Balancing Scientific Publication and National Security Concerns: Issues for Congress

Congressional research reportNov 13, 2006

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Prepared for Members and Committees of Congress

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The federal government has historically supported the open publication of federally funded

research results. In cases where such results presented a challenge to national security concerns,

several mechanisms have been employed. For fundamental research results, the federal policy has

been to use classification to limit dissemination. For advanced technology and technological

information, a combination of classification and export and arms trafficking regulation has been

used to inhibit its spread. The terrorist attacks of 2001 increased scrutiny of nonconventional

weapons, including weapons of mass destruction, and publication of some research results have

increased concerns over whether publication of federally funded extramural research results could

threaten national security.

The current federal policy, as described in National Security Decision Directive 189, is that

fundamental research should remain unrestricted and that in the rare case where it is necessary to

restrict such information, classification is the appropriate mechanism. Other mechanisms restrict

international information flow, such as Export Administration Regulations (EAR) and

International Traffic in Arms Regulations (ITAR) that control export of items and technical

information on specific lists. Both EAR and ITAR do not apply to sharing fundamental research

results, so long as they are not subject to any governmental prepublication review.

Historically, the areas where export regulation and classification have predominantly occurred

have been in mathematical, engineering, and physical sciences. Other contentious research areas,

such as genetic engineering and manipulation, have been overseen through scientists’ selfregulation and monitoring. The 1975 Asilomar conference produced a consensus statement on

recombinant DNA research that formed the basis for the National Institutes of Health

Recombinant DNA Advisory Committee. Recent research publications that have raised national

security concerns have fallen outside of the areas traditionally regulated through classification

and export control, and it is unclear how effective these mechanisms will be. The National

Science Advisory Board for Biosecurity was established to aid in determining whether proposed

federally funded research presents a biosecurity threat.

Stakeholders do not agree on the best method of balancing scientific publishing and national

security. Some believe that the current method of selective classification of research results is the

most appropriate. They assert that imposing new restrictions will only hurt scientific progress,

and that the usefulness of research results to terrorist groups is limited. Others believe that selfregulation by scientists, using an “Asilomar-like” process to develop a consensus statement, is a

better approach. They believe that, through inclusion of scientists, policymakers, and security

personnel in the development phase, a process acceptable to all will be found. Relying on

publishers to scrutinize articles for information which might potentially have security

ramifications is third option. Finally, mandatory review by federal funding agencies, either before

funding or publication, is seen as a potential federally based alternative. This report will not be

updated.

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Introduction ..................................................................................................................................... 1

Historical Overview and Context .................................................................................................... 1

Examples of Research Results of Concern...................................................................................... 3

Past and Current Controls on Information....................................................................................... 5

Current Federal Policy on Scientific Publication ............................................................................ 6

Mechanisms of Governmental Control ........................................................................................... 8

Classification............................................................................................................................. 8

Export Controls ......................................................................................................................... 9

Export of Technologies ....................................................................................................... 9

Export of Information ....................................................................................................... 10

Prepublication Review .............................................................................................................11

Policy Actions................................................................................................................................ 12

The Card Memorandum .......................................................................................................... 12

Response of Scientific Community......................................................................................... 13

Professional Societies ....................................................................................................... 14

The National Academies ................................................................................................... 14

Department of Homeland Security.......................................................................................... 17

Department of Health and Human Services ............................................................................ 18

Policy Options ............................................................................................................................... 19

Using Classification ................................................................................................................ 19

Self-Regulation by Scientists .................................................................................................. 21

Regulation by Publishers......................................................................................................... 23

Federal Regulation .................................................................................................................. 24

Prepublication Review of Sensitive, But Unclassified Results......................................... 24

Security Review at the Funding Stage .............................................................................. 25

Federal Licensing of Research.......................................................................................... 26

Oversight of Homeland Security-Related Research................................................................ 26

Concluding Observations .............................................................................................................. 27

Author Contact Information .......................................................................................................... 27

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Publication of scientific research results that might be used by terrorist groups has led some

policymakers to question whether the method used to control scientific research results, namely

classification, should be revisited. The Administration, legislators, and scientific professional

societies are reexamining policies relating to scientific information that might threaten national1

or homeland2 security. Policymakers may wish to determine what changes, if any, should be made

to current government policy regarding publication of federally funded research results, and

whether the options currently under consideration adequately balance the concerns and needs of

the security and scientific communities.

This report presents examples of scientific research results whose publication raised concern

regarding the threat they potentially pose to national security. Past and current information control

mechanisms are discussed, along with current federal policy concerning dissemination of

fundamental research results through the open literature. Recent policy actions regarding

dissemination of federal information and federally funded research results are outlined, along

with the responses these actions have evoked from various professional societies and publishers.

The advantages and disadvantages to potential policy actions addressing classification and other

controls over open publication of federally funded research results are also described.

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Since the 1950s, the United States has developed an established policy of identifying, prior to

publication, areas of basic and applied research where information controls may be required. This

research, typically related to weapon systems or nuclear technologies, may be designated

classified and have strict information controls placed upon it. When fundamental research is not

classified, the government generally did not place other information controls on it.

This policy remained essentially unchanged until the 1970s, when controls were developed on the

export of domestically developed, advanced, dual-use technologies and technological

information.3 Under export control regulations, even if a technology is barred from export, the

fundamental, basic science underlying the technology is generally exempt from controls and can

be published in the open literature.

In the early 1980s, foreign student and scientist access to technological information that might

fall under export control regulations became the focus of a Department of Defense effort to

restrict such information presented in classrooms and conferences. In 1985, following a report

from the National Academy of Sciences asserting that openness in science leads to stronger long-

National security is defined in Executive Order 12356 as “the national defense or foreign relations of the United

States.” Both broader and narrower definitions of national security have been suggested as well. For a discussion on

this topic, see Arvin S. Quist, Security Classification of Information. Volume 2. Principles for Classification of

Information (K/CG-1077/V2), (Oak Ridge, TN: Oak Ridge National Laboratory), September 1989, Chapter 5.

Homeland security is a concerted national effort to prevent terrorist attacks within the United States, reduce

America’s vulnerability to terrorism, and minimize the damage and recover from attacks that do occur. Office of

Homeland Security, National Strategy for Homeland Security, The White House, July 2002.

Dual-use technologies are those technologies that have both a legitimate civilian and military use.

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term security,4 President Reagan issued National Security Decision Directive 189 (NSDD-189),

reiterating that fundamental research results were to be controlled only through classification.

NSDD-189 continues to define federal policy on restricting the dissemination of fundamental

research results.5

Since then, the conduct of science and the composition of the scientific community have become

increasingly international, and concerns about the effectiveness of export control regulations have

grown. The international spread and independent development of dual-use technologies has made

the United States the sole technology source less often. Concern that export control regulation is

negatively impacting domestic business prosperity has led to attempts to lower the trade barriers

erected by export control. Additionally, the presence of foreign students and scientists in the

United States has increased the availability of education and training in basic skills that may be

transferred to other countries upon the return of those individuals to their home countries.

Since the terrorist events of 2001, concern that open publication of scientific and technological

results may provide unwitting assistance to other nations or terrorist groups in developing

weapons of mass destruction has resurged. Scientific research is conducted in many disparate

areas. Historically, the areas where the balance between scientific openness and national security

required consideration have been centered in the mathematical and physical sciences and their

applications, such as aerospace engineering, advanced computer technology, and cryptography.

Research in biology – such as the origins of virulence, development of vaccines, and the genetic

manipulation of biological agents – has emerged as an area of concern because of its potential

relevance to biological weapons of mass destruction. Whether the current method of using

classification to limit the dissemination of fundamental research results is the best or most

effective method of maintaining national security is an open question. It is unclear whether

classification will be effective when applied to research areas that have not historically been

classified, and whether a system of classified research will be embraced by scientists working in

these areas.

In March 2002, executive branch agencies were instructed by then-Assistant to the President and

Chief of Staff Andrew Card to determine if government-owned information, especially that

regarding weapons of mass destruction, was being inappropriately disclosed. Also in March 2002,

the Department of Defense (DOD) promulgated a draft regulation expanding information controls

to basic and applied science research and development.6 Scientific professional societies are

engaged in developing self-regulatory mechanisms to address the concerns of the national

security community. In 2003, at the annual meeting of the American Association for the

Advancement of Science, 32 editors of leading scientific journals issued a policy statement

regarding publication of research results that could be misused. Additionally that year, the

National Academy of Sciences held a meeting discussing whether current publication policies and

practices in the life sciences could lead to the inadvertent disclosure of “sensitive” information to

National Academy of Sciences, Scientific Communication and National Security, (Washington DC: National

Academy Press), 1982.

Assistant to the President for National Security Affairs Condoleezza Rice, Letter to Dr. Harold Brown, co-Chairman,

Center for Strategic and International Studies, November 1, 2001.

Basic research is experimental or theoretical work undertaken primarily to acquire new knowledge of the underlying

foundation of phenomena and observable facts, without any particular application or use in view. Applied research is

also original investigation undertaken in order to acquire new knowledge. It is, however, directed primarily towards a

specific practical aim or objective. Organisation for Economic Co-operation and Development, Frascati Manual,

(OECD), 2002, p. 30.

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those who might misuse it. In 2004, the National Research Council issued a report, Biotechnology

Research in an Age of Terrorism, which recommended an oversight structure, based on

institutional biosafety committees, for research in select areas of concern. Following some of the

recommendations presented in this report, the Department of Health and Human Services

established the National Science Advisory Board for Biosecurity to, among other duties, provide

advice, guidance, and leadership regarding biosecurity oversight of dual-use research.

Competing proposals regarding how to control federally funded research results have been

proposed, ranging from strict information control on all federally funded research to maintaining

the status quo. Some scientific professional societies have suggested that self-regulation, either by

scientists themselves or through the editors of scientific journals, would be an appropriate

mechanism for limiting the publication of research results that might aid terrorist groups. Others

have advocated more formal government oversight of potentially contentious research. The

development of a new category of “sensitive, but unclassified” information to protect information

which does not require classification, but may still have the potential to damage national security,

might encompass such research results.7 The potential impact of these options raises much

concern and debate.

A fundamental trade-off between scientific progress and security concerns is the crux of the

policy debate. The scientific enterprise is based upon open and full exchange of information and

thrives on the ability of scientists to collaborate and communicate their results. On the other hand,

this very openness provides potential enemies with information that may allow them to harm U.S.

interests. The technological advances arising from scientific breakthroughs contribute to

economic prosperity, but the openness required to continue this process creates risks, which may

be perceived as more acute since September 11, 2001. What level of risk caused via publication

of scientific advances is acceptable in the eyes of policymakers and the public? How will

controlling the publication of federally funded research results increase safety? If policymakers

determine that more control of these sorts of research results is warranted, what possible

mechanisms could be used to oversee these results?

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The publication of several scientific articles reignited concerns that information published in the

open literature may aid terrorist groups in developing weapons of mass destruction. Presented

below is a selection of some of the more highly publicized examples.

In 2000, researchers at the Co-operative Research Centre for the Biological Control of Pest

Animals (CRC) in Australia genetically modified mousepox virus while conducting rodent

fertility research. This modification unintentionally enabled the virus to infect mice that had been

previously vaccinated against mousepox.8 The publication of this result was greeted with

This report does not address the development of federal standards of usage for the term “sensitive, but unclassified”

material. For more information on federal government use of the term “sensitive, but unclassified” and efforts

regarding its standardization, see CRS Report RL33303, “Sensitive But Unclassified” Information and Other Controls:

Policy and Options for Scientific and Technical Information, by (name redacted).

R.J. Jackson, A.J. Ramsay, C.D. Christensen, et al., “Expression of Mouse Interleukin-4 by a Recombinant

Ectromelia Virus Suppresses Cytolytic Lymphocyte Responses and Overcomes Genetic Resistance to Mousepox,”

Journal of Virology, Vol. 75 (2001), pp. 1205-1210.

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criticism due to its weapons potential.9 This experiment was repeated in 2003 by Dr. Mark Buller

at the University of St. Louis using funding supplied by the National Institute of Allergy and

Infectious Diseases.10

Another article widely viewed as having bioweapon potential was published in July 2002.

Researchers at the State University of New York at Stony Brook assembled functional poliovirus

from chemical sequences ordered from a scientific mail-order firm.11 Dr. Eckard Wimmer, the

lead scientist, described the experiment as graphic proof that bioterror agents can be made

without a terrorist ever having access to dangerous microbes.12

Other scientific publications have been viewed as potentially aiding development of biological

weapons by terrorist groups or countries. Publication of successes in “reverse genetics” has led

some to believe that other viruses could be constructed in the laboratory without having access to

actual virus ahead of time.13 In October 2001, the full genome of Yersinia pestis, the bacteria

which causes bubonic and pneumonic plague, was published in the journal Nature.14

Simultaneous with the release of this article was the publication of an accompanying news article

in Nature Science Update that highlighted the existence of “a debate about whether releasing

genomic information for virulent diseases, such as plague or smallpox, might aid malicious

science.”15 The full genome sequence of Coxiella burnetii, the causative agent of Q fever, was

published in Proceedings of the National Academies of Science of the United States of America

(PNAS) in April 2003,16 and the annotated genome of Bacillus anthracis, the causative agent of

anthrax, was published in Nature.17

Researchers at the University of Pittsburgh identified key proteins which provide Variola major,

the causative virus of smallpox, with high virulence.18 Accompanying this article was a

commentary explaining how “the work is far more likely to stimulate advances in vaccinology or

viral therapy than it is to become a threat to biosecurity.”19 Researchers published in the Journal

of Clinical Microbiology a potential cause of enhanced virulence for some strains of Bacillus

J. Stephenson, “Biowarfare Warning,” Journal of the American Medical Association, Vol. 285, No. 6 (2001), p. 725.

Robert Roos, “Scientists Research Antidotes to Super Mousepox Virus,” CIDRAP News, November 6, 2003.

J. Cello, A.V. Paul, and E. Wimmer, “Chemical Synthesis of Poliovirus cDNA: Generation of Infectious Virus in the

Absence of Natural Template,” Science, Vol. 297 (August 9, 2002) pp. 1016-1018.

Rick Weiss, “Polio-Causing Virus Created in N.Y. Lab: Made-From-Scratch Pathogen Prompts Concerns About

Bioethics, Terrorism,” The Washington Post, July 12, 2002.

Sylvia Pagan Westphal, “Ebola Virus Could Be Synthesised,” New Scientist, July 17, 2002.

J. Parkhill, B.W. Wren, N.R. Thomson, et al., “Genome Sequence of Yersinia pestis, The Causative Agent of

Plague,” Nature, Vol. 413 (October 4, 2001) pp. 523-527.

J. Whitfield, “Black Death’s DNA,” Nature Science Update, October 4, 2001.

R. Seshadri, I.T. Paulsen, J.A. Eisen, et al., “Complete Genome Sequence of the Q-fever Pathogen Coxiella

burnetii,” Proc. Natl. Acad. Sci. USA, Vol. 100 (April 9, 2003) pp. 5455-5460.

T.D. Read, S.N. Peterson, N. Tourasse, et al., “The Genome Sequence of Bacillus anthracis Ames and Comparison

to Closely Related Bacteria,” Nature, Vol. 423, 2003, pp. 81-86.

A.M. Rosengard, Y. Liu, Z. Nie, and R. Jimenez, “Variola Virus Immune Evasion Design: Expression of a Highly

Efficient Inhibitor of Human Complement,” Proceedings of the National Academy of Sciences of the United States of

America, Vol. 99 (June 25, 2002) pp. 8808-8813.

P.J. Lachmann, “Microbial Subversion of the Immune Response,” Proceedings of the National Academy of Sciences

of the United States of America, Vol. 99 (2002) pp. 8461-8462.

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anthracis.20 The assessment of antibiotic resistance in select Bacillus anthracis isolates was also

identified as an article of potential concern.21

Articles such as these have led some to question the wisdom of openly publishing information

that could be used to threaten national security. An editorial in New Scientist stated:

That this mind-boggling quantity of information is going to transform medicine and biology

is beyond doubt. But could some of it, in the wrong hands, be a recipe for terror and

mayhem?22

Bioethicist Arthur Caplan from the University of Pennsylvania was reported as saying:

We have to get away from the ethos that knowledge is good, knowledge should be publicly

available, that information will liberate us. ... Information will kill us in the techno-terrorist

age, and I think it’s nuts to put that stuff on Web sites.23

Stewart Simonson, then-Assistant Secretary for Public Health Emergency Preparedness for the

Department of Health and Human Services (HHS), when discussing the decision of the

Proceedings of the National Academy of Sciences of the United States of America to publish an

article on vulnerabilities of the milk supply chain, reportedly stated through a spokesman that he

regretted the journal’s decision to publish the paper:

We recognize, of course, that this is an issue about which good and reasonable people

disagree. But I must say that if the Academy is wrong, the consequences could be dire and it

will be HHS–not the Academy–which will have to deal with it.24

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Past examples of research excluded from publication in the open literature have focused on

military applications such as cryptography and nuclear weapons. Prior to U.S. entry into World

War II, physicists in the private sector researching nuclear fission voluntarily stopped publishing

results in scientific journals, fearing that they would provide crucial information to Germany’s

nuclear bomb project.25 A joint National Academy of Sciences–National Research Council

Advisory Committee on Scientific Publications was established to restrict publication on nuclear

fission. While the United States was involved in World War II, this committee secured the

P.R. Coker, K.L. Smith, P.F. Fellows, et al., “Bacillus anthracis Virulence in Guinea Pigs Vaccinated with Anthrax

Vaccine Adsorbed Is Linked to Plasmid Quantities and Clonality,” Journal of Clinical Microbiology, Vol. 41 (March

2003) pp. 1212-1218.

A. Athamna, M. Athamna, N. Abu-Rashed, et al., “Selection of Bacillus anthracis Isolates Resistant to Antibiotics,”

J. Antimicrob. Chemother., Vol. 54 (2004) pp. 424-428.

“Surfing for a Satan Bug. Why Are We Making Life So Easy for Would-be Terrorists?” New Scientist, July 20, 2002,

p. 5.

Eric Lichtblau, “Response to Terror; Rising Fears That What We Do Know Can Hurt Us,” Los Angeles Times,

November 18, 2001, p. A1.

Alison McCook, “PNAS Publishes Bioterror Paper, After All,” The Scientist, 6(1), June 29, 2005.

Peter J. Westwick, “In the Beginning: The Origin of Nuclear Secrecy,” Bulletin of the Atomic Scientists, Vol. 56,

(November/December 2000), pp. 43-49.

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cooperation of scientific journals in restricting the transfer of select scientific information within

the United States.26

Nuclear power is another area where information controls have been instituted. Private industry

was permitted to explore applications of nuclear power under the Atomic Energy Act of 1954.

Prior to this act, nuclear energy activities were protected by the federal government with security

and secrecy programs. The federal government retains authority over results which relate to

atomic weapons, production of special nuclear material, and use of special nuclear material in the

production of energy.27 Information developed in those areas, even if developed privately without

federal government aid, is regarded as “born classified.”

Genetic engineering and recombinant species were an area of great contention in the 1970s, and

there were calls for regulation of the methods for manipulating DNA and of experiments

containing genetically engineered species. In response to criticism and public pressure, a

voluntary moratorium on such research was set. In 1975, at the Asilomar conference center in

Pacific Grove, California, discussion on how scientists could self-regulate such research was

held. A consensus statement regarding a voluntary moratorium on some types of recombinant

research and an increase in security and containment requirements for other research areas

successfully allayed many public concerns, and provided a uniform framework to address such

issues. This consensus statement formed the starting point for research rules developed by the

National Institutes of Health Recombinant DNA Advisory Committee, which was formed to

oversee such research.28

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In the United States, there has long been support for a policy of not restricting publication of

federally supported extramural and intramural research results, except where classified for

national security reasons. This position was restated in 1985 by President Ronald Reagan in

National Security Decision Directive 189, which said:

It is the policy of this Administration that, to the maximum extent possible, the products of

fundamental research remain unrestricted. It is also the policy of this Administration that,

where the national security requires control, the mechanism for control of information

generated during federally-funded fundamental research in science, technology and

engineering at colleges, universities and laboratories is classification. Each federal

government agency is responsible for: a) determining whether classification is appropriate

prior to the award of a research grant, contract, or cooperative agreement and, if so,

controlling the research results through standard classification procedures; b) periodically

reviewing all research grants, contracts, or cooperative agreements for potential

classification. No restrictions may be placed upon the conduct or reporting of federally-

Rexmond C. Cochrane, The National Academy of Sciences: The First Hundred Years, 1863-1963, (Washington, DC:

National Academy of Sciences), 1978, pp. 385-387.

Harold Relyea, Silencing Science: National Security Controls and Scientific Communication, (Norwood, New Jersey:

Ablex Publishing Corporation), 1994, pp. 94-96.

An overview of the Asilomar conference can be read in Donald S. Fredrickson’s “Asilomar and Recombinant DNA:

The End of the Beginning,” found in Biomedical Politics, (Washington, DC: National Academy Press), 1991, pp. 258298.

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funded fundamental research that has not received national security classification, except as

provided in applicable U.S. Statutes.29

Fundamental research is also defined within NSDD-189:

‘Fundamental research’ means 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 results of which ordinarily are restricted for

proprietary or national security reasons.30

NSDD-189 has not been superceded and continues to be the government policy regarding

controls on federally funded research results. In the wake of the terrorist attacks of September

2001, then-Assistant to the President for National Security Affairs Condoleezza Rice reaffirmed

this position in a letter to the Center for Strategic and International Studies, by stating,

...this Administration will review and update as appropriate the export control policies that

affect basic research in the United States. In the interim, the policy on the transfer of

scientific, technical, and engineering information set forth in NSDD-189 shall remain in

effect...31

Executive branch agencies have followed this general policy by requiring that the results of

agency-funded extramural research be published promptly and with wide dissemination. For

example, the National Science Foundation research policy states:

NSF expects significant findings from research and education activities it supports to be

promptly submitted for publication, with authorship that accurately reflects the contributions

of those involved. It expects investigators to share with other researchers, at no more than

incremental cost and within a reasonable time, the data, samples, physical collections and

other supporting materials created or gathered in the course of the work.32

Research performed with National Institutes of Health funding is also to be disseminated to the

public:

It is NIH policy to make available to the public the results and accomplishments of the

activities that it funds. Therefore, PIs [principal investigators] and grantee organizations are

expected to make the results and accomplishments of their activities available to the research

community and to the public at large, and to effect their timely transfer to industry for

commercialization.33

The Department of Defense also encourages the publication of research it funds. For example,

Office of Naval Research policy states:

White House, Office of the President, National Security Decision Directive-189, 1985.

Ibid.

Assistant to the President for National Security Affairs Condoleezza Rice, Letter to Dr. Harold Brown, co-Chairman,

Center for Strategic and International Studies, November 1, 2001.

The National Science Foundation, National Science Foundation (NSF) Grant General Conditions (GC-1), March 15,

2006, p. 27.

National Institutes of Health, NIH Grants Policy Statement (Rev. 03/01), U.S. Department of Health and Human

Services, March, 2001, p. 122.

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Publication of results of the research project in appropriate professional journals is

encouraged as an important method of recording and reporting scientific information.34

In general, federal agencies appear to agree that there should be open publication of research

results when the research has been funded by taxpayer dollars. The exception is when research is

classified. Classified research projects, even those performed by scientists outside of government

laboratories, are not published in the open literature, with information being transferred only

between those who possess requisite clearance.35 Some classified research areas are later

declassified, and the advances developed in these programs used more generally.36

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Current mechanisms for federal agencies to control the publication of federally funded extramural

research results include classification, export and arms trafficking regulations, and specifications

in federal contracts, such as prepublication review.

Generally, classification is to be used when it is necessary to control scientific information.37 The

advent of classified extramural research led most universities to clarify their positions on

acceptance of funding for classified research. Significant debate exists over the propriety of

conducting classified research in an academic setting.38 Some universities elect not to perform

classified research on campus, espousing that this is contrary to the founding beliefs of the

university or their university charters. For example, Duke University maintains:

No research can be undertaken at the University that involves information, research, or

results of research that are, or would be, classified by the sponsor or any third party. For

example, research for the federal government under a subcontract which is classified as

secret is not permitted.39

Universities that perform classified research typically establish research facilities specifically to

handle classified materials and research. These research facilities are often located off-campus.

Examples of such universities include the Massachusetts Institute of Technology and the Johns

Office of Naval Research, Educational Institutions, Nonprofit Institutions, and For-profit Organizations: Research

Grant Terms and Conditions, U.S. Department of Defense, December, 2005, p. 6.

Some classified research is contracted to private industry or academic groups.

An example would be adaptive optics technology, which was declassified in 1991 and now is used in astronomical

telescopes.

In addition to NSDD-189, Executive Order 12958, which was issued on April 17, 1995, describes the general

classification policy of the federal government. This Order was amended on March 25, 2003 via Executive Order

13292. Section 1.4e states that scientific, technological, or economic matters relating to the national security, which

includes defense against transnational terrorism, may be classified, and, in section 1.7b, reiterates that basic scientific

research information not clearly related to the national security may not be classified.

See, for example, Steven Aftergood, “Classified Research on Campus,” Secrecy News, September 26, 2003, for a

discussion of one debate regarding classified research performed at an academic institution.

Faculty Handbook, Duke University, September, 2004, Chapter 5, Section 5.2.7.

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Hopkins University.40 Some universities have developed mechanisms by which classified

research may be approved on a case-by-case basis.41

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Another federal control mechanism for private research results occurs through export control and

arms trafficking regulations. The Department of Commerce implements Export Administration

Regulations (EAR), which bar the export of items, technology, and technological information

found on the Commerce Control List without appropriate export license.42 The Department of

State implements the International Traffic in Arms Regulations (ITAR), which regulate the export

of items, technology, and technological information maintained on the Munitions Control List.43

Export control laws primarily constrain the flow of technology and technical information from

the United States to other nations. The EAR covers the transfer of dual-use commercial goods,

while ITAR is focused on armaments and military technologies. These regulations exist to

prohibit the proliferation of certain specific technologies for either national security or trade

reasons.

Because of the technological breadth of EAR and ITAR, private researchers, using private funds,

sometimes perform research in areas that fall within these regulations. For example, research

relating to aerospace technology or cryptography could fall under export regulation. Universities

performing basic research are sometimes uncertain whether the research being performed at the

institution falls under EAR or ITAR restrictions.

Both EAR and ITAR possess exemptions for “fundamental research.” Fundamental research is

defined under ITAR as:

... basic and applied research in science and engineering where the resulting information is

ordinarily published and shared broadly within the scientific community, as distinguished

from research the results of which are restricted for proprietary reasons or specific U.S.

Government access and dissemination controls. University research will not be considered

fundamental research if:

(i) The University or its researchers accept other restrictions on publication of scientific and

technical information resulting from the project or activity, or

D. Malakoff, “Universities Review Policies for Onsite Classified Research,” Science, Vol. 295 (February 22, 2002)

pp. 1438-1439.

For example, University of North Carolina at Chapel Hill, University of Colorado, University of Virginia, and

University of Michigan have each established mechanisms for faculty members who wish to engage in classified

research to apply to for permission from the university administration on a case-by-case basis.

The Commerce Control List for Export Administration Regulation can be found online at

http://www.access.gpo.gov/bis/index.html.

The Munitions Control List for the International Traffic in Arms Regulations can be found online at

http://www.access.gpo.gov/nara/cfr/waisidx_01/22cfr121_01.html.

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(ii) The research is funded by the U.S. Government and specific access and dissemination

controls protecting information resulting from the research are applicable.44

Universities generally rely on the fundamental research exclusion to exempt the research

performed there from export control. If the university research is not exempt through the

fundamental research exclusion, export licensing must be obtained and information controls with

respect to foreigners performed. Failure to obtain such a license can result in prosecution and

large fines.

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A further complication to export regulation is the concept of a “deemed export.” A deemed export

is transfer of information, not physical items, to a foreign national from select countries without

first obtaining an export license for that technology. This provision has been especially troubling

for universities, as foreign students and researchers who attend graduate-level classes may be

exposed to information relating to technology which falls under export controls.

There have been cases where export control of information and scientific research have

coincided. In the 1980s, research papers were removed by the Department of Defense from a

scientific convention because foreign nationals ineligible for export licenses would be attending,

and other conventions were held in private session, to avoid violation of the deemed export aspect

of these regulations.45 Some universities have reported problems in collaborations with foreign

researchers, and cited, as an example, difficulty in transferring some technologies developed by

foreign graduate students to industry.46

The Export Administration Act of 1979 (P.L. 96-72) has not been reauthorized. As a consequence,

President George W. Bush invoked the International Economic Emergency Powers Act (P.L. 95223) to maintain export administration regulation. While the International Economic Emergency

Powers Act continues export administration regulation, the penalties for violating this act and the

enforcement authority granted under this act are less than those under the Export Administration

Act of 1979.47

The USA PATRIOT Act (P.L. 107-56) created another mechanism to block certain foreign

nationals from obtaining specific information. Access to or information about biological and toxin

agents on the “select agent” list48 is barred to individuals, including students, originating from

countries which support terrorism. Under the USA PATRIOT Act, universities are charged with

improving security and access controls to select agents, and the Public Health Security and

The definition given here is from 22 CFR 120.11. It varies slightly from the definition given in NSDD-189 and from

the definition given in 15 CFR 734.8.

For example, in 1984, the 25th Structures, Structural Dynamics and Materials Conference closed two proceedings

sessions to foreign nationals. For other examples, see Harold Relyea, Silencing Science: National Security Controls and

Scientific Communication, (Norwood, New Jersey: Ablex Publishing Corporation), 1994, pp. 125-126.

Testimony by the Association of American Universities before the Senate Committee on Foreign Relations,

Subcommittee on International Economic Policy, Export, and Trade Promotion, June 15, 2000.

For more information on the reauthorization of the Export Administration Act of 1979, see CRS Report RL31832,

The Export Administration Act: Evolution, Provisions, and Debate, by (name redacted).

The select agent list consists of viruses, bacteria, rickettsiae, fungi, and toxins and is determined by the Secretary of

Health and Human Services. Agents on the select agent list are considered to have the potential to pose a severe threat

to public health and safety.

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Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188) requires sites with select

agents to keep a current inventory of those agents and register their possession with the

Department of Health and Human Services or with the Department of Agriculture, depending on

the nature of the select agent.

Most universities generally reconcile their dual roles, that of providing educational and research

opportunities to their students while simultaneously remaining in compliance with the limits of

export regulations, by relying on the fundamental research exclusion. Some universities affirm

their role as disseminators of knowledge and do not identify the nationality of students attending

classes, citing the incompatibility of closed classrooms with their academic charter.49

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Some federal funding agencies, for example, the U.S. Army Research Laboratory, Army Corps of

Engineers, the Department of Energy, and the Federal Aviation Administration, have occasionally

incorporated publication restrictions in the terms and conditions of their research contracts when

the area of research either may have potential defense applications or contain sensitive material.50

In general, these restrictions have not been applied to entire research fields, but, instead, have

been targeted at specific research considered to be of import or relevance to national defense or

where portions of a contract may contain classified information.

University administrators have been reportedly uneasy about such prepublication review clauses

within funding vehicles. Officials at Duke University reportedly renegotiated and rejected

contracts that had prepublication clauses inserted into them by the Department of Defense.51

Administrators at the Massachusetts Institute of Technology have refused contracts including

prepublication review language.52 While prepublication review clauses within Department of

Defense funding vehicles have caused concern among the academic community that they may

violate NSDD-189, the Director of the Office of Science and Technology Policy (OSTP), Dr.

John Marburger, has stated that the Department of Defense use of prepublication clauses in

contracts has been consistent with prior policy.53 Dr. Marburger requested that the academic

community provide OSTP with examples of such clauses. The Council on Government Relations

and the American Association of Universities prepared a joint report submitted to OSTP

For example, access to classrooms, libraries, laboratories, and specialized research facilities of the University of

California is open, without regard to citizenship, residency status, or visa category. Questions regarding citizenship

status may not be asked of those entering such facilities unless a special exception has been granted. Office of the

President, University of California, Operating Guidance Memo No. 00-05, October 30, 2000. The University of

California asserts such guidance does not hinder the University’s compliance with legal obligations under federal law.

Anne Marie Borrego, “Colleges See More Federal Limits on Research,” Chronicle of Higher Education, November

1, 2002, p. 24 and Connie Cass, “Science Community Struggles With Terror-Wary Feds,” Associated Press, January 2,

2003.

David Malakoff, “Universities Review Policies for Onsite Classified Research,” Science, Vol. 295 (February 22,

2002) pp. 1438-1439.

Anne Marie Borrego, “Colleges See More Federal Limits on Research,” Chronicle of Higher Education, November

1, 2002, p. 24.

Remarks of Dr. John Marburger, Director, Office of Science and Technology Policy, at the National Academies of

Science Roundtable on Scientific Communication and National Security, June 19, 2003.

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documenting 103 prepublication clauses presented over a six month period to a sample of

20 universities.54

Some universities fear that federal prepublication review clauses might invalidate the

fundamental research exemption that such research results normally enjoy. As a consequence,

university research done in an export-controlled area would no longer be excluded from export

control regulations.55

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The catastrophic terrorist attacks of 2001 led to an executive branch reevaluation of the treatment

of government-owned information. In the wake of these events, many government agencies

evaluated information which was available to the public through government websites and began

to reassess documents that had recently been declassified.56

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This process was marked by a memorandum on March 19, 2002 sent by Assistant to the President

and Chief of Staff Andrew Card to executive branch departments and agencies.57 This

memorandum became known as the “Card memo.” It cautioned that information possessed by the

federal government which could be reasonably expected to assist in weapons of mass destruction

development or use should not be inappropriately disclosed. Additionally, the guidance contained

within the Card memo reinforced the need to protect “sensitive, but unclassified” information

related to homeland security.

The term “sensitive, but unclassified” was not defined in the memorandum and it is not clear how

sweepingly construed this category might be.58 Further guidance regarding the use of this

category is found within the memo itself:

The need to protect such sensitive information from inappropriate disclosure should be

carefully considered, on a case-by-case basis, together with the benefits that result from the

open and efficient exchange of scientific, technical, and like information.59

American Association of Universities/Council on Government Relations, Restrictions on Research Awards:

Troublesome Clauses, April 8, 2004.

Eugene B. Skolnikoff, “Protecting University Research Amid National-Security Fears,” The Chronicle of Higher

Education, May 10, 2002, pp. B10-B12.

William J. Broad, “Nation Challenged: Domestic Security: U.S. Is Tightening Rules On Keeping Scientific Secrets,”

The New York Times, February 17, 2002.

The Card memo contained guidance from the Acting Director of the Information Security Oversight Office, National

Archives and Records Administration, and the Co-Directors of the Office of Information and Privacy, Department of

Justice. A copy of this memo is available at http://www.fas.org/sgp/bush/wh031902.html.

For more information on “sensitive, but unclassified” information, see CRS Report RL33303, “Sensitive But

Unclassified” Information and Other Controls: Policy and Options for Scientific and Technical Information, by

(name redacted).

Ibid.

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Several comparable, but still dissimilar, definitions of “sensitive, but unclassified” are in use at

different agencies.60 The Department of State describes “sensitive, but unclassified” information

as:

...information which warrants a degree of protection and administrative control that meets the

criteria for exemption from public disclosure set forth under Sections 552 and 552a of Title

5, United States Code: the Freedom of Information Act and the Privacy Act.61

The Department of Energy’s use of “sensitive, but unclassified” is described as:

Information for which disclosure, misuse, alteration or destruction could adversely affect

national security or government interests. National security interests are those unclassified

matters that relate to the national defense or foreign relations of the Federal Government.

Governmental interests are those related, but not limited to, the wide range of government or

government-derived economic, human, financial, industrial, agricultural, technological, and

law enforcement information, as well as the privacy or confidentiality of personal

information provided to the Federal Government by its citizens.62

The Department of Defense maintains several types of controlled, unclassified information. The

Department of State category of “sensitive, but unclassified” is a document designation

comparable to For Official Use Only.63 The criteria for allowing access to For Official Use Only

and “sensitive, but unclassified” information are the same. The Department of Defense describes

For Official Use Only as:

... a designation that is applied to unclassified information that may be exempt from

mandatory release to the public under the Freedom of Information Act (FOIA).64

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Scientists are divided about how to balance scientific openness and national security concerns.

While recognizing that security concerns are valid, some scientists assert that the value of

publication of research results is greater than the potential risks. Others state that publication of

select research results is troublesome and that mechanisms for determining which research results

fall into this category and addressing publication of these results need to be determined. The

National Academies of Science and multiple scientific professional societies have engaged with

other stakeholders in exploring the role of scientists, publishers, and the government in assessing

the security concerns of such research results.

For example, a GAO study identified 56 different sensitive but unclassified designations. Government Accountability

Office, Information Sharing: The Federal Government Needs to Establish Policies and Processes for Sharing

Terrorism-Related and Sensitive but Unclassified Information, GAO-06-385, March 2006.

Definition taken from the U.S. Department of State, Foreign Affairs Manual, located at 12 FAM 541.

Definition taken from Office of Security Affairs, Safeguards and Security Glossary of Terms, U.S. Department of

Energy, December 18, 1995, as cited in Commission on Science and Security, Science and Security in the 21st Century:

A Report to the Secretary of Energy on the Department of Energy Laboratories, The Center for Strategic and

International Studies, April, 2002.

As reported on the Defense Security Service website at http://www.dss.mil/search-dir/training/csg/security/S2unclas/

Intro.htm.

Department of Defense, “Information Security Program,” Department of Defense Directive 5200.1-R, January 1997.

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While many professional societies have wrestled with the balance between scientific openness

and security concerns, the actions of the American Society for Microbiology will be highlighted

here as an example of the actions taken to address these concerns.

The American Society for Microbiology, a professional organization which publishes many

scientific journals, including the Journal of Virology in which the mousepox article was printed,

has received requests by authors to be allowed to omit certain information from their

submissions.65 By omitting such information, the experiments described in the article would be

much more difficult to reproduce, perhaps impossibly so.

The American Society for Microbiology has adopted the position that all information necessary to

reproduce an experiment must be included in any submission for publication. Former American

Society for Microbiology president, Dr. Ronald Atlas, testified:

Omission of materials and methods from scientific literature would compromise the

scientific process and could lead to abuses as well as the perpetuation of errors. Independent

reproducibility is the heart of the scientific process. Even within the context of heightened

scrutiny, research articles must be published intact. If scientists cannot assess and replicate

the work of their colleagues, the very foundation of science is eroded.66

Recognizing as valid the concern that scientific information in journals might be inappropriately

used, the American Society for Microbiology has developed and established policy guidelines for

reviewers and editors of their journals. These guidelines establish a procedure for special review

of submissions concerning select agents, as defined by regulation, and for those submissions

which reviewers feel may possess the potential for inappropriate use.67

The American Society of Microbiology’s guidelines for publishing potentially contentious

research were tested with the publication of a manuscript in March 2003 in the journal Infection

and Immunity. This paper described the effects of proteins that accompany botulinum toxin

during natural production and assessed the proteins’ effects when inhaled. Upon receipt of the

manuscript, editors requested that some portions of the paper be modified, in order to allay the

editors’ security concerns.68

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The Presidents of the National Academies released a joint statement and background paper which

avers that the federal government should continue its current practice of classification and not

further develop a less well-defined category to encompass sensitive research results.69 They

Andrew Moesel, “Scientists Call For Withholding Sensitive Data,” University Wire, August 12, 2002.

Written testimony from Ronald M. Atlas, President, American Society for Microbiology, before the House of

Representatives Committee on Science, October 10, 2002.

The guidelines developed by the American Society for Microbiology for authors, editors, publishers, and reviewers

are found online at http://www.journals.asm.org/misc/Pathogens_and_Toxins.shtml.

Nell Boyce, “Keeping Details From the Devil,” U.S. News & World Report, March 10, 2003.

Statement on Science and Security in an Age of Terrorism from Bruce Alberts, Wm. A. Wulf, and Harvey Fineberg,

Presidents of the National Academies, October 18, 2002.

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asserted that scientific creativity and national security would both be lessened if clear distinctions

are not drawn between areas where open publication is acceptable or not. They also emphasized

that wide dissemination of research results and peer review are important aspects of research

science.70

A meeting entitled “Scientific Openness and National Security” was held at the National

Academy of Sciences on January 9, 2003.71 It addressed some aspects of the debate regarding

scientific publication and national security. Members of the academic scientific community, the

non-profit community, and the federal government met for a day-long symposium identifying the

significant contentious issues.

At this meeting, Dr. Marburger reiterated that NSDD-189 continues to define policy for

publication of federally funded research results. He suggested that research should be designated

as classified prior to awarding a federal grant or contract, and that the need for deviation from this

policy should be uncommon. He also stated that previous precedents of control in the physical

sciences may not provide adequate guidance for bioterrorism.72 Dr. Penrose Albright, then of the

Office of Science and Technology Policy and the Office of Homeland Security, also stated that an

articulated and defensible criteria for inappropriate research, able to distinguish dangerous and

benign research results, combined with a mechanism for identifying articles containing dangerous

but valuable information would be well received by the Executive Branch.73

Following the National Academies’ meeting, journal editors, scientist-authors, and other

stakeholders met and discussed the challenges posed by publication of certain research results,

eventually issuing a statement calling for renewed vigilance and personal responsibility for

potentially dangerous research presented to them for publication.74 This joint statement provided

the base for subsequent announcements in Science, Proceeding of the National Academies of

Science of the United States of America, and the British journal Nature affirming editorial policy

to both deal responsibly and effectively with security issues while maintaining the integrity of the

scientific publishing process.75 It has been asserted that the joint statement should be understood

as augmenting, but not supplanting, existing editorial policy at the signatory journals.76 For

example, the American Association for the Advancement of Science, the professional

organization which publishes Science, has implemented a formal policy on how to deal with

potentially dangerous reports in conjunction with existing editorial policy.77

Background Paper on Science and Security in an Age of Terrorism, National Academies of Science.

This meeting was co-hosted by the National Academy of Sciences and the Center for Strategic and International

Studies.

“NAS Forum on Scientific Openness Considers National Security Concerns,” Washington Fax, January 10, 2003.

Public comments, Penrose Albright at “Scientific Openness and National Security,” National Academy of Sciences,

January 9, 2003.

Lila Guterman, “Journal Editors and Scientists Call for More Caution in Publishing Potentially Dangerous

Research,” The Chronicle of Higher Education, February 17, 2003.

Journal Editors and Authors Group, “Uncensored Exchange of Scientific Results,” Proceedings of the National

Academy of Sciences of the United States of America, Vol. 100, No. 4, (February 18, 2003) 1464. “Statement on

Scientific Publication,” Science, Vol. 300, (February 21, 2003) 1149. “Statement on the Consideration of Biodefence

and Biosecurity,” Nature, Vol. 421, (February 20, 2003) 771.

See, for example, William Schulz, “Journal Editors Deal With Security Issues,” Chemical and Engineering News,

February 17, 2003, p. 15.

The new policy for potentially dangerous reports is described in Information for Contributors, Science, January 3,

2003.

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While consensus was not achieved among the attendees of the National Academies’ meeting

regarding the potential solutions, there was general agreement that a growing dialogue between

the scientific and security communities would aid in satisfying community members’ concerns.

Towards this goal, the National Academy of Sciences and the Center for Strategic and

International Studies convened a two-year, joint Roundtable on Scientific Communication and

National Security. Both the scientific and security community were invited to informally discuss,

and potentially develop, solutions to the tension over publication.78 This led to the formation of a

Commission on Scientific Communication and National Security by the Center for Strategic and

International Studies. This Commission published a white paper in 2005, recommending that the

federal government maintain NSDD-189 and that research institutions establish mechanisms to

ensure informed compliance with applicable regulations regarding dissemination of scientific

information.79

The National Academies continue to explore the issue of performing and publishing research that

has potential homeland security impact. Committees have been empaneled to consider these

impacts and possible mitigating approaches. The National Academies have released several

reports containing recommendations for the federal government on handling contentious research

and research results.

One report recommended that the policies of NSDD-189 be continued and that other mechanisms

should be developed to address the difficulties of assessing and responding to contentious

research.80 The report identified seven research areas where results might pose a security concern

and advocated that proposed research in these areas be reviewed, and potentially rejected, by a

committee, specifically the institutional biosafety committee within each research institution,

before the research is performed. Thus, research of concern could be identified and weighed

before results were generated. Editors and publishers would continue to exercise their

professional judgement in the publishing of manuscripts, without federal review or requirements.

Response to this proposal has been mixed. While many in the scientific community have

supported this framework as an appropriate balance of scientific self-regulation and federal

advisory oversight, others have criticized the proposal for not being legally binding or requiring

such review of government or industrial research.81 Additionally, it would not act as a barrier to

informal dissemination of research results that might fall in one of the seven research areas. As an

example of the limitations of the National Academies proposal, critics refer to the open discussion

of mousepox research results by Dr. Buller at a biosecurity convention in Geneva, Switzerland.82

A different report suggested the creation of an independent advisory body to partner with

intelligence officials and government leaders to analyze science and technology in order to

“National Security, Scientific Openness,” Center for Strategic and International Studies Press Release, March 14,

2003.

Commission on Scientific Communication and National Security, Security Controls on Scientific Information and the

Conduct of Scientific Research, June 2005.

National Research Council, Biotechnology Research in an Age of Terrorism, (Washington, DC: National Academies

Press), October, 2003.

See, for example, John Dudley Miller, “National Academy Proposes Scientists Self-Police,” The Scientist Online,

October 9, 2003.

See, for example, John D. Steinbruner and Elisa D. Harris, “When Science Breeds Nightmares,” International

Herald Tribune, December 3, 2003.

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anticipate future biological threats.83 The report asserted that scientists need to adopt a common

culture of awareness and responsibility regarding research in the life scientists, to prevent the

malevolent use of such research’s results. While some professional societies have adopted codes

of conduct, biosecurity experts assert that these codes are not all equivalent and may not pose a

sufficient barrier to prevent the misuse of benevolent science.

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The Homeland Security Act (P.L. 107-296) created the Department of Homeland Security, within

which many research and development functions relating to homeland security were aggregated

under the Science and Technology directorate. This directorate is responsible for researching,

developing, and deploying biological, chemical, nuclear, and radiological countermeasures. It

also has management of the Homeland Security Advanced Research Projects Agency, which

funds extramural homeland security research.

How homeland security information shall be handled by the Department of Homeland Security is

further described in the Homeland Security Act. While to the greatest extent practicable, the

results of research funded by the Department of Homeland Security are to be unclassified,84 the

President is also instructed to:

prescribe and implement procedures under which relevant Federal agencies ... identify and

safeguard homeland security information that is sensitive but unclassified. ... The President

shall ensure that such procedures apply to all agencies of the Federal Government.85

Congress has held many hearings to perform oversight of the Department of Homeland Security.

Issues raised in these hearings indicate that some policies are not yet in their final form. Since

extramural scientific research funded by the Department of Homeland Security might be

reasonably expected to also have security ramifications, an explicit policy relating to publication

of such sensitive but unclassified information will likely be needed.

The Department of Homeland Security has not, as of this writing, developed the methods by

which potentially contentious extramural research results will be identified and handled or

publicly disseminated policies regarding these results. Then-DHS Secretary Ridge, in remarks to

the Association of American Universities in April 2003, stated that the federal government

continued to uphold NSDD-189, and that he did not plan to apply sensitive but unclassified or

sensitive homeland security information guidelines to federally funded research. Instead, sensitive

homeland security information and sensitive but unclassified information would only be

information that the federal government already possesses.86

Then-Under Secretary for Science and Technology Charles McQueary told the American

Association for the Advancement of Science Colloquium on Science and Technology Policy that

National Research Council, Globalization, Biosecurity, and the Future of the Life Sciences, (Washington, DC:

National Academies Press) 2006.

P.L. 107-296, Section 306.

P.L. 107-296, Section 892(a).

Remarks by Secretary Tom Ridge to the Association of American Universities, Washington, DC, April 14, 2003.

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scientific organizations should establish their own criteria for prepublication review of risky

research articles and that scientists and journal publishers should set the bar for themselves.87

It has been reported that the Homeland Security Advanced Research Projects Agency follows a

Department of Defense model for quasi-classified broad agency announcements. The Homeland

Security Advanced Research Projects Agency reportedly holds back, in some circumstances,

information from broad agency announcements in order to avoid revealing vulnerabilities.88 The

criteria for these circumstances has not been made publicly available. Whether research results

arising from such broad agency announcements could be freely published has not been made

clear.

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Following the publication of Biotechnology Research in an Age of Terrorism, the Department of

Health and Human Services announced the establishment of a National Science Advisory Board

for Biodefense (NSABB), building on several of the National Academies’ recommendations.89

The NSABB is, among other duties, to provide advice, guidance, and leadership regarding

biosecurity oversight of dual-use research.90 While the NSABB is managed and supported by the

National Institutes of Health (NIH), it is to advise the Secretary of HHS, the Director of NIH, and

the heads of all federal departments and agencies that conduct or support life sciences research.91

The NSABB is composed of not more than 25 non-federal voting members appointed by the

Secretary of Health and Human Services in consultation with the heads of other federal

departments and agencies conducting life sciences research. It also contains non-voting ex officio

federal members who represent agencies and departments that conduct or support life sciences

research.92

The NSABB is developing guidelines and an oversight framework for considering federally

funded research that might pose security challenges. So far, the guidelines developed have closely

followed those suggested by the National Academies, while the issue of what oversight

framework would be most optimal is still under discussion.

The NSABB has also provided advice to the HHS Secretary regarding dual-use research and

reviewed the publication of specific scientific research results. In October 2005, a research article

was published in Science magazine describing the reconstruction of an influenza virus bearing all

Shirley Haley, “Scientists Should Decide For Themselves What Research Is Too Risky To Publish, DHS S&T Chief

Says,” Washington Fax, April 15, 2003.

Judi Hasson, “Research Arm Puts Lid on Contracts,” Federal Computer Week, August 14, 2003.

Department of Health and Human Services, “HHS Will Lead Government-wide Effort to Enhance Biosecurity in

‘Dual Use’ Research,” Press Release, March 4, 2004.

Dual-use research is defined as biological research with legitimate scientific purpose that may be misused to pose a

biologic threat to public health and/or national security. Department of Health and Human Services, National Science

Advisory Board for Biosecurity Charter, March 4, 2004.

For more discussion on the National Science Advisory Board for Biosecurity, see CRS Report RL33342, Oversight

of Dual-Use Biological Research: The National Science Advisory Board for Biosecurity, by (name redacted).

For more information on the National Science Advisory Board for Biosecurity, see online at

http://www.biosecurityboard.gov/.

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of the identified gene sequences of the 1918 influenza virus.93 Prior to the publication of the

research article, the HHS Secretary consulted with the NSABB for guidance.94 The NSABB met

and unanimously recommended that the scientific benefit of the information outweighed the

potential risk of misuse. It recommended that publication of the article be accompanied by an

editorial discussing the potential biosecurity implications of the research and how they compare

with its potential benefits.95

The use of the NSABB in vetting the publication of the 1918 flu research paper has been

identified by some observers as a successful exercise of the NSABB advisory mission.

Nevertheless, others have criticized the timing and mechanism of the review process, questioning

the role the board plays in advising policymakers and the threshold used for determining whether

NSABB guidance would be sought on a submitted publication.96

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The balance between publication of federally funded research results and protecting national

security raises numerous questions, such as: Should there be regulation of the publication of

federally-funded research results? Is the potential impact on scientific quality, productivity, and

advancement resulting from publication controls worth the added potential security gained

through such controls? How might relevant policy be uniformly employed by all agencies of the

federal government? Should such policy vary by scientific and technical disciplines? At what

stage, if any, of the civilian research process might regulation or restriction occur? How much

authority, if any, does the federal government have over the publishing of research results

developed through private funding? How might development or implementation of such authority

introduce first amendment conflicts? Since science is an increasingly international discipline, how

would national security concerns regarding federally funded research results be implemented in a

global context? How might the federal government encourage scientists to develop guidelines for

self-regulation? Given the international nature of scientific publication, might self-regulation by

domestic publishers cause sensitive research results to be published in international journals

rather than domestic journals? How might Congress provide oversight of this issue with respect to

extramural research and development funded by the Department of Homeland Security?

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Some members of the scientific community advocate that the status quo, where the mechanism

for blocking publication of federally-funded research results is classification, should remain the

federal government’s policy on controlling research. They assert that this mechanism has been

sufficient in the past, and that the vigor of scientific research could be unduly, and perhaps

Terrence M. Tumpey, Christopher F. Basler, Patricia V. Aguilar, et al., “Characterization of the Reconstructed 1918

Spanish Influenza Virus,” Science, vol. 310, October 7, 2005, pp. 77-80.

Centers for Disease Control and Prevention, “Researchers Reconstruct 1918 Pandemic Influenza Virus; Effort

Designed to Advance Preparedness,” Press Release, October 5, 2005.

This editorial was published in the same issue: Philip A. Sharp, “1918 Flu and Responsible Science,” Science, vol.

310, October 7, 2005, p. 17.

See also CRS Report RL33342, Oversight of Dual-Use Biological Research: The National Science Advisory Board

for Biosecurity, by (name redacted).

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seriously, impeded if new controls were developed and added.97 Advocates of classification assert

that, with the addition of the Secretary of Health and Human Services,98 the Secretary of

Agriculture,99 and the Administrator of the Environmental Protection Agency100 to the list of those

persons authorized to classify information, the federal government has greater capacity to identify

information for classification. They assert that, in line with NSDD-189, information which is not

classified should be freely publishable and distributable. Advocates of this position claim that

areas of proscribed research should be well defined and protected by strong barriers, such as those

provided under classification.

Advocates of retaining the status quo also cite substantial concern about the impact of publication

controls on science, especially in biological sciences.101 Some have claimed that there would be a

flow of scientists out of contentious research areas into areas where there is less concern about the

legal ramifications of their work.102

Additionally, some scientists believe that an unimpeded flow of scientific information is

important to maintaining national security. They assert that national security will be increased if

many researchers have access to information that may lead to new vaccines, detectors, and

treatments, or conversely, that impeded access may limit the development of countermeasures.103

Dr. Paul Keim, a scientist at Northern Arizona University, stated:

If the Bacillus anthracis genome had not been released, we would not have been able to

develop the high-resolution system that is currently so important [to the investigation of the

anthrax attacks].104

On the other hand, advocates for changing the current system contend that scientists are currently

making available to terrorist groups information that can be used to harm the populace.

Classification is not applied to information already published in the open literature, and research

results that threaten national security may arise from normally unclassified fields. Thus,

advocates of changing the current system assert that classification is insufficient to stop

dissemination of information arising from normally unclassified fields, as it may enter into the

open literature before it is identified as potentially harmful to national security. These proponents

claim that the continued publication of such information will harm national security, and that

changes should be made so that such federally funded research results can be classified before

they are distributed.

Some policymakers have also asserted that the current classification system may not be

appropriate for all sciences. They emphasize the difficulties in clearly defining what aspects of

D.J. Galas and H. Riggs, “Global Science and U.S. Security,” Science, Vol. 300, (June 20, 2003) 1847.

66 Fed. Reg. 64,345 (December 12, 2001).

67 Fed. Reg. 61,463 (September 30, 2002).

100

67 Fed. Reg. 31,109 (May 9, 2002).

101

Charles Vest, “Response and Responsibility. Balancing Security and Openness in Research and Education,” Report

of the President for the Academic Year 2001-2002, Massachusetts Institute of Technology, September 2002.

102

For example, see Mark Clayton, “Academia Becomes Target for New Security Laws,” The Christian Science

Monitor, September 24, 2002, p. 11.

103

Daniel J. Kevles, “Biotech’s Big Chill,” Technology Review, July/August 2003, pp. 41-49.

104

Debora MacKenzie and Sylvia Pagan Westphal, “Should the Genetic Sequences of Deadly Diseases Be Kept

Secret?” New Scientist, July 20, 2002, p7.

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biological research should be subject to regulation,105 and that, unlike other classified research

areas, much of microbiology is performed outside of the federal government.106 They suggest that

classifying basic biological research might be necessary for homeland security, but also might

unduly restrict future applied research. Thus, they claim a different method for handling such

results may be necessary.107

Advocates for adjusting the current system also assert that information published in scientific

journals may undermine biodefense efforts. For example, publishing which portion of a

pathogen’s genome is used in a new biodetection device could inform terrorists how to create a

pathogen which would avoid detection by that method.108, 109

The scientific and export communities interact when changes to export control regulation are

suggested. These interactions may indicate how different policy approaches regarding publication

of potentially dangerous research results may be discussed and developed in a mutually

acceptable manner. In export control, the concerns of national security are met while

simultaneously allowing research to continue. That said, implementation of export control

regulations has posed some challenges to researchers. Application of deemed export provisions

and proposed revision of these provisions have raised concerns among the academic community

as being unwieldy and potentially injurious to the research process.110

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While many individual scientists may identify reasonable and valid concerns regarding the

potential inappropriate use of information in scientific journals, opinions vary about how to best

address these concerns. Some have advocated a self-policing framework where scientists regulate

themselves through a combination of ethical agreements and publishing oversight.111 They claim

that scientists are in the best position to determine the threshold for responsible science and to

respond to new scientific developments. As was shown through the experience of the National

Institutes of Health Recombinant DNA Advisory Committee, amendment or adjustment of

regulation and rules related to science is often needed, as the subject matter continues to evolve

and progress.

Several mechanisms are possible within a self-regulating framework. One might involve review

boards within institutions to assess research results. Much research involving human subjects, for

example, is governed by local institutional review boards. A board’s purview generally extends to

all human research at the institution, irrespective of funding source. Although required by the

Public Health Service Act and the Federal Food, Drug and Cosmetic Act for certain human

105

Gigi Kwik, “Biosecurity: Science in the Balance,” Biodefense Quarterly, (Winter 2003).

Peg Brickley, “CIA Openness Report To Be Classified?” The Scientist, April 7, 2003.

107

D. Malakoff, “Researchers Urged to Self-Censor Sensitive Data,” Science, Vol. 299, (January 17, 2003) 321.

108

Nicholas Wade, “Traces of Terror: Bioterrorism; Scientists Worry Journals May Aid Terrorists,” The New York

Times, July 26, 2002, p. A19.

109

Richard Monastersky, “Publish and Perish? As the Nation Fights Terrorists, Scientists Weigh the Risks of Releasing

Sensitive Information,” The Chronicle of Higher Education, October 11, 2002, p. A16.

110

For one view of the concerns of the academic community regarding export control regulations, see Donald

Kennedy, “A Welcome New Look,” Science, Vol. 312, No. 5780, June 16, 2006, p. 1573.

111

See for example Joseph G. Perpich, “The Recombinant–DNA Debate and Bioterrorism,” The Chronicle of Higher

Education, March 15, 2002, p. 20.

106

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experimentation, the boards at extramural research institutions are not federal entities.112 These

institutional review boards have the ability and authority to approve, require modifications within,

or disapprove research projects. Similar review boards established within research facilities could

be given the role of screening manuscripts in a formal or informal manner prior to their

publication.

Another possibility would be to convene a new “Asilomar-like” conference, where members of

the scientific and national intelligence communities, along with public input, come together and

craft codes of conduct which will satisfy the varying needs of these disparate groups.113 By doing

so, a framework could be developed to identify sensitive research results and provide alternate

dissemination routes.114

NIH National Institute of Allergy and Infectious Diseases Director Anthony Fauci has voiced

support for the establishment of an oversight panel. For example, he suggested the formation of a

panel to determine the appropriateness of certain types of biomedical research and stated:

There should be a committee – a combination of academics and societies and perhaps journal

editors – to discuss [publication], so if there is a question in the mind of someone, you can

bring it to a body who can, in an unbiased way, give you an idea about whether or not you

should [publish].115

Whether scientific researchers would be able to properly weigh the security concerns of research

results is uncertain as well. For example, Dr. Stephen Morse, in endorsing the idea of an

Asilomar-like conference, pointed out:

Scientists are not in the age of innocence anymore. And they should be aware of the moral

implications of what they’re doing.116

Some have maintained that the natural inclination of scientists is to err on the side of openness

and publication,117 while others posit that since the science and security communities are

separated, trust in the actions of the opposing community is difficult to develop.118 Other

complications to self-regulation exist as well. As scientific research has become more

international in scope, it would be necessary for such a self-regulatory framework to be adhered

to on an international basis for optimal effectiveness. Without the agreement of international

scientists to maintain similar codes of conduct, contentious research results generated by

international scientists would continue to enter the open literature. Also, scientists within the U.S.

might preferentially publish in international journals, should the barrier to publication in a

domestic journal be raised significantly higher than found in international publishing.

112

More information about institutional review boards can be found online at http://www.fda.gov/oc/ohrt/irbs/

faqs.html.

113

Ronald M. Atlas, “National Security and the Biological Research Community,” Science Vol. 298, (October 25,

2002) pp.753-754.

114

For example, see Letter to the Editor, “Science Publishing and Security Concerns,” Science, Vol. 300, (May 2,

2003) p. 737.

115

Anthony Fauci, quoted in “Security Exceptions to Transparency in Publishing NIH-funded Research Will Be Rare,

Fauci Says,” Washington Fax, October 11, 2002.

116

Laurie Garrett, “Scientists Advocate Greater Security,” Newsday, October 14, 2001, p. A5.

117

M. Mechanic, “Publish and Perish?” East Bay Express, September 11, 2002.

118

D. Kennedy, “Two Cultures,” Science, Vol. 299, (February 21, 2003) p. 1148.

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The NIH guidelines developed out of the Asilomar conference are generally followed on an

international level, but the scientific community is much larger now than in the 1970s, and

developing agreement among such a community may be more difficult to achieve.119 Genetically

modified foods and stem cell research are examples of biological research areas around which a

community-wide, international consensus has not evolved.

The National Research Council report Biotechnology Research in an Age of Terrorism provides

recommendations for a potential self-regulatory mechanism. It identifies seven areas where

“experiments of concern” might exist, and recommends that experiments within these areas be

reviewed by an institutional biosafety committee to determine whether the experiments present

some degree of concern. The institutional biosafety committees would thus provide an initial

review of proposed experiments. If further review or consultation was needed to determine

whether an experiment was of concern, then the experiment could be referred to an expanded

Recombinant DNA Advisory Committee or to a higher authority for adjudication.120 The

establishment of the National Science Advisory Board for Biosecurity may be interpreted as

fulfilling this role and function, but issues regarding the authority and scope of the NSABB have

yet to be fully resolved.

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The actions undertaken by select journal editors for handling the results of potentially sensitive

research may be models for publishing houses to adhere to in the face of potential legislation or

federal regulation. By empowering journal editors to screen, review, and reject research papers on

the basis of their weapons potential, advocates hope to avoid new laws or regulations that might

constrain the research process and scientific productivity. The revelation that some journal papers

have been modified because of ethical concerns raised through the editorial process has been seen

as a success for this style of oversight.121

Still, some cite the opinions of the editor of Science and chief executive of the American

Association for the Advancement of Science initially expressed regarding the need for open

publication122 as indicative that the publishing community is not unified in perspective, and that

an editor-based effort might yield unsatisfactory results. Even if domestic publishers develop a

consensus protocol for handling research results which might threaten national security, it is

unclear if this would stop such information from entering the open literature. The competitive,

international nature of scientific publishing may lead foreign journals that lack such a protocol to

legally acquire and publish material that is prohibited from publication in domestic journals.

Finally, with the growing ability to disseminate scientific information to a wide audience without

resorting to formal publication, it has been questioned whether a publisher-based policy will be

effective in restricting the dissemination of contentious research.123

119

See G.L. Epstein, “Controlling Biological Warfare Threats: Resolving Potential Tensions Among the Research

Community, Industry, and the National Security Community,” Critical Reviews in Microbiology, Vol. 27, No. 4,

(2001) pp. 321-354.

120

National Research Council, Biotechnology Research in an Age of Terrorism, (Washington, DC: National Academies

Press), October, 2003.

121

Shaoni Bhattacharya, “Bioterrorist Fears Prompt Journal Paper Censorship,” NewScientist.com, February 17, 2003.

122

J. Couzin, “A Call for Restraint on Biological Data,” Science, Vol. 297, (August 2, 2002) pp. 749-751.

123

Steven Aftergood, “Science Journals Will Screen Papers For Hazards,” Secrecy News, February 18, 2003.

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The National Research Council report Biotechnology Research in an Age of Terrorism

recommends that journal editors continue to assess whether potentially contentious manuscripts

should be published. It asserts that a voluntary approach, where scientists and editors can

continue to refine and respond to criticism or other input, is essential to the credibility of such a

system within the research community.124 Without such credibility it is believed that scientists

may not take part in potentially contentious biodefense research.

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An option is the imposition by the federal government of sensitive, but unclassified status and

subsequent prepublication review of scientific research resulting from federal government

sponsorship or funding. Application of this standard would likely allow scientists with

appropriate credentials or need-to-know access to such scientific literature, but would bar others’

access. Advocates of such a standard point out that such information could be transferred among

scientists with fewer controls than classified information. It has been suggested that access to

sensitive, but unclassified research results could be controlled by the publisher through secure,

password-controlled websites.125 Other options might include dissemination of such material via

professional societies or directly from the federal government.

Opponents of such an approach cite the logistical difficulties in determining those scientists with

a bona fide reason for access to this information; determining how and in what manner

application of such a label would be implemented; and determining how such sensitive, but

unclassified material would be disseminated to those scientists eligible to receive it. A further

complication is that the categorization of what information might be sensitive, but unclassified is

still not clear or uniformly codified across all federal scientific funding agencies.126 Additionally,

some scientists or universities might choose not to participate in a process which would determine

access eligibility. A Massachusetts Institute of Technology report rejects such security reviews as

potentially becoming arbitrary.127

Another concern is the effectiveness of such a federally based review. The federal government

funds about 30% of the total research and development efforts in the United States. In terms of

basic and applied research, the federal government funds 62% and 38% respectively.128 If

prepublication review resides within the federal government, in contrast to a voluntary

124

National Research Council, Biotechnology Research in an Age of Terrorism, (Washington, DC: National Academies

Press), October, 2003.

125

R.A. Zilinskas and J.B. Tucker, “Limiting the Contribution of the Open Scientific Literature to the Biological

Weapons Threat,” Journal of Homeland Security, (December 2002).

126

Potential new regulations regarding the definition of sensitive, but unclassified information being studied by the

Office of Management and Budget may address these issues.

127

Massachusetts Institute of Technology, In The Public Interest. Report of the Ad Hoc Faculty Committee on Access

to and Disclosure of Scientific Information, June 2002.

128

Percentages calculated in constant 200 dollars. Total research and development funding information taken from

National Science Foundation, National Patterns of R&D Resources: 2004 Data Update, Table 2. Basic research

funding information taken from National Science Foundation, National Patterns of R&D Resources: 2004 Data

Update, Table 4. Applied research funding information taken from National Science Foundation, National Patterns of

R&D Resources: 2004 Data Update, Table 6.

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submission to professional societies or an ethical or moral statement developed and overseen by

journal publishers, then all basic and applied research would not be reviewed.

A strong sentiment held by many members of the scientific community is that all unclassified

scientific results should be shared widely. Results are sometimes construed to include actual

samples of research materials and all information necessary to reproduce an experiment. For

example, the National Academy of Sciences’ Board on Life Sciences has recommended that

authors of scientific papers allow unrestricted access to data and supporting materials related to

published findings.129 Such a position indicates a potential lack of support within the science

community for any credential system barring access to research results.

Lastly, universities fear that federal prepublication review to determine the sensitive, but

unclassified status of material in a publication might invalidate the fundamental research

exemption that such research results normally enjoy under EAR and ITAR. As a consequence,

university research done in an export-controlled area would no longer be excluded from export

control regulations.130

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Another suggestion to addressing research with security implications is to categorize such

research at the funding stage, rather than at the publication stage.131 Including voluntary or

mandatory prepublication review for federally funded research or the development of new

funding opportunities containing prepublication review as a condition of acceptance are potential

remedies. Individual funding vehicles have been offered to universities which would provide the

funding agency with access to research results prior to publication.132

Opponents of this approach cite the general unwillingness that universities have towards

restricted research funding.133 Some universities have explicit policies barring acceptance of

federal funding requiring prepublication review. Also, scientists may not be as willing to work in

research areas where publication is not allowed as in areas where publication is encouraged.134 As

a consequence, the pool of eligible scientists competing for federal funding might decrease,

potentially lowering the quality of research and development performed in these areas.

Additionally, determining at the funding stage whether research will lead to sensitive results is

129

National Research Council, Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the

Life Sciences, (Washington, DC: National Academies Press) 2003.

130

Eugene B. Skolnikoff, “Protecting University Research Amid National-Security Fears,” The Chronicle of Higher

Education, May 10, 2002, pp. B10-B12.

131

For example, see Joan Lowy, “Debate Flares on Bioterror Research,” Scripps Howard News Service, October 2,

2002.

132

Examples of contracts containing prepublication review being offered by federal funding agencies is found in Peg

Brickley, “Contract Conflicts,” The Scientist, January 7, 2003; D. Malakoff, “Universities Review Policies for Onsite

Classified Research,” Science, Vol 295 (February 22, 2002) pp. 1438-1439; and Andy Fell, “Homeland Security Goals

Create Impact: Campus Responds To Satisfy Range of New Terrorism Laws,” Dateline UCDavis, November 22, 2002.

See also American Association of Universities/Council on Government Relations, Restrictions on Research Awards:

Troublesome Clauses, April 8, 2004.

133

See, for example, AAU/COGR/NASULGC Letter to OSTP Director on Scientific Openness, found online at

http://www.aau.edu/research/Ltr1.31.03.pdf.

134

Philip Cohen, “Recipes For Bioterror: Censoring Science,” NewScientist.com, January 18, 2003 and Paul Elias,

“Academic Freedoms Said Hindered by 9/11,” Washington Post, September 11, 2003.

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considered difficult. For example, the often cited mousepox experiments were part of a fertility

research program aimed at techniques for pest control, and the results of the experiment were

unexpected.135

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Some experts have suggested that the role of the federal government should be expanded beyond

a gatekeeping role when considering research. Since much research that has potential terrorism

concerns also may play a role in biodefense, it has been suggested that such research should

continue, but only performed by select researchers at specific facilities. For example, Dr. John

Steinbruner has suggested, as part of a Biological Research Security System, that a national

federal authority be established to license qualified researchers and research facilities and oversee

research by licensed researchers in licensed facilities.136 Some scientists have asserted that

licensing researchers, facilities, or experiments would have a strong, negative impact on scientific

productivity in those areas.137 The registration of life scientists wishing to work with select agents

has shown though that some scientists are willing to engage in such licensed research.138

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Congress may continue to oversee development of policies relating to publication of extramural

research results funded by the Department of Homeland Security’s Science and Technology

directorate. Whether the Department of Homeland Security should adopt a currently existing

policy on extramural research or create a new policy; how this policy might be implemented; and

the degree to which extramural research funded by the Department of Homeland Security might

present security concerns may be areas where further congressional direction occurs.

Additional oversight may focus on the activities underway in the Department of Health and

Human Services, where the National Science Advisory Board for Biosecurity has been

established. The charter of the NSABB is broad and recommendations brought forth from the

body may impact much federally funded, homeland security-related research. The degree of

impact, the comprehensiveness of such recommendations, and their ramifications may be areas of

congressional interest. Alternately, should the NSABB be unable to provide practical

recommendations, the difficulties and barriers encountered by the board may draw attention.

135

“Biowarfare Warning,” Journal of the American Medical Association, Vol. 285, No. 6 February 14, 2001, p. 725.

An initial local level of review and an international review agency are also established as part of the Biological

Research Security System. J.D. Steinbruner and E.D. Harris, “Controlling Dangerous Pathogens,” Issues in Science and

Technology, Vol. 19, Spring 2003. For a regularly revised version of this system, see online at

http://www.cissm.umd.edu/documents/pathogensmonograph.pdf.

137

Peg Brickley, “Science Police Needed?”, The Scientist, April 8, 2003.

138

For more information on the Select Agent Program, see online at http://www.cdc.gov/od/sap/.

136

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Developing policy in this area balances many concerns, some of which may be more difficult to

address than others. How would a federal policy that encouraged self-regulation of manuscript

submissions, either by journal publishers or scientists, be enforced? How would the concerns of

security officials regarding national security be met if scientists are relied upon to review articles?

Conversely, how would the concerns of scientists regarding scientific openness and academic

freedom be met if security officials review articles? A policy involving review of research may

require the cooperation of members of both the scientific and security community, two

communities that generally have limited interaction. Finally, how would the success of a program

controlling scientific research results be measured? Some aspects of such a program, like the

economic costs involved in processing the articles, might be directly measurable, while others,

such as the success in blocking terrorist group access to this information, might not be so easily

measured.

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(name redacted)

Specialist in Science and Technology Policy

[redacted]@crs.loc.gov, 7-....

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