Good morning Chairman Boehlert, Ranking Member Hall and other Members of the Committee. I greatly appreciate the opportunity to discuss with you the goal of the Administration and Congress to ensure an open scientific environment in the U.S. and to maintain the security of our homeland.
The Honorable John H. Marburger
Office of Science and Technology Policy
Before the Committee on Science
U.S. House of Representatives
October 10, 2002
In the National Science and Technology Policy, Organization, and Priorities Act of 1976, OSTP is specifically charged with building strong partnerships among Federal, State and local governments, other countries, and with the scientific community. We take this responsibility very seriously. We also are very serious about the need, post-September 11, 2001, to weigh elements of an open scientific environment against adverse consequences to homeland security. Given our responsibility to "advise the President of scientific and technological considerations involved in areas of national concern," OSTP is the primary voice within the White House on how particular actions will impact the S&T enterprise. We have been involved in several issues that are at the nexus of science and security. Today I'd like to discuss 3 of these issues:
1) Select Agent Registration and Laboratory Biosecurity;Select Agent Rule and Laboratory Biosecurity
2) International Students; and
3) Sensitive Homeland Security Information
On June 12, 2002, the President signed Public Law 107-188, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The Act specifies that the Secretary of HHS shall establish and maintain a list of biological agents and toxins that have the potential to pose a severe threat to public health and safety ("select agents") and requires that all facilities and individuals in possession of the select agents register with the Department. The Act created an analogous program at USDA, which is being directed through the Animal and Plant Health Inspection Service (APHIS).
HHS has maintained a list of select agents since April 1997 (see 42 CFR part 72, Appendix A), under the management of CDC. This rule covered the transfer of select agents, including the registration of facilities engaging in transfers and exemptions from such registration.
P.L. 107-188 extends oversight beyond transferring to facilities possessing and using select agents and specifically aims to maintain "appropriate availability of biological agents and toxins for research, education, and other legitimate purposes." Under this Act, new regulations are necessary in order to enforce proper use, containment, and transfer of select agents. However, the Administration is sensitive to the need to avoid erecting barriers to legitimate scientific research. While this represents a new form of research oversight, other accepted measures are already in place to regulate the use of radioisotopes and human research subjects.
CDC convened an interagency working group, including USDA, to review the current list of biological agents and toxins from October 1997, and revise the list as necessary. The working group has (1) proposed a revised list of bacteria, viruses, fungi and toxins, (2) identified minimum quantities of toxins requiring registration, and (3) defined genetic elements requiring regulation.
On August 6, CDC published a Federal Register notice requiring notification by September 10 of all facilities in possession of select agents. A form was sent to over 200,000 institutions for this purpose, requesting a response, even if the facilities did not possess such agents. CDC has processed over 100,000 responses so far, only a small proportion of which declare possession of select agents. Responses are still coming in.
On the same date, CDC and USDA published a list of "overlap agents" or those that appear on both agencies' lists because they infect both animals and humans (67FR51060). Responses to USDA's request for notification are due October 10.
The law also requires "establishment of safeguard and security measures to prevent access for such agents and toxins for use in domestic or international terrorism or for any other criminal purpose." Therefore, the CDC-led working group has also been working on lab biosecurity measures, to maintain secure environments in laboratories possessing select agents. A revision to Appendix F of the Biosafety in Microbiological and Biomedical Laboratories Manual is underway, to address security issues in light of heightened awareness of potential bioterrorism.
A key element of these provisions will be a requirement that individuals deemed to have a legitimate need for access to select agents will undergo a background check administered by the Department of Justice, in accordance with P.L. 107-188. This will consist of a check against databases including criminal, immigration, national security and other electronic databases available to the Federal government.
Provisions necessary to enhance laboratory biosecurity will vary with each institution depending on its location and principal function, the nature of the agents in use, the conditions for their maintenance (for example, plant or animal pathogens often require facilities different from human pathogens), and vulnerabilities or types of threats most likely to be encountered.
Institutions will be required under the new regulations to prepare a comprehensive security plan based on threat analyses and risk assessments. The decision to purchase "guns, gates and guards" should be thought through carefully and any security enhancements should be based on a thorough, professional risk assessment. I am concerned that universities are already taking steps that incur great expense without ensuring a commensurate increase in security.
CDC also published a notice (Fed. Reg. August 23, 2002) including the revised list of select agents and associated genetic elements, recombinant nucleic acid and recombinant organisms that will require registration. Similarly, on August 12, USDA published for comment its initial list of biological agents and toxins (67FR52383). The interim final rule will be published in December and will contain the regulations on select agents, the registration process for individuals and facilities (including background check procedures), and exemptions for clinical and diagnostic laboratories and approved investigational products. The interim final rule goes into effect in February.
There is evidence that some terrorists have exploited the student visa program. One of the 19 hijackers entered the U.S. on a student visa but never showed up at school. Two other hijackers entered the country on tourist visas but applied for student visas after they arrived.
We must also consider the possibility that we are training future terrorists in sensitive and uniquely available knowledge. Of course the vast majority of international students are here for legitimate purposes, and we fully appreciate the important contribution they make to the nation's S&T enterprise.
The Administration and the Congress want to know who is in the country and if they are doing what they claimed they were going to do. Student visa overstays are not tolerated, but until now it has been very difficult to enforce student no-shows or students who don't leave when their study is completed.
A new tracking mechanism has been put in place named SEVIS: Student and Exchange Visitor Information System. This automated, web-based computer system replaces the existing paper-based system of reporting. Instead of sending reports and updates to the INS by mail, school officials have immediate access to a database where they can update their files real time. The SEVIS system notifies a school that a student is expected; if the student fails to turn up after 30 days, the system alerts officials to take appropriate action. The SEVIS system records address changes, changes in program status, and date of graduation. A student must then leave the country or switch to a different visa category, such as an H-1B visa, if they are hired by a U.S. research lab or firm.
Currently student and research scholar visa applicants with studies related to the 16 sensitive technologies that constitute the current U.S. Technology Alert List are forwarded to the State Department Consular Affairs Office in Washington, D.C. from foreign consulate offices for additional vetting. Most visa denials are due to the Consular Officer's judgement that the applicant is unlikely to return to his/her home country. Other visa denials are due to existing intelligence community information that may warrant exclusion on the grounds of national security concerns. Currently a name check is conducted by the State Department's Consular Lookout Automated Support System (CLASS), which includes name check information from overseas and domestic State Department offices, INS, Customs, FBI and CIA.
To prevent potential terrorists or those tied to terrorist organizations from receiving sensitive, uniquely available, training and knowledge, the President directed, through Homeland Security Presidential Directive-2, (HSPD-2) in October 2001, that, "It is the policy of the United States to work aggressively to prevent aliens who engage in or support terrorist activity from entering the United States and to detain, prosecute, or deport any such aliens who are within the United States." HSPD-2 goes on to direct that, "The Government shall implement measures to end the abuse of student visas and prohibit certain international students from receiving education and training in sensitive areas, including areas of study with direct application to the development and use of weapons of mass destruction."
But the Directive also cautioned that these measures should be implemented with great care because, "The United States benefits greatly from international students who study in our country. The United States Government shall continue to foster and support international students."
To fulfill the requirements of Homeland Security Presidential Directive (HSPD-2), OHS and OSTP established an interagency working group that included members from the Departments of State, Justice (headed by the Immigration and Naturalization Service (INS)), Agriculture, Commerce, Defense, Education, Energy, the National Science Foundation, the National Institutes of Health, and representatives from the intelligence, counterintelligence, and law enforcement agencies. This working group labored over several months to find the right balance between scientific openness and national security in implementing the requirements of HSPD-2. The Administration adopted the Working Group's recommendations, and agencies are now developing the processes and regulations needed to implement the Administration's policy.
The Administration has chosen to implement an enhanced mechanism to review the visa applications of advanced students and visiting scholars on a case-by-case basis. This review process will focus on international students who wish to participate in sensitive science and technology areas that are uniquely available in the United States and who may use the knowledge gained to threaten the security of the United States.
The Administration concluded that given the wide array of coursework and information freely available through academic institutions and other open sources, it becomes impossible to create a list of sensitive courses or even majors that would meaningfully enhance homeland security against terrorist threats from international students. Because of the focus on uniquely available, sensitive, scientific training or knowledge, it is logical to assume that graduate and postdoctoral researchers would be more likely to be reviewed than undergraduate students whose educational content tends to be more widely available.
The Administration will create an Interagency Panel on Advanced Science and Security (IPASS) to perform the enhanced review process. The IPASS co-chairs would be appointed by the Secretary of State and the Attorney General, and the members would be drawn from the State Department, the INS, federal science and technology agencies, and the intelligence, counterintelligence, and law enforcement agencies.
The State Department will refer select student and visiting scholar visa applicants for advanced science programs to the IPASS for review as part of the normal process of screening student visa applications. The INS will also refer select F, M or J visa holders (and applicants for change of status to F, M or J visas) for review when they seek involvement in uniquely available, sensitive training or knowledge areas.
IPASS will evaluate a number of variables, including the individual's background and previous education and training, their country of origin or affiliation, their scientific area of study, training, or research and the nature of the work currently conducted at the U.S. educational institution, and will provide the referring agency with an advisory opinion regarding the proposed visa applicant. Both the State Department and INS will retain their statutory authority to make the final determination in each case, although some changes to the visa process may be likely when the Department Homeland Security is created.
In addition, the IPASS will assess what uniquely available sensitive scientific knowledge is emerging, where it is available, and which terrorist groups or organizations might be trying to gain access to it. IPASS will work closely with U.S. educational institutions and scientific societies in this effort.
The Attorney General and the Secretary of State, along with OHS and OSTP, will routinely monitor the work of the IPASS to ensure that the Federal government has struck the right balance between scientific openness and homeland security. We are aware that there are great scientific institutions around the world, which provide an attractive alternative to studying or conducting research in the United States. We don't wish to turn away scientists unnecessarily.
Sensitive Homeland Security Information
On the subject of sensitive information, OHS has asked OMB to develop guidance for Federal agencies to ensure consistency of treatment of "sensitive homeland security information" across the Federal government and by the recipients of such information. Recipients might include first responders, State and local law enforcement personnel, public health officials and those responsible for developing and maintaining infrastructure.
The guidance is intended to promote consistent handling of sensitive homeland security information across Federal agencies. Consistent handling includes safeguarding for the proper duration, sharing via the appropriate means, and disclosing at the appropriate time. Many agencies have individual designations, such as law enforcement sensitive, but different methods for handling such information.
The designation Sensitive Homeland Security Information (SHSI) does not refer to some new category of information; rather it is the type of information that the government holds today which is not routinely released to the general public, such as law enforcement data and critical computer security threats or vulnerabilities. The vast majority of government information is and will remain publicly accessible.
Open access to fundamental research data is critical to continued scientific advancement and validation of such results. Indeed, it is valid to argue that homeland and national security rely heavily on our ability to conduct research exploring the underpinnings of disease processes or the biology of human, animal and plant pathogens in order to strengthen our defense against such agents, or to develop better sensors for radiological, chemical and biological weapons.
Sensitive Homeland Security Information is not classified information and does not require the practices and infrastructure necessary for handling classified information. The designation would be implemented under existing law and policy, and complements and does not supercede existing mechanisms for classification and declassification of government information.
It is important to note that this process is in the formative stage. The Administration has been engaged in "listening sessions" with various groups of stakeholders, including scientific societies, university organizations, private industry, public interest groups, state and local government representatives, and other interested parties, to listen to advice on best defining SHSI across different sectors, as well as questions and concerns about the potential impact of policy options. These meetings have been very helpful in to us in understanding how to shape a guidance document for public comment. We will also engage in an interagency process and the publication of the guidance in the Federal Register for comment. Therefore, I am happy to take back any concerns you express today to the group working this issue but I may not be able to answer all of your questions.
In the future, we will consult with these groups to determine if there is a need for clarification in the final guidance. Once OMB has issued guidance to the agencies, it becomes their responsibility to prepare rules, directives or otherwise ensure consistent handling of Sensitive Homeland Security Information.
In closing, I'd like to repeat a statement that I've made many times over the past year and which remains true today. This administration is determined not to let terrorism deflect America from its trajectory of world leadership in science. Our research enterprise has produced the means for great strides in science, and in accompanying technologies for improved health care, economic competitiveness, and quality of life. To impede this progress would be to fulfill the ambitions of terrorists to disrupt the American way of life. Having said this, we must also take measures to safeguard our research enterprise, particularly given that terrorists have already shown a willingness to use our technology against us on our own soil. The question is one of balance, and it is one that my office will continue to work to achieve as we move forward. I thank you for holding this hearing on this important subject.