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PubMed2006

Regulating biorisks: Developing a coherent policy logic (part I).

This is the first of two articles empirically detailing the working practices of regulators who are charged with overseeing biological research. Specifically, it considers how regulators from the Biological Agents Unit of the UK Health and Safety Executive review notifications and applications, carry out inspections of research centres, and enforce the law once breaches are uncovered. This first article focuses on the Unit's working practices before 9/11, and the second, forthcoming article focuses on the Unit's working practices after 9/11. I argue that an understanding of the implementation processes--that is, the strategies adopted by regulatory agencies and the styles employed by agency regulators in their interactions with those regulated--is critical to developing a coherent policy logic for the developing regulatory regime around biorisks.

Academies and Institutes↗
PubMed2006

Comments from the Center for Biosecurity of UPMC on proposed revisions to federal quarantine rules.

On November 30, 2005, the U.S. Centers for Disease Control and Prevention (CDC) proposed changes to federal quarantine regulations (42 CFR Parts 70 and 71). As stated in the proposed rules, the intent of changes is "to clarify and strengthen existing procedures to enable CDC to respond more effectively to current and potential communicable disease threats." Parts 70 and 71 of 42 CFR authorize the Secretary of the Department of Health and Human Services (HHS) to make and enforce regulations "as in his judgement are necessary to prevent the introduction, transmission, and spread of communicable diseases" from foreign countries (Part 71) and between states (Part 70). The Center for Biosecurity of UPMC reviewed the proposed revisions to the quarantine regulations and submitted to CDC the following analysis as its official comments on the revised rules.

Bioterrorism↗
PubMed2006

The dual-use dilemma for the life sciences: perspectives, conundrums, and global solutions.

The term "dual-use" traditionally has been used to describe technologies that could have both civilian and military usage, but this term has at least three different dimensions that pose a dilemma for modern biology and its possible misuse for hostile purposes: (1) ostensibly civilian facilities that are in fact intended for military or terrorist bioweapons development and production; (2) equipment and agents that could be misappropriated and misused for biological weapons development and production; and (3) the generation and dissemination of scientific knowledge that could be misapplied for biological weapons development and production. These three different aspects of the "dual-use dilemma" are frequently confused--each demands a distinct approach within a "web of prevention" in order to reduce the future risk of bioterrorism and biowarfare. This article discusses the nature of the different perspectives and divergent approaches as a contribution to finding a scientifically acceptable global solution to the problem posed by the dual-use dilemma. We propose that: (1) facilities that are intended for bioweapons development and production should be primarily prevented by a strengthened Biological and Toxin Weapons Convention (BTWC) effectively implemented in all nation states, one that includes provisions for adequate transparency to improve confidence and a mechanism for thorough inspections when there is sufficient cause, and enhanced law enforcement activities involving international cooperation and sharing of critical intelligence information; (2) potentially dual-use equipment and agents should be available to legitimate users for peaceful purposes, but strengthened national biosafety and physical and personnel biosecurity controls in all nations together with effective export controls should be implemented to limit the potential for the misappropriation of such equipment and materials; and (3) information should be openly accessible by the global scientific community, but a culture of responsible conduct involving the breadth of the international life sciences communities should be adopted to protect the ongoing revolution in the life sciences from being hijacked for hostile misuse of the knowledge generated and communicated by life scientists.

Access to Information↗
PubMed1990

The NIH "Points to Consider" and the limits of human gene therapy.

In this essay, I examine the sources and reach of the NIH "Points to Consider." These guidelines are based on normative considerations inherited from two sets of science policy deliberations that took place in the United States during the 1970s: the discussion of research with human subjects and the recombinant DNA debate. The combined lessons of those deliberations provide six criteria by which to evaluate human gene therapy proposals. While these criteria could be used to reject proposals to attempt germ-line gene therapy or enhancement engineering today, they provide no principled basis for publicly proscribing the development of these forms of genetic intervention. Instead, they will ultimately lead us to approach the moral limits of gene therapy as a professional policy question about the goals of medicine, rather than as a social policy question about the public good.

Advisory Committees↗
PubMed2006

Epidemiology of a primary pneumonic plague in Kantoshu, Manchuria, from 1910 to 1911: statistical analysis of individual records collected by the Japanese Empire.

BACKGROUND: Among the potential uses of Yersinia pestis, intentional release of its aerosolized form, causing person-to-person transmission, is thought to be the most threatening. With the current rarity of pneumonic plague epidemics, our epidemiological knowledge remains insufficient for detailed characterization of effective control measures. METHODS: Temporal patterns and key biological parameters of a pneumonic plague epidemic in Manchuria from 1910 to 1911 were analysed based on historical records collected by Kanto Totokufu, the administration of the Japanese Empire in Manchuria at that time. The serial intervals were fitted to gamma distribution using the maximum likelihood method, and time-delay distributions from onset-to-admission, admission-to-death, and onset-to-death were investigated. RESULTS: Whereas a total of 228 cases were diagnosed with pneumonic plague in areas under direct control of the Japanese Empire, 4,781 cases were also recorded in surrounding areas. Although the epidemic grew exponentially in the early phase, the average doubling time steadily increased reflecting successful control efforts. The estimated mean serial interval (and standard deviation) was 5.7 (3.6) days. All cases with known dates of onset were admitted to hospital within 4 days after onset, and the mean time from onset to admission was 1.1 (0.4) days. CONCLUSIONS: The increase in doubling time demonstrates the efficient and rapid countermeasures employed. Since the short interval from onset to death implies the importance of rapid responses, the challenge in confronting a future bioterrorist attack is to implement rapid and appropriate integration of control measures both at the individual and community level to prevent further transmissions as well as lower case fatality.

Containment of Biohazards↗
PubMed2005

Facility design considerations for select agent animal research.

The events of September 11, 2001, have piqued US interest and investment in infectious disease research and the facilities that support the research. Since 1999, federal grants for biosafety level (BSL)-3, -3 agricultural (Ag), and -4 research have increased by more than 900%--to 13.1B dollars in the fiscal years 2002 to 2004 compared with 1.2B dollars from 1999 to 2001. This dramatic growth has forced experienced professionals from government agencies, universities, industry, design firms, commissioning firms, and contractors to work together to construct buildings that meet the demanding and unique needs of the research. This discussion pertains primarily to select agent research and provides (1) an overview of the guidelines and standards pertinent to the design and construction of biocontainment research facilities using animals, (2) design considerations appropriate for these facilities, (3) special requirements associated with BSL-3Ag agricultural research, and (4) information to prepare for the use of a state-of-the-art infectious disease research facility.

Animal Experimentation↗
PubMed2005

Issues related to the use of animals in biocontainment research facilities.

The expansion and improvement of high-containment animal facilities has been driven by terrorism, economics, the emergence of new pathogens, and the re-emergence of other pathogens in new areas. Working with highly infectious viral agents requires a team of trained scientists, laboratory technicians, veterinarians, animal care staff, biological safety officers, engineers, and physical plant staff to ensure safety, biocontainment, and the animals' well being, while providing essential scientific data. The challenges of working with infectious disease agents in high levels of containment, and some solutions to these challenges, are described from an animal care point of view.

Animal Experimentation↗
PubMed2005

Select agent regulations.

In recent years, there has been an increase in research with biological agents, particularly those that pose a potential for use by terrorists. In this environment, laws have been enacted and regulations developed to ensure the appropriate use of specified "select agents and toxins" for legitimate research. Within this regulatory environment, it has been necessary for institutions and investigators to adapt to an entirely new set of requirements to begin or continue to work with these pathogens. Registration and approval for use of select agents and toxins, security and safety requirements, and daunting record-keeping requirements are only some of the regulatory challenges that researchers face in working with these agents. A brief overview of recent regulations is presented, as well as where to obtain additional information on regulations, standards, and guidelines related to work with select agents and toxins.

Animals↗
PubMed2005

Working with transmissible spongiform encephalopathy agents.

The family of illnesses called transmissible spongiform encephalopathies (TSEs), or "prion" diseases, is composed of a small number of human and animal neurodegenerative diseases caused by unique pathogenic agents that are still not fully defined. They are best considered as "protein-misfolding diseases" (together with Alzheimer's disease, Parkinson's disease, and a few other rare examples) resulting from the conversion of a normal body protein into a misfolded amyloid multimer. The pathogenic agents display a unique resistance to conventional disinfection methods and an extraordinary environmental durability, which has led the US Department of Agriculture to designate the causative agent of bovine spongiform encephalopathy as a bioterrorism security threat. In this review, precautions and regulations concerning the handling of TSE agents are discussed in relation to personnel and environmental biosafety.

Animals↗
PubMed2005

Containment of arthropod disease vectors.

Effective containment of arthropod vectors of infectious diseases is necessary to prevent transmission of pathogens by released, infected vectors and to prevent vectors that escape from establishing populations that subsequently contribute to increased disease. Although rare, past releases illustrate what can go wrong and justify the need for guidelines that minimize risks. An overview of recommendations for insectary facilities, practices, and equipment is provided, and features of four recently published and increasingly rigorous arthropod containment levels (ACLs 1-4) are summarized. ACL-1 is appropriate for research that constitutes the lowest risk level, including uninfected arthropods or vectors that are infected with micro-organisms that do not cause disease in humans, domestic animals, or wildlife. ACL-2 is appropriate for indigenous and exotic arthropods that represent a moderate risk, including vectors infected or suspected of being infected with biosafety level (BSL)-2 infectious agents and arthropods that have been genetically modified in ways that do not significantly affect their fecundity, survival, host preference, or vector competence. ACL-3 is recommended for arthropods that are or may be infected with BSL-3 infectious agents. ACL-3 places greater emphasis on pathogen containment and more restricted access to the insectary than ACL-2. ACL-4 is intended for arthropods that are infected with the most dangerous BSL-4 infectious agents, which can cause life-threatening illness by aerosol or arthropod bite. Adherence to these guidelines will result in laboratory-based arthropod vector research that minimizes risks and results in important new contributions to applied and basic science.

Animals↗