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Basic Principles of Radiation Protection Part 3, Rev 2

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    Presented by:

    Vangeline K ParamiLRE/NRLSD

    Baguio City, May 2008

    CPR Part 3: Standards for Protection

    Against Radiation

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    ICRP basic framework

    CPR Part 3:

    Standards for protection against radiation

    Outline

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    The International Commission

    On Radiological Protection (ICRP)

    Basic Framework

    Everyone in the world is exposed to radiation

    from natural and artificial sources

    Primary aim-

    to provide an appropriate standard of protection

    for man without unduly limiting the beneficial

    practices giving rise to radiation exposure

    include socialas well as scientific judgments

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    Global Average Individual

    Background Radiation Doses

    (mSv/y)

    TOTAL = 2.69Source: UNSCEAR

    Cosmic

    0.39

    Terrestrial

    0.46

    Internal K-40, C-140.23

    Radon

    1.3

    Medical 0.3

    Fallout 0.007

    Occupational

    0.002

    Discharges0.001

    Products

    0.0005

    TOTAL FROM

    NATURAL - 2.38

    TOTAL FROM ARTIFICIAL- 0.31

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    Practices

    human activities that increase the overall

    exposure to radiation, either by introducing

    new sources, pathways, and individuals, or

    by modifying the pathways from existing

    sources to man and thus increasing the

    exposure of individuals or the number of

    individuals exposed

    The ICRP Basic Framework

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    Intervention

    Other human activities that decrease the

    overall exposure by such activities asremoving existing sources, modifying

    pathways, or reducing the number of

    exposed individuals

    The ICRP Basic Framework

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    Stochastic effectscannot be completely avoided becausethere is no threshold for them, even small radiation dosesmay produce deleterious health effects.

    Since there are thresholds for deterministic effectsit ispossible to avoid them by restricting the doses toindividuals.

    The ICRP Basic Framework

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    The ICRP Basic Framework

    The basic framework is intended toprevent the occurrence of deterministiceffects, by keeping doses below the

    relevant thresholds, and to ensure thatall reasonable steps are taken toreduce the induction of stochastic

    effects.

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    Stochastic effect -

    based on probability

    as the dose increases, the probability (chance) of

    the effect increases

    not more serious for larger doses

    the same for a small dose as a large dose

    Only probability of it occurring increases with dose

    Stochastic Effects

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    Stochastic Effects

    Example:

    Cancer can be considered a yes or no

    effect. You either get it or you dont. Youmay get it with only a small dose or you maynot get it even with a large dose, but in eithercase (small or large dose) if you get it, its

    the same effect

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    The fact that there are regulatory dose limits would tendto imply that as long as the limit is not exceeded, there isno danger of harm.

    However, it is also required that steps be taken tomaintain doses As Low As Reasonably Achievable

    This is necessary assuming that the dose responsemodel is correct and that any dose, no matter how small,

    incurs some risk.

    The regulatory limit designates an acceptable risk but itdoesnt hurt to lower the risk even more if it isreasonable to do so.

    ALARA

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    A non-stochastic effect is one based on severity. As

    the dose increases, the severity (amount of injury)

    increases.

    Some examples of non-stochastic effects are:

    - skin damage (reddening, peeling, blistering, necrosis)

    - hair loss (epilation)

    - cataracts (eye damage)

    - sterility

    Deterministic Effects

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    (103) The effectiveness of protection can be related to:

    A source giving rise

    to individual doses

    (source-related)

    Individual dose received

    from all the relevant

    sources (individual-related)

    The ICRP Basic Framework

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    The basic Safety Standards of the IAEA detail

    how to implement the System for Radiation

    Protection described in ICRP Publication 60

    The Standards specify the basic requirements

    for protection of people against exposure to

    ionizing radiation and for the safety of radiation

    sources

    Part 3 is based on IAEA basic safety standards

    System of Radiological Protection

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    Part 3: Standards for protection against radiation

    I. General provisions

    Section 1. Purpose.

    (a) establishes the standards for protection against ionizingradiation arising from the use of radioactive materialsand related activities conducted under licenses issued bythe PNRI.

    (b) establishes the basic requirements for the safety ofradiation sources.

    (c) to control all activities by any licensee involvingradioactive material in such a manner that the total doseto an individual, except exposures to radiation fromnatural background sources or medical diagnosis andtherapy, does not exceed the Standards prescribed inthis Part.

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    Part 3: Standards for protection

    against radiationSection 2. Scope.

    (a) The requirements in this Part apply to all holders ofPNRI licenses issued pursuant to the regulations of theCode of PNRI Regulations (CPR).

    (b) The requirements in this Part are in addition to, and notin substitution for, other requirements of the CPR.

    (c) Specific provisions of the IAEA Safety Series No. 115,International Basic Safety Standards (IBSS) forProtection Against Ionizing Radiation and for the Safetyof Radiation Sources which are applicable in this Part,may be addressed pursuant to PNRI AdministrativeOrder No. 1, Series of 2001.

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    Part 3: Standards for protection

    against radiationSection 3. Exemptions.

    (a) The requirements in this Part do not apply to:

    (1) practices and sources involving radioactive materials that meet theexemption levels given in Appendix A; and

    (2) any exposure whose magnitude or likelihood is essentially unamenableto control through the requirements of this Part.

    (b) The dose limits prescribed in this Part do not apply to:(1) radiation exposures due to background radiation;

    (2) radiation exposure from individuals who have been administered withradioactive material and subsequently released in accordance with CPRPart 13; and

    (3) medical exposures which include:

    (i) radiation exposure incurred by patients as part of their own medicalor dental diagnosis or treatment; and

    (ii) radiation exposure of comforters and visitors of patientsundergoing medical diagnosis or treatment.

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    Section 4. Definitions.

    ACTION LEVEL; ACTIVITY; ALARA;Authorized Worker; bioassay; chronic

    exposure. . .

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    Section 5. Interpretation.

    Except as specifically authorized by the Director in writing,no interpretation of the meaning of the regulations in thisPart by any officer or employee of the PNRI other than a

    written interpretation by the Director will be recognizedto be binding upon PNRI.

    Section 6. Communication.

    All communication and reports concerning the regulationsin this Part should be addressed to the Director,Philippine Nuclear Research Institute, Commonwealth

    Avenue, Diliman, Quezon City.

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    II. RADIATION PROTECTION AND

    SAFETY PROGRAM

    Section 7. Radiation Protection and Safety Program.

    a. Each licensee shall use and observe, to the extent practicable theregulations in this Part and the radiation protection and safetyprinciples subscribed by PNRI.

    b. Each licensee shall establish, document, and implement aradiation protection and safety program that is commensurate withthe scope and extent of authorized activities and sufficient to ensurecompliance with the requirements of this Part and the conditions ofthe license.

    c. Each licensee shall review at least annually the content andimplementation of its radiation protection and safety program.

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    II. RADIATION PROTECTION AND SAFETY

    PROGRAM (2)Section 8. Format and Content of the Radiation Protection and Safety

    Program.

    The Radiation Protection and Safety Program shall include the followinginformation, as may

    be applicable:

    (a) A description of the radiation protection and safety organization

    (b) A description of the duties and responsibilities of the Radiological Health

    and Safety Officer (RHSO).(c) A description of the radiation facility

    (d) The number and type of equipment and devices incorporating radioactivesubstances, instruments and monitoring devices used and their propermaintenance;

    (e) Arrangement made for the assessment of the occupational exposure of

    workers and the maintenance of exposure records;(f) Methods for the implementation of the program that includes radiationexposure control, control of the workplace, monitoring of the workplace andassessment of the consequences of radioactive releases;

    (g) Methods for evaluating the performance of radiation protection and safetyprogram ;

    (h) An emergency plan

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    The System of Radiological Protection

    The system of radiological protection for

    proposed and continuing practices is

    based on the following general principles:

    Section 9. Justification of practices

    No practice involving exposures to

    radiation should be adopted unless it

    produces sufficient benefit to theexposed individuals or to society to

    offset the radiation detriment it causes.

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    Detriment defined

    The total harm that would be eventually

    experienced by an exposed group and its

    descendants as a result of the groups

    exposure to radiation from a source

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    Section 10. Optimization of protection and safety

    For any particular source within a practice, the

    magnitude of individual doses, the number of

    people exposed, and the likelihood of incurring

    exposures should all be kept as low asreasonably achievable (ALARA), economic and

    social factors being taken into account

    Dose and risk constraints should be used tolimit the inequity likely to result from the

    inherent economic and social judgments

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    Section 11. Dose constraint

    (a) Do not exceed either the appropriate values established oragreed to by PNRI for such a source or values which can cause thedose limits to be exceeded; and

    (b) Ensure, for any source (including radioactive waste managementfacilities) that can release radioactive substances to theenvironment, that the cumulative effects of each annual release fromthe source be restricted so that the effective dose in any year to anymember of the public, including people distant from the source andpeople of future generations, is unlikely to exceed any relevant doselimit, taking into account cumulative releases and the exposures

    expected to be delivered by all other relevant sources and practicesunder control.

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    The exposure of individuals shall be

    subject to dose limits, or to some control of

    risk in the case of potential exposures.

    This ensures that no individual is exposed

    to radiation risks that are judged to be

    unacceptable from these practices in any

    normal circumstances.

    Section 12. Individual dose and risk limits

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    Either by controlling the practice or by intervention theexposure of individuals can be restricted by applying

    action to the source, to the environment, or to the

    individual.

    Where available, controls applied

    at the sourceare preferred

    Examples:self shielded irradiator

    Gamma exposure device

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    Exposures are divided into three types:

    occupational exposure (exposure incurred at work

    principally as a result of work) - Section 13

    medical exposure (principally the exposure of

    persons as part of their diagnosis or treatment)

    Section 14

    public exposure (all other exposures)Section 15

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    Occupational Exposure

    For occupational exposures, controls occur at three

    points:

    at the source (e.g., containment)

    in the environment (e.g., shielding

    or ventilation)

    at the individual (e.g., administrativecontrols and protective clothing)

    For public exposures, controls should be applied at the

    source

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    Exposures may be known and

    predictable or possible but without

    certainty. These latter types are called

    potential exposures.

    Section 16. Potential exposure

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    Individual Dose Limits

    Apply to exposures attributable to practices,

    except medical exposures and of exposures

    from natural sources

    Not relevant for the control of potentialexposures

    Not relevant for decisions on whether and

    how to undertake an intervention

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    External Radiation Dose

    Gamma, beta or neutron radiationemitted by radioactive material

    outsidethe body exposing the skin,

    lens of the eye, extremities & the

    whole body (i.e. internal organs)

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    Internal Radiation Dose

    Alpha, beta orgamma radiation

    emitted by

    radioactive material

    insidethe bodyexposing internal

    organs such as:

    thyroid

    bone

    GI System

    lung

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    Individual Dose Limits

    Occupational Limit (adults):

    effective dose of 20 mSvper year averaged over five

    (5) consecutive years

    an effective dose of 50 mSvin any single (1) year

    an equivalent dose to the lens of the eye of 150 mSv

    in a (1) year

    an equivalent dose to the extremities (hands and

    feet) or the skin (averaged over 1 cm2)of 500 mSv in

    a (1) year

    Ad lt O ti l

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    Adult Occupational

    Dose Limits

    Whole Body (everything except extremities)

    50 mSv maximum per year

    20 mSv averaged over 5 years

    Extremities500 mSv per year

    Skin of the Whole Body

    500 mSv per year

    Lens

    150 mSv

    per year

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    The dose to the lens of the eyeis measured at a depth of 0.3 cm

    The shallow (skin) dose is

    measured at a depth of 0.007 cm

    The whole body dose is

    measured at a depth of 1 cm

    Depths at which External

    Radiation Dose is Measured

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    Individual Dose Limits

    December 31, 2007

    January 1, 2003

    1

    December 31, 2012

    January 1, 2008

    2

    December 31, 2017

    January 1, 2013

    3

    December 31, 2022

    January 1, 2018

    4

    January 1, 2003

    December 31, 2007

    1January 1, 2004

    December 31, 2008

    2

    December 31, 2009

    January 1, 2005

    3

    December 31, 2010

    January 1, 2006

    4

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    Individual Dose Limits

    December 31, 2007

    January 1, 2003

    1

    December 31, 2012

    January 1, 2008

    2

    January 1, 2003

    December 31, 2007

    1

    January 1, 2004

    December 31, 2008

    2

    5 mSv

    10 mSv

    15 mSv

    20 mSv

    50 mSv

    5 mSv

    10 mSv

    15 mSv

    20 mSv

    50 mSv

    5 mSv

    10 mSv

    15 mSv

    20 mSv50 mSv

    50 mSv

    50 mSv20 mSv

    15 mSv

    10 mSv20 mSv Avg

    20 mSv Avg

    20 mSv Avg

    29 mSv Avg

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    Individual Dose Limits

    Occupational Limit (apprentices and students 16 to 18

    years of age):

    effective dose of 6 mSvin a year

    equivalent dose to the lens of the eye of 50 mSv in a

    year

    equivalent dose to the extremities or the skin(averaged over 1 cm2)of 150 mSv in a year

    L

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    1618 Year Old Occupational

    Dose Limits

    Whole Body (everything except extremities)

    6 mSv maximum per year

    Extremities150 mSv per year

    Skin of the Whole Body

    150 mSv per year

    Lens

    50 mSv

    per year

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    Individual Dose Limits

    The estimated average doses to the relevant criticalgroups of members of the publicattributable to

    practices shall not exceed the following limits:

    an effective dose of 1 mSv in a year;

    in special circumstances, an effective dose of up to

    5 mSv in a single year provided that the average

    dose over five consecutive years does not exceed

    1 mSv per year;

    an equivalent dose to the lens of the eye of 15 mSv ina year; and

    an equivalent dose to the skin of 50 mSv in a year.

    L

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    Public

    Dose Limits

    Whole Body (everything except extremities)

    1 mSv per year

    **Special circumstances**

    5 mSv maximum per year

    1 mSv averaged over 5 years

    Extremities50 mSv per year

    Skin of the Whole Body

    50 mSv per year

    Lens

    15 mSv

    per year

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    Patient Comforter and Visiting

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    Patient Comforter and Visiting

    Children Dose Limits

    Whole Body (everything except extremities)

    Patient Comforters

    5 mSv per examination or treatment

    Children Visiting Patients

    1 mSv per patient hospital stay

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    Dose Limit Summary

    Whole

    Body

    (max)

    Whole Body

    (average)

    Lens

    of

    Eyes

    Skin Extremity

    Adult 50

    50

    20 over 5 yrs

    20 over 10 yrs

    150 500 500

    Minor 6 None 50 150 150

    Public 1

    5

    None

    1 over 5 yrs

    15 50 None

    Comforter 5 None None None None

    Child Visitor 1 None None None None

    NOTE: All numerical dose limits have units of mSv in one year except for

    the limits for comforters and visiting children. The limit for these last two

    groups is per patient diagnostic procedure or treatment

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    The dose limits apply to the sum of:

    the doses from external exposure in the specified

    period

    the committed doses from intakes in the same period

    The period for calculating the committed dose shall be:

    50 years for intakes by adults

    to age 70 years for intakes by children

    Individual Dose Limits

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    For compliance with dose limits, the sum of:

    the personal dose equivalent from external exposure

    to penetrating radiation in the specified period

    the committed equivalent dose or committed effective

    dose, as appropriate, from intakesof radioactive

    substances in the same period

    Individual Dose Limits

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    Estimates of probabilities of effects

    Effect Population Exposureperiod

    Exposuremodes

    Probability

    Fatal cancer

    (total)

    workers lifetime Low dose,

    low dose

    rate

    4 x 10-2/Sv

    Fatal cancer

    (total)

    General

    population

    lifetime Low dose,

    low dose

    rate

    5.0 x 10-2/Sv

    Hereditary Whole

    population

    All

    generations

    Low dose,

    low dose

    rate

    1.0 x 10-2/Sv

    R di i d ff i

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    Radiation dose effects at various

    dose levels(Health Physics Journal, Vol. 89, No. 5, Nov 2005)

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    Section 17. Emergency Exposure Situations

    Emergency plan

    Intervention

    Protection of workers during intervention

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    Intervention

    The system of radiological protection for interventionisbased on the following general principles:

    The proposed intervention shall do more good than

    harm (the reduction in detriment shall be sufficientto justify the harm and the costs, including social

    costs of the intervention)

    The net benefit of the intervention shall bemaximized (the reduction in radiation detriment,

    less the detriment associated with the intervention)

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    Dose limits do not apply in the case of intervention.

    There will be some level of projected dose above whichintervention will almost always be justified.

    Intervention

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    IV. SAFETY MEASURES AND CONTROL OF

    RADIOACTIVE MATERIAL

    Section 18. Surveys and Safety of

    Equipment

    Section 19. Transport of radioactivematerial

    Section 20. Storage and control of

    radioactive material

    V PRECAUTIONARY REQUIREMENTS

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    V. PRECAUTIONARY REQUIREMENTS

    Section 21. Caution Signs, Labels, and Posting Requirements.

    (a) Caution Signs and Labels.

    (1) Signs and labels prescribed by this section shall use contrasting colors. Theradiation

    caution symbol prescribed by this section is the conventional three-bladed design:

    RADIATION SYMBOL

    (i) cross-hatched area is black, and (ii) background is to be yellow.

    (2) In addition to the contents of signs and labels prescribed in this section, thelicensee

    may provide on or near such signs or labels any additional information which may be

    appropriate in aiding individuals minimize their exposure to radiation or to radioactive

    material.

    (2) Each licensee shall, prior to removal or disposal of empty uncontaminated

    containers, remove or deface the radioactive material label or otherwise clearly

    indicate that the container no longer contains radioactive materials.

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    (b) Posting.

    (1) Posting of RadiationAreas. The licensee shall posteach radiation area with a

    conspicuous sign or signs

    bearing the radiation symboland the words "CAUTION,

    RADIATION AREA".

    (2) Posting of High RadiationAreas. The licensee shall posteach high radiation area

    with a conspicuous sign or

    signs bearing the radiationsymbol and the words

    "CAUTION, HIGH RADIATIONAREA" or "DANGER, HIGHRADIATION AREA".

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    (c) Labelling of Containers. (1) Each licensee shall ensure that each container of licensed

    material bears a durable,

    clearly visible label bearing the radiation symbol and the words,"CAUTION,

    RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVEMATERIAL". The label

    must also provide sufficient information (such as the radionuclide(s)present, an

    estimate of the quantity of radioactivity, the date for which theactivity is estimated,

    radiation levels, kinds of materials, and mass enrichment) to permitindividuals

    handling or using the containers, or working in the vicinity of thecontainers, to take

    precautions to avoid or minimize exposures.

    S ti 22 P ti f N ti d

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    Section 22. Posting of Notices and

    Important Documents

    (a) Each licensee shall post at conveniently visiblelocations in the licensed facility current copies

    of the following documents:

    (1) the regulations, the license, and license conditions; (2) the operating procedures applicable to licensed

    activities; (3) the emergency procedures and local rules;and

    (4) the "Notice to Employees" form issued by PNRI.Refer to Appendix C.

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    Section 23. Instructions to Workers

    Each licensee shall ensure that all individuals working in or frequenting any portion of a

    controlled or supervised area are:

    (a) Kept informed of the storage, transfer, or use of radioactive materials or of the presence of

    radiation in such portions of the area;

    (b) Instructed on the health protection problems associated with exposure to such radioactive

    materials or radiation, in the precautions or procedures to minimize exposure, and in the

    purposes and functions of protective devices employed;

    (c) Instructed to observe, to the extent within the worker's control, the applicable provisions of the

    regulations of the Code and the specific conditions of the license for the protection of

    personnel from exposures to radiation or radioactive material;

    (d) Instructed of their responsibility to report promptly to the RHSO or the licensee any condition

    which may lead to or cause a violation of the regulation of the Code or license conditions, or

    to cause unnecessary exposure to radiation or to radioactive material;

    (e) Instructed on the appropriate response to warnings made in the event of any unusual

    occurrence or malfunction that may involve exposure to radiation or radioactive material; and (e) Advised as to the radiation exposure records which workers may request.

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    VI. WASTE MANAGEMENT AND DISPOSAL OF

    LICENSED RADIOACTIVE MATERIAL

    Section 24. General Requirements.

    (a) Each licensee shall dispose of licensed radioactive material only:

    (1) by transfer to an authorized recipient as provided in the regulations in Parts 2, 11, 12,

    13, 14, 16 and 20;

    (2) by decay in storage;

    (3) by discharge to the environment within the limits specified in Appendix D of this Part;

    (4) as authorized to dispose of as ordinary waste; or

    (5) by disposal as radioactive waste in accordance with an approved radioactive waste

    management program.

    (b) A person must be specifically authorized by PNRI to receive radioactive waste from PNRI

    licensees for:

    (1) treatment prior to disposal; or

    (2) interim storage; or

    (3) disposal at its facility specifically authorized by PNRI; or

    (4) disposal in accordance with a procedure not otherwise approved under this Part. (c) The facility design, capacity and radiological safety considerations of the facility for the

    disposal or interim storage of radioactive waste must be reviewed and approved by PNRI.

    S ti 25 T f f Li d

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    Section 25. Transfer of Licensed

    Radioactive Material

    (a) Any licensed radioactive material or sealed source that is disused or no longer suitable as

    originally intended in the license may be transferred to another person authorized by PNRI to

    receive such material in accordance with the requirement provided correspondingly in Parts

    2, 11, 12, 13, 14, 16 and 20 of the CPR.

    (b) If the transfer of disused sealed source to another person authorized by PNRI is not possible,

    the disused sealed source shall be returned to the supplier or manufacturer or disposed as

    radioactive waste to a person authorized by PNRI in Section 24 (a).

    (c) In the transport of disused sealed source to the supplier or manufacturer, the disused sealed

    source shall be packaged and shipped in the original shipping container, or provisions should

    be made to acquire another acceptable container if the original container is not available. The

    regulations of CPR Part 4, Rules and Regulations for the Safe Transport of Radioactive

    Materials in the Philippines, shall apply.

    .

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    Section 26. Storage of Radioactive Waste

    (a) All radioactive wastes that are for disposal shall be appropriatelystored in on-site facilities

    under controlled conditions. Interim storage of unconditioned wasteshall be as short as

    possible and not to exceed five (5) years.

    (b) Containers used for decay-in-storage shall be properly labeledincluding the date when the

    source may be disposed of as non-radioactive waste.

    (c) Storage facilities for radioactive wastes shall be constructed andsecured to prevent

    unauthorized access to the wastes and such that subsequenthandling, transport and

    disposal will not be endangered

    Section 27 Required Conditions During Normal

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    Section 27. Required Conditions During Normal

    Operation Involving Radioactive

    discharges

    (a) All radioactive discharges shall be kept as far belowthe authorized clearance levels as is

    reasonably achievable.

    (b) Radioactive discharges shall be monitored withsufficient detail and accuracy to demonstrate

    compliance with authorized clearance levels and topermit proper assessment of the

    exposure of critical groups.

    (c) Results of monitoring and exposures must berecorded and reported to the PNRI annually.

    (d) Radioactive discharges that exceed the authorizedclearance levels must be reported to PNRI

    in accordance with Section 38 of this Part.

    S ti 28 Di l b R l t th

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    Section 28. Disposal by Release to the

    Atmosphere

    (a) Work with radioactive gases or aerosols shall be done in a fumecupboard or in the

    immediate vicinity of an extraction hood. Fume cupboard exhausttrunking from active

    laboratories shall be isolated from normal ventilation systems andexhausted to the

    atmosphere through stacks so as not to re-enter the building oradjacent buildings.

    (b) If filtration of exhaust has been deemed necessary in particularcircumstances, then the

    appropriate type of filter must be employed for trapping theemission; the installation must

    have been approved; the assembly tested and the performancecontinuously monitored.

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    Section 30. Waste Management Program Section 31. Characterization, Segregation and Collection of Radioactive Waste.

    Section 32. Treatment and Conditioning of Radioactive Waste.

    .

    Section 33. Radioactive Waste that are Exempt from Regulatory Control.

    PNRI may exempt from regulatory control the discharge of radioactive waste if:

    (a) The effective dose expected to be received by any member of the public due to the waste is

    of the order of 10 Sv or less in a year; and

    (b) The activity of the waste does not exceed the clearance levels given in Appendix D of this

    Part.

    Section 34. Land Disposal of Radioactive Wastes.

    Exposure to members of the general public from off-site releases of radioactive material

    emanating from a land disposal facility shall not exceed the limits set forth in Section 15 of thisPart.

    Section 35. Compliance with Environmental and Health Protection Regulations.

    Nothing in this Part relieves the licensee from complying with other government regulations that cover any other toxic or hazardous properties of materials that may be disposed of under this

    Part.

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    VII. RECORDS, REPORTS AND NOTIFICATIONS

    Section 36. Records of Radiation Protection andSafety Program.

    (a) Each licensee shall maintain records of the radiationprotection and safety program and shall

    (1) the provisions of the program; and

    (2) results of audits and other reviews of program

    content and implementation. (b) The records required by this Section shall be retainedfor 3 years or until PNRI orders

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    Section 37. Documentation of Records. Each record required by this Part must be legibly written or printed on a specified form

    throughout the retention period. Each record must be authenticated by authorized personnel and shall

    have adequate safeguards against tampering or loss.

    Section 38. Reports of Overexposures and Excessive Levels and Concentrations.

    (a) In addition to any report or notification required by this Part, each licensee shall make a report

    in writing to PNRI concerning any one of the following incidents within 30 days of its

    occurrence:

    (1) exposure to individuals in excess of the limits of this Part allowed for occupational, or

    public exposures or as may be indicated in the license conditions; (2) levels of radiation or concentration of radioactive material in a controlled area in

    excess of any applicable limit in this Part or in the license; or

    (3) levels of radiation or concentrations of radioactive material, whether or not involving

    exposures of any individual, in a supervised area in excess of 10 times of any

    applicable limit set forth in this Part or in the license issued by PNRI.

    (b) Each report required under this Section must describe the extent of exposure of individuals to

    radiation or to radioactive material, including estimates of each individual's total exposure;

    levels of radiation and concentrations of radioactive material involved; the cause of the

    exposure; and corrective steps taken or planned to prevent a recurrence. (c) In any case where a licensee is required to report to PNRI any exposure of an individual to

    radiation or to radioactive material, the licensee shall also notify such individual of the nature

    and extent of exposure. Such notice shall be in writing and a copy shall be furnished to PNRI.

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    Section 39. Reports of Theft or Loss of Radioactive Material. (a) Each licensee shall immediately notify PNRI by telephone or by any other fast means of

    communication, of any lost, stolen, or missing radioactive material.

    (b) In addition to the notification required above, each licensee shall, within 30 days after the

    occurrence, make a report in writing to PNRI that shall include the following information:

    (1) a description of the radioactive material involved including kind, quantity, chemical,

    and physical form;

    (2) a description of the circumstances under which the loss or theft occurred;

    (3) a statement of disposition or probable disposition of the radioactive material involved;

    (4) estimated radiation exposures to individuals, circumstances under which the

    exposures occurred, and the extent of possible hazards;

    (5) actions which have been taken, or will be taken, to recover the material; and

    (6) procedures or measures which have been or will be adopted to prevent a recurrence

    of the circumstances which led to the loss or theft of the licensed material.

    (c) Notwithstanding the requirement to file a written report, the licensee shall also report

    immediately any substantive additional information on the loss or theft which becomes available to the licensee.

    (d) Any report filed with PNRI pursuant to this section shall identify the individuals who may be

    exposed to radiation or may be involved in the incident.

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    Section 40. Notification of Incidents. (a) Each licensee shall notify PNRI within 24 hours by telephone, or by any other fast

    means of

    communication, of any incident involving a licensed activity, licensed facility, sourcematerial,

    special fissionable material or any other radioactive material possessed by thelicensee that

    may have caused, or threatens to cause: (1) exposure of the whole body of any individual in excess of 0.05 Sv; or

    (2) the release of radioactive material inside or outside of a controlled area, so that, ifan

    individual is present in the area for 24 hours, the individual could have received an

    intake in excess of one occupational annual limit on intake.

    (b) Any report filed with PNRI pursuant to this Section shall specify the names of

    individuals who have received exposure to radiation and other persons involved in the incident,

    including

    telephone numbers and addresses as may be practicable.

    VIII EXEMPTIONS AND ADDITIONAL

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    VIII. EXEMPTIONS AND ADDITIONAL

    REQUIREMENTS

    Section 41. Applications for Exemptions.

    The PNRI may, upon application by any licensee or upon its owninitiative, grant such

    exemptions from the requirements of the regulations in this Part as itdetermines are authorized by law

    and will not result in undue hazard to life or property.

    Section 42. Additional Requirements.

    The PNRI may, by rule, regulation, or order impose upon anylicensee such requirements, in

    addition to those established in these regulations, as it deemsappropriate or necessary to protect

    health and safety of the public or to minimize danger to life orproperty.

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    IX. ENFORCEMENT

    Section 43. Violations.

    (a) Any person found to have violated any rule, regulation, or order issued by PNRI, or any term,

    condition, or limitation of any license issued thereunder shall be notified of such violation and

    required to take corrective steps to prevent recurrence.

    (b) Any license may be modified, suspended, or revoked, after due process, for any violation

    which PNRI determines to adversely affect the health and safety of the workers and the

    public.

    (c) Any person who willfully violates, attempts to violate, or conspires to violate any rule or

    regulation or order by PNRI issued hereunder may be guilty of a crime, and upon conviction,

    may be punished by a fine or imprisonment or both as provided by Sections 64 and 65 of

    Republic Act No. 5207.

    Section 44. Effective Date.

    The regulations in this Part shall take effect fifteen (15) days following its publication in the

    Official Gazette or in a newspaper of general circulation. Approved:

    (Signed)

    ALUMANDA M. DELA ROSA, Ph.D.

    Director, PNRI

    Date: July 2, 2004

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    the production of sources and the use of radiation or

    radioactive substances for medical, industrial, veterinary

    or agricultural purposes, or for education, training or

    research the generation of nuclear power, including activities in the

    nuclear fuel cycle

    practices involving exposure to natural sources specified

    by the Regulatory Authority as requiring control

    any other practice specified by the Regulatory Authority

    (2.1) The practices to which the CPR Part 3, Standardsfor protection against radiation (based on IBSS) apply

    include the following and any related activities which

    involve or could involve exposure to radiation or

    radioactive substances:

    System of Radiological Protection

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    No practice shall be:

    System of Radiological Protection

    Adopted

    Introduced Conducted

    Discontinued

    Ceased

    (continued on next slide)

    S f

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    System of Radiological Protection

    and no source within a practice shall be: mined milled processed designed

    manufactured constructed assembled acquired imported exported

    distributed sold loaned hired

    received sited located commissioned possessed used

    operated maintained repaired transferred

    decommissioned disassembled transported stored disposed of

    except in accordance with the appropriate requirementsof the Standards, unless the exposure from suchpractice or source is excluded or exempted

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    System of Radiological Protection

    (2.10) Any legal personintending to carry out any of the

    actions specified on the previous slide shall submit a

    notification to the Regulatory Authority of such an

    intention

    Notification for consumer products is required only with

    respect to:

    manufacturing

    assembling importing

    distributing

    S t f R di l i l P t ti

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    System of Radiological Protection

    Any legal person applying for an authorization shall:

    submit relevant information necessary to support theapplication;

    refrain from carrying out any of the actions describedon the previous slides until the registration or license,has been granted;

    make an assessment of the nature, magnitude andlikelihood of the exposures attributed to the source

    and take all necessary steps for the protection andsafety of both workers and the public; and have a safety assessment made and submitted as part

    of the application if the potential for an exposure isgreater than any level specified

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    System of Radiological Protection

    Typical practices that are amenable to registration arethose for which:

    safety can largely be ensured by the design of the

    facilities and equipment;

    the operating procedures are simple to follow;

    the safety training requirements are minimal; and

    there is a history of few problems with safety

    Registration is best suited to those practices for which

    operations do not vary significantly.

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    System of Radiological Protection

    Registrants and licensees shall notify the RegulatoryAuthority of their intentions to introduce modifications to

    any practice or source for which they are authorized,

    whenever the modifications could have significant

    implications for protection or safety, and shall not carryout any such modification unless specifically authorized

    by the Regulatory Authority.

    Sources, including substances, materials and objects,

    within notified or authorized practices may be released

    from further requirements of the Standards subject to

    complying with clearance levels approved by the

    Regulatory Authority.

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    References:

    International Commission On RadiologicalProtection, 1990 Recommendations of the

    International Commission on Radiological

    Protection, Publication No. 60, Ann. ICRP 21 1-3,

    Pergamon Press, Oxford and New York (1991) International Basic Safety Standards for Protection

    against Ionizing Radiation and for the Safety of

    Radiation Sources, Safety Series No. 115, IAEA,

    Vienna (1996)

    CPR Part 3, Standards for protection against

    radiation, Phil. Official Gazette, 2004

    IAEA training modules

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    hank you for your attentionAny questions?

    Th ICRP B i F k

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    (134) Occupational exposure - exposures incurred at workas the result of situations that can reasonably be

    regarded as being the responsibility of the operating

    management

    Thus potassium-40 in the body, cosmic rays at ground

    level, and radionuclides in the earths crust are alloutside any reasonable scope of control

    Only radon in workplaces and work with materials

    containing natural radionuclides can reasonably be

    regarded as the responsibility of management

    The ICRP Basic Framework

    Th ICRP B i F k

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    (139) Medical exposure - exposures incurred byindividuals as part of their own medical diagnosis or

    treatment or to exposures incurred knowingly and

    willingly by individuals helping in the support and comfort

    of patients undergoing diagnosis or treatment

    Exposures incurred by volunteers as part of a programme

    of biomedical research are also dealt with on the same

    basis as medical exposure

    (140) Public exposure - all exposures other than

    occupational and medical mostly from natural sources

    The ICRP Basic Framework

    Q titi d U it

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    the main physical quantities used in the Safety

    Standards are:

    the rate of nuclear transformation of radionuclides

    called the activity which has units of reciprocalseconds (sec-1) or disintegrations per second

    (dps) and is termed the Becquerel (Bq)

    the energy absorbed by a unit mass of asubstance from the radiation to which it is

    exposed called the absorbed dose which has units

    of joule per kilogram and is termed the gray (Gy)

    Quantities and Units

    Q titi d U it

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    The absorbed dose is the basic physical dosimetric

    quantity of the Standards

    However, the effectiveness in damaging human tissue

    differs for different types of ionizing radiation

    The absorbed dose averaged over a tissue or organ is

    multiplied by a radiation weighting factor (wR) to take

    account of the effectiveness of the given type ofradiation in inducing health effects; the resulting

    quantity is termed the equivalent dose

    (absorbed dose x wR)

    Quantities and Units

    Quantities and Units

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    The likelihood of stochastic effects due to a given

    equivalent dose differs for different organs andtissues

    The equivalent dose to each organ and tissue ismultiplied by a tissue weighting factor (w

    T

    ) to takeaccount of the organs radiosensitivity

    The sum total of such weighted equivalent doses forall exposed tissues in an individual is termed the

    effective dose whose unit is the same as that of theequivalent and absorbed dose, namely joule perkilogram, but the name sievert (Sv) is used to avoidconfusion with the unit of absorbed dose (Gy)

    Quantities and Units

    Quantities and Units

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    In summary:

    Absorbed Dose x wRx wT= Effective Dose

    Quantities and Units

    Equivalent Dose

    Absorbed Dose x wR= Equivalent DoseEquivalent Dose x wT= Effective Dose

    Quantities and Units

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    When radionuclides are taken into the body, the

    resulting dose is received throughout the period of

    time during which they remain in the body

    The committed dose is the total dose delivered duringthis period of time, and is calculated as a time integral

    of the rate of receipt of the dose

    Quantities and Units

    Q titi d U it

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    The impact of the radiation exposure from a given

    practice or source depends on the number of

    individuals exposed and on the doses they receive

    The collective dose, defined as the summation of theproducts of the mean dose in the various groups of

    exposed people and the number of individuals in each

    group may therefore be used to characterize the

    radiation impact of a practice or source

    The unit of collective dose is the man-sievert (man-Sv)

    Quantities and Units

    C ll ti D

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    The Linear No Threshold (LNT) dose-responserelationship assumes that all radiation dose produces

    some stochastic effect and that the probability of the

    effect increases linearly with dose

    small dose small chance of effect

    large dose large chance of effect

    Therefore, the total stochastic effectproduced in the

    population is dependent on the total dosereceived by the

    population. Therefore, the Collective Dose is important.

    Collective Dose

    Collective Dose

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    Theoretically, a radiation dose of 0.1 Sv to one individualwould result in the same probability of a stochasticeffect as 0.01 Sv each to 10 different individuals.

    For example, the one individual exposed to 0.1 Sv would

    have a certain probability (P) of developing cancer.

    The LNT theory states that the 10 individuals exposed to0.01 Sv each would each have 1/10 the probability (0.1P)of developing cancer.

    Thus the total probability of cancer in the population of10 individuals would be 10 x 0.1P = P, the same as theone individual who was exposed to 0.1 Sv.

    Collective Dose

    Collective Dose

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    Of course, there is one big difference between the twoscenarios. If you happen to be the one individualexposed to 0.1 Sv, you have incurred all the risk. Theprobability of getting or not getting cancer rests solelyon your shoulders.

    However, if you happen to be in the group of 10receiving 0.01 Sv each, your individual probability is1/10 as large. That may sound comforting, butremember, the probability of getting cancer for thegroup was the same as for the individual. Therefore,just as above, you may or may not get cancer. If youdo, it will be the same cancer. It wont be 1/10 of acancer.

    Collective Dose

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    Where to Get More Information

    International Commission On Radiological

    Protection, 1990 Recommendations of the

    International Commission on Radiological

    Protection, Publication No. 60, Ann. ICRP 21 1-3,

    Pergamon Press, Oxford and New York (1991)

    International Basic Safety Standards for Protection

    against Ionizing Radiation and for the Safety of

    Radiation Sources, Safety Series No. 115, IAEA,

    Vienna (1996)


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