Federal Register / Vol. 61, No. 13 / Friday, January 19, 1996 / Notices
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1482 Federal Register / Vol. 61, No. 13 / Friday, January 19, 1996 / Notices DEPARTMENT OF HEALTH AND of etiological agents described in the experiment by the Institutional HUMAN SERVICES Biosafety in Microbiological and Biosafety Committees and the Biomedical Laboratories, 3rd edition, investigators. Since the new Appendix National Institutes of Health May 1993, U.S. Department of Health B is primarily concerned with human and Human Services, should be pathogenicity, it addresses only the Recombinant DNA Research: Actions endorsed by the Committee. The human etiologic agents and omits all Under the Guidelines Committee retained the option to adopt animal agents. The Committee observed AGENCY: National Institutes of Health, any modifications to the Centers for that this omission created a problem PHS, DHHS. Disease Control and Prevention listing. because some of the animal agents, ACTION: Notice of Actions under the NIH The Committee recommended that the particularly the group of viruses known Guidelines for Research Involving revised Appendix B, Classification of as oncogenic viruses are frequently used Recombinant DNA Molecules (59 FR Microorganisms on the Basis of Hazard, as vectors for gene transfer in the 34496, 59 FR 40170, 60 FR 20726). submitted by Dr. Fleming should not be laboratories or in human studies. The adopted until the Committee received Recombinant DNA Advisory Committee SUMMARY: This notice sets forth an letters of concurrence from both the approved a motion to: (1) establish a action to be taken by the Director, Centers for Disease Control and working group to recommend National Institutes of Health (NIH), Prevention and the NIH Division of exemption of additional vector systems under the NIH Guidelines for Research Safety. in Appendix C (exempt host-vector Involving Recombinant DNA Molecules. In a telephone call on October 20, systems), and (2) accept the proposed FOR FURTHER INFORMATION CONTACT: 1994, Dr. Fleming stated that Appendix amendments to Appendix B with the Additional information can be obtained B, Classification of Microorganisms on provision to develop a new Appendix from Dr. Nelson A. Wivel, Director, the Basis of Hazard, would be reviewed B±V relating to animal viruses relevant Office of Recombinant DNA Activities by experts from the Centers for Disease to human studies, and to list specific (ORDA), Office of Science Policy and Control and Prevention and the examples of agents under Appendix B± Technology Transfer, National Institutes American Society for Microbiology. The I, Risk Group 1 (RG1) Agents. The of Health, Suite 302, 6000 Executive revised Appendix B was submitted to motion was approved by a vote of 17 in Boulevard, MSC 7010, Bethesda, the Recombinant DNA Advisory favor, 0 opposed, and no abstentions. Maryland 20892±7010, (301) 496±9838. Committee December 1±2, 1994, On June 13, 1995, the Office of SUPPLEMENTARY INFORMATION: Today's meeting for review and discussion. Recombinant DNA Activities forwarded action is being promulgated under the During the December 1994 meeting, the two versions of the Appendix B±V, NIH Guidelines for Research Involving Committee recommended publishing Animal Viral Etiologic Agents in Recombinant DNA Molecules. This the revised Appendix B in the Federal Common Use to the Appendix B proposed action was published for Register for public comment, with Subcommittee. Most of these agents comment in the Federal Register of further review of this proposal and were previously listed as Class 2 August 18, 1994 (58 FR 44098), possible approval during the March 6± oncogenic viruses in two separate November 8, 1994 (59 FR 55796), 7, 1995, meeting. categories of low and moderate risk During the March 6±7, 1995 meeting, February 8, 1995 (60 FR 7630), and May agents in the original Appendix B. Since the Recombinant DNA Advisory 22, 1995 (60 FR 27207), and reviewed none of these animal etiologic agents are Committee deferred approval of the associated with disease in healthy and recommended for approval by the proposed amendments to Appendix B human adults, one version of Appendix NIH Recombinant DNA Advisory pending additional revisions to the B±V listed these agents as a single group Committee (RAC) at its meeting on June remaining sections and appendices of recommended for Biosafety Level 1 8±9, 1995. the NIH Guidelines that are required to containment and another version listed I. Background Information and adequately accommodate the revised them in a two-tier system for either Decisions on Actions Under the NIH Appendix B (Sections II, III, IV, V, Biosafety Level 1 or Biosafety Level 2 Guidelines Appendices C, H, and Q). The motion containment. Subsequent discussion for deferral included a recommendation with the members of the Appendix B A. Amendments to Sections II, III, IV, V, that a subcommittee consisting of Dr. Subcommittee concluded that while Appendices B, C, H, and Q of the NIH Stephen Straus (Chair of the there was no reason to have a separate Guidelines Regarding Updating the Subcommittee), ad hoc experts, and group of ``moderate'' risk agents in this Classification of Microorganisms Office of Recombinant DNA Activities list, it was prudent to recommend In a letter dated June 24, 1993, Dr. staff would meet to develop the required conducting experiments under a Diane Fleming, President of the Mid- modifications. The motion passed by a Biosafety Level 2 containment with Atlantic Biological Safety Association vote of 17 in favor, 0 opposed, and no several agents that are capable of requested the revision and updating of abstentions. infecting human cells, e.g., amphotropic Appendix B, Classification of On May 5, 1995, the Appendix B and xenotropic murine leukemia virus. Microorganisms on the Basis of Hazard. Subcommittee met to finalize the During the September 11±12, 1995, The Mid-Atlantic Biological Safety document in terms of its listing of meeting, the Recombinant DNA Association submitted an updated list of pathogens and the text of the NIH Advisory Committee reviewed the the classification of microorganisms for Guidelines related to Appendix B in updated Appendix B along with other the Recombinant DNA Advisory other sections and appendices (Sections sections and appendices of the NIH Committee to review which included II, III, IV, V, Appendices C, H, and Q). Guidelines (Sections II, III, IV, V, the latest taxonomy and agent risk group During the June 8±9, 1995 meeting, the Appendices C, H, and Q) relating to classifications as defined by the Centers Recombinant DNA Advisory Committee classification of microorganisms. It was for Disease Control and Prevention. reviewed the document. There was a observed that some viruses in the During the September 9±10, 1993, concurrence that the Risk Group moderate risk group could infect human meeting, the Recombinant DNA classification serves as an initial cells but their replication was largely Advisory Committee recommended by guidance to assign an appropriate restricted to their animal hosts. Some consensus that the current classification containment level for a particular Committee members pointed out that Federal Register / Vol. 61, No. 13 / Friday, January 19, 1996 / Notices 1483 some viruses with oncogenes such as therapeutic interventions may be biosafety containment level for SV40 have been treated more cautiously available. (4) Risk Group 4 (RG4) agents recombinant DNA experiments than viruses without oncogenes; are likely to cause serious or lethal described in Sections III±A, therefore, a two-tier list should be used. human disease for which preventive or Experiments that Require Institutional Dr. Wivel explained that listing a group therapeutic interventions are not Biosafety Committee Approval, RAC of animal viruses as ``moderate risk'' usually available. Review, and NIH Director Approval agents introduces an inconsistency into Section II±A±2. Criteria for Risk Groups Before Initiation, III±B, Experiments that Appendix B. Some strains of these Require NIH/ORDA and Institutional viruses, although capable of infecting Classification of agents is based on the Biosafety Committee Approval Before human cells, have not been shown to be potential effect of a biological agent on Initiation, and III±C, Experiments that associated with any disease in healthy a healthy human adult and does not Require Institutional Biosafety human adults. They fall within the account for instances in which an Committee Approval Before Initiation. definition of Risk Group 1 agents, i.e., individual may have increased Careful consideration should be given agents that are not associated with susceptibility to such agents, e.g., to the types of manipulation planned for disease in healthy adult humans. Two preexisting diseases, medications, some higher Risk Group agents. For committee members inquired why compromised immunity, pregnancy or example, the RG2 dengue viruses may several viruses in the original Appendix breast feeding (which may increase be cultured under the Biosafety Level B are not listed in the new version. Dr. exposure of infants to some agents) (see (BL) 2 containment (see Section II±B); Thomas Shih (Executive Secretary, Appendix B, Classification of Human however, when such agents are used for Appendix B Subcommittee) explained Etiologic Agents on the Basis of Hazard). animal inoculation or transmission Personnel may need periodic medical that several rarely used viruses such as studies, a higher containment level is surveillance to ascertain fitness to chick embryo lethal orphan virus are recommended.