ML20134G164

Requests That Commission Approve Publication of Fr Notice Containing Proposed Agreement W/Massachusetts

ML20134G164
Person / Time
Issue date:	11/05/1996
From:	Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
SECY-96-228, SECY-96-228-R, NUDOCS 9611130067
Download: ML20134G164 (51)

Text

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RELEASED TO THE PDR  !

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• POLICY ISSUE (Notation Vote)

November 5, 1996 SECY-96-228 EDE: The Comissioners FROM: James M. Taylor Executive Director for Operations

SUBJECT:

PROPOSED AGREEMENT BETWEEN THE COMMONWEALTH OF MASSACHUSETTS AND THE COMMISSION PURSUANT TO SECTION 274 0F THE ATOMIC ENERGY ACT OF 1954, AS AMENDED PURPOSE:

To request Comission approval for publication of a Federal Reaister (FR) notice containing the proposed Agreement with Massachusetts.

SUMMARY

By letter dated March 28, 1996, Governor William F. Weld requests that the Commission enter into an Agreement with the Commonwealth of Mas.sachusetts under Section 274b of the Atomic Energy Act of 1954, as amended (Act). As required by Section 274e of the Act, staff proposes to publish the text of the proposed Agreement in the FR. The FR notice will also include a summary of the staff's draft assessment of the proposed Massachusetts regulatory program.

Comments on both the assessment and the Agreement will be requested.

BACKGROUND:

Section 274b of the Act authorizes the Commission to enter into an agreement with the Governor of a State providing for the discontinuance of the regulatory authority of the Commission with respect to certain materials. The Commission in 1981 adopted the revised policy statement entitled " Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through Agreement" (46 FR 7540; January 23, \

1981), as amended by statements published on July 16, 1981 (46 FR 36969), and

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Contact:

Richard L. B1anton, OSP SECY NOTE: TO BE MADE PUBLICLY AVAILABLE WHEN 415-2322 THE FINAL SRM IS MADE AVAILABLE.

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1 on July 21, 1983 (48 FR 33376), referred to hereafter as the " policy

! statement." Subsequently, staff adopted an internal procedure for applying i the policy statement in the processing of a new agreement. The criteria i elements and approaches in these documents form the basis for the staff's

j. evaluation of the Massachusetts request.

4 j

, DISCUSSION:

I In his letter, Governor Weld requests that the Commission enter into an  !

i Agreement with the Commonwealth pursuant to Section 274b of the Act. Governor i Weld certifies that the Commonwealth has a program for the control of

! radiation hatards which is adequate tu protect public health and safety within R l the Commonwealth with respect to the materials covered by the proposed l

. Agreement. The Governor further certifies that the Commonwealth wishes to  !

! assume the regulatory responsibility for those materials. Copies of Governor i j Weld's letter, and Chairman Jackson's response, are attached (Attachments 1 j and 2). The addition of Massachusetts will bring the number of Agreement

States to 30.

j The Governor requests five specific authorities be discontinued by the j j Commission. They are (1) the regulation of the acquisition, receipt, possession, use, and transfer of byproduct material as defined in Section I

Ile.(1) of the Act; (2) the regulation of the acquisition, receipt, i possession, use, and transfer of source material; (3) the regulation of the

. acquisition, receipt, possession, use, and transfer of special nuclear

! material in quantities not sufficient to form a critical mass; (4) the '

regulation of the land disposal of source, special nuclear, and byproduct

' material as defined in Section lle.(1) in the form of waste (as defined in 10 CFR Part 61) rec 61ved from ott.m; and (5) the evaluation of the suitability  ;

i for licensing for use in interstate commerce of sealed sources and devices J utilizing source, special nuclear, and byproduct material as defined in i i Section 11e.(1). The authority to regulate activities producing byproduct i j material as defined in Section lle.(2) of the Act, i.e., uranium and thorium j utiling activities, is not requested at this time.

The text of the proposed Agreement is included in the proposed FR notice in Attachment 3. Chairman Jackson's response to Governor Weld proposed an i effective date for the Agreement of October 1,1996. This date was  ;

! conditioned on the presumption that no issues would develop during the review  :

! which would require :further contact with the Commonwealth. Unfortunately, l several such issues did develop and required resolution. "As a result, the

October 1,1996, date could not be realized.

p

! The Commission should note that NRC staff has identified two generic issues:

i (1) regarding the definition of the term " pharmacist," and (2) the adoption of i regulatory requirements by Agreement States. The current NRC definition in

] 10 CFR 35.2 was adopted in the rulemaking " Preparation, Transfer for

Commercial Distribution, and Use of By>roduct Material for Medical Use,"

(59 FR 61767; December 2, 1994). In tie Statement of Consideration, the ,

l Commission specified that:

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The Commissioners 3 "All definitions contained in fl30.4 and 35.2 that are established or modified by this rulemaking are Division I levels of compatibility. These definitions must be the same for all NRC and Agreement State licensees so that national consistency can be  ;

maintained." l i

The NRC definition of pharmacist is:  ;

""Sans an individual licensed by a State or Territory of the j Uns '.ed States, the District of Columbia, or the Commonwealth of '

Puerto Rico to practice pharmacy." l The Massachu'setts definition of pharmacist is:

"Means an individual certified as such under M.G.L. c.112, i 24 to compound and dispense drugs, pr(scriptions, and poisons."  ;

Ordinarily, for NRC definitions that are considered to be Division I compatibility requirements, Agreement States are expected to adopt definitions l that are essentially verbatim to the NRC definition. NRC staff believes that '

even though the Massachusetts definition is not verbatim, it does capture the essence of the NRC definition. It is further r.oted that the Massachusetts definition would be acceptable under the proposed implementing procedure for the revised Commission policy on Agreement State adequacy and compatibility.  ;

NRC staff therefore proposes that the Commission accept the Massachusetts  ;

definition of pharmacist as compatible.

l t

Staff proposes to deviate from past practices by entering into the Agreement i before Massachusetts adopts (as needed for compatibility) the amendments to 10 I CFR Part 71, which became effective for NRC licensees on April ~1,1996. In the past, States were expected to have a full set of final and compatible regulations equivalent to the then current NRC regulations before the Agreement was signed. The purpose of this practice was to spare NRC licensees  !

that transferred to the State from the " whipsaw" effect of being subjected  !

first to the amended NRC requirements, then the pre-amendment requirements  !

under the State rules, then again to the new requirements when the State  :

adopted the NRC amendments.  !

Massachusetts has proposed to issue orders imposing the amended requirements }

of Part 71 on licensees as an interim measure while rulemaking action to adopt l the Part 7.1 amendments continues. The rulemaking is not expected to be i completed until the spring of 1997. NRC staff believes this proposed action  !

is consistent with the intent of the former practice.  !

The NRC staff believes that the specifics in the request for an Agreement and {

the supporting material meet the criteria set forth in Section 274 of the Act i and in the policy statement. This conclusion is based on the NRC staff j assessment of the proposed program against the 28 criteria contained in the '

policy statement (Attachment 3). l This paper has been coordinated with the Office of the General Counsel, which l has no legal objection. i i

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l I

The Commissioners 4 I '

RECOP94ENDATIONS:

] That the Commission: )

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1. Anorove:

l 4 The staff recommendation to accept the Massachusetts definition of

" pharmacist" as compatible. l

, 2. Annrove: i

! The staff recommendation to accept the Massachusetts plan to impose the regulatory requirements in 10 CFR Part 71 (as needed for compatibility), ,

as amended effective April 1,1996, by orders issued to licensees as an I interim method pending the completion of the Comonwealth's rulemaking. I

! 3. Anorove:

Publication of the FR notice for public review and coment on proposed 4

Agreement between the Comonwealth of Massachusetts and the Nuclear Regulatory Comission pursuant to Section 274 of the Act, to regulate byproduct material as defined in Section 11e.(1) of the Act, source j material, and special nuc. ear material in quantities not sufficient to form a critical mass, (Attachment 4).

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4. Note:

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a. Staff will place a copy of the full staff assessment (sumarized i in the FR notice) in the Public Document Room (Attachment 3).

b. Governor Weld's letter was acknowledged by a letter from the Chairman (Attachment 2).

c. The Office of Congressional Affairs will dispatch a letter to the cognizant Congressional Committees informing them that the Comission is considering entering into an Agreement with the Comonwealth (Attachment 5).

d. The Office of Public Affairs will issue e press release (Attachment 6).

e. Approximately 420 NRC licenses will transfer to the Commonwealth under the Agreement. The Massachusetts program is fully funded by licensing fees. Fees are deposited in a retained revenue account for exculsive use by the Radiation Control Program. j SCHEDULING: I Section 274 of the Act requires that the proposed Agreement be published in the FR once a week for four consecutive weeks. If approved by the Comission, the proposed Massachusetts Agreement and a sumary of the staff's assessment ,

of the Comonwealth's proposed program for the regulation of materials and  !

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The Commissioners 5 l activities covered by the Agreement will be published as required for public )

review and comment. The FR notice is contained in Attachment 4. '

When the public comment period closes, NRC staff will prepare an analysis of l the comments, the final staff assessment of the Massachusetts program, and the  :

final text of the proposed Agreement. This will be forwarded to the  ;

Commission for approval.

J 1

A Y.s

. mes M. lor xecutive Director for Operations Attachments:

1. Letter from Governor Weld to Chairman Jackson

2. Acknowledgment Letter from Chairman Jackson to Governor Weld

3. Draft NRC Staff Assessment of the Proposed 1

Massachusetts Agreement Materials Program

4. Draft Federal Reaister Notice 5 Draft Letter to Congressional Committees

6. Draft Press Release Commissioners' comments or consent should be provided directly to the Office of the Secretary by c.o.b. Wednesday, November 20, 1996. Commission staff office comments, if any, should be submitted to the Commissioners NLT November 13, 1996,, with an information copy to SECY. If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.

DISTRIBUTION:

Commissioners OGC OCAA DIG OPA OCA REGION I )

EDO , j SECY i l

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THE COMMONWEALTH OF MASEACHUSETTS S 9 2 EXECUTIVE DEPARTMENT STATE HOUSE

• BOSTON 02133

, 1817)727 3800 i

WILLIAM F. WELD l eowesusoa ARGEo PAUL CELLUCCI

, usursseamt sovesnuost l

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. March 28,1996 i

The Honorable Shirley A. Jackson Chairman United States Nuclear Regulatory Commission '

Washington. DC 20555 i

Dear Madam Chairman:

I am writing to reque:t formally an agreement between the United States Nuclear Regulatory Commission (NRC) and the Commonwealth of Massachusetts, as authorized under Section 274b of the Atomic Energy Act of 1954, as amended, and the Massachusetts General

12ws, Chapter 111H under which the Commission will discontinue and the Commonwealth will

assume certain regulatory authority for radioactive materials 'now under federaljurisdiction. The specific authority requested at this time is for

^

I A. Byproduct material as defined in Section lle(l) of the Act j B. Source materials '

C. Special nuclear materials in quantities not sufficient to form a critical mass D. Licensing of Low Level Radioactive Waste Facilities

(  :

1 I certify that the Commonwealth of Massachusetts wants to assume regulatory responsibility j for such materials, and that the Commonwealth has a program for the control of radiation hazards l

adequate to protect the public health and safety with respect to materials within Massachusetts

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covered by this proposed agreement. Enclosed is information describing the Commonwealth's I radiation control program and regulatory capabilities as well as a copy of our radiation control  !

regulations. ' At this time, the Commonwealth does not wish to assume authority over uranium

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milling activities. However, Massachusetts reserves the right to apply to the NRC at a future date

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, for an amended agreement to assume authority in this area.

Our Administration is hopeful that the proposed agreement may become effective by May 24, 1996.

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Sincerely, 4

g _

William F. Weld i Enclosures l ATTACHMENT 1  !

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/ '%#,t UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. F566-0001 h

Hay 7, 1996 k.....[e CHARMAN 1

The Honorable William F. Weld Governor of Massachusetts Boston, Massachusetts 02133

Dear Governor Weld:

I have received your letter of March 28, 1996, in which you propose an agreement between the Nuclear Regulatory Commission and the Commonwealth of Massachusetts pursuant to Section 274b of the Atomic Energy Act of 1954, as amended (Act). Under your proposal, Massachusetts would assume regulatory l authority over the acquisition, possession, use, transfer, and disposal of source material, byproduct material as defined in Section 11e.(1) of the Act, l and special nuclear material in quantities not sufficient to form a critical j

\ mass. '

The regulatory authority to be assumed would include the regulation of the land disposal of the subject materials received as waste from other persons, and the conduct of safety evaluations of sealed sources and devices to be transferred in interstate commerce. The regulatory authority would not, however, include the regulation of byproduct material as defined in Section 11e.(2) of the Act (tailings from uranium or thorium milling).

The NRC staff is preparing an assessment of the proposed Massachusetts program described in your submittal and will publish the assessment, along with the  :

proposed agreement, in the Federal Reoister for public comment. The Act l requires that the proposed agreement be published once a week for four consecutive weeks. A press release concerning your request will also be i issued. After the expiration of the four-week comment period required by the Act, the Commission will consider any comments received and make a final decision on your request. We will promptly inform you of our decision. In order to comply with the requirements of the Act and to ensure an orderly transfer of regulatory authority, we anticipate concluding an agreement effective October 1,1996, assuming that no issues arise during the review.

The Commission is pleased with your continued interest in participating in the Agreement State Program and looks forward to the continued excellent relationship we have enjoyed in the past.

Sincerely, p

Shirley Ann Jackson r

ATTACHMENT 2

_~ _.. _ _ _ _ __ _ _ _ - 7 I

l ASSESSMENT l l

of the proposed i i

NASSACHUSETTS PROGRAM FOR THE REGULATION OF AGREEMENT MATERIALS as described in the Commonwealth's Request for an Agreement This assessment, prepared by NRC staff,-examines the proposed radiation control program of the Commonwealth of Massachusetts.with respect to the ability of the program to regulate the possession, use, and disposal of radioactive materials subject to the Atomic Energy Act of 1954, as amended.  ;

The. assessment was performed against the criteria set forth in the Commission's policy statement " Criteria for Guidance of States and NRC in Discontinuance of NRC Reaulatory Authority and Assumption Thereof by States

)

Throuah Aareement" (referred to below as the " criteria")' using an internal l procedure developed by the Office of State Programs. Each criterion, and the  !

NRC staff's assessment related thereto, is addressed separately below.  :

OBJECTIVES

]

1. Protection. A State regulatory program shall be designed to protect the l health and safety of the people against radiation hazards. '

The NRC staff determined that the proposed radiation control program will have an organizational subdivision identified as the " Low-Level Waste and Agreement State" unit (referred to below as the " agreement materials unit") that will have the responsibility for regulating radioactive materials licensees and an anticipated future low-level radioactive waste disposal facility. The unit will regulate both users of radioactive materials covered by the Atomic Energy Act (known as agreement materials), and users of naturally occurring or accelerator produced radioactive materials. Other organizational subdivisions of the program will have responsibilities for regulating machine produced radiation (x-ray), licensing medical radiography technologists, etc.

NRC staff determined that this is a typical pattern for regulating radiation hazards that is used successfully in other Agreement States.

NRC staff concludes that the proposed Massachusetts radiation control program is appropriately designed to provide protection of the health and safety of the public against radiation hazards from the materials ATTACHMENT 3 NRC Statement of Policy p etished in the Federal Register January 23, 1981 (46 FR 7540 7546), a correction was published July 16,1981 (46 FR 36969) and a revision of Criterion 9 published in' the Federal Register July 21, 1983 (48 FR 33376).

2 and uses over which the Commonwealth proposes to assume regulatory responsibility.

References:

Program Narrative Description and Organizational Charts (Enclosure 3 and Attachment 1 to Enclosure 3 of the Request for an Agreement by Governor Weld.)

RADIATION PROTECTION STANDARDS

2. Standards. The State regulatory program shall adopt a set of standards for protection against radiation which shall apply to byproduct, source  ;

and special nuclear materials in quantities not sufficient to form a l critical mass.  !

The review of the request found that the authority to promulgate regulations for the control of exposure to sources of radiation is contained ia statute (Massachusetts General Law Chapter Ill, Section SN). In accordance with that authority, the Massachusetts Department of Public Health has adopted regulations [in Chapter 105 of the Code of Massachusetts Regulations, Section 120.001, et seg. (105 CMR 120.000, cited herein as the Massachusetts Regulations for the Control of '

Radiation or MRCR)] which are currently in effect. Theseregulations include radiation protection standards essentially identical to those in 10 CFR Part 20 which will apply to agreement materials, and standards equivalent to those in 10 CFR Part 61 which will apply to the land disposal of agreement material received as waste from other persons.

Reference:

Massachusetts General Law Chapter 111, Section SN; Massachusetts Regulations for the Control of Radiation at 105 CMR 120.001 - 120.019,105 CMR 120.120 - 120.197,105 CMR 120.200 -120.271, 105 CMR 120.300 - 120.398, 105 CMR 120.500 - 120.576, 105 CMR 120.750 -

120.760, 105 CMR 120.770 - 120.795, 105 CMR 120.800 - 120.897, 105 CHR 120.900 - 120.961.

Agreement State and NRC regulations are considered " essentially identical" If they are word for word the same, except for certain specific differences, such as:

e Rule raabers may be changed to conform to the State ru.nbering system.

e The provisions of a regulation may be re-sequenced.  ;

e Terms may be substituted for "ccanission," " agency," "this part," "this chapter" or "these l regulations."

o De word " rule" may be interchanged with the word " regulation," and the word "shall" may be '

interchanged with the word "must."

e other non-substantive wording changes similar in nature to the above may be made to conform the regulation to the State editorial style, y e The State regulation may be expanded to incorporate sources of radiation other than source, byproduct and special nuclear materials, provided the additional sources are subject to the same requirements.

e The State regulation may specify the use of SI units for recordkeeping and reporting.

e Any portion of the text of an NRC regulation Wich provides supplemental information, an example, or a reference (for convenience) to another regulation may be omitted.

3 Uniformity in Radiation Standards. It is important to strive for 3.

uniformity in technical definitions and terminology, particularly as 1 related to such things as units of measurement and radiation dose.

There shall be uniformity on maximum permissible doses and levels of l radiation and concentrations of radioactivity, as fixed by 10 CFR Part 20 of the NRC regulations based on officially approved radiation  ;

protection guides. i The NRC staff found that the technical definitions and terminology  ;

i adopted in the MRCR are essentially identical to the equivalent terms in '

the NRC regulations. Those terms that are related to units of i measurement and radiation doses are essentially identical to the terms  !

contained in 10 CFR Part 20. The MRCR contain all of the provisions on l

maximum permissible doses, levels of radiation, and concentrations of i radioactivity that NRC staff believes necessary in order to be -

compatible with the regulations of thu NRC on the effective date of the Agreement between the Commonwealth and the Commission. ,

Reference:

Massachusetts' Regulations for the Control of Radiation at  ;

l 105 CMR.120.005,105 CMR 120.203,105 CMR 120.302,105 CMR 120.502,105 CMR 120.772, 105 CMR 120.803, 105 CMR 120.902.

I 4.. Total Occupational Radiation Exoosure. The regulatory authority shall consider the total occupational radiation exposure of individuals, l l including that from sources which are not regulated by it. j i

l The review determined that under the MRCR, as adopted, licensees are L

required to evaluate the radiation dose received by those individuals  :

who are occupationally exposed to radiation in activities under the ,

licensee's control. In conducting the evaluation, the licensees are required to consider the total radiation doses to the individuals from i all sources of radiation (except background radiation and radiation from l medical treatment or examinations, as is the case in the NRC rules),  !

whether the sources are in the possession of the licensee or not. The  !

definitions related to occupational exposure are essentially identical  !

to those of the NRC. l

Reference:

Massachusetts Regulations for the Control of Radiation at 105.CMR 120.211 - 218, 105 CMR 120.221. .

1

5. Surveys. Monitorina. Appropriate surveys and persorinel monitoring under i the close supervision of technically competent people are essential in j actiieving radiological protection and shall be made in determining  ;

compliance with safety regulations.  ;

i l The review demonstrated that the MRCR impose requirements on the ,

l licensees to conduct surveys tc, evaluate potential exposures from j sources of radiation. Likewise, the MRCR contain requirements for  !

personnel monitoring. All of these requirements are based on, and  ;

I consistent with, the equivalent requirements contained in NRC 1 regulations. *

-i

4 The MRCR further specify requirements similar to those in NRC regulations for the training and experience of workers. The NRC staff believes that the MRCR requirements are adequate to assure the technical competency of workers conducting surveys and monitoring.

Reference:

Massachusetts Regulations for the Control of Radiation at 105 CMR 120.225.

6. Labels. Sions. Symbols. .

It is desirable to achieve uniformity in  !'

labels, signs, and symbols, and the posting thereof. However, it is essential that there be uniformity in labels, signs, and symbols affixed 4

to radioactive products which are transferred from person to person.

The review disclosed that the radiation labels, signs and symbols, and posting requirements adopted in the MRCR r.re essentially identical to i

I those contained in 10 CFR Part 20. The Massachusetts requirements for

labeling radioactive products and the equivalent NRC ' requirements also exhibit the required degree of uniformity. i i 1

Reference:

Massachusetts Regulations for the Control of Radiation at j 105 CMR 120.122G,105 CMR 120.1221,105 CMR 120.241 - 120.245.  !

i 7. Instruction. Persons working in or frequenting restricted areas shall l-1 be instructed with respect to the health risks associated with ex to radioactive materials and in precautions to minimize exposure.posure

[ Workers shall have the right to request regulatory authority inspections

j. as per 10 CFR 19, Section 19.16 and to be represented during inspections 4

as specified in Section 19.14 of 10 CFR 19.

j The NRC staff found that the MRCR contain all of the requirements for i instructions, notices to workers, notifications to and reports to individuals, that are required in order for the rules to be consistent i with those in 10 CFR Part 19. The MRCR specifically provide werkers i

' with the same rights as the NRC rules to request inspections and to be represented during inspections.

i lt is noted that the NRC regulations and definitions in 10 CFR Parts 19

{- and 20 have been amended since the Commission adopted the criteria. In i reviewing the Massachusetts request, NRC staff has evaluated the MRCR in j comparison to:the current NRC rules. In particular,10 CFR 19.12 was i

amended effective August 14, 1995 (60 FR 36038; July 13, 1995).

1 i

Criterion number seven reflects, in part, the pre-amendment rule. In per' forming the review, NRC staff has considered the amended statement of the rule, which requires instruction to be provided to all individuals l

who, in the course of their employment, are likely to receive an occupational dose in excess of _100 millirem in one year, whether the dose is received in a restricted area or not. The equivalent MRCR rule is found to be compatible with the current NRC rule.

Reference:

Massachusetts Regulations for the Control of Radiation at 105 CMR-120.750 - 120.760.

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J ASSESSMENT of the proposed MASSACHUSETTS PROGRAM FOR THE REGULATION OF AGREEMENT MATERIALI as described in the Commonwealth's Request for an Agreement This assessment, prepared by NRC staff, examines the proposed radiation j control program of the Commonwealth of Massachusetts with respect to the 1 ability of the program to regulate the possession, use, and disposal of  !

radioactive materials subject to the Atomic Energy Act of 1954, as amended.

The assessment was performed against the criteria set forth in the i Commission's policy statement " Criteria for Guidance of States and NRC in 1 Discontinuance of NRC Reaulatory Authority and Assumotion Thereof by States l Throuah Aareement" (referred to below as the " criteria")' using an internal i procedure developed by the Office of State Programs. Each criterion, and the i

NRC staff's assessment related thereto, is addressed separately below.

OBJECTIVES

1. Protection. A State regulatory program shall be designed to protect the health and safety of the people against radiation hazards.

The NRC staff determined that the proposed radiation control program will have an organizational subdivision identified as the " Low-Level Waste and Agreement State" unit (referred to below as the " agreement materials unit") that will have the responsibility for regulating radioactive materials licensees and an anticipated future low-level 4

radioactive waste disposal facility. The unit will regulate both users of radioactive materials covered by the Atomic Energy Act (known as agreement materials), and users of naturally occurring or accelerator produced radioactive materials. Other organizational subdivisions of the program will have responsibilities for regult. ting machine produced radiation (x-ray), licensing medical radiography technologists, etc.

NRC staff determined that this is a typical pattern for regulating radiation hazards that is used successfully in other Agreement States.

NRC staff concludes that the proposed Massachusetts radiation control  !

program is appropriately designed to provide protection of the health and safety of the public against radiation hazards from the materials ATTACHMENT 3 <

WRC Statement of Policy published in the Federal Register January 23,1981 (46 FR 7540-7546), a correction tsas published July 16, 1981 (46 FR 36969) and a revision of criterion 9 published in the Federal Resister July 21, 1983 (48 FR 33376). l

2 and uses over which the Commonwealth proposes to assume regulatory

responsibility.

References:

Program Narrative Description and Organizational Charts (Enclosure 3 and Attachment I to Enclosure 3 of the Request for an Agreement by Governor Weld.)

RADIATION PROTECTION STANDARDS

2. Standards. The State regulatory program shall adopt a set of standards for protection against radiation which shall apply to byproduct, source and special nuclear materials in quantities not sufficient to form a critical mass.

The review of the request found that the authority to promulgate regulations for the control of exposure to sources of radiation is contained in statute (Massachusetts General Law Chapter 111, Section SN). In accordance with that authority, the Massachusetts Department of Public Health has adopted regulations [in Chapter 105 of the Code of Massachusetts Regulations, Section 120.001, et seq. (105 CMR 120.000, cited herein as the Massachusetts Regulations for the Control of '

Radiation or MRCR)] which are currently in effect. These regulations include radiation protection standards essentially identical to those in 10 CFR Part 20 which will apply to agreement materials, and standards equivalent to those in 10 CFR Part 61 which will apply to the land disposal of agreement material received as waste from other persons.

Reference:

Massachuset'.s General Law Chapter 111, Section SN; Massachusetts Regulations for the Control of Radiation at 105 CMR 120.001 - 120.019,105 CMR 120.120 - 120.197,105 CMR 120.200 -120.271, 105 CMR 120.300 - 120.398, 105 CHR 120.500 - 120.576, 105 CMR 120.750 -

120.760, 105 CMR 120.770 - 120.795, 105 CMR 120.800 - 120.897, 105 CMR 120.900 - 120.961.

Agreement State and NRC regulations are considered " essentially identical" if they are word for word the same, except for certain specific differences, such as:

• Ru!* rvehs may be changed to conform to the State rn.9)eri.ig system.

e The provisions of a regulation may be re-sequenced.

e Terms may be substituted for "consnission," " agency," "this part," "this chapter" or "these regulations."

• The word " rule" may be interchanged with the word " regulation," and the word "shall" may be interchanged with the word "must."

e other non-substantive wording changes similar in nature to the above may be made to conform the regulation to the State editorist style.

• The State regulation may be expanded to incorporate sources of radiation other than source, byproduct and special nuclear materlats, provided the additional sources are subject to the same requirements.

• The State regulation may specify the use of SI units for recordkeeping and reporting.

• Any portion of the text of an NRC regulation which provides supplemental information, an example, or a reference (for convenience) to another regulation mry be omitted.

3

3. Uniformity in Radiation Standards. It is important to strive for uniformity in technical definitions and terminology, particularly as related to such things as units of measurement and radiation dose.

There shall be uniformity on maximum permissible doses and levels of radiation and concentrations of radioactivity, as fixed by 10 CFR Part 20 of the NRC regulations based on officially approved radiation prozection guides.

The NRC staff found that the technical definitions and terminology adopted in the MRCR are essentially identical to the equivalent terms in the NRC regulations. Those terms that are related to units of measurement and radiation doses are essentially identical to the terms contained in 10 CFR Part 20 The MRCR contain all of the provisions on maximum permissible doses, sevels of radiation, and concentrations of radioactivity that NRC staff believes necessary in order to be compatible with the regulations of the NRC on the effective date of the Agreement between the Commonwealth and the Commission.

Reference:

Massachusetts Regulations for the Control of Radiation at 105 CMR 120.005, 105 CMR 120.203, 105 CMR 120.302, 105 CMR 120.502, 105 CMR 120.772, 105 CMR 120.803, 105 CMR 120.902.

4. Total Occuoational Radiation Exposure. The regulatory authority shall consider the total occupational radiation exposure of individuals, including that from sources which are not regulated by it.

The review determined that under the MRCR, as adopted, licensees are required to evaluate the radiation dose received by those individuals who are occupationally exposed to radiation in activities under the licensee's control. In conducting the evaluation, the licensees are required to consider the total radiation doses to the individuals from all sources of radiation (except background radiation and radiation from medical treatment or examinations, as is the case in the NRC rules),

whether the sources are in the possession of the licensee or not. The definitions related to occupational exposure are essentially identical to those of the NRC.

Reference:

Massachusetts Regulations for the Control of Radiation at 105 CMR 120.211 - 218, 105 CMR 120.221.

5. Surveys. Monitorina. Appropriate surveys and persorinel monitoring under the. close suparvision of technically competent people are essential in achieving radiological protection and shall be made in determining compliance with safety regulations.

The review demonstrated that the MRCR impose requirements on the licensees to conduct surveys to evaluate potential exposures from sources of radiation. Likewise, the MRCR contain requirements for personnel monitoring. All of these requirements are based on, and consistent with, the equivalent requirements contained in NRC regulations.

4 The MRCR further specify requirements similar to those in NRC regulations for the training and experience of workers. The NRC staff believes that the MRCR requirements are adequate to assure the technical competency of workers conducting surveys and monitoring.

Reference:

Massachusetts Regulations for the Control of Radiation at 105 CMR 120.225.

6. Labels. Sions. Symbols. It is desirable to achieve uniformity in labels, signs, and symbols, and the posting thereof. However, it is essential that there be eniformity in labels, signs, and symbols affixed to radioactive products which are transferred from person to person.

The review disclosed that the radiation labels, signs and symbols, and posting requirements adopted in the MRCR are essentially identical to those contained in 10 CFR Part 20. The Massachusetts requirements for labeling radioactive products and the equivalent NRC requirements also exhibit the required degree of uniformity.

Reference:

Massachusetts Regulations for the Control of Radiation at 105 CMR 120.122G, 105 CMR 120.122I, 105 CMR 120.241 - 120.245.

7. Instruction. Persons working in or frequenting restricted areas shall be instructed with respect to the health risks associated with exposure to radioactive materials and in precautions to minimize exposure.

Workers shall have the right to request regulatory authority inspections as per 10 CFR 19, Section 19.16 and to be represented during inspections as specified in Section 19.14 of 10 CFR 19.

The NRC staff found that the MRCR contain all of the requirements for instructions, notices to workers, notifications to and reports to individuals, that are required in order for the rules to be consistent with those in 10 CFR Part 19. The HRCR specifically provide workers with the same rights as the NRC rules to request inspections and to be represented during inspections.

It is noted that the NRC regulations and definitions in 10 CFR Parts 19 and 20 have been amended since the Commission adopted the criteria. In reviewing the Massachusetts request, NRC staff has evaluated the MRCR in comparison to .~the current NRC rules. In particular,. 10 CFR 19.12 was amended effective August 14,1995 (60 FR 36038; July 13,1995).

Criterion number seven reflects, in part, the pre-amendment rule. In performing the review, NRC staff has considered the amended statement of the rule, which requires instruction to be provided to all individuals who, in the course of their employment, are likely to receive an occupational dose in excess of 100 millirem in one year, whether the dose is received in a restricted area or not. The equivalent MRCR rule is found to be compatible with the current NRC rule.

Reference:

Massachusetts Regulations for the Control of Radiation at 105 CMR 120.750 - 120.760.

i .

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4

.8. Storaae. Licensed radioactive material in storage shall be secured  ;

against unauthorized removal.

The NRC staff determined that the section in the MRCR imposing the requirements for the security of stored radioactive material is  ;

compatible with the equivalent section of the NRC regulations.  !

Reference:

Massachusetts Regulations for the Control of Radiation at 105 CMR 120.235.

9. Rad'ioactive Waste Discosal. (a) Waste disposal by material users. The standards for the disposal of radioactive materials into the air, water and sewer, and burial in the soil shall be in accordance with 10 CFR Part 20. Holders of radioactive material desiring to release or dispose of quantities or concentrations of radioactive materials in excess of prescribed limits shall be required to obtain special permission from the appropriate regulatory authority.

Requirements for transfer of waste for the purpose of. ultimate disposal at a land disposal facility (waste transfer and manifest system) shall be in accordance with 10 CFR 20. The waste disposal standards shall include a waste classification scheme and provisions for waste form, applicable to waste generators, that is equivalent to that contained in 10 CFR Part 61.

The review confirmed that the MRCR contain provisions relating to the disposal of radioactive materials into the air, water and sewer, and by burial in soil which are at least as protective as the equivalent rules in 10 CFR Part 20. The MRCR require licensees to apply f.or and obtain a i specific license condition to dispose of radioactive waste using methods other than as provided in the rules. j Waste transfer and manifest system requirements applicable to transfers of waste intended for ultimate disposal at a land disposal facility were also identified in the review and found to be as protective as the NRC rules. The Massachusetts waste disposal requirements include a waste classification scheme and requirements for waste form that were found to i be equivalent to the requirements in 10 CFR Part 61. l

Reference:

Massachusetts Regulations for the Control of Radiation at i

-105 CMR 120.251 - 120.257.

(b)' Land Disposal of waste received from other persons. The State shall promulgate 7egulations containing licensing requirements for land disposal of radioactive waste received from other persons which are compatible with the applicable technical definitions, performance objectives, technical requirements and applicable supporting sections set forth in 10 CFR Part 61. Adequate financial arrangements (under terms established by regulation) shall be required of each waste disposal site licensee to ensure sufficient funds for decontamination, closure and stabilization of a disposal site. In addition, Agreement State financial arrangements for long-term monitoring and maintenance of

6 a specific site must be reviewed and approved by the Commission prior to relieving the site operator of licensed responsibility (Section 151(a)(2), Pub. L.97-425).

Massachusetts has requested the authority to regulate the disposal of low-level radioactive waste received from other persons at a land disposal site. In support of this requested authority, Massachusetts has promulgated regulations that are equivalent to those in 10 CFR Part

61. The NRC staff review of these regulations determined that they contain all of the specified requirements of compatibility with two caveats.

First, it is noted that Massachusetts prohibits, by statute, shallow land burial as a disposal method. Secondly, an agency of the Commonwealth, the Low-Level Radioactive Waste Management Board (Board),

is designated by statute to be the owner of the site. The Board will select an operator for the site who will be the site licensee during operations. At the end of the site operation, the operator will transfer the license to the Board to start the institutional control period. Thus the Board will act as the custodial agency as defined in 10 CFR Part 61. The Board will, by statute, remain the site owner and licensee indefinitely.

Several definitions and rules related to waste disposal in the MRCR are different from the equivalent NRC definitions and rules in reflection of the statutory requirements noted above. For example, there is no provision for termination of the waste site license once issued. This alternate pattern of regulation has previously been accepted for a disposal site in the State of Utah.

NRC staff also considered two other issues concerning the handling and disposal of radioactive materials received as waste from other persons.

As provided in 105 CMR 120.801(B), Massachusetts will apply the radiation protection standard in 105 CMR 120.811 (the equivalent to 10 CFR 61.41) to waste storage facilities and waste processing facilities that receive radioactive materials as waste from other persons. Under NRC regulations, such facilities would not be subject to 10 CFR 61.41, rather only to the radiation protection standard in 10 CFR 20.1301 (Massachusetts has an equivalent standard in 105 CMR 120.221). NRC staff requested an interpretation of the provisions by Massachusetts legal staff, which was provided by the Deputy General Counsel for the Massachusetts Department of Public Health. Under the interpretation, the requirements of 105 CMR 120.811 will be enforced as a radiation protection standard for waste disposal facilities, and as a performance objective for waste treatment and waste storage facilities.

The other issue considered by NRC staff is the Massachusetts requirement in statute (Massachusetts General Law Chapter 111H, Section 38(b)), and in regulation (105 CMR 120.801(G)) which effectively prohibits a radioactive waste disposal site in Massachusetts from accepting waste from "an electric-power-generating facility" if the waste requires "more stringent management" than waste received from other licensees. It was

l l

7 of concern that this provision could cause a gap in the regulation of l radioactive waste by creating an " orphan" waste stream, since waste i management under NRC rules is related only to the classification of the '

waste pursuant to 10 CFR 61.55, regardless of the source of the waste.

NRC staff. requested an interpretation of the Massachusetts provisions by ,

Massachusetts legal staff, which was provided by the General Counsel for the Massachusetts Low-Level Radioactive Waste Management Board. Under the interpretation, waste from any source will be accepted provided it is properly classified according to the specifications of 105 CMR 120.299(A) (equivalent to 10 CFR 61.55), is properly packaged and labeled, and arrives undamaged and not leaking with a properly executed shippisng manifest.

NRC staff believes that on whole the provisions of Massachusetts law and.

regulations related to the management of low-level radioactive waste provide at least the same protection as is provided by the NRC requirements, and that the Massachusetts program for the management.of-low-level radioactive waste is compatible with the program of the Commission.

References:

Massachusetts General Law Chapter 111H, Section 38(b);

Massachusetts Regulations.for the Control of Radiation at 105 CMR 120.800 - 120.897; Letter with attachments frca Massachusetts Department of Public Health Commissioner Mulligan dated August 14, 1996.

10.- Reaulations Governina Shioment of Radioactive Materials. The State shall, to the extent of its jurisdiction, promulgate regulations applicable to the shipment of radioactive materials, such regulations to be compatible with those established by the U.S. Department of Transportation and other agencies of the United States whose jurisdiction over interstate shipment of such materials necessarily continues. State regulations regarding transportation of radioactive materials must be compatible with 10 CFR Part 71.

The NRC staff's review of the MRCR determined that the sections applicable to the preparation of radioactive materials for shipment are similar to the NRC regulations in 10 CFR Part 71 that were effective prior to April 1, 1996. On that date, amended regulations in Part 71 became effective. Since negotiations pursuant to Section 274b of the Act-were already in progress, Massachusetts chose to continue with the request for an Agreement while developing amended State regulations in parallel. NRC staff does not expect the amended Massachusetts rules to become effective before the Agreement is signed.

The Massachusetts radiation control program has committed to enforcing the provisions of the amended Part 71 rules by issuing appropriate '

regulatory orders to the affected licensees, and to continue the process of adopting amendments to the Massachusetts rules. The orders are intended to spare NRC licensees transferred to Massachusetts from the j

" whipsaw" effect of being regulated first under the amended NRC l regulations, then the old regulations wher the Agreement takes effect, then again under the amended regulations when later adopted by l

l l

l

' l 8  !

Massachusetts. Previously, NRC has required a State proposing to enter into an agreement to have regulations equivalent to current NRC  !

regulations in effect at the time the agreement is signed. However, the Commission's legal counsel has indicated that Agreement States have the flexibility to use alternate legally binding methods of imposing NRC regulatory requirements on their licensees. On this basis, NRC staff find that the Massachusetts plan is acceptable.

Since the amended NRC regulations are coordinated with the regulations of the U. S. Department of Transportation (DOT), the amended i Massachusetts regulations will also be compatible with the DOT l regulations. The NRC staff concludes, therefore, that the Massachusetts I radiation control program will satisfy the elements of this criterion. 1

)

References:

Massachusetts Regulations for the Control of Radiation at 'i 105 CMR 120.770.- 120.795; Letter with attachments from Massachusetts  ;

Department of Public Health Commissioner Mulligan dated August 14, 1996

11. Records and Reports. The State regulatory program shall require that l holders and users of radioactive materials (a) maintain records covering i personnel radiation exposures, radiation surveys, and disposals of-  !

materials; (b) keep records of the receipt and transfer of the j materials; (c) report significant incidents involving the materials, as prescribed by the regulatory authority; (d) make available upon t-equest of a former employee a report of the employee's exposure to radiation; (e) at request of an employee advise the employee of his or her annual radiation exposure; and (f) inform each employee in writing when the employee has received radiation exposure in excess of the prescribed limits. .

)

i The review confirmed that the MRCR require licensees to maintain the i specified records and to make reports similar to those specified in NRC  !

regulations. The requirements are generally consistent with the l equivalent NRC requirements. The NRC staff noted that for some NRC rules that specify a records retention period of less than five years, the retention period specified in the MRCR is shorter. The NRC staff i concluded, however, that the retention periods specified in the MRCR rules are adequate since the retention periods are long enov;h to permit examination of the records during routine inspections. The MRCR imposes retention requirements similar to the NRC rules for.. records which must be retained indefinitely or until the license is terminated.

Th MRCR contains sections similar to the rules in 10 CFR Part 19 that include the reporting requirements of Part 19, as reflected in criterion 11.

Reference:

Massachusetts Regulations for the Control of Radiation at 105 CMR 120.261 - 120.284.

- - _ - . - ~ - . . - - - . - - . - . - . . - - _ _ - . . - - - . - - - . _ ..

9 i

. 12. Additional Reauirements and Exemptions. Consistent with the overall criteria here enumerated and to accommodate special cases and i circumstances, the State regulatory authority shall be authorized in individual cases to inr;se additional requirements to protect health and safety, or to grant necessary exemptions which will not jeopardize l health and safety.

t The NRC staff determined that the Massachusetts radiation control program has the authority by Statute to impose additional requirements to the effective requirements specified in the regulations. The MRCR

, rule implementing the statute is similar in its provisions and j

conditions to the equivalent NRC rule. 1 The radiation control program also retains by regulation the authority to grant specific exemptions from the requirements of the regulations; this provision is essentially identical to the equivalent NRC rule.

Reference:

Massachusetts Regulations for the Control of Radiation at

105 CMR 120.130, 105 CMR 120.005.

l PRIOR EVALUATION OF USES OF RADIOACTIVE MATERIALS i 13. Prior Evaluation of Hazards and Uses. Exceptions. In the present state j of knowledge, it is necessary in regulating the possession and use of

byproduct, source and special nuclear materials that the State regulatory authority require the submission of information on, and

evaluation of, the potential hazards, and the capability of the user or i possessor prior to his receipt of the materials. This criterion is

! subject _to certain exceptions and to continuing reappraisal as knowledge i and experience in the atomic energy field increase. Frequently there j are, and increasingly in the future there may be, categories of materials and uses as to which there is sufficient knowledge to permit possession and use without prior evaluation of the hazards and the capability of the possessor and user. These categories fall into two groups - those materials and uses which may be completely exempt from regulatory controls, and those materials and uses in which sanctions for

misuse are maintained without pre-evaluation of the individual possession or use. In authorizing research and development _or other

activities involving multiple uses of radioactive materials, where an 4

institution hais people with extensive training and experience, the State 1 regulatory authority may wish to provide a means for authorizing broad  !

use. of materials without evaluating each specific use. l The review concluded that the MRCR contain regulations similar to the i current NRC regulations specifying the required content of applications i for licenses, renewals, and amendments. The MRCR also contain 3 requirements similar to the NRC requirements for issuing licenses and ,

i specifying the terms and conditions of licenses. In some cases, the '

Massachusetts requirements may be more stringent than the equivalent NRC requirements to reflect concerns unique to the Commonwealth. The agreement materials unit has adopted procedures for processing

, 1 i

y ,-- ,- -_.. , , - .- -

\

. i e 10 c ,

! applications that assure the regulatory requirements will be met or  !

(.

exceptions granted as provided for by regulation. l I The MRCR also provide for general licenses compatible with those .

provided by the NRC regulations. The MRCR allow the possession and use

]

of' agreement materials exempt from license under the same conditions as {

allowed by NRC. The MRCR note that a license authorizing ths  :

distribution of agreement materials that will subsequently be exempt  ;

from regulatory control may be issued only by the NRC. The agreement  ;

materials unit will regulate several licensees to whom NRC has' issued j licenses of broad scope. Staff has determined that the MRCR contains j provis, ions equivalent to the rules in 10 CFR Part 33 for the regulation  !

of broad scope licenses. j

-The NRC staff finds that the Massachusetts regulations .for licensing are  !

compatible with those of the NRC.

l

Reference:

Massachusetts Regulations for the Control of Radiation at j 105 CMR 120.133 - 120.135. >

-14. - Evaluation Criteria. In evaluating a proposal to use radioactive materials, the regulatory authority shall determine the adequacy of the applicant's facilities and safety equipment, his training and experience  !

in the use of the materials for the purpose _ requested, and his proposed }

administrative controls. States should develop guidance documents for- l use by license applicants. This guidance should be consistent with NRC licensing and regulatory guides for various categories of licensed activities. j The NRC staff found that the Massachusetts agreement mate' rials unit l licensing procedures manual contains instructions to the unit staff  :

addressing the specific elements listed in the criterion. .The licensing j procedures manual and the accompanying Massachusetts regulatory guides  !

are similar to NRC licensing procedures and regulatory guides.

]

References:

Massachusetts Radioactive Materials Licensing Procedures  !

Manual, Attachment 6 to Enclosure 3 of the Request for an Agreement by Governor Weld; Letter with attachments from Massachusetts Department of _

Public Health Commissioner Mulligan dated August 14, 1996. l

15. Human Use. The use of radioactive materials and radiation on or in humans shall not be permitted except by properly qualified persons (normally licensed physicians) possessing prescribed minimum experience in-the use of radioisotopes or radiation.

The staff determined that Massachusetts has adopted regulations similar to those found in 10 CFR Part 35. The training and experience requirements for persons to be licensed for the use of agreement materials on or in humans is specified in these regulations.

l 11 l

Reference:

Massachusetts Regulations for the Control of Radiation at '

105 CMR 120.566 - 120.572.

INSPECTION

16. Purpose. Freauency. The possession and use of radioactive materials shall be subject to inspection by the regulatety authority and shall be subject to the performance of tests, as required by the regulatory authority. Inspection and testing is conducted to determine and to assist in obtaining compliance with regulatory requirements. Frequency of inspection shall be related directly to the amount and kind of material and type of operation licensed, and it shall be adequate to insure compliance. l The review found that the Massachusetts radiation control program has the necessary statutory authority to conduct inspections of licensees.

The MRCR contain provisions relating to inspections and tests that are equivalent to the NRC requirements found in 10 CFR Part 30. The program has also adopted a policy providing for the inspection of licensees at least as frequently as the schedule used by NRC.

References:

Massachusetts Regulations for the Control of Radiation at 105 CMR 120.007 - 120.008; and Radioactive Materials Inspections ,

Procedures Manual, Attachment 7 to Enclosure 3 of the Request for an l Agreement by Governor Weld. 1

17. Insoections Comoulsor.y. Licensees shall be under obligation by law to provide access to inspectors.

The review confirmed that authority for Massachusetts rad'iation control program inspectors to enter public or private property at all reasonable times exists in the Massachusetts statute.

Reference:

Massachusetts General Law Chapter 111, Section 5N.

18. Notification of Results of Inspection. Licensees are entitled to be advised of the results of inspections and to notice as to whether or not they are in compliance.

The review found that Massachusetts has adopted policies, procedures, and form letters to convey the results of inspection's to the licensees, bot,h when violations are found, and when no violations are found.  !

Reference:

Radioactive Materials Inspection Manual, Attachment 7 to Enclosure 3 of the Request for an Agreement by Governor Weld.  !

ENFORCEMENT l

19. Enforcement. Possession and use of radioactive materials should be amenable to enforcement through legal sanctions, and the regulatory l authority shall be equipped or assisted by law with the necessary powers '

for prompt enforcement. This may include, as appropriate,

12 administrative remedies looking toward issuance of orders requiring affirmative action or suspension or revocation of the right to possess

and use materials, and the impounding of materials; the obtaining of j injunctive relief; and the imposing of civil or criminal penalties.

The review found that the radiation control program is authorized by  ;

4 statute to enforce the regulations using a variety of sanctions, i j including the imposition of civil penalties and the issuing of orders to j suspend, modify or revoke licenses. Although the impounding of materials is not directly provided, Massachusetts General Law Chapter 111, Section 50 allows the program to seek restraining orders, which may i bar the use of materials or the access to premises. The program has  !

adopted procedures to implement this authority. i I

References:

Massachusetts General Law Chapter Ill, Section 50; i

, Massachusetts Regulations for the Control of Radiation at 105 CMR l 120.016 - 120.019. j PERSONNEL

20. Qualifications of Reaulatory and Inspection Personnel. The regulatory agency shall be staffed with sufficient trained personnel. Prior evaluation of applications for licenses or authorizations and inspection of licensees must be conducted by persons possessing the training and experience relevant to the type and level of radioactivity in the proposed use to be evaluated and inspected. This requires competency to ,

evaluate various potential radiological hazards associated with the many '

uses of radioactive material and includes concentrations of radioactive materials in air and water, conditions of shielding, the, making of radiation measurements, knowledge of radiation instruments--their selection, use and calibration--laboratory design, contamination control, other general principles and practices of radiation protection, and use of management controls in assuring adherence to safety procedures. In order to evaluate some complex cases, the State regulatory staff may need to be supplemented by consultants or other State agencies with expertise in geology, hydrology, water quality,-

radiobiology and engineering disciplines.

To perform the functions involved in evaluation and inspection, it is desirable that there be personnel educated and trained in the physical and/or life sciences, including biology, chemistry, ^ physics and engineering, and that the personnel have had training and experience in radiation protection. For example, the person who will be responsible for the actual performance of evaluation and inspection of all of the various uses of byproduct, source and special nuclear material which might come to the regulatory body should have substantial training and extensive experience in the field of radiation protection. It is 1 desirable that such a person have a bachelor's degree or equivalent in '

the physical or life sciences, and specific training - radiation protection.

i j.

4 l

l 13 f

I It is recognized that there will also be persons in the program i

performing a more limited function in evaluation and inspection. These persons will perform the day-to-day work of the regul: tory program and deal with both routine situations as well as some which will be out of e

.the ordinary. These people should have a bachelor's degree or 4

equivalent in the physical or life sciences, training in health physics,

and approximately two years of actual work experience in the field of -

! radiation protection.

The foregoing are considered desirable qualifications for the staff who

will be responsible for the actual performance of evaluation and

inspection. In addition, there will probably be trainees associated i with the regulatory program who will have an academic background in the i physical or life sciences as well as varying amounts of specific training in radiation protection but little or no actual work experience

! in this field. The background and specific training of these persons j will indicate to some extent their potential role in the regulatory

program. These trainees, of cot'se, could be used initially to evaluate

and inspect those applications of radioactive materials which are considered routine or more standardized from the radiation safety

+

standpoint, for example, inspection of industrial gauges, small research programs, and diagnostic medical programs. As they gain experience and competence in the field, the trainees could be used progressively to

! deal with the more complex or difficult types of radioactive material j applications. It is desirable that such trainees have a bachelor's degree or equivalent in the physical or life sciences and specific

training in radiation protection. In determining the requirement for academic training of individuals in all of the foregoing categories, proper consideration should be given to equivalent competency which has been gained by appropriate technical and radiation protection experience.

i It !s recognized that radioactive materials and their uses are so varied i that the evaluation and inspection functions will require skills and experience in the different disciplines which will not always reside in one person. The regulatory authority should have the composite of such skills either in its employ or at its comand, not only for routine functions, but also for emergency cases.

!: The NRC staff reviewed the organizational charts and position

descriptions for the Massachusetts program staff, and the curricula vitae for the current program staff members.

1. Assessment of the Agreement Materials Unit Staffing i There are approximately 460 NRC licenses in Massachusetts, of which

! about 420.would be transferred to the program under the proposed Agreement. These would be added to the approximately 180 NARM licenses j that the program currently regulates, for a total of approximately 600

licenses. Based on the experience of other States, NRC staff expects

many of the NARM licensees to also hold NRC licenses, and that over a j j

period of time facilities holding both NARM and agreement materials  ;

\

l 4

- -- -. .. .__- . . . - , - __.--,m . _ ~ _ . - . _ _ _ - - _ - . . _ . ,, _.-.--,.__.m_. _ . . , _ _ _ . , - -

l 14 i licenses will seek to combine them. This experience suggests a final  !

number of 450 to 500 licenses. '

The organizational chart shows 31 professional staff positions, of which 13 would be assigned to the agreement materials program unit.

Currently, there are 7 individuals assigned to the unit full-time, and 5 assigned part time, with I vacancy. One of the part-time staff members is the program director, who will also act as the unit manager. The combined effort of the 5 part-time individuals sums to 2 full-time-equivalents (FTE). The NRC staff sums the total technical / professional effort of the 12 individuals to equal 9 FTEs.

l Although there is no current quantitative guideline in this area, NRC l has, in the past, used a guideline indicator of 1.0 to 1.5 FTE per 100 -

licenses in reviewing existing Agreement State programs. Using the  ;

estimates of 9 technical / professional FTEs in the agreement materials '

unit, and 600 licenses initially, there would be approximately 1.5 technical / professional FTE per 100 licenses. While this number is at the high end of the range, NRC staff notes that the Commonwealth will assume regulatory responsibility for several licensees with unusually '

complex operations, including large medical, university, and industrial manufacturing programs. NRC staff believes, therefore, that an initial staffing level at or above the high end of the range is appropriate. i NRC staff further notes that several of the agreement materials unit  !

positions will, in the future, be dedicated to the licensing and i regulation of an anticipated low-level radioactive waste disposal site.

The program does not, however, expect to receive an application for a waste disposal site in the near future. The anticipated. combination of NARM and agreement materials licenses by facilities that currently hold both types will reduce the total number of licenses as described above ,

and increase the staff-to-materials-license ratio. This will have the '

effect of allowing staff members to be reassigned to waste site issues.  ;

Further, when an application is received, the program plans to i supplement staff with contractors. For current activities related to waste management, the Massachusetts program director has stated that l less than one professional FTE is required.  ;

Based on the above, the NRC staff concludes that the Massachusetts ,

program staffing plan provides an adequate number of personnel to meet the anticipated program needs.

1

2. Assessment of Staff Education, Training and Experience j The 12 individual members of the agreement materials unit's professional / technical staff are trained in physics or health physics (5), life sciences including radiologic technology, biophysics, and )

l public health (6), and physical sciences (geophysics - 1). l l

Of the seven full-time agreement materials unit staff members, one has l 15 years experience in the Massachusetts program. The other six full-time staff members have 4 years or less experience in the Massachusetts j

15 program, although one individual has 3 years experience working in another radiation control program. Each of the six, however, has 5 years or more working experience in the fields of health physics, reactor health physics, or medical physics. The duties of these positions typically included the application of radiation protection principles and the occasional development of license amendments or renewals.

All of the agreement materials unit part-time staff members have more than 5 years experience in the Massachusetts radiation control program.

The review also disclosed that all 12 full- or part-time agreement materials unit staff members hold bachelor's degrees or have the equivalent in training and experience. One individual holds an Associate degree in Science and has more than 5 years experience in radiation protection. All others hold bachelor (1), master (9), or doctorate (1) degrees.

Agreement materials unit staff members have also completed specialty training courses, provided by NRC, for NRC and Agreement State regulatory personnel. Various unit staff members have completed training courses related to materials facilities licensing procedures, materials facilities inspection procedures, safety requirements for industrial radiography, safety requirements for medical uses of radioactive materials, sealed source and device safety evaluation, safety requirements for transportation of radioactive material, safety requirements for well-logging, and safety requirements for medical teletherapy. The NRC staff concludes that the unit staff, as a whole, has completed adequate speciality training to meet the program needs.

The unit has adopted a written program for the training and qualification of staff members, which covers both new staff members and the continuing qualification of existing staff. Criterion 20 contains no specific elements to address such programs. However, NRC staff notes that the Massachusetts radiation control program will be evaluated under the Commission's Integrated Materials Performance Evaluation Program (IMPEP). One IMPEP criterion addresses staff training and qualifications, and an element of the IMPEP criterion addresses training and qualification plans. NRC staff believes that the Massachusetts training and qualification plan meets the IMPEP criteria.

Based on the above, the NRC staff review concluded that the Massachusetts staff has substantial training and experience in radiation protection, that the staff training and experience is adequate, and that the unit has an adequate program for staff training and qualification.

References:

Organization Charts, (Attachment I to Enclosure 3), and Resumes / Lists of Nuclear Regulatory Training Courses Attended, (Attachment 2 to Enclosure 3), Attachments to the Program Description Statement (Enclosure 3 to the Request for an Agreement by Governor Weld).

a

-l 16  !

21. Conditions Acolicable to Soecial Nuclear Material. Source Material and l Tritium. Nothing in the State's regulatory program shall interfere with j the duties imposed on the holder of the materials by the NRC, for a example, the duty to report to the NRC, on NRC prescribed forms (1) transfers of special nuclear material, source material and tritium and (2) periodic inventor;, data. i i

The review found that~ the Massachusetts regulations do contain a  !'

provision to avoid interference with the duties imposed on State licensees by the NRC.

{

Reference:

Massachusetts Regulations for the Control of Radiation at l 105 CMR-120.002. ,

22. Special Nucle'ar Material Defined. Special nuclear material, in  !

quantities not sufficient to form a critical mass, for present purposes  ;

means uranium enriched in the isotope U-235 in quantities not exceeding ,

350 grams of contained U-235; uranium 233 in quantities not exceeding '

200 grams; plutonium in quantities not exceeding 200 grams; or ar.y combination of them in accordance with the following formula: For each- l kind of special nuclear material, determine the ratio between the ,

quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such  !

ratios for all of the kinds of special nuclear material in combination i should not exceed "1" (i.e., unity). For example, the following {

quantities in combination would not exceed the limitation and are within i the formula, as follows:  !

175 (grams contained U-235)/350 + 50 (grams U-233)/200  :

+ 50 (grams Pu)/200 = 1  !

(This definition is subject to change by future Commission rule or ,

regulation.) l The review of Massachusetts regulations equivalent to 10 CFR Part 150  :

revealed that the definition of the term "special nuclear material in i quantities not sufficient to form a critical mass" therein is essentially identical to the above definition.

]

Reference:

Massachusetts Regulations for the Control of Radiation at l

_105 -CMR 120.005, Definition of Special Nuclear Material in Quantities Not Sufficient to Form a Critical Mass.

17 1

ADMINISTRATION

23. Fair and Impartial Administration. State practices for assuring the fair and impartial administration of regulatory law, including provision for public participation where appropriate, should be incorporated in procedures for:

{

a. Formulation of rules of general applicability; I

b. Approving or denying applications for licenses or authorization to I 1 .

possess and use radioactive materials, and i

c. Taking disciplinary actions against licensees.

, The Massachusetts radiation control program is bound by statutory

provisions with respect to providing the opportunity for public participation in rulemaking, licensing actions, and disciplinary actions. The program has adopted regulations to implement the enforcement authority granted by law. The legislation also provides for the administrative and judicial review of actions taken by the program.

NRC staff has reviewed the pertinent statutes and regulations and determined that the criterion is met.

4

Reference:

Massachusetts General Law Chapter 111, Section 50.

24. State Aaency Desianation. The State should indicate which agency or agencies will have authority for carrying on the program and should provide the NRC with a summary of that legal authority. .There should be assurances against duplicate regulation and licensing by State and local authorities, and it may be desirabl that there be a single or central regulatory authority.

The Massachusetts Department of Public Health is designated to be the State's radiation control agency in the Massachusetts Low-Level Radioactive Waste Management Act. The law also provides that the regulations adopted by the Department shall apply exclusively throughout the Commonwealth.

The Massachusetts Department of Labor and Industries has, by statute, the general responsibility and authority to inspect 'workplace safety, and to adopt regulations to prevent workplace accidents and industrial or' occupational diseases. The Department of Public Health and the Department of Labor and Industries have entered into a Memorandum of Understanding, as authorized elsewhere in Massachusetts law, which  ;

provides for the Department of Public Health to exercise this responsibility and authority with respect to radiation and radioactive materials.

The Department of Environmental Protection is designated under the '

Low-Level Radioactive Waste Management Act as the agency to adopt regulatory standards for the suitability of any proposed disposal site.

s F 18  !

The Department of Public Health will license and regulate the site only  !

after the Executive Secretary for Environmental Affairs has determined  !

that a site characterization study shows the site to be suitable and the  ;

Low-Level Radioactive Waste Management Board has selected the operator.  ;

References:

Massachusetts General Law Chapter 111, Section SN, and <

Chapter 111H, Sections 2, and 14 through 31.

25. Existina NRC Licenses and Pendina Aoolications. In effecting the discontinuance of jurisdiction, appropriate arrangements will be made by i NRC and the State to ensure that there will be no interference with or i interr.uption of licensed activities or the processing of license applications by reason of the transfer. For example, one approach might .

be that the State, in assuming jurisdiction, could recognize and '

continue in effect, for an appropriate period of time under State law, l

- existing NRC licenses, including licenses for which timely applications i for renewal have been filed, except where good cause warrants the earlier reexamination or termination of the license.

The review of the Massachusetts regulations verified that a provision- '

has been included which deems the holder of an NRC license on the date  ;

of transfer to possess a like license issued under the Massachusetts  !

regulations and law. The regulations further provide that these i licenses will expire either 90 days after receipt from the Massachusetts  ;

radiation control program of a notice of expiration of such license or j on the date of expiration specified in the NRC license, whichever is earlier.

The Massachusetts regulations also provide for " timely renewal," the +

continuance of licenses for which an application for renewal has been i filed more than 30 days prior to the date of expiration of the license. - '

Licenses in timely renewal are not excluded from the transfer continuation provision.

Reference:

Massachusetts Regulations for the Control of Radiation at 105 CMR 120.133, 120.136.

26. Relations With Federal Government and Other States. There should be an inter. change of Federal and State information and assistance in ,

connection with the issuance of regulations and licenses or  !

authorizations, inspection of licensees, reporting of incidents and  !

violations, and training and education problems.

The NRC staff found that the proposed agreement commits the Commonwealth to use its best efforts to cooperate with the NRC and the other Agreement States in the formulation of standards and regulatory programs for the protection against hazards of radiation and to assure that the  :

Commonwealth's program will continue to be compatible with the Commission's program for the regulation of like materials. ,

Reference:

Proposed Agreement between the Commonwealth of Massachusetts and the Nuclear Regulatory Commission, Article VI.

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l 19

27. Coveraae. Amendments. Reciorocity. An Agreement providing for discontinuance of NRC regulatory authority and the assumption of regulatory authority by the State may relate to any one or more of the following categories of materials within the State, as contemplated by Public Law 86-373 and Public Law 95-604:

a. Byproduct materials as defined in Section 11e(1) of the Act,-

b. Byproduct materials as defined in Section 11e(2) of:the Act,

c. Source materials,

d. Special nuclear materials in quantities not sufficient to form a critical mass, l

e. Low-level wastos in permanent disposal facilities, as defined by statute or Commission rules or regulations containing one or more of the materials stated in a, c, and d above but not including byproduct material .as defined in Section 11e(2) of the Act; but ,

must relate to the whole of such category or categories and not to l

.a part of any category. If less than the five categories are

( included in any discontinuance of jurisdiction, discontinuance of L NRC regulatory authority and the assumption of regulatory 1

authority by the State of the others may be accomplished subsequently by an amendment or by a later agreement.

Arrangements should be made for the reciprocal recognition of State licenses and NRC licenser in connection with out-of-jurisdiction operations by a State or NRC licensee.

The review of the proposed Agreement disclosed that it provides for the  ;

Commission to discontinue, and the Commonwealth to assume, regulatory i authority for categories a, c, d, and e. The proposed Agreement does i i

not provide for the discontinuance of Commission regulatory authority )

for category b, however, it does contain a provision allowing the  !

Agreement to be amended to include this category.

The NRC staff notes that since the criterion was adopted, the Commission has determined in the Staff Requirements-Memorandum SECY-95-136, dated June 30, 1995' , authority to evaluate the safety thatofAgreement sealed sourcesStates andmay assume devices a the.i a separate portion '

. of the Agreement, or allow NRC to retain that authority. Massachusetts  !

hai chosen to assume this authority.

Reference:

Proposed Agreement between the Commonwealth of Massachusetts and the Nuclear Regulatory Commission, Articles I, II, and III.

l The proposed Agreement stipulates the_ desirability.of reciprocal L recognition of licenses, and commits the Commission and the Commonwealth to use their best efforts to accord such reciprocity.

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Reference:

Proposed Agreement between the Commonwealth of Massachusetts l

i and the Nuclear Regulatory Commission. Article VII. )

l 28. NRC and Department of Enerav Contractors. The State should provide  !

i exemptions for NRC and DOE contractors which are substantially i equivalent to the following exemptions:  !

a. Prime contractors performing work for the DOE at U.S. Sovernment-  !

owned or controlled sites; -

b. Prime contractors performing research in, or development, l

. manufacture, storage, testing, or transportation of, atomic weapons or components thereof; j

c. Prime contractors using or operating nuclear reactors or other nuclear devices in a U.S. Government-owned vehicle or vessel; and I

d. Any other prime contractor or subcontractor of DOE or NRC when the [

State and the NRC jointly determine (i) that, under the terms of the contract or subcuntract, there is adequate assurance that the  !

work thereunder can be accomplished without undue risk to the i public health and safety and (ii) that the exemption of such  !

contractor or subcontractor is authorized by law.  !

The NRC staff review of the Massachusetts regulations determined that t the regulations do provide exemptions from the State's requirements for  ;

licensing of sources of radiation for NRC and DOE contractors or i subcontractors in accordance with this criterion.  !

Reference:

Massachusetts Regulations for the Control of' Radiation at j 105 CMR 1006(B).

3 l

STAFF CONCLUSION Section 274d of the Atomic Energy Act of 1954, as amended, states: "The l Commission shall enter into an agreement under subsection b of this l section with any State if:

l (1) The Governor of that State certifies that the State has a program for the: control of radiation hazards adequate.to protect the

- public health and safety with respect to the materials within the -

State covered by the proposed agreement, and that the State ,

l desires to assume regulatory responsibility for such materials; and (2) The Commission finds that the State program is in accordance with the requirements of subsection o. and in all other respects compatible with the Commission's program for the regulation of such materials, and that the State program is adequate to protect  !

the public health and safety with respect to the materials covered ,

by the proposed amendment."

i f

21 The staff has concluded that the Commonwealth of Massachusetts meets the requirements of Section 274 of the Act. The statutes, regulations, personnel, licensing, inspection and administrative procedures are compatible with those of the Commission and adequate to protect the public health and safety with respect to the materials covered by the proposed Agreement. Since the Commonwealth of Massachusetts is not seeking authority over uranium milling activities, subsection o. is not applicable to the proposed Massachusetts agreement.

G:\RLB\ASSESSM2.RLB

[7590-01-P]

NUCLEAR REGULATORY COMMISSION Commonwealth of Massachusetts: Staff Assessment of Proposed Agreement Between the Nuclear Regulatory Commission and the Commonwealth of Massachusetts.

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of proposed Agreement with the Commonwealth of Massachusetts.

SUMMARY

The U. S. Nuclear Regulatory Commission (NRC) has received, from the Governor of the Commonwealth of Massachusetts, a propocal to enter into an Agreement pursuant to Section 274 of the Atomic Energy Act of 1954, as amended (Act). The proposed Agreement would permit Massachusetts to assume certain portions of the Commission's regulatory authority. As required by the Act, NRC is publishing the proposed Agreement for public comment. NRC is also publishing a summary of the NRC staff assessment of the propose.d Massachusetts radiation control program. Comments are requested on the proposed Agreement, especially public health and safety aspects, and the assessment.

The Agreement will effectively release (exempt) persons in Massachusetts from certain portions of the Commission's regulatory authority. The Act also requires that NRC publish those exemptions. Notice is hereby given that the pertinent exemptions have been previously published in the Federal Register and are codified in the Commission's regulations as 10 CFR Part 150.

l ATTACHMENT 4

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l DATES: The comment period expires (four weeks after first publication).

Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for coments received on or before this date.

ADDRESSES: Written comments may be submitted to Mr. David L. Meyer, Chief, Rules Review and Directives Branch, Division of Freedom of Information and  ;

Publications Services, Office of Administration, Washington, DC 20555-0001.

Copies of comments received by NRC may be examined at the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC. Copies of the proposed Agreement, along with copies of the request by Governor Weld including referenced enclosures, applicable legislation, regulations for the control of radiation, and the full text of the NRC staff assessment are also available l for public inspection in the NRC's Public Document Room.

FOR FURTHER INFORMATION CONTACT: Richard L. Blanton, Office of. State Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Telephone (301) 415-2322 or e-mail RLB9NRC. GOV.

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l SUPPLEMENTARY INFORMATION: The Comission has received a request from Governor  !

l William Weld of Massachusetts to enter into an Agreement whereby the NRC would  !

discontinue, and the Comonwealth would assume, certain regulatory authority as specified in the Act. Section 274 of the Act authorizes the Comission to enter into such an agreement.

Section 274e of the Act requires that the terms of the proposed Agreement be published for public coment once each week for four consecutive 2

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l l-weeks. This notice is being published in the Federal Register in fulfillment i of the requirement.

I. Background (a) Section 274d of the Act provides the mechanism whereby a State may assume regulatory authority, otherwise reserved to the NRC, over certain radioactive materials' and uses thereof. In a letter dated March 28, 1996, Governor Weld certified that the Commonwealth of Massachusetts has a program for the control of radiation hazards that is adequate to protect health and safety of the public within the Commonwealth with respect to the materials covered by the proposed Agreement, and that the Commonwealth desires to assume regulatory responsibility for these materials. Included with the letter was the text of the proposed Agreement, which is shown in Appendix A to this notice.

The specific authorities requested by the Commonwealth of Massachusetts under this proposed Agreement are (1) the regulation of byproduct materials as defined in Section 11e.(1) of the Act, (2) the regulation of source materials, (3) the regulation of special nuclear materials in quantities not sufficient to form a critical mass, (4) the evaluation of the safety of sealed sources and devices (containing materials covered by the Agreement) for distribution in interstate commerce, and (5) the land disposal of low-level radioactive waste (as defined in the Low-Level Radioactive Waste Policy Amendments Act of

'The materials, sornetimes referred to as " agreement rnatorials," are: (a) Byproduct materials as

, defined in Section 11e.(1) of the Act; (b) Byproduct materials as defined in Section 11e.(2) of the Act; j (c) Source materials as defined in Section 112. of the Act; and (d) Special nuclear materials as defined in Section 11aa. of the Act, restricted to quantities not sufficient to form a critical mass.

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I 1985, 42 U.S.C. 2021b) received from other persons. The commonwealth does not l l

wish to assume authority over the regulation of byproduct materials as defined l

in Section lle.(2)'of the Act, that is over tailings from the recovery of I source materials from ore, but does reserve the right to apply at a future  ;

date for an amended agreement to assume authority in this area.

(b) The proposed agreement contains nine articles that (1) list the

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materials and activities to be covered by the Agreement; (2) specify the j t

activity for which the Commission will retain regulatory authority; (3) allow l 1

for future amendment of the Agreement; (4) allow for certain regulatory j changes by the Commission; (5) reference the continued authority of the l Commission for purposes of safeguarding nuclear materials and restricted data; l i

(6) commit the Commonwealth and NRC to exchange information necessary to l l

maintain coordinated and compatible programs; (7) recognize reciprocity of  !

i licenses issued by the respective agencies; (8) identify criteria for the  !

suspension or termination of the Agreement; and (9) :.pecify the proposed i

effective date. The Commission reserves the option to modify the terms of the  !

i proposed Agreement in response to comments, to correct errors, and to make editorial changes in style. Also, because of several issues posed by this request which required resolution before the Agreement could be concluded, the l effective date requested by the Governor could not be realized. The final text  ;

of the Agreement, with the actual effective date, will be published after the Agreement.is approved by the Commission.  !

(c)' The Massachusetts radiation control program currently regulates s users of naturally-occurring and accelerator-produced radioactive materials, and users of certain radiation-producing electronic machines. The program was  !

t enabled by Massachusetts law (Massachusetts General Law [M.G.L.] Chapter 111, l i

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$ 58) in 1958. This statute was later replaced by M.G.L. Chapter Ill, Sections ,

SM through 5P. In 1987, M.G.L. Chapter 111H was added to provide for the  ;

regulation of low-level radioactive waste. Section 7 of the legislation

! contains the authority for the Governor to enter into an Agreement with the l

Commission.

The Massachusetts regulations contain provisions for the orderly transfer of authority over NRC licenses to the regulatory control of the Commonwealth. After the effective date of this proposed Agreement, licenses issued by NRC will continue in effect under Massachusetts regulatory authority until these licenses expire or are replaced by Commonwealth issued licenses.

(d) The NRC staff assessment finds the proposed Massachusetts program adequate to protect public health and safety, and compatible with the NRC program for materials regulation. .

II. Summary of the NRC Staff Assessment of the Massachusetts Program for the i

Control of Agreement Materials

]

i NRC staff has examined the proposed Massachusetts radiation control program with respect to the ability of the program to regulate agreement I materials. The examination was based on the Commission's policy statement

" Criteria for Guidance of States and NRC in Discontinuance of NRC Reaulatory Authority and Assumotion Thereof by States Throuah Aareement" (referred to 1

herein as'the " criteria") (46 FR 7540; January 23, 1981, as amended). i (a) Organization and Personnel. The proposed program unit responsible for regulating agreement materials will consist of 13 technical / professional positions within the existing radiation control program of the Massachusetts 5

- I Department of Public Health. The qualifications for staff members specified in the personnel position descriptions, and the qualifications of the current staff members, meet the criteria for education, training and experience. All current staff members hold at least bachelor's degrees in physical or life sciences, or have a combination of education and experience at least equivalent to a bachelor's degree. Most staff members hold advanced degrees, and have had additional training and experience in radiation protection.

Senior staff have more than five years experience each in radiation control programs. The program director has a master's degree in public health and 15  ;

years experience in regulatory health physics. i i

(b) Legislatfon and regulatfons. The Massachusetts Department of Public Health is designated by statute to be the radiation control agency. The Department is provided by statute with the authority to pror igate regulations, issue licenses, issue orders, conduct inspections, and to enforce compliance with regulations, license conditions, and orders. Licensees are required by law to provide access to inspectors.

The Department has adopted regulations (Massachusetts Regulations for the Control of Radiation or MRCR) providing radiation protection standards essentially identical to the standards in 10 CFR Part 20. Technical definitions in the MRCR are also essentially identical. The MRCR require consideration of the total radiation doses to individuals from all sources of radiation-(except background radiation and radiation from' medical treatment or examinations, as is the case in the NRC rules), whether the sources are in the i'

possession of the licensee or not. The MRCR also require appropriate surveys and personnel monitoring under the close supervision of technically competent j people, and the use of radiation labels, signs and symbols essentially 6

I identical to those contained in 10 CFR Part 20. Posting requirements and instruction of workers requirements adopted in the MRCR are compatible with the equivalent current requirements of the NRC.

Nothing in the Massachusetts statutes or regulations seeks to regulate areas not permitted by the Atomic Energy Act. The MRCR contain a provision to avoid interference with those regulatory requirements imposed by NRC pursuant to the Act, and for which Commonwealth licensees have not been exempted under the agreement.

(c) Storage and Disposal. The MRCR also contain compatible requirements for the storage of radioactive material, and for the disposal of radioactive material as waste. The waste disposal requirements cover both waste disposal by material users and the land disposal of waste received from other persons.

The NRC staff noted some differences in the MRCR waste regulations as compared !

to the NRC regulations in 10 CFR Part 61, but determined that the differences are related either to the prohibition of shallow land burial as a disposal technology or to the ownership of the disposal site by the Massachusetts Low-Level Radioactive Waste Management Board. Because of these special provisions, NRC staff determined that the differences in the regulations do not reduce the ability of the Massachusetts radiation control program to protect health and safety, nor reduce the compatibility of the program or the regulations themselves.

(d) Jransportation of Radioactive #aterial. The MRCR contains rules equivalent to 10 CFR Part 71 as in effect prior to April 1,1996. Effective on that date, the NRC amended Part 71. Under current policy, an existing Agreement State is allowed up to three years after NRC adopts a final rule to adopt a compatible rule, or to impose each regulatory provision of the rule 7

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using an alternate legally binding requirement (LBR), such as an order or license condition. A State seeking an agreement is expected to have effective rules or LBRs compatible with those of NRC in effect at the time the agreement becomes effective. The intent of this expectation is to spare licensees in the new Agreement State from the " whipsaw" effect of being subjected first to the new NRC requirements, then the old requirements when the agreement takes l

effect, then again to the new requirements when later adopted by the State.

Massachusetts is in the process of adopting rules compatible with the revised 10 CFR Part 71. However, these rules may not become effective before the Agreement is signed. Massachusetts intends to impose the requirements of the ]

new Part 71 rules in the interim by issuing appropriate orders to the affected licensees.  ;

(e) Recordkeeping and Incident Reporting. The MRCR incident reporting requirements are similar to the requirements in the NRC rules. The NRC staff  ;

4 noted that for some NRC rules that specify a records retention period of less than five years, the retention period specified in the MRCR is. shorter. The NRC staff concluded, however, that the retention periods specified in the MRCR rules are adequate since the retention periods are long enough to permit examination of the records during routine inspections. The MRCR imposes retention requirements similar to the NRC rules for records which must be retained indefinitely or until the license is terminated.

i j (f) Eva7uation of License App 1(catfons. The MRCR contains requirements equivalent to the current NRC regulations specifying the required content of applications for licenses, renewals, and amendments. The MRCR also provide requirements equivalent to the NRC requirements for issuing licenses and specifying the terms and conditions of licenses. The agreement materials I

8 l

program unit has edopted a procedure for processing applications that assures l the regulatory requirements will be met, or, if appropriate, exceptions l

l granted. The program unit has the authority by Statute to impose requirements in addition to the requirements specified in the regulations. The program unit l also retains by regulation the authority to grant specific exemptions from the requirements of the regulations. The MRCR specifies qualifications for the use of radioactive materials in or on humans that are similar to the NRC 1

requirements in 10 CFR Part 35. '

The Massachusetts licensing procedures manual, along with the l accompanying regulatory guides, are adapted from similar NRC documents and contain adequate guidance for the agreement materials program unit staff to use when evaluating license applications.

l (g) Inspections and Enforcement. The Massachusetts radiation control program has adopted a schedule providing for the inspection of licensees as frequently as, or more frequently than, the inspection schedule used by NRC.

The agreement materials program unit has adopted procedures for. the conduct of inspections, the reporting of inspection findings, and the report of -

inspection results to the licensees. The program has also adopted procedures for enforcement in the MRCR. t (h) Regulatory Administration. The Massachusetts Department of Public Health is bound by procedures specified in Commonwealth statute for rulemaking, The program has adopted procedures to assure fair and impartial treatment' of license applicants.

(i) Cooperation with Other Agencies. The MRCR deems the holder of an NRC l

license on the effective date of the Agreement to possess a like license issued by Massachusetts. The MRCR provides that these fermer NRC licenses will l

l l

expire either 90 days after receipt from the radiation control program of a notice of expiration of such license or on the date of expiration specified in the NRC license, whichever is earlier. The MRCR also provides for " timely renewal." This provision affords the continuance of licenses for which an application for renewal has been filed more than 30 days prior to the date of expiration of the license. Licenses in timely renewal are not excluded from the transfer continuation provision. The MRCR provide exemptions from the Commonwealth's requirements for licensing of sources of radiation for NRC and U.S. Department of Energy contractors or subcontractors.

The Department of Public Health and the Department of Labor and l 1

Industries have entered into a Memorandum of Understanding, as authorized )

i elsewhere in Massachusetts law, which provides for the Department of Public Health to exercise the responsibility and authority of the Department of Labor and Industries with respect to radiation and radioactive materials. The  !

Department of Environmental Protection is designated as the agency to adopt the suitability standards for any proposed disposal site under the Massachusetts Low-Level Radioactive Waste Management Act. The Department of Public Health will license and regulate the site only after the Executive Secretary for Environmental Affairs has determined that the report on the site characterization study is in conformance with the suitability standards, and the Low-Level Radioactive Waste Management Board has selected the operator.

The proposed Agreement commits the Commonwealth to use its best efforts

~

to cooper' ate with the NRC and the other Agreement States in the formulation of standards and regulatory programs for the protection against hazards of rndiation and to assure that the Commonwealth's program will continue to be compatible with the Commission's program for the regulation of like materials.

10

i

! The proposed Agreement stipulates the desirability of reciprocal recognition of licenses, and commits the Commission and the Commonwealth to use their best.

efforts to accord such reciprocity.

i III. Staff conclusion i.

Subsection 274d of the Act provides that the Commission shall enter into an agreement under subsection 274b with any State if:

(a) The Governor of the State certifies that the State has a program for the control of radiation hazards adequate to protect public health and safety l with respect to the materials within the State covered by the proposed Agreement, and that the State desires to assume regulatory responsibility for such materials; and  ;

(b) The Commission finds that the State program is in accordance with the requirements of Subsection 274o, and in all other respects compatible with the Commission's program for the regulation of such materials, .and that the State program is adequate to protect public health and safety with respect to the materials covered by the proposed Agreement.

On the basis of its assessment, the NP.C staff has concluded that the Commonwealth of Massachusetts meets the requirements of Section 274 of the Act. The Commonwealth's statutes, regulations, personnel, licensing, inspection, and administrative procedures are compatible with those of the ,

Commission and adequate to protect public health and safety with respect to the materials covered by the proposed Agreement. Since the Commonwealth is not seeking authority over byproduct material as defined in Section 11e.(2) of the j Act, Subsection 2740 is not applicable to the proposed Agreement.

11

IV. Small Business Regulatory Enforcement Fairness Act  ;

In accordance with the Small Business Regulatory Enforcement Fairness  ;

Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of the Office of Management and Budget (OMB).

• I Dated at Rockville, Maryland, this day of October, 1996.

For the U. S. Nuclear Regulatory Commission.

K1 chard L. Bangart Director, Office of State Programs.

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a - - - - - . - - , , - - A 4 m - - - - -

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1 O

a APPENDIX A PROPOSED AGREEMENT i

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4 a

AGREENENT BETWEEN.

i

THE UNITED STATES NUCLEAR REGULATORY COMISSION  !

AND f THE COMONWEALTH OF MASSACHUSETTS f

$ FOR THE DISCONTINUANCE OF CERTAIN COMISSION REGULATORY AUTHORITY  !

i f AND RESPONSIBILITY WITHIN THE COMONWEALTH PURSUANT TO  !

j SECTION 274 0F THE ATONIC ENERGY ACT OF 1954, AS ANENDED i a  !

t i

, WHEREAS, The United States Nuclear Regulatory Coraission (hereinafter  ;

referred to as the Commission) is authorized under Section 274 of the Atomic i

l Energy Act of 1954, as amended (hereinafter referred to as the Act), to enter ,

3 into agreements with the Governor of any State providing for discontinuance of  !

l the regulatory authority of the Commission within the State under Chapters 6, j 7, and 8, and Section 161 of the Act with respect to by-product, materials as i defined in Sections 11e.(1) and (2) of the Act, source materials, and special j nuclear materials in quantities not sufficient to form a critical mass; and, i

WHEREAS, The Governor of the Commonwealth of Massachusetts is authorized

under Massachusetts General Laws, Chapter IllH, to enter into this Agreement with the Commission; and, WHEREAS, The Governor of the Commonwealth of Massachusetts certified on

{ h:: 1, 2005, MMRM] that the Commonwealth of Massachusetts j (hereinafter referred to as the Commonwealth) has a program for the control of i radiation hazards adequate to protect ne public health and safety with l

mx w w

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. r respect to the materials within the Commonwealth covered by this Agreement, and that the Commonwealth desires to assume regulatory responsibility for such materials; and, l

WHEREAS, The Commission found on M="r 1, 2005, [ frig { tis]3Te 4iiilii3{

l that the program of the Commonwealth for the regulation of the materials covered by this Agreent is compatible with the Commission's program for the regulation of such materials and is adequate to protect public health and  ;

safety; and,

, WHEREAS, The Commonwealth and the Commission recognize the desirability and 7 importance of cooperations between the Commission and the Commonwealth in the  ;

formulation of standards for protection against hazards of radiation and in j assuring that Commonwealth and Commission programs for protection against l hazards of radiation will be coordinated and compatible; and, WHEREAS, The Commission and the Commonwealth recognize the desirability of reciprocal recognition of licenses and exemptions from licensing of those materials subject to this Agreement; and, WHEREAS, This Agreement is entered into pursuant to the provisions of the Atomic Energy Act of 1954, as amendad; NOW, THEREFORE, It is hereby agreed between the Comnission and the Governor l of the Commonwealth, acting in behalf of the Commonwealth, as follows:

2 I

4 .

, ARTICLE I Subject to the exceptions provided in Articles II, IV, and V, the Commission shall discontinue, as of the effective date of this Agreement, the regulatory l authority of the Commission in the Commonwealth under Chapters 6, 7, and 8, a

and Section 161 of the Act with respect to the following materials:

1 .

A. By-product materials as defined in Section lle.(1) of the Act; '

1 B. Source materials; i,

C. Special nuclear materials in quantities not sufficient to form a critical mass; and, 4

D. Licensing of Low-Level Radioactive Waste Facilities.

ARTICLE II i

This Agreement does not provide for discontinuance of any authority and the j

l Commission shall retain authority and responsibility with respect to

regulat'.on of

1 1

A. The construction and operation of any production or utilization facility; B. The export from or import into the United States of by-product, source, 3

. t or special nuclear material, or of any production or utilization facility; t

C. The disposal into the ocean or sea of by-product, source, or special nuclear waste materials as defined in regulations or orders of the Commission; D. The disposal of such other by-product, source, or special nuclear material as the Commission from time to time determines by regulation or order should, because of the hazards or potential hazards thereof, not be so disposed of without a license from the Commission; and, t

E. The extraction or concentration of source material from source material ore and the management and disposal of the resulting by-product material.  !

r ARTICLE III This Agreement may be amended, upon application by the Commonwealt ad approval by the Commission, to include the additional area (s) specit. d in Article II, paragraph E, whereby the Commonwealth can exert regulatory control over the materials stated therein.

ARTICLE IV Notwithstanding this Agreement, the Commission may from time to time by rule, 4

1 regulation, or order, require that the manufacturer, processor, or producer of  ;

I any equipment, device, commodity, or other product containing source, )

l by-product, or special nuclear material shall not transfer possession or  !

control of such product except pursuant to a license or an exemption from i licensing issued by the Commission.

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ARTICLE V -

, I This Agreement shall not affect the authority of the Commission under '

Subsection 161b or 1611 of the Act to issue rules, regulations, or orders to protect the common defense and security, to protect restricted data or to guard against the loss or diversion of special nuclear material.

ARTICLE VI The Camiission will use its best efforts to cooperate with the, Commonwealth and other Agreement States in the formulation of standards and regulatory programs of the Commonwealth and the Commission for protection against hazards of radiation and to assure that Commonwealth and Commission programs for protection against hazards of radiation will be coordinated and compatible.

The Commonwealth will use its best efforts to cooperate with the Commission .

I and other Agreement States in the formulation of standards and regulatory ,

I programs'of the Commonwealth and the Commission for protection against hazards l of radiation and to assure that the Commonwealth's program will continue to )

be compatible with the program of the Commission for the regulation of like materials. The Commonwealth and the Commission will use their best efforts to 5

. i keep each other informed of proposed changes in their respective rules and I regulations and licensing, inspection and enforcement policies and criteria, and to obtain the comments and assistance of the other party thereon.

ARTICLE VII .

I The Commission and the Commonwealth agree that it is desirable to provide .

I reciprocal recognition of licenses for the materials listed in Article I l licensed by the other party or by any other Agreement State. Accordingly, the Commission and the State agree to use their best efforts to develop appropriate rules, regulations, and procedures by which such reciprocity will be accorded. ,

ARTICLE VIII The Commission, upon its own initiative after reasonable notice and opportunity for hearing to the Commonwealth, or upon request of the Governor l t

of the Commonwealth, may terminate or suspend all or part of this Agreement and reassert the licensing and regulatory authority vested in it under the Act I if the Commission finds that (1) such termination or suspension is required to i protect public health and safety, or (2) the Commonwealth has not complied j with one or more of the requirements of Section 274 of-the Act. The

• Commission may also, pursuant to Section 274j of the Act, temporarily suspend f all or part of this Agreement if, in the judgement of the Commission, an emergency situation exists requiring immediate action to protect public health j and safety and the Commonwealth has failed to take necessary steps. The 6 l l

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.. 4 Commission shall periodically review this Agreement and actions taken by the  !

Commonwealth under this Agreement to-ensure compliance with Section 274 of the i

! Act.  ;

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ARTICLE IX l

This Agreement shall become effective on April 24,1005, (datE3 tai 6i "

Bifihill556{ and shall remain in effect unless and until such time as it is  !

terminated pursuant to Article VIII. l Done at Boston, Massachusetts, in triplicate, this B4th Day of Spril, 1005.

i FOR THE UNITED STATES NUCLEAR REGULATORY COMMISSION f

t Shirley Ann Jackson, Chairman i

FOR THE COMMONWEALTH OF MASSACHUSETTS i

William F. Weld, Governor l

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The Honorable Lauch Faircloth, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, D. C. 20510 >

Dear Mr. Chairman:

This is to inform the Subcommittee that by letter dated March 28, 1996,  ;

Governor William Weld on behalf of the Commonwealth of Massachusetts submitted  :

a proposed Agreement between the U.S. Nuclear Regulatory Commission and the  ;

Commonwealth of Massachusetts under Section 274 of the Atomic Energy Act of .

1954, as amended. l An announcement of the proposed Agreement, along with a summary of the NRC l staff assessment of the proposed Massachusetts program will be published in I the Federal Reaister. A pre-publication copy of the Federal Reaister Notice l 1s enclosed.

We will inform you when the Commission has completed its consideration 1 of the proposed program.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

As stated cc: Senator Bob Graham l

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i The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power Committee on Commerce United States House of Representatives Washington, D. C. 20515

Dear Mr. Chairman:

This is to inform the Subcommittee that by letter dated March 28, 1996, Governor William Weld on behalf of the Commonwealth of Massachusetts submitted a proposed Agreement between the U.S. Nuclear Regulatory Commission and the Commonwealth of Massachusetts ' der Section 274 of the Atomic Energy Act of 1954, as amended.

An announcement of the proposed Agreement, along with a summary of the NRC staff assessment of the proposed Massachusetts program will be published in the Federal Reaister. A pre-publication copy of the Federal Reaister Notice is enclosed.

We will inform you when the Commission has completed its consideration of the proposed program.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

As stated cc: Rep. Frank Pallone  !

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DRAFT PRESS RELEASE

[FOR IMMEDIATE RELEASE]

NRC 0NSIDERS AGREEMENT PROPOSAL FROM THE COMMONWEALTH OF MASSACHUSETTS The Nuclear Regulatory Commission has received a proposal from the Governor of Massachusetts, calling for the Commonwealth to assume part of the

! Commission's regulatory responsibility over certain radioactive materials.

Under the Agreement proposed by Governor William F. Weld, the Commission would discontinue exercising its authority, and the Commonwealth would exert its own regulatory authority over most Massachusetts users of the radioactive materials covered by the Agreement. These " agreement materials" include byproduct materials (i.e., those radioactive materials which are produced as byproducts of the operation of nuclear reactors), the source materials uranium and thorium, and small amounts of fissionable materials. The Commonwealth already exercises regulatory authority over naturally occurring radioactive materials such as radium, and radioactive materials produced in particle accelerators.

The proposed Agreement calls for Massachusetts to take the added 1

responsibility for regulating the possession, use, transfer, and disposal of the agreement materials, and the manufacture and distribution of most devices containing the agreement materials. The Commission would retain, however, responsibility and authority to regulate uranium and thorium mills and mill tailings, of which there are none in Massachusetts. The Commission also retains, by law, responsibility for regulating nuclear reactors and other major nuclear facilities, the use of the agreement materials by Federal agencies, and the distribution of the agreement materials to members of the public (for example, in smoke detectors). Approximately 450 Commission '

licenses would be transferred to the Commonwealth.

Approval of the proposed Agreement would bring to 30 the number of

" Agreement States." Currently, there are three other States (Pennsylvania, ,

Ohio, and Oklahoma) that have announced their intention to enter into l agreements. The Commission is authorized by Section 274b of the Atomic Energy i Act of 1954 to enter such agreements.

Before entering into the proposed Agreement with Massachusetts, the Commission must determine that the Commonwealth's radiation control program is adequate to protect public health and safety, and is compatible with the Commission's own program for regulating the radioactive materials covered in the Agreement.

The proposed Agreement, along with an assessment by Commission staff of the Massachusetts radiation control program will be published for comment in the Federal Reaister once each week for four consecutive weeks. The Commission will consider any comments before taking final action. Interested persons may submit comments and suggestions within 30 days after the initial publication of notice in the Federal Reaister. Comments should be addressed to Mr. David L. Meyer, Chief, Rules Review and Directives Branch, Division of Freedom of Information and Publications Services, Office of Administration, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

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