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It is possible for individuals within an organization tohave separate licenses, although it is more likely that instead of several ind i v i d u a l s h a v i n gseparate licenses, an in

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Furr, A Keith Ph.D "NONCHEMICAL LABORATORIES"

CRC Handbook of Laboratory Safety

Edited by A Keith Furr, Ph.D.

Boca Raton: CRC Press LLC,2000

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as well as chemical wastes as part of the larger problem of dealing with hazardous wastes Inthis chapter laboratory operations which involve special problems in other classes oflaboratories will be presented in greater detail Ho wever, in responding to these specialproblems, one should be careful not to neglect the safety measures associa t e d w i t h t h o s ehazards already covered.

II RADIOISOTOPE LABORATORIES

Exposure of individuals to ionizing radiation is a major concern in laboratories usingradiation as a research tool or in which radiation is a byproduct of the research Althoughthere are many types of research facilities in which ionizing radiation is generated by theequipment, e.g., accelerator laboratories, X-ray facilities, and laboratorie s u s i n g e l e c t r o nmicroscopes, the most common research application in which ionizing radiation is a matter ofconcern is the u s e of unstable forms of the commo n elements which emit radiation A verybrief discussion of some atomic and nuclear terms will be given next, with apologies for thosenot requiring this introduction to the subject

A Brief Summary of Atomic and Nuclear Concepts

A n atom of an element can be simply described as consisting of a positively chargednucleus and a cloud of negatively charged electrons around it The electron cloud definesthe chemical properties of the atom, which have been the subject up until now, while theprocesses primarily within the nucleus give rise to the nuclear concerns which will beaddressed next Although the nucleus is very complex, for the present purposes an atom of agiven element may be considered to have a fixed number of positive protons in the nucleus,equal in number to the numb er of electrons around the neutral atom, but can differ in thenumber of neutral neutrons, the different forms being called isotopes It is the property of theunstable forms, or radioisotopes, to emit radiation which makes them useful, since theirchemical properties are essentially identical to the stable form of the element (where a stableform exists; for elements with atomic numbers greater than that of bismuth, there are no

©2000 CRC Press LLC

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completely stable forms) The radia tion which the radioisotopes emit allows them to bedistinguished from the stable forms of the element in an experiment There are three types ofradiation normally emitted by various radio i s o t o p e s , a l p h a (α) particles, electrons (β), andgamma rays (γ) The properties of these radiations will be discussed later A fourth type ofradiation, neutrons, may be emitted under special circumstances, by a small number ofradioactive materials Most laboratories will not use materials emitting neutrons Theproperties of these radiations will be discussed in more detail later.

B Radiation Concerns

The radiation which makes radioisotopes useful also makes their use a matter of concern

to the users and the general public Exposure to high levels of radiation is known t o c a u s ehealth problems; at very high levels, death can follow rapidly A t lower, but still substantiallevels, other health effects are known to occur, some of which, including cancer, can bedelayed for many years A t very low levels, knowledge of the potential health effects is muchmore uncertain The generally accepted practice currently is to extrapolate statistically knowneffects on individuals exposed to higher levels to large groups of persons exposed to lowlevels of radiation in a linear fashion The concept is similar to the u s e of higher concen-trations of chemicals using a limited number of animals in health studies of chemical effects,instead of more normal concentrations in a very large number of t e s t animals There are somewho question the validity of this assumption in both cases, but it is a conservativeassumption and, in the absence of confirmed data, is a generally safe cours e of action tofollow However, the practice may have led to a misleading impression of the risks of manymaterials W h e n a scientist makes the statement that he does not know whether a givenmaterial is harmful or not, he is often simply stating in a very h o n e s t way that the data do notclearly show whether, at low levels of use or exposure, a harmful effect will result It does notnecessarily imply, as many assume, that there is a lack of research in discovering possibleharmful effects In many cases, major efforts have been made to unambiguously resolve theissue, as in the c a s e of radiation, and the data do not support a definite answer There arelevels of radiation below which no harmful effects can be detected directly In the case ofradiation, there is even a s u b s tantial body of experimental data (to which proponents of aconcept called “hormesis” call attention) that supports possibly positive effects of radiation

at very low levels This position is, of course, very controversial However, in chemical areasthere are many examples of chemicals essential to health in our diets in trace amounts that arepoisonous at higher levels It is not the intent of this section to attempt to resolve the issue ofthe effects of low-level radiation, but to emphasize that there are concern s b y m a n yemployees and the general public It may well be that, by being very careful not to go beyondknown information, scientists have actually contributed to these concerns Another way oflooking at the issue, and certainly a more comforting way, is that many unsuccessful attemptshave been made to demonstrate negative effects at low levels Radiation levels whichnormally accompany the u s e of radioisotopes are deliberately kept low, and the perception ofrisk by untrained individuals may be overstated However, a linear dose-effect relation is theaccepted basis for regulatory requirements at this time, and until better data are availablescientists u s ing radioactive substances must conform to the standards Users owe it tothemselves and the public to use the materials in ways known to be safe However, as ageneral concept, it would be wise for scientists, when speaking to persons not trained in theirfield, to be sure that when they say they do not know of possible harmful effects of anymaterial, that this s tatement is understood to be an informed uncertainty where this is thecase, as opposed to being based on a lack of effort

It is unfortunate that there is s o much concern about radiation sin ce there are manybeneficial effects, but because of the dramatization of the concerns, many individuals fearradiation out of all proportion to any known risks In an opinion poll in which members of the

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general public were asked to rank the relative risks of each of a number of hazards, nuclear

radiation was ranked highest but in reality, was the least dangerous of all the other risks

based on known data with all the others being much more likely to cause death or injury thanradiation Individuals who urgently have needed X-rays, the application of diagnostic u s e ofradioactive materials, or radiation therapy have declined to have them because of thisheightened fear Used properly, radiation is an extremely valuable research tool and has manybeneficial aspects Used improperly, it can be dangerous, but so can many other things in thelaboratory, many very much more so

The acknowledgment of natural sources of radiation is not intended to minimize concernsabout radiation, even the natural forms, but to point out that if there are concerns about lowlevels of radiation, then these natural levels must be considered as well as the artificialsources One of the naturally occurring radioactive materials, radon, has been receiving muchattention and may be a significant hazard, perhaps contributing to an increase of 1 to 5% ofthe number of lung cancer deaths each year This estimate, as in most cases dealing withattribution of specific effects of low levels of radiation, is supported by some and disputed byothers Note, however, that even in this case at least 95 to 99% of the lung cancer deaths areattributable to other causes Radon as an issue will be discussed in a separate section later inthis chapter A n isotope of potassium, an essential element nutritionally and present insubstantial amounts in citrus fruits and bananas, for example, emits significant amounts ofvery penetrating radiation

There are various estimates of the average source of radiation exposure for most viduals A n article by Komarov,1 who is associated with the World Health Organization,provides the following data about sources of radiation: 37% from cosmic r a y s a n d t h eterrestrial environment, 28% from building materials in the home, 16% from food and water,12% from medical usage (primarily X-rays), perhaps 4% from daily color television viewing,2% from long-distance airplane flights, and 0.6% (under normal operating conditions) fromliving near a nuclear power plant Note that the medical exposure to radiation is 20 timeslarger than from nuclear power plants even for those living near one The Komarov article waswritten before the Chernobyl incident, but even this outstanding example of poor

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indi-management is not sufficient to change the general picture Unlike the Chernobyl reactor,commercial nuclear power plants in the United States are protected by very strongconfinement enclosures to prevent unscheduled releases In the case of the Three-Mile Islandincident, in which the reactor core melted down, the confinement enclosure performed asdesigned and minimal amounts of radioactive material were released As the news mediareported some time after the initial furor, “the biggest danger from Three-Mile Island waspsychological fear,” to which the media contributed significantly by exaggerated newsreports of the potential dangers.

In summary, radiation is a valuable research tool In order to prevent raising publicconcerns and perhaps lead to further restrictions on its use, scientists need to be scrupulous-

ly careful to conform to accepted standards governing releases or over exposures nately, for common uses of radiation in research laboratories, this goal is easily achieved withreasonable care

Fortu-D Basic Concepts

Each scientific discipline has its own special terms and basic concepts on which it isfounded This section is, of course, not necessary for most scientists who routinely work withradiation, but it may be useful for establishing a framework within which to define someneeded terms As scientists work with accelerators of higher and higher energies, the concept

of matter is at once growing more complex and simpler; more complex in that more entities areknown to make up matter, but simpler in that theorists working with the data generated bythese gigantic machines are developing a coherent concept unifying all of the information.For the purposes of this discussion, a relatively simple picture of the atom will suffice, asnoted earlier

1 The Atom and Types of Decay

In the simple model of the atom employed here, as briefly described earlier in this chapter,the atom can be thought of as consisting of a very small dense nucleus, containing positivelycharged particles called protons and neutral particles called neutrons, surrounded by a cloud

of negatively charged electrons The number of protons and the number of electrons are equalfor a neutral atom, but the number of neutrons can vary substantially, resulting in differentforms of an element called, as already noted, isotopes of the element Some elements haveonly one stable isotope, although tin has ten There are unstable isotopes, logically calledradioisotopes, in which, over a statistically consistent time, a transition of some type occurswithin the nucleus Different types of transitions lead to different types of emitted radiation.Hydrogen, for example, has two stable forms and one unstable one, in which a transitionoccurs to allow an electron to be generated and emitted from the nucleus, producing a stableisotope of helium Prior to the transition, the electron did not exist independently in thenucleus A neutron is converted to a proton in the process, and the electron is created by atransformation of energy into matter This process is called beta decay No element with morethan 83 protons in the nucleus has a completely stable nucleus, although some undergotransitions (including by processes other than beta decay) extremely slowly

In s o me cases, the mass energy of the nucleus favors emission of a positive electron(positron) instead of a normal electron which has a negative charge This is called positivebeta decay or positron decay Here a proton is converted into a neutron A competitiveprocess to positive beta decay is electron capture (ε) in which an electron from the electroncloud around the nucleus is captured by the nucleus, a proton being converted into anneutron in the process In the latter process, X-rays are emitted as the electrons rearrangethemselves to fill the vacancy in the electron cloud However, following positron emission,

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the positive

Table 5.1 Properties of Radioactive Emissions

X-Rays 0 0 eVs-100 KeV

An amu is the mass of a single nucleon based on the 1/12th the mass of a carbon-12 nucleus.

electron eventually interacts with a normal electron in the surrounding medium, and the twovanish or annihilate each other in a flash of energy The amount of energy is equal to theenergy of conversion of the two electron masses according to E = mc2 This amounts to, inelectron volts, 1.02 million electron volts, or 1.02 MeV In order to conserve momentum, twophotons or gamma rays of 0.511 MeV each are emitted 180" apart in the process

In many case, the internal transitions accompanying adjustments in the nucleus results inthe emission of electromagnetic energy, or gamma rays These can be in the original or parentnucleus, in which case they are called internal transitions, and the semi-stable states leading

to these transitions are called metastable state s More often, the gamma-emitting transitionsoccur in the daughter nucleus after another type of decay such as beta decay (metastablestates can exist in the daughter nucleus also) The gamma emission distribution can be verycomplex In some instances, the internal transition energy is directly transferred to one of theelectrons close to the nucleus in a process called internal conversion, and the electron isemitted from the atom In this last case, energy from transitions in the orbital electron cloud isalso emitted as X-rays

Finally, the most massive entity normally emitted as radiation is the alpha (a) particlewhich consists of a bare (no electrons), small nucleus having two protons and two neutrons.The nucleons making up an alpha particle are very strongly bound together, and unlikeelectrons, the alpha particle appears to exist in the parent nucleus as a cohesive unit prior tothe decay in our simple model This process is somewhat more rare than β or γ decay

The processes briefly described above are the key decay processes in terms of safety inthe u s e of radioisotopes There is another very important aspect of the decay processes, andthat is the energy of the emitted radiation The electrons emitted in beta decay can haveenergies ranging from a few eV to between 3 and 4 MeV There is an unusual feature of thebeta decay process in that the betas are not emitted monoenergetically from the nucleus asmight be expected, and as does occur for alpha and gamma decay The most probable energy

of the betas in a decay process is approximately one third of the maximum energy beta emitted

in the process The reason is that, in addition to a beta being emitted, another particle, called aneutrino, of either zero mass or very close to it, is emitted simultaneously and shares thetransitional energy, with varying amounts going to the two entities The neutrino does notplay a role in radiation safety as it interacts virtually negligible with matter, although itsexistence is very important for many other reasons Gammas can have a similar range ofenergies to that of electrons, but the energies of the gammas are discrete instead of adistribution

Alpha particles have a relatively high energy, normally ranging from 4 to 6 MeV Thedecay of alphas with lower energies is so slow that it occurs very rarely while with an energyjust a little higher, the nucleus decays very rapidly The high energy, accompanying the highmass and the double positive charge, make the alpha particle a particularly dangerous type ofradiation, if it is emitted in the proximity of tissue which can be inj u r e d T h i s l a s t i s a nimportant safety qualification as will be seen later Table 5.1 summarizes the properties of the ©2000 CRC Press LLC

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types of radiation.

Graphically the decay process can be depicted as shown in Figure 5.1, where N = theneutron number and Z = the nuclear charge The box with N,Z is the parent nucleus and theothers are the possible daughters for the processes shown

2 The Fission Process

A major omission deliberately not mentioned in the preceding Section is not involved inmost laboratories using radioisotopes However, without this process many of the commonlyused radioisotopes would not be available, since they are obtained from reprocessing spentfuel and recovery of the remnants left over after the fission process The process of fissiondescribes the process by which a few very heavy atoms decay by splitting into two majorcomponents and a few neutrons, accompanied by the release of large amounts of energy,

~200 MeV The process can be spontaneous for some very heavy elements, e.g.,

Californium-252 but also can be initiated by exposing specific heavy nuclei to neutrons There are nocommon radioisotopes that normally emit neutrons, but there are several interactions in which

a neutron is generated Among these are several reactions in which a gamma ray interactswith beryllium to yield neutrons, s o that a portable source of neutrons can be created Thereare many other ways to generate neutrons but there is no need to describe these in this book.However, if a source of neutrons, n, is available and is used to bombard an isotope ofuranium, 235U, the following reaction can occur

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n + 235U -> X+Y + ~2.5n + energy (1)Here, X and Y are two major atomic fragments or isotopes resulting from the fissionprocess On average about 2.5 neutrons are emitted in the reaction plus energy The process

is enhanced if the initiating neutrons are slowed down until they are in or near thermalequilibrium with their surroundings X and Y themselves will typically decay after the originalfission event, a few by emitting additional neutrons, as well as betas and gammas A s notedearlier, about 200 MeV of energy are released in the process, much of it as kinetic energyshared by the particles Some of these fission fragments are long lived, and can be chemicallyseparated to provide radioisotopes of u s e in the laboratory These fission fragment derivedradioisotope s are the major source of the byproduct radioisotopes regulated by the NuclearRegulatory Commission (NRC) The fission reaction can, under appropriate circumstances, beself-sustaining in a chain reactio n In some configurations, the chain reaction is extremelyrapid, and an atomic bomb is the result However, by using the neutrons emitted by thefission fragments (called delayed neutrons), the process can be controlled safely in a reactor.Over a period of time, the fission products build up in the uranium fuel eventually can berecovered when the fuel element is reprocessed

Additional radioactive materials or radioisotopes are made by the following reaction:

n +AX-> (A+1)y* + a (2)

The asterisk indicates that the product nucleus, Y may be unstable and will undergo one(or more) of the modes of decay discussed previously The 'a’ indicates that there may be aparticle directly resulting from the reaction In many cas es, the source of neutrons forradioisotopes created by this reaction is a nuclear reactor s o these radioactive materials alsoare “byproduct materials, ” and are regulated by the Nuclear Regulatory Commission or Statesurrogates

Plutonium is made in nuclear reactors by the above reaction where 238U is the targetnucleus Although there are other reactions using different combinations of particles inEquation 2, in most cases these require energetic bombarding particles generated in accelera-tors Also, since there are no common radioisotopes that generate neutrons, there isessentially no probability that other materials in laboratories will be made r a d i o a c t i v e b yexposure to radiation from byproduct materials

Materials which will undergo fission and can be used to sustain a chain reaction are, inthe nomenclature of the NRC, “special” nuclear materials These inclu d e t h e i s o t o p e s o furanium with mass numbers 233 and 235, materials enriched in these isotopes, or theartificially made element, plutonium Materials which have uranium or thorium, which also has

a fissionable isotope, in them to the extent of 0.05% are called source materials

3 Radioactive Decay

A n important relationship concerning the actual decay of a given nucleus is that it ispurely statistical, dependent only upon the decay constant for a given material, i.e., theactivity A, is directly proportional to the number, N, of unstable atoms present:

Activity = A = dN/dt = C N (3)This can be reformulated to give the number of radioactive atoms N at a time t in terms ofthe number originally present

N(t) = N0e8t (4)

©2000 CRC Press LLC

~

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where λ = ln2/τ.

Table 5.2 Typical Decay of a Group of 1000 Radioactive Atoms

Equation 4 shows that during any interval, t = τ, theoretically half of the unstable nuclei at

the beginning of the interval will decay I n p r a c t i c e , approximately half will decay in a

half-life, τ This is illustrated in Table 5.2

The data in this table illustrate clearly that when small numbers are involved, the statisticalvariations cause the decrease to fluctuate around a decay of about one half of the remainingatoms during each successive half-life, but obviously between 3 and 4 half-lives in this table,

it would have been impossible to go down by precisely half The table also illustrates afairly often used rule-of-thumb: after radioactive waste has been allowed to decay by 10 half-lives, the activity has often decayed sufficiently to allow safe disposal This, of course,depends upon the initial activity

The daughter nucleus formed after a decay can also decay as can the second daughter,and s o forth However, eventually a nucleus will be reached which will be stable This is, infact, what occurs starting with the most massive natural elements, uranium and thorium All oftheir isotopes are unstable, and each of their daughters decays until eventually s t a b l e i s o -topes of lead are reached The existence of all of the elements above atomic number 83 owetheir existence to the most massive members of these chains that have very long half-livesthat are comparable to the age of the earth, so a significant fraction remains of that initiallypresent

4 Units of Activity

The units of activity are dimensionally the number of decays or nuclear disintegr a t i o n sper unit time Until fairly recently, the standard unit to measure practical amounts of activitywas the curie (Ci), which was defined to be 3.7 x 1010 disintegrations per second (dps) Otherunits derived from this were the millicurie (mCi) or 3.7 x 107 d p s , the microcurie (µCi) or 3.7 x

104 d p s , the nanocurie (nCi) or 37 dps and the picocurie (pCi) or 0.037 dps Many healthphysicists prefer to u s e disintegrations per minute (dpm), and the NRC also prefers the datalogged in laboratory surveys to be expressed in dpm The curie was originally supposed toequal the amount of activity of 1 g of radium This unit, and the derivative units, are still theones most widely used daily in this country; however, an international system of units, or SIsystem, has been established (and is used in s cientific articles) In this system, onedisintegration per second is defined as a becquerel (Bq) Larger units, which are multiples of

103, 106, 109, and 1012, are indicated by the prefixes kilo, mega, giga, and tera, respectively Inmost laboratories that u s e radioisotopes as tracers, the quantities used are typically about 104

to 108 dps There are other uses of radioisotopes (e.g., therapeutic use of radiation) which usemuch larger amounts

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A n alpha particle is said to have a high linear energy transfer (LET) A typical alpha particlehas a range of only about 0.04 mm in tissue or about 3 cm in air The thickness of the skin isabout 0.07 mm so that a typical alpha particle will not penetrate the skin However, if a materialthat emits alphas is ingested, inhaled, or, in an accident, becomes imbedded in an open skinwound, s o that it lodges in a sensitive area or organ, the alpha radiation can cause severelocal damage Since many heavier radioactive materials emit alpha radiation, this often makesthem more dangerous than materials that emit other types of radiation, especially if they arechemically likely to simulate an element retained by the body in a sensitive organ If they arenot near a sensitive area, they may cause local damage to nearby tissue, but this may notcause appreciable damage to the organism as a whole.

b Betas

Beta particles are energetic electrons They have a single negative or positive charge andare the same mass as the electrons around the atoms in the material through which they aremoving Normally, they also are considerably less energetic than an alpha particle Theytypically may move about two orders of magnitude more rapidly than alpha particles Theystill interact with matter by ionization and excitation of the electrons in matter, but the rate ofinteraction per unit distance traveled in matter is much less Typically, beta radiation, on theorder of 1 MeV, can penetrate perhaps 0.5 cm deep into tissue, or about 4 meters of air,although this is strongly dependent upon the energy of the beta Low-energy betas, such asfrom 14C, would penetrate only about 0.02 cm in tissue or about 16 cm in air Therefore, onlythose organs lying close to the surface of the body can be injured by external beta irradiationand then only by the more energetic beta emitters Radioactive materials emitting betas takeninto the body can affect tissues further away than those that emit alphas, but the LET is muchless

There is a secondary source of radiation from beta emitters As the electrons pass throughmatter, they cause electromagnetic radiation called “bremstrahlung,” or braking radiation to beemitted as their paths are deflected by passing through matter The energy that appears asbremstrahlung is approximately ZE/3000 (where Z is the atomic charge number of t h eabsorbing medium and E is the β energy in MeV.) This is not a problem with alpha particlessince their paths through matter are essentially straight Bremstrahlung radiation can haveimportant implications for certain energetic beta emitters such as 32P Protective shielding forenergetic beta emitters should be made of plastic or other low-Z material instead of a high-Zmaterial such as lead Because of the silicon in glass, even keeping 32P in a glass containercan substantially increase the radiation d o s e to the hands while handling the material in thecontainer as compared to the exposure that would result were bremstrahlung not a factor

c Gammas

Since gamma rays are electromagnetic waves, they are not charged and do not have anymass, they interact differently with matter than do alpha and beta particles, although the neteffect is usually still ionization of an orbital electron They interact with the electrons in matter

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by three different mechanisms In order to provide an understanding of the safetyimplications, a brief elaboration of these mechanisms follows Until one of the three processestakes place, the gamma ray can continue to penetrate matter without hindrance.

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as would a beta.

ii Compton Effect

The gamma ray can also scatter from an electron, transferring part o f i t s e n e r g y t o t h eelectron and thus becoming scattered as a lower energy gamma There is an upper limit to theamount of energy that can be transferred to the electron by this mechanism, so that in everyscattering event, a gamma ray remains after the interaction Dependent upon the energytransferred, the res idual gamma can be scattered in any direction, relative to the originaldirection, up to 180" This has important implications on shielding, since gammas can bescattered by the shielding itself, or by other nearby materials into areas shielded by a directbeam Equation 5 gives the energy of the scattered gamma as a function of the angle ofscattering The interaction with matter is considerably less dependent upon the energy of thegamma This is shown in Figure 5.3 Compton scattering is the primary mechanism ofinteraction for low atomic number elements, and decreases in relative importance as the atomicnumber increases

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iii Pai r Production

If the energy of the gamma is greater than the energy needed to create an positron pair, 1.02 MeV, then the gamma can interact with the absorbing medium to create thepair of electrons, an electron and a positron The probability of this process increases as theenergy increases The excess energy over 1.02 MeV is shared by the two p a r t i c l e s T h eincreases with the atomic number of the absorber, approximately proportionally to Z2 + Z.Gamma rays can penetrate deeply into matter, in theory infinitely, since unless the gammainteracts with an atom, it will go on unimpeded, just as in theory a rifle bullet fired into a forestcan continue indefinitely unless it hits a tree (assuming no loss of energy for the bullet due toair friction) The intensity I of the original radiation at a depth x in an absorbing mediumcompared to the intensity of the radiation at the surface I is:

I = I0e-:x (6)This equation is literally true if only gammas of the original energy are considered IfCompton scattering and the pair-production proces s are included, the decrease in the totalnumber of gammas is less than that given by Equation 6, because of the scattered gammasfrom the Compton process, and the contribution of the annihilation gammas as the positro neventually is destroyed by interacting with a normal electron The actual increase in theradiation levels is dependent on the gamma energy and the geometry of the scatteringmaterial

If the total effect of all three mechanisms is considered at low and high energies, higher Z

o

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Figure 5.4 Pair-production coefficient for lead as a function of

energy.

absorbers interact with gammas more strongly However, between about 1 and 3 MeV

is a relatively minor difference in the total absorption coefficient as a function of atomicnumber as shown in Figure 5.5 The discontinuities at lower energies are due to enhancedprobability of interactions with electrons at the ionization thresholds

A s can be noted, all of the mechanisms by which a gamma interacts with matter (exceptthe very small number of instances in which the gamma ray interacts with a nucleus) result inthe energy being transferred to an electron, s o a gamma is considered to have the same lowLET characteristics as do betas At very low energies the linear energy transfer characteristics

of electrons increase some However, unless a beta emitter is taken into the body, mostinternal organs will not be affected by beta radiation, while gammas can penetrate deeply intothe body and injure very sensitive organs such as the blood-forming t i s s u e s T h u s , o f t h ethree types of radiation, gamma rays are usually considered the most dangerous for externalexposures

iv Neutrons

As mentioned earlier, neutron radiation is rarely encountered in most laboratories that u s eradioisotopes in research programs However, it is useful to understand the difference in themechanisms by which a neutron interacts with matter compared to those involving other

types of radiation since neutron radiation may make the matter with which it interacts

radioactive The neutron has no charge, but it does have about one fourth of the mass of analpha particle, s o that it does have an appreciable mass compared to the atoms with which itinteracts

A n equation similar to Equation 6 gives the number of neutrons N, with an initial energy

E, of an original number N0 penetrating to a depth x in matter Note that in both Equations 6and 7, the units of x are usually converted into mg/cm2 for the commonly tabulated values of

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Figure 5.5 Total mass attenuation coefficient for ( absorption in lead as a

Scattering events also typically would transfer enough energy to break the chemicalbonds as long as the initial energy of the neutron is sufficiently high As with Comptonscattered gammas, the scattered neutrons can be scattered into virtually any direction, so thatthe equiv alent of Equation 7 for neutrons of all energies would, as for gammas, have to bemodified to include a buildup factor

No figure showing the systematics of the reaction mechanisms will be given here becausethe relationship s are extremely complex, varying widely not only between elements, butbetween isotopes of the same element In addition, the interaction probabilities can varyextremely rapidly as a function of energy, becoming very high at certain “resonant” energiesand far less only a few electron volts above or below the resonances However, a few

x

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generalizations are possible The probability of the capture process, excluding resonanceeffects, typically increases as the energy of the neutrons become lower, and for specificisotopes of certain elements, such as cadmium, gadolinium, samarium, and xenon, is extremelyhigh at energies equivalent to thermal equilibrium (about 0.025 eV for room temperaturematter) Energy can be lost rapidly by neutrons in scattering with low-Z materials, such ashydrogen, deuterium (2H), helium, and carbon Interposing a layer of water, paraffin, orgraphite only a few inches thick, backed up by a thin layer (about 1/32 inch) of cadmium, in abeam of fast neutrons makes an effective shield for a beam of neutrons Paraffin wax, in whichboric acid has been mixed also makes an effective and cheap neutron

shield (10B has quite a respectable capture cross-section at thermal neutron energies)

Overall, the estimate of the danger of neutrons interacting with matter is estimated to beabout ten times that of a gamma or electron, although this varies depending upon the energy

of the neutrons, thermal neutrons are about two times as effective in causing atoms in tissue

to be ionized, for example, as are betas and gammas while neutrons of 1 to 2 MeV energy areabout 11 times more damaging

6 Units of Exposure and Dose

There are two important concepts in measuring the relative impact of radiation on matter:one is the intensity of the radiation field, which represents a potential exposure problem, andthe other is the actual energy deposited in matter, or the dose Further, as far as human safety

is concern ed, the amount of energy absorbed in human tissue is more important than thatabsorbed in other types of matter Each of these quantities have been assigned specific units

in which they are measured

The original unit of measuring radiation intensity was the roentgen, defined as the amount

of X-ray radiation that would cause an ionization of 2.58 x 10-4 coulombs per kilogram of dryair at standard temperature and pressure As noted, the dose or energy deposited in matter ismore important, so another unit was subsequently defined, the rad, which was defined as thedeposition of 0.01 joules per kilogram of matter An exposure to 1 roentgen would result in anabsorbed d o s e of 0.87 rads in air A third unit, the rem, was subsequently defined whichmeasured the equivalent dose, allowing for the relative effectiveness of the various types ofradiation in causing biological damage This originally was allowed for by multiplying theabsorbed d o s e in rads by a relative biological effectiveness factor (RBE), to obtain a doseequivalent for tissue for the different varieties of radiation Later, it was decided to restrict theterm RBE to research applications and an equivalent multiplier called the quality factor, Q, wassubstituted For practical purposes, RBE and Q factors are equivalent, although the latter isthe one now commonly used

The terms rads and rems are still used by most American health physicists in their dailywork, and the current NRC regulations use these terms, as they do the curie and its derivativeunits However, there are internationally accepted SI units for d o s e and also for activity Theequivalent units are:

1 Gray (Gy) = 1 joule/kilogram = 100 rad = absorbed dose

1 Sievert (Sv) = 1 Gray x Q x N = do s e equivalent (N is a possible modifying factor, assigned a value of 1 at this time)

1 Sievert = 100 rem = dose equivalent

The quality factors for the various types of radiation are listed in Table 5.3 For neutrons

of specific energies, the quality factor can be found in 10 CFR 20, Table 1004

This concludes this very brief discussion of some basic terms and concepts in radiationphysics that will be employed in the next few sections Many important points and significantfeatures have been omitted that would be of importance primarily to professional health

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Table 5.3 Quality Factors Type of Radiation

physicists, but are of less importance to those individuals that use radiation as a research tool

to serve their more direct interests The role of the Nuclear Regulatory Commission will beheavily stressed because the NRC very strictly regulates all aspects of radiation involvingspecial nuclear materials and byproduct materials for safety and security through its licensingand oversight functions

E Licensing

This section will be restricted to a discussion of licensing of radioisotopes or byproductmaterials, rather than other types of applications such as a research reactor It has been sometime since any new applications for construction of a nuclear power plant in the United Stateshas been approved, and the number of operating non-governmental research reactors hasbeen diminishing Several of these research facilities are either in the process of terminatingtheir license or going into an inactive status At least some research reactors have closedrather than renew their license, as they must do periodically, because of excessive costsneeded to meet the concerns of the public The other major type of facility involved withradiation, laboratories using X-ray units, are usually regulated by state agencies, although thefederal Food and Drug Administration sets standards for the construction of the machinesand their applications X-ray facilities will be discussed in a separate section

Radioactive materials fall into two classes as far as regulation is concerned Radioactivematerials “yielded in or made radioactive by exposure to the radiation incident to the process

of producing or utilizing special nuclear material” are regulated by the NRC, or by equivalentregulations in states with whom the NRC has entered into an agreement allowing for thestates to act as the regulatory agency within their borders Radioactive materials that arenaturally radioactive or produced by means such as a cyclotron are regulated by the states inmost cases

The licensing of byproduct material is regulated under 10 CFR Part 30 or 33 Licenses areissued to “persons,” a term which may refer to an individual but may also mean organizations,groups of persons, associations, etc It is possible for individuals within an organization tohave separate licenses, although it is more likely that instead of several ind i v i d u a l s h a v i n gseparate licenses, an institution will apply for and be granted a license covering the entireorganization, if they can show that they have established an appropriate internal organization

s o that they can ensure the NRC that the individual users will conform to the terms of thelicense and regulations governing the use of radioactive materials This second class oflicenses is denoted as a byproduct license of broad scope There are different

types of broad licenses, A, B, and C A type A license is the least restriction and allows users

to use radioisotopes as allowed in 10 CFR 30.100 Schedule A A type B license is for users oflarger quantities of various radioisotopes, on the order of curies or more, and a type C license

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Office of Nuclear Material Safety and Safeguards

U.S Nuclear Regulatory Commission

Washington, D.C 20555

Not all uses of radioisotopes require securing a license There are many commercialproducts, such as watch dials and other self-luminous applications, and some types of smokedetectors that contain very small quantities of radioactive materials which the ownerobviously does not require a license to possess However, those who take advantage ofexemptions must u s e no more than the “exempt quantities” listed in Schedule B, 10 CFRSection 30.71 In Table 5.4, the units are in microcuries To convert to becquerels, multiplythe number given in microcuries by 37,000

Any byproduct material that is not listed in Table 5.4, other than aipha-emitting byproductmaterial, has an exempt quantity of 0.1 :Ci or 3700 Bq

M o s t users of radioisotopes would find it necessary to use more than the exemptquantities in Table 5.4 and should apply for a license This is done through NRC Form 113,which can be obtained from the NRC office in the local region If the activity planned has thepotential for affecting the quality of the environment, the NRC will weigh the benefits againstthe potential environmental effects in deciding whether to issue the license For mostresearch-related uses of radioisotopes, environmental consid erations will not usually apply,although where the isotopes will be used in the field, outside of a typical laboratory, theconditions and restrictions on their use to ensure that there will be no meaningful release intothe environment will need to be fully included in the application

There are three basic conditions that the NRC expects the applicant to meet in their plication In this context, “applicant” is used in the same s e n s e as the word “person,” whichcan be an individual or an organization, as noted earlier

ap-1 The purpose of the application is for a use authorized by the Act Legitimate basic andapplied research programs in the physical and life sciences, medicine, and engineeringare acceptable programs

2 The applicant*s proposed equipment and facilities are satisfactory in terms of ing the health of the employees and the general public, and being able to minimize therisk of danger to persons and property The laboratories in which the radioisotopes are

protect-to be used need protect-to be in good repair and contain equipment suitable for use withradioisotopes Depending upon the level of radioactivity to be us ed and the scale ofthe work program, this may mandate the availability of hoods designed for radio-isotope use It could require specific areas designated and restricted for i s o t o p e u s eonly, or the level of use and the amounts of activity may make it feasible to perform theresearch on an open bench in a laboratory In any event, it must be shown in theapplication that the level of facilities and equipment must be adequate for theproposed uses of radiation

3 The applicant must be suitably trained and experienced so as to be qualified to use thematerial for the purpose requested in a way that will protect the health of individuals

a nd minimize danger to life and property The experience and training mus t b e

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documented in the application.

Following are the specific NRC requirements for approval of a Type A, Broad License.The requirements for Type B and C licenses are a bit less stringent Most major users will findthat complying with the terms of Type A licenses to be most appropriate

“An application for a Type A specific license of broad scope will be approved if:

(b) The applicant satisfies the general requirements specified in Sec 30.33;

(b) The applicant has engaged in a reasonable number of activities involving the use ofbyproduct material; and

(c) The applicant has established administrative contro ls and provisions relating toorganization and management, procedures, record keeping, material control, andaccounting and management review that are necessary to as sure safe operations,including:

(1) The establishment of a radiation safety committee composed of such persons as aradiological safety officer, a representative of management, and persons trainedand experienced in the safe use of radioactive materials;

(2) The appointment of a radiological safety officer who is qualified by trainin g a n dexperience in radiation protection, and who is available for advice and assistance

on radiological safety matters; and

(3) The establishment of appropriate administrative procedures to assure:

(i) Control of procurement and use of byproduct material;

(ii) Completion of safety evaluations of proposed uses of byproduct materialwhich take into consideration such matters as the adequac y of facilities andequipment, training and experience of the user, and the operating or handlingprocedures; and

(iii) Review, approval, and recording by the radiation safety committee of safetyevaluations of proposed uses prepared in accordance with paragraph (c)(3)(ii) of this section prior to use of the byproduct material.”

Under item(3)(iii) the Radiation safe ty Committee also approves individual users ifradioisotopes under the Broad License In effect, they act as a local NRC governing use ofthe radioisotopes

Before granting the license, the NRC may require additional information, or may requirethe application to be amended The license is issued to a specific licensee and cannot betransferred without specific written approval of the NRC The radioisotopes identified in thelicense can be used only for the purposes authorized under the license, at the locationsspecified in the license If the licensee wishes to change the isotopes permitted to be used, to

s ignificantly modify the program in which they are used, or to change the locations wherethey are to be used, the license must be amended This typically takes a substantial length oftime, 1 to 3 months or even more not being unusual Consequently, most substantial users ofradioisotopes usually do apply for a “broad” license under 10 CFR Part 33

Under the terms of a broad license, the application usually covers a request to use dioisotopes with atomic numbers from 3 to 83, with individual limits on the quantities held ofspecific isotopes, and an overall limit of the total quantity of all isotopes held at once Inaddition, there should be specific identification of sealed sources held separately by theapplicant on the license

ra-The license will be granted for a specific period, and the ending date will be written intothe license If the licensee wishes to renew the license as the end of the license periodapproaches, the applicant must be sure to submit a renewal request at least 30 days before theexpiration date of the license If this deadline is met, the original license will remain in forceuntil the NRC acts on the request This may take some time During unusual periods when the

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Nickel 63 10 Nickel 65 100

NRC was under heavy work loads, it has taken over a year for action to take place

Table 5.4 Exempt Quantities

Byproduct Material

:Ci

Byproduct Material

:Ci

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ask the licensee to s h o w that s ecurity of radioactive material in the laboratory areas is notcompromised.

Under Section 30.51, records of all transfers, receipts, and disposal of radioactive materialsnormally must be kept for at least 2 years after transfer or disposal of a radioactive material, or

in some cases until the NRC authorizes the termination of the need to keep the records Thereare other record keeping requirements in other parts of Title 10

If for any reason there is a desire to terminate the license on or before the expiration date,Under 10 CFR 30.36 there are procedures that must be followed

1 Terminate the use of byproduct material

2 Remove radioactive contamination to the extent practicable (normally to backgroundlevel, see 5 below)

3 Properly dispose of byproduct material

4 Submit a completed Form NRC-314

5 Submit a radiation survey documenting the absence of radioactive contamination, orthe levels of residual contamination In the latter case, an effort will be required toeliminate the contamination

a The instruments used for the survey must be specified and then certified to beproperly calibrated and tested

b The radiation levels in the survey must be reported as follows:

(1) Beta and gamma levels in microrads per hour at 1 cm from the surface, andgamma levels at 1 meter from the surface

(2) Levels of activity in microcuries per 100 cm2 of fixed and removable surfacecontamination

(3) Microcuries per rub in any water

(4) Picocuries per gram in contaminated solids and soils

6 If the facility is found to be uncontaminated, the licensee shall certify that no tectable radioactive contamination has been found If the information provided isfound to be sufficient, the NRC will notify the licensee that the license is terminated

de-7 If the facility is contaminated, the NRC may require an independent survey acceptable

to the NRC The license will continue after the normal termination date However, the

u s e of byproduct materials will be restricted to the decontamination program andrelated activities The licensee must submit a decontamination plan for the facility.They must continue to control entry into restricted areas until they are suitable forunrestricted use, and the licensee is notified in writing that the license is terminated

In principle, the NRC has the right to modify, suspend, or revoke a license for a facilitythat is being operated improperly or if the facility were to submit false information to the NRC

If the failure to comply with the requirements of the license and other requirements for safelyoperating a facility can be shown to be willful or if the public interest, health, or safety can beshown to demand it, the modification, suspension, or revocation can be done withoutinstitution of proceedings which would allow the licensee an opportunity to demonstrate orachieve compliance

Normally, an inspection will be followed up with a written report by the inspector in which

a ny compliance problems will be identified These may be minimal, serious (whic h w o u l drequire immediate abatement), or graduated steps between these two extremes The facilitycan (1) appeal the findings and attempt to show that they were complying with theregulations or that the violation was less serious than the citation described or (2) accept thefindings Unless the facility can s h o w complia nce, it must show how they will bring the

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facility into compliance within a reasonable period.

In recent years, there have been increasing numbers of occasions when the NRC hasimposed substantial financial penalties on research facilities, including academic institutions,

as they are entitled to do under Section 30.63, for violations that are sufficiently severe.Further, a few years ago, one city filed 179 criminal charges against a major univer s i t y a n dseveral of its faculty members for failure to comply with radiation safety standards Manyindividual violations were relatively minor, but apparently the city attorney thought he had asubstantial c a s e for a pattern of failure to comply with the terms of the license and theregulations

The u s e of radioisotopes in research is continuing to increase, while the public concernabout the s afety of radiation continues unabated It behooves all licensees to follow allregulations scrupulously, not only to ensure safety, but also to avoid aggravating theconcerns of the public unnecessarily

1 Radiation Safety Committees

The primary function of the radiation safety committee (RSC), which is required under 10CFR 33, is to monitor the performance of the users of ionizing radiatio n in a facility It is, asnoted earlier, a local surrogate of the NRC or the equivalent state agency in an agreementstate Usually, it is the ultimate local authority in radiation matters In this one area at least, it

is assigned more authority than the usual senior administrative officials It is an operationalcommittee, charged with an important managerial role in the u s e of ionizing radiation withinthe organization, not in directly managing the research program but assuring that the research

is carried out safely Due to this power, the NRC holds the committee responsible forcompliance and will cite the committee and the parent organization for failure to provideappropriate oversight if the radiation users or radiation safety personnel under its supervisionfail to ensure compliance with the regulations

In addition to the responsibility of the RSC to ensure compliance with the provisions ofthe byproduct license and the other regulatory requirements of Title 10 CFR, it also mustestablish internal policies and procedures to guide those wishing to use radiation and toprovide the internal operational structure in which this is done The committee has otherduties as well, which will be discussed after the makeup of the committee is considered.The membership of an RSC should be carefully s e lected It would be highly desirable toselect much of the membership from among the active users of radiation within theorganization and across the major areas or disciplines represented among the users Eachprospective member should be scrutinized very carefully A RSC must enforce regulations set

by one of the strongest regulatory agencies, and it must be fully willing to accept t h edelegated authority Individuals on the committee must be willing, if necessary to establishpolicies that many users may feel are too restrictive As active users themselves, they have abetter chance of achieving compliance if the other users realize that the members of the RSChave accepted imposition of these same policies on their own activities The members of thecommittee should have a reputation for objectivity, fairness, and professional credibility Aprima donna has no place on such a committee

As professional scientists in their own right, the committee members will also understandthe impact of a given procedure or policy on labora tory operations, and can often findlegitimate ways to develop effective policies and procedures that are less burdensome on theusers to carry out than would otherwise be the case

The radia tion safety officer (RSO) of the organization must be part of the RSC, and is aperson who must maintain a current awareness of the rules and regulations required b y t h eNRC and of radiation safety principles This individual will serve to carry out the policies ofthe committee, and should be the individual to do the direct day-to-day monitoring of the

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operations of the laboratories using radioactive material The decisions of the committee can

be burdensome not only on the users, but, without input of the RSO, can be equallyburdensome for this individual to carry out

The working relationship between the RSO and the RSC is extremely important Nocommittee can effectively administer a program of any size on a daily basis It must delegatesome of its authority to a person, such as the RSO, or to an RSO through an alternate agencysuch as a Safety and Health Department charged with the daily administration of the area ofresponsibility assigned to an operational committee However, especially when the RSO is adynamic, effective person there is a tendency to defer to this person and to abrogate some ofthe committee*s oversight responsibility Both the RSC and the RSO should guard againstthis possibility The RSO should have a voice and an influential one in the committee*sdeliberations, but should not be allowed to dictate policies independently

The membership need not be limited to the persons already defined A relatively new NRC

requirement is that a senior management representativ e m u s t b e a n ex officio member of the

committee, and no official meeting can be held should the senior management represent-ativenot be present This individual cannot veto the actions of the committee, but by beingpresent guarantees that higher management is aware of the actions of the committee Thehead of the health and safety department, if different from the radiation safety officer, may be

a member because this individual would bring in a wider perspectiv e t h a n w o u l d t h e R S Oalone on the implications of some issues brought before the committee Some large organi-zations may wish to have a representative of the organization*s legal department as a member.Some may wish to have a representative of the public relations area as a member, especially ifthe facility is in an area in which there has been vigorous public opposition to the use ofionizing radiation Some may wish to include a layperson, if not as a voting member, thenperhaps as an observer, but the number of non-technical persons should not exceed thosewith sufficient technical expertise to fully understand the safety issues The membershipshould not become too large, however, so that it will be practical to set up meetings withouttoo much concern for having a quorum Committees that are too large also tend to be lessefficient, because of the time required for all the members to participate in discussions On theother hand, each major scientific discipline using radiation should be represented Areasonable size might be between 9 and 15 members, with a quorum established at between 5and 8 members

It is essential for the chair of the committ ee to be someone with prior experience withradiation, but it is also highly desirable if the chair is an individual with administrative cre-dentials Such a person will normally ensure that committee meetin g s will be conductedefficiently, but if the administrative experience is at a level carrying budgetary and personnelresponsibilities, the chair will bring still another dimension to the committee Some actions ofthe committee may carry c o s t or manpower implications; an individual with managerialexperience will recognize and perhaps have a feel for the feasibility of accommodating theserequirements

Besides the monitoring of existing programs, establishing polic ies, and providingguidance to radiation safety personnel, there are at least four other important functions thatthe committee must perform The first of these is to perform the same function as the NRC inauthorizing new participants to use radiation or radioactive materials Basically the sameinformation that the NRC requires for new applicants for a license should be required when anew internal facility is involved The adequacy of the facility, the purpose of the program forwhich the u s e of radiation is involved, and the qualifications of the users should all bereviewed A t academic institutions especially there is a considerable turnover in u s e r s ,represented by graduate students, postdoctoral research associates, and even faculty Oftenindividuals come from other facilities where internal practices may differ from local practices

To ensure that all users are familiar with not only the basic principles of radiation safety but

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also with local internal procedures, a simple written test, administered as part of theauthorization procedure, is an effective and efficient means of documenting that theprospective users have familiarized themselves with the information To a v o i d s e t t i n gstandards on who should take the test, it should be administered universally Some faculty orresearchers may object, but it serves an important legal point A passed quiz showsunequivocally that the individual is familiar with the risks and the requirements associatedwith the u s e of radiation at the facility An argument frequently put forward by those whoobject is that they are aware of the properties of the materials with which they are working,and this is undoubtedly true A rebuttal argument, however, is that they probably are not asaware of the details of the NRC regulations with which they must comply and on thecompliance with which they, and the organization, will be judged by an NRC inspector.

A n internal authorization should be issued to an individual Others may be added to theauthorization, but one person should be designated as the local, ultimately responsibleperson, responsible for compliance with applic able safety and legal standards related to theuse of radiation under the authorization In laboratories that involve multiple users, it may benecessary to formally identify a senior authorized user so as to provide the additionalauthority to this individual

The second additional function is to carefully review research or “new experiments,”substantially different in the application of radioactive materials or radiation envisioned fromwork previously performed under the license This role is easy to play when it is part of a newrequest for an authorization, but when an ongoing operation initiates a new direction in theirprogram, it will be necessary for the committee to make it clear that the user must address thequestion to himself, “Is this application covered under the scope of work previously reviewed

by the committee in my application?” If the answer is no, or “possibly not,” t h e n t h eresponsible individual should ask for a review by the committee The need to do this must beexplicitly included in the internal policies administered by the committee The RSC then mustconsider the proposed program in the same context as the institution*s application to theNRC Is the purpose of the work an approved purpose? This question must be answeredpositively in the context of the NRC facility license Are the facilities adequate to a l l o w t h ework to be done safely? Are the persons qualified because of training or experience to carry

out the proposed research program safely? Incidentally, i t i s not within the purview of the

committee*s responsibility to judge the validity or worth of the research program, but only ifthe proposed research can be done safely according to radiation safety and health standards

Of course, obviously frivolous research is unacceptable for approval

In the past, the u s e of proven research technology was sufficient to approve mostresearch and routine experiments did not receive the scrutiny that new experiments did In thelast few years, the NRC has required the investigators to formally review even standardprocedures for possible hazards, to establish procedures to prevent these potential hazardsfrom occurring, and to develop a response protocol W o r s t c a s e failure mode s must bereviewed It is enlightening to see the results of these analyses It is frequently fo u n d t h a tthere is far more potential for failure than most would anticipate The committee must reviewand approve of these hazard analyses

The fourth function not previously discussed is the role of the RSC as a disciplinarybody Occasions will arise when individual users will be found to not be in full compliancewith acceptable standards Often this will be done by the RSO in his periodic inspections, butmany will be reported by the users themselves The NRC will expect these situations to beevaluated and appropriate actions taken, which can include disciplin ary measures Not allviolations are equally serious Categories of violations should be established by the RSC toguide the RSO and the users A single instance of faulty record keeping is not as serious aspoor control over byproduct material usage, for example Allowing material to be lost or

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radioactive material to escape into the environment is a serious violation If the loss ordischarge is due to an unforeseen accident, it is less serious than if the cause is negligence.However, a continuing pattern of minor violations may s h o w carelessness or lack of concernabout compliance with the standards that could eventually lead to a more s erious incident.Such a continuing pattern should be considered as a serious violation Possible penaltiesshould be listed in the internal policies and guidelines issued by the RSC.

Every c a s e in which noncompliance is discovered or reported should be carefullyinvestigated by the RSO and a report made to the RSC The person responsible for the non-compliance and the responsible individual from the facility (if not the same person) should beinvited to meet with the committee and present their sides of the issue if they wish Few willnormally contest minor citations, but most will contest a citation that could affect their ability

to u s e radioactive materials After hearing both sides, the committee should take appropriatedisciplinary measures Issues are rarely black or white, and the penalties or corrective actionsshould be adapted to the circumstances An initial minor violation, for example, might elicit nomore than a cautionary letter from the committee However, a series of minor violations within

a s h o rt interval probably should result in a mandatory cessation of usage of radioisotopesuntil the user can s h o w the willingness and capability to comply with acceptable practice Aproven serious accidental violation should result in an immediate cessation of operationsuntil procedures can be adopted to prevent future recurrence of the problem A seriousviolation due to willful noncompliance should result in a mandatory cessation of the use ofradioisotopes for a substantial length of time or even permanently The elimination of theright to use radioisotopes is a very serious penalty, since the user*s research program maydepend upon this capability In an academic institution, even a relatively short hiatus in aresearch program could result in the loss of a research grant or failure to get tenure As aresult, a permanent or extended loss of the right to u s e radioactive material should not beimposed lightly, but if the user shows by action and attitude that future violations are likely tooccur, the committee may have no practical alternative except to do s o to protect the rest ofthe organization*s users from the loss of the institution*s license or the imposition of asubstantial fine by the NRC The committee must be willing to accept the responsibility,unpleasant though it may be If the users believe that the RSC is willing to be reasonable, butfirm and fair, they will be more likely to comply with the required procedures

The role of the RSO could be construed as the enforcement arm of the RSC and theradiation safety office (which may be part of a larger organization) If this were the case, theRSO wo uld be the equivalent of an NRC inspector However, as with many other personsworking in safety and health programs who have enforcement duties, their primary function isservice to the users In later sections the other duties will make this clear

F Radiation Protection, Discussion, and Definitions

Many basic terms were defined in some detail in the several subsections of Section 5.1.However, several additional concepts will be introduced in the following sections, and someadditional terms need to be defined

The original definitions of d o s e units primarily were employed for external exposure byusers of radioactive materials and other applications of ionizing radiation Concerns relating

to internal exposure generally were covered by establishing maximum permissibleconcentrations of radionuclides in air and water, in terms of the workplace and in terms of thepublic, in Appendix B to 10 CFR 20, Tables I and II, respectively Protection was provided byconsidering the amount of radiation given to the most critical organ by the intake of specificradioisotopes and their physical or chemical form The exposure limits to the whole body wereestablished by the organs assigned the lowest dose limits, the bone marrow, gonads, and lens

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The current 10 CFR Part 20 that went into effect January 1, 1994, sets standards for tection for users of radioisotopes and requires combining internal and external exposures Therevision contains several other changes in Part 20 based on many of the recommendationscontained in the International Commission on Radiological Protection (ICRP) Publications 26,

pro-30, and 32 The remainder of this section and some succeeding sections will discuss thecurrent regulations and will draw attention to significant changes to t h o s e ar e a s i n u s e f o rmany years

1 Selected Definitions

In order to discuss the current Part 20, some terms introduced into it from the ICRP 26 and

30 are needed

The first six main definitions are related to dose terms:

1 D o s e equivalent means the product of absorbed dose, quality factor, and all othernecessary modifying factors at the location of interest in tissue

2 External dose means that portion of the dose received from radiation sources fromoutside the body

a Deep d o s e equivalent (Hd) applies to the external whole-body exposure and istaken as the dose equivalent at a tissue depth of 1 cm

b Eye dose equivalent (He) applies to the external exposure of the lens of the eye and

is taken as the dose equivalent at a tissue depth of 0.3 cm

c Shallow d o s e equivalent (Ha) applies to the external exposure of the skin or anextremity and is taken as the d o s e equivalent at a tissue depth of 0.007 cm.,averaged over an area of one square centimeter

3 Internal d o s e is that portion of the dose equivalent received from radioactive materialtaken into the body

a Committed d o s e equivalent (H T,50 ) means the dose equivalent to organs or tissues ofreference (T) that will be received from an intake of radioactive material by anindividual during the 50-year period following the intake

b Effective dose equivalent (H E) is the sum of the products of the d o s e equivalent

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HE = å w HT T

HE, 50 = åw HT T, 50

(HT) to the organ or tissue (T) and the weighting factors ( wT) applicable to each of

Table 5.5 Definitions: Weighting Risk Coefficient

Weighting Factor Risk Coefficient Probability

receiving the highest dose at a

relative sensitivity of 0.06 each

(10)

d Collective effective d o s e equivalent is the sum of t h e p r o d u c t s o f t h e i n d i v i d u a lweighting dose equivalents received by a specified population from exposure to aspecified source of radiation

4 W e i g h t i n g f a c t o r wT, for an organ or tissue (T) is the proportion of the ris k o fstochastic effects resulting from the irradiation of that organ or tissue to the total risk

of stochastic effects when the whole body is irradiated uniformly See Table 5.6

5 Occupational d o s e means the dose received by an individual in the course ofemployment in which the individuals assigned duties involve exposure to radiation or

to radioactive material from licensed or unlicenced sources of radiation whether in thepossession of the licensee or other person It does not include doses received frombackground radiation, from any medical administration the individual has received,from exposure to individuals administered radioactive materials and released inaccordance with 10CFR part 35.75, from voluntary partic ipation in medical researchprograms, or as a member of the public

6 Public d o s e is an exposure of a member of the public to radiation or to the release ofradioactive material, or to another source, either in a licensee*s controlled area or inunrestricted areas This does not include background radiation or any kind ofmedically related exposures

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The next five definitions relate to dose control factors:

7 ALARA is an acronym that stands for “as low as reasonably achievable.” It is a policythat means making every reasonable effort to maintaining exposures to radiation as farbelow the dose limits as is practical consistent with the purpose for which the licensedactivity is undertaken, taking into account the state of technology, the economics ofimprovements in relation to benefits to the public health and safety, and other societaland socioeconomic considerations, and in relation to utilization of nuclear energy andlicensed materials in the public interest

8 Annual limit of intake (ALI) means the derived limit for the amount of radioactivematerial taken into the body of an adult worker by inhalation or ingestion in a year It isthe smaller of (1) the value of the intake of a given radionuclide in 1 year by thereference man that would result in a committed dose equivalent of 5 rems (0.05 Sv); (2)

a committed dose equivalent of 50 rem (0.5 Sv) to any individual organ or tissue

9 Derived air concentration (DAC) means the concentration of a given radionuclide in airwhich, if breathed by the reference man for a working year of 2,000 hours underconditions of light activity (corresponding to an inhalation rate of 1.2 m3 air per hour),results in an inhalation of 1 ALI These are comparable to the MPCs in the older Part20

10 Dose limits means the permissible upper bounds of radiation doses These are usuallyset for a calendar year They apply to the d o s e equivalent received during the setinterval, the committed effective d o s e equivalent resultin g from the intake of radio-active material during the interval or the effective d o s e equivalent received in 1 yearThe external d o s e and the internal d o s e must be combined so as not to exceed thepermissible limits The following equation can be used to compute the relative amounts

of each, for the annual intake IJ of nuclide J:

Two terms are used to describe two different classes of effects of radiation

11 Stochastic effects refers to health effects that occur randomly, s o that the probability(generally assumed to be linear, without a threshold) of an effect occurring, such as theinduction of cancer is a function of the dose rather than the severity of the effect

12 Non-stochastic effects are health effects for which the severity depends upon thedose, and for which there is probably a threshold

With these definitions in mind, the following section presents selected parts of the current

10 CFR Part 20, which went into effect on January 1, 1994 Holders of NRC licenses must haveformal programs to ensure that all programs covered by the regulations and all individualsworking with radioactive materials now comply with the revised standard

2 Selected Radiation Protection Standards from 10 CFR Part 20

The following section contains the s e n s e of the Part 20 regulations, paraphrased in someinstances for clarity and brevity A few comme nts are added in some sections, where theywere felt to be helpful M o s t of the areas covered by the standard will be gone into in moredetail in later sections describin g practical implementation of a program complying with thestandard

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The dose limits are the levels not to be exceeded, but they should not be considered as agoal The revised standard requires the licensee to use, to the extent practicable, proceduresand engineering controls based upon sound radiation protection principles to achieveoccupational doses and doses to members of the public that are ALARA.

i Whole body, head, trunk, arm above elbow, and leg above knee

The more limiting of:

! 5 rems per year (0.05 Sv per year)—includes summation of (external) deep doseequivalent and (internal) committed effective dose equivalent, or

! The sum of the deep-dose equivalent (the dose equivalent at a depth of 1 cm intissue) and the committed dose equivalent to any individual organ or tissue otherthan the lens of the eye being equal to 50 rems (0.5 Sv)

Without any intake of radioactive materials, the limits above correspond to the externalexposure limits of the previous standard

i i E y e s , S k i n , A r m s B e l o w E l b o w s , L e g s B e l o w K n e e s

! 15 rems per year (0.15 Sv year) to lens of eye, and

! A shallow d o s e equivalent (at a tissue depth of 0.007 cm over a 1 cm2 area) of 50rems(0.5 Sv) to the skin and any extremity

The assigned deep-dose equivalent and shallow-dose equivalent must be for the part ofthe body receiving the highest exposures These data can be inferred from surveys or othermeasurements if direct data are not available

The DAC and ALI values are given in Table 1, A p p endix B, of Part 20 and can be used

in the determination of an individual*s internal d o s e and to demonstrate compliance withrequired occupational d o s e limits Table 2, Appendix B lists the maximum permissibleconcentrations in effluents and Table 3 lists the maximum concentrations permitted forrelease into sewers

The limits s p ecified are for an individual The total exposures from work for differentemployers cannot exceed these limits

Significant changes are that the previous standa rd did not require addition of externaland internal d o s e s ; the basic interval over which radiation is measured has been extendedfrom a quarter to a year; the 5(N- 18) cumulative dose limit has been deleted; the higherlimits to eye exposure and the extremities reflects more information on the sensitivity toradiation for these areas In addition, the revised standard contains a new p r o v i s i o n f o rplanned special exposures for limited higher doses to an individual in exceptional caseswhen other alternatives are unavailable or impractical The licensee must specificallyauthorize the pla nned special exposure in writing before the event The individual who willreceive the exposure must be informed in advance of (1) the purpose of the operation, (2)the estimated doses and potential risks involved in the operation, and (3) measures to betaken to comply with the principles of ALARA, taking into account other risks that might

be involved The licensee must also determine in advance the cumulative lifetime dose ofthe individual participating in the exercise With these steps completed, the participatingindividual must not be caused to receive a dose from all planned special exposures and allother doses in excess of

! The numerical values of the allowable d o s e limits in any year, and

! Five times the annual d o s e limits during the individual*s lifetime

a Occupational Limits for Adult Employees

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The licensee must retain records of all planned special exposures In addition, thelicensee must provide exposed individuals with a report of the dose received and submit areport to the regional director of the NRC within 30 days of the event

It is not necessary in every case to sum the external and internal doses if the licenseecan s h o w that the internal dose does not contribute significantly If, for example, the onlyintake of radioactivity is by inhalation, the total effective dose equivalent is not exceeded ifthe deep-dose equivalent divided by the total effective dose equivalent, plus an estimate ofthe internal d o s e as determined by one of three procedures stipulated in the regulation doesnot exceed 1, the internal d o s e need not be added to the external dose Similarly, unless theamount of radioactivity ingested is more than 10% of the applicable ALI, it need not beincluded in the total d o s e equivalent M o s t laboratories using radioactive materials atreasonable levels under normal conditions will find that they need only consider externalexposures, just as they once did

Only individuals likely to receive within 1 year more than 10% of the allowable d o s e limitsare required to be monitored by the licensee However, unless the dose is monitored, it isdifficult to establish with certainty that an active user of radioisotopes may not have exceededthe 10% limit Many licensees do monitor most users of radioactive materials by providingpersonnel dosimeters to measure external exposures, excluding t h o s e who only work withweak beta emitters In order to monitor internal exposures, the licensee can performmeasurements of (1) concentrations of radioactive materials in the air in the workplace, (2)quantities of radionuclides in the body, (3) quantities of radionuclides excreted from the body,

or (4) combinations of these measurements

The personnel monitors normally used for individual monitoring must be processed by adosimetry processor holding personnel dosimetry accreditation from the National VoluntaryLaboratory Accreditation Program (NVLAP) of the National Institute of Standards andTechnology for the type of radiation or radiations included in the NVLAP program that mostclosely approximates the exposure characteristics for the individual wearing the dosimeter

b Occupational Limits for Minors (Under 18) and to an Embryo/Fetus

The annual occupational dose limits for minors are 10% of the limits for adult workers aslisted in 10 CFR 20.1201

The limits to a fetus are based on an exposure over the entire 9 months of the pregnancy

of a declared pregnant woman If the woman chooses not to declare her p r e g n a n c y t o h e remployer, the licensee may be in a legally difficult position Anti-discrimination laws prevent

an employer from discriminating against a woman, but the normal work regimen may not becompatible with the NRC regulation If the woman were to make an issue of a job changebased on an obvious but undeclared pregnancy, there could be problems It will be assumedhere that nearly all women in the workplace would wish to limit the exposure to their unbornchild as s o o n as possible and declare their pregnancy when they are sure This could stillcause up to an approximately 2-month period of higher exposure than desirable due touncertainty in the early stages of pregnancy Following is the text of Section 20.1208whichgoverns this situation

(a) The licensee shall ensure that the d o s e to an embryo/fetus during the entirepregnancy, due to occupational exposure of a declared pregnant woma n , d o e s n o texceed 0.5 rem (5 mSv) (For record keeping requirements, see Sec 20.2106.)

(b) The licensee shall make efforts to avoid substantial variation above a unifo rmmonthly exposure rate to a declared pregnant woman so as to satisfy the limit inparagraph (a) of this section

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(c) The dose to an embryo/fetus shall be taken as the sum of—

(1) The deep-dose equivalent to the declared pregnant woman; and

(2) The d o s e to the embryo/fetus from radionuclides in the embryo/fetus andradionuclides in the declared pregnant woman

(d) If the dose to the embryo/fetus is found to have exceeded 0.5 rem (5 mSv), or is within0.05 rem (0.5 mSv) of this dose, by the time the woman declares the pregnancy to thelicensee, the licensee shall be deemed to be in compliance with paragraph (a) of thissection if the additional d o s e to the embryo/fetus does not exceed 0.05 rem (0.5 mSv)during the remainder of the pregnancy

c Dose Limits for Individual Members of the Public

The licensee must conduct operations in such a way as to ensure (1) that the totaleffective d o s e to individual members of the public from the licensed operation does notexceed 100 mrem (1 mSv) in 1 year, exclusive of the d o s e contribution from the licensee*sdisposal of radioactive materials into sanitary sewerage, and (2) the d o s e in any unrestrictedarea from external sources does not exceed 2 mrem in any 1 hour

A licensee or license applicant may apply for prior NRC authorization to operate up to anannual d o s e limit for an individual member of the public of 0.5 rem (5 mSv) The licensee orlicense applicant shall include the following information in this application:(1) demonstra-tion

of the need for and the expected duration of operations in excess of the limit in paragraph (a)

of this section; (2) the licensee*s program to a s s e s s and control dose within the 0.5 rem (5mSv) annual limit; and (3) the procedures to be followed to maintain the dose as low as isreasonably achievable The licensee must make surveys, measurements, and/or calculations

to prove that the limits would not be exceeded for an individual likely to receive the highestdose from the licensed operations

There are also EPA regulations governing releases of radioactive materials into theenvironment that will be treated separately

d Surveys and Monitoring

Monitoring requirements have been covered in the section on occupational exposures foradult employees In addition to personnel monitoring, surveys are required The surveys can bedone with portable instruments or samples can be obtained and tested in laboratory instruments.These surveys are used to evaluate (1) the extent of radiation levels, (2) concentr a t i o n s o rquantities of radioactive materials, and (3) the potential radiological hazards that could be present.The equipment used for the surveys must be calibrated periodically for the radiation measured.Normally this is done at least annually A description of personnel monitoring and survey deviceswill be found later in this chapter, and recommended survey procedures

i Controlled Areas, Restricted Areas, Radiation Areas, High Radiation Areas, and Very High Radiation Areas

M o s t laboratories using radioisotopes do not u s e sufficient amounts of radioactive materials

s o that they evoke the NRC requirements for areas defined by these labels Access to a laboratorymay be controlled for a number of other reasons — secure u s e of biological pathogens, toxicchemicals, or explosives — but the level of radiation and u s e of radioactive materials in mostresearch laboratories is normally quite modest Exceptions would be reactor facilities, medical labsfor therapeutic radiation, fuel fabrication facilities, etc These facilities normally will have theirown radiation safety specialist who would be thoroughly familiar with these requirements, sothey will not be covered further here If information is needed, it can be found in 10CFR Part20.1003

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ii Storage and Control of Licensed Material

A matter of serious concern to the NRC is security of licensed materials A l t h o u g h n o texplicitly stated in the regulations, there have been interpretations by individuals in the NRC thatsince the regulation specifies licensed materials, exempt quantities of materials may be construed

as exempt from security requirements, but this interpretation is not necessarily firm It would beadvisable to treat exempt amounts of licensed materials as not exempt

! A licensee must assure that licensed materials stored in controlled or unrestricted areas are secure from unauthorized removal or access

! A licensee must control and maintain constant surveillance of licensed materials that are

in a controlled or unrestricted area and that are not in storage

The word “constant” was italicized in the last requirement for emphasis It is not permissible

to leave material alone and unsecured for brief visits to the soft drink machine, to step outside

to smoke, or even to go to the bathroom

iii Posting of Areas or Rooms in which Licensed Material is Used or Stored

The licensee must p o s t each area or room in which an amount of licensed material more than

10 times the quantity specified in Appendix C to 10 CFR Part 20 is used or stored with a

conspicuous sign or signs bearing the radiation symbol and the words CAUTION, RADIOACTIVE MATERIALS or DANGER, RADIOACTIVE MATERIALS.

There are some exceptions to these posting requirements, but it is normally appropriate topost There are additional posting requirements specified in 10 CFR Part 19 that will be discussedlater

iv Labeling Containers

Every container of licensed material must bear a clear, durable label bearing either CAUTION

or DANGER, RADIOACTIVE MATERIAL The label must also provide additional information,

such as the radionuclide in the container, the amount present, the date on which the activity wasestimated, radiation levels, and the kinds of materials in order for individuals to determine thelevel of precautions needed to minimize exposures The labels on empty, uncontaminatedcontainers intended for disposal must be removed or defaced before disposal There areexceptions to these labeling requirements, but most containers in use in a facility should belabeled

v Procedures for Ordering, Receiving, and Opening Packages

A supplier of radioactive materials must ensure that the facility ordering the material has avalid radioactive materials license before filling an order This is accomplished by the vendorbeing provided with a copy of the license Although not required, it is desirable if all radioactivematerials are ordered through the radiation safety office and delivery specified to that office Withall materials being ordered through one point of sale and receipt, it is sometimes possible toarrange discounts for bulk purchases, even if individual items are ordered separately

The regulations for receiving packages containing radioactive materials are covered by Part20.1906 Briefly, these are: Licensees expecting to receive packages containing more than a type

A quantity (defined in 10 CFR Part 71 and Appendix A to Part 71) must make arrangements toreceive the package upon delivery or receive notification of its arrival by a carrier, and arrange

to take possession of it expeditiously In most facilities the responsibility for receiving radioactivedeliveries for the entire organization is delegated to the radiation safety office The package must

be monitored for surface contamination and external radiation levels The limits for loosecontamination set by 49 CFR Part 173.443 are set for a swipe of 300 cm2 The limits for beta,gamma, and low toxicity alpha emitter contamination are 22 dpm/cm2 For all other alpha emitters,

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the loose surface contamination limits are 10% of these The radiation level due to the contents

of the package are set by both 10 CFR Part 20.71.47 and 49 CFR Part 173.441 to not exceed 200mrem/hr (2mSv/hour) at any point on the surface There are also limits set for the transporter.Levels in excess of these limits would require

immediate notification of the NRC If the levels are higher than anticipated or the package is aged, the package should be carefully opened, as a minimum safety precaution, in a fume hooddesignated for use with radioactive materials A glove box would be better

dam-Many carriers deliver packages outside normal working hours, and some organizations willreceive them at the portions of their facility that function 24 hours per day, such as a securityoffice If the packages are received during normal working hours, required monitoring must bedone no later than 3 hours after receipt If packages are received outside normal working hours,monitoring must be done no later than 3 hours from the beginning of the next working day

vi Disposal of Radioactive Waste

The activity in radioactive waste from radioisotopes is included in the possession limits for

a licensed facility until disposed of in an authorized manner Therefore, records of materialstransferred into waste must be maintained as with any other transfer by the individual user Atsome point, the waste from individual laboratories will be combined and disposed of by one ofthe means approved by the NRC The disposal options available to a generator of radioactivewaste are

! T ransfer to an authorized recipient according to the regulations in 10 CFR Parts 20(Appendices E - G), 30, 40, 60, 61, 70, or 72

! Decay in storage

! By release of effluents into the sanitary system subject to specific limitations(20.2003)

! By other approved technologies by persons authorized to use the technologies

A person can be specifically licensed to receive radioactive waste for disposal from a facilityfor:

! Treatment prior to enclosure (this often means solidification of liquid wastes or paction of dry wastes)

com-! Treatment or disposal by incineration

! Decay in storage

! Disposal at a land disposal facility licensed under 10 CFR Part 61

! Disposal at a geologic facility under 10 CER Part 60

The limitations on release into the sanitary system are

! The material must be readily soluble in water or is biological material readily dispersible

in water

! No more of a specific radioisotope can be released into the sanitary system in one monththan an amount divided by the total volume of water released into the system in onemonth that does not exceed the concentration listed in Table 3 of Appendix B to Part 20

! The total quantity of licensed and unlicenced material released into the sanitary system

in one year does not exceed 5 Ci (185 GBq) of 3H, 1 Ci (37 GBq) of 14C, and one Ci of allother radioactive materials combined

! Excreta containing radioactive material from persons undergoing medical diagnosis or

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therapy is not subject to the disposal limits.

The licensee can dispose of the following licensed materials as if they were not radioactive

! 0.05 :Ci (1.85 kBq) or less of 3H or 14C per gram of medium used for liquid scintillationcounting (Note that some liquid scintillation fluids are EPA-regulated RCRA wastes andmust be treated as hazardous wastes Alternative liquid scintillation fluids are availablewhich are not hazardous in this context.)

! 0.05 :Ci (1.85 kBq) or less of 3H or 14C per gram of animal tissue averaged over the weight

of the entire animal

Animal tissue containing radioactive material in the amounts specified cannot be disposed

of in a way that would allow its u s e as either animal or human food The licensee may useincineration to dispose of radioactive materials subject to the limitations of this section.Records must be maintained by the licensee of disposal of radioactive wastes Materialtransferred to a disposal firm is subject to requirements very similar to those covering chemicalwastes The manifest has specific requirements for the description of the physical and chemicalform of the radioactive materials and the radiation characteristics of the wastes There arespecialists in transporting radioactive waste who normally serve as the intermediary or brokerfor the generator and disposal facility

vii Records of Survey, Calibration, and Personnel Monitoring Data

Records of facility surveys, package monitoring data, and equipment calibrations must beretained for 3 years after they are recorded Where required to sum internal and external doses,data required to determine by measurement or calculation the doses to individuals or radioactiveeffluents released to the environment must be kept until the termination of the license requiringthe record

Personnel d o s e records, including internal and external doses where required, for all personnelfor whom monitoring is required must be kept until the NRC terminates the license for which therecord was required

viii Loss or Theft of Material

Losses of significant amounts of radioactive materials must be reported to the NRC both

by telephone and by a written report If the amount that is not accounted for is equal to or greaterthan 1000 times the quantity specified in Appendix C to 10 CFR Part 20, and it appears that anexposure could affect persons in unrestricted areas, the loss shall be reported by telephone as

s o o n it is known to the licensee Within 30 days after lost, stolen, or missing material isdiscovered, the NRC must be notified by telephone of any amount greater than 10 times thequantity specified in Appendix C that is still missing at that time Most facilities will make theirreport to the NRC Operations Center

After making the telephone report, the licensee must, within 30 days, make a written report

to the NRC providing details of the loss, including (1) the amount, kind, chemical, and physicalform of the material, (2) the circumstances of the loss, (3) the disposition or probable disposition

of the material, (4) exposures to individuals, h o w the exposures occurred, and the probable d o s eequivalent to persons in unrestricted areas, (5) steps taken or to be taken to recover the material,and (6) procedures taken or to be taken to ensure against a recurrence of the loss If at a later timethe licensee obtains additional information, it must be reported to the NRC within 30 days Names

of individuals who may have received exposure due to the lost material are to be stated in aseparate and detachable portion of the report

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e Notification of Incidents

Immediate notification is required for any event due to licensed materials that would causeany of the following conditions: (1) an individual to receive a total effective dose of 25 rem (0.25Sv) or more, (2) an eye dose of 75 rems (0.75 Sv) or more, (3) a shallow d o s e equivalent to the skin

or extremities of 250 rads (2.5 Gy) or more, (4) a release of material into the environment such that

an individual, if present for 24 hours, could have received an intake of five times the occupationalannual limit

Notification is required within 24 hours of the discovery of an event involving loss of control

of licensed radioactive material that may have caused or may cause any of the followingconditions: (1) an individual to receive within a 24-hour period an effective dose exceeding theannual limits for an effective d o s e equivalent, and eye d o s e equivalent, a shallow d o s e equivalent

to the skin or extremities, or an intake dose in excess of one occupational annual limit on intake.The times given are calendar days not working days

For most facilities, the reports must be made by telephone to the NRC Operations Center and

to the administrator of their regional office by telegram, mailgram, or facsimile

i Reports of Exposures, Radiation Levels, and Concentrations of Radioactive Materials Exceeding the Limits

A written report must be submitted within 30 days after learning of the event for any of thefollowing conditions: (1) an event requiring immediate or 24-hour notification, (2) doses in excess

of the occupational dose limits for adults, the occupational dose limits for a minor, the limits for

a fetus, or the limits for an individual member of the public, (3) any applicable limit in the license,

or (4) the ALARA constraints for air emissions, (5) levels of radiation or concentrations ofradioactive materials in a restricted area in excess of any applicable license limits or more than

10 times any applicable license limits in an unrestricted area A n individual need not be exposed

in the last two conditions The reports must contain the following information: (1) the extent ofexposure of individuals, including estimates of each exposed individual*s dose, (2) the levels ofradiation and concentrations of radioactive materials involved, (3) the cause of the incident, and(4) corrective steps taken or planned to ensure against a recurrence, including the schedule forachieving conformance with appli-cable regulations

The reports must include in a separate, detachable part the exposed individual*s name, SocialSecurity Number, and birth date The reports are to be sent to the U.S NRC Document ControlDesk, Washington, D.C., 20555, with a copy to the regional administrator

3 EPA, National Emission Standards for Hazardous Air Pollutants, Radionuclides

The EPA enacted a rule limiting emissions of radionuclides into the atmosphere for severalclasses of source facilities, among them facilities licensed by the NRC The rule became effective

on December 15, 1989 However, shortly after that the rule was stayed for NRC facilities andfederal facilities not owned by the Department of Energy On January 28, 1994, NRC licenseholders were informed that the rule was in effect, and unless licensees could show that they wereexempt, a report would have to be filed by March 31, 1994, and annually thereafter The primaryconcerns were with the potential for increased risk of cancer due to inhalation of radionuclides.For laboratory facilities using radioactive materials, fume hood exhausts normally would be thesource of emissions The groups of concern would be the receptors (homes, offices, schools,resident facilities, businesses nearest the emission source) Another source of concern would

be farms, including meat, vegetable, and dairy farms where the radionuclides could enter the foodchain The EPA provided several alternative means of determining whether a facility is exempt,

in compliance, or needs to come into compliance In their compliance guide, they stated that if

a facility uses more than about six nuclides and has multiple release points, the licensee would

be b e s t served by using a computer program called COMPLY, available from the EPA The results

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depend upon many input parameters, but once these have been determined, the program willquickly compute the results There has since been a shift in regulatory responsibility to the NRCand the EPA standards no longer apply to NRC licensed facilities except through the NRC Thiswent into effect on January 9, 1997 The basis for compliance is that the effective-dose equivalent

to an individual is less than 10 mrem per year

G Radioisotope Facilities and Practices

The following sections describe facilities and practices that comply with the regulationsoutlined in Sections II.D to II.D.3 of this chapter

1 Radiation Working Areas

The areas in which radiation is used should meet good laboratory standards for design,construction, equipment, and ventilation, as described in Chapter 3 The International AtomicEnergy Agency (IAEA) has defined three classes of laboratories suitable to work withradionuclides Their class II facility is essentially equivalent to a good quality level 2 facility asdescribed in that chapter while their class I facility would be similar to the level 3 or 4 laboratory,depending upon the degree of risk, and would be especially equipped to safely handle even highlevels of radioactive materials

One additional feature which may need to be included in the design of a laboratory usingradioactive materials is provision for using a HEPA (high efficiency particulate aerosol) filter, or

an activated charcoal filter for nonparticulate materials, on the exhaust of any fume hood in whichsubstantial levels of radioactive materials are used in order to comply with the constraints onrelease of airborne radionuclides described in the preceding section A problem with thisrequirement is the possibility of the filter becoming rapidly “loaded up” by the chemicals used

in the hood A velocity monitor should be mandatory on any fume hood, but especially oneequipped with a HEPA filter, to provide a warning should the face velocity fall below 100 fpm(assuming that is the standard established for a working face velocity) The definition of

“substantial” will depend upon the type of radioactive material used The levels of activity from

an unfiltered hood exhaust should not exceed the levels permitted in Appendix B, Table II (10CFR Part 20) under the worst possible circumstances, such as a spill of an entire container of aradioisotope in the hood The volume of material, the physical properties of the material, and therate at which air is pulled through the system should allow the maximum concentration in theexhausted air to be computed

M o s t laboratories using radionuclides are not required to be limited access facilities However,any area in which radioactive material is used or kept should be identified with a standardradiation sign such as shown in Figure 5.6 Unless the amount of material or exposure levels in

the facility trigger a more explicit warning, the legend should say only CAUTIO N , RADIOACTIVE MATERIAL Individuals working with radioactive materials must be trained in

safe procedures in working with radiation under the rules and regulations described in SectionII.D.2 Individuals working in the same area who do not u s e radioactive materials need not be

as thoroughly trained, but should be sufficiently informed s o that they understand the reasonsfor the care with which the others using the facility handle the radioactive materials, s o they willnot inadvertently become exposed to radiation levels in excess of those permitted for members

of the public, and s o that their actions or inactions do not cause an incident involving radiation

If licensed materials are stored in an unrestricted area, the materials must be securely locked

to prevent their removal from the area Many materials used in the life sciences must be kept either

in refrigerators or freezers, which should be purchased with locks or equipped with padlocksafterward If the radioactive materials in an unrestricted area are not in storage, they must beunder the constant surveillance and immediate control of the licensee

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As noted in Section II.D.2, this precludes leaving them unattended for any reason for even brief periods.

Some laboratory facilities, or portions of them, may need to be made into “restricted areas”because of the type of activities conducted within them or to ensure that members of the publicwill not be exposed to radiation in excess of that allowed by Part 20 for occupational exposuresand members of the public Access to a restricted area is not prohibited to a member of the public,but it must be controlled to provide the proper assurance of protection to them A sign should

be posted at the entrance to a restricted area stating

RESTRICTED AREA, ACCESS LIMITED TO AUTHORIZED PERSONNEL ONLY

The entrance always should be locked when the area is unoccupied and at such times thatunauthorized individuals could enter the area under circumstances that the occupants would beunaware of or unable to control their entrance

Within a restricted area, there may be specifically defined areas where the levels of radiationmay be significantly above the levels that would be acceptable for personnel to work on a normal

40 hours-per-week schedule Depending upon the level, these areas would be designated asRadiation Areas, High Radiation Areas, and Very High Radiation Areas Additional restrictionswould be imposed on entering these areas

2 External Radiation Exposure Areas

A Radiation Area within a restricted area is an area accessible to personnel where radiationexists (according to the legal definition) arising in whole or in part from licensed material at suchlevels that a major portion of the body could receive a dose of 5 mrem (0.05 mSv) in 1 hour, or

in excess of 100 mrem (1 mSv) in 5 consecutive days A Radiation Area must be conspicuouslyposted with one or more signs bearing the radiation symbol and the words

CAUTION (or DANGER) RADIATION AREA

Similarly, a High Radiation Area is an area within a restricted area accessible to personnel

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*

Radiation can also enter the body by ingestion, by absorption through the skin, or through a break in the skin, such as a cut However, the last of these is more likely to be due to unusual circumstances rather than due

to the presence of a continuing source.

where there exists radiation, arising in whole or in part from licensed material at such levels that

a major portion of the body could receive a dose of 100 mrem (1 mSv) in 1 hour A High RadiationArea must be posted with one or more signs carrying the radiation symbol and the legend

CAUTION (or DANGER) HIGH RADIATION AREA

In addition to the warning signs, additional measures must be taken to prevent individualsfrom accidentally entering a High Radiation Area These measures would include one or more

of the following

1 An automatic device must reduce the level to the 100 mrem per hour level upon entry of

a person into the area

2 T he area must be equipped with an automatic visual or audible alarm to war n t h eindividual and the licensee, or a supervisor, of the entry into the area

3 The area must be kept locked except at such time that entry into the area is required andpositive control is maintained over entry to the area at such times

4 In place of the three alternatives just listed, the licensee provides continuous direct orelectronic surveillance that is capable of preventing unauthorized entry

None of the control measures that might be adopted can be configured to restrict individualsfrom leaving the high radiation area

Part 20 also defines a Very High Radiation area, where even higher levels of activity may beencountered, i.e., where levels in excess of 500 rads per hour (5 grays per hour) could be received

at 1 meter from a sealed source that is used for irradiation of materials Note that a one hourexposure to levels of this magnitude would exceed the LD50 for individuals not receiving prompt

medical attention Instead of the word DANGER on the cautionary sign, the words GRAVE DANGER are to be used Holders of the license may apply to the NRC for additional control

measures

3 Areas with Possible Internal Exposures

The previous limits within a restricted area were based on external exposures to a majorportion of the whole body The most probable means of radioactive materials entering the body

to cause an internal exposure is through inhalation.1 Therefore, Section 20.1202 -1204 establishesrequirements for spaces in which airborne radioactivity is present A n y a r e a d e f i n e d a s a nairborne radiation area is one in which airborne radioactive material in excess of the derived airconcentrations (DACs) listed in Appendix B to Part 20 exists or, which averaged over the number

of hours present in the area in a week a person is in the area without respiratory protection, theperson could exceed 0.6% of the annual limit on intake (ALI) or 12 DAC-hours Each area meeting

or exceeding the required limits must be conspicuously posted with one or more signs with theradiation symbol and with the legend

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AIRBORNE RADIOACTIVITY AREA

Normally, individuals without respiratory protection should not work in such areas If feasible,engineering practices should be used to eliminate the need for individual respiratory protectivedevices The NRC in 10 CFR Part20, Subpart H, section 1703-1704, defines the procedures to befollowed should a respiratory protection program be required A discussion on the usage ofrespiratory protection will also be found in Chapter 6, Section I

In most research laboratory situations, it would be unusual to find an airborne radioactivityarea on other than a short-term basis If there is any possibility of an approach to the limits whileworking on an open bench, the use of radioactive materials should be restricted to a hood, or

in a glove box or hot cell In a facility with a broad license, it is recommended that at least some

of the more active individuals using radioisotopes should be included in a bioassay program forthe same reason that others wear a personal monitoring device, to ensure and document that noone is receiving an internal dose over the limits

H Material Control Procedures

The amount of materials that a licensee may p o s s e s s at any time is established by the terms

of its byproduct license A s lo ng as the total holdings are maintained within t h o s e limits,licensees may order radioactive materials, maintain them in storage, u s e them, transfer them toother licensees, and dispose of waste amounts as long as they comply with all of the applicableregulations Accurate records must be maintained for individual laboratories and for a facility as

a whole where the facility has a broad license For short-lived isotopes, there will be a continuingreduction of the amount on hand of a given material due to decay alone, while the distribution

of the remainder of the material in use, storage, or transferred to waste will fluctuate continuously.Written records should be maintained of the amounts involved in each of these processes,and it should be possible to account for nearly all of the material from the time it is received untildisposed of as waste Some uncertainty is certain to be introduced during actual experimentation,especially if there is a gaseous metabolic or combustion product released through the exhaustfrom a hood There also will be small quantities that will be retained on the interior of vesselscontaining radioactive liquids that will escape into the sanitary system when the container iswashed However, it should be possible to estimate these types of losses with reasonableaccuracy

Facility records of receipt, transfer, use, and disposal should be maintained at each individuallaboratory authorized to u s e radioisotopes This is the responsibility of the senior individual incharge of the facility to whom has been assigned the internal equivalence of a radioisotopelicense A technician may perform the actual record keeping, but the ultimate responsibility forthe radioactive material in the facility belongs to the principal authorized user Except for theremoval of material from the storage container for use within the laboratory, the organization'sradiation safety officer (RSO) should be involved in all of the transactions involving radioactivematerials and should be able to detect any anomalies or disparities It is the RSO’s responsibility

to maintain records for the overall inventory of the radioisotopes within the organization, andthese records can be used to compare with or audit the records for each internal facility.Laboratory managers may be assured that an NRC inspector will check the records of somelaboratories at a facility during each unannounced inspection, so records must be able to passthese inspections at any time

It has already been noted that materials in unrestricted areas must be kept in secure storagewhen the user is not present This requirement for security is applicable whenever the facility

(or DANGER) CAUTION

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3. Appendix C. Exemptions Under Section III-F-6Section III-F-6 states that exempt from these NIH Guidelines are “those that do not present a significant risk to health or the environment as determined by the NIH Director, with the advice of the RAG, and following appropriate notice and opportunity for public comment.” See Appendix C, Exemptions under Sections III-F-6. The following classes of experiments are exempt under Section III-F-6 Sách, tạp chí
Tiêu đề: NIH Guidelines "are “those that do not presenta significant risk to health or the environment as determined by the NIH Director, with the adviceof the RAG, and following appropriate notice and opportunity for public comment
4. Appendix D. Major Actions Taken under the NIH GuidelinesA s noted in the subsections of Section IV-C-1 -b-(1), the Director, NIH, may take certain actions with regard to the NIH Guidelines after the issues have been considered by the RAG.Some of the actions taken to date include the following: These are typically specific to a particular institution or experimenter and are omitted for that reason. There are 115 listed in the current NIH Guidelines Sách, tạp chí
Tiêu đề: NIH Guidelines" after the issues have been considered by the RAG.Some of the actions taken to date include the following: These are typically specific to a particularinstitution or experimenter and are omitted for that reason. There are 115 listed in the current
5. Appendix E. Certified Host-vector Systems (See Appendix I, Biological Containment) While many experiments using Escherichia coli K-12, Saccharomyces cerevisiae, and Bacillus subtilis are currently exempt from the NIH Guidelines under Section III-F, somederivatives of these host-vector systems were previously classified as Host-Vector 1 Systems or Host-Vector 2 Systems. A listing of those systems follows Sách, tạp chí
Tiêu đề: Biological Containment")While many experiments using "Escherichia "coli K-12, "Saccharomyces cerevisiae, "and "Bacillussubtilis
9. Appendix I. Biological Containment (See Appendix E) a. Appendix I-I. Levels of Biological ContainmentIn consideration of biological containment, the vector (plasmid, organelle, or virus) for the recombinant DNA and the h o s t (bacterial, plant, or animal cell) in which the vector is propagated in the laboratory will be considered together. Any combination of vector and h o s t which is to provide biological containment shall be chosen or constructed so that the following types of“escape” are minimized: (i) survival of the vector in its h o s t outside the laboratory, and (ii) transmission of the vector from the propagation h o s t to other non-laboratory hosts. The following levels of biological containment (host-vector systems) for prokaryotes are established.Appendices I-I-A through I-II-B describe levels of biological containment (host-vector systems) for prokaryotes. Specific criteria will depend on the organisms to be used Sách, tạp chí
Tiêu đề: escape
10. Appendix K. Physical Containment for Large Scale Uses of Organisms Containing Recombinant DNA MoleculesAppendix K specifies physical containment guidelines for large scale (greater than 10 liters of culture) research or production involving viable organisms containing recombinant DNA molecules. It shall apply to large scale research or production activities as specified in Section Khác
12. Appendix M-III. Informed ConsentIn accordance with the Protection of Human Subjects (45 CFR Part 46), investigators should indicate h o w subjects will be informed about the proposed study and the manner in which their consent will be solicited. They should indicate h o w the Informed Consent document makes clear the special requirements of gene transfer research. If a proposal involves children, special attention should be paid to the Protection of Human Subjects (45 CFR Part 46), Subpart D, Additional Protections for Children Involved as Subjects in Research Khác

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