Thank you, Senator Feinstein and members of the Subcommittee, for inviting me here today to discuss issues related to the regulation of dangerous biological agents and toxins and to present the perspective of the American Society for Microbiology (ASM). My name is Ronald M. Atlas. I am Professor of Biology, Dean of the Graduate School at the University of Louisville in Kentucky and co-director of the Center for Deterrence of Biowarfare and Bioterrorism at the University of Louisville, a major research institution with over 4,000 graduate students.
I am appearing today as President-Elect of the American Society for Microbiology, and co-chair of the ASM's Task Force on Biological Weapons Control. The ASM is the largest single life science society in the world. The ASM publishes 10 scientific journals, each of which focuses on a distinct specialty within the microbiological sciences. The ASM also annually publishes numerous scientific books and sponsors many scientific meetings, conferences, and workshops on a broad range of microbiological subjects. The ASM's membership consists of over 42,000 microbiologists, ranging in profession from laboratory clinicians to research scientists and Nobel Prize laureates. A common appreciation of science and a commitment to scientific integrity unites this large and diverse scientific community.
The recent misuse of microorganisms has shocked the academic and scientific communities. The deliberate and criminal spread of anthrax is beyond comprehension for civilized people. It is completely contrary to the ends of science. I hope our testimony today will be helpful to the fashioning of legislation that will substantially diminish the threat of bioterrorism, advance our nation's ability to respond to bioterrorism, and encourage aggressive research against the global problem of infectious diseases.
The ASM's mission is to advance the microbiological sciences to gain a better understanding of basic life processes and to promote the application of this knowledge for improved health, economic and environmental well being. Our members recognize a duty to propagate a true understanding of science. Scientists have an obligation to work for proper and beneficent application of scientific discoveries. The ASM and its members are committed to preventing misuse of microbiology contrary to the welfare of humankind.
The ASM has a long and distinguished history of bringing scientific, educational, and technical expertise to bear on issues surrounding biological weapons. Over the past 15 years, the ASM has worked with the Department of Health and Human Services (DHHS), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health, the Department of Defense U.S. Army Medical Research in Infectious Disease Command (USAMRID), the Department of Agriculture (USDA), and Congress. The ASM supports legislation and regulations that are based upon the essential principle of ensuring protection of public safety without encumbering legitimate scientific and medical research or clinical and diagnostic medicine for the diagnosis and treatment of infectious diseases.
The ASM premises its review of legislative and regulatory approaches on the need to pursue two goals with equal vigor and commitment. We must do everything possible to prevent bioterrorism or endangerment of the public welfare and, at the same time, we must continue to work with endless energy to eradicate the scourge of infectious diseases throughout the United States and the world.
As unfathomable as it is to the civilized mind, criminal attacks are occurring in the form of bioterrorism. Most certainly, therefore, the government, academic, and scientific communities are duty bound to take every reasonable precaution to minimize any risk of misuse of microorganisms for terrorism. The ASM unequivocally supports the urgent development of responsible safeguards against the dissemination of biological agents for misuse rather than for peaceful scientific purposes.
Even as we strive to prevent bioterrorism, however, we must recognize that legislation and regulation cannot provide absolute assurance that additional acts of bioterrorism will not occur. As important as our duty to attempt to prevent bioterrorism is, it is equally important to pursue aggressive research and public health improvements aimed at developing the most effective possible responses to acts of biological terror.
Those of us in the legislative, regulatory, academic, and scientific communities who must confront the prevention of bioterrorism face a dilemma. Implementation of restrictive controls to impede access to biological agents is inherently difficult and potentially could also deter the critical research and diagnostic activities to combat terrorism. Much of the material and equipment is in widespread use and commercially and internationally available; dangerous pathogens are naturally occurring; and, the research and technology knowledge base relevant to biological weapons is publicly available. This means that policy measures intended to limit access and use of dangerous biological agents may adversely affect legitimate research and clinical diagnostic testing. At the same time, we know that research and public health responses to terrorism are critical components of the public policy response to the threat that exists. All of us, therefore, must strive for the proper balance between safeguards that prevent bioterrorists from gaining access to select agents while not burdening important research or clinical diagnostic testing.
While we must deal with bioterrorism, we cannot lose sight of the fact that infectious diseases daily end the lives of thousands of Americans and tens of thousands around the world. Infectious diseases continue to be the third leading cause of death in the United States. Extreme control measures to prevent bioterrorism, instead of enhancing global security, could prove detrimental to that goal if scientists can no longer obtain authenticated cultures. We must remember that natural infectious diseases are a greater threat than bioterrorism. Infectious diseases remain the major cause of death in the world, responsible for 17 million deaths each year. Microbiologists and other researchers depend upon obtaining authenticated reference cultures as they work to reduce the incidence of and deaths due to infectious diseases.
Because the prevention and treatment of infectious diseases is critical to our population, we must minimize any adverse impact upon vital clinical and diagnostic research related to infectious diseases. The ASM believes that an essential part of obtaining the proper balance is cooperation and communication between and among government, academia, and scientific communities. The ASM is committed to a frank, open, and ongoing dialogue, and we welcome the opportunity presented by this Subcommittee and other members of Congress to work together to achieve the right balance between research, public health and law enforcement responses to the threat of bioterrorism. The ASM is committed to recommending approaches for additional policies that appropriately balance the crucial war on terrorism with vital research that is needed to counter terrorism and eradicate disease.
We continue to emphasize, that the Congress and the Administration must recognize that such an expansion of existing regulations requires additional financial and other resources for the CDC. The CDC must be funded properly if it is to carry out its important functions. Further, Congress must fund adequate prevention, control, and countermeasure programs on a national, regional, state, and local basis. We know, Senator Feinstein, that you and members of this Subcommittee and other members of Congress are committed to research and to development of countermeasure programs, and we welcome your understanding that such measures are very, very important.
While we recognize that much remains to be done, particularly in light of the recent shocking bioweapon attack on U.S. citizens, we should not overlook that progress has been made in developing safeguards against bioterrorism without unduly inhibiting research or clinical diagnostic testing. The 1989 Biological Weapons Act authorized the government to obtain a warrant to seize any biological agent, toxin, or delivery system the possession of which, under the circumstances, has no apparent justification for prophylactic, protective, or other peaceful purposes. The ASM worked with Congress to ensure that this legislation did not restrict legitimate research and the Senate report accompanying the bill stated that the bill would not interfere with such activities. The 1989 statute also authorized federal officials to intervene rapidly through an injunction or through a seizure made without a warrant based on probable cause. The right to intervene rapidly when there is probable cause to believe that possession of biological agents or toxins is not justified for peaceful purposes adds to the legal weapons against terrorism while protecting legitimate scientific endeavors.
The Antiterrorism and Effective Death Penalty Act of 1996 broadened penalties for development of biological weapons and illegitimate uses of microorganisms to spread disease. The ASM testified before the 104th Congress regarding the transportation of select agents and supported passage of Section 511(d) of the Act. Like the 1989 Biological Weapons Act, the Antiterrorism Act of 1996 protects dual public interests of safety and free and open scientific research through promulgation of rules implementing a program of registration of facilities engaging in the transfer of select agents.
The 1996 Antiterrorism Act expanded CDC's responsibilities and the regulatory structure for transporting dangerous biological agents. The Act added the responsibility to "prevent access to dangerous biological agents for use in domestic and international terrorism or for any other criminal purpose." It directs the Secretary of HHS to maintain a list of biological agents that have "the potential to pose a severe threat to public health and safety." The Secretary also must establish and enforce procedures for shipping such agents safely to ensure that laboratory facilities can appropriately handle, contain and dispose of them and must provide safeguards against access to them for illegitimate uses. Registration may be denied if there is "evidence that the facility has or intends to use covered agents in a manner harmful to the health of humans." The regulations authorize inspections of facilities, for cause or at random, to ensure compliance. Shipping institutions or individuals that wish to ship a select agent must check that the receiving facility is registered and must file a notification of the shipment with the registering facility.
The recipient must acknowledge receipt of the shipment. Importantly, the Antiterrorism Act of 1996 provides for "appropriate availability of biological agents for research, education and other legitimate uses." The ASM worked with the CDC to develop regulations that balance the needs for legitimate research and diagnostic testing with protection against the inappropriate acquisition of biothreat agents. The ASM also assisted in the development of a list of select agents that focused on the most dangerous with the highest potential for use as a biological weapon.
The final regulation exempts CLIA certified clinical laboratories if the agent is part of diagnostic, reference, verification, or proficiency testing. Isolates of covered agents from clinical specimens are to be disposed of after diagnostic, reference or verification procedures have been completed. This exemption ensures that clinical diagnostic procedures are not impeded and also averts the problem of having the system deal with several hundred thousand clinical laboratories and shipments of routine diagnostic specimens.
Regulations promulgated under the Antiterrorism Act of 1996 require that laboratories shipping and receiving select agents follow the biosafety guidelines in the CDC/NIH publication, "Biosafety in Microbiological and Biomedical Laboratories,'' Fourth Edition. These regulations effectively codify biosafety guidelines for laboratories receiving select agents. ASM members must abide by these regulations and the ASM provides information on the regulations and the necessity of compliance through its site on the Internet.
Indeed, the ASM favors extending the current CDC regulations to cover possession of select agents that may be used for bioterrorism. In 1999 ASM testified that additional measures should be taken to "prohibit possession of listed biological agents or listed toxins unless they are held for legitimate purposes and maintained under appropriate biosafety conditions." ASM supported "registration with the CDC of every institution that possesses and retains viable cultures (preserved and actively growing) of select agents along with the concomitant duty to follow all regulatory requirements related to such possession and usage. The ASM specifically recommended that:
"The CDC's responsibilities should include the duties to: (1) Continue to establish and periodically revise the list of select agents. (2) In accord with proper administrative procedures, promulgate any additional regulatory measures related to registration of facilities, establishment of biosafety requirements, institution of requirements for safe transportation, handling, storage, usage, and disposal of select agents, and the auditing, monitoring, and inspection of registered facilities. (3)The CDC should notify the Department of Justice about any concerns that it may have about institutions that possess select agents."
The ASM believed then, and continues to believe today, that the law should prohibit institutions and individuals from possessing cultures of select agents unless such institutions or individuals maintain the agents under appropriate biosafety and biosecurity conditions.
We believe H.R. 3162, Section 817, benefited greatly from discussions with the scientific community to avoid unintended consequences. The language originally proposed in early drafts of this provision illustrated the difficulties of criminalizing use of biological agents and did not take into account the fact that biological agents exist naturally in the environment. The final language in HR 3162, which we support, takes into account this qualification and excludes bona fide research from the reach of the revised Section 175 of Title 18.
The ASM agrees that the possession of biological agents, toxins, and delivery systems should be for prophylactic, protective, bona fide research, or other peaceful purposes. The ASM also completely agrees that some individuals should not have access to select agents. Therefore, we agree with the basic tenet of the provision that prevents restricted persons from knowing possession of a select agent. Candidly, the ASM believes the Act should have permitted the Attorney General, upon recommendation of the Secretary of HHS, to waive the prohibition against possession of select agents by aliens from countries designated as supporting terrorism if, and we emphasize this point, if there was a specific finding that a waiver for the particular individual served our national interest. However, our disagreement with the failure to provide the opportunity for a waiver for specific aliens does not diminish our support for the concept of setting reasonable limits upon persons who may possess select agents.
The ASM further supports the development of standards for possession of select agents to prevent access to such agents for use in terrorism. By placing this requirement within the structure of the Antiterrorism and Effective Death Penalty Act of 1996, Congress recognizes the benefits of using the existing regulatory system. The ASM concurs. The CDC is the only federal agency with the expertise and experience to act quickly and competently in this area. Further, and very importantly, the CDC currently possesses the confidence of the scientific community that it will act responsibly to balance the interests of preventing bioterrorism and advancing research in the area of infectious diseases and clinical diagnostic measures.
In summary, Congress has taken several significant steps in dealing with the threat of bioterrorism. Today, possession or use of a biological agent or toxin as a weapon is a serious criminal offense; knowing possession of a biological agent, toxin, or delivery system, of a type or quantity, not reasonably justified by peaceful purposes is a serious criminal offense; it is a serious criminal offense for persons who have engaged in specific types of misconduct to possess, ship, or receive select agents; a facility must register with the Secretary of HHS before transferring or receiving a select agent. These are significant steps in the right direction, but the ASM agrees that Congress must do more. We submit that, in taking additional action, Congress and federal agencies should continue to consult carefully with the scientific community to achieve the critical balance that is the underlying theme of our testimony.
Given that a number of legislative proposals are being considered, it is to that legislation that we now direct our attention. In the remainder of our testimony, we will address legislative proposals for: listing of select agents; registration of facilities possessing select agents; the definition of restricted individuals; imposition of civil penalties; unsafe handling provision; proposals for licensure of equipment; and the need for federal support of aggressive countermeasures programs.
ASM supports the need for periodic reviews of the list of select agents. These reviews must include consideration of agents that may be used in domestic or international bioterrorism. We believe that the CDC is the proper agency to lead such reviews. Such reviews must, and undoubtedly will, include close coordination and communication with other government agencies. Further, the CDC should view the scientific community as a partner in these endeavors. Only through active consultation with scientists may the CDC and other federal agencies hope to achieve a comprehensive, integrated regulatory system that serves the public interest by preventing terrorism without undue disruption of vital research and clinical diagnostic testing.
The ASM supports registration of laboratories that possess select agents and recommends that CDC conduct registration as an extension of the current select agent rule.
1. The Need for Registration. The CDC, acting in cooperation with the scientific and biomedical communities, and with public notice and input, should establish rules and provide regulations for governmental monitoring of possession of select agents posing a risk of bioterrorism. The registered institution must be responsible for assuring compliance with mandatory procedures and for assuring fully appropriate biosafety mechanisms, including appointment of a responsible official to oversee institutional compliance with biosafety requirements. It is the institution that ultimately is responsible for ensuring compliance with its legal and regulatory obligations.
These institutional responsibilities include assuring safety through proper procedures and equipment and through training of personnel. Thus, the institution must bear the final responsibility for training employees regarding the biosafety requirements, including the necessity for following those requirements, including such duties as reporting isolation of select agents or any breach in a biosafety protocol.
As institutions comply with appropriate safeguards, scientists may undertake their research with knowledge of clear procedures and with assurance that compliance with such procedures fulfills governmental requirements related to select agents. The institutions also should be required to maintain records of authorized users and to ensure that users are properly trained, as is currently the case for work with radioisotopes. Intentional removal of select agents from a registered facility should subject the individual to criminal sanctions.
However, in light of the expedited deadlines that are likely to be imposed for initial reporting, facilities should be allowed to report select agents found after the initial reporting deadline without incurring severe penalties. If strong sanctions are imposed at an early point, some institutions may be forced to destroy collections if they have not been able to determine whether they are free of select agents by the reporting deadline. Time is of the essence, and compliance with appropriate procedures is important. However, we need not act with such haste in the reporting area that entire collections are lost solely due to the inability to complete an inventory process by an arbitrary deadline.
2. Procedures: Registration, Inspections, and Regulations. CDC has an existing inspection mechanism. Additionally, the existing select agent rule incorporates biosafety and biosecurity procedures from the CDC Biosafety Manual. That manual is an appropriate starting point for standards and procedures in laboratories possessing select agents. The ASM understands that this Subcommittee is considering a "certification" program. We are not certain whether "certification" would mean something more than mandatory registration, safety and security procedures, standards, training, proper laboratory facilities to contain and dispose of select agents, and inspections, all of which the ASM supports.
We believe reasonable allowance should be made for the reporting of select agents later if they are discovered in inventories of archived samples. Otherwise, laboratories may need to destroy potentially valuable research tools. Institutions should report possession when they become aware of an agent they did not know they possessed without penalty.
3. Congress Must Recognize that Pathogens Occur in Nature and Craft Legislation Accordingly. Current legislative proposals appear to deal exclusively with research laboratories and to ignore the clinical side of the microbiological sciences. Consequently, the proposals ignore many of the exclusions that need to be made and which have been recognized in other legislation.
For example, regulations should provide exemptions for laboratories on the same basis as they are granted under the current regulations for shipment and receipt of select agents at 42 CFR § 72.6(h). Further, the proposals should exempt state public health and veterinary laboratories as they deal with naturally occurring pathogens without any effort to cultivate, collect, or extract such pathogens in a manner that lends itself to bioterrorism or public health risk.
In this vein, we know that Congress understands that pathogens exist in nature and people develop diseases from some of these pathogens each year. We recognize that the proposed definitions of a biological agent and toxin exclude a biological agent or toxin that is in its naturally-occurring environment, if it has not been cultivated, collected, or otherwise extracted from its natural source. ASM is uncertain that such language will prevent the unwarranted application of penalties to areas of scientific inquiry of naturally occurring phenomena. Legislation should focus on cultures rather than organisms.
4. Laboratory Practices. Registration with the CDC is tantamount to certification under current law. Language in some proposals we have seen raises difficult issues related to laboratory practices and the scope of application of procedures to individuals. Are individual couriers (or their employing enterprises) that transport select agents going to be certified? The scientific community must be able to get samples through the Laboratory Response Network to the public health labs and the CDC. In addition, cultures of some of these agents are transported to reference laboratories for identification. Certainly, proper procedures must be established and followed for the shipment of select agents but the CDC will need to consider carefully each of these special circumstances in developing regulations. Congress should not mandate procedures that prevent such consideration and the crafting of regulations that protect the public but permit maximum, appropriate freedom for the scientific research community and as expeditious as possible action by clinical diagnostic laboratories. Again, the ASM believes the CDC's Biosafety Manual, which covers both biosafety and biosecurity, should be the starting point for such regulations.
5. Disposal of Select Agents. Although the specific mandate may be left for regulation, ASM suggests that an appropriate authority should require destruction of pathogens within laboratories rather than through disposal as medical waste. Although the ASM does not discount entirely the possibility for exceptions, as a rule, pathogenic organisms should be destroyed (even by clinical laboratories) inside the laboratory. These materials should be autoclaved or killed by other means before disposal as waste in landfills. We recognize that this could require significant costly changes in protection currently employed by some diagnostic laboratories.
6. Protection of Intellectual Property. The ASM recognizes that existing legislative proposals contain provisions protecting information on registration statements from disclosure under the Freedom of Information Act. Certainly, such a provision must be included in any legislation. Congress, CDC, and other federal agencies must respect and protect the intellectual property rights of individuals and enterprises. Any authorized disclosure of such information must result in the imposition of a penalty upon the person, including government employees, responsible for a violation. We must be certain that confidential information is secure and protected.
7. Physical Security of Facilities. CDC and research laboratories recognized previously that the regulatory regime governing access to, and use of potentially dangerous biological agents, needed to anticipate theft or intentional misuse. Existing biosafety guidelines categorize biological agents into four groups according to the highest level of physical containment that is necessary to protect those who work with these agents or those in the surrounding environment. They specify access controls and physical barriers to agent release. In our new environment, CDC and laboratories will need to review carefully requirements for the physical security of facilities that house select agents. We must prevent unauthorized individuals from obtaining these agents.
Government must recognize that increased security and limiting access to select agents will impose costs and other burdens on facilities and researchers who use these agents for legitimate research.
The ASM urges, as with all aspects of eventual regulations, that the government impose security measures that are proportionate to the expected improvement in public safety. ASM will support such rational measures and is confident that the research community will accept costs that are proportionate to their benefits. As institutions develop and institute new standards for physical protection resulting in increased financial and operational implications, government assistance in offsetting costs of such security improvements is appropriate.
At the same time the ASM recognizes and supports the need for heightened awareness of the need for physical security, it recognizes that there are various sources of supply of dangerous agents. There should be no illusion that tightening security and access controls at research institutions in the United States will solve the bioterrorism problem. To the maximum extent possible, the United States should strive to extend reasonable physical security standards to laboratories on an international basis.
Congress must recognize that research regarding the causes and remedies for infectious disease proceeds on a global scale. For example, hundreds of foreign scientists attend scientific conferences, not just to learn but to contribute importantly to the exchange of scientific information. There are many hundreds or thousands of foreign nationals at work in laboratories in the United States where they are contributing to biomedical research.
A broad, mandatory prohibition that could significantly exclude qualified aliens from work in research and diagnostic laboratories is not in the best interest of the United States. The broad exclusion of aliens could have a serious impact on academic medicine. Almost certainly, it would restrict collaborative studies and critical training of individuals who will deal with the many diseases that occur throughout the world requiring advanced diagnostic methods and treatments.
1. Treatment of Aliens. Under the USA PATRIOT Act (H.R. 3162), the term "restricted person" includes aliens from countries designated by the U.S. as supporting terrorism. H.R. 3160 goes further and would expand that exclusion to all aliens admitted to the United States under a non-immigrant visa. We recognize that H.R. 3160 permits the Secretary to designate categories of individuals who have expertise valuable to the United States. However, without knowing the intended scope of this provision, we are very concerned that the initial classification of all aliens as restricted persons may adversely affect legitimate and essential biomedical research, including diagnostic laboratories. These laboratories are critical for diagnosing anthrax and diseases that may be caused by other biothreat agents.
ASM favors the narrower restriction on individuals from countries that are designated as supporting terrorism as enacted in the USA PATRIOT Act (H.R. 3162). Even then, as we testified before, we believe that Congress should authorize the Attorney General to grant a waiver for specific foreign nationals from those nations when it is in the interest of our nation.
If Congress finds that it must impose broadened restrictions on alien scientists, the Committee could include a special provision regarding registration by aliens and/or by the facility at which they work. Such a specific statement would alert authorities to the identity and presence of an alien at a facility and permit a greater degree of scrutiny. Finally, if Congress decides to retain a general prohibition, it should modify the current waiver language ("expertise valuable to the United States regarding select agents") to permit the Secretary to include other categories that the Secretary finds to be "in the interest of the United States."
2. Testing of Drug Abusers. The definition of "restricted persons" in H.R. 3160 refers to 18 U.S.C. § 922(g) that, in turn, includes any person "who is an unlawful user of or addicted to any controlled substance." The ASM assumes that inclusion of this category of individuals within the meaning of restricted persons will not require mandatory pre-employment or on-going drug testing of employees. If Congress intends to require mandatory drug testing, it should do so explicitly rather than through reference to 18 U.S.C. § 922(g).
Current legislative proposals establish very substantial civil penalties for individuals or entities that violate regulations on the shipment, receipt, or possession of select agents. These penalties may reach $250,000 on individuals and $500,000 on any other person. The present regulations governing shipment and receipt of select agents provide for a criminal fine or penalty for violations of the regulations. To the best of the ASM's information, no prosecution has occurred under this provision. Of course, there is a substantial difference between a criminal prosecution under a "reasonable doubt" standard of proof and the imposition of a civil penalty.
As we testified earlier, the ASM envisions an integrated, comprehensive set of guidelines for the possession of select agents. The ASM has suggested that the CDC's guidelines in its manual "Biosafety in Microbiological and Biomedical Laboratories" should be the starting point for any regulations.
Imposition of civil penalties on individuals or facilities is an area in which it is especially important to strike the proper balance between deterrence of bioterrorism and protection of the public welfare versus discouragement of scientific research and clinical laboratory diagnostic testing. The ASM understands and supports the need for a substantial inducement for compliance with regulations regarding possession of select agents. At the same time, the Committee should recognize the significance of imposing civil penalties and the impact of potential penalties up to $250,000 on individual employees. A civil penalty provision must be a thoughtful and well-designed provision.
The provision should take into account and specify: (a) in the first instance the facility, rather than an individual, is liable; (b) standards for determination of the amount of a penalty based upon a host of factors including the size of the facility, the significance of the violation, the degree of culpability, and other factors; (c) mitigating circumstances; (d) the means for adjudicating liability for, and the amount of, the penalty, (e) other factors related to a system for adjudicating civil liability. The Committee should not adopt a measure that simply provides for a penalty without any of the details necessary to assure the fair and appropriate administration of the penalty. To do so would engender unnecessary and unwarranted fears and burdens upon the very persons who are at the forefront of dealing with the threat of bioterrorism as well as the ongoing hardship of infectious diseases.
The ASM supports the principle that scientists must follow safe practices. Perhaps more than anyone else, ASM members recognize that unsafe handling of such agents places workers and the public at severe danger.
Of course, requirements related to handling procedures are largely not relevant to the prevention of bioterrorism. The prospect of a criminal penalty for unsafe handling of select agents will not deter a bioterrorist. Only in the area of assuring the security of select agents are handling procedures related to bioterrorism.
Handling procedures are relevant to the more general issue of protecting the public welfare related to laboratories that possess select agents. However, the specter of severe criminal penalties on the basis of laboratory procedures raises perhaps one of the most difficult areas for balancing between protection of the public and chilling the willingness of laboratories and scientists to engage in important research. Criminal penalties based on imprecise legal standards may unduly impede research. The ASM believes that the urgency with which the Congress is now dealing with the threat of terrorism does not make this a good time to strike the appropriate balance in this area. In this regard, the ASM does support the registration of laboratories and individuals. It further supports a duty to comply with "Biosafety in Microbiological and Biomedical Laboratories,'' Fourth Edition.
For the present, the ASM believes regulations based on these standards and practices by laboratories in the context of the registration process is the best approach in this area as they provide standards that are clear and coherent, streamlined and integrated, based on real risks, and effectively communicated to research facilities and individual researchers. It allows the scientific community a better understanding of what they are prohibited from doing, rather than attempting to follow an amorphous negligence or recklessness standard that is understood by attorneys but with which most scientists are unfamiliar. The goal of legislation must be sound scientific practices rather than a chilling of scientific inquiry through the threat of criminal penalties under imprecise standards.
The ASM understands and appreciates the concept that it may be easier to control the possession of pieces of equipment used for manufacture of weapons of bioterrorism than the actions of individuals or the quantities of select agents. The ASM further appreciates that, rather than specifying equipment or controls, the proposed legislative language we have seen would require promulgation of regulations after consideration of a broad range of factors. Indeed, in many respects, it is accurate to say that the weaponization of a biological agent raises engineering issues rather than microbiological issues.
At the same time, to be realistic, we must recognize that efforts to control equipment almost invariably encounter the problems that would limit the effectiveness of such measures. For example, equipment that could produce biological weapons is in wide use and as equipment is regulated, terrorists will turn to other types of equipment.
It is our understanding, for example, that UNSCOM revealed that Iraq was able to produce large quantities of biological weapons without using sophisticated fermentors. As worrisome as it may be, small flasks, canisters, home brewing bottles, and other similarly mundane equipment provide all that is needed to grow the bacteria that cause anthrax, plague, and other select agents. Thus, we must at least question the benefits of establishing any significant regulatory burden on a list of equipment and particularly the types of equipment found in many research and clinical laboratories as well as the biotechnology industry. For example, virtually every industrial biotechnology operation uses controlled fermentors. Every pharmaceutical company uses them and many universities have this equipment as well.
To cover the size relevant for bioterrorism one would have to capture everything of 5 liters and above and that would still not eliminate the possibility of growing the organisms in simpler vessels. Similarly, large temperature controlled centrifuges are present in virtually all microbiology and biochemistry laboratories, often many per lab. Certainly, biosafety hoods are present in most if not all clinical labs as well as many research labs. These hoods prevent environmental exposure to the pathogens being worked on. Freeze drying equipment is very widely distributed in research labs as well as in various industrial settings such as coffee making.
In essence, this is a cost-benefit issue for the Congress. There may be relatively little to gain by imposing an extensive regulatory regimen on widely used legitimate equipment, such as centrifuges, laminar flow hoods and fermentors. Indeed, we again point out that at this point, we do not know if the anthrax used in the bioterrorist attacks was produced overseas or in domestic facilities.
The ASM endorses significant government funding for development of countermeasures. Although we can never provide absolute protection, we can take aggressive steps to be prepared to control and counteract an attack. We need to be better prepared for a bioterrorist attack by spending the time, effort, and funds necessary to develop new vaccines and pharmaceuticals. Of course, we hope that we never need to use such new products to deal with a substantial bioterrorist attack. If one occurs, however, we need to have such protection. If we are fortunate and avoid such attacks, then the research inevitably will serve the important purpose of combating infectious diseases and, therefore, will serve the interest of every person on the globe.
In conclusion, legislative actions to enhance national security by adding protection against the criminal acts of bioterrorism can and must be done in a way that does not have a detrimental impact on the legitimate biomedical research. We need to improve the health of Americans and those beyond our shores. We need to ensure that we will have the vaccines, pharmaceuticals, and diagnostic capabilities to protect the public health of all Americans in the future from both natural infectious diseases and those from criminal bioterrorist attacks.
In doing so we must recognize that biomedical research is a global effort. If we fail to eradicate infectious diseases that occur primarily in other countries we run the risk that those diseases will threaten our country. We must work across international borders to improve public health and to combat the natural occurrences of infectious diseases that threaten global security. We cannot isolate our biomedical research community by excluding those legitimate scientists from other countries who like American scientists are fighting against the dreaded impacts of infectious diseases. The war against infectious diseases and the scientific and university communities around the world must join in the battle against bioterrorism.
We support a strengthened biological weapons convention that would criminalize the misuse of biological agents and the establishment of acceptable normative practices for the shipment, possession and safe use of select agents. We support the ongoing initiative of the Administration to strengthen the Biological and Toxins Weapons Convention and to achieve this aim through mechanisms that would harmonize the legal and regulatory frameworks for the possession, use and exchange of select agents, adopted in the United States with those of other nations. We support the efforts of Congress and the Administration to deter bioterrorism and provide strict criminal penalties for those who carry out egregious acts using biological weapons.
Even as we strive to prevent bioterrorism, we must recognize that no set of regulations can provide absolute protection against bioterrorism. Even as we strive to prevent acts of bioterrorism, we also have a duty to pursue research and public health improvements aimed at developing the most effective possible responses to acts of biological terror. Research and public health responses related to effectively combating an act of terror are a critical component of the public policy response to the threat that exists.
|
Source: U.S. Government Website |