Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety Requirements. Final rule.

In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. Following the review, HHS has decided: Not to finalize the proposed changes to the list of select agents and toxins at this time; to finalize provisions to address toxin permissible limits and the inactivation of select agents; to finalize specific provisions to the section of the regulations addressing biosafety; and to clarify regulatory language concerning security, training, incident response, and records. In a companion document published in this issue of the Federal Register, the U.S. Department of Agriculture (USDA) has made parallel regulatory changes.

Possession, Use, and Transfer of Select Agents and Toxins-- Addition of Bacillus Cereus Biovar Anthracis to the HHS List of Select Agents and Toxins. Interim final rule and request for comments.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is adding Bacillus cereus Biovar anthracis to the list of HHS select agents and toxins as a Tier 1 select agent. We are taking this action to regulate this agent that is similar to B. anthracis to prevent its misuse, which could cause a biological threat to public health and/or national security.

John Bartlett and bioterrorism.

Until 1997, the subject of bioterrorism was not discussed within the medical community and deliberately ignored in national planning efforts. Biological weapons were regarded as "morally repulsive." This complacency stemmed from a 1972 Biological Weapons Convention where all countries agreed to cease offensive biological weapons research. In the 1990s, however, the Soviet Union was discovered to have an extensive bioweapons program and a Japanese religious cult sought to launch an anthrax attack on Tokyo. Biological weapons such as smallpox and anthrax had the potential to cause a national catastrophe. However, little was done until John Bartlett in 1997 led a symposium and program to educate the medical community and the country of the need for definitive bioweapons programs. It was highly persuasive and received a final stimulus when the anthrax attack occurred in the United States in 2001.

Effects of the USA PATRIOT Act and the 2002 Bioterrorism Preparedness Act on select agent research in the United States.

A bibliometric analysis of the Bacillus anthracis and Ebola virus archival literature was conducted to determine whether negative consequences of the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism" (USA PATRIOT) Act and the 2002 Bioterrorism Preparedness Act on US select agent research could be discerned. Indicators of the health of the field, such as number of papers published per year, number of researchers authoring papers, and influx rate of new authors, indicated an overall stimulus to the field after 2002. As measured by interorganizational coauthorships, both B. anthracis and Ebola virus research networks expanded after 2002 in terms of the number of organizations and the degree of collaboration. Coauthorship between US and non US scientists also grew for Ebola virus but contracted for the subset of B. anthracis research that did not involve possession of viable, virulent bacteria. Some non-US institutions were dropped, and collaborations with others intensified. Contrary to expectations, research did not become centralized around a few gatekeeper institutions. Two negative effects were detected. There was an increased turnover rate of authors in the select agent community that was not observed in the control organism (Klebsiella pneumoniae) research community. However, the most striking effect observed was not associated with individual authors or institutions; it was a loss of efficiency, with an approximate 2- to 5-fold increase in the cost of doing select agent research as measured by the number of research papers published per millions of US research dollars awarded.

Genomics and future biological weapons: the need for preventive action by the biomedical community.

There is an increasing concern within both the scientific and security communities that the ongoing revolution in biology has great potential to be misused in offensive biological weapons programs. In light of the 11 September tragedy, we can no longer afford to be complacent about the possibility of biological terrorism. Here we review the major relevant trends in genomics research and development, and discuss how these capabilities might be misused in the design of new bioweapons. We also discuss how the breakthroughs that have come from the genomics revolution may be used to enhance detection, protection and treatment so that biological warfare agents are never used.

The insider threat--a new aspect of biosecurity.

The need for those responsible for security at hospital research centers to take steps to counter insider threats to use biomedical and microbiological research and for perverted purposes is real, says the author. He spells out what the threats consist of suspicious behaviors to be aware of and reporting procedures for effective resolution that will enable life science researchers and law enforcement to successfully work together to thwart such threats.

Ethical and regulatory challenges posed by synthetic biology.

Synthetic biology is a relatively new science with tremendous potential to change how we view and know the life sciences, but like many developing technologies, it has provoked ethical concerns from the scientific community and the public and confronts demands for new regulatory measures. The concerns raised involve the danger of "dual use," in which results for improving human well-being and the environment may be misappropriated for bioterror. To counteract these dangers, many governments, but the United States and Israel in particular, have introduced new laws and redoubled measures for biosafety and biosecurity. In the United States, the recent H5N1 results achieved by two groups of NIH-funded investigators highlighted the dilemma of balancing the risk of dual-use research and the freedom of science. In Israel, concern for unconventional terrorism is long-standing, and the country is constantly engaged in improving biosecurity and biodefense measures. In 2008, the Israeli parliament passed the Regulation of Research into Biological Disease Agents Law, a legislative framework for safeguarding research into biological disease agents. This article summarizes and analyzes the current state of affairs in the United States and Israel, ethical attitudes, and regulatory responses to synthetic biology.

Possession, use, and transfer of select agents and toxins; biennial review. Final rule.

In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and is republishing that list. As a result of our review, we have added Chapare virus, Lujo virus, and SARS-associated coronavirus (SARS-CoV) to the list of HHS select agents and toxins. We have also removed from the list of HHS and overlap select agents and toxins, or excluded from compliance with part 73, the agents and toxins described in the Executive Summary. Further, in accordance with Executive Order 13546, "Optimizing the Security of Biological Select Agents and Toxins in the United States," HHS/CDC has designated those select agents and toxins that present the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure; or public confidence as "Tier 1" agents; established new security requirements for entities possessing Tier 1 agents, including the requirement to conduct pre-access assessments and on-going monitoring of personnel with access to Tier 1 agents and toxins; and made revisions to the regulations to clarify regulatory language concerning security, training, biosafety, and incident response. In a companion document published in this issue of the Federal Register, the United States Department of Agriculture (USDA) has made parallel regulatory changes.

[Safe from biothreats? Legislation protects you and society]. / Biouhilta turvassa?--Säädökset suojaavat työntekijää ja yhteiskuntaa.

The 9/11 terror attacks, followed by mailing of letters containing anthrax spores, changed our comprehension on threats towards modern society. Finland is committed by international treaties to develop biosafety and biosecurity legislation, and general awareness of the legislation. However, the rapidly developing field of biosciences cannot be extensively regulated by legislation. Awareness of the risks and challenges involved in handling of biological agents is an important tool in threat prevention. Despite active efforts to update the legislation by government authorities, currently the sustenance and development of biosecurity are primarily in the hands of individual researchers and the scientific community.

Responsible conduct by life scientists in an age of terrorism.

The potential for dual use of research in the life sciences to be misused for harm raises a range of problems for the scientific community and policy makers. Various legal and ethical strategies are being implemented to reduce the threat of the misuse of research and knowledge in the life sciences by establishing a culture of responsible conduct.

Smarter regulations: commentary on "Responsible conduct by life scientists in an age of terrorism".

In the United States a rapidly increasing regulatory burden for life scientists has led to questions of whether the increased burden resulting from the Select Agent Program has had adverse effects on scientific advances. Attention has focussed on the regulatory "fit" of the Program and ways in which its design could be improved. An international framework convention to address common concerns about biosecurity and biosafety is a logical next step.

FDA's expanding postmarket authority to monitor and publicize food and consumer health product risks: the need for procedural safeguards to reduce "transparency" policy harms in the post-9/11 regulatory environment.

This article provides a summary of the expansion of FDA's discretionary authority in the post-9/11 period, particularly with respect to FDA's authority to monitor and publicize potential health risks linked to food, dietary supplements, nonprescription drugs, and other consumer health products. In addition, this article evaluates the need for FDA to establish procedural safeguards to reduce the significant risks of unintended and undue harm to people and regulated companies that can result from adverse publicity in the more "transparent" post 9/11 FDA regulatory environment. Specifically, Part I summarizes the amendments to the FDCA enacted during the post-9/11 period that have expanded FDA's postmarket authority to monitor, evaluate, and publicize potential health risks linked to food, dietary supplements, nonprescription drugs and other consumer health products marketed in the United States, in conjunction with FDA's Sentinel Initiative, Reportable Food Registry, and other adverse event reporting requirements. Part II discusses the convergence of FDA's expanded postmarket authority to publicize product-related risks with President Obama's transparency initiative aimed at fostering "open government" through increased public access to government information. In addition, Part II considers the nature of the procedural safeguards needed in the post-9/11 FDA regulatory environment, in view of FDA's historical record and illustrative cases that help expose how adverse "transparency" surrounding FDA warning letters, recalls and safety alerts concerning products in the marketplace can have undue and unintended prejudicial and harmful effects for the people and companies that are legally responsible for such products. Finally, based on these analysis, this article concludes with some observations concerning the nature of the procedural safeguards needed to reduce the significant risks of "transparency" policy harms in the pos-9/11 regulatory environment.