March 2020
and subsequently requested to be withdrawn by the submitting investigator in June
2020,” said Renate Myles, a spokeswoman for the National Institutes of Health.
She said that the investigator, whom she did not name, told the archive managers
that the sequences were being updated and would be added to a different database.6
Accordingly, please provide all records relating to the following:
1) All communications regarding the request to post the SARS-CoV-2 sequences to the
Sequence Read Archive in March 2020. This request covers all communications between
March 1, 2020 to March 31, 2020.
2) All communications regarding the request to withdraw the SARS-CoV-2 sequences from
Sequence Read Archive in June 2020. This request covers all communications between
June 1, 2020 to June 31, 2020.
3) All communications regarding these withdrawn sequences as reported by a preprint titled
“Recovery of deleted deep sequencing data sheds more light on the early Wuhan SARS-
CoV-2 epidemic” by Jesse Bloom, a virologist at the Fred Hutchinson Cancer Research
Center.7 This request covers all communications between Jesse Bloom and the NIH, from
January 1, 2021 and the present. This request all covers all communications inside the
NIH regarding the preprint from June 21, 2021 to the present.
4) All communications to, from, and within the NIH press office about the NIH statement
released on June 23, 2021, and about reports that these sequences were removed from
the Sequence Read Archive. This includes all emails related to the drafting of the
statement, communications about the reported removal, and communications with
reporters. This request covers all communications between June 21, 2021 to June 25,
2021.
4 Id.
5 Id.
6 Id.
7 “Recovery of deleted deep sequencing data sheds more light on the early Wuhan SARS-CoV-2 epidemic,” bioRxiv
(Jun 18, 2021).
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Fee Waiver Request
Empower Oversight requests a waiver of fees associated with processing this request, in
keeping with 5 U.S.C. § 552 (a)(4)(A)(iii). The information sought is in the public interest
because it is likely to contribute significantly to the public understanding of the operations or
activities of the government. Empower Oversight is a non-profit organization as defined under
Section 501(c)(3) of the Internal Revenue Code and has no commercial interest in making this
request. public has a significant interest in understanding how this pandemic started. Empower
Oversight is committed to government accountability and public integrity and is committed to
public disclosure of documents via its website, and by providing these documents to the media
for public dissemination.8
Request for Expedited Processing
Empower Oversight also requests expedited processing of this request. Understanding
how the SARS-CoV-2 pandemic started is of massive public interest both in the United States
and around the globe, particularly because understanding how this pandemic started can help us
stop future pandemics. The information requested is urgently needed to inform the public
concerning actual or alleged federal government activity, namely why were genetic sequences
removed from a United States federal database when they could help understand how the
pandemic started. The request is of widespread and exceptional media interest and the
information sought involves questions about research integrity, which affect public confidence in
the operations of NIH. Empower Oversight is engaged in disseminating information to the
public through its website and working with media.9 It is important that this request be
processed and the results publicly disseminated as quickly as possible to help the country guard
against future pandemics.
For ease of administration and to conserve resources, we ask that documents be produced
in a readily accessible electronic format. In the event our request for a fee waiver is denied or if
you have any questions about this request, please contact us immediately. Thank you for your
prompt attention to this matter.
Cordially,
/Jason Foster/
Jason Foster
Founder & President
8 “Mission,” Empower Oversight (http://empowr.us/mission).
9 Id.
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Attachment B
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Public Health Service
National Institutes of Health
Freedom of Information Office
Building 31, Room 5B-35
31 Center Drive, MSC 2107
Bethesda, Maryland 20892-2107
phone: (301) 496-5633
fax: (301) 402-4541
Via Email: info@empowr.us
August 4, 2021
Jason Foster
Founder & President
Empower Oversight
2615 Columbia Pike, #445
Arlington, VA 22204
RE: FOIA Request 56712
Dear Mr. Foster,
This is in reference to your July 15, 2021, Freedom of Information Act (FOIA) request addressed
to the FOIA Office, National Institutes of Health (NIH), and received in this office on the same
day. You requested a copy of the following:
1) All communications regarding the request to post the SARS-CoV-2 sequences to the
Sequence Read Archive in March 2020. This request covers all communications between
March 1, 2020 to March 31, 2020.
2) All communications regarding the request to withdraw the SARS-CoV-2 sequences
from Sequence Read Archive in June 2020. This request covers all communications
between June 1, 2020 to June 31, 2020.
3) All communications regarding these withdrawn sequences as reported by a preprint
titled “Recovery of deleted deep sequencing data sheds more light on the early Wuhan
SARS-CoV-2 epidemic” by Jesse Bloom, a virologist at the Fred Hutchinson Cancer
Research Center.7 This request covers all communications between Jesse Bloom and the
NIH, from January 1, 2021 and the present. This request all covers all communications
inside the NIH regarding the preprint from June 21, 2021 to the present.
4) All communications to, from, and within the NIH press office about the NIH statement
released on June 23, 2021, and about reports that these sequences were removed from the
Sequence Read Archive. This includes all emails related to the drafting of the statement,
communications about the reported removal, and communications with reporters. This
request covers all communications between June 21, 2021 to June 25, 2021.
You also requested expedited processing.
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Page 2 – Mr. Foster (56712)
The FOIA, 5 U.S.C. §552(a)(6)(E), requires agencies to consider requests for expedited
processing and grant them whenever a “compelling need” is shown and in other cases as
determined by the agency. The term “compelling need” is defined as (1) involving “an imminent
threat to the life or physical safety of an individual,” or (2) in the case of a request made by “a
person primarily engaged in disseminating information, urgency to inform the public concerning
actual or alleged Federal Government activity.” The compelling need standard is “intended to be
narrowly applied.” Al-Fayed v. CIA, 254 F.3d 300, 310 (D.C. Cir. 2001).
Your request does not meet the standards of “compelling need,” therefore, I am denying your
request for expedited processing.
We are searching the files of the NIH for records responsive to your request. If any documents
responsive to your request are located, they will be reviewed for releasability, and all releasable
information will be sent to you. We will do everything possible to comply with your request in a
timely manner. Please contact the NIH FOIA Office at nihfoia@od.nih.gov or 301-496-5633 for
additional information or to inquire about the status of your request.
Provisions of the FOIA allow us to recover part of the cost of complying with your request. We
shall charge you for records in accordance with the Department of Health and Human Services
(HHS) FOIA Regulations as they apply to educational institution requesters; i.e., you will be
charged for duplication at 10 cents per page although the first 100 pages are free; there is no
charge for search or review time. If there are any fees associated with processing this request,
you will be sent an invoice with our final response. Because we are uncertain that any applicable
fees will exceed our minimum charge ($25.00), we are not addressing your request for a fee
waiver at this time. However, if we determine there will be fees associated with processing your
request, we will contact you at that time.
If you are not satisfied with the processing and handling of this requests, you may contact the
NIH FOIA Public Liaison and/or the Office of Government Information Services (OGIS):
NIH FOIA Public Liaison OGIS
Stephanie Clipper National Archives and Records Admin.
Public Affairs Specialist 8601 Adelphi Rd - OGIS
Office of Communications and Public Liaison College Park, MD 20740-6001
Building 31, Room 5B35 202-741-5770 (phone)
31 Center Drive 1-877-684-6448 (toll-free)
Bethesda, MD 20814 202-741-5769 (fax)
301-496-5633 (phone) ogis@nara.gov (email)
301-496-0818 (fax)
nihfoia@od.nih.gov (email)
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Page 3 – Mr. Foster (56712)
In addition, you have the right to appeal this determination to deny you expedited processing of
your request. Should you wish to do so, your appeal must be sent within ninety (90) days of the
date of this letter, following the procedures outlined in Subpart C of the HHS FOIA Regulations
http://www.nih.gov/icd/od/foia/cfr45.htm) to:
Assistant Secretary for Public Affairs
Agency Chief FOIA Officer
U.S. Department of Health and Human Services
Office of the Assistant Secretary for Public Affairs
Room 729H
200 Independence Avenue, S.W.
Washington, DC 20201
Clearly mark both the envelope and your letter “Freedom of Information Act Appeal.”
Sincerely,
Gorka Garcia- Digitally signed by Gorka
Garcia-malene -S
Date: 2021.08.04 13:36:14
malene -S -04'00'
Gorka Garcia-Malene
Freedom of Information Officer, NIH
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 19 of 143 PageID# 406
Attachment C
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 20 of 143 PageID# 407
AO 440 (Rev. 06/1 2) Summons in a Civi l Action
UNITED STATES DISTRICT COURT
for the
Eastern District of Virginia
)
)
Empower Oversight Whistleblowers & Research )
)
Plaint/lJM
)
)
V. Civil Action No. 1 :21-cv-01275
)
)
)
National Institutes of Health )
)
Defendant(s) )
SUMMONS IN A CIVIL ACTION
To: (Defendant ·s name and address)
Jessica D. Aber, U.S. Attorney for the Eastern District of Virginia
Justin W. Williams United States Attorney's Building
2100 Jamieson Ave.
Alexandria , VA 22314
A lawsuit has been filed against you.
Within 21 days after service of this summons on you (not counting the day you received it) - or 60 days if you
are the United States or a United States agency, or an officer or employee of the United States described in Fed. R. Civ.
P. 12 (a)(2) or (3)-you must serve on the plaintiff an answer to the attached complaint or a motion under Rule 12 of
the Federal Rules of Civil Procedure. The answer or motion must be served on the plaintiff or plaintiff's attorney,
whose name and address are:
Michael J. Schrier
Husch Blackwell LLP
750 17th St NW, #900
Washington, DC 20006
202.378.2313
If you fail to respond, judgment by default will be entered against you for the relief demanded in the complaint.
You also must file your answer or motion with the comi.
CLERK OF COURT
U4~ Metre
Digitally signed by Dana Van
Date: 2021.11.19 13:35:40 -05'00'
Date: 11/19/2021
Signature of Clerk or Deputy Clerk
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UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF VIRGINIA
Alexandria Division
EMPOWER OVERSIGHT )
WHISTLEBLOWERS & RESEARCH, )
2615 Columbia Pike, #445 )
Arlington, VA 22204 )
)
Plaintiff, )
) Case No. - - - - -
V. )
)
NATIONAL INSTITUTES OF HEAL TH, )
9000 Rockville Pike )
Bethesda, MD 20892 )
)
Defendant. )
COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF
1. Plaintiff Empower Oversight Whistleblowers & Research (hereinafter "Empower
Oversight") brings this action against Defendant National Institutes of Health ("NIH") to compel
compliance with the Freedom of Information Act, 5 U.S.C. § 552 ( "FOIA"), including obtaining
access to records maintained by the NIH.
2. The records at issue, including but not limited to communications to and from NIH,
relate to SARS-CoV-2 sequences submitted by a Chinese researcher for posting to the Sequence
Read Archive (" SRA") in March 2020 and subsequently withdrawn by the NIH upon the
researcher' s request to SRA staff in June 2020. See infra ,i,i 4-7.
3. On June 18, 2021 , Dr. Jesse D. Bloom of the Fred Hutchen Cancer Research Center
published an article titled "Recovery of deleted deep sequencing data sheds more light on the early
Wuhan SARS-CoV-2 epidemic." Jesse Bloom, Recovery of deleted deep sequencing data sheds
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more light on the early Wuhan SARS-CoV-2 epidemic, bioRxiv (June 18, 2021),
https://www.biorxiv.org/content/10.110 l/202 1.06 .18.44905 l v l .full.pdf.
4. Dr. Bloom explained that in reviewing a March 2020 Wuhan University-associated
study containing a spreadsheet with information on 241 genetic sequences from the SRA, his own
searches for these sequences indicated that they were deleted from the SRA. See id. Nevertheless,
he was able to recover certain deleted files from Google Cloud and reconstruct partial sequences
of 13 early viruses. See id.
5. Dr. Bloom reasoned that "[t]he fact that such an informative data set was deleted
has implications beyond those gleaned directly from the recovered sequences," and that it
"therefore seems likely the sequences were deleted to obscure their existence." Id. at 7.
6. A June 23 , 2021 New York Times article, among numerous others, heightened the
national focus on Dr. Bloom ' s conclusions, reporting that he provided "intriguing new information
for discerning when and how the virus may have spilled over from a bat or another animal into
humans" and that it "raise[s] questions about why original sequences were deleted." See Carl
Zimmer, Scientist Finds Early Virus Sequences That Had Been Mysteriously Deleted, N.Y.T. (June
23, 2021) (updated July 22, 2021), available at
https://www .nvtimes.com/202 l/06/23/science/coronavirus-sequences. htm I.
7. The New York Times article revealed that, in fact, more than 200 data entries from
the genetic sequencing of early COVID-19 cases disappeared from an online scientific database in
the summer of 2020. See id. The article included confirmation by the National Library of
Medicine within the NIH, which manages the SRA, that these sequences were "submitted for
posting in SRA in March 2020 and subsequently requested to be withdrawn by the submitting
investigator in June 2020." See id.
2
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8. However, deletions from the SRA are reportedly rare. From March 2020 to March
2021 , the SRA repeatedly received approximately 2.4 million submissions of sequence data,
according to the NCBI spokeswoman. However, a mere 0.19% were withdrawn. See Amy
Dockser Marcus & Drew Hinshaw, After Covid-19 Data Is Deleted, NIH Reviews How Its Gene
Archive Is Handled, WALL ST. J. (Sept. 13, 2021), available at https://www.wsj.com/articles/after-
covid-19-data-is-deleted-nih-reviews-how-its-gene-archive-is-handled-1 163 1545490.
9. On June 28, 2021, Senators Grassley, Blackbum, and Marshall sent the NIH a letter
seeking records and responses to questions regarding the removal of the sequences from the SRA.
Letter from Sen. Grassley et al. to Francis S. Collins, June 28, 2021. The same Senators sent a
follow-up letter on September 16, 2021 , reiterating their requests. Letter from Sen. Grassley et al.
to Francis S. Collins, Sept. 16, 2021.
10. According to the Centers for Disease Control and Prevention ("CDC"), as of
November 6, 2021, over 756,000 deaths-and counting-have been attributed to COVID-19 in
the United States alone. See COVID-19 Mortality Overview, CDC (last accessed Nov. 16, 2021),
available at https://v,f\vw.cdc.gov/nchs/covid 19/mortality-overview .htm. Yet, upon information
and belief, there is no global consensus on the origin of the COVID-19 pandemic.
11. The public thus has a significant interest in understanding the reason why these
early sequences were removed from the SRA. In recognizing this significant interest, Empower
Oversight filed the three FOIA Requests described herein.
JURISDICTION AND VENUE
12. The Court has jurisdiction over this action pursuant to 5 U.S.C. § 552(a)(4)(B) and
28 U.S.C. § 1331.
3
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13. Venue is proper in this district and division pursuant to 5 U.S.C. § 552(a)(4)(B) and
28 U.S .C. § 139l(e)(l).
PARTIES
14. Plaintiff Empower Oversight is a nonprofit, nonpartisan educational organization
dedicated to enhancing independent oversight of government and corporate wrongdoing.
Empower Oversight has its principal place of business located at 2615 Columbia Pike, #445 ,
Arlington, VA 22204. Empower Oversight works to help insiders safely and legally report waste,
fraud, abuse, corruption, and misconduct to the proper authorities, as well as work to hold
authorities accountable to act on such reports.
15. Defendant NIH is an agency within the U.S . Department of Health and Human
Services, and a federal administrative agency within the meaning of 5 U.S.C. § 552(f)(l), with its
principal place of business located at 9000 Rockville Pike, Bethesda, MD 20892. Upon
information and belief, the NIH has possession, custody, and control of the records, within the
meaning of 5 U.S .C. § 552(f)(2), to which Empower Oversight seeks access.
LEGAL STANDARD
16. FOIA requires a federal administrative agency to promptly make available
requested, non-exempt agency records in response to a request that (a) reasonably describes such
records and (b) " is made in accordance with published rules stating the time, place, fees, ... and
procedures to be followed[.] " 5 U.S.C. § 552(a)(3)(A); see also 45 C.F.R. § 5.22.
17. FOIA requires an agency to respond to a valid request within twenty (20) days
(exempting Saturdays, Sundays, and legal public holidays) (hereinafter " working days") upon
receipt of such request, including notifying the requestor immediately of its determination, the
4
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reasons therefor, and the right to appeal any adverse determination. 5 U.S.C. § 552(a)(6)(A)(i);
see also 45 C.F.R. §§ 5.24, 5.28.
18. In certain circumstances, an agency may instead provide notice to the requester that
"unusual circumstances" merit additional time-up to an additional ten ( 10) working days-to
respond to the request. 5 U.S.C . § 552(a)(4)(viii)(II)(aa); see also 45 C.F.R. § 5.24(f). In the
event the agency provides notice to the requester of"unusual circumstances," and that it is not able
to respond to the records request within the statutory deadline, the agency must provide the
requester "an opportunity to arrange with the agency an alternative time frame for processing the
request." 5 U.S.C. § 552(a)(6)(B)(ii); 45 C.F.R. § 5.24(f).
19. If an agency does not respond to a FOIA request by the statutory deadline, the
requester is deemed to have exhausted administrative remedies and may immediately pursue
judicial review. 5 U.S.C. § 552(a)(6)(C)(i).
FACTS
20. On July 14, 2021 , Empower Oversight submitted a FOIA request to the NIH, see
Ex. A, seeking access to the following:
a. All communications regarding the request to post the SARs-CoV-2 sequences to
the Sequence Read Archive in March 2020. This request covers all
communications between March 1, 2020 to March 31, 2020.
b. All communications regarding the request to withdraw the SARS-CoV-2 sequences
from Sequence Read Archive in June 2020. This request covers all
communications between June 1, 2020 to June 31, 2020.
c. All communications regarding these withdrawn sequences as reported by a preprint
titled "Recovery of deleted deep sequencing data sheds more light on the early
Wuhan SARS-CoV-2 epidemic" by Jesse Bloom, a virologist at the Fred
Hutchinson Cancer Research Center. This request covers all communications
between Jesse Bloom and the NIH, from January 1, 2021 and the present. This
request covers all communications inside the NIH regarding the preprint from
June 21 , 2 021 to the present.
5
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d. All communications to, from , and within the NIH press office about the NIH
statement released on June 23 , 2021 , and about reports that these sequences were
removed from the Sequence Read Archive. This includes all emails related to the
drafting of the statement, communications about the reported removal, and
communications with reporters. This request covers all communications between
June 21 , 2021 to June 25 , 2021.
21. On September 30, 2021 , Plaintiff submitted two additional FOIA Requests to the
NIH. In one September 30, 2021 Request, see Ex. B, Plaintiff sought access to and copies of:
a. All communications regarding the letter by Senators Grassley and Blackbum dated
June 28, 2021.
b. All communications regarding the NIH's response to Senators Grassley and
Blackbum dated September 8, 2021.
c. All communications regarding the letter by Senators Grassley and Blackbum dated
September 16, 2021 .
22. In the other September 30, 2021 Request, see Ex. C, Plaintiff requested a copy of
the NIH ' s "log" ofrequests for records filed pursuant to the FOIA.
23. To date, Empower Oversight has yet to receive any correspondence whatsoever
from Defendant concerning any of its three pending FOIA Requests (hereinafter the "Three
Requests"), despite applicable regulations prescribing that the NIH, at a minimum, is required to
acknowledge receipt of all FOIA requests in writing within 10 working days. See 45 C.F.R. §
5.24; see also 45 C.F.R. § 5.4 (explaining that all operating divisions ("OpDivs") of HHS are
subject to the requirements in that regulation); 45 C.F.R. § 5.3 (defining NIH as an OpDiv of
HHS).
24. However, to date, Empower Oversight' s account on the NIH' s online FOIA portal
shows:
a. A Request 56712 as having been filed by Empower Oversight on July 15, 2021.
The "Description" of Request 56712 matches the four enumerated items on
6
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Empower Oversight' s July 14, 2021 Request, and the details of Request 56712
include an embedded link to a copy of Empower Oversight's request. Therefore,
upon information and belief, the responsible FOIA officer "received" that July 14,
2021 Request on or before July 15, 2021.
b. A Request 57151 as having been filed by Empower Oversight on October 7, 2021.
The "Description" of Request 57151 matches the substance of one of Empower
Oversight' s September 30, 2021 Requests, and the details of Request 57151 include
an embedded link to a copy of Empower Oversight' s request. Therefore, upon
information and belief, the responsible FOIA officer "received" that September 30,
2021 Request on or before October 7, 2021.
c. A Request 57199 as having been filed by Empower Oversight on October 14, 2021.
The "Description" of Request 57199 matches the substance of Empower
Oversight' s other September 30, 2021 Request, and the details of Request 57199
include an embedded link to a copy of Empower Oversight's September 30, 2021
Request. Therefore, upon information and belief, the responsible FOIA officer
"received" that September 30, 2021 Request on or before October 14, 2021.
25. To date, the NIH has not provided a determination as to Request 56712, 57151 , or
57199, despite the requirement of 5 U.S.C. § 552(a)(6)(A) that an agency respond within twenty
(20) working days, including by providing detail on the scope of the records the agency intends to
produce or withhold, the reasons for making that determination, and an explanation of the process
by which a requester can administratively appeal that determination.
7
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26. To date, the NIH also has not provided Empower Oversight notice that " unusual
circumstances" warrant a failure to comply with the statutory deadline with respect to any of the
Three Requests.
27. Empower Oversight has been required to expend resources to prosecute this action.
CLAIMS FOR RELIEF
Count I
Failure to Comply with Statutory Deadlines in Violation of FOIA, 5 U.S.C. § 552(a)(6)
28 . Plaintiff realleges and incorporates by reference each of the foregoing allegations,
contained in paragraphs 1-27, as if fully set forth herein.
29. To date, Defendant has failed to respond - timely or otherwise - to each of
Plaintiffs Three Requests identified above in paragraphs 20-22.
30. More than 20 working days have passed since each of the Three Requests were
received by the NIH as reflected on its online FOIA portal.
31 . FOIA requires Defendant to have provided a final determination within 20 working
days of each of the Three Requests. Defendant may extend this 20-day period in the event of
"unusual circumstances," as defined by 5 U.S.C. § 552(a)(6)(B)(iii), for a maximum ofl0 working
days, but must provide Empower Oversight with notice to do so. See 5 U.S.C.
§§ 552(a)(4)(A)(viii)(II)(aa), 552(a)(6)(B)(ii).
32. Defendant did not provide a final determination within 20 working days of each of
the Three Requests, nor did it contact Empower Oversight with a claim that unusual circumstances
exist as to any of the Three Requests.
33. The NIH has thus failed to timely make a determination on all Three Requests, in
violation of FOIA. See 5 U.S.C. § 552(a)(6).
8
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34. Empower Oversight has constructively exhausted all administrative remedies
required by FOIA as to each of the Three Requests. See 5 U.S.C. § 552(a)(6)(C)(i).
35. Plaintiff is being irreparably harmed by Defendant's violation of the FOIA, and
Plaintiff will continue to be irreparably harmed unless Defendant is compelled to comply with the
FOIA as to each of the Three Requests.
Count II
Unlawful Withholding of Agency Records in Violation of FOIA, 5 U.S.C. § 552(a)(3)
36. Plaintiff realleges and incorporates by reference each of the foregoing allegations,
contained in paragraphs 1-35, as if fully set forth herein.
37. FOIA requires Defendant to process records requests and promptly provide the
requested records or the reasonably segregable portion of records not subject to a FOIA exemption.
5 U.S.C. § 552(a)(3)(B).
38. However, Defendant has neither provided Empower Oversight any responsive
documents in response to any of its Three Requests, nor has it claimed that any responsive records
are exempt from disclosure.
39. Therefore, the NIH's acts and omissions for failing to produce records or claim
applicable exemptions violate FOIA. 5 U.S.C . § 552(a)(3)(B).
RELIEF REQUESTED
WHEREFORE, Plaintiff prays that this Court:
A. Declare that NIH failed to make timely determinations on each of Empower
Oversight's Three Requests, in violation of FOIA, 5 U.S .C. § 552(a)(6)(A)(i);
B. Declare that NIH failed to promptly provide records responsive to each of Empower
Oversight' s Three Requests, in violation of FOIA, 5 U.S.C. § 552(a)(3);
9
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C. Order NIH to immediately conduct a reasonable search for all responsive records,
as required by FOIA, 5 U.S .C. § 552(a)(3)(C);
D. Order NIH to immediately provide determinations on each of Empower Oversight' s
Three Requests, as required by FOIA, 5 U.S.C. § 552(a)(6)(A)(i);
E. Order NIH to promptly disclose to Empower Oversight all responsive, non-exempt
records, as required by FOIA, 5 U.S.C. § 552(a)(3);
F. Award Empower Oversight its costs and reasonable attorneys' fees incurred in this
action, pursuant to 5 U.S .C. § 552(a)(4)(E); and
G. Grant such other relief as the Court may deem just and proper.
November 17, 2021 Respectfully submitted,
Isl Michael J Schrier
Michael J. Schrier (VSB #65916)
HUSCH BLACKWELL LLP
750 17th Street, NW, Suite 900
Washington, DC 20006-4675
Tel. 202-378-2313
Fax 202-378-2319
michael.schrier@huschblackwell.com
Scott L. Glabe
HUSCH BLACKWELL LLP
235 E. High St., Suite 300
Jefferson City, MO 65101
Tel. 202-378-2396
Fax 292-378-2319
scott.glabe@huschblackwell.com
Attorneys for Plaintiff Empower Oversight
Whistleblowers & Research
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EXHIBIT A
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EMPOWER OVERSIGHT
Whistleblowers & Research w
EMPOWR.us
July 14, 2021
VIA ELECfRONIC TRANSMISSION: NIIIJIOIA@l\-L\IL. NIH.GOV
National Institutes of Health
Building 31 Room 5B35
9000 Rockville Pike
Bethesda, MD 20892
RE: RECORDS REGARDING NIH's SARS-CoV-2 (COVIDl 9) DATABASE
Dear FOIA Officer:
Empower Oversight Whistleblowers & Research ("Empower Oversight") is a
nonpartisan, nonprofit educational organization dedicated to enhancing independent oversight
of government and corporate wrongdoing. We work to help insiders safely and legally report
waste, fraud, abuse, corruption, and misconduct to the proper authorities help to hold those
authorities accountable to act on such reports.
We respectfully request records be delivered from the National Institutes of Health
(NIH) pursuant to this request under the Freedom of Information Act (FOIA), 5 U.S.C. 552
within the next 20 business days. As detailed below, we request access to certain records
regarding SARS-CoV-2 sequences submitted for posting to the Sequence Read Archive in March
2020 by Chinese researchers and subsequently requested to be withdrawn by the submitting
investigator in June 2020. Sequences of SARS-CoV-2 virus are critical to understanding how this
pandemic (which has killed more than 600,000 Americans) started, in order to prevent future
pandemics. 1 Furthermore, the State Department has noted that China has not been transparent
in its handling of the SARS-CoV-2 origin question and has removed virus sequences from its own
online databases that could help uncover how the pandemic started. 2
The New York Times and the Washington Post have reported on requests to remove
these sequences and this removal has added fuel to the SARS-CoV-2 origin debate. 3
1 "COVID Mortality Data," Johns Hopkins University (https://coronavirus.jhu.edu/data/mortalitv).
2 "Fact Sheet on Activity at the Wuhan Institute of Virology," U.S. State Dep't (https://2017-2021.state.gov/fact-
sheet-activity-at-the-vro.han-institute-of-virology/index.html)
3 "Scientist Finds Early Virus Sequences That Had Been Mysteriously Deleted," New York Times (Jun 23, 2021);
"Seattle scientist digs up deleted coronavirus genetic data, adding fuel to the covid origin debate," Washington Post
(,Jun 23, 2021 ).
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According to the Washington Post, "The NIH released a statement Wednesday saying
that a researcher who originally published the genetic sequences asked for them to be removed
from the NIH database so that they could be included in a different database." 4 In a statement to
the Washington Post, the NIH said:
These SARS-CoV-2 sequences were submitted for posting in SRA in March 2020
and subsequently requested to be withdrawn by the submitting investigator in June
2020. The requestor indicated the sequence information had been updated, was
being submitted to another database, and wanted the data removed from SRA to
avoid version control issues.s
And, according to the New York Times:
"These SARS-CoV-2 sequences were submitted for posting in SRA in March 2020
and subsequently requested to be withdrawn by the submitting investigator in June
2020," said Renate Myles, a spokeswoman for the National Institutes of Health.
She said that the investigator, whom she did not name, told the archive managers
that the sequences were being updated and would be added to a different database. 6
Accordingly, please provide all records relating to the following:
1) All communications regarding the request to post the SARS-CoV-2 sequences to the
Sequence Read Archive in March 2020. This request covers all communications between
March 1, 2020 to March 31, 2020.
2) All communications regarding the request to withdraw the SARS-CoV-2 sequences from
Sequence Read Archive in June 2020. This request covers all communications between
June 1, 2020 to June 31, 2020.
3) All communications regarding these withdrawn sequences as reported by a preprint titled
"Recovery of deleted deep sequencing data sheds more light on the early Wuhan SARS-
CoV-2 epidemic" by Jesse Bloom, a virologist at the Fred Hutchinson Cancer Research
Center. 7 This request covers all communications between Jesse Bloom and the NIH, from
January 1, 2021 and the present. This request all covers all communications inside the
NIH regarding the preprint from June 21, 2021 to the present.
4) All communications to, from, and within the NIH press office about the NIH statement
released on June 23, 2021, and about reports that these sequences were removed from
the Sequence Read Archive. This includes all emails related to the drafting of the
statement, communications about the reported removal, and communications with
reporters. This request covers all communications between June 21, 2021 to June 25,
2021.
4 Id.
5 Id.
6 Id.
7 "Recovery of deleted deep sequencing data sheds more light on the early Wuhan SARS-CoV-2 epidemic," bioRxiv
(,Jun 18, 202 1).
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Fee Waiver Request
Empower Oversight requests a waiver of fees associated with processing this request, in
keeping with 5 U.S.C. § 552 (a)( 4)(A)(iii). The information sought is in the public interest
because it is likely to contribute significantly to the public understanding of the operations or
activities of the government. Empower Oversight is a non-profit organization as defined under
Section 501(c)(3) ofthe Internal Revenue Code and has no commercial interest in making this
request. The public has a significant interest in understanding how this pandemic started.
Empower Oversight is committed to government accountability and public integrity and is
committed to public disclosure of documents via its website, and by providing these documents
to the media for public dissemination.8
Request for Expedited Processing
Empower Oversight also requests expedited processing of this request. Understanding
how the SARS-CoV-2 pandemic started is of massive public interest both in the United States
and around the globe, particularly because understanding how this pandemic started can help us
stop future pandemics. The information requested is urgently needed to inform the public
concerning actual or alleged federal government activity, namely why were genetic sequences
removed from a United States federal database when they could help understand how the
pandemic started. The request is of widespread and exceptional media interest and the
information sought involves questions about research integrity, which affect public confidence in
the operations of NIH. Empower Oversight is engaged in disseminating information to the
public through its website and working with media. 9 It is important that this request be
processed and the results publicly disseminated as quickly as possible to help the country guard
against future pandemics.
For ease of administration and to conserve resources, we ask that documents be produced
in a readily accessible electronic format. In the event our request for a fee waiver is denied or if
you have any questions about this request, please contact us immediately. Thank you for your
prompt attention to this matter.
Cordially,
/Jason Foster/
Jason Foster
Founder & President
s "Mission," Empower Oversight (http: //empowr.us/mission).
9 Id.
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EXHIBIT B
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EMPOWER OVERSIGHT
Whistleblowers & Research
'
EMPOWR.us
September 30, 2021
VIA ELECTRONIC TRANSMISSION: NIHFOJA@MAIL.NIH.GOV
National Institutes of Health
Building 31, Room 5B35
9000 Rockville Pike
Bethesda, MD 20892
RE: Records Regarding NIH'S SARS-COV-2 Database
Dear FOIA Officer:
Introduction
Empower Oversight Whistleblowers & Research ("Empower Oversight") is a
nonpartisan, nonprofit educational organization dedicated to enhancing independent
oversight of government and corporate wrongdoing. We work to help insiders safely
and legally report waste, fraud, abuse, corruption, and misconduct to the proper
authorities, and seek to hold those authorities accountable to act on those reports by,
among other means, publishing information concerning the same.
Background
The New York Times and The Washington Post, among others, have reported
on requests by Chinese researchers to have certain SARS-CoV-2 genetic sequences
withdrawn from the National Institutes of Health's ("NIH") Sequence Read Archive. 1
Genetic sequences for SARS-CoV-2 virus are critical to understanding how the
pandemic (which has killed more than 670,000 Americans) started, and
1 "Scientist Finds Early Virus Sequences That Had Been Mysteriously Deleted," New York Times (Jun
23, 2021); "Seattle scientist digs up deleted coronavirus genetic data, adding fuel to the covid origin
debate," Washington Post (Jun 23, 2021).
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understanding the origin of the pandemic is essential to furthering the prevention of
future pandemics. 2 Additionally, the State Department has noted that China has not
been transparent in its handling of the question of the origin of SARS-CoV-2 and, as
part of its hindrance of efforts to gain an understanding of the virus, has removed
genetic sequences from its own online databases.3
On June 28, 2021, Senators Charles Grassley and Marsha Blackbum sent the NIH
a letter seeking records and answers to seven questions regarding the removal of the
SARS-CoV-2 genetic sequences from the Sequence Read Archive. They received a
response to their inquiry on September 8, 2021, that they state "failed to fully and
completely answer all seven questions and failed to provide the requested records."4
Senators Grassley and Blackburn then sent a follow up letter on September 16, 2021,
demanding answers to their previous questions.s
Records Request
To shed light on the manner in which the NIH is addressing the SARS-CoV-2
pandemic and responding to information requests from members of Congress, we
respectfully request, pursuant to the Freedom of Information Act ("FOIA"), 5 U.S.C.
§ 552, copies of:
1. All communications regarding the letter by Senators Grassley and Blackburn
dated June 28, 2021.
2. All communications regarding the NI H's response to Senators Grassley and
Blackburn dated September 8, 2021.
3. All communications regarding the letter by Senators Grassley and Blackburn
dated September 16, 2021.
Definitions
"COMMUNICATION(S)" means every manner or method of disclosure,
exchange of information, statement, or discussion between or among two or more
persons, including but not limited to, face-to-face and telephone conversations,
correspondence, memoranda, telegrams, telexes, email messages, voice-mail
messages, text messages, meeting minutes, discussions, releases, statements, reports,
publications, and any recordings or reproductions thereof.
"DOCUMENT(S)" or "RECORD(S)" mean any kind of written, graphic, or
recorded matter, however produced or reproduced, of any kind or description,
2 "COVID Mortality Data," Johns Hopkins University (https://coronavirus.jhu.edu/data/mortality)
3 "Fact Sheet on Activity at the Wuhan Institute of Virology," U.S. State Dep't (https://2017-
2021.state.gov/ fact- sheet-activity-at-the-wuhan-institute-of-virology/ index.html)
4 https://www.grassley.senate.gov/news/news-releases/did-nih-improperly-delete-covid-19-data-at-
request-of-chinese-researchers-senators-want-answers
s https://www.grassley.senate.gov/news/news-releases/did-nih-improperly-delete-covid-19-data-at-
request-of-chinese-researchers-senators-want-answers
2
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whether sent, received, or neither, including drafts, originals, non-identical copies,
and information stored magnetically, electronically, photographically or otherwise.
As used herein, the terms "DOCUMENT(S)" or "RECORD(S)" include, but are not
limited to, studies, papers, books, accounts, letters, diagrams, pictures, drawings,
photographs, correspondence, telegrams, cables, text messages, emails, memoranda,
notes, notations, work papers, intra-office and inter-office communications,
communications to, between and among employees, contracts, financial agreements,
grants, proposals, transcripts, minutes, orders, reports, recordings, or other
documentation of telephone or other conversations, interviews, affidavits, slides,
statement summaries, opinions, indices, analyses, publications, questionnaires,
answers to questionnaires, statistical records, ledgers, journals, lists, logs,
tabulations, charts, graphs, maps, surveys, sound recordings, data sheets, computer
printouts, tapes, discs, microfilm, and all other records kept, regardless of the title,
author, or origin.
"PERSON" means individuals, entities, firms, organizations, groups,
committees, regulatory agencies, governmental entities, business entities,
corporations, partnerships, trusts, and estates.
"REFERS," "REFERRING TO," "REGARDS," REGARDING," "RELATES,"
"RELATING TO," "CONCERNS," "BEARS UPON," or "PERTAINS TO" mean
containing, alluding to, responding to, commenting upon, discussing, showing,
disclosing, explaining, mentioning, analyzing, constituting, comprising, evidencing,
setting forth, summarizing, or characterizing, either directly or indirectly, in whole or
in part.
Instructions
The time period of the requested records is June 28, 2021, through the
present.
The words "and" and "or" shall be construed in the conjunctive or disjunctive,
whichever is most inclusive.
The singular form shall include the plural form and vice versa.
The present tense shall include the past tense and vice versa.
In producing the records described above, you shall segregate them by
reference to each of the numbered items of this FOIA request.
If you have any questions about this request, please contact Bryan Saddler by
e-mail at bsaddler@empowr.us.
3
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PagelD# PageID# 426
Fee Waiver Request
Empower Oversight agrees to pay up to $25.00 in applicable fees, but notes
that it qualifies as a "news media requester" 6 and requests a waiver of any fees that
may be associated with processing this request, in keeping with 5 U.S.C. § 552
(a)(4)(A)(iii).
Empower Oversight is a non-profit educational organization as defined under
Section 501(c)(3) of the Internal Revenue Code, which helps insiders safely and
legally report waste, fraud, abuse, corruption, and misconduct to the proper
authorities, and seeks to hold those authorities accountable to act on such reports by,
among other means, publishing information concerning the same. Empower
Oversight has no commercial interest in making this request.
Further, the information that Empower Oversight seeks is in the public
interest because it is likely to contribute significantly to the public understanding of
the operations or activities of the NIH. Specifically, the public has a significant
interest in understanding how the NIH is addressing the SARS-CoV-2 pandemic and
responding to information requests from members of Congress. Empower Oversight is
committed to government accountability, public integrity, and transparency. In the
latter regard, the information that that Empower Oversight receives that tends to
explain the NIH's practices will be disclosed publicly via its website, and shared
copies with other news media for public dissemination. 7
Request for Expedited Processing
Although Empower Oversight fully expects the NIH to respond to this FOIA
request within the 20 business days allotted by the FOIA, it requests expedited
processing. Understanding how the NIH responds to FOIA requests can enlighten
the public concerning why SARS-CoV-2 genetic sequences were removed from a United
States' federal database when they could help researchers establish how the pandemic started.
The request is of widespread and exceptional media interest and the information sought
involves questions about research integrity that affect public confidence in the activities and
operations of the NIH. Empower Oversight is engaged in disseminating information to
the public through its website and working with media. 8 Accordingly, it is important
that this request be processed and the results publicly disseminated as quickly as
possible.
6 As the Securities Exchange Commission recently conceded, with its issuances of 'press releases'
describing its activities and findings, and its emails ofresearch papers, FOIA updates, and news
accounts of its activities to an address list more than 9,400 members of the press, Capitol Hill staff,
and key thought leaders, Empower Oversight qualifies as a news media requester for purposes of fees
assessed pursuant to the FOIA.
7 "Mission," Empower Oversight (http://empowr.us/mission).
s "Mission," Empower Oversight (http://empowr.us/mission).
4
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PagelD# PageID# 427
For ease of administration and to conserve resources, we ask that documents
be produced in a readily accessible electronic format. In the event our request for a
fee waiver is denied or if you have any questions about this request, please contact us
immediately. Thank you for your prompt attention to this matter.
Cordially,
/SI
Jason Foster
Founder & President
5
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 41 of 143 PageID# 428
Case 1:21-cv-01275 Document 1-3 Filed 11/17/21 Page 1 of 5 PagelD# 21
EXHIBIT C
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Case 1:21-cv-01275 Document 1-3 Filed 11/17/21 Page 2 of 5 PagelD# 22
EMPOWER OVERSIGHT
Whistleblowers & Research
EMPOWR.us
September 30, 2021
VIA ELECTRONIC TRANSMISSION: NIHFOIA@MAIL.NIH.GOV
National Institutes of Health
Building 31, Room 5B35
9000 Rockville Pike
Bethesda, MD 20892
RE: Record of NIH'S FOIA Log from March 2020 to Present
Dear FOIA Officer:
Introduction
Empower Oversight Whistleblowers & Research ("Empower Oversight") is a
nonpartisan, nonprofit educational organization dedicated to enhancing independent
oversight of government and corporate wrongdoing. We work to help insiders safely
and legally report waste, fraud, abuse, corruption, and misconduct to the proper
authorities, and seek to hold those authorities accountable to act on those reports by,
among other means, publishing information concerning the same.
Records Request
To shed light on the manner in which the National Institutes of Health
("NIH") administers its statutory obligations under the Freedom of Information Act
("FOIA"), 5 U.S.C. § 552, we respectfully request a copy of the NIH's "log" of requests
for records filed pursuant to the FOIA.
Definitions
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 43 of 143 PageID# 430
Case 1:21-cv-01275 Document 1-3 Filed 11/17/21 Page 3 of 5 PagelD# 23
"LOG" means all registers, processing queues, spreadsheets, indexes, or other
types of records that the NIH maintains or uses to administer and track the date of
receipt, subject matter, requester, date of response, and status of all FOIA requests
that NIH received from March 1, 2020, through the present.
"COMMUNICATION(S)" means every manner or method of disclosure,
exchange of information, statement, or discussion between or among two or more
persons, including but not limited to, face-to-face and telephone conversations,
correspondence, memoranda, telegrams, telexes, email messages, voice-mail
messages, text messages, meeting minutes, discussions, releases, statements, reports,
publications, and any recordings or reproductions thereof.
"DOCUMENT(S)" or "RECORD(S)" mean any kind of written, graphic, or
recorded matter, however produced or reproduced, of any kind or description,
whether sent, received, or neither, including drafts, originals, non-identical copies,
and information stored magnetically, electronically, photographically or otherwise.
As used herein, the terms "DOCUMENT(S)" or "RECORD(S)" include, but are not
limited to, studies, papers, books, accounts, letters, diagrams, pictures, drawings,
photographs, correspondence, telegrams, cables, text messages, emails, memoranda,
notes, notations, work papers, intra-office and inter-office communications,
communications to, between and among employees, contracts, financial agreements,
grants, proposals, transcripts, minutes, orders, reports, recordings, or other
documentation of telephone or other conversations, interviews, affidavits, slides,
statement summaries, opinions, indices, analyses, publications, questionnaires,
answers to questionnaires, statistical records, ledgers, journals, lists, logs,
tabulations, charts, graphs, maps, surveys, sound recordings, data sheets, computer
printouts, tapes, discs, microfilm, and all other records kept, regardless of the title,
author, or origin.
"PERSON" means individuals, entities, firms, organizations, groups,
committees, regulatory agencies, governmental entities, business entities,
corporations, partnerships, trusts, and estates.
"REFERS," "REFERRING TO," "REGARDS," REGARDING," "RELATES,"
"RELATING TO," "CONCERNS," "BEARS UPON," or "PERTAINS TO" mean
containing, alluding to, responding to, commenting upon, discussing, showing,
disclosing, explaining, mentioning, analyzing, constituting, comprising, evidencing,
setting forth, summarizing, or characterizing, either directly or indirectly, in whole or
in part.
Instructions
The time period of the requested records is March 1, 2020, through the
present.
2
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PagelD# PageID# 431
The words "and" and "or" shall be construed in the conjunctive or disjunctive,
whichever is most inclusive.
The singular form shall include the plural form and vice versa.
The present tense shall include the past tense and vice versa.
In producing the records described above, you shall segregate them by
reference to each of the numbered items of this FOIA request.
If you have any questions about this request, please contact Bryan Saddler by
e-mail at bsaddler@empowr.us.
Fee Waiver Request
Empower Oversight agrees to pay up to $25.00 in applicable fees, but notes
that it qualifies as a "news media requester" 1 and requests a waiver of any fees that
may be associated with processing this request, in keeping with 5 U.S.C. § 552
(a)(4)(A)(iii).
Empower Oversight is a non-profit educational organization as defined under
Section 501(c)(3) of the Internal Revenue Code, which helps insiders safely and
legally report waste, fraud, abuse, corruption, and misconduct to the proper
authorities, and seeks to hold those authorities accountable to act on such reports by,
among other means, publishing information concerning the same. Empower
Oversight has no commercial interest in making this request.
Moreover, the information that Empower Oversight seeks is in the public
interest because it is likely to contribute significantly to the public understanding of
the operations or activities of the NIH. Specifically, the public has a significant
interest in understanding how the NIH responds to FOIA requests. Empower
Oversight is committed to government accountability, public integrity, and
transparency. In the latter regard, the information that that Empower Oversight
receives that tends to explain the NIH's FOIA practices will be disclosed publicly via
its website, and shared copies with other news media for public dissemination. 2
For ease of administration and to conserve resources, we ask that documents
be produced in a readily accessible electronic format. In the event our request for a
1 As the Securities Exchange Commission recently conceded, with its issuances of 'press releases'
describing its activities and findings, and its emails of research papers, FOIA updates, and news
accounts of its activities to an address list more than 9,400 members of the press, Capitol Hill staff,
and key thought leaders, Empower Oversight qualifies as a news media requester for purposes of fees
assessed pursuant to the FOIA.
2
"Mission," Empower Oversight (http://empowr.us/mission).
3
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 45 of 143 PageID# 432
Case 1:21-cv-01275 Document 1-3 Filed 11/17/21 Page 5 of 5 PagelD# 25
fee waiver is denied or if you have any questions about this request, please contact us
immediately. Thank you for your prompt attention to this matter.
Cordially,
/Sf
Jason Foster
Founder & President
4
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 46 of 143 PageID# 433
JS 44 (Rev. 04/21) Case 1:21-cv-01275 o~wrotedv~~esllfi'ffl Page 1 of 2 PagelD# 26
The JS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except as
provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the
purpose of initiating the civil docket sheet. (SEE INSTRUCTIONS ON NEXT PAGE OF THIS FORM.)
I. (a) PLAINTIFFS DEFENDANTS
EMPOWER OVERSIGHT WHISTLEBLOWERS & NATIONAL INSTITUTES OF HEAL TH
RESEARCH
(b) County ofResidence ofFirst Listed Plaintiff Arlinaton (VA) County of Residence of First Listed Defendant
(EXCEPT IN U. S. PLAINTIFF CASES) (IN U.S. PLAINTIFF CASES ONLY)
NOTE: IN LAND CONDEMNATION CASES , USE THE LOCATION OF
THE TRACT OF LAND INVOLVED.
(C) Attorneys (Firm Name , Address, and Telephone Number) Attorneys (If Known)
Michael J. Schrier, Husch Blackwell LLP (202.378 .2313)
750 17th St NW#900 , Washington, DC 20006
II. BASIS OF JURISDICTION (Place an "X" in One Box Only) III. CITIZENSHIP OF PRINCIPAL PARTIES (Place an "X" in One Box for Plaintiff
(For Diversity Cases Only) and One Box for Defendant)
□1 U.S. Government 03 Federal Question PTF DEF PTF DEF
Plaintiff (U.S. Government Not a Party) Citizen of This State D I D Incol1'orated or Principal Place D 4 D4
of Business In This State
02 U.S. Government 04 Diversity Citizen of Another State □2 □ 2 Incol1'orated and Principal Place
□ Os
Defendant (Indicate Citizenship of Parties in hem III) of Business In Another State
Citizen or Subject of a
Foreign Country
03
□ 3 Foreign Nation
□6 06
IV. NATURE OF SUIT (Place an "X" in One Box Ont~ Click here for: Nature of Suit Code Descri lions.
CONTRACT TORTS
~
110 Insurance PERSONAL INJURY PERSONAL INJURY 625 Drug Related Seizure 422 Appeal 28 USC 158 375 False Claims Act
120 Marine 3 IO Airplane D 365 Personal Injury • orProperty 21 USC 881 423 Withdrawal 376 Qui Tarn (3 1 USC
130 Miller Act 315 Ail1llane Product Product Liability 690 Other 28 USC 157 3729(a))
140 Negotiable Instrument Liability D 367 Health Care/ '\,:A INTELLECTUAL 400 State Reapportionment
D 150 Recovery of Ovel1'ayment 320 Assault, Libel & Pharmaceutical ......G__H___T__S__-,...-l 4 IO Anti trust
E__R__T__Y__RI
t=:--P...R....O__P__
& Enforcement of Judgment Slander Personal Injury 430 Banks and Banking
0 I 5 I Medicare Act 330 Federal Employers' Product Liability 450 Commerce
D 152 Recovery of Defaulted Liability D 368 Asbestos Personal 460 Deportation
Student Loans 340 Marine Injury Product 470 Racketeer Influenced and
(Excludes Veterans) 345 Marine Product Liability Corrupt Organizations
D 153 Recovery of Ovel1'ayment Liability PERSONAL PROPERTY LABOR 880 Defend Trade Secrets 480 Consumer Credit
of Veteran's Benefits 350 Motor Vehicle D 370 Other Fraud 7 10 Fair Labor Standards Act of2016 (15 USC 1681 or 1692)
D 160 Stockholders' Suits 355 Motor Vehicle D 371 Truth in Lending Act 485 Telephone Consumer
D I 90 Other Contract Product Liability D 380 Other Personal 720 Labor/Management ~---,S"'oc=IAcc'"'L-S"'E::-CURI= -=. TY=--,- Protection Act
D 195 Contract Product Liability 360 Other Personal Property Damage Relations 861 HIA (l395ff) 490 Cable/Sat TV
D 196 Franchise Injury D 385 Property Damage 740 Railway Labor Act 862 Black Lung (923) 850 Securities/Commodities/
362 Personal Injury- Product Liability 751 Family and Medical 863 DIWC/DIWW (405(g)) Exchange
Medical Malpractice Leave Act 864 SSJD Title XVI 890 Other Statutory Actions
_ _...R
...E
...AL
-'"--Y"--"--R-"O_P_E__
R__T -...
Y_: '"
...'--+--,,--C...IY
......IL
__R...
IG...:U:
......
TS_......___P_RJ_SO_N_E_R
___
P_E_TI__TI
_O_N_S_=s 790 Other Labor Litigation 865 RSI (405(g)) 89 I Agricultural Acts
210 Land Condemnation 440 Other Civil Rights Habeas Corpus: 791 Employee Retirement 893 Environmental Matters
D 220 Foreclosure 441 Voting 463 Alien Detainee Income Security Act t=~E~~~ii~:;::SE;~[~iiI~[==t•~ 895 Freedom of Information
§D 230 Rent Lease & Ejectrnent
240 Torts to Land
245 Tort Product Liability
290 All Other Real Property
442 Employment
443 Housing/
Accommodations
445 Amer. w/Disabilities -
510 Motions to Vacate
Sentence
530 General
535 Death Penalty i,...,.,---,IM~~""U""G"'RA,..,..,.T"'IO"'".N"_ _.,-,
870 Taxes (U.S. Plaintiff
or Defendant)
871 IRS-Third Party
26 USC 7609
Act
896 Arbitration
899 Administrative Procedure
Act/Review or Appeal of
Employment Other: 462 Naturalization Application Agency Decision
446 Amer. w/Disabilities - 540 Mandamus & Other 465 Other Immigration 950 Constitutionality of
Other 550 Civil Rights Actions State Statutes
448 Education 555 Prison Condition
560 Civil Detainee -
Conditions of
Confinement
V. ORIGIN (Placean "X"inOneBoxOnly)
0 I Original D 2 Removed from D 3 _ Remanded from D 4 Reinstated or D 5 Transferred from D 6 Multidistrict D 8 Multidistrict
Proceeding State Court Appellate Court Reopened Another District Litigation - Litigation-
(specify) Transfer Direct File
Cite the U.S. Civil Statute under which you are filing (Do not cite jurisdictional statutes unless diversity) :
5 U.S.C. 552
VI. CAUSE OF A C T I O N . . , : . . : : = . : _ : ; _ : _ = - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Brief description of cause:
Complaint for declaratory and injunctive relief for failure to timely repsond to FOIA request and produce responsive records
VII. REQUESTED IN 0 CHECK IF THIS IS A CLASS ACTION DEMAND$ CHECK YES only if demanded in complaint:
COMPLAINT: UNDERRULE23,FRCvP . JURYDEMAND: 0Yes 0No
VIII. RELATED CASE(S)
(See instructions):
IF ANY JUDGE _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ DOCKET NUMBER _ _ _ _ _ _ _ _ _ __
DATE SIONA TURE OF ATTORNEY OF RECORD
11-17-2021 /s/ Michael J . Schrier
FOR OFFICE USE ONLY
RECEIPT# AMOUNT APPL YING IFP JUDGE MAG. JUDGE
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 47 of 143 PageID# 434
JS44Reverse (Rev04/21:,Case 1:21-cv-01275 Document 1-4 Fi led 11/17/21 Page 2 of 2 PagelD# 27
INSTRUCTIONS FOR ATTORNEYS COMPLETING CIVIL COVER SHEET FORM JS 44
Authority For Civil Cover Sheet
The JS 44 civil cover sheet and the information contained herein neither replaces nor supplements the filings and service of pleading or other papers as
required by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is
required for the use of the Clerk of Court for the purpose of initiating the civil docket sheet. Consequently, a civil cover sheet is submitted to the Clerk of
Court for each civil complaint filed. The attorney filing a case should complete the form as follows :
I.(a) Plaintiffs-Defendants. Enter names (last, first, middle initial) of plaintiff and defendant. If the plaintiff or defendant is a government agency, use
only the full name or standard abbreviations. If the plaintiff or defendant is an official within a government agency, identify first the agency and then
the official, giving both name and title.
(b) County of Residence. For each civil case filed, except U.S. plaintiff cases, enter the name of the county where the first listed plaintiff resides at the
time of filing. In U.S. plaintiff cases, enter the name of the county in which the first listed defendant resides at the time of filing. (NOTE: In land
condemnation cases, the county ofresidence of the "defendant" is the location of the tract of land involved.)
(c) Attorneys. Enter the firm name, address, telephone number, and attorney of record. If there are several attorneys, list them on an attachment, noting
in this section "(see attachment)".
II. Jurisdiction. The basis of jurisdiction is set forth under Rule 8(a), F.R.Cv.P., which requires that jurisdictions be shown in pleadings. Place an "X"
in one of the boxes. If there is more than one basis of jurisdiction, precedence is given in the order shown below.
United States plaintiff. (1) Jurisdiction based on 28 U.S.C. 1345 and 1348. Suits by agencies and officers of the United States are included here.
United States defendant. (2) When the plaintiff is suing the United States, its officers or agencies, place an "X" in this box.
Federal question. (3) This refers to suits under 28 U.S.C. 1331, where jurisdiction arises under the Constitution of the United States, an amendment
to the Constitution, an act of Congress or a treaty of the United States. In cases where the U.S. is a party, the U.S. plaintiff or defendant code takes
precedence, and box I or 2 should be marked.
Diversity of citizenship. (4) This refers to suits under 28 U.S.C. 1332, where parties are citizens of different states. When Box 4 is checked, the
citizenship of the different parties must be checked. (See Section III below; NOTE: federal question actions take precedence over diversity
cases.)
III. Residence (c itizensh ip) of Principal Parties. This section of the JS 44 is to be completed if diversity of citizenship was indicated above. Mark this
section for each principal party.
IV. Nature of Suit. Place an "X" in the appropriate box. If there are multiple nature of suit codes associated with the case, pick the nature of suit code
that is most applicable. Click here for: Nature of Suit Code Descriptions.
V. Origin. Place an "X" in one of the seven boxes.
Original Proceedings. (I) Cases which originate in the United States district courts.
Removed from State Court. (2) Proceedings initiated in state courts may be removed to the district courts under Title 28 U.S.C., Section 1441.
Remanded from Appellate Court. (3) Check this box for cases remanded to the district court for further action. Use the date of remand as the filing
date.
Reinstated or Reopened. ( 4) Check this box for cases reinstated or reopened in the district court. Use the reopening date as the filing date.
Transferred from Another District. (5) For cases transferred under Title 28 U.S.C. Section 1404(a). Do not use this for within district transfers or
multidistrict litigation transfers.
Multidistrict Litigation -Transfer. (6) Check this box when a multidistrict case is transferred into the district under authority of Title 28 U.S.C.
Section I 407 .
Multidistrict Litigation - Direct File. (8) Check this box when a multidistrict case is filed in the same district as the Master MDL docket.
PLEASE NOTE THAT THERE IS NOT AN ORIGIN CODE 7. Origin Code 7 was used for historical records and is no longer relevant due to
changes in statute.
VI. Cause of Action. Report the civil statute directly related to the cause of action and give a brief description of the cause. Do not cite jurisdictional
statutes unless diversity. Example: U.S. Civil Statute: 4 7 USC 553 Brief Description: Unauthorized reception of cable service.
VII. Requested in Complaint. Class Action. Place an "X" in this box if you are filing a class action under Rule 23, F.R.Cv.P.
Demand. In this space enter the actual dollar amount being demanded or indicate other demand, such as a preliminary injunction.
Jury Demand. Check the appropriate box to indicate whether or not a jury is being demanded.
VIII. Related Cases. This section of the JS 44 is used to reference related pending cases, if any. If there are related pending cases, insert the docket
numbers and the corresponding judge names for such cases.
Date and Atto rney Signature. Date and sign the civil cover sheet.
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 48 of 143 PageID# 435
Case 1:21-cv-01275 Document 3 Filed 11/17/21 Page 1 of 1 PagelD# 30
UNITED STATES DISTRJCT COURT
EASTERN DISTRJCT OF VIRGINIA
ALEXANDRIA DIVISION
EMPOWER OVERSIGHT 'M11STLEBLOWERS & RESEARCH
vs. Civil Action No. 1:21-cv-01275
NATIONAL INSTITUTES OF HEALTH
FINANCIAL INTEREST DISCLOSURE STATEMENT
Pursuant to Local Rule 7.1 of the Eastern District of Virginia and to enable Judges and
Magistrate Judges to evaluate possible disqualification or recusal, the undersigned counsel for
in the above captioned action, certifies that the following are parents, trusts, subsidiaries and/or
affiliates of said party that have issued shares or debt securities to the public or own more than
ten percent of the stock of the following:
Or
Pursuant to Local Rule 7.1 of the Eastern District of Virginia and to enable Judges and
Magistrate Judges to evaluate possible disqualification or recusal, the undersigned counsel for
in the above captioned action, certifies that the following are parties in the partnerships, general
or limited, or owners or members of non-publicly traded entities such as LLCs or other closely
held entities:
Or
Pursuant to Local Rule 7.1 of the Eastern District of Virginia and to enable Judges and
Magistrate Judges to evaluate possible disqualifications or recusal, the undersigned counsel for
Empower Oversight Whistleblowers & Research
in the above captioned action, certifies that there are no parents, trusts, subsidiaries and/or
affiliates of said party that have issued shares or debt securities to the public.
11-17-21 Isl Michael J . Schrier
Date Signature of Attorney or Litigant
Counsel for Plaintiff Empower Oversight
Whistleblowers & Research
Rev. 03/ 12/ 19
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 49 of 143 PageID# 436
Case 1:21-cv-01275-LMB-JFA Document 6-1 Filed 11/19/21 Page 1 of 1 PagelD# 41
UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF VIRGINIA
NOTICE
CONSENT TO TRIAL BY MAGISTRATE JUDGE
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Alexandria, VA 22314 Norfolk, VA 23510
(703) 299-2101 (757) 222-7201
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UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF VIRGINIA
Alexandria Division
EMPOWER OVERSIGHT )
WHISTLEBLOWERS & RESEARCH, )
601 King Street, Suite 200 )
Alexandria, VA 22314-3151 )
)
Plaintiff, )
) Case No. ___________
v. )
)
NATIONAL INSTITUTES OF HEALTH, )
9000 Rockville Pike )
Bethesda, MD 20892 )
)
Defendant. )
FIRST AMENDED COMPLAINT
FOR DECLARATORY AND INJUNCTIVE RELIEF
1. Plaintiff Empower Oversight Whistleblowers & Research (hereinafter “Empower
Oversight”) brings this action against Defendant National Institutes of Health (“NIH”) to compel
compliance with the Freedom of Information Act, 5 U.S.C. § 552 ( “FOIA”), including obtaining
access to records maintained by the NIH.
2. The records at issue, including but not limited to communications to and from NIH,
relate to SARS-CoV-2 sequences submitted by a Chinese researcher for posting to the Sequence
Read Archive (“SRA”) in March 2020 and subsequently withdrawn by the NIH upon the
researcher’s request to SRA staff in June 2020. See infra ¶¶ 4-7.
3. On June 18, 2021, Dr. Jesse D. Bloom of the Fred Hutchen Cancer Research Center
published an article titled “Recovery of deleted deep sequencing data sheds more light on the early
Wuhan SARS-CoV-2 epidemic.” Jesse Bloom, Recovery of deleted deep sequencing data sheds
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more light on the early Wuhan SARS-CoV-2 epidemic, bioRxiv (June 18, 2021),
https://www.biorxiv.org/content/10.1101/2021.06.18.449051v1.full.pdf.
4. Dr. Bloom explained that in reviewing a March 2020 Wuhan University-associated
study containing a spreadsheet with information on 241 genetic sequences from the SRA, his own
searches for these sequences indicated that they were deleted from the SRA. See id. Nevertheless,
he was able to recover certain deleted files from Google Cloud and reconstruct partial sequences
of 13 early viruses. See id.
5. Dr. Bloom reasoned that “[t]he fact that such an informative data set was deleted
has implications beyond those gleaned directly from the recovered sequences,” and that it
“therefore seems likely the sequences were deleted to obscure their existence.” Id. at 7.
6. A June 23, 2021 New York Times article, among numerous others, heightened the
national focus on Dr. Bloom’s conclusions, reporting that he provided “intriguing new information
for discerning when and how the virus may have spilled over from a bat or another animal into
humans” and that it “raise[s] questions about why original sequences were deleted.” See Carl
Zimmer, Scientist Finds Early Virus Sequences That Had Been Mysteriously Deleted, N.Y.T. (June
23, 2021) (updated July 22, 2021), available at
https://www.nytimes.com/2021/06/23/science/coronavirus-sequences.html.
7. The New York Times article revealed that, in fact, more than 200 data entries from
the genetic sequencing of early COVID-19 cases disappeared from an online scientific database in
the summer of 2020. See id. The article included confirmation by the National Library of
Medicine within the NIH, which manages the SRA, that these sequences were “submitted for
posting in SRA in March 2020 and subsequently requested to be withdrawn by the submitting
investigator in June 2020.” See id.
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8. However, deletions from the SRA are reportedly rare. From March 2020 to March
2021, the SRA repeatedly received approximately 2.4 million submissions of sequence data,
according to the NCBI spokeswoman. However, a mere 0.19% were withdrawn. See Amy
Dockser Marcus & Drew Hinshaw, After Covid-19 Data Is Deleted, NIH Reviews How Its Gene
Archive Is Handled, WALL ST. J. (Sept. 13, 2021), available at https://www.wsj.com/articles/after-
covid-19-data-is-deleted-nih-reviews-how-its-gene-archive-is-handled-11631545490.
9. On June 28, 2021, Senators Grassley, Blackburn, and Marshall sent the NIH a letter
seeking records and responses to questions regarding the removal of the sequences from the SRA.
Letter from Sen. Grassley et al. to Francis S. Collins, June 28, 2021. The same Senators sent a
follow-up letter on September 16, 2021, reiterating their requests. Letter from Sen. Grassley et al.
to Francis S. Collins, Sept. 16, 2021.
10. According to the Centers for Disease Control and Prevention (“CDC”), as of
November 6, 2021, nearly 923,000 deaths—and counting—have been attributed to COVID-19 in
the United States alone. See COVID-19 Mortality Overview, CDC (last accessed Feb. 22, 2022),
available at https://www.cdc.gov/nchs/covid19/mortality-overview.htm. Yet, upon information
and belief, there is no global consensus on the origin of the COVID-19 pandemic.
11. The public thus has a significant interest in understanding the reason why these
early sequences were removed from the SRA. In recognizing this significant interest, Empower
Oversight filed the three FOIA Requests described herein.
12. Only after Empower Oversight filed its Complaint did the NIH begin to produce
records as to any of the three FOIA Requests.
13. As detailed herein, NIH’s unlawfully-delayed productions are insufficient and fall
short of what FOIA commands. In particular, NIH has failed to conduct a search reasonably
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calculated to locate responsive materials and has withheld non-exempt portions of responsive
documents.
14. Thus, despite six months passing since its first production was due, the NIH still
flouts the minimal transparency required under federal law. Empower Oversight has amended its
Complaint accordingly.
JURISDICTION AND VENUE
15. The Court has jurisdiction over this action pursuant to 5 U.S.C. § 552(a)(4)(B) and
28 U.S.C. § 1331.
16. Venue is proper in this district and division pursuant to 5 U.S.C. § 552(a)(4)(B) and
28 U.S.C. § 1391(e)(1).
PARTIES
17. Plaintiff Empower Oversight is a nonprofit, nonpartisan educational organization
dedicated to enhancing independent oversight of government and corporate wrongdoing.
Empower Oversight has its principal place of business located at 601 King Street, Suite 200,
Alexandria, VA 22314-3151. Empower Oversight works to help insiders safely and legally report
waste, fraud, abuse, corruption, and misconduct to the proper authorities, as well as work to hold
authorities accountable to act on such reports.
18. Defendant NIH is an agency within the U.S. Department of Health and Human
Services, and a federal administrative agency within the meaning of 5 U.S.C. § 552(f)(1), with its
principal place of business located at 9000 Rockville Pike, Bethesda, MD 20892. Upon
information and belief, the NIH has possession, custody, and control of the records, within the
meaning of 5 U.S.C. § 552(f)(2), to which Empower Oversight seeks access.
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LEGAL STANDARD
19. FOIA requires a federal administrative agency to promptly make available
requested, non-exempt agency records in response to a request that (a) reasonably describes such
records and (b) “is made in accordance with published rules stating the time, place, fees, . . . and
procedures to be followed[.]” 5 U.S.C. § 552(a)(3)(A); see also 45 C.F.R. § 5.22.
20. FOIA requires an agency to make reasonable efforts to search for records
reasonably calculated to locate all records responsive to a FOIA request. See 5 U.S.C. §
552(a)(3)(C).
21. An agency may withhold responsive records only to the extent such records fall
within nine discrete categories of exemptions. See 5 U.S.C. § 552(b); see also 45 C.F.R. § 5.61.
FOIA requires an agency to respond to a valid request within twenty (20) days (exempting
Saturdays, Sundays, and legal public holidays) (hereinafter “working days”) upon receipt of such
request, including notifying the requester immediately of its determination, the reasons therefor,
and the right to appeal any adverse determination. 5 U.S.C. § 552(a)(6)(A)(i); see also 45 C.F.R.
§§ 5.24, 5.28.
22. In certain circumstances, an agency may instead provide notice to the requester that
“unusual circumstances” merit additional time—up to an additional ten (10) working days—to
respond to the request. 5 U.S.C. § 552(a)(4)(viii)(II)(aa); see also 45 C.F.R. § 5.24(f). In the
event the agency provides notice to the requester of “unusual circumstances,” and that it is not able
to respond to the records request within the statutory deadline, the agency must provide the
requester “an opportunity to arrange with the agency an alternative time frame for processing the
request.” 5 U.S.C. § 552(a)(6)(B)(ii); 45 C.F.R. § 5.24(f).
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23. If an agency does not respond to a FOIA request and process responsive records by
the statutory deadline, the requester is deemed to have exhausted administrative remedies and may
immediately pursue judicial review. 5 U.S.C. § 552(a)(6)(C)(i).
FACTS
24. On July 14, 2021, Empower Oversight submitted a FOIA request to the NIH, see
Exhibit (“Ex.”) A, seeking access to the following:
a. All communications regarding the request to post the SARs-CoV-2 sequences to
the Sequence Read Archive in March 2020. This request covers all
communications between March 1, 2020 to March 31, 2020.
b. All communications regarding the request to withdraw the SARS-CoV-2 sequences
from Sequence Read Archive in June 2020. This request covers all
communications between June 1, 2020 to June 31, 2020.
c. All communications regarding these withdrawn sequences as reported by a preprint
titled “Recovery of deleted deep sequencing data sheds more light on the early
Wuhan SARS-CoV-2 epidemic” by Jesse Bloom, a virologist at the Fred
Hutchinson Cancer Research Center. This request covers all communications
between Jesse Bloom and the NIH, from January 1, 2021 and the present. This
request covers all communications inside the NIH regarding the preprint from
June 21, 2021 to the present.
d. All communications to, from, and within the NIH press office about the NIH
statement released on June 23, 2021, and about reports that these sequences were
removed from the Sequence Read Archive. This includes all emails related to the
drafting of the statement, communications about the reported removal, and
communications with reporters. This request covers all communications between
June 21, 2021 to June 25, 2021.
25. On September 30, 2021, Plaintiff submitted two additional FOIA Requests to the
NIH. In one September 30, 2021 Request, see Ex. B, Plaintiff sought access to and copies of:
a. All communications regarding the letter by Senators Grassley and Blackburn dated
June 28, 2021.
b. All communications regarding the NIH’s response to Senators Grassley and
Blackburn dated September 8, 2021.
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c. All communications regarding the letter by Senators Grassley and Blackburn dated
September 16, 2021.
26. On October 14, 2021, the NIH acknowledged by email that it received this Request,
assigning it as No. 57199.
27. In the other September 30, 2021 Request, see Ex. C, Plaintiff requested a copy of
the NIH’s “log” of requests for records filed pursuant to the FOIA.
28. Before filing the instant lawsuit against NIH, Empower Oversight did not receive
any correspondence from Defendant concerning either its July 14, 2021 or second of the two
September 30, 2021 FOIA Requests, despite applicable regulations prescribing that the NIH, at a
minimum, is required to acknowledge receipt of all FOIA requests in writing within 10 working
days. See 45 C.F.R. § 5.24; see also 45 C.F.R. § 5.4 (explaining that all operating divisions
(“OpDivs”) of HHS are subject to the requirements in that regulation); 45 C.F.R. § 5.3 (defining
NIH as an OpDiv of HHS).
29. Therefore, Empower Oversight was resigned to verify NIH’s receipt of these two
Requests by viewing NIH’s online FOIA portal, which suggested proof of receipt as follows:
a. A Request No. 56712 as having been filed by Empower Oversight on July 15, 2021.
The “Description” of Request No. 56712 matches the four enumerated items on
Empower Oversight’s July 14, 2021 Request, and the details of Request No. 56712
include an embedded link to a copy of Empower Oversight’s request. Therefore,
upon information and belief, the responsible FOIA officer “received” that July 14,
2021 Request on or before July 15, 2021.
b. A Request No. 57151 as having been filed by Empower Oversight on October 7,
2021. The “Description” of Request No. 57151 matches the substance of one of
Empower Oversight’s September 30, 2021 Requests, and the details of Request No.
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57151 include an embedded link to a copy of Empower Oversight’s request.
Therefore, upon information and belief, the responsible FOIA officer “received”
that September 30, 2021 Request on or before October 7, 2021.
30. As of November 17, 2021, the NIH had not provided a determination as to Request
Nos. 56712, 57151, or 57199, despite the requirement of 5 U.S.C. § 552(a)(6)(A) that an agency
respond within twenty (20) working days, including by providing detail on the scope of the records
the agency intends to produce or withhold, the reasons for making that determination, and an
explanation of the process by which a requester can administratively appeal that determination.
31. Accordingly, on November 17, 2021, Empower Oversight filed the instant action
against NIH for failure to comply with statutory deadlines, in violation of FOIA, 5 U.S.C. §
552(a)(6), and for unlawful withholding of agency records, in violation of FOIA, 5 U.S.C. §
552(a)(3). See Dkt. 1.
32. On December 17, 2021, and as revised on December 23, 2021, NIH provided a final
determination letter as to Request No. 57151, corresponding to Empower Oversight’s second of
two September 20, 2021 Requests. See Ex. D.
33. In its December 23, 2021 letter, NIH explicitly confirmed to Empower Oversight
for the first time that it received Request No. 57151 on October 7, 2021.
34. Therefore, by affirming on December 23, 2021 that it received Request No. 57151
on October 7, 2021, NIH openly acknowledged—with no explanation— that it unlawfully delayed
its response to the Request. See 5 U.S.C. § 552(a)(6)(A)(i); see also 45 C.F.R. §§ 5.24, 5.28
(requiring a response within 20 working days).
35. Along with the December 23, 2021 letter, NIH attached 130 pages of responsive
records in the form of fiscal year (“FY”) 2020 and FY 2021 FOIA Logs.
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36. On February 7, 2022, NIH provided a final determination as to Requests 56712 and
57203 (renumbering request “57199”), 1 corresponding to Empower Oversight’s July 14, 2021
Request and its September 30, 2021 Request, respectively. See Ex. E.
37. In the February 7, 2022 letter, NIH explicitly confirmed to Empower Oversight for
the first time that it received Request No. 56712 on July 15, 2021 and Request No. 57203 on
October 12, 2021.
38. Therefore, by affirming on February 7, 2022 that it received the Requests on July
15, 2021 and October 12, 2021, respectively, NIH openly acknowledged—with no explanation—
that it unlawfully delayed its response to both Requests.
39. Also in the February 7, 2022 letter, NIH stated that it processed 255 pages of
responsive records. In addition, NIH asserted it was withholding redacted information within those
255 pages pursuant to FOIA exemptions (b)(5) and (b)(6). See id.; see also 5 U.S.C. § 552(b)(5)-
(6); 45 C.F.R. § 5.31(e)-(f).
40. On February 24, 2022, Empower Oversight transmitted two administrative appeal
letters in response to the NIH’s production corresponding to Request Nos. 56712 and 57203
(hereinafter the “Administrative Appeals”). See Ex. F (corresponding to Request No. 56712); Ex.
G (corresponding to Request No. 57203).
41. As its Administrative Appeals reflect, NIH’s respective productions remain in
violation of FOIA for three main reasons. First, the NIH did not perform a search for records that
was reasonably calculated to find all responsive records. See id. Second, NIH’s own production
appears to show that NIH claimed FOIA Exemption (b)(5) for records that were not both pre-
1
It is unclear why Request No. 57199, as designated previously on FOIA’s Portal, was renumbered as Request No.
57203. However, both numbers (referred to as “57203” going forward) reflects Empower Oversight’s September
30, 2021 Request.
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decisional and deliberative. See id. Third, NIH claimed FOIA Exemption (b)(6) for records that
did not reflect legitimate personal privacy interests. See Ex. F.
42. To date, the NIH has not responded to the Administrative Appeals.
43. Empower Oversight has been required to expend resources to prosecute this action.
CLAIMS FOR RELIEF
Count I
Failure to Comply with Statutory Deadlines
in Violation of FOIA, 5 U.S.C. § 552(a)(6)
44. Plaintiff realleges and incorporates by reference each of the foregoing allegations,
contained in paragraphs 1-43, as if fully set forth herein.
45. More than 20 working days passed since each of the Three Requests were received
by the NIH. See supra ¶¶ 26, 29, 33, 37.
46. FOIA requires Defendant to have provided a final determination within 20 working
days of each of the Three Requests. Defendant may extend this 20-day period in the event of
“unusual circumstances,” as defined by 5 U.S.C. § 552(a)(6)(B)(iii), for a maximum of 10 working
days, but must provide Empower Oversight with notice to do so. See 5 U.S.C.
§§ 552(a)(4)(A)(viii)(II)(aa), 552(a)(6)(B)(ii).
47. Defendant did not provide a final determination within 20 working days of each of
the Three Requests, nor did it contact Empower Oversight with a claim that unusual circumstances
exist as to any of the Three Requests.
48. The NIH thus failed to timely make a determination on all Three Requests, in
violation of FOIA. See 5 U.S.C. § 552(a)(6).
49. Empower Oversight constructively exhausted all administrative remedies required
by FOIA as to each of the Three Requests. See 5 U.S.C. § 552(a)(6)(C)(i).
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Count II
Failure to Conduct a Search Reasonably Calculated to Locate All Responsive Records,
in Violation of FOIA, 5 U.S.C. § 552(a)(6)
50. Plaintiff realleges and incorporates by reference each of the foregoing allegations,
contained in paragraphs 1-49, as if fully set forth herein.
51. FOIA requires Defendant to process records requests and promptly provide the
requested records or the reasonably segregable portion of records not subject to a FOIA exemption.
5 U.S.C. § 552(a)(3)(B).
52. However, upon information and belief, Defendant has not provided Empower
Oversight all responsive, non-exempt documents in response to Requests No. 56712 and 57203.
53. In compiling a response to a FOIA Request, an agency cannot ignore a responsive
document that clearly indicates the existence of other relevant documents. However, the NIH
appears to have done precisely that.
54. For example, the NIH produced a July 26, 2021 email, which states in relevant part,
“I’m also attaching the last set of QA (which we already sent to you last week).” See Ex. F at 7.
That email then forwards the “last” set of questions and answers, which is responsive to Request
No. 56712. See id. However, the earlier set(s) preceding this “last” set was not produced. Upon
information and belief, the earlier set(s) would been equally responsive.
55. As another example, the NIH produced an August 11, 2021 email from NIH to Dr.
Jesse Bloom, which begins: “Thank you for your reply.” See id. at 6-7. However, the prior
correspondence to which NIH replied is not included within the NIH’s production. Upon
information and belief, the earlier set(s) would been equally responsive.
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56. By timely filing its Administrative Appeals in response to Defendant’s inadequate
search, Empower Oversight has thus constructively exhausted all administrative remedies required
by FOIA as to Requests No. 56712 and 57203. See 5 U.S.C. § 552(a)(6)(C)(i).
57. The NIH’s failure to conduct a search reasonably calculated to locate all responsive
records—as clearly referenced in its own limited production—is in violation of FOIA. 5 U.S.C. §
552(a)(3)(B).
Count III
Unlawful Withholding of Non-Exempt Agency Records
in Violation of FOIA, 5 U.S.C. § 552(a)(3)
58. Plaintiff realleges and incorporates by reference each of the foregoing allegations,
contained in paragraphs 1-57, as if fully set forth herein.
59. FOIA requires Defendant to process records requests and promptly provide the
requested records or the reasonably segregable portion of records not subject to a FOIA exemption.
5 U.S.C. § 552(a)(3)(B).
60. However, as reflected in its pending Administrative Appeals concerning Requests
No. 56712 and 57203, Defendant has redacted responsive records that are neither both pre-
decisional and deliberative, and thus entitled to a (b)(5) FOIA exemption. See Exs. F-G; see also
5 U.S.C. 552(b)(5).
61. In addition, as reflected in its pending Administrative Appeal concerning Request
No. 56712, Defendant has withheld responsive records, the disclosure of which would not
constitute a clearly unwarranted invasion of personal privacy, and thus entitled to a (b)(6) FOIA
Exemption. See Ex. F; see also 5 U.S.C. 552(b)(6).
62. In addition, Defendant has withheld other responsive records entirely in accordance
with its failure to conduct a reasonable search for records. See supra ¶¶ 47-49; see also Exs. F-G.
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63. Therefore, the NIH’s acts and omissions to unlawfully withhold responsive records
and to improperly invoke Exemption (b)(5) and (b)(6) to redact and/or withhold entire documents
is in violation of FOIA. 5 U.S.C. § 552(a)(3)(B).
RELIEF REQUESTED
WHEREFORE, Plaintiff prays that this Court:
A. Declare that NIH failed to make timely determinations on each of Empower
Oversight’s Three Requests, in violation of FOIA, 5 U.S.C. § 552(a)(6)(A)(i);
B. Declare that NIH failed to conduct a reasonable and adequate search as to each of
Requests No. 56712 and 57203, in violation of FOIA, 5 U.S.C. § 552(a)(3)(C);
C. Declare that NIH failed to promptly provide records responsive to each of Empower
Oversight’s Three Requests, in violation of FOIA, 5 U.S.C. § 552(a)(3);
D. Declare that in responding to Requests No. 56712 and 57203, NIH improperly
invoked FOIA Exemption (b)(5) to redact information from produced documents
and/or withhold production of otherwise responsive documents;
E. Declare that in responding to Request No. 56712, NIH improperly invoked FOIA
Exemption (b)(6) to redact information from produced documents and/or withhold
production of otherwise responsive documents;
F. Order NIH to immediately conduct a reasonable search for all responsive records,
as required by FOIA, 5 U.S.C. § 552(a)(3)(C);
G. Order NIH to promptly disclose to Empower Oversight all responsive, non-exempt
records, as required by FOIA, 5 U.S.C. § 552(a)(3);
H. Order NIH to properly limit its use of FOIA Exemptions (b)(5) and (b)(6) and
provide appropriately unredacted documents;
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451
I. Award Empower Oversight its costs and reasonable attorneys’ fees incurred in this
action, pursuant to 5 U.S.C. § 552(a)(4)(E); and
J. Grant such other relief as the Court may deem just and proper.
February 25, 2022 Respectfully submitted,
/s/ Michael J. Schrier
Michael J. Schrier (VSB #65916)
HUSCH BLACKWELL LLP
750 17th Street, NW, Suite 900
Washington, DC 20006-4675
Tel. 202-378-2313
Fax 202-378-2319
michael.schrier@huschblackwell.com
Scott L. Glabe
HUSCH BLACKWELL LLP
750 17th Street, NW, Suite 900
Washington, DC 20006-4675
Tel. 202-378-2396
Fax 202-378-2319
scott.glabe@huschblackwell.com
Attorneys for Plaintiff Empower Oversight
Whistleblowers & Research
14
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Attachment E
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 66 of 143 PageID# 453
National Institutes of Health
Freedom of Information Office
Building 31, Room 5B-35
31 Center Drive, MSC 2107
Bethesda, Maryland 20892-2107
phone: (301) 496-5633
fax: (301) 402-4541
Via Email: info@empowr.us
February 7, 2022
Jason Foster
Founder & President
Empower Oversight
2615 Columbia Pike, #445
Arlington, VA 22204
Re: NIH FOIA Case No.: 56712 & 57203; Empower Oversight Whistleblowers & Research v.
NIH, Case No. 21-cv-01275
Dear Mr. Foster:
This is the final response to the Freedom of Information Act (FOIA) request that is the subject of
the complaint filed in Empower Oversight Whistleblowers & Research v. NIH, Case No. 21-cv-
01275, now pending in the U.S. District Court for Virginia. Your FOIA request 56712, dated
July 15, 2021, was received by the National Institutes of Health (NIH) FOIA Office, on the same
day. Your FOIA request 57203, dated October 12, 2021, was received by the National Institutes
of Health (NIH) FOIA Office, on the same day.
FOIA request 56712 requested:
1)All communications regarding the request to post the SARS-CoV-2 sequences to the
Sequence Read Archive in March 2020. This request covers all communications between
March 1, 2020 to March 31, 2020.
2)All communications regarding the request to withdraw the SARS-CoV-2 sequences
from Sequence Read Archive in June 2020. This request covers all communications
between June 1, 2020 to June 31, 2020.
3)All communications regarding these withdrawn sequences as reported by a preprint
titled “Recovery of deleted deep sequencing data sheds more light on the early Wuhan
SARS-CoV-2 epidemic” by Jesse Bloom, a virologist at the Fred Hutchinson Cancer
Research Center. This request covers all communications between Jesse Bloom and the
NIH, from January 1, 2021 and the present. This request all covers all communications
inside the NIH regarding the preprint from June 21, 2021 to the present.
4)All communications to, from, and within the NIH press office about the NIH statement
released on June 23, 2021, and about reports that these sequences were removed from the
Sequence Read Archive. This includes all emails related to the drafting of the statement,
communications about the reported removal, and communications with reporters. This
request covers all communications between June 21, 2021 to June 25, 2021.
FOIA Request 57203 requested:
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Page 2 – Mr. Foster (56712 & 57203; Empower. v. NIH, 21-cv-01275)
1) All communications regarding the letter by Senators Grassley and Blackburn dated
June 28, 2021.
2) All communications regarding the NIH’s response to Senators Grassley and Blackburn
dated September 8, 2021. 3) All communications regarding the letter by Senators
Grassley and Blackburn dated September 16, 2021.
In accordance with the Court’s order dated November 17, 2021, we have processed 255 pages of
responsive records for this litigation. The information being withheld is protected from release
pursuant to Exemptions (b)(5) and (b)(6) of the FOIA, 5 U.S.C. § 552 (b)(5) and (b)(6); and
sections 5.31 (e) and (f) of the HHS FOIA Regulations, 45 CFR Part 5. Exemption 5 permits the
withholding of internal government records which are pre-decisional and contain staff advice,
opinion, and recommendations. This exemption is intended to preserve free and candid internal
dialogue leading to decision-making. Exemption 6 permits the withholding of privacy
information, the release of which would constitute a clearly unwarranted invasion of personal
privacy.
Please direct any questions regarding this response to Meghan Loftus of the Department of
Justice, who can be reached at meghan.loftus@usdoj.gov.
Sincerely,
Digitally signed by
Karen E. Karen E. Lampe -S
Date: 2022.02.07
Lampe -S 14:22:16 -06'00'
for Gorka Garcia-Malene
Freedom of Information Act Officer, NIH
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 68 of 143 PageID# 455
Attachment F
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September 30, 2021
VIA ELECTRONIC TRANSMISSION: NIHFOIA@MAIL.NIH.GOV
National Institutes of Health
Building 31, Room 5B35
9000 Rockville Pike
Bethesda, MD 20892
RE: Records Regarding NIH’S SARS-COV-2 Database
Dear FOIA Officer:
Introduction
Empower Oversight Whistleblowers & Research (“Empower Oversight”) is a
nonpartisan, nonprofit educational organization dedicated to enhancing independent
oversight of government and corporate wrongdoing. We work to help insiders safely
and legally report waste, fraud, abuse, corruption, and misconduct to the proper
authorities, and seek to hold those authorities accountable to act on those reports by,
among other means, publishing information concerning the same.
Background
The New York Times and The Washington Post, among others, have reported
on requests by Chinese researchers to have certain SARS-CoV-2 genetic sequences
withdrawn from the National Institutes of Health’s (“NIH”) Sequence Read Archive.1
Genetic sequences for SARS-CoV-2 virus are critical to understanding how the
pandemic (which has killed more than 670,000 Americans) started, and
1 “Scientist Finds Early Virus Sequences That Had Been Mysteriously Deleted,” New York Times (Jun
23, 2021); “Seattle scientist digs up deleted coronavirus genetic data, adding fuel to the covid origin
debate,” Washington Post (Jun 23, 2021).
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 70 of 143 PageID# 457
understanding the origin of the pandemic is essential to furthering the prevention of
future pandemics.2 Additionally, the State Department has noted that China has not
been transparent in its handling of the question of the origin of SARS-CoV-2 and, as
part of its hindrance of efforts to gain an understanding of the virus, has removed
genetic sequences from its own online databases.3
On June 28, 2021, Senators Charles Grassley and Marsha Blackburn sent the NIH
a letter seeking records and answers to seven questions regarding the removal of the
SARS-CoV-2 genetic sequences from the Sequence Read Archive. They received a
response to their inquiry on September 8, 2021, that they state “failed to fully and
completely answer all seven questions and failed to provide the requested records.” 4
Senators Grassley and Blackburn then sent a follow up letter on September 16, 2021,
demanding answers to their previous questions.5
Records Request
To shed light on the manner in which the NIH is addressing the SARS-CoV-2
pandemic and responding to information requests from members of Congress, we
respectfully request, pursuant to the Freedom of Information Act (“FOIA”), 5 U.S.C.
§ 552, copies of:
1. All communications regarding the letter by Senators Grassley and Blackburn
dated June 28, 2021.
2. All communications regarding the NIH’s response to Senators Grassley and
Blackburn dated September 8, 2021.
3. All communications regarding the letter by Senators Grassley and Blackburn
dated September 16, 2021.
Definitions
“COMMUNICATION(S)” means every manner or method of disclosure,
exchange of information, statement, or discussion between or among two or more
persons, including but not limited to, face-to-face and telephone conversations,
correspondence, memoranda, telegrams, telexes, email messages, voice-mail
messages, text messages, meeting minutes, discussions, releases, statements, reports,
publications, and any recordings or reproductions thereof.
“DOCUMENT(S)” or “RECORD(S)” mean any kind of written, graphic, or
recorded matter, however produced or reproduced, of any kind or description,
2 “COVID Mortality Data,” Johns Hopkins University (https://coronavirus.jhu.edu/data/mortality)
3 “Fact Sheet on Activity at the Wuhan Institute of Virology,” U.S. State Dep’t (https://2017-
2021.state.gov/fact- sheet-activity-at-the-wuhan-institute-of-virology/index.html)
4 https://www.grassley.senate.gov/news/news-releases/did-nih-improperly-delete-covid-19-data-at-
request-of-chinese-researchers-senators-want-answers
5 https://www.grassley.senate.gov/news/news-releases/did-nih-improperly-delete-covid-19-data-at-
request-of-chinese-researchers-senators-want-answers
2
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 71 of 143 PageID# 458
whether sent, received, or neither, including drafts, originals, non-identical copies,
and information stored magnetically, electronically, photographically or otherwise.
As used herein, the terms “DOCUMENT(S)” or “RECORD(S)” include, but are not
limited to, studies, papers, books, accounts, letters, diagrams, pictures, drawings,
photographs, correspondence, telegrams, cables, text messages, emails, memoranda,
notes, notations, work papers, intra-office and inter-office communications,
communications to, between and among employees, contracts, financial agreements,
grants, proposals, transcripts, minutes, orders, reports, recordings, or other
documentation of telephone or other conversations, interviews, affidavits, slides,
statement summaries, opinions, indices, analyses, publications, questionnaires,
answers to questionnaires, statistical records, ledgers, journals, lists, logs,
tabulations, charts, graphs, maps, surveys, sound recordings, data sheets, computer
printouts, tapes, discs, microfilm, and all other records kept, regardless of the title,
author, or origin.
“PERSON” means individuals, entities, firms, organizations, groups,
committees, regulatory agencies, governmental entities, business entities,
corporations, partnerships, trusts, and estates.
“REFERS,” “REFERRING TO,” “REGARDS,” REGARDING,” “RELATES,”
“RELATING TO,” “CONCERNS,” “BEARS UPON,” or “PERTAINS TO” mean
containing, alluding to, responding to, commenting upon, discussing, showing,
disclosing, explaining, mentioning, analyzing, constituting, comprising, evidencing,
setting forth, summarizing, or characterizing, either directly or indirectly, in whole or
in part.
Instructions
The time period of the requested records is June 28, 2021, through the
present.
The words “and” and “or” shall be construed in the conjunctive or disjunctive,
whichever is most inclusive.
The singular form shall include the plural form and vice versa.
The present tense shall include the past tense and vice versa.
In producing the records described above, you shall segregate them by
reference to each of the numbered items of this FOIA request.
If you have any questions about this request, please contact Bryan Saddler by
e-mail at bsaddler@empowr.us.
3
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Fee Waiver Request
Empower Oversight agrees to pay up to $25.00 in applicable fees, but notes
that it qualifies as a “news media requester”6 and requests a waiver of any fees that
may be associated with processing this request, in keeping with 5 U.S.C. § 552
(a)(4)(A)(iii).
Empower Oversight is a non-profit educational organization as defined under
Section 501(c)(3) of the Internal Revenue Code, which helps insiders safely and
legally report waste, fraud, abuse, corruption, and misconduct to the proper
authorities, and seeks to hold those authorities accountable to act on such reports by,
among other means, publishing information concerning the same. Empower
Oversight has no commercial interest in making this request.
Further, the information that Empower Oversight seeks is in the public
interest because it is likely to contribute significantly to the public understanding of
the operations or activities of the NIH. Specifically, the public has a significant
interest in understanding how the NIH is addressing the SARS-CoV-2 pandemic and
responding to information requests from members of Congress. Empower Oversight is
committed to government accountability, public integrity, and transparency. In the
latter regard, the information that that Empower Oversight receives that tends to
explain the NIH’s practices will be disclosed publicly via its website, and shared
copies with other news media for public dissemination.7
Request for Expedited Processing
Although Empower Oversight fully expects the NIH to respond to this FOIA
request within the 20 business days allotted by the FOIA, it requests expedited
processing. Understanding how the NIH responds to FOIA requests can enlighten
the public concerning why SARS-CoV-2 genetic sequences were removed from a United
States’ federal database when they could help researchers establish how the pandemic started.
The request is of widespread and exceptional media interest and the information sought
involves questions about research integrity that affect public confidence in the activities and
operations of the NIH. Empower Oversight is engaged in disseminating information to
the public through its website and working with media.8 Accordingly, it is important
that this request be processed and the results publicly disseminated as quickly as
possible.
6 As the Securities Exchange Commission recently conceded, with its issuances of ‘press releases’
describing its activities and findings, and its emails of research papers, FOIA updates, and news
accounts of its activities to an address list more than 9,400 members of the press, Capitol Hill staff,
and key thought leaders, Empower Oversight qualifies as a news media requester for purposes of fees
assessed pursuant to the FOIA.
7 “Mission,” Empower Oversight (http://empowr.us/mission).
8 “Mission,” Empower Oversight (http://empowr.us/mission).
4
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For ease of administration and to conserve resources, we ask that documents
be produced in a readily accessible electronic format. In the event our request for a
fee waiver is denied or if you have any questions about this request, please contact us
immediately. Thank you for your prompt attention to this matter.
Cordially,
/S/
Jason Foster
Founder & President
5
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Attachment G-1
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 75 of 143 PageID# 462
From: Bryan Saddler <bsaddler@empowr.us>
Sent: Thursday, February 24, 2022 12:50 PM
To: Garcia-Malene, Gorka (NIH/OD) [E] <gorka.garcia-malene@nih.gov>
Cc: Jason Foster <jf@empowr.us>
Subject: [EXTERNAL] Appeal of FOIA Request Number 56712
CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you
recognize the sender and are confident the content is safe.
Dear Mr. Garcia-Malene: Attached is a letter appealing the NIH's February 7, 2022, response to
Empower Oversight's July 14, 2021, FOIA request, which the NIH designated as FOIA Request Number
56712.
Referencing the litigation pending in connection with the FOIA request, the NIH's February 7th letter
does not advise Empower Oversight how to appeal. I note, however, that the HHS has a web-portal
established to accept appeals of the NIH's FOIA responses. But, in light of the litigation and the risk of
the matter getting lost in the HHS's processes, I thought that it would be more efficient to forward the
appeal to your attention and request your advice concerning the effectuation of service. Please advise
me if I need to send a copy of the appeal to the HHS's web-portal, if your office is unable or unwilling to
accept the appeal.
Cordially, Bryan Saddler
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 76 of 143 PageID# 463
Attachment G
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February 24, 2022
VIA ELECTRONIC TRANSMISSION: gorka.garcia-malene@nih.gov
Gorka Garcia-Malene,
NIH Freedom of Information Institute/Center Coordinator
Office of the Director
Building 31 Room 5B35
9000 Rockville Pike
Bethesda, MD 20892
VIA ELECTRONIC TRANSMISSION: meghan.loftus@usdoj.gov
Meghan Loftus
Assistant United States Attorney
Office of the United States Attorney
Justin W. Williams U.S. Attorney’s Building
2100 Jamieson Ave.
Alexandria, VA 22314
RE: FREEDOM OF INFORMATION ACT APPEAL
FOIA REQUEST NUMBER 56712
Dear Mr. Garcia-Malene:
INTRODUCTION
With respect to the National Institutes of Health’s (“SEC”) Freedom of Information Act
(“FOIA”)1 Request Number 56712, Empower Oversight Whistleblowers & Research (“Empower
1 The FOIA is codified at 5 U.S.C. § 552.
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 78 of 143 PageID# 465
Oversight”)2 appeals the NIH’s February 7, 2022, initial determination on the grounds that
NIH’s FOIA staff:
• Did not perform a search for records that was reasonably calculated to find all responsive
records;
• Claimed FOIA Exemption b(5)—specifically for the deliberative process privilege—for
records that were not both pre-decisional and deliberative; and
• Claimed FOIA Exemption b(6) for records that do not invoke a legitimate personal
privacy interest.
Accordingly, Empower Oversight respectfully requests that the NIH review the nature
and scope of its FOIA staff’s records search and review, correct any deficiencies that are
identified, and apprise Empower Oversight of the results of such review.
BACKGROUND
1. Empower Oversight’s July 14, 2021, FOIA Request
On July 14, 2021, Empower Oversight filed with the NIH a request for records under the
FOIA.3 Empower Oversight’s July 14th FOIA request seeks:
1) All communications regarding the request to post the SARS-CoV-2 [genetic]
sequences to the Sequence Read Archive in March 2020. This request covers all
communications between March 1, 2020 to March 31, 2020.
2) All communications regarding the request to withdraw the SARS-CoV-2
sequences from Sequence Read Archive in June 2020. This request covers all
communications between June 1, 2020 to June 31, 2020.
3) All communications regarding these withdrawn sequences as reported by a
preprint titled “Recovery of deleted deep sequencing data sheds more light on the
early Wuhan SARS-CoV-2 epidemic” by Jesse Bloom, a virologist at the Fred
Hutchinson Cancer Research Center. This request covers all communications
between Jesse Bloom and the NIH, from January 1, 2021 and the present. This
request all covers all communications inside the NIH regarding the preprint from
June 21, 2021 to the present.
2 Empower Oversight is a nonpartisan, nonprofit educational organization, which is dedicated to enhancing independent oversight of
government and corporate wrongdoing. It works to help insiders safely and legally report waste, fraud, abuse, corruption, and misconduct to
the proper authorities, and seeks to hold those authorities accountable to act on such reports by, among other means, publishing information
concerning the same.
3 In compliance with the NIH’s procedures, which require all requesters to submit their FOIA requests “through [the NIH’s] online portal . . .
rather than mail, fax, or courier,” Empower Oversight registered with the NIH’s online portal, and used it to submit its request. See, NIH,
Submitting FOIA Requests (Last Reviewed on March 27, 2020), available at https://www.nih.gov/institutes-nih/nih-office-director/office-
communications-public-liaison/freedom-information-act-office/submitting-foia-requests.
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4) All communications to, from, and within the NIH press office about the NIH
statement released on June 23, 2021, and about reports that these sequences were
removed from the Sequence Read Archive. This includes all emails related to the
drafting of the statement, communications about the reported removal, and
communications with reporters. This request covers all communications between
June 21, 2021 to June 25, 2021.4
In addition, Empower Oversight requested: 1) a waiver of search and duplication fees associated
with the NIH’s processing of its FOIA request, and 2) expedited processing.
In support of its FOIA request, Empower Oversight explained that in March 2020
Chinese researchers submitted SARS-CoV-2 genetic sequences for posting to the NIH’s
Sequence Read Archive (“SRA”), and in June of 2020 they requested that the same sequences be
withdrawn from the SRA.5 Genetic sequences of the SARS-CoV-2 virus are critical to
understanding how the coronavirus pandemic (which has killed more than 934,000 Americans)6
started and how future pandemics can be prevented.7 Furthermore, the presence of the SARS-
CoV-2 genetic sequences on U.S. government storage resources is crucial because, as the U.S.
Department of State has advised, China has not been transparent in connection with efforts to
discover the origin of the SARS-CoV-2 virus.8 Indeed, China has removed from its own online
databases genetic sequences for RaTG13, which is a bat coronavirus that the Wuhan Institute of
Virology (“WIV”) has studied since at least 2016 and which it claimed to be the closest coronavirus
sample to SARS-CoV-2 in January 2020 (RaTG13 is reported to be 96.2% similar to SARS-CoV-
2).9
The New York Times and The Washington Post have reported on Chinese researchers’
requests to remove the SARS-CoV-2 genetic sequences from the NIH’s SRA.10 According to The
Washington Post, “The NIH released a statement [June 23, 2021] saying that a researcher who
originally published the genetic sequences asked for them to be removed from the NIH database
4 Empower Oversight’s July 14th FOIA request is attached as Exhibit 1.
5 Zimmer, Carl, Scientist Finds Early Virus Sequences That Had Been Mysteriously Deleted (June 23, 2021), available at
https://www.nytimes.com/2021/06/23/science/coronavirus-sequences.html; Achenbach, Joel, Guarino, Ben, Abutaleb, Yasmeen, Seattle
Scientist Digs up Deleted Coronavirus Genetic Data, Adding Fuel to the Covid Origin Debate (June 23, 2021), available at
https://www.washingtonpost.com/health/coronavirus-origin-nih-gene-sequence-deletion/2021/06/23/186e87d0-d437-11eb-a53a-
3b5450fdca7a_story.html.
6 Johns Hopkins University, Mortality Analyses, available at https://coronavirus.jhu.edu/data/mortality (last accessed on February 21, 2022).
7 See generally, U.S. Department of State, Fact Sheet: Activity at the Wuhan Institute of Virology, available at https://2017-2021.state.gov/fact-
sheet-activity-at-the-wuhan-institute-of-virology/index.html.
8 U.S. Department of State, Fact Sheet: Activity at the Wuhan Institute of Virology, available at https://2017-2021.state.gov/fact-sheet-activity-
at-the-wuhan-institute-of-virology/index.html.
9
U.S. Department of State, Fact Sheet: Activity at the Wuhan Institute of Virology, available at https://2017-2021.state.gov/fact-sheet-activity-
at-the-wuhan-institute-of-virology/index.html.
10 Zimmer, Carl, Scientist Finds Early Virus Sequences That Had Been Mysteriously Deleted (June 23, 2021), available at
https://www.nytimes.com/2021/06/23/science/coronavirus-sequences.html; Achenbach, Joel, Guarino, Ben, Abutaleb, Yasmeen, Seattle
Scientist Digs up Deleted Coronavirus Genetic Data, Adding Fuel to the Covid Origin Debate (June 23, 2021), available at
https://www.washingtonpost.com/health/coronavirus-origin-nih-gene-sequence-deletion/2021/06/23/186e87d0-d437-11eb-a53a-
3b5450fdca7a_story.html.
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so that they could be included in a different database.”11 In a statement to The Washington
Post, the NIH said:
These SARS-CoV-2 sequences were submitted for posting in SRA in March 2020
and subsequently requested to be withdrawn by the submitting investigator in June
2020. The requestor indicated the sequence information had been updated, was
being submitted to another database, and wanted the data removed from SRA to
avoid version control issues.12
And, according to The New York Times:
“These SARS-CoV-2 sequences were submitted for posting in SRA in March 2020
and subsequently requested to be withdrawn by the submitting investigator in June
2020,” said Renate Myles, a spokeswoman for the National Institutes of Health.
She said that the investigator, whom she did not name, told the archive managers
that the sequences were being updated and would be added to a different
database.13
Empower Oversight has no commercial interest in the records sought by its FOIA
request, instead it seeks the requested records to contribute significantly to the public’s
understanding of understanding how the NIH is addressing the SARS-CoV-2 pandemic. Part of
NIH’s responsibility in that regard necessarily includes furthering efforts to determine the origin
of the virus and prevent future pandemics. The potential usefulness of the SARS-CoV-2 genetics
sequences that NIH removed from the SRA has ignited an extraordinary interest among the
public in research integrity generally and in the NIH’s rationale for its removal of the SARS-
CoV-2 genetic sequences from the SRA specifically. Public confidence in the NIH’s activities and
operations is at stake, and thus it is Empower Oversight’s intention to enlighten the public about
these issues.
As November 17, 2021, Empower Oversight had not received any correspondence
whatsoever from the NIH concerning its FOIA request, and thus it filed against the NIH a
Complaint for Declaratory and Injunctive Relief—Civil Case Number 1:21-cv-01275—in the
United States Court for the Eastern District of Virginia. Empower Oversight’s complaint seeks,
among other things, declarations that the NIH failed to file a timely determination and promptly
provide responsive records, an order requiring the NIH to perform a reasonable search and
disclose all responsive, non-exempt records, and an award of costs and attorney’s fees.
11 Achenbach, Joel, Guarino, Ben, Abutaleb, Yasmeen, Seattle Scientist Digs up Deleted Coronavirus Genetic Data, Adding Fuel to the Covid
Origin Debate (June 23, 2021), available at https://www.washingtonpost.com/health/coronavirus-origin-nih-gene-sequence-
deletion/2021/06/23/186e87d0-d437-11eb-a53a-3b5450fdca7a_story.html.
12 Achenbach, Joel, Guarino, Ben, Abutaleb, Yasmeen, Seattle Scientist Digs up Deleted Coronavirus Genetic Data, Adding Fuel to the Covid
Origin Debate (June 23, 2021), available at https://www.washingtonpost.com/health/coronavirus-origin-nih-gene-sequence-
deletion/2021/06/23/186e87d0-d437-11eb-a53a-3b5450fdca7a_story.html.
13 Zimmer, Carl, Scientist Finds Early Virus Sequences That Had Been Mysteriously Deleted (June 23, 2021), available at
https://www.nytimes.com/2021/06/23/science/coronavirus-sequences.html.
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2. NIH’s February 7, 2022, Response to Empower Oversight’s FOIA Request
By letter dated February 7, 2022, the NIH responded to Empower Oversight’s July 14th
FOIA request.14 In its letter, the NIH designated the request as FOIA Request Number 56712,
and produced 238 pages of records, many of which have been redated pursuant to FOIA
Exemptions b(5) and b(6). With respect to FOIA Exemption b(5), the NIH explained that its
redactions are limited to the deliberative process privilege:
Exemption 5 permits the withholding of internal government records which are
pre-decisional and contain staff advice, opinion, and recommendations. This
exemption is intended to preserve free and candid internal dialogue leading to
decision-making.
ANALYSIS
As discussed in detail below, the 238 pages of records that the NIH produced in response
to FOIA Request Number 56712 include evidence indicating that the NIH’s FOIA staff made
significant errors when searching for responsive records and when reviewing responsive records
for FOIA exemptions.
1. The NIH’s Search for Responsive Records Was Not Reasonably Calculated to Locate All
Records Responsive to Empower Oversight’s FOIA Request
The legal standard governing the search for records responsive to FOIA requests requires
an agency to conduct a search that is “reasonably calculated to uncover all relevant
documents.”15 Such calculation involves both an understanding of the nature and scope of the
FOIA request and knowledge of where information may be stored within an agency. In the
former regard, courts have found searches to be sufficient when they are based on a reasonable
interpretation of the scope of the subject matter of the request.16
Regarding the issue of knowledge of the contents of an agency’s records storage
platforms, an agency must show that it conducted a good faith, reasonable search of all platforms
likely to possess the requested records.17 Hence, the reasonableness of an agency’s search can
often depend on whether the agency properly determined where responsive records were likely
to be found—and searched those locations,18 or whether the agency improperly limited its search
to certain platforms.19
14 The NIH’s February 7, 2021, response to Empower Oversight’s July 14th FOIA request is attached as Exhibit 2.
15 Weisberg v. DOJ, 705 F.2d 1344, 1351 (D.C. Cir. 1983).
16
Larson v. Dep’t of State, 565 F.3d 857, 869 (D.C. Cir. 2009) (affirming the adequacy of a search based on the agency’s reasonable
determination regarding records being requested).
17 See, Marino v. DOJ, 993 F. Supp. 2d 1, 9 (D.D.C. 2013) (internal citation omitted).
18
See, Karantsalis v. DOJ, 635 F.3d 497, 500-501 (11th Cir. 2011) (affirming the district court’s determination that the agency searched for
records in the system most likely to store responsive records and described how it retrieved records from the system); Lechliter v. Rumsfeld,
182 F. App'x 113, 115-16 (3d Cir. 2006) (concluding that the agency fulfilled its duty to conduct a reasonable search when it searched two
offices that it determined would be the only ones likely to possess responsive documents) (citing Oglesby v. Dep't of the Army, 920 F.2d 57, 68
(D.C. Cir. 1990).
19 See, Morley v. CIA, 508 F.3d 1108, 1119-20 (D.C. Cir. 2007) (holding that because the agency retained copies of the records transferred to
NARA and concedes that some transferred records are likely to be responsive, it was obligated to search those records in response to the FOIA
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Courts tend to afford agencies a fair amount of leeway when determining the locations to
search for responsive records, on the grounds that an agency generally “is not obliged to look
beyond the four corners of [a FOIA] request for leads to the location of responsive” records.20
On the other hand, an agency “cannot in good faith ignore . . . a lead that is both clear and
certain.”21 For example, an agency cannot ignore a responsive document that “clearly indicates
the existence of [other] relevant documents.”22
The NIH produced two documents that clearly indicate the existence of other records that
it did not produce. In that regard, the NIH produced an August 11, 2021, email from gb-
admin@ncbi.nlm.nih.gov to Dr. Jesse Bloom, which has the Subject “GenBank Submissions grp
8164050,” and states:
Dear Dr. Bloom,
Thank you for your reply:
I assembled the consensus sequences from a dataset that was
generated by Wuhan University, but then deleted from the SRA. So
I did not generate the data myself, but wanted to somehow put it in
a public sequence database. Is this allowed?
https://www.biorxiv.org/content/l0.l101/2021.06.l8.449051v2
GenBank accepts data directly determined by the submitter per our submission
guidelines outlined at https://www.ncbi.nlm.nih.gov/genbank/submit types/. In
some cases, sequence data not directly obtained by the submitter may be acceptable
for the Third Party Annotation database (https://www.insdc.org/documents/tpa-
submission-guidelines). However, the primary read data must be present in an
INSDC database.
Unfortunately, we are unable to accept your submission since it does not meet the
criteria for either GenBank or TPA.
The GenBank Submissions Staff
request); Jefferson v. DOJ, 168 F. App’x 448, 450 (D.C. Cir. 2005) (reversing the district court’s finding of a reasonable search when the agency
offered no plausible justification for searching only its investigative database and the agency essentially acknowledged that responsive files
might exist in a separate database); Oglesby v. Dep't of the Army, 920 F.2d 57, 68 (D.C. Cir. 1990) (holding that the agency may not limit its
search to one record system if others are likely to contain responsive records).
20 Kowalczyk v. DOJ, 73 F.3d 386, 389 (D.C. Cir. 1996).
21
Kowalczyk, 73 F.3d at 389.
22
Center for National Security Studies v. DOJ, 215 F. Supp. 2d 94, 110 (D.D.C. 2002) (holding that discovery of a document that “clearly
indicates the existence of [other] relevant documents” creates an “obligation” for agency to further search for those additional documents),
aff’d in part, rev’d in part & remanded on other grounds, 331 F.3d 918 (D.C. Cir. 2003); Tarullo v. DOD, 170 F. Supp. 2d 271, 275 (D. Conn. 2001)
(declaring agency’s search inadequate because “[w]hile hypothetical assertions as to the existence of unproduced responsive documents are
insufficient to create a dispute of material fact as to the reasonableness of the search, plaintiff here has [himself provided copy of agency
record] which appears to be responsive to the request”); Kronberg v. DOJ, 875 F. Supp. 861, 870 – 871 (D.D.C. 1995) (holding that search was
inadequate when agency did not find records required to be maintained and plaintiff produced documents obtained by other FOIA requesters
demonstrating that agency possessed files which may contain records sought).
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Bethesda, Maryland USA23
The August 11th email from gb-admin@ncbi.nlm.nih.gov responds to correspondence from Dr.
Bloom, which it to characterize as a “reply” to earlier correspondence. However, Dr. Bloom’s
correspondence and the correspondence that he allegedly replied to are not included among the
238 pages produced by NIH.
Similarly, a July 26, 2021, email from Diane Tuncer to Steve Sherry and Kim Pruitt,
which has the Subject “FW: FYI – News Report from China’s Xinhua News Agency,” states:
Hi Steve and Kim,
We shared this news article with NIH OCPL too, and they [NIH OCPL] responded
with the following information (see below). I’m also attaching the last set of QA
(which we already sent to you last week).
[Large text block redacted purportedly pursuant to FOIA Exemption b(5).]24
The July 26th email forwards to Drs. Sherry and Pruitt a “last set of” questions and answers
about Wuhan University dataset that was excluded from public access,25 which Ms. Tuncer
asserts had been forwarded to Drs. Sherry and Pruitt during the week of July 19, 2021 (i.e., “last
week”). However, the earlier email to Drs. Sherry and Pruitt, which would have been equally
responsive to Empower Oversight’s FOIA request, was not produced among the 238 pages
provided by the NIH. Neither was a separate email referring the Xinhua news article that Ms.
Tuncer asserts that “we” sent to the NIH’s OCPL.
This evidence that the NIH failed to conduct a search that was reasonably calculated to
lead to the discovery of all responsive records does not inspire confidence that the NIH has
satisfied its search responsibilities under the FOIA. Hence, Empower Oversight respectfully
requests that the NIH, subject to DOJ’s monitoring, review the work of its FOIA staff, ascertain
the nature and scope of their search plan, determine whether such plan was appropriate and
followed,26 correct any errors that are discovered, and apprise Empower Oversight of its
findings.
23 NIH FOIA Request 56712_Redacted, p. 92.
24 NIH FOIA Request 56712_Redacted, p. 93.
25 See, e.g., NIH FOIA Request 56712_Redacted, pp. 96 – 97.
26 Additionally, Federal agencies shoulder the burden of demonstrating that their searches are reasonable, and they typically do this by
describing their efforts in affidavits that they file in support of motions for summary judgment. See, e.g., Ethyl Corp. v. U.S. Environmental
Protection Agency, 25 F.3d 1241 (4th Cir. 1994); Cochran v. Dep’t of Homeland Security, 2019 WL 1433014 (D. Md. March 28, 20199). However,
an agency may not rely upon vague or conclusory affidavits to show that it has conducted a reasonable search. See, Cochran, 2019 WL
1433014, p. *5 – *6 (criticizing a conclusory FBI affidavit). Rather, a satisfactory “affidavit must be reasonably detailed, ‘setting forth the search
terms and the type of search performed and averring that all files likely to contain responsive materials (if such records exist) were searched’ so
as to give the requesting party an opportunity to challenge the adequacy of the search.” Ethyl Corp., 25 F.3d 1246 – 1247 (quoting Oglesby v.
U.S. Dep’t of the Army, 920 F.2d 57, 68 (D.C. Cir. 1990)). Accordingly, Empower Oversight requests that the NIH generate and share with
Empower Oversight affidavits fully describing the search efforts of the NIH’s FOIA staff.
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2. The NIH Asserted FOIA Exemption b(5) as Justification for Redacting Responsive Records
that Are Not Both Pre-decisional and Deliberative
Subsection b(5) of the FOIA provides that the FOIA “does not apply to matters that are”:
inter-agency or intra-agency memorandums or letters that would not be available
by law to a party other than an agency in litigation with the agency, provided that
the deliberative process privilege shall not apply to records created 25 years or
more before the date on which the records were requested.27
Courts have construed FOIA Exemption b(5) to “exempt those documents, and only those
documents, that are normally privileged in the civil discovery context.”28 Although the United
States Circuit Court of Appeals for the District of Columbia Circuit (“Circuit Court”) has held
that “all civil discovery rules” are incorporated into FOIA Exemption b(5),29 the NIH’s February
7th response to NIH FOIA Case Number 56712 appears to limit the NIH’s reliance on the
exemption to the deliberative process privilege (i.e., the NIH states, “Exemption 5 permits the
withholding of internal government records which are pre-decisional and contain staff advice,
opinion, and recommendations”).
The purpose of the deliberative process privilege is to “prevent injury to the quality of
agency decisions.”30 In this setting, the Circuit Court has explained that “quality” encompasses
encouraging frank discussions during policy making, preventing advance disclosure of decisions,
and protecting against public confusion that may result from disclosure of reasons or rationales
that were not in fact the grounds for agency decisions.31
To claim the deliberative process privilege with respect to a record, the Circuit Court has
held that an agency must show32 that the record is “pre-decisional” (i.e., “antecedent to the
adoption of agency policy”)33 and “deliberative” (i.e., “a direct part of the deliberative process in
that it makes recommendations and expresses opinions on legal or policy matters”).34
Unfortunately, it appears that the NIH, while purporting to follow FOIA Exemption b(5),
has redacted responsive records that are not both pre-decisional and deliberative.
27 5 U.S.C. § 552(b)(5).
28 NLRB v. Sears, Roebuck & Co., 421 U.S. 132, 149 (1975); see also, Martin v. Office of Special Counsel, 819 F.2d 1181, 1184 (D.C. Cir. 1987).
29 See, Martin, 819 F.2d at 1185.
30 Sears, 421 U.S. at 151.
31 See, Russell v. Dep't of the Air Force, 682 F.2d 1045, 1048 (D.C. Cir. 1982); Coastal States Gas Corp. v. DOE, 617 F.2d 854, 866 (D.C. Cir. 1980);
Jordan v. DOJ, 591 F.2d 753, 772 – 773 (D.C. Cir. 1978).
32
Coastal States Gas Corp., 617 F.2d at 866.
33 See, Ancient Coin Collectors Guild v. U.S. Dep't of State, 641 F.3d 504, 513 (D.C. Cir. 2011).
34 See, Vaughn v. Rosen, 523 F.2d 1136, 1143 – 1144 (D.C. Cir. 1975).
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A. The NIH Redacted Records that Are Not Pre-decisional
The Circuit Court has held that a document is “pre-decisional,” if it is “generated before
the adoption of an agency policy.”35 In determining whether a document is antecedent to the
generation of agency policy, courts have found that an agency does not necessarily have to point
to a specific agency final decision,36 but instead it must establish “what deliberative process is
involved, and the role played by the documents at issue in the course of that process.”37
On this point, the Supreme Court has been clear:
Our emphasis on the need to protect pre-decisional documents does not mean that
the existence of the privilege turns on the ability of an agency to identify a specific
decision in connection with which a memorandum is prepared. Agencies are, and
properly should be, engaged in a continuing process of examining their policies;
this process will generate memoranda containing recommendations which do not
ripen into agency decisions; and the lower courts should be wary of interfering with
this process.38
Thus, a document must be generated as part of such a continuing process of agency decision-
making for a court to find that FOIA Exemption b(5) is applicable.39
Communication with Dr. Bloom About a Request by a Wuhan University
Researcher to Exclude a Genome Dataset from the SRA
The NIH produced a record that its FOIA staff heavily redacted, purportedly pursuant to
FOIA Exemption b(5), that clearly was not part of the NIH’s decision-making process. In that
regard, on Friday, June 18, 2020, at 7:00 pm, Dr. Jesse Bloom emailed Francis Collins, Steve
Sherry, and Anthony Fauci to alert them that he had “identified a data set of early Wuhan SARS-
CoV-2 sequences that has been deleted from the NIH’s” SRA, to forward a copy of his pre-print
analysis of his recovery of the deleted data files from the Google Cloud, and to recommend that
the NIH commence a comprehensive examination of the SRA to search for other SARS-CoV-2
genomes that may have been deleted.40
The next morning, June 19, 2021, at 7:34 am, Steve Sherry sent Francis Collins, Jesse
Bloom, Anthony Fauci, and Patti Brennan an email, which has the Subject “RE: SARS-CoV-2
Data Deleted from the NIH/NCBI SRA,” and stated:
Dear Francis and Jesse,
35 Judicial Watch, Inc. v. FDA, 449 F.3d 141, 151 (D.C. Cir. 2006).
36 Rein v. U.S. Patent & Trademark Office, 553 F.3d 353, 373 (4th Cir. 2009).
37
Coastal States Gas Corp. v. DOE, 617 F.2d 854, 868 (D.C. Cir. 1980).
38 NLRB v. Sears, Roebuck & Co., 421 U.S. 132, 151 n.18 (1975).
39 See, e.g., New Hampshire Right to Life v. HHS, 778 F.3d 43, 53 – 54 (1st Cir. 2015).
40 NIH FOIA Request 56712_Redacted, pp. 176 – 177.
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Below is the June 2020 exchange between Wuhan University and SRA submission
staff. I have redacted names and the withdrawal request tracking ID for privacy.
Please read from the bottom up.
I would note that this request was received and processed according to SRA policy.
As Jesse notes in his manuscript, submitters own their SRA records and can
withdraw them upon request. SRA does not adjudicate the reason.
More generally, I have requested the SRA team to compile a report of all withdrawn
SARS-COV2 data so there is transparency into the status of all SRA SARS-COV2
sequence submissions. I will share the report as soon as it is available.
Kind regards,
Steve
(data withdrawal correspondence) -------------------------------------------------
[Large text block redacted purportedly pursuant to FOIA Exemption b(5).]
[Large text block redacted purportedly pursuant to FOIA Exemption b(5).]41
Here, the NIH, in response to unsolicited correspondence from an external party (i.e.,
Dr. Bloom), shares with Dr. Bloom a communication thread that Dr. Sherry characterizes as
being a “June 2020 exchange between Wuhan University and SRA submission staff” from which
he redacted names and a tracking identification number for “privacy” purposes (and at NIH
FOIA Request 56712_Redacted, pages 174 – 176, the NIH FOIA staff redacts the exchange in
its entirety).42 Thus, according to Dr. Sherry the redacted information is not part of the agency
decision-making process: it represented a correspondence exchange between the NIH and
Wuhan University concerning public access to SARS-CoV-2 data that Wuhan University had
posted on the SRA and later wished to exclude from public access. If there were an agency policy
decision involved, then it would have been the decision whether to grant Wuhan University’s
request, which Dr. Sherry describes as being something that the NIH grants as a matter of course
without “adjudicate[ing] the reason” for the request, or to follow Dr. Bloom’s recommendation
to examine the SRA, which Dr. Sherry advised he had implemented.
41 NIH FOIA Request 56712_Redacted, pp. 174 – 176.
42 The NIH appears to have twice produced Dr. Sherry’s June 19th email.Compare, NIH FOIA Request 56712_Redacted, pp. 174 – 176, and NIH
FOIA Request 56712_Redacted, pp. 229 – 230. As shown above, the version produced at pages 174 – 176 is fully redacted, purportedly
pursuant to FOIA Exemption b(5), whereas the version produced at pages 229 – 230 includes the exchange as described by Dr. Sherry in his
email. The NIH’s FOIA staff producing the same record with redactions at pages 174 – 176 and without redactions at pages 229 – 230 further
undermines the credibility of their exemption claim.
Moreover, much of the text redacted at pages 174 – 176, assuming that it is the same text that is produced without redaction at pages 229 –
230, is replete with factual information, compare, NIH FOIA Request 56712_Redacted, pp. 174 – 176, and NIH FOIA Request 56712_Redacted,
pp. 229 – 230, which, as described in the next section, is not protected by FOIA Exemption b(5).
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Internal Dissemination of Coverage of Dr. Bloom’s Findings by the
Official Press Agency of the Republic of China
Similarly, the NIH produced a July 26, 2021, email from Diane Tuncer to Steve Sherry
and Kim Pruitt, which has the Subject FW: FYI – News Report from China’s Xinhua News
Agency,” that purports to forward “information” from the NIH’s Office of Communications and
Public Liaison (“OCPL”). Further, given the context of the email, the forwarded “information”
would appear to pertain to OCPL’s analysis of an article published in Xinhua,43 as opposed to an
NIH policy under consideration.44 Ms. Tuncer’s July 26th email states:
Hi Steve and Kim,
We shared this news article with NIH OCPL too, and they [NIH OCPL] responded
with the following information (see below). I’m also attaching the last set of QA
(which we already sent to you last week).
[Large text block redacted purportedly pursuant to FOIA Exemption b(5).]45
B. The NIH Redacted Records that Are Not Deliberative
To be “deliberative,” a record must reflect[] the give-and-take of the consultative
process,” either by assessing the merits of a particular viewpoint, or by articulating the process
used by the agency to formulate policy.46
Factual information, on the other hand, is not covered by the deliberative process
privilege because the release of factual information does not expose the deliberations or opinions
of agency personnel.47 Accordingly, factual information is typically available in civil discovery
and its release is not considered to have a chilling effect on agency deliberations.48
Empower Oversight cannot see behind the NIH’s redactions, but other records produced
by the NIH raise serious questions regarding whether segregable factual information49 is
included within numerous large text block redactions that the NIH’s FOIA staff has made.
43 Xinhua is an official news service run by the Chinese state.
See, Markay, Lachlan, China Increases Spending 500% to Influence America (May
11, 2021), available at https://www.axios.com/china-foreign-influence-spending-317a9be4-8ead-4abf-8ac4-3f27974d7a9d.html. As such, its
United States branch is registered as a foreign agent under the Foreign Agents Registration Act, 22 U.S.C. § 611 et seq. Id.
44 Additionally, unless the information that Ms. Tuncer forwarded from OCPL excludes, for example, addressees, dates, and subject lines, it
clearly includes non-deliberative, factual information such as that discussed in the next section.
45
NIH FOIA Request 56712_Redacted, p. 93.
46 Coastal States Gas Corp., 617 F.2d at 867.
47
Coastal States Gas Corp., 617 F.2d at 867; see also, McGrady v. Mabus, 635 F. Supp. 2d 6, 18 – 21 (D.D.C. 2009) (distinguishing between draft
letters and memoranda that may be deliberative and data used during a decision-making process, e.g., key personnel data and evaluation
summaries used in promotion decisions, which contain only factual material and are not deliberative).
48 See, EPA v. Mink, 410 U.S. 73, 87 – 88 (1973); see also, Montrose Chem. Corp. v. Train, 491 F.2d 63, 66 (D.C. Cir. 1974) (holding that release of
factual material would not be "injurious" to decision making process).
49 “[W]ith regard to any document an agency believes falls under a FOIA exemption, the agency is required to “undertake a ‘segregability
analysis,’ in which it separates the exempt from the non-exempt portions of the document, and produces the relevant non-exempt
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Planned Response to Media Inquiries Concerning Dr. Bloom’s Reference
to the Exclusion of Information from Public Access on the SRA
The NIH produced a thread of emails that were designed to formulate an official
response to an expected surfeit of media inquiries and—seemingly consistent with the policy
underlying FOIA Exemption b(5)—emails that were created before the adoption of the official
response include text block redactions. In several cases large ones. However, comparison of the
pre-adoption emails with the official response that was ultimately adopted begs the question
whether segregable factual information is included among the NIH’s redactions. For example, a
June 21, 2021, 2:25 pm, email from Renate Myles to Diane Tuncer and Jody Nurik, which has
the Subject “FLAGGING: SARS-CoV-2 dated deleted from the NIH/NCBI SRA,” states:
Hi all:
The attached paper was submitted to BioRx for preprint. The researcher is focusing
on early genome sequence data on SARS-CoV-2 that the submitter requested be
deleted. Unfortunately, the author of the paper is assigning motive and suggesting
that the purpose of deletion was to obscure its existence. Below are reactive
statement and QA in case we get media interest. Please let me know ASAP if NLM
has any concerns with this language.
[Large text block redacted purportedly pursuant to FOIA Exemption b(5).]
Was there any motive for the investigator to remove the data?
[Text block redacted purportedly pursuant to FOIA Exemption b(5).]
Are investigators allowed to request that data be deleted from SRA?
[Text block redacted purportedly pursuant to FOIA Exemption b(5).]50
A June 21, 2021, 6:22 pm, email from Renate Myles to Diane Tuncer and Jody Nurik,
which has the Subject “RE: FLAGGING: SARS-CoV-2 dated deleted from the NIH/NCBI SRA,”
states:
Hi Diane:
Spoke with Patti and below is what we agreed on. So far, the paper still has not
posted. We’re keeping an eye out for it.
[Large text block redacted purportedly pursuant to FOIA Exemption b(5).]
Was there any motive for the investigator to remove the data?
[Text block redacted purportedly pursuant to FOIA Exemption b(5).]
Are investigators allowed to request that data be deleted from SRA?
information.” People for the American Way Foundation v. National Park Service, 503 F. Supp. 2d 284, 306 (D.D.C. 2007) (quoting Edmonds
Institute v. U.S., 383 F. Supp.2d 105, 108 (D.D.C. 2005)).
50 NIH FOIA Request 56712_Redacted, pp. 21 – 22.
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[Text block redacted purportedly pursuant to FOIA Exemption b(5).]51
However, a June 22, 2021, email from Renate Myles to Jody Nurik and Diane Tuncer,
which has the Subject “RE: FLAGGING: SARS-CoV-2 dated deleted from the NIH/NCBI SRA,”
states:
Thanks, Jody. We’ll need lots of eyes. Also, I made as light tweak to the response.
We’ll handle it here.
NIH is aware of Dr. Bloom’s preprint submission. Staff at the National Library of
Medicine, which hosts the Sequence Read Archive (SRA), have reviewed the
submitting investigator’s request to withdraw the data. These SARS-CoV-2
sequences were submitted for posting in SRA in March 2020 and subsequently
requested to be withdrawn by the submitting investigator in June 2020. The
requestor indicated the sequence information had been updated, was being
submitted to another database, and wanted the data removed from SRA to avoid
version control issues. The submitting investigator published relevant information
about these sequences by preprint in March, 2020 and in a journal in June, 2020.
Submitting investigators hold the rights to their data and can request withdrawal
of the data.
Was there any motive for the investigator to remove the data?
NIH can’t speculate on motive beyond the investigator’s stated intentions.
Are investigators allowed to request that data be deleted from SRA?
Submitting investigators hold rights to their data and can request withdrawal of the
data[.]52
Thus, unless the text redacted from Ms. Myles’ two June 21st emails differ dramatically
from the text of her June 22nd email, which she characterizes as including only a “light tweak,”
the NIH’s FOIA staff have redacted a surplus of factual information from the June 21st emails.
Indeed, Ms. Myles’ June 22nd email is entirely factual in nature; there is no policy discussion
reflected therein. She advises that:
• NIH is aware of Dr. Bloom’s preprint article;
• Staff at the NLM, which hosts the SRA, have reviewed the Wuhan University
researcher’s request to withdraw SARS-CoV-2 genetic data from the SAR;
• The data in question was submitted for posting on the SRA in March 2020, and
the withdraw request was submitted in June 2020;
51 NIH FOIA Request 56712_Redacted, p. 20.
52 NIH FOIA Request 56712_Redacted, p. 19. In July of 2021, NIH internally disseminated a more detailed question/answer sheet for responding
to media inquiries concerning the Wuhan University dataset that was excluded from public access on the SRA. See, NIH FOIA Request
56712_Redacted, p. 96 – 97.
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• The Wuhan University requester had indicated that the data in question had
been updated, was being submitted to another database, and that the removal
from the SRA was intended to avoid version control issues;
• Submitting researchers hold the rights to their data and can request the
withdrawal thereof; and
• The NIH can’t speculate on motive beyond the requester’s stated intentions.
Response to Inquiry by Dr. Bloom Related to an Assembly of
“Consensus Sequences” of a Dataset Generated by Wuhan University
and Later Excluded from Public Access on the SRA
Similarly, the NIH produced a thread of emails that were designed to respond to an offer
from Dr. Bloom, who had advised that he had assembled “consensus sequences” of the genetic
data that the Wuhan University researcher(s) had requested that the NIH remove from public
access on the SRA, and sought permission to upload such sequences to the GenBank.53 Again,
unless the pre-response emails differ dramatically from the text of the August 11, 2021, response
to Dr. Bloom, the NIH FOIA staff redacted a significant amount of factual information that is not
exempt from disclosure under FOIA Exemption b(5).
In that regard, an August 5, 2021, 5:35 pm, email from Ilene Mizrachi to Kim Pruitt and
Steve Sherry, which has the Subject “Genome Assemblies from Jesse Bloom,” states:
Hi,
[Large text block redacted purportedly pursuant to FOIA Exemption b(5).]
[Large text block redacted purportedly pursuant to FOIA Exemption b(5).]
Ilene54
Likewise, an August 5, 2021, 5:49 pm, email from Kim Pruitt to Steve Sherry, Ilene
Mizrachi, Patti Brennan, and Teresa Zayas Caban, which has the Subject “RE: Genome
Assemblies from Jesse Bloom,” states:
Was just about to send this reply —
53 GenBank is the NIH’s annotated collection of all publicly available DNA sequences.
See, National Center for Biotechnology Information
(“NCBI”), GenBank Overview (Last Updated April 26, 2021), available at https://www.ncbi.nlm.nih.gov/genbank/. It is part of the International
Nucleotide Sequence Database Collaboration (“INSDC”) with the DNA DataBank of Japan and the European Nucleotide Archive. Id. The DNA
sequences compiled in GenBank are submitted by the researcher that sequenced the DNA in question. See, NCBI, What Is a Third Party
Annotation (TPA) Sequence? (Last Updated October 15, 2020), available at https://www.ncbi.nlm.nih.gov/genbank/tpa/.
On the other hand, the SRA is a data base of raw “sequencing data from the next generation of sequencing platforms including Roche 454 GS
System®, Life Technologies AB SOLiD Systems®, Helicos Biosciences Heliscope®, Complete Genomics®, and Pacific Biosciences SMRT®.” See,
NCBI, DNA & RNA: Databases (Undated), available at https://www.ncbi.nlm.nih.gov/guide/dna-rna/. And, the Third Party Annotation Sequence
is an NIH “database designed to capture experimental or inferential results that support submitter-provided annotation for, or assembly of,
sequence data that the submitter did not” sequence but rather “derived from GenBank primary data.” See, NCBI, What Is a Third Party
Annotation (TPA) Sequence? (Last Updated October 15, 2020), available at https://www.ncbi.nlm.nih.gov/genbank/tpa/.
54 NIH FOIA Request 56712_Redacted, pp. 90 – 91.
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[Large text block redacted purportedly pursuant to FOIA Exemption b(5).]
Options:
[Large text block redacted purportedly pursuant to FOIA Exemption b(5).]
Kim55
An August 6, 2021, 12:28 pm, email from Ilene Mizrachi to Kim Pruitt, Steve Sherry,
Patti Brennan, and Teresa Zayas Caban, which has the Subject “RE: Genome Assemblies from
Jesse Bloom,” states:
This is the reply that we would like to send to Bloom. Is it ok?
[Large text block redacted purportedly pursuant to FOIA Exemption b(5).]
[Large text block redacted purportedly pursuant to FOIA Exemption b(5).]56
An August 9, 2021, 7:15 am, email from Teresa Zayas Caban to Steve Sherry, Ilene
Mizrachi, Kim Pruitt, and Patti Brennan, which has the Subject “RE: Genome Assemblies from
Jesse Bloom,” states:
Good morning all,
Am conferring with OGC on this but was wondering [text block redacted
purportedly pursuant to FOIA Exemption b(5)].
-Teresa57
An August 9, 2021, 12:12 pm, email from Linda Yankie to Teresa Zayas Caban, Steve
Sherry, Ilene Mizrachi, Kim Pruitt, and Pattie Brennan, which has the Subject “RE: Genome
Assemblies from Jesse Bloom,” states:
[Large text block redacted purportedly pursuant to FOIA Exemption b(5).]58
And, an August 9, 2021, 7:21 pm, email from Teresa Zayas Caban to Linda Yankie, Steve
Sherry, Ilene Mizrachi, Kim Pruitt, and Patti Brennan, which has the Subject “RE: Genome
Assemblies from Jesse Bloom,” states:
Pre-Decisional — Deliberative — Do Not Disclose
I conferred with OGC [text block redacted purportedly pursuant to FOIA Exemption b(5)].
55
NIH FOIA Request 56712_Redacted, pp. 89 – 90.
56 NIH FOIA Request 56712_Redacted, pp. 87 – 88.
57 NIH FOIA Request 56712_Redacted, p. 87.
58 NIH FOIA Request 56712_Redacted, p. 86.
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[Large text block redacted purportedly pursuant to FOIA Exemption b(5).]
[Large text block redacted purportedly pursuant to FOIA Exemption b(5).]
The GenBank Submissions Staff
Bethesda, Maryland USA59
Whereas, the August 11, 2021, email from gb-admin@ncbi.nlm.nih.gov to Dr. Jesse
Bloom, which has the Subject “GenBank Submissions grp 8164050,” states:
Dear Dr. Bloom,
Thank you for your reply:
I assembled the consensus sequences from a dataset that was
generated by Wuhan University, but then deleted from the SRA. So
I did not generate the data myself, but wanted to somehow put it in
a public sequence database. Is this allowed?
https://www.biorxiv.org/content/l0.l101/2021.06.l8.449051v2
GenBank accepts data directly determined by the submitter per our submission
guidelines outlined at https://www.ncbi.nlm.nih.gov/genbank/submit types/. In
some cases, sequence data not directly obtained by the submitter may be acceptable
for the Third Party Annotation database (https://www.insdc.org/documents/tpa-
submission-guidelines). However, the primary read data must be present in an
INSDC database.
Unfortunately, we are unable to accept your submission since it does not meet the
criteria for either GenBank or TPA.
The GenBank Submissions Staff
Bethesda, Maryland USA60
Thus, after quoting Dr. Bloom’s earlier correspondence, a fact, the NIH adds the
following facts:
• Its GenBank only accepts data from researchers that have directly prepared the
sequences, according to its guidelines published at
https://www.ncbi.nlm.nih.gov/genbank/submit types/;
• Experimental and inferential results from genetic sequences may be accepted
by the Third Party Annotation (“TPA”) database,
https://www.insdc.org/documents/tpa-submission-guidelines, if the
59 NIH FOIA Request 56712_Redacted, pp. 85 – 86.
60 NIH FOIA Request 56712_Redacted, p. 92.
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underlying genetic sequence is posted in an International Nucleotide Sequence
Database Collaboration (“INSDC”) database, such as GenBank; but
• The data offered by Dr. Bloom does not comply with the requirements of
GenBank or the TPA.
This evidence that the NIH inappropriately used FOIA Exemption b(5)—i.e., that while
purporting to follow FOIA Exemption b(5), the NIH redacted responsive records that are not
both pre-decisional and deliberative—does not inspire confidence that the NIH has satisfied its
review responsibilities under the FOIA. Hence, Empower Oversight respectfully requests that
the NIH, subject to DOJ’s monitoring, analyze all of its FOIA staff’s FOIA Exemption b(5) claims
in response to FOIA Case Number 56712—not just the items described above—to ensure that
their claims are consistent with the accepted legal parameters of the exemption, correct any
errors that are discovered, and apprise Empower Oversight of its findings.
3. The NIH Asserted FOIA Exemption b(6) as Justification for Redacting Responsive Records
that Do Not Invoke Substantial Privacy Interests
Subsection b(6) of the FOIA provides that the FOIA “does not apply to matters that are …
personnel and medical files and similar files the disclosure of which would constitute a clearly
unwarranted invasion of personal privacy.”61 Courts have found that the plain language of FOIA
Exemption b(6) requires agencies to engage in a four-step analysis of records that are potentially
responsive to a FOIA request; agencies must:
1. Determine whether a record at issue constitutes a personnel, medical, or “similar” file;
2. Determine whether there is a substantial privacy interest invoked by information in such
records;
3. Evaluate the requester’s asserted FOIA public interest in disclosure of the records that
include information that invoke a substantial privacy interest; and
4. Balance competing interests to determine whether disclosure of the records “would
constitute a clearly unwarranted invasion of personal privacy,” if there is a FOIA public
interest in disclosure of records that include information that invokes a substantial
privacy interest.62
Each step of the FOIA Exemption b(6) analysis is dependent upon the prior step being satisfied;
hence, for example, if the information in question does not satisfy the threshold requirement
(i.e., a personnel, medical, or similar file), it is unnecessary to evaluate the existence and
significance of privacy interests because the exemption is inapplicable.63
61 5 U.S.C. § 552(b)(6).
62 See, Multi Ag Media LLC v. USDA, 515 F.3d 1224, 1229 (D.C. Cir. 2008); NARA v. Favish, 541 U.S. 157, 172 (2004); Wash. Post Co. v. HHS, 690
F.2d 252, 261 (D.C. Cir. 1982).
63 Schonberger v. NTSB, 508 F. Supp. 941, 942 (D.D.C. 1981).
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The second step of the four-step FOIA Exemption b(6) analysis requires an agency to
“determine whether disclosure of the files ‘would compromise a substantial, as opposed to de
minimis, privacy interest. . . .’”64 Of course, for a privacy interest to be “substantial” it must be
real, not speculative.65 The Circuit Court explained that “mere speculation” of an invasion of
privacy is not sufficient.66
Further, courts generally have declined to find that the identities of citizens who have
petitioned the government to take an action to be information that raises substantial privacy
interests protected under FOIA Exemption b(6).67 They also have declined to find the identities
of government officials to represent substantial privacy interests protected by the exemption.68
In contrast to this precedent, the NIH—purportedly in reliance on FOIA Exemption
b(6)—has redacted the name(s) of one or more Wuhan University69 researcher(s) who petitioned
it to remove genome sequence data that he/she/they had submitted to the SRA for posting. In
that regard, pages 23 – 24, 35, 65, 70 – 72, 75 – 83, 103, 115, 145, and 150 – 163 of the 238
pages that the NIH produced in response to FOIA Case Number 56712 include emails and
correspondence between the NIH staff and one or more external contact(s) whose name(s) and
business affiliation(s)70 is(are) redacted—allegedly pursuant to FOIA Exemption b(6). The
emails and correspondence relate to:
• The NIH’s March 2020 acknowledgment of receipt of genome sequence data—for posting
on the SRA—from the external contact(s);71
64 See, Multi Ag Media LLC, 515 F.3d at 1229 (quoting National Association of Retired Federal Employees v. Horner, 879 F.2d 873, 874 (D.C. Cir.
1989)).
65 Department of the Air Force v. Rose, 425 U.S. 352, 380 n.19 (1976) (“The legislative history is clear that Exemption 6 was directed at threats
to privacy interests more palpable than mere possibilities.”)
66 National Association of Retired Federal Employees v. Horner, 879 F.2d 873, 878 (D.C. Cir. 1989) (citing Arieff v. U.S. Department of the Navy,
712 F.2d 1462, 1468 (D.C. Cir. 1983)), see also, Pinson v. DOJ, 313 F. Supp. 3d 88, 112 (D.D.C. 2018) (finding that “conclusory” and “generalized”
allegations of privacy harms are insufficient for protection of records under Exemption 6); Aqualliance v. U.S. Army Corps. of Engineers, 243 F.
Supp. 3d 193, 198 (D.D.C. 2017) (finding mailing lists of homeowners who lived in close proximity to a California water project to be too
speculative to be protected by FOIA Exemption b(6)).
67 People for the American Way Foundation, 503 F. Supp. 2d at 306 (determining that the mere identity of individuals who voluntarily
submitted comments regarding a proposal to change a video displayed for guests at the Lincoln Memorial does not raise the kind of privacy
concerns protected by FOIA Exemption b(6)) (quoting Lardner v. U.S. Department of Justice, 2005 WL 758267, at * 18 (D.D.C. 2005)); see also,
Landmark Legal Found. v. IRS, 87 F. Supp. 2d 21, 27 – 28 (D.D.C. 2000); Alliance for Wild Rockies v. Department of the Interior, 53 F. Supp.2d
32, 34 (D.D.C. 1999).
68 See, e.g., Aguirre v. SEC, 551 F. Supp. 2d 33, 54 (D.D.C. 2008) (“Correspondence does not become personal solely because it identifies
government employees”).
69 Wuhan University describes itself as “a . . . key university directly under the administration of the Ministry of Education.
It is also one of the
“‛211 Project’ and ‛985 Project’ universities with full support in the construction and development from the central and local government of
China.” See, Wuhan University, About WHU: Overview (2014), available at https://en.whu.edu.cn/About_WHU1/Overview.htm.
70 Although the NIH FOIA staff typically redacted the business affiliations of the external contact(s), i.e., Wuhan University, they neglected to do
so with respect to a June 19, 2020, email from Steve Sherry to Francis Collins, Jesse Bloom, Anthony Fauci, and Patti Brennan. See, NIH FOIA
Request 56712_Redacted, pp. 229 - 230. By his email, he forwarded a thread of three June 2020 emails between a Wuhan University
“Submitter” and a “SRA Curator.” The submitter’s name and the data identification numbers were redacted by Dr. Sherry, but he failed to
redact “Wuhan University” in the contact’s(s’) salutation block. See, NIH FOIA Request 56712_Redacted, p. 230; compare, NIH FOIA Request
56712_Redacted, pp. 81 – 82.
71 A March 17, 2020, email from “sra” to “b(6),” with the Subject “SRA submission SUB7147304, ‘Nanopore targeted sequencing for SARS-CoV-2
and other respiratory viruses, Mar 13 ‛20’” is an automatic acknowledgment of “b(6)”’s “recent submission to the SRA database.” See, NIH
FOIA Request 56712_Redacted, p. 70. The title in the subject line of the email corresponds to a pre-print article, Nanopore Target Sequencing
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• The NIH’s designation of the March 2020 data as Submission ID 7147304 and
BioProject Accession Number PRJNA612766;
• Troubleshooting concerning access to the data on the SRA;
• The NIH’s June 2020 acknowledgment of receipt of genome sequence data—for posting
on the SRA—from the external contact(s);
• The NIH’s designation of the June 2020 data as Submission ID 7554642 and BioProject
Accession Number PRJNA637497;
• The external contact’s(s’) request to “retract” Submission ID 7554642 and BioProject
Accession Number PRJNA637497, and the NIH’s hesitance to do so;
• The external contact’s(s’) request, with the Subject “Re:
SUB7554642/subs/sra/SUB7554642/overview,” to “withdraw” Submission ID
7147304; and
• The NIH’s inquiry regarding the scope of the external contact’s(s’) request, and
confirmation that it “had withdrawn everything.”
The external contact(s) are—on the basis of Dr. Sherry’s June 19th email72 and the title
of the preprint publication associated with Submission ID 7147304 and BioProject Accession
Number PRJNA61276673—affiliated with Wuhan University, and thus in some fashion is(are)
employed by the Chinese government. In other words, they are government officials operating
in their official capacity. Moreover, the external contact(s) clearly petitioned the NIH to take
action with respect to Submission IDs 7147304 and 7554642, and BioProject Accession
Numbers PRJNA612766 and PRJNA637497, i.e., to “retract” or “withdraw” them from the
SRA. Accordingly, the external contact(s) name(s) and business affiliation should not have
been redacted the NIH.74
Moreover, were the precedent controlling the privacy interests associated with petitions
for government action and government employees’ official actions not fatal to the NIH FOIA
staff’s FOIA Exemption b(6) assertions on pages 23 – 24, 35, 65, 70 – 72, 75 – 83, 103, 115,
145, and 150 – 163 of the NIH’s production, the question would arise whether there is a
substantial privacy interest at stake in the first place. It seems unlikely that there is. The data
designated Submission ID 7147304 and BioProject Accession Number PRJNA612766 was
submitted to the NIH to facilitate peer review of the methodology underlying a pre-print report
for Accurate and Comprehensive Detection of SARS-CoV-2 and Other Respiratory Viruses (March 2020), that was submitted by 15 authors
affiliated with Wuhan University, the Ministry of Education, Wuhan Dgensee Clinical Laboratory Co., Ltd., the Wuhan Institute of Virology,
Shanghai Jiao Tong University, and the Wuhan Institute of Biotechnology. See, Hu, Ben, et al, Nanopore Target Sequencing for Accurate and
Comprehensive Detection of SARS-CoV-2 and Other Respiratory Viruses (March 2020), available at https://pubmed.ncbi.nlm.nih.gov/32578378/.
72 See footnotes 70, above.
73 See footnotes 71, above.
74 Indeed, although Dr. Sherry erroneously counseled staff to redact the names of the external contact(s), several NIH staffers questioned his
guidance. See NIH FOIA Request 56712_Redacted, pp. 169 – 171. Apparently, to no avail.
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entitled Nanopore Target Sequencing for Accurate and Comprehensive Detection of SARS-
CoV-2 and Other Respiratory Viruses, which was submitted by 15 authors who freely attached
their names thereto. It seems implausible that such authors now would wish to be disassociated
with their report or the methodology supporting their research. Additionally, the NIH has
publicly stated that the authors of Nanopore Target Sequencing for Accurate and
Comprehensive Detection of SARS-CoV-2 and Other Respiratory Viruses: 1) own the genetic
data that they submitted to the SRA for posting, and 2) have the complete discretion to “retract”
or “withdraw” such data from public access on the SRA. It thus seems equally implausible that
the authors assertion of ownership over their data and their exercise of discretion over the use of
it would implicate a privacy issue. And, to date, the NIH has not offered any clues concerning
what such a privacy interest may look like.
This evidence that the NIH inappropriately used FOIA Exemption b(6) does not inspire
confidence that the NIH has satisfied its review responsibilities under the FOIA. Hence,
Empower Oversight respectfully requests that the NIH, subject to DOJ’s monitoring, analyze all
of its FOIA staff’s FOIA Exemption b(6) claims in response to FOIA Case Number 56712—not
just the items described above—to ensure that their claims are consistent with the accepted legal
parameters of the exemption, correct any errors that are discovered, and apprise Empower
Oversight of its findings. Moreover, because “[a]n agency [in litigation] must provide affidavits
containing ‘reasonable specificity of detail rather than merely conclusory statements’ to establish
a substantial invasion of privacy,”75 Empower Oversight requests that the NIH provide affidavits
supporting its findings.
Thank you for your time and consideration. Please don’t hesitate to contact me with any
questions.
Cordially,
/Jason Foster/
Jason Foster
Founder & President
75 Climate Investigations Center v. DOE, 331 F. Supp. 3d 1, 26 (D.D.C. 2018) (quoting Judicial Watch, Inc. v. U.S. Secret Service, 726 F.3d 208, 215
(D.C. Cir. 2013)).
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Exhibit 1
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July 14, 2021
VIA ELECTRONIC TRANSMISSION: NIHFOIA@MAIL.NIH.GOV
National Institutes of Health
Building 31 Room 5B35
9000 Rockville Pike
Bethesda, MD 20892
RE: RECORDS REGARDING NIH’S SARS-COV-2 (COVID19) DATABASE
Dear FOIA Officer:
Empower Oversight Whistleblowers & Research (“Empower Oversight”) is a
nonpartisan, nonprofit educational organization dedicated to enhancing independent oversight
of government and corporate wrongdoing. We work to help insiders safely and legally report
waste, fraud, abuse, corruption, and misconduct to the proper authorities help to hold those
authorities accountable to act on such reports.
We respectfully request records be delivered from the National Institutes of Health
(NIH) pursuant to this request under the Freedom of Information Act (FOIA), 5 U.S.C. 552
within the next 20 business days. As detailed below, we request access to certain records
regarding SARS-CoV-2 sequences submitted for posting to the Sequence Read Archive in March
2020 by Chinese researchers and subsequently requested to be withdrawn by the submitting
investigator in June 2020. Sequences of SARS-CoV-2 virus are critical to understanding how this
pandemic (which has killed more than 600,000 Americans) started, in order to prevent future
pandemics.1 Furthermore, the State Department has noted that China has not been transparent
in its handling of the SARS-CoV-2 origin question and has removed virus sequences from its own
online databases that could help uncover how the pandemic started.2
The New York Times and the Washington Post have reported on requests to remove
these sequences and this removal has added fuel to the SARS-CoV-2 origin debate.3
1 “COVID Mortality Data,” Johns Hopkins University (https://coronavirus.jhu.edu/data/mortality).
2 “Fact Sheet on Activity at the Wuhan Institute of Virology,” U.S. State Dep’t (https://2017-2021.state.gov/fact-
sheet-activity-at-the-wuhan-institute-of-virology/index.html)
3 “Scientist Finds Early Virus Sequences That Had Been Mysteriously Deleted,” New York Times (Jun 23, 2021);
“Seattle scientist digs up deleted coronavirus genetic data, adding fuel to the covid origin debate,” Washington Post
(Jun 23, 2021).
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According to the Washington Post, “The NIH released a statement Wednesday saying
that a researcher who originally published the genetic sequences asked for them to be removed
from the NIH database so that they could be included in a different database.”4 In a statement to
the Washington Post, the NIH said:
These SARS-CoV-2 sequences were submitted for posting in SRA in March 2020
and subsequently requested to be withdrawn by the submitting investigator in June
2020. The requestor indicated the sequence information had been updated, was
being submitted to another database, and wanted the data removed from SRA to
avoid version control issues.5
And, according to the New York Times:
“These SARS-CoV-2 sequences were submitted for posting in SRA in March 2020
and subsequently requested to be withdrawn by the submitting investigator in June
2020,” said Renate Myles, a spokeswoman for the National Institutes of Health.
She said that the investigator, whom she did not name, told the archive managers
that the sequences were being updated and would be added to a different database.6
Accordingly, please provide all records relating to the following:
1) All communications regarding the request to post the SARS-CoV-2 sequences to the
Sequence Read Archive in March 2020. This request covers all communications between
March 1, 2020 to March 31, 2020.
2) All communications regarding the request to withdraw the SARS-CoV-2 sequences from
Sequence Read Archive in June 2020. This request covers all communications between
June 1, 2020 to June 31, 2020.
3) All communications regarding these withdrawn sequences as reported by a preprint titled
“Recovery of deleted deep sequencing data sheds more light on the early Wuhan SARS-
CoV-2 epidemic” by Jesse Bloom, a virologist at the Fred Hutchinson Cancer Research
Center.7 This request covers all communications between Jesse Bloom and the NIH, from
January 1, 2021 and the present. This request all covers all communications inside the
NIH regarding the preprint from June 21, 2021 to the present.
4) All communications to, from, and within the NIH press office about the NIH statement
released on June 23, 2021, and about reports that these sequences were removed from
the Sequence Read Archive. This includes all emails related to the drafting of the
statement, communications about the reported removal, and communications with
reporters. This request covers all communications between June 21, 2021 to June 25,
2021.
4 Id.
5 Id.
6 Id.
7 “Recovery of deleted deep sequencing data sheds more light on the early Wuhan SARS-CoV-2 epidemic,” bioRxiv
(Jun 18, 2021).
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Fee Waiver Request
Empower Oversight requests a waiver of fees associated with processing this request, in
keeping with 5 U.S.C. § 552 (a)(4)(A)(iii). The information sought is in the public interest
because it is likely to contribute significantly to the public understanding of the operations or
activities of the government. Empower Oversight is a non-profit organization as defined under
Section 501(c)(3) of the Internal Revenue Code and has no commercial interest in making this
request. The public has a significant interest in understanding how this pandemic started.
Empower Oversight is committed to government accountability and public integrity and is
committed to public disclosure of documents via its website, and by providing these documents
to the media for public dissemination.8
Request for Expedited Processing
Empower Oversight also requests expedited processing of this request. Understanding
how the SARS-CoV-2 pandemic started is of massive public interest both in the United States
and around the globe, particularly because understanding how this pandemic started can help us
stop future pandemics. The information requested is urgently needed to inform the public
concerning actual or alleged federal government activity, namely why were genetic sequences
removed from a United States federal database when they could help understand how the
pandemic started. The request is of widespread and exceptional media interest and the
information sought involves questions about research integrity, which affect public confidence in
the operations of NIH. Empower Oversight is engaged in disseminating information to the
public through its website and working with media.9 It is important that this request be
processed and the results publicly disseminated as quickly as possible to help the country guard
against future pandemics.
For ease of administration and to conserve resources, we ask that documents be produced
in a readily accessible electronic format. In the event our request for a fee waiver is denied or if
you have any questions about this request, please contact us immediately. Thank you for your
prompt attention to this matter.
Cordially,
/Jason Foster/
Jason Foster
Founder & President
8 “Mission,” Empower Oversight (http://empowr.us/mission).
9 Id.
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Exhibit 2
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National Institutes of Health
Freedom of Information Office
Building 31, Room 5B-35
31 Center Drive, MSC 2107
Bethesda, Maryland 20892-2107
phone: (301) 496-5633
fax: (301) 402-4541
Via Email: info@empowr.us
February 7, 2022
Jason Foster
Founder & President
Empower Oversight
2615 Columbia Pike, #445
Arlington, VA 22204
Re: NIH FOIA Case No.: 56712 & 57203; Empower Oversight Whistleblowers & Research v.
NIH, Case No. 21-cv-01275
Dear Mr. Foster:
This is the final response to the Freedom of Information Act (FOIA) request that is the subject of
the complaint filed in Empower Oversight Whistleblowers & Research v. NIH, Case No. 21-cv-
01275, now pending in the U.S. District Court for Virginia. Your FOIA request 56712, dated
July 15, 2021, was received by the National Institutes of Health (NIH) FOIA Office, on the same
day. Your FOIA request 57203, dated October 12, 2021, was received by the National Institutes
of Health (NIH) FOIA Office, on the same day.
FOIA request 56712 requested:
1)All communications regarding the request to post the SARS-CoV-2 sequences to the
Sequence Read Archive in March 2020. This request covers all communications between
March 1, 2020 to March 31, 2020.
2)All communications regarding the request to withdraw the SARS-CoV-2 sequences
from Sequence Read Archive in June 2020. This request covers all communications
between June 1, 2020 to June 31, 2020.
3)All communications regarding these withdrawn sequences as reported by a preprint
titled “Recovery of deleted deep sequencing data sheds more light on the early Wuhan
SARS-CoV-2 epidemic” by Jesse Bloom, a virologist at the Fred Hutchinson Cancer
Research Center. This request covers all communications between Jesse Bloom and the
NIH, from January 1, 2021 and the present. This request all covers all communications
inside the NIH regarding the preprint from June 21, 2021 to the present.
4)All communications to, from, and within the NIH press office about the NIH statement
released on June 23, 2021, and about reports that these sequences were removed from the
Sequence Read Archive. This includes all emails related to the drafting of the statement,
communications about the reported removal, and communications with reporters. This
request covers all communications between June 21, 2021 to June 25, 2021.
FOIA Request 57203 requested:
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Page 2 – Mr. Foster (56712 & 57203; Empower. v. NIH, 21-cv-01275)
1) All communications regarding the letter by Senators Grassley and Blackburn dated
June 28, 2021.
2) All communications regarding the NIH’s response to Senators Grassley and Blackburn
dated September 8, 2021. 3) All communications regarding the letter by Senators
Grassley and Blackburn dated September 16, 2021.
In accordance with the Court’s order dated November 17, 2021, we have processed 255 pages of
responsive records for this litigation. The information being withheld is protected from release
pursuant to Exemptions (b)(5) and (b)(6) of the FOIA, 5 U.S.C. § 552 (b)(5) and (b)(6); and
sections 5.31 (e) and (f) of the HHS FOIA Regulations, 45 CFR Part 5. Exemption 5 permits the
withholding of internal government records which are pre-decisional and contain staff advice,
opinion, and recommendations. This exemption is intended to preserve free and candid internal
dialogue leading to decision-making. Exemption 6 permits the withholding of privacy
information, the release of which would constitute a clearly unwarranted invasion of personal
privacy.
Please direct any questions regarding this response to Meghan Loftus of the Department of
Justice, who can be reached at meghan.loftus@usdoj.gov.
Sincerely,
for Gorka Garcia-Malene
Freedom of Information Act Officer, NIH
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Attachment H-1
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From: Bryan Saddler <bsaddler@empowr.us>
Sent: Thursday, February 24, 2022 12:52 PM
To: Garcia-Malene, Gorka (NIH/OD) [E] <gorka.garcia-malene@nih.gov>
Cc: Jason Foster <jf@empowr.us>
Subject: [EXTERNAL] Appeal of FOIA Request Number 57203
CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you
recognize the sender and are confident the content is safe.
Dear Mr. Garcia-Malene: Attached is a letter appealing the NIH's February 7, 2022,
response to Empower Oversight's September 30, 2021, FOIA request, which the NIH
designated as FOIA Request Number 57203.
Referencing the litigation pending in connection with the FOIA request, the NIH's
February 7th letter does not advise Empower Oversight how to appeal. I note, however,
that the HHS has a web-portal established to accept appeals of the NIH's FOIA
responses. But, in light of the litigation and the risk of the matter getting lost in the
HHS's processes, I thought that it would be more efficient to forward the appeal to your
attention and request your advice concerning the effectuation of service. Please advise
me if I need to send a copy of the appeal to the HHS's web-portal, if your office is
unable or unwilling to accept the appeal.
Cordially, Bryan Saddler
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Attachment H
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February 24, 2022
VIA ELECTRONIC TRANSMISSION: gorka.garcia-malene@nih.gov
Gorka Garcia-Malene,
NIH Freedom of Information Institute/Center Coordinator
Office of the Director
Building 31 Room 5B35
9000 Rockville Pike
Bethesda, MD 20892
VIA ELECTRONIC TRANSMISSION: meghan.loftus@usdoj.gov
Meghan Loftus
Assistant United States Attorney
Office of the United States Attorney
Justin W. Williams U.S. Attorney’s Building
2100 Jamieson Ave.
Alexandria, VA 22314
RE: FREEDOM OF INFORMATION ACT APPEAL
FOIA REQUEST NUMBER 57203
Dear Mr. Garcia-Malene:
INTRODUCTION
With respect to the National Institutes of Health’s (“SEC”) Freedom of Information Act
(“FOIA”)1 Request Number 57203, Empower Oversight Whistleblowers & Research (“Empower
1 The FOIA is codified at 5 U.S.C. § 552.
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Oversight”)2 appeals the NIH’s February 7, 2022, initial determination on the grounds that
NIH’s FOIA staff:
• Did not perform a search for records that was reasonably calculated to find all responsive
records; and
• Claimed FOIA Exemption b(5)—specifically for the deliberative process privilege—for
records that were not both pre-decisional and deliberative.
Accordingly, Empower Oversight respectfully requests that the NIH review the nature
and scope of its FOIA staff’s records search and review, correct any deficiencies that are
identified, and apprise Empower Oversight of the results of such review.
BACKGROUND
1. Empower Oversight’s September 30, 2021, FOIA Request
On September 30, 2021, Empower Oversight filed with the NIH a request for records
under the FOIA.3 Empower Oversight’s September 30th FOIA request seeks:
1. All communications regarding the letter by Senators Grassley and Blackburn
dated June 28, 2021.
2. All communications regarding the NIH’s response to Senators Grassley and
Blackburn dated September 8, 2021.
3. All communications regarding the letter by Senators Grassley and Blackburn
dated September 16, 2021.4
In addition, Empower Oversight requested: 1) a waiver of search and duplication fees associated
with the NIH’s processing of its FOIA request, and 2) expedited processing.
In support of its FOIA request, Empower Oversight explained that The New York Times and The
Washington Post, among others, have reported on requests by Chinese researchers to have
certain SARS-CoV-2 genetic sequences withdrawn from public access on the NIH’s Sequence
2 Empower Oversight is a nonpartisan, nonprofit educational organization, which is dedicated to enhancing independent oversight of
government and corporate wrongdoing. It works to help insiders safely and legally report waste, fraud, abuse, corruption, and misconduct to
the proper authorities, and seeks to hold those authorities accountable to act on such reports by, among other means, publishing information
concerning the same.
3 In compliance with the NIH’s procedures, which require all requesters to submit their FOIA requests “through [the NIH’s] online portal . . .
rather than mail, fax, or courier,” Empower Oversight registered with the NIH’s online portal, and used it to submit its request. See, NIH,
Submitting FOIA Requests (Last Reviewed on March 27, 2020), available at https://www.nih.gov/institutes-nih/nih-office-director/office-
communications-public-liaison/freedom-information-act-office/submitting-foia-requests.
4
Empower Oversight’s September 30th FOIA request is attached as Exhibit 1.
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Read Archive (“SRA”).5 Genetic sequences for SARS-CoV-2 virus are critical to understanding
how the pandemic (which has killed more than 934,000 Americans) 6 started, and understanding
the origin of the pandemic is essential to furthering the prevention of future pandemics. 7
Additionally, the State Department has noted that China has not been transparent in its handling
of the question of the origin of SARS-CoV-2 and, as part of its hindrance of efforts to gain an
understanding of the virus, has removed genetic sequences from its own online databases.8
On June 28, 2021, Senators Marsha Blackburn, Charles Grassley, and Roger Marshall
sent the NIH a letter seeking records and answers to seven questions regarding the removal of
the SARS-CoV-2 genetic sequences from public access on the SRA. They received a response to
their inquiry on September 8, 2021, that they stated “failed to fully and completely answer all
seven questions and failed to provide the requested records.”9 Senators Blackburn, Grassley,
and Marshall then sent a follow up letter on September 16, 2021, demanding answers to their
previous questions.10
Empower Oversight has no commercial interest in the records sought by its FOIA
request, instead it seeks the requested records to contribute significantly to the public’s
understanding of understanding how the NIH is addressing the SARS-CoV-2 pandemic and how
it responds to legitimate Congressional oversight requests. Part of NIH’s responsibility in that
regard necessarily includes furthering efforts to determine the origin of the virus and prevent
future pandemics. The potential usefulness of the SARS-CoV-2 genetic sequences that NIH
removed from the SRA has ignited an extraordinary interest among the public in research
integrity generally and in the NIH’s rationale for its removal of the SARS-CoV-2 genetic
sequences from the SRA specifically. Public confidence in the NIH’s activities and operations is
at stake, and thus it is Empower Oversight’s intention to enlighten the public about these issues.
As November 17, 2021, Empower Oversight had not received any correspondence
whatsoever from the NIH concerning its FOIA request, and thus it filed against the NIH a
Complaint for Declaratory and Injunctive Relief—Civil Case Number 1:21-cv-01275—in the
United States District Court for the Eastern District of Virginia. Empower Oversight’s complaint
seeks, among other things, declarations that the NIH failed to file a timely determination and
5 Zimmer, Carl, Scientist Finds Early Virus Sequences That Had Been Mysteriously Deleted (June 23, 2021), available at
https://www.nytimes.com/2021/06/23/science/coronavirus-sequences.html; Achenbach, Joel, Guarino, Ben, Abutaleb, Yasmeen, Seattle
Scientist Digs up Deleted Coronavirus Genetic Data, Adding Fuel to the Covid Origin Debate (June 23, 2021), available at
https://www.washingtonpost.com/health/coronavirus-origin-nih-gene-sequence-deletion/2021/06/23/186e87d0-d437-11eb-a53a-
3b5450fdca7a_story.html.
6
Johns Hopkins University, Mortality Analyses, available at https://coronavirus.jhu.edu/data/mortality (last accessed on February 21, 2022).
7 See generally, U.S. Department of State, Fact Sheet: Activity at the Wuhan Institute of Virology, available at https://2017-2021.state.gov/fact-
sheet-activity-at-the-wuhan-institute-of-virology/index.html.
8 U.S. Department of State, Fact Sheet: Activity at the Wuhan Institute of Virology, available at https://2017-2021.state.gov/fact-sheet-activity-
at-the-wuhan-institute-of-virology/index.html.
9 Press Release: Did NIH Improperly Delete COVID-19 Data at Request of Chinese Researchers? Senators Want Answers (September 16, 2021),
available at https://www.grassley.senate.gov/news/news-releases/did-nih-improperly-delete-covid-19-data-at-request-of-chinese-researchers-
senators-want-answers.
10 Press Release: Did NIH Improperly Delete COVID-19 Data at Request of Chinese Researchers? Senators Want Answers (September 16, 2021),
available at https://www.grassley.senate.gov/news/news-releases/did-nih-improperly-delete-covid-19-data-at-request-of-chinese-researchers-
senators-want-answers.
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promptly provide responsive records, an order requiring the NIH to perform a reasonable search
and disclose all responsive, non-exempt records, and an award of costs and attorney’s fees.
2. NIH’s February 7, 2022, Response to Empower Oversight’s FOIA Request
By letter dated February 7, 2022, the NIH responded to Empower Oversight’s September
30th FOIA request.11 In its letter, the NIH designated the request as FOIA Request Number
57203, and produced 17 pages of records, many of which have been redated pursuant to FOIA
Exemptions b(5) and b(6).12 With respect to FOIA Exemption b(5), the NIH explained that its
redactions are limited to the deliberative process privilege:
Exemption 5 permits the withholding of internal government records which are
pre-decisional and contain staff advice, opinion, and recommendations. This
exemption is intended to preserve free and candid internal dialogue leading to
decision-making.
ANALYSIS
As discussed in detail below, the 17 pages of records that the NIH produced in response
to FOIA Request Number 57203 include evidence indicating that the NIH’s FOIA staff made
significant errors when searching for responsive records and when reviewing responsive records
for FOIA exemptions.
1. The NIH’s Search for Responsive Records Was Not Reasonably Calculated to Locate All
Records Responsive to Empower Oversight’s FOIA Request
The legal standard governing the search for records responsive to FOIA requests requires
an agency to conduct a search that is “reasonably calculated to uncover all relevant
documents.”13 Such calculation involves both an understanding of the nature and scope of the
FOIA request and knowledge of where information may be stored within an agency. In the
former regard, courts have found searches to be sufficient when they are based on a reasonable
interpretation of the scope of the subject matter of the request.14
Regarding the issue of knowledge of the contents of an agency’s records storage
platforms, an agency must show that it conducted a good faith, reasonable search of all platforms
likely to possess the requested records.15 Hence, the reasonableness of an agency’s search can
often depend on whether the agency properly determined where responsive records were likely
11
The NIH’s February 7, 2021, response to Empower Oversight’s September 30th FOIA request is attached as Exhibit 2.
12 The 17 pages produced by the NIH, i.e., NIH FOIA Request 57203_Redacted, is attached as Exhibit 3.
13 Weisberg v. DOJ, 705 F.2d 1344, 1351 (D.C. Cir. 1983).
14 Larson v. Dep’t of State, 565 F.3d 857, 869 (D.C. Cir. 2009) (affirming the adequacy of a search based on the agency’s reasonable
determination regarding records being requested).
15
See, Marino v. DOJ, 993 F. Supp. 2d 1, 9 (D.D.C. 2013) (internal citation omitted).
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to be found—and searched those locations,16 or whether the agency improperly limited its search
to certain platforms.17
Based upon 17 pages of records that the NIH produced as being all responsive records it
possessed in connection with its “communications”18 concerning the receipt and consideration of
two information requests from United States Senators and its development of a response to the
Senators’, NIH could not possibly have conducted a good faith, reasonable search for all
responsive records. In that regard, the 17 pages are comprised of:
• Two internal NIH communication threads (pages 1 – 3);
• Senators Blackburn, Grassley, and Marshall’s September 16, 2021, information
request (pages 4 – 6);
• Senators Blackburn, Grassley, and Marshall’s June 28, 2021, information request
(pages 7 – 8);
• The NIH’s September 8, 2021, responses to Senators Blackburn, Grassley, and
Marshall’s June 28th information request (pages 9 – 14),19 and
• An annotated version of Senators Blackburn, Grassley, and Marshall’s June 28th
information request, with redacted text blocks with the headings “Response” following
each of the Senators’ seven requests (pages 15 – 17).20
Thus, in order for one to believe that the NIH produced all records responsive to Empower
Oversight’s September 30th FOIA request, one has to believe that sum total of the NIH’s
communications regarding two Congressional oversight requests is:
16
See, Karantsalis v. DOJ, 635 F.3d 497, 500-501 (11th Cir. 2011) (affirming the district court’s determination that the agency searched for
records in the system most likely to store responsive records and described how it retrieved records from the system); Lechliter v. Rumsfeld,
182 F. App'x 113, 115-16 (3d Cir. 2006) (concluding that the agency fulfilled its duty to conduct a reasonable search when it searched two
offices that it determined would be the only ones likely to possess responsive documents) (citing Oglesby v. Dep't of the Army, 920 F.2d 57, 68
(D.C. Cir. 1990).
17 See, Morley v. CIA, 508 F.3d 1108, 1119-20 (D.C. Cir. 2007) (holding that because the agency retained copies of the records transferred to
NARA and concedes that some transferred records are likely to be responsive, it was obligated to search those records in response to the FOIA
request); Jefferson v. DOJ, 168 F. App’x 448, 450 (D.C. Cir. 2005) (reversing the district court’s finding of a reasonable search when the agency
offered no plausible justification for searching only its investigative database and the agency essentially acknowledged that responsive files
might exist in a separate database); Oglesby v. Dep't of the Army, 920 F.2d 57, 68 (D.C. Cir. 1990) (holding that the agency may not limit its
search to one record system if others are likely to contain responsive records).
18 Empower Oversight’s September 30th FOIA request defines “communications” as:
‘COMMUNICATION(S)’ means every manner or method of disclosure, exchange of information, statement, or discussion
between or among two or more persons, including but not limited to, face-to-face and telephone conversations,
correspondence, memoranda, telegrams, telexes, email messages, voice-mail messages, text messages, meeting minutes,
discussions, releases, statements, reports, publications, and any recordings or reproductions thereof.
See, Exhibit 1.
19 The NIH sent separate, but identical, responses to Senators Grassley, Blackburn, and Marshall.
20
See generally, Exhibit 3, NIH FOIA Request 57203_Redacted.
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• A June 28, 2021, thread of four emails assigning responsibility for responding to
Senators Blackburn, Grassley, and Marshall’s June 28th information request to the
NIH’s Office of Legislative and Policy Analysis (“OLPA”), which occurred over the
course of 50 minutes (pages 2 – 3);
• A September 8, 2021, thread of two emails seeking the formal approval of the NIH’s
Executive Secretariat to sign the September 8th responses to Senators Blackburn,
Grassley, and Marshall’s June 28th information request (page 1); and
• An annotated version of Senators Blackburn, Grassley, and Marshall’s June 28th
information request, with redacted text blocks with the headings “Response” following
each of the Senators’ seven requests (pages 15 – 17).
If true, that would mean that the NIH has no records of:
• The receipt (and acknowledgement of receipt) of the Senators’ June 28th and
September 16th information requests;
• The parallel assignment of the response to the September 16th information request to
an action office;
• Meeting invites or calendar entries for discussions of the Senators’ June 28th and
September 16th information requests and how to respond to them;
• Emails disseminating and vetting drafts of the September 8th response to Senators’
June 28th information request; or
• A parallel annotated version of the Senators’ September 16th information request, with
proposed responses to their seven requests.
Moreover, courts tend to afford agencies a fair amount of leeway when determining the
locations to search for responsive records, on the grounds that an agency generally “is not
obliged to look beyond the four corners of [a FOIA] request for leads to the location of
responsive” records.21 On the other hand, an agency “cannot in good faith ignore . . . a lead that
is both clear and certain.”22 For example, an agency cannot ignore a responsive document that
“clearly indicates the existence of [other] relevant documents.”23
21 Kowalczyk v. DOJ, 73 F.3d 386, 389 (D.C. Cir. 1996).
22 Kowalczyk, 73 F.3d at 389.
23
Center for National Security Studies v. DOJ, 215 F. Supp. 2d 94, 110 (D.D.C. 2002) (holding that discovery of a document that “clearly
indicates the existence of [other] relevant documents” creates an “obligation” for agency to further search for those additional documents),
aff’d in part, rev’d in part & remanded on other grounds, 331 F.3d 918 (D.C. Cir. 2003); Tarullo v. DOD, 170 F. Supp. 2d 271, 275 (D. Conn. 2001)
(declaring agency’s search inadequate because “[w]hile hypothetical assertions as to the existence of unproduced responsive documents are
insufficient to create a dispute of material fact as to the reasonableness of the search, plaintiff here has [himself provided copy of agency
record] which appears to be responsive to the request”); Kronberg v. DOJ, 875 F. Supp. 861, 870 – 871 (D.D.C. 1995) (holding that search was
inadequate when agency did not find records required to be maintained and plaintiff produced documents obtained by other FOIA requesters
demonstrating that agency possessed files which may contain records sought).
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The NIH produced a document that clearly indicates the existence of other records that it
did not produce. In that regard, the NIH produced a September 8, 2021, email from Adrienne
Hallett, the Associate Director of OLPA, to Lawrence Tabak and Patrice Allen-Gifford, with the
Subject “Signature Approval for SRA Letters,” that states:
Hey LAT,
Exec Sec needs your formal approval to sign the SRA response letters. I’ve attached
the back and forth with [Francis Collins] last week to jog your memory if need be.
Thanks!
Adrienne24
As shown above, however, “the back and forth with” with the Director of NIH during the first
week of September 2021 was not produced among the 17 pages that the NIH forwarded in
response to FOIA Request Number 57203, either on its own or as an attachment to Ms. Hallett’s
September 8th email.
This evidence that the NIH failed to conduct a search that was reasonably calculated to
lead to the discovery of all responsive records does not inspire confidence that the NIH has
satisfied its search responsibilities under the FOIA. Hence, Empower Oversight respectfully
requests that the NIH, subject to DOJ’s monitoring, review the work of its FOIA staff, ascertain
the nature and scope of their search plan, determine whether such plan was appropriate and
followed,25 correct any errors that are discovered, and apprise Empower Oversight of its
findings.
2. The NIH Asserted FOIA Exemption b(5) as Justification for Redacting Responsive Records
that Are Not Both Pre-decisional and Deliberative
Subsection b(5) of the FOIA provides that the FOIA “does not apply to matters that are”:
inter-agency or intra-agency memorandums or letters that would not be available
by law to a party other than an agency in litigation with the agency, provided that
the deliberative process privilege shall not apply to records created 25 years or
more before the date on which the records were requested.26
24 See, Exhibit 3, NIH FOIA Request 57203_Redacted, p. 1.
25 Additionally, Federal agencies shoulder the burden of demonstrating that their searches are reasonable, and they typically do this by
describing their efforts in affidavits that they file in support of motions for summary judgment. See, e.g., Ethyl Corp. v. U.S. Environmental
Protection Agency, 25 F.3d 1241 (4th Cir. 1994); Cochran v. Dep’t of Homeland Security, 2019 WL 1433014 (D. Md. March 28, 20199). However,
an agency may not rely upon vague or conclusory affidavits to show that it has conducted a reasonable search. See, Cochran, 2019 WL
1433014, p. *5 – *6 (criticizing a conclusory FBI affidavit). Rather, a satisfactory “affidavit must be reasonably detailed, ‘setting forth the search
terms and the type of search performed and averring that all files likely to contain responsive materials (if such records exist) were searched’ so
as to give the requesting party an opportunity to challenge the adequacy of the search.” Ethyl Corp., 25 F.3d 1246 – 1247 (quoting Oglesby v.
U.S. Dep’t of the Army, 920 F.2d 57, 68 (D.C. Cir. 1990)). Accordingly, Empower Oversight requests that the NIH generate and share with
Empower Oversight affidavits fully describing the search efforts of the NIH’s FOIA staff.
26
5 U.S.C. § 552(b)(5).
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Courts have construed FOIA Exemption b(5) to “exempt those documents, and only
those documents, that are normally privileged in the civil discovery context.”27 Although the
United States Circuit Court of Appeals for the District of Columbia Circuit (“Circuit Court”) has
held that “all civil discovery rules” are incorporated into FOIA Exemption b(5),28 the NIH’s
February 7th response to NIH FOIA Case Number 57203 appears to limit the NIH’s reliance on
the exemption to the deliberative process privilege (i.e., the NIH states, “Exemption 5 permits
the withholding of internal government records which are pre-decisional and contain staff
advice, opinion, and recommendations”).
The purpose of the deliberative process privilege is to “prevent injury to the quality of
agency decisions.”29 In this setting, the Circuit Court has explained that “quality” encompasses
encouraging frank discussions during policy making, preventing advance disclosure of decisions,
and protecting against public confusion that may result from disclosure of reasons or rationales
that were not in fact the grounds for agency decisions.30
To claim the deliberative process privilege with respect to a record, the Circuit Court has
held that an agency must show31 that the record is “pre-decisional” (i.e., “antecedent to the
adoption of agency policy”)32 and “deliberative” (i.e., “a direct part of the deliberative process in
that it makes recommendations and expresses opinions on legal or policy matters”).33
Unfortunately, it appears that the NIH, while purporting to follow FOIA Exemption b(5),
may have redacted responsive records that are not deliberative.
To be “deliberative,” a record must reflect[] the give-and-take of the consultative
process,” either by assessing the merits of a particular viewpoint, or by articulating the process
used by the agency to formulate policy.34
Factual information, on the other hand, is not covered by the deliberative process
privilege because the release of factual information does not expose the deliberations or opinions
27 NLRB v. Sears, Roebuck & Co., 421 U.S. 132, 149 (1975); see also, Martin v. Office of Special Counsel, 819 F.2d 1181, 1184 (D.C. Cir. 1987).
28 See, Martin, 819 F.2d at 1185.
29 Sears, 421 U.S. at 151.
30 See, Russell v. Dep't of the Air Force, 682 F.2d 1045, 1048 (D.C. Cir. 1982); Coastal States Gas Corp. v. DOE, 617 F.2d 854, 866 (D.C. Cir. 1980);
Jordan v. DOJ, 591 F.2d 753, 772 – 773 (D.C. Cir. 1978).
31 Coastal States Gas Corp., 617 F.2d at 866.
32 See, Ancient Coin Collectors Guild v. U.S. Dep't of State, 641 F.3d 504, 513 (D.C. Cir. 2011).
33 See, Vaughn v. Rosen, 523 F.2d 1136, 1143 – 1144 (D.C. Cir. 1975).
34
Coastal States Gas Corp., 617 F.2d at 867.
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of agency personnel.35 Accordingly, factual information is typically available in civil discovery
and its release is not considered to have a chilling effect on agency deliberations.36
Empower Oversight cannot see behind the NIH’s redactions, but other records produced
by the NIH raise serious questions regarding whether segregable factual information37 is
included within numerous large text block redactions that the NIH’s FOIA staff has made.
Specifically, the NIH produced an annotated version of Senators Blackburn, Grassley, and
Marshall’s June 28th information request, with redacted text blocks under the headings
“Response” following each of the Senators’ seven requests.38
The NIH also produced the September 16th responses that it actually transmitted to
Senators Blackburn, Grassley, and Marshall.39 However, those response letters failed to include
the specific answers to the Senators’ enumerated questions, a fact which the Senators themselves
noted. Yet, the NIH did gather those answers in the “Response” paragraphs that are fully
redacted from the documents produced to Empower Oversight.
The NIH’s September 16th response to the Senators is not a policy document; rather, it is
a partial response to the Senators’ seven multipart requests for factual information about the
NIH’s SRA and the Wuhan University researcher’s June 2020 request to withdraw SARS-CoV-2
genetic data from public access on the SRA.40 For example, the NIH’s September 16th response
provides:
• The SRA is managed by the NIH’s National Center for Biotechnology Information
(“NCBI”), which is a participating member of the International Nucleotide Sequence
Database Collaboration (“INSDC”), and the NCBI follows the INSDC’s policies for
data submission and change requests with respect to data submitted to the SRA, in
partial response to the Senators’ first request;
• In March 2020, a researcher at Wuhan University submitted SARS-CoV-2 genetic
sequences for public access on the SRA, and in June 2020 the same researcher
requested that his/her sequences be withdrawn from public access because he/she was
submitting updated sequences to different database and he/she wanted to prevent
version confusion, in partial response to the Senators’ third request;
35
Coastal States Gas Corp., 617 F.2d at 867; see also, McGrady v. Mabus, 635 F. Supp. 2d 6, 18 – 21 (D.D.C. 2009) (distinguishing between draft
letters and memoranda that may be deliberative and data used during a decision-making process, e.g., key personnel data and evaluation
summaries used in promotion decisions, which contain only factual material and are not deliberative).
36 See, EPA v. Mink, 410 U.S. 73, 87 – 88 (1973); see also, Montrose Chem. Corp. v. Train, 491 F.2d 63, 66 (D.C. Cir. 1974) (holding that release of
factual material would not be "injurious" to decision making process).
37
“[W]ith regard to any document an agency believes falls under a FOIA exemption, the agency is required to “undertake a ‘segregability
analysis,’ in which it separates the exempt from the non-exempt portions of the document, and produces the relevant non-exempt
information.” People for the American Way Foundation v. National Park Service, 503 F. Supp. 2d 284, 306 (D.D.C. 2007) (quoting Edmonds
Institute v. U.S., 383 F. Supp.2d 105, 108 (D.D.C. 2005)).
38 See, Exhibit 3, NIH FOIA Request 57203_Redacted, pp. 15 – 17.
39 See, Exhibit 3, NIH FOIA Request 57203_Redacted, pp. 9 – 14.
40
See generally, Exhibit 3, NIH FOIA Request 57203_Redacted, pp. 9 – 14.
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• “Withdrawal” of data from public accessibility on the SRA makes the data
undiscoverable, but it but does not erase the data; rather, NCBI retains the
“withdrawn” data for the scientific record and for disaster recovery, in partial response
to the Senators’ fourth request; and
• From January 2020 through June 2021, six institutions requested withdrawal of
SARS-Co V-2 genetic sequence packages from “NCBI services.” One request was from
the Wuhan University researcher and the rest were from researchers at other
institutions, predominantly domestic, in partial response to the Senators’ seventh
request.
Because the NIH’s September 16th response to Senators Blackburn, Grassley, and
Marshall’s June 28th letter is replete with factual information that is partially responsive to their
various requests, it is likely that the “Responses” that the NIH’s FOIA staff redacted from the
annotated version of Senators Blackburn, Grassley, and Marshall’s June 28th information
request also includes factual information that should have been produced to Empower Oversight
without redaction.
The redaction in full of paragraphs that appear likely to contain the very information that
the Senators publicly complained that the NIH withheld by failing to answer each of their
enumerated questions raises reasonable suspicions. Do the redacted paragraphs contain
additional relevant facts withheld from the Senators? Do they contain facts inconsistent with
what was ultimately disclosed to the senators in the September 16th response?
This evidence that the NIH inappropriately used FOIA Exemption b(5)—i.e., that while
purporting to follow FOIA Exemption b(5), the NIH redacted responsive records that are not
deliberative—does not inspire confidence that the NIH has satisfied its review responsibilities
under the FOIA. Hence, Empower Oversight respectfully requests that the NIH, subject to
DOJ’s monitoring, analyze all of its FOIA staff’s FOIA Exemption b(5) claims in response to
FOIA Case Number 57203 to ensure that their claims are consistent with the accepted legal
parameters of the exemption, correct any errors that are discovered, and apprise Empower
Oversight of its findings.
Thank you for your time and consideration. Please don’t hesitate to contact me with any
questions.
Cordially,
/Jason Foster/
Jason Foster
Founder & President
601 KING STREET, SUITE 200 | ALEXANDRIA, VA 22314-3151 Page 10 of 10
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Exhibit 1
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September 30, 2021
VIA ELECTRONIC TRANSMISSION: NIHFOIA@MAIL.NIH.GOV
National Institutes of Health
Building 31, Room 5B35
9000 Rockville Pike
Bethesda, MD 20892
RE: Records Regarding NIH’S SARS-COV-2 Database
Dear FOIA Officer:
Introduction
Empower Oversight Whistleblowers & Research (“Empower Oversight”) is a
nonpartisan, nonprofit educational organization dedicated to enhancing independent
oversight of government and corporate wrongdoing. We work to help insiders safely
and legally report waste, fraud, abuse, corruption, and misconduct to the proper
authorities, and seek to hold those authorities accountable to act on those reports by,
among other means, publishing information concerning the same.
Background
The New York Times and The Washington Post, among others, have reported
on requests by Chinese researchers to have certain SARS-CoV-2 genetic sequences
withdrawn from the National Institutes of Health’s (“NIH”) Sequence Read Archive.1
Genetic sequences for SARS-CoV-2 virus are critical to understanding how the
pandemic (which has killed more than 670,000 Americans) started, and
1 “Scientist Finds Early Virus Sequences That Had Been Mysteriously Deleted,” New York Times (Jun
23, 2021); “Seattle scientist digs up deleted coronavirus genetic data, adding fuel to the covid origin
debate,” Washington Post (Jun 23, 2021).
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 119 of 143 PageID# 506
understanding the origin of the pandemic is essential to furthering the prevention of
future pandemics.2 Additionally, the State Department has noted that China has not
been transparent in its handling of the question of the origin of SARS-CoV-2 and, as
part of its hindrance of efforts to gain an understanding of the virus, has removed
genetic sequences from its own online databases.3
On June 28, 2021, Senators Charles Grassley and Marsha Blackburn sent the NIH
a letter seeking records and answers to seven questions regarding the removal of the
SARS-CoV-2 genetic sequences from the Sequence Read Archive. They received a
response to their inquiry on September 8, 2021, that they state “failed to fully and
completely answer all seven questions and failed to provide the requested records.” 4
Senators Grassley and Blackburn then sent a follow up letter on September 16, 2021,
demanding answers to their previous questions.5
Records Request
To shed light on the manner in which the NIH is addressing the SARS-CoV-2
pandemic and responding to information requests from members of Congress, we
respectfully request, pursuant to the Freedom of Information Act (“FOIA”), 5 U.S.C.
§ 552, copies of:
1. All communications regarding the letter by Senators Grassley and Blackburn
dated June 28, 2021.
2. All communications regarding the NIH’s response to Senators Grassley and
Blackburn dated September 8, 2021.
3. All communications regarding the letter by Senators Grassley and Blackburn
dated September 16, 2021.
Definitions
“COMMUNICATION(S)” means every manner or method of disclosure,
exchange of information, statement, or discussion between or among two or more
persons, including but not limited to, face-to-face and telephone conversations,
correspondence, memoranda, telegrams, telexes, email messages, voice-mail
messages, text messages, meeting minutes, discussions, releases, statements, reports,
publications, and any recordings or reproductions thereof.
“DOCUMENT(S)” or “RECORD(S)” mean any kind of written, graphic, or
recorded matter, however produced or reproduced, of any kind or description,
2 “COVID Mortality Data,” Johns Hopkins University (https://coronavirus.jhu.edu/data/mortality)
3 “Fact Sheet on Activity at the Wuhan Institute of Virology,” U.S. State Dep’t (https://2017-
2021.state.gov/fact- sheet-activity-at-the-wuhan-institute-of-virology/index.html)
4 https://www.grassley.senate.gov/news/news-releases/did-nih-improperly-delete-covid-19-data-at-
request-of-chinese-researchers-senators-want-answers
5 https://www.grassley.senate.gov/news/news-releases/did-nih-improperly-delete-covid-19-data-at-
request-of-chinese-researchers-senators-want-answers
2
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 120 of 143 PageID# 507
whether sent, received, or neither, including drafts, originals, non-identical copies,
and information stored magnetically, electronically, photographically or otherwise.
As used herein, the terms “DOCUMENT(S)” or “RECORD(S)” include, but are not
limited to, studies, papers, books, accounts, letters, diagrams, pictures, drawings,
photographs, correspondence, telegrams, cables, text messages, emails, memoranda,
notes, notations, work papers, intra-office and inter-office communications,
communications to, between and among employees, contracts, financial agreements,
grants, proposals, transcripts, minutes, orders, reports, recordings, or other
documentation of telephone or other conversations, interviews, affidavits, slides,
statement summaries, opinions, indices, analyses, publications, questionnaires,
answers to questionnaires, statistical records, ledgers, journals, lists, logs,
tabulations, charts, graphs, maps, surveys, sound recordings, data sheets, computer
printouts, tapes, discs, microfilm, and all other records kept, regardless of the title,
author, or origin.
“PERSON” means individuals, entities, firms, organizations, groups,
committees, regulatory agencies, governmental entities, business entities,
corporations, partnerships, trusts, and estates.
“REFERS,” “REFERRING TO,” “REGARDS,” REGARDING,” “RELATES,”
“RELATING TO,” “CONCERNS,” “BEARS UPON,” or “PERTAINS TO” mean
containing, alluding to, responding to, commenting upon, discussing, showing,
disclosing, explaining, mentioning, analyzing, constituting, comprising, evidencing,
setting forth, summarizing, or characterizing, either directly or indirectly, in whole or
in part.
Instructions
The time period of the requested records is June 28, 2021, through the
present.
The words “and” and “or” shall be construed in the conjunctive or disjunctive,
whichever is most inclusive.
The singular form shall include the plural form and vice versa.
The present tense shall include the past tense and vice versa.
In producing the records described above, you shall segregate them by
reference to each of the numbered items of this FOIA request.
If you have any questions about this request, please contact Bryan Saddler by
e-mail at bsaddler@empowr.us.
3
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 121 of 143 PageID# 508
Fee Waiver Request
Empower Oversight agrees to pay up to $25.00 in applicable fees, but notes
that it qualifies as a “news media requester”6 and requests a waiver of any fees that
may be associated with processing this request, in keeping with 5 U.S.C. § 552
(a)(4)(A)(iii).
Empower Oversight is a non-profit educational organization as defined under
Section 501(c)(3) of the Internal Revenue Code, which helps insiders safely and
legally report waste, fraud, abuse, corruption, and misconduct to the proper
authorities, and seeks to hold those authorities accountable to act on such reports by,
among other means, publishing information concerning the same. Empower
Oversight has no commercial interest in making this request.
Further, the information that Empower Oversight seeks is in the public
interest because it is likely to contribute significantly to the public understanding of
the operations or activities of the NIH. Specifically, the public has a significant
interest in understanding how the NIH is addressing the SARS-CoV-2 pandemic and
responding to information requests from members of Congress. Empower Oversight is
committed to government accountability, public integrity, and transparency. In the
latter regard, the information that that Empower Oversight receives that tends to
explain the NIH’s practices will be disclosed publicly via its website, and shared
copies with other news media for public dissemination.7
Request for Expedited Processing
Although Empower Oversight fully expects the NIH to respond to this FOIA
request within the 20 business days allotted by the FOIA, it requests expedited
processing. Understanding how the NIH responds to FOIA requests can enlighten
the public concerning why SARS-CoV-2 genetic sequences were removed from a United
States’ federal database when they could help researchers establish how the pandemic started.
The request is of widespread and exceptional media interest and the information sought
involves questions about research integrity that affect public confidence in the activities and
operations of the NIH. Empower Oversight is engaged in disseminating information to
the public through its website and working with media.8 Accordingly, it is important
that this request be processed and the results publicly disseminated as quickly as
possible.
6 As the Securities Exchange Commission recently conceded, with its issuances of ‘press releases’
describing its activities and findings, and its emails of research papers, FOIA updates, and news
accounts of its activities to an address list more than 9,400 members of the press, Capitol Hill staff,
and key thought leaders, Empower Oversight qualifies as a news media requester for purposes of fees
assessed pursuant to the FOIA.
7 “Mission,” Empower Oversight (http://empowr.us/mission).
8 “Mission,” Empower Oversight (http://empowr.us/mission).
4
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 122 of 143 PageID# 509
For ease of administration and to conserve resources, we ask that documents
be produced in a readily accessible electronic format. In the event our request for a
fee waiver is denied or if you have any questions about this request, please contact us
immediately. Thank you for your prompt attention to this matter.
Cordially,
/S/
Jason Foster
Founder & President
5
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 123 of 143 PageID# 510
Exhibit 2
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 124 of 143 PageID# 511
National Institutes of Health
Freedom of Information Office
Building 31, Room 5B-35
31 Center Drive, MSC 2107
Bethesda, Maryland 20892-2107
phone: (301) 496-5633
fax: (301) 402-4541
Via Email: info@empowr.us
February 7, 2022
Jason Foster
Founder & President
Empower Oversight
2615 Columbia Pike, #445
Arlington, VA 22204
Re: NIH FOIA Case No.: 56712 & 57203; Empower Oversight Whistleblowers & Research v.
NIH, Case No. 21-cv-01275
Dear Mr. Foster:
This is the final response to the Freedom of Information Act (FOIA) request that is the subject of
the complaint filed in Empower Oversight Whistleblowers & Research v. NIH, Case No. 21-cv-
01275, now pending in the U.S. District Court for Virginia. Your FOIA request 56712, dated
July 15, 2021, was received by the National Institutes of Health (NIH) FOIA Office, on the same
day. Your FOIA request 57203, dated October 12, 2021, was received by the National Institutes
of Health (NIH) FOIA Office, on the same day.
FOIA request 56712 requested:
1)All communications regarding the request to post the SARS-CoV-2 sequences to the
Sequence Read Archive in March 2020. This request covers all communications between
March 1, 2020 to March 31, 2020.
2)All communications regarding the request to withdraw the SARS-CoV-2 sequences
from Sequence Read Archive in June 2020. This request covers all communications
between June 1, 2020 to June 31, 2020.
3)All communications regarding these withdrawn sequences as reported by a preprint
titled “Recovery of deleted deep sequencing data sheds more light on the early Wuhan
SARS-CoV-2 epidemic” by Jesse Bloom, a virologist at the Fred Hutchinson Cancer
Research Center. This request covers all communications between Jesse Bloom and the
NIH, from January 1, 2021 and the present. This request all covers all communications
inside the NIH regarding the preprint from June 21, 2021 to the present.
4)All communications to, from, and within the NIH press office about the NIH statement
released on June 23, 2021, and about reports that these sequences were removed from the
Sequence Read Archive. This includes all emails related to the drafting of the statement,
communications about the reported removal, and communications with reporters. This
request covers all communications between June 21, 2021 to June 25, 2021.
FOIA Request 57203 requested:
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 125 of 143 PageID# 512
Page 2 – Mr. Foster (56712 & 57203; Empower. v. NIH, 21-cv-01275)
1) All communications regarding the letter by Senators Grassley and Blackburn dated
June 28, 2021.
2) All communications regarding the NIH’s response to Senators Grassley and Blackburn
dated September 8, 2021. 3) All communications regarding the letter by Senators
Grassley and Blackburn dated September 16, 2021.
In accordance with the Court’s order dated November 17, 2021, we have processed 255 pages of
responsive records for this litigation. The information being withheld is protected from release
pursuant to Exemptions (b)(5) and (b)(6) of the FOIA, 5 U.S.C. § 552 (b)(5) and (b)(6); and
sections 5.31 (e) and (f) of the HHS FOIA Regulations, 45 CFR Part 5. Exemption 5 permits the
withholding of internal government records which are pre-decisional and contain staff advice,
opinion, and recommendations. This exemption is intended to preserve free and candid internal
dialogue leading to decision-making. Exemption 6 permits the withholding of privacy
information, the release of which would constitute a clearly unwarranted invasion of personal
privacy.
Please direct any questions regarding this response to Meghan Loftus of the Department of
Justice, who can be reached at meghan.loftus@usdoj.gov.
Sincerely,
for Gorka Garcia-Malene
Freedom of Information Act Officer, NIH
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 126 of 143 PageID# 513
Exhibit 3
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 127 of 143 PageID# 514
From: Tabak, Lawrence (NIH/OD) [E]
Sent: Wed, 8 Sep 202114:44:08 -0500
To: Hallett, Adrienne (NIH/OD) [E] ;Allen-Gifford, Patrice (NIH/OD) [E]
Cc: Cramer, Lindsay (NIH/OD) [E]
Subject: Re: Signature Approval for SRA letters
please proceed.
thanks
From: "Hallett, Adrienne (NIH/OD) [E]" (b) (6)
Date: Wednesday, September 8, 2021 at 3:40 PM
To: "Tabak, Lawrence (NIH/OD) [E]" (b) (6) , "Allen-Gifford, Patrice
(NIH/OD) [E]" (b) (6)
Cc: "Cramer, Lindsay (NIH/OD) [E]" (b) (6)
Subject: Signature Approval for SRA letters
Hey LAT,
Exec Sec needs your formal approval to sign the SRA response letters. I've attached the back and forth
with FC last week to jog your memory if need be.
Thanks!
Adrienne
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 128 of 143 PageID# 515
From: Downs, Austin (NIH/OD) [C]
Sent: Mon, 28 Jun 202114:24:32 -0500
To: McMahon, Christine {NIH/OD) [E]
Subject: RE : Incoming Congressional from Blackburn/Grassley/Marshall (WF 400559)
Per guidance from Higgins, please assign the letter to OLPA with necessary action/input from NLM.
Please let me know if there is anything else I can help you with on this matter.
Thank you kindly,
Austin
From: McMahon, Christine {NIH/OD) [E] (b) (6)
Sent: Monday, June 28, 2021 2:08 PM
To: Downs, Austin {NIH/OD) [C] (b) (6) >
Subject: RE: Incoming Congressional from Blackburn/Grassley/Marshall {WF 400559)
Great, thanks very much for checking!
Best,
Christine
From: Downs, Austin (NIH/OD) [C] (b) (6)
Sent: Monday, June 28, 2021 2:08 PM
To: McMahon, Christine {NIH/OD) [E] (b) (6)
Subject: RE : Incoming Congressional from Blackburn/Grassley/Marshall {WF 400559)
Good afternoon Christine, let me check with Lauren Higgins and get back to you with how we would like
to proceed.
Thank you,
Austin
From: McMahon, Christine (NIH/OD) [E] (b) (6)
Sent: Monday, June 28, 20211 :44 PM
To: Downs, Austin {NIH/OD) [C] (b) (6)
Subject: Incoming Congressional from Blackburn/Grassley/Marshall {WF 400559)
Hi Austin,
I wanted to check with you on how ES should assign the attached incoming Congressional letter. Is OLPA
taking the lead, or should NLM be the lead?
Thank you!
Christine
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 129 of 143 PageID# 516
Christine McMahon
Executive Secretariat
National Institutes of Health
(b) (6)
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 130 of 143 PageID# 517
nitrd tarts rn tt
WASHINGTON, DC 20510
September 16, 2021
VIA ELECTRONIC TRANSMISSION
Francis S. Collins, M.D., Ph.D
Director
National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892
Dear Dr. Collins:
On June 28, 2021, we wrote to you requesting answers to seven questions pertaining to
the NIH's role and responsibility with respect to the Sequence Read Archive (SRA) relating to
COVID-19 data. On September 8, 2021, your office provided a response that failed to fully and
completely answer all seven questions and failed to provide the requested records.
As we have made clear to you, Congress has a constitutional responsibility to engage in
oversight of the executive branch and the executive branch has an obligation to Congress and the
American people to substantively respond. In light of our responsibility and your obligation in
that regard, we are reposing the unanswered questions from our June 28, 2021, letter. If you are
unable to respond to each question and provide the requested records, please explain why that is
the case.
In addition, we'd like to note that in your most recent letter, you stated that the National
Center for Biotechnology Information has initiated "an independent review of the [Sequence
Read Archive] processes and standard operating procedures" with respect to the withdrawal
request relating to the COVID-19 data. 1 You also noted that NIH "conducted an analysis of
withdrawal requests from January 2020 through June 2021." 2 With that in mind, we request the
final report of investigation, or an equivalent document, for the latter review and an explanation
for why that review was done. Further, we request that you answer several additional questions,
provide the requested records and schedule a briefing to address your answers no later than
September 30, 2021 :
1 Letter from Lawrence A. Tabak, Principal Deputy Director, NIH, to Sens. Grassley, Blackbum, Marshall (Sept. I 0, 2021 ).
2 Id.
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 131 of 143 PageID# 518
Page2
1. With respect to deleting data from the NIH Sequence Archive, please name all personnel
that have the authority to do so. In your answer, please provide the names and titles of
the personnel that were involved in the deletion of SARS-CoV-2 data.
2. With respect to the Wall Street Journal report, which Chinese researcher(s) requested that
the data be deleted from the NIH Sequence Read Archive? 3 When did the deletion
occur?
3. After deletion, does the NIH Sequence Read Archive maintain any accessible back-up of
the deleted data? If so, please provide all records to us.
4. Please list all collaborating partners to the NIH Sequence Read Archive.
5. In the past five years, how many researchers and other personnel associated with the
communist Chinese government, as well as those not associated with the Chinese regime,
have requested that data be deleted from the NIH Sequence Read Archive? Please list by
requestor, date, reason, and the information to be deleted. Please also note whether and
when that material was in fact deleted.
6. More specifically, in the past five years, how many researchers and other personnel
associated with the communist Chinese government, as well as those not associated with
the Chinese regime, have requested that data be deleted from the NIH Sequence Read
Archive relating to coronaviruses? Please list by requestor, date, reason, and the
information to be deleted. Please also note whether and when that material was in fact
deleted.
7. In your letter, you stated NCBI has initiated "an independent review of the SRA
processes and standard operating procedures" with respect to the withdrawal request
relating to the COVID-19 data.
a. When was that review initiated?
b. Which unit and personnel will be involved in the review?
c. What are the other countries that have requested withdrawal of data from the
database?
d. Do you plan to analyze withdrawal requests that occurred prior to the COVID-
19 outbreak? If not, why not?
3 Amy Dockser Marcus, Betsy McKay, Drew Hinshaw, Chinese Covid-19 Gene Data That Could Have Aided Pandemic
Research Removed from NIH Database, WALL ST. J. (June 23, 2021), https://www.wsj.com/articles/covid-19-gene-data-that-
could-have-aided-research-on-early-epidemic-removed-from-database-11624472105; Amy Dockser Marcus and Drew Hinshaw,
After Covid-19 Data Is Deleted, NIH Reviews How its Gene Archive Is Handled, WALL ST. J. (Sept. 13, 2021).
https://www.wsj.com/articles/after-covid- l 9-data-is-deleted-nih-reviews-how-its-gene-archive-is-handled-11631545490
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 132 of 143 PageID# 519
Page 3
Thank you for your attention to this important matter.
Sincerely,
Charles E. Grassley Marsha Blackburn
Ranking Member U.S. Senator
Committee on the Judiciary
Roger Marshall, M.D.
U.S. Senator
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 133 of 143 PageID# 520
WASHINGTO , DC 20510
June 28, 2021
VIA ELECTRONIC TRANSMISSION
Francis S. Collins, M.D., Ph.D
Director
National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892
Dear Dr. Collins:
On June 23, 2021, the Wall Street Journal reported that Chinese researchers "directed"
the National Institutes of Health (NIH) "to delete gene sequences of early COVID-19 cases from
a key scientific database," called the NIH Sequence Read Archive. 1 The article states that NIH
confirmed that it deleted the sequences. 2 The article further reports that the deleted data includes
genomic sequences from SARS-CoV-2 and that these sequences were from viral samples
collected in Wuhan "in January and February 2020" from patients in the hospital. 3
This type of data may contain important and relevant information that could help to better
determine the virus's origins. The efforts by Chinese researchers to delete the data demands
additional explanation. As you are aware, the Chinese government has failed, from the
beginning, to be open and transparent with the world with respect to its role in the pandemic.
The COVID-19 pandemic has resulted in more than 600,000 deaths, and Congress has
spent trillions of dollars to support the American people, businesses, and the economy during
these difficult times. Simply put, the American people deserve to know what their government
knows about the origins of this global illness. As part of our continuing oversight with respect to
NIH's role during the COVID-19 pandemic, we request additional information about the NIH
Sequence Read Archive and the actions taken by Chinese researchers to have NIH delete
SARS-CoV-2 related data. Accordingly, please answer the following no later than July 12,
2021:
1. Please describe, in detail, how and under what circumstances data can be provided to the
NIH Sequence Read Archive and how and under what circumstances data can be deleted
from the same.
1 https://www.wsj.com/articles/covid-19-gene-data-that-could-have-aided-research-on-early-epidemic-removed-from-database-
11624472105?mod=searchresults_pos 1&page= 1
2 Id.
3 Id.
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 134 of 143 PageID# 521
2. With respect to deleting data from the NIH Sequence Archive, please name all personnel
that have the authority to do so. In your answer, please provide the names and titles of
the personnel that were involved in the deletion of SARS-CoV-2 data.
3. With respect to the Wall Street Journal report, which Chinese researcher(s) requested that
the data be deleted from the NIH Sequence Read Archive? When was the request made
and when did the deletion occur?
4. After deletion, does the NIH Sequence Read Archive maintain any accessible back-up of
the deleted data? If so, please provide all records to us.
5. Please list all collaborating partners to the NIH Sequence Read Archive.
6. In the past five years, how many researchers and other personnel associated with the
communist Chinese government have requested that data be deleted from the NIH
Sequence Read Archive? Please list by requestor, date, reason, and the information to be
deleted. Please also note whether and when that material was in fact deleted.
7. More specifically, in the past five years, how many researchers and other personnel
associated with the communist Chinese government have requested that data be deleted
from the NIH Sequence Read Archive relating to coronaviruses? Please list by requestor,
date, reason, and the information to be deleted. Please also note whether and when that
material was in fact deleted.
Thank you for your attention to this important matter.
Sincerely,
Marsha Blackbum Charles E. Grassley
U.S. Senator U.S. Senator
~M~
Roger Marshall
U.S. Senator
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 135 of 143 PageID# 522
/'~ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
l,,.:::::l'-
National Institutes of Health
Bethesda, Maryland 20892
September 8, 2021
The Honorable Marsha Blackbum
United States Senate
Washington, DC 20510
Dear Senator Blackbum:
Thank you for your June 28, 2021, letter regarding the National Library of Medicine's (NLM)
Sequence Read Archive (SRA).
Early in the pandemic, the National Institutes of Health (NIH) and other federal agencies moved
quickly to make COVID-19 open-access data and computational resources freely available to
researchers. NIH's National Library of Medicine (NLM) has a broad portfolio of open-access
databases, including the Sequence Read Archive (SRA), the world's largest publicly available
repository of high-throughput sequencing data. In the past year, SRA received approximately
2.4 million submissions of sequence data.
SRA is managed by NLM's National Center for Biotechnology Information (NCBI), which is the
U.S. participating member of the International Nucleotide Sequence Database Collaboration
(INSDC) since 1987. NCBI follows the INSDC policies 1 and guidelines for data submission and
change requests, 2 and collaborates with participating organizations in updating policies and
guidelines as described in this 2018 article.3
The guidelines describe the criteria for which submitting researchers can request a change in data
status (for example, if the data have been corrupted) and actions taken if the criteria are met.
Submitting institutions must contact NLM/NCBI to request that data be withdrawn. NLM/NCBI
staff review the request against the INSDC guidelines.
In March 2020, the SARS-CoV-2 sequences you mention in your letter were submitted by a
researcher at Wuhan University for public release status via SRA. The researcher from Wuhan
University published relevant information about these sequences by preprint in March 2020 4 and
in an international scientific journal in June 2020. 5 In June 2020, NCBI received a request to
withdraw the sequences from the same researcher. The reason given by the researcher was they
were depositing updated data in a different database and they wanted to prevent version
confusion. In response, NCBI withdrew the sequences from the SRA but they remained
1 https://www.insdc.org/policy.html
2 https://www.insdc.org/documents/insdc-status-document
3 https://www.ncbi.nlrn.nih.gov/pmc/articles/PMC5753279/
4 https://www.medrxiv.org/content/10.1101/2020.03.04.20029538v1
5 https://onlinelibrary. wiley.com/doi/fulVl 0.1002/smll.202002169
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 136 of 143 PageID# 523
The Honorable Marsha Blackbum
Page 2
available to the world's scientists and researchers through the publication and on other platforms.
No conditions were made on that request and no conditions were granted.
NIH subsequently conducted an analysis of withdrawal requests from January 2020 through June
2021. Withdrawal requests were generally submitted for scientific reasons. Examples include
problems with the quality of the data, data were not correctly attributed to their owner, or data
were not correctly identified. In that time, six institutions requested withdrawal of SARS-CoV-2
submission packages through NLM/NCBI services. This included the one requested by the
researcher at Wuhan University and the rest from researchers at institutions from other countries,
predominantly the U.S. In addition, NCBI received withdrawal requests from five institutions
through INSDC collaborators for sequence data that were in the collaborating repositories and
were replicated within the SRA.
While NIH considers the policies and guidelines of the INSDC sound, NCBI has initiated an
independent review of SRA processes and standard operating procedures to determine whether
the appropriate steps were taken to assess this withdrawal request. Withdrawal makes the data
undiscoverable but does not erase it. Per the INSDC guidelines, NCBI retains withdrawn data
for the scientific record and for disaster recovery. Pending outcome of the review, NCBI will
work with INDSC to assign the data to the appropriate status.
Thank you for your interest in NIH's National Library of Medicine's broad portfolio of
open-access databases. I hope this information is helpful to you. I have also sent an identical
letter to the co-signers of your letter.
Sincerely,
(b) (6)
Lawrence A. Tabak, D.D.S., Ph.D.
Principal Deputy Director
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 137 of 143 PageID# 524
/'~ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
l,,.:::::l'-
National Institutes of Health
Bethesda, Maryland 20892
September 8, 2021
The Honorable Charles E. Grassley
United States Senate
Washington, DC 20510
Dear Senator Grassley:
Thank you for your June 28, 2021, letter regarding the National Library of Medicine's (NLM)
Sequence Read Archive (SRA).
Early in the pandemic, the National Institutes of Health (NIH) and other federal agencies moved
quickly to make COVID-19 open-access data and computational resources freely available to
researchers. NIH's National Library of Medicine (NLM) has a broad portfolio of open-access
databases, including the Sequence Read Archive (SRA), the world's largest publicly available
repository of high-throughput sequencing data. In the past year, SRA received approximately
2.4 million submissions of sequence data.
SRA is managed by NLM's National Center for Biotechnology Information (NCBI), which is the
U.S. participating member of the International Nucleotide Sequence Database Collaboration
(INSDC) since 1987. NCBI follows the INSDC policies 1 and guidelines for data submission and
change requests, 2 and collaborates with participating organizations in updating policies and
guidelines as described in this 2018 article.3
The guidelines describe the criteria for which submitting researchers can request a change in data
status (for example, if the data have been corrupted) and actions taken if the criteria are met.
Submitting institutions must contact NLM/NCBI to request that data be withdrawn. NLM/NCBI
staff review the request against the INSDC guidelines.
In March 2020, the SARS-CoV-2 sequences you mention in your letter were submitted by a
researcher at Wuhan University for public release status via SRA. The researcher from Wuhan
University published relevant information about these sequences by preprint in March 2020 4 and
in an international scientific journal in June 2020. 5 In June 2020, NCBI received a request to
withdraw the sequences from the same researcher. The reason given by the researcher was they
were depositing updated data in a different database and they wanted to prevent version
confusion. In response, NCBI withdrew the sequences from the SRA but they remained
1 https://www.insdc.org/policy.html
2 https://www.insdc.org/documents/insdc-status-document
3 https://www.ncbi.nlrn.nih.gov/pmc/articles/PMC5753279/
4 https://www.medrxiv.org/content/10.1101/2020.03.04.20029538v1
5 https://onlinelibrary. wiley.com/doi/fulVl 0.1002/smll.202002169
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 138 of 143 PageID# 525
The Honorable Charles E. Grassley
Page 2
available to the world's scientists and researchers through the publication and on other platforms.
No conditions were made on that request and no conditions were granted.
NIH subsequently conducted an analysis of withdrawal requests from January 2020 through June
2021. Withdrawal requests were generally submitted for scientific reasons. Examples include
problems with the quality of the data, data were not correctly attributed to their owner, or data
were not correctly identified. In that time, six institutions requested withdrawal of SARS-CoV-2
submission packages through NLM/NCBI services. This included the one requested by the
researcher at Wuhan University and the rest from researchers at institutions from other countries,
predominantly the U.S. In addition, NCBI received withdrawal requests from five institutions
through INSDC collaborators for sequence data that were in the collaborating repositories and
were replicated within the SRA.
While NIH considers the policies and guidelines of the INSDC sound, NCBI has initiated an
independent review of SRA processes and standard operating procedures to determine whether
the appropriate steps were taken to assess this withdrawal request. Withdrawal makes the data
undiscoverable but does not erase it. Per the INSDC guidelines, NCBI retains withdrawn data
for the scientific record and for disaster recovery. Pending outcome of the review, NCBI will
work with INDSC to assign the data to the appropriate status.
Thank you for your interest in NIH's National Library of Medicine's broad portfolio of
open-access databases. I hope this information is helpful to you. I have also sent an identical
letter to the co-signers of your letter.
Sincerely,
(b) (6)
Lawrence A. Tabak, D.D.S., Ph.D.
Principal Deputy Director
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 139 of 143 PageID# 526
/'~ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
l,,.:::::l'-
National Institutes of Health
Bethesda, Maryland 20892
September 8, 2021
The Honorable Roger Marshall
United States Senate
Washington, DC 20510
Dear Senator Marshall:
Thank you for your June 28, 2021, letter regarding the National Library of Medicine's (NLM)
Sequence Read Archive (SRA).
Early in the pandemic, the National Institutes of Health (NIH) and other federal agencies moved
quickly to make COVID-19 open-access data and computational resources freely available to
researchers. NIH's National Library of Medicine (NLM) has a broad portfolio of open-access
databases, including the Sequence Read Archive (SRA), the world's largest publicly available
repository of high-throughput sequencing data. In the past year, SRA received approximately
2.4 million submissions of sequence data.
SRA is managed by NLM's National Center for Biotechnology Information (NCBI), which is the
U.S. participating member of the International Nucleotide Sequence Database Collaboration
(INSDC) since 1987. NCBI follows the INSDC policies 1 and guidelines for data submission and
change requests, 2 and collaborates with participating organizations in updating policies and
guidelines as described in this 2018 article.3
The guidelines describe the criteria for which submitting researchers can request a change in data
status (for example, if the data have been corrupted) and actions taken if the criteria are met.
Submitting institutions must contact NLM/NCBI to request that data be withdrawn. NLM/NCBI
staff review the request against the INSDC guidelines.
In March 2020, the SARS-CoV-2 sequences you mention in your letter were submitted by a
researcher at Wuhan University for public release status via SRA. The researcher from Wuhan
University published relevant information about these sequences by preprint in March 2020 4 and
in an international scientific journal in June 2020. 5 In June 2020, NCBI received a request to
withdraw the sequences from the same researcher. The reason given by the researcher was they
were depositing updated data in a different database and they wanted to prevent version
confusion. In response, NCBI withdrew the sequences from the SRA but they remained
1 https://www.insdc.org/policy.html
2 https://www.insdc.org/documents/insdc-status-document
3 https://www.ncbi.nlrn.nih.gov/pmc/articles/PMC5753279/
4 https://www.medrxiv.org/content/10.1101/2020.03.04.20029538v1
5 https://onlinelibrary. wiley.com/doi/fulVl 0.1002/smll.202002169
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 140 of 143 PageID# 527
The Honorable Roger Marshall
Page 2
available to the world's scientists and researchers through the publication and on other platforms.
No conditions were made on that request and no conditions were granted.
NIH subsequently conducted an analysis of withdrawal requests from January 2020 through June
2021. Withdrawal requests were generally submitted for scientific reasons. Examples include
problems with the quality of the data, data were not correctly attributed to their owner, or data
were not correctly identified. In that time, six institutions requested withdrawal of SARS-CoV-2
submission packages through NLM/NCBI services. This included the one requested by the
researcher at Wuhan University and the rest from researchers at institutions from other countries,
predominantly the U.S. In addition, NCBI received withdrawal requests from five institutions
through INSDC collaborators for sequence data that were in the collaborating repositories and
were replicated within the SRA.
While NIH considers the policies and guidelines of the INSDC sound, NCBI has initiated an
independent review of SRA processes and standard operating procedures to determine whether
the appropriate steps were taken to assess this withdrawal request. Withdrawal makes the data
undiscoverable but does not erase it. Per the INSDC guidelines, NCBI retains withdrawn data
for the scientific record and for disaster recovery. Pending outcome of the review, NCBI will
work with INDSC to assign the data to the appropriate status.
Thank you for your interest in NIH's National Library of Medicine's broad portfolio of
open-access databases. I hope this information is helpful to you. I have also sent an identical
letter to the co-signers of your letter.
Sincerely,
(b) (6)
Lawrence A. Tabak, D.D.S., Ph.D.
Principal Deputy Director
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 141 of 143 PageID# 528
June 28, 2021
VIA ELECTRONIC TRANSMISSION
Francis S. Collins, M.D., Ph.D
Director
National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892
Dear Dr. Collins:
On June 23, 2021, the Wall Street Journal reported that Chinese researchers "directed"
the National Institutes of Health (NIH) "to delete gene sequences of early COVID-19 cases from
a key scientific database," called the NIH Sequence Read Archive. 1 The article states that NIH
confirmed that it deleted the sequences. 2 The article further reports that the deleted data includes
genomic sequences from SARS-CoV-2 and that these sequences were from viral samples
collected in Wuhan "in January and February 2020" from patients in the hospital. 3
This type of data may contain important and relevant information that could help to better
determine the virus's origins. The efforts by Chinese researchers to delete the data demands
additional explanation. As you are aware, the Chinese government has failed, from the
beginning, to be open and transparent with the world with respect to its role in the pandemic.
The COVID-19 pandemic has resulted in more than 600,000 deaths, and Congress has
spent trillions of dollars to support the American people, businesses, and the economy during
these difficult times. Simply put, the American people deserve to know what their government
knows about the origins of this global illness. As part of our continuing oversight with respect to
NIH's role during the COVID-19 pandemic, we request additional information about the NIH
Sequence Read Archive and the actions taken by Chinese researchers to have NIH delete SARS-
CoV-2 related data. Accordingly, please answer the following no later than July 12, 2021:
1. Please describe, in detail, how and under what circumstances data can be provided to the
NIH Sequence Read Archive and how and under what circumstances data can be deleted
from the same.
Response:
(b) (5)
1 https ://www.wsj .com/articles/covid-19-gene-data-that-could-have-aided-research-on-early-
epidemic-removed-from-database-11624472105?mod=searchresults pos 1&page= 1
2 Id.
31d.
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 142 of 143 PageID# 529
(b) (5)
2. With respect to deleting data from the NIH Sequence Archive, please name all personnel
that have the authority to do so. In your answer, please provide the names and titles of the
personnel that were involved in the deletion of SARS-CoV-2 data.
Response:
(b) (5)
3. With respect to the Wall Street Journal report, which Chinese researcher(s) requested that
the data be deleted from the NIH Sequence Read Archive? When was the request made
and when did the deletion occur?
Response:
(b) (5)
4. After deletion, does the NIH Sequence Read Archive maintain any accessible back-up of
the deleted data? If so, please provide all records to us.
Response:
(b) (5)
5. Please list all collaborating partners to the NIH Sequence Read Archive.
Response:
Case 1:21-cv-01275-LMB-JFA Document 37-1 Filed 06/10/22 Page 143 of 143 PageID# 530
(b) (5)
6. In the past five years, how many researchers and other personnel associated with the
communist Chinese government have requested that data be deleted from the NIH
Sequence Read Archive? Please list by requestor, date, reason, and the information to be
deleted. Please also note whether and when that material was in fact deleted.
Response:
(b) (5)
7. More specifically, in the past five years, how many researchers and other personnel
associated with the communist Chinese government have requested that data be deleted
from the NIH Sequence Read Archive relating to coronaviruses? Please list by requestor,
date, reason, and the information to be deleted. Please also note whether and when that
material was in fact deleted.
Response:
(b) (5)
Thank you for your attention to this important matter.
Sincerely,
Marsha Blackbum Charles E. Grassley
U.S. Senator U.S. Senator
Roger Marshall
U.S. SenatorFile and source
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