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Assurance of Hazardous Procedures - Environmental Safety

Assurance of Hazardous Procedures - Environmental Safety. Janet Peterson Biological Safety Officer peterson@umd.edu 5-3975. March 7, 2007. Acronyms. PI : Principal Investigator rDNA : recombinant DNA IBC : Institutional Biosafety Committee

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Assurance of Hazardous Procedures - Environmental Safety

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  1. Assurance of Hazardous Procedures - Environmental Safety Janet Peterson Biological Safety Officer peterson@umd.edu 5-3975 March 7, 2007

  2. Acronyms • PI: Principal Investigator • rDNA: recombinant DNA • IBC: Institutional Biosafety Committee • ORAA: Office of Research Administration and Advancement • DES: Department of Environmental Safety • BSO: Biological Safety Officer • RSO: Radiation Safety Officer • DSO: Dive Safety Officer

  3. Hazardous Procedures are research using • Biological materials (rDNA, infectious agents, human blood) • Radioactivity • Scientific diving • Animals • Human subjects

  4. Why do assurances? • Federal and State agencies have specific requirements for use of hazardous materials • National Institutes of Health (NIH) • Nuclear Regulatory Commission (NRC) • Centers for Disease Control and Prevention • OSHA • USDA

  5. rDNA Guidelines • “As a condition for NIH funding of recombinant DNA research, institutions shall ensure that such research conducted at or sponsored by the institution, irrespective of the source of funding, shall comply with the NIH Guidelines.”

  6. Radiation Safety Regulations • As a condition for possession and use of radioactive materials and/or radiation producing machines, institutions shall ensure that such use is conducted under the NRC and agreement state regulations (COMAR), irrespective of the source of funding.

  7. Diving Safety Program • Individuals conducting scientific diving under the auspices of UM must be registered with the Diving Safety Program. • For more information, 5-3982 or www.des.umd.edu/risk_comm/diving/index.html

  8. Who is responsible for assurances? • The Vice President for Research is responsible for “reviewing matters involving human subjects, DNA research, hazardous substances, and the experimental use of animals.”

  9. Who provides the assurances? • Biological, radioactive, scientific diving • Dept. of Environmental Safety via various faculty committees • Animals • Institutional Animal Care and Use Committee • Human subjects • Institutional Review Board

  10. Environmental Safety • Radiation Safety Officer • Radioisotopes • Ionizing radiation producing devices • Non-ionizing radiation producing devices • Biological Safety Officer • Recombinant DNA • Infectious agents • Human blood / tissue / cell culture • Dive Safety Officer • Scientific diving

  11. What does DES do? • Environmental Safety helps PIs comply with requirements.

  12. Sequence of Events • PI writes grant application. • PI checks “yes” in question 23 of Internal Routing Form.

  13. Question 23 • Biological materials • rDNA (approval #:________) – Not needed to submit grant. • Infectious agents • Toxins • Human blood, unfixed human tissue • Primary human cell cultures

  14. Question 23 • Radioactive materials, or • Ionizing radiation producing devices (x-rays, accelerators) • Non-ionizing radiation producing devices (lasers, IR, UV, etc.) • Scientific diving

  15. Sequence of Events • VP for Research routes “yes” applications to DES. • Grant application reviewed by DES and compared with PI’s previous registrations • If researcher is authorized for possession and use of radioactivity, the protocol will be approved by RSO. • If researcher has previously registered same types of biological experiments, the protocol will be approved by BSO. • DSO reviews applications involving scientific diving

  16. Sequence of Events • If grant contains research that is not already registered, BSO contacts PI. • If needed, PI submits registration for new experiments. • Institutional Biosafety Committee (IBC) reviews registration • IBC approves/disapproves registration and sets level of containment.

  17. Sequence of Events • Submit online registration form for rDNA and infectious agents only if similar experiments have not been registered previously.

  18. Forms • All forms available on ORAA’s web page: www.umresearch.umd.edu/oraa • and on DES’ web page: www.des.umd.edu

  19. Sequence of Events • DES enters approval status into ORAA’s database. • ORAA releases funds only after approval is received.

  20. Changes • “Intent to perform recombinant DNA experiments” form no longer used. • “Assurance on Hazardous Procedures” form no longer used. • rDNA and infectious agents registration is now online. • Researcher only needs to register new rDNA experiments in grant application.

  21. Regulations/Guidelines • “NIH Guidelines for Research Involving Recombinant DNA Molecules” (NIH Guidelines), April 2002. • COMAR – Code of Maryland Regulations 26.12.01.01 “Regulations for the Control of Ionizing Radiation.” • OSHA – Guidelines for Scientific Diving

  22. Summary of Requirements • Compliance with NIH rDNA Guidelines is not optional – it is a condition for NIH funding. • Authorization is a condition for possession and use of radioactivity. • DSO reviews and approves scientific diving • BSO/IBC reviews, approves, and sets containment for experiments involving rDNA and infectious agents. • RSO/RSC reviews and approves use of radioactivity and sets conditions of use.

  23. Bird Flu strikes Florida

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