scholarly journals Regulating Biotechnology in the Age of Homeland Security

2003 ◽  
Vol 16 (2) ◽  
pp. 38-51
Author(s):  
Judith Reppy

The anthrax letters in the United States in October 2001, coming soon after the September 11 terrorist attacks, raised the fear of bioterrorism to a high level. Legislation to restrict access to select agents (i.e., those pathogens considered likely to be used in biological weapons) and to screen laboratory personnel for security risks soon followed; in addition, the major scientific journals in the field have agreed to practice self-censorship to prevent the publication of information that might be useful to terrorists. These developments are ushering in a new relationship between the field of biology and the state, raising important issues of governance. In this article I summarize the new regulatory regime, analyse its likely impact on the research community, and discuss the problems that the current approach to rule making creates for legitimacy and acceptance of the new regime.

2009 ◽  
Vol 23 (2) ◽  
pp. 221-237 ◽  
Author(s):  
Steven M. Glover ◽  
Douglas F. Prawitt ◽  
Mark H. Taylor

SYNOPSIS: The Sarbanes-Oxley Act of 2002 (SOX) established the Public Company Accounting Oversight Board (PCAOB) to oversee the accounting firms that audit publicly traded companies in the United States. In this commentary we outline why we believe the PCAOB’s audit standard-setting and inspection models are inefficient and dysfunctional. We assert that the Board’s ability to achieve its mission is limited by its early choices, together with its incentives, organizational composition, and structure. We support our assertions with a number of indicators of serious problems and flaws in the current approach. We also present high-level recommendations for change for policy makers, regulators, and leaders in the profession to consider in developing improved approaches to audit standard setting, inspection, and enforcement.


2005 ◽  
Vol 10 (3) ◽  
pp. 405-424
Author(s):  
Michael Moodie

AbstractThis essay considers the difficulties confronting the international community in addressing the challenge of biological weapons through multilateral negotiations. After a brief review of the Biological and Toxin Weapons Convention, the article addresses four categories of factors that help understand the relative lack of success: those related to the structure and conduct of the negotiating process, those stemming from the unique nature of the life sciences, those associated with domestic political dynamics in the United States, and those associated with changes in the structure and dynamics of the international system. It closes with reflections on how the international community can embed negotiations in a broader strategy for bolstering capabilities to manage the security risks related to the advances of the life sciences and related technology.


2001 ◽  
Vol 7 (S2) ◽  
pp. 180-181
Author(s):  
Richard F. Meyer

In the event of a bioterrorist attack, rapid screening, agent identification, and confirmatory diagnosis will be critical, so that prevention and treatment measures can be implemented quickly. However, because few biologic agents thought likely to be used as biological weapons represent major public health problems in the United States, we have limited capacity to diagnose them, either at the state and local or the federal level. to begin to address this new public health challenge the Laboratory Response Network for Bioterrorism (LRN) was established.The LRN is a multi-level system designed to link state and local public health laboratories, clinical, military, veterinary, agricultural, water and food-testing laboratories. Operational in August of 1999, the LRN was established as a consequence of Presidential Decision Directive 39, increased congressional awareness of the huge biological weapons program in the former Soviet Union, the high level of risk to national security and subsequent emergency funding to the Centers for Disease Control and Prevention under the DHHS Operating Plan for Anti- Bioterrorism Initiative.


Author(s):  
María Cristina García

In response to the terrorist attacks of 1993 and 2001, the Clinton and Bush administrations restructured the immigration bureaucracy, placed it within the new Department of Homeland Security, and tried to convey to Americans a greater sense of safety. Refugees, especially those from Iraq, Afghanistan, and Syria, suffered the consequences of the new national security state policies, and found it increasingly difficult to find refuge in the United States. In the post-9/11 era, refugee advocates became even more important to the admission of refugees, reminding Americans of their humanitarian obligations, especially to those refugees who came from areas of the world where US foreign policy had played a role in displacing populations.


Author(s):  
Leah Plunkett ◽  
Urs Gasser ◽  
Sandra Cortesi

New types of digital technologies and new ways of using them are heavily impacting young people’s learning environments and creating intense pressure points on the “pre-digital” framework of student privacy. This chapter offers a high-level mapping of the federal legal landscape in the United States created by the “big three” federal privacy statutes—the Family Educational Rights and Privacy Act (FERPA), the Children’s Online Privacy Protection Act (COPPA), and the Protection of Pupil Rights Amendment (PPRA)—in the context of student privacy and the ongoing digital transformation of formal learning environments (“schools”). Fissures are emerging around key student privacy issues such as: what are the key data privacy risk factors as digital technologies are adopted in learning environments; which decision makers are best positioned to determine whether, when, why, and with whom students’ data should be shared outside the school environment; what types of data may be unregulated by privacy law and what additional safeguards might be required; and what role privacy law and ethics serve as we seek to bolster related values, such as equity, agency, and autonomy, to support youth and their pathways. These and similar intersections at which the current federal legal framework is ambiguous or inadequate pose challenges for key stakeholders. This chapter proposes that a “blended” governance approach, which draws from technology-based, market-based, and human-centered privacy protection and empowerment mechanisms and seeks to bolster legal safeguards that need to be strengthen in parallel, offers an essential toolkit to find creative, nimble, and effective multistakeholder solutions.


2007 ◽  
Vol 101 (2) ◽  
pp. 453-459
Author(s):  
Daniel Bodansky ◽  
Simon Lester

European Communities—Measures Affecting the Approval and Marketing of Biotech Products. WT/DS291/R, WT/DS292/R, & WT/DS293/R. At <http://www.wto.org/english/tratop_e/dispu_e/dispu_status_e.htm>.World Trade Organization Panel, September 29, 2006 (adopted November 21, 2006).In what was by far the longest panel report in the World Trade Organization’s history, a WTO panel ruled last September that various parts of the European Communities’ regulatory regime for the approval and marketing of “biotech products” (that is, products that contain, or are made from or with, genetically modified organisms (GMOs)) violated the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). The panel report was not appealed and was adopted by the WTO Dispute Settlement Body on November 21, 2006.In recent years, a heated international debate has developed regarding the production and consumption of food made from or with GMOs. Among the key players in this debate, the United States, supported by many companies who have developed GMO-based products, has pushed for their acceptance; by contrast, the European Communities (EC) and its member states, backed by consumer groups and other activists, have tried to restrict their use through various regulations.


Author(s):  
James Lee Brooks

AbstractThe early part of the twenty-first century saw a revolution in the field of Homeland Security. The 9/11 attacks, shortly followed thereafter by the Anthrax Attacks, served as a wakeup call to the United States and showed the inadequacy of the current state of the nation’s Homeland Security operations. Biodefense, and as a direct result Biosurveillance, changed dramatically after these tragedies, planting the seeds of fear in the minds of Americans. They were shown that not only could the United States be attacked at any time, but the weapon could be an invisible disease-causing agent.


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