ML20206A480

Informs That Commission Has Concluded That Pennsylvania low-level Radiation Waste Regulations Have Been Found to Be Compatible with NRC Regulatory Program.List of Outstanding Issues Remaining Submitted

ML20206A480
Person / Time
Issue date:	02/04/1993
From:	Kammereer C NRC OFFICE OF STATE PROGRAMS (OSP)
To:	Dornsife W PENNSYLVANIA, COMMONWEALTH OF
Shared Package
ML20206A456	List: ML20206A452 ML20206A480
References
NUDOCS 9904280179
Download: ML20206A480 (63)

Text

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1. UNITED STATES

! o NUCLEAR REGULATORY COMMISSION i I wAsHWGTON, D. C. 20865 February 4,1993 Mr. William P. Dornsife, Director Bureau of Radiation Protection Department of Environmental Resources Fulton Building, 16th Floor Third and Locust Streets Harrisburg, Pennsylvania 17120

Dear Mr. Dornsife:

We are pleased to inform you that the Commission has concluded that Pennsylvania's low-level radioactive waste regulations have been found to be compatible with NRC's regulatory program. In view of this' finding, we look forward to an expeditious processing of your application once other outstanding issues The relating to your Limited Agreement application are resolved.

outstanding issues remaining are:

1. A response to the comments raised in letter dated January 9, 1991 (copy enclosed) conct,rning the draft i

)

program narrative;

2. Development of the State regulations equivalent to 10 CFR Part 20, " Standards for Protection Against Radiation;" and

3. Development of the State regulations equivalent to 10 CFR Part 71, " Packaging and Transportation of Radioactive Material."

Moreover, we understand there has been significant changes We in your program since the first draft package was submitted.

would like to meet with you to discuss these matters and to agree on a schedule for processing your Limited Agreement application.

Please contact us regarding your earliest availability for a meeting. I can be reached at 301-504-2321.

Sincerely, mn riton Kammerar, Director l

Office of State Programs

Enclosure:

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"* 12/3/98 DRAFT PROPOSED i

CEhPWR 215. EMBRAL PRWISIONS N PRWISIONS Sec. 215.1. Purpose and scope. j (e) NOTNITHSTANDING THE REQUIREMENTS INCORPORATED BY REFERENCE, NOTHING CONTAINED IN THIS ARTICLE RELIEVES OR LIMITS A PERSON FROM COMPLYING WITH THE

. REQUIREMENTS OF PENNSYLVANIA LAN, INCLUDING THE RADIATION PROTECTION ACT AND THE LON-LEVEL RADIOACTIVE WASTE DISPOSAL ACT.

(f) IF A PROVISION OF THE CODE OF FEDERAL REGUIATIONS INCORPORATED BY REFERENCE IN THIS ARTICLE INCLUDES A SECTION WHICH IS INCONSISTENT WITH THE PENNSYLVANIA CODE, THE PENNSYLVANIA CODE CONTROLS TO THE EXTENT FEDERAL LAN DOES NOT PREEMPT COBOCIRIEALTH LAN. IF A PROVISION OF THE CODE OF FEDERAL REGULATIONS INCORPORATED BY REFERENCE IN THIS ARTICLE IS BEYOND THE SCOPE OF

, AUTHORITY GRANTED THE DEPARTMENT UNDER STATUTE, OR IS IN EXCESS OF THE STATUTORY AUTHORITY, THE PROVISICIIS SHALL BE RWD RBEAIN EFFECTIVE ONLY TO THE EXTENT AUTNDRISED SY PREISYLVANIA LAN.

~ (g) APPROPRIATE PARTS OF ;10 CFR MAY BE OBTAINED FROM THE FOLLONING:

. m. '. t. z 9 e .n ~ . . . . . , ,

(1) UNITED STNfES @VENDENT PRINTING OT!? ICE, 2005 STORE, ROOM 118,, .

FEDERAL BUILDING,1000 LIBEItrY AVBlUE, PITTSBURGB, PSDISYLVANIA 15222, 412-664-2721.

(2) UNITED STATES GOVERNMENT PRINTING OFFICE, BOOK STORE, 100 NORTH 17TH STREET, ROBERT MORRIS BUILDING, PHILADELPHIA, PENNSYLVANIA 19103, 215-597-0677.

(3) UNITED STATES SUPERINTENDENT OF DOCUMENTS, UNITED STATES GOVERNMENT PRINTING OFFICE, WASHINGTON, D.C. 20402, 202-783-3238.

Sec. 215.2. Definitions.

-The following words and-terms, when used in this article, have the following meanings, unless the context clearly indicates otherwise:-

[ALARA--As low as is reasonably achievable (AIARA)--making every reasonable effort to maintain exposures to radiation as far below the dose limits in these regulations as is practical, consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of

-improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of

. nuclear energy and licensed or registered sources of radiation in th public interest.

A --the maximum activity of special form radioactive material permitted in a t

Type A package.

215-1

o A2

-- tha maximum activity of rrdioactiva material, other then spscial form radioactive material, permittsd in a Typa A packega. These valuas are either ,,

listed in Chapter 230, Appendix A (relating to packaging and transportation of radioactive materials)c Table I, or may be derived in accordance with the procedure prescribed in Chapter 230, Appendix A.

Absorbed dose--the energy imparted by ionizing radiation per unit mass of irradiated material. The units of' absorbed dose are the gray (Gy) and the rad.]

[ Agreement state--A state with which the NRC or the AEC has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954 (42 U.S.C.A. Sec. 2021(b)).

Airborne radioactive material--Radioactive ' material dispersed in t.he air in the form of dusts, fumes, particulates, mists, vapors or gases. 3 l

Airborne radioactivity area-- a ~ i roome enclosure; or area in which radioactive I

materials exist in concentrations as set forth in one of the following:

(i)

In excess of the derived air concentrations (DACs) specified in Chapter 219, Appendix B, Table I (relating to occupational values).

(ii) To such a degree that:an individual presenti in;the area without respiratory protective equipment-ciould exceed, during the hours an' individual'is present in a week, an intake of 0.6% of the annual limit on intake (ALI) or 12 DAC-hours.

BackgNoidubradiatk r ation from sa c s  ; naturaliy~ occurring radioactivelsatMials,7 " uding renon', except" as _afdecay ' product: of source or special nu' clear material,' andVincluding glbbalefaillout!"as. it: exists in the The term does not

) environment from the testing of nuclear explosive devices. include sources of radiation fr O+>

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Department.

Aa Becquerel (Bq)--theS 'I unit of a'ctivity. One becquerel is equal to 1 disintegration or transformation per second (dps or tps).]

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c p ' esses . .

(Byproduct material--One of the followings (i) Radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation

• incident to the process of producing or utilizing special nuclear material.' * ,

(ii) The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes-resulting from uranium or thorium solution extraction processes.

• Underground ore bodies depleted by these solution extraction' operations do not constitute " byproduct material" within this

't definition.

Calendar quarter--Not less than 12 consecutive weeks, nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January, and subsequent calendar quarters'shall be arranged so that no day is included in more than one calendar quarter and no day in one year is omitted from inclusion within a calendar quarter. No licensee or registrant may change the method observed by him of determining calendar quarters'for purposes of this article except at the beginning of a calendar year.

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, s l Collcctiva d 00--Th3 cum of tha individusi do Os rsc2ivsd in a giv2n psriod j

,, of time by c cpecified populatica from sxposura to a epscified sourca of j 2 radiation, j 1

Conunitted dose equivalent (H,,u)--The dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.

Committed effective dose equivalent (Hz,u)--The sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (Hz,5o = E w e, H,,so) .

Controlled area--an area, outside of a restricted area but inside the site I

boundary, access to which can be limited by the licensee or registrant for any reason.

Curie (C1)--The special unit of quantity of radioactivity. One curie (Ci) is that quantity of radioactive material which decays at the rate of 3.7 x 10" transformations per second (tps).

Deep dose equivalent (H4 ), which applies to external whole body exposure--

the dose aquivalent at a tissue depth of 1 centimeter (1000 mg/cm*) .

Depleted uranium--The source material uranium in which the isotope uranium- )

235 constitutes less than 0.711 weight percent of the total uranium present. 1 Depleted uranium does not include special nuclear material.

1 Dose-- A generic t '.that means absorbed dose, dose equivalent, effective f dose equivalent, ocaunit (dose equivalent, committed effective dose equivalent, l or total effdctive dosd .g valent. For purposes of this article, " radiation s

j dose" is an equivalent- . ... .

1 Dose equivalent (H,)--the prodiact of. the absorbed dose in tissue, quality

) factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (SV) and rem.

Dose limits--The permissible upper, bounds of radiation doses established in accordance with this article. For purposes of this article, " limits" is an equivalent term. ,

Effective dose equivalent (Hg)--the sum of the products of the dose equivalent to each organ or tissue (H,) and the weighting factor (w )r applicable to each of the body organs or tissues that are irradiated (He = E wdh) .

Embryo / fetus--the developing human organism from conception until the time of birth.]

[ Exposure--the quotient of dQ by dm where "dQ" is the absolute value of the total charge of the ions of one sign p.roduced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass "dm" are completely stopped in air. The special unit of exposure is the roentgen (R) . See Sec. 215.3 Units of Exposure and Dose for the SI equivalent.

Exposure rate--The exposure per unit of time, such as R per minute or mR per hour.

External dose--That portion of the dose _ equivalent received from any source

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l of radiation outside the body.

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1 Extremity--A hand, olbsw, arm b21cw iha albow, foot, knsa, or 1sg balow ths knas. ,,

Eye dose equivalent--The external dose equivalent to the lens of the eye at a tissue depth of 0.3 centimeter (300 mg/an*) .]

[ Generally applicable envirorumental radiation standards--Standards issued by the EPA under the authority of the Atomic Energy Act of 1954 (42 U.S.c.A. $$ 2011-

-229 -4) that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

Gray (Gy)--The SI unit of. absorbed dose.- One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).

High radiation area--An area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> at 30 centimeters from any source of radiation or from any surface that the radiation penetrates.)

[ Individual monitoring--the assessment of one of the followings (1). Dose equivalent by the use of individual monitoring devices or survey data.

(ii) Committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, that

) is, DAC-hours. See the definition of DAC-hours in 5 219.3 (relating to

' definitions).

Individual monitoring devices--Devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of this article,

" personnel dosimeter" and " dosimeter" are equivalent terms. Examples of. indi'vidual monitoring devices are-film badges, thermoluminescent dosimeters (TLDs), pocket ionization chambers, and personal air sampling devices.]

[ Internal dose--that portion of the dose equivalent received from radioactive material taken into the body.]

[ Licensed material--Radioactive material received, possessed, used, transferred or disposed of under a general or specific license issued by the

-Department.)

[ Lost or missing licensed or registered source of radiation--A licensed or registered source of radiation whose location is unknown. Th<s term includes licensed material that has been shipped but has not reached it... planned

' destination and whose location cannot be readily traced in the transportation system.

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Member of th3 public--An individuel [in a centrolled or unrastricted ares. An

.- individual.io nst a member of tha public during eny p3riod in which th2] EXCEPT

WHEN THAT individual [ receives) IS RECEIVING ~an occupational dose.

Minor--an individual under-18 years.of age.]

Misa& ministration FROM X-RAY THERAPY--The administration to a human being of l . [(i) A radiopharmaceutical dosage greater than 30 microcuries (1.11 MBq) of either sodium iodide I-125 or I-131 under one of the following conditions:

(A) Involving the. wrong patient or wrong pharmaceutical.

i '(B) When both the administered dosage differs from the prescribed dosage by more than 20% of the prescribed dosage and the difference between the administered and prescribed dosage exceeds 30 microcuries (1.11 MBq).

(ii) A therapeutic radiopharmaceutical dosage, other than sodium iodide I--

125 or I-131 under one of the following conditions:

l l (A) Ic.volving the wrong patient, wrong radirspharmaceutical, or wrong route of administration.

(B) When the administered dosage differs from the prescribed dosage by more than 20% of the prescribed dosage.

(iii) A gamma stereotactic radiosurgery radiation dose under one of the following conditions :

(A) Involving tNo wrong patient or wrong treatment site.

- (B) When the calculated total administereo dose differs from the j~ . total prescribed dose by more than 10% of the total prescribed dose.

l (iv) A teletherapy radiation dose under one of the following conditi ns:

(A) Involving the wrong patient, wrohg mode of treatment, or wrong j treatment site..

l (B) When the treatment consists of three or fewer fractions and thy l calculated total administered dose differs from the total prescribed dose by more than 10% of the total prescribed dose.

(C) When the calculated weekly administered dose is 306 greater than the l

weekly prescribed dose.

(D) When the calculated total administered dose differs from the total I prescribed dose by more than 20% of the total prescribed dose.

(v) A brachytherapy radiation dose under one of the following conditions:

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l L (A) Involving the wrong patient, wrong radioisotope, or wrong treatment j l~ site --eacluding,~.for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site);

(B)- Involving a sealed source that is leaking.

. (C) When, for a temporary implant, one or more sealed sources are not removed.upon completion of the procedure.

(D) When the calcul'ated administered dose differs from the prescribed

g. dose by more than 20% of the prescribed dose. ,

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(vi) A dicgnostic rediophnrmactutical drcega, othar than qurntities greater

• l than 30 microcuries (1.11 MBq) of either sodium iodide I-125 or I-131,when the .

conditions in clauses (a) and (b) apply:

[

(A) Involving the wrong patient, wrong radiopharmaceutical, wrong route of administration, or when the administered dosage differs from the prescribed dosage.

l (B) When the dose to the patient exceeds 5 rem (50 mSv) effective dose equivalent or 50 rems (0.5 Sv) dose equivalent to any individual organ.]

((vii) i) An X-ray therapy dose (with energies less than 1 MeV) under one of the following conditions:

(A) Involving the wrong patient, wrong mode of treatment, wrong treatment site, wrong tube potential, or wrong filtration.

(B) When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than 10% of the prescribed dose.

(C) When the calculated weekly administered dose is 30% greater than the weekly prescribed dose.

(D) When the calculated total administered dose differs from the total prescribed dose by more than 20% of the total prescribed dose.

([viii) ii) A radiation therapy dose using X-rays or electron beams with ve under one of the following conditions:

energies of 1 MeV and ,gyg% , i,.,- .

- o-(A) Involving the wrong patient, [ wrong mode of treatment,] wrong treatment site,[wrohg pNotoncor electron beam energy, wrong applicator] or wrong treatment (geometry] DELIVERY RMSULTING IN A DOSE DEVIATION DESCRIBED IN (B) - (D)

) BELOW. .

(Monitoring--The measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of this article, " radiation monitoring" and " radiation protection monitoring" are equivalent terms.]

NRC--United States Nuclear Regulatory Commission or ITS AUTHORIZED REPRESENTATIVES.

[ Normal form--Material in any form that does not qualify as "special form."

l Occupational dose--The dose received by an individual in a restricted area or I in the course of employment in which the individual's assigned duties involve exposure to sources of radiation, whether in the possession of the licensee, registrant, or other person. This term does not include dose received: from background radiation, as a patient from medical practices, from voluntary participation in medical research programs, or as a member of the public.)

)

[ Personnel monitoring equipment--See the definition of " individual monitoring devices".)

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[ Prescribed do' sage--The quantity of radiopharmaceutical activity as documented in one of the following methods:

t (i) In a written directive.

(ii) Either in the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user for diagnostic procedures.]

Prescribed dose FOR X-RAY THERAPY-[One of the following:

(i) For gasuna stereotactic radiosurgery, the total dose as documented in the written directive.]

[(ii)] For [ teletherapy,) X-ray therapy [,) and electron beam therapy, the total dose and dose per fraction as documented in the written directive.

. [(iii).For brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive.]

[Public dose--the dose received by a member of the public from exposure to sources of radiation either within a licensee's or registrant's controlled area or l

l in unrestricted areas. The term does not include occupational dose, dose received from background radiation, dose received as a patient from medical practices or dose from voluntary participation in medical resserch programs.]

Qualified emport-[An individual having the knowledge, training and experience to measure ionising radiation, to evaluate safety techniques and to advise regarding radiation protection needs. Examples include relevant certification by the American Board of Health Physics, the American Board of Radiology, or the <

equivalent.] AN INDIVIDUAL HAVING THE KNONLEDGE AND TRAINING TO MEASURE IONIZING RADIATION, TO EVALUATE SAFETY TECIDfIQUES, AND TO ADVISE REGARDING RADIATION PROTECTION NEEDS, FOR EXAMPLE, INDIVIDUALS CERTIFIED IN THE APPROPRIATE FIELD BY THE AMERICAN BOARD OF RADIOLOGY, OR THE AMERICAN BOARD.0F HEALTH PHYSICS, OR THE AMERICAN BOARD OF MEDICAL PHYSICS, OR THOSE HAVING EQUIVALENT QUALIFICATIONS.

WITH REFERENCE TO THE CALIBRATION OF RADIATION THERAPY EQUIPMENT, AN INDIVIDUAL l HAVING, IN ADDITION TO THE ABOVE QUALIFICATIONS, TRAINING AND EEPERIENCE IN THE CLINICAL APPLICATIONS OF RADIATION PHYSICS TO RADIATION THERAPY, FOR EXAMPLE, INDIVIDUALS CERTIFIED IN THERAPEUTIC RADIOIDGICAL PHYSICS OR X-RAY AND RADIUM PHYSICS BY THE AMERICAN BOARD OF RADIOLOGY, OR RADIATION ONCOLOGY PHYSICS BY THE AMERICAN BOARD OF MEDICAL PHYSICS, OR THOSE HAVING EQUIVALENT QUALIFICATIONS.

[ Rad--the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram (0.01 gray) .]

[ Radiation area--An area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.]

[ Radioactive material--A material--solid, liquid or gas--which emits radiation spontaneously.

i Radioactivity--The transformation of unstable atomic nuclei accompanied by the emission of radiation.]

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(Radiopharmaceutical--A pharmaceutical containing radioactive material.]

[ Rem--The special unit.of any of the quantities expressed as dose equivalent.

The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rma = 0.01 sievert).

Research and development--One of the followings (i) Theoretical analysis, exploration or experimentation.

(ii) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. The tema does not include the internal or external administration of radiation or radioactive material to human beings.

Restricted area--An area to which access is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. The tema does not include areas used for residential quarters, although a separate room in a residential building may be set. apart as a restricted area.

Roentgen (R)--The special unit of exposure, one roentgen equals 2.58 x 10" coulombs / kilogram of air. See exposure.

A3 Sealed' source--Radioactive material that is permanently bonded or-fixed in a capsule or matrix designed to prevent release and dispersal of the radioactive i

material under the most severe conditions'which are likely'to be encountered in

) normal use and handling.

S2--the abbreviation for the International System of Units.

Shallow dose equivalent (H.), which ' applies to the external exposure of the skin or an extremity--The dose equivalent at a tissue depth of 0.007 centimeter (7 tg/ ca') averaged over an area of 1" square centimeter.

Sievert (Sv)--The SI unit of anyLof the quantities expressed as dose equivalent. . The dose equivalent in. sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 ren) .

Site boundary--That line beyond-which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

Source material--Uranium or thorium, or a combination thereof, in a physical or chemical form or ores which contain by weight 0.05% or more of uranium, thorium or a combination thereof. The term does not include special nuclear material.

Special form--Radioactive material which satisfies the following conditions:

.(i) The material is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule.

(ii) The piece or capsule has at least one dimension not less than 5 millimeters (0.197 inch).

g (iii) The material satisfies the test requirements of regulations of the United States Department of Transportation 49 CFR 173.469. Special form 215-8

E j .

, encapsulaticns d331gned in acc:rd:nc3 with th2 requirements of 49 CFR 173.389(g)

[ . .~

• in offect en Jun3 30,_1983, cnd canstructed prior to July 1,1985 may continua to i 4 be used. Special form encapsulations either designed or constructed after June 30, 1985 shall meet the requirements of this subparagraph.

Special nuclear material--Plutonium, uranium 233, uranium enriched in the l ' isotope 233 or the isotope 235; material artificially enriched in plutonium, i

uranium 233, uranium enriched in the isotope 233 or the isotope 235. The term does not include source material.

Special nuclear material in quantities not sufficient to foca a critical mass--Uranium enriched in the isotope U-235 in quantities not exceeding 350 grams l of contained U-235;. uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or a combination of them in accordance with l the following formula For each kind of special nuclear material, determine the

ratio between tha quantity of that special nuclear material and the quantity l specified above'for the same kind of special nuclear material. The sum of the l ratios for all of the kinds of special nuclear material in combination may not i exceed "1" (i.e., unity). For example, the following quantities in combination would not exceed the lLaitation

175(grass contained U-235)/350 + 50(grams U-233)/200 + 50(grama Pu)/200 = 1 Survey--An evaluation of the production, use, release, disposal or presence

! of radiation sources under a specific set of conditions to determine actual or j potential radiation hazards. When appropriate, the evaluation includes, but is not limited to, tests, physical examinations and measurements of levels of radiation j or concentrations of radioactive material present.

l l TEDE--Total"offective' dose equivalent--The sum of the deep dose equivalent for external esposures % the committed effective dose equivalent for internal exposures.]

) ,

(Unrefined and unprocessed ore--Ore in its natural form prior to processing, such as grinding, roasting., beneficiating or refining.

l Unrestricted area--An area to which access 1s neither limited nor controlled by the licensee or registrant. For purposes of this article, " uncontrolled area"

.is an equivalent term.]

(Week--Seven consecutive days starting on Sunday.

l

' Whole body--For purposes of external exposure, the head, trunk including male gonada, arms above the elbow, or legs above the knee.]

l (Working level (WL)--A combination of radon-222 daughters in one liter of air

-which will result in the ultimate emission of 1.3 x 10' million electron volts of alpha particle energy.

Working level month (NLM)--The exposure resulting from inhalation of air containing a radon daughter concentration of 1 WL for 170 working hours.]

l Written directive FOR X-RAY THERAPY--An order in writing for a specific patient, dated and signed by an authorized user or licensed practitioner prior to the administration of (a radiopharmaceutical or radiation, except as specified in g subparagraph (vi), containing the following information] AN X-RAY THERAPY TREATMENT:

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((i) For any administration of quantities greater than 30 microcuries (1.11 .

MBq) of either sodium iodide I-125 or I-131, the dosage.

(ii) For a therapeutic administration of a radiopharmaceutical other than sodium iodide I-125 or I-131: the radiopharmaceutical, dosage, and route of administrations (iii) For gamma stereotactic radiosurgery: target coordinates, collimator size, plug pattern, and total dose.

(iv) For teletherapy: the total dose, dose per fraction, treatment site, and overall treatment period.

(v) For high-dose-rate remote afterloading brachytherapy: the radioisotope, -

treatment site, and total dose.

(vi) For all other brachytherapy the following apply:

(1) Prior to implantation: the radioisotope, number of sources, and source strengths, number, type and size of applicator.

(2) After implantation but prior to completion of the procedures the radioisotope, treatment site, and. total source strength and exposure time (or, equivalently, the total dose).]

((vii) i) For X-ray therapy at potentials less than 1 MeV: the total dose, dose per fraction, treatment site, field size (s), tube potential and filtration, and overall treatment period.

([viii] 11) For X-ray and electron beam therapy at energies of 1 MeV and above: the totaTdose, dose per fraction, treatment site, field size, beam type and energy, applicator, use of bema blocking or shaping devices, treatment

) geometry, and overall treatment period.

(Year--the period of time beginning in January used to determine compliance with this article. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that-the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.]

[Sec. 215.3 Units of Exposure and Dose.

(a) As used in this article, the unit of exposure is the coulomb per kilogram (c/kg) of air, one roentgen is equal to 2.58 x 10" coulomb per kilogram ~o f air.

(b) As used in this article, the units of dose ares (1) Gray (Gy) which is the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad) .

(2) Rad which is the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram (0.01 Gy).

(3) Ram is the special unit of any of the quantities expressed as dose equivalent.

The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rea = 0.01 Sv).

(4). Sievert is the SI unit of any of the quantities expressed as dose equivalent.

The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem).

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• (c) As used in this article, tha qunlity fcctero for crnvarting cb:orbsd done to do o cquivalent cra shrwn in e

TABLE I QUALITY FACTORS AND ABSORBED DOSE EQUIVALENCIES TYPE OF RADIATION Quality Factor (Q) Absorbed Dose Equal to a Unit Dose Equivalent

• X gamma or beta radiation 1 1 and high-speed electrons Alpha particles multiple- 20 0.05 charged particles fission fragments and heavy particles of unknown charge Neutrons of unknown energy 10 0.1 High-energy protons 10 0.1

• Absorbed dose in gray equal to 1 S'y or the absorbed dose in rad equal to I rem.

(d) If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in sievert per hour or rem per hour, as provided in subsection (c), 0.01 Sv (1 rem) of neutron radiation of unknown energies may, for purposes of this article, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the

). neutrons,thelicenseeorregistrantmayusethefluencerateperunitdose equivalent or the appropriate Q value from Table II to convert a measured tissue dose in gray or rad to dose equivalent in sievert or rem.

I l

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1

)

TABLE II '.

MEAN QUALITY FACTORS, Q, AND FLUENCE PER UNIT DOSE EQUIVALENT FOR MONOENERGETIC NEUTRONS Neutron Energy (MeV) Quality Factor

• Fluence per Uni,t Fluence per Unit (Q) Dose Equivalent- Dose Equivalent" (neutrons mi* rem'*) (neutrons cui* Sv'2) 2 980E+6 980E+8 (thermal) 2.5E-8 980E+6 980E+8 IE-7 2 1E-6 2 810E+6 810E+8 1E-5 2 810E+6 810E+8 2 840E+6 840E+8 1E-4 1E-3 2 980E+6 980E+8 1E-2 2.5 1010E+6 1010E+8 IE-1 7.5 170E+6 170E+8 11 39E+6 39E+8 SE-1 '

11 27E+6 27E+8 1

2.5 9 29E+6 29E+8 l 8 23E+6 23E+8 5

7 24E+6 24E+8

'7 6.5 24E+6 24E+8 10 7.5 17E+6 17E+8 14 8 16E+6 16E+8 20 .

7 14E+6 14E+8 40 60

5. 5 - 16E+6 16E+8

'? 6l 4 20994 20E+8 1E+2

's3.5% + 195+6 19E+8 2E+2 *?' s A7 !

"'m 3.5

• u -

165+6 16E+8 3E+2 .'

3.5 14E+6 14E+8

) ~*value 4E+2of quality factor (Q)'at the point where the dose equivalent is maximum in a 30-centimeter diameter cylinder tissue-equivalent phantom.

"Monoenergetic neutrons incident, normally on a 30-centimeter diameter cylinder tissue-egttivalent phantom.]

(Sec. 215.4 Units of Activity.

For purposes of this article, activity is expressed in the SI unit of beoquerel (Bq) or in the special unit of airborne curie (C1), or their multiples, or disintegrations or transformations per unit of time.

(a) One becquerel (Bq) = 1 disintegration or transformation per second (dps or tps).

(b) One curie (C1) = 3.7 x 10 1' disintegrations or transformations per second

. (dpa or tps) = 3.7 x 10** becquerel (Bq) = 2.22 x 10** disintegrations or transformations per minute (dpa or tpm).]

SEC. 215.5 EFFECT OF INCORPORATION OF THE CODE OF FEDERAL REGUIAFIONS (a) TITLE AND NANE CNANGES. TO RECONCILE DIFFERENCES BETWEEN THIS CHAPTER AND THE INCORPORATED SECTIONS OF FEDERAL REGULATIONS AND TO EFFECTUATE THEIR JOINT ENFORCBIENT, THE FOL A35ING WORDS AND PHRASES SHALL BE SUBSTITUTED FOR THE LANGUAGE OF THE raum-A ,' REGULATIONS AS FOLI4WS

)

(1) A REFERENCE TO NRC OR COBSGSSION MEANS DEPARTMENT.

215-12

a

- (2) A REFERENCE TO "NRC OR AGREEMENT STATE" MEANS " DEPARTMENT, NRC OR AGREEMENT STATE."

(b) FORMS AND DOCfDfENTS. REFERENCES TO FORMS IN THE FEDERAL REGULATIONS INCORPORATED BY REFERENCE WILL BE REPLACED BY THE APPROPRIATE FORMS PRESCRIBED BY THE DEPARTMENT.

RIGHTS AND RESPONSIBILITIES OF THE DEPARTMENT Sec. 215.11. Records.

[ Licensees and registrants shall maintain records showing the receipt, transfer and disposal of radiation sources.]

(a) REGISTRANTS SHALL MAINTAIN RECORDS SHOWING THE RECEIPT, TRANSFER AND DISPOSAL OF RADIATION PRODUCING MACHINES.

(b) LICENSEES SHALL MAINTAIN RECORDS SHOWING THE RECEIPT, TRANSFER AND DISPOSAL OF RADIOACTIVE MATERIAL AS DESCRIBED IN 10 CFR 30.51 (RELATING TO RECORDS).

Sec. 215.12. Inspections.

(c) Inspections byw,the Department.

, q .m s (1) facilities of registrants o.f radiation pr),oducing machines and licensees ofThe' Departm radiosctive material at'thelfollowing fr'equenciest" '

(1) for major medical'facilitie's,' including hospitals, at least once every [2] 3 years FOR X-RAY OPERATIONS.

(ii) for all other facilities, at least once'every four years for x-ray operations.

(iii) FOR LICENSEES, AT THE FREQUENCIES RECOfMENDED BY THE NRC.

S 215.25 DELIBERATE MISCONDUCT.

THE REQUIREMENTS UNDER 10 CFR 30.10 (RELATING TO DELIBERATE MISCONDUCT)

ARE INCORPORATED BY REFERENCE. THIS REQUIREMENT ALSO APPLIES TO REGISTRANTS.

5 215.26 EMPLOYEE PROTECTION.

THE REQUIREMENTS UNDER 15 CFR'30.7'(RELATING'TO EMPLOYEE PROTECTION) ARE INCORPORATED BY REFERENCE. THIS REQUIREMENT M SO APPLIES TO REGISTRANTS.

EIEMPTIONS S 215.32 Exemption qualifications.

The following sources, uses and type's'of users are exengt from Chapters 216-[230]

I 232.

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I

• 6 DRAFT PROPOSED Editors notes Sections 217.11-217.18, 217.21-217.24, 217.31o 217.32 217.41-217.49: 217.51-217. 5 7, 217. 65, 217. 71 -217. 74, 217.81-217. 93, 217.121 and 217.121 have been deleted and are not reprinted here.

l 12/3/98 CHAPTER 217. LICENSING OF RADIOACTIVE MATERIAL Subchapter A. GENERAL 5 217.1. Purpose and scope.

I *****

(b) A licensee is subject to Chapters 215, 218, 219, 220 and 230 (relating

! to general provisions! FEES 2 standards for protection against radiation, and l

notices, instructions and reports to workersi inspections 1 and l

transp rtation of radioactive material). A licensee engaged in industrial USES AIG radiographic operations is subject to Chapter 225 (relating to i

radiation safety requirements for industrial radiographic operations).'A j- licensee using radioactive material for human use is subject to Chapter 224 (relating to medical use of radioactive material). A licensee using sealed sources in well logging is subject to Chapter 226 (relating to LICENSES AND radiation safety requirements for (wireline service operations and subsurface tracer studies] WELL LOGGING),- A LICENSEE USING SEALED SOURCES IN IRRADIATORS IS SUBJECT TO CHAPTER 232 (RELATING TO LICENSES AND RADIATION l LAFETY REQUIREMENTS POR IRRADIATORS). A LICENSEE POR THE DISPOSAL OF LON-LEVEL RADIQACTIVE WASTES RECEIVED FROM OTHER PERSONS IS SUBJECT TO CHAPTER l ')

236 (RELATING TO LON-LEVEL RADIQACTIVE WASTE MANAGEMENT AND DISPOSAL).

r' *****

S 217.2. Address.

An application for a license, license renewal and license amendments and j

I other conununications under this chapter shall be addressed to the Bureau of l_

Radiation Protection, Department of Environmental (Resources] PROTECTION, Post Office Box (2063] 8469, Harrisburg, Pennsylvania (17120] 17105-8469.

f Editors notes Sections 217.11-217.18, 217.21-217.24o 217.31, 217.32, 217.41-217.49, 217.51-217.57, 217.65 217.11 -217. 74 r 217.81-217.93, 217.121 and 217.121 have been deleted and are not reprinted here.

Editor's notes The following proposed regulations are printed in normal font for readability.

SUBCHAPTER B. (EXEMPTIONS] GENERAL PROVISIONS FOR RADIQACTIVE MATERIAL S 217.130 Incorporation by reference.

(a) Except as provided in:this subchapter, the requirements of 10 CFR Part 30 (relating to rules of general applicability to domestic licensing of byprodnet material) are incorporated by reference.

(b) Notwithstanding the requirements incorporated by reference, 10 CFR 30.5

.(relating to interpretations), 10 CFR 30.8 (relating to comununications), 10 CFR 30.8 (relating to information collection requirements: OMB approval), 10 I CFR Part 30.63 (relating to violations) and 10 CFR Part 30.64 (relating to criminal penalties)'are not incorporated by reference.

217-1 1

7 o j o

'S 217.131.- Effect of incorporation of 10 CFR Part 30.

To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 30, the following words and phrases shall be substituted for the language in 10 CFR Part 30 as follows:

(1) A reference to NRC or Commission means Department.

(2) A reference to NRC or Agreement State means Department, NRC or Agreement State.

(3) The definition of sealed source includes NARM.

(4) The definition of licensed material includes NARM.

5 217.132. Persons possessing a license for source, byproduct or special nuclear material in quantities not sufficient to form a critical mass on the date the Commonwealth becomes an agreement state as published in the Federal Register.

On the date the Cossoonwealth becomes an agreement state as published in the Federal Register, a person who possesses a general or specific license issued by the NRC for source, byproduct or special nuclear material in quantities not sufficient to fona a critical mass, is deemed to possess a like license issued under this chapter and the act. The license shall expire either 90 days after receipt from the Department of a notice of expiration of the license, or on the date of expiration specified in the NRC license, whichever is earlier.

S 217.133. Filing application for specific licenses.

1 In addition to incorporation by reference,. an application for a specific l license shall be accompanied by the fee required under Chapter 218 (relating i to fees). l S 217.134. Renewal of licenses.

(a) An application for renewal of a specific license shall be filed under S 217.133 (relating to filing application for specific licenses).

(b) If a renewal application is filed prior to 30 days before the expiration of a license, the existing license does not expire until definitive notice has been given by the Department of its action on the renewal application. This subsection also applies to new lirsnse applications incorporating other licenses.  ;

5 217.135 Exempt concentrations. l In addition to the parts of 10 CFR 30 incorporated by reference, the i following requirements apply i (a) Except as provided in subsection (b), a person may receive, possess, use, transfer, own or acquire products or materials containing radioactive material introduced in concentrations less than those listed in Table 1 without possession of a license under this chapter.

I (b) Except under'a specific license issued under subchapter D (relating to specific licenses to manufacture or transfer certain items containing 217-2 I

. \

radioactive material), or the general license under subchapter F (relating to reciprocity), no person may introduce radioactive material into a product or material for distribution to persons exempt under subsection (a) or equivalent regulations of the NRC, an agreement state or licensing state.

TABLE 1 EXEMPT CONCENTRATIONS "E"

NOTE: SOME OF THE VALUES IN TABLE A-1 ARE PRESENTED IN THE COMPUTER NOTATION. IN THIS NOTATION A VALUE OF 6E-02 REPRESENTS A VALUE OF 6 X 10 OR 0.06, 6E+2 REPRESENTS 6 X 10' OR 600, AND 6E+0 REPRESENTS 6 X 10* OR 6.

Column il Column i Liquid and solid Element Gas concentration concentrat ion isotope pCi/ml pCi/ml (Momic number)

Ao 228 9E-04 Adinium (89)

Cd 109 2E-03 Cadmium (48)

Co-129 3E-03 Cesium (56)

Europk51(63) Eu-154 2E-04 Ga-67 2E-03 Gallium (31)

Germanium (32) Ge48 9E-03 Au-195 1E-02 Gold (79) in-111 1E-03 indium (49) 1-123 3E-04 lodine (53) l-124 4E-06 l-125 2E-06 ,

I Pb-212 2E-04 Lead (82)

Phosphorus (15) P-33 3E-04 f Potassium (19) K-43 2E-04 l 2E 03 l Protactinium (91) Pa-230 Ra-223 7E-06 l Radium (88) I Ra-224 2E-05 Ra 228 3E-07 Redon (86) Rn-220 1E-07 Rn 222 3E-08 Sodium (11) No-22 4E-04 Technetium (43) To 97m 4E-03 Xenon (54) Xe-127 4E-06 Yttrium (39) Y-88 8E-04 5 217.136 Exempt quantities.

)

In addition to the parts of 10 CFR 30 incorporated by reference, the following requirements apply:

217-3 1

3

[-

i  :.

. g3

)

(a)'A person may receive, possess, use, transfer, own or acquire radioactive material-in individual quantities each of which is less than those listed in Table 2 if the person does not produce, package or repackage radioactive i material for purposes of comunercial distribution or incorporate radioactive material into products intended for comunercial distribution.

(b) Except under a specific license issued by the NRC under 10 CFR 32.18 (relating to manufacture, distribution and transfer ef exempt quantities of byproduct material Requirements for license) or by the Department under 5 217.82 (relating to licensing the distribution of NARM in exempt quantities) which states that the radioactive material may be transferred by the licensee to persons exempt under this section or the equivalent regulations of the NRC, an agreement state or licensing state, no person may, for purposes of commercial distribution,, transfer radioactive material for distribution to persons exempt under subsection (a) or equivalent regulations of the NRC, an agreement state or licensing state.

TABLE 2 EXEMPT QUANTITIES Radoeceve Malertal Microcuries kAc22s) 1  ;

seryWim 7 $7) 10 eismuih 207(ei207). 10

' cesium-12e (cs t2s) 100 ,

Cobs 2-57 (Co 57) 100 GalNum47 (Ga 67) 100 j Germanium 4s 10  ;

GoW-195 (Au 195) '10  ;

Gold-1se (Au iss) 1  !

. Insum-111 On 111) 100 1 iodine 123 0123) 100  !

loane 124 0124) 1 leteum-is0or190) 100 Lead-203 (Pb 203) 100 Lead-210 (Pb 210) 0.1 Lead-212 (Pb 212) 10 Phosphorus-33 (P 33) 10 Potassium 43 (K 43) 10 Protactinium-230 (Pa 230) 10 Protactinium 231 Pe 231) 0.1 Resum-223 (Ra 223) 1 RaJium-224 (Ra 224) 1 Radium-226 (Ra 228) 0.1 Radum-228 (Ra 228) 0.1 Redon-220 (Rn 220) 1 i I 1 Redon-222 (Rn 222)

Ahenium 183 (Re 183)- 100 t

Riiesiisn-147 (Re 187) 100 p

Rubidum41 (Rb 81) 10 217-4

e Scandium-46 (Sc 46) 10 SodeJm-22 (Na 22) 10 Technetkun-96m (Tc 96m) 100 Xenon 127 (Xe 127) 1,000 Yurium-87 (Y 87) 10 Yurium-88 (1f 88) 10 SUBCHAPTER C. GENERAL LICENSES FOR RADI0 ACTIVE MATERIAL S 217.140 Incorporation by reference.

(a) Except as provided in this subchapter, the requirements of 10 CFR Part 31 (relating to general domestic licenses for byproduct material) are incorporated by reference.

(b) Notwithstanding the requirements incorporated by reference, 10 CFR 31.4 (relating to information collection requirements: OMB approval), 10 CFR Part 31.13 (relating to violations) and 10 CFR Part 31.14 (relating to criminal penalties) are not incorporated by reference.

S 217.141. Effect of incorporation of 10 CFR Part 31.

To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 31, the following words and phrases shall be substituted for the language in 10 CFR Part 31 as follows:

(1) A reference to NRC or Comunission means Department. 1 l (2) A reference to NRC or Agreement State means Department, NRC or Agreement State.

(3) The definition of sealed source includes NARM.

(4)'The definition of licensed material includes NARM.

S 217.142 Certain measuring, gauging or controlling devices.

In add l tion to the parts of 10 CFR 30.5 incorporated by reference, general licensees must also comply with the following (a) Conduct a physical inventory every 6 months to account for all sources and/or devices received and possessed under this section and do the following (1) Maintain the physical inventory records for 3 years from the date of each inventory.

(2) Furnish a report to the Department annually showing to the extent practical, the make, model, serial number, isotope, source activity and location of each device. The report shall list an individual to contact regarding questions about this report.

(b) For portable devices, shall also comply with the following:

(1) A person who initiates acquisition of a portable device and does not already hold a license under subsection (a) must notify the Department within 15 days of their action.

l \

I 217-5

f- 1 l .

(2) Portable devices may only be used by or under the direct supervision l of individuals who have been instructed in the operating and emergency procedures necessary for ensuring safe use.

(3) For each individual that the licensee permits to use a portable device, the licensee shall maintain a record showing the type of device use permitted and the basis for that authorization such as training certificates. I An individual's record shall be kept for at least 3 years after the individual terminates association with the licensee.

(4) Portable devices shall be secured against access by unauthorized i personnel when not under the direct surveillance of an individual authorized l to use the device.

(5) The licensee shall maintain current logs, which shall be kept available for inspection by the Department for 3 years from the date of the event, showing for each portable device the following applicable information.

(i) the model and serial number of the device.

(ii) the name of the assigned user.  !

(iii) Locations and dates of use.

(6) Emergency instructions shall accompany each portable device taken off the premises.of the' licensee.

' . 0- .mo .

2 S 217.143. Incidental.raldioactive material produced by a particle accelerator. l

)

A general license is issued to possess radioactive material produced i incidentally to the operation of a particle accelerator. The general license is subject to the applicable provisions of Chapters 215, 217, 219 and 220.

A licensee may transfer this radioactive material only under subchapter H and Chapter 230 (relating to transfer of materials and packaging and transportation of radioactive material). A licensee.may dispose of this radioactive material only with Department approval.

1 SUBCHAPTER D. (TRANSFER OF RADIOACTIVE MATERIAL) SPECIFIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING RADIOACTIVE MATERIAL

$ 217.150 Incorporation by reference.

l (a) Except as provided in this subchapter, the requirements of 10 CFR Part 32 (relating to specific domestic licenses to manufacture or transfer certain items containing byproduct material) are incorporated by reference, l (b) Notwithstanding the requirements incorporated by reference, 10 CFR 32.8 (relating to information collection requirements: OMB approval) is not  ;

incorporated by reference.

Section 217.151. Effect of incorporation of 10 CFR Part 32. l To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 32, the following words.and phrases shall be substituted for

) the language in 10 CFR Part 32 as follows:

217-6 l

I.

(1) A reference to NRC or Conunission means Department.

(2) A reference to NRC or Agreement State means Department, N1 C or Agreement State.

(3) The definition of sealed source includes NARM.

(4) The definition of " licensed material" includes NARM.

(5) A reference to byproduct material includes NARM.

S 217.152. Licensing the incorporation of NARM a.nto gas' anc' aerosol detectors.

An application for a specific license authorizing the inct tporation of NARM into gas and aerosol detectors to be distributed to persors exempt under subchapter B(relating to general provisions for radioactite material) will be approved if the application satisfies requirements equivt/ ant to those in 10 CFR 32.26--32.29. The maximum quantity of radium-226 may not exceed 0.1 microcuries (3.7 kBq). 1 S 217.153. Special requirements for license to manufac' are calibration sources containing americium-241, or radium-226.

In addition to the incorporated by reference of 10 C' R 32.57 (relating to l calibration sources containing americium-241) applirants using radium-226 in calibration or reference sources must comply with 7> CFR 30.57.

i S 217.154. Manufacture and distribution of radios.tive material for certain in vitro clinical or laboratory. testing under gener,1 license.

I (a)- In addition to the requirements incorpora'.ed by reference of 10 CFR 32.71

-(relating to manufacture and distribution of adioactive material for certain in vitro clinical or laboratory testing unde . general license)' applicants using cobalt-57 saast prepare for distributi a the cobalt-57 in prepackaged -

units that do not exceed 10 microcuries (?' O kBq) . of cobalt-57.

(b) A prepackaged unit must bear a duralle, clearly visible label identifying the radioactive contents as to chemical. form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 microcuries (370 kBq) cobalt-57.

SUBCHAPTER E. [ RESERVED]

SUBCHAPTER F. [ RECIPROCITY) SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR RADIOACTIVE MATERIAL S 217.160 Incorporation by reference.

(a) Except as provided in this subchapter, the' requirements of 10 CFR Part 33 (relating to specific domestic licenses of broad scope for byproduct material) are incorporated by reference.

(b) Notwithstanding the requirements incerporated by reference, 10 CFR 33.8 (relatinl, to information collection requirements: OMB approval), 10 CFR Part 33.21 (relating to violations) and 10 CFR Part 33.22 (relating to criminal penalties) are not-incorporated by reference.

5 217.161. Effect of incorporation of 10 CFR Part 32.

.y.

217-7

I

• f; To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 32, the following words and phrases shall be substituted for l the language in 10 CFR Part 32 as follows:

I ' (1) A reference to NRC or Cossaission means Department.

(2) A reference to NRC or Agreement State means Department, NRC or Agreement State.

l (3) The definition of sealed source includes NARM.

l (4) The definition of " licensed material" includes NARM.

(5) A reference to byproduct material includes NARM.

S 217.162. Types of specific licenses of broad scope.

In addition to the incorporation by reference of 10 CFR 33.11 (relating to types of specific licenses of broad scope), the following requirements for licensees using NARM also apply:

(a) A Type B specific license of broad scope is a specific license

! authorizing receipt, acquisition, ownership, possession, use and transfer of a chemical or physical form of radioactive material specified in Table 3, for an authorized purpose. The possession limit for a Type B broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Column I, Table 3. If two or more radionuclides are possessed thereunder, the possession limit for.each is determined as follows: for each'radionuclide,-determine the ratio of the quantity I' possessed to the applicable quantity specified in Column I, Table 3, for that radionuclide; the sum of the ratios for radionuclides possessed under

( the license.may not exceed unity.

(b) A Type C specific license of broad scope is a specific license .

authorizing receipt, acquisition, ownership, possession, use and transfer of a chemical or physical form of radioactive material specified in Appendix D,

for an authorized purpose. The possession limit for a Type C broad license,

if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Column II, Table 3. If two or more radionuclides I are possessed thereunder, the possession limit is determined for each as follows

for each radionuclide detersd.ne the ratio of the quantity possessed to the applicable quantity specified in Column II, Table 3, for that radionuclide; the sum of the ratios for radionuclides possessed under the license may not exceed unity.

l TABLE 3 l

l LIMITS FOR BROAD LICENSES l

I Radioactive Material Col. I curies Cel. Il curies i

Beryllium-7 10 0.1 Cobalt 57 10 0.1 Radium-226 0.0001 i ' Sodium-22 0.1 0.001 217-8

__m-

n SUBCHAPTER G.' LICENSING OF SOURCE MATERIAL

$ 217.170 Incorporation by reference.

(a) Except as provided in this subchapter, the requirements of 10 CFR Part 40 (relating to domestic licensing of source material) are incorporated by reference.

(b) Notwithstanding the requirements incorporated by reference, 10 CFR 40.5 (relating to conmounications), 10 CFR 40.6 (relating to interpretations), 10 -

CFR 40.8 (relating to information collection requirements: OMB approval), 10 CFR Part.40.81.(relating to violations) and 10 CFR Part 40.82 (relating to  !

crianinal penalties) are not incorporated by reference.

S 217.171. Effect of incorporation of 10 CFR Part 40.

To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 40, the following words and phrases shall be substituted for the language in 10 CFR Part 40 as follows:

(1) A reference to NRC or Commission means Department.

(2) A reference to NRC or ' Agreement State means Department, NRC or Agreement

's>

State. 'r.. a y. , .y n; -e. v (3) The defisiition of sailled souros; includes

• NARM. 4- . x

~

(4)'The definition of licensed material'inciudes MAIW(. .

).

SUBCHAPTER H., LICENSING OF SPECIAL NUCLEAR MATERIAL

$ 217.180 Incorporation by reference. .

(a) Except.as provided in this subchapter, the requirements of 10 CFR Part 70

-(relating to domestic licensing of special nuclear material) are incorporated by reference.

(b) Notwithstanding the requirements incorporated by reference, 10 CFR 70.5 (relating'to communications), 10 CFR 70.6 (relating to interpretations), 10 CFR 70.8 (relating to information collection requirements: OMB approval), 10 CFR Part 70.71 (relating to violations) and 10 CFR Part 70.72 (relating to criminal penalties) are not incorporated by reference.

S 217.181.. Effect of incorporation of 10 CFR Part 70.

'To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 70, the following words and phrases shall be substituted for the language in 10 CFR Part 70 as follows:

(1) A reference to NRC ~or Commission means Department.

(2) A reference to NRC or Agreement State means Department, NRC or Agreement State.

(3) The definition of sealed source includes NARM.

(4) The: definition of." licensed material" includes NARM.

217-9 L

Lu . _ _ _ >

i .

h b

Subchapter I. TRANSFER OF RADIOACTIVE MATERIAL S 217.190. Transfer of material.

(a) Subject to subsections (b)--(d), a licensee may transfer radioactive material only:

(1) To the Department, but only after receiving prior approval from the Department.

(2) To the United States Department of Energy.

(3) To a person exempt from this article to the extent penmitted under the exemption.

(4) To a person authorized to receive the material under terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the Department, the NRC, an agreement state or a licensing state, or to a person otherwise authorized to receive the material by the Federal government or an agency thereof, the Department, an agreement state or a licensing state.

(5) Toapersonotherwis.e[/authorizedbytheDepartmentinwriting.

, m;P (b) Before transferring radioactive. material to a specific licensee of the Department, of the NRC, of an agreement state or of a licensing state, or to a g general licensee who is required to furnish information to the Department

/ under subchapter C (relating to general licenses for radioactive material) or subchapter G (relating to licensing of source material), or, to the NRC, to an agreement state or to a 1,icensing state prior to receipt of the radioactive material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form and quantity of radioactive material to be transferred.

(c) The following methods for the verification required by subsection (b) are acceptable:

(1) The transferor may possess a current copy of the transferee's specific license or certificate.

(2) The transferor may possess a written certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, foam and quantity of radioactive material to be transferred, specifying the license or certificate number, issuing agency and expiration date.

(3) For emergency shipments the transferor may accept oral certification from the transferee that he is authorized by license'or certificate to receive the type, form and quantity of radioactive material to be transferred, specifying the license or certificate number, issuing agency and expiration date. The oral certification shall be confirmed in writing within 10 days.

(4) The transferor may obtain.other sources of information compiled by a reporting service from official records of the Department, the NRC, the licensing agency of an agreement state or a licensing state as to the identity I of licensees and the. scope and expiration dates of licenses.

217-10

p (5) If none of the methods of verification described in paragraphs (1)--(4) are readily available or if a transferor desires to verify that information received by one of the methods is correct or up-to-date, the transferor may obtain and record conficantion- from the Department, the NRC, or the licensing agency of an agreement state or a licensing state that the transferee is licensed to receive the radioactive material.

(d) Preparation for shipment and transport of radioactive material shall be in accordance with Chapter'230 (relating to packaging and transportation of radioactive material) .

Subchapter J. RECIPROCITY S 217.200 Incorporation by reference.

(a) Except as provided in this subchapter, the requirements of 10 CFR Part 150.2 (relating to scope)and 10 CFR Part 150.20 (relating to recognition of Agreement State licenses) are incorporated by reference.

'S 217.201. Effect.of incorporation of 10 CFR Part 150.

To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 150, the following words and phrases shall be substituted for the language in 10 CFR.Part 150 as follows:

(1) A reference to'NRC or Commission means Department.

(2) A reference to NRC or Agreement State means Department, NRC or Agreement

.I State.

(3) The definition of sealed ~ source includes MARN.

(4) The definition of licensed material includes NARN.

5 217.202. Reciprocity of licenses of naturally occurring and accelerator-produced radioactive material.

(a) Subject to this article, a person who holds a specific license from a licensing state where the licensee maintains an office, issued by the agency having jurisdiction to direct the licensed activity and to maintain radiation safety records, is granted a general licenso to conduct the activities authorized in the licensing document within this commonwealth for a period not in excess of 180 days in a calendar year if:

(1)' The licensing document does not limit the activity authorized by the document to specified installation or locations.

(2) The out-of-State licensee notifies the Department in writing at least 3 days prior to engaging in the activity. The notification shall indicate the location, period and type'of proposed possession and use within this Commonwealth, and shall be accompanied by a copy of the pertinent licensing i- . document. If for a specific case, the 3-day period would impose an undue hardship on the out-of-State licensee, the licensee may, upon application to the Department, obtain permission to proceed sooner. The Department may waive-the requirement for filing additional written notifications during the remainder. of the ~ calendar year following the receipt of the initial

.) : notification from a person engaging in activities under the general license provided in this subsection.

217-11

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I (3)' The out-of-State licensee complies with this title and with the terms and

't- conditions of the licensee's document, except terms and conditions which may j be inconsistent with this title. ,

1 (4) The out-of-State licensee supplies other infonnation as the Department may request.

(5)'The'out-of-State licensee does not transfer or dispose of radioactive material possessed or used under the general license provided in this subsection except by transfer to a person who is one of the followings (1) Specifically. licensed by the. Department or Lv another licensing state to receive the material.

-(ii) Exempt from the requirements _for a license for the material under subchapter B (relating to general provisions for radioactive material).

(b) Notwithstanding the provisions of subsection (a), a person who holds a specific license issued by a licensing state authorizing the holder to

< manufacture, transfer, install or service a device described in subchapter C (relating to general licenses :for radioactive material) within areas subject to the jurisdiction of the licensing body is granted a general license to i install, transfer, demonstrate or service .the device in this cosmoonwealth if: j I

(1) The person files a re of a calendar quarter in' which port with the Department a device within is transferred,to 30 installed ort. days after inthe end this commonwealth. The report shall identify the general licensee'to whom the.

device is transferred by name and address, the type of device transferred and the quantity and type of radioactive material contained in the device.

(2) The device has been manufactured, labeled, installed and serviced in accordance with the specific license issued to the person by a licensing l

state.

(3) The person assures that labels required to be affixed to the device under

' regulations of the authority which licensed manufacture of the device bear a statement that " Removal of this label is prohibited."

l l

(4) The holder of the specific license furnishes to the general licensee to

! whom the specific licensee transfers the device.or on whose premises the.

l specific licensee installs the device a copy of the general license contained l in subchapter C (relating to Janeral licenses for radioactive material).

(c) The Department may withdraw, limit or qualify its. acceptance of a specific license or equivalent licensing document issued by another agency, or product distributed under the licensing document, upon determining that the action is i- necessary'in order to prevent undue hazard to public health and safety or property.

(d) when a person is granted a general license under subsection (a) and '

i subsequently exceeds the prescribed 180-day period, the person shall file a license application with the Department under subchapter B (relating to general provisions for radioactive material) within 30 days after the end of the 180-day period.

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]

217-12

n DRAFT PROPOSED 11/12/98 Editors notes Sections 219.3, 219.4, 219.21, 219.31-219.38, 219.52, 219.71, 219.72, 219.91-219.93, 219.111-219.113, 219.151-219.158, 219.161, 219.162, 219.181-219.186, 219.201-219.211, and 219.221-219.226 have been deleted and are not reprinted here.

CNAPTER 219 gammene yOR PROTECTIN hahmsT RADIATIM subahapter A. meummat PROVISIOhis Editors notes Sections 219.3, 219.4 are being deleted and are not printed here. , ,

SEC 219.5 INCORPORATION BY' REFERENCE.

(a) EXCEPT AS PROVIDED IN THIS CHAPTER, THE REQUIREMENTS OF 10 CFR PART 20 (*"2*SG TO STANIERDS FOR PROTECTION AGAINST RADIATION) ARE INCORPORATED SYJtRFERWCE. .,.,

(b) NOTiiITESTANDING THE REQUIRMENTS INCORPORATED BY REFERENCE, 10 CFR

) 20.1006 (RELATING TO INTERPRETATIONS), 10 CFR 20.1009.(RELATING TO INFORMATION COLLECTION REQUIREMENTS: OMB APPROVAL), 10 CFR PART 20.2401 (RELATING TO VIDIATIONS) AND 10 CFR PART 20.2402 (RELATING TO CRIMINAL PENALTIES) ARE NOT INCORPORATED BY REFERENCE.

SECTION 219.6. EFFECT OF INCORPORATION OF 10 CFR PART 20.

TO RECONCILE DIFFERENCES BETWEEN THIS CHAPTER AND THE INCORPORATED SECTIONS OF 10 CFR PART 20, THE FOLLOWING NORDS AND PHRASES SHALL BE SUBSTITUTED FOR THE LANGUAGE IN 10 CFR PART 20 AS FOLLONS:

(1) A REFERENCE TO NRC OR CO N SSION MEANS DEPARTMENT.

I (2) A REFERENCE TO NRC OR AGREEMENT STATE MEANS " DEPARTMENT, NRC OR AGREEMENT STATE.

(3) A REFERENCE TO LICENSEE INCLUDES REGISTRANT.

(4) A REFERENCE TO LICENSE INCLUDES REGISTRATION.

(5) A REFERENCE TO LICENSED INCLUDES REGISTERED.

(7) A REFERENCE TO DEPARTMENT IN THIS CHAPTER MEANS THE U.S.

DEPARTMENT OF ENERGY 2 Editors notet Sections 219.3, 219.4, 219.21, 219.31-219.38 and are  ;

being deleted and are not printed here.

219-1

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Sec. 219.51 Dose limits for individual members of the public.

(a) IN ADDITION TO INCORPORATION BY REFERENCE OF 10 CFR PART 20, I (The] A [ licensee or] registrant [shall] MAY conduct operations so that the (following conditions are mett]

[(1) Except as provided in paragraph (2),the total effective dose equivalent to individual members of the.public from the licensed or registered operation does not exceed 1 mSv (0.1 rem) in a year, exclusive of the dose contribution from the licensee's or registrant's .

disposal of radioactive saterial into sanitary sewerage in accordance '

with Sec. 219.183 (relating to disposal by release into sanitary sewerage)] . TOTAL EFFECTIVE DOSE EQUIVALENT TO INDIVIDUAL MEMBERS OF THE PUBLIC IN UNRESTRICTED AREAS FROM EXPOSURE TO RADIATION FROM DIAGNOSTIC RADIATION MACHINES DOES NOT EXCEED 5 mSv (0.5 REM) PER YEAR.

[(2) The total effective dose equivalent to individual members of the public in unrestricted areas from exposure to radiation from diagnostic radiation machines does not exceed 5 mSv (0.5 rem) per year (3) The dose in any unrestricted area from external sources does not ,

exceed 0.02 mSv (0.002 rem) in any one hour, if an individual were  !

continuously present in the area.]

(b) *****

.)' [(c) If the licensee or registrant permits members of the public to have access to controlled areas, the limits for members of the public continue to apply to those individuals.

(d) A licensee or registrant may apply for Department authorization to operate up to an annual dose limit for an individual member of the public of 5 mSv (0.5 rem). This application shall include the following informations (1) A demonstration of the need for and the expected duration of operations in excess of the limit in subsection (a), including anticipated average radiation levels and anticipated occupancy times for each unrestricted area involved.

(2) The licensee's or registrant's program to assess and control dose within the 5 mSv (0.5 run) annual limit.

(3) The procedures to be followed to maintain the dose ALARA.

(e) In addition to the requirements of this chapter, a licensee or registrant subject to the provisions of the U.S. Environmental Protection Agency's generally applicable env1ronmental radiation standards in 40 CFR Part 190 (relating to environmental radiation protection standards for nuclear power operations) shall comply with

! those standards.

I (f) The Department may impose additional restrictions on radiation

) levels in unrestricted areas and on the total quantity of s

e 219-2

. )

radionuclides that a licensee or registrant may release in effluents in order to restrict the collective dose.)

Editors notes section 219.52 has been deleted and is not reprinted here.

Sec. 219.61 Testing for leakage or contamination of sealed sources.

(a) IN ADDITION TO INCORPORATION BY REFERENCE OF 10 CFR PART 20, [A]

a, licensee possessing any sealed source shall assure that:

Editors notes Sections 219.71, 219.72, 219.91-219.93, 219.111-219.113 have been deleted and are not reprinted here.

Sec. 219.131 Security of stored sources of radiation.

IN ADDITION TO INCORPORATION BY REFERENCE OF 10 CFR PART 20, [The licensee or) a registrant shall secure frost unauthorized removal or access (licensed or registered or) sources of radiation that are stored in controlled or unrestricted areas.

i.

Sec. 219.132 ; control of sources of' radiation not in storage.

4:

[(afThelioensesshallcontrolandmaintainconstantsurveillanceof licensed radioactive material that is in a controlled or unrestricted area and that is not'in storage or in a. patient.) .

)-

[(b)) IN ADDITION TO INCORPORATION BY REFERENCE OF 10 CFR PART 20, l [The) a, registrant shall maintain control of radiation machines that are not in storage'.

Editors notes Sections 219.151-219.158, are being deleted.and are not reprinted here.

I

! Sec. 219.159 Posting of radiation-producing machines.

['ahel A registrant shall ensure that each radiation machine is labeled in a conspicuous manner which cautions individuals that radiation is produced when it is energized. For example:

CAUTION -- RADIATION

-THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED Sec. 219.160 Exceptions to posting requirements.

[(a) A licensee or registrant is not required to post caution signs in areas or rooms containing sources of radiation for periods of less than 8._ hours, if each of the following conditions is met:

-(1) The sources of radiation are constantly attended during these periods by antindividua10who takes the precautions necessary to

) prevent the espo'sure of individuals to sources of radiation in excess of the limits established in this chapter.

219-3

7_. _

e (2) The area or room is subject to the licensee's or registrant's control.

(b) Rooms or other areas in health care facilities in which patients containing radioactive material are present are not required to be posted with caution signs under Sec. 219.153 (relating to posting of radiation areas) so long as the patient could be released from confinement under See 224.109 (relating to release of patients containing radiopharmaceuticals or permanent implants).

(c) A room or area is not required to be posted with a caution sign because of the presence of a sealed source if the radiation level at 30 centimeters from the surface of the sealed source container or housing does not exceed 0.05 mSv (0.005 rem) per hour.]

[(d)) IN ADDITION TO INCORPORATION BY REFERENCE 7F 10 CFR PART 20, [A]

a room or area is not required to be posted with a caution sign because of the presence of radiation machines used solely for diagnosis in the healing arts.

[(e) A room or other area is not required to be posted with a caution sign, and control is not required for each entrance or access point to a roam or other area solely because of the presence of radioactive material prepared for transport and packaged and labeled under 49 CFR Parts 171-179 "(rel,ating to hazardous materials regulations) and 67 Pa.

Code,. Chapter 40.3*(relating to hazardous materials transportation).]

Editors notes Sections, 219.161, 219.162, 219.181-219.186, 219.201-

) 219.211, and 219.221-219.226 have been deleted and are not reprinted here.

Sec. 219.228 Reports of misadministrations FROM X-RAY THERAPY.

(a) For a misadministration FROM X-RAY THERAPY the [ licensee or]

registrant shall do the following:

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t 219-4 l l

DRAFT PROPOSED 3 11/12/98 I

Editor's Note: Sections 220.3 through 220.8 have been deleted and are not reprinted here.

CEAPTNR 220. NOTICES, INSTRUCTIONS AM REPORTS TO

- a; INSPECTIONS A m INVESTIGATIONS

-5 220.2. Posting of notices to workers.

(d) Department documents posted under subsection -(a) (4) shall be posted within [5) 2, working days after receipt of the documents from the Department; the licensee's or registrant's response shall be posted within 5 working days after dispatch from the licensee or registrant. The documents shall remain posted for a mininsan of 5 working days or until action-correcting the violation has been completed, whichever is later.

SEC 220.9 INCORPORATION BY REFERENCE.

(a) EXCEPT AS PROVIDED IN THIS CHAPTER, THE REQUIREMENTS OF 10 CFR PART 19 (RELATING TO NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS: INSPECTIONS AND INVESTIGATIONS) ARE INCORPORATED BY REFERENCE.

(b) NOTWITESTANDING THE REQUIREMENTS INCORPORATED BY REFERENCE, 10 CFR 19.4 (RELATING TO INTERPRETATIcilS), 10 CFR 19.5 (RELATING TO CODMINICATIONS)',

• 10 CFR 19.8 (RELATING TO INPORMATION COLLECTION

) REQUIREMENTS: OMB APPROVAL), 10 CFR PART 19.30 (RELATING TO VIOLATIONS)

AND 10 CFR PART 19.40 (RELATING TO CRIMINAL PENALTIES) ARE NOT INCORPORATED BY REFERENCE.

-SECTION 220.10. EFFECT OF INCORPORATION OF 10 CFR PART 19.

TO RECONCILE DIFFERENCES BETWEEN THIS CHAPTER AND THE INCORPORATED SECTIONS OF 10 CFR PART 19, THE POLLONING WORDS AND PHRASES SHALL BE

-SUBSTITUTED FOR THE LANGUAGE IN 10 CFR PART 19 AS POLLOWS:

-(1) A REFERENCE TO NRC OR CODSGSSION MEANS DEPARTMENT.

(2) A REFERENCE TO NRC OR AGREEMENT STATE MEANS DEPARTMENT, NRC OR AGREEMENT STATE.

I i

220-1 1

l

.f' DRAFT PROPOSED Editor's Notes Sections 224.2 ~224.9 and 224.51-224.502 have been deleted and are not reprinted here.

1/12/98 CHAPTER 224. MEDICAL USE OF RADIQACTIVE MMT&T.

Subchapter A. - af.

SEC 224.11 INCORPORATION BY REFERENCE.

(a) EXCEPT AS PROVIDED IN THIS CHAPTER, THE REQUIREMENTS OF 10 CFR PART 35 (RELATING TO MEDICAL USE OF BYPRODUCT MATERIAL) ARE INCORPORATED BY REFERENCE.

(b) NOTWITHSTANDING THE REQUIREMENTS INCORPORATED BY REFERENCE, 10 CFR 35.8 (REIATING TO INFOIDIATION COLLECTION REQUIREMENTS: OMB APPROVAL),

10 CFR PART 35.990-(RELATING TO VIOLATIONS) AND 10 CFR PART 35.991 (REIATING TO CRIMINAL PENALTIES) ARE NOT INCORPORATED BY REFERENCE _.

) SECTION 224.12. EFFECT OF INCORPORATION OF 10 CFR PART 35.

TO RECONCILE DIFFERENCES BETWEEN THIS CHAPTER AND THE INCORPORATED SECTIONS OF 10 CFR PART 35, THE EDLLOWING WORDS AND PHRASES SHALL BE SUBSTITUTED FOR THE IANGUAGE IN 10 CFR PART 35 AS FOLLOWS (1) A REFERENCE TO NRC OR COD 9tISSION MEANS DEPARTMENT.

(2) A REFERENCE TO NRC OR AGREEMENT STATE MEANS DEPARTMENT, NRC OR AGREEMENT STATE.

(3) THE DEFINITION OF BYPRODUCT MATERIAL MEANS RADIOACTIVE MATERIAL INCLUDING NARM.

(4) THE DEFINITION OF SEALED SOURCE INCLUDES NARM.

(5) THE DEFINITION OF MISADMINISTRATION INCLUDES I-123.

(6) A REFERENCE TO THE ADVISORY COMMITTEE ON THE MEDICAL USES OF l I

ISOTOPES IS SYNONYMOUS WITH THE DEPARTMENT'S RADIATION PROTECTION ADVISORY COMMITTEE. )

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224-1 1

r-Subabapter 3. (-17. ADMINIST5&TIVE] OTHER REQUIREbENTS S 224.20. SUPERVISIOlf.

IN ADDITION TO THE INCORPORATION BY REFERENCE OF 10 CFR PART 35, THE LICENSEE SHALL ALSO:

(1) PERMIT ONLY AUXILIARY PERSONNEL WHO HAVE MET THE APPLICABLE RADIOLOGIC REQUIREMENTS OF 49 PA. CODE, PART I, SUBPART A (RELATING TO PROFESSIONAL AND OCCUPATIOIIAL AFFAIRS) TO USE RADIOACTIVE MATERIALS FOR DIAGNOSTIC OR THERAPEUTIC PURPOSES.

(2) PERMITONLYAUXILkNRYPERSolfNELEMPLOYEDBYAHEALTHCARE FACILITY REGULATED BY THE DEPARTMBfT OF HEALTH, THE DEPARTMENT OF PUBLIC WELFARE OR THE FEDERAL GOVERNMENT TO USE RADIOACTIVE MATERIALS FOR DIAGNOSTIC OR THERAPEUTIC PURPOSES IN ACCORDANCE WITH WRITTEN JOB DESCRIPTIONS AND EMP14YEE uGALIFICATIONS.

$ 224.21. DECAY-IN-STORAGE.

IN ADDITION 10 TEk INOdRPORATICIf SY REFEREICE OF 10 CFR PART 35, A LICBISEE MAY EDIS1EALED SOURCES OF ACCELERATOR PRODUCED RADIQACTIVE MATERIAL WITE A 75YSIE ''*-LIFE-OF UP. TO 300 DAYS FOR DECAY-IN-STORRSE _ _ 8 -- ~~~'HIN- ^ r- --" TRASE . ,

't ' s.y.

7" y, ,3.7p<; f: - -

) '

e o

224-2

g..

DRAFT PROPOSED Rev11/12/98 CEEP5WL 225. RADIATION SAFETI 33GUIRBENTS WOUL i ImonSumIAL USES ano anoIOsmAruIC OrERATIONS Subabspter A. ENERAL pmOVISIONS 1

l $ 225.1. Purpose and scope. j (a) This chapter establishes radiation safety requirements for persons utilizing radiation sources for industrial (radiography] USES RADIOGRAPHIC OPERATIONS. Licensess and' registrants who use radiation sources for industrial (radiography) USES AND RADIOGRAPHIC OPERATIONS shall comply with this chapter. .The requirements of this chapter are in addition to, and not in substitution for, other applicable requirements in this article, IN PARTICULAR, THE REQUIREMENTS AND PROVISIONS OF CHAPTERS 215, 217-220, 228 AND 230.

(b) PERSONS USING ONLY X-RAY MACHINES FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS OR VETERIMARIANS UNDER CHAPTER 223 (RELATING TO VETERIt:ARY MEDICINE), NEED NDP OtBEPLY WITH THE REQUIRBENTS OF SECTION 225.2 (REIAT NG 10 IMOORDORNPION BY REPERENCE) UNLESS OPHEIBISE SPECIFIED IN SUD.:EAPTER E (REIATING TO RADIATION PRODUCING MACHINES) .

~

(c) TEIS.CEAPT N NDP APPLY TO' MEDICAL DIAdBOOSIS OR THERAPY.

O: 5, lh&pany% r. , m;wp - ;, 2 ,

c Editor's Notet Sections 225.2, 225.11-225.18, 225.21-225.23, 225.31-225.33, 225.41-225.44 and 225.51-225.53 are being deleted and are not reprinted here. l Editor's Note 8 proposed rulemakings printed below are all new and are printed in noms 1 font to enhance readability.

Sec 225.2a Incorporation by reference.

(a) Except as provided in this. chapter, the requirements of 10 CFR Part 34 (relating to licensei'for industrial radiography and radiation safety requirements for industrial radiographic operations) are incorporated by reference., .

1 tb) Notwithstandingtherequirements[incorporatedbyreference,10 l i

CFR 34.5 (relating to. interpretations), 10 CFR 34.8 (relating to information collection requirements: OMB approval), 10 CFR Part l 34.121 (relating to violations) and 10 CFR Part 34.123 (relating to criminal penalties) are not incorporated by reference.

Section 225.3a Effect of iricorporation of 10 CFR Part 34.

To reconcile differences between this chapter and the incorporated l sections of 10 CFR Part 34, the following words and phrases shall be substituted for the language in 10 CFR Part 34 as follows:

(1) A reference to NRC or Cosuaission means Department.

I ' (2) A reference to NRC or Agreement State means Department, NRC or Agreement State.

225-1

1 (3) The definition of sealed source includes NARM.

(4) The definition of licensed material includes NARM.

5 225.4a. Radiation safety program.

A person who intends to use x-ray machines for industrial radiography shall have a program for training personnel, written operating procedures and emergency procedures, an internal review system, and an organizational ctructure for industrial uses or radicgraphic operations which includes specified delegations of authority and responsibility for operation of the program. This pr'agram shall be approved by the Department before commencing industrial radiography.

5 225.5a. Reciprocity Out-of-state users of x-ray machines shall meet the requirements of S 216.7 '(relating to out-of-state radiation producing machines).

5 225.6a Prohibitions Use of x-ray machines covered under this chapter is not permitted for diagnosis or therapy on humans or animals. I SUBCHAPTER B. RADIATION PRODUCING MACHINES

' GENERAL ADMINISTRATIVE REQUIREMENTS S 225.70. Definitions.

The following words and terms, when used this subchapter, have the following meanings, unless the context clearly indicates otherwise:

Cabinet radiography--Industrial radiography or fluoroscopy conducted in an enclosure or cabinet so shielded that doses to individual members to the public at every location on the exterior meet the Ibnitations specified in 10 CrR 20.1301 (relating to dose limits for individual members of the public).

Cabinet x-ray system--An x-ray system with the x-ray tube installed in an enclosed, interlocked cabinet, designed to exclude personnel from its interior during operation. Included are all x-ray systems designed primarily for the inspection of baggage or packages.

-An x-ray tube used within a shielded part of a building or x-ray equipment which may temporarily or occasionally incorporate portable shielding is not considered a cabinet x-ray system.

Certified cabinet x-ray system--An x-ray system which has uen certified under al CFR 1010.2 (relating to certification) as being manufactured and assembled under 21 CrR 1020.40 (relating to cabinet x-ray systems).

Industrial radiography--The industrial examination of the macroscopic structure of materials by nondestructive methods utilizing radiation sources.

)-

225-2 L m

Y Permanent radiographic installation--A shielded installation or structure designed or intenced for radiography in which radiography is regularly performed.

Personal supervision--The provision of guidance and instruction to a radiographer's assistant by a radiographer who is-(i) Physically present at the site.

(ii) In visual contact with the radiographer's assistant while the assistant is using radiation sources.

]

(iii) In such proximity that immediate assistance can be given if required.- l Radiographer--An. individual who performs, or who, in attendance  ;

at the site where the radiation source is being used, personally l supervises industrial radiographic operations and who is responsible to the registrant for assuring compliance with the requirements of the Department's regulations and the conditions of the registration.

Radiographic operations--All activities associated with a ,

radiation producing machine during use of the machine, to include j surveys to confirm adequacy of boundaries, setting up equipment and  ;

any activity inside restricted area boundaries. I

)

Shielded roosa radiography--Industrial radiography which is conducted in an enclosed roan, the interior of which is not occupied during radiographic operations.  ;

' Temporary job site--A location where industrial radiography is performed for 180 days or less during any consecutive 12 months other  !

than the location listed in a registration.

S 225.71. Duties of personnel.

(a) The radiation Safety Officer (RSO) shall be an individual who shall ensure that radiation safety activities are being performed in accordance with approved procedures and requirements in the daily operation of the registrant's program, and in compliance with Department requirements, and who has the authority to suspend or terminate operations which are not being conducced in accordance with .

registration conditions.

(b) The radiographer shall be_an individual who performs, or who is in attendance at the site where the radiation producing machine is being used, who personally supervises industrial radiographic operations and who is responsible to the registrant for assuring coupliance with the requirements of the Department's regulations and the conditions of the registration. ]

(c) The radiographer's assistant shall be an individual who, under '

the personal supervision of a radiographer, uses radiographic x-ray machines, or radiation survey instrumentation.

(d) The radiography trainee is an individual who is in the process of becoming a radiographer's assistant or a radiographer, in accordance with the registrant's procedures. The trainee is not permitted to

) operate radiographic x-ray machines, or radiation survey instrumentation.

225-3

+.

o 225.72 Training of personnel (a) A registrant shall not allow an individual to act as a radiographer.or assistant radiographer unless that individual meets the requirements of S 225.73'(relating to training and testing),

appropriate registration requirements, and operating and emergency procedures.

(b) Persons performing temporary job site radiography must comply with the training requirements in 10 CFR 34, Subpart D (relating to radiation safety requirements).

225.73 Training and testing (a) The registrant shall not permit an individual to act as a radiographer until that individual:

(1) . Has been instructed in the subjects outlined in Appendix A of this chapter.

(2) Has received copies of this chapter, Chapters 219, and 220, (relating to standards for protection against radiation and relating to notices, instructions, and reports to workers, and inspections).

A copy of the certificate of registration issued to the registrant and copies of the, registrant's operating and emergency procedures.

(3) Has been instructed in the use of the registrant's radiation-producing machines, radiation survey instruments, regulations, and operating and emergency procedures.

}

(4).Has demonstrated, to the satisfaction of the' registrant, competency and understanding of the information as evidenced by having successfully completed a written test and a field examination.

(b) The registrant shall nor permit an individual to act as a radiographer's assistant until that individuals (1) Has received copies of, and instruction in, the registrant's operating and emergency procedures.

(2) Has been instructed in the use, and has demonstrated, to the satisfaction of the registrant, that when the individual is under I the direct personal supervision of the radiographer, the individual is competent in the use of sources of radiation, and radiation survey instruments that will be used.

(3) Has demonstrated, to the satisfaction of the registrant, an understanding of the information as evidenced by having successfully ,

completed a written or oral test and a field examination on the j subjects relevant to being an assistant radiographer.

(c) Records of the training required under (a) and (b), including copies of written tests, dates of oral tests and field examinations, shall be maintained for inspection by the department for a period of five years following termination of employment by the individual or until the certificate of registration is terminated.

I L225.74 Audits'and safety reviews of radiographers and radiographer's assistants.

225-4

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(a) The registrant shall provide safety reviews for radiographers and radiographerda croistants at least during each calendar year.

l (b) The registrant shall conduct an annual inspection program for the I

job performance of each radiographer and radiographer's assistant to ensure that the department's regulations, certificate of registration requirements and the registrant's operating and emergency procedures

! 'are followed. This audit program shall:

(1) Include observation of.the performance of each radiographer l and radiographer's assistant during an actual radiographic operation at intervals not to exceed one calendar year.

(2) Provide that, if a radiographer or radiographer's assistant has not participated in a radiographic operation for more than six months since the last inspection, the. individual's performance shall be observed and recorded when the individual next participates in a radiographic operation.

(c) The registrant shall maintain records of the above training to include certification documents, written and field examinations, annual safety reviews, and annual audits of job performance. These records.shall'hs'. maintained by the licensee or registrant for inspection by-the department for a period of five years following termination.oftesNppeent by the individual or until the certificate of registratiionCisiterminated.. , .

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225.75 Reporting requirements I (a) In addition to the reporting requirements in Chaptet 219 (relating to standards for protection against radiation), each registrant shall- provide to the department, within 30 days of its occurrence, a written report.on any of the following incidents involving radiographic equipment us'ed for industrial radiography:

(1) Inability to terminate irradiation with an x-ray machine.

(2) Failure of an interlock in shielded room radiography.

(b) The registrant shall include the following information in each.

report submitted under subsection (a):

(1) Description of the equipment problem.

(2) Cause of the incident, if known or determined.

(3) Manufacturer and model number of the equipment involved.

(4) Place, time, and date of the incident.

(5) Action taken to reestablish normal operations.

(6) Corrective action taken or planned to prevent reoccurrence.

(7) Names and qualifications of personnel involved.

(c)- Reports of overexposures, required under 10 CFR 20.2202 (relating I to notification of incidents) or of excessive exposures, required 225-5

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under 10 CFR 20.2203 (relating to reports of exposures, radiation l

levels and concentrations of radioactive material exceeding the limits) which involve the failure of safety components of radiog'raphy equipment shall also include the information specified under subsection (b).

annermat TECHNICA!,BBQUIREbErfS 225.00 Permanent radiographic installations.

(a) Permanent radiographic installations having high radiation area entrance controls of the types described in 10 CFR 20.1601 and 10 CFR 20.1902 (relating to control of access to high radiation areas; and posting requirements) shall also meet the following requirements.

(1) Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation shall have both visible and audible warning signals to warn of the presence of radiation. the visible signal shall be activated by radiation whenever the x-ray tube is energized. the audible signal shall be actuated when an attempt is made to enter the installation while the q x-ray tube is energized.

(2) The entrance control device or alarm system shall be tested ,

for proper function prior to beginning operations on each day of use.

1 (3) The radiographic exposure system shall not be used if an entrance control device or alarm system is not operating. properly.

If an entrance control device or alarm system is not functioning j properly, it shall be removed from service and repaired or replaced immediately. If no replacement is available, the facility may continue to be used provided that the registrant tuplements the continuous surveillanca under 10 CFR 34.51 and 10 CFR 34.52 (relating to surveillance; posting), S 225.83 (relating to operating requirements) and uses an alarming ratemeter. Before the entrance control device or alarm system is returned to service, the radiation safety officer or an individual resignated by the radiation safety officer shall validate the repair.

(b) Records of the testa performed under (a) shall be maintained for inspection by the department for five (5) years.

225.83 operating requirements (a) When radiography is performed at a location other than a permanent radiographic installation, a adnimum of two radiographic personnel shall be present to operate the radiographic exposure l device. At least one of the radiographic personnel shall be a certified radiographer. The other individual may be either a certified radiographer or a radiographer's assistant.

(b) Other than a radiographer, or a radiographer's assistant who is under the personal supervision of a radiographer, no individual shall manipulate the controls or operate the equipment used in industrial radiographic operations.

(c) At each job site, the following shall be supplied' by the registrants 225-6

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(1) The appropriate barrier ropes and warning signs.

(2) At least one operable, calibrated radiation survey instrument.

(3) A current whole body individual monitoring device, for example, a " film badge" or *TLD" for each worker.

(4) An operable, calibrated pocket ionization chamber, that is, a " pocket dosimeter" with a range of zero to 51.6 pc/kg (200 milliroentgen) for each worker.

(d) an industrial radiographic operation shall not be performed if any of the items in subsection (c) is not available at the job site or is inoperable..

i 225.84 Records required at temporary job sites l Each registrant using a source of radiation at a temporary job site l shall maintain and have available at that job site, for inspection by l the department, the following records or documents:  !

(1) The-certificate of registration or equivalent document, and personnel certifications. o, (2),.0perating and, emergency procedures.

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(3), Relevant} regulations of the department.

s .

). (4) Survey records required under this chapter for the period of operation at the site.

(5) Daily pocket ionisation chamber records for the period of operatien at the site..

(7) Both the latest radiation survey meter calibration records and sealed source leakage or contamination test records for specific devices in use at the site. Acceptable records include tags or labels that are affixed to the device or survey meter and decay charts showing leakage or contamination test results for the sources that have been manufactured within the last six months.

225.85 Operating and emergency procedures The registrant's operating and emergency procedures shall include instruction in at least the following:

(1) Handling and use of sources of radiation to be employed such that no individual is likely to be exposed to radiation in excess of the limits established in Chapter 219 (relating to standards for protection against radiation).

(2) Methods and occasions for conducting the radiation surveys.

(3) Methods for controlling access to areas where radiographic operations are being conducted.

g (4) Methods and occasions for locking and s'ocuring sources of radiation.

225-7

)

(5) Personnel monitoring and the use of individual monitoring devices, including steps that are to be taken immediately by radiographic personnel in the event of an ionization chamber, that is, a " pocket dosimeter" is found to be off-scale.

(6) Methods and procedures for minimizing exposure of individuals in the event of an accident.

(7) The procedure for notifying proper personnel in the event of an accident.

(8) Maintenance of records required by the department.

(9) The inspection and maintenance of radiation-producing unchines.

S 225.86.. Surveys and survey records (a) A survey with a calibrated radiation survey instrument shall be made after each radiographic exposure to determine that the radiation-producing machine x-ray tube is de-energized.

(b) Records of the surveys required by subsection (a) shall be maintained for inspection by the department) for five (5) years. If the survey has been used to determine an individual's exposure, however, the records of the survey shall be maintained until the department authorizes their disposition.

S 225.87. Utilization logs.

) A registrant shall maintain current logs, which shall be kept available for inspection by the department for five (5) years from the date of the event, showing for each radiation-producing machina, the following applicable information:

(1) The identity (name and signature) of the operator to whom the radiation-producing machine is assigned.

(2) The model and serial number of the radiation-producing machine.

(3) The location and date of use.

(4) The technique factors (tube kilovoltage, tube current, exposure time) used for each radiographic exposure.

RADIATICII SURVEY INSTRutdENT AMD PERSOUREEL Bd0ttI'K8 TING REQUIREBENTS 225.90 Radiation survey meter requirements (a) A registrant shall maintain sufficient calibrated and operable radiation survey instruments to make physical radiation surveys as required by this chapter and Chapter 219 (relating to standards for the protection against radiation).

(b) No radiographic operation may be conducted unless calibrated and

}

y operable radiation survey instrumentation is available and used at 225-8

l 3,

each site where radiographic exposures and radiation producing machines are used.

(c) Immediately prior to use, a radiation survey instrument shall be checked to ensure that it is operating properly by bringing it near a source of radiation and observing its response. instruments that fail to respond shall not be used.

225.91 Radiation survey meter calibration requirements.

(a) In addition to the requirements of $225.90 (relating to survey meter requirements), instruments required by this chapter shall have a range ssch that 0.516 pc/kg (2 mr) per hour through 258 pc/kg (1 r) per hour.can be measured.

(b) Each radiation instrument shall be calibrated:

(1).At energies appropriate for use.

(2) At intervals not to exceeds (i) For radiation-producing machines, six months.

(ii) After each instrument servicing, other than battery replacement.

(3) such that accuracy within +/- 204 can be demonstrated.

(4) For linear scale instruments, at two points located I

approximately one-third and two-thirds of full scale on each scales for- logarithmic scale instruments, at mid-range of each decade, and at two points of at least one decade; and for digital instruments, at three points between 0.516 pC/kg (2 mr) and 258 pc/kg (1 R) per hour.

(5) By a person authorized by the department, the NRC, or an agreement state.  !

(c) Records of calibration shall be maintained for five years after  !

the calibration date for inspection by the department. l 225.92 Personnel monitoring control (a) The registrant shall not permit any individual to act as a radiographer or as a radiographer's assistant, unless, at all times during radiographic operations, each individual wears a combination of direct-reading pocket dosimeter and either a film badge or a thermoluminescent dosimeter (TLD). The individual shall wear the '

i personnel monitors on the trunk of the body. Each film badge or TLD shall be assigned to and worn by only one individual.

(b) Film badges shall be replaced at intervals not to exceed one month and thermoluminescent dosimeters (TLDS) shall be replaced at l intervals not to exceed three months. l (c) Pocket dosimeters shall meet the criteria as in ANSI N13.5-1972,

• performance specifications for direct reading and indirect reading pocket dosimeters for x- and genuma-radiation" published in 1972,

) exclusive of subsequent amor.dments or additions.

225-9 l

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(d) The use of pocket dosimeters is subject to the following requiresnants:

(1) Pocket ionization chambers shall have a range of zero to  ;

51.6 C/kg (200 mr) and shall be recharged at least daily or at the start of each work shift. F.loctronic personal dosimeters may only be used in place of ion-chamber pocket dosimeters.

(2) Pocket ionization chambers shall be read and exposures recorded at least at the beginning and end of each worker's shift involving the use of a source of radiation.

(3) Pocket dosimeters shall be checked for correct response to radiation at periods not to exceed one year, and acceptable dosimeters shall sead within +/- 30% of the true radiation exposure.

Records of pocket dosimeter calibration shall be maintained for inspection by the department for five years.

(4) If an individual's pocket dosimeter is discharged beyond its range, that is, "off-scale", industrial radiographic operations by that individual shall cease i==a'fiately and the individual's film badge or TLD shall.he

• sent i===riistely for processing. The individucl shall not use any sources of radiation until the individual's _ radiation' dose has 'been determined.

(e) Rdpdrts from film badge or TLD processors and workers with daily ' pocket lonisation" chambers, that is.',' pocket dosimeters readings shall be kept for inspection by the department until the certificate of registration is terminated or until the department I authorizes their disposition, in' writing, following a determination by the department that tho' records contain inaccurate personnel

-monitoring information.

RADIATItlW PRODUCIse MaruTma W 1 225.100 Cabinet x-ray systems (a) It shall not be possible to energize a cabinet x-ray system unless all openings are secure?y closed and the openings meet the requirements of 10 CFR 20.1201 (relating to occupational dose limits for adults). F.ach access door to the cabinet shall have an interlock that terminates the exposure whenever the door is opened. The enclosure shall be shielded so that every location on the exterior meets the conditions for an unrestricted area.

(b) A registrant may not permit an individual to operate a cabinet x-ray system until the individual has received a copy of, and instruction in, the operating procedures for the system and hes demonstrated an undeutanding of the operating procedures and competency in the use of the cabinet x-ray system.

(c) The registrant shall evaluate the cabinet x-ray system to assure compliance with 10 CFR 20.1201 (relating to occupational dose liaits for adults) and with 21 CFR 1020.40 if the system is a certifird e

-cabinet x-ray system. The records of these evaluations shall be maintained for inspection by the department for a period of five t$)

years after evaluation.

225-10

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(d) The registrant shall test the on-off switch, the unit interlocks and safety devices at intervals not exceeding one (1) year, and make repairs as necessary. Records of these tests shall be maintained for inspection by the department for a period of five (5) years.

(e) cabinet x-ray systems are exempt from all other provisions of this chapter.

S 225.101 shielded room x-ray machine radiography (a) A room used for shielded roan radiography shall be shielded so i that every location on the exterior meets conditions for an  !

unrestricted area and the only access to the room is through openings which are interlocked so that the radiation source will not operate unless all openings are securely closed and meet the requirements of 10 crR 20.1601 (relating to control of access to high radiation areas).

(b) The registrant shall provide personnel monitoring equipment to every individual who operates, positions material for irradiation, or  !

performs maintenance on a radiation-producing machine for shielded j room radiography. i l

(c) The operator shall condu,ct a physical radistion survey to j determine that the radiation. machine x-ray tube is de-energized prior l

i toeachentryintgythe,4adiogragci exposure area,

. . . %.s L + >: , .v a l 5 22.102.- Temporary; job site radiography.  !

(a) The operator shall conduct a physical radiation survey to j

)

.- determine that the radiation machine x-ray tube is de-energized prior  ;

to each entry into'the radiographic exposure area. Survey resulta ,

and records of the boundary location shall be maintained and kept i available for inspection by the department for a period of five (5)  ;

years.

(b) Mobile or portable radiation-producing machines shall be physically secured to prevent tampering or removal by unauthorized personnel.

l 5 225.103. Bomb detection and baggage / package x-ray systems. 1 (a) This section applies to x-ray systems whose purpose is to produos an image which may be used to'sdreen packages for the presence of  ;

explosive devices or components, weapons, or other contraband or prohibited items. This section does not apply to cabinet x-ray

. systems designed and used primarily for the inspection of baggage or packages at airports.

(b) An x-ray system used for explosives or weapons detection may not be used on human beings or animals. X-ray systems whose purpose is the irradiation of human beings for medical diagnosis are covered under chapter 221 (relating'to human use of x-ray machines). X-ray systems whose purpose is the irradiation of animals for diagnosis or therapy are covered under chapter 223 (relating to veterinary medicine).

(c) Radiographic equipment shall conform to the following:

225-11

I -

l' (1) The leakage radiation from the source assembly measured at a distance of 1 meter in any direction from the source may not exceed l

25.8 pc/kg (100 mm) in 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> when the x-ray tube is operated at its leakage technique factors. Compliance shall be determined by l

measurements averaged over an area of 100 square centimeters with no r linear dimension greater than 20 centimeters.

(2) Portable x-ray systems shall be equipped with collimators which are capable of restricting the useful beam to the area of interest. . collimators shall provide the same degree of protection required in subsectim .~ (1) .

(3) A means shall be provided to terminate the exposure after a preset time or exposure or a preset product of exposure time and tube current.

(4) The x-ray control shall have a dead-man type exposure switch.

(5) The x-ray controls shall indicate the technique fa: tors, (that is., kilovoltage,' tube current and exposure time or the product of tube current and exposure time).

(6) The x-ray machine shall be labeled with a readily discernible sign bearing the radiation symbol and the words, " caution radiation--this equipment produces radiation when energized" or words containing a similar warning, near any switch that energizes the x-ray tube.

g (7) For fixed radiographic equipment, an easily visible warning i light shall be located adjacent to the x-ray tube and labeled with the words" x-ray on" or worda containing a similar warning. this light'shall be illuminated only when t.5e x-ray tube is energized or only when the shutter is open.

(d) Fluoroscopic equipment shall be as follows:

(1) The leakage radiation from the source assembly measured at a distance of 1 meter in any direction from the source may not exceed 25.8 pc/kg (100 mr) in 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> when the x-ray tube is operated at its leakage technique factors. compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

-(2) The x-ray machine shall be labeled with a readily discernible sign bearing the' radiation symbol and the words, ' caution radiation--this equipment produces radiation when energized" or words containing a - similar warning, near any switch that energizes the x-ray tube.

(3) To the extent practicable, the x-ray system (x-ray tube, imaging system, and the object being irradiated) shall be completely enclosed such that every location on the exterior meets conditions for an unrestricted area and the only access to the room or enclosure is through openings which are interlocked so that the radiation source will not operate unless all openings are securely closed and meet the requirements of 10 CFR 20.1601 (relating to control of

. access to high' radiation areas).

225-12 L I

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(4) The equipment shall be so constructed that, under i conditions of normal use, the entire cross-section of the useful beam shall be attenuated by a primary. protective barrier permanently 4 incorporated into the equipment. I (5) The x-ray control shall have a dead-man type expcsure switch. activation of the x-ray beam shall be possible only by continuous pressure on the exposure switch.

(6) An easily visible warning light shall be located adjacent l to the x-ray tube or on the outside of the enclosure and be icbeled with the words" x-ray on" or words containing a similar warning. This light shall be illuminated only when the x-ray tube is energized or only when the shutter is open.

1 (f) Portable x-ray radiographic equipment operating procedures are as ,

follows: i (1) To the extent practicable, portable x-ray tube heads shall i be supported by a stand. 1 (2) To the extent practicable, supporting or positiening devices for the film shall be used for radiation exposures.

(3) Individuals, other than those whose presence is necessary ,

to conduct the x-ray procedure, shall be located at least 5 meters  !

away fram the x-ray tube and the object being irradiated during exposures.

(4) An individual may not be regularly employed to support the

) film or object during radiation exposures.

(g) Fixed radiographic equipment operating procedures are as follows: l l

I (1) A registrant shall test the safety and. warning devices, including interlocks, at intervals not to exceed 12 months. Records I cf these tests shall be maintained for inspection by the department  !

I for a period of 5 years after the test has been conducted.

(2) A safety or warning device which is found not to be functioning properly shall be repaired as necessary.

$ 225.104. X-ray calibration systems (a) This section applies to registrants who regularly, or for commercial purposes, calibrate equipment used to measure the output of radiation for medical diagnosis and therapy, or for radiation survey meters and similar instrumentation.

(b) A room or enclosure used for calibration shall be shielded so that every location on the exterior meets conditions for an unrestricted area and the only access to the room or enclosure is through openings which are interlocked so that the radiation source will not operate unlesa all openings are securely closed and meet the requirements of 10 crR 20.1601 (relating to control of access to high radiation areas).

(c) The operator shall conduct a physical radiation survey to

.I determine that the radiation machine x-ray tube is de-energized prior to each entry into the radiographic exposure area.

225-13

e (d) As an. alternative to the radiation survey requirement of subsection (c), the registrant may use an independent radiation 1 monitoring systemt that displays the radiation intensity or displays when radiation levels have returned to their pre-irradiation levels.

r

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) -

225-14

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. i DRAFT PROPOSED 1

11/12/98 Editor's Notes Sections 226.2, 226.11 through 226.51 have been deleted and are not reprinted here.

1 1

CEAPTER 226. LICENSES AMD RADIATION SAEETI REQUIREMENTS FOR  ;

[ WIRELINE SERVICE OPERATIONS AMD SUESURFACE TRACER STUDIES] MELL '

InesImo rannrant.

1 S 226.1 Purpose and scope This chapter establishes radiation safety requirements for persons using radiation sources for (wireline service operations incJuding mineral logging,] NELL LOGGING IN A SINGLE WELL, radioactive markers, URANIUM SINKER BARS and subsurface tracer studies. Persons who use radiation sources for [ wireline service) WELL LOGGING operations shall comply with this chapter, which is in addition to and not in substitution for other applicable requirements of this i article, IN PARTICULAR, THE REQUIREMENTS.AND PROVISIONS OF CHAPTERS l 215, 217-220 228 AND 230.

)

S 226.3. [ Prohibition) ABANDONMENT OF A SEALED SOURCE.

(A licensee may perform wireline service operations with a sealed source unless, prior to commencement of.the operation, the licensee has a written agreement with the well operator, well owner or drilling contractor thats i (1) If a sealed source is lodged downhole, a reasonable effoet.

at recovery shall be made.

(2)] IN ADDITION TO INCORPORATION BY REFERENCE OF 10 CFR PART 39, [If a decision is made to abandon the sealed source downhole, the requirements of S 226.51(c) (relating to notification of incidents, abandonment and lost sources) and] the requirements of S 79.111 (relating to the abandonment ) shall ALSO be met.

S 226.4 INCORPORATION BY REFERENCE.

(a) EXCEPT AS PROVIDED IN THIS CHAPTER, THE REQUIREMENTS OF 10 CFR PART 39 (RELATING TO LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING) ARE INCORPORATED BY REFERENCE.

(b) NOTWITHSTANDING THE REQUIREMENTS INCORPORATED BY REFERENCE, 10 CFR 39.5 (RELATING TO INTERPRETATIONS), 10 CFR 39.8 (RELATING TO INF035tATION COLLECTION REQUIREMENTS: OMB APPROVAL), 10 CFR PART 226-1

a

.o e

9 39.101 (RELATING TO VIOLATIONS) AND 10 CFR PART 36.103 (RELATING TO CRIMINAL PENALTIES) ARE NOT INCORPORATED BY REFERENCE.

S 226.5 EFFECT OF INCORPORATION OF 10 CFR PART 39.

TO RECONCILE DIFFERENCES BETNEEN THIS CHAPTER AND THE INCORPORATED SECTIONS OF 10 CFR PART 39, Tl!E FOLLOWING NORDS AND PHRASES SHALL BE SUBSTITUTED FOR THE LANGUAGE IN 10 CFR PART 39 AS FOLLONS:

(1) A REFERENCE TO NRC OR COMMISSION MEANS DEPARTMENT.

(2) A REFERENCE TO NRC OR AGREEMENT STATE MEANS "DEPARTPCNT, NRC OR AGREEMENT STATE.

. r.w (3) THE DEFINITION OF SEALED SOURCE INCLUDES NARM.

(4) THE DEFINI'fION OF LICEN.etED MATERIAL INCLUDES NARM.

samTIcus arvwmentes S 226.10. PARTICLE ACCELERATORS.

. b . .Mi e, : c a. u tr, iu , .a .,.

4 ..(a) A LICENSEE OR.-REGISTRANT.MAY.NOT PERMIT ABOVEGROUND TESTING OF PARTICLE ACCELERATORS DESIGNED FOR USE IN WELL-IDGGING WHICH RESULTS IN THE PRODUCTION OF RADIATION, EXCEPT IN AREAS OR

) FACILITIES CONTROLLED OR SHIELDED SO THAT THE~ REQUIREMENTS OF 10 CFR 20.1301 (RELATING TO RADIATION DOSE TO DOSE LIMITS LOR INDIVIDUAL MEMBERS OF THE PUBLIC), ARE NET.

(b)THE USE OF PARTICUE ACCELERATORS FOR WELL LOGGING SHALL BE CONDUCTED UNDER THE LICENSING PROVISIONS OF CHAPTER 228 (RELATING TO RADIATION SAFETY REQUIREMENTS FOR PARTICLE ACCELERATORS) .

i

'a 1i

,t . n. : tr l

l l

f-226-2 L............ .

1

e.

DRAFT PROPOSED 11/12/98 Editor's Note Sections 230.2, 230.11, 230.12, 230.14, 230.21 -

230.26, 230.41 - 230.46 and 230.51 are being deleted and are not reprinted here. -

CHAPTER 230 PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Editor's notes section 230.2 is being deleted and is not reprinted  :

.here.  !

5 230.3 INCORPORATION BY REFERENCE.

(a) EXCEPT AS PROVIDED IN THIS CHAPTER, THE REQUIREMENTS OF 10 CFR PART 71 (RELATING.TO PA(ERGING AND TRANSPORTATION OF RADIQACTIVE MATERIAL)

ARE INCORPORATED BY REFERENCE.

, cp (b) NOTNITNSTANDIEStTER REQUIRB erFS INCORPORATED BY REFERENCE, 10 CFR 71.2-(RELkTING 30CD TERPRETATIONS), 10 CFR 71.6 (REIATING TO- i INPOIGULTIS ""* ION REQUIREWITS: CNB APPROVAL), 10 CFR PART 39.99 l (REIATING TO VIDIATIONS) AND 10 CFR PART 36.100 (REIATING TO CRIMINAL  ;

) PENALTIES) ARE NOT INCORPORATED BY REFERMCE. *

$ 230.4. EFFECT OF INCORPORATION OF 10 CFR PART 71.

TO RECONCILE DIFFERENCES BETNEEN THIS CHAPTER AND THE INCORPORATED SECTIONS OF 10 CFR PART 71, THE FOLLONING NORDS AND PHRASES SHALL BE SUBSTITUTED FOR THE LANGUAGE IN 10 CFR PART 71 AS FOLIANS:

I (1) A REFERENCE TO NRC OR CODGESSION MEANS DEPARTMENT. )

(2) A REFERENCE TO NRC OR AGREEMENT STATE MEANS DEPARTMENT, NRC OR AGREEMENT STATE.

(3) THE DEFINITION OF SEALED SOURCE INCLUDES NARN.

(4) THE DEFINITION OF LICENSED MATERIAL INCLUDES NARN.

5 230.5 CCDOIUNICATIONS.

NOTNITHSTANDING THE INCORPORATION BY REFERENCE OF 10 CFR PART 71.1 (REIATING TO CODOIUNICATIONS AND RECORDS), ALL CODetUNICATIONS CONCERNING THE REQUIREMENTS OF THIS CHAPTER SHOULD BE SENT TO THE ADDRESS LISTED UNDER $ 215.42 (REIATING TO ADDRESS) .

l l

Editor's Notes sections 230.11, and 230.12 are being deleted and are not reprintek.here.

230-1

. =

s' 4

5 230.13 Transportation of licensed material.

IN ADDITION TO THE INCORPORATlSN OF 10 CFR PART 71 BY REFERENCE, if 67 Pa. Code Chaptar 403 (relating to hazardous materials transportation) or the regulations of the United States Department of Transportation are not applicable to a shipment of licensed material, the licensee shall conform to the standards and requirements of those regulations to the same extent as if the shipment was subject to the regulations.

Editor's Note: Sections SS 230.21 - 230.26 and SS 230.41 - 230.16 ere being deleted sad are not reprinted here. i S 230.47 Advance notification of transport of nuclear waste.

IN ADDITION TO THE INCORPORATION OF 10 CFR PART 71 BY REFERENCE, THE LICENSEE SHALL BE RESPONSIBLE 19R THE FOLIDWING:

(a) Prior to the transport of nuclear waste outside the licensee's facility or other place of use or storage, or prior to the delivery of nuclear waste to a carrier for transport, each licensee shall provide advance notification of the transport,to the governor, or governor's designee, of..each state through'which the waste will'he transported, and to the Department.

-) ((b) Advance notification is required only under the following circumstances:

(1) The nuclear waste is required to be in Type B packaging for transportation.

(2) The nuclear waste is being transported to, through or across state boundaries to a disposal site or to a collection point for transport to a disposal site.

(3) The quantity of licensed material in a single package exceeds one of the followings (i) 5,000 curies (185 TBq) of special form radionuclides.

(ii) 5,000 curies (185 TBq) of uncompressed gases of argon-41, krypton-85m, krypton-87, xenon-131m, or xenon-135. ,

l (iii) 50,000 curies (1.85 PBq) of argon-37, or of uncompressed gases of krypton-85 or xenon-133, or of hydrogen-3 as a gas, as luminous paint, or absorbed on solid material. j (iv) 20 curies (740 GBq) of other non-special form radionuclides for which Ae is less than or equal to 4 curies (148 GBq).

(v) 200 curies (7.4 TBq) of other non-special form

) radionuclides for which Ae is greater than 4 curies (148 GBq).

230-2

f' ...

e .

(c) Each advance notification required by subsection (a) shall contain the following informations

! (1) The name, address and telephone number of the shipper, l carrier and receiver of the shipment.

l (2) A description of the nuclear waste contained in the j

shipment as required by 49 CFR 172.202 and 172.203(d)

(relating to description of hazardous material on shipping papers; and additional description requirements).

(3) The point of origin of the shipment and the 7-day period during which departure of the shipment is estimated to j occur.

, (4) The 7-day period during which arrival shipment at

! state boundaries is estimated to occur.

(5) The destination of the shipment, and the 7-day period during which arrival of the shipment is estimated to occur.

(6) A point of contact with a telephone number for current shipment information.]

([d] b) ***

([e] c) ***

) ((f] d) ***

,([g] e) ***

Editor's Notes 230.51 is being deleted and are not reprinted here.

I 230-3

.. o i

DRAFT PROPOSED CNAPTER 232 LICENSES AMD R&DIATICII SAFETY REQUIREMENTS FOR IRR&DIAICES 11/12/98 5 232.1 Purpose and scope

-(a) This chapter contains the requirements for the issuance of a license authorizing the use of sealed sources containing radioactive materials in irradiators used to irradiate objects or materials using gasuna radiation.

(b) The requirements of this chapter are in addition to, and not in substitution for, other applicable requirements in this article, in particular, the requirassents and provisions of Chapters 215, 217-220 and 230.

5 232.2 Incorporation by. reference.

(a) Except as provided in this chapter, the requirements of 10 CFR Part 36 (z.elatig to licenses and radiation safety requirements for Irradiators)

• age incorporated by reference.

l.( *

• i ib.

(b) Notwithstanding the requirassents incorporated by reference, 10 g CFR 36.5 (relating to interpretations), 10 CFR 36.8 (relating to

/ information collection requirements: OMB approval), 10 CFR Part 36.91 (relating to violations) and 10 CFR Part 36.93 (relating to criminal penalties) are not; incorporated by reference.

Section 232.3. Effect of incorporation of l'0 CFR Part 36.

To reconcile differences between this chapter and the incorporated sections of 10 CFR Part 36, the following words and phrases shall be substituted for the language in 10 CFR Part 36 as follows:

(1) A reference to NRC or Comunission means Department.

(2) A reference to NRC or Agreement State means Department, NRC or Agreement State.

(3) The definition of sealed source includes NARM.

)

1 232-1 J

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m a= b ram changes. doc REV 2/11/99 RADIOACTIVE MATERIAL REGULATIONS CHANGES FROM EXISTING TO PROPOSED This document was created to assist the Radiation Protection Advisory Committee members in understanding the changes to be made from existing regulations to proposed rulemaking.

How to read the changes:

TEXT ADDED AT PROPOSED RULEMAKING IS CAPITALIZED AND UNDERLINED.

[ Text deleted at proposed rulemaking ir enclosed in brackets.]

TEXT ADDED AT FINAL RULEMAKING IS CAPITALIKED, UNDERLINED AND BOLDED.

[ Text deleted at fi.sl rulamaking is enclosed in brackets and bolded.]

I (TEXT ADDED AT PROPOSED RULEMAKING, BUT DELETED AT FINAL RULIMAKING IS CAPITALIEED, UNDERLIFED, BOLDED AND ENCLOSED IN BRACKETS.)

Text which was deJ5ced at proposed rulemaking, but retained at final  ;

rulemaking, appears as normal text as it exists in the Pa. Code.

1 1

The proposed rule = making is attached as a separate document. l l

The reasons for the changes to the attached proposed rulemaking are j given below: I Chapter 215, General Provisions )

5 215.2, Definitions. The following definitions were deleted because they are incorporated by reference: "ALARA, " "An " "A 2, " " absorbed i dose," " agreement state," " airborne radioactive material," airborne radioactivity area," " background radiation," " Becquerel," " byproduct material," " calendar quarter," " collective dose," " committed dose equivalent," " controlled wrea," curie," " deep dose equivalent," depleted uranium," " dose," " dose equivalent," " dose limits," " effective dose equivalent," " embryo / fetus," " exposure," " exposure rate," " external dose," " extremity," " eye dose equivalent," " generally applicable environmental radiation standards," " Gray," "high radiation area,"

" individual monitoring," individual monitoring devices," " internal dose," " licensed material," " lost or missing licensed or registered source of radiation," " member of the public," " minor," " monitoring,"  ;

" normal form," " occupational dose," " personnel monitoring equipment," '

" prescribed dosage," "public dose," " rad," " radiation area,"

" radioactive material," " radioactivity," "radiopharmaceutical," " rem,"

"research and development," " restricted area," " Roentgen," " sealed source," "SI," " shallow dose equivalent," " Sievert," " site boundary,"

" source naterial," "special form," "special nuclear material," "special nuclear material in quantities not sufficient to form a critical mass,"

" survey," "TEDE," " unrefined and unprocessed ore," " unrestricted area,"

" week," "whole body," " working level," " working level month," and 1 of 7

F 1

. p.

tam changes.coe

" year." The following definitions were updated: "NRC," and " qualified expert." The definition of " prescribed dose" was changed to "

prescribed dose for x-ray therapy" by deleting references to radioactive material. The definition of " written directive" was changed to "

written directive for x-ray therapy" by deleting references to radioactive material.

5 215.3 (units of exposure and dose) and S 215.4 (units of activity) were deleted because they are incorporated by reference.

S 215.5(effect of incorporation of the Code of Federal Regulations) was added for clarification.

S 215.11 (records) was amended to clarify the separate recordkeeping requirements of licensees and registrants.

S 215.12 (inspections) was amended to change the target inspection frequency for major medical facility x-ray operations from every 2 years to every 3 years.

A new S 215.25 (deliberate udsconduct) was added for compatibility with the NRC.

A new S 215.26 (employee protection) was added for compatibility witn the NRC.

S 215.'32 .(exempt qualifications) was amended to add the new Chapter 232 to the list of chapters.

Chapter 217, Licensing of Radioactive Material 5 217.1 (purpose and scope) was amended to include references to chapters 218 (fees) and 232 (licenses and radiation safety requirements for irradiators.

5 217.2 (address) was updated with the new Department name and address.

SS 217.11-217.18, 217.21-217.24, 217.31, 217.32, 217.41-217.49, 217.51-217. 57, 217. 65, 217.71-217.74, 217.81-217. 93, 217.121 and 217.121 were deleted because of the incorporation by reference of NRC regulations.

A new subchapter B (general provisions for radioactive material)was created to incorporate 10 CFR 30 (relating to rules of general applicability to domestic licensing of byproduct material).

SS 217.130 (incorporation by reference) and 217.131 (effect of incorporation of 10 CFR Part 30) explain the incorporation by reference.

S 217.132 (persons possessing a license for source, byproduct or special nuclear material in quantities not sufficient to form a critical mass on the date the Commonwealth becomes an agreement state as published in the Federal Register) is the existing S 217.24.

5 217.133 (filing application for specific licenses) is the existing S 217.51(d) and alerts the applicant for a license that a fee is required.

S 217.134 (renewal of licenses) is similar to the existing 5 217.55 and was amended to alert the' licensee to the Department's renewal requirements.

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. ram changes. doc 5 217.135 (exempt concentrations) is the existing S 217.12 amended to include NARM isotopes which were not incorporated by reference.

S 217.136 (exempt quantities) is the existing S 217.13 amended to include NARM isotopes =which were not incorporated by reference A new subchapter C (general licenses for radioactive material)was created to incorporate 10 CFR 31 (relating to general domestic licenses for byproduct material).

SS 217.140 (incorporation by reference) and 217.141 (effect of incorporation of 10 CFR Part 30) explain the incorporation by reference.

S 217.142 (certain measuring, gauging or controlling devices) is the existing S 217.42 and was amended to include some Department requirements which were not included in the incorporation by reference.

S.217.143 (incidental radioactive material produced by a particle accelerator) is the existing S 217.48 and was amended to include a Department requirement which was'not included in the incorporation by reference.

A new subchapter D (specific licenses to manufacture or transfer certain items containing radioactive material)was created to incorporate 10 CFR 32 (relating to specific domestic licenses to manufacture or transfer certain items containing byproduct material).

SS 217.150 (incorporation by reference) and 217.151 (effect of incorporation of 10 CFR Part 32) explain the incorporation by reference.

S 217.152 (licensing the incorporation of NARM into gas and aerosol detectors) is the existing 5 217.83 and was amended to include a Department requirement for using radium-226 which was not included in the incorporation by reference.

S 217.153 (special requirements for license to manufacture calibration sources containing americium-241, or radium-226) is the existing 5 217.86 and was amended to include a Department requirement for using radium-226 which was not included in the incorporation by reference.

217.154 (manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license) is the existing S 217.08 and was amended to include Department requirements for using HARM which were not included in the incorporation by reference.

A new subchapter F (specific domestic licenses of broad scope for radioactive material) was created to incorporate 10 CFR 33 (relating to specific domestic licenses of broad scope for byproduct material).

SS 217.160 (incorporation by reference) and 217.161 (effect of incorporation of 10 CFR Part 32) explain the incorporation by reference.

5 217.162 (types of specific licenses of broad scope) is the existing SS 217.72 (type B application) and 217.73 (type C application) combined into one section and was amended to include Department requirements for using NARM which were not included in the incorporation by reference 3 of 7

.. y ram changes. doc A new subchapter G (licensing of source material) was created to incorporate 10 CFR 40 (relating to domestic licensing of source material).

SS 217.170 (incorporation by reference) and 217.171 (effect of incorporation of 10 CFR Part 40) explain the incorporation by reference.

A new subchapter H (licensing of special nuclear material) was created to incorporate 10 CFR 70 (relating to domestic licensing of special material).

SS 217.180-(incorporation by reference) and 217.181 (effect of j incorporation of 10 CFR Part 70) explain the incorporation by reference. q A new subchapter I (transfer of radioactive material) is the existing subchapter D and S 217.190 is the existing S 219.101.

A new subchapter J (reciprocity) is the existing subchapter F amended to incorporate 10 CFR Part'150.2 (relating to scope)and 10 CFR Part 150.20 (relating to recognition of Agreement State licenses).

55.217.200 (incorporation by reference) and 217.201 (effect of incorporation of 10 CFR Part 150) explain the incorporation by reference.

S 217.202 (reciprocity of licenses of naturally occurring and accelerator-produced radioactive naterial) is the existing S 217.122.

Chapter 219, Standards for Protection Against Radiation S 219.3 (definitions) was deleted because it was incorporated by reference.

S 219.4 (implementation) was deleted because it is obsolete.

SS 219.5(incorporation by reference) and 219.6 ( effect of incorporation of 10 CFR Part 20) were added to clarify the differences between Chapter 219 and 10 CFR Part 20.

SS 219.21, and 219.31-219.38 were deleted because they were incorporated by reference.

5 219.51 (dose limits for individual members of the public) was amended by removing references to radioactive material.

5 219.52 (compliance with dose limits for individual members of the public) was deleted because it was incorporated by reference.

S 219.61 (testing for leakage or contamination of sealed *ources) was amended to clarify that the requirements are in addition to incorporation by reference.

1 SS 219.71, 219.72, 219.91-219.93, and 219.111-219.113 were deleted because of incorporation of 10 CFR Part 20 by reference.

SS 219.131 (security of stored sources of radiation) and 219.132 (control of sources of radiation not in storage) were amended to apply only to registrants.

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l SS 219.151 - 219.158 were deleted because of incorporation of 10 CFR 3

Part 20 by reference.

l- An editorial change was made to S 219.159 ( posting of radiation

! producing machines) by changing the words "The registrant" to "A

! registrant" at the beginning of the first sentence, l  !

i 5 219.160'(exceptions to posting requirements) was amended by deleting {

! sections incorporated by reference. )

SS 219.161, 219.162, 219.181-219.186, 219.201-219.211, and 219.221-

[ 219.226 were deleted because they were incorporated by reference.

5-219.228 (reports of misadministrations) was renamed to " Reports of misadministrations from x-ray therapy."

Chapter 220, Notices, Instructions and Reports to Workers; Inspections l 5 220.2 (posting of notices to workers)was updated for compatibility with the NRC.

-SS 220.3 through 220.8 were deleted because they were incorporated.by reference.-

SS 220.9(incorporation by reference) and 220.10 (effect of incorporation of 10 CFR Part 19).were added to clarify the differences between Chapter 220 and 10 CFR Part 19.

Chapter 224, Medical Use of Radioactive Material b6 224.2 - 224.9 and 224.51-224.502 were deleted because they were incorporated by reference.

SS 224.11 (incorporation by reference) and 224.12-(effect of incorporation of 10 CFR Part 35) were added to clarify the differences between Chapter 224 and 10 CFR Part 35.

5 224.55 (supervision) was renumbered as S 224.20 and amended to clarify which auxiliary personnel may handle radioactive material.

$ 224.112 (decay-in-storage) was amended to allow sealed sources of accelerator produced radioactive material with a physical half-life of up.to 300 days to be held for decay-in-storage.

Chapter-225, Radiation Safety Requirements for Industrial Radiographic Operations Chapter 225 was renamed " Radiation Safety Requirements for Industrial Uses and Radiographic operations".

Subsection . 225.1 (a ) was amended to include industrial radiographic  !

operations as well as traditional industrial radiography. Subsection l

'225.1(b) was added to' exempt persons using only x-ray machines from the )

requirements of 10 CFR Part 35 incorporated by reference except as may be noted in subchapter B. Subsection (c) was added to clearly indicate that chapter 225 does not apply to medical diagnosis or therapy. i l

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-ram changes. doc SS 225.2, 225.11-225.18, 225.21-225.23, 225.31-225.33, 225.41-225.44 and 225.51-225.53 were deleted because they are incorporated by reference.

SS 225.2a (incorporation by reference) and 225.3a (effect of incorporation of 10 CFR Part 34) were added to clarify the differences between Chapter 224 and 10 CFR Part 34.

5 225.4a (radiation safety programs) was added for x-ray machine users only. This section includes a requirement that a person using x-ray machines for industrial radiography get Department approval before commencing operations.

5 225.5a (reciprocity) was added to alert out-of-state users of x-ray machines to the requirements of 5 216.7 (out-of-state radiation producing machines).

S 225.6a (prohibitions) was added to clarify that the use of x-ray machines covered under this chapter is not permitted for diagnosis or therapy on humans or animals.

A new Subchapter.B (radiation producing machines) was added for those persons who only have x-ray machines and do not need to meet the requirements incorporated by reference.

S 225.70 (definitions) was added to include definitions for terms used in Subchapter B. These definitions are: " cabinet radiography,"

" cabinet x-ray system," " certified cabinet x-ray system," " industrial radiography," permanent radiographic installation," " personal supervision," " radiographer," " radiographic operations," " shielded room radiography," and " temporary job site."

A new heading, " General-Administrative Requirements," includes requirements for the duties of personnel, training of personnel, training and testing, audits and safety reviews of radiographers and radiographer assistants and reporting requirements. These requirements are in SS 225.70-75 respectively.

A new heading, " General Technical Requirements," includes requirements for permanent radiographic installations, operating requirements, records at temporary job sites, operating and emergency procedures, surveys an survey records, and utilization logs.. These requirements are in SS 225.80-87 respectively.

A new heading, " Radiation Survey Instrument and Personnel Monitoring,"

includes requirements for radiation survey meters, radiation survey meter calibration, and personnel monitoring control. These requirements are in SS 225.90-92.

A new heading, " Radiation Producing Machine Requirements," includes requirements for cabinet x-ray systems, shielded room x-ray machine radiography, temporary jcb site radiography, bomb detection and baggage / package x-ray systems, and x-ray calibration systems. These requirements are in SS 225.100-104.

Chapter 226, Radiation Safety Requirements for Wireline Service Operations and Subsurface Tracer Studies 6 of 7

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ram changes. doc

\ e Chapter 226 was renamed " Radiation Safety Requirements for Well Logging."

S 226.1 (purpose and scope) was generally updated and revised to include persons using uranium sinker bars.

S 226.2 (definitions) was deleted because the definitions are incorporated by reference.

S 226.3 (prohibition) was amended by deleting (1) which is incorporated by reference and changing the section title to " abandonment of a sealed

-source."

SS 226.4 (incorporation by reference) and 226.5 (effect of incorporation of 10 CFR Part 39) were added to clarify the differences between Chapter 226 and 10 CFR Part 39.

S 226.34 (particle accelerators) was renumbered to S 226.10 and a reference to Chapter 228 (radiation safety requirements for particle accelerators) was added.

SS 226.11 through 226.51 were deleted because they were incorporated by reference, Chapter 230, Packaging of and Transportation of Radioactive Material SS 230.2, 230.11, 230.12, 230.14, 230.21 - 230.26, 230.41 - 230.46, 230.51, Appendix A, and Tables I - IV were deleted because they were incorporated by reference.

SS 230.3 (incorporation by reference) and 230.4 (effect of incorporation of 10 CFR Part 71) were added to clarify the differences between Chapter 230 and 10 CFR Part 71.

S 230.5 (communications) was added to ensure that communications were sent to the Department's address.

S 230.13 (transportation of licensed material) was amended to include I the existing subsection (b) with the incorporation by reference.  ;

I 5 230.47 (advance notification of transport of nuclear waste) was l amended to ensure that the governor or governor's designee and the j Department will receive the required notifications and information. '

Chapter 232, Licenses and Radiation Safety Requirements for Irradiators Chapter.232 is a new chapter which is compatible with 10 CFR Part 36,

" Licenses and Radiation Safety Requirements for Irradiators."

i S 232. 1 (purpose and scope) explains that this chapter applies only to '

ecaled sources containing radioactive naterials in irradiators used to i irradiate objects or materials using gamma radiation.

SS 232.2 (incorporation by reference) and 232.3 (effect of incorporation of 10 CFR Part 36) clarifies the differences between Chapter 232 and 10 CFR Part 36.  !

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Agreement State Application 3'd Draft i September 14,1998 1

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c1 t Table of Contents 1 Agreement State Application i I

1 2 L Cens ng the Low-Level Radioactive Waste Disposal Facility j

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3 Statutory Authority 4 History l

l 5 Organization 6 Budget l 1

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- 7 Resumes  ;

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8 Position Description l Training l 10 Equipment 11 inspection vorms 12 etsies l

_ 1 13 '

Executive Summaries l

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_. 14 neguistiom 15 k AVEIW e READY WDEX* WDEXING SYSTEM