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3 Information Restriction and Control Regimes INTRODUCTION The terrorist attacks of September 11, 2001 and the subsequent an- thrax mailings in which five people died have produced a new sense of vulnerability in the United States. The governmental re- sponse has been wide ranging, affecting almost every sector of society. With respect to the life sciences, the most important initiatives to date are those embodied in the PATRIOT Act and the Bioterrorism Response Act. As dis- cussed in Chapter 2, the latter legislation provides for the regulation of ac- cess to select agents and toxins through registration and screening of all institutions and individuals that possess, use, or transfer select agents. Some have proposed that government control should go beyond the reg- istration of laboratories and researchers who work with specified agents to include broad controls on the dissemination of research results, as well as the vetting of research proposals. Should these proposals be adopted they would require a regulatory framework that would involve procedures for reviewing research proposals and restrictions on dissemination of research results; inevitably these regulations would profoundly affect research prac- tices in biology laboratories. In effect, areas of life sciences research that were deemed "sensitive" because they could theoretically aid terrorists or be used in the production of biological weapons would be treated as secret. Such a step should not be taken lightly; openness in science is highly valued. As the 1982 "Corson" report stated: Free communication among scientists is viewed as an essential factor in scientific advance. Such communication enables critical new findings or 79
80 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM new theories to be readily and systematically subjected to the scrutiny of others and thereby verified or debunked. Moreover, because science is a cumulative activity each scientist builds on the work of others the free availability of information both provides the foundations for further sci- entific advance and prevents needlessly redundant work. Such commu- nications also serve to stimulate creativity, both because scientists com- pete keenly for the respect of their peers by attempting to be first in publishing the answers to difficult problems and because communica- tion can inspire new lines of investigation. Finally, free communication helps to build the necessary willingness to confront any idea, no matter how eccentric, and to assess it on its merits.2 This chapter reviews the existing and emerging regulatory and over- sight structure that governs the control of information related to biologi- cal research. Because issues of secrecy and sensitive information are new for much of the biological sciences, the chapter first discusses the experi- ence of other scientific disciplines with these concerns. How other disci- plines have addressed concerns about security suggests lessons that the Committee believes are relevant to the biological sciences as they respond to these issues. PAST AS PROLOGUE? The life sciences differ from the physical sciences in that they have not been deeply involved in developing new weapons in the United States since the Biological and Toxin Weapons Convention banned biological weapons in the early 1970s.3 While many countries pursued BW work prior to the BWC entering into force, only a few had large-scale programs, and even in those countries military support for biological research was dwarfed by the resources going into nuclear and conventional weapons programs.4 The main patrons of research in the life sciences in the United States have been the National Institutes of Health (NIH), the Department of Agriculture (USDA), the National Science Foundation (NSF), the Depart- ment of Defense (DOD, the Department of Energy (DOE), and the phar- maceutical and agricultural industries. Secrecy issues involving national security concerns, as distinct from questions of intellectual property, have largely been absent in the life sciences. When the military did fi- nance research in fields that had a biological content, such as oceanogra- phy, the result was to shift the balance in the field away from biology and toward the physical sciences that were familiar to the military pro- gram officers and advisory boards.5 It should also be recognized, how- ever, that the Defense Department has had a long-standing interest in fundamental basic and applied medical research for the development of
INFORMATION RESTRICTION AND CONTROL REGIMES 81 diagnostic and medical countermeasures to "exotic" diseases that could adversely affect personnel readiness. The Nuclear Weapons Complex It is instructive to compare the situation in the life sciences to other areas of science in which the military has taken a stronger interest. The U.S. nuclear weapons program offers an example in which the Depart- ments of Defense and Energy have played dominant roles in funding and shaping developments in nuclear physics and related fields. Nuclear weapons design is carried out in the Energy Department's national labo- ratories (primarily the Los Alamos National Laboratory, Sandia National Laboratories, and Lawrence Livermore National Laboratory). This work requires a special security clearance that restricts access to a small number of scientists who, in effect, constitute a closed society.6 Although the prin- ciples that underlie the design of nuclear warheads are well understood by scientists around the world, the details of nuclear weapons design re- main highly classified. Under the Atomic Energy Act of 1954, all informa- tion concerning nuclear weapons is "born classified," so that even research done outside the national laboratories under private sponsorship may be automatically classified if it is deemed relevant to nuclear weapons.7 The category of "unclassified controlled nuclear information" (UCNI) is ex- empt from release under the Freedom of Information Act.8 Exports of nuclear materials and related technologies are controlled under provisions of the Atomic Energy Act, the Nuclear Nonproliferation Act of 1978, and the Nuclear Nonproliferation Treaty, with nuclear dual use items covered by the Export Administration Act. As discussed below, "technology" can include information and various kinds of technical data and knowledge. In short, there is a pervasive system of governmental secrecy and con- trol for all research and development information related to nuclear weap- ons design and testing. Moreover, there is substantial consensus among scientists and the public that secrecy in the case of nuclear weapons is justified and should be maintained. Nuclear weapons scientists exchange their freedom to publish for relatively secure jobs and the satisfaction of feeling that they are contributing to national security.9 Other structural elements further distinguish nuclear weapons from biological and chemical weapons. Although some of the knowledge and facilities related to nuclear energy are relevant to the production of nuclear weapons, many steps intervene between the underlying science and suc- cessful production of a reliable nuclear weapon. Production of weapons- grade material, for example, requires industrial-scale processes. The pro- liferation of nuclear weapons capabilities has in every case so far required the resources of a state-sponsored program.~° This means that in the case
82 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM of nuclear weapons there are relatively few interests that might argue for greater openness for research results. By contrast, in the case of biological weapons, the basic science relevant for civilian uses is essentially the same as that relevant to military and especially terrorist applications. No "bright line" exists between purely defensive and purely offensive uses of infrastructure and knowledge. Box 3-1 offers additional comparisons of the distinct differences between fissile materials and biological pathogens that fundamentally affect the security concerns related to research rel- evant to nuclear and biological weapons. Some scientists have argued that a small group of terrorists, using knowledge that has long been publicly available, could assemble a crude bomb based on highly enriched uranium (HEU). Such a device would not be a weapon of the sort designed in state weapons programs; it could, nevertheless, potentially equal the explosive power of the bomb used at
INFORMATION RESTRICTION AND CONTROL REGIMES 83 Hiroshima. This possibility makes the safeguarding of stockpiles of fissile materials paramount, since controlling access to HEU remains the pri- mary technical barrier to this type of weapons proliferation. Cryptography Cryptography offers a second comparative case with potential les- sons for the regulation of biotechnology. For hundreds of years cryptog- raphy was the province of governments that wanted to conceal state se- crets diplomatic and military from others. To that end, they also kept information secret about the codes they used in order to make decryption by others less likely. The situation changed when private corporations developed a serious interest in cryptography as they began to do business electronically and needed to be able to conduct their affairs in private. Over the last three decades researchers in academic and industrial labora- tories have entered the field in increasing numbers. Cryptography has thus become a dual use technology. The new users of cryptography do not always see eye to eye with the government, which has an interest in retaining the ability to crack codes used by criminals and by foreigners doing business in the United States. In the 1990s controversy flared over the government's attempt as part of a new encryption standard to impose a key escrow feature, which would have enabled it to read any message it desired. The cryptography com- munity and commercial interests argued that such a system would com- promise privacy and undermine consumer confidence in business con- ducted over the Internet. It might also provide an opportunity for abuse of power by government agents holding the key. The encryption escrow feature was retained in the new standard, but use of the standard is vol- untary.~2 More significant for the debate over secrecy was the government's attempt in the late 1980s to put some academic research papers dealing with cryptography under export control laws and to require that research publications be vetted by the National Security Agency (NSA). The secu- rity concern was (and is) that open publication of some research could reveal vulnerabilities in encryption algorithms that an enemy could ex- ploit. The cryptography community, by contrast, has argued consistently that in a well-designed cryptographic system only the key should be se- cret. In addition, algorithms should be public and open to challenge, so that problems can be quickly identified and fixed; that is, cryptography, like other sciences, progresses best under conditions of openness. The outcome of this controversy provides an alternative model for addressing security concerns. In this case, the government dropped its efforts to impose secrecy in exchange for an informal system in which
84 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM cryptographers often (but not always) submit their proposals and papers to the NSA for prepublication review, even when NSA is not the funding agency.~3 Thus, although there is no "born secret" category for cryptogra- phy research, the government has been able to keep track of ongoing re- search and to exercise some control over publication of results. Compli- ance is not universal, but there appears to be an informal norm in large segments of the cryptography community that cooperating with the gov- ernment on this issue is a sign of good citizenship. Lessons from the Comparisons What lessons do these examples offer for possible governmental con- trols on research in the life sciences? We can compare structural condi- tions in the three cases in at least four dimensions. In all three cases, the government has an interest in controlling access to information for secu- rity reasons: there is a prima facie argument for keeping some research secret from potential enemies. The ease with which research results can be transformed into weapons or a technological advantage to be used against the United States varies sharply, however. In the case of nuclear weapons, understanding the principles behind the bomb is only part of what is needed to produce a weapon. lust as important and far more difficult to obtain is access to plutonium or weapons-grade uranium and the know-how to construct the device. Cryptography lies at the opposite extreme: a cryptographer can pursue his or her research with no more than pencil and paper, or at least with computing capabilities that are widely available.~4 Research in biology lies between these two extremes. Traditionally, biology has been considered a small-scale science. Although work in genomics, proteomics, and bionanotechnology is overturning this para- digm, the research and development associated with biological weapons programs do not necessarily require large-scale investment or specialized, dedicated facilities. Creating pathogen weapons poses certain technical challenges, but the ability to produce enough material to cause morbidity, mortality, public panic, and economic costs is within the capability of many laboratories. The degree to which the three technologies are dual use also varies. The civilian uses of nuclear energy have been cordoned off from weapons developments through a large investment in security classification, inter- national diplomacy, and a discourse that insists that nuclear weapons are special.~5 Cryptography, as we have seen, has recently become a dual use technology, but its applications in the civilian world are growing rapidly in tandem with the Internet. The life sciences lie beyond cryptography in the dual use dimension; civilian uses dominate in the field, and the
INFORMATION RESTRICTION AND CONTROL REGIMES 85 military's interest in the life sciences, although not negligible, has been dwarfed by their interest in the physical sciences. This is seen most clearly, perhaps, in the dominance until fairly recently of the NIH, NSF, and USDA, rather than DOD and DOE, in federal support of research in the life sciences. The size of the field is also important when contemplating govern- ment controls. One reason the cryptography solution has worked rela- tively well may be that the number of publications is so small. The lead- ing journal, The Journal of Cryptology, publishes only about 20 papers a year, and researchers present about 125 papers annually at conferences. By contrast, the American Society for Microbiology's 11 journals publish 6,000 papers a year, and by some estimates there are between 10,000 and 20,000 journals published in the life sciences internationally.~7 Even if only a very small fraction of the research in these journals potentially arouses concern, the sheer volume of publication in the life sciences would make any effort to devise a screening mechanism for information deemed "sen- sitive" or to ensure compliance a daunting challenge. In addition, there are many more life scientists than there are nuclear physicists or cryptographers. Only a few scientists are likely to be work- ing with the list of select agents that have been the target of control so far, but many more would be included in a control regime that encompassed sensitive techniques as well as an expanded list of select agents. Further- more, unlike the nuclear physicists, the life scientists are in many widely dispersed locations. The more people and facilities subject to control, the higher the costs. Finally, there is no established culture of working with the national security community among life scientists as currently exists in the fields of nuclear physics and cryptography. As a group, biologists lack the ex- perience of either nuclear physicists or cryptographers in interacting with the security agencies of the federal government, and conversely those agencies lack close ties and working relationships with the life sciences community. The tradition of classified government research is well estab- lished in the latter two fields; the counterpart in the life sciences was the DOD program for research on biological weapons centered at Fort Detrick, MD, which ended in 1970. As noted above, however, that bioweapons program was only a small part of the government's funding of basic re- search in the life sciences and its very secrecy tended to isolate it from the larger community of life scientists. Since 1970, when President Nixon ended offensive biological weapons research, Fort Detrick has been a rela- tively open facility, housing a number of military and civilian tenants, including a large array of National Cancer Institute laboratories, as well as the U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID). The number of life scientists involved in intramural research
86 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM sponsored by the Department of the Army remains, however, relatively smaller It should be noted that other DOD agencies, such as the Defense Advanced Research Projects Agency (DARPA) and the Defense Threat Reduction Agency, have become significant sponsors of biodefense re- search, as have other federal agencies such as the Department of Home- land Security and the intelligence community. DARPA-sponsored re- search, while sometimes controversial, is unclassified. The differences among the three areas are instructive. They suggest that controls on information flows in the life sciences will face obstacles rather different from those encountered in nuclear science and cryptogra- phy. The situation would be further complicated by the expansion of cat- egories of information that the government wishes to control. SECRET AND SENSITIVE INFORMATION An excellent summary of the different types of information control regimes in the United States is published by the Association of American Universities and is reproduced in Box 3-2. 20 Secret Information The U.S. government handles issues of secrecy through a complex mix of statutes, regulations, and procedures that govern the control of classified information, public access to government information, and the
INFORMATION RESTRICTION AND CONTROL REGIMES 87
88 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM
INFORMATION RESTRICTION AND CONTROL REGIMES 89
So BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM
INFORMATION RESTRICTION AND CONTROL REGIMES 9 maintenance of government records. Only those with security clearances are given access to classified information. Having a clearance, however, is not enough to provide access to classified information. An individual must also have a "need to know" the information in question. There is a formal system for controlling access to certain areas of information on a need-to- know basis. This additional layer of categories and controls adds to the complexity of the system. With two exceptions, only one of which is relevant to the life sciences, designating information as secret requires an affirmative action by a gov- ernment official and can be applied only to information created within an agreed framework that makes classification a possibility. That is, the gov- ernment has no authority to designate information produced outside this framework as classified; in effect, the classification system applies only to work done in government laboratories or under government contract. The first exception, described above, is the Atomic Energy Act, where infor-
92 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM mation related to nuclear weapons may be "born classified" without any prior involvement of the government in its generation. The second exception, which is potentially relevant to aspects of bio- technology research, permits information received as part of the patent application process to be classified. Under the Invention Secrecy Act of 1951, the government is required to impose "secrecy orders" on certain patent applications that contain sensitive information.22 The disclosure of the invention is restricted and the grant of a patent is withheld. As sum- marized by the Project on Government Secrecy of the Federation of Ameri- can Scientists, "this requirement can be imposed even when the applica- tion is generated and entirely owned by a private individual or company. There are several types of secrecy order which range in severity from simple prohibitions on export (but allowing other disclosure for legiti- mate business purposes) to a classification requiring secure storage of the application and prohibition of all disclosure."23 In the wake of the September 11th attacks, President Bush has ex- tended classification authority to a number of agencies not previously in- volved in these matters, including the USDA, HHS, and EPA. Their new authority will be exercised under the existing classification system. Under the current system, in most agencies the task of managing po- tentially classified authority is so large that the authority to classify infor- mation has been delegated extensively. Literally thousands of government officials have classification authority. Detailed guides attempt to provide standards by which to judge whether particular information should be considered classified, but the more removed the issues are from specific details or facts, the more judgment becomes involved.24 One would ex- pect the same delegation to occur as the USDA, HHS and EPA exercise their new authority. As discussed above, the struggle to decide whether areas of scien- tific research should be restricted in the name of national security re- curred throughout the Cold War. During the early 1980s the Reagan Administration sought to restrict scientific communication in a num- ber of fields. That controversy eventually led to a presidential direc- tive in 1985, influenced in part by the Corson report.25 National Secu- rity Decision Directive 189 (NSDD-189) states that federally funded fundamental research, such as that conducted in universities and labo- ratories, should "to the maximum extent possible" be unrestricted.26 Where restriction is deemed necessary, the control mechanism is for- mal classification. "No restrictions may be placed upon the conduct or reporting of federally-funded fundamental research that has not re- ceived national security classification, except as provided in applicable U.S. statutes." This policy is still in force and was reaffirmed as re-
INFORMATION RESTRICTION AND CONTROL REGIMES 93 cently as November 2001, pending completion of an administration review of export policy controls.27 For all the serious concerns that can arise over whether information is properly classified, and how such decisions are made, debates over the classification of scientific research take place within a system of reason- ably well-specified and understood rules. For the life sciences, with the exception noted above of the potential imposition of secrecy in the patent process, the question of whether research would be carried out under the restrictions of classification and whether research results might be classi- fied would be part of the initial process of defining the terms under which the research is funded. Far more problematic is the interest in designating certain areas of research and certain types of knowledge in the life sci- ences wherever they are produced and however they are funded as "sensitive but unclassified." Sensitive Information The issue of "sensitive information" is not new. Classification is only one of the ways in which the U.S. government controls public access to informa- tion. Across the federal government there are many other categories that ap- ply narrowly or broadly to specific types of information.28 Some of the cat- egories are defined in statute, some through regulation, and some only through administrative practices. Different agencies may also assign a vari- ety of civil and even criminal penalties for violation of their restrictions.29 The most extensive restrictions are exceptions to the Freedom of Information Act (FOIA), which enable the government to deny public ac- cess to particular classes of information.30 The withheld information, con- sidered "For Official Use Only," must be tied to a particular FOIA exemp- tion, for example, to protect individual privacy or proprietary business information. Some of the categories of exemptions are sufficiently gen- eral, however, to give federal agencies considerable latitude in withhold- ing information related to internal decision making. At a time of heightened concern about the proliferation of weapons of mass destruction to states or terrorists, many kinds of information can seem potentially relevant to U.S. adversaries and hence targets for ex- panded controls. For scientists the chief concern in any government-im- posed requirement to shield "sensitive" information lies in the potential fuzziness of the category, coupled with the severity of possible penalties for failing to protect the information.3~ The most relevant categories of restricted information for research in the biological sciences are those re- lated to "sensitive but unclassified" information and to "dual use" infor- mation covered by export controls.
94 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM Defining "Sensitive" Information Sensitive but unclassified (SBU) information includes information generated within the government but may also extend to knowledge gen- erated purely in the private sector. Particularly in the wake of the Septem- ber llth attacks, the standard examples of sensitive information tend to be those that relate to the vulnerability of critical infrastructures, including facilities that are privately owned. The key nodes in an electricity grid are a frequently cited example, and information related to the design and op- eration of a nuclear power plant or transport of nuclear materials has long been protected as Unclassified Controlled Nuclear Information. In addi- tion, it is easy to imagine that information such as the location of biologi- cal research programs might be considered sensitive, if the theft of select agents is considered a threat.32 The Bioterrorism Response Act exempts information on possession of select agents from FOIA. The Bush Administration has urged federal agencies to use all ap- plicable exemptions to the Freedom of Information Act when consider- ing requests for "sensitive but unclassified information." The White House assigned the Office of Management and Budget the task of devel- oping uniform policy guidance for government agencies on defining and controlling sensitive information.33 Section 892 of the Homeland Secu- rity Act directs the President to "identify and safeguard homeland secu- rity information that is sensitive but unclassified."34 No definition of "sensitive" is provided in the statute, however, and the fact that differ- ent agencies have put forward different definitions is a further con- cern.35 A key question is whether restraints on sensitive information might be extended beyond the information held internally by federal agencies, and, if so, who would be responsible for determining what counts as "sensitive." The DOE provides an illustrative example of the difficulties associ- ated with attempts to define "sensitive" information. In the wake of the scandals over alleged Chinese spying at DOE laboratories in 1999, the Defense Authorization Act for FY2000 added a provision that imposed signficant civil penalties for disclosure of "sensitive" information even though no implementing regulations were ever produced. In lanuary 2000 the DOE general counsel took the position that, since no definition of sen- sitive information existed in the Atomic Energy Act or departmental regu- lations, legal restrictions could not be applied or enforced on DOE em- ployees or federal contractors.36 More generally, one basic DOE document defined "sensitive but un- classified information" as: Information for which disclosure, misuse, alteration, or destruction could adversely affect national security or government interests. National se-
INFORMATION RESTRICTION AND CONTROL REGIMES curity interests are those unclassified matters that relate to the national defense or foreign relations of the Federal Government. Government in- terests are those related, but not limited to, the wide range of govern- ment or government-derived economic, human, financial, industrial, agricultural, technological, and law enforcement information, as well as the privacy or confidentiality of information provided to the Federal Government by its citizens.37 95 DOE also maintains a "Sensitive Subjects List" to guide what infor- mation can be discussed with non-U.S. citizens without triggering the need for an export license (see below). One list promulgated in 1999 in- cluded a set of topics under "Chemical and Biological Weapons" de- scribed as "illustrative but not exhaustive." Information regarding these topics "may pertain to the research, design, development, testing, manu- facturing, production, or use." The proposed topics included (numbering from original): 2. Genetic research, techniques, and specialized equipment related to chemical or biological agents,for example: a) genome sequences and databases b) genetic engineering techniques 7. Defenses against, and vulnerabilities to, the use of chemical or biologi- cal agents,for example: a) vaccines, antitoxins b) equipment, including protective clothing38 This example is directly relevant only to DOE or DOE-contractor em- ployees although important work on the human genome is conducted at DOE facilities. Nonetheless, it illustrates the dilemmas scientists could face if there were a concerted government effort to promulgate and en- force such categories. Recently, however, DOE has sought to clarify its policies, in part to address concerns about whether real or anticipated restrictions were ham- pering the vitality of the national laboratories. The Department is attempt- ing to implement a policy in which "Official Use Only" information, based on the Freedom of Information Act, will be the standard for deciding whether and how to control unclassified information, gradually replacing the various other information categories that have emerged over the years.39 In addition, a department-wide memo on May 12, 2003 reaffirmed that the provisions of NSDD-189 remain the basis for DOE policy regard- ing restrictions on fundamental research.40 These DOE policies would presumably need to be reconciled with the regulations that will be re- quired to define and implement Section 892 of the Homeland Security Act, which created the new category of "sensitive homeland security in- formation."
96 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM Dual Use Information Scientists may also face restrictions on their communications with foreign colleagues under various export control restrictions on sharing information regarding dual use technology. These restrictions can apply to communication both within the United States and with scientists abroad. Limits on foreign scientists through the visa system were de- scribed in Chapter 2. As with the Technology Alert List designed to prompt scrutiny of visa applications, the export controls governed by the Export Administration Act and its implementing regulations also extend to the transfer of dual use technology. Technology is considered "specific information necessary for the 'development,' 'production,' or 'use' of a product," and providing such information to a foreign national within the United States may be considered a "deemed export" whose transfer requires an export license.4~ Technology "which arises during or as a result of fundamental research" is not subject to export restric- tions which relieves many scientists but not those engaged in propri- etary research sponsored by commercial interests at public and private universities.42 PUBLICATION OF SENSITIVE INFORMATION IN THE LIFE SCIENCES Until recently, there were very few cases of problems related to the publication of research results in the life sciences that attracted signifi- cant public attention. Some specialists in bioterrorism, however, had warned that, given continuing advances in biotechnology, open publi- cation could provide information of use to terrorists.43 The publication of the "mousepox" study, as well as other studies discussed in Chapter 1, made the issue a major concern for journal editors.44 The public per- ception of potential risks associated with publication of such informa- tion led to calls for scientific journals to refrain from publishing "dan- gerous" research or to delete some data from published research results in order to preclude others from replicating the results.45 Journals in the life sciences have responded in a number of ways to the concerns that published articles might provide useful knowledge or a road map for terrorists or rogue states. In addition to the results of fundamental research, the compilation, synthesis, and assessment of already published results in review articles may provide an understanding of a field that could guide or assist terror- ists. Even more difficult are the concerns raised by reports that result when scientists are assembled to render their judgment as experts about par- ticular problems, even when they rely completely on open sources of in-
INFORMATION RESTRICTION AND CONTROL REGIMES 97 formation.46 Against these risks, one must weigh the genuine service to the research community provided by review articles and the contribu- tions of expert panels to informed public debate and decision-making on issues where scientific knowledge and perspective play a role. The Com- mittee wanted to acknowledge these problems, which it expects will re- main and perhaps grow as a concern, but they are beyond the scope of this report. In response to the concerns about publication of research results, the American Society for Microbiology (ASM) determined that the 11 jour- nals it publishes would not restrict the information in the materials and methods section of articles. But ASM has also instituted formal proce- dures as part of the peer-review process for submitted articles so that reviewers address the potential risks of the research results to national security. At present, these policies apply primarily although not exclu- sively to research conducted on select agents.47 In 2002, of the 13,929 manuscripts submitted to ASM journals, 313 select agent manuscripts received special screening, and of these two manuscripts received addi- tional screening by the full ASM publication board. The statistics through July 2003 are 8,557 manuscripts submitted, 262 select agent manuscripts screened, and none referred to the publication board for further review.48 Other journals, such as Science, the Proceedings of the National Academy of Sciences, and Nature, have also become alert to po- tential articles that could cause concern and have moved to develop re- view procedures of their own. These new procedures have been the subject of intense discussion within the life sciences community and between life scientists and the national security community. In January 2003, for example, the National Academy of Sciences and the Center for Strategic and International Stud- ies convened a one-day workshop to review the general question of sensi- tive information and specific issues of publication. Gatherings such as this attest to the seriousness with which the scientific and national security communities regard these issues but also to the difficulty of establishing productive communication and even more of devising satisfactory, workable solutions.49 In mid-February 2003, the editors of the major journals in the life sciences, including Nature, Cell, Science, and the Proceedings of the Na- tional Academy of Sciences (PNAS), published a joint statement on "Scien- tific Publication and Security."50 The statement, which appears in Box 3-3, was the outcome of discussions begun at the January workshop. It has generated substantial comment and controversy, but is also an ex- ample of the efforts of the scientific community to respond to issues related to potential risks through the development of self-governance mechanisms.5~
98 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM
INFORMATION RESTRICTION AND CONTROL REGIMES 99 CONCLUSIONS Any argument about imposing information controls whether through formal classification or restrictions on "sensitive" information- must be made in the context of the specific institutional history and re- search culture of the life sciences research community. Like all sciences, the life sciences rely upon a culture of openness in research, where the free exchange of ideas allows researchers to build on the results of others, while simultaneously opening scientific results to critical scrutiny so that mistakes can be recognized and corrected sooner rather than later. Most
100 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM scientists would argue that the openness that characterizes much of the scientific research enterprise is the source of the extraordinary gains in scientific knowledge that have enriched us materially and intellectually. It is not that individual researchers, research groups, university ad- ministrators, or editors do not know how to keep secrets. Anyone who has spent much time in a university recognizes that there are categories of information that are not widely shared, from faculty salaries at private universities to the location of animal testing facilities. Academic journals and funding agencies keep secret the names of their reviewers. Research performed under contract to proprietary interests routinely requires a period of secrecy and prepublication review of manuscripts intended for presentation and publication in the peer-reviewed literature as a contrac- tual condition of funding. These areas of secrecy, however, are the result of widely accepted understandings and local negotiations, and the num- ber of people affected is limited to those directly concerned. As already discussed, compared with other disciplines such as phys- ics, the life sciences have relatively little experience with classified re- search. Beyond this, the life sciences cover a broad set of disciplines, from evolution and ecology to genomics and proteomics. Unlike nuclear weap- ons research, much of life sciences research is not of interest either to "rogue" offensive weapons programs or to potential terrorists. The range of scientists and institutions affected would thus be hard to enumerate, let alone monitor. The costs of complying with information controls on life sciences re- search would range from their impact on the culture of the research labo- ratories, which is generally acknowledged to be extraordinarily open, to financial costs borne by institutions in complying with government regu- lations, to the creation of obstacles to monitoring compliance with inter- national arms control measures directed at biological weapons. The re- strictions already in effect on select agents have caused some laboratories to destroy archived samples and to limit exchanges of materials between scientists. To extend government controls to the information contained in laboratory reports, conference papers, and journal articles would further constrict avenues of communication, both formal and informal, which have been an essential source of the dynamism of biological research in the modern era. Perhaps most important, major universities have proscribed classi- fied research on campus. Those who do accept classified research have usually created separate facilities where access can be limited and con- trolled.52 Secrecy would thus deprive the government of the graduate students and postdoctoral fellows who drive much of biological re- search in many cases the best minds engaged in rapidly developing fields. Even without formal classification, the specter of information con-
INFORMATION RESTRICTION AND CONTROL REGIMES 101 trots on "sensitive" information, given the current vagueness of the cat- egories and the great difficulty of being any more exact about most of the dual use research, could be a significant deterrent to scientists to under- take research in some areas, such as infectious diseases. Yet these are pre- cisely the areas where the best researchers are needed to help develop the nation's defenses against biological weapons, bioterrorism, and emerg- ing-disease threats. Thus there is a danger that the life sciences as a field of study would come to be regarded as less inviting, affecting the quality of researchers entering the field or making it more attractive to work outside the United States. Unlike the situation with nuclear weapons design/development/ production and testing, biotechnology-related research in the life sci- ences is an international activity and proliferation-relevant knowledge is widely held. Limiting the development of biotechnology in the United States would reduce our worldwide competitiveness in this rapidly changing field. We conclude that imposing mandatory information con- trols on research in the life sciences, if attempted, will be difficult and expensive with little likely gain in genuine security. The next chapter describes the system that the Committee has concluded can best meet the needs of reducing the risks of misuse of biological research while still enabling vitally needed research to meet civilian and biodefense needs to go forward. NOTES ~ The Department of Defense, for example, proposed in early 2002 that researchers be required "to obtain DoD approval to discuss or publish findings of all military- sponsored unclassified research." The draft was withdrawn in the face of consid- erable criticism from the research community. Knezo, G.~. 2003. "Sensitive But Unclassified' and Other Federal Security Controls on Scientific and Technical In- formation: History and Current Controversy." (Washington, D.C.: Congressional Research Service), April 2. A critique of the proposed regulations by Don DeYoung, executive assistant to the director of research at the U.S. Naval Research Laboratory, can be found at: www.fas.org/sgp/othergov/deyoung.html. 2 National Academy of Sciences. 1982. Scientific Communication and National Secu- rity. Washington, D.C.: National Academy Press. Available atwww. nap.edu/ books/0309033322/html/, p. 24. This is often called the "Corson report," after its chair, Dale Corson, president emeritus of Cornell University. 3 The 1925 Geneva Protocol had already banned the "use in war" of chemical and biological weapons. The 1972 Biological and Toxin Weapons Convention, which entered into force in 1975, bans the development, production, stockpiling, and transfer of biological weapons. 4 For a description of national chemical and biological weapons programs prior to 1970, see SIPRI. 1973. "The Problem of Chemical and Biological Warfare," CB
102 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM Weapons Today, Vol. II (New York: Humanities Press), Chap. 3. As noted in Chap- ter 1, the Soviet Union maintained a secret BW program into the l990s. 5 Doel, R. 2001. "Constituting the postwar earth sciences: The military's influence on the environmental sciences in America after 1945." Social Studies of Science 33:5 [Special Issue: The Earth Sciences in the Cold War, l. Cloud and l. Reppy, guest editors]. 6 Gusterson, H. 1996. Nuclear Rites: A Weapons Laboratory at the End of the Cold War (Berkeley: University of California Press), Chapter 4. 7 Hewlett, R.G. 1981. "Born classified in the AEC: A historian's view." Bulletin of the Atomic Scientist, 37, December:20-27. ~ In 1981 Congress gave the Department of Energy authority under the AEA to prevent unauthorized dissemination of information regarding "unclassified con- trolled nuclear information" (UCNI), which includes: (1) the design of production or utilization facilities; (2) security measures for such facilities or for nuclear mate- rial in such facilities or in transit; and (3) the "design, manufacture, or utilization of any atomic weapon or component if that information has previously been de- classified or removed from the restricted data category." A discussion of the evo- lution of UCNI may be found in National Research Council. 1995. A Review of the Department of Energy Classification Policy and Practice (Washington, D.C.: National Academy Press). 9 With the end of nuclear testing by the United States and the creation of the Stockpile Stewardship Program (SSP) to maintain the safety and reliability of the U.S. nuclear arsenal, knowledge from a number of other unclassified areas of sci- entific research, such as advanced computing, became essential for the large-scale simulations and other measures that were part of the SSP. For scientists in those areas, work in the national laboratories has caused significant tensions between security measures and maintaining contact with the unclassified research com- munity from which advances relevant to their work will come. These issues are discussed in Center for Strategic and International Studies. 2002. Science and Secu- rity in the 21st Century: A Report to the Secretary of Energy on the Department of En- ergy Laboratories (Washington, D.C.: The CSIS Press). in For a discussion of the barriers to nuclear weapons proliferation, see MacKenzie, D. and G. Spinardi. 1995. "Tacit knowledge, weapons design, and the uninvention of nuclear weapons." American Journal of Sociology 101 July):44-99. ii The topic is discussed briefly in National Research Council, Committee on Sci- ence and Technology for Countering Terrorism. 2002. Making the Nation Safer: The Role of Science and Technology in Countering Terrorism (Washington, D.C.: The Na- tional Academies Press), Chapter 2. It is worth noting that public discussion of these possibilities is problematic in the same way that the publication of the mousepox and polio virus research has been. i2 Dam, K., and H. Lin, eds. 1996. Cryptography's Role in Securing the Information Society [CRISIS] (Washington, D.C.: National Academy Press), especially Ch. 5. Following the September 11 attacks, the idea of requiring the "clipper chip" was briefly resurrected in Congress, but then dropped. is CRISIS, p. 417. See also Scientific Communication and National Security, Appendix E (fn. 8~.
INFORMATION RESTRICTION AND CONTROL REGIMES 103 id There is, however, a considerable distance between the mathematics of devising an encryption algorithm and constructing a secure working system; in most sys- tems there are multiple vulnerabilities outside the encryption process. For ex- ample, users may share their passwords or keep them on a note posted on their computers. i5 U.S. nuclear nonproliferation policy has tried to discourage the development of civilian nuclear power in states it considers would-be proliferators, however, in part to deny such states "cover" for their programs and in part because the techni- cal skills and knowledge obtained through working on civilian nuclear power are considered useful in a general sense for those trying to develop nuclear weapons. i6 Monatersky, R. 2002. "Publish and Perish? As the Nation Fights Terrorism, Sci- entists Weigh the Risks of Releasing Sensitive Information," The Chronicle of Higher Education, October 11. i7 "Openness in an insecure world." 2003. The Lancet Infectious Diseases 3 (Febru- ary). See also discussion in Chapter 1 of this report, p. 25. i~ The financial costs could be considerable. An estimate of the costs of the U.S. nuclear weapons program between 1940 and 1995 suggests a rough figure of 575 billion for secrecy. Representative items on the list that would apply to the control of biological select agents include costs for screening personnel; for secure filing cabinets; for guards; and for routine inventories of controlled material. Schwartz, S.I. 1995. "Four trillion dollars and counting," Bulletin of the Atomic Scientists 51 (Nov/Dec):32-52, especially p. 50-51. i9 For example, USAMRIID has only 650 employees, a third of which are Army officers. Enserink, M. 2002. "On Biowarfare's Frontline," Science 296 (5575~: 1954- 1956. For a sense of the activities supported at Fort Detrick, see Covert, N. 1993. Cutting Edge: A History of Fort Detrick, Maryland, 1943-1993, Public Affairs Office, Headquarters U.S. Army Garrison, Fort Detrick, MD. In addition to the work per- formed in defense laboratories, the Army and other services and agencies fund research on biodefense in industry and universities. 20 Association of American Universities. March 2003. Definitions and Regulations Involved in the Classified-Sensitive Information-Unclassified Debate. 2i Meridian Corporation. 1992. "Classification Policy Study," Report prepared for the U.S. Department of Energy Office of Classification, Washington, D.C.; July 4: p. 87. 22 The Invention Secrecy Act of 1951, 35 U.S.C. 181-188. Available at http:// www. fast org. / sap / othergov / invention / 35usc 1 7.html. 23 The Project on Government Secrecy of the Federation of American Scientists. Available at http: / /www.fas.org/sgp/othergov/invention. 24 See Aftergood, S. "Government Secrecy and Knowledge Production: A Survey of Some General Issues," in l. Reppy, ea., Secrecy and Knowledge Production, Peace Studies Occasional Paper # 23, Cornell University Peace Studies Program, Octo- ber 1999. 25 See footnote 2. 26 "Fundamental" research is defined as "basic and applied research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community, as distinguished from proprietary research and from industrial development, design, production and product utilization, the re-
104 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM suits of which ordinarily are restricted for proprietary or national security rea- sons." See National Security Decision Directive 189, September 21,1985. Available at http: / /www.fas.org/irp/offdocs/nsdd/nsdd-189.htm. 27 Rice, C. Assistant to the President for National Security Affairs, Letter to Dr. Harold Brown, November 1, 2001. Available at http://www.fas.org/sgp/bush/ crllO101.html. John Marburger, Director of the Office of Science and Technology Policy, Executive Office of the President, reaffirmed NSDD-189 in a speech to a workshop on "Scientific Openness and National Security" at The National Acad- emies on January 9, 2003. Available at http://www.ostp.gov/html/new.html. 28 The CSIS Commission on Science and Security in the 21St Century identified at least 20 types of information that could be considered "sensitive" within the De- partment of Energy, most without consistent, department-wide definitions or ap- plication. See Center for Strategic and International Studies, op. cit., p. 55. 29 Knezo, op. cit., p.l0. 30 U.S. Congress. 1996. The Freedom of Information Act, 5 U.S.C. § 552, as Amended by P.L. 104-231, 110 Stat.2422, October 2, which states that "Geological and geophysical information and data, including maps, concerning wells" may be withheld under FOIA. 3i See report of the Ad Hoc Faculty Committee on Access to and Disclosure of Scientific Information. 2002. In the Public Interest. Massachusetts Institute of Technology, June 12. Available at http: / /web.mit.edu/faculty/reports/ publicinterest.pdf. See also Statement on "Science and Security in an Age of Terrorism" by the presidents of The National Academies regarding "sensitive but unclassified" information, October 18, 2002. Excerpt cited in Chapter 4. Available at http: / /www4. nationalacademies.org/news.nsf/isbnslO182002b?0pen Document. 32 The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 calls for a national registry of facilities holding select agents, and requires that information about the sites be kept secret. Ronald M. Atlas, immediate past president of the American Society for Microbiology, points out that this runs counter to the requirement that Institutional Biosafety Committees operate with community participation and maximum transparency. Atlas, R.M. "Applicability of the National Institutes of Health Recombinant DNA Advisory Committee para- digm for reducing the threat of bioterrorism," Draft paper prepared for the Con- trolling Dangerous Pathogens Project, CISSM, School of Public Affairs, University of Maryland, p. 26. 33 Card, A.H. Jr. 2002. "Action to safeguard information regarding weapons of mass destruction and other sensitive documents related to Homeland Security," March 19. Memorandum for the heads of executive departments and agencies. Available at http://www.fas.org/sgp/bush/whO31902.html. See also Matthews, W. 2002."0MB weighs info classification," Federal Computer Week September 16. Guidance accompanying the memo states that: "The need to protect such sensi- tive information from inappropriate disclosure should be carefully considered on a case-by-case basis, together with the benefits that result from the open and effi- cient exchange of scientific, technical, and like information." 34 U.S. Congress. Homeland Security Act of 2002. P.L. 107-296 (November 25~. Available at http: / /www.cio.gov/documents/pl_107_296_nov_25_2002.pdf.
INFORMATION RESTRICTION AND CONTROL REGIMES 105 35 An excellent review of the legislation, policies, and issues surrounding sensitive information may be found in the Congressional Research Service study by G. Knezo, op. cit. 36 Washington Post. February 13, 2000.The potential penalties included civil fines of up to 5100,000. "Sloppy Secrecy,"p. B6. 37 U.S. Department of Energy, Office of Security Affairs. 1995. "Safeguards and Security Glossary of Terms," December 18 (cited in CSIS, op. cit., p. 56~. Available at http: / /www.directives.doe.gov/pdfs/nnglossary/termss_z.pdf. 38 Department of Energy. 1999. "Sensitive Countries and Sensitive Subjects List," Memorandum for heads of departmental elements and contractor organizations, July 27, p. 7-9. 39Laplante, P.R. 2003. The DOE OUO Program, Briefing to the Roundtable on Sci- entific Communication and National Security, The National Academies and the Center for Strategic and International Studies. Washington, D.C., June 19. 40 Abraham, S. 2003. "Memorandum for heads of all departmental elements," May 12. Available at http://www.fas.org/sgp/othergov/doe/secO51203.pdf. In his memo Secretary Abraham cited the recommendations of the CSIS commission cited in footnote 9. 4i "Generally, technologies subject to the Export Administration Regulations (EAR) are those which are in the United States or of U.S. origin, in whole or in part. Most are proprietary. Technologies which tend to require licensing for trans- fer to foreign nationals are also dual use (i.e., have both civil and military applica- tions) and are subject to one or more control regimes, such as national security, nuclear proliferation, missile technology, or chemical and biological warfare. See "Deemed Exports Questions and Answers," Bureau of Industry and Security, De- partment of Commerce. Available at http://www.bxa.doc.gov/DeemedExports/ DeemedExportsFAQs.html#TopofPage. The International Traffic in Arms Regulations (ITAR), administered by the Department of State, controls the export of technology, including technical infor- mation, related to items on the U.S. Munitions List. Unlike the EAR, however, "publicly available scientific and technical information and academic exchanges and information presented at scientific meetings are not treated as controlled tech- nical data." See Knezo, op. cit., p. 4. 42 Ibid. 43 Zilinskas, R. and l.B. Tucker. 2002. "Limiting the contribution of the open scien- tific literature to the biological weapons threat." Online journal of Homeland Secu- rity, December. Available at http://www.homelandsecurity.org/journal/Ar- ticles/tucker.html. 44 Jackson, R.~ ., Ad . Ramsay, C .D. Christensen, S. Beaton, D. F. Hall, and I.A. Ramshaw. 2001. "Expression of Mouse Interleukin-4 by a recombinant Ectromelia virus suppresses cytolytic lymphocyte responses and overcomes genetic resistance to Mousepox." journal of Virology 75:1205-1210. 45 Schemo, D.S. 2002. "Sept. 11 Strikes at Labs' Door," New York Times, August 13, p. F1, 2. See also Shea, D.A. 2003. "Balancing Scientific Publication and National Security Concerns: Issues for Congress." Congressional Research Service, Report RL31695, January 10. In a hearing before the House Committee on Science on October 10, 2002, the President's Science Adviser, Dr. John Marburger, stated: "I'm
106 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM aware that there is an impression that the administration is considering a policy of pre-publication review of sensitive federally funded research. This is incorrect- this is not the thrust of the considerations, and it's important to note that this process is in the formative stage." See "President's science advisor clarifies plan for sensitive research." Available at http://www.house.gov/science/press/107/ 107-299.htm. 46 An example of this dilemma is illustrated by the controversy over a report on the risks of agricultural bioterrorism completed by the National Academies in late 2002. The report is National Research Council. 2002. Countering Agricultural Bioterrorism. (Washington, D.C.: The National Academies Press). For an account of the controversy, see Monastersky article cited in footnote 16. 47 The ASM policy is not restricted to select agents exclusively. At the present time, all manuscripts addressing research conducted on select agents are flagged but others may be as well. At the NAS-CSIS international workshop on "Scientific Openness and National Security" January 9, 2003 in Washington, D.C.), Donald Kennedy, editor of Science, indicated that his journal had a system of review that used outside consultants. 48 Atlas, R.M. Email communication. August 15, 2003. 49 The National Academies and Center for Strategic and International Studies. 2003. "Scientific Openness and National Security," January 9. Further information about the workshop, including transcripts of presentations, is available at http:// www7.nationalacademies.org/pga/Scientific_Openness_Homepage.html. 50 Journal Editors and Authors Group. 2003. "Statement on Scientific Publica- tion and Security," Science Online 299 (5610~:1149. Available at http://www. sciencemag.org/cgi/reprint/299/5610/1149.pdf. This statement also appeared in the February 18, 2003 issue of the Proceedings of the National Academy of Sciences and the February 20, 2003 issue of Nature. 5i See, for example, Hesman, T. 2003. "Critics question journals' bow to security," St. Louis Post-Dispatch, February 23; Kennedy, D.2003. "To Publish or Perish?" The Times Higher Education Supplement, February 21. 52 Ad Hoc Faculty Committee on Access to and Disclosure of Scientific Informa- tion. 2002. In the Public Interest. Massachusetts Institute of Technology, June 12. Report is available at http://web.mit.edu/faculty/reports/publicinterest.pdf.