biological and radiological regulatory concerns for research administrators megan g. marks, ph.d....

Biological and Biological and Radiological Regulatory Radiological Regulatory Concerns for Research Concerns for Research AdministratorsAdministrators

Megan G. Marks, Ph.D.Megan G. Marks, Ph.D.

Biological and Radiological Safety Biological and Radiological Safety ManagerManager

Carnegie Mellon UniversityCarnegie Mellon University

August 2003August 2003

IntroductionIntroduction

Biological and Radiological Agents Biological and Radiological Agents are valuable tools in research.are valuable tools in research.

Both types of agents are used in a Both types of agents are used in a variety of disciplines, ranging variety of disciplines, ranging from the biological sciences to from the biological sciences to physics.physics.

Purpose of TrainingPurpose of Training

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

Biological Regulatory ConcernsBiological Regulatory Concerns

DefinitionsDefinitions

Biological agentsBiological agents– means any microorganism (including, but means any microorganism (including, but

not limited to, bacteria, viruses, fungi, not limited to, bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious rickettsiae, or protozoa), or infectious substance, or any naturally occurring, substance, or any naturally occurring, bioengineered, or synthesized component bioengineered, or synthesized component of any such microorganism or infectious of any such microorganism or infectious substance, capable of causing death, substance, capable of causing death, disease, or other biological malfunction in a disease, or other biological malfunction in a human, an animal, a plant, or another living human, an animal, a plant, or another living organism; deterioration of food, water, organism; deterioration of food, water, equipment, supplies, or material of any equipment, supplies, or material of any kind; or deleterious alteration of the kind; or deleterious alteration of the environment environment

In short: an infectious substance that has the potential to cause disease in other living organisms



DNADNA– Deoxyribonucleic acid (DNA)Deoxyribonucleic acid (DNA)

Building block of lifeBuilding block of life Molecule encodes different characteristics in all Molecule encodes different characteristics in all

living thingsliving things All living things have different DNA moleculesAll living things have different DNA molecules

– Identical twin exceptionIdentical twin exception

– Recombinant DNA (rDNA)Recombinant DNA (rDNA) DNA manipulated outside the body but is not DNA manipulated outside the body but is not

injected into a personinjected into a person



Select AgentSelect Agent– means a biological agent included in the Code of means a biological agent included in the Code of

Federal Regulations Title 7 Part 331.3, Title 9 Part Federal Regulations Title 7 Part 331.3, Title 9 Part 121.3, and Title 42 Part 73.4121.3, and Title 42 Part 73.4

– Refer to listing provided at the end of the Refer to listing provided at the end of the presentationpresentation

Bloodborne PathogenBloodborne Pathogen– Bloodborne pathogens means pathogenic Bloodborne pathogens means pathogenic

microorganisms that are present in human blood microorganisms that are present in human blood and can cause disease in humans. These and can cause disease in humans. These pathogens include, but are not limited to, pathogens include, but are not limited to, hepatitis B virus (HBV) and human hepatitis B virus (HBV) and human immunodeficiency virus (HIV).immunodeficiency virus (HIV).



Controlled SubstancesControlled Substances– Drugs and certain other chemicals, both Drugs and certain other chemicals, both

narcotic and non-narcotic, which come narcotic and non-narcotic, which come under the jurisdiction of federal and state under the jurisdiction of federal and state laws regulating their manufacture, sale, laws regulating their manufacture, sale, distribution, use and disposal.distribution, use and disposal.


Regulatory AgenciesRegulatory Agencies

Department of Health and Human Department of Health and Human Services (DHHS)Services (DHHS)

Center for Disease ControlCenter for Disease Control United States Department of AgricultureUnited States Department of Agriculture

– Department of TransportationDepartment of Transportation– Drug Enforcement Agency (DEA)Drug Enforcement Agency (DEA)– National Institute of HealthNational Institute of Health

NIH Guidelines for Research Involving NIH Guidelines for Research Involving rDNA moleculesrDNA molecules


University CommitteeUniversity Committee

Institutional Biological Safety Institutional Biological Safety Committee (IBC)Committee (IBC)– rDNArDNA– *Biological agents, select agents, *Biological agents, select agents,

and controlled substancesand 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.


Principal Investigator Principal Investigator ResponsibilityResponsibility

PIs must submit an authorization application to PIs must submit an authorization application to the Office of Sponsored Research and receive the Office of Sponsored Research and receive approval by the Institutional Biosafety approval by the Institutional Biosafety Committee (IBC) prior to the commencement of Committee (IBC) prior to the commencement of any research utilizing recombinant DNA (rDNA).any research utilizing recombinant DNA (rDNA).

PIs must contact the Biosafety Office prior to PIs must contact the Biosafety Office prior to purchasing any select agent or importing any purchasing any select agent or importing any biological agent or environmental sample. Any biological agent or environmental sample. Any effort to purchase or import such agents must be effort to purchase or import such agents must be coordinated through the Biosafety Officecoordinated through the Biosafety Office

All select agents All select agents mustmust be shipped to the be shipped to the Biosafety OfficeBiosafety Office



The CM *The CM *Safety Safety Plan for the Use Plan for the Use of Biological of Biological AgentsAgents contains contains information that all information that all users of biological users of biological agents at CM should agents at CM should knowknow

To Be Completed

•Presently, this is being authored. Upon final review of the IBC it will beDistributed and posted on the EHS website.


Users of Biological Agents Users of Biological Agents ResponsibilityResponsibility

Follow the rules and regulations Follow the rules and regulations established by CM and all established by CM and all applicable lawsapplicable laws

Escort untrained personnel, Escort untrained personnel, contractors, and visitors in areas contractors, and visitors in areas that biological agents are stored that biological agents are stored and/or used.and/or used.


Further Further Information………….Information…………. Questions can be addressed to Questions can be addressed to

the Biosafety Officethe Biosafety Office– 268-3221268-3221– [email protected]@andrew.cmu.edu– Web site Web site

*http://www.cmu.edu/ehs/biosafety.*http://www.cmu.edu/ehs/biosafety.htmhtm

– Location 313 Mellon InstituteLocation 313 Mellon Institute•Presently, this web-site is under construction.

Radiological Regulatory ConcernsRadiological Regulatory Concerns

DefinitionsDefinitions Sources of RadiationSources of Radiation

– Radionuclides, radioactivated materials (by Radionuclides, radioactivated materials (by irradiation or by exchange processes), "Radiation irradiation or by exchange processes), "Radiation Producing Machines or Devices," "Generally Producing Machines or Devices," "Generally Licensed Devices," and those quantities of Licensed Devices," and those quantities of radioisotopes defined by regulation to be exempt radioisotopes defined by regulation to be exempt quantities.quantities.

Radiation Producing DevicesRadiation Producing Devices– A machine or device capable of generating A machine or device capable of generating

radiation, such as X-ray producing machines, radiation, such as X-ray producing machines, particle accelerators, high voltage power particle accelerators, high voltage power supplies, electron microscopes, high voltage supplies, electron microscopes, high voltage rectifiers, high voltage projection equipment, and rectifiers, high voltage projection equipment, and other types of high voltage machines.other types of high voltage machines.


Regulatory AgenciesRegulatory Agencies

Nuclear Regulatory CommissionNuclear Regulatory Commission Pennsylvania Department of Pennsylvania Department of

Environmental ProtectionEnvironmental Protection Department of TransportationDepartment of Transportation Environmental Protection AgencyEnvironmental Protection Agency


University CommitteeUniversity Committee

Radiation Safety Committee Radiation Safety Committee (RSC)(RSC)– Radioactive materialRadioactive material– Radiation Producing DevicesRadiation Producing Devices


Principal Investigator Principal Investigator ResponsibilityResponsibility PIs must submit an authorization application PIs must submit an authorization application

to the Radiation Safety (RS) Office and to the Radiation Safety (RS) Office and receive approval by the Radiation Safety receive approval by the Radiation Safety Committee (RSC) prior to the Committee (RSC) prior to the commencement of any research utilizing commencement of any research utilizing radionuclides or radiation producing radionuclides or radiation producing equipment.equipment.

All radioactive material must be ordered All radioactive material must be ordered through the RS Officethrough the RS Office

All radioactive material All radioactive material mustmust be shipped to be shipped to the RS Office, 313 Mellon Institute, 4400 Fifth the RS Office, 313 Mellon Institute, 4400 Fifth Avenue, Pittsburgh, PA 15213Avenue, Pittsburgh, PA 15213



The CM The CM Safety Plan Safety Plan for the Use of for the Use of Radioactive Radioactive Materials and Materials and Radiation Radiation Producing Producing DevicesDevices contains contains information that all information that all users of radiation users of radiation sources at CM sources at CM should knowshould know


Radiation Worker Radiation Worker ResponsibilityResponsibility

Follow the rules and attempt to Follow the rules and attempt to maintain ALARA at all times.maintain ALARA at all times.

Escort untrained personnel or Escort untrained personnel or contractors.contractors.

Survey hands and feet prior to Survey hands and feet prior to exiting RAM area that unsealed exiting RAM area that unsealed sources are used or stored.sources are used or stored.


Further Further Information………….Information…………. Questions can be addressed to Questions can be addressed to

the Radiation Safety Officethe Radiation Safety Office– 268-3221268-3221– [email protected]@andrew.cmu.edu– Web site Web site

http://www.cmu.edu/ehs/radiation.hthttp://www.cmu.edu/ehs/radiation.htmm

– Location 313 Mellon InstituteLocation 313 Mellon Institute

biological and radiological regulatory concerns for research administrators megan g. marks, ph.d....

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