November 3, 2015
Dr. Tom Frieden
Director
Centers for Disease Control and Prevention
1600 Clifton Road
Atlanta, GA 30333
Dear Dr. Frieden:
On October 29, 2015, the White House issued a memo to federal agencies titled “Next steps to enhance
biosafety and biosecurity in the United States.” The memo stresses the importance of transparency
about select agent research and incidents and the need for there to be “accountability to the public.”
(http://bit.ly/1Wu2FMQ)
Over the past year, the Centers for Disease Control and Prevention has repeatedly denied USA TODAY’s
requests for basic, yet critical information about select agent incidents and enforcement actions –
information that sheds important light on the operations at these labs and the effectiveness of federal
oversight. Indeed, the White House memo’s attachments cite USA TODAY’s reporting in making the
new transparency recommendations.
While USA TODAY continues to believe that the CDC is required to provide access to the requested
information under the federal Freedom of Information Act, the White House memo and its related
documents make clear that the CDC can and should voluntarily release the information we’ve been
seeking.
We therefore ask that the CDC, as a demonstration of compliance with the White House’s new select
agent transparency directives, “voluntarily” release – no later than Nov. 30, 2015 – certain key
pieces of information (detailed below) that CDC has previously withheld under unsupportable claims
that information about incidents and enforcement actions would pose a security threat.
CDC has engaged in a practice of withholding information about the types of select agent pathogens
involved in incidents inside its own labs. In addition, the CDC has withheld from USA TODAY the
names of labs that have been the subject of enforcement actions. The CDC has contended, without any
justification, that the mere naming of select agent labs poses a security threat.
Yet even the White House’s own homeland security and scientific experts, who served on the Fast Track
Action Committee on the Select Agent Regulations (FTAC) that developed many of the
recommendations in the new memo, dispute the premise of CDC’s risk theory.
“The FTAC recommends that information about BSAT research or incidents in BSAT

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laboratories be shared with the public, to the maximum extent possible. In most cases, withholding
this information has negligible security value, since the research, researchers,
institutions, and agents involved with BSAT research are often published in scientific
journals or can readily be inferred from public materials,” according to the FTAC report that
is attached to the White House memo. (http://bit.ly/1Oj2ip9)
The FTAC is made up of members of the government’s National Science and Technology Council,
Committee on Homeland and National Security and Subcommittee on Biological Defense Research and
Development.
USA TODAY, in its requests for information – both under the FOIA and simply through the CDC press
office, has repeatedly pointed out that the names of select agent labs aren’t secret and the CDC and its
regulatory partners at the USDA specifically allow labs to publicize their select agent research in journal
articles and on their websites.
While the FTAC’s experts note there may be some specific types of information that might not be able to
be “fully” released – information such as certain “characterization of biological threats” or information
about how pathogens could be used for biocrimes – that’s not the kind of information that USA TODAY
has been seeking. And any specific portions of information could be redacted.
The FTAC experts make clear that even if the CDC believes it can’t release information under the FOIA,
such restrictions “do not preclude research institutions or government laboratories from voluntarily
disclosing such information.”
While USA TODAY continues to believe that such information must be released under the FOIA, the
memo – as well as CDC’s own actions -- make clear that select agent enforcement action information
can be voluntarily released outside of the FOIA. Indeed, as USA TODAY has previously noted in its
FOIA requests, the CDC has already engaged in an arbitrary practice of releasing select agent incident
and select agent regulatory enforcement information if it wants to. Two examples:
•

In February 2015, the CDC created a document based on information about a select agent
violation investigation at the Tulane National Primate Research Center after an incident
involving the release of the select agent bacterium Burkholderia pseudomallei. The press release
document was posted on the CDC’s website and discloses the name of the Tulane National
Primate Research Center, states that the center works with select agents and provides the name
of the select agent pathogen involved in the regulatory investigation.
http://www.cdc.gov/media/releases/2015/s0207-melioidosis.html

•

In March 2015, the CDC created a document and posted a public statement about the conclusion
of the agency’s select agent release investigation at the Tulane National Primate Research
Center. http://www.cdc.gov/media/releases/2015/s0313-burkholderia-pseudomallei.html This
statement discloses that the Federal Select Agent program “suspended” TNPRC – a clear and
public disclosure of a select agent enforcement action and details the types of lax safety practices
that likely resulted in the release.

The White House memo and related recommendations call for such voluntary release of information to
be the norm, not the exception and certainly not for it to be done arbitrarily.
As the Fast Track Action Committee’s report notes, it is not the first to call attention to the importance
of transparency in maintaining public support for biological research. The FTAC says: “Greater

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transparency was a key recommendation from the TFTF and FESAP reports, as well as reports from the
National Science Advisory Board on Biosecurity (NSABB), (10) the National Science Foundation,
Institute of Medicine advisory groups, professional societies and the broader community. These reports
highlight the important role that communication and information sharing with communities that
surround high-level containment laboratories play in good-neighbor relationships and in fostering a
culture of transparency.”
Therefore, USA TODAY calls on the CDC to voluntarily release the following information no later
than Nov. 30, 2015:
1. The names of all select agent entities that have been referred more than once by CDC’s DSAT to
the HHS OIG since 2003 for potential enforcement actions because of violation of select agent
regulations. By information and belief, most if not all of these are federal agency labs –
including those operated by the CDC. (This information is readily available to CDC in that it was
already gathered and provided to the House Energy and Commerce Committee and was
redacted from CDC’s response to USA TODAY FOIA 15-00891. Please see the CDC response to
the committee’s Question 4.)
2. The names of 23 select agent entities that were referred to the HHS OIG for enforcement actions
in which more than one regulatory violation was cited in the referral, as well as the number of
violations cited in the referral. (This information is readily available to CDC in that it was
already gathered and provided to the House Energy and Commerce Committee and was
redacted from CDC’s response to USA TODAY FOIA 15-00891.
3. The names of select agent entities that were kicked out of the Federal Select Agent Program
since 2003 and the general reasons they had their registrations revoked. (This information is
readily available to CDC in that it was already gathered and provided to the House Energy and
Commerce Committee and was redacted from CDC’s response to USA TODAY FOIA 15-00891.
Please see the CDC response to the committee’s Question 6.)
4. The names of select agent entities that are or were suspended from doing select agent research
and the general reason for their suspension/reinstatement and the dates of the suspensions.
(This information is readily available to CDC in that it was already gathered and provided to the
House Energy and Commerce Committee and was redacted from CDC’s response to USA
TODAY FOIA 15-00891. Please see the CDC response to the committee’s Question 7.)
5. The names of select agent entities currently under supervision of a federal performance
improvement plan. (This information is readily available to CDC in that it was already gathered
and provided to the House Energy and Commerce Committee and was redacted from CDC’s
response to USA TODAY FOIA 15-00891. Please see the CDC response to the committee’s
Question 8.)
6. The names of select agent labs that have received civil money penalties (fines) since 2003, the
date each was referred for enforcement action, the amount of the CMP and the general issue the
entity was alleged to have violated. (This information is readily available to CDC in that it was
already gathered and provided to the House Energy and Commerce Committee and was
redacted from CDC’s response to USA TODAY FOIA 15-00891. Please see the CDC response to
the committee’s Question 9.)

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7. The name of the select agent pathogen involved in an incident on or about May 8, 2013 inside
one of the CDC’s own labs (NCEZID/DVED). According to a summary of lab incidents created
for the CDC director, the incident involved a “missing flea.” The CDC has previously refused to
disclose to USA TODAY what pathogen was involved/potentially involved in the incident.
(Please see last incident on the bottom of p. 8 of this CDC spreadsheet summary:
http://www.documentcloud.org/documents/2163000-cdc-summary-of-lab-incidents-releasedto-usa.html .)
8. The names of all of the select agent pathogens involved in incidents in CDC’s own labs that were
part of this spreadsheet that was created for the CDC director’s office:
http://www.documentcloud.org/documents/2163000-cdc-summary-of-lab-incidents-releasedto-usa.html
Please note that in addition to seeking to compel the release of this information through the FOIA, USA
TODAY had in many cases also separately asked for the CDC media relations staff to voluntary release
the information itemized above – especially the names of labs that had been suspended or revoked, but
the agency refused. So we are again asking that CDC voluntarily provide all of this information in the
spirit of transparency and note that there is nothing that can be construed as a security risk by simply
disclosing what select agent lab facilities have been referred for enforcement actions or paid fines or
been kicked out of the select agent program. Indeed, those facilities that have had their select agent
registrations revoked are not able to do any work with potential bioterror agents. While informing the
public about labs’ select agent revocations may be embarrassing for the lab operators, it doesn’t pose a
select agent security risk as they are not allowed to possess select agents.
Please be aware that the CDC’s response to this letter will be publicly reported on in an upcoming article
examining what the transparency recommendations of the White House memo and expert panels mean
for public access to information about select agent incidents and enforcement actions.
Thank you in advance for your attention to this issue by Nov. 30, 2015.
Sincerely,

Alison Young
Reporter
703-854-6466
ayoung@usatoday.com
cc:

Lisa O. Monaco, assistant to the President for Homeland Security and Counterterrorism
John P. Holdren, assistant to the President for Science and Technology
Sylvia Mathews Burwell, Secretary, U.S. Department of Health and Human Services