Band 3, Heft 1

The purpose of this document is to provide an introduction and overview regarding the substantive materials included in Volume 3 of the Journal for Biosecurity, Biosafety and Biodefense Law. This volume raises new and important legal issues within the field of biosecurity, biosafety and biodefense law, both from a practical as well as a theoretical perspective.

The American whistleblower protection scheme as applied to whistleblowers in the laboratory context is a complex patchwork of federal, state, and local laws. Substantial differences in whistleblower protection for laboratory employee whistleblowers depend on a number of factors, including whether the laboratory employee whistleblowers work for public or private institutions and the location of the whistleblower. This document provides a basic summary of the American whistleblower protection scheme applicable to workers employed in laboratories in the United States, with a focus on biological laboratories, and those working with select agents, which are highly infectious agents that warrant special regulations for public safety and national security reasons.

Despite the attacks of September 11th and other subsequent terrorist attacks, the world community, as a whole, seemingly fails to comprehend the high risk of a biological health incident. Not only can an infectious disease cause significantly more damage than any number of physical terrorist attacks combined, but the relative ease with which an outbreak can occur is frightening. Such biological health threats are compounded by the possibility that such outbreaks may result from the lack of malicious intent. Thus, the question becomes more of a matter of when, not if, a major outbreak will occur. The global population needs to be aware of the imminent threat that a biological outbreak poses, especially during international travel. Because of the imminent nature of a likely biological disaster, countries need to be well prepared to handle such situations. History has shown that even the most developed and technologically advanced countries have failed at controlling extreme biological situations. The increasing charge of international flight travel further magnifies the fragile nature of global health. A small incident with a single patient can snowball quickly into a world-wide pandemic, well before anyone is even aware of a problem. As a result, countries have a vital interest in regulating international flight patterns and follow various rules and regulations in order to promote safe and efficient air travel. This paper examines the different legal issues and authorities that would come into play and then provides recommendations to address biologically threatening situations.

This article seeks to answer the question: What would have changed, had the World Health Organization spearheaded the investigation of the Yellow Rain Incident instead of the U.S. State Department? This article will begin with a brief discussion of the Yellow Rain Incident. It will then describe the role and function of the World Health Organization. Next, it will begin analyzing ways in which the World Health Organization could have participated in the investigation of the Yellow Rain Incident. This discussion will also analyze the level at which the World Health Organization could participate in an investigation had the Yellow Rain Incident happened today. Finally, the discussion will return to the original question and attempt to offer an answer after having considered all of the facts and data.

Biological warfare has been used longer than most conventional weapons, yet international and domestic response protocol and regulations designed to effectively manage, investigate, and prosecute biocrimes have only recently been implemented. Even with such protocol and regulations, significant difficulties arise in the investigation and prosecution of perpetrators. This article will identify and describe many of these challenges, beginning with the scope of biocrimes, which can generally be defined as a malevolent use of pathogens or toxins to harm others. Other challenges surrounding the investigation of biocrimes which will be addressed within this article include: identifying what biological agent caused an illness or disease outbreak; characterizing the event as a deliberate attack or a naturally occurring outbreak; and balancing an infected person’s civil liberties with conducting a thorough and accurate investigation. The final significant challenge of investigation and prosecuting biocrimes is the extremely high cost of mistakes. Ultimately, this article recommends ways to remove some the challenges to investigating and prosecuting biocrimes through greater information sharing and standardized investigative and prosecutorial training.

One of the nation’s most complex investigations in its history stemmed from the 2001 anthrax attack letters. Filled with dead-ends, false leads, and flustered FBI and Postal Inspection officers trying to grapple with intricate scientific details, the Amerithrax investigation caused many to question the efforts of America's forefront investigative entity. The specialized American bioweapons community remained in a constant state of paranoia from late 2001 to 2008, and over 30,000 members of the American Society for Microbiology received a letter indicating the high probability “that one or more of you know” the anthrax killer. Finally, in 2007 the Amerithrax Task Force named Dr. Bruce Ivins, a civilian bioweapons specialist at the United States Army Medical Research Institute for Infectious Diseases (USAMRIID), who only a few years before helped the officers sort through the complicated task of studying the weaponized anthrax, as the prime suspect. Investigative efforts ratcheted up in fall of 2007 when a series of warrants were issued to search Dr. Ivins’ home, office, and vehicles.Since the ratification of the Fourth Amendment in 1791, the United States has recognized the importance of a system with laws designed to prohibit unfettered investigations by the leaders of our country. This paper analyzes the search warrants utilized in the Dr. Ivins’ investigation and discusses the Fourth Amendment implications. First, a brief review of the state of America in September 2001 is detailed. Next, the paper discusses the facts of the Amerithrax investigation, including the mishap involving Steven Hatfill. Section III explains some Fourth Amendment search warrant basics before getting to the meat of this analysis: the actual search warrants of the Amerithrax investigation.

The majority of the bioterrorism articles and reports written since the 2001 anthrax attacks in the United States have focused on the threat of biological weapons or biological agents directed towards human targets. Although this threat should not be diminished, it is only one aspect of the human environment that is susceptible to attack. Effective attacks could be mounted against the food chain outside the United States on imported food bound for the United States. These potential attacks bear the risk of going undetected until individuals or animals consume tainted products. This article focuses on the role that regulations play in protecting the food chain from these international attacks, and addresses some of the complications that arise from the current legal framework.

Synthetic biology promises to be one of the most exciting developments in bioengineering. Through synthetic biology, scientists can now recreate the genomes of extinct organisms, modify existing organism to give them functions that they previously never possessed, and eventually create novel organisms entirely. Synthetic biology has attracted the attention of both professional scientists as well as the attention of a growing movement of amateur biologists, a testament to the increasing democratization of previously rarefied science. As a result, while this powerful new technology, along with the increased dissemination of its techniques and methods, may lead to greater influence in the future and to substantial benefits for society, it also raises concerns for biosecurity. Consequently, scientists and policy makers have begun to seriously consider the issues posed by this developing science in the context of a world where such knowledge and technology is becoming widely accessible to the general population. Part one of the paper will provide background on synthetic biology and do-it-yourself biology, briefly describing their nature, prospects, and risks to biosecurity. Part two of the paper will shift the focus from description to evaluation. It will summarize some of the existing policy responses to this issue and legal infrastructure within the United States before arguing for a holistic approach to addressing this issue. Then the focus will be upon three separate areas of possible regulation while noting some of the interconnections between these areas.

The purpose of this Paper is to analyze the question of whether the Department of Health and Human Services should impose greater regulations restricting individuals from donating blood for transfusions in order to prevent transmission of diseases which blood donors may have unknowingly acquired abroad. Discussion of this question requires an analysis of: (1) what types of diseases can be transmitted via blood transfusion; (2) what tests are conducted on donated blood; (3) what is the balance between the desperate need for donated blood and the necessary precautions to be taken; and (4) what impact would regulations have on an individual’s willingness to donate.This Paper proposes implementing regulations and restrictions to act as safeguards against the spread of foreign acquired diseases. Part I discuses the current regulations of the blood donation process. Part II discusses diseases an individual can contract while traveling abroad. Part III proposes a policy that addresses the risk of foreign disease epidemics promulgated through the blood donation system. Finally, Part IV discusses the implications of the implementation of such measures.

Foot-and-mouth Disease (FMD) is a devastating viral disease that affects all domesticated cloven-hoofed animals and over seventy species of wild cloven-hoofed animals. The virus is highly infectious and extremely communicable. There has been an outbreak in virtually every corner of the world, and it is currently present in every continent besides North America and Australia. FMD has the potential to cause severe economic losses resulting from poor animal yields, bans on livestock exportation, and expenses involved in eradication and control. FMD can also have a distressing social and psychological toll on those affected. This article will discuss the development of the disease, historical outbreaks and threats, and evaluate the infrastructure currently in place to prohibit future outbreaks.

This article seeks to determine whether countries in the global community have governance systems or domestic laws that will enable them to be effective in their preparation and response to influenza pandemics. It begins by analyzing the 2009 H1N1 pandemic, discussing the events leading up to Mexico triggering the IHRs and determining which aspects of Mexico’s pandemic influenza preparedness and response should be used again in the future and which should be retired. It will then take a closer look at how six WHO member states—Australia, Canada, France, Japan, the United Kingdom, and the United States—have or have not integrated lessons learned from the swine flu into their own plans for outbreaks of influenza, evaluating the plans from a comparative perspective in order to determine which plans provide the best guidance for the future.