U.S. Statement on Enhanced Pathogen Security MeasuresAmbassador Donald Mahley, Acting Deputy Assistant Secretary for Multilateral and Conventional Arms Control
Statement to the Annual Meeting of States Parties for the Biological Weapons Convention (BWC), November 10-14, 2003
November 13, 2003
Under the 2003 Work Program, the focus of the second week of Experts Meetings was oversight and security of dangerous pathogens -- what we call biosecurity. Although a number of attempts were made to delineate biosecurity from biosafety, presentations during the meeting indicated that a number of States Parties link these two concepts inappropriately. While linked, they are not the same, and they are not interchangeable concepts. Biosecurity practices and principles are designed to reduce the risk of unauthorized release of or access to dangerous pathogens and toxins. In simple terms, they are practices designed to keep pathogens and toxins safe and out of the hands of unauthorized people. As such, it is clearly a non-proliferation and anti-terrorism issue and, is directly relevant to the BWC. Biosafety, on the other hand, involves practices and procedures that protect individual investigators or technicians from dangers to their health caused by the organisms they work with. In effect, biosafety practices are designed to keep people safe from pathogens. While important, biosafety is not as directly related to the aim of the security missions and objectives of the BWC. It is essential that States Parties understand the differences between biosafety and biosecurity and the particular relevance of the latter to the BWC.
The United States strongly believes that measures that raise biosecurity awareness and practice at specific sites enhance both local and global security. Thus, implementation of enhanced biosecurity practices at all facilities possessing dangerous pathogens and toxins reduces the global threat from biological weapons and bioterrorism. Enhanced biosecurity initiatives, therefore, support the overall objectives of the BWC and all States Parties should strive to implement and enforce national measures necessary to prevent unauthorized diversion of dangerous pathogens and toxins from approved use.
One repeated theme in various national presentations was that biosecurity is site-specific, and as such, no single plan or set of standards is universally applicable to all facilities. Effective biosecurity begins with thorough risk and vulnerability assessments of facilities, followed by implementation of specific measures to eliminate or reduce those vulnerabilities and risks. Effective biosecurity efforts require that agents of concern be identified and that plans be developed to regulate and monitor those agents. Though universal guidelines and practices are impractical, general concepts for biosecurity are plausible. The most effective means for ensuring global biosecurity are comprehensive, strictly enforced national biosecurity plans that require site-specific biosecurity assessments, and development and implementation of security plans.
Another recurring theme of the Experts Meeting was that biosecurity also requires national oversight. Many States Parties have established one or more agencies to define national biosecurity principles and practices, to define the agents to be regulated, and to ensure that biosecurity plans are developed. These national oversight plans should be regularly reviewed to ensure they meet the needs of the rapidly advancing fields of microbiology and biotechnology.
Two related themes from week two of the Experts Meeting were transport and record keeping. Effective biosecurity also requires that facilities establish procedures for the secure receipt, handling, transfer, inventory, and destruction of restricted agents. Most States Parties that have addressed transport and record keeping issues have implemented methods for tracking the receipt and transfer of strains of dangerous pathogens and toxins. All who spoke in substance on the issue noted the importance of maintaining detailed, accurate records of possession, transport, storage, use, and personnel approved to work with the dangerous agents.
A repeated observation made by a number of experts was the need for specific training in biosecurity practices and procedures. While biosafety practices are regular components of formal training for microbiologists and others likely to work with dangerous agents, the same cannot be said for biosecurity practices. Consequently, to assure effective biosecurity, a much broader spectrum of personnel are in need of training in the procedures and practices established to safeguard pathogens at a given site.
Finally, many experts recognized that biosecurity plans address the use of materials that have some similarities to issues dealt with in the handling of controlled substances. Consequently, in order to reduce the risk of unauthorized diversion of samples, practices should be established to properly screen the background of persons who will be given access to these agents.
It is important to note that effective biosecurity need not be an expensive endeavor and is therefore achievable by all States Parties. The most valuable underpinnings of biosecurity are increased awareness and practical procedures to keep dangerous pathogens and toxins out of the hands of those who would use them for malicious purposes, not in elaborate and expensive physical security infrastructure.
As was the case for national implementing legislation, the United States and a number of other States Parties that have made progress in the area of biosecurity of pathogens and toxins have extended offers to assist other countries in developing biosecurity practices appropriate for the needs of the assisted State Party. We encourage all States Parties to take advantage of these offers for assistance so that as many BWC States Parties as possible will be able to report implementation of effective national biosecurity practices by the 2006 Review Conference. The work program approach delivered an important means of cooperation between States Parties in the form of expert assistance to all interested nations in developing effective national biosecurity strategies. Given the amount of work to be done and the pace at which it could be accomplished, a realistic window to measure success in achieving meaningful improvements in biosecurity will be at the 2006 Review Conference.