Resources

Resources

Information for Investigators

  • Biohazardous Waste Handling
  • Biosafety Guidance sheets
    • BSL-2 Laboratory Inspections (PDF)
    • Laboratory Coat Laundry Guidelines (PDF)
    • Working with Pregnant Sheep Inside Facilities (PDF)

Texas A&M Resources

    • Rules and Standard Administrative Procedures
      • 15.02.99.Q0.02: Technology Control Guidelines (PDF)
      • 15.99.03.M1: Ethics in Research, Scholarship and Creative Work (PDF)
      • 15.99.03.M1.03: Guidelines for Gathering, Storage, and Retention of Data and Results (PDF)
      • 24.01.01.M4: Environmental Health and Safety Programs (PDF)
      • 24.01.01.M4.01: Bloodborne Pathogens Exposure Control (PDF)
      • 15.99.06.M1: Use of Biohazards, Biological Toxins and Recombinant DNA (PDF)
      • 25.07.03.M0.01: Procurement Services Administration (PDF)

      Regulatory Documents

      • Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, CDC / NIH
        • Complete 5th Edition of BMBL (All Sections) (PDF)
        • Comparative Analysis of the 4th and 5th Editions of BMSL (PDF)
      • Commerce Control List for Exports (Biological Agents and Toxins) (PDF)
      • NIH Guidelines for Research Involving Recombinant DNA Molecules

      Select Agent Regulations

      • CDC Select Agent Regulations (42 CFR 73) (PDF)
      • APHIS Select Agent Regulations (7 CFR 331 and 9 CFR 121) (PDF)
      • Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PDF)
      • USA PATRIOT Act of 2001 (PDF)

      Other Biosafety Resources


      Appendix A

      Voting Members

      Dr. Vernon L. Tesh, Chair
      Professor
      College of Medicine
      Texas A&M University System Health Science Center
      tesh@medicine.tamhsc.edu

      Ms. Lynn Baker
      Community Representative
      pab06@suddenlink.net

      Dr. Tammy Beckham
      Director
      Texas Veterinary Medical Diagnostic Laboratory (TVMDL)
      tbeckham@tvmdl.tamu.edu

      Dr. Thomas A. Ficht
      Professor
      TAES
      Veterinary Medical Tower
      t-ficht@tamu.edu

      Dr. Vincent Gresham
      Clinical Veterinarian
      Comparative Medicine Program
      Texas A&M University
      vgresham@vprmail.tamu.edu

      Dr. Patricia Klein
      Associate Professor
      Institute for Plant Genomics & Biotechnology
      Texas A&M University
      pklein@tamu.edu

      Dr. Blanca Lupiani
      Associate Professor

      Veterinary Pathobiology & Poultry Science
      blupiani@cvm.tamu.edu

      Mr. Victor Pantusa
      Chief Safety Officer
      Texas A&M University System Health Science Center
      vpantusa@tamhsc.edu

      Dr. Jon T. Skare
      Professor
      Microbial and Molecular Pathogenesis Microbiology & Immunology
      Texas A&M University System Health Science Center
      jskare@medicine.tamhsc.edu

      Rabbi Peter Tarlow
      Community Representative
      ptarlow@startel.net

      Dr. Bruce Whitney
      Biological Safety Officer/Responsible Official
      Division of Research
      Texas A&M University
      bwhitney@tamu.edu

      Dr. Heather H. Wilkinson
      Associate Professor
      Plant Pathology and Microbiology
      Texas A&M University
      h-wilkinson@tamu.edu

      Information for People Who Enter Biosafety Laboratories

      For any questions related to the following information, please contact us at biosafety@tamu.edu or 979.862.4549.

      Every biosafety laboratory is required to have a sign posted at each entry. The biosafety sign will provide information about the specific agents in use, the entry requirements, emergency contact information, and the biosafety level.

      For People Entering Only BL1 Laboratories

      There are no Biosafety Occupational Health Program (BOHP) or institutional-level biosafety training requirements for people entering BL1 laboratories and working with Risk Group 1 agents. If an individual needs to enter a BL2 laboratory, that person must now meet all BL2 training and BOHP requirements listed below. Please notify the Office of Research Compliance and Biosafety if such a situation arises.

      For People Entering BL2 Laboratories

      Any person entering a BL2 laboratory needs to be enrolled in the Biosafety Occupational Health Program and attend annual BL2 training. This includes all students (paid, unpaid, REU, etc.) and any personnel associated with the University such as technicians, facilities staff, or others who need to enter the laboratory. Additionally, any person who may be exposed to materials potentially containing human pathogens (including human blood, tissue, and cell lines; non-human primate blood, tissue, and cell lines) needs to attend annual Bloodborne Pathogen Training. For occasional visitors, the Institutional Biosafety Committee offers guidance on visitor's information for BL2 laboratories.

      For People Entering BL3 Laboratories

      Only authorized personnel may enter a BL3 laboratory. Please contact the Office of Research Compliance and Biosafety for more information.

      Institution Roles and Responsibilities for Recombinant DNA Research

      Section IV-B. Responsibilities of the Institution

      Section IV-B-1. General Information
      Each institution conducting or sponsoring recombinant DNA research which is covered by the NIH Guidelines is responsible for ensuring that the research is conducted in full conformity with the provisions of the NIH Guidelines. In order to fulfill this responsibility, the institution shall:

      Section IV-B-1-a. Establish and implement policies that provide for the safe conduct of recombinant DNA research and that ensure compliance with the NIH Guidelines. As part of its general responsibilities for implementing the NIH Guidelines, the institution may establish additional procedures, as deemed necessary, to govern the institution and its components in the discharge of its responsibilities under the NIH Guidelines. Such procedures may include: (i) statements formulated by the institution for the general implementation of the NIH Guidelines, and (ii) any additional precautionary steps the institution deems appropriate.

      Section IV-B-1-b. Establish an Institutional Biosafety Committee that meets the requirements set forth in Section IV-B-2-a and carries out the functions detailed in Section IV-B-2-b.

      Section IV-B-1-c. Appoint a Biological Safety Officer (who is a member of the Institutional Biosafety Committee) if the institution: (i) conducts recombinant DNA research at Biosafety Level (BL) 3 or BL4, or (ii) engages in large scale (greater than 10 liters) research. The Biological Safety Officer carries out the duties specified in Section IV-B-3.

      Section IV-B-1-d. Appoint at least one individual with expertise in plant, plant pathogen, or plant pest containment principles (who is a member of the Institutional Biosafety Committee) if the institution conducts recombinant DNA research that requires Institutional Biosafety Committee approval in accordance with Appendix P, Physical and Biological Containment for Recombinant DNA Research Involving Animals.

      Section IV-B-1-e. Appoint at least one individual with expertise in animal containment principles (who is a member of the Institutional Biosafety Committee) if the institution conducts recombinant DNA research that requires Institutional Biosafety Committee approval in accordance with Appendix Q, Physical and Biological Containment for Recombinant DNA Research Involving Animals.

      Section IV-B-1-f. Ensure that when the institution participates in or sponsors recombinant DNA research involving human subjects: (i) the Institutional Biosafety Committee has adequate expertise and training (using ad hoc consultants as deemed necessary), and (ii) all aspects of Appendix M, Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA Molecules into One or More Human Subjects (Points to Consider), have been appropriately addressed by the Principal Investigator prior to submission to NIH/ORDA. Institutional Biosafety Committee approval must be obtained from each institution at which recombinant DNA material will be administered to human subjects (as opposed to each institution involved in the production of vectors for human application and each institution at which there is ex vivo transduction of recombinant DNA material into target cells for human application).

      Section IV-B-1-g. Assist and ensure compliance with the NIH Guidelines by Principal Investigators conducting research at the institution as specified in Section IV-B-4.

      Section IV-B-1-h. Ensure appropriate training for the Institutional Biosafety Committee Chair and members, Biological Safety Officer and other containment experts (when applicable), Principal Investigators, and laboratory staff regarding laboratory safety and implementation of the NIH Guidelines. The Institutional Biosafety Committee Chair is responsible for ensuring that Institutional Biosafety Committee members are appropriately trained. The Principal Investigator is responsible for ensuring that laboratory staff are appropriately trained. The institution is responsible for ensuring that the Principal Investigator has sufficient training; however, this responsibility may be delegated to the Institutional Biosafety Committee.

      Section IV-B-1-i. Determine the necessity for health surveillance of personnel involved in connection with individual recombinant DNA projects; and if appropriate, conduct a health surveillance program for such projects. The institution shall establish and maintain a health surveillance program for personnel engaged in large scale research or production activities involving viable organisms containing recombinant DNA molecules which require BL3 containment at the laboratory scale. The institution shall establish and maintain a health surveillance program for personnel engaged in animal research involving viable recombinant DNA - containing microorganisms that require BL3 or greater containment in the laboratory. The Laboratory Safety Monograph discusses various components of such a program (e.g., records of agents handled, active investigation of employees' work experience). Certain medical conditions may place a laboratory worker at increased risk in any endeavor where infectious agents are handled. Examples cited in the Laboratory Safety Monograph include gastrointestinal disorders and treatment with steroids, immunosuppressive drugs, or antibiotics. Workers with such disorders or treatment should be evaluated to determine whether they should be engaged in research with potentially hazardous organisms during their treatment or illness. Copies of the Laboratory Safety Monograph are available from the Office of Recombinant DNA Activities. National Institutes of Health/MSC 7010, 6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892-7010, (301) 496-9838.

      Section IV-B-1-j. Report any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to NIH/ORDA within thirty days, unless the institution determines that a report has already been filed by the Principal Investigator or Institutional Biosafety Committee. Reports shall be sent to the Office of Recombinant DNA Activities, National Institutes of Health/MSC 7010, 6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892-7010, (301) 496-9838.

      Institutional Biosafety Committee Roles and Responsibilities for Recombinant DNA Research

      A summary of the roles and responsibilities of the IBC

      Section IV-B-2. Institutional Biosafety Committee (IBC)
      The institution shall establish an Institutional Biosafety Committee whose responsibilities need not be restricted to recombinant DNA. The Institutional Biosafety Committee shall meet the following requirements.

      Section IV-B-2-a. Membership and Procedures

      Section IV-B-2-a-(1). The Institutional Biosafety Committee must be comprised of no fewer than five members so selected that they collectively have experience and expertise in recombinant DNA technology and the capability to assess the safety of recombinant DNA research and to identify any potential risk to public health or the environment. At least two members shall not be affiliated with the institution (apart from their membership on the Institutional Biosafety Committee) and who represent the interest of the surrounding community with respect to health and protection of the environment (e.g., officials of state or local public health or environmental protection agencies, members of other local government bodies, or persons active in medical, occupational health, or environmental concerns in the community). The Institutional Biosafety Committee shall include at least one individual with expertise in plant, plant pathogen, or plant pest containment principles when experiments utilizing Appendix P, Physical and Biological Containment for Recombinant DNA Research Involving Plants, require Institutional Biosafety Committee prior approval. When the institution conducts recombinant DNA research at BL3, BL4, or Large Scale (greater than 10 liters), a Biological Safety Officer is mandatory and shall be a member of the Institutional Biosafety Committee (see Section IV-B-3, Biological Safety Officer). When the institution participates in or sponsors recombinant DNA research involving human subjects, the institution must ensure that: (i) the Institutional Biosafety Committee has adequate expertise and training (using ad hoc consultants as deemed necessary) and (ii) all aspects of Appendix M, Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA Molecules into One or More Human Subjects (Points to Consider), have been appropriately addressed by the Principal Investigator prior to submission to NIH/ORDS. Institutional Biosafety Committee approval must be obtained from each institution at which recombinant DNA material will be administered to human subjects (as opposed to each institution involved in the production of vectors for human application and each institution at which there is ex vivo trandsuction of recombinant DNA material into target cells for human application).

      Note: Individuals, corporations, and institutions not otherwise covered by the NIH Guidelines, are encouraged to adhere to the standards and procedures set forth in Sections I through IV (see Section IV-E, Voluntary Compliance. The policy and procedures for establishing an Institutional Biosafety Committee under Voluntary Compliance, are specified in Section IV-D-2, Institutional Biosafety Committee Approval).

      Section IV-B-2-a-(2). In order to ensure the competence necessary to review and approve recombinant DNA activities, it is recommended that the Institutional Biosafety Committee: (i) include persons with expertise in recombinant DNA technology, biological safety, and physical containment; (ii) include or have available as consultants persons knowledgeable in institutional commitments and policies, applicable law, standards of professional conduct and practice, community attitudes, and the environment, and (iii) include at least one member representing the laboratory technical staff.

      Section IV-B-2-a-(3). The institution shall file an annual report with the NIH/ORDA which includes: (i) a roster of all Institutional Biosafety Committee members clearly indicating the Chair, contact person, Biological Safety Officer (if applicable), plant expert (if applicable), human gene therapy expertise or ad hoc consultant (if applicable); and (ii) biographical sketches of all Institutional Biosafety Committee members (including community members).

      Section IV-B-2-a-(4). No member of an Institutional Biosafety Committee may be involved (except to provide information requested by the Institutional Biosafety Committee) in review or approval of a project in which he/she has been or expects to be engaged or has a direct financial interest.

      Section IV-B-2-a-(5). The institution, that is ultimately responsible for the effectiveness of the Institutional Biosafety Committee, may establish procedures that the Institutional Biosafety Committee shall follow in its initial and continuing review and approval of applications, proposals, and activities.

      Section IV-B-2-a-(6). When possible and consistent with protection of privacy and proprietary interests, the institution is encouraged to open its Institutional Biosafety Committee meetings to the public.

      Section IV-B-2-a-(7). Upon request, the institution shall make available to the public all Institutional Biosafety Committee meeting minutes and any documents submitted to or received from funding agencies which the latter are required to make available to the public. If public comments are made on Institutional Biosafety Committee actions, the institution shall forward both the public comments and the Institutional Biosafety Committee's response to the Office of Recombinant DNA Activities, National Institutes of Health/MSC 7010, 6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892-7010, (301) 496-9838.

      Section IV-B-2-b. Functions
      On behalf of the institution, the Institutional Biosafety Committee is responsible for:

      Section IV-B-2-b-(1). Reviewing recombinant DNA research conducted at or sponsored by the institution for compliance with the NIH Guidelines as specified in Section III, Experiments Covered by the NIH Guidelines, and approving those research projects that are found to conform with the NIH Guidelines. This review shall include: (i) independent assessment of the containment levels required by the NIH Guidelines for the proposed research; (ii) assessment of the facilities, procedures, practices, and training and expertise of personnel involved in recombinant DNA research; and (iii) ensuring compliance with all surveillance, data reporting, and adverse event reporting requirements required by the NIH Guidelines.

      Section IV-B-2-b-(2). Notifying the Principal Investigator of the results of the Institutional Biosafety Committee's review and approval.

      Section IV-B-2-b-(3). Lowering containment levels for certain experiments as specified in Section III-D-2-a, Experiments in which DNA from Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems.

      Section IV-B-2-b-(4). Setting containment levels as specified in Sections III-D-4-b, Experiments Involving Whole Animals, and III-D-5, Experiments Involving Whole Plants.

      Section IV-B-2-b-(5). Periodically reviewing recombinant DNA research conducted at the institution to ensure compliance with the NIH Guidelines.

      Section IV-B-2-b-(6). Adopting emergency plans covering accidental spills and personnel contamination resulting from recombinant DNA research.

      Note: The Laboratory Safety Monograph describes basic elements for developing specific procedures dealing with major spills of potential hazardous materials in the laboratory, including information and references about decontamination and emergency plans. The NIH and Centers for Disease Control and Prevention are available to provide consultation and direct assistance, if necessary, as posted in the Laboratory Safety Monograph. The institution shall cooperate with the state and local public health departments by reporting any significant research-related illness or accident that may be hazardous to the public health.

      Section IV-B-2-b-(7). Reporting any significant problems with or violations of the NIH Guidelines and any significant research-related accidents or illnesses to the appropriate institutional official and NIH/ORDA within 30 days, unless the Institutional Biosafety Committee determines that a report has already been filed by the Principal Investigator. Reports to NIH/ORDA shall be sent to the Office of Recombinant DNA Activities, National Institutes of Health/MSC 7010, 6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892-7010, (301) 496-9838.

      Section IV-B-2-b-(8). The Institutional Biosafety Committee may not authorize initiation of experiments which are not explicitly covered by the NIH Guidelines until NIH (with the advice of the RAC when required) establishes the containment requirement.

      Section IV-B-2-b-(9). Performing such other functions as may be delegated to the Institutional Biosafety Committee under Section IV-B-2, Institutional Biosafety Committee.

        Principal Investigator Roles and Responsibilities for Recombinant DNA Research

        Section IV-B-7. Principal Investigator (PI) On behalf of the institution, the Principal Investigator is responsible for full compliance with the NIH Guidelines in the conduct of recombinant DNA research.

        Section IV-B-7-a. General Responsibilities As part of this general responsibility, the Principal Investigator shall:

        Section IV-B-7-a-(1). Initiate or modify no recombinant DNA research which requires Institutional Biosafety Committee approval prior to initiation (see Sections III-A, III-B, III-C, III-D, and III-E, Experiments Covered by the NIH Guidelines) until that research or the proposed modification thereof has been approved by the Institutional Biosafety Committee and has met all other requirements of the NIH Guidelines;

        Section IV-B-7-a-(2). Determine whether experiments are covered by Section III-E, Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation, and ensure that the appropriate procedures are followed;** Note: Texas A&M requires IBC approval before initiation for all biosafety research.

        Section IV-B-7-a-(3). Report any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to the Biological Safety Officer (where applicable), Greenhouse/Animal Facility Director (where applicable), Institutional Biosafety Committee, NIH/ORDA, and other appropriate authorities (if applicable) within 30 days. Reports to NIH/ORDA shall be sent to the Office of Recombinant DNA Activities, National Institutes of Health/MSC 7010, 6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892-7010, (301) 496-9838;

        Section IV-B-7-a-(4). Report any new information bearing on the NIH Guidelines to the Institutional Biosafety Committee and to NIH/ORDA (reports to NIH/ORDA shall be sent to the Office of Recombinant DNA Activities, National Institutes of Health/MSC 7010, 6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892-7010, (301) 496-9838);

        Section IV-B-7-a-(5). Be adequately trained in good microbiological techniques;

        Section IV-B-7-a-(6). Adhere to Institutional Biosafety Committee approved emergency plans for handling accidental spills and personnel contamination; and

        Section IV-B-7-a-(7). Comply with shipping requirements for recombinant DNA molecules (see Appendix H, Shipment, for shipping requirements and the Laboratory Safety Monograph for technical recommendations).

        Section IV-B-7-b. Submissions by the Principal Investigator to NIH/ORDA
        The Principal Investigator shall:

        Section IV-B-7-b-(1). Submit information to NIH/ORDA for certification of new host-vector systems;

        Section IV-B-7-b-(2). Petition NIH/ORDA, with notice to the Institutional Biosafety Committee, for proposed exemptions to the NIH Guidelines;

        Section IV-B-7-b-(3). Petition NIH/ORDA, with concurrence of the Institutional Biosafety Committee, for approval to conduct experiments specified in Sections III-A-1, Major Actions Under the NIH Guidelines, and III-B, Experiments that Require NIH/ORDA and Institutional Biosafety Committee Approval Before Initiation;

        Section IV-B-7-b-(4). Petition NIH/ORDA for determination of containment for experiments requiring case-by-case review; and

        Section IV-B-7-b-(5). Petition NIH/ORDA for determination of containment for experiments not covered by the NIH Guidelines.

        Section IV-B-7-b-(6). Ensure that all aspects of Appendix M, Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA Molecules into One or More Human Subjects (Points to Consider), have been appropriately addressed prior to submission of human gene therapy experiments to NIH/ORDA.

        Section IV-B-7-c. Submissions by the Principal Investigator to the Institutional Biosafety Committee
        The Principal Investigator shall:

        Section IV-B-7-c-(1). Make an initial determination of the required levels of physical and biological containment in accordance with the NIH Guidelines;

        Section IV-B-7-c-(2). Select appropriate microbiological practices and laboratory techniques to be used for the research;

        Section IV-B-7-c-(3). Submit the initial research protocol and any subsequent changes (e.g., changes in the source of DNA or host-vector system), if covered under Sections III-A, III-B, III-C, III-D, or III-E (Experiments Covered by the NIH Guidelines), to the Institutional Biosafety Committee for review and approval or disapproval; and

        Section IV-B-7-c-(4). Remain in communication with the Institutional Biosafety Committee throughout the conduct of the project.

        Section IV-B-7-d. Responsibilities of the Principal Investigator Prior to Initiating Research
        The Principal Investigator shall:

        Section IV-B-7-d-(1). Make available to all laboratory staff the protocols that describe the potential biohazards and the precautions to be taken;

        Section IV-B-7-d-(2). Instruct and train laboratory staff in: (i) the practices and techniques required to ensure safety, and (ii) the procedures for dealing with accidents; and

        Section IV-B-7-d-(3). Inform the laboratory staff of the reasons and provisions for any precautionary medical practices advised or requested (e.g., vaccinations or serum collection).

        Section IV-B-7-e. Responsibilities of the Principal Investigator During the Conduct of Research
        The Principal Investigator shall:

        Section IV-B-7-e-(1). Supervise the safety performance of the laboratory staff to ensure that the required safety practices and techniques are employed;

        Section IV-B-7-e-(2). Investigate and report any significant problems pertaining to the operation and implementation of containment practices and procedures in writing to the Biological Safety Officer (where applicable), Greenhouse/Animal Facility Director (where applicable), Institutional Biosafety Committee, NIH/ORDA, and other appropriate authorities (if applicable) (reports to NIH/ORDA shall be sent to the Office of Recombinant DNA Activities, National Institutes of Health/MSC 7010, 6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892-7010, (301) 496-9838);

        Section IV-B-7-e-(3). Correct work errors and conditions that may result in the release of recombinant DNA materials; and

        Section IV-B-7-e-(4). Ensure the integrity of the physical containment (e.g., biological safety cabinets) and the biological containment (e.g., purity and genotypic and phenotypic characteristics).

        Section IV-B-7-e-(5). Comply with reporting requirements for human gene transfer experiments conducted in compliance with the NIH Guidelines (see Appendix M-VII, Reporting Requirements--Human Gene Transfer Protocols).

        Requirements and Procedures for Recombinant DNA Research

        General Information
        Recombinant DNA research is conducted with molecules constructed outside living cells, where DNA segments are joined or replicated, where a DNA sequence may be modified, or where related research is conducted with this type of material. The purpose of this document is to summarize requirements, procedures and expectations for conducting recombinant DNA research at Texas A&M University (including facilities with an memorandum of understanding for related services). Certain general procedures are outlined to aid scientists in compliance.

        Any research conducted with recombinant DNA, regardless of the source of funding or source of recombinant material, must be conducted in accordance with institutional requirements and federal guidelines. Texas A&M adheres to NIH Guidelines for Research Involving Recombinant DNA and appropriate Administrative Supplements, as issued. Research on recombinant DNA should also be conducted in accordance with CDC/NIH Biosafety Guidelines (Biosafety in Microbiological and Biomedical Laboratories), as appropriate. Experiments involving livestock or plants may require compliance with additional regulations and approval by the Office of Agricultural Biotechnology, U.S. Department of Agriculture.

        It is essential that recombinant DNA research be conducted in accordance with the intent, as well as specific requirements and guidelines. Because research is dynamic, it is not possible to anticipate every situation. The conscientious effort and good judgment of personnel are essential for protection of health and the environment during recombinant DNA research. Primary responsibility for compliance with institutional and governmental requirements and for safe and proper experimentation resides with the principal investigator (PI). The Institutional Biosafety Committee and Biological Safety Officer are appointed to review and monitor recombinant DNA research on behalf of Texas A&M.

        Registration, Review and Approval of Recombinant DNA Research
        All recombinant DNA research conducted at Texas A&M must be registered with the IBC. All proposals for recombinant DNA research, unless specifically exempted by the NIH Guidelines, must be reviewed and approved by the Institutional Biosafety Committee (IBC) prior to initiating work. This includes, but is not limited to: recombinant products, DNA probes, vector systems, and related material received from outside sources. Review and approval by the IBC of cooperating institutions may be required. Coordinated reviews may be arranged by IBC chairpersons of cooperating institutions or agencies. PIs and unit heads should seek clarification regarding institutional requirements for protocol or project approval and safety (independent of their own interpretations or uncertainties).

        Review by the IBC includes evaluation for compliance and conformance with the NIH Guidelines; assessment of the containment levels required by the NIH Guidelines; assessment of the facilities, procedures and practices; and consideration of the training and expertise of recombinant DNA personnel.

        A. Research and Related Activities Requiring IBC Review and Approval
        Projects
        All research (regardless of the source of funding) conducted at Texas A&M, involving recombinant DNA (including recombinant DNA used as probes or obtained from another laboratory) must be registered, reviewed and approved by the IBC. NOTE: Certain types of research that are specifically exempted (by NIH Guidelines) from review only require registration with the IBC (See B below).

        • Grant Proposals - All extramural grant proposals for research involving recombinant DNA should be identified as such by the PI, acknowledged by the unit head, and reviewed by the IBC prior to submission to the sponsor. The project number should be included if the research is supported by the Texas A&M AgriLife Research.
        • Project Modifications - Additional IBC review and approval is required if the nature or content of research changes significantly, or if recombinant DNA, either cloned or received from an outside source is involved. For example, collaborative work may require evaluation of unanticipated recombinant products or in locations where prior recombinant DNA research was not anticipated. Proposal changes must be reviewed and approved before work proceeds.
        • Testing, Evaluation and/or Release - Research plans, protocols and provisions for containment for recombinant DNA work under field conditions (outside a lab, growth chamber, containment or cage) require additional information and IBC review. Environmental safety and risk must be considered for potentially self-replicating biological material. Investigators should anticipate potential testing, evaluation or release of recombinant DNA products (at least one year lead time) for preparation and review of approval documents.


        B. Registration of Recombinant DNA Research
        All research projects involving recombinant DNA must be registered with the IBC. Completion of the IBC application will fulfill this requirement. Submission of additional documentation is not required for research that is specifically exempted from IBC review.

        C. Submitting Protocols for IBC Review
        The IBC application must accompany material submitted for review.

        Documents for recombinant DNA review by the IBC should be submitted through established administrative channels; that is, Texas A&M departments and research groups should route proposals through the appropriate sponsored project office. Proposals from research units, departments and centers supported by Texas A&M AgriLife Research should be routed to their office.

        D. Records Retention
        All research-related (data) records must be maintained for at least 7 years after the project completion per 15.99.03.M1.03 Guidelines for Gathering, Storage, and Retention of Data and Results http://rules-saps.tamu.edu/PDFs/15.99.03.M1.03.pdf.


        NOTE: Prior review by the IBC is required for all documents to be forwarded to the Recombinant DNA Advisory Committee of the National Institutes of Health (NIH/RAC). Documents submitted to the IBC for review must include complete and adequate information and protocols to allow appropriate peer review.

      1. NIH Guidelines for Research Involving Recombinant DNA Molecules
      2. Select Agents

        What is a 'select agent'?
        The Anti-terrorism and Effective Death Penalty Act was passed in 1996 and built upon the Biological Weapons Anti-terrorism Act (1989) and other earlier anti-terrorism legislation. This legislation directed the Department of Health and Human Services to develop and maintain a list of biological agents that could pose a threat to the public health and the regulate the transfer of such agents while maintaining the availability of these agents for research, education, and other legitimate purposes. In response to this legislation, the CDC developed a list of 31 infectious agents and 12 biological toxins with additional provisions for recombinant organisms and drug resistant organisms and exemptions for research quantities and vaccine strains of organisms. The list of organisms provided below is referred to as the select agent list.

        The CDC has developed regulations on the transfer and transport of these select agents. The also require that facilities receiving these agents be registered with the federal government, that they fulfill the proper biosafety level requirements for handling, containment, and disposal, and that a person at the facility be responsible for the oversight of the transfer of such agents.

        Any University research working with or storing select agents will be required to follow all applicable federal regulations. In addition, recent regulations have required that persons working with select agents or having access to laboratories where select agents used or stored, attest to the fact that they are not ‘restricted persons’. For information about use of select agents, please contact a biosafety officer in the Office of Research Compliance and Biosafety, 979.862.4549.

        Records Retention
        All research-related (data) records must be maintained for at least seven years after the project completion, per 15.99.03.M1.03 Guidelines for Gathering, Storage, and Retention of Data and Results.

        Resources

        Biohazardous Waste Handling

        Download a PDF, printable file with detailed information.

        Instructions for disposing of biohazardous waste:

        • Collect solid biohazard waste in a red or orange biohazard bag for autoclaving.
        • Prior to autoclaving, deface the biohazard symbol on the bag with autoclave tape.
        • Label the waste bag or container with the name of the principal investigator (PI), building number, and lab room number.
        • After autoclaving, place a treatment sticker on biohazard bag to document wastes were treated in accordance with 25TAC1.136.
        • Place the biohazard bag inside a second black trash bag.
        • Dispose of autoclaved waste in the appropriate dumpster.
        • Do not leave it on the curb or street or place it in container labeled for composting or other waste.
        • NEVER dispose of anything sharp inside of the biohazard trash bag. This would include serological pipets and pipet tips, as they can poke through the bag and cause injury to personnel.

        If you have any questions about proper biohazardous waste disposal, please contact the Biosafety Program at 979.862.4549 or biosafety@tamu.edu.

        Checklist for New Researchers IBC

        PDF document icon New PI Checklist.pdf — PDF document, 153 KB (157594 bytes)

        Biological Safety Cabinet Certification Information

        The operational integrity of a Biosafety Cabinet (BSC) must be validated before it is placed into service and after it has been repaired or relocated. Relocation may break the HEPA filter seals or otherwise damage the filters or the cabinet. Each BSC should be tested and certified at least annually to ensure continued, proper operation. On-site field testing must be performed by experienced, qualified personnel.

        The principal investigator is responsible for calling Precision Air*, the Texas A&M University contractor for BSC certification, and scheduling the certification at least a month prior to the certification expiration date. If a BSC which is located in a BL2 or higher laboratory has lapsed or is past due for annual certification, it cannot be used.

        Please make sure that the recertification of your BSC is on your schedule or your designate’s schedule. Do not depend on your department, EHSD, or Research Compliance and Biosafety office to schedule this service for you.  

        *Precision Air Technology
        2318 Parkdale Drive
        Kingwood, Texas 77339
        Phone: 713.875.3288
        Fax: 801.740.3346
        http://www.precisionairtechnology.com/

        Out of Service sign for posting if BSC is not certified for use (PDF)

        Sample letter for removing BSC from service (PDF)

        USDA Permits for Livestock and Poultry Pathogens

        Q.  What agents require a USDA permit? Is there a list of permitted strains of agents to which investigators can refer?

        A.   Regulation 9 CFR 122 Organisms and vectors is under review to actually indicate which agents need an import/transport permit.  Currently the USDA requires permits for all materials that may represent a health risk to livestock and poultry and ranging from prions to macroscopic nematodes.

        Q.  Is a USDA permit required for any and all pathogens of livestock (or plants) or can this be narrowed down?

        A.  It will be narrowed to high risk materials.

        Q.  Who needs the transport permit?

        A.  The person that receives the material = permittee.  Please note that the regulation applies to interstate or foreign importation of materials.  We do not regulate intrastate transport of materials, unless it is a Select Agent as defined under 9 CFR 121.  The shipper will be identified if needed. Applicants usually have multiple suppliers so the USDA does not list them specifically on the permit, but they may be included in the application (VS Form 16-3).

        Q.  Does the transport permit also regulate USE or work with the permitted agent?

        A.   The USDA regulates the transport and use of the materials.  If the material is considered high risk and it is not a Select Agent, for example low pathogenicity influenza virus, West Nile virus, PRRSV, and others, they will request that the USDA Field inspector evaluate the level of containment of the applicant facility.  Most laboratory or animal facilities are BSL-2 based upon the recommendations/guidelines of the BMBL (HHS).  The USDA will issue the permit once they receive a satisfactory report from the USDA Field inspector.

        Q.  Do agents or pathogens purchased from a commercial source, such as the ATCC, require a USDA permit?

        A.  Yes.  The ATCC catalog will indicate if a USDA transport permit is required for purchasing the material.  In general, if the material can be classified as a health risk to livestock and poultry, 9 CFR 122 is applicable and a permit is required.

        Q.  May the permit holder share the permitted organism(s) with collaborators on campus?

        A.  The new permit can be issued to more than one person on campus. When applying for the permit, the individual should list the collaborators in the importer section. If the material is shared after the permit is issued, the USDA can amend the permit to allow local movement.  The pertinent statement is changed to indicate that the material will be shared provided the permittee keeps records of the movement and provides documentation to USDA if needed.

        Q.  If the permittee is still working with the permitted strain and the permit is about to expire, must the permit be renewed?

        A.  It depends upon the material. If the permittee is working with high risk material, such as avian influenza virus low path, a USDA BSL-2 inspection and an active permit are required; for lower risk material the USDA does not consider the permit expired unless the investigator intends to receive more material. The USDA considers the permit active or “on” even with an expired date and they do not search for expired permits.  It is not necessary to renew the permits every year unless there are changes to the permittee section, like a new address.  However, USDA recommends that permits remain current, in case there is an incident with the strain.

        Q. If the permittee wishes to ship an agent that has been inactivated, or wishes to ship extracted DNA from organisms that would require a permit, would the permit need to reflect these items as well?

        A.  Yes, the USDA would issue a broad permit stating the species, as well as derivatives including nucleic acids, are included.

        Q. If the permittee wishes to receive nucleic acids encoding for Select Agents or Select Agent Toxins that have been generated synthetically, is a permit required?

        A.  Yes, since the material is regulated under 9 CFR 121.3 or 9 CFR 122.

        USDA Permits for Materials Representing a Health Risk to Agriculture

        Q.  What plant pest organisms require a USDA permit? Is there a list of permitted organisms to which investigators can refer?

        A.   Regulation 7 CFR 330 covers the authority of the USDA to regulate plant health and plant pest movements.  Currently the USDA requires permits for all materials that may represent a health risk to agriculture. There are no lists that investigators can look at. We regulate pest permits based on type and risk on a case by case basis. According to 7 CFR 330.200 to 330.221 “a plant pest means any living stage of any insects, mites, nematodes, slugs, snails, protozoa, or other invertebrate animals, bacteria, fungi, other parasitic plants or reproductive parts thereof, viruses, or any organisms similar to or allied with any of the foregoing, or any infectious substances which can directly or indirectly injure or cause disease or damage in any plants or parts thereof, or any processed, manufactured, or other products of plants."

        Q.  Is a USDA permit required for any and all pathogens of plants or can this be narrowed down?

        A.  It is narrowed to higher risk materials.

        Q.  Who needs the transport permit?

        A.  The person that receives the regulated organism would be the permittee.  Please note that the regulation applies to interstate or foreign importation of materials.  We do not regulate intrastate transport of materials. The shipper will be identified if needed.

        Q.  Does the transport permit also regulate USE or work with the permitted organism?

        A.   The USDA regulates the transport and use of the regulated organisms.  If the regulated organism is considered a significant risk and it is not a Select Agent, they will request that the USDA inspectors evaluate the level of containment of the applicant facility.  Most laboratory facilities are BSL-2. The USDA will evaluate the permit application once they receive a satisfactory report from the USDA inspectors.  The USDA issues a permit if the applicant can meet the permit conditions.

        Q.  Do agents or pathogens purchased from a commercial source require a USDA permit?

        A.  Yes.

        Q.  May the permit holder share the permitted organism(s) with collaborators on campus?

        A.  Generally no. Insects are can if the work is being done by the same lab or in the same facility on organism and intended use.

        Q.  If the permittee is still working with the permitted organism and the permit is about to expire, must the permit be renewed?

        A.  Yes. Currently, it is suggested that permittees start the renewal process for their permits at least 3-4 months early. If a new containment facility is necessary, then the permittee/applicant should start the process 6 months early.

        Q. If the permittee wishes to ship an organism that is dead or wishes to ship extracted DNA from organisms that would require a permit, would a permit need to be obtained?

        A.  No, the USDA does not require permits for dead organisms or extracted nucleic acids.

        Q. If the permittee wishes to receive plant pest organisms that have been generated synthetically, is a permit required?

        A.  Yes, those permits are handled through USDA; APHIS; BRS.

        Q. Can the permittee hand-carry regulated organisms into this country? If so, what is needed?

        A.  Yes. A hand-carry event can only occur if:

        • The permittee has a permit which allows hand carry.
        • The hand carrier is named on the permit.
        • There is a 20 day notice to PPB that includes: hand carrier passport, return itinerary, description of how samples will be transported and a third party confirmation of organisms/soil arrived at designated facility.

        Laboratory Decommissioning

        This information is provided for the purpose of assisting departments and investigators vacating biosafety lab space, to ensure that the space has been cleared of all biohazardous material including biological agents and recombinant DNA, and to ensure that any remaining equipment has been properly decontaminated. This information specifically applies to BL1 and BL2 laboratories. Additional procedures are required for decommissioning BL3 space. Also, refer to the University SAP for laboratory decommissioning online at http://rules.tamu.edu/PDFs/24.01.01.M4.04.pdf.

        To schedule your lab for decommissioning, please observe the following steps:

        1. Contact the Biosafety program at 979.862.4549 to provide notification and to schedule an appointment for inspection of the lab space to be decommissioned. The biosafety lab decommission checklist will be sent to the principal investigator (PI) or PI designee.
        2. Following the steps listed on the checklist, the PI or PI designee should dispose of all biohazardous agents/recombinant material present in the lab (which may include autoclaving the material or transferring the material to another facility) and perform laboratory and equipment disinfection.
        3. Solid biohazard trash should be decontaminated by autoclaving and must be disposed of properly (i.e. placement of the autoclaved waste inside a second black trash bag and placement in the dumpster).
        4. Liquid biohazard waste may be decontaminated either by autoclaving or by use of concentrated bleach (10% final) solution. If bleach is used to decontaminate liquids, the solution should be allowed to sit for at least 30 minutes prior to pouring down the drain. Be sure to rinse with copious amounts of water. Bleach containing solutions should never be autoclaved.
        5. Any remaining laboratory equipment should be decontaminated using an appropriate disinfectant. (10% bleach solution followed by 70% ethanol is recommended.)
        6. All cabinets and drawers should be emptied and cleaned.
        7. The floor should be mopped with disinfectant solution.

         

          To ensure that all laboratory waste and biohazardous agents have been disposed of properly, and that all laboratory equipment has been decontaminated using approved disinfectants, the lab will be inspected by staff from the Biosafety program. Biosafety personnel will remove the door signage once the clean-up procedure has been completed.

          In order to document completion of the laboratory decommissioning, notification will be provided to the PI and the Department Head by the Biosafety program. A copy of this notice will be forwarded to the appropriate Environmental Health and Safety Department.

          Biosafety Checklist for New Researchers

          New PI Checklist for Work with Biohazards and Recombinant DNA
          Office of Biosafety



          1.    Texas A&M Institutional Biosafety Committee (IBC) approval is needed for all research, teaching or testing activities conducted by a member of the faculty or staff of Texas A&M University or a Texas A&M System component with a signed Memorandum of Understanding with Texas A&M IBC prior to initiation of the following work with:
          a.    Pathogens and potential pathogens of humans, animals, or plants;
          b.    Materials potentially containing human pathogens (human blood, tissue, and cell lines; non-human primate blood, tissues, and cell lines);
          c.    Recombinant DNA (and RNA) including the creation or use of transgenic plants and animals;
          d.    Biological toxins;
          e.    Select Agents and Toxins, including strains and amounts exempted from the Select Agent Regulations; and
          f.    Any material(s) requiring a CDC Import license or USDA permit.

          2.    Registration with the IBC:
          a.    The initial step for approval to work with biohazards is to submit a complete IBC permit application to the IBC.
          b.    All applicable forms are available on-line (http://imedris.tamu.edu)
          c.    Instructions and assistance are available. (979.845.4969 or IBC@tamu.edu)

          3.    IBC Training Requirements:
          a.    Principal Investigators (PI) conducting research involving recombinant DNA molecules must complete NIH Guidelines training. This training is offered online via the CITI program and must be completed once every three years.
          b.    All personnel who will be listed on a biosafety level two (BL2) permit must complete BL2 training, provided by the Office of Biosafety, before being permitted to work in the BL2 lab. Instructor led BL2 training is offered weekly and upon special request. BL2 Training is valid for three years and may be refreshed on-line via the CITI program.
          c.    All personnel who will be listed on a biosafety level three (BL3) permit must complete BL3 training, provided by the Office of Biosafety, before being permitted to work in the BL3 lab.  Instructor led BL3 training is available upon request, as needed. Please contact the Office of Biosafety at 979.862.4549 or biosafety@tamu.edu for assistance. BL3 training must be renewed annually via classroom training.
          d.    All personnel listed on either BL2 or BL3 IBC permits must also be provided lab/agent specific training by the PI. Documentation of this training must be provided to the IBC by the PI.  The Office of Biosafety can provide PIs with a template form to fulfill this requirement; the form  is included in the IBC Application.
          e.    Bloodborne Pathogen (BBP) Training is required for all personnel at occupational risk of exposure to human and/or non-human primate blood, tissues, body fluids, and/or other potentially infectious materials. Annual retraining is mandatory. The first training must be completed in the classroom setting; instructor led classes are offered at least every 10 days. Thereafter, refresher training may be completed on-line via the CITI program.
          f.    For personnel working in BL2 and BL3 labs a one-time TrainTraq training on the safe usage of a biosafety cabinet will also be assigned.

          4.    Laboratory Inspection and Certification:
          a.    As part of the IBC review and approval process, laboratories will be scheduled for inspection.
          b.    The IBC permit cannot be approved until all lab space has been inspected and certified for the appropriate biosafety level.
          c.    Example inspection checklists are available: (http://rcb.tamu.edu/biohazards/forms/bl2labinspections/view)

          5.    IBC Approval:
          a.    The IBC meets the third Wednesday of each month. IBC meetings are open to the public. To view a full schedule of Committee Meetings see the front page of RCB at http://rcb.tamu.edu.
          b.    IBC applications describing rDNA studies which are not exempt of the NIH Guidelines must be reviewed by the full committee during a regularly convened meeting. NOTE: An application must be submitted at least 10 business days before the meeting date in order to be considered for review during the upcoming meeting.
          c.    IBC applications describing non-recombinant work with biohazards, or recombinant work that is exempt of the NIH Guidelines, must still be registered with the IBC but can be approved by the IBC Chair on behalf of the IBC.

          6.    Commencement of Work:
          a.    Once the approval memo, signed by the IBC Chair, is received by the PI, approved experiments may commence.
          b.    The IBC approval will detail the specific outline of the work permitted, including a list of approved agents, locations and assigned biosafety level(s).
          c.    IBC approval is valid for three years; annual renewals are required as described below.
          d.    A copy of the IBC approval letter will be provided to the PI, and the Department Head.

          7.    Annual Requirements:
          a.    A one-page annual renewal questionnaire must be submitted by the PI 60 days prior to the first and second anniversary of the IBC permit approval.
          b.    Annual renewal forms are accessible on-line in the iRIS program.
          c.    A laboratory inspection will be scheduled as part of the annual renewal.
          d.    Personnel training requirements will be reviewed annually to ensure that all personnel are current with respect to required trainings.

          8.    Amendments are required prior to implementing any changes to the existing IBC approval including changes in:
          a.    Personnel: Any deletion or addition of laboratory personnel to BL2 and BL3 IBC permits must be submitted on-line in the iRIS program.
          b.    Funding: Any addition of funding must be submitted for review by the IBC.
          c.    Agents: Addition of agents, procedures, etc. must be submitted for review by the IBC
          d.    Locations: Any changes in locations must be submitted to the IBC.
          i.    The room being vacated must be decontaminated, chemical and biological agents properly disposed of (and/or secured for transport). The vacated lab will be inspected and decommissioned by Environmental Health and Safety and the Office of Biosafety.
          ii.    The new lab must be inspected and certified before work in the new space may commence.
          9.    Termination of IBC Permit:
          a.    Investigators leaving the institution or ceasing all work with biohazardous materials should submit a termination request to the IBC.
          b.    Requests for termination will initiate the laboratory decommission process described in 8.d.i.

          Other Research Activities:
          All research involving animals must be registered separately with the Institutional Animal Care and Use Committee (IACUC). IBC approval does not convey IACUC approval. Please see: http://rcb.tamu.edu/animals

          All research involving human subjects must be reviewed by and may approval from  the Institutional Review Board (IRB). IBC approval does not convey IRB approval. Please see: http://rcb.tamu.edu/humansubjects

          Any research that may be subject to Export Control regulations must be in compliance with Federal guidelines. Please see: http://vpr.tamu.edu/resources/export-controls

          Research activities involving the use of other hazards are not the scope or oversight responsibility of the Office of Biosafety. For questions regarding general lab safety, laser safety and/or work with chemicals, radiation, etc., please contact Environmental Health and Safety: http://ehsd.tamu.edu/

          BL2 Laboratory Manual Suggested Table of Contents

          Each Principal Investigator (PI) in a BL2 laboratory must develop and maintain a Laboratory Specific Biosafety Manual for their lab.  This Biosafety Manual should: 1) contain safety information relevant to the lab’s specific hazards and research materials, 2) serve as a training tool for personnel and include documentation of such training, 3) be readily available to all research personnel in the lab and 4) be modified as needed to contain current laboratory SOPs and practices.

          At a minimum, the laboratory Biosafety manual should include:

            • Lab contact information (PI name, phone number, including after hours number)
                • Relevant sections of the Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5thEdition, (e.g. Sections I, II, and III pertaining to standard  BL1 and BL2 practices, Appendix H, pertaining to work with Human cells and tissues  if applicable).

                  http://www.cdc.gov/biosafety/publications/index.htm

                    • A list of Agents used and Agent Summary Statement(s) or MSDS for  each agent used in the lab;
                        • Project specific SOPs;
                            • Laboratory specific Biosafety policies, including:
                              • PPE required for working in the lab
                              • Infectious Waste Disposal procedures for:
                                  1. Liquids
                                  2. Sharps
                                  3. Solids
                                  4. Research Animals (if applicable)
                                • Biohazardous Spill Clean-Up Procedures
                              • Copy of current IBC approval letter
                                • copies of recent laboratory inspection report(s).
                                  • Documentation of lab/agent specific training (date and topics covered) provided by PI (or designee) to all personnel working in the lab, signed by PI and personnel.

                                    Institutional Review of Research with Dual Use Potential

                                    Overview

                                    On September 24, 2014, the US Government released its Policy for institutional oversight of Dual Use Research of Concern (“DURC”). The Policy addresses institutional oversight of DURC and identifies the criteria for what qualifies as DURC by listing specific agents and toxins and descriptions of the types of experiments which, when combined, define the parameters for research considered DURC. Compliance with The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (Policy) commenced on September 24, 2015.

                                    What are Dual Use Research and Dual Use Research of Concern?

                                    Dual Use Research is defined as research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products which could be utilized for both benevolent and harmful purposes. 

                                    Dual Use Research of Concern, or DURC, is a subset of Dual Use Research and is defined as 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 national security.

                                    What is Texas A&M University’s Review and Approval Process for DURC?

                                    Texas A&M University is committed to the shared responsibility of upholding the integrity of science and to reducing the risk of its misuse.  Review and oversight of DURC are outlined in  TAMU Rule 15.99.06.M1  Use of Biohazards, Biological Toxins and Recombinant DNA and Dual Use Research of Concern and IRE SOP 019 “Institutional Review of Research with Dual Use Potential”.

                                    Per TAMU Rule 15.99.06.M1, TAMU’s Institutional Biosafety Committee (IBC) serves as TAMU’s Institutional Review Entity (IRE) and is responsible for reviewing potential DURC and executing the requirements in The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern review (September 2014).

                                    Who is TAMU’s Institutional Contact for Dual Use Research (“ICDURC”)?

                                    TAMU’s Vice President for Research has designated Dr. Christine McFarland, the Director of Biosafety, and Responsible Official, to serve as TAMU’s internal resource for issues regarding compliance with and implementation of the requirements for oversight of DURC as well as the liaison (as necessary) between the university and the relevant Federal funding agency.  For guidance about DURC, contact Dr. McFarland at ctmcfarland@tamu.edu.

                                    What research must be reviewed by TAMU’s IRE?

                                    Research with one or more of the fifteen agents and/or toxins currently listed in Section 6.2.1 of the Policy and which  produces, aims to produce or can be reasonably anticipated  to produce one or more of the  effects listed in Section 6.2.2 of the Policy must be evaluated by the IRE for its DURC potential. Additionally, if the USG has notified TAMU that specific research requires IRE review, the research must be reviewed by the IRE.

                                    What do researchers need to do?

                                    1.  Notify the IRE if:
                                    • their research involves non-attenuated forms of one or more of the agents listed in Section 6.2.1 of the Policy;
                                    • their research with non-attenuated forms of one or more of the listed agents also produces, aims to produce, or can be reasonably anticipated to produce one or more of the seven experimental effects listed in Section 6.2 the Policy; and
                                    • The researcher concludes that his/her research with non-attenuated forms of one or more of the listed agents that also produces, aims to produce, or can be reasonably anticipated to produce one or more of the seven listed experimental effects may meet the definition of DURC and should be considered or reconsidered by the IRE for its DURC potential.

                                     
                                    2. Work with the IRE to develop risk mitigation measures where appropriate;

                                    3. Conduct DURC in accordance with the provisions of the risk mitigation plan;

                                    4. Be knowledgeable about, and comply with, all institutional and Federal policies and requirements for oversight of DURC;

                                    5. Ensure that laboratory personnel (i.e., those under the supervision of laboratory leadership including graduate students, postdoctoral fellows, research technicians, laboratory staff and visiting scientists)  conducting life sciences research that falls within the scope of  the Policy have received education and training on DURC; and

                                    6.   Communicate DURC in a responsible manner and in compliance with any risk mitigation plan stipulated by the IRE.

                                    What if research meets the definition of DURC?

                                    If the IRE determines that a research project meets the definition of DURC, the ICDURC will notify the USG in accordance with the Policy and work together with the IRE and the researcher to develop a draft risk mitigation plan for final approval by the USG. Once the draft risk mitigation plan is approved, the IRE will continue to monitor the research project and provide compliance oversight until the project has been completed. Any changes in the status of a DURC project or proposed changes to the risk mitigation plan must be communicated to the USG.  Changes in the risk mitigation plan require USG approval. 

                                    What is not DURC?

                                    The review and oversight requirements presented in the USG Policy do not apply to research that involves the use of the genes from any of the listed agents, in silico experiments (e.g., modeling experiments, bioinformatics approaches) involving the biology of the listed agents, or research related to the public, animal, or agricultural health impact of the listed agents (e.g., modeling the effects of a toxin, developing new vaccine delivery methods, developing surveillance mechanisms for a listed agent).

                                    Does IBC approval for research involving use of select agents satisfy the IRE’s requirement to review the research?

                                    No. IBC review and approval, prior to initiation of any research project involving the use of pathogens, materials potentially containing human pathogens (human blood, tissues or cell lines), rDNA (or rRNA) including the creation of transgenic plants and animals, and select agents and toxins, remains a separate institutional requirement, distinct from the IRE review process. Furthermore, experiments with select agents and toxins (excluding attenuated strains or permissible toxin amounts) also require review by and approval from the Federal Select Agents Program  

                                    How do I contact the IRE?The Texas A&M University IRE is administratively managed and supported by the Office of Biosafety.  For questions related to the IRE, please contact ire@tamu.edu.

                                    Additional Resources

                                    United State Government Policy for Oversight of Life Sciences Dual Use Research of Concern (March 2012) .  http://www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf

                                    United States Government Policy for Institutional Oversight of Dual Use Research of Concern (September 2014) http://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf

                                    FAQs on USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern

                                    http://www.phe.gov/s3/dualuse/Documents/durc-faqs.pdf

                                    National Institutes of Health – Office of Science Policy: Dual Use Research of Concern.

                                    http://osp.od.nih.gov/office-biotechnology-activities/biosecurity/dual-use-research-concern

                                    Tools for the Identification, Assessment, Management, and Responsible Communication of Dual Use Research of Concern: A Companion Guide to the United States Government Policies for Oversight of Life Sciences Dual Use Research of Concern.

                                    http://www.phe.gov/s3/dualuse/Documents/durc-companion-guide.pdf

                                    Training Slide Set: Training on the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern.

                                    http://www.phe.gov/s3/dualuse/Documents/durc-us-policy-trng.pdf