Radiation Regulations and Protection



Fig. 16.1
Various radiation caution signs and labels



Caution: Radiation Area. This sign must be posted in radiation areas.

Caution: High Radiation Area or Danger: High-Radiation Area . This sign must be posted in high-radiation areas.

Caution: Radioactive Material or Danger: Radioactive material. This sign is posted in areas or rooms in which 10 times the quantity of any licensed material specified in Appendix C of 10CFR20 are used or stored. All containers with quantities of licensed materials exceeding those specified in Appendix C of 10CFR20 should be labeled with this sign. These labels must be removed or defaced before disposal of the container in the unrestricted areas .

Caution signs are not required in rooms storing the sealed sources, provided the radiation exposure at 1 foot (30 cm) from the surface of the source reads less than 5 mrem (50 µSv)/h. Caution signs are not needed in rooms where radioactive materials are handled for less than 8 h, during which time the materials are constantly attended.



Occupational Dose Limits


The annual limit of the occupational dose to an individual adult is the more limiting of (a) TEDE of 5 rem (0.05 Sv) or (b) the sum of the deep-dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 50 rem (0.5 Sv). It should be noted that there is no lifetime cumulative dose limit in 10CFR20, although the NCRP recommends a lifetime cumulative dose of 1 rem (10 mSv) × age in years.

The annual limit on the occupational dose to the lens of the eye is 15 rem (0.15 Sv).

The annual limit of the occupational dose to the skin and other extremities is the shallow-dose equivalent of 50 rem (0.5 Sv).

Depending on the license conditions, both internal and external doses have to be summed to comply with the limits. A licensee may authorize under planned special procedures an adult worker to receive additional dose in excess of the prescribed annual limits, provided no alternative procedure is available. The total dose from all planned procedures plus all doses in excess of the limits must not exceed the dose limit (5 rem or 50 mSv) in a given year, nor must it exceed five times the annual dose limits in the individual’s lifetime.

The annual occupational dose limits for minors is 10 % of the annual dose limits for adults. The dose limit to the fetus/embryo during the entire pregnancy (gestation period) due to occupational exposure of a declared pregnant woman is 0.5 rem (5 mSv), which amounts to approximately 50 m rem (0.5 mSv) per month assuming a 10 month pregnancy.

The total effective dose equivalent to individual members of the public is 0.1 rem (1 mSv) per year. However, this limit can be increased to 0.5 rem (5 mSv) provided the need for such a higher limit is demonstrated.


ALARA Program


The established dose limits are the upper limits for radiation exposure to individuals. The NRC has instituted the ALARA (as low as reasonably achievable) concept to reduce radiation exposure to individuals to a minimum. The ALARA concept calls for a reasonable effort to maintain individual and collective radiation exposure as low as possible. Under this concept, techniques, equipment, and procedures are all critically evaluated. According to NRC Regulatory Guide, under the ALARA concept, when the exposure to a radiation worker exceeds 10 % of the occupational exposure limit in a quarter (Action Level I), an investigation is made by the RSO, and the report is reviewed by the RSC. When the exposure exceeds 30 % of the occupational exposure limit (Action Level II), corrective actions are taken or the licensee must justify a higher dose level for ALARA in that particular situation, but not to exceed annual occupational dose limit.


Principles of Radiation Protection


Of the various types of radiation, the α-particle is most damaging because of its charge and large mass, followed in order by the β-particle and the γ-ray . Heavier particles have shorter ranges and therefore deposit more energy per unit path length in the absorber, causing more damage. On the other hand, γ-rays and x-rays have no charge or mass and therefore have a longer range in matter and cause relatively less damage in tissue. Knowledge of the type and energy of radiations is essential in understanding the principles of radiation protection .

The cardinal principles of radiation protection from external sources are based on four factors: time , distance , shielding , and activity .


Time


The total radiation exposure to an individual is directly proportional to the time of exposure to the radiation source . The longer the exposure, the higher the radiation dose. Therefore, it is wise to spend no more time than necessary near radiation sources.


Distance


The intensity of a radiation source, and hence the radiation exposure, varies inversely as the square of the distance from the source to the point of exposure . It is recommended that an individual should keep as far away as practically possible from the radiation source. Procedures and radiation areas should be designed so that individuals conducting the procedures or staying in or near the radiation areas receive only minimum exposure.

The radiation exposure from γ-ray and x-ray emitting radionuclides can be estimated from the exposure rate constant , Γ, which is defined as the exposure from γ-rays and x-rays in R/h from 1 mCi (37 MBq) of a radionuclide at a distance of 1 cm. Each γ– and x-ray emitter has a specific value of Γ, which has the unit of R · cm2/mCi · h at 1 cm or, in System Internationale (SI) units, µGy · m2/GBq · h at 1 m. The Γ values are derived from the number of γ-ray and x-ray emissions from the radionuclide, their energies, and their mass absorption coefficients in air.1 Because γ-rays or x-rays below some 10 or 20 keV are absorbed by the container and thus do not contribute significantly to radiation exposure, often γ-rays and x-rays above these energies only are included in the calculation of Γ. In these instances, they are denoted by Γ 10 or Γ 20. The values of Γ 20 for different radionuclides are given in Table 16.1.


Table 16.1
Exposure rate constants of commonly used radionuclides
























































Radionuclides

Γ 20 (R · cm2/mCi h at 1 cm)

Γ 20 (µGy m2/GBq · h at 1 m)a

137Cs

3.26

88.11

99mTc

0.59

15.95

201Tl

0.45

12.16

99Mo

1.46

39.46

67Ga

0.76

20.54

123I

1.55

41.89

111In

2.05

55.41

125I

1.37

37.03

57Co

0.56

15.16

131I

2.17

58.65

18Fb

5.70

154.05


aR · cm2/mCi · h is equal to 27.027 µGy m2/GBq h.

bPersonal communication with Dr. M. Stabin, Oak Ridge Associated Universities, Inc., Oak Ridge, Tennessee.

Adapted from Goodwin PN: Radiation safety for patients and personnel. In: Freeman LM, ed. Freeman and Johnson’s Clinical Radionuclide Imaging. 3rd ed. Philadelphia: WB Saunders Co; 1984: 320.

The exposure rate X from an n-mCi radionuclide source at a distance d cm is given by





$$ X=\frac{n\Gamma }{{{d}^{2}}} $$

(16.1)

where Γ is the exposure rate constant of the radionuclide.

It should be pointed out that because the patient is not a point source, the exposure rate does not vary exactly as the inverse square of the distance.


Problem 16.1

Calculate the radiation exposure at 25 cm from a vial containing 30 mCi (1.11 GBq) of 201Tl.

Answer

The exposure rate constant Γ 20 of 201Tl is 0.45 R · cm2/mCi · h at 1 cm from Table 16.2. Therefore, using Eq. (16.1), at 25 cm


Table 16.2
Activities and dose rates for authorizing patient releasea
























































Radionuclide

Activity at or below which patients may be released

Dose rate at 1 m at or below which patients may be released
 
GBq

mCi

mSv/h

mrem/h

123I

6.0

160

0.26

26

67Ga

8.7

240

0.18

18

131I

1.2

33

0.07

7

111In

2.4

64

0.2

20

99mTc

28

760

0.58

58

201Tl

16

430

0.19

19


aNRC NUREG 1556, vol. 9, 2002.





$$ X=\frac{30\times 0.45}{{{25}^{2}}}=21.6\text{ mR/h} $$

Because Γ 20 of 201Tl in SI units is 12.16 µGy · m2/GBq · h at 1 m, X for 1.11 GBq of 201Tl at 25 cm is





$$ \begin{aligned} X&=\frac{1.11\times 12.16}{{{(0.25)}^{2}}} \nonumber\\& ={215}.{96}~\mu \text{Gy}/\text{hr}\end{aligned} $$


Shielding


Various high atomic number (Z) materials that absorb radiations can be used to provide radiation protection . Because the ranges of α– and β-particles are short in matter, the containers themselves act as shields for these radiations. γ-Radiations, however, are highly penetrating. Therefore, highly absorbing material should be used for shielding of γ-emitting sources, although for economic reasons, lead is most commonly used for this purpose. The half-value layer (HVL) of absorbent material for different radiations is an important parameter in radiation protection and is related to linear attenuation coefficient of the photons in the absorbing material. This has been discussed in detail in Chap. 6.

Obviously, shielding is an important means of protection from radiation. Radionuclides should be stored in a shielded area. The radiopharmaceutical dosages for patients should be carried in shielded syringes. Radionuclides emitting β-particles should be stored in containers of low-Z material such as aluminum and plastic because in high-Z material, such as lead, they produce highly penetrating bremsstrahlung radiations. For example, 32P is a β emitter and should be stored in plastic containers instead of lead containers.


Problem 16.2

Calculate the number of HVLs and the amount of lead necessary to reduce the exposure rate from 100 mCi (3.7 GBq) of 131I to less than 10 mR/h at 10 cm from the source. (Γ = 2.17 R · cm2/mCi · h at 1 cm and 1 HVL = mm of lead).

Answer





$$ \text{Exposure at 10 cm}=\frac{{2170}\times {100}}{{1}{{{0}}^{{2}}}}=2170\text{ mR/hr}. $$

A factor of 2170/10 = 217 factor of 2170/10 HVL ce. ( (from the source. (d necessary to redmR/h. In terms of HVL, 28 h256, that is, 8 HVLs would be needed. Since 1 HVL = 56, that is, 8 HVLs would be needed. Since 1Therefore, 8 HVLs or 24 mm of lead would be necessary.


Activity


It should be obvious that the radiation exposure increases with the intensity of the radioactive source . The greater the source strength, the more the radiation exposure. Therefore, one should not work unnecessarily with large quantities of radioactivity.


Personnel Monitoring


According to 10CFR20, personnel monitoring is required under the following conditions:

1.

Occupational workers including minors and pregnant women likely to receive in 1 year a dose in excess of 10 % of the annual limit of exposure from the external radiation source

 

2.

Individuals entering high or very high radiation areas

Monitoring for occupational intake of radioactive material is also required if the annual intake by an individual is likely to exceed 10 % of the ALIs in 10CFR20, Table 16.1, Appendix B, and if minors and pregnant women are likely to receive a committed effective dose equivalent in excess of 0.05 rem (0.5 mSv) in 1 year.

 

Three devices are used to measure the exposure of ionizing radiations received by an individual: the pocket dosimeter , the film badge, and the thermoluminescent dosimeter . The pocket dosimeter (Fig. 16.2) has been described in Chap. 7.

A978-1-4614-4012-3_16_Fig2_HTML.gif


Fig. 16.2
a Film badge. b Film badge holder. c TLD ring badge. d Pocket dosimeter


Film Badge


The film badge is most popular and cost-effective for personnel monitoring and gives reasonably accurate readings of exposures from β-, γ– and x-radiations. The film badge consists of a radiation-sensitive film held in a plastic holder (Fig. 16.2a, b). Filters of different metals (aluminum, copper, and cadmium) are attached to the holder in front of the film to differentiate exposure from radiations of different types and energies. Filters of metals of different densities stop different energy radiations, thus discriminating exposures from them. After exposure the optical density of the developed film is measured by a densitometer and compared with that of a calibrated film exposed to known radiation. Film badges are usually changed monthly for radiation workers in most institutions. Film badges provide an integral dose and a permanent record. The main disadvantage of the film badge is the long waiting period (a month) before the exposed personnel know about their exposure. The film badge also tends to develop fog resulting from heat and humidity, particularly when in storage for a long time, and this may obscure the actual exposure reading. The film badges of all workers are normally sent to a commercial firm that develops and reads the density of the films and sends back the report of exposure to the institution. The commercial firm must be accredited by the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology.


Thermoluminescent Dosimeter


A thermoluminescent dosimeter (TLD) consists of inorganic crystals (chips) such as lithium fluoride (LiF) and manganese-activated calcium fluoride (CaF2:Mn) held in holders like the film badges and plastic rings (Fig. 16.2c) . When these crystals are exposed to radiation, electrons from the valence band are excited and trapped by the impurities in the forbidden band. If the radiation-exposed crystal is heated to 300 to 400°C, the trapped electrons are raised to the conduction band; they then fall back into the valence band, emitting light. The amount of light emitted is proportional to the amount of radiation absorbed in the TLD. The amount of light is measured and read as the amount of radiation exposure by a TLD reader, a unit that heats the crystal and reads the exposure as well. The TLD gives an accurate exposure reading and can be reused after proper heating (annealing).

It should be noted that exposure resulting from medical procedures and background radiations are not included in occupational dose limits . Therefore, radiation workers should wear film badges or dosimeters only at work. These devices should be taken off during any medical procedures involving radiation such as radiographic procedures and dental examinations, and also when leaving after the day’s work. Also radiation workers should not wear these badges for certain period of time after undergoing a diagnostic or therapeutic nuclear medicine procedure or radiation therapy permanent implant procedure.


Dos and Don’ts in Radiation Protection Practice


Do wear laboratory coats and gloves when working with radioactive materials.

Do work in a ventilated fume hood while working with volatile material.

Do cover the trays and workbench with absorbent paper.

Do store and transport radioactive material in lead containers.

Do wear a film badge while working in the radiation laboratory.

Do identify all radionuclides and dates of assay on the containers.

Do survey work areas for contamination as frequently as possible.

Do clean up spills promptly and survey the area after cleaning.

Do not eat, drink, or smoke in the radiation laboratory.

Do not pipette any radioactive material by mouth.

Do monitor hands and feet after the day’s work.

Do notify the radiation safety officer (RSO) in the case of any major spill or other emergencies related to radiation.


Bioassay


NRC Regulatory Guide 8.20 gives the details of bioassay requirements for 131I and 125I radionuclides. Bioassays are required when the level of radioiodine activity handled (volatile or dispersible) exceeds the following values:

Open bench: 1 mCi (37 MBq)

Fume hood: 10 mCi (370 MBq)

Glove box: 100 mCi (3.7 GBq)

When the radioiodinated material is nonvolatile, the limits of activity are higher by a factor of 10. Stricter limits may be imposed in the license by the NRC.

For iodine radionuclides, bioassay is performed by the thyroid uptake test within 72 h and at 14 days after handling the radioactivity. Sometimes urine analysis may also be required soon after the exposure. Bioassays may be required for other radionuclides, depending on the amount and type of radionuclides.


Receiving and Monitoring of Radioactive Packages


Individual users or institutions are authorized to possess and use radioactive materials on issuance of a radioactive material license by the NRC or the Agreement State . The suppliers require documentation of licensing of the user as to the types and limits of quantities of radioactive material before shipping.

Monitoring of packages is required if the packages are labeled as containing radioactive material to check if the packages are damaged or leaking. A radioactive shipment must be monitored as soon as possible after receipt but no later than 3 h after delivery if the delivery takes place during normal hours, or not later than 3 h from the beginning of the next working day if it is received after working hours. Two types of monitoring are performed: survey for external exposure and wipe test for contamination on the surface of the package resulting from potential leakage of liquid. The survey reading of external exposure should not exceed 200 mrem/h (2 mSv/h) on the surface of the container or 10 mrem/h (100 µSv/h) at 1 m from the surface of the container. The wipe test is performed by swabbing an area of 300 cm2 of the package and should show less than the limit of 6600 dpm or 110 Bq/300 cm2. If the readings exceed these limits, the NRC and the final delivering carrier must be notified by telephone and telegram, mailgram, or facsimile. Advice should be sought from these authorities as to whether the shipment should be returned.

After all surveys are completed, the data must be entered into a receipt book. The information logged in includes the date of the receipt, the manufacturer, the lot number, name and quantity of the product, date and time of calibration, and survey data along with the name of the individual processing the receipt.


Radioactive Waste Disposal


Radioactive waste generated in nuclear medicine or pharmacy (e.g., syringes, needles, vials containing residual activities and contaminated papers, tissues, and liners) are disposed of by the following methods according to the guidelines set forth in 10CFR20 and 10CFR35 .



1.

Decay in storage

 

2.

Release into a sewerage system

 

3.

Transfer to authorized recipient (commercial land disposal facilities)

 

4.

Other disposal methods approved by the NRC (e.g., incineration of solid waste and atmospheric release of radioactive gases)

 

The following is a brief description of different methods of radioactive waste disposal, but one should consult 10CFR20 and 10CFR35 for details.


Decay in Storage


Although 10CFR20 does not spell out the conditions of the decay-in-storage method , 10CFR35.92 describes this method in detail. Radionuclides with half-lives less than 120 days usually are disposed of by this method. These radionuclides are allowed to decay in storage and monitored before disposal. If the radioactivity reading of the waste is indistinguishable from background, it can be disposed of in the normal trash after removal or defacing of all radiation labels. This method is most appropriate for short-lived radionuclides such as 99mTc, 123I , 201Tl, 111In, 67Ga and 131I commonly used in nuclear medicine. Radioactivities should be stored separately according to half-lives for convenience of timely disposal of each radionuclide.


Release into Sewerage System


The NRC permits radioactive waste disposal into the sewerage system provided the radioactive material is soluble or dispersible in water and the quantity disposed of monthly does not exceed the maximum permissible limits set in 10CFR20 . Disposal depends on the total volume and flow rate of water used but is limited to 1 Ci (37 GBq) of 14C, 5 Ci (185 GBq) of 3H , and 1 Ci (37 GBq) of all other radionuclides annually. Excreta from humans undergoing medical diagnosis or treatment with radioactive material are exempted from these limitations. However, items contaminated with radioactive excreta (e.g., linen, diapers, etc., contaminated with urine or feces) are not exempted from these limitations. To adopt this method of radioactive disposal, one must determine the total volume and the flow of sewer water in the institution and the number of users of a specific radionuclide so that for each individual user, a limit can be set for sewer disposal of the radionuclide in question.


Transfer to Authorized Recipient


This method of transfer to an authorized recipient is adopted for long-lived radionuclides and usually involves transfer of radioactive wastes to authorized commercial firms that bury or incinerate at approved sites or facilities .

Although the columns of the 99Mo–99mTc generators may be decayed to background for disposal to normal trash, a convenient method of disposing of this generator is to return them to the vendors, who let them decay and later dispose of them. Normally, the used generator is picked up by the authorized carrier when a new one is delivered.


Other Disposal Methods


A licensee may adopt methods of radioactive waste disposal different from those mentioned here, provided regulatory agency approval is obtained . Impact of such disposal methods on environment, nearby facilities, and population is heavily weighed before approval. Incineration of solid radioactive waste and carcasses of research animals containing radioactive materials is allowed by this method . Radioactive gases such as 133Xe and 127Xe are released by venting through the fumehood, provided their maximum permissible concentration at the effluent side of the exhaust to the atmosphere does not exceed the NRC limits. Radioactive waste containing 0.05 µCi (1.85 kBq) or less of 3H or 14C/g of medium used for liquid scintillation counting or animal tissue may be disposed of in the regular nonradioactive trash.

Records must be maintained as to the date of storage and the amount and kind of activity stored in a waste disposal log book. The stored packages must be labeled with pertinent information. The date of disposal and the amount of disposed activity must also be recorded in the log book, along with the initials of the individual disposing of the waste.


Radioactive Spill


Accidental spillage of radioactivity can cause unnecessary radiation exposure to personnel and must be treated cautiously and expeditiously. Appropriate procedures must be established for handling radioactive spills . There are two types of spills: major spill and minor spill. No definitive distinction exists between a minor and a major spill. A major spill usually occurs when the spilled activity cannot be contained in a normal way and can cause undue exposure to personnel. In the case of a major spill, the RSO should be notified immediately. In either case, the access to the area should be restricted. Areas, personnel, and equipment must be decontaminated, keeping in mind the principle of containment of radioactivity. Survey and wipe tests must be performed after decontamination. The RSO will investigate the accident and recommend corrective action if a major spill occurs.


Recordkeeping


Records must be maintained for the receipt, storage, and disposal of radioactive materials, as well as for various activities performed in the radiation laboratories . According to the NRC regulations, these records must contain specific information and must be kept for a certain period of time specified by the NRC.



Medical Uses of Radioactive Materials


The NRC and Agreement States regulate the medical uses of by-product materials by implementing 10CFR35. There are six categories of medical uses of radioactive materials according to 10CFR Part 35 . They are: (1) radiopharmaceuticals for uptake, dilution, and excretion (10CFR35.100); (2) radiopharmaceuticals for imaging and localization including generators and kits (10CFR35.200); (3) radiopharmaceuticals for therapy (10CFR35.300); (4) sealed sources for brachytherapy (10CFR35.400); (5) sealed sources for diagnosis such as sources of 125I and 153Gd for bone mineral analysis (10CFR35.500); and (6) sealed sources for teletherapy such as sources of 60Co and 137Cs in teletherapy units or gamma stereotactic radiosurgery units (10CFR35.600).

The regulations for the medical use of all radioactive materials are given in 10CFR35, but radiopharmaceuticals under categories 1, 2, and 3 only are relevant in nuclear medicine. These radiopharmaceuticals must be approved for human clinical use by the FDA under an IND or NDA. The 99mTc activity is eluted from the 99Mo-99mTc generator and reagent kits are used to prepare 99mTc-labeled radiopharmaceuticals according to instructions given by the manufacturer in the package inserts. Only reagent kits that are approved by the FDA under an IND or NDA may be used for radiopharmaceutical preparation. Many other radiopharmacenticals are prepared by the manufacturs using appropriate labeling methods. The following is a brief description of the pertinent rules of 10CFR35.


Applications, Amendments, and Notifications


As already mentioned, applications for a license and its renewals must be made by the licensee’s management for the medical uses of by-product materials. Amendments to the license must be made by the licensee’s management for the following:



(a)

Appointment or discontinuation of an authorized user , radiation safety officer, authorized medical physicist, or authorized nuclear pharmacist

 

(b)

Change of name or address of the licensee

 

(c)

Change or addition of the use areas

 

(d)

Use of excess or new by-product materials not permitted before in the license

 

Notification of the above must be made within 30 days of occurrence. Change or addition of areas of use for uptake and dilution (10CFR35.100) and for localization and imaging (10CFR35.200) need not be amended. Licenses with Type A specific license of broad scope are exempt from these requirements.


Authority and Responsibilities of the Licensee


According to 10CFR35.24, the licensee’s management is responsible for the overall implementation of the radiation protection program in the medical uses of by-product material. The licensee’s management shall approve in writing all new authorized users , radiation safety officer , or nuclear pharmacist, and ministerial changes in the radiation safety program that do not require license amendment (10CFR35.26).

The licensee’s management shall appoint a Radiation Safety Officer (RSO) , who accepts in writing responsibilities to implement a radiation protection program. It may appoint one or more temporary RSOs for 60 days in a year, if all conditions of an RSO are met.

The licensee’s management also must appoint a Radiation Safety Committee (RSC) , if the licensee is authorized for two or more different types of uses of by-product material. Examples are the use of therapeutic quantities of unsealed by-product material (10CFR35.300) and manual brachytherapy (10CFR35.400), or manual brachytherapy and low-dose-rate therapy units (10CFR35.600), or teletherapy units (10CFR35.600) and gamma knife units (10CFR35.600). Use of by-product materials for both uptake and dilution (10CFR35.100) and imaging and localization (10CFR35.200) does not require an RSC. The RSC must include as a minimum an authorized user of each type of use permitted in the license, the RSO, a representative of the nursing service, and a representative of management, and in addition, other members, if appropriate. The NRC does not prescribe any definite frequencies of the RSC meetings nor record-keeping of the minutes.


Supervision


According to 10CFR35.27, a licensee that permits an individual to work under an authorized user or authorized nuclear pharmacist using by-product material must instruct the supervised individual to follow strictly all regulations and conditions of the license and all procedures involving by-product material. There is no requirement for periodic review of the supervised individual’s work and records. The licensee is responsible for the acts and omissions of the supervised individuals.

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Aug 27, 2016 | Posted by in NUCLEAR MEDICINE | Comments Off on Radiation Regulations and Protection

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