November 3, 2015
Tom Vilsack
Secretary of Agriculture
U.S. Department of Agriculture
Washington, D.C.
Sent via press staff by email
Dear Secretary Vilsack:
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 U.S. Department of Agriculture’s Animal and Plant Health
Inspection Service (APHIS) 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 USDA 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 USDA can and should
voluntarily release the information we’ve been seeking.
We therefore ask that the USDA, 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 are of the type
USDA has refused to release in the past under unsupportable claims that identifying
select agent labs that have faced enforcement actions would pose 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 USDA’s risk
theory.
“The FTAC recommends that information about BSAT research or incidents in BSAT
laboratories be shared with the public, to the maximum extent possible. In most
cases, withholding this information has negligible security value, since the

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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 has repeatedly pointed out that the names of
select agent labs aren’t secret and that the USDA and its regulatory partners at the CDC
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 USDA 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 makes clear that select agent enforcement action information can
be voluntarily released outside of the FOIA. Indeed, the CDC – USDA’s partner agency in
the Federal Select Agent Program -- has already engaged in an arbitrary practice of
releasing select agent incident and select agent regulatory enforcement information if it
wants to. Two examples:
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In February 2015, the CDC created a document based on information about a
joint CDC-USDA 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 joint CDC-USDA select agent release investigation at the
Tulane National Primate Research Center.
http://www.cdc.gov/media/releases/2015/s0313-burkholderiapseudomallei.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.

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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 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 USDA to voluntarily release the following
information no later than Nov. 30, 2015:
1. The names of all select agent entities that USDA/APHIS has referred more than
once for potential enforcement actions because of violation of select agent
regulations. This information should be readily known to USDA/APHIS
2. The names all select agent entities referred by APHIS select agent staff for further
investigation and possible enforcement action and basic information about when
and why the referrals occurred, as well as the outcome of the referrals. (This
information is readily available to USDA as it is contained in the unredacted
version of this spreadsheet: http://bit.ly/1WuFUOb which was produced to USA
TODAY under FOIA # 2015-APHIS-00984-F.)
3. An unredacted version of this spreadsheet: http://bit.ly/1WuFUOb
4. The names of select agent entities that were kicked out of the Federal Select
Agent Program since 2003 by USDA/APHIS and the general reasons they had
their registrations revoked.
5. 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.
6. The names of select agent entities currently under supervision of a federal
performance improvement plan and that were put into that PIPP program by
USDA/APHIS.
We are asking that USDA 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 or enforcement actions may be embarrassing for the lab operators, it doesn’t
pose a select agent security risk.

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Please be aware that the USDA’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