Guest Editorial: Special Focus on the Pathology of Biological Select Agents and Toxins in Animals and Research Challenges in Biological Defense

Outbreaks of highly pathogenic agents such as those that cause anthrax, smallpox, influenza, and Ebola fever have affected humankind and animals throughout recorded history. These and other agents make up the so-called biological select agents and toxins (BSATs), a specific group of pathogens that pose a severe threat to human, animal, and plant health and are of significant concern as potential agents of biowarfare or bioterrorism. The BSAT list is published as part of the US Code of Federal Regulations (42 CFR 73.3). Other pathogens not on the current list are also significant causes of disease in humans and animals. Accordingly, research with these agents is subject to a number of safety, security, and regulatory requirements. BSATs have been used as weapons of biological warfare for hundreds of years. For example, historical records show that the Mongols hurled the bodies of plague victims over the city wall of Caffa during their war with the Genoese in the 14th century in an effort to infect the city’s inhabitants. In the late 19th century, British forces fighting in the French and Indian War were reported to have deliberately given Native Americans blankets believed to be infected with smallpox virus. A number of countries have conducted biological weapons programs during the 20th century. A watershed event occurred in 1972, when the production of biological weapons was outlawed by the Biological Weapons Convention, as signed by the United States and more than 100 other countries. In spite of the convention, research on offensive bioweapons has occurred since that time, as evidenced by the former Soviet program known as Biopreparat. Interested readers are referred to a number of resources that document the history of biological warfare, such as those by Alibek, Eitzen, and Martin. The use of biological agents as an act of terrorism is generally a more recent occurrence, highlighted by the mailing of the anthrax letters in 2001 that resulted in several human fatalities and caused great anxiety in the United States. Fears that terrorist groups such as al-Qaeda and others might obtain and use biological weapons have increased steadily since 2001. The US Commission on the Prevention of WMD Proliferation and Terrorism (http://www.preventwmd.gov) recently expressed great concern about the threat of bioterrorism and the international community’s efforts to deal with the threat. The commission issued its report World at Risk in 2008 and a follow-up assessment, The WMD Report Card, in January 2010. This later report emphasized the critical need to develop medical countermeasures to thwart the use of biological weapons, estimating that such efforts would require an investment of billions of dollars in the next few years. The dangers posed by BSATs and other hazardous pathogens, whether in nature or through intentional dissemination, require that a variety of vaccines, antibiotics, and other drugs and biologics be developed. However, many factors complicate the development of such medical countermeasures. Certainly, the scientific and regulatory challenges are extensive in bringing needed products to licensure for use in humans. There is also the necessity to handle these infectious agents and toxins safely and securely during research. Finally, there are political and societal issues related to research involving BSATs. For these and other reasons, efforts aimed at developing the medical products needed to prevent or treat pathogens of high consequence face many hurdles. A limited number of institutions have the physical capabilities—including biocontainment facilities and other safety, security, and personnel systems—needed to conduct research involving BSATs. Historically, biodefense research in the United States has fallen on three agencies—the Department of Defense at the US Army Medical Research Institute of Infectious Diseases, the Department of Agriculture, and the Centers for Disease Control and Prevention. The number of biocontainment laboratories has proliferated significantly in recent years, however, owing to the increased concern about biological agents and the need to develop countermeasures to address these concerns. Recognizing that BSATs represent a significant threat to civilian populations, the US National Institute of Allergy and Infectious Diseases has taken on an increasingly greater role in biodefense research, including the development of a system of national and regional biocontainment laboratories (http://www.fas.org/programs/ssp/bio/resource/research. html). In addition, laboratories affiliated with other elements of the US government are in different stages of development. These include the National Biodefense Analysis and Countermeasures Center and the National Bio and Agro-Defense Facility, components of the Department of Homeland Security. The Veterinary Pathology 47(5) 772-773 a The American College of Veterinary Pathologists 2010 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0300985810377311 http://vet.sagepub.com