October 14, 2011 - CDC Proposed Rule Changes for Importation of Etiologic Agents
The CDC published a Notice of proposed rulemaking in the October 14 Federal Register to revise regulations that cover the importation of etiological agents, hosts and vectors. The rule proposes changes to the Foreign Quarantine regulations, including section heading, terms and definitions (eg,“host”, “vector”); a requirement for appropriate biosafety measures as a prerequisite for a permit and a provision for CDC inspection authority to inspect an applicant’s facility for the conduct of research at the biosafety levels 3 and 4 if it has not been inspected by the select agent program; permit exemptions are described for select agents, diagnostic specimens, genomic material, and regulated products. The importer must be in compliance with all applicable laws concerning the packaging and shipment of infectious substances.
June 21, 2011 - ASM Participates in Conference on Emerging Technologies and Institutional Biosafety Committees
The NIH Office of Biotechnology Activities (NIH OBA) invited ASM to participate in and serve on the planning committee for their recent biennial conference that focused on biosafety issues and Institutional Biosafety Committee (IBC) oversight of laboratory research involving emerging technologies. The conference was intended to increase understanding of biosafety and biosecurity issues surrounding advances in select agent research, synthetic biology, nanotechnology, and the implications for institutional biosafety programs including IBCs. Presentations and panel discussions outlined strategies and resources for addressing program gaps, strengthening IBC risk assessment s for emerging technologies, developing comprehensive training programs, raising biosecurity awareness, and aspects of personnel reliability programs. The program was targeted towards IBC members and staff, biosafety professionals, research administrators, scientists, regulators and others involved in the conduct and oversight of research. Approximately 200 people attended the June 12-14 conference in San Diego. Claudia Mickelson, Ph.D., a member of the PSAB’s Committee on Biomedical Research represented ASM at the conference.
May 11, 2011 - MMWR Special Supplement: Guidelines for Biosafety Laboratory Competency CDC and the Association of Public Health Laboratories
These guidelines for biosafety laboratory competency outline the essential skills, knowledge, and abilities required for working with biologic agents at the three highest biosafety levels (BSLs) (levels 2, 3, and 4). The competencies are tiered to a worker’s experience at three levels: entry level, midlevel (experienced), and senior level (supervisory or managerial positions). These guidelines are intended for laboratorians working with hazardous biologic agents, obtained from either samples or specimens that are maintained and manipulated in clinical, environmental, public health, academic, and research laboratories.
August 13, 2010 – ASM Submits Comments to CDC on Draft Guidelines for Safe Work Practices in Human and Animal Clinical Diagnostic Laboratories
On August 13, the PSAB Committee on Laboratory Practices submitted comments to the Centers for Disease Control and Prevention on its draft Guidelines for Safe Work Practices in Human and Animal Clinical Diagnostic Laboratories.
May 3, 2005 - The CDC has posted an Interim CDC-NIH Recommendation for Raising the Biosafety Level for Laboratory Work Involving Noncontemporary Human Influenza (H2N2) Viruses. The recommendation is excerpted from the draft Biosafety in Microbiological and Biomedical Laboratories, 5th edition.
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