WASHINGTON – Governmental Affairs Committee Ranking Member Joe Lieberman, D-Conn., Wednesday said the Administration has not properly certified over 500 research labs using dangerous biological agents, as called for in the law, nor conducted requisite background checks on 3,600 employees at these labs.
In a letter to the Secretaries of the Health and Human Services, Agriculture, and Justice Departments, Lieberman noted that November 12, 2003, was the deadline for labs and individuals working with substances such as anthrax, ricin, and smallpox to comply with the law, enacted to safeguard Americans in the wake of the 2001 anthrax attacks through the mail.
As of November 3, not a single lab, out of 513, had been certified. This failure is all the more striking because the November 12, 2003, deadline was set by the administration based on a number of anticipated lab and scientist applications that was far greater than the number of applications actually received.
Last week, in order to avoid disruption of the research being conducted at these labs, the Administration changed the rules to allow individuals and labs to obtain “provisional” certification if they had submitted the appropriate application papers.
“Instead of a robust system of safeguards over these dangerous materials envisioned by Congress, we have presented both those who conduct research on these agents and citizens who must be protected from the release of these agents with a conundrum,” Lieberman wrote. “On the one hand, the Administration has created a system where provisional certification will be granted based in large part on the timely submission of the applicant’s paperwork and not on a determination that statutorily prescribed safeguards are genuinely in place.
“On the other hand, the Administration’s implementation failures have left laboratories and researchers unable to comply with the regulatory time lines for implementation of controls over select agents. In some cases, this inability to comply with regulatory deadlines has reportedly resulted in the destructions of sample collections and the disruption of research.”
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002
established new safeguards to protect the American public from potential terrorist attacks using biological agents from commercial, academic, and government research labs. All lab employees conducting research on materials that pose a grave danger to public health are required to submit to a background check by the FBI. In addition, the labs are required to submit security plans for their physical facilities.
“It appears that a major factor in this delay has been the failure of the applicants to obtain the required security risk assessments or background checks from the Justice Department in a timely manner,” Lieberman wrote. He said the FBI has conducted 5,400 of 9,000 individual security reviews.
Below is a copy of the letter:
November 12, 2003
The Honorable Tommy G. Thompson
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
The Honorable Ann M. Veneman
Department of Agriculture
1400 Independence Avenue, SW
Washington, DC 20201
The Honorable John Ashcroft
Department of Justice
950 Pennsylvania Avenue, NW
Washington, DC 20530
Dear Secretary Thompson, Secretary Veneman and Attorney General Ashcroft,
I am writing to seek explanations for the Administration’s failure to implement key congressional mandates aimed at protecting the U.S. from bioterrorism. Last year, Congress enacted The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188). That Act established significant, new safeguards to protect the American public from potential bioterrorism attacks utilizing dangerous biological agents and toxins held at commercial, academic and government research facilities in the United States. Enacted in the wake of the anthrax mail attacks, the Act responded to deep concerns that laboratories within the U.S. itself could be used as a source of dangerous biological agents for terrorists.
Unfortunately, it appears that the Administration has not acted forcefully and expeditiously to implement the Act’s mandates. In rules issued eleven months ago, both the Department of Health and Human Services (HHS) and the Department of Agriculture (USDA) set deadlines of November 12, 2003 for laboratories and individuals already in possession of these materials to be in full compliance with these regulatory and statutory requirements. It is now clear that these deadlines will not be met. As of November 3, 2003, for example, neither HHS nor USDA had issued a single certificate of compliance. In order to avoid the wholesale disruption of ongoing research because of the lack of these certifications, on November 3, 2003 HHS and USDA issued revised regulations allowing both laboratories and individuals to obtain “provisional” certifications even though they are not in full compliance with the Act’s requirements.
The Act required all laboratories and individuals conducting research on materials deemed to be a threat to public health by the Secretary of Health and Human Services and known as “select agents” to register with HHS and to meet specific requirements, including a security risk assessment or background investigation conducted by the Attorney General. These materials include pathogens which, if released, would pose grave threats to human health. The Act similarly required all laboratories and individuals conducting research on materials deemed to be a threat to animal or plant health by the Secretary of Agriculture to register with the USDA and to meet specific requirements, including a security risk assessment or background investigation conducted by the Attorney General. HHS and USDA were charged with coordinating their efforts to address situations where a laboratory or individual worked with agents covered by both Departments or “overlap” agents. Other requirements include the preparation and implementation of safety plans and security plans to safeguard against terrorist or criminal acts. At the same time, Congress directed the agencies to implement this program in a manner that minimized the disruption of research in this area. On December 13, 2002, both agencies established schedules for bringing laboratories and research personnel into compliance with the Act and set November 12, 2003, as the date for full compliance for those laboratories and individuals already in possession and working with select agents.
It is now apparent that the deadlines will not be met by many, perhaps even all, laboratories and researchers. (As noted, as of November 3, neither HHS nor USDA had issued any certifications whatsoever.)
It appears that a major factor in this delay has been the failure of the applicants to obtain the required security risk assessments or background checks from the Justice Department in a timely manner. Although the Justice Department has taken a number of steps to improve its processing of the required clearances, only 5,400 of some 9,000 security reviews that have been requested have been completed to date.
Faced with the imminent shutdown of hundreds of research activities, HHS and USDA have now elected to “revise” the deadline by allowing both laboratories and researchers to be granted “provisional” certifications of compliance as long as they have submitted complete applications for background investigations to the Justice Department by November 12 and are deemed to have met all other requirements. It appears that most, if not all, laboratories that are allowed to operate after November 12 will do so under these provisional certificates.
While provisional certificates may now seem necessary to avoid major disruptions in bioterrorism research that would otherwise occur, the use of provisional certificates raises a number of issues. First, it is not clear that HHS and USDA will be physically able to issue all of the provisional certificates by the November 12 deadline, especially in those cases where they are waiting to receive verification from the FBI that it has received complete applications for security reviews. Timely issuance of provisional certificates is made more problematic by the fact that the deadline set for receipt of these applications by the FBI is also November 12, thereby leaving very little time, if any, for the FBI to validate receipt of last minute applications and the USDA and HHS to process the provisional certificate. And, if there is such a delay, applicants may be unable or unwilling to continue research activities since the failure to fully comply carries significant criminal penalties.
Provisional certificates also allow both laboratories and researchers to continue to work with select agents in the absence of the security checks required by the Act. In fact, these provisional certificates have no time limit and would remain valid until rescinded or permanent certificates were issued. Inquiries by the Committee’s minority staff indicate that approximately 3,600 of the 9,000 requests to the Justice Department for background investigations remain to be completed. In addition, your agencies must also expect and prepare to process additional new requests from laboratories, and especially from individuals, seeking to begin work with select agents in support of new bioterrorism defense efforts or resulting from the inevitable personnel changes that occur at research and academic institutions. New applicants submitting registration requests after November 12 appear to go to the end of the line. An inability to address new applications received after the November 12 compliance deadline in a timely manner will inevitably result in delays in bringing new employees and graduate students into these laboratories to conduct both ongoing and new work and could certainly have a negative impact on this important research. As a result, the legislative goal of ensuring that individuals handling these materials have background checks without significant disruption in research activities remains unmet and could remain so for an indeterminate period of time.
Similarly, although the laboratories seeking provisional certificates are theoretically required to meet all requirements, other than the background checks, no physical inspection of the laboratory is required to ensure either that the required security and safety plans are in place or that adequate controls have been implemented – even for laboratories that have never been previously certified to handle select agents. Further, although HHS and USDA do conduct on-site inspections, their protocols do not appear to require such inspections prior to, or as a condition of, either form of certification. And although both HHS and USDA have made inspections a “goal” of their select agent registration programs, it does not appear that they have adequate resources to ensure prompt inspections. At current rates, for example, HHS is capable of inspecting approximately 100 select agent laboratories a year. Thus, some of the more than 400 laboratories that have applied to HHS might not be inspected for a significant period of time.
Consequently, instead of the robust system of safeguards over these dangerous materials envisioned by Congress, we have presented both those who conduct research on these agents and citizens who must be protected from the release of these agents with a conundrum: on the one hand, the Administration has created a system where provisional certification will be granted based in large part on the timely submission of the applicants’ paperwork and not on a determination that statutorily prescribed safeguards are genuinely in place. On the other hand, the Administration’s implementation failures have left laboratories and researchers unable to comply with the regulatory timelines for implementation of controls over select agents. In some cases, this inability to comply with regulatory deadlines has reportedly resulted in the destruction of sample collections and the disruption of research. In short, the Administration’s efforts appear to have failed to meet the two statutory goals to both implement the desired safeguards on the one hand and to minimize disruption to research efforts on the other.
It is not clear why this situation has been allowed to occur. At the outset, the regulatory timeline, including the November 12 compliance deadline, was established by the Administration by regulation, based on its judgment on how best to implement the requirements of the Act without disruption of ongoing research. In setting these deadlines, the Administration determined what was achievable and was in a position to ensure that adequate resources were allocated to achieving this schedule including assistance to individual laboratories to aid them in coming into compliance while minimizing disruption of research activities.
While some implementation difficulties could be expected in a program of this magnitude and complexity, the Administration was actually aided by the fact that it received a much smaller number of applications than it initially anticipated. For example, in its regulatory analysis of the rule, HHS concluded that some 817 laboratories were expected to register and that “(t)he expected registered entities are estimated to have about 20,000 staff that will be required to submit information to the Attorney General for approval.” It now appears that HHS has received applications for only 414 laboratories or roughly half the number originally anticipated. In USDA’s regulatory analysis, USDA concluded that some 1653 laboratories would be affected by the combined USDA/HHS registration programs. Inquiries by the Committee’s minority staff indicate that the combined number of applicants is 513, or roughly one third of the total expected. Similarly, information provided to the Committee’s minority staff indicates that approximately 9,000 individual applications have been received for security reviews from both USDA and HHS registration programs. This number is just 45% of the number of individual applicants expected for the HHS select agent registration program alone.
Consequently, it appears that notwithstanding its receipt of far fewer applications from laboratories and individuals than expected, the Administration has still been unable to process the necessary certifications in a timely manner and has been able to avoid a widespread disruption of bioterrorism research only through the creation, at the last minute, of provisional permits.
Given the importance of this matter to homeland security and the negative impact that delays in certification could have on both efforts to prevent an act of terrorism and on current and future bioterrorism research, I request that you respond to the following questions by December 1, 2003:
1) Why has the Administration been unable to process the select agent certification applications for laboratories or individuals prior to the November 12 compliance date, especially in light of the fact that far fewer applicants applied than were originally contemplated?
2) What steps are being taken by each of your agencies to ensure that adequate resources are provided to process the backlog of applications and background checks as well as timely processing of the additional new applications that are to be expected as bioterrorism research efforts expand and normal laboratory personnel transfers, hires, and graduate student rotations occur?
3) By what date do you expect to process all of the current laboratory and individual applicants for each of your agencies?
4) What steps are being taken by HHS and USDA to ensure that laboratories are inspected to ensure they have implemented, and are truly in compliance with, regulatory and statutory safeguards for select agents and toxins?
5) Why was the decision made to have provisional certifications valid for an indefinite period of time and what additional measures, if any, are going to be required in laboratory security plans or other procedures to address the fact that research personnel will not have received the required background investigations?
If you have any questions regarding this matter, please have your staff contact David Berick of the Committee’s minority staff at 202-224-2627.
Joseph I. Lieberman
cc: The Honorable Susan Collins