July 9, 1996 - CDC Regulation on Transferring and Receiving Select Infectious Agents

Lynn Myers
Office of Health and Safety
Centers for Disease Control and Prevention
1600 Clifton Road
Atlanta, GA 30333

Re: 42 CFR Part 72, R1N0905 - AE70

Dear Ms. Myers:

The American Society for Microbiology (ASM) appreciates the opportunity to comment on the Centers for Disease Control and Prevention's (CDC) Notice of Proposed Rulemaking for "Additional Requirements for Facilities Transferring and Receiving Select Infectious Agents," published in the June 10, 1996 Federal Register (Vol. 61, No. 112). The ASM is the largest single life science society in the world, representing over 42,000 microbiologists in both basic and applied fields, who work in university, public health, clinical, government and industrial laboratories. The ASM has a long history of bringing scientific, educational and technical expertise to bear on issues surrounding the safe study, handling and exchange of pathogenic microorganisms. The exchange of scientific information, including microbial strains and cultures, among scientists is a common occurrence and is essential to progress in all areas of research in microbiology.

The ASM recognizes the public concern about the potential for pathogenic microorganisms being used as biological weapons by individuals as well as nations. Through its Public and Scientific Affairs Board, the ASM has provided advice to government agencies and to Congress concerning technical and policy issues arising from control of biological weapons. The Board has established a Task Force on Biological Weapons, composed of scientific experts, to provide a forum for discussion and formulation of policy positions on this important issue.

The ASM believes the proposed regulatory framework developed by the CDC to track and monitor sample shipments, and ensure their proper disposal, provides a degree of assurance of safety and enforcement. Its implementation, with some modifications, should not result in overly intrusive regulatory requirements that could interfere with research activities on infectious diseases. The ASM is of the firm belief that scientific research on infectious diseases must not be discouraged or delayed by unreasonable restrictions or unnecessary costs, which could deprive society of important scientific advances to eradicate disease and improve human life. The proposed CDC rulemaking is a constructive step toward the safe management of the transfer of select pathogens to ensure that they do not end up in the hands of persons who are unqualified to handle them or intend to use them for illicit purposes that could harm the public health.

Some of the selected infectious agents listed in Appendix A are endemic in the geographic regions where they occur. It should be recognized that knowledgeable, dedicated, terrorists may be able to obtain pathogenic microorganisms from natural sources. The nation must, therefore, maintain a strong capacity for surveillance, response and prevention of outbreaks of disease to safeguard the public health and increase the ability to detect and respond to epidemic threats that could be caused by the illicit use of infectious agents.

We would like to submit the following comments which are intended to improve the proposed requirements for transferring and receiving select infectious agents.

In general, the overall process and approach proposed in the rulemaking of relying on a list of a limited number of well defined infectious agents that have the potential for causing widespread disease in humans is reasonable in our opinion. It should be recognized that the proposed list of select agents covered by the proposed rule will be in need of regular updating to take account of advancing scientific knowledge. Although the notice states that CDC will continue to consult with experts representing affected professional groups and will update the list as necessary, we recommend that the review and update of the list be done on a regular basis in consultation with expert scientists from the CDC and those identified by the American Society for Microbiology. We also recommend specifying a mechanism for notifying the scientific community of any revisions to the list.

The proposed list of select infectious agents published for public comment in Appendix A requires further consideration to be certain it represents a broad consensus by the scientific community about which infectious agents should be covered by the proposed rule. Because of scientific questions raised by experts in the field about specific agents that are listed in Appendix A and their demonstrated potential for causing widespread harm to public health, for example, Easter equine encephalitis, Western equine encephalitis and Japanese encephalitis viruses and all members of the hantavirus classification, we strongly encourage the CDC to convene a group of appropriate experts from the scientific community to determine the agents which should be covered by the new rule. We recommend that Histoplasma capsulatum be removed from the list because it is a commonly found fungus which is easily isolated from soil in this country and in many areas of the world and mainly results in only mild disease in humans. It is highly unlikely that this fungus could be used as an effective biological weapon. The ASM would be pleased to work with the CDC in further refining the proposed list of selected infectious agents in Appendix A.

We recommend that multiple strains of the same organism be included on one form as well as organisms that are in the same classification in order to minimize the number of forms. We also note the need for education, guidance and dissemination of information to research investigators, who must clearly understand their roles and responsibilities. The ASM offers its assistance in working with the CDC to disseminate information and to determine the sites which would be covered by the proposed rule.

We strongly recommend that centralized responsibility for the regulations remain with the CDC. The additional shipping and handling requirements for laboratory facilities transferring or receiving select infectious agents capable of causing substantial harm to human health should be handled by the CDC, which has the appropriate expertise and background for implementing the regulations in an appropriate manner. Because of the importance of the new regulations, particularly for national security, we do not believe that the Secretary should delegate responsibilities to a "state agency" or organization other than CDC.

Section 72.7 includes stringent penalties for individuals and organizations that violate the regulations. The primary responsibility for compliance with the regulations is placed on institutions, which must meet their responsibilities or face significant penalties . These penalties will help assure that compliance with the regulations is achieved. We , therefore, believe that inspections should be "for cause" and in cases where CDC is unfamiliar with the institution that is registering. The CDC does not need to inspect every facility because many research intensive institutions have well equipped BSL 2 and/or 3 laboratories with oversight in place. Limited resources for biomedical research should be used wisely, and inspections should occur only in cases where a problem has been identified or where the site has no track record, no known capability for working with the covered agent and is not equipped with biosafety facilities at the required level. There should be a fixed time period in which events occur associated with the registration, renewal and inspection process.

There would be advantages to having state health departments check with the CDC or the registering entity for information about covered infectious agents. Information on the location of agents and toxins on the list of selected infectious agents could be useful to surveillance systems for detecting unusual disease outbreaks.

It is our understanding that the proposed rule exempts clinical specimens, whether plant, animal or human, and a suspect isolate of a covered agent which may be sent to a reference laboratory for identification or confirmation. We believe the proposed rule should clarify how suspect agents should be handled by clinical, public health and commercial clinical or reference laboratories so that they clearly understand their responsibilities.

The ASM appreciates the opportunity to comment on the proposed rule and stands ready to assist the CDC in any way possible.