Section: Radioactive Materials                                                       

Date: November 25, 1996

Replaces: November 1, 1993

The Radiation Safety section of Environmental Health & Safety provides radiation safety training for radiation workers at MCVH/VCU and maintains documentation of this training. Following is a list of radiation safety training programs and manuals.

         Training Course                                                  Target Audience

         Safety Awareness Program                                    Orientation for new employees

         Radiation Safety Lecture                                        Radiation workers and refresher training

         Radiation Safety Short Course                               1 credit, 15 hour course

         Radiation Safety Inservice Training                         Specific for area, as requested

         Training Manual                                                  Target Audience

         Safety Awareness Employee Handbook                 Orientation for new employees

         Radiation Safety Manual for Nuclear Medicine        Radiation workers in Nuclear Medicine                                                                                         Radiation Safety

         Radiation Safety Manual for Radiation Oncology     Radiation workers in Radiation Oncology                                                                                         Radiation

         Radiation Safety Manual for Nurses                         Nurses who work with brachytherapy                                                                                          patients

         Radiation Safety Manual for Radiology                     Radiation workers in Radiology

         Radiation Safety Guide                                             Radiation workers in laboratories

         Radiation Safety Manual for Dental Radiography      Radiation Workers in Dentistry

         Radiation Safety for Animal Facility                          Radiation Workers in the Animal Facility

Questions and requests for information about the radiation safety training programs and manuals should be directed to the Radiation Safety Section of OEHS at 828-9131.

Section: Radioactive Materials                                                      

Date: November 25, 1996

Replaces: November 1, 1993

Some employees are likely to be exposed to radiation in the course of their normal job duties. Radiation and radioactivity are used in several areas of the university and in MCVH, including the departments of Nuclear Medicine, Diagnostic Radiology (X-Ray), Radiation Oncology, Clinical Pathology, and in many of the university's research laboratories. Some employees who work in these areas are classified as radiation workers and subject to radiation protection controls.

Exposure to high levels of radiation have been associated with cancer, birth defects, and health problems. At the dose levels permitted for employees at VCU there are no known health effects, but it is sensible to keep radiation exposure as low as possible. In general, the risks associated with occupational exposure are smaller than the risks associated with most day-to-day activities.

Natural radiation is everywhere. We are exposed to a constant stream of radiation from outer space. Radioactivity is in the ground, the air, the buildings we live in, the food we eat, the water we drink, and the products we use.

Radiation exposure is measured in Sieverts or rems. An individual in the United States averages approximately 2.6 milliSieverts (or 260 millirem) of exposure each year from natural sources. In addition, many of us will average another 1 milliSievert (or 100 millirem) per year from medical procedures.

Sources of radiation exposure at include laboratories which perform research using radioactive materials, patients undergoing medical procedures using radioactive medicines or sources, and radiation producing devices such as X-ray machines. Radiation exposure can occur by contamination of skin or clothing, eating and breathing radioactive materials, exposure to radiation from patients , and from activated x-ray or therapy machines. Patients can also be a significant source of radiation when they have undergone treatment using radioactive medicines or sources. The chart and door to the patient's room are labeled during such therapies. Patients who are given very small amounts of radioactive medicine do not pose significant radiation hazards and their rooms are not labeled.

Section: Radioactive Materials                                                     

Date: November 25, 1996

Replaces: November 1, 1993

VCU is committed to keeping radiation exposures as low as reasonably achievable (ALARA). Coordinated by the University's Radiation Safety Committee, the ALARA program sees that every activity involving radiation is planned to minimize exposure for employees, students, patients, and visitors.

The use of radiation and radioactivity is governed by the Nuclear Regulatory Commission and the State Health Department. The Radiation Safety staff directs and coordinates the university's radiation safety program and is responsible for its day-to-day operation, including 24 hour radiation emergency response. The Radiation Safety Committee, which is appointed to review the radiation safety program, is committed by written policy to keep radiation doses for employees, students, patients and visitors as low as reasonably achievable. The Radiation Safety staff is responsible for ensuring that all radiation safety regulations set forth by the Nuclear Regulatory Commission (NRC), the Commonwealth of Virginia, and VCU are observed.

Copies of NRC and State licenses, results of NRC and State inspections, and Parts 19 and 20 of 10 CFR, which are the NRC regulations concerning "Notices, Instructions and Reports to Workers; and Inspections" and "Standards for Protection Against Radiation" are available from the Radiation Safety Office.

Instruction in safety measures which individuals should use to minimize their radiation exposure have been developed for all applicable areas. In some cases specific procedures must be followed. Your supervisor should advise you of the precautions to be taken and identify all applicable procedures.

Section: Radioactive Materials                                                     

Date: November 25, 1996

Replaces: November 1, 1993

In accordance with VCU, State and Federal regulations, all applications involving the use of radioactive material in humans must be approved by the Radiation Safety Committee (RSC) before final approval can be given by the Committee on the Conduct of Human Research (CCHR). Applications involving the use of radiation producing devices (X-rays) on humans in a manner that does not directly benefit the individual*, must also be approved by the RSC before final approval can be given by the CCHR. The applicant must include the following information in the body of the protocol:

1.      The dose equivalent to the gonads, breast, red bone marrow, lung, thyroid and bone          surfaces.

2.      The dose equivalent to any other organs that are exposed to more than 6% of the          effective dose equivalent.

3.      The whole body effective dose equivalent (EDE)**.

In the consent form, radiation doses that fall into the ranges specified in the following table must be characterized by the appropriate risk statement (see table).

Applicants should contact Radiation Safety at 8-9131 and make an appointment with the Radiation Safety Officer or his delegate to discuss their research proposal. All protocols involving the use of radiation must be reviewed by the RSO prior to CCHR submission. Any amendments of conditions or protocols approved by the CCHR which affect radiation dose must also be submitted to the Radiation Safety Committee for re-approval.

*    If all the radiation components of a protocol being submitted have been previously       approved by the Radiation Safety Committee, and these component procedures are for      the direct benefit of the individual, no further Radiation Safety Committee approval is      necessary. For instance, approved diagnostic Nuclear medicine procedures that are      included in a proposal, and would have normally been used to diagnose or treat the      individual's condition, do not require Radiation Safety Committee approval.

    If a protocol involves procedures utilizing radiation, and those procedures have not     been approved by the Radiation Safety Committee, or the procedures have been     approved by the Radiation Safety Committee but are not being performed for the direct     medical benefit of the individual, Radiation Safety Committee approval is required. For     example, a protocol includes an approved lung scanning procedure, the results of which     will be correlated with routine chest x-rays. If the lung scan would not normally be     done and is being performed for reasons other than the individual's direct medical     benefit, this protocol now requires Radiation Safety Committee approval.

** As defined in ICRP Publication 26 "Recommendation of the International Commission      on Radiological Protection", Pergamon Press, Volume 1 No. 3, 1977.

Section: Radioactive Materials                                                       

Date: November 25, 1996

Replaces: November 1, 1993

This document has been created by the Radiation Safety Committee (RSC) in response to a request from the Committee on the Conduct of Human Research (CCHR) to present the scientific and philosophic justifications for the radiation risk statements included in human use consent forms. In granting approval to proceed with a study, the RSC assumes that the Responsible Investigator supports this philosophy and conveys its intent in discussing issues of risk raised by research subjects.

The RSC's present position on radiation risk is based on the National Research Council's Committee on the Biological Effects of Ionizing Radiation Report, Health Effects and Exposure to Low Levels of ionizing Radiation, otherwise referred to as BEIR V (December 1989) and national council on Radiation Protection and Measurements Report No. 91, Recommendation On Limits For Exposure To Ionizing Radiation (June 1, 1987.)

Radiation effects are divided into three major categories: heritable effects, carcinogenic effects and mental retardation. Low level radiation risks are generally extrapolated from effects observed at doses that are higher than 10 rad. The 10 rad dose level is usually looked upon as the dividing line between low level and high level doses. Most of the observations of low-LET radiation effects are restricted largely to high dose rates. The carcinogenic effect of low-LET radiation is generally reduced at low doses or dose rate.

The average annual exposure to individuals living in the United States may be used for comparison purposes. Background radiation levels from cosmic, terrestrial, and internal sources average 95 millirem a year. The effect dose associated with radon exposure in the home averages 200 millirem a year. Taken together with the average x-ray and nuclear medicine exposure to the general public, the average annual population exposure in the United States is now estimated to be 360 millirem a year.

Heritable Effects. By extrapolation from to man, it is estimated that at least 100 rad of low dose rate, low LET radiation is required to double the mutation rate in man. Heritable effects of radiation have not yet been demonstrated in man. The risk coefficient to the first generation is 1 x 10^-6 dominant disorders per rad. In general the heritable risks is an order of magnitude less than that associated with radiation carcinogenesis.

Carcinogenic Risk. The excessive lifetime risk associated with an acute exposure of 10 rad of low LET radiation is 0.8% according to the BEIR V report. The accumulation of the same dose over weeks or months is expected to reduce the risk by a factor of 2 or more. The upper limit for this dose reduction effect factor (DREF) may be as great as 10. An acute dose of 10 rad to the entire U.S. population would result in about a 4% increase in the current baseline cancer risk assuming no dose reduction effect factor. If the upper limit of the DREF is assumed, this results in only a 0.4% increase.

Mental Retardation. The frequency of severe mental retardation associated with in utero exposure is highest in the 8th to 15th week of gestation. The risk is approximately 0.4% per rad. Diminution of IQ at a rate of 0.3 points per rad has also been noted. This again has its highest probability in the 8th to 15th week of gestation. Other fetal effects may include a cancer risk which is estimated to be 2 to 2.5 x 10⁴ per rad in the first ten years of life. Other

Section: Radioactive Materials                                                      

Date: November 25, 1996

Replaces: November 1, 1993

epidemiology studies suggest an association between utero exposure and carcinogenic risks in adult life.

The BEIR V report conclusions on radiation risk include two very specific statement which should be strongly considered when evaluating the risk/benefit of low level radiation.

"studies of population chronically exposed to low level radiation, such as those             residing in regions of elevated natural background radiation, have not shown             consistent or conclusive evidence of any associated risk in the increase of cancer."

 "epidemiological data cannot rigorously exclude the existence of a threshold and             that at low dose and low dose rates the lower limits of the range of uncertainty in             the risk estimate extends to zero.

The heritable, carcinogenic, and mental retardation risks associated with low dose, low LET radiation are risks which are based on theoretical models rather than actual epidemiological data. At this point in time it is unclear as to whether or not we will ever be able to demonstrate whether or not a risk exists at these levels of radiation.

The doses associated with most research protocols reviewed by the RSC are generally very low, often comparable to the average annual exposure received by the general population (360 mrem/yr). The risks associated with these levels is very small especially when compared with the spontaneous occurrence of cancer and genetic effects in the population or the risk associated with the activities of everyday life.

Based on these factors the RSC has adopted the following dose guidelines when considering the risks associated with both research and clinical uses of radiation. The justifications are based on information found in the references previously referred to as well as FDA and NRC regulations. The statements have been developed to conform with the general philosophy of the CCHR regarding consent:

   (1)    inform subjects that they will receive some (or additional) radiation exposure as a            participant in the study and to indicate the level of risk,

   (2)    avoid the inclusion of emotional terms like cancer, death, etc., so as not to alarm             the subject and,

   (3)    avoid comparison to risks associated with other radiological procedures which are             not familiar to the subject.

Section: Radioactive Materials                                                     

Date: November 25, 1996

Replaces: November 1, 1993

¹    Nuclear Regulatory Commission Policy Statement, Below Regulatory Concern, July 3,       1990.

2    NCRP Report No. 91, Recommendation On Limits for Exposure To Ionizing       Radiation, Bethesda, MD, June 1, 1987

³    10 CFR 20 Standards for Protection Against Radiation, Federal Register, Vol 56., No       98, May 21, 1991.

⁴    21 CFR 361, Prescribed Drugs for Humans Use Generally Recognized as Safe and      Effective and Not Misbranded: Drugs Used in Research, Federal Register, April 1,      1990.

Section: Radioactive Materials                                                       

Date: November 25, 1996

Replaces: November 1, 1993

The RSC present position on radiation risk is based on the National Research Council's Committee on the Biological Effects of Ionizing Radiation Report, Health Effects and Exposure to Low Levels of Ionizing Radiation otherwise referred to as BEIR V (December 1989) and National Council on Radiation Protection and Measurements Report No. 91, Recommendation On limits For Exposure To ionizing Radiation (June 1, 1987).

Radiation effects are divided into three major categories, heritable effects, carcinogenic effects and mental retardation. Low level radiation risks are generally extrapolated from effects observed at doses that are higher than 10 rad. The dose level 10 rad is usually looked upon as the dividing line between low level and high level doses. Most of the observations of low-let radiation effects are restricted largely to high dose rates. The carcinogenic effect of low-let radiation is generally reduced at low doses or dose rate.

The average annual exposure to individuals living in the United States may be used for comparison purposes. Background radiation levels from cosmic, terrestrial, and internal sources average 95 millirem a year. The effective dose associated with radon exposure in the home averages 200 millirem a year. Taken together with the average x-ray and nuclear medicine exposure to the general public, the average annual population exposure in the United states is now estimated to 360 millirem a year.

Heritable Effects. By extrapolation from mouse to man, it is estimated that at least 100 rad of low dose rate, low LET radiation is required to double the mutation rate in man. Heritable effects of radiation have not yet been demonstrated in man. The risk coefficient to the first generation is 1 x 10^-6 dominant disorder per rad. In general the heritable risks is an order of magnitude less than that associated with a radiation carcinogenesis.

Carcinogenic Risk. The excessive lifetime risk associated with an acute exposure of 10 rad of low LET radiation is 0.8% according to the BEIR V report. The accumulation of the same dose over weeks or months is expected to reduce the risk by a factor of 2 or more. The upper limit for this dose reduction effect factor may be as great as 10. An acute does of 10 rad to the entire U.S. population would result in about a 4% increase in the current baseline cancer risk assuming no dose reduction effect factor. If the upper limit of the DREF is assumed, results in only a .4% increase.

Mental Retardation. The frequency of severe mental retardation associated with in utero exposure is highest in the 8th to 15th week of gestation. The risk is approximately 0.4% per rad. Diminution of IQ at a rate of 0.3 points per rad has also been noted. This again has its highest probability in the 8th to 15th week of gestation. Other fetal effects may include a cancer risk which is estimated to be 2 to 2.5 x 10⁴ per rad in the first ten years of life. Other epidemiology studies suggest an association between utero exposure and carcinogenic risks in adult life.

BEIR V risks conclusion include two very specific statements which should be strongly considered when evaluating the risk/benefit of low level radiation.

 "studies of populations chronically exposed to low level radiation, such as those             residing in regions of elevated natural background radiation, have not shown             consistent or conclusive evidence of any associated risk in the increase of cancer.

 epidemiological data cannot rigorously exclude the existence of a threshold and that          at low dose and dose rates the lower limits of the range of uncertainty in the risk          estimate extends to zero.

The heritable, carcinogenic, and mental retardation risks associated with low dose, low LET radiation are risks which are based on theoretical models rather than actual epidemiological data. At this point and time it is unclear as to whether or not we will ever really be able to demonstrate whether or not a risk exists as these levels of radiation can be clearly defined.

Section: Radioactive Materials                                                       

Date: November 25, 1996

Replaces: November 1, 1993

The Radiation Emergency Plan is distributed to the departments and offices which are involved in planning or participating in radiation emergency drills and actual incidents. The locations listed below should have copies of the plan.

          MCVH Administration                                        

          MCVAP Risk Manager

          Office of Marketing and Public Affairs

          Patient Representative's Office

          Emergency Department

          Nuclear Medicine Division

          Telepage (Notification pages)

          VCU Campus Police

          Central Services

          Hospital Transportation Department

          Pharmacy Services

          Radiation Safety Section of the Office of Environmental Health & Safety (OEHS)

          Chemical Safety Section of OEHS

          MCVH Safety & Security

Questions and requests for information about the Radiation Emergency Plan should be directed to the Radiation Safety Section of OEHS at 828-9131.

OEHS