September 23, 2009 - ASM Comments on the Weapons of Mass Destruction Prevention and Preparedness Act of 2009

The Honorable Joseph I. Lieberman
Chair, Committee on Homeland Security
and Governmental Affairs
United States Senate
340 Dirksen Senate Office Building
Washington, DC  20510

Dear Senator Lieberman:

The American Society for Microbiology (ASM) submits the following comments for the hearing record on the Weapons of Mass Destruction Prevention and Preparedness Act of 2009, S 1649.  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 are focused on developing new preventions, therapies and cures for infectious diseases. To meet the challenges of emerging and reemerging infectious diseases, microbiologists work in laboratories in which highly pathogenic agents are stored and studied.  The ASM is interested in assuring that such agents are maintained in a manner that is safe for laboratory personnel and the public.

The ASM commends your efforts and that of the Senate Committee on Homeland Security and Governmental Affairs to prevent the proliferation of weapons of mass destruction and to enhance preparedness for biological terrorism. The ASM supports responsible regulation, oversight, practices and guidelines that promote biosecurity and improve biosafety in laboratories.  We appreciate the opportunity to meet with your staff and to offer comments on the proposed legislation.

General Comments on Title I – Enhanced Biosecurity

The ASM supports the critical role of the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), the US Department of Agriculture Animal Plant Health Inspection Service (APHIS) and the Department of Justice (DOJ)/FBI in administering the select agent and toxin regulations for facilities that possess, use or transfer select agents and toxins.  The HHS, CDC and APHIS are experienced and knowledgeable about infectious diseases and are committed to the protection of public health and safety.  The DOJ/FBI assists in establishing security requirements for registered entities and a personnel screening protocol for access to select agents and toxins.

Since 1995, the ASM has submitted recommendations to Congress, the Administration and federal agencies on policies to enhance biosafety and biosecurity.  In those comments, the ASM has emphasized the need to balance enhanced security with the critical need to conduct public health activities, clinical diagnostic testing and research on pathogens that will lead to new and improved vaccines, therapeutics, diagnostics, and other measures that will protect public health against infectious diseases, whether naturally occurring or the result of an act of bioterrorism. The ASM supports the central role of HHS/CDC in protecting public health and fostering research on human pathogens in a safe and secure manner. It supports the role of USDA/APHIS in performing similar functions to protect plant and animal health. Further, the ASM and Congress have supported locating the Select Agent Program at the HHS/CDC for human and overlap agents and at the USDA/APHIS for animal and plant pathogens because these agencies have the appropriate public health expertise, experience in the life sciences, and oversight capacity for biosafety and biosecurity.

The Select Agent regulations, first established in 1996 for transfers of select agents and toxins and expanded in 2002 to include registration for possession and use, mandate an FBI security risk assessment for entities and individuals authorized to have access to select agents and toxins and they require safety and security plans to safeguard select agents based on risk assessment. The Select Agent regulations were enacted to ensure reasonable safety and security requirements to prevent misuse of select agents and toxins; to date there is no documentation that they are not fulfilling that mandate.

In 2002, the Department of Homeland Security (DHS) was established and given a role with respect to risk assessment of select agents for purposes of developing countermeasures, but not to inform regulation. An interagency committee reviews the select agent list every two years and it is published for comment in the Federal Register where there is opportunity to make changes to the list of regulated agents.

The ASM position regarding the primacy of HHS and USDA is supported by the 2008 Report of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism which calls for the HHS to take the lead on regulatory programs, including registration of laboratories.  The report states on page 29, “The Department of Health and Human Services, in coordination with the Department of Homeland Security, should take the lead for an interagency effort to tighten government oversight of high containment laboratories.”

The ASM is concerned about a number of the provisions in Title I of S 1649.  The bill’s focus is on creating a role for the DHS as compared to HHS and establishes multiple lists of regulated agents which will be confusing and cumbersome to administer.  Further, passage of legislation at this time would precede the issuance of two important reports from the Executive Order Working Group on Strengthening the Biosecurity of the United States and the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight. We understand that these reports should be released in the relatively near future.

The ASM recommends that Title I be omitted from the current legislation and that Congress  wait for the recommendations of the Executive Order Working Group on Strengthening Biosecurity and the Trans Federal Task Force on Optimizing Biosafety and Biocontainment Oversight before moving forward with legislation mandating new or changed regulations. If changes are needed to improve biosafety and biosecurity, we recommend that any such changes be made after careful consideration of the recommendations in these reports and build upon existing programs, including the Select Agent Program, rather than through new statutory programs.

We also are concerned that the legislation would establish a largely redundant oversight program at DHS, an agency which does not have the appropriate experience or expertise in the life sciences. Creating another list of biological agents for biosecurity will be confusing to the user community and will be a strong disincentive to conduct work on any of the agents that end up on the list. Insertion of DHS in the process may impede research and public health activities related to select agents without significant improvement in biosafety and biosecurity.  Further, inclusion of the DHS on inspections done by HHS and USDA under the select agent program raises concerns. Substantive oversight of the regulatory program by DHS appears only to create confusion or, even worse, to require that an agency issue rules and conduct inspections notwithstanding the absence of expertise in the area being regulated or the facilities being inspected.

Specific Comments on Title I

Section 101—Designation of Tier 1 Agents

In discussions with the EO Working Group, the ASM has supported the tiering of select agents so that some agents would require more security over others. In effect this already occurs for smallpox which is limited by international agreement and federal law to the CDC laboratory. The ASM view is that 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. Title II, Enhancing Controls on Dangerous Biological Agents and Toxins, of PL 107-188 already gives HHS and USDA the authority to revise the list of select agents and toxins commensurate with risk to public health and safety, including the risk of use in terrorism.

Under the Select Agent regulations, agents or toxins have been listed under Paragraph 1(A) of Section 351A of the Public Health Service Act (42 U.S.C. 262a) based on criteria mandated in Title II of PL 107-188.  Title II requires that the HHS Secretary shall consider the following four criteria: 1) the effect on human health of exposure to the agent or toxin; 2) the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans; 3) the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or toxin and 4) any other criteria, including the needs of children and other vulnerable populations that the Secretary considers appropriate.

Section 101 of S 1649 would require that an agent or toxin must be classified as a Tier 1 agent if either (a) it has been determined to be a Material Threat under Section 319F-2(c)(2) unless inclusion is not warranted, or (b) it meets the criteria identified in subparagraph (B).  Material Threat Determinations (MTD) currently have been issued for: Bacillus anthracis, Botulinum toxins, Burkholderia mallei, Burkholderia pseudomallei, Ebola virus, Francisella tularensis, Junin virus, Marburg virus, Multi drug resistant Bacillus anthracis, Radiological/Nuclear agents, Rickettsia prowazeki, typhus, Variola virus, Volatile nerve agents and Yersinia pestis.

It is not clear that an agent with an MTD must necessarily be classified as a Tier I agent.  Further, the criteria in the legislation for designation as a Tier I agent include (a) significant potential to be used effectively in an attack, (b) risk requires biosecurity measures beyond those required for select agents, (c) information available from bioterrorism risk assessments, and (d) “other criteria” determined by DHS. Given the breadth and relative subjectivity of these criteria, it is difficult to identify parameters to predict which, if any, agents other than those for which a MTD has been made would trigger the expanded security and safety measures required in Section 102.  As a result, it is difficult to understand the scope and impact of the potential enhanced classification of certain agents as Tier I agents.

Section 102—Enhanced Biosecurity Measures

The proposed legislation requires that the DHS establish through negotiated rulemaking  enhanced biosecurity measures for entities registered under section 351A(d) of the Public Health Service Act to use in handling Tier I agents, which shall include (1) standards for personnel reliability programs; (2) standards for training and requirements for responsible officials, lab personnel and support personnel employed by registered entities; (3) standards for performing laboratory risk assessments; (4) risk based laboratory security performance standards; (5) any other standards determined necessary by the Secretary; and (6) procedures, with appropriate restrictions on access, for sharing information, including vulnerability assessments, site security plans, and other security related information, as the Secretary determines appropriate, with State, local, and tribal government officials, including law enforcement officials and emergency response providers.

We do not believe DHS is the appropriate agency in which to place authority for rulemaking regarding enhanced biosecurity measures for agents and toxins. As stated above, the DHS does not have the expertise to promulgate regulations in the areas specified for regulation, including laboratory practices. The required expertise is different from, and more extensive than, the ability to make threat determinations or to undertake other DHS enforcement actions. Any additional rulemaking for select agents and toxins should be managed and promulgated jointly by HHS in coordination with the Department of Agriculture.

The proposed legislation mandates that the Secretary of Homeland Security shall inspect laboratories that handle Tier I agents for compliance with the new regulations required for such agents.  Part (B) Inspections by the DHS, HHS and USDA, states that inspections of the same laboratory for compliance with the Select Agent and Tier I regulations shall be conducted simultaneously “to the extent practicable.”  Is it practicable if each agency has its own set of rules and who will determine “practicality?”  What recourse does a laboratory have if it believes that inspections are not being done jointly and under common standards to the maximum extent practicable or if contradictory findings or recommendations are made under the two programs.

Section 103—Laboratory and Facility Registration and Database

Section 103 raises the issue of the desirability of a separate registration for laboratories handling a new category of Registry Agents and the implementation of the vague criteria for Registry Agents in Subsection (f)(2) (C).

Section (f)(1) requires the HHS to maintain a database and register laboratories and facilities that have a sufficient potential to pose a public health threat.  The HHS Secretary shall by regulation establish criteria defining which laboratories and facilities to include in the database and shall by regulation require the registration of laboratories and facilities that meet the criteria. The criteria shall include (i) whether a laboratory or facility handles a biological agent or toxin designated as a Registry Agent; (ii) whether a laboratory or facility has specified characteristics, features or equipment that could facilitate the misuse of the laboratory or facility for the purposes of developing a biological weapon, which may include (I) technology that is particularly suitable to the development of an effective biological weapon, such as technology that would enable synthesis of Tier I agents and (II) features that would protect an individual developing a biological weapon from accidental exposure or discovery and (iii) such other characteristics as the Secretary determines appropriate.

The broad language in the proposed legislation effectively leaves the extent of the database and registration of laboratories and facilities entirely in the discretion of the regulatory authority.  Laboratories that do not handle agents that pose a serious threat could be included in the database and registry on the vague criteria specified in Section (f)(2) (C), which is not precise or determinative.

Section 103 (4)  Registry Agents, provides that the HHS Secretary establish and maintain by regulation a list of biological agents and toxins that have the potential to pose a serious threat to public, animal or plant health but for which the potential to be used effectively in a biological attack has not been clearly established.  Section 103 excludes Select agents and toxins from the list and requires a review of the select agent and toxin list to determine which listed agents and toxins more accurately fit the criteria for Registry Agents as described in subsection (f)(4). The DHHS Secretary “shall promote biosecurity and biosafety best practices to registered entities.”

Section 103 lacks details on important aspects of creation of the database and registration of laboratories and facilities. The conferral of broad and discretionary authority to require registration of laboratories without details of the information that constitutes “registration” and extent of penalties for noncompliance is a major concern. The bill does not provide for the development, including the procedure to be used for the development of biosecurity and biosafety practices.  Further, there is no indication what the word “promote” means or implies.  The criteria for Registry Agents are vague and unclear and could include all microorganisms and require registration of thousands of research and testing laboratories.

In its consultation with the Trans Federal Task Force on Optimizing Biosafety and Biocontainment, the ASM has supported registration of high containment laboratories. This is consistent with the position taken by the WMD Commission.  The ASM has recommended carefully defining the scope of high containment laboratories that would be required to register and the additional requirements that would be imposed upon those registered laboratories.  In this regard the ASM has recommended a step-wise approach that would begin by assessing the costs and benefits of moving toward an accreditation system for high containment laboratories.  The ASM also supports adequate and validated training of laboratory personnel, including technical, support and facilities personnel, rigorous implementation of appropriate laboratory practices and containment, biosafety oversight at multiple levels, ensuring the safety and upkeep of equipment and the maintenance of facilities, formal risk assessment for biosafety and biosecurity  and reporting and analysis of laboratory acquired infections.

We have submitted comments to the Committee staff on other titles of the legislation and have attached the comments to this letter.  Again, we appreciate the opportunity to comment on the proposed legislation and hope that our comments and recommendations will be useful to the Committee.

Sincerely,

Roberto Kolter, Ph.D., President, ASM
Ruth L. Berkelman, M.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

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