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nih biohazard list Section I The scope of the Guidelines “Guidelines” does not mean “optional” The NIH Guidelines are a term and condition of NIH funding for research with recombinant or synthetic nucleic acid molecules . ) Decomissioning, Toxics releases (PCBs, asbestos, lead based paint, mercury) Page 42 Appendix B-III-D: Addition of specified Orthomyxoviruses to the list of RG3 agents Page 70 Updated reference to the Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th edition (hyperlinked). Check each type of hazardous material that has been used with or is contained in this property. Agents requiring implementation of Biosafety Level 3 or 4 containment are not used or stored at Berkeley Lab. See if you are working with a select agent or toxin. It is also assigned to an NIH institute or center (IC) that will pay the grant if it receives a favorable review. Click here to go directly to Appendix B ⇗ Although it is not a regulatory agency, the NIH said in a statement that agency staff have made site visits to 100 institutions in recent years in an effort to help improve biosafety committee Since 2008, the Biohazard Panel has published on a regular basis an update of the microbial strains submitted for approval and extends the list of species which have been granted QPS status. Steering Committee. NIH Exposure Control Program. The BMBL requires that a biohazard sign be posted at the laboratory entry when biohazardous materials are present . 2 NIH Guidelines Human Etiologic Agents. LIST OF TABLES Table 1 Biohazardous Materials Table 2 Summary of Biosafety Levels (BL-1 to BL-3) (at laboratory scale) Table 3 Increasing Resistance to Chemical Disinfectants LIST OF ABBREVIATIONS AND ACRONYMS BL biosafety level BMBL Biosafety in Microbiological and Biomedical Laboratories BSC biological safety cabinet BSO Biosafety Officer University of Denver Biosafety Manual Version 1. The printed 2014 NIH Waste Disposal Guide - PDF (2. Biosafety level 4 laboratories are designed for diagnostic work and research on easily respiratory-acquired viruses which can often cause severe and/or fatal disease. Bleaching Agents (2) Blocking Agents, Sperm Maturation (0) see Antispermatogenic Agents. The NIH Guidelines ⇗ are a set of rules that govern research on recombinant/synthetic DNA in the United States. Does the lab have access to NIH’s. The duties of the BSO as defined by the NIH Guidelines include, but need not be limited to: Research conducted at UCLA is governed by numerous agencies that have guidelines and standards that we must follow. The National Institutes of Health (NIH) governs many biosafety practices through funding that is received by UCLA. The IBC uses the biosafety levels recommended by the CDC and NIH as the usual standards of containment to be set for work with a given biohazardous material. Richmond, Ph. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed. coli laboratory strains are K12 or derived from K-12 and therefore most research utilizing these strains is exempt from the NIH Guidelines. Summary of Biosafety Level Criteria . This section provides a list of human pathogens and their Risk Group (RG) 2, RG3, and RG4 designations as excerpted from Appendix B, Classification of Human Etiologic Agents on the Basis of Hazard, of the NIH Guidelines, amendment effective November 6, 2013. Biosafety Level 1 (BL1) Facilities; A biohazard sign must be posted on the entrance to the laboratory or facility whenever infectious agents are present. Harmonization of Biosafety and Biosecurity Standards for High-Containment Facilities in Low- and Middle-Income Countries: An Approach From the Perspective of Occupational Safety and Health. EH&S posts signs at laboratory entrances that include the universal biohazard symbol, the biosafety level of the agents present in the room, and the name and contact information for the primary and secondary emergency contacts. The biosafety levels described in the NIH Guidelines for Research Involving rDNA Molecules are based on and consistent with the biosafety levels presented here. D. (4) NIH and CDC guidelines, entitled Biosafety in Microbiological and Biomedical Laboratories; and the NIH Guidelines for Research Involving Recombinant DNA Molecules (“the NIH Guidelines”)11 There are a number of basic aspects to working with Select Agents that are codified under 42 CFR part 73: the Select Use of Biohazardous Materials in Research and Instruction PURPOSE The University of Massachusetts Amherst (the University) is committed to ensuring the safe handling, storage, and disposal of potentially biohazardous materials, as defined below, used in University research or instructional projects. o. The table below, which was excerpted from the NIH Recombinant DNA Guidelines, presents the basis for the classification of biohazardous agents by risk group. Any research related accidents or illnesses ii. The goal of the biohazard risk assessment process is to identify the biohazard risk management parameters to conduct the procedure safely and in Procedures are based on the CDCNIH Biosafety Guidelines and the NIH rDNA from PHILOSOPHY 100 at Oxford University eligibility, particularly as it relates to eligibility for funding from the National Institutes of Health (NIH). microorganisms, toxins and allergens derived from Standard Operating Procedure Requirements for . It was usually determined that there was a need for someone to oversee the institution's biohazards operations. In 1984, the The IBC serves as an advisory committee for University projects involving possible biohazards that do not appear to fall into one of the areas listed below. Table 1 describes the risk groups, Table 2 relates them to the laboratory designations, and Table 3 summarizes the requirements at the four biosafety levels. proposed research using the NIH Guidelines as a minimum standard. pneumophila Leptospira interrogans - all The NIH Guidelines apply to… Research involving recombinant or synthetic (or both) nucleic acid molecules that is Performed at or sponsored by an institution that receives any NIH funding Rationale: For biosafety to be meaningful, it has to be observed by all investigators at an institution This applicability is broader than many GHS, the Globally Harmonized System of Classification and Labeling of Chemicals, was developed by the United Nations as a way to bring into agreement the chemical regulations and standards of different countries. Methanol | CH3OH or CH4O | CID 887 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological activities, safety The course will include basic concepts of microbiology and disease transmission in the workplace. Biological Agents Exempt from the NIH Guidelines . To comply with NIH regulations, the University of Utah Biosafety Office facilitates reporting of potential laboratory exposures, spills, or other incidents (1) to the NIH Office of Biotechnology Activities (OBA). Knowing how to work safely in a BSC is key. Laboratory personnel *The Institutional Biosafety Committee has recently been combined with the Biohazards Committee. Compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules is mandatory for every institution that receives NIH funding for research involving recombinant DNA (rDNA). There are many possible occupational hazards, but this review is intended to concentrate on common hazards and safety concerns. E. PROGRAMS FOR MEDICAL AND DENTAL STUDENTS. The purpose of this article is to address common occupational hazards and safety concerns of nuclear medicine technologists. According to the NIH guidelines, this contact would be reportable to NIH Office of Science Policy (NIH OSP). utah. 15 Office of Biotechnology Activities (OBA): The NIH office responsible for promoting sciences, safety and ethics in the development of public policies in the areas of Biomedical Technology Assessment, Biosafety, and Biosecurity. Below is a list of some commonly used strains of E. Decontaminate the property according to the procedures referenced below. Identifies substantive biomedical research areas where biohazards may exist. Examples of potential exposures to a BL3 agent are any accidents, equipment failure, or splash to intact skin. microorganisms, toxins and allergens derived from Today’s litigation against the NIH is one part of our efforts to try to uncover what is known about the origins of SARS-CoV-2, and the risks of biosafety labs and gain-of-function research, which seeks to augment the infectivity or lethality of potential pandemic pathogens. gov. According to NIH Grants Policy Statement (NIH GPS, chapter 8. 1. In all cases, degrees are granted by the university partner. The NIH IBC determines the biosafety level based on a risk assessment including such factors as the agent in use, laboratory procedures, quantity of material being manipulated, etc. 2. Institutional Biosafety Committees National Institutes of Health, (NIH) National Jewish Health Nature Coast Clinical Research (Crystal River) Biohazards. Such research is also subject to Administrative Procedure: Activities Involving Potentially Hazardous Biological Agents, including review and approval by the IBC. Biosafety addresses the safe handling and containment of biohazardous material. Find more information about nucleic acid molecules policy and IBCs on the NIH Office of Science Policy website. BSL-1 Laboratory Facilities . B. National Institutes of Health Embedded in the sprawling campus of the National Institutes of Health (NIH) in Bethesda, Md. Table 1. . 2. Containment is achieved through the use of work practices, safety equipment, PPE and facility features. oxytoca (RG1) Legionella including L. It does not list Risk Group 1 organisms. According to the United State Government Accountability Office (GAO) report published on October 4, 2007, a total of 1356 CDC/USDA registered BSL-3 facilities were identified throughout the United States (GAO-08-108T ). Animal Activities Table. environment. This particular laboratory is growing large volumes of the rabies virus and isolating the virus in a centrifuge. 1. , is a small but mighty high-level containment facility known as the The MPW box kit (five boxes, ten bags, and plastic bag closures ties) is available from the NIH Self-Service Store and NIH Stock Catalog (NSN-8115-00-L04-0680). o. The IBC also reviews all research involving biohazardous materials and has overall oversight and responsibility for the Biosafety program at BU and BMC. 06. 99. 1. coli, and the NIH Guidelines category applicable to those strains. Institutional Biosafety Committee registration is not required for these exempt experiments. CDC/NIH: Biosafety in Microbiological and Biomedical Laboratories, 4th edition, 1999. Overt Exposure: A definitive contact with a Biosafety Level Two or Biosafety Level Three recombinant or synthetic CRM. Submissions must be received by close of business (5:00 p. BMBL: The Centers for Disease Control and Prevention (CDC) and The National Institutes of Health (NIH) published guidelines “Biosafety in Microbiological and Biomedical Laboratories 5th Edition” contains summary information and should be consulted for further information. The biosafety and containment procedures must be sufficient to contain the select agent or toxin (e. 15–17 The contact information for the responsible person, instructions for entering and exiting the area, the designated biosafety level, name of the products, and the universal biohazard symbol must be posted Biosafety for NIH supported research, • Biosecurity, including oversight of dual use research, and • Registration of new stem cells lines for NIH funded research. The UCLA EH&S Biosafety Program offers training on the safe use of biosafety cabinets. The NIH Guidelines (Appendix B) classifies pathogenic agents into one of four risk groups according to specific criteria. Amend an Existing Registrations Biosafety in Microbiological and Biomedical Laboratories (BMBL) has served as the cornerstone of biosafety practice in the United States since its initial release in 1984. 2 NIH Guidelines Human Etiologic Agents. Use 2 bags per box for double containment. This includes sites outside of the United States. In order to receive NIH funding, UCLA must be in compliance with the NIH rDNA guidelines, the PHS Policy on Humane Care and Use of Laboratory Animals and other standards. Sample Standard Operating Procedure Requirements for BSL2 Containment Principal Investigators (PI) at the University of Toledo have the responsibility to inform the laboratory personnel of the hazards associated with biological agents and the appropriate research procedures. Wilson, DrPH, CBSP Farhad Memarzadeh, Ph. Experiments considered as Major Actions under the NIH Guidelines cannot be initiated without submission of relevant information on the proposed experiment to the Office of Science Policy, National Institutes of Health, preferably by email to: NIHGuidelines@od. Research Program at NIH, which I encourage you to read. MUST NOT. Ensure all information is directly visible in your PDF. for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), National Institutes of Health . g. The goals of the biosafety program are to protect personnel from exposure to infectious agents, to prevent environmental contamination, to provide an environment for high quality research while maintaining a safe work place, and to comply with applicable federal, state and local requirements. Biosafety level designations are based on a composite of the design features, construction, containment facilities, equipment, practices and operational procedures The 6th edition of the Biosafety in Microbiology and Biomedical Laboratories is Available: November 23, 2020: Fall 2020: 11/23/2020: The NIH Employee Assistance Program (EAP) can help you reflect on what has worked for you in the past with previous life stressors. 4 pg. The BSL-2 section must also be completed if any of the vectors or agents involved are biosafety 2 (or Risk Group 2) agents. Biohazards (0) see Hazardous Substances. Oversight. Biological Response Modifiers (0) see Immunologic Factors. Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) Guidelines on: Biosafety in Microbiological and Biomedical Laboratories (BMBL). Complete the certification at the bottom. Full instructions page R-37 Other Attachments When an application arrives at NIH, it is referred to a study section for review. National Institutes of Health Biosafety Level 3 Laboratory Certification Requirements By; Deborah E. Chief, External Activities Program and WHO Collaborating Center for Biosafety and Training Office of Health and Safety Centers for Disease Control and Prevention Robbin S. Biosafety Level 1 represents a basic level of containment that relies on standard microbiological practices with no special primary or secondary Technology, the NIH Guidelines for Research Involving Recombinant DNA Molecules and the Biosafety in Research website (www. The NIH Guidelines defines the risk groups as: Risk Group 1 (RG1) - Agents that are not associated with disease in healthy adult humans. 1. Institutional Biosafety Committee (IBC): the Institutional Biosafety Committee sets campus policy for work with biohazardous agents and biohazardous materials, and evaluates Biological Use Authorizations. 5 Classification of Etiologic Agents on the Basis of Hazard is a somewhat comprehensive list of organisms assigned to appropriate biosafety levels that is updated by the NIH periodically. The IBC meets once every month, on the 2nd Thursday of each month. Please always refer to the official NIH SF424 application guide and funding opportunity announcement for specific instructions. The BSLs described in this manual should be differentiated from Risk Groups, as described in the NIH Guidelines and the World Health Organization Laboratory Biosafety Manual. What is RAC? The Recombinant DNA Advisory Committee, or “RAC,” is a federal advisory committee that provides recommendations to the NIH Director related to basic and National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 NSF International/American National Standards Institute (ANSI) 49 Annex E—Biosafety Cabinetry: Design, Performance, and Field Certification NIH Guidelines Quick Reference Provides principal investigators and others responsible for the conduct of recombinant and synthetic nucleic acid research experiments, and Institutional Biosafety Committee (IBC) members who review these experiments, with training on the requirements of the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules. It is the responsibility of the Principal Investigator (PI) to make sure that his/her laboratory is in compliance. o. Medical Surveillance and additional training is required. Scope . The NIH Guidelines outline roles/responsibilities for the institution, IBC, biosafety officer, and PIs (outlined in the following module). e. Slides are now available, click here. Biosafety Level 2 Guide University of Illinois at Urbana-Champaign . A list of such exchangers will be prepared and periodically revised by the NIH Director with advice from the RAC after Biosafety The Hazard Communication Sign (shown below) incorporates language as indicated in the publication CDC/NIH Biosafety in the Microbiology and Biomedical Laboratory, 5th edition (BMBL). Page 76 Appendix G-II-C-5: Biosafety Level 3 Enhanced for Research Involving Risk Group 3 Influenza Viruses. Bleaching Agents (2) Blocking Agents, Sperm Maturation (0) see Antispermatogenic Agents. It is University of NIH Guidelines for rDNA. July 2006 Introduction Biosafety Level 3 (BSL-3/ABSL-3) containment laboratories for animals and research are the most difficult containment level facilities to design and operate. By However, the list is not comprehensive and principal investigators can confirm that toxins they propose to work with do not require IBC registration (LD50 >100 µg/kg body weight and not on Select Agent list) by contacting the Biosafety Office (biosafety@ehs. The Institutional Biosafety Committee (IBC) is responsible for the review of University research or teaching activities involving recombinant or synthetic nucleic acid molecules, potentially hazardous infectious agents, and potentially hazardous biologically-derived toxins as described in the University of The 1, 2, 3's of Biosafety Levels Jonathan Y. The sign must include the name of the agent(s) in use and the name and telephone number of the Principal Investigator. 3 Significant Changes to Human Subjects, Animal Subjects, Biohazards and/or Select Agents Scientific justification for any changes involving research with human subjects, vertebrate animals, biohazards, and/or select agents planned for the next reporting period should be described in Section B. g. The guidelines were revised and approved in 2012, and the current edition was approved in September 2019, by the Scientific Directors. msu. The guidelines for human biospecimens were originally developed by a committee appointed by the NIH Scientific Directors, who approved them in 2007. These include radiation safety issues and conce … The NIH Guidelines apply to all institutional research involving recombinant or synthetic nucleic acids regardless of funding status or funding agency (i. SOP 900 Approval Process for Inactivation Methods for Infectious Material. All research on potentially biohazardous agents must be done according to the NIH-CDC publication, “Biosafety in Microbiological and Biomedical Laboratories” (BMBL). NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (April 2019) Biosafety Considerations for Research with Lentiviral Vectors Animal Experiments Under the NIH Guidelines. Proposal Requirements Notes Title Up to 200 characters including spaces Assessments will include an evaluation/review of biosafety criteria referenced from lab specific IBC related SOPs, UVM Lab Safety Policies, the NIH Guidelines and the Biosafety in Microbiological and Biomedical Laboratories. o. For inquiries, information requests, and report submissions: NIHGuidelines@od. o. Biohazards (0) see Hazardous Substances. 2. biosafety. gov. Sample Standard Operating Procedure Requirements for BSL2 Containment Principal Investigators (PI) at the University of Toledo have the responsibility to inform the laboratory personnel of the hazards associated with biological agents and the appropriate research procedures. Laboratories should have doors for access control. Any significant programs or violations of the NIH Guidelines (e. Risk groups are the result of a classification of microbiological agents based on their association with, and resulting severity of, disease in humans. coli O157:H7 Haemophilus ducreyi, H. 00249. Annual Biosafety Inspection Checklist. Select Agents. The webinar was an opportunity to clarify expectations for both the FIRST Cohort and FIRST CEC RFAs (RFA-20-022 and RFA-20-023). BSL2 Containment. nih. Diets high in vegetables and fruits, which are good sources of antioxidants, have been found to be healthy; however, research has not shown antioxidant supplements to be beneficial in preventing diseases. The CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, and legislation on bioterrorism and select agents are also included. 5. Laboratories, Office of Science and Technology Policy, August 28, 2014 Did you know that NIH is the largest public funder of biomedical research in the world, investing more than $32 billion a year to enhance life, and reduce illness and disability? NIH funded research has led to breakthroughs and new treatments, helping people live longer, healthier lives, and building the research foundation that drives discovery. If it is unclear whether a material constitutes a potential biohazard, consult the biosafety officer or the director of the Office of Research Assurances. * The IBC is composed of no fewer than 5 voting members with the collective experience and expertise to assess the safety of research involving recombinant DNA/nucleic acid, biohazardous material, and DURC. The Federal Select Agent Program oversees the possession, use and transfer of biological select agents and toxins, which have the potential to pose a severe threat to public, animal or plant health or to animal or plant products. Guidelines for Research Involving Recombinant DNA Molecules liquid biohazardous waste disposal 5 nanomaterial-containing waste 6 pharmaceutical waste 6 reference list 7 appendix a – nih ics chemical waste disposal contacts list 8 appendix b – expanded list of chemical solutions approved for drain disposal 9 B. Diets high in vegetables and fruits, which are good sources of antioxidants, have been found to be healthy; however, research has not shown antioxidant supplements to be beneficial in preventing diseases. Summary of Laboratory Biosafety Levels; BSL Agents Special Practices a Primary Barrier and Personal Protective Equipment a Facilities (Secondary Barriers) a; 1: Well-characterized agents not known to consistently cause disease in immunocompetent adult humans and present minimal potential hazard to laboratory personnel and the environment. 1. Office of Biosafety. The UNL Biosafety Guidelines describe the methods, means, procedures, and policies that All biosafety activities involving the use of Biosafety Level 2 or 3 agents AND/OR non-exempt recombinant DNA AND/OR synthetic nucleic acid molecules, as defined by the National Institutes of Health (NIH), AND/OR agents identified as Dual Use Research of Concern shall be reviewed by the Panel regardless of the source of funding for the project. IBC Calendar. Additional References Animal Welfare Assurances - this section of the Topic Index provides additional guidance on Assurances found in Commentaries, Articles, FAQs, and NIH Guide Notices. 2019. • NIH Design Requirements Manual for Biomedical Laboratories and Animal Research Facilities (DRM), 2019 • NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), 2016 • National Institutes of Health Biosafety Level 3 Laboratory Certification Requirements, 2006 Professional Credentials in Biosafety For years the practitioners of biosafety have come from many different disciplines. Risk Groups; Infectious agents may be classified into risk groups based on their relative hazard. 4 pg. Also find grants process. Synthetic University of Rochester Disinfectants for Biohazardous Materials Guidelines 2 Descending Order of Resistance to Germicidal Chemicals (Adapted from Appendix B Table 1 of CDC/NIH 5th Edition “Biosafety in Microbiological and Biomedical CDC/NIH: Biosafety in Microbiological and Biomedical Laboratories, 4th edition, 1999. The publication Biosafety in Microbiological and Biomedical Laboratories 1 is a principal reference and the resource for much of the information presented in this month NIH Director’s memo to IBC chairs, contacts, and biological safety officers, August 28, 2014 Ensuring Biosafety and Biosecurity in U. CFR: Section 12 (c)(3) In developing a biosafety plan, an individual or entity should consider: The “NIH Plans for appropriate biosafety, biocontainment and security of the select agents. National Institutes of Health Bethesda, MD 20892 . Institutional Biosafety Committee (IBC) — IBC Office No relationships with industry relevant to the content of this educational activity have been disclosed. , physical structure and features of the entity, and operational and procedural safeguards). The topic of your proposed research determines the study section to which your application is referred and the IC to which it is assigned. The Biosafety in Microbiological and Biomedical Laboratories (BMBL) , which is published by the CDC , is an essential resource for establishing practices that address the safe use of infectious pathogens and hazardous biological materials in biomedical research. NIH - Working Safely with HIV in the Research Laboratory Biosafety Level, 2/3, 1988. The NIH Guidelines established a comparable classification and assigned human etiological agents into four risk groups on the basis of hazard The descriptions of the WHO and NIH risk group classifications are presented below. Experiments using recombinant DNA technology must follow the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (March 2013). o. gov may be a synthetic equivalent are exempt from these NIH Guidelines (see . BSP is available to assist principal investigators and researchers with the registration of their biological research, performance of research risk assessments, compliance with CAB/ESCRO-required laboratory inspections, and completion of laboratory safety trainings. Description: This training covers the following topics: General laboratory biosafety (bioagents, risk groups, biosafety principles, biocontainment, etc. Synthetic ) is an institutional committee created under the NIH National Institutes of Health Guidelines to review research involving recombinant DNA and synthetic nucleic acid research. The OSHA Bloodborne Pathogens Standard, including the OSHA enforcement guidelines will be discussed. III-B-2: Experiments that have been Approved (under Section III-A-1-a) as Major Actions under the NIH Guidelines New BMBL Sixth Edition now available. All work that is subject to the UNL Biosafety Guidelines must be conducted under the appropriate level of containment. Please note that RFA RM-20-023 is no longer open, RFA RM-21-019 has replaced it This section contains a comprehensive list of hazardous waste types, information about the responsibilities of biohazardous waste generators, biohazard waste minimization, disinfecting and disposing of biohazardous liquids in the lab, preparing biohazardous waste for autoclaving or disposal and more. The role of an institutional biosafety committee (IBC) is to conduct risk assessments for research involving engineered genetic material to ensure an appropriate risk mitigation plan is in place. Medical and dental students can come to the NIH in several ways. Biohazardous agents fall into Risk Group 2 or above as defined by the NIH Guidelines for Research Involving Recombinant DNA (See . NIH Basis for Classification of Biohazards Agents by Risk Group. NIH Checklist Note this checklist is a general guide for “R01” type grants. Privately sponsored studies routinely employ Advarra biosafety services to enable them to qualify for NIH support, to support third-party regulatory requirements, or for enhanced research safety oversight. BSL-2/ABSL-2 research is never exempt. 01/13) 3. For more informati on, please refer to the following section of this manual: Biosafety and Recombinant DNA or Synthetic Nucleic Acid Molecule Technology, the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and the Biosafety in Research website. It is meant to prevent lab-acquired infections and/or prevent release into agricultural or natural ecosystems. Any research related accidents or illnesses ii. The PI is responsible for assuring that the transgenes do not include gammaretroviral LTRs of more than one-half HGT research subject to the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines) must be approved by an NIH-registered Institutional Biosafety Committee. If an incident (sharps injury, splash, spill, unauthorized work, etc) occurs, the following steps must be taken by the PI: Report incident within 24 hours… – National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC) Testimony: •Establishment of a Trans-Federal Task Force on Optimizing Biosafety Oversight, consisting of representatives of a broad range of Federal agencies concerned with biosafety risks –Biosafety Curriculum Development and Biosafety Training biohazards NIH Guidelines – Requirements for Institutional Biosafety Committees (IBC) The NIH Guidelines require: • IBCs to have no fewer than 5 members Plant, plant pathogen, plant containment specialist Animal containment specialist At least 2, local, unaffiliated community members BSO IBC Meetings are open to the public NIH F31 Application Checklist Updated 03/09/15 Application Section Page Limits Introduction (resubmissions only) 1 page Biosketch for applicant and sponsor(s) 4 for old format, 5 for new format Project Summary 30 lines of text Cover Letter N/A Letter of reference from sponsor(s) N/A SECTION III-B: Experiments That Require NIH/OBA and Institutional Biosafety Committee Registration Before Initiation III-B-1: Cloning of Toxin Molecules with LD 50 of <100ng/kg of body weight. List of “Veterinary Pathogens of Significance” (can be found in Appendix D of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, 5th Today’s litigation against the NIH is one part of our efforts to try to uncover what is known about the origins of SARS-CoV-2, and the risks of biosafety labs and gain-of-function research, which seeks to augment the infectivity or lethality of potential pandemic pathogens. be used for disposal of general waste such as soda cans, papers, cardboard, The NDSU Biosafety Guidelines are designed to minimize or eliminate potential adverse effects on human, plant, and animal health, and the environment, from research, clinical, and educational activities involving the following potential biohazards: National Institutes of Health. Blood Substitutes (6) Bone Cements (3) • Adhesives used to fix prosthetic devices to bones and to cement bone to bone in difficult fractures. Updated July 2020 Page 2 of 18 . Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or A biohazard sign template is available from EH&S that can be used to communicate room-specific information. You may use this system to: Submit a new IBC registration NIH Institutional Biosafety Committee (IBC) - The NIH Institutional Biosafety Committee reports to the Director, NIH or his or her designee on matters pertaining to the control of biological hazards. The assessment checklist is located in appendix A of this document and includes the following sections: Facilities List biosafety-related publications such as: Hot Zone, Biohazard, The Demon in the Freezer, and Outbreak (Cases in Real-World Microbiology). Animal Biosafety Level 1 (ABSL-1) ABSL-1 is appropriate for research conducted with well-characterized strains of viable microorganisms or viruses not known to cause disease in healthy adult humans. Work at BSL-3 requires enhanced facility design, operational controls and special practices, which will be outlined in this section. It was a position born out of necessity and was usually given over to either a senior research scientist with some background […] Containment facilities are described in the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories (BMBL) and in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). Please contact EHS Biosafety for more information. This 1 hour lecture class provides information specific to working safely around NIH Biological Safety Level 3 laboratories. This information is organized in a series of appendices: Appendix A: This section contains a list of organisms that exchange DNA by known physiological methods; this section can be used to determine if an experiment would fall under this Biosafety Protocol (the Protocol), the reference documents cited within it, the NIH Guidelines Biosafety in Microbiological and Biomedical and Laboratories. We wish to emphasize that the sixth edition of BMBL remains an advisory document recommending best practices for the safe conduct of work in biomedical and clinical NATIONAL INSTITUTES OF HEALTH RISK GROUP Escherichia coli - all enteropathogenic, enterotoxigenic, enteroinvasive and strains bearing K1 antigen, including E. facilities as basic – Biosafety Level 1, basic – Biosafety Level 2, containment – Biosafety Level 3 and maximum containment – Biosafety Level 4. The Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) are our main sources for biological safety information for infectious agents. NIH Institutional Biosafety Committees FAQs on the NIH Review Process for Human Gene Transfer Trials NIH IBC PI Dashboard PROCEDURES Note: All applicable protocols must be reviewed by the NIH IBC; however, the need for RAC review is determined by IBC and IRB. The table below contains a list of agents and their categories. Table 1. NIH 2683 (Rev. Chief, Laboratory Safety Branch Office of Health and Safety This system supports online submission of IBC registrations and annual registration updates to the NIH Office of Science Policy (OSP). 5), change in scope refers to a change in the direction, type of research or training from the aims, objectives, or purposes of the approved project. Any significant programs or violations of the NIH Guidelines (e. Toxin Experiments NIH, or other sponsoring federal entity, within 30 days of: i. Even if there is no NIH support involved, IBC review is a best practice. 4. EHS also reviews and assists researchers by inspecting laboratories with compliance with federal and state requirements for biological research including the NIH rDNA Guidelines and the CDC/NIH Standard Operating Procedure Requirements for . Biological Agents and Associated Biosafety Levels . See Appendix B of the Biosafety Program or the NIH Guidelines for a list and risk group categorization of human etiologic agents. 5 2. NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) 78 FR 66751 (November 6th, 2013), as amended. Elevating awareness of biohazards and the biosafety regulatory landscape among core facility operators is essential for the establishment of a framework for both project and material risk assessment. Research Facility Biohazard Warning Signs. National Institutes of Health. Discuss the impact of Public law 107-56 (USA Patriot Act) and the Public Health Security and Bioterrorism Response Act on research. 2. (RG1, Exempt, NIH Guideline III-F, F-8, Appendix C-II) This is a specialty training provided to those who provide support services to NIH BSL-3 laboratories (only). Containment is achieved through the use of work practices, safety equipment, PPE and facility features. The International Dairy Federation (IDF) and the European Food and Feed Cultures Association (EFFCA) have, since 2002, been conducting a project on the The NIH Guidelines also include over 90 pages of additional information on biosafety and biological research. Infectious agents requiring handling conditions above Biosafety Level-1. ), IBC oversight, NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acids, OSHA Bloodborne Pathogen Standard, and prevention of laboratory-acquired infections. NIH Guidelines, Appendix B for list of Risk Groups). NIH Guidelines, Appendix B. The goal of this initiative is to bring awareness to the importance of biosafety standards and to strengthen biosafety oversight and practice by reaffirming a commitment to biosafety at all levels of NIH OFFICE OF SCIENCE POLICY CONTACT INFORMATION: Office of Science Policy, National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, MD 20892-7985 (20817 for non-USPS mail), (301) 496-9838; (301) 496-9839 (fax). To learn more about safe practices and how BSCs work, watch this video from the National Institutes of Health (NIH Use the menu on the left or bottom of the screen for more information. A biosafety level (BSL) is based on at each site. Biological Basic Laboratory Design for Biosafety Level 3 Containment facilities are described in the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories (BMBL) and in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). Offerors. Spill in Laboratory. Biosafety Levels (BL) – guidelines for laboratory practices, equipment, and containment of organisms containing rDNA for the purpose of minimizing The NIH guidelines and BMBL have more distinct signage requirements than USP chapter 800 for the designation of drug handling areas. Biosafety level 4 (BSL-4) is the highest level of biosafety precautions, and is appropriate for work with agents that could easily be aerosol-transmitted within the laboratory and cause severe to fatal disease in humans for which there are no available vaccines or treatments. Find funding opportunities, grant programs, and staff contacts. Example: Let’s assume that you are working with the rabies virus, which per the NIH risk group classification list is a Risk Group 2 agent, so ordinarily researchers would follow the Biosafety Level 2 requirements. NIH Institutional Biosafety Committee (IBC) - The NIH Institutional Biosafety Committee reports to the Director, NIH or his or her designee in matters pertaining to the control of biological hazards. The BMBL outlines biosafety best practices in biomedical and microbiological laboratories and is identified in the University Rule for Biohazards (15. These agents represent no or little risk to an individual and no or little risk to the community. BSL2 Deposting Checklist . D. A list of agents by Risk Group can be found in Appendix B of the NIH Guidelines. Use the up-to-date list of select agents, toxins, and overlap select agents and toxins list at HHS and USDA Select Agents and Toxins. Please note that biosafety levels can vary depending on the activity. Select Agent Program. Appendix B of the guidelines gives a list of pathogens in Risk Groups 2, 3, and 4. Sharps Handling and Disposal Guidelines see Biohazardous Waste . A list of websites which provides information on biosafety and biosecurity, the availability and authentication of cell lines, and the characteristics of various infectious agents follows below. Dartmouth Biosafety Training Presentation May, 2014. 2019 Sep 12;7:249. edu or 801-581-6590). University of Rochester Disinfectants for Biohazardous Materials Guidelines 2 Descending Order of Resistance to Germicidal Chemicals (Adapted from Appendix B Table 1 of CDC/NIH 5th Edition “Biosafety in Microbiological and Biomedical Research Involving Potential Biohazards Infectious Agents Work may only be conducted with prior approval of the IBC regardless of the safety classification of the agent You must follow the requirements as specified in the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories Manual Containment requirements may be subject to National Institutes of Health Bethesda, MD 20814-1460. The following E. If there is no hazardous material, check "none" for each hazard. Safety Data Sheets. Recording is now available, click here. We can help you look at what is depleting and what is restorative for you. The classification of biological agents is a basic requirement for both biosafety and biodefense. IBC review is required when the research or the site/institution has ties to NIH funding. Antioxidants are man-made or natural substances that may prevent or delay some types of cell damage. 0 July 2017 5 | P a g e 1. Blood Substitutes (6) Bone Cements (3) • Adhesives used to fix prosthetic devices to bones and to cement bone to bone in difficult fractures. NIH, or other sponsoring federal entity, within 30 days of: i. influenzae Helicobacter pylori Klebsiella - all species except K. termination of NIH funding for all NIH sponsored programs at Clemson University. 2. Biological safety cabinets (BSCs) are used to protect personnel, products and the environment from exposure to biohazards and cross contamination. 4. The NIH IBC is the primary reviewing and biosafety approval body for all proposed research associated with the intramural use of microbiological The descriptions of biosafety levels (BSL) 1 – 4 parallel those in the NIH Guidelines for research involving recombinant DNA. Biohazard Safety Checklist . 3389/fpubh. o NIH Primary Containment for Biohazards: Selections, Installation and Use of Biosafety Cabinets Biosafety Supply Vendors Saf-T-Pak (Infectious Agent Packaging and Training) Biosafety in Microbiological and Biomedical Laboratories (BMBL), recommends that work be done using one of four levels of containment: Biosafety Level 1 (BSL1), BSL2, BSL3 and BSL4 (see next chapter). IBCs ensure that research with potentially biohazardous agents is conducted according to the NIH Guidelines and current best biosafety practices. m. The BSL categories are divided up by risk of disease combined with availability of preventive and therapeutic treatments. GW's research and teaching laboratories that work with biohazards are required to have annual inspections by Office of Laboratory Safety : Biosafety and Biosecurity professionals. 2. The training is required for personnel using, purchasing, working with infectious materials under Biosafety Level 2 or higher (including materials under the Bloodborne Pathogens 4. Harvard Biosafety Manual 2016 Page 6 Committee on Microbiological Safety (COMS) Institutions that receive any research funding from the National Institutes of Health (NIH) are required to abide by the “ NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules” (rDNA Guidelines). These Guidelines apply to all research projects (NIH-funded and non-NIH-funded) that involve recombinant or synthetic nucleic acid molecules and are conducted at or sponsored by an organization that receives NIH support for recombinant or synthetic nucleic acid molecule research. List all personnel, no salary information Section F‐K Lines 8‐10 “other”: IRB fee, tuition, patient care costs, Use person‐months effort; do not exceed NIH salary cap Indirect cost type: MTDC: rate:% Base: (exclusions: see OSP quick reference guide) Working at Biosafety Level 3 (BSL-3) Work with agents or materials at Biosafety Level 3 (BSL-3) requires additional registration and approvals set forth by federal regulations, CDC/NIH guidelines, and University policy. Table 1 describes the risk groups, Table 2 relates them to the laboratory designations, and Table 3 summarizes the requirements at the four biosafety levels. ” recommends their use in four biosafety levels of operation with infectious agents. Authors disclosure of relevant financial relationships with any entity producing, marketing, re-selling, or distributing health care goods or services, used on, or consumed by, patients Definition Biohazard An agent or material of biological origin that has the capacity to produce deleterious effects on humans, i. National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 NSF International/American National Standards Institute (ANSI) 49 Annex E—Biosafety Cabinetry: Design, Performance, and Field Certification NIH Guidelines Quick Reference List of BSL-4 Facilities This section requires expansion with: information completing the table, and citations. nih. Image source: WHO Laboratory Biosafety Manual, 3rd edition. Section III-F-6, Exempt Experiments). This group includes a list of animal viral etiologic agents in common use. 1. Director, Office of Health and Safety Centers for Disease Control and Prevention Atlanta, GA 30333 adapted from the CDC/NIH 3rd edition of Biosafety in Microbiological and Biomedical Laboratories Introduction The Biosafety Officer or the Assistant Biosafety Officer will work with the Primary Investigator to gather the details of the incident to make a determination if the incident does need to be reported to NIH OBA, and if deemed necessary, consult with NIH OBA to determine if the incident warrants a report. eCollection 2019. The classification of biological agents is a basic requirement for both biosafety and biodefense. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. Laboratories using recombinant DNA molecules must comply with the General Biosafety and the rDNA sections of this checklist. Front Public Health. We promote biological safety at the NIH through a broad range of support services, consultation and The NIH Guidelines also lay out the responsibilities of institutions, investigators, and Institutional Biosafety Committees (IBCs) for oversight. A change in an animal activity can be both a significant change requiring IACUC review and a change in scope requiring notification • Establish procedures that the Institutional Biosafety Committee (IBC) must follow in the review and approval of applications, proposals and activities. The NIH IBC is the primary reviewing and biosafety approval body for all proposed research associated with the intramural use of microbiological In response, the NIH announced last week a new Biosafety Stewardship initiative, naming this September as National Biosafety Stewardship Month. Recombinant DNA; Human blood and blood products, human body fluids, human tissue, and/or human cells. Biosafety addresses the safe handling and containment of biohazardous material. This policy is designed to ensure that employees, The committee is charged with ensuring full compliance with CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL), NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (referred to herein as the NIH Guidelines) and the UTHealth Institutional Biosafety Manual. This checklist will be used during the annual inspections. 2. About Biological Safety at the NIH. Biosafety Level 3 (BSL-3) is the recommended containment for work with agents or toxins that may cause serious or potentially fatal disease through inhalation exposure. Phone: 301-496-6610. Antioxidants are man-made or natural substances that may prevent or delay some types of cell damage. Biological Response Modifiers (0) see Immunologic Factors. 1030 NIH Guidelines for Research Involving Recombinant DNA Materials. These biosafety levels are described below. nih. It is intended as a summary only; the reader is urged to obtain full, detailed information pertaining to each subject from within the text of this • The IBC gives final approval to the biosafety level of containment (NIH Guidelines, Section II) 10 • List of biohazard materials using in the lab 1. 1. CDC/NIH Biosafety in the Microbiological and Biomedical Laboratories OSHA Occupational Exposure to Bloodborne Pathogens Standard Title 29, CFR Part 1910. 5. back to the top. 2013. . Biosafety level designations are based on a composite of the design features, construction, containment facilities, equipment, practices and operational procedures Control and National Institutes of Health • NIH Guidelines. 2. • File an annual report to NIH that includes a list of the IBC members. pg. All visitors to this page may also access information on IBC compliance and view a list of IBCs that are currently registered with OSP. BSL2 Containment. they are not exclusive to NIH-funded projects). They correlate with but do not equate to biosafety levels. M1) as one of several guidance documents researchers are expected to follow to ensure the safe and compliant use of biohazardous materials. NIH - Working Safely with HIV in the Research Laboratory Biosafety Level, 2/3, 1988. (Biosafety Level determinations are based on the recommendations outlined by the CDC-NIH publication Biosafety in Microbiological and Biomedical Laboratories. As recommended by the NIH Guidelines, a BSO must be appointed by any institution conducting research requiring biosafety level 3 (BL-3) or higher containment conditions and practices or engaging in large-scale research. S. 6. 2. 12 3. This section provides a list of human pathogens and their Risk Group (RG) 2, RG3, and RG4 designations as excerpted from Appendix B, Classification of Human Etiologic Agents on the Basis of Hazard, of the NIH Guidelines, amendment effective November 6, 2013. Potential applicants were encouraged join a pre-application Technical Assistance webinar January 25, 2021. Laboratory facilities are designated as basic – Biosafety Level 1, basic – Biosafety Level 2, containment – Biosafety Level 3, and maximum containment – Biosafety Level 4. Full instructions page R-37 Equipment List major items of equipment already available for this project and, if appropriate identify location and pertinent capabilities. The IBC reviews and approves Biological Use Authorization applications that involve work with recombinant DNA, work with infectious agents Transgenic Animals: See the reference table from the NIH Office of Science Policy for a listing of animal experiments covered under the NIH Guidelines with references to the corresponding NIH Guidelines sections and biosafety levels. Laboratory facilities are designated as basic – Biosafety Level 1, basic – Biosafety Level 2, containment – Biosafety Level 3, and maximum containment – Biosafety Level 4. The unique features of the BSL-3 laboratory will be explained along with security and entry and exit procedures. edu). We compared and analyzed the Biological Agent Laboratory Biosafety Category list and the defining criteria according to the World Health Organization (WHO), the National Institutes of Health (NIH), the European Union (EU) and China. The university through the Institutional Biosafety Committee (IBC) reviews and authorizes research with recombinant DNA and biohazardous materials. ) at least 10 days prior for consideration at the IBC monthly meeting. doi: 10. e. g. Introduction This guide is designed for users working with biological materials and is intended to be used alongside Biosafety Containment Levels The Center for Disease Control (CDC) and NIH have established four levels that provide a combination of laboratory practices and techniques, containment or safety equipment, laboratory design, and laboratory facilities that are appropriate to the type of activity being performed and based on the potential hazard of AFTER AN NIH OBA SITE VISIT Any appropriate photo could go here The University of Washington’s Response to the NIH OBA Findings NIH OBA Biosafety and Security Conference June 17, 2013 Seattle, WA Katia Harb Assistant Director, Research & Occupational Safety UW Environmental Health and Safety Department Federal Regulations (NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules)require that membership of the IBC include at a minimum, five members, who collectively have experience in general issues of laboratory biosafety, use of infectious materials, and expertise in recombinant or synthetic nucleic acid molecule Organism Names & Biosafety Level BIOL 2420: Microbiology for the Health Sciences Alcaligenes faecalis – 1 Aspergillus niger – 1 Bacillus cereus – 1 Bacillus megaterium – 1 Bacillus subtilis – 1 Clostridium sporogenes – 1 Enterobacter aerogenes – 1 Enterobacter cloacae – 1 Enterococcus faecalis – 2 Escherichia coli – 1 All exempt research below must be conducted in Biosafety Level 1 or Animal Biosafety Level 1 (see part B, below, for definitions of biosafety levels). See Appendix B-IV of the NIH Guidelines for Research Involving Recombinant or Synthetic DNA Molecules (NIH Guidelines) for a list of these agents. facilities as basic – Biosafety Level 1, basic – Biosafety Level 2, containment – Biosafety Level 3 and maximum containment – Biosafety Level 4. The table below, which was excerpted from the NIH Recombinant DNA Guidelines, presents the basis for the classification of biohazardous agents by risk group. 4. CDC Guidelines for protection against Viral Hepatitis and Hepatitis B prevention. , P. BIOSAFETY GUIDELINES AND STANDARDS The CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, the OSHA Occupational Exposure to Bloodborne Pathogens Standard, and the NIH Guidelines involving Research (“NIH Guidelines”) • UT Biohazard Safety Committee formed in 1977: – Identify existing biological hazards; – Review all research proposals for use of biohazards in research; – Review, inspect, monitor all individuals & facilities using biohazards • Biosafety Office established in 2004: – Develop comprehensive biosafety program to Submit Assurance and program changes to OLAW by fax to 301-451-5672 or e-mail to olawdoa@mail. National Institutes of Health F. The text has served as a functional biosafety manual for the University. , failure to adhere to the containment and biosafety practices articulated in the NIH Guidelines) Note: Certain types of accidents must be reported on a more expedited basis Harvard Biosafety Manual 2016 Page 6 Committee on Microbiological Safety (COMS) Institutions that receive any research funding from the National Institutes of Health (NIH) are required to abide by the “ NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules” (rDNA Guidelines). In the past, the University has also distributed copies of the Centers f or Disease Control/National Institutes of Health Biosafety in Microbiological and Biomedical Laboratories to all Yale research laboratories. Safety By Design: Biosafety Monograph. based on the NIH Office of Science Policy. The MPW box . It is meant to prevent lab-acquired infections and/or prevent release into agricultural or natural ecosystems. 2013. Performs the function of an Institutional Biosafety Committee as specified in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. Please make note of the 2021 Institutional Biosafety Committee (IBC) Calendar. Risk Groups and Associated Agents from the NIH Guidelines . Institutional Biosafety Committee (IBC) – A committee that (1) meets the requirements for membership specified in the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), Institutional Biosafety Committee (IBC), and (2) reviews, approves, and oversees projects in accordance with the responsibilities defined in the Experiments using biohazardous materials and toxins must follow the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) Guidelines (5th Edition-2009). We compared and analyzed the Biological Agent Laboratory Biosafety Category list and the defining criteria according to the World Health Organization (WHO), the National Institutes of Health (NIH), the European Union (EU) and China. *See CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, 5 th Edition (BMBL) (or the most current edition) for a complete list of all controls and practices required for each level. NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) 78 FR 66751 (November 6th, 2013), as amended. Describe any special facilities used for working with biohazards or other potentially dangerous substances. Weyant, PhD . Enforces the NIH Guidelines to ensure that IBC approved conditions Students come to the NIH either as part of formal institutional partnerships or via individual agreements negotiated between their university mentor and an investigator at the NIH. Risk Groups; Infectious agents may be classified into risk groups based on their relative hazard. gov, the publication of the proposal in the Federal Register for 15 days of 4. 4 It is the policy of the IBC that Biosafety Containment Level 4 (BSL-4) agents may not be used or stored at the University of South Florida. , failure to adhere to the containment and biosafety practices articulated in the NIH Guidelines) Note: Certain types of accidents must be reported on a more expedited basis Biosafety Levels. Containment requirements are subject to modification by the IBC at its discretion, depending on the circumstances presented by a specific project. CDC Guidelines for protection against Viral Hepatitis and Hepatitis B prevention. A good summary of the Animal Biosafety Levels can be found in the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, 5th edition. 4 pg. What follows is a list of select agents that have specific biocontainment requirements according to US federal law. 35 MB) is the most current and may differ from the web version. Medical Pathological Waste Generation (sharps, biohazard contaminated materials, autoclave wastes, animal carcasses) Chemical spills/leaks to water or ground (fuel, hydraulic leaks, POL, storage tanks, etc. NIH Turning Discovery Into Health ® Definition Biohazard An agent or material of biological origin that has the capacity to produce deleterious effects on humans, i. Biohazard Materials pg. e. Email: history@nih. Shanna Nesby-O’Dell, DVM, MPH . Biological Safety. Sharps such as needle with syringe, blades, and Pasteur pipettes (these are discouraged/not needed if substitutions have been made) are placed within a conveniently located puncture resistant, autoclavable (vented) biohazard sharps container, closed when 2/3 filled or sooner, placed in an autoclavable biohazard bag and autoclaved for 90 minutes The Biosafety Program (BSP) provides administrative support and biosafety expertise to the CAB/ESCRO. Biosafety Guidelines and Standards . If you need to combine information from different sources into a single document prior to uploading, do not use “bundling” or “portfolio” features which combine multiple documents into a single file by providing links to the individual files. nih biohazard list