The Honorable Bennie G. Thompson
Committee on Homeland Security
U.S. House of Representatives
Washington, D.C. 20515
Dear Chairman Thompson:
The American Society for Microbiology (ASM) writes to provide comments on the WMD Prevention and Preparedness Act of 2010 (HR 5498). The ASM is the largest single life science organization with approximately 40,000 members. The ASM is devoted to the study and advancement of the scientific knowledge of microbiology for the benefit of human welfare. ASM members are involved in basic and applied research, clinical laboratory testing and public health activities that focus on developing new preventions, therapies and cures for infectious diseases. To meet the challenges of infectious diseases, microbiologists work in laboratories in which highly pathogenic agents are stored and studied. The ASM, therefore, is vitally interested in assuring that such agents are studied and maintained in a manner that is safe for laboratory personnel and the public.
The ASM supports responsible oversight, practices, guidelines and regulations that promote biosecurity and biosafety in laboratories and recognizes the critical public interest in fostering ongoing research related to pathogenic organisms. The ASM is pleased to see the President’s Executive Order on Optimizing the Security of Biological Agents and Toxins in the United States, released on July 2. The ASM concurs with the Administration’s approach which directs the Department of Health and Human Services (HHS), the Department of Agriculture (USDA), and the Department of Justice to institute changes in their implementation of the Select Agent Program and Regulations within existing statutory authorities and to take actions to improve the overall coordination, consolidation and oversight of select agents and toxins. Many of the provisions of the Executive Order have been supported by the ASM in testimony, letters and statements to Congress. The Society looks forward to working with the Administration, federal agencies and Congress as the process begins to revise and change the regulations for select agents and toxins.
The ASM has already commented on S 1649, the Weapons of Mass Destruction (WMD) Prevention and Preparedness Act of 2009, which is being considered by the Senate. Although HR 5498 differs in certain important respects from S 1649, there are many similarities and some identical wording. The ASM attaches to this letter a copy of the Society’s letter to Senator Joseph Lieberman with respect to S 1649. The comments in the letter to Senator Lieberman provide important background regarding the views of the ASM on this legislation. The ASM submits the following additional specific comments on HR 5498 for consideration by the Committee:
1. Designation of Tier I Material Threat Agents
The ASM supports the recognition in HR 5498 of the primary roles for the HHS and USDA in designating Tier I Material Threat Agents. The President’s Executive Order on Select Agents places primary oversight of program revisions, coordination and implementation with the HHS and USDA, which the ASM strongly supports. Section 304(a) and (b) of the Bill provides that, within their respective spheres, HHS and USDA in consultation with the Department of Homeland Security (DHS) shall designate Tier I Material Threat Agents. The ASM agrees that HHS and USDA possess the requisite expertise to evaluate agents for designation of Tier I Material Threat Agents and should have the responsibility for making such determinations.
The primacy of HHS and USDA is not assured, in the proposed legislation, however, as Section 304 requires HHS or USDA to designate an agent for the list if DHS determines an agent “clearly present[s] a material threat to the Nation.” Under this standard, DHS hypothetically may override HHS and USDA’s lead authority and designate agents for Tier I status based upon its own decision of a “threat to the Nation.” It is difficult to imagine circumstances in which HHS or USDA would not designate an agent for Tier I status if DHS advised these agencies of threat assessments indicating that an agent clearly threatened the Nation or, conversely, that DHS could even make such a determination without consultation with, and concurrence by, HHS or USDA. Scientific expertise stands at the center of a Tier I Material Threat Agent designation and HHS and USDA are best equipped to make such designations in consultation with DHS.
It is critical to ensure input from the scientific and public health communities in determining which agents should be designated as Tier 1 agents and which agents should be designated as select agents. A broad discussion among the public health, scientific and security communities could define which agents are the most significant biothreats requiring greater security measures and which agents may have lesser security requirements. The legislation should mandate that input from the scientific and public health communities be obtained by the Secretaries.
The criteria identified in HR 5498 for determining whether to designate an agent for listing essentially are so open ended that they do not constitute an actual statement of criteria. The Bill provides that the criteria include “such other criteria and information as the Secretary, in coordination with the Secretary of Homeland Security, determines appropriate and relevant.” The ASM recognizes that the Committee does not want HHS or USDA to be hindered in the designation of Tier I Material Threat Agents by an overly restrictive listing of specific items. However, the ASM submits that the designation of criteria, including a final “catchall” element can be tied more specifically to the degree of a substantial risk to the public from the possession, use, or transfer of the organism.
2. List of Tier I Material Threat Agents and Enhanced Biosecurity Practices
Careful delineation of the authority and criteria for designating Tier I Material Threat Agents is particularly important because Section 201 of HR 5498 mandates the promulgation by DHS through negotiated rulemaking of substantive enhanced biosecurity measures for persons and laboratories possessing, using, or transferring such Tier I Material Threat Agents. The Bill provides that such substantive rules shall “include” personnel surety, training of personnel, laboratory vulnerability assessments, risk-based performance standards, an undefined array of civil penalties and intermediate sanctions, and “any other security standards deemed necessary” by appropriate federal agencies that is, potentially every aspect of laboratory staffing and operation
The ASM supports the tiering of select agents within the existing Select Agent Rule, so that some agents are specified for appropriately enhanced biosecurity and biosafety measures. At the same time, the ASM emphasizes the importance of careful consideration of the interplay of the establishment of a list of Tier I Material Threat Agents (Section 304 of the Bill) and issuance of enhanced biosecurity and biosafety measures governing laboratory staffing and operation (Section 201 establishing a new 6 U.S.C. 2104). Both sides of the equation (designation of Tier I agents and promulgation of rules) and the interaction between them must be considered carefully on the basis of scientific expertise and experience.
We recommend changing the term “personnel surety” which is used in the Bill to “personnel reliability.” The term “personnel surety” was developed for the nuclear weapons program and is inappropriate when applied to the life sciences. We also urge that any additional personnel reliability requirements be carefully balanced against the potential adverse impact on research and development of countermeasures. Personnel reliability must not exclude those who can contribute necessary expertise to a strong biodefense program which depends upon graduate student and foreign scientist participation.
The ASM continues to advocate the primacy of HHS and USDA in the development of rules governing laboratories, including laboratories working with Tier I Material Threat Agents. Again, the President’s Executive Order on Select Agents assigns the lead role for biological select agent rules to HHS and USDA. HHS and USDA have the necessary expertise to best evaluate the areas specified for regulation, including most particularly laboratory practices. Certainly, DHS’ expertise in security matters and threat assessment is important in considering biosecurity and biosafety practices. However, both the listing of Tier I agents and promulgation of substantive rules depend most fundamentally upon expert scientific evidence and determinations and require the expert scientific community to assess, weigh, and balance the risks and benefits of broad enhanced biosecurity measures in the interest of safety to laboratory staff and the public safety. Primary authority for both designation of Tier I agents and enhanced biosecurity measures should reside in HHS and USDA, the agencies with the fundamental expertise on pathogenic organisms and laboratory practices.
The ASM commends the inclusion in the listing of factors to be considered in the negotiated rulemaking of “representatives from the scientific community for methods to minimize any disincentives to biological research from enhanced biosecurity measures.” By explicitly requiring input from the scientific community on means of minimizing disincentives to research, the Bill recognizes the need for a structured and objective consideration of all interests, including enhanced scientific research, as part of the rulemaking process.
The ASM also urges inclusion of scientific participation in the synthetic genomics section (Title II, Section 203), directing consultation with public, private, academic experts to ensure that the rules ultimately developed are effectively written to apply to this area of science.
The ASM further commends placement of enforcement responsibilities within HHS and USDA. In this respect, HR 5498 usefully recognizes that scientific expertise is the cornerstone of effective biosecurity measures. That principle should apply in each area of biosecurity and/or biosafety addressed by the Bill.
In amending Section 2104 of Title XXI of the Homeland Security Act of 2002 (Title II, Section 201) the Bill calls for coordination of agency inspections of laboratories, which is a positive step. It would be helpful for the bill to also require that a single, consolidated multi agency report be issued from the coordinated inspections, thus reducing the often redundant and inconsistent nature of separate reports.
3. Civil Penalties or Intermediate Sanctions Should Assure Proper Adherence to Lawful Rules Without Discouraging the Advanced Scientific Research.
The ASM recognizes that, if a new statute is enacted, it is likely to establish penalties and penalty procedures to further assure scrupulous compliance with enhanced biosecurity measures. In this regard, the ASM submits that the specific inclusion of the scientific community in the establishment of enhanced biosecurity measures to minimize disincentives to biological research should also be applied to the establishment of penalty measures.
An enforcement regimen of civil penalties, intermediate sanctions, and/or criminal penalties could curtail scientific research simply by threatening imposition of institutional or personal sanctions of such a nature that entities and individuals would choose to forego research rather than risk an inadvertent violation. It will be important, therefore, for the Bill to provide specific guidance that any substantive and procedural penalty provisions should be reasonably calculated to assure compliance with enhanced biosecurity measures without creating undue disincentives to biological research. Moreover, the Bill should mandate input from the scientific community as part of the process of instituting the substance of, and procedures for, assessment of civil penalties or intermediate sanctions. Participation by the scientific community will be important to the effort to arrive at system of enforcement that does not unnecessarily curtail research that serves the public interest.
In closing, the ASM appreciates the Committee’s recognition of the leading roles that HHS and USDA should play in important areas of biosecurity and biosafety and of the importance of including the scientific community in areas of regulatory action. However, the bill includes a number of provisions that raise serious concern for the scientific community and biodefense. We urge Congress to recognize the appropriate step that the Administration has taken in the Executive Order Optimizing the Security of Biological Agents and Toxins in the United States and recommend congressional support for the President’s directive to revise the Select Agent Program and Regulations within their existing statutory authorities.
Thank you for the opportunity to comment on HR 5498. We would be pleased to assist the Committee in anyway possible.
Roberto Kolter, Ph.D., Chair, Public and Scientific Affairs Board
Ronald M. Atlas, Ph.D., Co-Chair, Committee on Biodefense
Kenneth I. Berns, M.D., Ph.D., Co-Chair, Committee on Biodefense
Stephen M. Ostroff, M.D., Chair, Committee on Public Health