The Current and Evolving Regulatory Environment

Urban Survival Guide

Urban Survival Secrets for Terrorist Attacks

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In the United States, the USA PATRIOT Act of 2001 and the Bioterrorism Preparedness and Response Act of 2002 already establish the statutory and regulatory basis for protecting biological materials from inadvertent misuse. Once fully implemented, the mandated registration for possession of certain pathogens (the "select agents"), designation of restricted individuals who may not possess select agents, and a regulatory system for the physical security of the most dangerous pathogens within the United States will provide a useful accounting of domestic laboratories engaged in legitimate research and some reduction in the risk of pathogens acquired from designated facilities falling into the hands of terrorists. The Committee stresses that implementation of current legislation must not be overly restrictive given the critical role that the development of effective vaccines, diagnostics, therapeutics, and detection systems, along with a responsive public health system, will play in providing protection against bioterrorism — and other serious health threats. Otherwise these legislative solutions may unintentionally limit the research on dangerous pathogens by legitimate laboratories and investigators. To be effective, a harmonized, international system for the regulatory oversight of the possession of dangerous pathogens and toxins, comparable to the one being put in place in the United States, is needed.

With regard to oversight of research, no country has developed guidelines and practices to address all aspects of biotechnology research. The Committee has concluded that existing domestic and international guidelines and regulations for the conduct of basic or applied genetic engineering research may ensure the physical safety of laboratory workers and the surrounding environment from contact with or exposure to pathogenic agents or "novel" organisms. However, they do not currently address the potential for misuse of the tools, technology, or knowledge base of this research enterprise for offensive military or terrorist purposes. In addition, no national or international review body currently has the legal authority or self-governance responsibility to evaluate a proposed research activity prior to its conduct to determine whether the risks associated with the proposed research, and its potential for misuse, outweigh its potential benefits. The Committee concluded that the existing fragmentary system must be adapted, enhanced, supplemented, and linked to provide a system of oversight that will give confidence that the potential risks of misuse of dual use research are being adequately addressed while enabling vital research to go forward. The

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