Need for evaluation of the HHS and USDA Interim Final Rules for Select Agents to determine if the regulatory processes are working, to identify problems and benefits, and to assess whether the regulations are interfering with research, surveillance, or the ability to respond to bioterrorism or naturally occurring infectious disease threats:
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law l07-188) recognized the importance of research and diagnostic testing and specifically instructed that implementation of regulations for dangerous biological agents and toxins not inhibit research and provide for the “appropriate availability of biological agents and toxins for research, education and other legitimate purposes.” Congress intended that regulations for biological agents and toxins that have the potential to pose a severe threat to public health and safety not discourage or impede research that represents protection against infectious diseases, new and emerging diseases and bioterrorism. Section 351A (b) (4) of PL 107-188 mandates that the Secretary of Health and Human Services “(4) evaluates the impact of such section 351A on research on biological agents and toxins listed pursuant to such section….” The legislation also mandates in section 351A (e) (1) that “Regulations …shall include appropriate safeguard and security requirements for persons possessing, using or transferring a listed agent or toxin commensurate with the risk such agent or toxin poses to public health and safety….”
The ASM recommends that OSTP develop good evaluation tools and criteria to assess whether the regulatory processes are working efficiently, whether the biosecurity requirements are commensurate with risk for specific agents and sites, whether there are mechanisms to assess the appropriateness of biosecurity plans and levels and whether the regulations are impeding research in any way. A carefully designed evaluation is important to inform the development of the final rule.
Need for additional agency coordination and harmonization to reduce administrative burden on facilities and investigators:
There is need for a single registration system that is transparent, well understood and works efficiently. Facilities should interface with one agency, the Centers for Disease Control and Prevention (CDC). USDA/APHIS should work to harmonize its efforts with CDC and with other USDA/APHIS regulatory requirements for importation and interstate transfer of overlap and USDA-only agents. For example, Section 331.13 (a) and 121.14 (a) provide that in addition to the permit required under 7 CFR part 330 or 9 CFR part 12 respectively, biological agents or toxins may only be imported or moved interstate with the prior authorization of APHIS or, for overlap agents or toxins, APHIS or CDC. To obtain such authorization, the sender and the responsible official for the recipient must complete and submit APHIS Form 2041 to APHIS or CDC, in accordance with 331.13 (c) and 121.14 (c). Investigators must obtain an APHIS Form 2041 for a select agent transfer and a second USDA permit for the same organism that is harmful or infectious to animals. Obtaining a second USDA permit for an organism that is a select agent adds significantly to the time and effort required. The microbiological community can only conduct its critically important tasks through the timely sharing and accessing of scientific materials for legitimate scientific and public health purposes. USDA/APHIS should review all its regulatory requirements for infectious agents and toxins to ensure that they are not duplicative and are not unnecessarily delaying research. USDA/APHIS must devote adequate attention and resources to implementation of the regulations and permitting requirements for plant and animal agents and toxins. CDC and APHIS inspections should be coordinated to minimize the burden on facilities.
Need for an external scientific advisory committee to be consulted about the select and agricultural agent list and the scope of the regulations: The Public Health Security and Bioterrorism Preparedness Act mandates a biennial review and republication of the select agent list and requires the Secretary of HHS to “consult with appropriate federal departments and agencies and with scientific experts representing appropriate professional groups….” in determining whether to include an agent or toxin on the list. Scientific societies such as the ASM should be consulted as often as needed, as mandated in the legislation, to review the select agent list. The ASM also continues to recommend that a committee of scientific experts, including experts from outside the government, be consulted to periodically review the list and proposed exclusions to the list to ensure that the list of agents is scientifically justified.
Within the current select agent list there continue to be issues raised with inclusion of the fungus Coccidioides for clinical and research laboratories. Obtaining clinical laboratory isolated strains of this infectious agent for research and surveillance purposes is becoming increasingly difficult because CLIA laboratories are unable to afford the costs associated with transferring strains to a registered repository. Such issues which impact public health must be reviewed and addressed by the agencies.
Need for maximum timely registration and screening of personnel:
In October 2003 a large number of incomplete applications for Security Risk Assessments and processing time involved revealed that thousands of SRAs would not be completed by the regulatory deadline. Provisional registration and granting of access were allowed in a November 3, 2003, amended Interim Final Rule to ensure that ongoing and new research efforts were not disrupted in accordance with section 202 ( c ) of the legislation. It is our understanding that it takes 45 days to process an SRA and 6 months if further investigation is deemed necessary. To accomplish the goal of conducting security assessments in an effective and timely manner, the Biopreparedness legislation provided for the prompt use of available electronic databases to carry out the clearance process. The ASM recommends that the timeliness and maximum efficiency of this process be reviewed and its impact on the needs of the science and infectious disease community. Involvement of law enforcement agencies in assessing scientists for security is a new paradigm for the scientific community. The ASM has also asked the Department of Justice to incorporate appropriate questions and responses into the Federal Bureau of Investigation’s website concerning Form FD-961.
Need for increased communication and outreach to the regulated community and training initiatives for biosecurity issues:
There is need to develop guidance, practices, principles and training for biosecurity. Biosecurity measures are different from biosafety in that they are designed to reduce theft, loss, diversion and unauthorized access or use of dangerous pathogens and toxins. Agencies should work with scientific organizations and institutions to raise biosecurity awareness and practices. Although a single, universal plan applicable to all facilities is not recommended because it does not take into account site and agent specific risk, general principles and practices for biosecurity should be developed and reviewed regularly to ensure they meet the needs of rapidly advancing science. Biosafety practices are components of formal training of microbiologists and biosecurity awareness and issues should also be included. Effective biosecurity need not be an expensive and elaborate undertaking and should be achievable without undue costs and interference with research efforts. The most valuable underpinning of biosecurity is an increased awareness and widely accepted, practical procedures to prevent unauthorized activities. Such an approach in the United States will be useful for the international scientific community as well.