?r U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Centers for Disease Control and Prevention (CDC) Atlanta GA 30333 November 30, 2015 Ms. Alison Young Reporter, USA oday 7950 Jones Branch Drive McLean, Virginia 22108 Dear Ms. Young: Thank you for your letter to Dr. Thomas Frieden concerning biosafety and biosecurity and requesting that the Centers for Disease Control and Prevention (CDC) release information about incidents involving select agents. The Fast Track Action Committee on Select Agents (F TAC) recommended sharing this information to the maximum extent possible. CDC agrees with the recommendations of TAC and recognizes the importance of transparency. We continue to work to balance protecting sensitive information that may pose a security risk with the public?s legitimate interest in being informed. Laboratory research is a critical component in America?s defense against nattu'ally-occun'ing disease and bioterrorism. All research on select agents and toxins has some risk, and our goal is to minimize that risk. We are committed to doing all we can to protect laboratory workers and the communities around them, while supporting scienti?c advancement to combat evolving threats. CDC has two distinct roles in our work with select agents, regulated entity and regulator. As a result, any request to release information may have two components: 1) what CDC releases as a regulated entity about its own laboratories; and 2) what CDC, in its role as a regulator, releases about entities registered with our agency under the Federal Select Agent Program (FSAP). The White House memorandum discussing recent recommendations encourages federal and non-federal regulated entities to voluntarily release information about select agents in their own facilities. Your request for FSAP to release information about regulated entities redirects this call for transparency from the regulated entity, as the White House memorandum stated, to the regulator. FTAC recommended that information about select agent research, including laboratory incidents, be ?periodically provided to the public, and that federal laboratories adopt, to the maximum extent feasible, a policy of transparency regarding both the agents used and laboratory incidents?. We agree with this recommendation and are diligently working with federal partners on a plan to implement it. As a regulator, CDC has since 2003 focused its efforts on reducing the risk of thefts, losses, and releases of select agents and toxins through monitoring facilities and enforcing regulations. Regulating select agents and toxins is a shared federal responsibility involving the U.S. Departments of Health and Human Services, Agriculture, and Justice, so the decision to release information about other regulated entities is not alone. Within the next year, FSAP plans to develop a deliberative process to periodically publish aggregate reports?as speci?ed in recommendation?of laboratory incidents involving select agents and toxins and our Page 2 Ms. Alison Young inspection ?ndings. In addition, individual registered select agent research entities may opt to voluntarily release information, in accordance with applicable laws, about their own operations, including when publishing research. We recognize your frustration with redactions of certain information from our response to your Freedom of Information Act (FOIA) requests. CDC, as well as all federal departments and agencies, is prohibited by law from releasing certain select agent information under a FOIA request. For more details about this statutory provision, please see the additional information provided in the enclosure. Your letter mentions press releases about an incident at Tulane National Primate Research Center as an example of CDC releasing registered entity- related information outside of the 01A process. However, following standard practice, CDC publicly released these documents only after local authorities and the regulated entity held a press conference to publicly disclose the incident. In consultation with our Office of General Counsel and federal partners, CDC is providing responses to your questions 3, 7, and 8. As a regulated entity, CDC has made laboratory safety and transparency a priority, and for that reason, we are leading by example and voluntarily releasing information about our own laboratories to respond to questions 7 and 8. Over the past year, we have voluntarily released information about incidents at our regulated laboratories to the public through multiple channels and have implemented new measures to improve culture of safety. We are also able to provide you with a response to question 3, because these CDC?registered entities are no longer in possession of select agents, and therefore, releasing this information does not present a security risk. However, we cannot disclose at this time any information responsive to your remaining questions. As previously noted, the regulation of select agents is a shared federal responsibility, so any decision to release information to the public is also shared and must follow a collaborative, deliberative process. CDC recognizes that the media has a crucial role in keeping the public informed, including on matters related to select agents. At the same time, any decision to voluntarily release information about select agents must carefully balance our responsibility to protect sensitive information that may pose a security with the public?s legitimate interest in being informed. We will continue to work closely with our federal partners to meet the FTAC implementation goal of releasing meaningful, aggregate information about PSAP inSpection ?ndings and incidents. Sincerely, Stephen C. Redd, MD (RADM, USPHS) tephan S. Monroe, Director, Of?ce of Public Health Associate Director for Laboratory Science Preparedness and Response, CDC and Safety, CDC Enclosures Centers for Disease Control and Prevention (CDC) Responses to November 3, 2015, letter from Ms. Alison Young of USA orlav 3. The names of the select agent entities whose registrations have been revoked by the Federal Select Agent Program since 2003 and the general reasons they had their registrations revoked. Since 2003, CDC has revoked the select agent registration for two regulated entities. Both are state public health laboratories that were registered with CDC to possess biological select agents and toxins to conduct quality control for diagnostic testing. Both laboratories identified alternative, registered sites to conduct diagnostic testing. They are no longer in possession of select agents and are not authorized to receive select agent transfers. These entities are: 0 Colorado Department of Public Health and Environment (CDPHE) This entity initially registered in January 2005 and remained registered until July 2010. It was only registered for Bacillus anthracis to support diagnostic testing of this agent. Its registration was revoked as CDPHE no longer owned the laboratory in question, and the laboratory did not have an approved Responsible Official to provide administrative oversight regarding select agent activities. I Florida Department of Health, Bureau of Laboratories (Pensacola Branch) This entity registered in September 2003 and remained registered until March 2012 for 13 select agents to support diagnostic testing for those particular agents. Its registration was revoked due to inadequate progress in its Performance Improvement Plan and the Responsible Of?cial?s insufficient administrative oversight to ensure compliance with the select agent regulations. 7. The name of the select agent pathogen involved in an incident on or about May 8, 2013 inside one of the own labs According to a summary of lab incidents created for the CDC director, the incident involved a ?missing flea.? The incident described as a ?missing ?ea? involved a project studying Yersinia pestis. CDC laboratory staff performed a preliminary count of uninfected ?eas by unaided eye, prior to exposing them to this pathogen. After exposure, a subsequent count conducted by microscope indicated one less ?ea than previously counted. CDC reported the incident to the Federal Select Agent Program (F SAP). The investigation revealed that a miscount of the ?eas was most likely the cause of the incident. Following the investigation, CDC implemented an enhanced procedure for counting ?eas in the laboratory. 8. The names of all of the select agent pathogens involved in incidents in own labs that were part of this spreadsheet that was created for the CDC director?s office. The information reported in the spreadsheet referenced in your letter was the result of a one-time data collection effort to cast a wide net for reports of lab?related activity during a specified time period. The majority of the reports did not constitute a lab?related incident 01' involve a select agent pathogen. In some instances, the report includes the name of the laboratory, which indicates the type of pathogens generally worked with in that area, but does not imply that any exposure occurred or the report itself had anything to do with the potential for exposure to the pathogen. Further, no laboratory-acquired illness or community-wide risks were associated with any of these reports. The pathogen names that were redacted include: 0 Bacillus anfhracis Influenza A (H5N1) Smallpox vaccine (vaccinia) Yersinia pestis Mmtkeypox Bui'kholde?a pseudomallei Coxiella bm'netfi Highly pathogenic avian influenza 0 Attenuated reassortant in?uenza Virus Additional Information about the Freedom of Information Act and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 as Related to the Public Release of Select Agent Information. The Freedom of Information Act (5 USC 552) provides at 5 USC 552(b)(3) that the Freedom of Information Act ?does not apply to matters that are?specifically exempted from disclosure by statute (other than section 552b of this title [5 USCS 552b]), if that requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue; 01' (ii) establishes particular criteria for withholding 01' refers to particular types of matters to be withheld; The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (42 USC 262a) in subsection (N ondisclosure of certain information) provides ?no Federal agency specified in paragraph (2) shall disclose under section 552 of title 5, United States Code, any of the following: (A) Any registration or transfer documentation submitted under [the select agents and toxins regulations] 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 speci?c registered person or discloses the identity or location of a speci?c registered person. (B) The national [select agents and toxins] database . . . or any other compilation of the registration or transfer information submitted under [the select agents and toxins regulations] to the extent that such compilation discloses site-speci?c registration or transfer information. (C) Any portion of a record that discloses the site?specific or transfer-specific safeguard and security measures used by a registered person to prevent unauthorized access to listed agents and toxins. (D) Any noti?cation of a release of a listed agent or toxin submitted under [the select agents and toxins regulations], or any notification of theft or loss submitted under [the select agents and toxins regulations]. (B) Any portion of an evaluation or report of an inspection of a specific registered person conducted under [under the select agents and toxins regulations] that identifies the listed agent or toxin possessed by a specific registered person or that discloses the identity or location ofa specific registered person if the agency determines that public disclosure of the information would endanger public health or safety. 42 USC 262a specifies the Department of Health and Human Services.