Related Resources:
FOIA Request to CDC, 22 January
News Release on CDC denial, 31 JanuaryThe Sunshine Project
News Release
11 March 2005Boston University Lab-Acquired Tularemia:
FOIA Appeal to Overturn CDC Secrecy(Austin, 11 March) - After being denied basic information about the laboratory-acquired tularemia infections at Boston University by the US Centers for Disease Control (CDC), the Sunshine Project today filed a Freedom of Information Act (FOIA) Appeal with CDC's parent agency, the US Department of Health and Human Services. Laboratory-acquired infections and other accidental or deliberate releases of biological weapons agents pose a major risk to public health and there is an urgent need to clarify activities of the federal government related to permissions to handle such agents.
The leaders of the Boston University (BU) tularemia project have been publicly identified by HHS, BU, and the media; but CDC is refusing to reveal when the scientists were first permitted to handle virulent tularemia. CDC says the reason why is that revealing anything about the researchers' federal permits poses a bioterrorist threat. "CDC's argument is breathtakingly backwards," says Sunshine Project Director Edward Hammond, "The threat that this request is about has nothing to do with foreign terrorists. Rather, it is the threat posed by the release of biological weapons agents from biodefense labs, a danger palpably proven by Boston University's microbiological mess."
CDC's response confirms what many feared about new US bioterrorism law: that it would be invoked to prevent release of information of high public interest and zero security value that is requested by citizens and public interest organizations concerned about biological safety and public accountability. Says Hammond, "We've explained to HHS why release of this information poses no security threat and does not violate the Bioterrorism Act. Unless HHS reverses its secretive position, many will conclude that the real target of CDC's implementation of the Bioterrorism Act is the public's right to know."
The Sunshine Project filed its FOIA request on January 22nd. CDC replied by fax on January 31st; but didn't formally deny the expedited request until a letter received on February 14th. The appeal was filed today.
11 March 2005
Deputy Assistant Secretary for Public Affairs (Media)
US Department of Health and Human Services
Room 17A-46
5600 Fishers Lane
Rockville MD 20857By fax (301-443-0925) and certified mail
FREEDOM OF INFORMATION ACT EXPEDITED REQUEST APPEAL
Dear Sir or Madam:
By this letter sent within 30 days of receipt of initial denial, the Sunshine Project appeals the Centers for Disease Control’s denial of our Freedom of Information Act (FOIA) request of 22 January 2005. Specifically, we appeal denial of items one through seven of our request, wherein we asked for:
1. Any record indicating the effective date of CDC permission to Peter A. Rice, Boston University to handle the select agent tularemia, as required by the Bioterrorism Act of 2002 and implementing regulations;
2. Any record indicating the effective date of CDC permission to Mary Ellenberger, Boston University to handle the select agent tularemia, as required by the Bioterrorism Act of 2002 and implementing regulations;
3. Any record indicating the effective date of CDC permission to Daniel S. Shapiro, Boston University to handle the select agent tularemia, as required by the Bioterrorism Act of 2002 and implementing regulations;
4. Any record indicating the effective date of CDC permission to Jacqueline Sharon, Boston University to handle the select agent tularemia, as required by the Bioterrorism Act of 2002 and implementing regulations;
5. Any record indicating the effective date of CDC permission to Lee M. Wetzler, Boston University to handle the select agent tularemia, as required by the Bioterrorism Act of 2002 and implementing regulations;
6. Any record indicating the effective date of CDC permission to handle the select agent tularemia, as required by the Bioterrorism Act of 2002 and implementing regulations, by any other person at Boston University working under NIAID grant 1U19AI056543;
7. Any record indicating the effective date of approval for work with the select agent tularemia in each Boston University laboratory utilized by the persons identified in items one through six of this request;
CDC did not perform a search and denied our request citing the Public Health Security and Bioterrorism and Bioterrorism Preparedness and Response Act of 2002, more commonly known as the Bioterrorism Act of 2002. The denial refers to section 351A(h)(1)(A), which states that CDC may not, under FOIA, divulge:
CDC / BU FOIA Denial Appeal, 11 March 2005, p. 2
Any registration or transfer documentation submitted under subsections (b) and (c) for the possession, use, or transfer of a listed agent or toxin; or information derived therefrom to the extent that it identifies the listed agent or toxin possessed, used, or transferred by a specific registered person or discloses the identity or location of a specific registered person.
We appeal this denial because release of the only information that we have requested that is not already public record – the dates on which select agent permits were issued – is not prohibited by Bioterrorism Act of 2002 nor, for that matter, would its release create even the slightest security vulnerability. In fact, because one or more of these individuals may have mishandled a select agent (leading to three laboratory-acquired infections), possibly in violation of the same Bioterrorism Act that CDC cites, release of the dates of registry of these individuals is of profound public interest and would encourage safety in biomedical research.
The Bioterrorism Act of 2002 prohibits release (under FOIA) of two types of information: 1) select agent registration documentation submitted to CDC and 2) CDC information derived from that documentation to the extent that it identifies registered persons and select agents (or toxins) utilized or transferred.
In this request, the effective date of CDC permission to five registered persons is the Sunshine Project’s only interest (we have requested any record bearing the dates, which might be something so simple as a list). Contrary to CDC’s denial, the Bioterrorism Act simply does not prohibit release of dates of registry: The date is determined by CDC and is not contained in BU’s application, so dates are not “registration or transfer documentation submitted”.Nor are dates of registry among the types of derived information that are exempted in the Act: A date is not a person, nor an agent or a toxin, nor a location or transfer. Therefore, no date of registry can be withheld under the Bioterrorism Act of 2002.
In this context, with respect to the names of these registered persons, the names have already been identified in the request. They were included in the request on the basis of information released to the public by HHS. This information may be obtained from the NIH’s Computer Retrieval of Information on Scientific Projects (CRISP) database at: http://crisp.cit.nih.gov. Please refer to grant 1U19AI056543 (“Immuno-Prophylaxis-Therapy & Diagnosis of Tularemia”) and its subprojects. Therefore, because HHS already publicly identifies these individuals as registered persons, CDC may reply to the request without releasing the persons’ identities – because they are already released.
It also bears mentioning that the identities of these registered persons may also be obtained by filing a FOIA request with HHS that included any of a variety of records related to this research award (e.g. the contract). And, of course, nearly all recipients of NIH awards involving handling of select agents have websites and publish papers that identify them as registered persons. In fact, the easiest way to identify such registered persons, working for HHS or in extramural activities, is by performing a search on NIH’s own PubMed.
As HHS is well-aware, short of classifying biomedical research in general, which few would disagree would be a disaster for US science and international peace and security, the identities and activities of scientists that HHS funds to handle select agents will in most cases remain public record.
The purpose of the narrow FOIA exemptions set forth in the Bioterrorism Act are not as CDC claims. They do not create a blanket prohibition on FOIA release of information that is already public, nor on information about HHS grants, nor are they intended to hide the identities of registered persons in
CDC / BU FOIA Denial Appeal, 11 March 2005, p. 3
general. (If the latter was the case, then scientific meetings and the scientific publication enterprise insofar as they relate to infectious disease and toxins might as well be shut down.)
Rather, the exemptions of the Bioterrorism Act are aimed at 1) protecting some personal and security-related information contained in the applications for registry and 2) preventing the filing of a FOIA requests whose intent is to use CDC select agent registry as a means of identifying classified activities. We have not requested the first type of information, and this request does not use FOIA for the second purpose. Accordingly, our request does not run afoul of the Bioterrorism Act’s intent and CDC’s denial is incorrect.
We have filed this expedited FOIA request because of widely-publicized safety lapses at Boston University. The dates upon which individuals at Boston University were permitted to handle tularemia is of widespread public interest because it is an important aspect of a current news story that has garnered national headlines. The information we have requested has an important bearing on issues of laboratory biosafety, particularly in view of the expanding biodefense program. and may prove relevant to the effective investigation of incidents and enforcement of other provisions the Bioterrorism Act.
In view of the above, the Sunshine Project insists that the records requested be released immediately.
Sincerely,
Edward Hammond
Director