July 13, 2015
FOIA Officer
HHS Office of Inspector General
Cohen Building, Suite 1062
330 Independence Ave., S.W.
Washington, DC. 20201
Via online FOIA form

FOIA REQUEST: Dugway select agent enforcement records

This is a request under the federal Freedom of Information Act for access to and copies certain
records relating to enforcement referrals made about the U.S. Army Dugway Proving Ground by
select agent regulators at the Centers for Disease Control and Prevention.
According to the CDC, the agency’s select agent regulators referred Dugway to the HHS OIG for
possible enforcement action or fines in 2007 for failing to properly kill specimens of anthrax and
ignoring test results that indicated their test process wasn’t effective. No fine was ever issued,
the CDC said in response to questions for this June 12, 2015 news article:
http://www.usatoday.com/story/news/2015/06/12/dugway-live-anthrax-shipments/71093540/
USA TODAY seeks copies of key records about this referral and what action HHS OIG took after
receiving it. Because USA TODAY does not know what records HHS OIG possesses or how they
are kept, it is difficult for use to specify individual records. We would ask to have a telephone
conversation with a records custodian in order to help make our request as narrow as possible,
while still providing USA TODAY and the public with a clearer picture of what occurred in this
enforcement action referral.
The records we seek include such documents as:
• The main or initial document from CDC referring the Dugway Proving Ground to the HHS
OIG for potential enforcement action and any related attachments. There presumably is
some sort of master referral document that explains the violations by Dugway and/or
what enforcement actions CDC recommended be taken.
• Any enforcement case synopsis or summary record that the HHS OIG may have created
that provides an overview of the enforcement case, actions taken and the case’s
resolution.
• Any final case decision report, correspondence or memo. It would seem the HHS OIG
should have some sort of main record of its final decision in what action to take or not
take on the recommended enforcement action against the Dugway Proving Ground.

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•

Any correspondence notifying the CDC and/or Dugway of the HHS OIG’s decision.

The Justice Department has issued guidance that encourages FOIA Offices to engage in
conversations with requesters to help develop the best, most efficient and effective approach to
establishing the scope of a request. In discussing the “importance of good communication with
FOIA requesters,” the Justice Department notes: “Many times FOIA requesters do not know
how agency records are organized or what might be involved in searching for the records they
seek. Having the ability to talk through an approach to the request and reach an understanding
can be very helpful to both the requester and the agency.”
http://www.justice.gov/oip/blog/foia-post-2010-oip-guidance-importance-goodcommunication-foia-requesters
This request should receive expedited processing as there is an urgent need for the public and
members of Congress (who are currently investigating the adequacy of lab safety and select
agent oversight) to know details about how government regulators handled Dugway’s incident
that prompted the 2007 enforcement action.
In May a massive international investigation was launched after a private biotech company
discovered that what was supposed to be a dead sample of anthrax it had recently received
from Dugway – was actually alive and capable of growing and causing disease. As the weeks
have passed, federal investigators have concluded that Dugway has been mistakenly sending
out live anthrax for 10 years – as far back as 2005. (Please see: “Army lab lacked effective
anthrax-killing procedures for 10 years.”
http://www.usatoday.com/story/news/2015/06/17/anthrax-shipments-bruce-ivinsemails/28883603/ )
This request clearly relates to an activity of government and sheds important light on how the
CDC and HHS OIG performed in enforcing federal select agent regulations, as well as the
effectiveness of government enforcement actions in preventing future recurrences of serious
safety issues.
The adequacy of lab safety and oversight has been an issue of significant public concern and was
among the issues explored at an oversight hearing in July 2014 before a subcommittee of the
House Committee on Energy and Commerce.
http://energycommerce.house.gov/hearing/review-cdc-anthrax-lab-incident
These records are being requested for a news article examining safety and security at research
labs and the effectiveness of current federal oversight programs. As such, my request clearly
relates to an activity of government – and given the recent concerns expressed by members of
Congress in light of several earlier high-profile lab accidents – it is also clearly an issue of
national significance and timely importance.
Important note about select agent names and facilities: The HHS OIG has in some cases
redacted the names of research institutions and pathogen names under Exemption (b)(3) and 42
U.S. C. 262a(h). The statute only applies to certain types of records and to information that
meets certain tests. Sec. 262a only applies to very specific and limited types of records that
involve select agent registration and transfer records. It does not allow for the redaction of

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select agent names from any mention in any other type of documents. Enforcement records are
not the specific type of records covered by by 262a.

Sec. 262a is generally aimed at regulating the possession and use of dangerous
biological agents and toxins (“select agents”) for research purposes. Subsection (h)
within that statute restricts the release of certain information in five limited
circumstances – none of which are present in the instant case. First, Sec. 262a(h)(A)
restricts the disclosure of registration or transfer documentation, or information
derived therefrom to the extent that it identifies the listed agent or toxin or
discloses the identity or location of a specific person authorized to possess a listed
agent. The records we seek are enforcement records related an Army lab that the
CDC has publicly disclosed was the subject of a select agent enforcement action and
that the Pentagon has disclosed is currently under investigation for mistakenly
shipping live anthrax.
The records sought by this request are not registration or transfer records subject
to exemption under Sec. 262a(h)(A). Although the enforcement records might
contain information which may also appear in registration or transfer documents,
the information in the requested records are not “derived” from registration or
transfer documents that receive protection under 262a(H)(A).

To the extent that the HHS OIG considers the information in the requested records
to be “derived” from registration forms, such a broad interpretation of Sec.
262a(h)(A) cannot stand in light of the HHS’s own history of releasing names of labs
– and the select agent pathogens they work with – that are involved in select agent
enforcement actions and that receive HHS funding for select agent research.

For example, the CDC released the name of the Tulane National Primate Research
Center and the name of a select agent pathogen – Burkholderia pseudomallei – in
documents containing information about the agency taking enforcement action to
suspend the center from the Federal Select Agent Program, and also in a document
about the Federal Select Agent Program’s conclusions about the lab’s violations in a
release of this select agent pathogen. If Sec. 262a(h)(A) allows the disclosure of this
type of information in public relations documents about select agent enforcement
actions, the statute must also allow the disclosure of the same type of information in
the enforcement records sought in this FOIA request. Here are two examples:
• “Ongoing Inquiry into Melioidosis Illness at Tulane National Research
Center” http://www.cdc.gov/media/releases/2015/s0207-melioidosis.html
• “Conclusion of Select Agent Inquiry into Burkholderia pseudomallei Release
at Tulane National Primate Research Center”
http://www.cdc.gov/media/releases/2015/s0313-burkholderiapseudomallei.html
In addition, an attempt at an improperly broad interpretation of Sec. 262a(h)(A)
cannot stand in light of the HHS’ National Institute of Health’s policy of regularly
publicizing the names and locations of labs and select agents they use in their

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research. Attached are five examples of project descriptions from the NIH eReporter
website, which is publicly accessible. As you will see, the descriptions include the
same type of information the HHS OIG in the past has asserted is not authorized for
release under federal law – including names of select agent pathogens, lab locations,
and even the names of project investigators. The enclosed examples are not outliers;
the eReporter website is full of similar project descriptions. Therefore, if Sec.
262a(h)(A) allows the disclosure of this type of information in the project
descriptions, the statute must also allow the disclosure of the same type of
information in the enforcement records sought in this FOIA request.

Sections 262a(h)(B)-(D) exempt site-specific registration or transfer information,
site-specific or transfer-specific safeguard and security measures, and notifications
of releases, thefts or losses of biological agents. Again, this FOIA request seeks
enforcement records relating to Dugway Proving Ground’s failures several years ago
to properly inactivate anthrax – and it is therefore not among the categories of
documents exempt from disclosure under subsections (B) through (D).
Furthermore, the requested enforcement records are not “an evaluation or report of
an inspection of a specific registered person” that would be exempt from disclosure
pursuant to Sec. 262a(h)(E). Even if the Dugway enforcement records could be
considered an evaluation or inspection report – which they cannot – nondisclosure
is permitted only if the HHS OIG “determines that public disclosure would endanger
public health or safety.” Considering that the CDC, the NIH and even select agent labs
themselves have routinely touted the names of pathogens involved in research at
individual institutions – in publicly available scientific journal articles, on the NIH
grants database and even in some CDC select agent enforcement actions, it stands to
reason that this information does not pose any threat to public health or safety. In
fact, the release of the requested information would benefit the public health and
safety by informing the public and policymakers about the effectiveness of CDC and
the HHS OIG in enforcing select agent regulations. As a result, even if the requested
records can be considered evaluations or inspection reports subject to subsection
(E), no information can be redacted on grounds that disclosure would endanger
public health or safety.

Request for estimated release date: As required by law, I ask that HHS OIG provide its estimate
of the date it expects to release responsive records.
This information is being sought for a news article that will be published in USA TODAY, the
nation’s largest newspaper, and on our web site, www.usatoday.com. The stories will also be
published and aired throughout the entire Gannett news organization, which includes dozens of
newspapers across the country. http://www.gannett.com/section/WHOWEARE06.
If this request is denied, in whole or in part, I ask that you give specific legal justifications for the
denial or redactions. I am seeking explanations beyond an exemption citation, to allow me to
craft an adequate appeal, if necessary. Under presidential directive, FOIA staff have been
instructed to view request such as these with an eye toward transparency. I’d urge the agency
to use its discretion to release records.

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Please be aware that USA TODAY will challenge attempts to excessively redact or withhold in
their entirety purely factual material in records under claims that the material is pre-decisional
in nature. The decisions in this enforcement action were made years ago.
Fee waiver request: I am seeking a waiver of fees as the release of this information is clearly in
the public interest for the reasons stated above. If you deny the fee waiver request, I ask that
you address the specific merits of this particular case in detail and explain specifically why you
believe it doesn’t qualify. If, on appeal, a fee waiver ultimately is not granted, I agree to pay
reasonable duplication charges. However please notify me in advance if they will exceed $25.
Please be aware that as a general circulation newspaper reporting on a matter of significant
national and international interest this request meets the criteria for a public interest fee
waiver.
If you have any questions, please call me at 703-854-6466 or send them to me by email at
ayoung@usatoday.com
Thank you in advance for your assistance, I look forward to hearing from you within 10 days
about my request for expedited processing, as required by law. Please send correspondence to
me by email at ayoung@usatoday.com. And if responsive records are in digital format, I’d
welcome receiving them that way.
Sincerely,

Alison Young
Reporter
USA TODAY
7950 Jones Branch Drive
McLean, VA 22108
703-854-6466