1. Biological and Radiological Regulatory Concerns for Research Administrators Megan G. Marks, Ph.D. Biological and Radiological Safety Manager Carnegie Mellon University August 2003

2. Introduction Biological and Radiological Agents are valuable tools in research. Biological and Radiological Agents are valuable tools in research. Both types of agents are used in a variety of disciplines, ranging from the biological sciences to physics. Both types of agents are used in a variety of disciplines, ranging from the biological sciences to physics.

3. Purpose of Training Provide the necessary knowledge to assist the university and its researchers in maintaining local, state, and federal compliance regarding the use of biological and radiological agents Provide the necessary knowledge to assist the university and its researchers in maintaining local, state, and federal compliance regarding the use of biological and radiological agents

4. Biological Regulatory Concerns Definitions Biological agents Biological agents –means any microorganism (including, but not limited to, bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substance, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious substance, capable of causing death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism; deterioration of food, water, equipment, supplies, or material of any kind; or deleterious alteration of the environment In short: an infectious substance that has the potential to cause disease in other living organisms

5. Biological Regulatory Concerns Definitions DNA DNA –Deoxyribonucleic acid (DNA) Building block of life Building block of life Molecule encodes different characteristics in all living things Molecule encodes different characteristics in all living things All living things have different DNA molecules All living things have different DNA molecules –Identical twin exception –Recombinant DNA (rDNA) DNA manipulated outside the body but is not injected into a person DNA manipulated outside the body but is not injected into a person

6. Biological Regulatory Concerns Definitions Select Agent Select Agent –means a biological agent included in the Code of Federal Regulations Title 7 Part 331.3, Title 9 Part 121.3, and Title 42 Part 73.4 –Refer to listing provided at the end of the presentation Bloodborne Pathogen Bloodborne Pathogen –Bloodborne pathogens means pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV) and human immunodeficiency virus (HIV).

7. Biological Regulatory Concerns Definitions Controlled Substances Controlled Substances –Drugs and certain other chemicals, both narcotic and non-narcotic, which come under the jurisdiction of federal and state laws regulating their manufacture, sale, distribution, use and disposal.

8. Biological Regulatory Concerns Regulatory Agencies Department of Health and Human Services (DHHS) Department of Health and Human Services (DHHS) Center for Disease Control Center for Disease Control United States Department of Agriculture United States Department of Agriculture –Department of Transportation –Drug Enforcement Agency (DEA) –National Institute of Health NIH Guidelines for Research Involving rDNA molecules NIH Guidelines for Research Involving rDNA molecules

9. Biological Regulatory Concerns University Committee Institutional Biological Safety Committee (IBC) Institutional Biological Safety Committee (IBC) –rDNA –*Biological agents, select agents, and controlled substances Presently, there is not a review established for the agents and substances that are not rDNA. It is the intent of the Biosafety Program to initiate this process.

10. Biological Regulatory Concerns Principal Investigator Responsibility PIs must submit an authorization application to the Office of Sponsored Research and receive approval by the Institutional Biosafety Committee (IBC) prior to the commencement of any research utilizing recombinant DNA (rDNA). PIs must submit an authorization application to the Office of Sponsored Research and receive approval by the Institutional Biosafety Committee (IBC) prior to the commencement of any research utilizing recombinant DNA (rDNA). PIs must contact the Biosafety Office prior to purchasing any select agent or importing any biological agent or environmental sample. Any effort to purchase or import such agents must be coordinated through the Biosafety Office PIs must contact the Biosafety Office prior to purchasing any select agent or importing any biological agent or environmental sample. Any effort to purchase or import such agents must be coordinated through the Biosafety Office All select agents must be shipped to the Biosafety Office All select agents must be shipped to the Biosafety Office

11. Biological Regulatory Concerns Principal Investigator Responsibility The CM *Safety Plan for the Use of Biological Agents contains information that all users of biological agents at CM should know The CM *Safety Plan for the Use of Biological Agents contains information that all users of biological agents at CM should know To Be Completed Presently, this is being authored. Upon final review of the IBC it will be Distributed and posted on the EHS website.

12. Biological Regulatory Concerns Users of Biological Agents Responsibility Follow the rules and regulations established by CM and all applicable laws Follow the rules and regulations established by CM and all applicable laws Escort untrained personnel, contractors, and visitors in areas that biological agents are stored and/or used. Escort untrained personnel, contractors, and visitors in areas that biological agents are stored and/or used.

13. Biological Regulatory Concerns Further Information…………. Questions can be addressed to the Biosafety Office Questions can be addressed to the Biosafety Office –268-3221 –mmarks@andrew.cmu.edu –Web site *http://www.cmu.edu/ehs/biosafety.htm http://www.cmu.edu/ehs/biosafety.htm –Location 313 Mellon Institute Presently, this web-site is under construction.

14. Radiological Regulatory Concerns Definitions Sources of Radiation Sources of Radiation –Radionuclides, radioactivated materials (by irradiation or by exchange processes), "Radiation Producing Machines or Devices," "Generally Licensed Devices," and those quantities of radioisotopes defined by regulation to be exempt quantities. Radiation Producing Devices Radiation Producing Devices –A machine or device capable of generating radiation, such as X-ray producing machines, particle accelerators, high voltage power supplies, electron microscopes, high voltage rectifiers, high voltage projection equipment, and other types of high voltage machines.

15. Radiological Regulatory Concerns Regulatory Agencies Nuclear Regulatory Commission Nuclear Regulatory Commission Pennsylvania Department of Environmental Protection Pennsylvania Department of Environmental Protection Department of Transportation Department of Transportation Environmental Protection Agency Environmental Protection Agency

16. Radiological Regulatory Concerns University Committee Radiation Safety Committee (RSC) Radiation Safety Committee (RSC) –Radioactive material –Radiation Producing Devices

17. Radiological Regulatory Concerns Principal Investigator Responsibility PIs must submit an authorization application to the Radiation Safety (RS) Office and receive approval by the Radiation Safety Committee (RSC) prior to the commencement of any research utilizing radionuclides or radiation producing equipment. PIs must submit an authorization application to the Radiation Safety (RS) Office and receive approval by the Radiation Safety Committee (RSC) prior to the commencement of any research utilizing radionuclides or radiation producing equipment. All radioactive material must be ordered through the RS Office All radioactive material must be ordered through the RS Office All radioactive material must be shipped to the RS Office, 313 Mellon Institute, 4400 Fifth Avenue, Pittsburgh, PA 15213 All radioactive material must be shipped to the RS Office, 313 Mellon Institute, 4400 Fifth Avenue, Pittsburgh, PA 15213

18. Radiological Regulatory Concerns Principal Investigator Responsibility The CM Safety Plan for the Use of Radioactive Materials and Radiation Producing Devices contains information that all users of radiation sources at CM should know The CM Safety Plan for the Use of Radioactive Materials and Radiation Producing Devices contains information that all users of radiation sources at CM should know

19. Radiological Regulatory Concerns Radiation Worker Responsibility Follow the rules and attempt to maintain ALARA at all times. Follow the rules and attempt to maintain ALARA at all times. Escort untrained personnel or contractors. Escort untrained personnel or contractors. Survey hands and feet prior to exiting RAM area that unsealed sources are used or stored. Survey hands and feet prior to exiting RAM area that unsealed sources are used or stored.

20. Radiological Regulatory Concerns Further Information…………. Questions can be addressed to the Radiation Safety Office Questions can be addressed to the Radiation Safety Office –268-3221 –mmarks@andrew.cmu.edu –Web site http://www.cmu.edu/ehs/radiation.htm http://www.cmu.edu/ehs/radiation.htm –Location 313 Mellon Institute